UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒
☐
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2018
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number: 001-31326
ELOXX PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
84-1368850
(I.R.S. Employer
Identification No.)
950 Winter Street
Waltham, Massachusetts 02451
(Address of Principal Executive Offices and Zip Code)
(781) 577-5300
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, $0.01 par value
Name of each exchange on which registered
NASDAQ Global Market
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that
the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐ No ☒
Indicate by check mark whether the registrant has submitted electronically and on its corporate Web site, if any, every Interactive Data File required to be submitted and pursuant to Rule 405 of Regulation S-T during the
preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “accelerated filer”,
“large accelerated filer”, “smaller reporting company” or “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Non-accelerated filer
☐
☐
Accelerated filer
Smaller reporting company
Emerging growth company
☒
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☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to
Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The aggregate market value of the voting stock held by non-affiliates of the registrant on June 30, 2018, the last business day of the registrant’s most recently completed second quarter, was $247,531,848, based on the
closing price for such stock as reported on the NASDAQ Capital Market on that date.
As of December 31, 2018, there were 35,860,114 shares of the Registrant’s common stock, par value $0.01 per share, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Certain information required by Part III, Items 10-14 of this Form 10-K is incorporated by reference to the Registrant’s definitive Proxy Statement for the 2019 Annual Meeting of Stockholders to be filed with the
Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year covered by this Form 10-K, provided that if such Proxy Statement is not filed within such period, such
information will be included in an amendment to this Form 10-K to be filed within such 120-day period.
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ELOXX PHARMACEUTICALS INC.
TABLE OF CONTENTS
PART I
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
PART II
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Selected Financial Data
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosure About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
PART III
Directors, Executive Officers and Corporate Governance
Executive and Director Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accounting Fees and Services
PART IV
Exhibits and Financial Statement Schedules
Form 10-K Summary
SIGNATURES
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Special Note Regarding Forward-Looking Statements
Eloxx Pharmaceuticals, Inc., together with its subsidiaries, is collectively referred to herein as “we,” “our,” “us,” “Eloxx” or the “Company”). Hyperlinks
and web addresses are provided as a convenience and for informational purposes only. Eloxx bears no responsibility for the security or content of external websites.
This Annual Report on Form 10-K, or this Report and the other documents we have filed with the SEC that are incorporated herein by reference, contains
forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, including statements regarding
our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking
statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,”
“should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these
identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue
reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-
looking statements we make. In particular, you should consider the numerous risks described in the “Risk Factors” section in this Report.
Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity,
performance or achievements. You should not rely upon forward-looking statements as predictions of future events. Unless required by law, we will not undertake
and we specifically disclaim any obligation to release publicly the result of any revisions which may be made to any forward-looking statements to reflect events or
circumstances after the date of such statements or to reflect the occurrence of events, whether or not anticipated. In that respect, we wish to caution readers not to
place undue reliance on any such forward-looking statements, which speak only as of the date they are made.
This report and the other documents incorporated by reference herein includes statistical and other industry and market data that we obtained from industry
publications and research, surveys and studies conducted by third parties. Industry publications and third party research, surveys and studies generally indicate that
their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we
believe these industry publications and third party research, surveys and studies are reliable, we have not independently verified such data.
The following are some risks and uncertainties, among others, that could cause actual results to differ materially from those expressed or implied by forward
looking statements in this Report:
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risks related to our ability to progress any product candidates in preclinical or clinical trials;
the uncertainty of clinical trial results and the fact that positive results from preclinical studies are not always indicative of positive clinical results;
risks related to the scope, rate and progress of our preclinical studies and clinical trials and other research and development activities;
risks related to the competition for patient enrollment from drug candidates in development;
risks related to our ability to obtain the capital necessary to fund our operations;
risks relating to the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
risks related to our ability to obtain adequate financing in the future through product licensing, public or private equity or debt financing or otherwise;
general business conditions; competition; business abilities and judgment of personnel; and the availability of qualified personnel; and
risks related to the reverse merger and potentially significant, unexpected costs and liabilities arising with respect to the historic Sevion business and
operations.
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ITEM 1.
BUSINESS
Company Overview
PART I
We are a clinical-stage biopharmaceutical company developing novel ribonucleic acid (RNA)-modulating drug candidates (designed to be eukaryotic
ribosomal selective glycosides (ERSG)) that are formulated to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that
disrupt the stability of the impacted messenger RNA (mRNA) and the protein synthesis from that mRNA. As a consequence, patients with premature stop codon
diseases have reduced levels of, or no, protein from a gene whose product performs an essential function. This type of mutation accounts for some of the most severe
phenotypes across genetic diseases. Nonsense mutations have been identified in over 1,800 rare and ultra-rare diseases. Read-through therapeutic development is
focused on increasing mRNA stability and enabling functional protein synthesis. As opposed to a typical gene therapy approach of targeting a single, unique
mutation in a target disease, this small molecule strategy enables targeting an entire class of mutations across the rare disease landscape. Our small molecule
approach has the potential to address a range of different premature stop codons in a single gene since our ERSG are targeted to the ribosomes. ELX-02, our lead
investigational drug product candidate, is a small molecule designed to restore production of full-length functional proteins. ELX-02, is in the early stages of clinical
development for systemic administration for cystic fibrosis and cystinosis. ELX-02 is an investigational drug that has not been approved by any global regulatory
body. In addition, we recently announced a new program studying intravitreal administration of ERSG compounds for rare inherited retinal disorders with a focus on
Usher Syndrome. Our preclinical candidate pool consists of a library of 170 novel ERSG drug candidates identified based on read-through potential and cytoplasmic
ribosomal selectivity.
From the outset, our research and development strategy targets rare or ultra-rare diseases where: a high unmet medical need exists, an identified nonsense
mutation-bearing patient population is established, preclinical read-through can be established in predictive personalized medicine models, a definable path through
Orphan Drug development, regulatory approval, patient access and commercialization is identifiable. We believe patient advocacy to be an important element of
patient focused drug development and seek opportunities to collaborate with patient advocacy groups throughout the discovery and development process. Our current
clinical focus for our lead investigational drug product candidate, ELX-02, is Cystic Fibrosis where we expect to complete our multiple ascending dose (“MAD”)
study in the first half of 2019 and report top line results from our Phase 2 clinical trial in the second half of 2019. We have participated in the North American Cystic
Fibrosis Foundation (CFF) CFTR Translational Read-through Workshop and are engaged with CFF on extending our Cystic Fibrosis clinical studies to the United
States. In 2018, the European Cystic Fibrosis Society Clinical Trial Network assigned a “high priority” rating to our Phase 2 program. We have recently initiated a
new program studying inherited retinal disease and are conducting IND enabling studies for several ERSG compounds from our library. We entered into a multiyear
partnership with the Foundation Fighting Blindness (FFB) to support the inherited retinal degenerative disease registry and educational programs. We presented as
part of the FFB “Investing in Cures” 2019 meeting and believe that the ongoing R&D consultation and support provided by the FFB will accelerate our development
programs that seek to support patients with ocular disease and high unmet medical need.
We intend to be the global leader in the application of the science of translational read-through and the associated pathway of nonsense mediated decay
(NMD). We believe that expanding our expertise across these basic science areas of mRNA regulation, ribosomal function, and protein translation forms a solid
foundation to support our discovery and development activities. Our ERSG compounds modulate the activity of the ribosome, a complex of RNAs and proteins, and
therefore, a ribonucleoprotein, responsible for protein production, a process also known as translation. These novel small molecule ERSG compounds are designed to
allow the ribosome to read-through a nonsense mutation in mRNA (which is transcribed from the DNA sequence), to restore the translation process to produce full-
length, functional proteins and increase the amount of mRNA that would otherwise be degraded as part of a phenomenon called nonsense mediated mRNA decay. As
our ERSG compounds target the general mechanism for protein production in the cell, we believe they have the potential to treat hundreds of genetic diseases where
nonsense mutations have impaired gene function. Since nonsense mutations may occur at different positions within a given gene, a potential advantage of the small
molecule ERSG approach is being able to use one molecule to address a range of mutations within a given disease state. Our subcutaneously injected ERSG
molecules have the potential to be self-administered for systemic disease and to be active at most tissue locations across the body.
We believe that our library of related novel small molecules holds the potential to be disease-modifying therapies that may change the course of hundreds of
genetic diseases and improve the lives of patients. Our early preclinical data in animal models of nonsense mutations suggests that drug product candidates from our
read-through compound library may have potential beneficial effects for each of the following diseases: cystic fibrosis, cystinosis, a variety of inherited retinal
diseases, mucopolysaccharidosis type 1, Duchenne muscular dystrophy and
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Rett syndrome, and have demonstrated the potential for beneficial effects in multiple organs such as the brain, eye, kidney, muscles and others. Of the 170 novel
compounds in the ERSG Library, approximately 30 compounds have been selected, based on read-through activity, for continued preclinical research and we
anticipate additional compounds advancing toward IND filings.
Currently our lead program, ELX-02, is focused on development for cystic fibrosis and cystinosis patients with diagnosed nonsense mutations. Our clinical
trial application (“CTA”) has been approved by the Federal Agency for Medicines and Health Products (the “FAMHP”) in Brussels and our IND submitted to the
U.S. Food and Drug Administration (the “FDA”) is open. Our Phase 2 program has been given a “high priority” ranking by the European Cystic Fibrosis Society
Clinical Trial Network. We expect to initiate Phase 2 studies in cystic fibrosis and cystinosis following completion of our ongoing Phase 1b MAD study in the first
half and to report top line Phase 2 data in the second half of 2019.
As part of our clinical program, we have completed a Phase 1 single ascending dose (“SAD”) study in a total of 60 healthy volunteers at sites in Israel
(ClinicalTrials.gov Identifier: NCT02807961) and Belgium (ClinicalTrials.gov Identifier: NCT03292302). The results of the SAD study were published in the
Journal of Clinical Pharmacology in January 2019. Our MAD study is being conducted in Belgium (ClinicalTrials.gov Identifier: NCT03309605). We have initiated
the 6th cohort of the MAD study and expect to complete the final cohort in the U.S. in the first half of this year.
In 2018, we initiated a new program studying inherited retinal disorders with a focus on Usher Syndrome by conducting pre-IND enabling studies on several
compounds from our library. We expect to advance one or more compounds into development for intravitreal administration.
We believe there is a significant unmet medical need in the treatment of cystic fibrosis patients carrying nonsense mutations on one or both alleles of the
Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”) gene. Cystic fibrosis is the most prevalent genetic disease in the western world and there are no
currently approved therapies that target the impairment associated with Class 1 CFTR mutations. We believe that nonsense mutations may impact a similar
proportion of patients diagnosed with cystinosis. There are no currently approved therapeutics that target the nonsense mutation mediated impairment of cystinosin,
the cystine-selective transport channel in the lysosomal membrane that is attributed as the cause for the accumulation of cystine in this disease state. Given the high
proportion of pediatric patients in each of these rare orphan diseases we intend to apply for relevant Orphan Drug incentives in the US and Europe, including the
Rare Pediatric Disease Priority Review Voucher in the U.S.
Currently, the European Medicines Agency (the “EMA”) has designated ELX-02 as an orphan medicine for the treatment of cystic fibrosis and
mucopolysaccharidosis type I (“MPS I”), and the FDA has granted orphan drug designation to ELX-02 for the treatment of cystinosis, MPS I, and Rett Syndrome.
We hold worldwide development and commercialization rights to ELX-02 and other novel compounds in our read-through library, for all indications, in all
territories, under a license from the Technion Research and Development Foundation Ltd. (“TRDF”). Professor Timor Baasov, the inventor of our compounds, has
served as our senior consultant since our incorporation.
Our Technology
Nonsense mutations, also known as premature termination or stop codons, are single point mutations within the DNA sequence which are either inherited or
acquired that result in the premature termination of the translational process leading to truncated or absent proteins. Nonsense mutations are involved in a large
number of genetic diseases such as cystic fibrosis, cystinosis, primary ciliary dyskinesia, advance polycystic kidney disease, and an estimated 300 inherited retinal
diseases, including Usher Syndrome. According to the Human Gene Mutation Database (http://www.hgmd.cf.ac.uk/ac/index.php), nonsense mutations account for
approximately twelve percent (12%) of patients with a given genetic disease. The disease phenotypes caused by nonsense mutations are frequently more severe than
those caused by other kinds of mutations because these mutations often lead to a complete loss of protein production or function. In general, these diseases do not
have specific therapies beyond symptomatic and palliative interventions.
In eukaryotic cells, the cytoplasmic ribosome is responsible for the production of proteins by a process called translation. As part of the translation process,
the genetic information stored in DNA is transcribed to mRNA to specify the sequence of amino acids, the building blocks of protein, required to produce a
functional product. The mRNA is decoded by a complex known as the ribosome in the cytoplasm of the cell. The ribosome slides along the
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mRNA and matches three nucleotide stretches, referred to as a codon, with a corresponding aminoacyl transfer RNA (a-tRNA) which carry the correct amino acid to
add onto the growing protein chain.
Normal translation termination in eukaryotic cells occurs when a natural (canonical) termination codon enters the ribosomal decoding region. The ribosome
pauses at these special termination sequences, since there are no complementary a-tRNA for these codons. A complex of termination factors, including eRF1 and
eRF3 will next bind to the ribosome and initiate the release of the newly synthesized protein.
When a nonsense mutation occurs, a single DNA nucleotide is substituted for the typical version, changing a codon for an amino acid into a stop codon. For
example, a tryptophan “TGG” codon may be changed to read “TGA” or “TAG”, either of which would result in a premature termination signal for the protein. While
non-functional, truncated proteins can result from this type of mutation, more often the protein product is unstable and degraded. Since most genes have two copies
(referred to as alleles) within the genome, a nonsense mutation on a single copy can be compensated if the other copy still codes for a healthy protein. However,
when mutations occur on both alleles, disease may occur. The two mutations can be the same mutation (homozygous) or two different disease-causing mutations
(heterozygous).
Cells have a system to detect nonsense mutation bearing mRNA copies and remove them from the cell. This process is called nonsense mediated mRNA
decay. During the first round of translation the ribosome removes proteins that are found along the newly made mRNA at regions called exon-exon borders. These
regions are remnants of a splicing process that occurs in the nucleus while the mRNA is being transcribed. If a stop codon is found by the ribosome during this first
round of translation in a location before the last of these exon-exon junction protein complexes, the mRNA is targeted for degradation. Therefore, nonsense
mutations result in a double hit for the gene, unstable mRNA and reduced functional protein (shown in Figure 1 below).
Figure 1: Nonsense Mutations Cause Unstable mRNA and Reduced Functional Protein
Read-through of nonsense mutations is a naturally occurring process that can be attributed to the redundancy “wobble” in the three-nucleotide codon
structure. Native read-through occurs in up to 1% of instances in which a ribosome pauses at a stop codon. During read-through, either the typical healthy or a near-
cognate substitute tRNA competes out the termination factor complex to enable the insertion of an amino acid and continuation of translation. By directly binding to
the ribosome decoding region, ELX-02 enhances the likelihood of this process by increasing the probability of a tRNA to out-compete the termination complex. As
read-through allows the ribosome to proceed with translation through the premature stop, a reduction in nonsense mediated decay and stabilization of the mRNA
pool is an additional expected outcome of this process (shown in Figure 2 below). Indeed, ELX-02 is found to increase both the mRNA and functional protein across
multiple nonsense mutations. Beyond ELX-02, multiple compounds within our ERSG library demonstrate results consistent with this mechanism of action.
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Figure 2: Read-through Allows the Ribosome to Proceed with Translation through the Premature Stop, Reducing mRNA Decay and Increasing the Translation of
Functional Protein
We believe that the segment of cystic fibrosis, cystinosis, and inherited retinal disease patients with diagnosed nonsense mutations on one or both alleles
represents a high unmet medical need as there are currently no approved therapeutics targeting the impairment caused by these mutations. There are existing in vitro
assays, animal models and/or biomarker screens that have been demonstrated to be useful in assessing the potential therapeutic benefit of development compounds
for these disease states. The design of clinical trials and the endpoints for measuring clinical benefit have been established for the currently approved therapeutics for
these disorders. We believe these to be attractive development targets based on the potential use of these precedents to de-risk the program.
We believe that our library of related novel small molecules hold the potential to be disease-modifying therapies that may change the course of hundreds of
genetic diseases and improve the lives of patients. Our early preclinical data in animal models of nonsense mutations suggest that drug product candidates from our
read-through compound library may have potential beneficial effects for each of the following diseases: cystic fibrosis, cystinosis, a variety of inherited retinal
disorders, mucopolysaccharidosis type 1, Duchenne muscular dystrophy and Rett syndrome, and have demonstrated the potential for beneficial effects in multiple
organs such as the lung, eye, kidney, muscles and others. We believe that additional molecules from our ERSG library have the potential to demonstrate a sufficient
activity profile to become drug product candidates and we are conducting ongoing preclinical evaluation of these molecules.
Current Data Indicating the Mechanism of Action of ELX-02
ELX-02 is a novel eukaryotic ribosomal selective glycoside (ERSG) with increased selectivity for the eukaryotic ribosome. Due to the markedly decreased
affinity for the prokaryotic and mitochondrial ribosomes ERSG compounds have little of the antibiotic activity associated with aminoglycosides. Aminoglycosides,
such as gentamicin, are potent antibiotics that bind with high affinity to the decoding site in the prokaryotic ribosome and inhibit protein translation in bacteria. The
early observations of eukaryotic read-through activity were made in patients treated with aminoglycosides due to bacterial infections. In eukaryotic cells,
aminoglycosides may induce a conformational change that reduces the codon-anticodon recognition, enhancing the ability of an a-tRNA to compete with the release
factor complex for binding to the premature termination codon and increasing the probability that translational read-through of premature termination codons occurs.
However, despite the promising clinical observations of read-through activity, aminoglycoside use as a read-through therapy is restricted since aminoglycosides may
cause damage to the kidney and ear after prolonged administration. The effect of aminoglycosides on the hair cells of the ear and the proximal tubular cells of the
kidney may be attributed, in part, to the inhibition of mitochondrial protein production in these cells. Because ERSGs are selective for the eukaryotic cytoplasmic
ribosome and have markedly decreased affinity for the mitochondrial ribosome, ERSGs are anticipated to show a safety and tolerability profile acceptable for chronic
use. We believe that compounds with increased read-through activity and a reduced affinity for the mitochondrial ribosome may demonstrate an acceptable profile
for chronic use. When compared in laboratory tests to gentamicin, a classic aminoglycoside, ELX-02 thus far has shown a 100-fold lower antibacterial activity and
nine-fold higher read-through activity for nonsense mutations; this has been attributed to higher selectivity towards the cytoplasmic eukaryotic ribosome. We believe
that the library of ERSG compounds has the potential to show improvements in read-through activity with a reduced potential for impairment of the mitochondrial
ribosome may have an improved safety profile.
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ERSGs with improved selectivity for the eukaryotic cytoplasmic ribosome are expected to demonstrate improved rates of full-length protein translation and
a reduction in triggered nonsense mediated decay. By binding to the cytoplasmic ribosome and reducing ribosomal stalling, ERSGs are expected to demonstrate
increases in mRNA and full-length protein production. Therefore, the Eloxx read-through activity screening program has used these endpoints to evaluate our
compound library portfolio.
Using a well-characterized cell line harboring a nonsense mutation, Eloxx is evaluating its compound library for both read-through mediated protein
restoration and stabilization of mRNA. While plasmid-based evaluations offer a convenient methodology to evaluate across disease related mutations, this approach
is limited to demonstrating the potential for protein restoration alone. Therefore, Eloxx has focused on using our molecules to detect read-through of a native
mutation, which is subject to nonsense mediated decay, in order to better model an actual disease setting. In this cell line, the protein of interest and its mRNA are
significantly reduced. We evaluated a subset of our compounds in the cell by quantitative polymerase chain reaction (qPCR), western blot protein analysis and for
proper localization of the restored protein by immunofluorescence. Consistent with our overall hypothesis, we have found that molecules in our library significantly
increase both the mRNA (dose-dependent increases of 30-fold over vehicle control) and protein of interest (increased normalized full-length protein 4.7-fold over
vehicle control) as well as the proteins proper sub-cellular localization. In addition to supporting our overall mechanism of action hypothesis, these studies have
enabled Eloxx to develop a robust (z’ factor = 0.88), high-throughput assay within this system to further evaluate compound-mediated read-through across our
library.
Our mechanism of action is further supported within disease-relevant model systems, further detailed below. In vitro models of cystinosis and CF
demonstrate dose-dependent increases in target mRNA as well as significant increases in functional protein. Unlike previous read-through programs reported by
other groups, ELX compounds have consistently demonstrated activity against both of these hallmark consequences of nonsense mutations. We believe this
understanding of ELX compound activity has enabled our clinical development programs to move forward with confidence.
Cystic Fibrosis
Cystic fibrosis (CF) is the most prevalent genetic disease in the western world and affects an estimated 70,000 to 100,000 patients worldwide, with the vast
majority of affected individuals in the United States (“U.S.”), Canada, Europe and Australia. CF is the most common fatal inherited disease in Caucasians. The
incidence of CF varies across the globe ranging between one in 3,500 births in the U.S. and one in 2,000 to 3,000 births in Europe, and Australia.
Approximately 13% of the CF patients carry a nonsense mutation on the CFTR gene. CF is a progressive disease caused by a deficiency in CFTR activity
with insufficient ionic transconductance in the cell membrane, which, in turn, leads to the accumulation of thick mucus in vital organs, particularly the lungs,
pancreas and gastrointestinal tract. As a result, CF patients experience respiratory infections, chronic lung inflammation, and poor absorption of nutrients as well as
many other conditions, and, in most cases, progressive respiratory failure. Although the life expectancy of CF patients has improved, the median age of death in the
U.S. in 2014 was only 29 years, with a vast majority of such deaths resulting from respiratory failure.
Cystic Fibrosis occurs at a rate of 1 in 2,500–6,000 newborns, depending on the region and ethnic origin. Patients with CF caused by nonsense mutations
have some of the most severe forms of the disease and, other than palliative therapies, no treatment currently exists for them. Mutations in the gene that encodes
CFTR protein, which play a critical role in regulating the viscosity of the mucus layer that lines human organs, cause CF. The CFTR protein forms an ion channel
that regulates the flow of ions in and out of the cells of vital organs such as the lungs, pancreas and gastrointestinal tract. We refer to this as ion flow. When CFTR
protein expels the ions, osmosis draws water out of the cell and hydrates the cell surface. Through regulation of the location of the ions across the cell membrane, the
amount of salts in the fluid both inside and outside the cell remains balanced.
In CF patients, the CFTR gene is defective, and as a result, CF patients lack the functional CFTR protein ion channel necessary to regulate ion flow. An
altered ion concentration gradient between the inside and the outside of the cell reduces the amount of water molecules outside the cell, causing the accumulation of
thick mucus on the epithelial surface as shown below in Figure 3.
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Figure 3: Ion Flow in Normal CFTR Protein Compared to Mutant CFTR Protein
The deficiency in CFTR protein activity in CF patients is particularly problematic in the lungs, where the build-up of thick mucus obstructs airflow and
impairs proper immune response, which leads to chronic infection and persistent inflammation. In the pancreas and the gastrointestinal tract, the build-up of mucus
prevents the release of digestive enzymes that help the body break down food and impairs the absorption of nutrients, resulting in poor growth and development.
Inherited Retinal Diseases
Inherited retinal disorders (also called inherited retinal dystrophies, or IRDs) are a group of rare eye disorders caused by inherited gene mutations which can
result in vision loss or blindness. Some inherited retinal diseases, such as Retinitis Pigmentosa (RP), Usher Syndrome, or Choroideremia (CHM) are associated with
a gradual loss of vision, eventually leading to complete blindness. In other conditions such as Leber’s Congenital Amaurosis (LCA), patients may be born with or
experience vision loss in infancy or early childhood.
A specific IRD, Usher Syndrome, is the most common genetic disorder involving hearing and vision abnormalities, and is the most common cause of
deafness-blindness with visual impairment due to photoreceptor degeneration. Three types of Usher Syndrome have been identified based on genetic causes, severity
of hearing loss and age of onset. USH1 patients are typically born with severe hearing loss and are diagnosed early in life with vision problems beginning at or
before age of 10 years. USH2 patients are characterized by progressive hearing loss from birth, with onset of vision loss at adolescence and often are not diagnosed
until their early 20s. In USH3, vision loss develops within the second decade of life. In most countries, USH1 accounts for one-third of all patients with USH2
accounting for about two-thirds of all USH patients. US Prevalence is estimated at approximately 6.2 thousand Type 1 and approximately 8.9 thousand Type 2
patients. It is estimated that there are over 4,000 patients in North America with nonsense forms of Usher Syndrome. Effective read-through has been demonstrated
in vitro for USH2A (USH2), PCDH15 (USH1) and USH1C (USH1) NS mutations. USH2A nonsense variants are estimated to affect more than 2,500 patients in the
US alone. There are four usher splice site variants, with the largest having over 70 exons, potentially limiting gene therapy development due to vector size
limitations.
Another IRD, Retinitis Pigmentosa (RP), causes night blindness in adolescence and gradual visual field loss in adulthood (most patients are legally blind by
age 40). RP can occur as a localized disorder with visual impairment only, or as part of a broader syndrome (e.g., Usher Syndrome). More than 50 different causative
genes have been identified and the US incidence is estimated at approximately 67 thousand patients. Given this high genetic heterogeneity even in nonsense
mediated disease (no single gene comprises more than 10% of nonsense RP cases), there is a significant need to identify broader cross-gene therapies. Read-through
proof of principle has been shown via in vitro models of USH2A RHO, MERTK, and RP2 nonsense mutation variants, with 5-20% rescue of protein function
demonstrated.
In December 2017, the U.S. Food and Drug Administration approved Spark Therapeutics LuxturnaÒ as the first gene therapy for retinal dystrophy caused
by mutations in the RPE65 gene and targeting approximately 1000-2,000 patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. While many
gene therapies focus on specific inherited retinal diseases, many target genes share related ocular disease pathways suggesting a broader gene-agnostic approach may
provide greater treatment opportunities. IRDs such as Usher Syndrome and
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Retinitis Pigmentosa represents a favorable target for readthrough therapeutics given the high unmet need, the opportunity to target multiple nonsense mutations
across a variety of genes, and offer potential treatment for patient subsets not addressed by gene therapy due to gene size or small patient subsets.
Cystinosis
Cystinosis is an ultra-rare autosomal recessive lysosomal storage disease. Mutations in the CTNS gene (cystinosin), on the short arm of chromosome 17
(17p13), cause the primary defect in the disease. Cystinosin is a ubiquitous cystine-selective transport channel in the lysosomal membrane. Loss-of-function
mutations prevent cystine efflux from the lysosome, causing massive accumulation of intra-lysosomal cystine in tissues throughout the body, and lead to apoptotic
cell death, impaired physiology and end organ damage.
Affected children may appear fairly well until the age of 4-6 months, when progressive dysfunction and atrophy of the proximal renal tubule cause Fanconi
syndrome and failure to thrive. By 10-12 years of age, dialysis or kidney transplantation is required to treat end-stage renal disease. Although the renal allograft is
spared, lifespan is diminished by the inexorable dysfunction of other organs.
The most common nonsense mutation in the CTNS gene is W138X which has an overall incidence rate of 1 in every 62,500 live births in Quebec, Canada.
Current treatment includes cysteamine bitartrate (Cystagon® or Procysbi®). Cystagon was approved in the U.S. and Europe in 1994 and Procysbi was
approved in the U.S. and Europe in 2013. Both therapies delay but do not cure the condition and despite treatment, patients eventually require dialysis and renal
transplantation and experience significant morbidity in other organ systems.
Primary Ciliary Dyskinesia
Primary Ciliary Dyskinesia (PCD) is a genetically heterogeneous disease which is predominantly inherited as an autosomal recessive disorder. PCD is
associated with abnormal ciliary function resulting in impaired mucociliary clearance, recurrent /chronic upper and lower respiratory tract infection and male
infertility. PCD prevalence is estimated to involve 1:20,000 individuals however, disease symptom variability and low familiarity with PCD likely leads to
substantial patient under-diagnosis. PCD patient treatment largely focuses on airway clearance (devices and aerosolized therapies), infection control (anti-microbial
therapy), and inflammation control (antibiotic therapy). There have been few randomized trials of PCD treatment to date.
More than 30 different genes have been identified to be causative for PCD with approximately 25% of identified gene mutations having nonsense mutations.
Cell- based and in vitro studies of aminoglycoside-mediated readthrough in PCD nonsense mutations found positive read-through efficacy in several UGA associated
stop codons. PCD is an attractive disease target given the high unmet medical need, positive preclinical read-through data, potential for treatment across multiple
genes, high prevalence of nonsense mutations, and lack of disease modifying treatments.
Polycystic Kidney Disease
Polycystic Kidney Disease (PKD) is a progressive genetic disorder causing the growth of cysts in the kidneys, reducing kidney function and ultimately
leading to kidney failure or end stage renal disease (ESRD). It is found in all races and occurs equally in men and women. The autosomal dominant form of
polycystic kidney disease (ADPKD) is the most common genetic nephropathology accounting for 5%–8% of ESRD. Worldwide, ADPKD affects approximately 4 to
7 million individuals and accounts for 7-15% of patients on renal replacement therapy. In North America and Europe, ADPKD is responsible for 6-10% of ESRD
cases. It’s estimated that one per 800-1000 population carries a mutation for this condition.
Approximately 85-90% of patients with ADPKD have the ADPKD1 gene; most of the remaining patients have the ADPKD2 gene. Estimates suggest over
30% of ADPKD1 mutations are nonsense variants and therefore represent a favorable target for readthrough therapeutics given the large patient population,
substantial subset of nonsense mutations, disease severity and limited treatment options.
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Other Nonsense Mediated Genetic Disorders
Muscular dystrophies are genetic disorders involving progressive muscle wasting and weakness. Duchenne muscular dystrophy (nmDMD) is the most
common and one of the most severe types of muscular dystrophy with the average age of death for DMD patients in the mid-twenties. DMD occurs when a mutation
in the dystrophin gene prevents the cell from making a functional dystrophin protein. Because the dystrophin gene is located on the X chromosome, DMD occurs
almost exclusively in young boys. Genetic tests are available to determine if a patient’s DMD is caused by a nonsense mutation. Based on a publication from Prior, et
al. (1995) in the American Journal of Human Genetics, it is estimated that a nonsense mutation is the cause of DMD in approximately 13% of patients. Treatments
for DMD include Translarna™ (ataluren), approved in the European Union (“EU”) for the treatment of the underlying cause of nmDMD.
EXONDYS 51® (eteplirsen) Injection is also approved in the US for the treatment of DMD patients with exon 51 skipping mutations.
Mucopolysaccharidosis type I (MPS I) is a chronic, progressive genetic disorder caused by a deficiency of the enzyme alpha-L-iduronidase (IDUA).
Children with severe MPS I often die in the first decade of life due to respiratory failure, cardiac valvulopathy, and cardiorespiratory problems. The deficiency of the
IDUA enzyme leads to the accumulation of a class of molecules called glycosaminoglycans (GAGs). The accumulation of GAGs causes disruption in the movement
of molecules inside the cell and leads to the subsequent dysfunction of cells, tissues and organs. Globally, MPS I occurs in about 1 in every 100,000 births for the
severe form and 1 in 500,000 for the attenuated form. About 70% of MPS I patients carry one of two nonsense mutations; Q70X and W402X. Estimates suggest that
50%- 80% of all MPS I patients present with the severe versus attenuated form of the disease. MPS I disease-specific treatments include enzyme replacement therapy
(ERT) and hematopoietic stem cell transplantation (HSCT).
Rett syndrome is a X-linked neurodevelopmental disorder that predominantly affects girls and has a worldwide incidence of 1 in every 10,000-15,000
female births. The condition generally follows normal development in the first 6-18 months of age, followed by a period of regression in language and motor skills
including repetitive stereotyped hand movements. Rett Syndrome patients also have numerous comorbidities that are thought to contribute to a shortened lifespan.
There is a high unmet medical need in Rett syndrome given no current treatment exists for the underlying cause of the disease. Loss-of-function mutations in the
gene encoding the transcriptional regulator methyl-CpG binding protein 2 (“Mecp2”) account for most cases of Rett syndrome. Nonsense mutations in the Mecp2
gene account for approximately 30% of Rett syndrome cases. The most prominent nonsense mutations found in Rett syndrome, R168X, R255X, R270X and R294X,
are all caused by a change of arginine to the stop codon, UGA.
Status of Preclinical Programs
We have completed a comprehensive series of preclinical studies to assess the safety, pharmacokinetics and pharmacology of ELX-02. In addition, we have
verified read-through activity of additional library molecules and identified a set of promising candidate molecules to evaluate across new indications. Finally, we
have initiated our preclinical assessment of ELX compound activity in inherited retinal disease, validating read-though activity against several Usher Syndrome
mutations and initiating ocular tolerability and IND-enabling studies.
Safety and Pharmacokinetic Studies of ELX-02
A comprehensive toxicology program in accordance with the ICH guideline M3 (R2) was completed for ELX-02 to support clinical studies.
In definitive, 28-day, repeat-dose toxicity studies in rats and dogs, ELX-02 had little or no effect on body weight, food consumption, clinical signs of
toxicity, ophthalmology, cardiovascular parameters, hematology or coagulation parameters. At dose levels higher than those intended for humans, ELX-02 has no
cochlear toxicity as evidenced in anatomic and functional hearing studies in 28-day rat studies. We have recently completed 3-month toxicology studies in juvenile
rats and in young dogs, as well as chronic toxicology studies in these 2 species for 6- and 9-months, respectively. These studies showed no mortality and no
significant in-life toxicity. ELX-02 was not genotoxic in the core battery of in vitro and in vivo genotoxicity assays. Collectively, these results support the human
lifetime use of ELX-02. As an aminoglycoside, ELX-02 has poor oral bioavailability but is 100% bioavailable following sub-cutaneous administration. Additionally,
ELX-02 does not undergo metabolization and is excreted unchanged almost exclusively via the urine.
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Pharmacology Studies of ELX-02
We have conducted a series of preliminary studies to demonstrate the primary pharmacodynamics of ELX-02 in several genetic disease indications. We have
tested the translational read-through capabilities of ELX-02 in vitro and in vivo, in cells and in animal models of nonsense mutations.
We have shown the in vitro read-through activity of ELX-02 in an array of plasmids engineered to contain nonsense mutations of genetic diseases and in
cell-based models of CF, cystinosis, Duchenne Muscular Dystrophy, MPS 1, and Rett syndrome.
In CF, ELX-02 induced about 30% of wild type CFTR levels after 48 h in heterozygous G542/F508del human bronchial epithelial cells. In the G542X
transgenic mouse, ELX-02 showed an approximate 5-fold increase in CFTR activity compared to control after twice weekly treatment for four weeks with 60 mg/kg.
In order to evaluate read-through across a series of CF genotypes, we initiated a program to evaluate restoration of CFTR activity in patient-derived
organoids. Organoids are a three-dimensional, multi-cellular in vitro system derived from stem cells isolated from rectal biopsies. When grown suspended in an
extracellular matrix substrate, the cells adopt a polarized endothelial spheroid structure. CFTR protein localizes to the apical surface (the inner surface of the sphere)
and is capable of driving chloride ions into the inner lumen. When an ion imbalance, relative to the ion concentration surrounding the organoid is present, water is
driven into the inner lumen of the organoid as a means to equilibrate the concentration. This action results in the swelling of the organoid, a function measurable by
high-content imaging. Similar to measuring CFTR conductivity in other systems, such as human bronchial epithelial cells, CFTR activity is stimulated in the
organoid system with forskolin to produce cyclic adenosine monophosphate, a signaling molecule that stimulates CFTR channel activity. Organoids derived from
nonsense mutation CF patients lack apparent swelling in this system due to their lack of functional CFTR. As a stem cell derived system, organoids are a renewable
model permitting repeat testing from a single patient’s biopsy. Eloxx partners with the Hubrecht Organoid Technology (HUB), a not-for-profit organization founded
out of the Hubrecht Institute, KNAW and University Medical Center Utrecht, The Netherlands to evaluate the nonsense-bearing CF patient organoids in its biobank.
These studies demonstrate that across the most common CF causing nonsense mutations (G542X, W1282X, R553X, R1162X, R1066C and E60X) ELX-02
significantly increases CFTR function and CFTR mRNA in a dose dependent fashion. ELX-02 mediated CFTR function is observed in both homozygous and
complex heterozygous nonsense bearing patient-derived organoids. ELX-02 is the first clinical development candidate molecule to demonstrate activity against these
nonsense mutations in the organoid model system. Activity in the organoid swelling assay is dependent on both proper production and localization of functional
CFTR protein; therefore, the activity observed with ELX-02 supports that the CFTR protein resulting from read-through of these mutations is both functional and
localized to the correct cellular location. CFTR mRNA levels were monitored by NanoString which demonstrated that G542X and W1282X CF organoids have the
expected reduction in CFTR mRNA resulting from nonsense mediate decay. ELX-02 increased CFTR mRNA dose-dependently to the range observed in healthy
organoids. While approved CF therapies lack efficacy against this type of CF mutation, organoids with responsive mutations (e.g. G551D, F508del) demonstrate
activity in the organoid swelling assay in a manner that correlates with clinical responsiveness in informative endpoints such as FEV1 and sweat chloride change.
When considering the ELX-02 results with the correlation reports of other approved molecules in this assay, the response mediated by ELX-02 read-through meets or
exceeds the activity necessary to significantly improve FEV1 and sweat chloride concentration.
In cystinosis, ELX-02 increased read-through of the CTNS W138X mutation by 30-fold in a cell-free plasmid assay system. In primary homozygous W138X
fibroblasts, ELX-02 led to a dose-dependent increase in normalized CTNS mRNA levels, consistent with a decrease in nonsense mediated mRNA decay. Functional
protein restoration was supported in primary fibroblasts by demonstrating a ELX-02 mediated reduction in cellular cystine levels to wild-type levels. When
combined with the standard of care, cysteamine, ELX-02 reduction in cellular cystine levels was additive. These data support that ELX-02 has the potential to impact
the primary etiology of this ultra-rare disease.
In inherited retinal diseases, a series of academic collaborations have shown that the candidate ELX compounds demonstrate dose-dependent increases in
read-through of Usher Syndrome 2A and 1F mutations in a cellular plasmid-based reporter assay; they also show restoration of Usher 1C protein and harmonin.
Upcoming studies will confirm these findings. Additionally, Eloxx is evaluating multiple ELX compounds for ocular tolerability, as measured by preservation of the
electroretinogram and retinal histology, when delivered by
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intravitreal injection in rabbits. These studies demonstrate ELX compounds to have a favorable tolerability profile in comparison to the reference aminoglycoside,
gentamicin. These findings are consistent with our hypothesis that the improved specificity for the eukaryotic cytosolic ribosome over the mitochondrial ribosome
will reduce off-target associated toxicities.
Ongoing Screening and IND Enabling Studies of Eloxx ERSG Library Compounds
As part of his research to discover molecules that bind selectively to the eukaryotic ribosome Professor Timor Baasov evaluated over 170 compounds. These
compounds are of several structural classes and many were tested for read through activity. A select group was further evaluated in 2018 against specific gene
constructs designed to evaluate their potential utility in disease involving the presence of nonsense mutations. In addition to ELX-02, we currently have multiple
compounds progressing in IND enabling studies based on data demonstrating positive activity on nonsense mutations in inherited retinal disorders and a favorable
profile. We believe that one or more of these preclinical ERSG drug-candidates are potentially suitable for clinical development and we are continuing to conduct
pre-IND studies to evaluate their potential.
Status of Clinical Programs
We have completed our Phase 1a study and have advanced our Phase 1b study. In support of our planned Phase 2 studies, we have advanced our global
health authority interactions and manufacturing activities.
Phase 1 Clinical Studies
We are completing a Phase 1 program in healthy volunteers that is designed to support studies of ELX-02 in patient populations in any indication caused by
nonsense mutations and assess the safety of ELX-02. This initial phase of testing includes a small number of healthy volunteers. The studies assess the effects of
ELX-02 on humans and measure bioavailability, excretion, safety and side effects, as well as the pharmacokinetics (what the body does to the drug) with increasing
doses. Phase 1 studies include single ascending dose, or Phase 1a, and multiple ascending dose, or Phase 1b, studies.
The Phase 1a single ascending dose (“SAD”) study was completed in 2018 and the results were published in the Journal of Clinical Pharmacology in
January 2019. The SAD study included five doses of ELX-02 ranging from 0.3 mg/kg to 7.5mg/kg in order to determine the pharmacokinetic profile and safety from
single administration. The completed Phase 1a study enrolled healthy volunteers at Tel Aviv Sourasky Medical Center, Clinical Research Center (EL‐001
(NCT02807961)) and at SGS Life Sciences Services, Clinical Pharmacology Unit (EL‐006 (NCT03292302). ELX‐02 was shown to be generally well tolerated over
the dose range of the SAD studies with no observations of renal toxicity. During the study observations of transient adverse events resulting from ELX-02
administration were mild with the exception of a single moderate auditory adverse effect of interest but of unclear physiological significance and without clinical
impact. Overall the results were supportive of continued clinical development.
We plan to complete the ongoing Phase 1b multiple ascending dose (MAD) study in healthy volunteers in the first half of 2019. The study has been designed
as a randomized, double-blinded, placebo-controlled, multiple dose escalating study in healthy male and female subjects. The study has been expanded to include
additional cohorts to evaluate lower drug concentrations and/or administration schedule. To date, five cohorts of nine subjects each have been completed and have
undergone DSMB review. The sixth cohort has been initiated in Belgium and we intend to complete the seventh, final cohort, at a study site in the U.S.. Subjects
have been randomized to receive nine doses of ELX-02 or placebo at a ratio of 2:1 in each cohort. To date, the study has been conducted in Belgium after having
undergone review and approval by the FAMHP in Belgium, and by the Institutional Review Board in August 2017 in Antwerp, Belgium.
Phase 2 Clinical Studies
In January 2018, we held a Pre-CTA regulatory meeting with the FAMHP and submitted the CTA for our Phase 2 study of cystic fibrosis in Belgium. The
CTA has been reviewed and approved by FAMHP. Additionally, our Phase 2 program has been given a “high priority” ranking by the European Cystic Fibrosis
Society Clinical Trial Network. We are on track to conduct our Phase 2 CF study focusing on patients bearing one or two alleles with the G542X nonsense mutation
and report top line data in 2019. The study will enroll no more than 24 patients to
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evaluate multiple doses of ELX-02 for the primary endpoint of safety and the secondary endpoints to include an assessment of sweat chloride and FEV1.
In 2018, Eloxx entered into a collaboration with Dr. Paul Goodyer at McGill University as part of the Genome Canada Genomic Applications Partnership
Program (GAPP), to conduct clinical trials of ELX-02 for the treatment of cystinosis. During 2018, Eloxx submitted an IND to the FDA for the conduct of Phase 2
studies in cystinosis and the IND is now open. The Phase 2 program as discussed with the FDA will enroll no more than 6 patients to evaluate multiple doses of
ELX-02 for the primary endpoint of safety and exploratory endpoints that will include white blood cell cystine levels. In support of the cystinosis program where
many patients have impaired renal function, we have initiated a renal impairment safety study that will complete in the first half of 2019.
Manufacturing Status
We have completed the manufacture of the clinical drug product to support our full Phase 2 clinical trial program. We have further identified a commercial
manufacturer and are engaged in process development and scale up activities required to support Phase 3 clinical development.
Intellectual Property
Patent Portfolio
Our licensed and owned patent portfolio includes three families of patents and applications relating to our lead compound ELX-02 (formerly known as
NB124) and over 40 other read-through inducing compounds. Each of these families is described briefly below.
With regard to ELX-02, our primary composition of matter coverage derives from a first family of patents and applications that we exclusively license
through the Research and License Agreement with Technion Research and Development Foundation Ltd. (“TRDF”), dated August 29, 2013. This family includes
claims directed to ELX-02 and other read-through inducing compounds, as well as claims directed to pharmaceutical compositions of the disclosed compounds and
methods of using the compounds and compositions to treat genetic disorders associated with premature stop codon mutations including cystic fibrosis, cystinosis,
Duchenne’s muscular dystrophy, ataxia-telangiectasia, Hurler syndrome, hemophilia A and B, Usher Syndrome, and Tay-Sachs. Patents that have issued or which
may issue in the future from this family are currently expected to expire in 2031, not including any extensions of term for which we may be eligible that we may be
granted. As of December 31, 2018, this family included issued patents in the U.S., Europe, Canada, Hong Kong, and Japan, and pending applications in the U.S.,
Europe, Hong Kong, India, Israel and Japan.
We own two additional families that may provide additional protection for specific uses or methods of manufacturing ELX-02 beyond the current expiration
date of the primary composition of matter patents. The first of these is directed to the use of ELX-02 and other read-through inducing compounds for the treatment
of Rett Syndrome. As of December 31, 2018, this family included pending applications in the U.S., Europe, Canada, Hong Kong, India, Israel and Japan. Any
patents issuing from this family are currently expected to expire in 2035, not including any extensions of term for which we may be eligible that we may be
granted. The second is directed to methods for large-scale synthesis of ELX-02 and other read-through inducing compounds. As of December 31, 2018, this family
includes a pending PCT application and a pending application in India. We currently plan to enter the national phase in the U.S. and other selected jurisdictions
worldwide for this family in 2019. Any patents issuing from these anticipated applications are currently expected to expire in 2038, not including any extensions of
term for which we may be eligible that we may be granted.
Our other three families of licensed and owned patents and applications are directed to additional read-through inducing compounds. The first of these is
exclusively licensed under the Research and License Agreement with TRDF, and includes claims directed to ELX-03 (formerly known as NB84) and other
compounds, as well as claims directed to pharmaceutical compositions and methods of treating genetic disorders including cystic fibrosis, Duchenne muscular
dystrophy, ataxia-telangiectasia, Hurler syndrome, hemophilia A, hemophilia B, Usher Syndrome, and Tay-Sachs. Patents that have issued or which may issue in the
future from this family are currently expected to expire in 2027 and 2028, not including any extensions of term for which we may be eligible that we may be
granted. As of December 31, 2018, this family included issued patents in the U.S., Europe, Canada, India, Israel and Japan, and pending applications in the U.S. and
Europe.
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The second and third of these families include claims directed to additional read-through inducing compounds and pharmaceutical compositions and uses
thereof. As of December 31, 2018, one of these families included pending applications in the U.S., Europe, Australia, Brazil, Canada, China, Hong Kong, India,
Israel and Japan, while the other included a pending PCT application that we plan to use for national entry in the U.S. and other selected jurisdictions in 2019 or
2020. Patents that may issue from these families are currently expected to expire in 2036 and 2038, respectively, not including any extensions of term for which we
may be eligible that we may be granted.
Patent Term Extension
The term of a U.S. patent is 20 years from its earliest effective filing date, assuming all maintenance fees are paid, the patent has not been terminally
disclaimed, and the patent has not been invalidated through administrative and/or court proceedings. The term of foreign patents varies, but is generally also 20
years from the earliest effective filing date. In certain instances, the term of U.S. and certain foreign patents may be extended.
In the U.S., patent term may be extended in certain instances by patent term adjustment, or PTA, which compensates for administrative delays by the U.S.
Patent & Trademark Office (USPTO) during examination of the patent. We have received PTA for one of our exclusively licensed patents relating to ELX-01 and
other related read-through inducing compounds, extending the expiration date of that patent from 2027 to 2028. However, we do not know whether any PTA will be
granted for any of our future patents.
For pharmaceutical products that have received FDA approval, the term of a U.S. patent covering the approved product, a method of manufacturing the
approved product, or an approved method of use of the product may be extended under the Drug Price Competition and Patent Term Restoration Act of 1984,
referred to as the Hatch-Waxman Act, in certain instances if specific statutory and regulatory requirements are satisfied. The Hatch-Waxman Act provides for a
patent term extension, or PTE, of up to five years as compensation for effective patent term lost during product development and the FDA regulatory review
process. PTE is only available for the first approval of a particular product, the total patent term including the restoration period must not exceed 14 years from the
date of FDA approval, and only one patent may be extended for a particular regulatory review period. In Europe, a similar mechanism exists for extending patent
term up to five years through the grant of a Supplementary Protection Certificate (SPC) following EMEA approval. Similar regulatory extensions are available or
may be available in the future in other jurisdictions. If and when ELX-02 or other of our read-through inducing compounds are approved by the FDA, EMEA, or
other foreign regulatory authorities, we will apply for these and other patent term extensions on patents covering the approved products, methods of use, or methods
of manufacture if the patents are eligible for such extension. However, we cannot provide any assurance that such extensions will be granted for any of our currently
issued or future patents.
Trade Secrets and Know-How
With respect to our synthetic-aminoglycosides-based technology platform, we primarily rely on trade secrets and know-how to protect the proprietary nature
of our platform. However, trade secrets and know-how can be difficult to protect. We seek to protect our proprietary technology and processes, in part, by
confidentiality agreements with our employees, consultants, scientific advisors and contractors. We also seek to preserve the integrity and confidentiality of our data,
know-how and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we
have confidence in these individuals, organizations and systems, agreements or security measures may be breached, and we may not have adequate remedies for any
breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our consultants, contractors or
collaborators use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
License Agreements
Research and License Agreement with Technion Research and Development Foundation Ltd.
On August 29, 2013, we entered into a license agreement with TRDF, which was further amended and addended to reflect, inter alia, the assignment of
patents and extension of research periods, with respect to certain technology relating to aminoglycosides and the redesign of aminoglycosides for the treatment of
human genetic
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diseases caused by premature stop mutations and further results of the research of the technology, in order to develop and commercialize products based on such
technology. The license agreement provides us with an exclusive, worldwide, non-transferrable license, with a right to grant sublicenses, and royalty-bearing licenses
to the TRDF inventions, TRDF patent rights, TRDF’s interest in the joint inventions and joint patent rights, and certain materials and research results owned by
TRDF, solely with respect to products in the field of prevention, diagnosis or treatment of any human disease or condition therefor. In return for the license we will
pay TRDF (i) milestone payments with respect to each licensed product upon the achievement of certain pre-defined goals by us or one of our sublicensees as
follows: $100,000 upon first dosing of a patient in Phase II clinical study; $1,000,000 upon first dosing of a patient in pivotal study; $1,000,000 upon first filing on a
new drug application (NDA); (ii) certain royalties in the low- to mid- single-digit percentage of all net sales (subject to change in the case of (a) sublicensing to a big
pharmaceutical or biotechnology company, or (b) payment of royalties to third parties, or (c) commercialization by a third party of an authorized generic to a licensed
product); and (iii) a low- to mid- double-digit percentage of any non-royalty sublicense income. In addition to the milestone payments, we undertook to annually
fund the research activities under the license, currently in the estimated annual amount of $0.1 million per year. The license agreement further provides TRDF with
an additional pre-emptive right, in force until the first exit event, to invest an amount equal to up to 5% of the amount contemplated to be raised in a proposed
investment. TRDF is also entitled, until the closing of an exit event, to appoint an observer to the board under certain restrictions such as confidentiality or conflict of
interest. Furthermore, we will reimburse TRDF for all patent filing expenses as of the effective date of the license agreement and for past patent filing expenses in the
amount of several hundred thousand New Israeli Shekels upon the occurrence of certain conditions.
Under the license agreement, TRDF reserved the right, for itself, the Technion and other not-for-profit research organizations to utilize the technology solely
for educational purposes. Furthermore, Professor Bassov, the principal investigator, had ongoing research programs involving covered compounds (as defined in the
agreement) that are being funded by the National Institute of Health in the U.S., or the NIH, under sub-awards from the University of Alabama and the University of
Michigan and it is possible that such research programs will overlap with the research conducted according to the terms of the agreement. In the case of any such
overlap, the work product of such research will be subject to the terms and conditions of such sub-awards, including certain obligations under 35 U.S.C. §§ 200-212
or 37 C.F.R. § 401 et seq. in the case of any TRDF inventions that are also “subject invention” as defined in 35 U.S.C. § 201.
The license agreement shall continue in full force and effect on a product-by-product and country-by-country basis until the expiration of all payment
obligations for any such licensed product as described above. Upon the expiration, we will have a fully-paid up, worldwide non-exclusive, perpetual, irrevocable
license (with the right to grant sublicenses) to use certain materials and the research results, solely with respect to products in the field of prevention, diagnosis or
treatment of any human disease or condition.
Manufacturing
ELX-02 is manufactured under current Good Manufacturing Practice (“cGMP”) conditions and is formulated as a sterile frozen liquid or lyophilized powder
in glass vials. ELX-02 is administered by parenteral subcutaneous (SC) injection after appropriate dilution or reconstitution, as required.
We do not own or operate manufacturing or distribution facilities for the production of clinical quantities of ELX-02 or for our other preclinical product
candidates. We currently rely, and expect to continue to rely, on third parties for the manufacture, packaging, labeling and distribution of clinical supplies of ELX-02
as well as any other candidate that we may develop.
We engage separate manufacturers for drug substance and drug product. We have a relationship with a manufacturer that is capable of providing fill and
finish services for our clinical product at the current scale. To support later clinical trials, transfer of the manufacturing and release to a manufacturer with higher lot
scale capacity will be needed for our clinical product.
All of our current drug candidates are organic compounds of low molecular weight. We have selected our lead compounds not only on the basis of their
potential efficacy and safety but also for their ease of synthesis and reasonable cost of their starting materials. ELX-02 is manufactured in reliable and reproducible
synthetic processes. We currently rely on a single third-party manufacturing source for the production of a key raw material, produced by bacterial fermentation. We
do not currently have any agreements with third-party manufacturers for the long-term
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commercial supply of ELX-02 in connection with regulatory approval of ELX-02 or for the fermentation-derived starting material, although we may seek to establish
such arrangements in the future.
We currently obtain clinical supplies of ELX-02 from third-party manufacturers pursuant to agreements that include specific supply timelines and volume
expectations. If a manufacturer should become unavailable to us for any reason, we would seek to obtain supply from another manufacturer engaged by us for the
applicable product or service. In the event that we were unable to procure the applicable supply from a currently qualified manufacturer, we believe that there are a
number of potential replacements for each of our outsourced services, however we would likely experience delays in our ability to supply ELX-02 in advancing our
clinical trials while we identify and qualify replacement suppliers.
Government Regulation
Drug Development and Approval in the United States
The preclinical studies and clinical testing, manufacture, labeling, storage, record keeping, advertising, promotion, export, and marketing, among other
things, of our product candidates are subject to extensive regulation by governmental authorities in the U.S., the EU and other territories. In the U.S., pharmaceutical
products are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (the “FDCA”) and other laws, including, in the case of biologics, the Public
Health Service Act. Failure to comply with FDA requirements, both before and after product approval, may subject us and/or our partners, contract manufacturers,
and suppliers to administrative or judicial sanctions, including FDA refusal to approve applications, warning letters, product recalls, product seizures, total or partial
suspension of production or distribution, fines and/or criminal prosecution.
The process for obtaining regulatory approval to market a medicine is expensive, often takes many years, and can vary substantially based on the type,
complexity, and novelty of the product candidates involved. The steps required before a drug may be approved for marketing of an indication in the U.S. generally
include:
(a)
(b)
(c)
(d)
(e)
(f)
preclinical laboratory tests and animal tests;
submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may commence;
adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for its intended use;
submission to the FDA of a NDA;
FDA pre-approval inspection of the manufacturing and clinical study sites identified in the NDA; and
FDA review and approval of the NDA.
Preclinical studies include laboratory evaluation of product chemistry and formulation, as well as toxicological and pharmacological animal studies to assess
the potential safety and efficacy of the product candidates. Preclinical safety tests intended for submission to FDA must be conducted in compliance with FDA’s
current Good Laboratory Practice (“cGLP”) regulations and the U.S. Department of Agriculture’s Animal Welfare Act. The results of the preclinical tests, together
with manufacturing information and analytical data, are submitted to the FDA as part of an IND application that must become effective before human clinical trials
may be commenced. The IND will automatically become effective 30 days after receipt by the FDA, unless the FDA before that time raises concerns about the drug
candidate or the conduct of the trials as outlined in the IND. The IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can proceed.
We cannot assure you that submission of an IND will result in FDA authorization to commence clinical trials or that once commenced, other concerns will not arise.
FDA may stop the clinical trials by placing them on “clinical hold” because of concerns about the safety of the product being tested, or for other reasons.
Clinical trials involve the administration of the investigational product to healthy volunteers or to patients, under the supervision of qualified principal
investigators. The conduct of clinical trials is subject to extensive regulation, including compliance with the FDA’s bioresearch monitoring regulations and current
Good Clinical Practice (“cGCP”) requirements, which establish standards for conducting, recording data from, and reporting the results of clinical trials, and are
intended to assure that the data and reported results are credible and accurate, and that the rights, safety, and well-being of study participants are protected.
Clinical trials must be conducted in accordance with protocols that detail the objectives of the study, the criteria for determining subject eligibility, the
dosing plan, patient monitoring requirements, timely reporting of
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adverse events, and other elements necessary to ensure patient safety, and any efficacy criteria to be evaluated. Each protocol must be submitted to FDA as part of
the IND; further, each clinical study at each clinical site must be reviewed and approved by an independent institutional review board, or IRB, prior to the
recruitment of subjects. The IRB’s role is to protect the rights and welfare of human subjects involved in clinical studies by evaluating, among other things, the
potential risks and benefits to subjects, processes for obtaining informed consent, monitoring of data to ensure subject safety, and provisions to protect the subjects’
privacy. Foreign studies conducted under an IND application must meet the same requirements that apply to studies being conducted in the U.S. Data from a foreign
study not conducted under an IND may be submitted in support of a NDA if the study was conducted in accordance with cGCP and FDA is able to validate the data.
Clinical trials are typically conducted in three sequential phases, but the phases may overlap, and different trials may be initiated with the same drug
candidate within the same phase of development in similar or differing patient populations. Phase I studies may be conducted in a limited number of patients but are
usually conducted in healthy volunteer subjects. The drug is usually tested for safety and, as appropriate, for absorption, metabolism, distribution, excretion,
pharmacokinetics and pharmacodynamics. Phase II usually involves studies in a larger, but still limited patient population to evaluate preliminarily the efficacy of the
drug candidate for specific, targeted indications; to determine dosage tolerance and optimal dosage; and to identify possible short-term adverse effects and safety
risks. Phase III trials are undertaken to gather additional information to evaluate the product’s overall risk-benefit profile, and to provide a basis for physician
labeling. Phase III trials evaluate clinical efficacy of a specific endpoint and test further for safety within an expanded patient population at geographically dispersed
clinical study sites. Phase I, Phase II or Phase III testing might not be completed successfully within any specific time period, if at all, with respect to any of our
product candidates. Results from one trial are not necessarily predictive of results from later trials. Furthermore, the FDA, sponsor or IRB may suspend clinical trials
at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.
We must register each controlled clinical trial, other than Phase I trials, on a website administered by the NIH (http://clinicaltrials.gov). Registration must
occur not later than 21 days after the first patient is enrolled, and the submission must include descriptive information (e.g., a summary in lay terms of the study
design, type and desired outcome), recruitment information (e.g., target number of participants and whether healthy volunteers are accepted), location and contact
information, and other administrative data (e.g., FDA identification numbers). Within one year of a trial’s completion, information about the trial including
characteristics of the patient sample, primary and secondary outcomes, trial results written in lay and technical terms, and the full trial protocol must be submitted to
the ClinicalTrials.gov databank. The results information is posted to the website unless the drug has not yet been approved, in which case the NIH posts the
information shortly after approval. A NDA, and certain other submissions to the FDA, require certification of compliance with these clinical trials database
requirements. There are proposals to expand these registration requirements to additional studies.
The results of the preclinical studies and clinical trials, together with other detailed information, including information on the manufacture and composition
of the product and proposed labeling for the product, are submitted to the FDA as part of a NDA requesting approval to market the product candidate for a proposed
indication. Under the Prescription Drug User Fee Act, as amended, the fees payable to the FDA for reviewing a NDA, as well as annual fees for commercial
manufacturing establishments and for approved products, can be substantial. The NDA review fee alone can exceed $2.45 million subject to certain limited deferrals,
waivers and reductions that may be available to a qualifying NDA sponsor. Each NDA submitted to the FDA for approval is typically reviewed for administrative
completeness and reviewability within sixty days following submission of the application. If the FDA finds the NDA sufficiently complete, the FDA will “file” the
NDA, thus triggering a full review of the application. The FDA may refuse to file any NDA that it deems incomplete or not properly reviewable at the time of
submission. Current FDA performance goals provide for action on an application within 12 months of submission. The FDA, however, may not approve a drug
within these established timeline goals and its review clock for a particular NDA is subject to change from time to time because the review process is often
significantly extended by FDA requests for additional information or clarification. We may encounter difficulties or unanticipated costs in our efforts to secure
necessary FDA approvals, which could delay or preclude us from marketing our products. As part of its review, the FDA may refer applications for novel drug
products or drug products that present difficult questions of safety or efficacy to an advisory committee composed of outside experts review, for evaluation and a
recommendation as to whether the application should be approved and under what conditions. The advisory committee process may cause delays in the approval
timeline. The FDA is not bound by the recommendation of an advisory committee, but it considers such recommendations carefully, particularly after negative
recommendations or limitations, when making drug approval decisions.
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Further, the outcome of the review, even if generally favorable, may not be an actual approval but instead a “complete response letter” communicating the
FDA’s decision not to approve the application at that time, outlining the deficiencies in the NDA that need to be addressed in order to be eligible for approval, and
identifying what information and/or data (including additional preclinical or clinical data) is required before the application can be approved. Even if such additional
information and data are submitted, the FDA may decide that the NDA still does not meet the standards for approval. Data from clinical trials are not always
conclusive and the FDA may interpret data differently than we do.
The testing and approval process requires substantial time, effort and financial resources, and each may take years to complete. Data obtained from clinical
trials are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant
approval on a timely basis, or at all.
The FDA typically will inspect one or more clinical sites to assure compliance with cGCP before approving a NDA. The FDA also will inspect the facility
or the facilities at which the product is manufactured before the NDA is approved to assure compliance with cGMP. The FDA will not approve the product unless
cGCP and cGMP compliance is satisfactory. The FDA may also take into account results of inspections performed by certain counterpart foreign regulatory agencies
in assessing compliance with cGCP or cGMP. The FDA has entered into international agreements with foreign agencies, including the EMA, in order to facilitate this
type of information sharing. If the FDA determines the application, clinical sites, manufacturing process or manufacturing facilities are not acceptable, it will outline
the deficiencies in the submission and often will request additional testing or information.
The FDA may deny approval of a NDA if applicable statutory or regulatory criteria are not satisfied, or may require additional testing or information, which
can delay the approval process. FDA approval of any application may include many delays or never be granted. Notwithstanding the submission of any requested
additional information, the FDA ultimately may decide that a NDA does not satisfy the regulatory criteria for approval. If a product is approved, the approval will
impose limitations on the indicated uses for which the product may be marketed, may require that warning statements be included in the product labeling, and may
require that additional studies be conducted following approval as a condition of the approval. The FDA may limit the indications for use, approve narrow labeling
relegating a drug to second- line or later-line use, add limitations of use to the labeling or place other conditions on approvals, which could restrict the marketing of
an approved product. Further, FDA may require that certain contraindications, warnings or precautions be included in the product labeling. FDA also may impose
restrictions and conditions on product distribution, prescribing or dispensing in the form of a Risk Evaluation Mitigation Strategy (“REMS”) to ensure the safe use of
the drug, or otherwise limit the scope of any approval. In determining whether a REMS is necessary, the FDA must consider the size of the population likely to use
the drug, the seriousness of the disease or condition to be treated, the expected benefit of the drug, the duration of treatment, the seriousness of known or potential
adverse events, and whether the drug is a new molecular entity. A REMS may be required to include various elements, such as a medication guide or patient package
insert, a communication plan to educate health care providers of the drug’s risks, limitations on who may prescribe or dispense the drug, or other measures that the
FDA deems necessary to assure the safe use of the drug. To market an approved product for other indicated uses, or to make certain manufacturing or other changes,
requires FDA review and approval of a NDA Supplement or new NDA, which may themselves necessitate further clinical testing, and the payment of applicable
review fees. Further post-marketing testing and surveillance to monitor the safety or efficacy of a product may be required. In addition, new government
requirements may be established that could delay or prevent regulatory approval of our product candidates under development.
