UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2020.
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: 001-15911
CELSION CORPORATION
(Exact Name of Registrant as Specified in Its Charter)
DELAWARE
(State or other jurisdiction of
incorporation or organization)
997 LENOX DRIVE, SUITE 100,
LAWRENCEVILLE, NJ
(Address of Principal Executive Offices)
52-1256615
(I.R.S. Employer
Identification No.)
08648
(Zip Code)
Registrant’s telephone number, including area code: (609) 896-9100
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, Par Value $0.01 Per Share
Trading Symbol(s)
CLSN
Name of each exchange on which registered
NASDAQ CAPITAL 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 [X]
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes [ ] No [X]
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 [X] No [ ]
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).
Yes [X] No [ ]
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 the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “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
[ ]
[X]
[ ]
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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal
control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared
or issued its audit report. [ ]
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934).
Yes [ ] No [X]
The aggregate market value of the common stock held by non-affiliates of the Registrant was approximately $121.8 million as of June 30, 2020 (the last
business day of the Registrant’s most recently completed second fiscal quarter) based on the closing sale price of $3.72 for the Registrant’s common stock
on that date as reported by The Nasdaq Capital Market (“NASDAQ”). For purposes of this calculation, shares of common stock held by directors, officers
and stockholders who own greater than 10% of the Registrant’s outstanding stock at June 30, 2020 were excluded. This determination of executive officers
and directors as affiliates is not necessarily a conclusive determination for any other purpose.
As of March 18, 2021, 75,011,774 shares of the Registrant’s common stock were issued and outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
None
CELSION CORPORATION
FORM 10-K
TABLE OF CONTENTS
PART I
ITEM 1. BUSINESS
FORWARD-LOOKING STATEMENTS
OVERVIEW
IMMUNO-ONCOLOGY PROGRAM
THERAPLAS Technology Platform
Ovarian Cancer Overview
GEN-1 Immunotherapy
OVATION I Study
OVATION 2 Study
PLACCINE DNA VACCINE TECHNOLOGY PLATFORM
COVID-19 Vaccine Overview
Our Next Generation Vaccine Initiative
THERMODOX® DIRECTED CHEMOTHERAPY
THERMODOX® for the Treatment of Primary Liver Cancer
Primary Liver Cancer Overview
Celsion’s Approach
OPTIMA Study
Investigator-Sponsored Studies with ThermoDox®
BUSINESS STRATEGY AND DEVELOPMENT PLAN
RESEARCH AND DEVELOPMENT EXPENDITURES
GOVERNMENT REGULATION
MANUFACTURING AND SUPPLY
SALES AND MARKETING
PRODUCT LIABILITY AND INSURANCE
COMPETITION
GEN-1
ThermoDox ®
INTELLECTUAL PROPERTY
Patents and Proprietary Rights
EMPLOYEES
COMPANY INFORMATION
AVAILABLE INFORMATION
RECENT EVENTS
ITEM 1A. RISK FACTORS
ITEM 1B. UNRESOLVED STAFF COMMENTS
ITEM 2. PROPERTIES
ITEM 3. LEGAL PROCEEDINGS
ITEM 4. MINE SAFETY DISCLOSURES
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CELSION CORPORATION
FORM 10-K
TABLE OF CONTENTS (continued)
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF
EQUITY SECURITIES
Market for Our Common Stock
Record Holders
Dividend Policy
Securities Authorized for Issuance Under Equity Compensation Plans
Unregistered Shares of Equity Securities
Issuer Purchases of Equity Securities
ITEM 6. SELECTED FINANCIAL DATA
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Overview
Business Plan
Financing Overview
Critical Accounting Policies and Estimates
Results of Operations
Financial Condition, Liquidity and Capital Resources
Off-Balance Sheet Arrangements
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
ITEM 9A. CONTROLS AND PROCEDURES
ITEM 9B. OTHER INFORMATION
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
ITEM 11. EXECUTIVE COMPENSATION
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
1. FINANCIAL STATEMENTS
2. FINANCIAL STATEMENT SCHEDULES
3. EXHIBITS
ITEM 16. FORM 10-K SUMMARY
SIGNATURES
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ITEM 1.