Under the Pediatric Research Equity Act of 2003 (“PREA”), NDAs or supplements to NDAs must contain data to assess the safety and effectiveness of the
drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug
is determined by the FDA to be safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers, to a qualifying NDA sponsor.
Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan designation has been granted. As the FDA has not
issued regulations applying PREA to orphan-designated indications, submission of a pediatric assessment is not presently required for an application to market a
product for an orphan-designated indication. However, PREA compliance may be required if approval is sought for other indications for which the drug has not
received orphan designation.
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Post-approval Requirements
After FDA approval of a product is obtained, we will be required to comply with a number of post-approval requirements, including, among other things,
establishment registration and product listing, record-keeping requirements, reporting certain adverse reactions and production problems to the FDA, providing
updated safety and efficacy information, and complying with requirements concerning advertising and promotional labeling. As a condition of approval of a NDA,
the FDA may require the applicant to conduct additional clinical trials or other post-market testing and surveillance to further monitor and assess the drug’s safety
and efficacy.
The FDA regulates strictly the marketing, labeling, advertising and promotion of drug products that are placed on the market. Although physicians may
prescribe a drug for off-label uses, manufacturers may only promote for the approved indications and in accordance with the approved labeling. The FDA and other
agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses and any other false or misleading promotion. Failure to comply with
the laws and regulations governing advertising and promotion can have negative consequences, including adverse publicity, warning and untitled letters from the
FDA, requests for corrective advertising or communications with doctors, and civil penalties or criminal prosecution.
In addition, the distribution of approved prescription pharmaceutical products is subject to the Prescription Drug Marketing Act (“PDMA”), which regulates
the distribution of drugs and drug samples at the federal level and sets minimum standards for the registration and regulation of drug distributors by the states.
Similarly, the Drug Supply Chain Security Act (“DSCSA”) regulates the distribution of prescription pharmaceutical drugs, requiring passage of a pedigree to track
and trace each prescription drug at the saleable unit level through the distribution system. The DSCSA also imposes obligations on drug manufacturers related to
suspect product identification/removal, verification, dealing only with authorized trading partners, and other elements. The DSCSA will be effective incrementally
over a 10-year period, with serialization of prescription drug products distributed in the U.S. effective November 27, 2017 for drug manufacturers. The PDMA,
DSCSA, and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution.
Also, quality control and manufacturing procedures must continue to conform to cGMP after approval. The FDA periodically inspects manufacturing
facilities to assess compliance with cGMP, which imposes certain procedural and recordkeeping requirements. Accordingly, manufacturers must continue to expend
time, money and effort in the area of process and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.
We rely, and expect to continue to rely, on third parties for the production of clinical and any future commercial quantities of our product candidates. Future
FDA inspections may identify compliance issues at our facilities or at the facilities of our contract manufacturers that may disrupt production or distribution or
require substantial resources to correct. In addition, discovery of problems with a product or the failure to comply with applicable requirements may result in
restrictions on a product, manufacturer or holder of an approved NDA, including withdrawal or recall of the product from the market or other voluntary, FDA-
initiated or judicial action that could delay or prohibit further marketing.
Once approval is granted, FDA may withdraw the approval if compliance with regulatory requirements is not maintained or if issues bearing on the
product’s safety or efficacy are discovered. Newly discovered or developed safety or effectiveness data or other information may also require changes to a product’s
approved labeling, including the addition of new warnings and contraindications, and also may require the implementation of other risk management measures. New
government requirements, including those resulting from new legislation, may be established that could delay or prevent FDA approval of our products under
development or negatively impact the marketing of any future approved products.
Orphan Drug Designation
We have received orphan drug designation from the FDA for ELX-02 for the treatment of MPS I for the treatment of Rett syndrome, and for the treatment of
cystinosis. The FDA may grant orphan drug designation to drugs intended to treat a “rare disease or condition,” which is defined as a disease or condition that affects
fewer than 200,000 individuals in the U.S., or more than 200,000 individuals in the U.S. and for which there is no reasonable expectation that the cost of developing
and making available in the U.S. a drug for this type of disease or condition will be recovered from sales in the U.S. for that drug. Orphan drug designation must be
requested before
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submitting an application for marketing approval. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and
approval process. Orphan drug designation can provide opportunities for grant funding towards clinical trial costs, tax advantages and FDA user-fee benefits. In
addition, if a product which has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the
product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a
period of seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity. Competitors may receive
approval of different drugs or biologics for the indications for which the orphan product has exclusivity.
Rare Pediatric Disease Designation and Priority Review Voucher
Some orphan drugs may also qualify for designation as a “rare pediatric disease” under Section 529 of the FDCA. Section 529 is similar to the Orphan Drug
Act, as both require that the “rare disease or condition” affect fewer than 200,000 persons in the U.S. In the Advancing Hope Act of 2016, Section 529 was changed
so that the “rare pediatric disease” must also meet the additional criteria of being a serious or life-threatening disease in which the serious or life-threatening
manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents. Under
Section 529 of the FDCA, FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet these criteria. Under this
program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed to receive a priority
review of a subsequent marketing application for a different product.
Hatch-Waxman Regulatory Exclusivity
Market and data exclusivity provisions under the FDCA can delay the submission or the approval of certain applications for competing products. The FDCA
provides a five-year period of non-patent data exclusivity within the U.S. to the first applicant to gain approval of a NDA for a new chemical entity. A drug is a new
chemical entity if the FDA has not previously approved any other new drug containing the same active moiety. During the exclusivity period, the FDA generally may
not accept for review an abbreviated new drug application (“ANDA”) or a 505(b)(2) NDA submitted by another company that references the previously approved
drug. An ANDA or 505(b)(2) NDA may be submitted after four years if it contains a certification of patent invalidity or non-infringement.
For some applications that do not qualify for five-year exclusivity, the FDCA provides a shorter three-year period of market exclusivity. Three-year
exclusivity applies to a NDA, 505(b)(2) NDA, or supplement to an existing NDA or 505(b)(2) NDA if new clinical investigations, other than bioavailability studies,
that were conducted or sponsored by the applicant, are deemed by the FDA to be essential to the approval of the application, for example, for new indications,
dosages, strengths or dosage forms of an existing drug. This three-year exclusivity covers only the conditions of use associated with the new clinical investigations
and, as a general matter, does not prohibit the FDA from approving ANDAs or 505(b)(2) NDAs for generic versions of the original, unmodified drug product. Five-
year and three-year exclusivity will not delay the submission or approval of a full NDA; however, an applicant submitting a full NDA would be required to conduct
or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.
Pediatric Exclusivity
Pediatric exclusivity is another type of non-patent market exclusivity in the U.S. and, if granted, provides for the attachment of an additional six months of
market protection to the term of any existing Orange Book-listed patents or regulatory exclusivity, including the non-patent exclusivity periods described above. This
six-month exclusivity may be granted based on the voluntary completion of a pediatric study or studies in accordance with an FDA-issued “Written Request” for
such a study or studies.
Regulation Outside the United States
In order to market any product outside of the U.S., we would need to comply with numerous and varying regulatory requirements of other countries
regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of any future approved
products. Whether or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable regulatory authorities of
foreign countries before we can commence clinical trials or marketing of the product in
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those countries. The approval process varies from country to country and can involve additional product testing and additional administrative review periods. The
time required to obtain approval in other countries might differ from and be longer than that required to obtain FDA approval. Regulatory approval in one country
does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in
others.
Regulation in the European Union
We have obtained an orphan medicinal product designation from the European Commission, following an evaluation by the EMA’s Committee for Orphan
Medicinal Products, for ELX-02 for the treatment of MPS I and for the treatment of cystic fibrosis. The European Commission can grant orphan medicinal product
designation to products for which the sponsor can establish that it is intended for the diagnosis, prevention, or treatment of (1) a life-threatening or chronically
debilitating condition affecting not more than five in 10,000 people in the EU, or (2) a life threatening, seriously debilitating or serious and chronic condition in the
EU and that without incentives it is unlikely that sales of the drug in the EU would generate a sufficient return to justify the necessary investment. In addition, the
sponsor must establish that there is no other satisfactory method approved in the EU of diagnosing, preventing or treating the condition, or if such a method exists,
the proposed orphan drug will be of significant benefit to patients. Orphan drug designation is not a marketing authorization. It is a designation that provides a
number of benefits, including fee reductions, regulatory assistance, and the possibility to apply for a centralized EU marketing authorization, as well as 10 years of
market exclusivity following a marketing authorization. During this market exclusivity period, neither the European Medicines Agency, nor the European
Commission nor the Member States can accept an application or grant a marketing authorization for a “similar medicinal product.” A ‘similar medicinal product’ is
defined as a medicinal product containing a similar active substance or substances as contained in an authorized orphan medicinal product, and which is intended for
the same therapeutic indication. The market exclusivity period for the authorized therapeutic indication may be reduced to six years if, at the end of the fifth year, it
is established that the orphan designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance
of market exclusivity. In addition, a competing similar medicinal product may in limited circumstances be authorized prior to the expiration of the market exclusivity
period, including if it is shown to be safer, more effective or otherwise clinically superior to our product. Our product can lose orphan designation, and the related
benefits, prior to us obtaining a marketing authorization if it is demonstrated that the orphan designation criteria are no longer met.
Overview of Application Process
To obtain regulatory approval of a drug under the EU’s regulatory systems and authorization procedures, an applicant may submit a Marketing
Authorization Application (“MAA”) under a centralized, decentralized, or national procedure. The centralized procedure is compulsory for certain medicinal
products, including orphan medicinal products, like ELX-02 and medicinal products produced by certain biotechnological processes, and optional for certain other
innovative products. The centralized procedure enables applicants to obtain a marketing authorization that is valid in all EU member states based on a single
application. Under the centralized procedure, the EMA’s Committee for Human Medicinal Products (“CHMP”), is required to adopt an opinion on a valid application
within 210 days, excluding clock stops, during which additional written or oral information is to be provided by the applicant in response to questions. More
specifically, on day 120 of the procedure, once the CHMP has received the preliminary assessment reports and opinions from the rapporteur and co-rapporteur, the
CHMP prepares a list of potential outstanding issues, referred to as “other concerns” or “major objections.” These are sent to the applicant together with CHMP’s
recommendation. The CHMP can make one of two recommendations: (1) the marketing authorization could be granted provided that satisfactory answers are given
to the “other concerns” and/or “major objections” identified and that all conditions outlined in the list of outstanding issues are implemented and complied with; or
(2) the product is not approvable since there are “major objections.”
Applicants have three months from the date of receiving the potential outstanding issues to respond to the CHMP, and can request a three-month extension if
necessary. The granting of a marketing authorization will depend on the recommendations and potential major objections identified by the CHMP as well as the
ability of the applicant to adequately respond to these findings. An accelerated assessment can be granted by the CHMP in exceptional cases, when a medicinal
product is expected to be of major public health interest, in particular from the viewpoint of therapeutic innovation. In this circumstance, the EMA ensures that the
opinion of the CHMP is given within 150 days. After the adoption of the CHMP opinion, a decision on the MAA must be adopted by the European Commission,
after consulting the EU member states, which in total should be completed in 67 days.
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An applicant for an MAA may request a re-examination in the event of a negative opinion, in connection with which CHMP appoints new rapporteurs.
Within 60 days of receipt of the negative opinion, the applicant must submit a document explaining the basis for its request for re-examination. The CHMP has
60 days to consider the applicant’s request for re-examination. The applicant may request an oral explanation before the CHMP, which is routinely granted, following
which CHMP will adopt a final opinion. The final opinion, whether positive or negative, is published by the CHMP shortly following the CHMP meeting at which
the oral explanation takes place.
Conditional Marketing Authorizations
In specific circumstances, EU legislation enables applicants to obtain a marketing authorization on a conditional basis prior to obtaining the comprehensive
clinical data required for an application for a full marketing authorization. Such conditional approvals may be granted for products designated as orphan medicinal
products, if (1) the risk-benefit balance of the product is positive, (2) it is likely that the applicant will be in a position to provide the required comprehensive clinical
trial data, (3) the product fulfills unmet medical needs, and (4) the benefit to public health of the immediate availability on the market of the medicinal product
concerned outweighs the risk inherent in the fact that additional data are still required. A conditional marketing authorization may contain specific obligations to be
fulfilled by the marketing authorization holder, including obligations with respect to the completion of ongoing or new studies, and with respect to the collection of
pharmacovigilance data. Conditional marketing authorizations are valid for one year, and may be renewed annually, if the risk-benefit balance remains positive, and
after an assessment of the need for additional or modified conditions and/or specific obligations. The timelines for the centralized procedure described above also
apply with respect to the review by the CHMP of applications for a conditional marketing authorization. The granting of a conditional marketing authorization will
depend on the applicant’s ability to fulfill the conditions imposed within the agreed upon deadline.
Variations to Conditional Marketing Authorizations
After the granting of a conditional marketing authorization, the marketing authorization holder may submit an application to vary the conditional marketing
authorization under a variation procedure. In the case of the introduction of an additional therapeutic indication, the timeframe for the variation procedure for the
initial assessment of the dossier is generally 90 days (plus up to 20 days for validation).
In the framework of a variation application assessment procedure, however, the EMA may send one or more requests for supplementary information to the
marketing authorization holder, requiring that additional information be provided by the marketing authorization holder to support its variation application. Such
supplementary requests will be sent together with a timetable stating the date by when the marketing authorization holder must submit the requested data and, where
appropriate, the extended evaluation period to be applied to such variation procedure. The 90-day variation procedure may be suspended for up to three months for
the marketing authorization holder to submit its responses to such supplementary requests. The marketing authorization holder will be notified of the outcome of the
CHMP’s assessment of the variation procedure within 15 days from the adoption of the CHMP opinion. If unfavorable, the CHMP opinion may be subject to a re-
examination procedure upon the marketing authorization holder’s request. This may imply an additional minimum two-month procedure. If the CHMP opinion is
favorable, the European Commission will vary the marketing authorization to introduce the additional therapeutic indication within approximately two months from
the receipt of the final CHMP opinion.
Additional Requirements and Considerations
Prior to obtaining a marketing authorization in the EU, applicants have to demonstrate compliance with all measures included in an EMA-approved
Pediatric Investigation Plan (“PIP”), covering all subsets of the pediatric population, unless the EMA has granted (1) a product-specific waiver, (2) a class waiver, or
(3) a deferral for one or more of the measures included in the PIP. In the case of orphan medicinal products, completion of an approved PIP can result in an extension
of the aforementioned market exclusivity period from ten to twelve years.
In the EU, independently generated data submitted as part of a full marketing authorization application dossier are protected by regulatory data protection
(‘data exclusivity’) for a period of eight years from the granting of a marketing authorization for a ‘reference product’. This means that for a period of eight years,
competent authorities may not accept marketing authorization applications that rely on the independently generated data in the marketing authorization dossier of the
reference product. Generic medicinal products that rely on the independently generated data of the reference product may not be placed on the market for 10 years
from the granting of the initial marketing authorization for the reference medicinal product. These periods of data exclusivity and market exclusivity do not prevent
other companies from obtaining a marketing authorization based on their own independently generated data.
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Were we able to obtain a marketing authorization for ELX-02 for any indication in the EU, we would be required to comply with a range of requirements
applicable to the manufacturing, marketing, promotion and sale of medicinal products. We must, for example, comply with the EU’s stringent pharmacovigilance or
safety reporting rules, pursuant to which post-authorization studies and additional monitoring obligations can be imposed. Other requirements relate to, for example,
the manufacturing of products and active pharmaceutical ingredients in accordance with good manufacturing practice standards. Competent authorities of EU
member states may conduct inspections to verify our compliance with applicable requirements, and we will have to continue to expend time, money and effort to
remain compliant. Non-compliance with EU requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of
products for the pediatric population, can also result in significant financial penalties in the EU Similarly, failure to comply with the EU’s requirements regarding the
protection of individual personal data can also lead to significant penalties and sanctions. Individual EU member states may also impose various sanctions and
penalties in case we do not comply with locally applicable requirements.
Off-label promotion of medicinal products is prohibited in the EU. The applicable laws at the EU level and in the individual EU member states also prohibit
the direct-to-consumer advertising of prescription-only medicinal products. Violations of the rules governing the promotion of medicinal products in the EU could be
penalized by administrative measures, fines and imprisonment. These laws may further limit or restrict our promotional activities with health care professionals. In
addition, legislation adopted at the EU level and by individual EU member states require that promotional materials and advertising in relation to medicinal products
comply with the product’s Summary of Product Characteristics (“SmPC”), as approved by the competent authorities. The SmPC is the document that provides
information to physicians concerning the safe and effective use of the medicinal product. Promotion of indications not covered by the SmPC is specifically
prohibited.
The EMA is responsible for coordinating inspections to verify compliance with the principles of GCP, cGMP, GLP, and good pharmacovigilance practice
(“GVP”). These inspections are also intended to verify compliance with other aspects of the supervision of authorized medicinal products in use in the EU. The EMA
coordinates any inspection requested by the CHMP in connection with the assessment of MAAs. Inspections may be routine or triggered by issues arising during the
assessment of the dossier or by other information, such as previous inspection experience. Inspections usually are requested during the initial review of an MAA but
could arise post-authorization.
Inspectors are drawn from member states of the EU and the European Economic Area. Following an inspection, the inspectors provide a written inspection
report to the inspected site or applicant and provide an opportunity for response. Some inspection reports require follow-up and may result in additional adverse
consequences due to critical or major findings. The inspectors and the CHMP will comment on any response from an inspected site or applicant and may monitor
future compliance with any proposed corrective action plan.
Possible consequences of critical and major findings resulting from GCP inspections include rejection of clinical trial data, causing significant delays in
obtaining final marketing authorization, or other direct action by national regulatory authorities.
Early Access Programs
Many jurisdictions around the world allow the supply of unauthorized medicinal products in the context of strictly regulated and exceptional early access
programs, and some countries may provide reimbursement for drugs provided in the context of such programs. In the EU, the legal basis for early access programs,
also referred to as named-patient and compassionate use programs, is set out in the EU legislation regulating the authorization, manufacture, distribution and
marketing of medicinal products. Detailed regulatory requirements applicable to early access programs have been adopted and implemented by EU member states in
their national laws. The promotion, advertising and marketing of unauthorized medicinal products is generally prohibited, and authorization for early access
programs must generally be obtained from national competent authorities, which might not grant such authorization. Obtaining authorization for an early access
program in one country does not ensure that authorization will be obtained in another country. U.S. law permits “expanded access” (also known as compassionate
use and treatment use) for certain patients with serious diseases who have no comparable alternative treatment options. To provide expanded access, sponsors must
submit detailed regulatory information to the FDA. FDA authorization depends on several different factors, including whether expanded access will interfere with
related clinical trials or drug development. In addition, the Right to Try Act was signed into law in the U.S. on May 30, 2018, and allows certain eligible patients to
have access to certain eligible investigational drugs outside of clinical trials if the patient’s licensed treating physician certifies that the patient has exhausted FDA-
approved treatment options and cannot participate in a clinical trial of the investigational drug. Sponsors may not promote products as safe or effective for expanded-
access or right to try uses.
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Pharmaceutical Pricing and Reimbursement
The containment of healthcare costs has become a priority of federal, state and foreign governments, and the prices of pharmaceuticals have been a focus of
this effort. The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs to limit the
growth of government-paid healthcare costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for
branded prescription drugs. For example, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 expanded Medicare coverage for drug
purchases by the elderly and changed the way Medicare covers and pays for pharmaceutical products. Cost reduction initiatives and other provisions of this law may
decrease the coverage and reimbursement rate that we may receive for any products approved in the U.S. Likewise, healthcare reform measures under the Patient
Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, referred to together as the Affordable Care
Act, contain provisions that may reduce the profitability of drug products by increasing the minimum level of Medicaid rebates payable by manufacturers of brand-
name drugs from 15.1% to 23.1%, effective 2011, extending the Medicaid rebate to Medicaid managed care plans, changing the Medicaid rebate rates for line
extensions or new formulations of oral solid dosage form, mandating discounts for certain Medicare Part D beneficiaries, and imposing a non-deductible annual fee
on pharmaceutical manufacturers or importers who sell “branded prescription drugs,” effective 2011, expanding the types of entities eligible for the “Section 340B
discounts” for outpatient drugs, requiring manufacturers to participate in a coverage gap discount program, under which they must agree to offer 50% point-of-sale
discounts off negotiated prices of applicable branded drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient
drugs to be covered under Medicare Part D and creating a process for approval of biologic therapies that are similar or identical to approved biologics. There are
numerous steps required to implement the Affordable Care Act, and implementation remains ongoing. Congress also has enacted, and may continue to seek,
legislative changes that alter, delay, or eliminate some of its provisions. On February 1, 2016, the Centers for Medicare and Medicaid Services released a long-
awaited new rule, the Medicaid Program Covered Outpatient Drug Final Rule, effective April 1, 2016, implementing various provisions of the Affordable Care Act
related to “covered outpatient drugs,” including revising the calculation of “average manufacturer price” and addressing other issues relating to Medicaid price
reporting and reimbursement. These and other changes contribute to the uncertainty of the ongoing implementation and impact of the Affordable Care Act; they also
underscore the potential for additional reform going forward. Certain provisions of enacted or proposed legislative changes may negatively impact coverage and
reimbursement of healthcare items and services.
Increasing pricing pressure continues from managed care organizations, government agencies and programs, particularly for new and innovative therapies,
that could negatively affect the company’s sales and profit margins for any product candidate for which we receive regulatory approval for commercial sale. In the
U.S., these include practices of managed care groups, federal and state exchanges, and institutional and governmental purchasers. Changes to the health care system
enacted as part of health care reform in the U.S., as well as increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private sector
beneficiaries, could negatively impact the company’s sales and profit margins. Such pressures may also increase the risk of litigation or investigations by the
government regarding pricing calculations. There has also been recent negative publicity and Congressional scrutiny around pharmaceutical drug pricing in the U.S.
These dynamics may give rise to negative reactions to pricing decisions for products for which we may receive regulatory approval in the future, possibly limiting
our ability to generate revenue and attain profitability. Moreover, the pharmaceutical industry will likely face greater regulation and political and legal action in the
future. In this healthcare regulatory climate, there may be significant delays in and impediments to obtaining coverage and reimbursement for newly approved drugs.
Any regulatory approval of our products is limited to specific diseases and indications for which our products have been deemed safe and effective by the FDA.
Coverage by federal healthcare programs may be more limited than the purposes for which the drug is approved by the FDA or comparable foreign regulatory
authorities’ coverage of the same products. In the U.S. and markets in other countries, sales of any products for which we receive regulatory approval for commercial
sale will depend in part on the extent to which the costs of the products will be covered and reimbursed by third-party payors, including government healthcare
programs such as Medicare and Medicaid, private health insurers and other organizations. Obtaining reimbursement for orphan drugs may be particularly difficult
because of the higher prices typically associated with drugs directed at smaller populations of patients. In addition, third-party payors are likely to impose strict
requirements for reimbursement in the use of a higher priced drug. Net prices for products may be reduced by mandatory discounts or rebates required by
government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of products from countries where they may be
sold at lower prices than in the U.S.
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The process for determining whether a payor will provide coverage for a product may be separate from the process for setting the price or reimbursement
rate that the payor will pay for the product once coverage is approved. Third-party payors may limit coverage to specific products on an approved list, or formulary,
which might not include all of the FDA approved products for a particular indication. Third-party payors are increasingly challenging the price and examining the
cost-effectiveness of medical products and services. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the cost-effectiveness of
our products. Our product candidates may not be considered cost-effective. In the future, we may need to conduct direct head-to-head studies to demonstrate clinical
superiority and cost-effectiveness. Our product candidates may not be considered clinically superior and cost-effective to competitor products.
The marketability of any products for which we receive regulatory approval for commercial sale may suffer if the government and other third-party payors
fail to provide adequate coverage and reimbursement. In addition, there is an increasing emphasis on managed care in the U.S. that may negatively impact
pharmaceutical pricing.
In some countries, particularly the countries of the EU, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries,
pricing and reimbursement negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. In addition,
there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. In
some countries, governments can set conditions that must be satisfied for prices to be set at a certain value. Political, economic and regulatory developments may
further complicate pricing and reimbursement negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by
various EU member states, and parallel distribution (arbitrage between low-priced and high-priced member states), can further reduce prices. In some countries we
may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of our product candidate to other available therapies in order to obtain
reimbursement or pricing approval.
Freedom of Information Requests
We are also subject, in the U.S. and many other countries, to various regulatory schemes that require disclosure of clinical trial data or allow access to our
data via freedom of information requests. We have been and may, from time to time, be notified by regulators, such as the EMA or the competent authorities of EU
member states or FDA that they have received a freedom of information request for documents that they hold relating to our company, including information related
to our product candidates.
Fraud and Abuse Laws
Any present or future arrangements with third-party payors, healthcare providers and professionals and customers may expose us to broadly applicable fraud
and abuse and other healthcare laws and regulations that may restrict certain marketing and contracting practices. These laws include, and are not limited to, anti-
kickback and false claims statutes.
Both the federal Foreign Corrupt Practices Act (“FCPA”), and the UK Bribery Act of 2010 (“Bribery Act”), are broad in scope and will require companies
to make and keep books and records that accurately and fairly reflect the transactions of the company and to devise and maintain an adequate system of internal
accounting controls. The FCPA prohibits the offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly, to a non-U.S.
government official in order to improperly influence any act or decision, secure any other improper advantage, or obtain or retain business. Under the Bribery Act,
companies which carry on a business or part of a business in the United Kingdom may be held liable for bribes given, offered or promised to any person, including
non-UK government officials and private persons, by employees and persons associated with the company in order to obtain or retain business or a business
advantage for the company.
The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or
indirectly, in cash or kind, to induce or reward either the referral of an individual for, or the purchase, or order or recommendation of, any good or service, for which
payment may be made under federal and state healthcare programs such as Medicare and Medicaid. This statute has been broadly interpreted to apply to
manufacturer arrangements with prescribers, purchasers and formulary managers, among others. Although a number of statutory exemptions and regulatory safe
harbors exist to protect certain common activities from prosecution, the exemptions and safe harbors for this statute are narrow, and practices that involve
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compensation intended to induce prescriptions, purchases, or recommendations may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Our
practices may not always meet all of the criteria for safe harbor protection. Further, the Affordable Care Act amended the intent requirement of the federal anti-
kickback and criminal health care fraud statutes. This amendment provides that a person or entity no longer needs to have knowledge of these statutes or specific
intent to violate them. In addition, the government may assert that a claim including items or services resulting from a violation of the federal anti-kickback statute
constitutes a false or fraudulent claim for purposes of the federal False Claims Act. Several other countries, including the United Kingdom, have enacted similar anti-
kickback, fraud and abuse laws and regulations.
The federal False Claims Act imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly
presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or
conceal an obligation to pay money to the federal government. Several pharmaceutical and health care companies have been prosecuted under these laws for
allegedly providing free product to customers with the expectation that the customers would bill federal programs for the free product. Other companies have been
prosecuted for causing false claims to be submitted because of these companies’ marketing of a product for unapproved, and thus non-reimbursable, uses. Potential
liability under the federal False Claims Act includes mandatory treble damages and significant per claim penalties, currently set at $5,500 to $11,000 per false claim.
The majority of states also have statutes or regulations similar to the federal anti-kickback statute and False Claims Act, which apply to items and services
reimbursed under Medicaid and other state programs; furthermore, in several states, these statutes and regulations apply regardless of the payor. Sanctions under
these federal and state laws may include civil monetary penalties, exclusion of a manufacturer’s product from reimbursement under government programs,
debarment, criminal fines, and imprisonment.
The Affordable Care Act included a provision requiring certain providers and suppliers of items and services to Federal Health Care Programs to report and
return overpayments within sixty days after they are “identified,” or the Overpayment Statute. In February 2016, the Centers for Medicare and Medicaid Services
(“CMS”) released long-awaited regulatory guidance (in the form of a final rule) to Medicare Part A and Part B providers and suppliers regarding how to comply with
the Overpayment Statute. CMS had previously released a final rule addressing overpayments involving Medicare Part C and Part D providers in May 2014. Although
Medicare Part A/B/C/D providers and suppliers have faced federal False Claims Act liability since 2010 for failures to comply with the Overpayment Statute, these
final rules interpreting the Overpayment Statute provide guidance to providers and suppliers regarding how to comply appropriately with applicable obligations, and
guidance to government regulators and enforcement authorities regarding monitoring and prosecuting suspected violations. This final rule is not directly applicable
to manufacturers, but may impact their customers and potential customers who are Medicare providers and suppliers.
The federal Physician Payments Sunshine Act, enacted as part of the Affordable Care Act, and its implementing regulations, require manufacturers of drugs,
devices, biologics and medical supplies to report to the Department of Health and Human Services information related to payments and other transfers of value made
to covered recipients, such as physicians and teaching hospitals, as well as physician ownership and investment interests. Payments made to physicians and certain
research institutions for clinical trials are included within the ambit of this law. Pharmaceutical manufacturers are required to report and disclose payments and
ownership and investment interests held by physicians and their immediate family members during the preceding calendar year. Manufacturers were required to
make these first reports for information collected in 2013 by March 31, 2014. Such information is publicly available from the Secretary of Health and Human
Services in a searchable format, with data collected in each calendar year published the following June. Failure to submit required information may result in civil
monetary penalties of up to $150,000 per year (and up to $1.0 million per year for “knowing failures”) for all payments, transfers of value or ownership or
investment interests not reported in an annual submission. If not preempted by this federal law, several states currently require pharmaceutical companies to report
expenses relating to the marketing and promotion of pharmaceutical products and to report gifts and payments to individual physicians in those states. Depending on
the state, legislation may prohibit various other marketing related activities, or require the posting of information relating to clinical studies and their outcomes. In
addition, certain states, such as California, Nevada, Connecticut and Massachusetts, require pharmaceutical companies to implement compliance programs or
marketing codes and several other states are considering similar proposals. Manufacturers that fail to comply with these state laws can face civil penalties.
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Statutory requirements to disclose publicly payments made to healthcare professionals and healthcare organizations have also been enacted in certain EU
member states. In addition, self-regulatory bodies of the pharmaceuticals industry, such as the European Federation of Pharmaceutical Industries and Associations
(EFPIA”) have published codes of conduct to which its members have agreed to abide by, that require the public disclosure of payments made to healthcare
professionals and healthcare organizations.
The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical
Health Act, imposes criminal liability for executing a scheme to defraud any healthcare benefit program and for knowingly and willfully falsifying, concealing or
covering up a material fact or making any materially false statements in connection with the delivery of or payment for healthcare benefits, items or services. HIPAA
also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable
health information, and imposes criminal and civil liability for violations of these obligations. Recently, the U.S. federal government criminally prosecuted an
employee of a pharmaceutical company for an alleged violation of the privacy requirements under HIPAA. Furthermore, certain privacy laws and genetic testing
laws may apply directly to our operations and/or those of our collaborators and may impose restrictions on our use and dissemination of individuals’ health
information.
The foregoing discussion should be read in conjunction with the information appearing under “Risk Factors—Our relationships with customers, healthcare
providers and professionals and third-party payors are or will be subject to applicable anti-kickback, fraud and abuse, transparency and other healthcare laws and
regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings” which
contains important information regarding some of the risks to our business arising as a result of fraud and abuse laws.
Competition
Our industry is highly competitive and subject to rapid and significant technological change. New therapies and treatments based on innovative discoveries
emerge frequently.
Our potential competitors are public and private companies, pharmaceutical companies and biotechnology companies who may be engaged in targeting the
same biological processes that our compounds are designed to impact and who may be developing products for the same indications as our investigational drug
candidates. Potential competitors could also include academic institutions, government agencies, other public and private research organizations and charitable
venture philanthropic organizations that conduct research, seek patent protection and/or establish collaborative arrangements for research, development,
manufacturing and commercialization.
Many of our competitors have substantially greater financial resources, technical resources, expertise in research and development, manufacturing,
preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. These competitors also compete with us in
recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials. As a result, our
competitors may commercialize products more rapidly or effectively than we do, which would affect our competitive position, the likelihood that our drug
candidates, if approved, would achieve and maintain market acceptance and our ability to generate meaningful revenues from our products.
Our commercial opportunities could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have
fewer side effects, are more convenient or are more affordable than any products that we develop. The key competitive factors affecting the success of ELX-02 and
our other product candidates are their impact on the targeted diseases, superiority over competing products, long-term safety, convenience, price and the availability
of coverage and reimbursement from government and other third-party payors.
Several companies are involved in researching and developing molecules targeting suppression of nonsense mutations and enhancement of translational
read-through. However, we believe that ELX-02 is the only drug candidate in clinical development designed to treat nonsense mutations in CFTR the underlying
cause of cystic fibrosis and cystinosis, our lead indications. Additional competition to ELX-02 may arise from other programs that do not target a specific CFTR
mutation class but work via other mechanisms.
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Employees
As of February 28, 2019, we currently have 29 full-time employees. Of these employees, six are located at our Rehovot, Israel research and development
facility and twenty-three full-time employees are located in the U.S. We also use consultants as necessary to support key functions.
Our success is highly dependent on our ability to attract and retain qualified employees. Competition for employees is intense in the pharmaceutical
industry. None of our employees are covered by a labor union or are subject to collective bargaining agreement and we have never experienced any work stoppage.
We consider our relations with our employees to be good.
Additional Information
On December 19, 2017, Sevion Therapeutics, Inc. (“Sevion”), a Delaware corporation, acquired Eloxx Pharmaceuticals, Ltd. (“Eloxx Limited”), an Israeli
company, pursuant to a merger between the companies (the “Transaction”). Upon consummation of the Transaction (the “Closing”), Sevion adopted the business
plan of Eloxx Limited and discontinued the pursuit of Sevion’s business plan. In connection with the Transaction, Sevion acquired all of the outstanding capital stock
of Eloxx Limited in exchange for the issuance of an aggregate 20,316,656 shares of the Sevion’s common stock, par value $0.01 per share (the “Common Stock”),
after giving effect to a 1-for-20 reverse split effected immediately prior to the Transaction. As a result of the Transaction, Eloxx Limited became a wholly-owned
subsidiary of Sevion. While Sevion was the legal acquirer in the Transaction, Eloxx Limited was deemed the accounting acquirer. Immediately after giving effect to
the Transaction, on December 19, 2017, Sevion changed its name to Eloxx Pharmaceuticals, Inc.
Our principal executive offices are located at 950 Winter Street, Waltham, Massachusetts 02451, and our phone number is (781) 577-5300. In December
2017, we changed our name from Sevion Therapeutics Inc. to Eloxx Pharmaceuticals, Inc. and also changed our ticker symbol from SVON to ELOX. Our wholly-
owned subsidiary is Eloxx Pharmaceuticals, Limited.
Our internet address is http://www.eloxxpharma.com. The public can access, through a link on the “Investor Relations” section of our website, free of
charge, all reports and other information on file with the Securities and Exchange Commission (“SEC”), immediately after we electronically submit such material to
the SEC. In addition, we will provide electronic or paper copies of our filings free of charge upon request. Information contained on our corporate website or any
other website is not incorporated into this Report and does not constitute a part of this Report.
In addition, the public may read and copy any materials filed by the Company with the SEC at the SEC’s Public Reference Room located 100 F Street, NE,
Washington, DC 20549. Interested parties may call 1-800-SEC-0330 for further information. The SEC also maintains a website containing publicly available
information, at https://www.sec.gov.
We post our code of business conduct and ethics, which applies to all employees, including all executive officers, senior financial officers and directors, in
the “Corporate Governance” sub-section of the “Investor Relations” section of our corporate website at www.eloxxpharma.com. Our code of business conduct and
ethics complies with Item 406 of SEC Regulations S-K and the Rules of the NASDAQ Stock Market. We intend to disclose any changes to the code that affect the
provisions required by Item 406 of Regulation S-K and any waivers of the code of ethics for our executive officers, senior financial officers or directors, on our
corporate website.
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ITEM 1A.
RISK FACTORS
Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with all
other information in this Report, before you decide to purchase our common stock. If any of the possible adverse events described below actually occurs, we may be
unable to conduct our business as currently planned and our financial condition and operating results could be harmed. In addition, the trading price of our
common stock could decline due to the occurrence of any of the events described below, and you may lose all or part of your investment. Additional risks that we
currently do not know about, or that we currently believe immaterial, may also impair our business.
Risks Related to Drug Discovery, Development, Regulatory Approval and Commercialization
We depend heavily on the success of our lead product candidate, ELX-02. If ELX-02 fails during development or suffers any material delays, it may adversely
impact the commercial viability of ELX-02 and our business.
We currently have no products approved for sale. To date, we have invested substantially all of our efforts and financial resources in the research and
development of ELX-02, which is currently our only product candidate in clinical development. Our ELX-02 program is focused on development for cystic fibrosis
and cystinosis patients with diagnosed nonsense mutations. Our CTA has been approved by the FAMHP in Brussels and our IND submitted to the FDA is now open.
We expect to initiate Phase 2 studies in cystic fibrosis and cystinosis following completion of our ongoing Phase 1b MAD study and report top line results in 2019.
We also recently initiated a new program focused on rare inherited retinal disease and are conducting IND enabling studies for several compounds from our library.
Our ability to achieve and sustain profitability depends on obtaining regulatory approvals, and successfully commercializing ELX-02 and any future product
candidates, either alone or with third parties. Before obtaining regulatory approval for the commercial distribution of our therapeutic product candidates, we or a
collaborator must conduct extensive preclinical studies and clinical trials to demonstrate the safety and efficacy in humans of our product candidates. The clinical
trials, manufacturing and marketing of ELX-02, and any future product candidates, will be subject to extensive and rigorous review and regulation by numerous
governmental authorities in the U.S., the EU and other jurisdictions where we intend to test and, if approved, market our current and future product candidates.
Before obtaining regulatory approvals for the commercial sale of any product candidate, we must demonstrate through preclinical studies and clinical trials that the
product candidate is safe and effective for use in each target indication, and potentially in specific patient populations, including the pediatric population. This
process can take many years and may include post-marketing studies and surveillance, which would require the expenditure of substantial resources. Of the large
number of drugs in development for approval in the U.S. and the EU, only a small percentage successfully complete the FDA or EMA regulatory approval processes
and are commercialized. Accordingly, even if we are able to obtain the requisite financing to continue to fund our research, development and clinical programs, we
cannot assure you that ELX-02 or any of our future product candidates will be successfully developed or commercialized.
Preclinical studies and clinical trials are expensive, difficult to design and implement, can take many years to complete and are uncertain as to outcome. The
start or end of a clinical trial is often delayed or halted due to changing regulatory requirements, manufacturing challenges, required clinical trial administrative
actions, slower than anticipated patient enrollment, changing standards of care, availability or prevalence of use of a comparative therapeutic or required prior or
combination therapy, clinical outcomes or financial constraints. For instance, delays or difficulties in patient enrollment or difficulties in retaining trial participants
can result in increased costs, longer development times or termination of a clinical trial. Clinical trials of a new product candidate require the enrollment of a
sufficient number of patients, including patients who are suffering from the disease the product candidate is intended to treat and who meet other eligibility criteria.
Rates of patient enrollment are affected by many factors, including the size of the patient population, the eligibility criteria for the clinical trial, the age and condition
of the patients, the stage and severity of disease, the nature of the protocol, the proximity of patients to clinical sites and the availability of effective treatments for the
relevant disease.
We and our collaborating partners may be subject, directly or indirectly, to federal and state healthcare fraud and abuse and false claims laws and regulations. If
we or our collaborating partners are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
All marketing activities associated with product candidates that are approved for sale in the U.S., if any, will be, directly or indirectly through our customers,
subject to numerous federal and state laws governing the marketing and promotion of pharmaceutical products in the U.S., including, without limitation, the federal
Anti-Kickback
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Statute, the federal False Claims Act and the Health Insurance Portability and Accountability Act (“HIPAA”). These laws may adversely impact, among other things,
our proposed sales, marketing and education programs.
The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or
indirectly, to induce either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may be made under a
federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value,
including for example, gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of co-payments and deductibles,
ownership interests and providing anything at less than its fair market value. The reach of the Anti-Kickback Statute was also broadened by the Patient Protection
and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or the PPACA, which, among other things, amends the
intent requirement of the federal Anti-Kickback Statute and the applicable criminal healthcare fraud statutes. Pursuant to the amendment, a person or entity no longer
needs to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation. In addition, PPACA provides that the government
may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes
of the civil False Claims Act (discussed below) or the civil monetary penalties statute, which imposes penalties against any person who is determined to have
presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as
claimed or is false or fraudulent. Penalties for violations of the federal Anti-Kickback Statute include criminal penalties and civil sanctions such as fines,
imprisonment and possible exclusion from Medicare, Medicaid and other state or federal healthcare programs. Many states have also adopted laws similar to the
federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, not only the Medicare and
Medicaid programs.
The federal False Claims Act imposes liability on any person who, among other things, knowingly presents, or causes to be presented, a false or fraudulent
claim for payment by a federal healthcare program. The “qui tam” provisions of the False Claims Act allow a private individual to bring civil actions on behalf of the
federal government alleging that the defendant has submitted a false claim to the federal government, and to share in any monetary recovery. In addition, various
states have enacted false claims laws analogous to the False Claims Act. Many of these state laws apply where a claim is submitted to any third-party payer and not
merely a federal healthcare program. When an entity is determined to have violated the False Claims Act, it may be required to pay up to three times the actual
damages sustained by the government, plus civil penalties up to approximately $22,000 for each separate false claim.
The HIPAA created several new federal crimes, including health care fraud, and false statements relating to health care matters. The health care fraud statute
prohibits knowingly and willfully executing a scheme to defraud any health care benefit program, including private third-party payors. The false statements statute
prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection
with the delivery of or payment for health care benefits, items or services.
We are unable to predict whether we could be subject to actions under any of these or other fraud and abuse laws, or the impact of such actions. Moreover,
to the extent that any of our product candidates, if approved for marketing, will be sold in a foreign country, we and our current or future collaborators, may be
subject to similar foreign laws and regulations. If we or any of our current or future collaborators are found to be in violation of any of the laws described above and
other applicable state and federal fraud and abuse laws, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from
government healthcare reimbursement programs and the curtailment or restructuring or our operations, any of which could have a material adverse effect on our
business, results of operations and financial condition.
Positive results from preclinical or in vitro and in vivo testing of ELX-02 are not necessarily predictive of the results of future clinical trials of ELX-02. If we
cannot achieve positive results in our clinical trials for ELX-02, we may be unable to successfully develop, obtain regulatory approval for and commercialize
ELX-02.
Positive results from our preclinical testing of ELX-02 in vitro and in vivo may not necessarily be predictive of the results from our ongoing and planned
clinical trials in humans. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving
positive results in
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preclinical and in vitro and in vivo studies, and we, or the third parties whose product candidates we expect to be co-administered with ELX-02, may face similar
setbacks. Preclinical and clinical data are often susceptible to varying interpretations and analyses, and the FDA or EMA or other regulatory agencies may require
changes to our protocols or other aspects of our clinical trials or require additional studies. Additionally, many companies that believed their product candidates
performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or EMA approval. If we fail to secure positive results from our
clinical trials of ELX-02 or regulatory agencies require us to undertake significant additional studies as a result of our data, the development timeline, regulatory
approval and commercialization prospects for our lead product candidate, and, correspondingly, our business and financial prospects, would be materially adversely
affected, which may result in termination of development activities, the inability to raise additional needed capital and/or a precipitous decline in our stock price, as
well as impair our ability to enter into collaboration arrangements or damage existing strategic partnerships.
Our product candidates, including ELX-02, may cause adverse events or have other properties that could delay or prevent their regulatory approval or limit the
scope of any approved label or market acceptance.
Undesirable side effects caused by our product candidates, such as ELX-02, could cause us or regulatory authorities to interrupt, delay or halt clinical trials
and could result in the denial of regulatory approval by the FDA or other comparable foreign regulatory authorities. It is possible that, during the course of the
clinical development of ELX-02 or other product candidates, results of our clinical trials could reveal an unacceptable severity and prevalence of side effects. For
example, in preclinical testing of ELX-02, we observed renal toxicities in the animals we tested following administration of this compound at doses in excess of the
doses we expect to administer in our clinical trials. As a result of this or any other side effects, our clinical trials could be suspended or terminated or not even
allowed to commence, and the FDA or comparable foreign regulatory authorities could order us to cease further development, or deny approval, of our product
candidates for any or all targeted indications. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or
result in potential product liability claims.
Additionally, if one or more of our product candidates receive marketing approval, and we or others later identify undesirable side effects caused by such
products, a number of potentially significant negative consequences could result, including:
•
•
•
•
•
regulatory authorities may withdraw approvals of such product or impose restrictions on its distribution in the form of a new or modified risk
evaluation and mitigation strategy;
regulatory authorities may require additional labeling, such as additional warnings or contraindications, which may negatively impact sales;
we may be required to change the way the product is administered or to conduct additional clinical studies;
we could be sued and held liable for harm caused to patients; and
our reputation may suffer.
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could
significantly harm our business, results of operations and prospects.
Our clinical trials may be costly and lengthy, time-consuming and difficult to design and implement, may result in unforeseen costs and could be delayed or
terminated, which may have a material adverse effect on our business, results of operations and financial condition.
For human trials, patients must be recruited, and each product candidate must be tested at various doses and formulations for each clinical indication. In
addition, to ensure safety and effectiveness, the effect of drugs often must be studied over a long period of time, especially for the chronic genetic diseases that we
will be studying. Many of our programs focus on diseases with small patient populations making patient recruitment and enrollment difficult. Insufficient patient
enrollment in our clinical trials could delay or cause us to abandon a product development program. We may decide to abandon development of a product candidate
or a study at any time due to unfavorable results, or we may have to spend considerable resources repeating clinical trials or conducting additional trials, either of
which would increase costs and delay any revenue from those product candidates, if any.
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Failure or delay in the commencement or completion of our clinical trials may be caused by several factors, including:
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slower than expected rates of patient recruitment, particularly with respect to trials of rare diseases such as nonsense mutation cystic fibrosis;
determination of dosing levels and corresponding effect analysis;
unforeseen safety issues;
lack of effectiveness during clinical trials;
inability to monitor patients adequately during or after treatment;
inability or unwillingness of medical investigators and IRBs to follow our clinical protocols; and
lack of sufficient funding to finance the clinical trials.
We may find it difficult to recruit and enroll patients in our clinical trials, which could cause significant delays in the completion of such trials or may cause us
to abandon one or more clinical trials.
Some of the diseases that our product candidates are intended to treat are rare and ultra-rare and we expect only a subset of the patients with these diseases
will be eligible for our clinical trials. Because ELX-02 targets small populations and patient numbers have not been determined definitively, we must be able to
identify patients in order to complete our development programs, secure regulatory approval and commercialize ELX-02 successfully.
In addition, the protocol for our clinical trials generally mandates that a patient cannot be involved in more than one clinical trial for the same indication.
Therefore, subjects that participate in ongoing clinical trials for products that are competitive with our product candidates are not available to participate in our
clinical trials. We cannot guarantee that any of our programs will identify a sufficient number of patients to complete clinical development, pursue regulatory
approval and market our product candidates if approved. The combined number of patients in the U.S., Japan and Europe and elsewhere may turn out to be lower
than expected, may not be otherwise amenable to treatment with ELX-02, or new patients may become increasingly difficult to identify, all of which would adversely
affect our results of operations and our business. An inability to recruit and enroll a sufficient number of patients for any of our current or future clinical trials would
result in significant delays or may require us to abandon one or more clinical trials altogether, which could impact our ability to develop our product candidates and
may have a material adverse effect on our business, results of operations and financial condition.
Because our clinical trials depend upon third-party researchers, scientists and consultants, the results of our clinical trials and such research activities are
subject to delays and other risks that are, to a certain extent, beyond our control, which could impair our clinical development programs and our competitive
position.
We depend on independent investigators, consultants, researchers, medical experts, collaborators, chemists, toxicologist and a small number of medical
institutions and third-party contract research organizations to assist with our research efforts and conduct our preclinical and clinical trials and related activities.
These collaborators, scientists, consultants and other third parties have provided, and we expect that they will continue to provide, valuable advice and services
regarding our clinical development programs and product candidates. These collaborators, scientists, consultants and other third parties are not our employees, may
have other commitments that would limit their future availability to us and typically will not enter into non-compete agreements with us. We cannot control the
amount or timing of resources that they devote to our preclinical and or clinical development programs and they may not assign as great a priority to our preclinical
or clinical development programs or pursue them as diligently as we would if we were undertaking such programs directly. If outside collaborators fail to devote
sufficient time and resources to our preclinical and clinical development programs, or if their performance is substandard, the authorization of investigational new
drug applications (“INDs”) and pre-clinical trial applications (“CTAs”) and the approval of anticipated new drug applications (“NDAs”) and other marketing
applications, and our introduction of new drugs, if any, may be delayed or impeded, which could impair our clinical development programs and would have a
material adverse effect on our business and results of operations. These collaborators may also have relationships with other commercial entities, some of whom may
compete with us and we may be unable to prevent them from establishing competing businesses or developing competing products.
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We are subject to extensive governmental regulation including the requirements of FDA and comparable foreign regulatory authorities for development and
approval of our product candidates before they can be marketed.
We, our product candidates, our suppliers, our contract manufacturers, our contract testing laboratories and our clinical trial sites and clinical trial
researchers are subject to extensive regulation by the FDA and comparable foreign regulatory authorities. Failure to comply with applicable requirements of the FDA
or comparable foreign regulatory authorities could result in, among other things, any of the following actions:
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warning letters;
fines and other monetary penalties;
unanticipated expenditures;
holds on the initiation or continuation of clinical trials;
delays in the FDA’s or other foreign regulatory authorities’ approving, or the refusal of any regulatory authority to approve, any product candidate;
product recall or seizure;
interruption of manufacturing or clinical trials;
operating restrictions;
injunctions; and
criminal prosecutions.
In addition to the approval requirements, other numerous and pervasive regulatory requirements apply, both before and after approval of our product
candidates, to us, our product candidates, and our suppliers, contract manufacturers, and contract laboratories, and our clinical trial sites and clinical trial researchers
including requirements related to testing, manufacturing, quality control, labeling, advertising, promotion, distribution, exporting product materials, reporting to the
FDA of certain adverse experiences associated with use of the product candidate, and obtaining additional approvals for certain modifications to the product
candidate or its labeling or claims following approval, if any.
We also are subject to inspection by the FDA and comparable foreign regulatory authorities, to determine our compliance with regulatory requirements, as
are our suppliers, contract manufacturers, contract testing laboratories, and our clinical trial sites and clinical researchers and there can be no assurance that the FDA
or any other comparable foreign regulatory authority will not identify compliance issues that may disrupt production or distribution, or require substantial resources
to correct. We may be required to make modifications to our manufacturing operations in response to these inspections, which may require significant resources and
may have a material adverse effect upon our business, results of operations and financial condition.
The approval process for any product candidate may also be delayed by changes in government regulation, future legislation or administrative action or
changes in policy of the FDA and comparable foreign regulatory authorities that occur prior to or during their respective regulatory reviews of such product
candidate. Delays in obtaining regulatory approvals with respect to any product candidate may:
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delay commercialization of, and our ability to derive product revenues from, such product candidate;
delay any regulatory-related milestone payments payable under outstanding collaboration agreements;
require us to perform costly procedures with respect to such product candidate; or
otherwise diminish any competitive advantages that we may have with respect to such product candidate.
We may not obtain the necessary FDA, EMA or other worldwide regulatory approvals to commercialize our product candidates in a timely manner, if at all,
which would have a material adverse effect on our business, results of operations and financial condition.
We need FDA approval to commercialize our product candidates in the U.S., EMA approval to commercialize our product candidates in the EU and
approvals from other foreign regulatory authorities to commercialize our
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product candidates elsewhere in the world. In order to obtain FDA approval of any of our product candidates, we must submit to the FDA a NDA demonstrating that
the product candidate is safe for humans and effective for its intended use. This demonstration requires significant research and animal tests, which are referred to as
preclinical studies, as well as human tests, which are referred to as clinical trials. In the EU, we must submit a Marketing Authorization Application, or MAA, to the
EMA. Satisfaction of the FDA’s, the EMA’s and other foreign regulatory authorities’ regulatory requirements typically takes many years, depends upon the type,
complexity and novelty of the product candidate and requires substantial resources for research, development and testing. Even if we comply with all the requests of
regulatory authorities, they may ultimately reject any marketing applications that we file for our product candidates, or we might not obtain regulatory clearance in a
timely manner if at all. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced or late-stage clinical trials,
even after obtaining promising earlier trial results or preliminary findings or other comparable results for such clinical trials. Further, even if favorable testing data is
generated during the clinical trials of a product candidate, the applicable regulatory authority may not accept or approve the marketing application filed by a
pharmaceutical or biotechnology company for the product candidate. Failure to obtain approval of the FDA, EMA or comparable foreign regulatory authorities of
any of our product candidates in a timely manner, if at all, will severely undermine our business, financial condition and results of operation by reducing our
potential marketable products and our ability to generate corresponding product revenues.
Our research and clinical efforts may not result in drugs that the FDA, EMA or other foreign regulatory authorities consider safe for humans and effective
for indicated uses, which would have a material adverse effect on our business, results of operations and financial condition. After clinical trials are completed for
any product candidate, if at all, the FDA, EMA and other foreign regulatory authorities have substantial discretion in the drug approval process of the product
candidate in their respective jurisdictions and may require us to conduct additional clinical testing or perform post- marketing studies, which would cause us to incur
additional costs. Incurring such costs may have a material adverse effect on our business, results of operations and financial condition.
If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell any of our product candidates that
obtain regulatory approval, we may be unable to generate any revenue.
We have no experience selling and marketing our product candidates or any other products. To successfully commercialize any products that may result
from our clinical development programs and obtain regulatory approval, we will need to develop these capabilities, either on our own or with the assistance of others.
We may seek to enter into collaborations with other entities to utilize their marketing and distribution capabilities, but we may be unable to do so on favorable terms,
if at all. If any future collaborative partners do not commit sufficient resources to commercialize our future products, if any, and we are unable to develop the
necessary marketing capabilities on our own, we will be unable to generate sufficient product revenue to sustain our business. We will be competing with many
companies that currently have extensive and well-funded marketing and sales operations. Without an internal team or the support of a third party to perform
marketing and sales functions, we may be unable to compete successfully against these more established companies or successfully commercialize any of our
product candidates.
Even though we have received orphan drug designation from the FDA for ELX-02 for the treatment of cystinosis, we may not be able to obtain orphan drug
marketing exclusivity for ELX-02 or any of our other potential product candidates for other indications.
Regulatory authorities in some jurisdictions, including the U.S. and the EU, may designate drugs for relatively small patient populations as orphan drugs.
Under the Orphan Drug Act of 1983, the FDA may designate a drug as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined
as a patient population of fewer than 200,000 individuals annually in the U.S. Similarly, in Europe, a medicinal product may receive orphan designation under
Article 3 of Regulation (EC) 141/2000. This applies to products that are intended for a life-threatening or chronically debilitating condition and either the condition
affects no more than five in 10,000 persons in the EU when the application is made or the product, without the benefits derived from orphan status, would unlikely
generate sufficient return in the EU to justify the necessary investment. Moreover, in order to obtain orphan designation in the EU, it is necessary to demonstrate that
there exists no satisfactory method of diagnosis, prevention or treatment of the condition authorized for marketing in the EU, or if such a method exists, that the
product will be of significant benefit to those affected by the condition.
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The FDA has granted orphan drug designation for ELX-02 for the treatment of cystinosis as well as for the treatment of MPS I and the treatment of Rett
syndrome. We may seek orphan drug designation for our other product candidates, and with respect to other indications. Generally, if a drug with an orphan drug
designation subsequently receives the first FDA marketing approval for the indication for which it has such designation, the drug is entitled to a period of marketing
exclusivity, which precludes the FDA from approving another marketing application for the same drug for the same indication for that time period. The applicable
period is seven years in the U.S. Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective or if
the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.
Even if we obtain orphan drug exclusivity for a product candidate, that exclusivity may not effectively protect the candidate from competition because
different drugs can be approved for the same condition. Even after an orphan drug is approved, the applicable regulatory authority can subsequently approve another
drug for the same condition if it concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to
patient care. Similarly, if our competitors are able to obtain orphan product exclusivity for their products in the same indications for which we are developing our
product candidates, we may not be able to have our products approved by the applicable regulatory authority for a significant period of time.
Developments by competitors may render our products or technologies obsolete or non-competitive which would have a material adverse effect on our business,
results of operations and financial condition.
We compete with fully integrated biopharmaceutical companies and smaller biopharmaceutical companies that are collaborating with larger pharmaceutical
companies, academic institutions, government agencies and other public and private research organizations. Our product candidates will have to compete with
existing therapies and potential therapies under development by our competitors. In addition, our commercial opportunities may be reduced or eliminated if our
competitors develop and market products that are less expensive, more effective or safer than our product candidates. Other companies have product candidates in
various stages of preclinical or clinical development to treat diseases for which we are also seeking to develop product candidates. Some of these potential competing
drugs are further advanced in development than our product candidates and may be commercialized earlier. Even if we are successful in developing effective drugs,
our products may not compete successfully with products produced by our competitors.
Most of our competitors, either alone or together with their collaborative partners, operate larger research and development programs, staff and facilities,
and have substantially greater financial resources than we do, as well as significantly greater experience in:
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developing drugs;
undertaking preclinical testing and human clinical trials;
obtaining marketing approvals from the FDA and other regulatory authorities;
formulating and manufacturing drugs; and
launching, marketing and selling drugs.
These organizations also compete with us to attract qualified personnel, acquisitions and joint ventures candidates and for other collaborations.
Efforts to compete and the pursuit of activities of our competitors may impose unanticipated costs on our business, which would have a material adverse
effect on our business, results of operations and financial condition.
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If we are unable to develop and commercialize our product candidates, our business will be adversely affected.
A key element of our strategy is to develop and commercialize a portfolio of new products. We seek to do so through our internal research programs and
strategic collaborations for the development of new products. Research programs to identify new product candidates require substantial technical, financial and
human resources, whether or not any product candidates are ultimately identified. Our research programs may initially show promise in identifying potential product
candidates, yet fail to yield product candidates for clinical development for many reasons, including:
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a product candidate is not capable of being produced in commercial quantities at an acceptable cost, or at all;
a product candidate that is developed and approved may not be accepted by patients, the medical community or third-party payors;
competitors may develop alternatives that render our product candidates obsolete;
the research methodology used may not be successful in identifying potential product candidates; or
a product candidate may on further study be shown to have harmful side effects or other characteristics that indicate it is unlikely to be safe or
effective or otherwise does not meet applicable regulatory approval requirements.
Any failure to develop or commercialize any of our product candidates may have a material adverse effect on our business, results of operations and
financial condition.
Risks Related to Our Financial Position and Need for Additional Capital
We have incurred significant operating losses since our inception and anticipate that we will continue to incur substantial operating losses for the foreseeable
future. We may never achieve or maintain profitability.
Since our inception, we have incurred significant operating losses. Our net loss was $47.2 million and $21.2 million for 2018 and 2017, respectively. As of
December 31, 2018, we had an accumulated deficit of $86.1 million. On April 30, 2018, we completed an underwritten public offering of 5,899,500 shares of our
common stock at a price to the public of $9.75 per share, including 769,500 shares sold pursuant to the exercise in full of the underwriters’ option to purchase
additional shares, or the Public Offering. The gross proceeds from the Public Offering were approximately $57.5 million, before deducting the underwriting
discounts and commissions and offering expenses. Historically, we have financed our operations primarily through equity capital investments, and to a lesser extent
from loans and grants from the Israeli Innovation Authority of the Ministry of Economy and Industry, or the IIA. We have devoted substantially all of our financial
resources and efforts to research and development. We expect that it will be many years, if ever, before we receive regulatory approval and have a product candidate
ready for commercialization. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. Our net losses may
fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially if and as we:
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advance ELX-02 further into clinical trials;
continue the preclinical development of our research programs and advance candidates into clinical trials;
identify additional product candidates and advance them into preclinical development;
pursue regulatory authorization to conduct clinical trials of additional product candidates;
seek marketing approvals for our product candidates that successfully complete clinical trials;
establish a sales, marketing and distribution infrastructure to commercialize any product candidates for which we obtain marketing approval;
maintain, expand and protect our intellectual property portfolio;
hire additional clinical, regulatory, management and scientific personnel;
add operational, financial and management information systems and personnel, including personnel to support product development;
acquire or in-license other product candidates and technologies; and
operate as a public company.
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We have never generated any revenue from product sales and may never be profitable. To become and remain profitable, we and our collaborators must
develop and eventually commercialize one or more product candidates with significant market potential. This will require us to be successful in a range of
challenging activities, including completing preclinical studies and clinical trials of our product candidates, obtaining marketing approval for these product
candidates, manufacturing, marketing and selling those product candidates for which we may obtain marketing approval, securing coverage and reimbursement for
those product candidates for which we may obtain marketing approval, and satisfying any post-marketing requirements. We may never succeed in these activities
and, even if we do, may never generate revenue that is significant or large enough to achieve profitability. Our failure to become and remain profitable would
decrease the value of the company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our
operations. A decline in the value of our Company could also cause you to lose all or part of your investment.
We will need substantial additional funding. If we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate our product
development programs or commercialization efforts.
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue and
initiate clinical trials of, and seek marketing approval for ELX-02, and as we become obligated to make milestone payments pursuant to our outstanding license
agreements. In addition, if we obtain marketing approval for any of our current or future product candidates, we expect to incur significant commercialization
expenses related to product sales, marketing, manufacturing and distribution of the approved product. Our future capital requirements will depend on many factors,
including:
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the scope, progress, results and costs of drug discovery, clinical development, laboratory testing and clinical trials for ELX-02 and other product
candidates;
the costs, timing and outcome of any regulatory review of ELX-02 and other product candidates;
the cost of any other product candidate programs we pursue;
the costs and timing of commercialization activities, including manufacturing, marketing, sales and distribution, and securing coverage and
reimbursement for any product candidates that receive marketing approval;
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual
property-related claims;
our ability to establish and maintain collaborations on favorable terms, if at all; and
the extent to which we acquire or in-license other product candidates and technologies.
Identifying potential product candidates and conducting preclinical studies and clinical trials are time consuming, expensive and uncertain processes that
take years to complete, and we may never generate the necessary data or results required to obtain marketing approval or achieve product sales for any of our current
or future product candidates. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenue, if any, will be derived
from sales of products that we do not expect to be commercially available for many years, if at all.
Accordingly, despite the Public Offering, we will need substantial additional funding in connection with our continuing operations and to achieve our goals.
However, our existing cash and cash equivalents may prove to be insufficient for these activities. If we are unable to raise capital when needed or on attractive terms,
we would be forced to delay, reduce or eliminate our research and development programs, product portfolio expansion or future commercialization efforts. Adequate
additional financing may not be available to us on acceptable terms, or at all. In addition, we may seek additional financing due to favorable market conditions or
strategic considerations, even if we believe we have sufficient funds for our operating plans.
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product
candidates.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity and debt
financings, as well as entering into new collaborations, strategic alliances and licensing arrangements. We do not have any committed external source of funds. To
the extent that we raise
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additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include
liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing, if available, may involve agreements that include
covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, and may be
secured by all or a portion of our assets. If we raise funds by entering into new collaborations, strategic alliances or licensing arrangements with third parties, we may
have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be
favorable to us. If we are unable to raise additional funds through equity or debt financings or through collaborations, strategic alliances or licensing arrangements
when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and
market product candidates that we would otherwise prefer to develop and market ourselves.
Risks Related to Our Business and Operations
Maintaining and improving our financial controls and the requirements of being a public company may strain our resources, divert management’s attention and
affect our ability to attract and retain qualified board members.
The trading market for our common stock is influenced by the research and reports that securities or industry analysts publish. As a public company, we are
subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, or the Exchange Act, the Sarbanes-Oxley Act of 2002, or the Sarbanes-
Oxley Act, and Nasdaq stock market rules. The requirements of these rules and regulations have increased and will continue to significantly increase our legal and
financial compliance costs, including costs associated with the hiring of additional personnel, making some activities more difficult, time-consuming or costly, and
may also place undue strain on our personnel, systems and resources. The Exchange Act requires, among other things, that we file annual, quarterly and current
reports with respect to our business and financial condition.
The Sarbanes-Oxley Act requires, among other things, that we maintain disclosure controls and procedures and internal control over financial reporting.
Ensuring that we have adequate internal financial and accounting controls and procedures in place, as well as maintaining these controls and procedures, is a costly
and time-consuming effort that needs to be re-evaluated frequently. Section 404 of the Sarbanes-Oxley Act, or Section 404, requires that we annually evaluate our
internal control over financial reporting to enable management to report on the effectiveness of those controls. In connection with the Section 404 requirements, we
test our internal controls and could, as part of that documentation and testing, identify material weaknesses, significant deficiencies or other areas for further attention
or improvement.
Implementing any appropriate changes to our internal controls may require specific compliance training for our directors, officers and employees, require
the hiring of additional finance, accounting and other personnel, entail substantial costs to modify our existing accounting systems, and take a significant period of
time to complete. These changes may not, however, be effective in maintaining the adequacy of our internal controls, and any failure to maintain that adequacy, or
consequent inability to produce accurate financial statements on a timely basis, could increase our operating costs and could materially impair our ability to operate
our business. Moreover, adequate internal controls are necessary for us to produce reliable financial reports and are important to help prevent fraud. As a result, our
failure to satisfy the requirements of Section 404 on a timely basis could result in the loss of investor confidence in the reliability of our financial statements, which
in turn could cause the market value of our common stock to decline.
Various rules and regulations applicable to public companies make it more difficult and more expensive for us to maintain directors’ and officers’ liability
insurance, and we may be required to accept reduced coverage or incur substantially higher costs to maintain coverage. If we are unable to maintain adequate
directors’ and officers’ liability insurance, our ability to recruit and retain qualified officers and directors, especially those directors who may be deemed independent
for purposes of the Nasdaq stock market rules, will be significantly curtailed.
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We are seeking to expand our business through strategic initiatives. Our efforts to identify opportunities or complete transactions that satisfy our strategic
criteria may not be successful, and we may not realize the anticipated benefits of any completed acquisition or other strategic transaction.
Our business strategy includes expanding our product candidates and capabilities. We regularly evaluate potential merger, acquisition, partnering and in-
license opportunities that we expect will expand our pipeline or product offerings, and enhance our research platforms.
To manage effectively our current and future potential growth, we must continue to enhance and develop our global employee base, and our operational and
financial processes. Supporting our growth strategy will require significant capital expenditures and management resources, including investments in research,
development, sales and marketing, manufacturing and other areas of our operations. The development or expansion of our business, any acquired business or any
acquired or in-licensed products may require a substantial capital investment by us. We may not have these necessary funds or they might not be available to us on
acceptable terms or at all. We may also seek to raise funds by selling shares of our capital stock, or securities convertible into our capital stock, which could dilute
current stockholders’ ownership interest in our Company.
Our business could be affected by litigation, government investigations and enforcement actions.
We operate in many jurisdictions in a highly regulated industry and we could be subject to litigation, government investigation and enforcement actions on a
variety of matters in the U.S. or foreign jurisdictions, including, without limitation, intellectual property, regulatory, product liability, environmental, whistleblower,
Qui Tam, false claims, privacy, anti-kickback, anti-bribery, securities, commercial, employment, and other claims and legal proceedings which may arise from
conducting our business. Any of these actions or proceedings may result in significant costs, fines, penalties or imposition of burdensome restrictions on the
Company, any of which could have a material adverse effect on our business, results of operations and financial condition.
Comprehensive tax reform bills could adversely affect our business and financial condition.
On December 22, 2017, and effective January 1, 2018, the U.S. government enacted H.R. 1, “An Act to provide for reconciliation pursuant to titles II and V
of the concurrent resolution on the budget for fiscal year 2018” (informally titled the “Tax Cuts and Jobs Act”), which includes significant changes to the taxation of
business entities. The Tax Cuts and Jobs Act, among other things, contains significant changes to corporate taxation, including reduction of the corporate tax rate
from a top marginal rate of 35% to a flat rate of 21%, limitation of the tax deduction for interest expense to 30% of adjusted earnings (except for certain small
businesses), implementation of a “base erosion anti-abuse tax” which requires U.S. corporations to make an alternative determination of taxable income without
regard to tax deductions for certain payments to affiliates, taxation of certain non-U.S. corporations’ earnings considered to be “global intangible low taxed income”
(also referred to as “GILTI”), repeal of the alternative minimum tax, or AMT, for corporations and changes to a taxpayer’s ability to either utilize or refund the AMT
credits previously generated, changes in the attribution rules relating to shareholders of certain “controlled foreign corporations”, limitation of the deduction for net
operating losses to 80% of current year taxable income and elimination of net operating loss carrybacks, one time taxation of offshore earnings at reduced rates
regardless of whether they are repatriated, elimination of U.S. tax on foreign earnings (subject to certain important exceptions), immediate deductions for certain new
investments instead of deductions for depreciation expense over time, and modifying or repealing many business deductions and credits. Notwithstanding the
reduction in the corporate income tax rate, the Tax Cuts and Jobs Act remains subject to interpretation and further guidance from US taxing authorities and as a result
the overall impact of this tax reform is uncertain and may change due to interpretation changes, and our business and financial condition could be adversely affected.
In addition, it is uncertain if and to what extent various US states will conform their tax laws to the Tax Cuts and Jobs Act. The impact of the Tax Cuts and Jobs Act
on holders of our common stock is also uncertain and could be adverse. We are unable to predict what tax reform may be proposed or enacted in the future or what
effect such changes would have on our business, but such changes, to the extent they are brought into tax legislation, regulations, policies or practices, could affect
our effective tax rates in the future in countries where we have operations and have an adverse effect on our overall tax rate in the future, along with increasing the
complexity, burden and cost of tax compliance. We urge our stockholders to consult with their legal and tax advisors with respect to the Tax Cuts and Jobs Act and
the potential tax consequences of investing in or holding our common stock.
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Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations.
As of December 31, 2018, we had U.S. federal and state net operating loss, or “NOL”, carry forwards of $89.8 million and $40.0 million, respectively, and
federal research tax credit carryforwards of $0.7 million. Certain U.S. NOL carryforwards will begin to expire, if not utilized, beginning in 2019 through 2037, and
the research tax credits will expire beginning in 2027 through 2037. Included in these U.S. federal NOL carryforwards are $13.1 million of NOLs generated after the
effective date of the Tax Cuts and Jobs Act which are not subject to expiration. Under the Tax Cuts and Jobs Act, federal NOLs generated in 2018 and future years
may be carried forward indefinitely but may not be carried back and are only eligible to offset up to a maximum of 80% of taxable income generated in a given year.
It is uncertain if and to what extent various U.S. states will conform their net operating loss rules to the Tax Cuts and Jobs Act.
In general, under Section 382 of the United States Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership
change” is subject to limitations on its ability to utilize its pre-ownership change NOLs to offset future taxable income. We may have experienced ownership changes
in the past, including in connection with the Reverse Merger on December 19, 2017 at which time our pre-change U.S. federal NOL carryforward was $77.2 million
and research tax credit was $0.7 million. We may experience additional ownership changes in the future as a result of subsequent shifts in our stock ownership, some
of which may be outside of our control. Although we have not completed our analysis, it is reasonably possible that our federal NOLs available to offset future
taxable income could materially decrease. This reduction will be offset by an adjustment to the existing valuation allowance for an equal and offsetting amount.
Additionally, our state NOLs available to offset future state income could similarly decrease which would also be offset by an equal and offsetting adjustment to the
existing valuation allowance. Given the offsetting adjustments to the existing valuation allowance, any ownership change is not expected to have an adverse material
effect on our Consolidated Financial Statements. Finally, as of December 31, 2018, we had Israeli NOL carryforwards of $34.6 million, which carry forward
indefinitely.
Our ability to utilize our NOLs is dependent on attaining profitability sufficient to offset such available NOLs prior to their expiration. In addition, we may
not be able to utilize a portion of the NOLs reflected on our balance sheet, even if we attain profitability.
We could be subject to additional tax liabilities.
We are subject to federal, state and local taxes in the U.S. and Israel. Significant judgment is required in evaluating our tax positions and our worldwide
provision for taxes. During the ordinary course of business, there are many activities and transactions for which the ultimate tax determination is uncertain. In
addition, our tax obligations and effective tax rates could be adversely affected by changes in the relevant tax, accounting and other laws, regulations, principles and
interpretations, including those relating to income tax nexus, by our earnings being lower than anticipated in jurisdictions where we have lower statutory rates and
higher than anticipated in jurisdictions where we have higher statutory rates, by changes in foreign currency exchange rates, or by changes in the valuation of our
deferred tax assets and liabilities. We may be audited in various jurisdictions, and such jurisdictions may assess additional taxes against us. Although we believe our
tax estimates are reasonable, the final determination of any tax audits or litigation could be materially different from our historical tax provisions and accruals, which
could have a material adverse effect on our operating results or cash flows in the period or periods for which a determination is made.
Changes in healthcare laws and implementing regulations, as well as changes in healthcare policy, may affect coverage and reimbursement of our product
candidates in ways that we cannot currently predict and these changes could adversely affect our business and financial condition.
In the U.S., a number of legislative and regulatory initiatives have focused on containing the cost of healthcare. The Patient Protection and Affordable Care
Act, or PPACA, was enacted in March 2010. This law substantially changes the way healthcare is financed by both governmental and private insurers in the U.S.,
and significantly impacts the pharmaceutical industry. PPACA contains a number of provisions that are expected to impact our business and operations, in some
cases in ways we cannot currently predict. Changes that may affect our business include those governing enrollment in federal healthcare programs, reimbursement
changes, rules regarding prescription drug benefits under health insurance exchanges, expansion of the 340B program, expansion of state Medicaid programs, fraud
and abuse enforcement and rules governing the approval of biosimilar products. These changes will impact existing government healthcare programs and will result
in the development of new programs, including Medicare payment for performance initiatives and improvements to the physician quality reporting system
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and feedback program. In early 2016, CMS issued final regulations to implement the changes to the Medicaid Drug Rebate Program under PPACA. These
regulations became effective on April 1, 2016. Moreover, in the future, Congress could enact legislation that further increases Medicaid drug rebates or other costs
and charges associated with participating in the Medicaid Drug Rebate Program. Legislative changes to the PPACA also remain possible and appear likely under the
current administration. The issuance of regulations and coverage expansion by various governmental agencies relating to the Medicaid Drug Rebate Program has and
will continue to increase our costs and the complexity of compliance, has been and will be time-consuming, and could have a material adverse effect on our results of
operations.
Governments in countries where we operate have adopted or have shown significant interest in pursuing legislative initiatives to reduce costs of healthcare.
We expect that the implementation of current laws and policies, the amendment of those laws and policies in the future, as well as the adoption of new laws and
policies, could have a material adverse effect on our industry generally and on our ability to generate or increase future product sales, if any, or successfully
commercialize our product candidates, or could limit or eliminate our future spending on development projects. In many cases, these government initiatives, even if
enacted into law, are subject to future rulemaking by regulatory agencies. Although we have evaluated these government initiatives and the impact on our business,
we cannot know with certainty whether any such law, rule or regulation will adversely affect coverage and reimbursement of our product candidates, or to what
extent, until such laws, rules and regulations are promulgated, implemented and enforced, which could sometimes take many years. The announcement or adoption
of regulatory or legislative proposals could delay or prevent our entry into new markets, affect our reimbursement or sales in the markets where we are already
selling our approved products, if any, and materially harm our business, financial condition and results of operations.
We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage.
We are subject to laws and regulations covering data privacy and the protection of personal information including health information. The legislative and
regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues which may
affect our business. In the U.S., we may be subject to state security breach notification laws, state health information privacy laws and federal and state consumer
protections laws which impose requirements for the collection, use, disclosure and transmission of personal information. Each of these laws is subject to varying
interpretations by courts and government agencies, creating complex compliance issues for us. If we fail to comply with applicable laws and regulations we could be
subject to penalties or sanctions, including criminal penalties if we knowingly obtain individually identifiable health information from a covered entity in a manner
that is not authorized or permitted by HIPAA or for aiding and abetting the violation of HIPAA.
Numerous other countries have, or are developing, laws governing the collection, use and transmission of personal information as well. EU member states
and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations. For example, in May 2016, the EU
formally adopted the General Data Protection Regulation, or GDPR, which applies to all EU member states as of May 25, 2018 and replaces the former EU Data
Protection Directive. The regulation introduces new data protection requirements in the EU and imposes substantial fines for breaches of the data protection rules.
The GDPR must be implemented into national laws by the EU member states imposes strict obligations and restrictions on the ability to collect, analyze, and transfer
personal data, including health data from clinical trials and adverse event reporting. Data protection authorities from different EU member states have interpreted the
privacy laws differently, which adds to the complexity of processing personal data in the EU, and guidance on implementation and compliance practices are often
updated or otherwise revised. Any failure to comply with the rules arising from the GDPR and related national laws of EU member states could lead to government
enforcement actions and significant penalties against us, and adversely impact our operating results. The GDPR will increase our responsibility and liability in
relation to personal data that we process and we may be required to put in place additional mechanisms ensuring compliance with EU data protection rules.
Security breaches, cyber-attacks, or other disruptions could expose us to liability and affect our business and reputation.
We are increasingly dependent on our information technology systems and infrastructure for our business. We collect, store, and transmit sensitive
information including intellectual property, proprietary business information and personal information in connection with business operations. The secure
maintenance of this information is
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critical to our operations and business strategy. Some of this information could be an attractive target of criminal attack by third parties with a wide range of motives
and expertise, including organized criminal groups, “hacktivists,” patient groups, disgruntled current or former employees, and others. Cyber-attacks are of ever-
increasing levels of sophistication, and despite our security measures, our information technology and infrastructure may be vulnerable to such attacks or may be
breached, including due to employee error or malfeasance. We have implemented information security measures to protect patients’ personal information against the
risk of inappropriate and unauthorized external use and disclosure. However, despite these measures, and due to the ever-changing information cyber-threat
landscape, we may be subject to data breaches through cyber-attacks. Any such breach could compromise our networks and the information stored there could be
accessed, publicly disclosed, lost or stolen. If our systems become compromised, we may not promptly discover the intrusion. Like other companies in our industry,
we have experienced attacks to our data and systems, including malware and computer viruses. If our systems failed or were breached or disrupted, patient and other
data and information may become compromised, we could lose sales for approved products, if any, and suffer reputational damage and loss of confidence by
patients, investors and business partners. Such incidents would result in notification obligations to affected individuals and government agencies, legal claims or
proceedings, and liability under federal and state laws that protect the privacy and security of personal information. Any one of these events, or similar events
occurring through one of our vendors that maintain such information on our behalf, could cause our business to be materially harmed and our results of operations to
be adversely impacted.
We expect to rely on third parties to conduct some or all aspects of our product manufacturing, protocol development, research and preclinical and clinical
testing, and these third parties may not perform satisfactorily.
We do not expect to independently conduct all aspects of our product manufacturing, protocol development, research and preclinical and clinical testing. We
currently rely, and expect to continue to rely, on third parties with respect to these items.
Any of these third parties may terminate their engagements with us at any time. If we need to enter into alternative arrangements, it could delay our product
development activities. Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us
of our responsibility to ensure compliance with all applicable laws and regulations and study protocols. If these third parties do not successfully carry out their
contractual duties, meet expected deadlines or conduct our studies in accordance with regulatory requirements or our stated study plans and protocols, we will not be
able to complete, or may be delayed in completing, the preclinical studies and clinical trials required to support future NDA submissions and approval of our product
candidates.
Reliance on third-party manufacturers, testing sites, and investigators entails risks to which we would not be subject if we developed, researched, tested, and
manufactured the product candidates ourselves, including:
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the inability to negotiate manufacturing, testing, and research agreements with third parties under commercially reasonable terms;
reduced control as a result of using third-party manufacturers, testing laboratories, and research sites and investigators for all aspects of
manufacturing, testing, and research activities;
termination or nonrenewal of manufacturing, testing, or research agreements with third parties in a manner or at a time that is costly or damaging to
us; and
disruptions to the operations of our third-party manufacturers or suppliers, testing facilities, or research sites caused by conditions unrelated to our
business or operations, including unrelated regulatory action against or the bankruptcy of the manufacturer or supplier, testing facility, or research site.
Any of these events could lead to clinical trial delays or failure to obtain regulatory approval, or impact our ability to successfully commercialize future
products. Some of these events could be the basis for FDA action, including injunction, recall, seizure or total or partial suspension of production or testing. Any one
of these events could cause our business to be materially harmed and our results of operations would be adversely impacted.
Our future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
The success of our business is dependent in large part on our continued ability to attract and retain our senior management, and other highly qualified
personnel in our scientific, clinical, manufacturing and commercial organizations. Intense competition exists in the biopharmaceutical industry for these types of
personnel. Our
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business is specialized and global and we must attract and retain highly qualified individuals across many geographies. We may not be able to continue to attract and
retain the highly qualified personnel necessary for developing, manufacturing and commercializing our product candidates. If we are unsuccessful in our recruitment
and retention efforts, or if our recruitment efforts take longer than anticipated, our business may be harmed.
We are highly dependent on principal members of our senior management, including Robert Ward, our Chief Executive Officer. While we have entered into
employment agreements or offer letters with each of our executive officers, any of them could leave our employment at any time, as all of our employees are “at
will” employees. Recruiting and retaining other qualified employees, consultants and advisors for our business, including scientific and technical personnel, will also
be critical to our success. Competition for skilled personnel is intense and the turnover rate can be high. We may not be able to attract and retain personnel on
acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for individuals with similar skill sets. In addition, failure to
succeed in preclinical studies or clinical trials may make it more challenging to recruit and retain qualified personnel. The inability to recruit or loss of the services of
any executive, key employee, consultant or advisor may impede the progress of our research, development and commercialization objectives. If we fail to attract and
retain highly qualified personnel, we may not be able to successfully develop, manufacture or commercialize our product candidates.
Risks Related to Intellectual Property
If we fail to adequately protect or enforce our intellectual property rights or secure rights to third party patents, the value of our intellectual property rights
would diminish, and our business, competitive position and results of operations would suffer.
As of December 31, 2018, we owned or licensed 19 issued patents and 34 pending patent applications in the U.S. and abroad, not including U.S. provisional
applications. However, with regard to the pending provisional applications, the filing of a patent application does not mean that we will be issued a patent, or that any
patent eventually issued will be as broad as requested in the patent application or sufficient to protect our technology. Any modification required to a currently
pending patent application may delay the approval of such patent application which could have a material adverse effect on our business, results of operations and
financial condition. In addition, there are a number of factors that could cause our current or future issued patents to become invalid or unenforceable or that could
cause our pending patent applications to not be granted, including known or unknown prior art, deficiencies in the patent application or lack of originality of the
technology. Our competitive position and future revenues will depend in part on our ability and the ability of our licensors and collaborators to obtain and maintain
patent protection for our product candidates, methods, processes and other technologies, to preserve our trade secrets, to prevent third parties from infringing on our
proprietary rights and to operate without infringing the proprietary rights of third parties. However, we cannot predict:
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the degree and range of protection any patents will afford us against competitors and those who infringe upon our patents, including whether third
parties will find ways to invalidate or otherwise circumvent our licensed patents;
if and when patents will issue;
whether or not others will obtain patents claiming aspects similar to those covered by our owned or licensed patents and patent applications; or
whether we will need to initiate litigation or administrative proceedings, which may be costly, and whether we win or lose.
If patent rights covering our products or technologies are not sufficiently broad, they may not provide us with sufficient proprietary protection or
competitive advantages against competitors with similar products and technologies. Furthermore, if the U.S. Patent and Trademark Office or foreign patent offices
issue patents to us or our licensors, others may challenge the patents or circumvent the patents, or the patent office or the courts may invalidate the patents. Thus, any
patents we own or license from or to third parties may not provide any protection against our competitors and those who infringe upon our patents.
Furthermore, the life of our patents is limited. With regard to our lead compound ELX-02, patents that have issued or that may issue in the future from our
primary composition of matter patent family are currently set to expire in 2031. We have pending patent families directed to specific methods of using and
manufacturing ELX-02,
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and any patents that may issue from these families would be expected to expire in 2035 and 2038, respectively. However, these applications may not issue, and even
if they do issue the resultant patents may not provide adequate coverage to meaningfully block competitors from launching their products. We will likely pursue
additional patent protection relating to ELX-02 in the future, including for example additional methods of use or manufacture, specific formulations, or combinations
of ELX-02 with other therapeutic agents. However, as with our pending patent families, any applications we file in the future may not issue, or may not result in
adequate coverage to adequately protect our assets.
Depending upon the timing, duration, and conditions of any FDA marketing approval for ELX-02, one or more of our patents may be eligible for patent
term extension of up to five years under the Hatch-Waxman Act. However, we may not receive an extension if we fail to exercise due diligence during the testing
phase or regulatory review process, fail to apply for an extension within applicable deadlines, or otherwise fail to satisfy applicable requirements. Moreover, the
length of the extension could be less than we request. Only one patent per approved product can be extended, the extension cannot extend the total patent term
beyond 14 years from approval and only those claims covering the approved drug, an approved method of using the approved drug, or a method of manufacturing the
approved drug may be extended. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which
we can enforce our patent rights for ELX-02 will be shortened and our competitors may obtain approval to market competing products sooner. As a result, our
revenue from applicable products could be reduced. Further, if this occurs, our competitors may take advantage of our investment in development and trials by
referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case, and our business could be harmed.
If we cannot obtain new patents, maintain our existing patents and protect the confidentiality and proprietary nature of our trade secrets and other intellectual
property, our business and competitive position may be harmed.
Our success will depend in part on our ability to obtain and maintain patent and regulatory protections for our product candidates, to preserve our trade
secrets and other proprietary rights, to operate without infringing the proprietary rights of third parties, and to prevent third parties from circumventing our rights.
Due to the time and expense of bringing new product candidates through development and regulatory approval to the marketplace, there is particular importance in
obtaining patent and trade secret protection for significant new technologies, products and processes.
We have and may in the future obtain patents or the right to practice patents through ownership or license. Our patent applications may not result in the issue
of patents in the U.S. or other countries. Our patents may not afford adequate protection for our products. Third parties may challenge our patents. If any of our
patents are narrowed, invalidated or become unenforceable, competitors may develop and market products similar to ours that do not conflict with or infringe our
patents rights, which could have a material adverse effect on our financial condition. We may also finance and collaborate in research conducted by government
organizations, hospitals, universities or other educational or research institutions. Such research partners may be unwilling to grant us exclusive rights to technology
or products developed through such collaborations. There is also a risk that disputes may arise as to the rights to technology or products developed in collaboration
with other parties. Our product candidates are expensive and time-consuming to test and develop. Even if we obtain and maintain patents, our business may be
significantly harmed if the patents are not broad enough to protect our products from copycat products.
Significant legal questions exist concerning the extent and scope of patent protection for biopharmaceutical products and processes in the U.S. and
elsewhere. Accordingly, there is no certainty that patent applications owned or licensed by us will issue as patents, or that our issued patents will afford meaningful
protection against competitors. Once issued, patents are subject to challenge through both administrative and judicial proceedings in the U.S. and other countries.
Such proceedings include re-examinations, inter partes reviews, post-grant reviews and interference proceedings before the U.S. Patent and Trademark Office, as
well as opposition proceedings before the European Patent Office and other non-U.S. patent offices. Litigation may be required to enforce, defend or obtain our
patent and other intellectual property rights. Any administrative proceeding or litigation could require a significant commitment of our resources and, depending on
outcome, could adversely affect the scope, validity or enforceability of certain of our patent or other proprietary rights.
In addition, our business requires using sensitive technology, techniques and proprietary compounds that we protect as trade secrets. However, we may also
rely heavily on collaboration with, or discuss the potential for collaboration with, suppliers, outside scientists and other biopharmaceutical companies. Collaboration
and
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discussion of potential collaboration present a strong risk of exposing our trade secrets. If our trade secrets were exposed, it would help our competitors and
adversely affect our business prospects.
If we are found to be infringing on patents owned by others, we may be forced to pay damages to the patent owner and/or obtain a license to continue the
manufacture, sale or development of our product candidates. If we cannot obtain a license, we may be prevented from the manufacture, sale or development of our
product candidates, which would adversely affect our business.
If we infringe the rights of third parties we could be prevented from selling products, forced to pay damages and required to defend against litigation which
could result in substantial costs and may have a material adverse effect on our business, results of operations and financial condition.
We have not received to date any claims of infringement by any third parties. However, as our product candidates progress into clinical trials and
commercialization, if at all, our public profile and that of our product candidates may be raised and generate such claims. Defending against such claims, and
occurrence of a judgment adverse to us, could result in unanticipated costs and may have a material adverse effect on our business and competitive position. If our
products, methods, processes and other technologies infringe the proprietary rights of other parties, we may incur substantial costs and we may have to:
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obtain licenses, which may not be available on commercially reasonable terms, if at all;
redesign our products or processes to avoid infringement, which could significantly impede development and impair or block our ability to secure
regulatory approval of any redesigned product or process;
stop using the subject matter claimed in the patents held by others, which could cause us to lose the use of one or more of our product candidates;
defend litigation or administrative proceedings that may be costly whether we win or lose, and which could result in a substantial diversion of
management resources; or
pay damages.
Any costs incurred in connection with such events or the inability to develop or sell our products may have a material adverse effect on our business, results
of operations and financial condition.
We rely on confidentiality agreements that could be breached and may be difficult to enforce which could have a material adverse effect on our business and
competitive position.
Our policy is to enter agreements relating to the non-disclosure of confidential information with third parties, including our contractors, consultants, advisors
and research collaborators, as well as agreements that purport to require the disclosure and assignment to us of the rights to the ideas, developments, discoveries and
inventions of our employees and consultants while we employ them. However, these agreements can be difficult and costly to enforce. Moreover, to the extent that
our contractors, consultants, advisors and research collaborators apply or independently develop intellectual property in connection with any of our projects, disputes
may arise as to the proprietary rights to the intellectual property. If a dispute arises, a court may determine that the rights belong to a third party, and enforcement of
our rights can be costly and unpredictable. In addition, we rely on trade secrets and proprietary know-how that we seek to protect in part by confidentiality
agreements with our employees, contractors, consultants, advisors and other third parties. Despite the protective measures we employ, we still face the risk that:
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these agreements may be breached;
these agreements may not provide adequate remedies for the applicable type of breach; or
our trade secrets or proprietary know-how will otherwise become known.
Any breach of our confidentiality agreements or our failure to effectively enforce such agreements may have a material adverse effect on our business and
competitive position.
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If we cannot meet requirements under our license agreement, we could lose the rights to our product candidates, which could have a material adverse effect on
our business.
We depend on the license agreement with TRDF to maintain the intellectual property rights to certain of our product candidates. Our license agreement
requires us to make payments and satisfy performance obligations in order to maintain our rights under this agreement. This agreement lasts either throughout the life
of the patents that are the subject of the agreement, or with respect to other licensed technology, for a number of years after the first commercial sale of the relevant
product.
In addition, we are responsible for the cost of filing and prosecuting certain patent applications and maintaining certain issued patents licensed to us. If we
do not meet our obligations under our license agreement in a timely manner, we could lose the rights to our proprietary technology, which could have a material
adverse effect on our business, results of operations and financial condition.
Risks Related to Our Operations in Israel
Potential political, economic and military instability in Israel, where our research facilities are located, may adversely affect our results of operations.
Our research offices and lab are located in Israel. Accordingly, political, economic and military conditions in Israel and the surrounding region may directly
affect our business. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its neighboring countries,
and certain militant groups and terrorist organizations. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its trading
partners could adversely affect our operations and results of operations. Since October 2000, there have been increasing occurrences of terrorist violence in the
region. Ongoing and revived hostilities or other Israeli political or economic factors, could negatively affect business conditions in Israel in general and our business
in particular.
In addition, since 2010 political uprisings and conflicts in various countries in the Middle East have been affecting the political stability of those countries
and the region in general. It is not clear how this instability will develop and how it will affect the political and security situation in the Middle East. This instability
has raised concerns regarding security in the region and the potential for armed conflict. Additionally, various groups are involved in hostilities in the region.
Although these groups’ activities have not directly affected the political and economic conditions in Israel, a stated purpose is to take control of the Middle East,
including Israel. The tension between Israel and these other groups may escalate in the future and turn violent, which could affect the Israeli economy in general and
us in particular. Such instability may lead to deterioration in the political and trade relationships that exist between Israel and certain other countries. Any armed
conflicts, terrorist activities or political instability in the region could adversely affect business conditions, could harm our results of operations and could make it
more difficult for us to raise capital. Several countries, principally in the Middle East, still restrict doing business with Israel and Israeli companies, and additional
countries may impose restrictions on doing business with Israel and Israeli companies if hostilities in Israel or political instability in the region continues or
increases. Similarly, Israeli companies are limited in conducting business with entities from several countries. In addition, the political and security situation in Israel
may result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those
agreements pursuant to force majeure provisions in such agreements.
Our insurance does not cover losses that may occur as a result of an event associated with the security situation in the Middle East or for any resulting
disruption in our operations. Although the Israeli government has in the past covered the reinstatement value of direct damages that were caused by terrorist attacks
or acts of war, we cannot provide assurance that this government coverage will be maintained or, if maintained, will be sufficient to compensate us fully for damages
incurred and the government may cease providing such coverage or the coverage might not suffice to cover potential damages. Any losses or damages incurred by us
could have a material adverse effect on our business. Any armed conflicts or political instability in the region would likely negatively affect business conditions
generally and our business in particular.
Furthermore, in the past, Israel and Israeli companies have been subjected to economic boycotts. Several countries still restrict business with Israel and with
Israeli companies. These restrictive laws and policies, even though we are a U.S.-based company, may have an adverse impact on our operating results, financial
conditions or the expansion of our business.
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Our research operations may be disrupted by the obligations of our personnel to perform military service which could have a material adverse effect on our
business.
Our employees and consultants in Israel may be obligated to perform one month, and in some cases longer periods, of military reserve duty until they reach
the age of 40 (or older, for citizens who hold certain positions in the Israeli armed forces reserves) and, in the event of a military conflict or emergency
circumstances, may be called to immediate and unlimited active duty. In the event of severe unrest or other conflict, individuals could be required to serve in the
military for extended periods of time. In response to increases in terrorist activity, there have been periods of significant call-ups of military reservists. It is possible
that there will be similar large-scale military reserve duty call-ups in the future. Our operations could be disrupted by the absence of a significant number of our
Israeli personnel related to military service. Such disruption could adversely affect our business and research operations. Additionally, the absence of a significant
number of the employees of our Israeli suppliers and contractors related to military service or the absence for extended periods of one or more of their key employees
for military service may disrupt their operations.
Because a certain portion of our expenses are incurred in New Israeli Shekels, or NIS, our results of operations may be seriously harmed by currency
fluctuations and inflation.
We report our financial statements in U.S. dollars, our functional currency. Although most of our expenses are incurred in U.S. dollars, we pay a portion of
our expenses in New Israeli Shekels, or NIS, and as a result, we are exposed to risk to the extent that the inflation rate in Israel exceeds the rate of devaluation of the
NIS in relation to the U.S. dollar or if the timing of these devaluations lags behind inflation in Israel. In that event, the U.S. dollar cost of our operations in Israel will
increase and our U.S. dollar-measured results of operations will be adversely affected. To the extent that the value of the NIS increases against the dollar, our
expenses on a dollar cost basis increase. Our operations also could be adversely affected if we are unable to guard against currency fluctuations in the future. To date,
we have not engaged in hedging transactions. In the future, we may enter into currency hedging transactions to decrease the risk of financial exposure from
fluctuations in the exchange rate of the U.S. dollar against the NIS. These measures, however, may not adequately protect us from material adverse effects.
We received Israeli government grants for our research and development activities and programs. The terms of such grants may require us, in the future, to pay
royalties and to satisfy specific conditions if and to the extent we receive future royalties or in order to complete the sale of such grant-based technologies and
programs. We may be required to pay penalties in addition to payment of the royalties.
Our research and development efforts have been financed, in part, through royalty-bearing grants from the Israel Innovation Authority, or IIA. To date, we
have received the aggregate amount of approximately $2.6 million from the IIA for the development of our technologies. With respect to such grants we are
committed to pay certain royalties (including accrued LIBOR interest) up to $2.7 million. We are required to comply with the requirements of the Israeli
Encouragement of Research, Development and Technological Innovation in the Industry Law, 5744-1984, as amended, and related regulations, or the R&D Law,
with respect to these past grants. If we fail to comply with the R&D Law, we may be required to refund certain grants previously received and/or to pay interest and
penalties and we may become subject to criminal charges.
We have not commenced the payment obligation of the royalties and have a contingent obligation with respect to royalty-bearing participation received or
accrued, to include LIBOR interest, in the amount of approximately $2.7 million.
In addition, with respect to such grants we are obligated to pay royalties at a rate of 3% to 6% from the revenues generated from the sale of product (as well
as revenue from associated services) developed using the IIA grants up to a maximum amount equal to repayment of the grants plus accrued interest.
The R&D Law and the regulations promulgated thereunder provide that when a company develops know-how, technology or products using IIA grants, the
terms of these grants and the R&D Law restrict the transfer of such know-how, and the transfer of manufacturing or manufacturing rights of such products,
technologies or know-how outside of Israel, without the prior approval of the IIA. Therefore, if aspects of our technologies are deemed to have been developed with
IIA funding according to the R&D Law, the discretionary approval of the IIA may be required for any assignment and/or transfer to third parties inside or outside of
Israel of know-how or transfer outside of Israel of manufacturing or manufacturing rights related to those aspects of such technologies, and may result in payment of
increased royalties (both increased royalty rates and increased royalty ceilings) and/or payment of
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additional amounts to the IIA. Furthermore, the IIA may impose certain conditions on any arrangement under which it permits us to transfer technology or
development out of Israel (including for the purpose of manufacturing). Such approvals may not be granted by the IIA and any conditions imposed may not be
acceptable to the Company.
The R&D Law and the regulations promulgated thereunder provide that the transfer of IIA-supported technology or know-how outside of Israel may involve
the payment of additional amounts depending upon the value of the transferred technology or know-how, the amount of IIA support, the time of completion of the
IIA-supported research project and other factors up to a maximum of six times the amount of grants received. These restrictions and requirements for payment may
impair our ability to sell our technology assets outside of Israel or to outsource or transfer development or manufacturing activities with respect to any product or
technology outside of Israel. Furthermore, the consideration available to our stockholders in a transaction involving the transfer outside of Israel of technology or
know-how developed with IIA funding may be reduced by any amounts that we are required to pay to the IIA. Our obligations and limitations pursuant to the R&D
Law are not limited in time and may not be terminated by us at will. As of the date hereof, we have not been required to pay any royalties with respect to the IIA
grants.
We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation and
adversely affect our business.
We enter into agreements with our employees pursuant to which they agree that any inventions created in the scope of their employment or engagement are
assigned to us or owned exclusively by us, depending on the jurisdiction, without the employee retaining any rights. A significant portion of our intellectual property
has been developed by our employees in the course of their employment for us. Under the Israeli Patent Law, 5727-1967 (the “Patent Law”), inventions conceived by
an employee during the scope of his or her employment with a company are regarded as “service inventions,” which belong to the employer, absent a specific
agreement between the employee and employer giving the employee service invention rights. The Patent Law also provides that if there is no such agreement
between an employer and an employee, the Israeli Compensation and Royalties Committee (the “Committee”), a body constituted under the Patent Law, shall
determine whether the employee is entitled to remuneration for his or her inventions. Previous decisions by the Committee have created uncertainty in this area
regarding whether the right to receive remuneration for service inventions can be voluntarily waived by an employee and whether such waiver is enforceable. In
addition, the Committee determined that even if such right to receive compensation and royalties for service inventions may be waived, the waiver should be
specific. Subsequent court cases have not provided significant clarity on these matters.
Risks Related to Our Common Stock
Our stock price may be volatile and purchasers of our common stock could incur substantial losses.
Our common stock began trading on The Nasdaq Global Market on April 26, 2018 under the symbol “ELOX.” On April 30, 2018, we completed a public
offering of our common stock, which resulted in gross proceeds to us of approximately $57.5 million. The trading price of our common stock has been volatile and
may continue to be volatile and subject to wide fluctuations in the future. Many factors could have an impact on our stock price, including fluctuations in our or our
competitors’ operating results, clinical trial results or adverse events associated with our product candidates, product development by us or our competitors, changes
in laws, including healthcare, regulatory, tax or intellectual property laws, intellectual property developments, acquisitions or other strategic transactions, changes in
financial or operational estimates or projections and the perceptions of our investors that we are not performing or meeting expectations. The trading price of the
common stock of many biopharmaceutical companies, including ours, has experienced extreme price and volume fluctuations, which have at times been unrelated to
the operating performance of the companies whose stocks were affected. In addition, the securities market has from time to time experienced significant price and
volume fluctuations that are not related to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the
market price of shares of our common stock.
46
Our Directors, executive officers, principal stockholders and affiliated entities own a significant percentage of our capital stock, and they may make decisions
that an investor may not consider to be in the best interests of our stockholders.
Our directors, executive officers, principal stockholders and affiliated entities beneficially own, in the aggregate, a significant percentage of our common
stock, giving effect to options and other derivative securities that are held by such persons. As a result, if some or all of them acted together, they would have the
ability to exert substantial influence over the election of our board of directors and the outcome of issues requiring approval by our stockholders. This concentration
of ownership may have the effect of delaying or preventing a change in control of our Company that may be favored by other stockholders. This could prevent the
consummation of transactions favorable to other stockholders, such as a transaction in which stockholders might otherwise receive a premium for their shares over
current market prices.
Future sales and issuances of our securities or rights to purchase securities, including pursuant to our equity incentive plans, could result in additional dilution
of the percentage ownership of our stockholders and could cause the prices of our securities to fall.
Additional capital will be needed in the future to continue our planned operations. To the extent we raise additional capital by issuing equity securities, our
stockholders may experience substantial dilution. We may sell common stock, convertible securities or other equity securities in one or more transactions at prices
and in a manner, we determine from time to time. If we sell common stock, convertible securities or other equity securities in one or more transactions, existing
investors may be materially diluted by subsequent sales, and new investors could gain rights superior to our existing stockholders.
Pursuant to the 2013 Plan, the 2008 Plan, and the 2018 Plan, our management is authorized to grant share options and other equity-based awards to our
employees, directors and consultants. The 2018 Plan became effective on April 20, 2018. As of December 31, 2018, individuals held share options to purchase an
aggregate of 3,261,719 shares of our common stock. If our board of directors elects to increase the number of shares available for future grant by the maximum
amount each year, our stockholders may experience additional dilution, which could have a negative effect on our share price.
Risks Related to the Reverse Merger
The risks arising with respect to the historic Sevion business and operations may be different from what we anticipate, which could lead to significant,
unexpected costs and liabilities and could materially and adversely affect our business going forward.
We may not have fully anticipated the extent of the risks associated with the reverse merger between Sevion and Eloxx Limited. After the reverse merger,
Sevion’s historic business was discontinued, but prior to the transaction Sevion had a long operating history. As a consequence, we may be subject to claims,
demands for payment, regulatory issues, costs and liabilities that were not and are not currently expected or anticipated. Notwithstanding our exercise of due
diligence pre-transaction and risk mitigation strategies post-transaction, the risks involved with taking over a business with a long operating history and the costs and
liabilities associated with these risks may be greater than we anticipate. Further, we do not have rights of indemnification against the pre-transaction stockholders of
Sevion. We may not be able to contain or control the costs or liabilities associated with Sevion’s historic business, which could materially and adversely affect our
business, liquidity, capital resources or results of operation, and may divert management’s time and attention from conducting the business of the Company.
ITEM 1B.
UNRESOLVED STAFF COMMENTS
None.
ITEM 2.
PROPERTIES
Our principal executive offices are currently located at 950 Winter Street, Waltham, Massachusetts, and consist of 10,674 square feet of office space under
lease until August 2021, with an option to extend the lease period for additional three years. We also lease additional office space in Morristown, New Jersey and
Rehovot, Israel.
47
ITEM 3.
LEGAL PROCEEDINGS
From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. We are currently
unaware of any material pending legal proceedings to which we are party or of which our property is the subject. However, we may at times in the future become
involved in litigation in the ordinary course of business, which may include actions related to or based on our intellectual property and its use, customer claims,
employment practices and employee complaints and other events arising out of our operations. When appropriate in management’s estimation, we will record
adequate reserves in our financial statements for pending litigation. Litigation is subject to inherent uncertainties, and an adverse result in any such matters could
adversely impact our reputation, operations, and our financial operating results or overall financial condition. Additionally, any litigation to which we may become
subject could also require significant involvement of our senior management and may divert management’s attention from our business and operations.
ITEM 4.
MINE SAFETY DISCLOSURES
None.
48
PART II
ITEM 5.
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF
EQUITY SECURITIES
Market Information for Common Stock
Since April 26, 2018, our common stock has traded on The NASDAQ Capital Market under the symbol “ELOX.” Prior to that date, our common stock
traded on the OTCQB under the symbol “ELOX”. Following the Reverse Merger and reverse stock split, and commencing December 20, 2017, the Company’s
Common Stock symbol on the OTCQB marketplace changed to “SVOND”, and subsequently changed to “ELOX” on January 19, 2018. Prior to the completion of
the Transaction on December 19, 2017, our common stock was traded on the OTCQB Market under the symbol “SVON.”
Holders
As of March 4, 2019, there were approximately 77 holders of record of our common stock. The actual number of holders of our common stock is greater
than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers or held by other
nominees. This number of holders of record also does not include stockholders whose shares may be held in trust by other entities.
Recent Sales of Unregistered Securities
None, except as previously disclosed on our Quarterly Reports on Forms 10-Q and Current Reports on Forms 8-K.
Purchases of Equity Securities by the Issuer or Affiliated Purchaser
There were no repurchases of shares of our common stock during the fourth quarter ended December 31, 2018.
Dividend Policy
We have not paid dividends on our common stock since inception and we do not intend to pay any dividends in the foreseeable future. We expect that any
earnings, which we may realize, will be retained to finance the growth of our Company. The declaration of dividends in the future will be at the election of our board
of directors and will depend upon our earnings, capital requirements, financial position, general economic conditions, and other factors the board of directors deem
relevant.
ITEM 6.
SELECTED FINANCIAL DATA
Not applicable to a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K.
49
ITEM 7.
MANAGEMENT’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION
The following information should be read in conjunction with the consolidated financial statements and related notes thereto included in this Report.
Except for the historical information contained herein, the matters discussed in this Report may be deemed to be forward-looking statements that involve
risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and
other federal securities laws. In this Report, words such as “may,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or
expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.
Our actual results and the timing of certain events may differ materially from the results discussed, projected, anticipated, or indicated in any forward-
looking statements. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial
condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Report.
In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the
forward-looking statements contained in this Report, they may not be predictive of results or developments in future periods.
The following information and any forward-looking statements should be considered in light of factors discussed elsewhere in this Report, including those
risks identified under Item 1A. Risk Factors. In many instances, dollar amounts contained in the narrative descriptions in the following section of this Report are
stated in approximate values, pursuant to generally accepted rounding conventions. We caution readers not to place undue reliance on any forward-looking
statements made by us, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to
publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may
be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Company Overview
We are a clinical-stage biopharmaceutical company developing novel ribonucleic acid (RNA)-modulating drug candidates (designed to be eukaryotic
ribosomal selective glycosides (ERSG)) that are formulated to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that
disrupt the stability of the impacted messenger RNA (mRNA) and the protein synthesis from that mRNA. As a consequence, patients with premature stop codon
diseases have reduced levels of, or no, protein from a gene whose product performs an essential function. This type of mutation accounts for some of the most severe
phenotypes across genetic diseases. Nonsense mutations have been identified in over 1,800 rare and ultra-rare diseases. Read-through therapeutic development is
focused on increasing mRNA stability and enabling functional protein synthesis. As opposed to a typical gene therapy approach of targeting a single, unique
mutation in a target disease, this small molecule strategy enables targeting an entire class of mutations across the rare disease landscape. Our small molecule
approach has the potential to address a range of different premature stop codons in a single gene since our ERSG are targeted to the ribosomes. ELX-02, our lead
investigational drug product candidate, is a small molecule designed to restore production of full-length functional proteins. ELX-02, is in the early stages of clinical
development for systemic administration for cystic fibrosis and cystinosis. ELX-02 is an investigational drug that has not been approved by any global regulatory
body. In addition, we recently announced a new program studying intravitreal administration of ERSG compounds for rare inherited retinal disorders with a focus on
Usher Syndrome. Our preclinical candidate pool consists of a library of 170 novel ERSG drug candidates identified based on read-through potential and cytoplasmic
ribosomal selectivity.
From the outset, our research and development strategy targets rare or ultra-rare diseases where: a high unmet medical need exists, an identified nonsense
mutation-bearing patient population is established, preclinical read-through can be established in predictive personalized medicine models, a definable path through
Orphan Drug development, regulatory approval, patient access and commercialization is identifiable. We believe patient advocacy to be an important element of
patient focused drug development and seek opportunities to collaborate with patient advocacy groups throughout the discovery and development process. Our current
clinical focus for our lead investigational drug product candidate, ELX-02 is Cystic Fibrosis where we expect to complete our MAD study in the first half of 2019
and report top line results from our Phase 2 clinical trial in the second half of 2019. We have participated in the North American Cystic Fibrosis Foundation (CFF)
CFTR Translational Read-through Workshop
50
and are engaged with CFF on extending our Cystic Fibrosis clinical studies to the United States. In 2018, the European Cystic Fibrosis Society Clinical Trial
Network assigned a “high priority” rating to our Phase 2 program. We have recently initiated a new program studying inherited retinal disease and are conducting
IND enabling studies for several ERSG compounds from our library. We entered into a multiyear partnership with the Foundation Fighting Blindness (FFB) to
support the inherited retinal degenerative disease registry and educational programs. We presented as part of the FFD “Investing in Cures” 2019 meeting and believe
that the ongoing R&D consultation and support provided by the FFB will accelerate our development programs that seek to support patients with ocular disease and
high unmet medical need.
We intend to be the global leader in the application of the science of translational read-through and the associated pathway of nonsense mediated decay
(NMD). We believe that expanding our expertise across these basic science areas of mRNA regulation, ribosomal function, and protein translation forms a solid
foundation to support our discovery and development activities. Our ERSG compounds modulate the activity of the ribosome, a complex of RNAs and proteins, and
therefore, a ribonucleoprotein, responsible for protein production, a process also known as translation. These novel small molecule ERSG compounds are designed to
allow the ribosome to read-through a nonsense mutation in mRNA (which is transcribed from the DNA sequence), to restore the translation process to produce full-
length, functional proteins and increase the amount of mRNA that would otherwise be degraded as part of a phenomenon called nonsense mediated mRNA decay. As
our ERSG compounds target the general mechanism for protein production in the cell, we believe they have the potential to treat hundreds of genetic diseases where
nonsense mutations have impaired gene function. Since nonsense mutations may occur at different positions within a given gene, a potential advantage of the small
molecule ERSG approach is being able to use one molecule to address a range of mutations within a given disease state. Our subcutaneously injected ERSG
molecules have the potential to be self-administered for systemic disease and to be active at most tissue locations across the body.
We believe that our library of related novel small molecules holds the potential to be disease-modifying therapies that may change the course of hundreds of
genetic diseases and improve the lives of patients. Our early preclinical data in animal models of nonsense mutations suggests that drug product candidates from our
read-through compound library may have potential beneficial effects for each of the following diseases: cystic fibrosis, cystinosis, a variety of inherited retinal
diseases, mucopolysaccharidosis type 1, Duchenne muscular dystrophy and Rett syndrome, and have demonstrated the potential for beneficial effects in multiple
organs such as the brain, eye, kidney, muscles and others. Of the 170 novel compounds in the ERSG Library, approximately 30 compounds have been selected, based
on read-through activity, for continued preclinical research and we anticipate additional compounds advancing toward IND filings.
Currently our lead program, ELX-02, is focused on development for cystic fibrosis and cystinosis patients with diagnosed nonsense mutations. Our clinical
trial application (“CTA”) has been approved by the Federal Agency for Medicines and Health Products (the “FAMHP”) in Brussels and our IND submitted to the
U.S. Food and Drug Administration (the “FDA”) is open. Our Phase 2 program has been given a “high priority” ranking by the European Cystic Fibrosis Society
Clinical Trial Network. We expect to initiate Phase 2 studies in cystic fibrosis and cystinosis following completion of our ongoing Phase 1b MAD study in the first
half and to report top line Phase 2 data in the second half of 2019.
As part of our clinical program, we have completed a Phase 1 SAD study in a total of 60 healthy volunteers at sites in Israel (ClinicalTrials.gov Identifier:
NCT02807961) and Belgium (ClinicalTrials.gov Identifier: NCT03292302). The results of the SAD study were published in the Journal of Clinical Pharmacology in
January 2019. Our MAD study is being conducted in Belgium (ClinicalTrials.gov Identifier: NCT03309605). We have initiated the 6th cohort of the MAD study and
expect to complete the final cohort in the U.S. in the first half of this year.
In 2018, we initiated a new program studying inherited retinal disorders with a focus on Usher Syndrome by conducting pre-IND enabling studies on several
compounds from our library. We expect to advance one or more compounds into development for intravitreal administration.
We believe there is a significant unmet medical need in the treatment of cystic fibrosis patients carrying nonsense mutations on one or both alleles of the
Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”) gene. Cystic fibrosis is the most prevalent genetic disease in the western world and there are no
currently approved therapies that target the impairment associated with Class 1 CFTR mutations. We believe that nonsense mutations may impact a similar
proportion of patients diagnosed with cystinosis. There are no currently approved therapeutics that target the nonsense mutation mediated impairment of cystinosin,
the cystine-selective transport channel in the lysosomal membrane that is attributed as the cause for the accumulation of cystine in this disease state. Given the
51
high proportion of pediatric patients in each of these rare orphan diseases we intend to apply for relevant Orphan Drug incentives in the U.S. and Europe, including
the Rare Pediatric Disease Priority Review Voucher in the U.S.
Currently, the European Medicines Agency (the “EMA”) has designated ELX-02 as an orphan medicine for the treatment of cystic fibrosis and
mucopolysaccharidosis type I (“MPS I”), and the FDA has granted orphan drug designation to ELX-02 for the treatment of cystinosis, MPS I, and Rett Syndrome.
We hold worldwide development and commercialization rights to ELX-02 and other novel compounds in our read-through library, for all indications, in all
territories, under a license from the Technion Research and Development Foundation Ltd. (“TRDF”). Professor Timor Baasov, the inventor of our compounds, has
served as our senior consultant since our incorporation.
On April 30, 2018, we completed an underwritten public offering of 5,899,500 shares of our common stock at the public offering price of $9.75 per share.
We received net proceeds of approximately $53.6 million after deducting underwriting discounts and commissions and estimated offering expenses. We believe that
our cash and cash equivalents of $48.6 million at December 31, 2018, together with $14.8 million in net proceeds from a debt issuance in January 2019, will enable
us to meet the anticipated cash needs required to maintain our current and planned operations into the second quarter of 2020.
Since our inception, we have incurred significant operating losses. Our net losses were $47.2 million, $21.2 million and $9.8 million for the years ended
December 31, 2018, 2017 and 2016, respectively. As of December 31, 2018, we had an accumulated deficit of $86.1 million. To date, we have financed our
operations primarily through equity capital investments, and to a lesser extent, from loans and grants from the Israeli Innovation Authority of the Ministry of
Economy and Industry, or the IIA. We have devoted substantially all of our financial resources and efforts to research and development. We expect that it will be
many years, if ever, before we receive regulatory approval and have a product candidate ready for commercialization. We expect to continue to incur significant
expenses and increasing operating losses for the foreseeable future. Our net losses may fluctuate significantly from quarter to quarter and year to year. We anticipate
that our expenses will increase substantially if, and as, we:
•
•
•
•
•
•
•
•
•
•
•
advance ELX-02 further into clinical trials;
continue the preclinical development of our research programs and advance candidates into clinical trials;
identify additional product candidates and advance them into preclinical development;
pursue regulatory authorization to conduct clinical trials of additional product candidates;
seek marketing approvals for our product candidates that successfully complete clinical trials;
establish a sales, marketing and distribution infrastructure to commercialize any product candidates for which we obtain marketing approval;
maintain, expand and protect our intellectual property portfolio;
hire additional clinical, regulatory, management and scientific personnel;
add operational, financial and management information systems and personnel, including personnel to support product development;
acquire or in-license other product candidates and technologies; and
operate as a public company.
Reverse Merger
On December 19, 2017, Sevion Therapeutics, Inc. (“Sevion”) acquired Eloxx Pharmaceuticals, Ltd. (“Eloxx Limited”) pursuant to a merger between the
companies (the “Transaction”). Upon consummation of the Transaction, Sevion adopted the business plan of Eloxx Limited and discontinued the pursuit of Sevion’s
business plan. In connection with the Transaction, Sevion acquired all of the outstanding capital stock of Eloxx Limited in exchange for the issuance of an aggregate
20,316,656 shares of Sevion’s common stock, par value $0.01 per share (the “Common Stock”), after giving effect to a 1-for-20 reverse split effected immediately
prior to the Transaction. As a result of the Transaction, Eloxx Limited became a wholly-owned subsidiary of Sevion. While Sevion was the legal
52
acquirer in the Transaction, Eloxx Limited was deemed the accounting acquirer. Immediately after giving effect to the Transaction, on December 19, 2017, Sevion
changed its name to Eloxx Pharmaceuticals, Inc.
Our annual consolidated financial statements included elsewhere in this Report reflect the operations of the acquirer for accounting purposes, together with a
deemed issuance of shares, equivalent to the shares held by the stockholders of the legal acquirer and a recapitalization of the equity of the accounting acquirer. The
annual consolidated financial statements include our accounts since the effective date of the Transaction and the accounts of Eloxx Limited since inception.
Critical Accounting Policies and Significant Judgments and Estimates
Our discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements and the notes thereto
included elsewhere in this Report, which have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The
preparation of these annual consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities
and the disclosure of contingent assets and liabilities at the date of the consolidated financial statement, as well as the expenses during the reporting period. We
evaluate our estimates and judgments on an ongoing basis. These items are monitored and analyzed by us for changes in facts and circumstances and material
changes in these estimates could occur in the future. We base our estimates on historical experience and on various other factors that we believe are reasonable under
the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other
sources. Actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are more fully described in Note 2 to our annual consolidated financial statements appearing elsewhere in this
Report, we believe that the following accounting policies related to accrued expenses and accrued clinical trial costs and contract research liabilities are the most
critical accounting policies for fully understanding and evaluating our financial condition and results of operations.
Accrued Expenses and Accrued Clinical Trial Costs and Contract Research Liabilities
As part of the process of preparing our financial statements, we are required to estimate accrued expenses. This process involves identifying services which
have been performed on our behalf and estimating the level of service performed and the associated cost incurred for such service as of each balance sheet date in our
financial statements. Given our current business, the primary area of uncertainty concerning accruals which could have a material effect on our operating results is
with respect to service fees paid to contract manufacturers in conjunction with the production of clinical drug supplies and to contract research organizations in
connection with our pre-clinical research and clinical trials. In connection with all of the foregoing service fees, our estimates are most affected by our understanding
of the status and timing of services provided. The majority of our service providers, including contract research organizations, invoice us in arrears for services
performed. In the event that we do not identify some costs which have begun to be incurred, or we under or overestimate the level of services performed or the costs
of such services in a given period, our reported expenses for such period would be understated or overstated. We currently reflect the effects of any changes in
estimates based on changes in facts and circumstances directly in our operations in the period such change becomes known.
Our arrangements with contract research organizations in connection with clinical trials often provide for payment prior to commencing the project or based
upon predetermined milestones throughout the period during which services are expected to be performed. We recognize expense relating to these arrangements
based on the various services provided over the estimated time to completion. The date on which services commence, the level of services performed on or before a
given date, and the cost of such services are often determined based on subjective judgments. We make these judgments based upon the facts and circumstances
known to us based on the terms of the contract and our ongoing monitoring of service performance. During the years ended December 31, 2018, we had
arrangements with multiple contract research organizations whereby these organizations commit to performing services for us over multiple reporting periods. We
recognize the expenses associated with these arrangements based on our expectation of the timing of the performance of components under these arrangements by
these organizations. Generally, these components consist of the costs of setting up the trial, monitoring the trial, closing the trial and preparing the resulting data.
Costs related to patient enrollment in clinical trials are accrued as patients are enrolled in the trial.
53
With respect to financial reporting periods presented in this Report, the timing of our actual costs incurred have not differed materially from our estimated
timing of such costs. In light of the foregoing, we do not believe our practices for estimating future expenses and making judgments concerning the accrual of
expenses are reasonably likely to change in the future.
Results of Operations
Comparison of the Years Ended December 31, 2018, 2017 and 2016
The following table is in thousands:
Operating expenses:
Research and development, net
General and administrative
Reverse merger related expenses
Total operating costs
Loss from operations
Other (income) expense, net
Loss before income taxes
Provision for income taxes
Net loss
2018
Year Ended December 31,
2017
2016
2018 / 2017
2017 / 2016
$
$
20,489 $
26,482
594
47,565
(47,565)
(502)
(47,063)
122
(47,185) $
16,398 $
2,702
1,290
20,390
(20,390)
824
(21,214)
—
(21,214) $
$
8,986
854
—
9,840
(9,840)
7
(9,847)
—
(9,847) $
4,091
23,780
(696)
27,175
(27,175)
(1,326)
(25,849)
122
(25,971)
25% $
880%
-54%
133%
133%
-161%
122%
100%
122% $
7,412
1,848
1,290
10,550
(10,550)
817
(11,367)
—
(11,367)
82%
216%
100%
107%
107%
11671%
115%
—
115%
Research and development expenses, net
Research and development expenses were $20.5 million for the year ended December 31, 2018 compared to $16.4 million for the year ended December 31,
2017, an increase of $4.1 million. The increase in research and development expenses was primarily related to an increase in salaries and other personnel related
costs of $3.4 million and fees incurred to subcontractors, consultants and advisors in connection with continued clinical phase development of ELX-02 of $0.7
million.
Research and development expenses were $16.4 million for the year ended December 31, 2017 compared to $9.0 million for the year ended December 31,
2016, an increase of $7.4 million. The increase in research and development expenses was primarily related to the provision recorded related to the exit fee for
Technion of $3.4 million, along with fees incurred to subcontractors, consultants and advisors in connection with research and development of our ELX-02 of
$3.2 million (including a deduction of research and development grants we received from the IIA) and salaries and other personnel related costs of $0.8 million.
General and administrative expenses
General and administrative expenses were $26.5 million for the year ended December 31, 2018 compared to $2.7 million for the year ended December 31,
2017, an increase of $23.8 million. The increase in general and administrative expenses was primarily related to stock-based compensation of $11.6 million, an
increase in headcount and related salaries, and other personnel related costs of $4.4 million, and fees attributable principally to infrastructure related costs including
legal, accounting and other professional fees of $7.8 million.
General and administrative expenses were $2.7 million for the year ended December 31, 2017 compared to $0.9 million for the year ended December 31,
2016, an increase of $1.8 million. The increase in general and administrative expenses was primarily related to salaries, stock-based compensation, and other
personnel related costs of $1.0 million and professional services of $0.8 million.
Reverse merger related expenses
We recorded professional service fees of $0.6 million for the year ended December 31, 2018 compared to $1.3 million for the year ended December 31,
2017 related primarily to the reverse merger we completed on December 19, 2017. No professional service fees were recorded for the year ended December 31,
2016.
54
Other (income) expense, net
We recorded $(0.5) million in other (income) expense, net for the year ended December 31, 2018 compared to $0.8 million for the year ended December 31,
2017, an increase of $1.3 million. The increase in other (income) expense, net was primarily due to an increase in interest income of $0.6 due to our higher cash
balance resulting from net proceeds received of $53.6 million from our offering in April 2018, a decrease in interest expense of $0.6 million on debt issuance costs
resulting from the conversion of the convertible loan into Series C preferred stock and a decrease in foreign exchange losses of $0.1 million.
We recorded $0.8 million in other (income) expense for the year ended December 31, 2017 compared to $7 thousand for the year ended December 31, 2016,
an increase of $0.8 million. The increase in other (income) expense, net was primarily due to $0.6 million of amortization and revaluation of embedded conversion
feature in respect to convertible loan and $0.2 million of exchange rate differences.
Provision for income taxes
We recorded provision for income taxes of $0.1 million for the year ended December 31, 2018 primarily as a result of current income tax expense for
subsidiary operations and a correction of a prior year tax return partially offset by a prior year provision adjustment. There was no provision for income taxes
recorded for the years ended December 31, 2017 and 2016.
Net operating loss carryforwards
As of December 31, 2018, we had U.S. federal and state NOL carryforwards of $89.8 million and $40.0 million, respectively, and federal research tax credit
carryforwards of $0.7 million. Certain U.S. net operating loss carryforwards will begin to expire, if not utilized, beginning in 2019 through 2037, and the research tax
credits will expire beginning in 2027 through 2037. These NOL carryforwards could expire unused and be unavailable to offset future income tax liabilities. Included
in these U.S. federal NOL carryforwards are $13.1 million of NOLs generated after the effective date of the Tax Cuts and Jobs Act which are not subject to
expiration, but may not be carried back and are only eligible to offset up to a maximum of 80% of taxable income generated in a given year. Under the newly
enacted Tax Cuts and Jobs Act (“Tax Act”), federal net operating losses incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility
of such federal net operating losses is limited. It is uncertain if and to what extent various states will conform to the newly enacted federal tax law. Finally, as of
December 31, 2018, we had Israeli NOL carryforwards of $34.6 million, which carryforward indefinitely.
Liquidity and Capital Resources
Liquidity is the ability of a company to generate funds to support its current and future operations, satisfy its obligations, and otherwise operate on an
ongoing basis. Significant factors in the management of liquidity are funds generated by operations and levels of accounts receivable and accounts payable and
capital expenditures. Since our inception and through December 31, 2018 we have funded our operations primarily through equity and convertible debt financings in
private placements and public offerings of our common stock, as described below.
We have a history of net losses and negative cash flows from operating activities since inception, and as of December 31, 2018, had an accumulated deficit
of $86.1 million. We expect to continue to incur net losses and use cash in our operations in the foreseeable future. To date, we have not generated revenue from the
sale of any product or service and do not expect to generate significant revenue unless and until obtaining marketing approval and commercialization of our product
candidates currently in development. A successful transition to profitable operations is dependent upon achieving a level of revenues adequate to support our cost
structure.
We have financed our operations primarily from the sale of our equity securities. We may never achieve profitability, and unless and until we do, we will
continue to need to raise additional cash to fund our operations. We believe that our cash and cash equivalents of $48.6 million at December 31, 2018, together with
$14.8 million in net proceeds from a debt issuance in January 2019, will enable us to meet the anticipated cash needs required to maintain our current and planned
operations into the second quarter of 2020. Our cash and cash equivalents are highly liquid investments with original maturities of 90 days or less at the date of
purchase and consist of cash in operating accounts.
55
Management intends to fund future operations through private or public debt or equity financing transactions, and may seek additional capital through
arrangements with strategic partners or from other sources. If we are unable to obtain financing, we will evaluate options which may include reducing or deferring
operating expenses which may have a material adverse effect on our operations and future prospects.
Principal Financing Activities
In February 2016, Eloxx Limited issued shares of preferred stock and warrants to purchase shares of preferred stock for an aggregate gross amount of
$6.0 million.
In August 2016, Technion Investment Opportunities Fund L.P (the “TIOF) and TRDF exercised 124,786 and 311,964 warrants, respectively, to purchase
shares of preferred stock for total consideration of $0.4 million.
In September 2016, Eloxx Limited achieved a milestone in connection with a prior issuance of securities, pursuant to which Eloxx Limited paid a
$0.1 million milestone payment and issued to investors additional shares of preferred stock and warrants to purchase preferred stock for an aggregate amount of
$3.7 million.
In May 2017, Eloxx Limited entered into a Share Purchase Agreement (the “2017 SPA”) with certain existing and new investors, whereby, an aggregate
gross amount of $21.5 million, which included the conversion of the loan as detailed in Note 7 of the Notes to Consolidated Financial Statements contained
elsewhere in this Report, was received by Eloxx Limited in exchange for the issuance of shares of preferred stock including shares of preferred stock that were issued
as a result of the anti-dilution effect of the Reverse Merger. The related issuance costs were $0.6 million.
Upon the closing of the Reverse Merger in December 2017, we issued 6,333,333 shares of common stock related to the 2017 SPA for an aggregate gross
amount of $17.5 million. Additionally, Sevion raised $1.5 million prior to the Reverse Merger. The related issuance costs for these transactions was $0.5 million.
On April 30, 2018, we completed an underwritten public offering of 5,899,500 shares of our common stock, including the exercise in full by the underwriter
of its overallotment option to purchase an additional 769,500 shares, at the public offering price of $9.75 per share for gross proceeds of approximately $57.5
million, before deducing the underwriting discounts and commissions and offering expenses of approximately $3.9 million.
In November 2018, we entered into an Equity Distribution Agreement with Citigroup Global Markets Inc. and Cantor Fitzgerald & Co., pursuant to which
we sold 201,100 shares of common stock and received proceeds of $2.2 million, net of issuance costs of $0.1 million as of December 31 2018. The shares sold were
pursuant to an effective registration statement as described below.
Subsequent Event – Debt Financing
On January 30, 2019, we entered into a Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank (“SVB”), in its capacity as
administrative agent, collateral agent and lender, and WestRiver Innovation Lending Fund VIII, L.P. (“WestRiver”). Pursuant to the terms and conditions of the Loan
Agreement, the Lenders agreed to extend term loans to us in an aggregate principal amount of up to $25 million, comprised of (i) an initial loan advance of $15
million and (ii) a subsequent loan advance of $10 million, subject to first achieving certain conditions (collectively, the “Term Loan Advances”). The initial term loan
was funded on January 30, 2019. The subsequent loan advance is available at our election after the occurrence of certain milestone events relating to data from our
clinical trials and receipt by us of certain minimum cash proceeds of at least $75 million from an additional equity offering through a private placement or a public
offering.
56
Cash Flows
The following table presents the major components of net cash flows provided by (used in) operating, investing and financing activities for the periods
presented (in thousands):
Net cash used in operating activities
Net cash used in investing activities
Net cash provided by financing activities
Year Ended
December 31,
2018
Year Ended
December 31,
2017
Year Ended
December 31,
2016
$
$
$
(31,367) $
(317) $
56,184 $
(15,935) $
(114) $
37,950 $
(8,844)
(36)
9,736
Our operating activities used cash of $31.4 million, $15.9 million and $8.8 million for the years ended December 31, 2018, 2017 and 2016 respectively.
Cash used in operations resulted primarily from our net loss adjusted for non-cash items and changes in working capital. During the year ended December 31, 2018,
our net loss was $47.2 million partially offset by non-cash charges of $13.4 million related to stock-based compensation and $0.2 million of depreciation expense.
Changes in working capital for the period were $2.2 million related primarily for accounts payable and accrued expenses. During the year ended December 31, 2017,
our net loss of $21.2 million, partially offset by non-cash charges of $3.4 million for the provision related to the Technion exit fee, $0.6 million related to the
amortization and revaluation of the discount on our convertible loan and $0.1 million related to stock-based compensation. Changes in working capital for the period
of $1.0 million related primarily to decreases in prepaids expenses and other current assets and increases in accrued expenses offset by decreases in accounts payable.
During the year ended December 31, 2016, our net loss of $9.8 million, offset by non-cash charges including $0.9 million related to changes in working capital and
$0.1 million related to stock-based compensation. Changes in working capital for the period of $0.9 million related primarily to increases in accounts payable and
accrued expenses offset by decreases in prepaids expenses and other current assets.
Our investing activities used cash of $0.3 million, $0.1 million and $36 thousand for the years ended December 31, 2018, 2017 and 2016, respectively. Cash
used in investing activities was primarily for the purchase of property and equipment and deposits on leased spaces. During the year ending December 31, 2018, we
paid additional deposit amounts associated with the amendment of one of our lease facilities.
Our financing activities provided cash of $56.2 million, $38.0 million and $9.7 million for the years ended December 31, 2018, 2017 and 2016, respectively.
Cash provided resulted primarily from the net proceeds on sales of our common stock and preferred stock. During the year ended December 31, 2018, net proceeds
from the 2018 offering was $53.6 million, sales under an equity sales agreement of $2.2 million, and proceeds from share-based compensation arrangements of $0.4
million. During the year ended December 31, 2017, net proceeds from the sale of preferred stock was $18.4 million, net proceeds from the conversion of convertible
loans into preferred stock was $2.5 million, and net proceeds from the sale of common stock was $17.0 million, respectively. During the year ended December 31,
2016, net proceeds from the sale of preferred stock and warrants were approximately $9.4 million and $0.3 million from the exercise of warrants.
Form S-3 and Equity Sales Agreement
On April 10, 2018, we filed a shelf registration statement (“April 2018 Shelf”) on Form S-3 with the Securities and Exchange Commission (the “SEC”). The
2018 Shelf (File No. 333-224207) was declared effective on April 20, 2018 and covers the offering, issuance and sale of up to $125 million of our common stock,
preferred stock, debt securities or warrants and other securities, either individually or in combination.
In November 2018, we entered into an Equity Distribution Agreement (“the Agreement”) with Citigroup Global Markets Inc. and Cantor Fitzgerald & Co.
(collectively, the “Sales Agents”), pursuant to which we may sell and issue shares of our common stock up to an aggregate of $50 million through the Sales Agents.
The shares were offered pursuant to the April 2018 Shelf. We agreed to pay the Sales Agents a commission of up to 3% of the gross proceeds of any sales of
common stock pursuant to the Agreement. We incurred approximately $0.3 million related to legal, accounting and other fees in connection with the Agreement. For
the year ended December 31, 2018, under the Agreement, we sold 201,100 shares of common stock and received net proceeds of $2.2 million. At December 31,
2018, there was approximately $47.5 million available for future sales pursuant to the Agreement. In January 2019, we sold 35,362 shares of common stock and
received net proceeds of $0.7 million.
57
On November 16, 2018, we filed a shelf registration statement (“November 2018 Shelf”) on Form S-3 with the SEC. The November 2018 Shelf (File No.
333-228430) was declared effective on November 26, 2018 and covers the offering, issuance and sale of up to $200 million of our common stock, preferred stock,
debt securities or warrants and other securities, either individually or in combination, and is available for future issuances.
Government Grants from the Israeli Innovation Authority (“IIA”)
To date, we have received research and development grants from the IIA totaling $2.6 million. We received research and development grants from the IIA in
the amounts of $0.9 million and $1.2 million, for the years ended December 31, 2017 and 2016, respectively. No grant was received for the year ended December 31,
2018.
Under the research and development agreements with the IIA and pursuant to applicable law, we are required to pay royalties at the rate of 3% on sales to
end customers of product candidates developed with funds provided by the IIA, up to an amount equal to 100% of the IIA research and development grants received,
plus interest based on the 12-month LIBOR rate. If we do not generate sales of product candidates developed with funds provided by the IIA, we are not obligated to
pay royalties or repay the grants.
As of December 31, 2018, we have not commenced the payment obligation of the royalties and have a contingent obligation with respect to royalty-bearing
participation received or accrued, amounting to $2.7 million, including accrued LIBOR interest.
Technion Research and Development Foundation Limited Agreement
On August 29, 2013, we entered into an agreement (“Technion Agreement”) with Technion Research and Development Foundation Limited (“TRDF”), with
respect to certain technology relating to aminoglycosides and the redesign of aminoglycosides for the treatment of human genetic diseases caused by premature stop
mutations and further results of the research of the technology, in order to develop and commercialize products based on such technology. Under the Technion
Agreement, TRDF is obligated to provide us with research services for an estimated annual payment of $0.1 million, the precise amount to be agreed by the parties
prior to the beginning of each year of the research period. During the years ended December 31, 2018, 2017 and 2016, we recorded general and administrative
expenses amounting to $0, $7 thousand and $0.2 million, respectively, in relation to the Technion Agreement. In addition, during the years ended December 31,
2018, 2017 and 2016, we recorded research and development expenses amounting to $0.1 million, $3.5 million and $33 thousand, respectively, in relation to the
Technion Agreement for reimbursement of costs incurred during the preparation, filing, prosecution and maintenance of the TRDF patent rights related to Eloxx
Limited. As of December 31, 2018 and 2017, amounts recorded in accrued expenses were $25 thousand and $25 thousand, respectively.
In addition, TRDF granted us a license to use, market, sell or sub-license the rights of the product developed under the TRDF research results (the “Licensed
Product”), as defined in the Technion Agreement, for the following considerations: (a) milestone payments up to total consideration of $6.1 million, to be transferred
upon meeting certain milestones as defined in the Technion Agreement; (b) certain royalties in the low- to mid- single-digit percentage of net sales (subject to change
in the case of (x) sublicensing to a big pharmaceutical or biotechnology company, or (y) payment of royalties to third parties, or (z) commercialization by a third
party of an authorized generic to a licensed product), for a period until the later of (i) the expiration of a valid claim on the Licensed Product in each country the
Licensed Product is sold to, or (ii) a certain amount of years from the date of the first commercial sale of the Licensed Product in such country, and (c) a low- to mid-
double-digit percentage of any non-royalty sub-license income received by us from a sub-licensed entity. In addition, we agreed to pay a fee to TRDF upon certain
exit events as described in the Technion Agreement.
On August 9, 2017, we received a letter from TRDF regarding TRDF’s alleged entitlement to an exit fee in accordance with the Technion Agreement. We
recorded a $3.4 million research and development expense with an offsetting adjustment to additional paid-in capital for the year ended December 31, 2017, related
to the planned issuance of shares to TRDF at fair market value on the purported date of the exit event. On June 30, 2018, we issued 569,395 shares to TRDF in
satisfaction of this claim representing fulfilment of the exit payment obligation.
58
Off-Balance Sheet Arrangements
As of December 31, 2018 and 2017, we did not have any off-balance sheet arrangements, as such term is defined under Item 303 of Regulation S-K, that
have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations,
liquidity, capital expenditures or capital resources that is material to investors.
ITEM 7A.
QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
Not applicable to a “smaller reporting company”, as defined in Item 10(f)(1) of Regulation S-K
ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The consolidated financial statements and supplementary data required by this item are set forth indicated in Item 15, set forth in this Report.
ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
The Company’s annual financial statements for the fiscal year ended December 31, 2017 was audited by Kost Forer Gabbay & Kasierer, a member of
Ernst & Young Global, or EY, as the independent registered public accounting firm. On June 18, 2018, the Company appointed Deloitte & Touche LLP, or Deloitte,
as the independent registered public accounting firm to audit the Company’s financial statements for the year ended December 31, 2018. During the fiscal years
ended December 31, 2017 and 2016 and the subsequent interim period through June 18, 2018, there were (1) no disagreements (as defined in Item 301(a)(1)(iv) of
Regulation S-K) with EY on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreement, if
not resolved to the satisfaction of EY, would have caused EY to make reference thereto in their reports on the Company’s financial statements, and (ii) no “reportable
events” (as defined in Item 304(a)(1)(v) of Regulation S-k).
During the year ended December 31, 2018 and the subsequent interim period, neither the Company nor anyone acting on its behalf consulted Deloitte
regarding the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on the
Company’s financial statements.
ITEM 9A.
CONTROLS AND PROCEDURES
Management’s Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit
under the Securities and Exchange Act of 1934 is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms
and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions
regarding required disclosure.
As of December 31, 2018, our management, under the supervision and with the participation of our principal executive officer and principal financial
officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the
Securities and Exchange Act of 1934 (the “Exchange Act”)). Our management recognizes that any controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Our principal executive officer and principal financial officer have concluded based upon the evaluation described
above that, as of December 31, 2018, our disclosure controls and procedures were effective in ensuring that material information relating to the Company, including
its consolidated subsidiaries, required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed,
summarized, and reported within the time periods specified in the SEC’s rules and forms, including ensuring that such material information is accumulated and
communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding
required disclosure.
59
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act
Rules 13a-15(f) and 15d-15(f). Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an
evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2018 based on the guidelines established in Internal Control-
Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Based on this evaluation, our
management concluded that our internal control over financial reporting was effective as of December 31, 2018.
The effectiveness of our internal control over financial reporting as of December 31, 2018 has been audited by Deloitte & Touche LLP, an independent
registered public accounting firm, as stated in their report, which appears herein.
Changes in Internal Control over Financial Reporting
During the quarter ended December 31, 2018, there have been no changes in our internal control over financial reporting, as such term is defined in Rules
13a-15(f) and 15(d)-15(f) promulgated under the Securities Exchange Act of 1934, that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
60
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the stockholders and the Board of Directors of Eloxx Pharmaceuticals, Inc.
Opinion on Internal Control over Financial Reporting
We have audited the internal control over financial reporting of Eloxx Pharmaceuticals, Inc. and subsidiaries (the “Company”) as of December 31, 2018, based on
criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission
(COSO). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2018, based on
criteria established in Internal Control — Integrated Framework (2013) issued by COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial
statements as of and for the year ended December 31, 2018, of the Company and our report dated March 14, 2019, expressed an unqualified opinion on those
financial statements.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal
control over financial reporting, included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express
an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities
and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance
about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal
control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control
based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable
basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial
reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions
and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with
authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
March 14, 2019
61
ITEM 9B.
OTHER INFORMATION
None.
62
PART III
ITEM 10.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this Item 10 will be included under the captions “Executive Officers,” “Election of Directors,” “Section 16(a) Beneficial
Ownership Reporting Compliance,” “Code of Ethics,” “Information Regarding Committees of the Board of Directors” and “Information regarding the Board of
Directors and Corporate Governance” in our definitive proxy statement to be filed pursuant to Regulation 14A within 120 days after the end of the fiscal year
covered by this Report.
ITEM 11.
EXECUTIVE AND DIRECTOR COMPENSATION
The information required by this Item 11 will be included under the captions “Executive Compensation” and “Director Compensation” in our definitive
proxy statement to be filed pursuant to Regulation 14A within 120 days after the end of the fiscal year covered by this Report.
ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS
The information required by this Item 12 will be included under the captions “Security Ownership of Certain Beneficial Owners and Management” and
“Equity Compensation Plan Information” in our definitive proxy statement to be filed pursuant to Regulation 14A within 120 days after the end of the fiscal year
covered by this Report.
ITEM 13.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this Item 13 will be included, as applicable, under the captions of “Independence of the Board of Directors,” “Employment
Arrangements” and “Transactions with Related Persons” in our definitive proxy statement to be filed pursuant to Regulation 14A within 120 days after the end of the
fiscal year covered by this Report.
ITEM 14.
PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this Item 14 will be included under the captions “Principal Accountant Fees and Services” and “Pre-Approval Policies and
Procedures” in our definitive proxy statement to be filed pursuant to Regulation 14A within 120 days after the end of the fiscal year covered by this Report.
63
ITEM 15.
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
PART IV
Item 15(a)
(1) Financial Statements
The financial statements required by this item are submitted in a separate section beginning on page F-1 of this Report.
(2) Financial Statement Schedules
Schedules have been omitted because of the absence of conditions under which they are required or because the required information is included in the
financial statements or notes thereto beginning on page F-1 of this Report.
(3) Exhibits:
The exhibits listed in the Exhibit Index at the end of this report are filed or incorporated by reference as part of this Report.
Item 15(b)
Exhibits
See (a)(3) above.
Item 15(c)
Financial Statement Schedules
See (a)(2) above.
ITEM 16.
FORM 10-K SUMMARY
Not applicable.
64
Exhibit
No.
2.1
2.2
2.3
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
EXHIBIT INDEX
Description of Exhibit
Agreement, dated as of May 31, 2017, by and among Sevion Therapeutics, Inc., Sevion Sub, Ltd. and Eloxx Pharmaceuticals Ltd. (Incorporated by
reference to Exhibit 2.1 of the Company’s Current Report on Form 8-K filed on June 6, 2017, SEC File No. 001-31326)
Amendment to Agreement, dated as of August 1, 2017, by and among Sevion Therapeutics, Inc., Sevion Sub, Ltd. and Eloxx Pharmaceuticals Ltd.
(Incorporated by reference to Exhibit 2.3 of the Company’s Annual Report on Form 10-K filed on October 13, 2017, SEC File No. 001-31326)
Second Amendment to Agreement, dated as of November 23, 2017, by and among Sevion Therapeutics, Inc., Sevion Sub, Ltd. and Eloxx
Pharmaceuticals Ltd. (Incorporated by reference to Exhibit 2.1 of the Company’s Current Report on Form 8-K filed on November 29, 2017, SEC File
No. 001-31326)
Amended and Restated Certificate of Incorporation of Senesco Technologies, Inc. filed with the State of Delaware on January 22, 2007. (Incorporated
by reference to Exhibit 3.1 of our Quarterly Report on Form 10-Q filed on February 14, 2007, SEC File No. 001-31326).
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Senesco Technologies, Inc. filed with the State of Delaware on
December 13, 2007. (Incorporated by reference to Exhibit 3.1 of our Quarterly Report on Form 10-Q filed on February 14, 2008, SEC File No. 001-
31326).
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Senesco Technologies, Inc. filed with the State of Delaware on
September 22, 2009. (Incorporated by reference to Exhibit 3.3 of our Annual Report on Form 10-K filed on September 28, 2009, SEC File No. 001-
31326).
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Senesco Technologies, Inc. filed with the State of Delaware on
May 25, 2010. (Incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K filed on May 28, 2010, SEC File No. 001-31326).
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Senesco Technologies, Inc. filed with the State of Delaware on
December 22, 2011. (Incorporated by reference to Exhibit 3.1 to our Quarterly Report on Form 10-Q filed on February 14, 2011, SEC File No. 001-
31326).
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Senesco Technologies, Inc. filed with the State of Delaware on
April 1, 2013. (Incorporated by reference to Exhibit 3.1 to our Quarterly Report on Form 10-Q filed on May 15, 2013, SEC File No. 001-31326).
Certificate of Amendment to the Company’s Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of
Delaware on October 16, 2013. (Incorporated by reference to Exhibit 3.1 of our Current Report on Form 8-K filed on October 21, 2013, SEC File No.
001-31326).
Certificate of Amendment to the Company’s Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of
Delaware on September 29, 2014. (Incorporated by reference to Exhibit 3.1 of our Current Report on Form 8-K filed on October 3, 2014, SEC File
No. 001-31326).
Certificate of Amendment to the Company’s Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of
Delaware on December 19, 2017. (Incorporated by reference to Exhibit 3.1 of our Current Report on Form 8-K filed on December 22, 2017, SEC File
No. 001-31326).
Certificate of Amendment to the Company’s Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of
Delaware on December 19, 2017. (Incorporated by reference to Exhibit 3.2 of our Current Report on Form 8-K filed on December 22, 2017, SEC File
No. 001-31326).
Certificate of Designations to the Company’s Certificate of Incorporation. (Series A) (Incorporated by reference to Exhibit 3.1 to our Current Report
on Form 8-K filed on March 29, 2010, SEC File No. 001-31326).
65
Exhibit
No.
3.12
3.13
4.1
10.1*
10.2*
10.3
10.4
10.5
10.6
10.7
10.8
10.9
Description of Exhibit
Certificate of Designations to the Company’s Certificate of Incorporation. (0% Series C Convertible Preferred Stock) (Incorporated by reference to Exhibit 3.1
of our Current Report on Form 8-K filed on May 6, 2015, SEC File No. 001-31326).
Amended and Restated Bylaws of Eloxx Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 3.2 of the Company’s Current Report on Form 8-
K filed on December 27, 2017, SEC File No. 001-31326).
Specimen of Common Stock Certificate (Incorporated by reference to Exhibit 4.1 of our Annual Report on Form 10-K filed on March 16, 2018, SEC
File No. 001-31326).
Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx Pharmaceuticals Ltd., dated
August 29, 2013 (Incorporated by reference to Exhibit 10.1 of our Annual Report on Form 10-K filed on March 16, 2018, SEC File No. 001-31326).
First Amendment to Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx
Pharmaceuticals Ltd., dated November 26, 2013 (Incorporated by reference to Exhibit 10.2 of our Annual Report on form 10-K filed on March 16,
2018, SEC File No. 001-31326).
Second Amendment to Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx
Pharmaceuticals Ltd., dated January 14, 2014 (Incorporated by reference to Exhibit 10.3 of our Annual Report on form 10-K filed on March 16, 2018,
SEC File No. 001-31326).
Third Amendment to Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx
Pharmaceuticals Ltd., dated June 9, 2014 (Incorporated by reference to Exhibit 10.4 of our Annual Report on form 10-K filed on March 16, 2018, SEC
File No. 001-31326).
First Addendum to Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx
Pharmaceuticals Ltd., dated August 3, 2014 (Incorporated by reference to Exhibit 10.5 of our Annual Report on form 10-K filed on March 16, 2018,
SEC File No. 001-31326).
Second Addendum to Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx
Pharmaceuticals Ltd., dated January 21, 2015 (Incorporated by reference to Exhibit 10.6 of our Annual Report on form 10-K filed on March 16, 2018,
SEC File No. 001-31326).
Third Addendum to Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx
Pharmaceuticals Ltd., dated February 9, 2015 (Incorporated by reference to Exhibit 10.7 of our Annual Report on form 10-K filed on March 16, 2018,
SEC File No. 001-31326).
Fourth Addendum to Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx
Pharmaceuticals Ltd., dated April 29, 2015 (Incorporated by reference to Exhibit 10.8 of our Annual Report on form 10-K filed on March 16, 2018,
SEC File No. 001-31326).
Fifth Addendum to Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx
Pharmaceuticals Ltd., dated June 2, 2015 (Incorporated by reference to Exhibit 10.9 of our Annual Report on form 10-K filed on March 16, 2018,
SEC File No. 001-31326).
10.10
Sixth Addendum to Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx
Pharmaceuticals Ltd., dated January 11, 2016 (Incorporated by reference to Exhibit 10.10 of our Annual Report on form 10-K filed on March 16,
2018, SEC File No. 001-31326).
66
Exhibit
No.
10.11
10.12
10.13
10.14
Seventh Addendum to Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx
Pharmaceuticals Ltd., dated March 6, 2016 (Incorporated by reference to Exhibit 10.11 of our Annual Report on form 10-K filed on March 16, 2018,
SEC File No.
001-31326).
Description of Exhibit
Eighth Addendum to Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx
Pharmaceuticals Ltd., dated July 16, 2017 (Incorporated by reference to Exhibit 10.12 of our Annual Report on form 10-K filed on March 16, 2018,
SEC File No. 001-31326).
Ninth Addendum to Research and License Agreement by and between Technion Research and Development Foundation Ltd. and Eloxx
Pharmaceuticals Ltd., dated July 16, 2017 (Incorporated by reference to Exhibit 10.13 of our Annual Report on form 10-K filed on March 16, 2018,
SEC File No. 001-31326).
Amendment to Research and License Agreement, by and among Eloxx Pharmaceuticals, Inc., Eloxx Pharmaceuticals Ltd. and Technion Research &
Development Foundation Ltd., dated as of June 13, 2018 (Incorporated by reference to Exhibit 10.1 of our Current Report on Form 8-K filed on June
14, 2018, SEC File No. 001-31326).
10.15**
Consulting Agreement, dated December 1, 2014, by and between Eloxx Pharmaceuticals Ltd. and Dr. Silvia Noiman (Incorporated by reference to
Exhibit 10.1 of our Current Report on Form 8-K filed on December 22, 2017, SEC File No. 001-31326).
10.16**
Memorandum of Understanding, dated March 13, 2018, by and between Eloxx Pharmaceuticals, Inc. and Dr. Silvia Noiman (Incorporated by reference to
Exhibit 10.15 of our Quarterly Report on Form 10-Q filed on May 10, 2018, SEC File No. 001-31326).
10.17**
Employment Agreement, dated as of December 26, 2017, between Eloxx Pharmaceuticals, Inc. and Robert E. Ward (Incorporated by reference to our
Current Report on Form 8-K filed on December 27, 2017, SEC File No. 001-31326).
10.18**
Employment Agreement, dated as of March 12, 2018, between Eloxx Pharmaceuticals Inc. and Gregory Weaver (Incorporated by reference to Exhibit
10.19 of our Annual Report on Form 10-K filed on March 16, 2018, SEC File No. 001-31326).
10.19**
Form of Indemnification Agreement (Incorporated by reference to Exhibit 10.4 of our Current Report on Form 8-K filed on December 22, 2017, SEC
File No. 001-31326).
10.20**
Amended and Restated Senesco Technologies, Inc. 2008 Incentive Compensation Plan. (Incorporated by reference to Exhibit 10.3 of our quarterly
report on Form 10-Q for the period ended March 31, 2014., SEC File No. 001-31326)
10.21**
Form of Stock Option Agreement under the Senesco Technologies, Inc. 2008 Stock Incentive Plan. (Incorporated by reference to Exhibit 10.5 of our
quarterly report on Form 10-Q for the period ended September 30, 2009, SEC File No. 001-31326).
10.22**
Eloxx Pharmaceuticals Share Ownership and Option Plan (2013) (Incorporated by reference to Exhibit 10.24 of our Annual Report on Form 10-K filed
on March 16, 2018, SEC File No. 001-31326).
10.23**
Forms of Option Agreement, Stock Option Grant Notice and Notice of Exercise under the Eloxx Pharmaceuticals Share Ownership and Option Plan
(2013) (Incorporated by reference to Exhibit 10.25 of our Annual Report on Form 10-K filed on March 16, 2018, SEC File No. 001-31326).
10.24**
10.25**
10.26**
Performance Stock Option Grant Notice and Stock Option Agreement (Inducement Grant) between Eloxx Pharmaceuticals, Inc. and Robert E. Ward,
dated March 5, 2018 (Incorporated by reference to Exhibit 10.25 of our Annual Report on Form 10-K filed on March 16, 2018, SEC File No. 001-
31326).
Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement (Inducement Grant) between Eloxx Pharmaceuticals, Inc. and Robert E.
Ward, dated March 5, 2018 (Incorporated by reference to Exhibit 10.25 of our Annual Report on Form 10-K filed on March 16, 2018, SEC File No.
001-31326).
Performance Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement (Inducement Grant) between Eloxx Pharmaceuticals, Inc. and
Robert E. Ward, dated March 5, 2018 (Incorporated by reference to Exhibit 10.25 of our Annual Report on Form 10-K filed on March 16, 2018, SEC
File No. 001-31326).
67
Exhibit
No.
10.27**
Stock Option Grant Notice and Stock Option Agreement (Inducement Grant) between Eloxx Pharmaceuticals, Inc. and Robert E. Ward, dated March
5, 2018 (Incorporated by reference to Exhibit 10.25 of our Annual Report on Form 10-K filed on March 16, 2018, SEC File No. 001-31326).
Description of Exhibit
10.28** Retention Policy. (Incorporated by reference to Exhibit 10.1 of our current report on Form 8-K filed on October 15, 2012, SEC File No. 001-31326).
10.29
10.30
10.31
10.32
10.33
10.34
10.35
10.36
Lease Agreement by and between Eloxx Pharmaceuticals, Inc. and BP Pay Colony LLC, dated October 26, 2017 (Incorporated by reference to Exhibit
10.25 of our Annual Report on Form 10-K filed on March 16, 2018, SEC File No. 001-31326).
Eloxx Pharmaceuticals, Inc. 2018 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 of our Quarterly Report on Form 10-Q filed on
June 30, 2018, SEC File No. 001-31326).
Form of Stock Option Grant Notice, Option Agreement and Notice of Exercise under the Eloxx Pharmaceuticals, Inc. 2018 Equity Incentive Plan
(incorporated by reference to Exhibit 10.2 of our Quarterly Report on Form 10-Q filed on June 30, 2018, SEC File No. 001-31326).
Form of Restricted Stock Unit Grant Notice for non-Israeli employees (incorporated by reference to Exhibit 10.3 of our Quarterly Report on Form 10-
Q filed on June 30, 2018, SEC File No. 001-31326).
Israeli Sub-Plan under the Eloxx Pharmaceuticals, Inc. 2018 Equity Incentive Plan (incorporated by reference to Exhibit 10.4 of our Quarterly Report
on Form 10-Q filed on June 30, 2018, SEC File No. 001-31326).
Form of Israeli Stock Option Grant Package under the Israeli Sub-Plan under the Eloxx Pharmaceuticals, Inc. 2018 Equity Incentive Plan
(incorporated by reference to Exhibit 10.5 of our Quarterly Report on Form 10-Q filed on June 30, 2018, SEC File No. 001-31326).
Form of Restricted Stock Unit Grant Notice for Israeli employees (incorporated by reference to Exhibit 10.6 of our Quarterly Report on Form 10-Q
filed on June 30, 2018, SEC File No. 001-31326).
First Amendment to Lease Agreement by and between Eloxx Pharmaceuticals, Inc. and BP Pay Colony LLC, dated June 21, 2018 (incorporated by
reference to Exhibit 10.1 of our Current Report on Form 8-K filed on June 26, 2018, SEC File No. 001-31326).
10.37**
Executive Employment Agreement between Eloxx Pharmaceuticals, Inc. and Gregory C. Williams dated as of June 22, 2018 (incorporated by
reference to Exhibit 10.2 of our Current Report on Form 8-K filed on June 26, 2018, SEC File No. 001-31326).
10.38
Executive Employment Agreement between Eloxx Pharmaceuticals, Inc. and David Snow dated as of June 18, 2018.
10.39
Equity Distribution Agreement, dated November 16, 2018, by and between Eloxx Pharmaceuticals, Inc., Citigroup Global Markets Inc. and Cantor
Fitzgerald & Co. (incorporated by reference to Exhibit 10.1 of our Current Report on Form 8-K, filed on November 16, 2018, SEC File No. 001-
31326).
10.40
Loan and Security Agreement, dated as of January 30, 2019, by and among Silicon Valley Bank, WestRiver Innovation Lending Fund VIII, L.P., Eloxx
Pharmaceuticals, Inc., and Eloxx Pharmaceuticals Ltd.
16.1
21.1
23.1
23.2
Letter of Kost Forer Gabbay & Kasierer, a Member of Ernst & Young Global, dated June 21, 2018 (incorporated by reference to Exhibit 16.1 of our
Current Report on Form 8-K filed on June 21, 2018, SEC File No. 001-31326).
List of Subsidiaries of the Company.
Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm.
Consent of Kost Forer Gabbay & Kasierer, a member of Ernst & Young Global, Independent Registered Public Accounting Firm.
68
Exhibit
No.
31.1
31.2
32.1
32.2
Description of Exhibit
Certification of the Company’s Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act of 1934, as
amended, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of the Company’s Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act of 1934, as
amended, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of the Company’s Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
Certification of the Company’s Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
101.INS XBRL Instance Document
101.SCH XBRL Taxonomy Extension Schema Document
101.CAL XBRL Taxonomy Extension Calculation Document
101.DEF XBRL Taxonomy Extension Definition Linkbase Document
101.LAB XBRL Taxonomy Extension Labels Linkbase Document
101.PRE XBRL Taxonomy Extension Presentation Link Document
+
*
**
Confidential treatment was granted for portions of such exhibit.
Confidential treatment requested under 17 C.F.R. §§200.80(b)(4) and 24b-2. The confidential portions of this exhibit have been omitted and are marked
accordingly. The confidential portions have been filed separately with the Securities and Exchange Commission pursuant to the confidential treatment
request.
Indicates a management contract or compensatory plan or arrangement required to be filed pursuant to Item 15(b) of Form 10-K
69
Pursuant to the requirements of Section 13 or 15(d) of the Securities and Exchange Act of 1934, as amended the registrant has duly caused this report to be
signed on its behalf by the undersigned thereunto duly authorized.
SIGNATURES
Date: March 14, 2019
ELOXX PHARMACEUTICALS INC.
(Registrant)
/s/ Robert E. Ward
Robert E. Ward
Chairman of the Board of Directors and Chief Executive Officer
(On behalf of the Registrant and as Principal Executive Officer)
70
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Robert E. Ward and Gregory
Weaver, and each of them, as his or her true and lawful attorneys-in-fact and agents, each with the full power of substitution, for him or her and in his or her name,
place or stead, in any and all capacities, to sign any and all amendments to this report, with exhibits thereto and other documents in connection therewith, with the
U.S. Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and
every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby
ratifying and confirming all that said attorneys-in-fact and agents, or their, his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended this report has been signed below by the following persons on behalf of
the Registrant and in the capacities and on the dates indicated.
Signature
/s/ Robert E. Ward
Robert E. Ward
/s/ Gregory Weaver
Gregory Weaver
/s/ Tomer Kariv
Tomer Kariv
/s/ Ran Nussbaum
Ran Nussbaum
/s/ Silvia Noiman
Silvia Noiman, PhD
/s/ Gadi Veinrib
Gadi Veinrib
/s/ Zafrira Avnur
Zafrira Avnur, PhD
/s/ Martijn Kleijwegt
Martijn Kleijwegt
/s/ Steven D. Rubin
Steven D. Rubin
/s/ Jasbir Seehra
Jasbir Seehra, Ph.D.
Chairman of the Board of Directors and Chief Executive Officer
March 14, 2019
(Principal Executive Officer)
Title
Date
Chief Financial Officer (Principal Financial Officer and Principal
March 14, 2019
Accounting Officer)
Director
Director
Director
Director
Director
Director
Director
Director
71
March 13, 2019
March 13, 2019
March 13, 2019
March 13, 2019
March 13, 2019
March 13, 2019
March 13, 2019
March 13, 2019
ELOXX PHARMACEUTICAL INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets as of December 31, 2018 and 2017
Consolidated Statements of Operation for the Years Ended December 31, 2018, 2017 and 2016
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity for the Years Ended December 31, 2018, 2017 and 2016
Consolidated Statements of Cash Flows for the Years Ended December 31, 2018, 2017 and 2016
Notes to Consolidated Financial Statements
Page
F-2
F-4
F-5
F-6
F-7
F-8
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the stockholders and the Board of Directors of Eloxx Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of Eloxx Pharmaceuticals, Inc. and subsidiaries (the "Company") as of December 31, 2018,
the related consolidated statements of operations, convertible preferred stock and stockholder’s equity, and cash flows, for the year ended December 31, 2018, and
the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial
position of the Company as of December 31, 2018, and the results of its operations and its cash flows for the year ended December 31, 2018, in conformity with
accounting principles generally accepted in the United States of America.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's
internal control over financial reporting as of December 31, 2018, based on criteria established in Internal Control — Integrated Framework (2013) issued by the
Committee of Sponsoring Organizations of the Treadway Commission and our report dated March 14, 2019, expressed an unqualified opinion on the Company's
internal control over financial reporting.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial
statements based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in
accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures
included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting
principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit
provides a reasonable basis for our opinion.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
March 14, 2019
We have served as the Company's auditor since 2018.
F-2
Kost Forer Gabbay & Kasierer
144 Menachem Begin Road, Building A
Tel-Aviv 6492102, Israel
Tel: +972-3-6232525
Fax: +972-3-5622555
ey.com
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors of Eloxx Pharmaceuticals Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Eloxx Pharmaceuticals, Inc. (the “Company”) as of December 31, 2017 and 2016, the
related consolidated statements of operations, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2017 and the related
notes (collectively referred to as the “ consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects,
the financial position of the Company at December 31, 2017 and 2016 and the results of its operations and its cash flows for each of the three years in the period
ended December 31, 2017, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities
and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over
financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we
express no such opinion.audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud,
and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the
overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ KOST FORER GABBAY & KASIERER
A Member of Ernst & Young Global
Tel-Aviv, Israel
March 16, 2018
F-3
ELOXX PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data )
Assets
Current assets:
Cash and cash equivalents
Restricted bank deposit
Prepaids and other current assets
Total current assets
Property and equipment, net
Other long-term assets
Total assets
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payables
Accrued expenses
Taxes payable
Total current liabilities
Commitments and contingencies (Note 9)
Stockholders’ equity:
Preferred Stock, $0.01 par value 5,000,000 authorized as of
December 31, 2018 and 2017, respectively; 0 shares issued and
outstanding as of December 31, 2018 and 2017, respectively
Common stock, $0.01 par value 500,000,000 and 500,000,000 shares
authorized as of December 31, 2018 and 2017, respectively;
35,951,537 and 27,527,738 shares issued and 35,860,114 and
27,527,738 shares outstanding as of December 31, 2018 and
2017, respectively
Additional paid-in capital
Common stock in treasury stock, at cost, 91,423 and 0 shares at
December 31, 2018 and 2017, respectively
Accumulated deficit
Total stockholders’ equity
Total liabilities and stockholders’ equity
December 31,
2018
2017
48,606 $
45
1,690
50,341
248
129
50,718 $
747 $
6,938
122
7,807
24,049
102
355
24,506
278
—
24,784
1,530
1,893
—
3,423
—
—
360
129,825
(1,129)
(86,145)
42,911
50,718 $
274
60,047
—
(38,960)
21,361
24,784
$
$
$
$
See accompanying notes consolidated financial statements
F-4
ELOXX PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except per share and per share data )
Operating expenses:
Research and development, net
General and administrative expenses
Reverse merger related expenses
Total operating expenses
Loss from operations
Other (income) expenses, net
Loss before income taxes
Provision for income taxes
Net loss
Less: Dividends accumulated for the period
Net loss available to common stockholders
Basic and diluted net loss per share
2018
Year ended December 31,
2017
2016
$
$
$
20,489 $
26,482
594
47,565
(47,565)
(502)
(47,063)
122
(47,185)
—
(47,185) $
(1.45) $
16,398 $
2,702
1,290
20,390
(20,390)
824
(21,214)
—
(21,214)
(2,404)
(23,618) $
(4.75) $
8,986
854
—
9,840
(9,840)
7
(9,847)
—
(9,847)
(1,100)
(10,947)
(2.60)
Weighted average number of Common Stock used in computing
basic and diluted loss per share
32,436,506
4,976,377
4,205,277
See accompanying notes consolidated financial statements
F-5
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
(Amounts in thousands, except share and per share data)
ELOXX PHARMACEUTICALS, INC.
Preferred Stock
Common Stock
Treasury Stock
Number
of Shares
4,097,699
Amount
$
41
Number
of Shares
4,205,278
Amount
$
42
Additional
paid-in
capital
$
8,459
Number
of Shares
—
Amount
$
—
Accumulated
deficit
Total
Stockholders’
Equity
$
(7,899) $
643
Balance as of December 31, 2015
Issuance of Series B-1 preferred stock and warrants to
purchase common stock, net of $264 issuance costs
Exercise of warrants into Series A preferred stock
Issuance of Series B-1 preferred stock and
warrants to purchase Series B-1 preferred stock
Stock-based compensation related to equity-classified awards
Net loss
Balance as of December 31, 2016
Issuance of Series C preferred stock, net
of $573 issuance costs
Conversion of convertible loan into Series
C preferred stock of $0.01 par value
Exercise of stock options
Stock-based compensation related to equity-classified awards
Issuance of common stock, net of $494 issuance costs
Conversion of Series A, B-1, B-2 and C preferred stock
into common stock with respect to the Reverse Merger
Shares issued with respect to the Reverse Merger
Provision related to the Technion exit fee
Net loss
Balance as of December 31, 2017
Exercise of stock options
Issuance of common stock upon Technion settlement
Issuance of shares upon execution of warrants
Issuance of shares upon public offering
Issuance of common stock from at-the-market sales agreement
Repurchase of common stock
Vesting of restricted shares
Stock-based compensation related to equity-classified awards
Net loss
Balance as of December 31, 2018
1,929,676
436,750
1,174,138
—
—
7,638,263
6,311,076
825,213
—
—
—
19
4
12
—
—
76
63
8
—
—
—
—
—
—
—
—
4,205,278
—
—
16,699
—
6,333,333
(14,774,552)
—
—
—
—
—
—
—
—
—
—
—
—
—
—
$
(147) 14,774,552
2,197,876
—
—
27,527,738
1,334,522
569,395
60,989
5,899,500
201,100
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(5,076)
271,946
—
—
35,860,114
$
—
—
—
—
—
42
—
—
—
—
63
147
22
—
—
274
14
6
1
60
2
—
3
—
—
360
5,717
346
3,638
78
—
18,238
18,364
3,160
17
101
16,943
—
(192)
3,416
—
60,047
432
(6)
51
53,513
2,421
—
(3)
13,370
—
$ 129,825
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(3,385)
—
—
(5,000)
(83,038)
—
—
(91,423) $
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(52)
—
—
(31)
(1,046)
—
—
(1,129) $
—
—
—
—
(9,847)
(17,746)
—
—
—
—
—
—
—
(21,214)
(38,960)
—
—
—
—
—
—
—
—
(47,185)
(86,145) $
5,736
350
3,650
78
(9,847)
610
18,427
3,168
17
101
17,006
—
(170)
3,416
(21,214)
21,361
446
—
—
53,573
2,423
(31)
(1,046)
13,370
(47,185)
42,911
See accompanying notes consolidated financial statements.
F-6
ELOXX PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
Cash flows from operating activities:
Net loss
Adjustments to reconcile net loss to net cash used in operating
activities:
Stock-based compensation
Depreciation
Loss on disposal of property and equipment
Amortization and revaluation of discount in respect to
convertible loan
Provision related to the Technion exit fee
Change in operating assets and liabilities:
Prepaid expenses and other current assets
Other assets
Accounts payable
Accrued expenses
Taxes payable
Net cash (used) in operating activities
Cash flows from investing activities:
Purchase of property and equipment
Proceeds from sale of property and equipment
Cash paid for long-term deposits
Cash received upon the Reverse Merger
Net cash (used in) provided by investing activities
Cash flows from financing activities:
Proceeds from the underwritten public offering, net of issuance costs
Proceeds from exercise of warrants into Series A preferred stock
Proceeds from share-based compensation arrangements
Proceeds from Equity Sales Agreement
Proceeds from issuance of Series B-1 preferred stock and warrants to
purchase Series B-1 preferred stock, net of issuance costs
Proceeds from issuance of Series C preferred stock
Proceeds from issuance of common stock
Proceeds from convertible loan and related financial derivative
into Series C preferred stock
Net cash provided by financing activities
Increase in cash and cash equivalents
Cash and cash equivalents at the beginning of the year
Cash and cash equivalents at the end of the year
Reconciliation of cash, cash equivalents and restricted cash to condensed
consolidated balance sheet
Cash and cash equivalents
Restricted cash included in restricted bank deposit
Total cash, cash equivalents and restricted cash
Supplemental disclosure of non-cash financing activities:
Non-cash acquisition of treasury shares
Conversion of convertible loan into Series C preferred stock
Issuance expenses of Series C Preferred Shares
Non-cash acquisition of shares from Equity Sales Agreement
2018
Year ended December 31,
2017
2016
$
(47,185) $
(21,214) $
(9,847)
13,370
216
12
—
—
(1,080)
(41)
(780)
3,999
122
(31,367)
(235)
6
(88)
—
(317)
53,573
—
446
2,165
—
—
—
—
56,184
24,500
24,151
48,651
$
48,606
45
48,651
$
$
1,129
—
—
255
$
$
$
$
101
39
—
668
3,416
709
—
(583)
929
—
(15,935)
(237)
—
—
123
(114)
—
—
17
—
—
18,427
17,006
2,500
37,950
21,901
2,250
24,151
$
24,049
102
24,151
$
$
—
3,168
242
—
$
$
$
$
78
8
—
—
—
(482)
—
1,250
149
—
(8,844)
(36)
—
—
—
(36)
—
350
—
—
9,386
—
—
—
9,736
856
1,394
2,250
2,212
38
2,250
—
—
—
—
$
$
$
$
$
$
$
See accompanying notes consolidated financial statements
F-7
ELOXX PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Nature of the Business
Eloxx Pharmaceuticals, Inc., together with its wholly-owned subsidiary Eloxx Pharmaceuticals, Ltd. (collectively “Eloxx” or the “Company”), is a clinical-
stage biopharmaceutical company developing novel ribonucleic acid (RNA)-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides
(ERSG)) that are formulated to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt the stability of the
impacted messenger RNA (mRNA) and the protein synthesis from that mRNA. As a consequence, patients with premature stop codon diseases have reduced levels
of, or no, protein from a gene whose product performs an essential function. This type of mutation accounts for some of the most severe phenotypes across genetic
diseases. Nonsense mutations have been identified in over 1,800 rare and ultra-rare diseases. Read-through therapeutic development is focused on increasing mRNA
stability and enabling functional protein synthesis. As opposed to a typical gene therapy approach of targeting a single, unique mutation in a target disease, this small
molecule strategy enables targeting an entire class of mutations across the rare disease landscape. The small molecule approach has the potential to address a range of
different premature stop codons in a single gene since the ERSG are targeted to the ribosomes. ELX-02, the Company’s lead investigational drug product candidate,
is a small molecule designed to restore production of full-length functional proteins. ELX-02, is in the early stages of clinical development for systemic
administration for cystic fibrosis and cystinosis. ELX-02 is an investigational drug that has not been approved by any global regulatory body. In addition, the
Company recently announced a new program studying intravitreal administration of ERSG compounds for rare inherited retinal disorders with a focus on Usher
Syndrome. The Company’s preclinical candidate pool consists of a library of 170 novel ERSG drug candidates identified based on read-through potential and
cytoplasmic ribosomal selectivity. Eloxx is headquartered in Waltham, MA, with additional offices in New Jersey and Rehovot, Israel.
The Company’s research and development strategy targets rare or ultra-rare diseases where: a high unmet medical need exists, and identified nonsense
mutation-bearing patient population is identified, preclinical read-through can be established in predictive personalized medicine models, a definable path through
Orphan Drug development, regulatory approval, patient access and commercialization is identifiable. The Company believes patient advocacy to be an important
element of patient focused drug development and seeks opportunities to collaborate with patient advocacy groups throughout the discovery and development process.
The Company’s current clinical focus for its lead investigational drug product candidate, ELX-02, is Cystic Fibrosis where the Company expects to complete its
multiple ascending dose (“MAD”) study in first half of 2019 and report top line results from its Phase 2 clinical trial in the second half of 2019. Eloxx has
participated in the North American Cystic Fibrosis Foundation (CFF) CFTR Translations Read-through Workshop and is engaged with CFF on extending its Cystic
Fibrosis clinical studies to the United States. In 2018, the European Cystic Fibrosis Society Clinical Trial Network assigned a “high priority” rating to Eloxx’s Phase
2 program. Eloxx has recently initiated a new program studying inherited retinal disease and is conducting IND enabling studies for several ERSG compounds from
its library. The Company entered into a multiyear partnership with the Foundation Fighting Blindness (FFB) to support the inherited retinal degenerative disease
registry and educational programs. Eloxx presented as part of the FFG “Investing in Cures” 2019 meeting and believes that the ongoing R&D consultation and
support provided by the FFB will accelerate the Company’s development programs that seek to support patients with ocular disease and high unmet medical need.
Eloxx Pharmaceuticals, Ltd. (“Eloxx Limited”) was incorporated in Israel on September 17, 2013 and acquired by the Company in a reverse merger
described below. The Company focuses its activity on the discovery, development and commercialization of compounds for the treatment of genetic diseases caused
by nonsense mutations primarily through a license agreement (the “Technion Agreement” with the Technion Research and Development Foundation Ltd. (“TRDF”))
entered into in 2013. For more information relating to the Technion Agreement, see Note 8.
F-8
Reverse Merger
On December 19, 2017, Sevion Therapeutics, Inc. (“Sevion”) acquired Eloxx Limited pursuant to a merger between the companies (the “Transaction” or
“Reverse Merger”). Upon consummation of the Transaction (the “Closing”), Sevion adopted the business plan of Eloxx Limited and discontinued the pursuit of
Sevion’s business plan. In connection with the Transaction, Sevion acquire all of the outstanding capital stock of Eloxx Limited in exchange for the issuance of an
aggregate 20,316,656 shares of Sevion’s common stock, par value $0.01 per share (the “Common Stock”), after giving effect to a 1-for-20 reverse split immediately
prior to the Transaction. As a result of the Transaction, Eloxx Limited became a wholly-owned subsidiary of Sevion. While Sevion was the legal acquirer in the
transaction, Eloxx Limited was deemed the accounting acquirer. Immediately after giving effect to the Transaction, on December 19, 2017, Sevion changed its name
to Eloxx Pharmaceuticals, Inc.
The annual consolidated financial statements of the Company reflect the operations of the acquirer for accounting purposes, together with a deemed issuance
of shares, equivalent to the shares held by the former stockholders of the legal acquirer and a recapitalization of the equity of the accounting acquirer. The annual
consolidated financial statements include the accounts of the Company since the effective date of the reverse capitalization and the accounts of Eloxx Limited since
inception.
Liquidity
The Company has a history of net losses and negative cash flows from operating activities since inception, and as of December 31, 2018, had an
accumulated deficit of $86.1 million. The Company expects to continue to incur net losses and use cash in its operations for the foreseeable future. To date, the
Company has not generated revenue from the sale of any product or service and does not expect to generate significant revenue unless and until obtaining marketing
approval and commercialization of its product candidates currently in development. A successful transition to profitable operations is dependent upon achieving a
level of revenues adequate to support the Company’s cost structure.
The Company has financed its operations primarily from the sale of equity securities. The Company may never achieve profitability, and unless and until it
does, the Company will continue to need to raise additional cash to fund its operations. The Company believes that its cash and cash equivalents of $48.6 million at
December 31, 2018, together with $14.8 million in net proceeds from a debt issuance in January 2019 (see Note 16), will enable it to meet anticipated cash needs
required to maintain its current and planned operations through the next twelve months from the date of the filing of this Form 10-K. Management intends to fund
future operations through private or public debt or equity financing transactions and may seek additional capital through arrangements with strategic partners or from
other sources. If the Company is unable to obtain financing, it will evaluate options which may include reducing or deferring operating expenses which may have a
material adverse effect on the Company’s operations and future prospects.
2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements have been prepared by the Company in accordance with accounting principles generally accepted accounting
principles in the United States of America (“U.S. GAAP”) as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”)
of the Financial Accounting Standards Board (“FASB”).
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany balances and transactions have been
eliminated upon consolidation.
Reclassifications
Certain amounts in the prior period financial statements have been reclassified to conform to the presentation of the current period financial statements.
These classification had no effected on the previously report net loss.
F-9
Use of Estimates
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and
assumptions. The Company’s management believes that the estimates, judgments and assumptions used are reasonable based upon information available at the time
they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities
at the dates of the consolidated financial statements, and the reported amounts of expenses during the reporting period. The Company evaluates estimates on an
ongoing basis in light of changes in circumstances, facts and experiences. Actual results could materially differ from those estimates.
Foreign Currency Translation
The functional currency of the Company is the U.S. dollar. Accordingly, monetary accounts maintained in currencies other than the dollar are re-measured
into U.S. dollars in accordance with ASC Topic 830, “Foreign Currency Matters”. All foreign currency transaction gains and losses arising from transactions
denominated in foreign currencies, whether realized or unrealized, are recorded in the statements of operation as other income or expenses, as appropriate. The only
item comprising comprehensive loss is net loss.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. The Company’s
cash and cash equivalents includes holdings in checking and overnight sweep accounts. The Company’s cash equivalents, which are money market funds held in a
sweep account, are measured at fair value on a recurring basis. As of December 31, 2018, the balance of cash and cash equivalents was $48.6 million, which
approximates fair value and was determined based upon Level 1 inputs. The sweep account is valued using quoted market prices with no valuation adjustments
applied. Accordingly, these securities are categorized as Level 1.
Restricted bank deposits
At December 31, 2018, and 2017, restricted bank deposits consisted of guarantees related to Eloxx Limited corporate facilities lease and credit card.
Concentrations of credit risk
Financial instruments that subject us to significant concentrations of credit risk consist primarily of cash. Substantially all of the Company’s cash is held at
financial institutions that management believes to be of high-credit quality.
The Company has no off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other foreign hedging
arrangements.
Property and Equipment
Property and equipment is recorded at cost, less accumulated depreciation. Leasehold improvements are amortized over the lesser of the estimated useful life
or the expected term of the lease. Costs associated with maintenance and repairs are expensed as incurred. Depreciation expense is computed on a straight-line
method over the estimated useful lives of the respective assets, as follows:
Computers and software
Office furniture and equipment
Laboratory equipment
Leasehold improvement
Useful Life (Years)
3 years
5 – 12 years
5 years
Over the shorter of the expected lease term or
estimated useful life
F-10
Upon sale or disposition of property and equipment, the cost and related accumulated depreciation are eliminated from the accounts and any resultant gain
or loss is credited or charged to operations.
Impairment of long-lived assets
Property and equipment subject to depreciation are reviewed for impairment in accordance with ASC Topic 360, “Accounting for the Impairment or
Disposal of Long-Lived Assets,” whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such assets
are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the
assets. The Company continually evaluates whether events or circumstances have occurred that indicate that the remaining useful life of its long-lived assets may
warrant revision or that the carrying value of these assets may be impaired. Factors that the Company considers in deciding when to perform an impairment review
include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned
changes in the use of the assets.
Evaluation of recoverability of the asset or asset group is based on an estimate of undiscounted future cash flows resulting from the use of the asset or asset
group and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the asset or asset group, the
assets are written down to their estimated fair value. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value,
determined based on discounted cash flows. As of each balance sheet date presented, none of the Company’s long-lived assets were impaired. The Company has not
recorded any impairment losses to date.
Legal and Other Contingencies
The Company accounts for its contingent liabilities in accordance with ASC Topic 450 “Contingencies”. A provision is recorded when it is both probable
that a liability has been incurred and the amount of the loss can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to reflect
the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter. For the
years ended December 31, 2018 and 2017, the Company was not a party to any litigation that could have a material adverse effect on the Company’s business,
financial position, results of operations or cash flows (see also Note 9). Legal costs incurred in connection with loss contingencies are expensed as incurred.
Research and Development Costs
Research and development costs are comprised of costs incurred in performing research and development activities, including salaries, stock-based
compensation and benefits, facilities costs, depreciation, third-party license fees, and external costs of outside vendors engaged to conduct preclinical development
activities and clinical trials. Research and development costs are expensed as incurred and include the Company’s costs of performing services in connection with its
collaboration agreements and research grants.
Nonrefundable prepayments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized.
Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be
delivered, or the services rendered.
Government Grants
The Company received royalty-bearing grants to Eloxx Limited for the years ended 2015 to 2017 totaling $2.6 million, which represents participation in
approved research and development programs of the Israeli Innovation Authority (“IIA”) (previously known as the Office of the Chief Scientist of the Ministry of
Economy). These amounts are recognized on the accrual basis as a reduction of research and development expenses as such expenses are incurred.
F-11
Fair value of financial instruments:
ASC Topic 820, “Fair Value Measurements and Disclosures” (“ASC 820”), defines fair value as the price that would be received to sell an asset or paid to
transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date.
In determining fair value, the Company uses various valuation approaches. ASC 820 establishes a hierarchy for inputs used in measuring fair value that
maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available.
Observable inputs are inputs that market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of
the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the assumptions market participants would use in pricing the asset or
liability developed based on the best information available in the circumstances. The hierarchy is broken down into three levels based on the inputs as follows:
Level 1 —Valuations based on quoted prices (unadjusted) in active markets for identical assets that the Company has the ability to access.
Level 2 —Valuations based on one or more quoted prices in markets that are not active or for which all significant inputs are observable, either directly or
indirectly.
Level 3 —Valuations based on inputs that are unobservable and significant to the overall fair value measurement.
The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair
value.
The carrying amounts of cash and cash equivalents, restricted bank deposits, prepaids and other current assets, accounts payables and accrued expenses
approximate their fair value due to the short-term maturities of such instruments.
Stock-Based Compensation
The Company accounts for stock-based compensation in accordance with ASC Topic 718, “Compensation-Stock Compensation”, (“ASC 718”), which
requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The Company recognizes
compensation expenses for the value of its awards granted based on the straight-line method over the requisite service period of each of the awards or over the
implicit service period when a performance condition affects the vesting, and it is considered probable that the performance condition will be achieved.
The Company estimates the fair value of stock options granted using the Binomial Option-Pricing Model (“Binomial Model”) which requires a number of
assumptions, of which the most significant are the fair market value of the underlying Ordinary Shares, expected stock price volatility, suboptimal exercise factor and
the expected option term. Expected volatility was calculated based upon historical volatilities of similar entities in the related sector index. The expected option term
represents the period that the Company’s stock options are expected to be outstanding and is determined based on the simplified method until sufficient historical
exercise data will support using expected life assumptions. The suboptimal exercise factor is estimated using historical option exercise information. The suboptimal
exercise factor is the ratio by which the stock price must increase over the exercise price before employees are expected to exercise their stock options. The risk-free
interest rate is based on the yield from U.S. treasury bonds with an equivalent term. The Company has historically not paid dividends and has no foreseeable plans to
pay dividends.
F-12
Income taxes
The Company accounts for income taxes in accordance with ASC Topic 740, “Income Taxes” (“ASC 740”), which prescribes the use of the asset and
liability method whereby deferred tax assets and liability account balances are determined based on differences between financial reporting and tax bases of assets
and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to be recovered or settled. The Company
provides a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value if it is more likely than not that a portion or all of the
deferred tax assets will be realized. The Company considers many factors when assessing the likelihood of future realization of deferred tax assets, including recent
earnings results, expectations of future taxable income, carryforward periods available and other relevant factors. The Company records changes in the required
valuation allowance in the period that the determination is made.
Based on ASC 740, a two-step approach is used to recognize and measure uncertain tax positions. The first step is to evaluate the tax position taken or
expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical
merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as
the largest amount that is more than 50% likely to be realized upon ultimate settlement. As of December 31, 2018, and 2017, no liability for unrecognized tax
positions has been recorded. Accordingly, no interest or penalties related to uncertain tax positions are recorded, either. It is the Company’s policy that any interest or
penalties associated with unrecognized tax positions would be reflected as a component of income tax expense.
Net Loss per Share
For the years ended December 31, 2017 and 2016, the Company applied the two-class method as required by ASC Topic 260-10, “Earnings Per Share”
(“ASC 260-10”), which requires the income or loss per share for each class of shares (ordinary and preferred shares) to be calculated assuming 100% of the
Company’s earnings are distributed as dividends to each class of shares based on their contractual rights. For the year ended December 31, 2018, the Company had
no outstanding preferred shares and was not required to apply the two-class method under ASC 260-10.
No dividends were declared or paid during the reported periods. According to the provisions of ASC 260-10, the Company’s preferred shares are not
participating securities in losses and, therefore, are not included in the computation of net loss per share.
Basic loss per share is computed by dividing the loss for the period applicable to ordinary shareholders by the weighted average number of ordinary shares
outstanding during the period. In computing diluted income per share, basic earnings per share are adjusted to reflect the potential dilution that could occur upon the
exercise of share options granted to grantees and upon conversion of restricted stock units and warrants issued to investors and service providers using the “treasury
stock method”.
Recent Accounting Pronouncements adopted
In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): “Restricted Cash” (ASU 2016-18), which requires companies to
include amounts generally described as restricted cash and restricted cash equivalents in cash and cash equivalents when reconciling beginning-of-period and end-of-
period total amounts shown on the statement of cash flows. The amendments in this update are effective for public business entities for fiscal years beginning after
December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. The Company adopted ASU
2016-18 on January 1, 2018 on a retrospective basis and increased the beginning-of-period amounts on the statement of cash flows to include the balance of
restricted cash.
F-13
In January 2017, the FASB issued ASU 2017-01 Business Combinations (Topic 805): “Clarifying the Definition of a Business”. ASU 2017-01 provides
amendments to clarify the definition of a business and affect all companies and other reporting organizations that must determine whether they have acquired or sold
a business. The amendments are intended to help companies and other organizations evaluate whether transactions should be accounted for as acquisitions (or
disposals) of assets or businesses. The guidance is effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods
within those fiscal years and should be applied prospectively as of the beginning of the period of adoption. Early adoption is permitted under certain circumstances.
The Company adopted ASU 2017-01 on January 1, 2018 and it did not have an impact on its accounting and disclosures.
Recent Accounting Pronouncements not adopted yet
In February 2016, the FASB issued ASU 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 establishes ASC Topic 842 which amends ASC 840, Leases, by
introducing a lessee model that requires balance sheet recognition for most leases and the disclosure of key information about leasing arrangements. Leases will be
classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. Topic 842 was
subsequently amended during 2018. The Company will adopt the new standard on January 1, 2019 and use the effective date as its date of initial application.
Consequently, financial information will not be updated and the disclosure required under the new standard will not be provided for dates and periods prior to
January 1, 2019.
Topic 842 provides several optional practical expedients in transition. The Company expects to elect the package of practical expedients which would allow
the Company to not reassess its existing conclusions on lease identification, classification and initial direct costs. Further, the Company expects to elect the hindsight
practical expedient and to utilize the short-term lease exemption for all leases with an original term of 12 months or less, for purposes of applying the recognition and
measurement requirements of the new standard. The Company also expects to elect the practical expedient which will allow it to not separate lease and non-lease
components for all its leases.
The adoption of the new standard is expected to result in the recognition of additional lease liability and right to use assets ranging between $0.9 million and
$1.4 million as of January 1, 2019. The Company does not expect that the new standard will have a material impact to the Company’s consolidated statement of
operations or cash flows. See Note 9 for additional information related to the Company’s lease obligations.
3. Reverse Merger
As described in Note 1, “Nature of the Business”, the Reverse Merger was accounted for as a reverse recapitalization which is outside the scope of ASC
Topic 805, “Business Combinations” (“ASC 805”). Under reverse capitalization accounting, Eloxx Limited is considered the acquirer for accounting and financial
reporting purposes and acquired the assets and assumed the liabilities of the Company. The assets acquired and liabilities assumed are reported at their historical
amounts. The annual consolidated financial statements of the Company reflect the operations of the acquirer for accounting purposes together with a deemed
issuance of shares, equivalent to the shares held by the former stockholders of the legal acquirer and a recapitalization of the equity of the accounting acquirer. The
annual consolidated financial statements include the accounts of the Company since the effective date of the reverse merger and the accounts of Eloxx Limited since
inception.
F-14
The following summarizes the assets and liabilities assumed at the date of the Reverse Merger (in thousands):
Cash and cash equivalents
Prepaid expenses and other current assets
Property, plant and equipment, net
Restricted bank deposits
Total assets acquired
Accounts payable
Accrued expenses
Total liabilities acquired
Total net liabilities acquired
December 19,
2017
123
220
39
6
388
(215)
(343)
(558)
(170)
$
$
Additionally, the Company incurred approximately $0.6 million and $1.3 million for the years ended December 31, 2018 and 2017, respectively, in
professional fees related to the Reverse Merger. No fees were incurred for the year ended December 31, 2016.
4. Prepaids and other current assets
Prepaids and other current assets consisted of the following (in thousands):
Prepaid insurance
Other governmental agencies
Prepaid research and development
Prepaid other
5. Property and Equipment, net
Property and equipment, net consisted of the following (in thousands):
Cost:
Computers and software
Office furniture and equipment
Laboratory equipment
Leasehold improvement
Accumulated depreciation
Property and equipment, net
December 31,
2018
2017
251 $
20
864
555
1,690 $
December 31,
2018
2017
146 $
165
—
141
452
204
248 $
—
88
—
267
355
124
118
37
53
332
54
278
$
$
$
$
Depreciation expense was $216 thousand, $39 thousand and $8 thousand for the years ended December 31, 2018, 2017 and 2016, respectively.
F-15
6. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
Accrued payroll and related expenses
Accrued research and development expenses
Accrued professional services
Accrued other
December 31,
2018
2017
2,562 $
3,086
985
305
6,938 $
402
704
787
—
1,893
$
$
7. Convertible Loan
On January 26, 2017 (the “Closing Date”), the Company entered into a Convertible Loan Agreement (the “Agreement”) with five of its shareholders (the
“Lenders”), pursuant to which the Company raised an aggregate amount of $2.5 million (the “Convertible Loan”). The Convertible Loan included interest at an
annual rate of 5%. According to the Agreement, the outstanding portion of the Convertible Loan (without accrued interest) automatically converts upon the
consummation of an equity investment by a third party of an aggregate amount of at least $5.0 million (the “Qualified Equity Investment”), prior to the date that is
two years from the Closing Date (the “Maturity Date”), into equity securities of the same class issued by the Company in such Qualified Equity Investment.
In accordance with ASC Topic 815 “Derivatives and Hedging”, features related to convertible loans qualify as embedded derivative instruments at the date
of issuance, since these are considered as stock settled debt. In determining fair value, the Company uses various valuation approaches. ASC 820 establishes a
hierarchy for inputs used in measuring fair value. The embedded conversion feature is classified under level 3 in the hierarchy. The fair value assigned to the
embedded conversion feature on the issuance dates amounted to $0.3 million. The embedded instruments are marked to market in each reporting period and changes
are recorded in financial expenses. The discount is amortized using the effective interest over the loan period.
On May 31, 2017, the Convertible Loan (without accrued interest) was converted into 825,213 Series C preferred stock, according to the price per share that
was paid in the 2017 Share Purchase Agreement (see Note 10). During the year ended December 31, 2017, the Company recorded $0.7 million as other (income)
expenses, net, as a result of changes in the embedded instruments. In connection with the conversion, the embedded instrument together with all accrued interest in
the amount of $0.7 million and was classified to additional paid in capital.
The following table presents reconciliations for the Company’s liabilities measured and recorded at fair value on a recurring basis, using significant
unobservable inputs (in thousands):
Balance at January 26, 2017
Amortization and revaluation embedded conversion
feature
Conversion of convertible loan into Series C preferred
stock
Balance at December 31, 2017
F-16
Significant
Unobservable
Inputs
(Level 3)
$
$
(308)
(317)
625
—
8. Related Parties
On August 29, 2013, the Company entered into an agreement (“Technion Agreement”) with TRDF, with respect to certain technology relating to
aminoglycosides and the redesign of aminoglycosides for the treatment of human genetic diseases caused by premature stop mutations and further results of the
research of the technology, in order to develop and commercialize products based on such technology. Under the Technion Agreement, TRDF is obligated to provide
the Company with research services for an estimated annual payment of $0.1 million, the precise amount to be agreed by the parties prior to the beginning of each
year of the research period. During the years ended December 31, 2018, 2017 and 2016, the Company recorded general and administrative expenses amounting to
$0, $7 thousand and $0.2 million, respectively, in relation to the Technion Agreement. In addition, during the years ended December 31, 2018, 2017 and 2016, the
Company recorded research and development expenses amounting to $0.1 million, $3.5 million, and $33 thousand, respectively, in relation to the Technion
Agreement for the reimbursement of costs incurred during the preparation, filing, prosecution and maintenance of the TRDF patents rights related to Eloxx Limited.
As of December 31, 2018 and 2017, amounts recorded in accrued expenses were $25 thousand and $25 thousand, respectively.
In addition, TRDF granted the Company a license to use, market, sell or sub-license the rights of the product developed under the TRDF research results
(the “Licensed Product”), as fully defined in the Technion Agreement, for the following considerations: (i) milestone payments up to total consideration of
$6.1 million, to be transferred upon meeting certain milestones as defined in the Technion Agreement; (ii) certain royalties in the low- to mid- single-digit percentage
of net sales (subject to change in the case of (a) sublicensing to a big pharmaceutical or biotechnology company, or (b) payment of royalties to third parties, or (c)
commercialization by a third party of an authorized generic to a licensed product), for a period until the later of (i) the expiration of a valid claim on the Licensed
Product in each country the Licensed Product is sold to, or (ii) a certain amount of years from the date of the first commercial sale of the Licensed Product in such
country, and (iii) a low- to mid- double-digit percentage of any non-royalty sub-license income received by the Company from a sub-licensed entity. In addition, the
Company shall pay certain fee to TRDF upon an exit event as described in the Technion Agreement.
Moreover, upon the closing of an exit event which is not an Initial Public Offering (“IPO”), as defined in the Technion Agreement, TRDF shall be entitled to
an amount equal to 3% of all non-refundable, non-contingent consideration, whether in cash or in kind, actually received by the Company and / or its shareholders.
Upon the closing of an exit event which is an IPO, as defined in the Technion Agreement, TRDF shall be entitled to a number of Ordinary Shares of the Company
representing 3% of the Company’s outstanding shares on a fully diluted basis immediately prior to the closing of such IPO.
On August 9, 2017 the Company received a letter from TRDF regarding TRDF’s alleged entitlement to an exit fee in accordance with the Technion
Agreement. The Company recorded a $3.4 million research and development with an offsetting adjustment to additional paid-in capital for the year ended December
31, 2017 related to the planned issuance of shares to TRDF at fair market value on the purported date of the exit event. On June 13, 2018 the Company entered into
an amendment to the license agreement to proving that in exchange for the issuance by the Company to TRDF of 569,395 shares, the Company and TRDF agreed to
terminate (i) TRDF’s rights to receive payments from the Company upon the Company’s consummation of certain business transactions such as a merger or an initial
public offering, (ii) certain preemptive rights provided by the Articles of Association of Eloxx Limited and (iii) TRDF’s right designate an observer to board of
directors. On June 30, 2018, the Company issued 569,395 shares to TRDF in satisfaction of this claim.
9. Commitments and Contingencies
Operating Leases
The Company entered into a lease agreement for office space in Waltham, MA for a period of 37 months commencing November 15, 2017 and until
December 17, 2020. On May 2, 2018, the Company amended the operating lease agreement for the office space in Waltham, MA for a period of three years
commencing September 1, 2018 and until August 31, 2021 with annual lease payments in the amount of $0.5 million. The Company has an option to extend the lease
for a term of three years.
F-17
The Company entered into a lease agreement for office space in Rehovot, Israel for a period of three years commencing March 8, 2017 and until April 30,
2020 with annual lease payments in the amount of $0.1 million. The Company has an option to extend the lease for a term of two years.
The Company’s significant outstanding contractual obligations relate to operating leases for the Company’s facilities. The Company facility leases are non-
cancellable and contain renewal options. The Company’s future contractual obligations as of December 31, 2018 were as follows (in thousands):
As of December 31, 2018
2019
2020
2021
$
$
Total
541
490
310
1,341
The Company recorded lease expenses in the amounts of $0.4 million, $0.2 million and $0.1 million for the year ended December 31, 2018, 2017 and 2016,
respectively.
Royalty Commitments to the IIA
To date, the Company has received research and development grants from the IIA totaling $2.6 million. The Company received research and development
grants from the IIA in the amounts of $0.9 million and $1.2 million, for the years ended December 31, 2017 and 2016, respectively. No grant was received for the
year ended December 31, 2018.
Under the research and development agreements with the IIA and pursuant to applicable law, the Company is required to pay royalties at the rate of 3% on
sales to end customers of products candidates developed with funds provided by the IIA, up to an amount equal to 100% of the IIA research and development grants
received, plus interest based on the 12-month LIBOR rate. If the Company does not generate sales of products developed with funds provided by the IIA, the
Company is not obligated to pay royalties or repay the grants.
As of December 31, 2018, the Company has not commenced the payment obligation of the royalties and has a contingent obligation with respect to royalty-
bearing participation received or accrued, amounting to $2.7 million, including accrued LIBOR interest.
Commitments to TRDF
Since August 29, 2013, the Company has had an ongoing agreement with TRDF. Refer to Note 8: Related Parties for further information.
Contingencies
From time to time, the Company may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. The
Company is currently unaware of any material pending legal proceedings to which it is a party or of which its property is the subject. However, the Company may at
times in the future become involved in litigation in the ordinary course of business, which may include actions related to or based on its intellectual property and its
use, customer claims, employment practices and employee complaints and other events arising out of its operations. When appropriate in management’s estimation,
the Company will record adequate reserves in its financial statements for pending litigation. Litigation is subject to inherent uncertainties, and an adverse result in
any such matters could adversely impact its reputation, operations, and its financial operating results or overall financial condition. Additionally, any litigation to
which the Company may become subject could also require significant involvement of its senior management and may divert management’s attention from its
business and operations.
F-18
10. Stockholders’ Equity
For accounting purposes, all common stock, preferred stock, warrants, options to purchase common stock and loss per share amounts have been adjusted to
give retroactive effect to the exchange ratio and reverse stock split for all periods presented in these consolidated financial statements.
As of December 31, 2018, the Company had 500,000,000 shares authorized of common stock, $0.01 par value, of which 35,860,114 shares were issued and
outstanding and 5,000,000 shares authorized of preferred stock, $0.01 par value, of which none was issued and outstanding.
Common Stock
Public Offering
On April 30, 2018, the Company closed an underwritten public offering of 5,899,500 shares of its common stock, including the exercise in full by the
underwriter of its overallotment option to purchase an additional 769,500 shares, at the public offering price of $9.75 per share for gross proceeds of approximately
$57.5 million, before deducting the underwriting discounts and commissions and offering expenses of approximately $3.9 million. The shares of common stock were
offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-224207) that was filed with the Securities and Exchange Commission
(the “SEC”) on April 10, 2018 and declared effective on April 20, 2018, which covers the offering, issuance and sale of up to $125,000,000 million of its common
stock, preferred stock, debt securities or warrants and other securities, either individually or in combination (“the April 2018 Shelf”).
Form S-3 and Equity Sales Agreement
In November 2018, the Company entered into an Equity Distribution Agreement (“the Agreement”) with Citigroup Global Markets Inc. and Cantor
Fitzgerald & Co. (collectively, the “Sales Agents”), pursuant to which the Company may sell and issue shares of its common stock up to an aggregate of $50 million
through the Sales Agents. The shares were offered pursuant to the April 2018 Shelf. The Company agreed to pay the Sales Agents a commission of up to 3% of the
gross proceeds of any sales of common stock pursuant to the Agreement. The Company incurred approximately $0.3 million related to legal, accounting and other
fees in connection with the Agreement. For the year ended December 31, 2018, under the Agreement, the Company sold 201,100 shares of common stock and
received proceeds of $2.2 million. At December 31, 2018, there was approximately $47.5 million available for future sales pursuant to the Agreement.
On November 16, 2018, the Company filed a shelf registration statement (“November 2018 Shelf”) on Form S-3 with the SEC. The November 2018 Shelf
(File No. 333-228430) was declared effective on November 26, 2018 and covers the offering, issuance and sale of up to $200 million of the Company’s common
stock, preferred stock, debt securities or warrants and other securities, either individually or in combination.
Preferred and Common Stock
In February 2016, Eloxx Limited issued shares of preferred stock to purchase shares of preferred stock for an aggregate gross amount of $6.0 million.
In August 2016, Technion Investment Opportunities Fund L.P (the “TIOF) and TRDF exercised 124,786 and 311,964 warrants, respectively, to purchase
shares of preferred stock for total consideration of $0.4 million.
In September 2016, Eloxx Limited achieved a milestone in connection with the prior issuance of securities, pursuant to which Eloxx Limited paid a
$0.1 million milestone payment and issued to investors additional shares of preferred stock and warrants to purchase preferred stock for an aggregate amount of
$3.7 million.
In May 2017, Eloxx Limited entered into a Share Purchase Agreement (the “2017 SPA”) with certain existing and new investors, whereby, an aggregate
gross amount of $21.5 million, which included the conversion of the loan (as detailed in Note 7), was received by Eloxx Limited in exchange for the issuance of
preferred stock including shares of preferred stock that were issued as a result of the anti-dilution effect of the Reverse Merger. The related issuance costs recorded in
2017 were $0.6 million.
F-19
Upon the closing of the Reverse Merger in December 2017, the Company issued 6,333,333 shares of common stock related to the 2017 SPA for an
aggregate gross amount of $17.5 million. Additionally, Sevion raised $1.5 million prior to the Reverse Merger. The related issuance costs for these transactions
recorded in 2017 was $0.5 million.
Warrants
Eloxx Limited had issued warrants to purchase shares in conjunction with the Share Purchase Agreements prior to the Transaction. During the year ended
December 31, 2018, transactions related to warrants were as follows:
Warrants outstanding at December 31, 2017
Exercised
Forfeited
Warrants outstanding at December 31, 2018
Warrants exercisable at December 31, 2018
11. Stock-Based Compensation
Stock Incentive Plans
Weighted
average
exercise
price
3.97
0.80
8.00
3.77
3.77
Shares
480,049 $
(64,374)
(68,434)
347,241 $
347,241 $
Weighted
average remaining
contractual
life (Years)
4.24
3.92
3.92
Prior to April 20, 2018, the Company had two equity compensation plans which provided options to purchase ordinary shares of Eloxx Limited or ordinary
shares of Eloxx Limited may be granted to employees, officers, directors, service providers and consultants of Eloxx Limited; the Sevion 2008 Incentive Plan (the
“2008 Plan) and the Eloxx Limited 2013 Share Ownership and Option Plan (the “2013 Plan”).
In March 2018, the Company’s Board of Directors (the “Board”) adopted the 2018 Equity Incentive Plan (the “2018 Plan”). The 2018 Plan became effective
on April 20, 2018 with the outstanding awards and shares available for future grant under all prior plans being assumed by the 2018 Plan and the total number of
shares available for awards to employees, non-employee directors and other key personnel increased by 5,000,000 shares. Upon the 2018 Plan becoming effective,
the Company ceased granting awards under each of the 2008 Plan and the 2013 Plan (the “Prior Plans”). The 2018 Plan provides for the grant of stock options, stock
appreciation rights, restricted stock, stock units, and performance-based incentive awards to employees, consultants and non-employee directors in order to align the
long-term financial interests of its employees, consultants, and directors with the financial interest of its stockholders. In addition, the Board believes that the ability
to grant options and other equity-based awards will help the Company to attract, retain and motivate employees, consultants, and directors and encourage them to
devote their best efforts to the Company’s business and financial success.
Equity awards granted have a ten-year contractual life and, upon termination, vested options are generally exercisable between one and three months
following the termination date, while unvested options are forfeited immediately.
In 2017, the Company issued an inducement award outside of the Prior Plans to the Company’s Chief Executive Officer in the form of an option to purchase
22,427 shares of the Company’s common stock with an exercise price per share equal to $8.00, and an award of restricted stock units for 22,427 shares of the
Company’s common stock (collectively the “Performance Option Awards”). Subject to continued service through the vesting date, the Performance Option Awards
will vest and become immediately exercisable upon the date that marks the first successful completion of a Phase-2B study with respect to any indication. The
Company recognized $0.1 million of expense associated with these awards during the year ended December 31, 2018.
In addition, the Company issued an inducement award outside of the Prior Plans to the Company’s Chief Executive Officer in the form of an option to
purchase 640,785 shares of the Company’s common stock with an exercise price per share equal to $8.00, and an award of restricted stock units for 640,785 shares of
the Company’s common stock (collectively the “Time-Vesting Awards”). Subject to continued service through the vesting date, 1/3
F-20
of the Time-Vesting Awards will vest and become immediately exercisable on the first anniversary of the effective date, with an additional 1/12 of the Time-Vesting
Awards vesting on each quarterly anniversary of the effective date, provided that vesting of the Time-Vesting Awards shall be subject to acceleration following the
achievement of certain milestones.
Summary of Option Activity
Transactions related to the grant of options to employees, non-employee directors and non-employees during the year ended December 31, 2018, were as
follows:
Options outstanding as of December 31, 2017
Granted
Exercised
Forfeited
Options outstanding as of December 31, 2018
Options exercisable at December 31, 2018
Weighted
average
exercise
price
Weighted
average
remaining
contractual life
(Years)
Aggregate
intrinsic
value
4.91
18.06
0.34
9.66
13.09
11.26
7.76 $
20,479,722
8.56 $
11,650,373
7.00 $
6,598,055
Amount
3,215,661 $
1,711,881
(1,334,522)
(331,301)
3,261,719 $
1,019,835 $
As of December 31, 2018, the unrecognized compensation cost related to the outstanding options was $18.7 million and is expected to be recognized over a
weighted-average period of 2.28 years.
The weighted average grant date fair value of the options granted during the years ended December 31, 2018, 2017 and 2016 were $18.06, $3.68 and $0.14,
respectively.
The following table presents the assumptions used to estimate the fair values of the options granted in the period presented:
Dividend yield
Volatility
Risk free interest
Contractual term (years)
Forfeiture rate post-vesting
Suboptimal exercise
Summary of Restricted Stock Unit Activity
2018
0%
90.3%-92%
2.55%-3.2%
10
10%
2.3
Year ended December 31,
2017
0%
2016
0%
87.17%-116.69%
64.46%-105.57%
1.22%-2.5%
10
10%
2.3
0.47%-2.35%
10
10%
2.3
Transactions related to the grant of restricted stock units to employees, non-employee directors and non-employees during the year ended December 31,
2018, were as follows:
Unvested at December 31, 2017
Granted
Vested
Forfeited
Unvested at December 31, 2018
F-21
Weighted
average
grant date
fair value
price
8.00
18.36
14.08
14.95
9.34
Shares
663,212 $
349,241
(354,985)
(103,321)
554,147 $
As of December 31, 2018, the unrecognized compensation cost related to the outstanding options was $8.3 million and is expected to be recognized over a
weighted-average period of 2.56 years.
Stock-based Compensation Expense
Stock-based compensation expense for all stock options and restricted stock units related to all of the Company’s equity-based awards were recognized as
follows (in thousands):
Research and development
General and administrative
Total stock-based compensation
expenses
2018
2017
2016
Year ended December 31,
$
$
1,745 $
11,625
13,370 $
39 $
62
101 $
61
17
78
12. Income Taxes
The components of income (loss) before taxes on income are as follows (in thousands):
U.S.
Israel
Loss before taxes on income
2018
2017
2016
Year ended December 31,
$
$
(24,439) $
(22,624)
(47,063) $
(21) $
(21,145)
(21,166) $
44
(9,883)
(9,839)
Taxes on income during the year ended December 31, 2018 results primarily from subsidiary income as a result of the implementation of a cost-plus
arrangement. The income tax current provision consists of the following (in thousands):
Federal:
State and local:
Foreign:
Income tax provision
2018
December 31,
2017
2016
$
$
94 $
28
—
122 $
— $
—
—
— $
—
—
—
—
The significant components of the Company’s deferred tax assets are comprised of the following (in thousands):
Deferred tax assets:
Net operation loss carryforward
Stock-based compensation
Reserves and allowances
U.S. tax credits and other
Research and development
Other
Net deferred tax assets
Valuation allowance
Net deferred tax assets
December 31,
2018
2017
$
$
29,521 $
1,001
377
714
4,216
40
35,869
(35,869)
— $
23,689
1,125
11
714
2,604
—
28,143
(28,143)
—
Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statements and income tax purposes. The
Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. As of December 31, 2018 and 2017, based on the
Company’s history of
F-22
operating losses, the Company has concluded that it is not more likely than not that the benefit of the deferred tax assets will be realized. Accordingly, the Company
has provided a full valuation allowance for deferred tax assets as of December 31, 2018 and 2017.
As of December 31, 2018 and 2017, the Company provided a valuation allowance of approximately $35.9 million and $28.1 million, respectively, on U.S.
federal and state and Israeli tax jurisdiction deferred tax assets to reduce the amount of these assets to zero. The net change in the Company’s valuation allowance
was an increase of $7.7 million and an increase of $24.1 million during the years ended December 31, 2018 and December 31, 2017, respectively. For the year ended
December 31, 2018, the increase in the valuation allowance was primarily related to losses generated during the period, partially offset by a reduction in stock
compensation deferred tax asset associated with cancelled awards. For the year ended December 31, 2017, the increase in the valuation allowance was primarily
related to the reverse merger of Sevion and losses generated during the period, partially offset by a decrease associated in the U.S. federal corporate tax rate on
December 22, 2017.
For the year ended December 31, 2018, the expected tax expense based on the federal statutory rate reconciled with the actual tax expense as follows:
U.S. federal statutory rate
State tax rate, net of federal benefit
Permanent differences
Adjustments to deferred taxes
Effect of rate differences than Statutory
Tax reform - Federal tax rate change
Tax Reform - Change in valuation allowance
Change in valuation allowance
Other
Income Tax Provision
Year ended
December 31,
2018
21.0%
2.4%
-3.0%
-1.8%
0.8%
0.1%
-0.1%
-19.5%
-0.2%
-0.3%
The main reconciling item between the statutory tax rate of the Company and the effective tax rate is the recognition of valuation allowances in respect to
deferred taxes related to accumulated net operating losses carried forward and temporary difference due to the uncertainty of the realization of such deferred taxes.
For the years ended December 31, 2018 and 2017, the Company had U.S. federal net operating loss (“NOL”) carryforwards $89.8 million and $77.2
million. Our U.S. federal NOL carryforwards will begin to expire, if not utilized, beginning in 2019 through 2037. Included in the U.S. federal NOL carryforward are
$13.1 million of NOLs generated after the effective date of the Tax Act which are not subject to expiration. but may not be carried back and are only eligible to offset
up to a maximum of 80% of taxable income generated in a given year. It is uncertain if and to what extent various U.S. states will conform their net operating loss
rules to the Tax Cuts and Jobs Act.
For the years ended December 31, 2018 and 2017, the Company had U.S. state NOL carryovers of $40.0 million and $27.4 million, which may be available
to offset future income tax liabilities.
As of December 31, 2018 and 2017, the Company had federal research tax credit carryforwards of $0.7 million and $0.7 million, respectively, available to
reduce future tax liabilities which expire at dates beginning in 2027 through 2037.
As of December 31, 2018, and December 31, 2017, the Company had Israeli NOL carryforwards of $34.6 million, and $24.9 million, respectively, which
carryforward indefinitely.
The enactment of the Tax Cuts and Jobs Act (“Tax Act”) in December 2017, as further discussed below, resulted in the remeasurement of the Company’s net
deferred tax assets due to the reduction in corporate rates from 35% to a 21% flat tax. The effect on deferred tax assets and liabilities of a change in law or tax rates is
recognized in income in the period that includes the enactment date. The Tax Act also includes a provision designed to currently tax global intangible low-taxed
income (“GILTI”). The Company will record the U.S. income tax effect of future GILTI inclusions in the period in which they arise, if ever. After the enactment of
the Tax Act, the SEC issued Staff
F-23
Accounting Bulletin No. 118 (“SAB 118”) which provided guidance on accounting for the enactment effect of the Tax Act. SAB 118 addressed the application of
U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to
complete the accounting for certain income tax effects of the Tax Act. SAB 118 provided or a measurement period of up to one year from the Tax Act enactment date
for companies to complete their accounting under ASC 740. The Company had calculated a provisional estimate of deferred tax expense of $10.2 million related to
the remeasurement of its U.S. deferred tax assets in the future, which was fully and equally offset by a corresponding reduction in the valuation allowance. During
the quarter ended December 31, 2018, the Company completed the accounting for the income tax effects of the Tax Act, which resulted in an immaterial change in
the net deferred tax asset, before valuation allowance, as of the enactment date.
Under the provisions of the Internal Revenue Code (“IRC”), the net operating loss and tax credit carryforward are subject to review and potential
adjustments by the Internal Revenue Service and state tax authorities. Under Section 382 of the Internal Revenue Code and corresponding provisions of state law, if a
corporation undergoes an “ownership change,” which is generally defined as a greater than 50 percent change, by value, in its equity ownership over a three-year
period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited.
The Company may have experienced ownership changes in the past, including the Reverse Merger of Sevion Therapeutics, Inc. on December 19, 2017 at which time
our pre-change U.S. federal NOL carryforward was $77.2 million and research tax credit was $0.7 million. The Company may experience additional ownership
changes in the future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. Although the Company has not completed
its analysis, it is reasonably possible that its federal NOLs available to offset future taxable income could materially decrease. This reduction will be offset by an
adjustment to the existing valuation allowance for an equal and offsetting amount. Additionally, the state NOLs available to offset future state income could similarly
decrease which would also be offset by an equal and offsetting adjustment to the existing valuation allowance. Given the offsetting adjustments to the existing
valuation allowance, any ownership change is not expected to have an adverse material effect on the Consolidated Financial Statements.
The Company is subject to income taxes in the United States and Israel. The Company files income tax return in the United States and in several states. The
federal and state tax returns are generally subject to tax examination by taxing authorities for tax years beginning in June 30, 2015 to present. To the extent the
Company has tax attribute carryforwards, the tax years in which the attribute was generated may still be adjusted upon examination by the Internal Revenue Service
or state tax authorities to the extent utilized in a future period. The Israeli income tax returns remain open to examination beginning in 2013 to present. If and when
the Company claims NOL carryforwards from any prior years against future taxable income, those losses may be examined by the taxing authorities.
13. Net Loss Per Share
The loss and the weighted average number of shares used in computing basic and diluted net loss per share for the years ended December 31, 2018, 2017
and 2016, is as follows (amounts in thousands, except share numbers):
Numerator:
Net loss
Less: Dividends accumulated for the period(1)
Net loss available to stockholders of Common
Stock
Denominator:
Weighted average number of common shares
outstanding used in computing net loss per share
of Common Stock, basic and diluted
Net loss per share of Common Stock, basic and
diluted
2018
Year ended December 31,
2017
2016
$
(47,185) $
—
(21,214) $
(2,404)
(9,847)
(1,100)
$
(47,185) $
(23,618) $
(10,947)
32,436,506
4,976,377
4,205,277
$
(1.45) $
(4.75) $
(2.60)
(1)
The net loss used for the computation of basic and diluted net loss per share include 8% per share per annum compounded annually which was related to
distributions for preferred stockholders of Eloxx Limited. On December 19, 2017 in conjunction with the Reverse Merger all preferred shares were
converted to common shares.
F-24
For the years ended December 31 2018, 2017 and 2016, the total outstanding preferred stock, stock options under the Prior Plans, stock warrants and
restricted shares, as applicable, excluded from the calculation of the diluted net loss per share due to their anti-dilutive effect was 4,163,107, 19,027,306 and
12,746,823, respectively.
14. Other (Income) Expenses, net
Other (income) expenses consisted of the following (in thousands):
Interest and other income
Exchange rate differences
Amortization and revaluation of embedded
conversion feature in respect to convertible loan
Interest expenses in respect to convertible loan
Interest and other expense
Total other (income) expense, net
2018
Year ended December 31,
2017
2016
$
$
(601) $
92
—
—
7
(502) $
— $
156
625
43
—
824 $
—
7
—
—
—
7
15. Segment and Geographic Information
Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) about which discrete
financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance.
The Company’s chief operating decision maker is the Chief Executive Officer. The chief operating decision maker reviews consolidated operating results to make
decisions about allocating resources and assessing performance for the entire company. The Company views its operations and manages its business as one operating
segment; however, it operates in two geographic regions: United States and Israel. Substantially all of the Company’s assets are located in the United States.
16. Subsequent Events
Loan and Security Agreement
On January 30, 2019, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) by and among Silicon Valley Bank (“SVB”), in its
capacity as administrative agent, collateral agent and lender and WestRiver Innovation Lending Fund VIII, L.P. (“WestRiver”). Pursuant to the terms and conditions
of the Loan Agreement, the Lenders agreed to extend term loans to the Company in an aggregate principal amount of up to $25 million, comprised of (i) an initial
loan advance of $15 million; and (ii) a subsequent loan advance of $10 million, subject to first achieving certain conditions (collectively, the “Term Loan
Advances”). The initial term loan was funded on January 30, 2019. The subsequent term loan advance is available at the Company’s election after the occurrence of
certain milestone events relating to data from the Company’s clinical trials and receipt by the Company of certain minimum cash proceeds of at least $75 million
from an additional equity offering through a private placement or a public offering.
F-25
Any outstanding principal on the Term Loan Advances will accrue interest at a floating rate equal to the greater of (i) 5.25% per annum and (i) the sum of
2.5% plus the prime rate, as published in the Wall Street Journal. Interest payments are payable monthly following the funding of a Term Loan advance. The
Company will be required to make principal payments on the outstanding balance of the Term Loan Advances commencing on February 1, 2020 (the “Term Loan
Amortization Date”) in 36 equal monthly instalments, plus interest; provided that if the Company has achieved the milestones described above relating to the
availability of the subsequent loan advance on or prior to December 31, 2019, then the Term Loan Amortization Date is automatically extended to February 1, 2021.
Any amounts outstanding under the Term Loan Advances, if not repaid sooner, are due and payable on January 1, 2023 (the “Maturity Date”)
In conjunction with the Loan Agreement, the Company issued warrants to SVB and WestRiver to purchase the Company’s common stock (the “Warrants”).
The Warrants are exercisable for up to an aggregate of 68,058 shares of the Company’s common stock at a warrant exercise price of $11.02 (subject to certain
adjustments), which price was calculated using the 10-day average bid price of the Company’s common stock prior to the date of the Loan Agreement.
F-26
Exhibit 10.38
EXECUTIVE EMPLOYMENT AGREEMENT
This EXECUTIVE EMPLOYMENT AGREEMENT (the “Agreement”) between Eloxx Pharmaceuticals, Inc. (the
“Company”), and David Snow (the “Executive”) is dated as of June 18, 2018 and shall become effective on June 25, 2018 (the
“Effective Date”).
W I T N E S S E T H:
WHEREAS, the Company desires the Executive to provide employment services to the Company, and wishes to provide the
Executive with certain compensation and benefits in return for such employment services; and
WHEREAS, the Executive wishes to be employed by the Company and to provide employment services to the Company in
return for certain compensation and benefits;
NOW THEREFORE, in consideration of the foregoing, of the mutual promises contained herein and of other good and
valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:
1.
EMPLOYMENT TERM. The Company hereby offers to employ the Executive, and the Executive hereby accepts
employment by the Company, upon the terms and conditions set forth in this Agreement, during the period commencing on the Effective
Date and ending on the date of the termination of the Executive’s employment in accordance with Section 6 below (the “Employment
Term”). The Executive shall be employed at will, meaning that either the Company or the Executive may terminate this Agreement and
the Executive’s employment at any time, for any reason or no reason, with or without cause, subject to the terms of this Agreement.
2.
POSITION & DUTIES.
(a)
Except as provided in Section 2(b) below, the Executive shall serve as the Chief Business Officer of the
Company and its US subsidiary, Eloxx Pharmaceuticals U.S. Sub, Inc. during the Employment Term. As Chief Business Officer, the
Executive shall have such duties, authorities and responsibilities as are commensurate with the position of Chief Business Officer and
such other duties and responsibilities as the Company’s Chief Executive Officer shall designate that are consistent with the Executive’s
position as Chief Business Officer.
(b)
During the Employment Term, the Executive agrees to devote his full business time, attention and
energies to the performance of all of the lawful duties, responsibilities and authority that may be assigned to him hereunder. Nothing
contained in this Agreement will preclude the Executive from (i) devoting time to personal and family investments, (ii) serving as a
director of any not-for-profit company, (iii) serving as a director for for-profit company that is approved by the Chief Executive Officer
(such approval not to be unreasonably withheld) or (iv) from participating in charitable or industry associations, in each case, provided
that such activities or services do not (x) materially interfere with the Executive’s performance of duties hereunder or (y) violate the terms
of the Confidentiality Agreement (as defined below).
offices in Waltham, Massachusetts, subject to customary
(c)
During the Employment Term, the Executive’s principal place of employment shall be the Company’s
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1.
business travel consistent with the Executive’s duties and responsibilities.
3.
BASE SALARY. The Company agrees to pay the Executive a base salary (the “Base Salary”) at an annual rate of
US$ 375,000. The Base Salary will be payable bimonthly in accordance with the regular payroll practices of the Company. The
Executive’s Base Salary shall be subject to review by the Board (or a Committee thereof) at least annually and may be increased, but not
decreased, from time to time by the Board. The base salary as determined herein from time to time shall constitute “Base Salary” for
purposes of this Agreement.
4.
BONUSES.
(a)
ANNUAL BONUS. With respect to each full calendar year during the Employment Term, the Executive
shall be eligible to earn an annual, performance-based bonus (an “Annual Bonus”) with a target bonus value equal to forty percent (40%)
of the Executive’s Base Salary (the “Target Bonus”) based upon the achievement of performance targets, which shall be established by
the Board (or a committee thereof) in consultation with the Executive within the first 90 days of each calendar year during the
Employment Term, with the actual amount of the Annual Bonus for a particular year determined by the Board (or a committee thereof) in
its discretion. The Board (or a committee thereof) shall consider the Executive’s performance in the entire 2018 calendar year without
regard to the effective date when determining the Executive’s Annual Bonus for the 2018 calendar year. Subject to Section 8 below, in
order to be eligible for an Annual Bonus, the Executive must remain employed for the entire calendar year for which the performance
targets will have been set. Any Annual Bonus earned by the Executive will be paid no later than March 15 of the calendar year
immediately following the calendar year in which the Annual Bonus is being measured. The Executive’s Target Bonus shall be subject to
review by the Board (or a committee thereof) at least annually and may be increased, but not decreased, from time to time by the Board.
5.
EQUITY COMPENSATION. The Company will grant to the Executive on the first day of employment following
the Effective Date (the “Grant Date”) equity compensation awards under the 2013 Share Ownership and Option Plan (as amended, the
“Plan”) for share of the Company’s common stock (“Common Stock”) as follows:
(a)
TIME-VESTING AWARDS. A stock option to purchase 200,000 shares of Common Stock on the Grant
Date that will vest and become exercisable or payable, respectively, with respect to 1/3 of the shares on the first anniversary of the
Effective Date of this Agreement and with respect to an additional 1/12 of the shares on each quarterly anniversary of the Grant Date
thereafter, subject to the Executive’s continued employment with the Company through each such date. In addition, the vesting of the
Time-Vesting Awards, and any future stock options, restricted stock units or other equity compensation awards granted to the Executive,
shall be accelerated and become fully vested and exercisable or payable, respectively, immediately prior to a Significant Event (as
defined in the Plan)
ANNUAL AWARDS. Each year, the Executive will be eligible for annual awards of stock options and or
restricted stock units as determined by the Board. Nothing herein shall be construed as an obligation to grant such awards, which shall be
subject to the sole discretion of the Board.
(c)
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2.
(d)
TAX WITHHOLDING. At Executive’s request, the Company will withhold from the shares of Common
Stock otherwise payable to Executive with respect to vested portions of the Time-Vesting Shares the number of whole shares of Common
Stock required to satisfy the applicable tax withholding obligation, the number of shares so withhold to be determined by the Company
based on the fair market value of the Common Stock on the date the Company is required to withhold.
6.
EMPLOYEE BENEFITS.
(a)
BENEFIT PLANS. The Executive shall be entitled to participate in all employee benefit plans that the
Company generally makes available to its senior executives (other than severance plans) from time to time, including any group health
plans, dental plans, life, disability and AD&D insurances, a 401(k) plan, tuition reimbursement, recreation allowance, parking or public
transportation and various types of paid time off, subject to the terms and conditions of such benefit plans. The Executive may elect to
continue with COBRA insurance from the Executive’s prior employer, is such an event, the Company will reimburse the Executive for
100% of the Executive’s out of pocket cost of COBRA insurance coverage from Executive’s prior employer.
(b)
VACATION. The Executive shall be entitled to twenty (20) days of paid vacation per year, in accordance
with the Company’s vacation policy; provided that the Executive shall be entitled to twenty-five (25) days of paid vacation per year after
three (3) full calendar years of employment. Vacation may be taken at such times as the Executive elects with due regard to the needs of
the Company.
(c)
BUSINESS EXPENSES. The Company will reimburse the Executive for all reasonable business expenses
incurred by the Executive in connection with the discharge of his duties for the Company, subject to the Company’s expense
reimbursement policy in effect from time to time.
(d)
INDEMNIFICATION. The Company shall indemnify the Executive to the maximum extent that its
officers, directors and employees are entitled to indemnification pursuant to the Company’s Certificate of Incorporation and Bylaws for
any acts or omissions by reason of being a director, officer or employee of the Company as of the Effective Date. At all times during the
Employment Term, the Company shall maintain in effect a director and officers liability insurance policy with the Executive as a covered
officer and director.
7.
TERMINATION. The Executive’s employment and the Employment Term shall terminate on the first of the
following to occur:
(a)
DISABILITY. Upon the 30th day following the Executive’s receipt of notice of the Company’s intention to
terminate the Executive’s employment due to Disability (as defined in this Section 7(a)); provided that, the Executive has not returned to
full-time performance of his duties within 30 days after receipt of such notice. If the Company determines in good faith that the Executive’s
Disability has occurred during the term of this Agreement, it will give the Executive written notice of its intention to terminate his employment. For
purposes of this Agreement, “Disability” shall mean the Executive’s inability to substantially perform the essential duties of his job with or without
reasonable accommodation on a full-time basis for 180 calendar days during any consecutive twelve-month period or for 90 consecutive days as a
result of incapacity due to mental or physical illness.
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3.
(b)
(c)
DEATH. Automatically on the date of death of the Executive.
CAUSE. Immediately upon written notice by the Company to the Executive of a termination for Cause.
“Cause” shall mean (i) the Executive’s commission of an act of fraud, embezzlement or theft against the Company or its subsidiaries; (ii)
the Executive’s conviction of, or a plea of no contest to, a felony; (iii) willful nonperformance by the Executive (other than by reason of
illness) of his material duties as an employee of the Company, which, to the extent it is curable by the Executive, is not cured within thirty
(30) days after written notice thereof is given to the Executive by the Company; (iv) the Executive’s material breach of this Agreement or
any other material agreement between the Executive and the Company or any of its subsidiaries, including the Confidentiality
Agreement, which, to the extent it is curable by the Executive, is not cured within thirty (30) days after written notice thereof is given to
the Executive by the Company; or (v) the Executive’s gross negligence, willful misconduct or any other act of willful disregard for the
Company’s or any of its subsidiaries’ best interests, which, to the extent it is curable by the Executive, is not cured within thirty (30) days
after written notice thereof is given to the Executive by the Company.
months after the Effective Date of an involuntary termination without Cause and other than due to death or Disability.
(d)
WITHOUT CAUSE. Upon written notice by the Company to the Executive no earlier than eighteen (18)
(e)
GOOD REASON. “Good Reason” for the Executive to terminate the Executive’s employment hereunder
shall mean the occurrence of any of the following conditions during the Employment Term without the Executive’s express written
consent; provided that any resignation by the Executive due to any of the following conditions shall only be deemed for Good Reason if:
(i) the Executive gives the Company written notice of the intent to terminate for Good Reason within sixty (60) days following the first
occurrence of the condition(s) that the Executive believes constitutes Good Reason, which notice shall describe such condition(s); (ii) the
Company fails to remedy, if remediable, such condition(s) within thirty (30) days following receipt of the written notice (the “Cure
Period”) of such condition(s) from the Executive; and
(iii)
the Executive actually resigns his employment within the first thirty (30) days after expiration of the Cure Period:
initially set forth herein or as the same may be increased from time to time;
(1)
any material reduction by the Company of the Executive’s Base Salary or Target Bonus as
(2)
(3)
any material diminution in the Executive’s duties, title, responsibilities or authority;
a requirement that the Executive report to a corporate officer or employee other than the
Company’s Chief Executive Officer, other than any such requirement following a Significant Event (as defined in the Company’s 2013
Share Ownership and Option Plan);
(4)
any material breach of this Agreement, including a breach of the Company’s obligations under
Section 4, 5 or Section 11 (b); or
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4.
five (75) miles from Waltham, Massachusetts.
(5)
a requirement that the Executive relocate to a principal place of employment more than seventy-
(f)
WITHOUT GOOD REASON. The Executive shall provide two (2) weeks’ prior written notice (the
“Transition Period”) to the Company of the Executive’s intended termination of employment without Good Reason (“Voluntary
Termination”). During the Transition Period, the Executive shall assist and advise the Company in any transition of business, customers,
prospects, projects and strategic planning, and the Company shall pay the pro rata portion of the Executive’s Base Salary and benefits
through the end of the Transition Period. The Company may, in its sole discretion, upon written notice to the Executive, make such
termination of employment effective earlier than the expiration of the Transition Period (“Early Termination Right”), but it shall pay the
pro rata portion of the Executive’s Base Salary and benefits through the earlier of: the end of the Transition Period, or the date that the
Executive accepts employment or a consulting engagement from a third party.
8.
CONSEQUENCES OF TERMINATION. Any termination payments made and benefits provided under this
Agreement to the Executive shall be in lieu of any termination or severance payments or benefits for which the Executive may be eligible
under any of the plans, policies or programs of the Company or its affiliates as may be in effect from time to time. Subject to satisfaction
of each of the conditions set forth in Section 9, the following amounts and benefits shall be due to the Executive:
(a)
DISABILITY. Upon employment termination due to Disability, the Company shall pay or provide the
Executive: (i) any unpaid Base Salary through the date of termination and any accrued vacation; (ii) reimbursement for any unreimbursed
expenses owed to Executive; and (iii) all other payments and benefits to which the Executive is entitled under the terms of any applicable
compensation arrangement or benefit, equity or other plan or program, including but not limited to any applicable insurance benefits,
payable on the next regularly scheduled Company payroll date following the date of termination or earlier if required by applicable law
(collectively, “Accrued Amounts”). In addition, upon the Executive’s termination due to Disability, the Company shall pay the amounts
described in Sections 8(d)(3) and 8(d)(4) to the Executive.
(b)
DEATH. In the event the Employment Term ends on account of the Executive’s death, the Executive’s
estate (or to the extent a beneficiary has been designated in accordance with a program, the beneficiary under such program) shall be
entitled to any Accrued Amounts, including but not limited to proceeds from any Company sponsored life insurance programs. In
addition, upon the Executive’s death, the Company shall pay the amounts described in Sections 8(d)(3) and 8(d)(4) to the Executive’s
estate.
TERMINATION FOR CAUSE OR WITHOUT GOOD REASON. If the Executive’s employment should
be terminated (i) by the Company for Cause, or (ii) by the Executive without Good Reason, the Company shall pay to the Executive any
Accrued Amounts only, and shall not be obligated to make any additional payments to the Executive.
(c)
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5.
(d)
TERMINATION WITHOUT CAUSE OR FOR GOOD REASON. If the Executive’s employment by the
Company is terminated by the Company other than for Cause (and not due to Disability or death) or by the Executive for Good Reason,
other than in circumstances described in Section 8(e), then the Company shall pay or provide the Executive with the Accrued Amounts
and subject to compliance with Section 11:
(1)
continued payment of the Executive’s Base Salary as in effect immediately preceding the last
day of the Employment Term for a period of twelve (12) months following the termination date (the “Salary Severance Period”) in
accordance with the Company’s ordinary payroll practices (for purposes of calculating the Executive’s severance benefits, the Executive’s
Base Salary shall be calculated based on the rate in effect prior to any material reduction in Base Salary that would give the Executive the
right to resign for Good Reason (as provided in Section 7(e)(1)));
(2)
if the Executive timely elects continued coverage under COBRA for himself and his covered
dependents under the Company’s group health plans following such termination, then the Company shall pay the COBRA premiums
necessary to continue the Executive’s and his covered dependents’ health insurance coverage in effect on the termination date until the
earliest of (i) twelve (12) months following the termination date (the “COBRA Severance Period”); (ii) the date when the Executive
becomes eligible for substantially equivalent health insurance coverage in connection with new employment or self-employment; or (iii)
the date the Executive ceases to be eligible for COBRA continuation coverage for any reason, including plan termination (such period
from the termination date through the earlier of (i)-(iii), the “COBRA Payment Period”). Notwithstanding the foregoing, if at any time the
Company determines that its payment of COBRA premiums on the Executive’s behalf would result in a violation of applicable law
(including but not limited to the 2010 Patient Protection and Affordable Care Act, as amended by the 2010 Health Care and Education
Reconciliation Act), then in lieu of paying COBRA premiums pursuant to this Section 8(d)(2), the Company shall pay the Executive on
the last day of each remaining month of the COBRA Payment Period, a fully taxable cash payment equal to the COBRA premium for
such month, subject to applicable tax withholding (such amount, the “Special Severance Payment”), such Special Severance Payment to
be made without regard to the Executive’s payment of COBRA premiums. Nothing in this Agreement shall deprive the Executive of his
rights under COBRA or ERISA for benefits under plans and policies arising under his employment by the Company.
(3)
in the event that the Executive’s employment is terminated after December 31 of any
performance year, but prior to the Annual Bonus payment date for such performance year, the Executive shall receive: (i) the amount of
the Annual Bonus as determined by the Board in good faith for the performance year immediately prior to the year in which the
Executive’s termination occurs if the Company has not determined the amount of the Executive’s Annual Bonus as of the date of the
Executive’s termination; or (ii) the amount of the Annual Bonus as already determined by the Board in good faith for the performance
year immediately prior to the year in which the Executive’s termination occurs if the Company has already determined the amount of the Executive’s
Annual Bonus as of the date of the Executive’s termination, payable in either case as a lump sum at the same time annual bonuses are paid to the
Company’s executives generally, but no later than March 15 of the calendar year immediately following the calendar year in which the Annual Bonus
is being measured;
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6.
(4)
in the event that the Executive’s employment is terminated: (i) on or before the date Annual
Bonus performance goals are established for the performance year in which the Executive’s termination occurs, the Executive shall
receive a pro-rata portion of the Executive’s Target Bonus for the performance year in which the Executive’s termination occurs, with
such pro-rata portion calculated based upon the number of days that the Executive was employed during such performance year divided
by the total number of days in such performance year; or (ii) after the date Annual Bonus performance goals are established for the
performance year in which the Executive’s termination occurs (but on or before December 31 of such performance year), the Executive
shall receive a pro-rata portion of the Executive’s Target Bonus for the performance year in which the Executive’s termination occurs,
with such pro-rata portion calculated based upon the Executive’s achievement of performance goals as determined by the Board in good
faith, payable in either case as a lump sum payment on the Company’s first ordinary payroll date occurring on or after the General
Release effective date (namely, the date it can no longer be revoked) or as soon thereafter as is reasonable practicable thereafter; and
(e)
TERMINATION WITHOUT CAUSE OR FOR GOOD REASON FOLLOWING A SIGNIFICANT
EVENT. If the Executive’s employment by the Company is terminated by the Company other than for Cause (and not due to Disability or
death), or by the Executive for Good Reason, in either case on or within twenty-four (24) months immediately following a Significant
Event, then the Company shall pay or provide the Executive with the Accrued Amounts and all of the benefits described in Section 8(d)
above, subject to compliance with Section 10; provided that: (i) the Salary Severance Period defined in Section 8(d)(1) shall be increased
to a total of eighteen (18) months following the termination date; (ii) the COBRA Severance Period defined in Section 8(d)(2) shall be
increased to a total of eighteen (18) months following the termination date; and (iii) in lieu of the pro-rata bonus described in Section 8(d)
(4), the Company shall pay the Executive the full Target Bonus for the performance year in which the Executive’s termination occurs,
payable as a lump sum payment on the Company’s first ordinary payroll date occurring on or after the General Release effective date
(namely, the date it can no longer be revoked).
9.
CONDITIONS. Any payments or benefits made or provided pursuant to Section 8 (other than Accrued Amounts) are
subject to the Executive’s (or, in the event of the Executive’s death, the beneficiary’s or estate’s, or in the event of the Executive’s
Disability, the guardian’s):
(a)
compliance with the provisions of Section 11 hereof;
(b)
delivery to the Company of the executed Agreement and General Release (the “General Release”), which
shall be in the form attached hereto as Appendix A (with such changes therein or additions thereto as needed under then applicable law to
give effect to its intent and purpose) within 21 days following the date of termination of employment, and permitting the General Release
to become effective in accordance with its terms; and
Company, its affiliates and employee benefit plans, by no later than 90 days following termination of employment.
(c)
delivery to the Company of a resignation from all offices, directorships and fiduciary positions with the
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7.
Notwithstanding the due date of any post-employment payments, any amounts due following a termination under this
Agreement (other than Accrued Amounts) shall not be due until after the expiration of any revocation period applicable to the General
Release without the Executive having revoked such General Release, and any such amounts shall be paid or commence being paid to
the Executive on the Company’s first ordinary payroll date occurring on or after the expiration of such revocation period without the
occurrence of a revocation by the Executive (or such later date as may be required under Section 18 or the final sentence of this Section
9). Nevertheless (and regardless of whether the General Release has been executed by the Executive), upon any termination of
Executive’s employment, Executive shall be entitled to receive any Accrued Amounts, payable after the date of termination in
accordance with the Company’s applicable plan, program, policy or payroll procedures. Notwithstanding anything to the contrary in this
Agreement, if any severance pay or benefits are deferred compensation under Section 409A (as defined below), and the period during
which the Executive may sign the General Release begins in one calendar year and ends in another, then the severance pay or benefit
shall not be paid or the first payment shall not occur until the later calendar year.
10.
CONFIDENTIALITY AND POST-EMPLOYMENT OBLIGATIONS. As a condition of employment, the
Executive agrees to execute and abide by the Company’s current form of Confidentiality and Non-Competition Agreement
(“Confidentiality Agreement”), which may be amended by the parties from time to time without regard to this Agreement. The
Confidentiality Agreement contains provisions that are intended by the parties to survive and do survive termination of this Agreement.
11.
ASSIGNMENT.
written consent of the Company.
(a)
The Executive may not assign or delegate any rights or obligations hereunder without first obtaining the
(b)
This Agreement shall be binding upon and inure to the benefit of the Company and its successors, assigns
and legal representatives. The Company will require any acquirer or successor of the Company in any merger, consolidation, sale, or
acquisition of the Company, or a similar transaction to assume the Company’s obligations under this Agreement, and any failure to do so
shall constitute a material breach of this Agreement.
12.
NOTICE. For the purpose of this Agreement, notices and all other communications provided for in this Agreement
shall be in writing and shall be deemed to have been duly given (a) on the date of delivery if delivered by hand, (b) on the date of
transmission, if delivered by confirmed facsimile, (c) on the first business day following the date of deposit if delivered by guaranteed
overnight delivery service, or (d) on the fourth business day following the date delivered or mailed by United States registered or certified
mail, return receipt requested, postage prepaid, addressed as follows: If to the Executive: at the address (or to the facsimile number) shown on the
records of the Company.
If to the Company:
Eloxx Pharmaceuticals, Inc.
950 Winter Street
Waltham, MA 02451
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8.
or to such other address as either party may have furnished to the other in writing in accordance herewith, except that notices of change
of address shall be effective only upon receipt.
13.
SECTION HEADINGS; INCONSISTENCY. The section headings used in this Agreement are included solely
for convenience and shall not affect, or be used in connection with, the interpretation of this Agreement. If there is any inconsistency
between this Agreement and any other agreement plan, program, policy or practice (collectively, “Other Provision”) of the Company the
terms of this Agreement shall control over such Other Provision.
14.
SEVERABILITY. The provisions of this Agreement shall be deemed severable and the invalidity of
unenforceability of any provision shall not affect the validity or enforceability of the other provisions hereof.
15.
COUNTERPARTS. This Agreement may be executed in counterparts, each of which shall be deemed to be an
original but all of which together will constitute one and the same instruments. One or more counterparts of this Agreement may be
delivered by facsimile, with the intention that delivery by such means shall have the same effect as delivery of an original counterpart
thereof.
16.
MISCELLANEOUS. No provision of this Agreement may be modified, waived or discharged unless such waiver,
modification or discharge is agreed to in writing and signed by the Executive and such officer or director of the Company as may be
designated or authorized by the Board. No waiver by either party hereto at any time of any breach by the other party hereto of, or
compliance with, any condition or provision of this Agreement to be performed by such other party shall be deemed a waiver of similar
or dissimilar provisions or conditions at the same or at any prior or subsequent time. This Agreement together with all exhibits hereto and
the Confidentiality Agreement sets forth the entire agreement of the parties hereto in respect of the subject matter contained herein. No
agreements or representations, oral or otherwise, express or implied, with respect to the subject matter hereof have been made by either
party which are not expressly set forth in this Agreement. The validity, interpretation, construction and performance of this Agreement
shall be governed by the laws of the Commonwealth of Massachusetts without regard to its conflicts of law principles.
17.
SECTION 409A.
(a)
Notwithstanding anything to the contrary herein, the following provisions apply to the extent severance
benefits provided herein are subject to Section 409A of Code and the regulations and other guidance thereunder and any state law of
similar effect (collectively “Section 409A”). Severance benefits payable upon a termination of employment shall not commence until
Executive has a “separation from service” for purposes of Section 409A. Each installment of severance benefits is a separate “payment” for purposes
of Treas. Reg. Section 1.409A-2(b)(2)(i), and the severance benefits are intended to satisfy the exemptions from application of Section 409A provided
under Treasury Regulations Sections 1.409A-1(b)(4), 1.409A-1(b)(5) and 1.409A-1(b)(9). However, if such exemptions are not available and
Executive is, upon separation from service, a “specified employee” for purposes of Section 409A, then, solely to the extent necessary to avoid adverse
personal tax consequences under Section 409A, the timing of the severance benefits shall be delayed until the earlier of (i) six (6) months and one day
after Executive’s separation from service, or (ii) Executive’s death. Any payment or benefit otherwise payable or to be provided in the six (6) month
period following separation from service that is not so paid or provided by reason of this Section 17 shall be accumulated and paid or provided in a
single lump sum, as soon as practicable (and in all events within 15 days) after the date that is six (6) months after Executive’s separation from service
(or, if earlier, as soon as practicable, and in all events within 15 days, after the date of Executive’s death)
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9.
(b)
It is intended that this Agreement shall comply with the requirements of Section 409A, and any ambiguity
contained herein shall be interpreted in such manner so as to avoid adverse personal tax consequences under Section 409A.
Notwithstanding the foregoing, the Company shall in no event be obligated to indemnify the Executive for any taxes or interest that may
be assessed by the IRS pursuant to Section 409A of the Code on payments made pursuant to this Agreement.
18.
MITIGATION OF DAMAGES. In no event shall the Executive be obliged to seek other employment or take any
other action by way of mitigation of the severance benefits payable to the Executive under any of the provisions of this Agreement, nor
shall the amount of any severance benefit hereunder be reduced by any compensation earned by the Executive as a result of employment
by another employer, except as set forth in this Agreement.
19.
REPRESENTATIONS. The Executive represents and warrants to the Company that the Executive has the legal
right to enter into this Agreement and to perform all of the obligations on the Executive’s part to be performed hereunder in accordance
with its terms and that the Executive is not a party to any agreement or understanding, written or oral, which could prevent the Executive
from entering into this Agreement or performing all of the Executive’s obligations hereunder. The Executive further represents and
warrants that he has been advised to consult with an attorney and that he has been represented by the attorney of his choosing during the
negotiation of this Agreement (or chosen not to be so represented), that he has consulted with his attorney before executing this
Agreement (or chosen not to consult an attorney), that he has carefully read and fully understand all of the provisions of this Agreement
and that he is voluntarily entering into this Agreement.
20.
NON-DISPARAGEMENT. Both during and after the Employment Term, the Executive and the Company (through
its officers and directors) agree not to disparage the other party, and the other party’s officers, directors, employees, shareholders,
affiliates and agents, in any manner likely to be harmful to them or their business, business reputation or personal reputation; provided
that both the Executive and the Company may respond accurately and fully to any question, inquiry or request for information when
required by legal process and provided further that nothing in this Section 21 shall preclude any party from making truthful statements that are
reasonably necessary or to enforce or defend the party’s rights under this Agreement.
21.
WITHHOLDING. The Company may withhold from any and all amounts payable under this Agreement such
federal, state and local taxes as may be required to be withheld pursuant to any applicable law or regulation.
22.
SURVIVAL. The respective obligations of, and benefits afforded to, the Company and the Executive which by their
express terms or clear intent survive termination of the Executive’s employment with the Company, including, without limitation, the
provisions of Sections 8 through 26, inclusive, of this Agreement, will survive termination of the Executive’s employment with the
Company, and will remain in full force and effect according to their terms.
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10.
23.
AGREEMENT OF THE PARTIES. The language used in this Agreement will be deemed to be the language
chosen by the parties hereto to express their mutual intent. Neither the Executive nor the Company shall be entitled to any presumption in
connection with any determination made hereunder in connection with any arbitration, judicial or administrative proceeding relating to or
arising under this Agreement.
24.
DISPUTE RESOLUTION. In the event of any controversy, dispute or claim between the parties under, arising out
of or related to this Agreement (including but not limited to, claims relating to breach, termination of this Agreement, or the performance
of a party under this Agreement) whether based on contract, tort, statute or other legal theory (collectively referred to hereinafter as
“Disputes”), the parties shall follow the dispute resolution procedures set forth below. Any Dispute shall be finally settled by arbitration
in accordance with the Employment Arbitration Rules & Procedures of JAMS (“JAMS”) then in force, and that the arbitration hearings
shall be held in Boston, Massachusetts. The parties agree to (i) appoint an arbitrator who is knowledgeable in employment and human
resource matters and, to the extent possible, the industry in which the Company operates, and instruct the arbitrator to follow substantive
rules of law; (ii) require the testimony to be transcribed; and (iii) require the award to be accompanied by findings of fact and a statement
of reasons for the decision. The arbitrator shall have the authority to permit discovery, to the extent deemed appropriate by the arbitrator,
upon request of a party, but such discovery process shall continue for no more than thirty (30) days. The arbitrator shall have no power or
authority to add to or detract from the written agreement of the parties. If the parties cannot agree upon an arbitrator within ten (10) days
after demand by either of them, either or both parties may request JAMS name a panel of five (5) arbitrators. The Company shall strike
the names of two (2) off this list; then, the Executive shall strike two (2) of the remaining names; and the remaining name shall be the
arbitrator. The Company and the Executive shall each pay for their own attorneys’ fees and expenses and their pro rata share of the JAMS
fees and expenses. Any award shall be final, binding and conclusive upon the parties and a judgment rendered thereon may be entered in
any court having jurisdiction thereof. This Section shall not limit the right of any party to sue for injunctive relief for a breach of the
obligations of this Agreement.
[signature page follows]
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11.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement, effective as of the date first written above.
ELOXX PHARMACEUTICALS, INC.
By:
/s/ Robert Ward
Robert Ward
Its: Chief Executive Officer and Director
EXECUTIVE
/s/ David Snow
David Snow
[Signature Page to Employment Agreement]
Exhibit 10.40
LOAN AND SECURITY AGREEMENT
THIS LOAN AND SECURITY AGREEMENT (this “Agreement”) dated as of January 30, 2019 (the “Effective Date”) among (a) SILICON
VALLEY BANK, a California corporation (“SVB”), in its capacity as administrative agent and collateral agent (“Agent”), (b) SILICON VALLEY BANK, a
California corporation, as a lender, (c) WESTRIVER INNOVATION LENDING FUND VIII, L.P., a Delaware limited partnership (“WestRiver”), as a lender
(SVB and WestRiver and each of the other “Lenders” from time to time a party hereto are referred to herein collectively as the “Lenders” and each individually as a
“Lender”), and (d) (i) ELOXX PHARMACEUTICALS, INC., a Delaware corporation (“US Borrower”) and (ii) ELOXX PHARMACEUTICALS LTD., a
company organized under the laws of the State of Israel (“ISR Borrower”) (US Borrower and ISR Borrower are hereinafter jointly and severally, individually and
collectively, referred to as “Borrower”), provides the terms on which Agent and the Lenders shall lend to Borrower and Borrower shall repay Agent and the
Lenders. The parties agree as follows:
1
ACCOUNTING AND OTHER TERMS
Accounting terms not defined in this Agreement shall be construed following GAAP. Calculations and determinations must be made following GAAP.
Notwithstanding the foregoing, all financial covenant calculations (if any) shall be computed with respect to Borrower only, and not on a consolidated
basis. Capitalized terms not otherwise defined in this Agreement shall have the meanings set forth in Section 14 of this Agreement. All other terms contained in this
Agreement, unless otherwise indicated, shall have the meaning provided by the Code to the extent such terms are defined therein.
2
LOAN AND TERMS OF PAYMENT
2.1
Promise to Pay. Borrower hereby unconditionally promises to pay to Agent, for the ratable benefit of each Lender, the
outstanding principal amount of all Credit Extensions advanced to Borrower by such Lender and accrued and unpaid interest thereon, together with any fees as and
when due in accordance with this Agreement.
2.1.1
Term Loan Advances
(a)
Availability. Subject to the terms and conditions of this Agreement, upon Borrower’s request, the Lenders, severally
and not jointly, shall make one (1) term loan advance to Borrower on or about the Effective Date in an original principal amount of Fifteen Million Dollars
($15,000,000.00) according to each Lender’s Term A Loan Advance Commitment as set forth on Schedule 1.1 hereto (the “Term A Loan Advance”). Subject to the
terms and conditions of this Agreement, upon Borrower’s request, during the Draw Period, the Lenders, severally and not jointly, shall make one (1) term loan
advance available to Borrower in an original principal amount of Ten Million Dollars ($10,000,000.00) according to each Lender’s Term A Loan Advance
Commitment as set forth on Schedule 1.1 hereto (the “Term B Loan Advance”). The Term A Loan Advance and the Term B Loan Advance are hereinafter referred
to singly as a “Term Loan Advance” and collectively as the “Term Loan Advances”. After repayment, no Term Loan Advance (or any portion thereof) may be
reborrowed.
Interest Period. Commencing on the first (1st) Payment Date of the month following the month in which the Funding
Date of the applicable Term Loan Advance occurs, and continuing on the Payment Date of each month thereafter, Borrower shall make monthly payments of interest
to Agent, for the account of the Lenders, in arrears, on the principal amount of each Term Loan Advance, at the rate set forth in Section 2.2 (a).
(b)
(c)
Repayment. Commencing on the Term Loan Amortization Date, and continuing on each Payment Date thereafter,
Borrower shall repay the aggregate outstanding Term Loan Advances to Agent, for the account of the Lenders, in (i) consecutive equal monthly installments of
principal based on the Repayment Schedule, plus (ii) monthly payments of accrued interest at the rate set forth in Section 2.2(a). All outstanding principal and
accrued and unpaid interest with respect to the Term Loan Advances, and all other outstanding Obligations under the Term Loan Advances, are due and payable in
full on the Term Loan Maturity Date.
(d)
Permitted Prepayment. Borrower shall have the option to prepay all, but not less than all, of the Term Loan Advances
advanced by the Lenders under this Agreement, provided Borrower (i) provides written notice to Agent of its election to prepay the Term Loan Advances at least ten
(10) days prior to such prepayment, and (ii) pays to Agent, for the account of the Lenders in accordance with its respective Pro Rata Share, on the date of such
prepayment (A) all outstanding principal plus accrued and unpaid interest, (B) the Prepayment Premium, (C) the Final Payment and (D) all other sums, if any, that
shall have become due and payable, including Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts.
(e)
Mandatory Prepayment Upon an Acceleration. If the Term Loan Advances are accelerated by Agent pursuant
to Section 9.1 hereof, following the occurrence of an Event of Default, Borrower shall immediately pay to Agent, for the account of the Lenders in accordance with
its respective Pro Rata Share, an amount equal to the sum of (i) all outstanding principal plus accrued and unpaid interest with respect to the Term Loan Advances,
(ii) the Prepayment Premium, (iii) the Final Payment and (iv) all other sums, if any, that shall have become due and payable, including Lenders’ Expenses and
interest at the Default Rate with respect to any past due amounts.
2.2
Payment of Interest on the Credit Extensions.
Interest Rate. Subject to Section 2.2(b), the principal amount outstanding under each Term Loan Advance
shall accrue interest at a floating per annum rate equal to the greater of (i) five and one-quarter of one percent (5.25%) and (ii) two and one-half of one percent
(2.50%) above the Prime Rate, which interest, in each case, shall be payable monthly in accordance with Section 2.2(d) below.
(a)
(b)
Default Rate. Immediately upon the occurrence and during the continuance of an Event of Default,
Obligations shall bear interest at a rate per annum which is four percent (4.0%) above the rate that is otherwise applicable thereto (the “Default Rate”). Fees and
expenses which are required to be paid by Borrower pursuant to the Loan Documents (including, without limitation, Lenders’ Expenses) but are not paid when due
shall bear interest until paid at a rate equal to the highest rate applicable to the Obligations. Payment or acceptance of the increased interest rate provided in this
Section 2.2(b) is not a permitted alternative to timely payment and shall not constitute a waiver of any Event of Default or otherwise prejudice or limit any rights or
remedies of Agent or any Lender.
Prime Rate shall be effective on the effective date of any change to the Prime Rate and to the extent of any such change.
(c)
Adjustment to Interest Rate. Changes to the interest rate of any Credit Extension based on changes to the
(d)
Payment; Interest Computation. Interest is payable monthly on the Payment Date and shall be computed on
the basis of a 360-day year for the actual number of days elapsed. In computing interest, (i) all payments received after 12:00 p.m. Eastern time on any day shall be
deemed received at the opening of business on the next Business Day, and (ii) the date of the making of any Credit Extension shall be included and the date of
payment shall be excluded; provided, however, that if any Credit Extension is repaid on the same day on which it is made, such day shall be included in computing
interest on such Credit Extension.
2.3
Fees. Borrower shall pay to Agent:
Commitment Fee. A fully earned, non-refundable Term Loan Advance commitment fee of One Hundred
Twenty Five Thousand Dollars ($125,000.00), payable on the Effective Date, to be shared between the Lenders pursuant to their respective Term Loan Commitment
Percentages;
(a)
respective Term Loan Commitment Percentages;
(b)
Final Payment. The Final Payment, when due hereunder, to be shared between the Lenders pursuant to their
pursuant to their respective Term Loan Commitment Percentages;
(c)
Prepayment Premium. The Prepayment Premium, when due hereunder, to be shared between the Lenders
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documentation and negotiation of this Agreement) incurred through and after the Effective Date, when due (or, if no stated due date, upon demand by Agent).
(d)
Lenders’ Expenses. All Lenders’ Expenses (including reasonable attorneys’ fees and expenses for
Unless otherwise provided in this Agreement or in a separate writing by Agent, Borrower shall not be entitled to any credit, rebate, or repayment of any
fees earned by Agent or any Lender pursuant to this Agreement notwithstanding any termination of this Agreement or the suspension or termination of any Lender’s
obligation to make loans and advances hereunder. Agent may deduct amounts owing by Borrower under the clauses of this Section 2.2 pursuant to the terms of
Section 2.4(e). Agent shall provide Borrower written notice of deductions made from the Designated Deposit Account pursuant to the terms of the clauses of this
Section 2.3.
2.4
Payments; Pro Rata Treatment; Application of Payments; Debit of Accounts.
(a)
All payments (including prepayments) to be made by Borrower under any Loan Document shall be made to
Agent for the account of Lenders, in immediately available funds in Dollars, without setoff or counterclaim, before 12:00 p.m. Eastern time on the date when due.
Agent shall distribute such payments to Lenders in like funds as set forth in Section 2.5. Payments of principal and/or interest received after 12:00 p.m. Eastern time
are considered received at the opening of business on the next Business Day. When a payment is due on a day that is not a Business Day, the payment shall be due
the next Business Day, and additional fees or interest, as applicable, shall continue to accrue until paid.
Commitment Percentages of the relevant Lenders.
(b)
Each borrowing by Borrower from Lenders hereunder shall be made according to the respective Term Loan
(c)
Except as otherwise provided herein, each payment (including each prepayment) by Borrower on account of
principal or interest on the Term Loan Advances shall be applied according to each Lender’s Pro Rata Share of the outstanding principal amount of the Term Loan
Advances. The amount of each principal prepayment of the Term Loan Advances shall be applied to reduce the then remaining installments of the Term Loan
Advances based upon each Pro Rata Share of Term Loan Advances.
(d)
Agent has the exclusive right to determine the order and manner in which all payments with respect to the
Obligations may be applied. Borrower shall have no right to specify the order or the accounts to which Agent shall allocate or apply any payments required to be
made by Borrower to Agent or otherwise received by Agent or any Lender under this Agreement when any such allocation or application is not specified elsewhere
in this Agreement.
and interest payments or any other amounts Borrower owes Agent or any Lender when due. These debits shall not constitute a set-off.
(e)
Agent may debit any of Borrower’s deposit accounts, including the Designated Deposit Account, for principal
(f)
Unless Agent shall have been notified in writing by Borrower prior to the date of any payment due to be made
by Borrower hereunder that Borrower will not make such payment to Agent, Agent may assume that Borrower is making such payment, and Agent may, but shall not
be required to, in reliance upon such assumption, make available to Lenders their respective Pro Rata Share of a corresponding payment amount. If such payment is
not made to Agent by Borrower within three (3) Business Days after such due date, Agent shall be entitled to recover, on demand, from each Lender to which any
amount which was made available pursuant to the preceding sentence, such amount with interest thereon at the rate per annum equal to the daily average Federal
Funds Effective Rate. Nothing herein shall be deemed to limit the rights of Agent or any Lender against Borrower.
2.5
Settlement Procedures. If Agent receives any payment for the account of Lenders on or prior to 12:00 p.m. (Eastern time) on any
Business Day, Agent shall pay to each applicable Lender such Lender’s Pro Rata Share of such payment on such Business Day. If Agent receives any payment for
the account of Lenders after 12:00 p.m. (Eastern time) on any Business Day, Agent shall pay to each applicable Lender such Lender’s Pro Rata Share of such
payment on the next Business Day.
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2.6
Withholding by US Borrower. Payments received by Agent from US Borrower under this Agreement will be made free and clear
of and without deduction for any and all present or future taxes, levies, imposts, duties, deductions, withholdings, assessments, fees or other charges imposed by any
Governmental Authority (including any interest, additions to tax or penalties applicable thereto). Specifically, however, if at any time any Governmental Authority,
applicable law, regulation or international agreement requires US Borrower to make any withholding or deduction from any such payment or other sum payable
hereunder to Agent, US Borrower hereby covenants and agrees that the amount due from US Borrower with respect to such payment or other sum payable hereunder
will be increased to the extent necessary to ensure that, after the making of such required withholding or deduction, Agent receives a net sum equal to the sum which
it would have received had no withholding or deduction been required, and US Borrower shall pay the full amount withheld or deducted to the relevant
Governmental Authority. US Borrower will, upon request, furnish Agent with proof reasonably satisfactory to Agent indicating that US Borrower has made such
withholding payment; provided, however, that US Borrower need not make any withholding payment if the amount or validity of such withholding payment is
contested in good faith by appropriate and timely proceedings and as to which payment in full is bonded or reserved against by US Borrower. The agreements and
obligations of US Borrower contained in this Section 2.6 shall survive the termination of this Agreement.
2.7
Tax Forms. Each Lender shall deliver to Borrower, at such times as are reasonably requested by Borrower, such properly
completed and executed tax documentation prescribed by law (including FATCA), or reasonably requested by Borrower, to establish such Lender’s status for
withholding tax purposes or, if such Lender is entitled to an exemption from or reduction in withholding tax with respect to payments hereunder, to allow Borrower
to make payments hereunder without withholding for any taxes (or otherwise at a reduced rate of withholding), including without limitation, Forms W-9, W-8BEN-
E, W-8BEN, W-8IMY, or W-8EXP, as applicable. In addition, each Lender, if reasonably requested by Borrower, shall deliver such other documentation reasonably
requested by Borrower as will enable Borrower to determine whether or not such Lender is subject to backup withholding or information reporting
requirements. Any costs and expenses incurred by Lenders in connection with this Section 2.7 shall constitute Lenders’ Expenses.
2.8
Net Payments and Withholding.
(a)
All payments by ISR Borrower on account of the Obligations shall be made subject to applicable withholding
taxes under the Israeli Income Tax Ordinance and the rules and regulations promulgated thereunder, provided however, that if a Lender provides ISR Borrower with
a valid certificate of exemption from tax withholding or a determination applying a reduced withholding tax rate or any other instructions regarding the payment of
withholding issued by the Israeli Tax Authority, in form and substance reasonably acceptable to ISR Borrower, then the withholding (if any) of any amounts from the
payments to be made by ISR Borrower to Agent shall be made only in accordance with the provisions of such certificate.
(b)
ISR Borrower will furnish Agent with proof reasonably satisfactory to Agent indicating that ISR Borrower
has made all such withholding tax payments, if and to the extent such withholding tax payment is required to be made in accordance with applicable law, and will
cooperate with Agent and the Lenders in connection with any information and documentation reasonably required by Agent and the Lenders in connection with
credits, exemptions, rebates, or other benefits to be obtained by Agent or the Lenders in connection with such withholding payments made by ISR Borrower, which
credits, exemptions, rebates, or other benefits shall be property of Agent and the Lenders, without payment to Borrower or application to any Obligations hereunder.
(c)
The agreements and obligations of Borrower contained in this Section 2.8 shall survive the termination of this
Agreement.
3
CONDITIONS OF LOANS
3.1
Conditions Precedent to Initial Credit Extension. Each Lender’s obligation to make the initial Credit Extension hereunder is
subject to the condition precedent that Agent shall have received, in form and substance satisfactory to Agent and the Lenders, such documents, and completion of
such other matters, as Agent may reasonably deem necessary or appropriate, including, without limitation:
(a)
duly executed original signatures to the Loan Documents;
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(b)
duly executed original signatures to the Warrant;
the Operating Documents and long-form good standing certificates of US Borrower certified by the Secretary
of State of the State of Delaware each other jurisdiction in which US Borrower is qualified to conduct business, each dated as of a date no earlier than thirty (30)
days prior to the Effective Date;
(c)
(d)
(e)
duly executed signatures to the completed Borrowing Resolutions for each Borrower;
a certificate of an officer of ISR Borrower with respect to articles, incumbency and resolutions authorizing the
execution and delivery of this Agreement, the Debentures and the other Loan Documents to which it is a party;
(f)
the Lender Intercreditor Agreement, together with the duly executed original signatures thereto;
(g)
certified copies, dated as of a recent date, of Lien searches (including without limitation, UCC searches and
Israeli Registrar of Companies searches), as Agent may request, accompanied by written evidence (including any UCC termination statements and other Lien
releases) that the Liens indicated in any such financing statements or other filings either constitute Permitted Liens or have been or, in connection with the initial
Credit Extension hereunder, will be terminated or released;
(h)
(i)
the Perfection Certificate of each Borrower, together with the duly executed signatures thereto;
a legal opinion (authority and enforceability) of Borrower’s US counsel dated as of the Effective Date,
together with the duly executed signature thereto;
Borrower’s Israeli counsel dated as of the Effective Date, together with the duly executed signature thereto;
(j)
a legal opinion (authority and with respect to Loan Documents governed by Israeli law also enforceability) of
evidence satisfactory to Agent that the insurance policies and endorsements required by Section 6.5 hereof are
in full force and effect with respect to the US Borrower, together with appropriate evidence showing lender loss payable and/or additional insured clauses or
endorsements in favor of Agent;
(k)
(l)
receipt by Agent of a first-ranking Lien in favor of Agent on the Charged Property pursuant to the Debentures
in proper form for filing with the Israeli Registrar of Companies together with a Hebrew convenience translation thereof, all in accordance with the terms of the
Debentures and the other Loan Documents; and
(m)
payment of the fees and Lenders’ Expenses then due as specified in Section 2.3 hereof.
3.2
Conditions Precedent to all Credit Extensions. Each Lender’s obligation to make each Credit Extension, including the initial
Credit Extension, is subject to the following conditions precedent:
Form;
(a)
timely receipt by the Lenders of (i) an executed Disbursement Letter and (ii) an executed Payment/Advance
(b)
the representations and warranties in this Agreement and the Debentures shall be true, accurate, and complete
in all material respects on the date of the Disbursement Letter (and the Payment/Advance Form) and on the Funding Date of each Credit Extension; provided,
however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text
thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material
respects as of such date, and no Event of Default shall have occurred and be continuing or result from the Credit Extension. Each Credit Extension is Borrower’s
representation and warranty
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on that date that the representations and warranties in this Agreement and the Debentures remain true, accurate, and complete in all material respects; provided,
however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text
thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material
respects as of such date; and
Agent and each Lender determine to its satisfaction that there has not been any material impairment in the
general affairs, management, results of operation, financial condition or the prospect of repayment of the Obligations, or any material adverse deviation by Borrower
from the most recent business plan of Borrower presented to and accepted by Agent and the Lenders.
(c)
3.3
Covenant to Deliver. Borrower agrees to deliver to Agent and each Lender each item required to be delivered to Agent and each
Lender under this Agreement as a condition precedent to any Credit Extension. Borrower expressly agrees that a Credit Extension made prior to the receipt by Agent
and each Lender of any such item shall not constitute a waiver by Agent or Lenders of Borrower’s obligation to deliver such item, and the making of any Credit
Extension in the absence of a required item shall be in each Lender’s sole discretion.
3.4
Procedures for Borrowing.
(a)
Term Loan Advances. Subject to the prior satisfaction of all other applicable conditions to the making of a
Credit Extension set forth in this Agreement, to obtain a Credit Extension, Borrower shall notify Agent (which notice shall be irrevocable) by electronic mail,
facsimile, or telephone by 12:00 p.m. Eastern time at least five (5) Business Days before the proposed Funding Date of such Credit Extension. Together with any
such electronic or facsimile notification, Borrower shall deliver to Agent by electronic mail or facsimile a completed Disbursement Letter (and Payment/Advance
Form) executed by an Authorized Signer. Agent may rely on any telephone notice given by a person whom Agent believes is an Authorized Signer. On the Funding
Date, Agent shall credit the Credit Extensions to the Designated Deposit Account. Agent may make Credit Extensions under this Agreement based on instructions
from an Authorized Signer or without instructions if the Credit Extensions are necessary to meet Obligations which have become due
(b)
Funding. In determining compliance with any condition hereunder to the making of a Credit Extension that,
by its terms, must be fulfilled to the satisfaction of a Lender, Agent may presume that such condition is satisfactory to such Lender unless Agent shall have received
notice to the contrary from such Lender prior to the making of such Credit Extension. Unless Agent shall have been notified in writing by any Lender prior to the
date of any Credit Extension, that such Lender will not make the amount that would constitute its share of such borrowing available to Agent, Agent may assume that
such Lender is making such amount available to Agent, and Agent may, in reliance upon such assumption, make available to Borrower a corresponding amount. If
such amount is not made available to Agent by the required time on the Funding Date therefor, such Lender shall pay to Agent, on demand, such amount with
interest thereon, at a rate equal to the greater of (i) the Federal Funds Effective Rate or (ii) a rate determined by Agent in accordance with banking industry rules on
interbank compensation, for the period until such Lender makes such amount immediately available to Agent. If such Lender’s share of such Credit Extension is not
made available to Agent by such Lender within three (3) Business Days after such Funding Date, Agent shall also be entitled to recover such amount with interest
thereon at the rate per annum applicable to the Term Loan Advances, on demand, from Borrower.
4
CREATION OF SECURITY INTEREST
4.1
Grant of Security Interest. Borrower hereby grants Agent, for the ratable benefit of the Lenders, to secure the payment and
performance in full of all of the Obligations, a continuing security interest in, and pledges to Agent, for the ratable benefit of the Lenders, the Collateral, wherever
located, whether now owned or hereafter acquired or arising, and all proceeds and products thereof. For clarity, any reference to “Agent’s Lien” or any granting of
collateral to Agent in this Agreement or any Loan Document means the Lien granted to Agent for the ratable benefit of the Lenders.
Borrower acknowledges that it previously has entered, and/or may in the future enter, into Bank Services Agreements with SVB. Regardless of the terms
of any Bank Services Agreement, Borrower agrees that any amounts
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Borrower owes SVB thereunder shall be deemed to be Obligations hereunder and that it is the intent of Borrower and SVB to have all such Obligations secured by
the first priority perfected security interest in the Collateral granted herein and the first ranking charges granted under the Debentures (subject only to Permitted
Liens that are permitted pursuant to the terms of this Agreement to have superior priority to Agent’s Lien in this Agreement), and by any and all other security
agreements, mortgages or other collateral granted to Agent by Borrower as security for the Obligations, now or in the future.
If this Agreement is terminated, Agent’s Lien in the Collateral shall continue until the Obligations (other than inchoate indemnity obligations) are repaid
in full in cash. Upon payment in full in cash of the Obligations (other than inchoate indemnity obligations) and at such time as the Lenders’ obligation to make
Credit Extensions has terminated, Agent shall, at the sole cost and expense of Borrower, release its Liens in the Collateral (and provide a payoff letter and other
reasonably requested termination documents and filings) and all rights therein shall revert to Borrower. In the event (x) all Obligations (other than inchoate
indemnity obligations), except for Bank Services, are satisfied in full, and (y) this Agreement and the Debentures are terminated, Agent shall terminate the security
interest granted herein and the charges granted under the Debentures (in each case, including by the delivery of a payoff letter and other terminations and releases
reasonably requested from time to time by Borrower, in each case at the sole cost and expense of Borrower) upon Borrower providing to SVB cash collateral
acceptable to SVB in its good faith business judgment for Bank Services, if any. In the event such Bank Services consist of outstanding Letters of Credit, Borrower
shall provide to SVB cash collateral in an amount equal to (x) if such Letters of Credit are denominated in Dollars, then at least one hundred five percent (105.0%);
and (y) if such Letters of Credit are denominated in a Foreign Currency, then at least one hundred ten percent (110.0%), of the Dollar Equivalent of the face amount
of all such Letters of Credit plus, in each case, all interest, fees, and costs due or to become due in connection therewith (as estimated by SVB in its business
judgment), to secure all of the Obligations relating to such Letters of Credit.
4.2
Priority of Security Interest. Borrower represents, warrants, and covenants that the security interests granted herein and in the
Debentures are and shall at all times continue to be a first priority perfected security interests in the Collateral (subject only to Permitted Liens that are permitted
pursuant to the terms of this Agreement to have superior priority to Agent’s Lien under this Agreement). If Borrower shall acquire a commercial tort claim that
could reasonably be expected to result in proceeds to Borrower in excess of Two Hundred Fifty Thousand Dollars ($250,000.00), Borrower shall promptly notify
Agent in a writing signed by Borrower of the general details thereof and grant to Agent, for the ratable benefit of the Lenders, in such writing a security interest
therein and in the proceeds thereof, all upon the terms of this Agreement, with such writing to be in form and substance reasonably satisfactory to Agent.
4.3
Debentures. ISR Borrower undertakes to create, in favor of Agent, for the ratable benefit of the Lenders, a first ranking floating
charge over all of the present and future assets of ISR Borrower whether now existing or hereafter created, and a first ranking fixed charge over ISR Borrower’s
registered and unissued share capital, its reputation and goodwill, Accounts, its rights to receive funds from its customers and other fixed assets and any tax benefit it
may have, in accordance with a debenture of floating charge and fixed charge in the form of debenture attached as Exhibit D and Exhibit D-1 respectively (as
amended, modified or restated from time to time, jointly, the “Debentures” and each, a “Debenture”). The initial exhibits A and B to be attached to ISR Borrower’s
fixed charge Debenture are attached hereto as Exhibit D-2 and Exhibit D-3, respectively. In addition, ISR Borrower undertakes to create within twenty (20) days of
the end of each calendar year, and more often if requested at the sole and absolute discretion of Agent, a first ranking fixed charge over (i) each Account which is
outstanding at such time, (ii) ISR Borrower’s rights, whether then existing or thereafter created, to receive funds from its customers and (iii) ISR Borrower’s
Equipment, all in accordance with a debenture of fixed charge in the form of the debenture attached hereto as Exhibit D-1) (or in the form of an amendment to the
existing Debenture, at the Agent’s discretion; each such new and/or amended debenture shall also be included in the definition of the term “Debenture” herein).
Borrower warrants and represents that the charges of the Debentures, upon the filing thereof, shall be first priority fixed and floating charges (as provided therein) in
the Collateral.
In addition to and without limiting the foregoing, all Obligations shall also be secured by (a) any and all properties, rights and assets of ISR Borrower
granted by ISR Borrower to Agent now, or in the future, in which ISR Borrower obtains an interest, or the power to transfer rights in, including, without limitation,
the Charged Property as set forth in the Debentures, and (b) any and all security agreements, mortgages or other collateral agreements granted by ISR Borrower to
Agent, now or in the future.
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4.4
Authorization to File Financing Statements. Borrower hereby authorizes Agent, on behalf of the Lenders, to file financing
statements and other similar forms, without notice to Borrower, with all appropriate jurisdictions to perfect or protect Agent’s and Lenders’ interest or rights
hereunder, including a notice that any disposition of the Collateral, by either Borrower or any other Person, shall be deemed to violate the rights of Agent under the
Code. Such financing statements and other similar forms may indicate the Collateral as “all assets of the Debtor” or words of similar effect, or as being of an equal
or lesser scope, or with greater detail, all in Agent’s discretion.
5
REPRESENTATIONS AND WARRANTIES
Borrower represents and warrants as follows:
5.1
Due Organization, Authorization; Power and Authority. Borrower is duly organized, validly existing, and with respect to ISR
Borrower, not in a status of “breaching company” (as such term is defined under the Israeli Companies Law 5759-1999), and with respect to US Borrower, in good
standing as a Registered Organization in its jurisdiction of formation and is qualified and licensed to do business and is in good standing in any other jurisdiction in
which the conduct of its business or its ownership of property and other assets or business which it is engaged in requires that it be qualified except where the failure
to do so could not reasonably be expected to have a material adverse effect on Borrower’s business. In connection with this Agreement, each Borrower has delivered
to Agent and each Lender a completed certificate signed by such Borrower, entitled “Perfection Certificate” (collectively, the “Perfection Certificate”). Each
Borrower represents and warrants to Agent and each Lender that: (a) such Borrower’s exact legal name is that indicated on the Perfection Certificate and on the
signature page hereof; (b) such Borrower is an organization of the type and is organized or in incorporated in the jurisdiction set forth in the Perfection Certificate;
(c) the Perfection Certificate accurately sets forth Borrower’s organizational identification number or accurately states that Borrower has none; (d) the Perfection
Certificate accurately sets forth such Borrower’s place of business, or, if more than one, its chief executive office as well as such Borrower’s mailing address (if
different than its chief executive office); (e) except as indicated on the Perfection Certificate, such Borrower (and each of its predecessors) has not, in the past five (5)
years, changed its jurisdiction of formation, organizational structure or type, or any organizational number assigned by its jurisdiction; and (f) all other information
set forth on the Perfection Certificate pertaining to such Borrower and each of its Subsidiaries is accurate and complete in all material respects (it being understood
and agreed that Borrower may from time to time update certain information in the Perfection Certificate after the Effective Date to the extent permitted by one or
more specific provisions in this Agreement). If any Borrower is not now a Registered Organization but later becomes one, such Borrower shall promptly notify
Agent of such occurrence and provide Agent with such Borrower’s organizational identification number.
The execution, delivery and performance by Borrower of the Loan Documents to which it is a party have been duly authorized, and do not (i) conflict
with any of Borrower’s organizational documents, (ii) contravene, conflict with, constitute a default under or violate any material Requirement of Law, (iii)
contravene, conflict or violate any applicable order, writ, judgment, injunction, decree, determination or award of any Governmental Authority by which Borrower or
any of its Subsidiaries or any of their property or assets may be bound or affected, (iv) require any action by, filing, registration, or qualification with, or
Governmental Approval from, any Governmental Authority (except such Governmental Approvals which have already been obtained and are in full force and effect,
filings and registrations contemplated by this Agreement, the filing and registration of Debentures with the Israeli Registrar of Companies to be made on a post-
closing basis and approval from the Israeli Innovation Authority as described in Schedule 5.13) or (v) conflict with, contravene, constitute a default or breach under,
or result in or permit the termination or acceleration of, any material agreement by which Borrower is bound. Borrower is not in default under any agreement to
which it is a party or by which it is bound in which the default could reasonably be expected to have a material adverse effect on Borrower’s business.
5.2
Collateral. Borrower has good title to, rights in, and the power to transfer each item of the Collateral upon which it purports to
grant a Lien under this Agreement and under the Debentures and other Loan Documents, free and clear of any and all Liens except Permitted Liens. Borrower has
no Collateral Accounts at or with any bank or financial institution other than SVB or SVB’s Affiliates except for the Collateral Accounts described in the Perfection
Certificate delivered to Agent and each Lender in connection herewith and which US Borrower has given Agent notice and taken such actions as are necessary to
give Agent, for the ratable benefit of the Lenders, a perfected
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security interest therein, pursuant to the terms of Section 6.6(b). The Accounts are bona fide, existing obligations of the Account Debtors.
The Collateral is not in the possession of any third party bailee (such as a warehouse) except as otherwise provided in the Perfection Certificate. None
of the components of the Collateral shall be maintained at locations other than as provided in the Perfection Certificate or as permitted pursuant to Section 7.2.
All Inventory is in all material respects of good and marketable quality, free from material defects.
Borrower is the sole owner of the Intellectual Property which it owns or purports to own except for (a) non-exclusive licenses granted to its customers in
the ordinary course of business, (b) over-the-counter software that is commercially available to the public, and (c) material Intellectual Property licensed to Borrower
and noted on the Perfection Certificate. Each Patent which it owns or purports to own and which is material to Borrower’s business is valid and enforceable, and no
part of the Intellectual Property which Borrower owns or purports to own and which is material to Borrower’s business has been judged invalid or unenforceable, in
whole or in part. To the best of Borrower’s knowledge, no claim has been made that any part of the Intellectual Property violates the rights of any third party except
to the extent such claim would not reasonably be expected to have a material adverse effect on Borrower’s business. Except as noted on the Perfection Certificate,
Borrower is not a party to, nor is it bound by, any Restricted License.
5.3
Litigation. There are no actions or proceedings pending or, to the knowledge of any Responsible Officer, threatened in writing by
or against Borrower or any of its Subsidiaries reasonably expected to result in liability involving more than, individually or in the aggregate, Two Hundred Fifty
Thousand Dollars ($250,000.00).
5.4
Financial Statements; Financial Condition. All consolidated financial statements for Borrower and any of its Subsidiaries
delivered to Agent and the Lenders fairly present in all material respects Borrower’s consolidated financial condition and Borrower’s consolidated results of
operations. There has not been any material deterioration in Borrower’s consolidated financial condition since the date of the most recent financial statements
submitted to Agent and the Lenders.
5.5
Solvency. The fair salable value of Borrower’s consolidated assets (including goodwill minus disposition costs) exceeds the fair
value of Borrower’s liabilities; Borrower is not left with unreasonably small capital after the transactions in this Agreement; and Borrower is able to pay its debts
(including trade debts) as they mature.
5.6
Regulatory Compliance. Borrower is not an “investment company” or a company “controlled” by an “investment company”
under the Investment Company Act of 1940, as amended. Borrower is not engaged as one of its important activities in extending credit for margin stock (under
Regulations X, T and U of the Federal Reserve Board of Governors). Borrower (a) has complied in all material respects with all Requirements of Law, and (b) has
not violated any Requirements of Law the violation of which could reasonably be expected to have a material adverse effect on its business. None of Borrower’s or
any of its Subsidiaries’ properties or assets has been used by Borrower or any Subsidiary or, to the best of Borrower’s knowledge, by previous Persons, in disposing,
producing, storing, treating, or transporting any hazardous substance other than legally. Borrower and each of its Subsidiaries have obtained all consents, approvals
and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective
businesses as currently conducted.
5.7
Subsidiaries; Investments. Borrower does not own any stock, partnership, or other ownership interest or other equity securities
except for Permitted Investments.
5.8
Tax Returns and Payments; Pension Contributions. Borrower has timely filed all required tax returns and reports, and
Borrower has timely paid all foreign, federal, Israeli, state and local taxes, assessments, deposits and contributions owed by Borrower except (a) to the extent such
taxes are being contested in good faith by appropriate proceedings promptly instituted and diligently conducted, so long as such reserve or other appropriate
provision, if any, as shall be required in conformity with GAAP shall have been made therefor, or (b) if such taxes, assessments, deposits and contributions do not,
individually or in the aggregate, exceed Twenty-Five Thousand Dollars ($25,000.00).
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To the extent Borrower defers payment of any contested taxes, Borrower shall (i) notify Agent in writing of the commencement of, and any material
development in, the proceedings and (ii) post bonds or take any other steps required to prevent the Governmental Authority levying such contested taxes from
obtaining a Lien upon any of the Collateral that is other than a “Permitted Lien.” Borrower is unaware of any claims or adjustments proposed for any of Borrower’s
prior tax years which could result in additional taxes becoming due and payable by Borrower in excess of Twenty-Five Thousand Dollars ($25,000.00). Borrower
has paid all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with their terms, and Borrower has not
withdrawn from participation in, and has not permitted partial or complete termination of, or permitted the occurrence of any other event with respect to, any such
plan which could reasonably be expected to result in any liability of Borrower, including any liability to the Pension Benefit Guaranty Corporation or its successors
or any other governmental agency.
5.9
Use of Proceeds. Borrower shall use the proceeds of the Credit Extensions as working capital and to fund its general business
requirements and not for personal, family, household or agricultural purposes.
5.10
Full Disclosure. No written representation, warranty or other statement of Borrower in any certificate or written statement given
to Agent or any Lender in connection with the Loan Documents, or the transactions contemplated thereby, as of the date such representation, warranty, or other
statement was made, taken together with all such written certificates and written statements given to Agent or any Lender, contains any untrue statement of a material
fact or omits to state a material fact necessary to make the statements contained in the certificates or statements not misleading (it being recognized by Agent and
each Lender that the projections and forecasts provided by Borrower in good faith and based upon reasonable assumptions are not viewed as facts and that actual
results during the period or periods covered by such projections and forecasts may differ from the projected or forecasted results).
5.11
Definition of “Knowledge.” For purposes of the Loan Documents, whenever a representation or warranty is made to Borrower’s
knowledge or awareness, to the “best of” Borrower’s knowledge, or with a similar qualification, knowledge or awareness means the actual knowledge, after
reasonable investigation, of any Responsible Officer.
5.12
No Winding-Up. Borrower has not taken any corporate or other action nor has any application been made or any other steps been
taken or legal proceedings been started or (to the best of Borrower’s knowledge and belief having made due and proper enquiry) threatened in writing against
Borrower or any of its Subsidiaries for its winding-up or for the appointment of a liquidator, trustee, receiver, administrative receiver, administrator, examiner or
similar officer of it or of any or all of its assets.
5.13
The Israel Innovation Authority and Investment Center. As of the Effective Date, Borrower has not received any grants,
funds or benefits (including, but not limited to, tax benefits) from the IIA (formerly known as, the Office of Chief Scientist) or Investment Center, or the Binational
Industrial Research and Development Foundation or any other Governmental Authority except as provided in Schedule 5.13. Borrower is not obligated to pay any
royalties or any other payments to the IIA or Investment Center or the Binational Industrial Research and Development Foundation or any other Governmental
Authority, except as provided in Schedule 5.13. The transactions contemplated under this Agreement, the Debentures and any other Loan Document (including the
realization of the Charged Property) are not subject to any right and do not require the approval of the Israel Innovation Authority or Investment Center or the
Binational Industrial Research and Development Foundation or any other Governmental Authority, except as provided in Schedule 5.13.
6
AFFIRMATIVE COVENANTS
Borrower shall do all of the following:
6.1
Government Compliance.
formation and maintain qualification in each jurisdiction in which the failure to so qualify would
(a)
Maintain its and all its Subsidiaries’ legal existence and good standing in their respective jurisdictions of
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reasonably be expected to have a material adverse effect on Borrower’s business or operations. Borrower shall comply, and have each Subsidiary comply, in all
material respects, with all laws, ordinances and regulations to which it is subject.
Obtain all of the Governmental Approvals necessary for the performance by Borrower of its obligations under the
Loan Documents to which it is a party and the grant of a security interest to Agent, for the ratable benefit of the Lenders, in all of its property as provided hereunder
and under the Debentures. Borrower shall promptly provide copies of any such obtained Governmental Approvals to Agent.
(b)
6.2
Financial Statements, Reports, Certificates. Provide Agent and each Lender with the following:
Monthly Financial Statements. As soon as available, but no later than thirty (30) days after the last day of
each month, a company prepared consolidated balance sheet, and income statement covering Borrower’s consolidated operations for such month certified by a
Responsible Officer of US Borrower and in a form of presentation reasonably acceptable to Agent (the “Monthly Financial Statements”);
(a)
(b)
Monthly Compliance Certificate. Within thirty (30) days after the last day of each month and together with
the Monthly Financial Statements, a duly completed Compliance Certificate signed by a Responsible Officer, certifying that as of the end of such month, Borrower
was in full compliance with all of the terms and conditions of this Agreement, and setting forth calculations showing compliance with the financial covenants (if any)
set forth in this Agreement and such other information as Agent or the Lenders may reasonably request;
the Board and promptly following any Board approved updates or changes thereto, annual operating budgets and financial projections;
(c)
Board Projections. As soon as available, at least annually, but no later than thirty (30) days after approval by
(d)
Annual Audited Financial Statements. As soon as available, but no later than within one hundred eighty (180)
days after the last day of Borrower’s fiscal year, audited consolidated financial statements prepared under GAAP, consistently applied, together with an unqualified
opinion on the financial statements from an independent certified public accounting firm reasonably acceptable to Agent (it being understood and agreed that
Deloitte and any other public accounting firm of nationally recognized standing is acceptable to Agent);
available to Borrower’s security holders or to any holders of Subordinated Debt;
(e)
Other Statements. Within five (5) days of delivery, copies of all statements, reports and notices made
(f)
SEC Filings. In the event that Borrower becomes subject to the reporting requirements under the Exchange
Act, within five (5) days of filing, copies of all periodic and other reports, proxy statements and other materials filed by Borrower with the SEC, any Governmental
Authority succeeding to any or all of the functions of the SEC or with any national securities exchange, or distributed to its shareholders, as the case may
be. Documents required to be delivered pursuant to the terms hereof (to the extent any such documents are included in materials otherwise filed with the SEC) may
be delivered electronically and if so delivered, shall be deemed to have been delivered on the date on which Borrower posts such documents, or provides a link
thereto, on Borrower’s website on the internet at Borrower’s website address; provided, however, Borrower shall promptly notify Agent and the Lenders in writing
(which may be by electronic mail) of the posting of any such documents;
Legal Action Notice. A prompt report of any legal actions pending or threatened in writing against Borrower
or any of its Subsidiaries that would reasonably be expected to result in damages or costs to Borrower or any of its Subsidiaries of, individually or in the aggregate,
Two Hundred Fifty Thousand Dollars ($250,000.00) or more;
(g)
(h)
Additional Reporting Requirement. A written description of any changes to the beneficial ownership
information set out in Section 14 of the Perfection Certificate in the Compliance Certificate. Borrower understands and acknowledges that each Lender relies on
such true, accurate and up-to-date beneficial ownership information to meet such Lender’s regulatory obligations to obtain, verify and record information about the
beneficial owners of its legal entity customers; and
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(i)
Other Financial Information. Other financial information reasonably requested by Agent or any Lender.
Notwithstanding anything in this Section 6.2 to the contrary, any financial statement required to be furnished pursuant to Section 6.2(d), (e), (f) or (g) shall be
deemed to have been furnished on the date on which Borrower has filed such financial statement with the SEC and such financial statement is available on the
EDGAR website on the Internet at www.sec.gov or any successor government website that is freely and readily available to Agent without charge.
6.3
Taxes; Pensions. (i) Timely file, and require each of its Subsidiaries to timely file, all required tax returns and reports and timely
pay, and require each of its Subsidiaries to timely pay, all foreign, federal, state and local taxes, assessments, deposits and contributions owed by Borrower and each
of its Subsidiaries, except for (x) deferred payment of any taxes contested pursuant to the terms of Section 5.8 hereof, and shall deliver to Agent, on demand,
appropriate certificates attesting to such payments, or (y) such taxes, assessments, deposits and contributions that do not, individually or in the aggregate, exceed
Twenty-Five Thousand Dollars ($25,000.00), and (ii) pay all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in
accordance with their terms.
6.4
Inventory; Returns. Keep all Inventory in good and marketable condition, free from material defects. Returns and allowances
between Borrower and its Account Debtors shall follow Borrower’s customary practices as they exist at the Effective Date. Borrower must promptly notify Agent
and the Lenders of all returns, recoveries, disputes and claims that involve more than One Hundred Thousand Dollars ($100,000.00).
6.5
Insurance.
(a)
Keep its business and the Collateral insured for risks and in amounts standard for companies in Borrower’s
industry and location and as Agent may reasonably request. Insurance policies shall be in a form, with financially sound and reputable insurance companies that are
not Affiliates of Borrower, and in amounts that are satisfactory to Agent. All property policies shall have a lender’s loss payable endorsement showing Agent as the
sole lender loss payee. All liability policies shall show, or have endorsements showing, Agent as an additional insured. Agent shall be named as lender loss payee
and/or additional insured with respect to any such insurance providing coverage in respect of any Collateral.
(b)
Ensure that proceeds payable under any property policy are, at Agent’s option, payable to Agent for the
ratable benefit of the Lenders on account of the Obligations.
(c)
At Agent’s request, Borrower shall deliver certified copies of insurance policies and evidence of all premium
payments. Each provider of any such insurance required under this Section 6.5 shall agree, by endorsement upon the policy or policies issued by it or by independent
instruments furnished to Agent, that it will give Agent thirty (30) days prior written notice before any such policy or policies shall be materially altered or
canceled. With respect to any insurance policy of ISR Borrower, Agent shall be designated as a “Motav” in the meaning and for the purposes of the Israeli Insurance
Contract Law 5741-1981. If Borrower fails to obtain insurance as required under this Section 6.5 or to pay any amount or furnish any required proof of payment to
third persons and Agent, Agent may make all or part of such payment or obtain such insurance policies required in this Section 6.5, and take any action under the
policies Agent deems prudent.
6.6
Operating Accounts.
Maintain all of Borrower’s and all of its Subsidiaries’ operating, depository and securities/investment
accounts with SVB and SVB’s Affiliates. Notwithstanding the foregoing, ISR Borrower may maintain accounts with financial institutions in Israel, provided that,
after the Transition Period, the maximum aggregate balance in all such accounts together shall not at any time exceed Two Million Dollars ($2,000,000.00).
(a)
Provide Agent five (5) days prior written notice before establishing any Collateral Account at or with any
bank or financial institution other than SVB or SVB’s Affiliates. Borrower shall indicate in the Compliance Certificate provided to Agent in accordance with Section
6.2(b) above any deposit or securities account it holds at or with any bank or financial institution other than SVB or SVB’s Affiliates and the aggregate value of
(b)
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deposits and/or securities in any such account. In addition, for each account that the Lenders in their sole discretion permit Borrower at any time to open or maintain
(other than accounts at SVB), Borrower shall cause the applicable bank or financial institution (other than SVB) at or with which any such Collateral Account is
opened or maintained to execute and deliver a Control Agreement or other appropriate instrument with respect to such Collateral Account to perfect Agent’s Lien in
such Collateral Account in accordance with the terms hereunder, which Control Agreement may not be terminated without the prior written consent of the
Lenders. The provisions of the previous sentence shall not apply to (a) ISR Borrower’s accounts at Bank and other financial institutions in Israel, subject to the
provisions of Section 6.6(a) above, and (b) deposit accounts exclusively used for payroll, payroll taxes and other employee wage and benefit payments to or for the
benefit of Borrower’s employees and identified to Agent and the Lenders by Borrower as such.
6.7
Protection of Intellectual Property Rights.
(a)
(i) Protect, defend and maintain the validity and enforceability of any Intellectual Property material to
Borrower’s business; (ii) promptly advise Agent in writing of material infringements or any other event that could reasonably be expected to materially and adversely
affect the value of its Intellectual Property material to Borrower’s business; and (iii) not allow any Intellectual Property material to Borrower’s business to be
abandoned, forfeited or dedicated to the public without Agent’s written consent.
(b)
Provide written notice to Agent within ten (10) days of entering or becoming bound by any Restricted License
(other than over-the-counter software that is commercially available to the public). Borrower shall take such commercially reasonable steps as Agent reasonably
requests to obtain the consent of, or waiver by, any person whose consent or waiver is necessary for (i) any Restricted License to be deemed “Collateral” and for
Agent to have a security interest in it that might otherwise be restricted or prohibited by law or by the terms of any such Restricted License, whether now existing or
entered into in the future, and (ii) Agent to have the ability in the event of a liquidation of any Collateral to dispose of such Collateral in accordance with Agent’s and
the Lenders’ rights and remedies under this Agreement (subject to the terms of Section 9.1 hereof) and the other Loan Documents.
6.8
Litigation Cooperation. From the date hereof and continuing through the termination of this Agreement, make available to
Agent, without expense to Agent or any Lender, Borrower and its officers, employees and agents and Borrower’s books and records, to the extent that Agent and/or
the Lenders may deem them reasonably necessary to prosecute or defend any third-party suit or proceeding instituted by or against Agent and/or any Lender with
respect to any Collateral or relating to Borrower.
6.9
Access to Collateral; Books and Records. Allow Agent or its agents, at reasonable times, on five (5) Business Days’ notice
(provided no notice is required if an Event of Default has occurred and is continuing), to inspect the Collateral and audit and copy Borrower’s Books. Such
inspections or audits shall be conducted no more often than once every twelve (12) months unless an Event of Default has occurred and is continuing in which case
such inspections and audits shall occur as often as Agent shall determine is necessary. The foregoing inspections and audits shall be at Borrower’s expense and the
charge therefor shall be Two Thousand Dollars ($2,000.00) per person per day (or such higher amount as shall represent Agent’s then-current standard charge for the
same), plus reasonable out-of-pocket expenses. In the event Borrower and Agent schedule an audit more than eight (8) days in advance, and Borrower cancels or
reschedules the audit with less than eight (8) days written notice to Agent, then (without limiting any of Agent’s or any Lender’s rights or remedies) Borrower shall
pay Agent a fee of Two Thousand Dollars ($2,000.00) plus any out-of-pocket expenses incurred by Agent to compensate Agent for the anticipated costs and
expenses of the cancellation or rescheduling.
6.10
Further Assurances. Execute any further instruments and take further action as Agent and the Lenders reasonably request to
perfect or continue Agent’s Lien in the Collateral or to effect the purposes of this Agreement. Deliver to Agent and the Lenders, within five (5) days after the same
are sent or received, copies of all correspondence, reports, documents and other filings with any Governmental Authority regarding compliance with or maintenance
of Governmental Approvals or Requirements of Law or that could reasonably be expected to have a material effect on any of the Governmental Approvals or
otherwise on the operations of Borrower or any of its Subsidiaries.
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6.11
Grants. Obtain the prior written consent of Agent and the Lenders (not to be unreasonably withheld) before receiving any grants,
funds or benefits, or filing for an application to receive funding from the IIA or the Investment Center or the Binational Industrial Research and Development
Foundation or any other Governmental Authority.
6.12
Post-Closing Deliverable. Deliver to Agent, in form and substance satisfactory to Agent and the Lenders, (a) within forty-five
(45) days after the Effective Date, written approval from the IIA with respect to the creation of the security interest by ISR Borrower over Intellectual Property with
respect which grants from the Israeli Innovation Authority were received in favor of Agent and (b) within thirty (30) days after the Effective Date, evidence
satisfactory to Agent that the insurance policies and endorsements required by Section 6.5 hereof are in full force and effect with respect to ISR Borrower.
7
NEGATIVE COVENANTS
Borrower shall not do any of the following without the prior written consent of the Lenders:
7.1
Dispositions. Convey, sell, lease, transfer, assign, or otherwise dispose of (collectively a “Transfer”), or permit any of its
Subsidiaries to Transfer, all or any part of its business or property, except for Transfers (a) of Inventory in the ordinary course of business; (b) of worn-out or obsolete
Equipment that is, in the reasonable judgment of Borrower, no longer economically practicable to maintain or useful in the ordinary course of business of Borrower;
or (c) consisting of Permitted Liens and Permitted Investments.
7.2
Changes in Business, Management, Control, or Business Locations. (a) Engage in or permit any of its Subsidiaries to engage in
any business other than the businesses currently engaged in by Borrower and such Subsidiary, as applicable, or reasonably related thereto; (b) liquidate or dissolve;
(c) fail to provide notice to Agent and Lenders of any Key Person departing from or ceasing to be employed by Borrower within ten (10) Business Days after such
Key Person’s departure from Borrower; or (d) permit or suffer any Change in Control.
Borrower shall not, without at least ten (10) days prior written notice to Agent: (1) add any new offices or business locations, including warehouses
(unless such new offices or business locations contain less than One Hundred Thousand Dollars ($100,000.00) in Borrower’s assets or property) or deliver any
portion of the Collateral valued, individually or in the aggregate, in excess of One Hundred Thousand Dollars ($100,000.00) to a bailee at a location other than to a
bailee and at a location already disclosed in the Perfection Certificate, (2) change its jurisdiction of organization, (3) change its organizational structure or type, (4)
change its legal name, or (5) change any organizational number (if any) assigned by its jurisdiction of organization. If Borrower intends to add any new offices or
business locations, including warehouses, containing in excess of One Hundred Thousand Dollars ($100,000.00) of Borrower’s assets or property, then Borrower will
cause the landlord of any such new offices or business locations, including warehouses, to execute and deliver a landlord consent in form and substance satisfactory
to Agent. If Borrower intends to deliver any portion of the Collateral valued, individually or in the aggregate, in excess of One Hundred Thousand Dollars
($100,000.00) to a bailee, and Agent and such bailee are not already parties to a bailee agreement governing both the Collateral and the location to which Borrower
intends to deliver the Collateral, then Borrower will cause such bailee to execute and deliver a bailee agreement in form and substance reasonably satisfactory to
Agent.
7.3
Mergers or Acquisitions. Merge or consolidate, or permit any of its Subsidiaries to merge or consolidate, with any other Person,
or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock or property of another Person (including, without limitation, by the
formation of any Subsidiary). A Subsidiary may merge or consolidate into another Subsidiary or into Borrower.
7.4
Indebtedness. Create, incur, assume, or be liable for any Indebtedness, or permit any Subsidiary to do so, other than Permitted
Indebtedness.
7.5
Encumbrance. Create, incur, allow, or suffer any Lien on any of its property, or assign or convey any right to receive income,
including the sale of any Accounts, or permit any of its Subsidiaries to do so, except for Permitted Liens, permit any Collateral not to be subject to the first priority
security interest granted herein or the charges granted under the Debentures, or enter into any agreement, document, instrument or other arrangement (except
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with or in favor of Agent, for the ratable benefit of the Lenders) with any Person which directly or indirectly prohibits or has the effect of prohibiting Borrower or
any Subsidiary from assigning, mortgaging, pledging, granting a security interest in or upon, or encumbering any of Borrower’s or any Subsidiary’s Intellectual
Property, except as is otherwise permitted in Section 7.1 hereof and the definition of “Permitted Liens” herein.
7.6
Maintenance of Collateral Accounts. Maintain any Collateral Account except pursuant to the terms of Section 6.6(b) hereof.
7.7
Distributions; Investments. (a) Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital
stock, provided that (i) Borrower may make payments in cash for any fractional units in connection with the exercise or conversion of warrants or other securities in
an amount not to exceed Fifty Thousand Dollars ($50,000.00) per fiscal year, (ii) ISR Borrower and any other Subsidiary may make dividends or distributions to US
Borrower, and (iii) Borrower may repurchase the stock of former employees, officers, directors or consultants pursuant to stock repurchase agreements so long as an
Event of Default does not exist at the time of such repurchase and would not exist after giving effect to such repurchase, provided that the aggregate amount of all
such repurchases does not exceed One Hundred Fifty Thousand Dollars ($150,000.00) per fiscal year; or (b) directly or indirectly make any Investment (including,
without limitation, by the formation of any Subsidiary) other than Permitted Investments, or permit any of its Subsidiaries to do so.
7.8
Transactions with Affiliates. Directly or indirectly enter into or permit to exist any material transaction with any Affiliate of
Borrower, except for transactions that are in the ordinary course of Borrower’s business, upon fair and reasonable terms that are no less favorable to Borrower than
would be obtained in an arm’s length transaction with a non-affiliated Person.
7.9
Subordinated Debt. (a) Make or permit any payment on any Subordinated Debt, except under the terms of the subordination,
intercreditor, or other similar agreement to which such Subordinated Debt is subject, or (b) amend any provision in any document relating to the Subordinated Debt
which would increase the amount thereof, provide for earlier or greater principal, interest, or other payments thereon, or adversely affect the subordination thereof to
Obligations owed to Agent and the Lenders.
7.10
Compliance. Become an “investment company” or a company controlled by an “investment company”, under the Investment
Company Act of 1940, as amended, or undertake as one of its important activities extending credit to purchase or carry margin stock (as defined in Regulation U of
the Board of Governors of the Federal Reserve System), or use the proceeds of any Credit Extension for that purpose; fail to (a) meet the minimum funding
requirements of ERISA, (b) prevent a Reportable Event or Prohibited Transaction, as defined in ERISA, from occurring, or (c) comply with the Federal Fair Labor
Standards Act, the failure of any of the conditions described in clauses (a) through (c) which could reasonably be expected to have a material adverse effect on
Borrower’s business; or violate any other law or regulation, if the violation could reasonably be expected to have a material adverse effect on Borrower’s business, or
permit any of its Subsidiaries to do so; withdraw or permit any Subsidiary to withdraw from participation in, permit partial or complete termination of, or permit the
occurrence of any other event with respect to, any present pension, profit sharing and deferred compensation plan which could reasonably be expected to result in
any liability of Borrower, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other governmental agency.
8
EVENTS OF DEFAULT
Any one of the following shall constitute an event of default (an “Event of Default”) under this Agreement:
8.1
Payment Default. Borrower fails to (a) make any payment of principal or interest on any Credit Extension when due, or (b) pay
any other Obligations within three (3) Business Days after such Obligations are due and payable (which three (3) Business Day cure period shall not apply to
payments due on the Term Loan Maturity Date). During the cure period, the failure to make or pay any payment specified under clause (b) hereunder is not an Event
of Default (but no Credit Extension will be made during the cure period);
8.2
Covenant Default.
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(a) Borrower fails or neglects to perform any obligation in Sections 6.2, 6.3, 6.4, 6.5, 6.6, 6.7(b), 6.11, or 6.12, or violates any covenant in Section 7; or
(b) Borrower fails or neglects to perform, keep, or observe any other term, provision, condition, covenant or agreement contained in this Agreement or
any Loan Documents, and as to any default (other than those specified in this Section 8) under such other term, provision, condition, covenant or agreement that can
be cured, has failed to cure the default within ten (10) days after the occurrence thereof; provided, however, that if the default cannot by its nature be cured within the
ten (10) day period or cannot after diligent attempts by Borrower be cured within such ten (10) day period, and such default is likely to be cured within a reasonable
time, then Borrower shall have an additional period (which shall not in any case exceed thirty (30) days) to attempt to cure such default, and within such reasonable
time period the failure to cure the default shall not be deemed an Event of Default (but no Credit Extensions shall be made during such cure period). Cure periods
provided under this section shall not apply, among other things, to financial covenants or any other covenants set forth in clause (a) above;
8.3
8.4
Material Adverse Change. A Material Adverse Change occurs;
Attachment; Levy; Restraint on Business.
(a)
(i) The service of process seeking to attach, by trustee or similar process, any funds of Borrower or of any
entity under the control of Borrower (including a Subsidiary), or (ii) a notice of lien or levy is filed against any of Borrower’s assets by any Governmental Authority,
and the same under subclauses (i) and (ii) hereof are not, within ten (10) days after the occurrence thereof, discharged or stayed (whether through the posting of a
bond or otherwise); provided, however, no Credit Extensions shall be made during any ten (10) day cure period; or
trustee or receiver, or (ii) any court order enjoins, restrains, or prevents Borrower from conducting all or any material part of its business;
(b)
(i) any material portion of Borrower’s assets is attached, seized, levied on, or comes into possession of a
8.5
Insolvency. (a) Borrower is unable to pay its debts (including trade debts) as they become due or otherwise becomes insolvent;
(b) Borrower begins an Insolvency Proceeding; or (c) an Insolvency Proceeding is begun against Borrower and is not dismissed or stayed within forty-five (45) days
(but no Credit Extensions shall be made while any of the conditions described in clause (a) exist and/or until any Insolvency Proceeding is dismissed);
8.6
Other Agreements. There is, under any agreement to which Borrower is a party with a third party or parties, (a) any default
resulting in a right by such third party or parties, whether or not exercised, to accelerate the maturity of any Indebtedness in an amount individually or in the
aggregate in excess of Two Hundred Fifty Thousand Dollars ($250,000.00); or (b) any breach or default by Borrower, the result of which could reasonably be
expected to have a material adverse effect on Borrower’s business;
8.7
Judgments; Penalties. One or more fines, penalties, or final judgments, orders or decrees for the payment of money in an amount,
individually or in the aggregate, of at least Two Hundred Fifty Thousand Dollars ($250,000.00) (not covered by independent third-party insurance as to which
liability has been accepted by such insurance carrier) shall be rendered against Borrower by any Governmental Authority, and the same are not, within ten (10) days
after the entry, assessment or issuance thereof, discharged, satisfied, or paid, or after execution thereof, stayed or bonded pending appeal, or such judgments are not
discharged prior to the expiration of any such stay (provided that no Credit Extensions will be made prior to the satisfaction, payment, discharge, stay, or bonding of
such fine, penalty, judgment, order or decree);
8.8
Misrepresentations. Borrower or any Person acting for Borrower makes any representation, warranty, or other statement now or
later in this Agreement, any Loan Document or in any writing delivered to Agent or any Lender or to induce Agent or any Lender to enter this Agreement or any
Loan Document, and such representation, warranty, or other statement is incorrect in any material respect when made;
8.9
Subordinated Debt. Any document, instrument, or agreement evidencing any Subordinated Debt shall for any reason be revoked
or invalidated or otherwise cease to be in full force and effect, any Person shall be in
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breach thereof or contest in any manner the validity or enforceability thereof or deny that it has any further liability or obligation thereunder, or the Obligations shall
for any reason be subordinated or shall not have the priority contemplated by this Agreement; or
8.10
Governmental Approvals. Any Governmental Approval shall have been (a) revoked, rescinded, suspended, modified in an
adverse manner or not renewed in the ordinary course for a full term or (b) subject to any decision by a Governmental Authority that designates a hearing with
respect to any applications for renewal of any of such Governmental Approval or that could result in the Governmental Authority taking any of the actions described
in clause (a) above, and such decision or such revocation, rescission, suspension, modification or non-renewal (i) cause, or could reasonably be expected to cause, a
Material Adverse Change, or (ii) adversely affects the legal qualifications of Borrower or any of its Subsidiaries to hold such Governmental Approval in any
applicable jurisdiction and such revocation, rescission, suspension, modification or non-renewal could reasonably be expected to affect the status of or legal
qualifications of Borrower or any of its Subsidiaries to hold any Governmental Approval in any other jurisdiction.
9
RIGHTS AND REMEDIES
9.1
Rights and Remedies. Upon the occurrence and during the continuance of an Event of Default, Agent, in accordance with the
Lender Intercreditor Agreement or, if such rights and remedies are not addressed in the Lender Intercreditor Agreement, as directed by a majority of the Lenders,
may, without notice or demand, do any or all of the following:
occurs all Obligations are immediately due and payable without any action by Agent or any Lender);
(a)
declare all Obligations immediately due and payable (but if an Event of Default described in Section 8.5
(b)
agreement among Borrower, Agent and/or any Lenders;
stop advancing money or extending credit for Borrower’s benefit under this Agreement or under any other
(c)
demand that Borrower (i) deposit cash with SVB in an amount equal to at least (x) one hundred five percent
(105.0%) of the Dollar Equivalent of the aggregate face amount of all Letters of Credit denominated in Dollars remaining undrawn, and (y) one hundred ten percent
(110.0%) of the Dollar Equivalent of the aggregate face amount of all Letters of Credit denominated in a Foreign Currency remaining undrawn (plus, in each case, all
interest, fees, and costs due or to become due in connection therewith (as estimated by SVB in its good faith business judgment)), to secure all of the Obligations
relating to such Letters of Credit, as collateral security for the repayment of any future drawings under such Letters of Credit, and Borrower shall forthwith deposit
and pay such amounts, and (ii) pay in advance all letter of credit fees scheduled to be paid or payable over the remaining term of any Letters of Credit;
(d)
terminate any FX Contracts;
verify the amount of, demand payment of and performance under, and collect any Accounts and General
Intangibles, settle or adjust disputes and claims directly with Account Debtors for amounts on terms and in any order that Agent and/or the Lenders consider
advisable, and notify any Person owing Borrower money of Agent’s security interest in such funds;
(e)
(f)
make any payments and do any acts Agent or any Lender considers necessary or reasonable to protect the
Collateral and/or its security interest in the Collateral. Borrower shall assemble the Collateral if Agent requests and make it available as Agent designates. Agent
may enter premises where the Collateral is located, take and maintain possession of any part of the Collateral, and pay, purchase, contest, or compromise any Lien
which appears to be prior or superior to its security interest or charges and pay all expenses incurred. Borrower grants Agent a license to enter and occupy any of its
premises, without charge, to exercise any of Agent’s rights or remedies;
(g)
owing to or for the credit or the account of Borrower;
apply to the Obligations (i) any balances and deposits of Borrower it holds, or (ii) any amount held by Agent
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(h)
ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise for sale, and sell the
Collateral. Agent, for the benefit of the Lenders, is hereby granted a non-exclusive, royalty-free license or other right to use, without charge, Borrower’s labels,
Patents, Copyrights, mask works, rights of use of any name, trade secrets, trade names, Trademarks, and advertising matter, or any similar property as it pertains to
the Collateral, in completing production of, advertising for sale, and selling any Collateral and, in connection with Agent’s exercise of its rights under this Section,
Borrower’s rights under all licenses and all franchise agreements inure to Agent, for the ratable benefit of the Lenders;
any entitlement order, or other directions or instructions pursuant to any Control Agreement or similar agreements providing control of any Collateral;
(i)
place a “hold” on any account maintained with Agent or Lenders and/or deliver a notice of exclusive control,
(j)
demand and receive possession of Borrower’s Books; and
exercise all rights and remedies available to Agent and the Lenders under the Loan Documents or at law or
equity, including all remedies provided under the Code (including disposal of the Collateral pursuant to the terms thereof) or any other applicable law, including
realization of securities and the exercise of all of Agent’s and any Lender’s rights and remedies with respect to the Debentures..
(k)
9.2
Power of Attorney. Borrower hereby irrevocably appoints Agent, for the benefit of the Lenders, as its lawful attorney-in-fact,
exercisable upon the occurrence and during the continuance of an Event of Default, to: (a) endorse Borrower’s name on any checks or other forms of payment or
security; (b) sign Borrower’s name on any invoice or bill of lading for any Account or drafts against Account Debtors; (c) settle and adjust disputes and claims about
the Accounts directly with Account Debtors, for amounts and on terms Agent determines reasonable; (d) make, settle, and adjust all claims under Borrower’s
insurance policies; (e) pay, contest or settle any Lien, charge, encumbrance, security interest, and adverse claim in or to the Collateral, or any judgment based
thereon, or otherwise take any action to terminate or discharge the same; and (f) transfer the Collateral into the name of Agent or a third party as the Code permits.
Borrower hereby appoints Agent as its lawful attorney-in-fact to sign Borrower’s name on any documents necessary to perfect or continue the perfection of Agent’s
security interest in the Collateral regardless of whether an Event of Default has occurred until all Obligations have been satisfied in full and Lenders are under no
further obligation to make Credit Extensions hereunder. Agent’s foregoing appointment as Borrower’s attorney in fact, and all of Agent’s rights and powers, coupled
with an interest, are irrevocable until all Obligations have been fully repaid and performed and each Lender’s obligation to provide Credit Extensions terminates.
9.3
Protective Payments. If Borrower fails to obtain the insurance called for by Section 6.5 or fails to pay any premium thereon or
fails to pay any other amount which Borrower is obligated to pay under this Agreement or any other Loan Document or which may be required to preserve the
Collateral, Agent may obtain such insurance or make such payment, and all amounts so paid by Agent are Lenders’ Expenses and immediately due and payable,
bearing interest at the then highest rate applicable to the Obligations, and secured by the Collateral. Agent will make reasonable efforts to provide Borrower with
notice of Agent obtaining such insurance at the time it is obtained or within a reasonable time thereafter. No payments by Agent are deemed an agreement to make
similar payments in the future or Agent’s or and Lender’s waiver of any Event of Default.
9.4
Application of Payments and Proceeds Upon Default. If an Event of Default has occurred and is continuing, Agent shall have
the right to apply in any order any funds in its possession, whether from Borrower account balances, payments, proceeds realized as the result of any collection of
Accounts or other disposition of the Collateral, or otherwise, to the Obligations. Agent shall pay any surplus to Borrower by credit to the Designated Deposit
Account or to other Persons legally entitled thereto; Borrower shall remain liable to Agent and the Lenders for any deficiency. If Agent, directly or indirectly, enters
into a deferred payment or other credit transaction with any purchaser at any sale of Collateral, Agent shall have the option, exercisable at any time, of either
reducing the Obligations by the principal amount of the purchase price or deferring the reduction of the Obligations until the actual receipt by Agent of cash therefor.
9.5
Liability for Collateral. So long as Agent and Lenders comply with reasonable banking practices regarding the safekeeping of the
Collateral in their possession or under the control of Agent and/or Lenders, Agent and Lenders shall not be liable or responsible for: (a) the safekeeping of the
Collateral; (b) any loss or damage to the
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Collateral; (c) any diminution in the value of the Collateral; or (d) any act or default of any carrier, warehouseman, bailee, or other Person. Borrower bears all risk of
loss, damage or destruction of the Collateral.
9.6
No Waiver; Remedies Cumulative. Agent’s and any Lender’s failure, at any time or times, to require strict performance by
Borrower of any provision of this Agreement or any other Loan Document shall not waive, affect, or diminish any right of Agent or any Lender thereafter to demand
strict performance and compliance herewith or therewith. No waiver hereunder shall be effective unless signed by the party granting the waiver and then is only
effective for the specific instance and purpose for which it is given. Agent’s and each Lender’s rights and remedies under this Agreement and the other Loan
Documents are cumulative. Agent and each Lender have all rights and remedies provided under the Code, by law, or in equity. Agent’s or any Lender’s exercise of
one right or remedy is not an election and shall not preclude Agent or any Lender from exercising any other remedy under this Agreement or any other Loan
Document or other remedy available at law or in equity, and Agent’s or any Lender’s waiver of any Event of Default is not a continuing waiver. Agent’s or any
Lender’s delay in exercising any remedy is not a waiver, election, or acquiescence.
9.7
Demand Waiver. Borrower waives demand, notice of default or dishonor, notice of payment and nonpayment, notice of any
default, nonpayment at maturity, release, compromise, settlement, extension, or renewal of accounts, documents, instruments, chattel paper, and guarantees held by
Agent on which Borrower is liable.
9.8
Borrower Liability. Each Borrower may, acting singly, request Credit Extensions hereunder. Each Borrower hereby appoints the
other as agent for the other for all purposes hereunder, including with respect to requesting Credit Extensions hereunder. Each Borrower hereunder shall be jointly
and severally obligated to repay all Credit Extensions made hereunder, regardless of which Borrower actually receives said Credit Extensions, as if each Borrower
hereunder directly received all Credit Extensions. Each Borrower waives (a) any suretyship defenses available to it under the Code or any other applicable law and
(b) any right to require Agent or Lenders to: (i) proceed against any Borrower or any other person; (ii) proceed against or exhaust any security; or (iii) pursue any
other remedy. Agent and the Lenders may exercise or not exercise any right or remedy each has against any Borrower or any security it holds (including the right to
foreclose or realize its security by judicial or non-judicial sale) without affecting any Borrower’s liability. Notwithstanding any other provision of this Agreement or
other related document, each Borrower irrevocably waives all rights that it may have at law or in equity (including, without limitation, any law subrogating Borrower
to the rights of Agent or the Lenders under this Agreement) to seek contribution, indemnification or any other form of reimbursement from any other Borrower, or
any other Person now or hereafter primarily or secondarily liable for any of the Obligations, for any payment made by Borrower with respect to the Obligations in
connection with this Agreement or otherwise and all rights that it might have to benefit from, or to participate in, any security for the Obligations as a result of any
payment made by Borrower with respect to the Obligations in connection with this Agreement or otherwise. Any agreement providing for indemnification,
reimbursement or any other arrangement prohibited under this Section shall be null and void. If any payment is made to a Borrower in contravention of this Section,
such Borrower shall hold such payment in trust for Agent and such payment shall be promptly delivered to Agent for application to the Obligations, whether matured
or unmatured.
AGENT
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10.1
Appointment and Authority.
Each Lender hereby irrevocably appoints SVB to act on its behalf as Agent hereunder and under the other Loan
Documents and authorizes Agent to take such actions on its behalf and to exercise such powers as are delegated to Agent by the terms hereof or thereof, together
with such actions and powers as are reasonably incidental thereto.
(a)
(b)
The provisions of this Section 10 are solely for the benefit of Agent and Lenders, and Borrower shall not have rights as
a third party beneficiary of any of such provisions. Notwithstanding any provision to the contrary elsewhere in this Agreement, Agent shall not have any duties or
responsibilities to any Lender or any other Person, except those expressly set forth herein, or any fiduciary relationship with any Lender, and no implied covenants,
functions, responsibilities, duties, obligations or liabilities shall be read into this Agreement or any other Loan Document or otherwise exist against Agent.
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10.2
Delegation of Duties. Agent may perform any and all of its duties and exercise its rights and powers hereunder or under any
other Loan Document by or through any one or more sub-agents appointed by Agent. Agent and any such sub-agent may perform any and all of its duties and
exercise its rights and powers by or through their respective Indemnified Persons. The exculpatory provisions of this Section 10.2 shall apply to any such sub-agent
and to the Indemnified Persons of Agent and any such sub-agent, and shall apply to their respective activities in connection with the syndication of the credit
facilities provided for herein as well as activities as Agent.
10.3
Exculpatory Provisions. Agent shall have no duties or obligations except those expressly set forth herein and in the other Loan
Documents. Without limiting the generality of the foregoing, Agent shall not:
(a)
occurred and is continuing;
be subject to any fiduciary, trust, agency or other similar duties, regardless of whether any Event of Default has
(b)
have any duty to take any discretionary action or exercise any discretionary powers, except discretionary rights and
powers expressly contemplated hereby or by the other Loan Documents that Agent is required to exercise as directed in writing by the Lenders, as applicable;
provided that Agent shall not be required to take any action that, in its opinion or the opinion of its counsel, may expose Agent to liability or that is contrary to any
Loan Document or applicable law; and
except as expressly set forth herein and in the other Loan Documents, have any duty to disclose, and Agent shall not be
liable for the failure to disclose, any information relating to Borrower or any of its Affiliates that is communicated to or obtained by any Person serving as Agent or
any of its Affiliates in any capacity.
(c)
Agent shall not be liable for any action taken or not taken by it (i) with the consent or at the request of the Lenders (or as Agent shall believe in good
faith shall be necessary, under the circumstances as provided in Section 13.7) or (ii) in the absence of its own gross negligence or willful misconduct.
Agent shall not be responsible for or have any duty to ascertain or inquire into (i) any statement, warranty or representation made in or in connection
with this Agreement or any other Loan Document, (ii) the contents of any certificate, report or other document delivered hereunder or thereunder or in connection
herewith or therewith, (iii) the performance or observance of any of the covenants, agreements or other terms or conditions set forth herein or therein or the
occurrence of any Event of Default, (iv) the validity, enforceability, effectiveness or genuineness of this Agreement, any other Loan Document or any other
agreement, instrument or document or (v) the satisfaction of any condition set forth in Section 3 or elsewhere herein, other than to confirm receipt of items expressly
required to be delivered to Agent.
10.4
Reliance by Agent. Agent shall be entitled to rely upon, and shall not incur any liability for relying upon, any notice, request,
certificate, consent, statement, instrument, document or other writing (including any electronic message, internet or intranet website posting or other distribution)
believed by it to be genuine and to have been signed, sent or otherwise authenticated by the proper Person. Agent also may rely upon any statement made to it orally
or by telephone and believed by it to have been made by the proper Person, and shall not incur any liability for relying thereon. Agent may consult with legal
counsel (who may be counsel for Borrower), independent accountants and other experts selected by it, and shall not be liable for any action taken or not taken by it in
accordance with the advice of any such counsel, accountants or experts. In determining compliance with any condition hereunder to the making of a Credit
Extension that, by its terms, must be fulfilled to the satisfaction of a Lender, Agent may presume that such condition is satisfactory to such Lender unless Agent shall
have received notice to the contrary from such Lender prior to the making of such Credit Extension. Agent shall in all cases be fully protected in acting, or in
refraining from acting, under this Agreement and the other Loan Documents in accordance with a request of the Lenders, and such request and any action taken or
failure to act pursuant thereto shall be binding upon Lenders and all future holders of the Credit Extensions.
10.5
Notice of Default. Agent shall not be deemed to have knowledge or notice of the occurrence of any Event of Default (except
with respect to defaults in the payment of principal, interest or fees required to be paid to Agent for the account of Lenders), unless Agent has received notice from a
Lender or Borrower referring to this Agreement, describing such Event of Default and stating that such notice is a “notice of default”. In the event that
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Agent receives such a notice, Agent shall give notice thereof to Lenders. Agent shall take such action with respect to such Event of Default as shall be reasonably
directed by the Lenders.
10.6
Non-Reliance on Agent and Other Lenders. Each Lender expressly acknowledges that neither Agent nor any of its officers,
directors, employees, agents, attorneys in fact or affiliates has made any representations or warranties to it and that no act by Agent hereafter taken, including any
review of the affairs of a Group Member or any Affiliate of a Group Member, shall be deemed to constitute any representation or warranty by Agent to any
Lender. Each Lender represents to Agent that it has, independently and without reliance upon Agent or any other Lender, and based on such documents and
information as it has deemed appropriate, made its own appraisal of, and investigation into, the business, operations, property, financial and other condition and
creditworthiness of the Group Members and their Affiliates and made its own decision to make its Credit Extensions hereunder and enter into this Agreement. Each
Lender also represents that it will, independently and without reliance upon Agent or any other Lender, and based on such documents and information as it shall
deem appropriate at the time, continue to make its own credit analysis, appraisals and decisions in taking or not taking action under this Agreement and the other
Loan Documents, and to make such investigation as it deems necessary to inform itself as to the business, operations, property, financial and other condition and
creditworthiness of the Group Members and their Affiliates. Except for notices, reports and other documents expressly required to be furnished to Lenders by Agent
hereunder, Agent shall have no duty or responsibility to provide any Lender with any credit or other information concerning the business, operations, property,
condition (financial or otherwise), prospects or creditworthiness of any Group Member or any Affiliate of a Group Member that may come into the possession of
Agent or any of its officers, directors, employees, agents, attorneys in fact or Affiliates.
10.7
Indemnification. Each Lender agrees to indemnify Agent in its capacity as such (to the extent not reimbursed by Borrower and
without limiting the obligation of Borrower to do so in accordance with the terms hereof, according to its Term Loan Commitment Percentage in effect on the date on
which indemnification is sought under this Section 10.7 (or, if indemnification is sought after the date upon which the Commitments shall have terminated and the
Obligations shall have been paid in full, in accordance with its Term Loan Commitment Percentage immediately prior to such date), from and against any and all
liabilities, obligations, losses, damages, penalties, actions, judgments, suits, costs, expenses or disbursements of any kind whatsoever that may at any time (whether
before or after the payment of the Credit Extensions) be imposed on, incurred by or asserted against Agent in any way relating to or arising out of, the Commitments,
this Agreement, any of the other Loan Documents or any documents contemplated by or referred to herein or therein or the transactions contemplated hereby or
thereby or any action taken or omitted by Agent under or in connection with any of the foregoing; provided that no Lender shall be liable for the payment of any
portion of such liabilities, obligations, losses, damages, penalties, actions, judgments, suits, costs, expenses or disbursements that are found by a final and
nonappealable decision of a court of competent jurisdiction to have resulted primarily from Agent’s gross negligence or willful misconduct. The agreements in this
Section shall survive the payment of the Credit Extensions and all other amounts payable hereunder.
10.8
Agent in Its Individual Capacity. The Person serving as Agent hereunder shall have the same rights and powers in its capacity
as a Lender as any other Lender and may exercise the same as though it were not Agent and the term “Lender” or “Lenders” shall, unless otherwise expressly
indicated or unless the context otherwise requires, include each such Person serving as Agent hereunder in its individual capacity. Such Person and its Affiliates may
accept deposits from, lend money to, act as the financial advisor or in any other advisory capacity for and generally engage in any kind of business with Borrower,
any Guarantor or any Subsidiary or other Affiliate thereof as if such Person were not Agent hereunder and without any duty to account therefor to Lenders.
10.9
Successor Agent. Agent may at any time give notice of its resignation to Lenders and Borrower, which resignation shall not be
effective until the time at which the majority of the Lenders have delivered to Agent their written consent to such resignation. Upon receipt of any such notice of
resignation, the Lenders shall have the right, in consultation with Borrower, to appoint a successor, which shall be a financial institution with an office in the State of
California, or an Affiliate of any such bank with an office in the State of California. If no such successor shall have been so appointed by the Lenders and shall have
accepted such appointment within thirty (30) days after the retiring Agent has received the written consent of the majority of the Lenders to such resignation, then the
retiring Agent may on behalf of Lenders, appoint a successor Agent meeting the qualifications set forth above; provided that in no event shall any such successor
Agent be a Defaulting Lender and provided further that if the retiring Agent shall notify Borrower and Lenders that no qualifying Person has accepted such
appointment, then such resignation shall
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nonetheless become effective in accordance with such notice and (1) the retiring Agent shall be discharged from its duties and obligations hereunder and under the
other Loan Documents (except that in the case of any collateral security held by Agent on behalf of the Lenders under any of the Loan Documents, the retiring Agent
shall continue to hold such collateral security until such time as a successor Agent is appointed and such collateral security is assigned to such successor Agent) and
(2) all payments, communications and determinations provided to be made by, to or through Agent shall instead be made by or to each Lender directly, until such
time as the Lenders appoint a successor Agent as provided for above in this Section 10.9. Upon the acceptance of a successor’s appointment as Agent hereunder,
such successor shall succeed to and become vested with all of the rights, powers, privileges and duties of the retiring (or retired) Agent, and the retiring Agent shall
be discharged from all of its duties and obligations hereunder or under the other Loan Documents (if not already discharged therefrom as provided above in this
Section 10.9). The fees payable by Borrower to a successor Agent shall be the same as those payable to its predecessor unless otherwise agreed between the
Borrower and such successor. After the retiring Agent’s resignation hereunder and under the other Loan Documents, the provisions of this Section 10 shall continue
in effect for the benefit of such retiring Agent, its sub-agents and their respective Indemnified Persons in respect of any actions taken or omitted to be taken by any of
them while the retiring Agent was acting as Agent.
10.10
Defaulting Lender.
becomes a Defaulting Lender, then, until such time as such Lender is no longer a Defaulting Lender, to the extent permitted by applicable law:
(a)
Defaulting Lender Adjustments. Notwithstanding anything to the contrary contained in this Agreement, if any Lender
(i)
Waivers and Amendments. Such Defaulting Lender’s right to approve or disapprove any amendment, waiver or
consent with respect to this Agreement shall be restricted as long as said Lender is a Defaulting Lender.
(ii)
Defaulting Lender Waterfall. Any payment of principal, interest, fees or other amounts received by the Agent for the
account of such Defaulting Lender (whether voluntary or mandatory, at maturity, pursuant to Section 8 or otherwise, and including any
amounts made available to the Agent by such Defaulting Lender pursuant to Section 13.10), shall be applied at such time or times as may
be determined by the Agent as follows: first, to the payment of any amounts owing by such Defaulting Lender to the Agent hereunder;
second, as the Borrower may request (so long as no Event of Default exists), to the funding of any Term Loan Advance in respect of which
such Defaulting Lender has failed to fund its portion thereof as required by this Agreement, as determined by the Agent; third, if so
determined by the Agent and Borrower, to be held in a Deposit Account and released pro rata to satisfy such Defaulting Lender’s potential
future funding obligations with respect to Term Loan Advances under this Agreement; fourth, so long as no Event of Default has occurred
and is continuing, to the payment of any amounts owing to the Borrower as a result of any judgment of a court of competent jurisdiction
obtained by the Borrower against such Defaulting Lender as a result of such Defaulting Lender’s breach of its obligations under this
Agreement; and fifth, to such Defaulting Lender or as otherwise directed by a court of competent jurisdiction; provided that if (A) such
payment is a payment of the principal amount of any Term Loan Advances in respect of which such Defaulting Lender has not fully funded
its appropriate share and (B) such Term Loan Advances were made at a time when the conditions set forth in Section 3.1 were satisfied or
waived, such payment shall be applied solely to pay the Loans of all non-Defaulting Lenders on a pro rata basis prior to being applied to
the payment of any Term Loan Advances of such Defaulting Lender until such time as all Term Loan Advances are held by the Lenders pro
rata in accordance with the Term Loan Commitments under this Agreement. Any payments, prepayments or other amounts paid or payable
to a Defaulting Lender that are applied (or held) to pay amounts owed by a Defaulting Lender pursuant to this Section 10.10(a)(ii) shall be
deemed paid to and redirected by such Defaulting Lender, and each Lender irrevocably consents hereto.
(iii)
Certain Fees. No Defaulting Lender shall be entitled to receive any fee pursuant to Section 2.3(b) or Section 2.3(c)
for any period during which such Lender is a Defaulting Lender
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(and the Borrower shall not be required to pay any such fee that otherwise would have been required to have been paid to such Defaulting
Lender).
(b)
Defaulting Lender Cure. If Borrower and Agent agree in writing that a Lender is no longer a Defaulting Lender, Agent
will so notify the parties hereto, whereupon as of the effective date specified in such notice and subject to any conditions set forth therein, such Lender will, to the
extent applicable, purchase at par that portion of outstanding Term Loan Advances of the other Lenders or take such other actions as Agent may determine to be
necessary to cause the Term Loan Advances to be held on a pro rata basis by the Lenders in accordance with their respective Term Loan Commitment Percentages,
whereupon such Lender will cease to be a Defaulting Lender; provided that no adjustments will be made retroactively with respect to fees accrued or payments made
by or on behalf of Borrower while such Lender was a Defaulting Lender; and provided further that, except to the extent otherwise expressly agreed by the affected
parties, no change hereunder from Defaulting Lender to Lender will constitute a waiver or release of any claim of any party hereunder arising from such Lender
having been a Defaulting Lender.
(c)
Termination of Defaulting Lender. The Borrower may terminate the unused amount of the Term Loan Commitment of
any Lender that is a Defaulting Lender upon not less than ten (10) Business Days’ prior notice to Agent (which shall promptly notify the Lenders thereof), and in
such event the provisions of Section 10.10(a)(ii) will apply to all amounts thereafter paid by Borrower for the account of such Defaulting Lender under this
Agreement (whether on account of principal, interest, fees, indemnity or other amounts); provided that (i) no Event of Default shall have occurred and be continuing,
and (ii) such termination shall not be deemed to be a waiver or release of any claim Borrower, Agent or any Lender may have against such Defaulting Lender.
(d)
If the Person serving as Agent is a Defaulting Lender pursuant to clause (d) of the definition thereof, the non-
Defaulting Lenders may, to the extent permitted by applicable law, by notice in writing to Borrower and such Person, remove such Person as Agent and, in
consultation with Borrower, appoint a successor. If no such successor shall have been so appointed by the non-Defaulting Lenders and shall have accepted such
appointment within thirty (30) days (or such earlier day as shall be agreed by the non-Defaulting Lenders) (the “Removal Effective Date”), then such removal shall
nonetheless become effective in accordance with such notice on the Removal Effective Date.
11
NOTICES
All notices, consents, requests, approvals, demands, or other communication by any party to this Agreement or any other Loan Document must be in
writing and shall be deemed to have been validly served, given, or delivered: (a) upon the earlier of actual receipt and three (3) Business Days after deposit in the
U.S. mail, first class, registered or certified mail return receipt requested, with proper postage prepaid; (b) upon transmission, when sent by electronic mail or
facsimile transmission; (c) one (1) Business Day after deposit with a reputable overnight courier with all charges prepaid; or (d) when delivered, if hand-delivered by
messenger, all of which shall be addressed to the party to be notified and sent to the address, facsimile number, or email address indicated below. Agent or Borrower
may change its mailing or electronic mail address or facsimile number by giving the other party written notice thereof in accordance with the terms of this Section
11.
If to Borrower:
with a copy to:
Eloxx Pharmaceuticals, Inc.
950 Winter Street
Waltham, Massachusetts 02451
Attn:
Email:
Eloxx Pharmaceuticals, Inc.
950 Winter Street
Waltham, Massachusetts 02451
Attn: Neil Belloff
Email: neil.belloff@eloxxpharma.com
Greg Weaver
greg@eloxxpharma.com
If to Agent or SVB:
Silicon Valley Bank
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275 Grove Street, Suite 2-200
Newton, Massachusetts 02466
Attn:
Email:
Lauren Cole
LCole@svb.com
with a copy to:
Riemer & Braunstein LLP
100 Cambridge Street
Boston, Massachusetts 02114
Attn: David A. Ephraim, Esquire
Fax: (617) 880-3456
Email:
DEphraim@riemerlaw.com
If to WestRiver:
WestRiver Innovation Lending Fund VIII, L.P.
c/o WestRiver Management, LLC
3720 Carillon Point
Kirkland, Washington 98033-7455
Attn: Trent Dawson
Email: tdawson@westrivermgmt.com
12
CHOICE OF LAW, VENUE AND JURY TRIAL WAIVER
Except as otherwise expressly provided in any of the Loan Documents, New York law governs the Loan Documents without regard to principles of
conflicts of law. Except to the extent otherwise set forth in the Loan Documents, Borrower, Agent and Lenders each submit to the exclusive jurisdiction of the State
and Federal courts in New York, New York; provided, however, that nothing in this Agreement shall be deemed to operate to preclude Agent or Lenders from
bringing suit or taking other legal action in any other jurisdiction to realize on the Collateral or any other security for the Obligations, or to enforce a judgment or
other court order in favor of Agent or any Lender. Borrower expressly submits and consents in advance to such jurisdiction in any action or suit commenced in any
such court, and Borrower hereby waives any objection that it may have based upon lack of personal jurisdiction, improper venue, or forum non conveniens and
hereby consents to the granting of such legal or equitable relief as is deemed appropriate by such court. Borrower hereby waives personal service of the summons,
complaints, and other process issued in such action or suit and agrees that service of such summons, complaints, and other process may be made by registered or
certified mail addressed to Borrower at the address set forth in, or subsequently provided by Borrower in accordance with, Section 11 of this Agreement and that
service so made shall be deemed completed upon the earlier to occur of Borrower’s actual receipt thereof or three (3) days after deposit in the U.S. mails, proper
postage prepaid.
TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, BORROWER, AGENT AND EACH LENDER EACH WAIVE THEIR
RIGHT TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION ARISING OUT OF OR BASED UPON THIS AGREEMENT, THE LOAN
DOCUMENTS OR ANY CONTEMPLATED TRANSACTION, INCLUDING CONTRACT, TORT, BREACH OF DUTY AND ALL OTHER CLAIMS.
THIS WAIVER IS A MATERIAL INDUCEMENT FOR ALL PARTIES TO ENTER INTO THIS AGREEMENT. EACH PARTY HAS REVIEWED
THIS WAIVER WITH ITS COUNSEL.
This Section 12 shall survive the termination of this Agreement.
13
GENERAL PROVISIONS
13.1
Termination Prior Maturity Date; Survival. All covenants, representations and warranties made in this Agreement continue in
full force until this Agreement has terminated pursuant to its terms and all Obligations have been satisfied. So long as Borrower has satisfied the Obligations (other
than inchoate indemnity obligations, any other obligations which, by their terms, are to survive the termination of this Agreement, and any Obligations under Bank
Services Agreements that are cash collateralized in accordance with Section 4.1 of this Agreement), this Agreement may be terminated prior to the Term Loan
Maturity Date by Borrower, effective three (3) Business Days after written notice of termination is given to Agent. Those obligations that are expressly specified in
this Agreement as surviving this Agreement’s termination shall continue to survive notwithstanding this Agreement’s termination.
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No termination of this Agreement shall in any way affect or impair any right or remedy of Agent or any Lender, nor shall any such termination relieve Borrower of
any Obligation to any Lender, until all of the Obligations have been paid and performed in full. Those Obligations that are expressly specified in this Agreement as
surviving this Agreement’s termination shall continue to survive notwithstanding this Agreement’s and the Debentures’ termination and payment in full of the
Obligations then outstanding.
13.2
Successors and Assigns. This Agreement binds and is for the benefit of the successors and permitted assigns of each party.
Borrower may not assign this Agreement or any rights or obligations under it without Agent and Lenders’ prior written consent (which may be granted or withheld in
Agent’s and Lenders’ sole discretion). Agent and each Lender has the right, without the consent of or notice to Borrower, to sell, transfer, assign, negotiate, or grant
participation in all or any part of, or any interest in, such Lender’s obligations, rights, and benefits under this Agreement and the other Loan Documents (other than
the Warrant, as to which assignment, transfer and other such actions are governed by the terms thereof). Notwithstanding the foregoing, prior to the occurrence of
an Event of Default that is continuing, no Lender shall assign any interest in the Loan Documents to any Person who is (a) a direct competitor of Borrower, or (b) a
vulture fund or distressed debt fund.
13.3
Indemnification. Borrower agrees to indemnify, defend and hold Agent, each Lender and their respective directors, officers,
employees, agents, attorneys, or any other Person affiliated with or representing Agent or any Lender (each, an “Indemnified Person”) harmless against: (i) all
obligations, demands, claims, and liabilities (collectively, “Claims”) claimed or asserted by any other party in connection with the transactions contemplated by the
Loan Documents; and (ii) all losses or expenses (including Lenders’ Expenses) in any way suffered, incurred, or paid by such Indemnified Person as a result of,
following from, consequential to, or arising from transactions between Agent, Lenders and Borrower contemplated by the Loan Documents (including reasonable
attorneys’ fees and expenses), except for Claims and/or losses directly caused by such Indemnified Person’s gross negligence or willful misconduct. This Section
13.3 shall survive until all statutes of limitation with respect to the Claims, losses, and expenses for which indemnity is given shall have run.
13.4
Time of Essence. Time is of the essence for the performance of all Obligations in this Agreement.
13.5
enforceability of any provision.
13.6
the agreement of the parties.
Severability of Provisions. Each provision of this Agreement is severable from every other provision in determining the
Correction of Loan Documents. Agent may correct patent errors and fill in any blanks in the Loan Documents consistent with
13.7
Amendments in Writing; Waiver; Integration. No purported amendment or modification of any Loan Document, or waiver,
discharge or termination of any obligation under any Loan Document, or release, or subordinate Lenders’ security interest in, or consent to the transfer of, any
Collateral shall be enforceable or admissible unless, and only to the extent, expressly set forth in a writing signed by Agent, with the consent of the Lenders in
accordance with the Lender Intercreditor Agreement or, if such item is not addressed in the Lender Intercreditor Agreement, as consented to by a majority of the
Lenders, and Borrower. Without limiting the generality of the foregoing, no oral promise or statement, nor any action, inaction, delay, failure to require performance
or course of conduct shall operate as, or evidence, an amendment, supplement or waiver or have any other effect on any Loan Document. Any waiver granted shall
be limited to the specific circumstance expressly described in it, and shall not apply to any subsequent or other circumstance, whether similar or dissimilar, or give
rise to, or evidence, any obligation or commitment to grant any further waiver. The Loan Documents represent the entire agreement about this subject matter and
supersede prior negotiations or agreements. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject
matter of the Loan Documents merge into the Loan Documents. In the event any provision of any other Loan Document is inconsistent with the provisions of this
Agreement, the provisions of this Agreement shall exclusively control.
13.8
Counterparts. This Agreement may be executed in any number of counterparts and by different parties on separate counterparts,
each of which, when executed and delivered, is an original, and all taken together, constitute one Agreement.
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13.9
Confidentiality. In handling any confidential information, Agent and the Lenders agree to exercise the same degree of care that it
exercises for its own proprietary information and maintain the confidentiality of Information (as defined below), except that Information may be disclosed (a) to
Agent and/or any Lender’s subsidiaries, Affiliates, employees, directors, agents, attorneys, accountants and other professional advisors (collectively,
“Representatives” and, together with Agent and the Lenders, collectively, “Lender Entities”); (b) to prospective transferees, assignees, credit providers or
purchasers of any of the Lenders’ or Agent’s interests under or in connection with this Agreement and their Representatives (provided, however, Agent and the
Lenders shall use their best efforts to obtain any such prospective transferee’s, assignee’s, credit provider’s, purchaser’s or their Representatives’ agreement to the
terms of this provision); (c) as required by law, regulation, subpoena, or other order; (d) to Agent’s or any Lender’s regulators or as otherwise required in connection
with Agent’s or any Lender’s examination or audit; (e) as Agent or any Lender considers appropriate in exercising remedies under the Loan Documents; and (f) to
third-party service providers of Agent and/or the Lenders so long as such service providers have executed a confidentiality agreement with Agent or the Lenders, as
applicable, with terms no less restrictive than those contained herein. The term “Information” means all information received from Borrower regarding Borrower or
its business, in each case other than information that is either: (i) in the public domain or in Agent’s or any Lender’s possession when disclosed to Agent or such
Lender, or becomes part of the public domain (other than as a result of its disclosure by Agent or a Lender in violation of this Agreement) after disclosure to Agent
and/or the Lenders; or (ii) disclosed to Agent and/or the Lenders by a third party, if Agent/the Lenders do not know that the third party is prohibited from disclosing
the information.
Lender Entities may use anonymous forms of confidential information for aggregate datasets, for analyses or reporting, and for any other uses not
expressly prohibited in writing by Borrower. The provisions of the immediately preceding sentence shall survive termination of this Agreement.
13.10
Right of Setoff. Borrower hereby grants to Agent, for the ratable benefit of the Lenders, a Lien, security interest, fixed and
floating charge and a right of setoff as security for all Obligations to Agent and the Lenders, whether now existing or hereafter arising upon and against all deposits,
credits, collateral and property, now or hereafter in the possession, custody, safekeeping or control of Agent or any entity under the control of Agent (including a
subsidiary of Agent) or in transit to any of them. At any time after the occurrence and during the continuance of an Event of Default, without demand or notice,
Agent or any Lender may setoff the same or any part thereof and apply the same to any Obligation of Borrower then due regardless of the adequacy of any other
collateral securing the Obligations. ANY AND ALL RIGHTS TO REQUIRE AGENT OR ANY LENDER TO EXERCISE ITS RIGHTS OR REMEDIES WITH
RESPECT TO ANY OTHER COLLATERAL WHICH SECURES THE OBLIGATIONS, PRIOR TO EXERCISING ITS RIGHT OF SETOFF WITH RESPECT
TO SUCH DEPOSITS, CREDITS OR OTHER PROPERTY OF BORROWER, ARE HEREBY KNOWINGLY, VOLUNTARILY AND IRREVOCABLY
WAIVED.
Agent or any Lender may set off any matured obligation due from ISR Borrower under the Loan Documents against any matured obligation owed by
Agent or any Lender to ISR Borrower, regardless of the place of payment, banking branch or currency of either obligation. Further, ISR Borrower authorizes Agent
to apply (without prior notice) any credit balance (whether or not then due) to which ISR Borrower is at any time beneficially entitled on any account at, any sum
held to its order by and/or any liability or obligation (whether or not matured) of, any office of Agent or any Lender in or towards satisfaction of any sum then due
and payable by it to Agent or any Lender under the Loan Documents and unpaid. For these purposes, Agent and the Lenders may convert one currency into another,
provided that nothing in this Section 13.10 shall be effective to create a charge.
13.11
Electronic Execution of Documents. The words “execution,” “signed,” “signature” and words of like import in any Loan
Document shall be deemed to include electronic signatures or the keeping of records in electronic form, each of which shall be of the same legal effect, validity and
enforceability as a manually executed signature or the use of a paper-based recordkeeping systems, as the case may be, to the extent and as provided for in any
applicable law, including, without limitation, any state law based on the Uniform Electronic Transactions Act. For the avoidance of doubt, this Section 13.11 shall
not apply to the Debentures and their translation to Hebrew, the notices to the Israeli Registrar of Companies for the registration of the Debentures and the approval
of the translations’ compatibility.
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13.12
Captions. The headings used in this Agreement are for convenience only and shall not affect the interpretation of this
Agreement.
13.13
Construction of Agreement. The parties mutually acknowledge that they and their attorneys have participated in the
preparation and negotiation of this Agreement. In cases of uncertainty this Agreement shall be construed without regard to which of the parties caused the
uncertainty to exist.
13.14
Relationship. The relationship of the parties to this Agreement is determined solely by the provisions of this Agreement. The
parties do not intend to create any agency, partnership, joint venture, trust, fiduciary or other relationship with duties or incidents different from those of parties to an
arm’s-length contract.
13.15
Third Parties. Nothing in this Agreement, whether express or implied, is intended to: (a) confer any benefits, rights or remedies
under or by reason of this Agreement on any persons other than the express parties to it and their respective permitted successors and assigns; (b) relieve or discharge
the obligation or liability of any person not an express party to this Agreement; or (c) give any person not an express party to this Agreement any right of subrogation
or action against any party to this Agreement.
13.16
Patriot Act. Each Lender hereby notifies Borrower that pursuant to the requirements of the USA PATRIOT Act, it is required to
obtain, verify and record information that identifies Borrower and each of its Subsidiaries, which information includes the names and addresses of each Borrower
and each of its Subsidiaries and other information that will allow Lender, as applicable, to identify Borrower and each of its Subsidiaries in accordance with the USA
PATRIOT Act.
14
DEFINITIONS
14.1
Definitions. As used in the Loan Documents, the word “shall” is mandatory, the word “may” is permissive, the word “or” is not
exclusive, the words “includes” and “including” are not limiting, the singular includes the plural, and numbers denoting amounts that are set off in brackets are
negative. As used in this Agreement, the following capitalized terms have the following meanings:
“Account” is any “account” as defined in the Code or any other applicable law with such additions to such term as may hereafter be made, and includes,
without limitation, all accounts receivable and other sums owing to Borrower.
“Account Debtor” is any “account debtor” as defined in the Code or any other applicable law with such additions to such term as may hereafter be
made.
“Affiliate” is, with respect to any Person, each other Person that owns or controls directly or indirectly the Person, any Person that controls or is
controlled by or is under common control with the Person, and each of that Person’s senior executive officers, directors, partners and, for any Person that is a limited
liability company, that Person’s managers and members.
“Agent” is defined in the preamble hereof.
“Agreement” is defined in the preamble hereof.
“Authorized Signer” is any individual listed in Borrower’s Borrowing Resolution who is authorized to execute the Loan Documents, including any
Credit Extension request, on behalf of Borrower.
“Bank Services” are any products, credit services, and/or financial accommodations previously, now, or hereafter provided to Borrower or any of its
Subsidiaries by SVB or any SVB Affiliate, including, without limitation, any letters of credit, cash management services (including, without limitation, merchant
services, direct deposit of payroll, business credit cards, and check cashing services), interest rate swap arrangements, and foreign exchange services as any such
products or services may be identified in SVB’s various agreements related thereto (each, a “Bank Services Agreement”).
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“Bank Services Agreement” is defined in the definition of Bank Services.
“Board” means Borrower’s board of directors.
“Borrower” is defined in the preamble hereof.
“Borrower’s Books” are all Borrower’s books and records including ledgers, federal and state tax returns, records regarding Borrower’s assets or
liabilities, the Collateral, business operations or financial condition, and all computer programs or storage or any equipment containing such information.
“Borrowing Resolutions” are, with respect to any Person, those resolutions adopted by such Person’s board of directors (and, if required under the
terms of such Person’s Operating Documents, stockholders) and delivered by such Person to Agent approving the Loan Documents to which such Person is a party
and the transactions contemplated thereby, together with a certificate executed by its secretary on behalf of such Person certifying (a) such Person has the authority to
execute, deliver, and perform its obligations under each of the Loan Documents to which it is a party, (b) that set forth as a part of or attached as an exhibit to such
certificate is a true, correct, and complete copy of the resolutions then in full force and effect authorizing and ratifying the execution, delivery, and performance by
such Person of the Loan Documents to which it is a party, (c) the name(s) of the Person(s) authorized to execute the Loan Documents, including any Credit
Extension request, on behalf of such Person, together with a sample of the true signature(s) of such Person(s), and (d) that Agent and Lenders may conclusively rely
on such certificate unless and until such Person shall have delivered to Agent and Lenders a further certificate canceling or amending such prior certificate.
“Business Day” is any day that is not a Saturday, Sunday or a day on which Agent is closed.
“Cash Equivalents” means (a) marketable direct obligations issued or unconditionally guaranteed by the United States or any agency or any State
thereof having maturities of not more than one (1) year from the date of acquisition; (b) commercial paper maturing no more than one (1) year after its creation and
having the highest rating from either Standard & Poor’s Ratings Group or Moody’s Investors Service, Inc.; (c) SVB’s certificates of deposit issued maturing no more
than one (1) year after issue; and (d) money market funds at least ninety-five percent (95%) of the assets of which constitute Cash Equivalents of the kinds described
in clauses (a) through (c) of this definition.
“Change in Control” means (a) at any time, any “person” or “group” (as such terms are used in Sections 13(d) and 14(d) of the Exchange Act), shall
become, or obtain rights (whether by means of warrants, options or otherwise) to become, the “beneficial owner” (as defined in Rules 13(d)-3 and 13(d)‑5 under the
Exchange Act), directly or indirectly, of forty percent (40.0%) or more of the ordinary voting power for the election of directors of Borrower (determined on a fully
diluted basis) other than by the sale of Borrower’s equity securities in a public offering or to venture capital or private equity investors so long as Borrower identifies
to the Agent and the Lenders the venture capital or private equity investors at least seven (7) Business Days prior to the closing of the transaction and provides to
Agent and the Lenders a description of the material terms of the transaction; (b) during any period of twelve (12) consecutive months, a majority of the members of
the board of directors or other equivalent governing body of Borrower cease to be composed of individuals (i) who were members of that board or equivalent
governing body on the first day of such period, (ii) whose election or nomination to that board or equivalent governing body was approved by individuals referred to
in clause (i) above constituting at the time of such election or nomination at least a majority of that board or equivalent governing body or (iii) whose election or
nomination to that board or other equivalent governing body was approved by individuals referred to in clauses (i) and (ii) above constituting at the time of such
election or nomination at least a majority of that board or equivalent governing body; or (c) at any time, Borrower shall cease to own and control, of record and
beneficially, directly or indirectly, one hundred percent (100.0%) of each class of outstanding capital stock of each Subsidiary of Borrower free and clear of all Liens
(except Liens created by this Agreement or the Debentures).
“Charged Property” is defined in the Debentures.
“Claims” is defined in Section 13.3.
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“Code” is (a) with respect to US Borrower or any assets located in the United States, the Uniform Commercial Code, as the same may, from time to
time, be enacted and in effect in the State of New York; provided, that, to the extent that the Code is used to define any term herein or in any Loan Document and
such term is defined differently in different Articles or Divisions of the Code, the definition of such term contained in Article or Division 9 shall govern; provided
further, that in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection, or priority of, or remedies with respect to, Agent’s
Lien on any Collateral is governed by the Uniform Commercial Code in effect in a jurisdiction other than the State of New York, the term “Code” shall mean the
Uniform Commercial Code as enacted and in effect in such other jurisdiction solely for purposes of the provisions thereof relating to such attachment, perfection,
priority, or remedies and for purposes of definitions relating to such provisions; and (b) with respect to ISR Borrower or any assets located outside of the United
States, any applicable law.
“Collateral” is (a) any and all properties, rights and assets of Borrower described on Exhibit A and (b) any and all properties, rights and assets subject to
a Lien granted by ISR Borrower to Agent as set forth in the Debentures, including, without limitation, the Charged Property, pursuant and subject to the express
terms of such Debenture.
“Collateral Account” is any Deposit Account, Securities Account, or Commodity Account.
“Commitment” and “Commitments” means the Term Loan Commitment(s).
“Commodity Account” is any “commodity account” as defined in the Code or any other applicable law with such additions to such term as may
hereafter be made.
“Compliance Certificate” is that certain certificate in the form attached hereto as Exhibit B.
“Contingent Obligation” is, for any Person, any direct or indirect liability, contingent or not, of that Person for (a) any indebtedness, lease, dividend,
letter of credit or other obligation of another such as an obligation, in each case, directly or indirectly guaranteed, endorsed, co‑made, discounted or sold with
recourse by that Person, or for which that Person is directly or indirectly liable; (b) any obligations for undrawn letters of credit for the account of that Person; and (c)
all obligations from any interest rate, currency or commodity swap agreement, interest rate cap or collar agreement, or other agreement or arrangement designated to
protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; but “Contingent Obligation” does not include endorsements in the
ordinary course of business. The amount of a Contingent Obligation is the stated or determined amount of the primary obligation for which the Contingent
Obligation is made or, if not determinable, the maximum reasonably anticipated liability for it determined by the Person in good faith; but the amount may not
exceed the maximum of the obligations under any guarantee or other support arrangement.
“Control Agreement” is any control agreement entered into among the depository institution at which Borrower maintains a Deposit Account or the
securities intermediary or commodity intermediary at which Borrower maintains a Securities Account or a Commodity Account, Borrower, and Agent pursuant to
which Agent obtains control (within the meaning of the Code or any other applicable law) for the benefit of the Lenders over such Deposit Account, Securities
Account, or Commodity Account.
“Copyrights” are any and all copyright rights, copyright applications, copyright registrations and like protections in each work of authorship and
derivative work thereof, whether published or unpublished and whether or not the same also constitutes a trade secret.
“Credit Extension” is any Term Loan Advance or any other extension of credit by any Lender for Borrower’s benefit.
“Data Event” means delivery by Borrower to Agent and the Lenders, on or prior to December 31, 2019, of evidence satisfactory to Agent and each
Lender in Agent’s and each Lender’s reasonable discretion that Borrower has received positive data with respect to Borrower’s phase 2 clinical trial of ELX-02
sufficient to begin phase 3 protocols in at least one (1) indication.
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“Debenture” and “Debentures” are defined in Section 4.3 of this Agreement.
“Default Rate” is defined in Section 2.2(b).
“Defaulting Lender” is, subject to Section 10.10(b), any Lender that (a) has failed to (i) fund all or any portion of its Term Loan Advances within two
(2) Business Days of the date such Term Loan Advances were required to be funded hereunder unless such Lender notifies Agent and Borrower in writing that such
failure is the result of such Lender’s reasonable determination that one or more conditions precedent to funding (each of which conditions precedent, together with
any applicable default, shall be specifically identified in such writing) has not been satisfied, or (ii) pay to Agent or any other Lender any other amount required to be
paid by it hereunder within two (2) Business Days of the date when due, (b) has notified Borrower or Agent in writing that it does not intend to comply with its
funding obligations hereunder, or has made a public statement to that effect (unless such writing or public statement relates to such Lender’s obligation to fund a
Term Loan Advance hereunder and states that such position is based on such Lender’s reasonable determination that a condition precedent to funding (which
condition precedent, together with any applicable default, shall be specifically identified in such writing or public statement) cannot be satisfied), (c) has failed,
within three (3) Business Days after written request by Agent or Borrower, to confirm in writing to Agent and Borrower that it will comply with its prospective
funding obligations hereunder (provided that such Lender shall cease to be a Defaulting Lender pursuant to this clause (c) upon receipt of such written confirmation
by Agent and Borrower), or (d) has, or has a direct or indirect parent company that has, (i) become the subject of an Insolvency Proceeding, or (ii) had appointed for
it a receiver, custodian, conservator, trustee, administrator, assignee for the benefit of creditors or similar Person charged with reorganization or liquidation of its
business or assets, including the Federal Deposit Insurance Corporation or any other state or federal regulatory authority acting in such a capacity; provided that a
Lender shall not be a Defaulting Lender solely by virtue of the ownership or acquisition of any equity interest in that Lender or any direct or indirect parent company
thereof by a Governmental Authority so long as such ownership interest does not result in or provide such Lender with immunity from the jurisdiction of courts
within the United States or from the enforcement of judgments or writs of attachment on its assets or permit such Lender (or such Governmental Authority) to reject,
repudiate, disavow or disaffirm any contracts or agreements made with such Lender. Any determination by Agent that a Lender is a Defaulting Lender under any
one or more of clauses (a) through (d) above shall be conclusive and binding absent manifest error, and such Lender shall be deemed to be a Defaulting Lender
(subject to Section 10.10(b)) upon delivery of written notice of such determination to Borrower and each Lender.
“Deposit Account” is any “deposit account” as defined in the Code with such additions to such term as may hereafter be made.
“Designated Deposit Account” is the multicurrency account denominated in Dollars, account number 825 (last three digits), maintained by Borrower
with SVB (provided, however, if no such account number is included, then the Designated Deposit Account shall be any deposit account of Borrower maintained
with SVB as chosen by the Lenders).
“Disbursement Letter” is that certain form attached hereto as Exhibit E.
“Dollars,” “dollars” or use of the sign “$” means only lawful money of the United States and not any other currency, regardless of whether that
currency uses the “$” sign to denote its currency or may be readily converted into lawful money of the United States.
“Dollar Equivalent” is, at any time, (a) with respect to any amount denominated in Dollars, such amount, and (b) with respect to any amount
denominated in a Foreign Currency, the equivalent amount therefor in Dollars as determined by Agent at such time on the basis of the then-prevailing rate of
exchange in San Francisco, California, for sales of the Foreign Currency for transfer to the country issuing such Foreign Currency.
“Draw Period” is the period of time commencing upon the occurrence of the Milestone Event and continuing through the earlier to occur of (a)
December 31, 2019 or (b) an Event of Default.
“Effective Date” is defined in the preamble hereof.
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“Equipment” is all “equipment” as defined in the Code or any other applicable law with such additions to such term as may hereafter be made, and
includes without limitation all machinery, fixtures, goods, vehicles (including motor vehicles and trailers), and any interest in any of the foregoing.
“Equity Event” means Borrower has received, after the Effective Date, but on or prior to December 31, 2019, in one or more transactions, unrestricted
and unencumbered (except for Liens in favor of Agent) net cash proceeds of at least Seventy-Five Million Dollars ($75,000,000.00) from the issuance and sale by
Borrower of its equity securities in a (x) private placement to investors acceptable to Agent in its reasonable discretion or (y) public offering.
“ERISA” is the Employee Retirement Income Security Act of 1974, and its regulations.
“Event of Default” is defined in Section 8.
“Exchange Act” is the Securities Exchange Act of 1934, as amended.
“FATCA” means Section 1471 through 1474 of the Internal Revenue Code, as of the date of this Agreement (or any amended or successor version that
is substantively comparable and not materially more onerous to comply with), any current or future regulations or official interpretations thereof, any agreements
entered into pursuant to Section 1471(b)(1) of the Internal Revenue Code and any fiscal or regulatory legislation, rules or practices adopted pursuant to any
intergovernmental agreement, treaty or convention among Governmental Authorities and implementing such Sections of the Internal Revenue Code.
“Federal Funds Effective Rate” means, for any day, the weighted average of the rates on overnight federal funds transactions with members of the
Federal Reserve System arranged by federal funds brokers, as published on the next succeeding Business Day by the Federal Reserve Bank of New York, or, if such
rate is not so published for any day that is a Business Day, the average of the quotations for the day of such transactions received by SVB from three federal funds
brokers of recognized standing selected by it.
“Final Payment” is a payment (in addition to and not in substitution for the regular monthly payments of principal plus accrued interest) equal to the
original principal amount of each Term Loan Advance extended by the Lenders to Borrower hereunder multiplied by six percent (6.0%), due on the earliest to occur
of (a) the Term Loan Maturity Date, (b) the payment in full of such Term Loan Advance, (c) as required by Section 2.1.1(d) or 2.1.1(e) or (d) the termination of this
Agreement.
“Foreign Currency” means lawful money of a country other than the United States.
“Funding Date” is any date on which a Credit Extension is made to or for the account of Borrower which shall be a Business Day.
“FX Contract” is any foreign exchange contract by and between Borrower and SVB under which Borrower commits to purchase from or sell to SVB a
specific amount of Foreign Currency on a specified date.
“GAAP” is generally accepted accounting principles set forth in the opinions and pronouncements of the Accounting Principles Board of the American
Institute of Certified Public Accountants and statements and pronouncements of the Financial Accounting Standards Board or in such other statements by such other
Person as may be approved by a significant segment of the accounting profession, which are applicable to the circumstances as of the date of determination.
“General Intangibles” is all “general intangibles” as defined in the Code or any other applicable law in effect on the date hereof with such additions to
such term as may hereafter be made, and includes without limitation, all Intellectual Property, claims, income and other tax refunds, security and other deposits,
payment intangibles, contract rights, options to purchase or sell real or personal property, rights in all litigation presently or hereafter pending (whether in contract,
tort or otherwise), insurance policies (including without limitation key man, property damage, and business interruption insurance), payments of insurance and rights
to payment of any kind.
-31-
“Governmental Approval” is any consent, authorization, approval, order, license, franchise, permit, certificate, accreditation, registration, filing or
notice, of, issued by, from or to, or other act by or in respect of, any Governmental Authority.
“Governmental Authority” is any nation or government, any state or other political subdivision thereof, any agency, authority, instrumentality,
regulatory body, court, central bank or other entity exercising executive, legislative, judicial, taxing, regulatory or administrative functions of or pertaining to
government, any securities exchange and any self-regulatory organization.
“Group Member” means Borrower and its Subsidiaries.
“IIA” is the Israel Innovation Authority of the Israeli Ministry of the Economy.
“Indebtedness” is (a) indebtedness for borrowed money or the deferred price of property or services, such as reimbursement and other obligations for
surety bonds and letters of credit, (b) obligations evidenced by notes, bonds, debentures or similar instruments, (c) capital lease obligations, and (d) Contingent
Obligations.
“Indemnified Person” is defined in Section 13.3.
“Information” is defined in Section 13.9.
“Insolvency Proceeding” is any proceeding by or against any Person under the United States Bankruptcy Code, the Israeli Companies Ordinance 5743-
1983, the Israeli Companies Law 5759-1999, or any other bankruptcy or insolvency law, including assignments for the benefit of creditors, compositions, extensions
generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief.
“Intellectual Property” means, with respect to any Person, all of such Person’s right, title, and interest in and to the following:
(a)
(b)
inventions, know-how and operating manuals;
its Copyrights, Trademarks and Patents;
any and all trade secrets and trade secret rights, including, without limitation, any rights to unpatented
(c)
(d)
(e)
any and all source code;
any and all design rights which may be available to such Person;
any and all claims for damages by way of past, present and future infringement of any of the foregoing, with
the right, but not the obligation, to sue for and collect such damages for said use or infringement of the Intellectual Property rights identified above; and
(f)
all amendments, renewals and extensions of any of the Copyrights, Trademarks or Patents.
“Inventory” is all “inventory” as defined in the Code or any other applicable law in effect on the date hereof with such additions to such term as may
hereafter be made, and includes without limitation all merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished
products, including without limitation such inventory as is temporarily out of Borrower’s custody or possession or in transit and including any returned goods and
any documents of title representing any of the above.
“Investment” is any beneficial ownership interest in any Person (including stock, partnership interest or other securities), and any loan, advance or
capital contribution to any Person.
“ISR Borrower” is defined in the preamble of this Agreement.
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“Key Person” is each of Borrower’s (a) Chief Executive Officer, who is Robert Ward as of the Effective Date, and (b) Chief Financial Officer, who is
Gregory Weaver as of the Effective Date.
“Lender” and “Lenders” is defined in the preamble.
“Lender Entities” is defined in Section 13.9.
“Lender Intercreditor Agreement” is, collectively, any and all intercreditor agreement, master arrangement agreement or similar agreement by and
between WestRiver and SVB, as each may be amended from time to time in accordance with the provisions thereof.
“Lenders’ Expenses” are all of Agent’s and the Lenders’ audit fees and expenses, costs, and expenses (including reasonable attorneys’ fees and
expenses) for preparing, amending, negotiating, administering, defending and enforcing the Loan Documents (including, without limitation, those incurred in
connection with appeals or Insolvency Proceedings) or otherwise incurred with respect to Borrower.
“Letter of Credit” is a standby or commercial letter of credit issued by SVB upon request of Borrower based upon an application, guarantee, indemnity,
or similar agreement.
“Lien” is a claim, mortgage, deed of trust, levy, charge, pledge, security interest or other encumbrance of any kind, whether voluntarily incurred or
arising by operation of law or otherwise against any property.
“Loan Documents” are, collectively, this Agreement and any schedules, exhibits, certificates, notices, and any other documents related to this
Agreement, the Debentures, the Warrant, the Perfection Certificate, each Disbursement Letter, the Lender Intercreditor Agreement, any Bank Services Agreement,
any Control Agreement, any subordination agreement, any note, or notes or guaranties executed by Borrower, and any other present or future agreement by Borrower
with or for the benefit of Agent and the Lenders in connection with this Agreement or Bank Services, all as amended, restated, or otherwise modified.
“Material Adverse Change” is: (a) a material impairment in the perfection or priority of Agent’s, for the ratable benefit of the Lenders, Lien in the
Collateral or in the value of such Collateral; (b) a material adverse change in the business, operations, or condition (financial or otherwise) of Borrower; or (c) a
material impairment of the prospect of repayment of any portion of the Obligations.
“Milestone Event” means confirmation in writing by Agent on or prior to December 31, 2019, that both the Data Event and the Equity Event have
occurred.
“Monthly Financial Statements” is defined in Section 6.2(a).
“Obligations” are Borrower’s obligations to pay when due any debts, principal, interest, fees, Lenders’ Expenses, the Final Payment, the Prepayment
Premium, and other amounts Borrower owes Agent or any Lender now or later, whether under this Agreement, the other Loan Documents (other than the Warrant),
or otherwise, including, without limitation, all obligations relating to Bank Services, if any, and including interest accruing after Insolvency Proceedings begin and
debts, liabilities, or obligations of Borrower assigned to Agent and/or the Lenders, and to perform Borrower’s duties under the Loan Documents (other than the
Warrant).
“Operating Documents” are, for any Person, such Person’s formation documents, as certified by the Secretary of State (or equivalent agency) of such
Person’s jurisdiction of organization on a date that is no earlier than thirty (30) days prior to the Effective Date, and, (a) if such Person is a corporation, its bylaws or
memorandum and articles of association (or similar documents as the case may be) in current form, (b) if such Person is a limited liability company, its limited
liability company agreement (or similar agreement), and (c) if such Person is a partnership, its partnership agreement (or similar agreement), each of the foregoing
with all current amendments or modifications thereto.
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“Patents” means all patents, patent applications and like protections including without limitation improvements, divisions, continuations, renewals,
reissues, extensions and continuations-in-part of the same.
“Payment/Advance Form” is that certain form attached hereto as Exhibit C.
“Payment Date” is the first (1st) calendar day of each month.
“Perfection Certificate” is defined in Section 5.1.
“Permitted Indebtedness” is:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(a)
(b)
(c)
(d)
(e)
(a)
Borrower’s Indebtedness to Agent and the Lenders under this Agreement and the other Loan Documents;
Indebtedness existing on the Effective Date which is shown on the Perfection Certificate;
Subordinated Debt;
unsecured Indebtedness to trade creditors incurred in the ordinary course of business;
Indebtedness incurred as a result of endorsing negotiable instruments received in the ordinary course of business;
Indebtedness secured by Liens permitted under clauses (a) and (c) of the definition of “Permitted Liens” hereunder;
other unsecured Indebtedness not otherwise permitted by Section 7.4 not exceeding Two Hundred Fifty Thousand Dollars ($250,000.00) in
the aggregate outstanding at any time; and
extensions, refinancings, modifications, amendments and restatements of any items of Permitted Indebtedness (a) through (g) above;
provided that the principal amount thereof is not increased or the terms thereof are not modified to impose more burdensome terms upon Borrower or its
Subsidiary, as the case may be.
“Permitted Investments” are:
Investments (including, without limitation, Subsidiaries) existing on the Effective Date which are shown on the Perfection Certificate;
Investments consisting of Cash Equivalents;
Investments by US Borrower in ISR Borrower for ordinary, necessary and current operating expenses in an amount not to exceed Three
Million Five Hundred Thousand Dollars ($3,500,000.00) per fiscal year, provided that an Event of Default does not exist at the time of any such
Investment and would not exist after giving effect to any such Investment;
any Investments permitted by Borrower’s investment policy as in effect as of the Effective Date (as may be amended from time to time with
the prior written consent of Agent); and
other Investments not otherwise permitted by Section 7.7 not exceeding One Hundred Thousand Dollars ($100,000.00) in the aggregate
outstanding at any time.
“Permitted Liens” are:
Liens existing on the Effective Date which are shown on the Perfection Certificate or arising under this Agreement and the other Loan
Documents;
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(b)
(c)
(d)
(e)
Liens for taxes, fees, assessments or other government charges or levies, either (i) not due and payable or (ii) being contested in good faith
and for which Borrower maintains adequate reserves on its Books, provided that no notice of any such Lien has been filed or recorded under the Internal
Revenue Code of 1986, as amended, and the Treasury Regulations adopted thereunder;
purchase money Liens (i) on Equipment acquired or held by Borrower incurred for financing the acquisition of the Equipment securing no
more than Fifty Thousand Dollars ($50,000.00) in the aggregate amount outstanding, or (ii) existing on Equipment when acquired, if the Lien is
confined to the property and improvements and the proceeds of the Equipment;
Liens arising from attachments or judgments, orders, or decrees in circumstances not constituting an Event of Default under Sections 8.4 and
8.7; and
Liens incurred in the extension, renewal or refinancing of the indebtedness secured by Liens described in (a) through (d), but any extension,
renewal or replacement Lien must be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness may not
increase.
“Person” is any individual, sole proprietorship, partnership, limited liability company, joint venture, company, trust, unincorporated organization,
association, corporation, institution, public benefit corporation, firm, joint stock company, estate, entity or government agency.
“Prepayment Premium” shall be an additional fee, payable to Agent, for the ratable benefit of the Lenders based on their Pro Rata Share, with respect
to the Term Loan Advances, in an amount equal to:
Date, three percent (3.0%) of the then outstanding principal amount of the Term Loan Advances immediately prior to the date of such prepayment;
(a)
for a prepayment of the Term Loan Advances made on or prior to the first (1st) anniversary of the Effective
for a prepayment of the Term Loan Advances made after the first (1st) anniversary of the Effective Date, but
on or prior to the second (2nd) anniversary of the Effective Date, two percent (2.0%) of the then outstanding principal amount of the Term Loan Advances
immediately prior to the date of such prepayment; and
(b)
for a prepayment of the Term Loan Advances made after the second (2nd) anniversary of the Effective Date,
but prior to the Term Loan Maturity Date, one percent (1.0%) of the then outstanding principal amount of the Term Loan Advances immediately prior to the date of
such prepayment.
(c)
“Prime Rate” is the rate of interest per annum from time to time published in the money rates section of The Wall Street Journal or any successor
publication thereto as the “prime rate” then in effect; provided that, in the event such rate of interest is less than zero, such rate shall be deemed to be zero for
purposes of this Agreement; and provided further that if such rate of interest, as set forth from time to time in the money rates section of The Wall Street Journal,
becomes unavailable for any reason as determined by Agent, the “Prime Rate” shall mean the rate of interest per annum announced by SVB as its prime rate in effect
at its principal office in the State of California (such SVB announced Prime Rate not being intended to be the lowest rate of interest charged by SVB in connection
with extensions of credit to debtors); provided that, in the event such rate of interest is less than zero, such rate shall be deemed to be zero for purposes of this
Agreement.
“Pro Rata Share” is, as of any date of determination,, with respect to each Lender, a percentage (expressed as a decimal, rounded to the ninth decimal
place) determined by dividing the outstanding principal amount of Term Loan Advances held by such Lender by the aggregate outstanding principal amount of all
Term Loan Advances.
“Registered Organization” is any “registered organization” as defined in the Code or any other applicable law with such additions to such term as may
hereafter be made.
“Removal Effective Date” is defined in Section 10.10(d).
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“Repayment Schedule” means the period of time equal to thirty-six (36) consecutive months; provided, however, upon the occurrence of the Milestone
Event, the Repayment Schedule shall mean the period of time equal to twenty-four (24) consecutive months.
“Representatives” is defined in Section 13.9.
“Requirement of Law” is as to any Person, the organizational or governing documents of such Person, and any law (statutory or common), treaty, rule
or regulation or determination of an arbitrator or a court or other Governmental Authority, in each case applicable to or binding upon such Person or any of its
property or to which such Person or any of its property is subject.
“Responsible Officer” is any of the Chief Executive Officer, President and Chief Financial Officer of Borrower.
“Restricted License” is any material license or other agreement with respect to which Borrower is the licensee (a) that prohibits or otherwise restricts
Borrower from granting a security interest in, or a fixed or floating charge over, Borrower’s interest in such license or agreement or any other property, or (b) for
which a default under or termination of could interfere with the Agent’s right to sell any Collateral.
“SEC” shall mean the Securities and Exchange Commission, any successor thereto, and any analogous Governmental Authority.
“Securities Account” is any “securities account” as defined in the Code or any other applicable law with such additions to such term as may hereafter
be made.
“Subordinated Debt” is indebtedness incurred by Borrower subordinated to all of Borrower’s now or hereafter indebtedness to Agent and the Lenders
(pursuant to a subordination, intercreditor, or other similar agreement in form and substance satisfactory to Agent and the Lenders, entered into between Agent, the
Lenders and the other creditor), on terms acceptable to Agent and the Lenders.
“Subsidiary” is, as to any Person, a corporation, partnership, limited liability company or other entity of which shares of stock or other ownership
interests having ordinary voting power (other than stock or such other ownership interests having such power only by reason of the happening of a contingency) to
elect a majority of the board of directors or other managers of such corporation, partnership or other entity are at the time owned, or the management of which is
otherwise controlled, directly or indirectly through one or more intermediaries, or both, by such Person. Unless the context otherwise requires, each reference to a
Subsidiary herein shall be a reference to a Subsidiary of Borrower.
“SVB” is defined in the preamble hereof.
“Term A Loan Advance” is defined in Section 2.1.1(a).
“Term B Loan Advance” is defined in Section 2.1.1(a).
“Term Loan Advance” and “Term Loan Advances” are each defined in Section 2.1.1(a).
“Term Loan Amortization Date” is February 1, 2020; provided, however, upon the occurrence of the Milestone Event, the Term Loan Amortization
Date shall be February 1, 2021.
“Term Loan Commitment” means, for any Lender, the obligation of such Lender to make a Term Loan Advance as and when available, up to the
principal amount shown on Schedule 1. “Term Loan Commitments” means the aggregate amount of such commitments of all Lenders.
“Term Loan Commitment Percentage” means, as to any Lender at any time, the percentage (carried out to the fourth decimal place) of the Term Loan
Commitments represented by such Lender’s Term Loan Commitment at
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such time. The initial Term Loan Commitment Percentage of each Lender is set forth opposite the name of such Lender on Schedule 1.
“Term Loan Maturity Date” is January 1, 2023.
“Trademarks” means any trademark and servicemark rights, whether registered or not, applications to register and registrations of the same and like
protections, and the entire goodwill of the business of Borrower connected with and symbolized by such trademarks.
“Transfer” is defined in Section 7.1.
“Transition Period” is the period of time commencing upon the Effective Date and continuing through the earlier to occur of (a) March 31, 2019 or (b)
an Event of Default.
“US Borrower” is defined in the preamble of this Agreement.
“Warrant” means, collectively, (a) that certain warrant to purchase stock dated as of the Effective Date between US Borrower and SVB and (b) that
certain warrant to purchase stock dated as of the Effective Date between US Borrower and WestRiver Innovation Lending Fund VIII, L.P., in each case as may be
amended, modified, supplemented and/or restated from time to time.
“WestRiver” is defined in the preamble hereof.
[Signature page follows.]
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the Effective Date.
BORROWER:
ELOXX PHARMACEUTICALS, INC.
By /s/ Gregory Weaver
Name: Gregory Weaver
Title: Chief Financial Officer
ELOXX PHARMACEUTICALS LTD.
By /s/ Gregory Weaver
Name: Gregory Weaver
Title: Chief Financial Officer
AGENT:
SILICON VALLEY BANK, as Agent
By /s/ Lauren Cole
Name: Lauren Cole
Title: Vice President
LENDERS:
SILICON VALLEY BANK
By /s/ Lauren Cole
Name: Lauren Cole
Title: Vice President
WESTRIVER INNOVATION LENDING FUND VIII, L.P
By /s/ Trent Dawson
Name: Trent Dawson
Title: CFO
[Signature Page to Loan and Security Agreement]
SCHEDULE 1
LENDERS AND COMMITMENTS
TERM LOAN COMMITMENTS
Lender
Term A Loan Advance Commitment
Silicon Valley Bank
$7,500,000.00
Term A Loan Advance Commitment
Percentage
50.0000%
WestRiver Innovation Lending Fund
VIII, L.P.
TOTAL
$7,500,000.00
$15,000,000.00
50.0000%
100.0000%
Lender
Term B Loan Advance Commitment
Silicon Valley Bank
$5,000,000.00
Term B Loan Advance Commitment
Percentage
50.0000%
WestRiver Innovation Lending Fund
VIII, L.P.
TOTAL
$5,000,000.00
$10,000,000.00
50.0000%
100.0000%
The Collateral consists of all of Borrower’s right, title and interest in and to the following personal property:
EXHIBIT A
All goods, Accounts (including health-care receivables), Equipment, Inventory, contract rights or rights to payment of money, leases, license
agreements, franchise agreements, General Intangibles (except as provided below), commercial tort claims, documents, instruments (including any promissory
notes), chattel paper (whether tangible or electronic), cash, deposit accounts, certificates of deposit, fixtures, letters of credit rights (whether or not the letter of credit
is evidenced by a writing), securities, and all other investment property, supporting obligations, and financial assets, whether now owned or hereafter acquired,
wherever located; and
all Borrower’s Books relating to the foregoing and any and all claims, rights and interests in any of the above and all substitutions for, additions,
attachments, accessories, accessions and improvements to and replacements, products, proceeds and insurance proceeds of any or all of the foregoing.
Notwithstanding the foregoing, the Collateral does not include (a) any property to the extent that such grant of security interest is prohibited by any
Requirement of Law of a Governmental Authority or constitutes a breach or default under or results in the termination of or requires any consent not obtained under,
any contract, license, agreement, instrument or other document evidencing or giving rise to such property, except to the extent that such Requirement of Law or the
term in such contract, license, agreement, instrument or other document providing for such prohibition, breach, default or termination or requiring such consent is
ineffective under Section 9-406, 9-407, 9-408 or 9-409 of the Code (or any successor provision or provisions) of any relevant jurisdiction or any other applicable law
(including the Bankruptcy Code) or principles of equity; provided, however, that such security interest shall attach immediately at such time as such Requirement of
Law is not effective or applicable, or such prohibition, breach, default or termination is no longer applicable or is waived, and to the extent severable, shall attach
immediately to any portion of the Collateral that does not result in such consequences or (b) any Intellectual Property; provided, however, the Collateral shall include
all Accounts and all proceeds of Intellectual Property. If a judicial authority (including a U.S. Bankruptcy Court) would hold that a security interest in the underlying
Intellectual Property is necessary to have a security interest in such Accounts and such property that are proceeds of Intellectual Property, then the Collateral shall
automatically, and effective as of the date a written approval of the IIA is received pursuant to Section 6.12, include the Intellectual Property to the extent necessary
to permit perfection of Agent’s, for the ratable benefit of the Lenders, security interest in such Accounts and such other property of Borrower that are proceeds of the
Intellectual Property.
Pursuant to the terms of a certain negative pledge arrangement with Agent and the Lenders, Borrower has agreed not to encumber any of its Intellectual
Property without Agent and the Lenders’ prior written consent.
TO:
Date:
FROM: ELOXX PHARMACEUTICALS, INC. and ELOXX PHARMACEUTICALS LTD.
SILICON VALLEY BANK, as Agent, SVB, and WESTRIVER
EXHIBIT B
COMPLIANCE CERTIFICATE
The undersigned authorized officer of ELOXX PHARMACEUTICALS, INC. and ELOXX PHARMACEUTICALS LTD. (jointly and severally,
individually and collectively, “Borrower”) certifies that under the terms and conditions of the Loan and Security Agreement among Borrower, SVB, and WestRiver
(as amended, the “Loan Agreement”), (1) Borrower is in complete compliance for the period ending _______________ with all required covenants except as noted
below, (2) there are no Events of Default, (3) all representations and warranties in the Agreement are true and correct in all material respects on this date except as
noted below; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by
materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and
complete in all material respects as of such date, (4) Borrower, and each of its Subsidiaries, has timely filed all required tax returns and reports, and Borrower has
timely paid all foreign, federal, state and local taxes, assessments, deposits and contributions owed by Borrower except as otherwise permitted pursuant to the terms
of Section 5.8 of the Agreement, and (5) no Liens have been levied or claims made against Borrower or any of its Subsidiaries relating to unpaid employee payroll or
benefits of which Borrower has not previously provided written notification to Agent. Attached are the required documents supporting the certification. The
undersigned certifies that these are prepared in accordance with GAAP consistently applied from one period to the next except as explained in an accompanying
letter or footnotes. The undersigned acknowledges that no borrowings may be requested at any time or date of determination that Borrower is not in compliance with
any of the terms of the Agreement, and that compliance is determined not just at the date this certificate is delivered. Capitalized terms used but not otherwise
defined herein shall have the meanings given them in the Agreement.
Please indicate compliance status by circling Yes/No under “Complies” column.
Reporting Covenants
Required
Complies
Monthly financial statements with
Compliance Certificate
Annual financial statement (CPA Audited)
Monthly within 30 days
FYE within 180 days
10‑Q, 10‑K and 8-K
Board Projections
Within 5 days after filing with SEC
At least annually and within 30 days of
Board approval, and as amended/updated
by Board approval
Yes No
Yes No
Yes No
Yes No
Aggregate balance in ISR Borrower’s Israeli bank accounts: $________ (not to exceed $2,000,000.00)
Other Matters
ve there been any amendments of or other changes to the capitalization table of Borrower
d to the Operating Documents of Borrower or any of its Subsidiaries? If yes, provide
pies of any such amendments or changes with this Compliance Certificate.
Yes
No
The following are the exceptions with respect to the certification above: (If no exceptions exist, state “No exceptions to note.”)
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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-------------------------------------
1
ELOXX PHARMACEUTICALS, INC.
SVB USE ONLY
Received by: _____________________
AUTHORIZED SIGNER
Date: _________________________
Verified: ________________________
AUTHORIZED SIGNER
Date: _________________________
Compliance Status:Yes No
By:
Name:
Title:
ELOXX PHARMACEUTICALS LTD.
By:
Name:
Title:
2
EXHIBIT C
LOAN PAYMENT/ADVANCE REQUEST FORM
Fax To:
Date: _____________________
PAYMENT:
ELOXX PHARMACEUTICALS, INC. and ELOXX PHARMACEUTICALS LTD.
Account #________________________________
To Account #__________________________________________
pal $____________________________________
and/or Interest $________________________________________
(Deposit Account #)
(Loan Account #)
rized Signature:
Name/Title:
ADVANCE:
Phone Number:
ete Outgoing Wire Request section below if all or a portion of the funds from this loan advance are for an outgoing wire.
Account #________________________________
To Account #__________________________________________
(Loan Account #)
(Deposit Account #)
nt of Term Loan Advance $___________________________
rrower’s representations and warranties in the Loan and Security Agreement are true, correct and complete on the date of the request for an advance:
rized Signature:
Name/Title:
Phone Number:
OING WIRE REQUEST:
lete only if all or a portion of funds from the loan advance above is to be wired.
ne for same day processing is noon, Eastern Time
ciary Name: _____________________________
ciary Bank: ______________________________
nd State:
ciary Bank Transit (ABA) #:
ediary Bank:
rther Credit to:
l Instruction:
Amount of Wire: $
Account Number:
(For International Wire Only)
Transit (ABA) #:
Beneficiary Bank Code (Swift, Sort, Chip, e
ning below, I (we) acknowledge and agree that my (our) funds transfer request shall be processed in accordance with and subject to the terms and conditions set forth in
ments(s) covering funds transfer service(s), which agreements(s) were previously received and executed by me (us).
rized Signature: ___________________________
Name/Title: ______________________________
2nd Signature (if required): _______________________________
Print Name/Title: ______________________________________
one #:
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EXHIBIT D
Debenture - Floating Charge
1
DEBENTURE
Made and executed this 30 day of January 2019
WHEREAS,
the undersigned, Eloxx Pharmaceuticals Ltd., a company organized under the laws of the State of Israel with its registered
office at 10 Prof. Menachem Plaut Street, Rehovot, Israel 767062 (hereinafter: the “Pledgor”), intends to receive, jointly and
severally with its parent company Eloxx Pharmaceuticals, Inc., a Delaware corporation (hereinafter: the “Parent
Company”) from Silicon Valley Bank, a California corporation with a registered loan production office at 275 Grove Street,
Suite 2-200, Newton, Massachusetts 02466 in its capacity as an Agent (as defined therein) (the “Agent”) and the several
Lenders specified in the Loan and Security Agreement (as defined below) (each a “Lender” and, collectively, the “Lenders”),
credits, various loans, overdrafts in current account, in revolving debitory account or in any other account, and various
banking facilities and other services (hereinafter: the “Banking Services”) from time to time, including without limitations
pursuant to, for such purpose and on such conditions as specified in the provisions of that certain Loan and Security
Agreement entered into between and among the Agent, the Lenders, the Pledgor and the Parent Company on January 30, 2019
(hereinafter, as may be amended, modified, restated, replaced or supplemented from time to time in accordance with its terms,
and together with the Loan Documents (as defined thereunder), collectively, the “Loan Agreement”);
THEREFORE,
it has been agreed that the Pledgor shall secure the repayment of the various amounts of money which the Pledgor may owe
and/or may be liable to the Agent and/or the Lenders in connection with the granting of the Banking Services and/or the Loan
Agreement and/or in connection with other liabilities not being Banking Services and/or otherwise, all in accordance with the
terms hereinafter contained.
NATURE OF THE DEBENTURE
1.
This Debenture has been made to secure the full and punctual payment of all the sums due and to become due to the
Agent and/or the Lenders from the Pledgor in connection with the granting of the Banking Services to the Pledgor
and/or in connection with the Loan Agreement, including without limitations in connection with the Obligations (as
defined in the Loan Agreement) and/or in connection with other liabilities not being Banking Services or in any other
manner whatsoever, whether due from the Pledgor alone or jointly with others, whether the Pledgor may have
incurred or will incur liability with respect thereto in the future, as obligor and/or as guarantor and/or as endorser or
otherwise, now due or becoming due in the future, which are payable prior to the realisation of the collateral security
to which this Debenture is applicable or subsequent thereto, whether due absolutely or contingently, directly or
indirectly, unlimited in amount together with interest, commissions, charges, fees and expenses of whatever nature,
including costs of realising the collateral security, reasonable documented external lawyers’ fees, insurance, stamp
duty and any other payments arising from this Debenture and together with any nature of linkage differences due and
becoming due from the Pledgor to the Agent and/or the Lenders in any manner whatsoever in respect of linked
principal and interest and any other linked sum (all the foregoing sums being jointly and severally hereinafter referred
to as the “Secured Sums”).
Debenture - Floating Charge
THE CHARGE
2
2.
As collateral security for the full and punctual payment of all of the Secured Sums (whether at stated maturity,
acceleration or otherwise), and without derogating from any other security, the Pledgor hereby absolutely and
unconditionally charges and pledges in favour of the Agent and its successors, for the ratable benefit of the Lenders,
by way of a first ranking floating charge all of the Pledgor's property, assets and rights, now or at any time belonging
to or acquired by the Pledgor and the profits and benefits derived therefrom, (other than Intellectual Property, as such
term is defined under the Loan Agreement, provided, however, that the Assets Subject to a Floating Charge shall
include all Accounts and all proceeds of Intellectual Property (as such terms are defined under the Loan Agreement),
and if a judicial authority would hold that a security interest in the underlying Intellectual Property is necessary to
have a security interest in such Accounts and such property that are proceeds of Intellectual Property, then the Assets
Subject to a Floating Charge shall automatically, and effective as of the Effective Date (as such terms are defined
under the Loan Agreement), include the Intellectual Property to the extent necessary to permit perfection of Agent’s,
for the ratable benefit of the Lenders, security interest in such Accounts and such other property of Borrower that are
proceeds of the Intellectual Property) including without derogating from the generality of the aforementioned, the
property, assets and rights set forth below (hereinafter together, the “Assets Subject to a Floating Charge”):
(a)
(b)
(c)
(d)
All the assets, monies, property and rights of any kind whatsoever without exception, whether now or hereafter at
any time in the future owned by or in the possession of the Pledgor in any manner or way whatsoever (including, for
the avoidance of any doubt, and without limitation, all accounts, license and royalty fees and other revenues,
proceeds, or income arising out of or relating to any Intellectual Property);
All the current assets, without exception, now or hereafter at any time in the future owned by or in the possession of
the Pledgor in any manner or way whatsoever, the expression 'current assets' meaning all the assets, monies,
property and rights of any kind with the exception of land, buildings and fixtures;
All the fixed assets now or hereafter at any time in the future owned, belonging to, acquired by or in possession of
the Pledgor in any manner or way whatsoever, the expression 'fixed assets' to include, inter alia, equipment, land,
buildings, fixtures and fittings and fixed plant and machinery thereon;
All the stocks, shares, debentures, bonds, notes, instruments, Bills drawn or made by others, securities and other
documents or instruments of any kinds owned by the Pledgor and/or which the Pledgor has any right in connection
thereto or is entitled to give instructions to sell now and at any time in the future, held by the Agent and/or by others
and/or any rights in respect thereof;
3.
4.
As further collateral security for the full and punctual payment of all of the Secured Sums, the Pledgor hereby absolutely
and unconditionally pledges and charges to the Agent and its successors, for the ratable benefit of the Lenders, by way of a
first ranking fixed pledge and charge the uncalled and/or called but unpaid share capital of the Pledgor and its reputation
and goodwill of the Pledgor, as presently and in the future at any time existing (hereinafter, jointly and severally – the
“Charged Assets”).
As further collateral security for the full and punctual payment of all of the Secured Sums, the Pledgor hereby absolutely
and unconditionally assigns to the Agent, for the ratable benefit of the Lenders, by way of first ranking fixed charge and
pledge all rights, claims and remedies of
Debenture - Floating Charge
3
the Pledgor, including without limitation, any right to exemptions, relief, or reduction under and deriving from the Income
Tax Ordinance [New Version], 5721-1961 and/or the Land Appreciation Tax Law, 5723-1963 and/or the Property Tax and
Compensation Fund Law, 5721-1961 and/or any other applicable law.
5.
As further collateral security for the full and punctual payment of all the Secured Sums, the Pledgor hereby pledges and
charges to the Agent, for the ratable benefit of the Lenders, all such securities, documents and instruments, Bills drawn or
made by others which the Pledgor has delivered or may deliver to the Agent from time to time whether for collection,
safekeeping or otherwise (hereinafter the “Charged Documents”) and upon the delivery thereof shall be and be deemed
pledged and charged to the Agent, for the ratable benefit of the Lenders, by way of a first ranking fixed pledge and charge
according to the terms of this Debenture the provisions of which, mutatis mutandis, shall apply to the charge and pledge
thereof. The Agent shall be exempt from taking any action whatsoever in connection with the Charged Documents and
shall not be liable for any loss or damage which may be caused in connection therewith and the Pledgor undertakes to
indemnify the Agent in any event that the Agent is sued for any such loss of damage by others.
The Pledgor hereby waives in advance any defence based on prescription in relation to the Charged Documents.
6.
The Assets Subject to a Floating Charge, the Charged Assets and the Charged Documents shall be hereinafter called the
“Charged Property”.
The pledge and charge created by operation of this Debenture shall apply to all and any rights to compensation or indemnity which
may accrue to the Pledgor by reason of the loss of, damage to or appropriation of the Charged Property.
DECLARATIONS OF THE PLEDGOR
7.
The Pledgor hereby declares as follows:
(a)
(b)
(c)
(d)
That the Charged Property is not charged, pledged or attached in favour of any other persons or parties other than
any charge, pledge or attachment created by any Permitted Lien, as defined under the Loan Agreement provided
however, that to the extent that such Permitted Liens are specific first ranking limited-in-amount liens created by
Pledgor in favour of another bank or financial institution, then, with respect to each such Permitted Liens, for as
long as it is in effect, the terms of this Debenture, including without limitation, the definition of “Charged Property”
hereunder shall be construed in a manner to give full force and effect to such Permitted Lien and enable this
Debenture to be enforced to the maximum extent possible under applicable law or under such Permitted Liens
agreements.
That the Charged Property is, in its entirety, in the exclusive possession and ownership of the Pledgor, except as
specifically permitted under the Loan Agreement.
That no restriction or condition of law or any agreement exists or applies to the ability of the Pledgor to transfer or
charge the Charged Property, except as otherwise provided or permitted hereunder or under the Loan Agreement,
including, inter alia, the approval of the Israeli Innovation Authority to be provided by Pledgor in accordance with
the provisions of the Loan Agreement.
That the Pledgor is capable of and entitled to charge the Charged Property in accordance with the provisions hereof
and any applicable law.
Debenture - Floating Charge
(e)
That no assignment of rights or other disposition has occurred derogating from the value of the Charged Property.
4
(f)
The Pledgor has received all permits, consents and authorizations that shall be necessary or required to consummate
this Debenture.
COVENANTS OF THE PLEDGOR
8.
The Pledgor hereby covenants as follows, as long as the floating charge created by this Debenture is in force and until the
Agent has certified in writing that this Debenture is null:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
To hold the Charged Property in accordance with the provisions of the Loan Agreement;
To use and deal with the Charged Property with the utmost care and to notify the Agent of any case of material
disrepair, damage, loss, fault or defect affecting same and to remedy any disrepair, damage, fault or defect affecting
the Charged Property due to use or for any other reason, and to be liable towards the Agent for any disrepair,
damage, fault or defect as aforesaid;
To allow any representative of the Agent, at any time, to inspect and examine the condition of the Charged Property
wherever the Charged Property may be situated, in accordance with the provisions of the Loan Agreement;
Following the occurrence of any of the events enumerated in Section 16 hereof, upon Agent's first demand, to
deliver to the Agent or to any bailee on its behalf, the Charged Property. In the event of the refusal of the Pledgor to
comply with the provisions of this sub-clause, the Agent may, without the consent of the Pledgor, remove the
Charged Property from the Pledgor's possession and hold the same or deliver the same to a bailee on behalf of the
Agent at the expense of the Pledgor. Where the Charged Property has been so delivered to a bailee, the Agent shall
be exempt from any loss or damage which for any reason may be caused to the Charged Property;
Not to sell, assign, dispose of, surrender, relinquish, waive or transfer any of the Charged Property and not to allow
any person to do any of the foregoing acts, without the prior written consent of the Agent, except as specifically
permitted under the Loan Agreement;
Except as stated otherwise in the Loan Agreement, to notify the Agent forthwith upon its becoming aware of the
levying of any attachment on the Charged Property, to forthwith notify the attachor of the charge hereunder and to
take at the Pledgor's own expense immediately and without delay all such measures as are required for discharging
such attachment;
Not to charge or pledge in any manner or way the Charged Property and any Intellectual Property (as defined under
the Loan Agreement) by conferring any rights ranking pari-passu, prior to or deferred to the rights of the Agent and
not to make any assignment of any right which the Pledgor may have in the Charged Property without receiving the
prior written consent of the Agent, all except as specifically permitted under the Loan Agreement;
To be liable towards the Agent for any defect in the Pledgor's title to the Charged Property and/or any default
thereunder and to bear the responsibility for the authenticity, regularity and correctness of all the signatures,
endorsements and particulars of any Bills, documents, instruments and securities which have been or may be
delivered to the Agent by way of collateral security;
Debenture - Floating Charge
5
(i)
(j)
(k)
(l)
To pay when due all taxes and compulsory payments levied against the Charged Property and/or the income
accruing thereon under any law and to furnish the Agent, at its request, with all the receipts for such payments
(unless provided otherwise under the Loan Agreement). If the Pledgor fails to make such payments when due, the
Agent may pay the same for the account of the Pledgor and debit the Pledgor with the payment thereof coupled with
expenses, and interest at the Default Rate (as defined in the Loan Agreement). Such payments shall be secured by
this Debenture;
Not to wind up, liquidate or dissolve, sell, exchange, lease, transfer or otherwise dispose of all or substantially all its
properties or other assets;
That no structural change is or will be effected in the Pledgor and/or that no change of control in the Pledgor will
occur, except as specifically permitted under the Loan Agreement.
Not to create, incur, assume, allow, or suffer to be created any Lien (as defined under the Loan Agreement) on any
of its property, or assign or convey any right to receive income, including the sale of any Accounts (as defined
under the Loan Agreement), or permit its subsidiaries to do so, except for Permitted Liens (as defined under the
Loan Agreement), or permit any Collateral (as defined under the Loan Agreement) not to be subject to the first
priority security interest granted in the Loan Agreement, or the charges granted hereunder or under any other Loan
Document (as defined under the Loan Agreement), or enter into any agreement, document, instrument or other
arrangement (except with or in favor of Agent) with any Person (as defined in the Loan Agreement) which directly
or indirectly prohibits or has the effect of prohibiting Pledgor or its subsidiaries from assigning, mortgaging,
pledging, granting a security interest or charge in, over or upon, or encumbering any of Pledgor’s and/or the Parent
Company's or any other subsidiary's Intellectual Property (as defined under the Loan Agreement), all except as
specifically permitted under the Loan Agreement.
9.
The Pledgor undertakes to notify the Agent forthwith upon its becoming aware of any of the following:
(a)
(b)
(c)
(d)
(e)
INSURANCE
of any claim of right to any collateral security given to the Agent to which this Debenture is applicable and/or of
any execution or injunction proceedings or other steps taken to attach, preserve or realise any such collateral
security;
of any of the events enumerated in Clause 15 hereof;
of any material reduction in value of any collateral security granted or which may be granted by the Pledgor;
of any application filed for the winding-up of the Pledgor's affairs or for the appointment of a receiver over the
Pledgor's assets as well as any resolution regarding any structural change in the Pledgor or any intention to do so;
of any change of address of the Pledgor.
10.
The Pledgor hereby undertakes to keep the Charged Property insured at all times as provided in the Loan Agreement,
Debenture - Floating Charge
6
11.
All the rights of the Pledgor deriving from the insurance of the Charged Property, as in force at any relevant time and under
any other law, whether or not assigned to the Agent as aforesaid, are hereby charged to the Agent, for the ratable benefit of
the Lenders, by way of a first ranking fixed charge and pledge.
INTEREST
12.
The Agent shall be entitled to calculate interest on the Secured Sums at such rate as has been or may be agreed upon from
time to time between the Agent and the Pledgor according to the terms of the Loan Agreement.
REPAYMENT DATES
13.
14.
15.
16.
The Pledgor hereby undertakes to pay the Agent all and any of the Secured Sums promptly on the maturity dates
prescribed or which may be prescribed therefore from time to time, all in accordance with the provisions of the Loan
Agreement.
Prepayments of the Secured Sums shall be made subject to and in accordance with the provisions of the Loan Agreement,
and the Pledgor shall not be entitled to redeem all or any of the Charged Property by discharging the Secured Sums and/or
any part thereof prior to their prescribed maturity dates and/or full prepayments of the Secured Sums in accordance with
the provisions of the Loan Agreement, unless the redemption is being made subject to and in accordance with the
provisions of the Loan Agreement.
Neither the Pledgor nor any person having a right liable to be affected by the pledges and charges hereby created or the
realisation thereof shall have any right under Section 13(b) of the Pledges Law, 5727-1967, or any other statutory
provisions in substitution therefore.
Without derogating from the generality of the provisions of this Debenture, the Agent shall be entitled to demand the
immediate payment of the Secured Sums and to debit any account of the Pledgor with the amount thereof in any one of the
events numerated below, in which case the Pledgor undertakes to pay the Agent all of the Secured Sums, and the Agent
shall be entitled to take whatever steps it sees fit, subject to applicable law, for the collection of the Secured Sums and in
particular to crystallise the floating charge on the Assets subject to a Floating Charge as provided in Clause 20(a) hereof
and to realise, at the Pledgor's expense, the collateral securities by any means allowed by law;
(a)
(b)
The Pledgor is in breach of (i) any of its obligations, undertakings, representations or warranties under Sections
7(b), 7(d), 7(f), 8(b), 8(d), 8(e), 8(g) through (l), 9(b), 10 and 11 of this Debenture, or (ii) any of its other
obligations, undertakings, representations or warranties under this Debenture, which breach under this clause (ii)
has not been cured within 5 Business Days after the occurrence thereof, except to the extent that such breach could
reasonably be expected to have a Material Adverse Effect (as defined in the Credit Agreement), in which case such
cure period shall not apply (the foregoing shall not derogate from any right, under any law, granted to the Agent or
the Lenders in respect of any other breach by Pledgor); and/or;
There occurs and continues to subsist (i) an Event of Default (as defined under the Loan Agreement), or (ii) any
other event which gives the Agent right to demand payment, under any document signed between the Pledgor and
the Agent and/or the Lenders, (including, inter alia, under the Loan Agreement), provided that any period (if any)
given to the
Debenture - Floating Charge
7
Pledgor to effect such payment under such document shall have elapsed and as long as such payment is not actually
effected;
RIGHTS OF THE AGENT (ON BEHALF OF THE LENDERS)
17.
18.
19.
20.
The Agent shall have the right of possession, lien, set-off and charge over any amounts, assets and/or rights including
securities, coins, gold, banknotes, documents in respect of goods, insurance policies, Bills, assignments of rights, deposits,
collaterals and their countervalue, in the possession of or under the control of the Agent at any time for or on behalf of the
Pledgor, including such as have been delivered for collection, as security, for safe-keeping or otherwise. The Agent shall be
entitled to retain the said assets until payment in full of the Secured Sums or to realise them by selling them and applying
the countervalue thereof in whole or in part in payment of the Secured Sums, and in any event in accordance with
applicable law. Nothing contained herein shall limit the rights of set off of any Lender provided in the Loan Agreement.
The Pledgor confirms that the Agent's and the Lenders’ books, accounts and entries shall be binding upon the Pledgor,
shall be deemed to be correct and shall serve as prima facie evidence against the Pledgor in all their particulars, including
all reference to the computation of the Secured Sums, the particulars of the Bills, guarantees and other collateral securities
and any other matter related hereto.
Without derogating from the other provisions contained in this Debenture, any waiver, extension, concession, acquiescence
or forbearance (hereinafter: “waiver”) on the Agent's part as to the non-performance, partial performance or incorrect
performance of any of the Pledgor's obligations pursuant to this Debenture, such waiver shall not be treated as a waiver on
the part of the Agent of any rights but as a limited consent given in respect of the specific instance.
In any of the events enumerated in Clause 16 hereof, and subject to the provisions of The Encouragement of Research,
Development and Technological Innovation in the Industry Law 5744-1984;
(a) the Agent shall be entitled to adopt all the measures it deems fit, subject to any applicable law, in order to recover the Secured
Sums and realise all of its rights hereunder, including the realisation of the Charged Property, in whole or in part, and to apply the
proceeds thereof to the Secured Sums without the Agent first being required to realise any other guarantees or collateral securities, if
such be held by the Agent.
Should the Agent decide to realise securities, Bills and other negotiable instruments, in accordance with Section 4(2) of the
(b)
Pledges Law 5727-1967, then three (3) days' advance notice regarding the steps that the Agent intends to take shall be deemed to be
reasonable advance notice for the purpose of Section 19(b) of the Pledges Law, 5727-1967, or any other statutory provisions in
substitution therefor.
(c)
As long as the Secured Sums are not paid in full, the Agent may, subject to any applicable law, as attorney-in-fact of the
Pledgor (and, for the purpose hereof, the Pledgor irrevocably appoints the Agent to be its attorney-in-fact for the benefit of the
Lenders), sell all or any of the Charged Property by public auction or otherwise, by itself or through others, for cash or instalments
thereof or otherwise, at a price and on such terms as the Agent in its absolute discretion shall deem fit, and likewise the Agent may of
its own accord or through the court or an execution office, realise the Charged Property or any other property, inter alia, by appointing
a receiver or receiver and manager on behalf of the Agent, who shall be empowered, inter alia,:
(1)
to call in all or any part of the Charged Property.
Debenture - Floating Charge
(2)
to carry on or to participate in the management of the business of the Pledgor, as they see fit.
8
(3)
(4)
to sell or agree to the sale of the Charged Property, in whole or in part, to dispose of same or agree to dispose of
same in such other manner on such terms as they deem fit.
to make such other arrangements regarding the Charged Property or any part thereof as they deem fit.
(d)
All income to be received by the receiver or the receiver and manager from the Charged Property as well as any proceeds
to be received by the Agent and/or by the receiver or receiver and manager from the sale of the Charged Property or any part thereof
shall be applied, subject to any applicable law and the provisions of the Loan Agreement, in such order as Agent shall determine in its
sole discretion. provided, in the event that Agent has independently sold any Charged Property, that any amount remaining after the
payment to the Lenders of the Secured Sums in full, shall be transferred to the Pledgor, subject to the provisions of applicable law.
21.
Should the payment date of the Secured Sums or any part thereof not yet have fallen due at the time of the sale of the
Charged Property, or the Secured Sums be due to the Agent contingently only, then the Agent shall be entitled to recover
out of the proceeds of the sale an amount sufficient to cover the Secured Sums and the amount so recovered shall be
charged to the Agent as security for, and be held by the Agent until the discharge in full of, the Secured Sums.
NATURE OF THE COLLATERAL SECURITY
22.
23.
24.
25.
The collateral securities which have been or may be given to the Agent under this Debenture shall be continuing and
revolving securities and shall remain in force until all Secured Sums have been fully discharged and the Agent, on behalf
of the Lenders, has certified in writing that this Debenture is null. After the Secured Sums have been fully discharged, the
Agent shall promptly certify in writing that this Debenture is null, and shall execute and provide the Pledgor with any
documents reasonably necessary in order to remove the charge created by this Debenture.
All collateral securities and guarantees which have been or may be given to the Agent for payment of the Secured Sums
shall be independent of one another.
The nature and effect of the collateral securities to which this Debenture is applicable shall not be affected nor shall the
validity of any of the securities and obligations of the Pledgor hereunder be impaired or affected by any compromise,
concession, granting of time or other like release consented to by the Agent with respect to the Pledgor and/or its
subsidiaries or by any variation in the Pledgor's and/or its subsidiaries’ obligations towards the Agent in connection with
the Secured Sums or by any release or waiver by the Agent of any other collateral security or guarantees.
In any of the events enumerated in Clause 16 hereof, the Agent may deposit all or any of the collateral given or which may
be given pursuant to this Debenture with a bailee of its own choosing, at its discretion and at the Pledgor's expense, and
may substitute such bailee with another from time to time. The Agent may register all or any of such collaterals with any
competent authority in accordance with any law and/or in any public register.
RIGHT OF ASSIGNMENT
Debenture - Floating Charge
9
26.
The Agent may at any time, at its own discretion and without the Pledgor's consent being required, assign this Debenture
and its rights arising thereunder, including the collaterals in whole or in part to any assignee of Agent’s rights under the
Loan Agreement. Such assignment may be effected by endorsement on this Debenture or in any other way the Agent or
any subsequent assignor deems fit.
NOTICE OF OBJECTION
27.
The Pledgor undertakes to notify the Agent in writing of any objection or contention it may have regarding any statement
of account, extract thereof, certificate or notice received by it from the Agent including information received through any
automatic terminal facility. Where no such objection or contention is received by the Agent, then the Pledgor will be
deemed to have confirmed the correctness thereof.
EXPENSES
28.
All the expenses in connection with this Debenture as detailed in the Loan Agreement and in any other documents signed
between the Agent and/or the Lenders and the Pledgor in connection with the Banking Services and in accordance
therewith, including the fee for preparing credit and security documents, the stamping and registration of documents, and
all and any expenses involved in the realisation of the collateral security and institution of proceedings for collection
(including reasonable documented fees of the Agent's external lawyers), insurance, safe-keeping, maintenance and repair of
the Charged Property shall be paid by the Pledgor to the Agent on its first written demand, together with interest at the
Default Rate from the date demand was made until payment in full, and until payment in full, all the above expenses
together with interest thereon shall be secured by this Debenture. The Agent may debit the Pledgor with the aforesaid
expenses, together with interest thereon.
29.
[Reserved[
INTERPRETATION; AMENDMENT
30.
31.
Any of the representations, warranties and covenants made by Pledgor hereunder shall be in addition to, and shall not
derogate in any manner from, any representations, warranties and covenants made by Pledgor under the Loan Agreement
and any other document related to the granting of the Banking Services. In case of any conflict between this Debenture
and Loan Agreement, including with respect to interest, commissions, charges, fees and expenses (specifically excluding
the specific rights of the Lenders in connection with the creation and realisation of the security interest hereunder), the
provisions of the Loan Agreement shall prevail.
In this Debenture - (a) the singular includes the plural and vice versa; (b) the masculine gender includes the feminine
gender and vice versa; (c) “Agent” means Silicon Valley Bank and any of its branches existing on the date hereof and/or to
be subsequently opened, wherever they may be, its assigns, successors, or attorneys-in-fact; (d) “Bills” means: promissory
notes, bills of exchange, cheques, undertakings, guarantees, sureties, assignments, bills of lading, deposit notes and any
other negotiable instruments; (e) “Interest at the Default Rate” means interest at such default rate as is defined in the
Loan Agreement; (f) the headings are only indicative and are not to be used in construing this Debenture; (g) the recitals
hereto form an integral part hereof.
Debenture - Floating Charge
10
Unless otherwise defined herein, terms capitalized herein shall have the meanings ascribed to them in the Loan Agreement
32.
33.
Any term of this Debenture may be amended and the observance of any term hereof may be waived (either prospectively
or retroactively and either generally or in a particular instance) with the written consent of both parties only.
To the extent required, this Debenture may be translated into Hebrew for the sole purpose of the registration and filing of
this Debenture with the Israeli Registrar of Companies and/or any other relevant Israeli official registrations.
Notwithstanding the aforesaid, the executed English version of this Debenture shall prevail and supersede for all purposes
and for all respects, in the event of any discrepancy or inconsistency between the English version and the translation
NOTICES AND WARNINGS
34.
(a) Each communication to be made under this Debenture shall be made in writing and, unless otherwise stated, may be made also by
facsimile transmission or by electronic mail.
(b) Each communication or document to be made or delivered by each party to another pursuant to this Debenture shall (unless that
other party has by written notice, specified another address) be made or delivered to that party, addressed as follows:
(i)
if to the Pledgor:
Eloxx Pharmaceuticals Ltd.
10 Prof. Menachem Plaut Street
Rehovot, Israel 7670621
Attn.: Greg Weaver
Email: greg@eloxxpharma.com
With a copy to (which shall not be deemed notice):
Meitar Liquornik Geva Leshem Tal, Law Offices
16 Abba Hillel Road, Ramat Gan, 5250608
Attn: Dana Yagur, Adv.
Fax: (972)-3-610-3100
Email: yagurd@meitar.com
Debenture - Floating Charge
(ii)
if to the Agent:
11
Silicon Valley Bank
275 Grove Street, Suite 2-200
Newton, Massachusetts 02466
Attn: Lauren Cole
Email: LCole@svb.com
with a copy to:
Shibolet & Co. with Raved, Magriso, Benkel & Co.
4 Berkowitz Street, Tel-Aviv 6423806, Israel
Attn: Einat Weidberg, Adv.
Fax: +972-3-7778444
Email: E.weidberg@shibolet.com
and shall be deemed to have been made or delivered (a) upon the earlier of actual receipt and five (5) business days after deposit in
regular mail, first class, registered or certified mail return receipt requested, with proper postage prepaid; (b) upon transmission, when
sent by electronic mail or facsimile transmission with receipt confirmation; (c) one (1) Business Day after deposit with a reputable
overnight courier with all charges prepaid; or (d) when delivered, if hand-delivered by messenger.
GOVERNING LAW AND PLACE OF JURISDICTION
35.
(a)This Debenture shall be construed in accordance with the laws of the State of Israel.
(b)The exclusive place of jurisdiction for the purpose of this Debenture is hereby established as the competent court of law in
Israel situated in Tel Aviv-Jaffa.
*****
Debenture - Floating Charge
12
IN WITNESS WHEREOF THE PARTIES HAVE SIGNED THIS DEBENTURE OF
FLOATING CHARGE
ELOXX PHARMACEUTICALS LTD.
/s/__Gregory Weaver___________________________
By: Gregory Weaver
Title: Chief Financial Officer
SILICON VALLEY BANK
/s/__Lauren Cole___________________________
By: Lauren Cole
Title: Vice President
[Signature Page – Eloxx Pharmaceuticals Ltd – Floating Charge Debenture]
EXHIBIT D-1
Debenture – Fixed Charge
DEBENTURE
Made and executed this 30 day of January 2019
WHEREAS,
the undersigned, Eloxx Pharmaceuticals Ltd, a limited liability company organised and existing under the laws of the State of
Israel with its registered office at 10 Prof. Menachem Plaut Street, Rehovot, Israel 767062 (hereinafter: the “Pledgor”),
intends to receive, jointly and severally with its parent company Eloxx Pharmaceuticals, Inc. a Delaware corporation
(hereinafter: the “Parent Company”) from Silicon Valley Bank, a California corporation with a registered loan production
office at 275 Grove Street, Suite 2-200, Newton. Massachusetts 02466 in its capacity as an Agent (as defined therein) (the
“Agent”) and the several Lenders specified in the Loan and Security Agreement (as defined below) (each a “Lender” and,
collectively, the “Lenders”), credits, various loans, overdrafts in current account, in revolving debitory account or in any other
account, and various banking facilities and other services (hereinafter: the “Banking Services”) from time to time, including
without limitations pursuant to, for such purpose and on such conditions as specified in the provisions of that certain Loan and
Security Agreement entered into between and among the Agent, the Lenders, the Pledgor and the Parent Company on January
30, 2019 (hereinafter, as may be amended, modified, restated, replaced or supplemented from time to time in accordance with
its terms, the “LSA”, and together with the Loan Documents (as defined thereunder), collectively, the “Loan Agreement”);
THEREFORE,
it has been agreed that the Pledgor shall secure the repayment of the various amounts of money which the Pledgor may owe
and/or may be liable to the Agent and/or the Lenders in connection with the granting of the Banking Services and/or the Loan
Agreement and/or in connection with other liabilities not being Banking Services and/or otherwise, all in accordance with the
terms hereinafter contained.
NATURE OF THE DEBENTURE
1.
This Debenture has been made to secure the full and punctual payment of all the sums due and to become due to the Agent
and/or the Lenders from the Pledgor in connection with the granting of the Banking Services to the Pledgor and/or in
connection with the Loan Agreement, including without limitations in connection with the Obligations (as defined in the
Loan Agreement) and/or in connection with other liabilities not being Banking Services or in any other manner
whatsoever, whether due from the Pledgor alone or jointly with others, whether the Pledgor may have incurred or will
incur liability with respect thereto in the future, as obligor and/or as guarantor and/or as endorser or otherwise, now due or
becoming due in the future, which are payable prior to the realisation of the collateral security to which this Debenture is
applicable or subsequent thereto, whether due absolutely or contingently, directly or indirectly, unlimited in amount
together with interest, commissions, charges, fees and expenses of whatever nature, including costs of realising the
collateral security, reasonable documented external lawyers’ fees, insurance, stamp duty and any other payments arising
from this Debenture and together with any nature of linkage differences due and becoming due from the Pledgor to the
Agent and/or the Lenders in any manner whatsoever in respect of linked principal and interest and any other linked sum
(all the foregoing sums being jointly and severally hereinafter referred to as the “Secured Sums”).
Debenture – Fixed Charge
PLEDGE AND FIXED CHARGE
2.
3.
4.
As collateral security for the full and punctual payment of all of the Secured Sums (whether at stated maturity,
acceleration or otherwise), and without derogating from any other security, the Pledgor hereby absolutely and
unconditionally charges and pledges to the Agent and its successors, for the ratable benefit of the Lenders, by way of
a first ranking fixed charge and pledge, and by an assignment by way of pledge, as applicable, all Pledgor's rights,
whether now existing or thereafter created, (A) (i) to receive funds from all of its customers, including without
limitations the customers listed under Schedule D-2 of the LSA (the “Customers List”), and (ii) in and to each
outstanding account including without limitations the accounts specified in Schedule D-3 of the LSA (the “Pledged
Accounts”); and (B) in and to all the fixed assets listed under Appendix A (the “Equipment List”) (hereinafter, (A)
and (B) , jointly and severally - the “Charged Property”).
It is hereby agreed and acknowledged that the description of the Charged Property, including without limitations, the Customers List,
Pledged Accounts and Equipment List, shall be amended and updated from time to time by the Pledgor, in accordance with the provisions
of the Loan Agreement.
The pledge and charge created by operation of this Debenture shall apply to all and any rights to compensation or
indemnity which may accrue to the Pledgor by reason of the loss of, damage or appropriation of the Charged
Property.
The Pledgor shall have the right to receive and use all payments pursuant to and accordance with the Pledged
Accounts, subject to, and as specifically permitted under, the terms and provisions of the Loan Agreement.
DECLARATIONS OF THE PLEDGOR
5.
The Pledgor hereby declares as follows:
(a)
(b)
(c)
(d)
(e)
(f)
That the Charged Property is not charged, pledged or attached in favour of any other persons or parties;
That the Charged Property is, in its entirety, in the exclusive possession and ownership of the Pledgor or in the
possession or under control of the Bank, except as otherwise specifically provided or permitted under the Loan
Agreement;
That no restriction or condition of law or any agreement exists or applies to the ability of the Pledgor to transfer
or charge the Charged Property;
That the Pledgor is capable of and entitled to charge the Charged Property in accordance with the provisions
hereof and any applicable law;
That no assignment of rights or other disposition has occurred derogating from the value of the Charged Property.
The Pledgor has received all permits, consents and authorizations that shall be necessary or required to
consummate this Debenture.
Debenture – Fixed Charge
COVENANTS OF THE PLEDGOR
6.
The Pledgor hereby covenants as follows, as long as the fixed charge created by this Debenture is in force and until
the Agent has certified in writing that this Debenture is null:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
To hold the Charged Property in accordance with the provisions of the Loan Agreement;
To observe and perform, in all material respects, all covenants and obligations of the Pledgor in connection with each Pledged
Account, and any of the related agreements to which Pledgor is a party or by which it is bound;
To use and deal with the Charged Property with utmost care and to notify the Agent of any case of material disrepair, damage,
loss, fault or defect affecting same and to remedy any disrepair, damage, fault or defect affecting the Charged Property due to
use or for any other reason, and to be liable towards the Agent for any disrepair, damage, fault or defect as aforesaid;
To allow any representative of the Agent, at any time, to inspect and examine the condition of the Charged Property wherever
the Charged Property may be situated, in accordance with the provisions of the Loan Agreement;
Following the occurrence of any of the events enumerated in Section Error! Reference source not found. 14 hereof, upon
Agent's first demand, to deliver to the Agent or to any bailee on its behalf, the Charged Property. In the event of the refusal of
the Pledgor to comply with the provisions of this sub-clause, the Agent may, without the consent of the Pledgor, remove the
Charged Property from the Pledgor's possession and hold the same or deliver the same to a bailee on behalf of the Agent at the
expense of the Pledgor. Where the Charged Property has been so delivered to a bailee, the Agent shall be exempt from any loss
or damage which for any reason may be caused to the Charged Property;
Not to sell, assign, dispose of, relinquish or waive, surrender or transfer any of the Charged Property and not to allow any
person to do any of the foregoing acts, without the prior written consent of the Agent except as specifically permitted under the
Loan Agreement;
[Reserved];
Except as stated otherwise in the Loan Agreement, to notify the Agent forthwith upon its becoming aware of the levying of any
attachment on the Charged Property, to forthwith notify the attachor of the charge hereunder and to take at the Pledgor's own
expense immediately and without delay all such measures as are required for discharging such attachment;
Not to charge or pledge in any manner or way the Charged Property by conferring any rights ranking pari-passu, prior to or
deferred to the rights of the Agent and not to make any assignment of any right which the Pledgor may have in the Charged
Property without receiving the prior written consent of the Agent except as specifically permitted under the Loan Agreement;
To be liable towards the Agent for any defect in the Pledgor's title to the Charged Property and/or any default thereunder and to
bear the responsibility for the authenticity, regularity and correctness of all the signatures, endorsements and particulars of any
Bills, documents, instruments and securities which have been or may be delivered to the Agent by way of collateral security;
Debenture – Fixed Charge
(k)
(l)
(m)
(n)
To pay when due all taxes and compulsory payments levied against the Charged Property and/or the income accruing thereon
under any law and to furnish the Agent, at its request, with all the receipts for such payments (unless provided otherwise under
the Loan Agreement). If the Pledgor fails to make such payments when due, the Agent may pay the same for the account of the
Pledgor and debit the Pledgor with the payment thereof coupled with expenses, and interest at the Default Rate (as defined in
the Loan Agreement). Such payments shall be secured by this Debenture;
Not to wind up, liquidate or dissolve, sell, exchange, lease, transfer or otherwise dispose of all or substantially all its properties
or other assets;
That no structural change is or will be effected in the Pledgor and/or that no change of control in the Pledgor will occur, except
as specifically permitted under the Loan Agreement;
Not to create, incur, assume, allow, or suffer to be created any Lien (as defined under the Loan Agreement) on any of its
property, or assign or convey any right to receive income, including the sale of any Accounts (as defined under the Loan
Agreement), or permit its subsidiaries, to do so, except for Permitted Liens (as defined under the Loan Agreement), or permit
any collateral not to be subject to the first priority security interest granted in the Loan Agreement, or the charges granted
hereunder or under any other Loan Document (as defined under the Loan Agreement), or enter into any agreement, document,
instrument or other arrangement (except with or in favor of Agent) with any Person (as defined in the Loan Agreement) which
directly or indirectly prohibits or has the effect of prohibiting Pledgor or its subsidiaries from assigning, mortgaging, pledging,
granting a security interest or charge in, over or upon, or encumbering any of Pledgor’s and/or the Parent Company's or any
other subsidiary's Intellectual Property (as defined under the Loan Agreement), all except as specifically permitted under the
Loan Agreement.
7.
The Pledgor undertakes to notify the Agent forthwith upon its becoming aware of any of the following:
(a)
(b)
(c)
(d)
(e)
INSURANCE
of any claim of right to any collateral security given to the Agent to which this Debenture is applicable and/or of any execution
or injunction proceedings or other steps taken to attach, preserve or realise any such collateral security;
of any of the events enumerated in Clause 14 hereof;
of any material reduction in value of collateral security granted (including if caused by any default under any agreement related
to the Pledged Accounts or the infringements of any intellectual property being a collateral security granted or which may be
granted by the Pledgor);
of any application filed for the winding-up of the Pledgor’s affairs or for the appointment of a receiver over the Pledgor’s
assets as well as any resolution regarding any structural change in the Pledgor or any intention to do so;
of any change of address of the Pledgor.
8.
The Pledgor hereby undertakes to keep the Charged Property insured at all times as provided in the Loan Agreement.
Debenture – Fixed Charge
9.
All the rights of the Pledgor deriving from the insurance of the Charged Property, as in force at any relevant time and under
any other law, whether or not assigned to the Agent as aforesaid, are hereby charged to the Agent, for the ratable benefit of
the Lenders, by way of a first ranking fixed charge and pledge.
INTEREST
10.
The Agent shall be entitled to calculate interest on the Secured Sums at such rate as has been or may be agreed upon from
time to time between the Agent and the Pledgor according to the terms of the Loan Agreement.
REPAYMENT DATES
11.
12.
13.
14.
The Pledgor hereby undertakes to pay the Agent all and any of the Secured Sums promptly on the maturity dates
prescribed or which may be prescribed therefore from time to time, all in accordance with the provisions of the Loan
Agreement.
Prepayments of the Secured Sums shall be made subject to and in accordance with the provisions of the Loan Agreement,
and the Pledgor shall not be entitled to redeem all or any of the Charged Property by discharging the Secured Sums and/or
any part thereof prior to their prescribed maturity dates and/or full prepayments of the Secured Sums in accordance with
the provisions of the Loan Agreement, unless the redemption is being made subject to and in accordance with the
provisions of the Loan Agreement.
Neither the Pledgor nor any person having a right liable to be affected by the pledges and charges hereby created or the
realisation thereof shall have any right under Section 13(b) of the Pledges Law, 5727-1967, or any other statutory
provisions in substitution therefore.
Without derogating from the generality of the provisions of this Debenture, the Agent shall be entitled to demand the
immediate payment of the Secured Sums and to debit any account of the Pledgor with the amount thereof in any one of the
events numerated below, in which case the Pledgor undertakes to pay the Agent all of the Secured Sums, and the Agent
shall be entitled to take whatever steps it sees fit, subject to applicable law, for the collection of the Secured Sums and to
realise, at the Pledgor's expense, the collateral securities by any means allowed by law:
(a)
(b)
The Pledgor is in breach of (i) any of its obligations, undertakings, representations or warranties under
Sections 5(b), 5(d), 5(f), 6(b), 6(c), 6(e), 6(f), 6(i) through (n), 7(b), 8 and 9 of this Debenture, or (ii) any
of its other obligations, undertakings, representations or warranties under this Debenture, which breach
under this clause (ii) has not been cured within 5 Business Days after the occurrence thereof, except to
the extent that such breach could reasonably be expected to have a Material Adverse Effect (as defined
in the Loan Agreement), in which case such cure period shall not apply (the foregoing shall not derogate
from any right, under any law, granted to the Agent or the Lenders in respect of any breach by Pledgor);
and/or;
There occurs and continues to subsist (i) an Event of Default (as defined in the Loan Agreement), or (ii)
any other event which gives the Agent right to demand payment, under any document signed between
the Pledgor and the Agent and/or the Lenders, (including, inter alia, under the Loan Agreement),
provided that any period (if any) given to the
Debenture – Fixed Charge
Pledgor to effect such payment under such document shall have elapsed and as long as such payment is
not actually effected.
RIGHTS OF THE AGENT (ON BEHALF OF THE LENDERS)
15.
16.
17.
The Agent shall have the right of possession, lien, set-off and charge over any amounts, assets and/or rights including
securities, coins, gold, bank notes, documents in respect of goods, insurance policies, Bills, assignments of rights, deposits,
collaterals and their countervalue, in the possession of or under the control of the Agent at any time for or on behalf of the
Pledgor, including such as have been delivered for collection, as security, for safe-keeping or otherwise. The Agent shall be
entitled to retain the said assets until payment in full of the Secured Sums or to realise them by selling them and applying
the countervalue thereof in whole or in part in payment of the Secured Sums, and in any event in accordance with
applicable law. Nothing contained herein shall limit the rights of set off of any Lender provided in the Loan Agreement
The Pledgor confirms that the Agent's and the Lender’s books, accounts and entries shall be binding upon the Pledgor,
shall be deemed to be correct and shall serve as prima facie evidence against the Pledgor in all their particulars, including
all reference to the computation of the Secured Sums, the particulars of the Bills, guarantees and other collateral securities
and any other matter related hereto.
Without derogating from the other provisions contained in this Debenture, any waiver, extension, concession, acquiescence
or forbearance (hereinafter: “waiver”) on the Agent's part as to the non-performance, partial performance or incorrect
performance of any of the Pledgor's obligations pursuant to this Debenture, such waiver shall not be treated as a waiver on
the part of the Agent of any rights but as a limited consent given in respect of the specific instance.
18.
In any of the events enumerated in Clause 14 hereof:
(a)
(b)
(c)
The Agent shall be entitled to adopt all the measures it deems fit, subject to any applicable law, in order to
recover the Secured Sums and realise all of its rights hereunder, including the realisation of the Charged Property,
in whole or in part, and to apply the proceeds thereof to the Secured Sums without the Agent first being required
to realise any other guarantees or collateral securities, if such be held by the Agent.
Should the Agent decide to realise securities, Bills and other negotiable instruments, in accordance with Section
4(2) of the Pledges Law 5727-1967, then three (3) days' advance notice regarding the steps that the Agent intends
to take shall be deemed to be reasonable advance notice for the purpose of Section 19(b) of the Pledges Law,
5727-1967 or any other statutory provisions in substitution therefor.
As long as the Secured Sums are not paid in full, the Agent may, subject to any applicable law, as attorney-in-fact
of the Pledgor (and, for the purpose hereof, the Pledgor irrevocably appoints the Agent to be its attorney-in-fact
for the benefit of the Lenders), sell all or any of the Charged Property by public auction or otherwise, by itself or
through others, for cash or instalments thereof or otherwise, at a price and on such terms as the Agent in its
absolute discretion shall deem fit, and likewise the Agent may of its own accord or through the court or an
execution office, realise the Charged Property or any other property, inter alia, by appointing a receiver or
receiver and manager on behalf of the Agent, who shall be empowered, inter alia,:
(1)
to call in all or any part of the Charged Property.
Debenture – Fixed Charge
(2)
(3)
(4)
to carry on or to participate in the management of the business of the Pledgor, as they see fit.
to sell or agree to the sale of the Charged Property, in whole or in part, to dispose of same or
agree to dispose of same in such other manner on such terms as they deem fit.
to make such other arrangements regarding the Charged Property or any part thereof as they
deem fit.
(d)
All income to be received by the receiver or the receiver and manager from the Charged Property as well as any
proceeds to be received by the Agent and/or by the receiver or receiver and manager from the sale of the Charged
Property or any part thereof shall be applied, subject to any applicable law and the provisions of the Loan
Agreement, in such order as Agent shall determine in its sole discretion, provided, in the event that Agent has
independently sold any Charged Property, that any amount remaining after the payment to the Lenders of the
Secured Sums in full, shall be transferred to the Pledgor, subject to the provisions of applicable law.
19.
Should the payment date of the Secured Sums or any part thereof not yet have fallen due at the time of the sale of the
Charged Property, or the Secured Sums be due to the Agent contingently only, then the Agent shall be entitled to recover
out of the proceeds of the sale an amount sufficient to cover the Secured Sums and the amount so recovered shall be
charged to the Agent as security for, and be held by the Agent until the discharge in full of, the Secured Sums.
NATURE OF THE COLLATERAL SECURITY
20.
21.
22.
23.
The collateral securities which have been or may be given to the Agent under this Debenture shall be continuing and
revolving securities and shall remain in force until all Secured Sums have been fully discharged and the Agent, on behalf
of the Lenders, has certified in writing that this Debenture is null. After the Secured Sums have been fully discharged, the
Agent shall promptly certify in writing that this Debenture is null, and shall execute and provide the Pledgor with any
documents reasonably necessary in order to remove the charge created by this Debenture.
All collateral securities and guarantees which have been or may be given to the Agent for payment of the Secured Sums
shall be independent of one another.
The nature and effect of the collateral securities to which this Debenture is applicable shall not be affected nor shall the
validity of any of the securities and obligations of the Pledgor hereunder be impaired or affected by any compromise,
concession, granting of time or other like release consented to by the Agent with respect to the Pledgor and/or its
subsidiaries or by any variation in the Pledgor’s and/or its subsidiaries’ obligations towards the Agent in connection with
the Secured Sums or by any release or waiver by the Agent of any other collateral security or guarantees.
In any of the events enumerated in Clause 14 hereof, the Agent may deposit all or any of the collateral given or which may
be given pursuant to this Debenture with a bailee of its own choosing, at its discretion and at the Pledgor's expense, and
may substitute such bailee with another from time to time. The Agent may register all or any of such collaterals with any
competent authority in accordance with any law and/or in any public register.
RIGHT OF ASSIGNMENT
Debenture – Fixed Charge
24.
The Agent may at any time at its own discretion and without the Pledgor's consent being required, assign this Debenture
and its rights arising thereunder, including the collaterals in whole or in part to any assignee of Agent’s under the Loan
Agreement. Such assignment may be effected by endorsement on this Debenture or in any other way the Agent or any
subsequent assignor deems fit.
NOTICE OF OBJECTION
25.
The Pledgor undertakes to notify the Agent in writing of any objection or contention it may have regarding any statement
of account, extract thereof, certificate or notice received by it from the Agent including information received through any
automatic terminal facility. Where no such objection or contention is received by the Agent, then the Pledgor will be
deemed to have confirmed the correctness thereof.
EXPENSES
26.
All the expenses in connection with this Debenture as detailed in the Loan Agreement and in any other documents signed
between the Agent and/or the Lenders and the Pledgor in connection with the Banking Services and in accordance
therewith, including the fee for preparing credit and security documents, the stamping and registration of documents, and
all and any expenses involved in the realisation of the collateral security and institution of proceedings for collection
(including reasonable documented fees of the Agent’s external lawyers), insurance, safe-keeping, maintenance and repair
of the Charged Property – shall be paid by the Pledgor to the Agent on its first written demand, together with interest at the
Default Rate from the date demand was made until payment in full, and until payment in full, all the above expenses
together with interest thereon shall be secured by this Debenture. The Agent may debit the Pledgor with the aforesaid
expenses, together with interest thereon.
27.
[Reserved]
INTERPRETATION; AMENDMENT
28.
29.
Any of the representations, warranties and covenants made by Pledgor hereunder shall be in addition to, and shall not
derogate in any manner from, any representations, warranties and covenants made by Pledgor under the Loan Agreement
and any other document related to the granting of the Banking Services. In case of any conflict between this Debenture and
Loan Agreement, including with respect to interest, commissions, charges, fees and expenses (specifically excluding the
specific rights of the Lenders in connection with the creation and realisation of the security interest hereunder), the
provisions of the Loan Agreement shall prevail.
In this Debenture - (a) the singular includes the plural and vice versa; (b) the masculine gender includes the feminine
gender and vice versa; (c) “Agent” means Silicon Valley Bank and any of its branches existing on the date hereof and/or to
be subsequently opened, wherever they may be, its assigns, successors, or attorneys-in-fact; (d) “Bills” means: promissory
notes, bills of exchange, cheques, undertakings, guarantees, sureties, assignments, bills of lading, deposit notes and any
other negotiable instruments (e) “Interest at the Default Rate” means interest at such default rate as is defined in the Loan
Agreement; (f) the headings are only indicative
Debenture – Fixed Charge
and are not to be used in construing this Debenture; (g) the recitals hereto form an integral part hereof.
Unless otherwise defined herein, terms capitalized herein shall have the meanings ascribed to them in the Loan Agreement.
30.
31.
Any term of this Debenture may be amended and the observance of any term hereof may be waived (either prospectively
or retroactively and either generally or in a particular instance) with the written consent of both parties only.
To the extent required, this Debenture may be translated into Hebrew for the sole purpose of the registration and filing of
this Debenture with the Israeli Registrar of Companies and/or any other relevant Israeli official registrations.
Notwithstanding the aforesaid, the executed English version of this Debenture shall prevail and supersede for all purposes
and for all respects, in the event of any discrepancy or inconsistency between the English version and the translation.
NOTICES AND WARNINGS
32.
(a)
(b)
Each communication to be made under this Debenture shall be made in writing and, unless otherwise stated, may
be made also by facsimile transmission or by electronic mail.
Each communication or document to be made or delivered by each party to another pursuant to this Debenture
shall (unless that other party has by written notice, specified another address) be made or delivered to that party,
addressed as follows:
(ii)
if to the Pledgor:
Eloxx Pharmaceuticals Ltd.
10 Prof. Menachem Plaut Street
Rehovot, Israel 7670621
Attn.: Greg Weaver
Email: greg@eloxxpharma.com
with a copy to (which shall not be deemed notice):
Meitar Liquornik Geva Leshem Tal, Law Offices
16 Abba Hillel Road, Ramat Gan, 5250608
Attn: Dana Yagur, Adv.
Fax: (972)-3-610-3100
Email: yagurd@meitar.com
(iii)
if to the Agent:
Silicon Valley Bank
275 Grove Street, Suite 2-200
Newton, Massachusetts 02466
Attn: Lauren Cole
Email: LCole@svb.com
with a copy to:
Debenture – Fixed Charge
Shibolet & Co. with Raved, Magriso, Benkel & Co.
4 Berkowitz Street, Tel-Aviv 6423806, Israel
Attn: Einat Weidberg, Adv.
Fax: +972-3-7778444
Email: E.weidberg@shibolet.com
and shall be deemed to have been made or delivered (a) upon the earlier of actual receipt and five (5) business days after deposit in
regular mail, first class, registered or certified mail return receipt requested, with proper postage prepaid; (b) upon transmission, when
sent by electronic mail or facsimile transmission with receipt confirmation; (c) one (1) Business Day after deposit with a reputable
overnight courier with all charges prepaid; or (d) when delivered, if hand-delivered by messenger.
GOVERNING LAW AND PLACE OF JURISDICTION
33.
(a)
(b)
This Debenture shall be construed in accordance with the laws of the State of Israel.
The exclusive place of jurisdiction for the purpose of this Debenture is hereby established as the competent court
of law in Israel situated in Tel Aviv-Jaffa.
*****
Debenture – Fixed Charge
IN WITNESS WHEREOF THE PLEDGOR HAS SIGNED THIS DEBENTURE OF FIXED CHARGE
ELOXX PHARMACEUTICALS LTD.
__/s/__Gregory Weaver___________________________
By: Gregory Weaver
Title: Chief Financial Officer
SILICON VALLEY BANK
__/s/__Lauren Cole___________________________
By: Lauren Cole
Title: Vice President
[Signature Page – Eloxx Pharmaceuticals Ltd – Fixed Charge Debenture]
Debenture – Fixed Charge
Appendix A
Equipment List
EXHIBIT D-2
None
EXHIBIT D-3
None
EXHIBIT E
Form of Disbursement Letter
[see attached]
DISBURSEMENT LETTER
[DATE]
The undersigned, being the duly elected and acting
of (i) ELOXX PHARMACEUTICALS, INC., a Delaware corporation (“US Borrower”) and (ii)
ELOXX PHARMACEUTICALS LTD., a company organized under the laws of the State of Israel (“ISR
Borrower”) (US Borrower and ISR Borrower are hereinafter jointly and severally, individually and collectively,
referred to as “Borrower”), does hereby certify to (a) SILICON VALLEY BANK, a California corporation
(“SVB”), in its capacity as administrative agent and collateral agent (“Agent”), (b) SILICON VALLEY BANK,
a California corporation, as a lender, (c) WESTRIVER INNOVATION LENDING FUND VIII, L.P., a
Delaware limited partnership (“WestRiver”), as a lender (SVB and WestRiver and each of the other “Lenders”
from time to time a party hereto are referred to herein collectively as the “Lenders” and each individually as a
“Lender”) in connection with that certain Loan and Security Agreement dated as of [_________], by and among
Borrower, Agent and the Lenders from time to time party thereto (the “Loan Agreement”; with other capitalized
terms used below having the meanings ascribed thereto in the Loan Agreement) that:
The representations and warranties made by Borrower in Section 5 of the Loan Agreement and in the other Loan Documents are true and correct in all
material respects as of the date hereof.
No event or condition has occurred that would constitute an Event of Default under the Loan Agreement or any other Loan Document.
Borrower is in compliance with the covenants and requirements contained in Sections 4, 6 and 7 of the Loan Agreement.
All conditions referred to in Section 3 of the Loan Agreement to the making of a Credit Extension to be made on or about the date hereof have been
satisfied or waived by Agent.
No Material Adverse Change has occurred.
The undersigned is an Authorized Signer.
[Balance of Page Intentionally Left Blank]
1.
2.
3.
4.
5.
6.
7.
The proceeds of the Term Loan Advance shall be disbursed as follows:
Disbursement from SVB:
Loan Amount
Plus:
‑‑Deposit Received
Less:
‑‑Commitment Fee
‑‑Lender’s Legal Fees
Net Proceeds due from SVB:
Disbursement from WestRiver:
Loan Amount
Plus:
‑‑Deposit Received
Less:
‑‑Commitment Fee
‑‑Lender’s Legal Fees
Net Proceeds due from WestRiver:
TOTAL TERM LOAN ADVANCE NET PROCEEDS FROM LENDERS
8.
The aggregate net proceeds of the Term Loan Advance shall be transferred to the Designated Deposit Account as follows:
Account Name:
Bank Name:
Bank Address:
Account Number:
ABA Number:
____________________________________
Silicon Valley Bank
3003 Tasman Drive
Santa Clara, California 95054
____________________________________
____________________________________
[Balance of Page Intentionally Left Blank]
$_______________
$__________
($_________)
($_________)*
$_______________
$_______________
$__________
($_________)
($_________)*
$_______________
$_______________
* Legal fees and costs are through the Effective Date. Postclosing legal fees and costs, payable after the Effective Date, to be invoiced and paid postclosing.
Dated as of the date first set forth above.
BORROWERS:
ELOXX PHARMACEUTICALS, INC.
By
Name:
Title:
ELOXX PHARMACEUTICALS LTD.
By
Name:
Title:
AGENT AND LENDER:
SILICON VALLEY BANK
By
Name:
Title:
LENDER:
SILICON VALLEY BANK
By
Name:
Title:
LENDER:
WESTRIVER INNOVATION LENDING FUND
VIII, L.P.
By
Name:
Title:
[Signature Page to Disbursement Letter]
SCHEDULE 5.13
Grants received under file number 51851, 54914, 57349, 58134 and 55465 from the Israeli Innovation Authority (the “IIA”):
The ISR Borrower has received grants from the IIA in the amount of US $2,621,599. The ISR Borrower is obligated to pay future royalties on all income of the ISR
Borrower in connection with the grants received by the IIA. As of January 24, 2019, the ISR Borrower has not repaid any amount to the IIA.
The creation of the security interest by ISR Borrower over Intellectual Property with respect which grants from the IIA were received is subject to the Approval of
the IIA.
Eloxx Pharmaceuticals Ltd., a private limited company organized under the laws of Israel
Subsidiaries of Eloxx Pharmaceuticals, Inc.
as of December 31, 2018
Exhibit 21.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in Registration Statement Nos. 333-228430 and 333-224207 on Form S-3 and Registration Statement No. 333-224860
on Form S-8 of our reports dated March 14, 2019, relating to the consolidated financial statements of Eloxx Pharmaceuticals, Inc., and the effectiveness of Eloxx
Pharmaceuticals, Inc.’s internal control over financial reporting, appearing in this Annual Report on Form 10-K of Eloxx Pharmaceuticals, Inc. for the year
ended December 31, 2018.
EXHIBIT 23.1
/s/ Deloitte & Touche LLP
Boston, Massachusetts
March 14, 2019
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Exhibit 23.2
We consent to the incorporation by reference in Registration Statement Nos. 333-228430 and 333-224207 on Form S-3 and Registration Statement
No. 333-224860 on Form S-8 of our reports dated March 16, 2018, relating to the consolidated financial statements of Eloxx Pharmaceuticals, Inc.,
for the years ended December 31, 2017 and December 31, 2016, appearing in this Annual Report on Form 10-K of Eloxx Pharmaceuticals, Inc.
Tel Aviv, Israel
March 14, 2019
/s/ Kost Forer Gabbay and Kasierer
KOST FORER GABBAY & KASIERER
A member of Ernst & Young Global
Exhibit 31.1
I, Robert E. Ward, certify that:
1. I have reviewed this annual report on Form 10-K of Eloxx Pharmaceuticals, Inc.;
CERTIFICATION
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that
material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal
quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to
adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting.
Date: March 14, 2019
/s/ Robert E. Ward
Robert E. Ward
Chief Executive Officer
(Principal Executive Officer)
Exhibit 31.2
I, Gregory Weaver, certify that:
1. I have reviewed this annual report on Form 10-K of Eloxx Pharmaceuticals, Inc.;
CERTIFICATION
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that
material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal
quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to
adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting.
Date: March 14, 2019
/s/ Gregory Weaver
Gregory Weaver
Chief Financial Officer
(Principal Financial Officer)
CERTIFICATION(1)
Exhibit 32.1
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63
of Title 18 of the United States Code (18 U.S.C. §1350), I, Robert E. Ward, Chief Executive Officer of Eloxx Pharmaceuticals, Inc. (the “Company”), hereby certify
that, to the best of my knowledge:
1.
2.
The Company’s Annual Report on Form 10-K for the period ended December 31, 2018, to which this Certification is attached as Exhibit 32.1 (the “Annual
Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and
The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
IN WITNESS WHEREOF, the undersigned have set their hands hereto as of the 14th day of March, 2019.
/s/ Robert E. Ward
Robert E. Ward
Chief Executive Officer
(Principal Executive Officer)
(1)
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be
incorporated by reference into any filing of Eloxx Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of
1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.
CERTIFICATION(1)
Exhibit 32.2
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63
of Title 18 of the United States Code (18 U.S.C. §1350), I, Gregory Weaver, Chief Financial Officer of Eloxx Pharmaceuticals, Inc. (the “Company”), hereby certify
that, to the best of my knowledge:
1.
2.
The Company’s Annual Report on Form 10-K for the period ended December 31, 2018, to which this Certification is attached as Exhibit 32.1 (the “Annual
Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and
The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
IN WITNESS WHEREOF, the undersigned have set their hands hereto as of the 14th day of March, 2019.
/s/ Gregory Weaver
Gregory Weaver
Chief Financial Officer
(Principal Financial and Accounting Officer)
(1)
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be
incorporated by reference into any filing of Eloxx Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of
1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.