BUSINESS
PART I
FORWARD-LOOKING STATEMENTS
Certain of the statements contained in this Annual Report on Form 10-K (this “Annual Report”) are forward-looking and constitute forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”). In addition, from time to time we may publish forward-looking statements relating to such matters as
anticipated financial performance, business prospects, technological developments, product pipelines, clinical trials and research and development
activities, the adequacy of capital reserves and anticipated operating results and cash expenditures, current and potential collaborations, strategic
alternatives and other aspects of our present and future business operations and similar matters that also constitute such forward-looking statements.
These statements involve known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity,
performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by
such forward-looking statements. Such factors include, among other things, unforeseen changes in the course of research and development activities and in
clinical trials; possible changes in cost, timing and progress of development, preclinical studies, clinical trials and regulatory submissions; our
collaborators’ ability to obtain and maintain regulatory approval of any of our product candidates; possible changes in capital structure, financial
condition, future working capital needs and other financial items; changes in approaches to medical treatment; introduction of new products by others;
success or failure of our current or future collaboration arrangements, risks and uncertainties associated with possible acquisitions of other technologies,
assets or businesses; our ability to obtain additional funds for our operations; our ability to obtain and maintain intellectual property protection for our
technologies and product candidates and our ability to operate our business without infringing the intellectual property rights of others; our reliance on
third parties to conduct preclinical studies or clinical trials; the rate and degree of market acceptance of any approved product candidates; possible
actions by customers, suppliers, strategic partners, potential strategic partners, competitors and regulatory authorities; compliance with listing standards
of The Nasdaq Capital Market; and those listed under “Risk Factors” below and elsewhere in this Annual Report.
In some cases, you can identify forward-looking statements by terminology such as “expect,” “anticipate,” “estimate,” “plan,” “believe, “could,”
“intend,” “predict”, “may,” “should,” “will,” “would” and words of similar import regarding the Company’s expectations. Forward-looking statements
are only predictions. Actual events or results may differ materially. Although we believe that our expectations are based on reasonable assumptions within
the bounds of our knowledge of our industry, business and operations, we cannot guarantee that actual results will not differ materially from our
expectations. In evaluating such forward-looking statements, you should specifically consider various factors, including the risks outlined under “Risk
Factors.” The discussion of risks and uncertainties set forth in this Annual Report is not necessarily a complete or exhaustive list of all risks facing the
Company at any particular point in time. We operate in a highly competitive, highly regulated and rapidly changing environment and our business is in a
state of evolution. Therefore, it is likely that new risks will emerge, and that the nature and elements of existing risks will change, over time. It is not
possible for management to predict all such risk factors or changes therein, or to assess either the impact of all such risk factors on our business or the
extent to which any individual risk factor, combination of factors, or new or altered factors, may cause results to differ materially from those contained in
any forward-looking statement. Except as required by law, we assume no obligation to revise or update any forward-looking statement that may be made
from time to time by us or on our behalf for any reason, even if new information becomes available in the future. Unless the context requires otherwise or
unless otherwise noted, all references in this Annual Report to “Celsion”, “the Company”, “we”, “us”, or “our” are to Celsion Corporation, a Delaware
corporation and its wholly owned subsidiary, CLSN Laboratories, Inc., also a Delaware Corporation.
Trademarks
The Celsion brand and product names, including but not limited to Celsion® and ThermoDox®, contained in this document are trademarks, registered
trademarks or service marks of Celsion Corporation or its subsidiary in the United States (the “U.S.”) and certain other countries. This document also
contains references to trademarks and service marks of other companies that are the property of their respective owners.
1
OVERVIEW
Celsion Corporation (“Celsion” and the “Company”) is a fully integrated, clinical stage biotechnology company focused on advancing a portfolio of
innovative treatments including DNA-based immunotherapies, next generation vaccines and directed chemotherapies through clinical trials and eventual
commercialization. The Company’s product pipeline includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer and
ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently under investigator-sponsored development for several cancer
indications. Celsion has two feasibility stage platform technologies for the development of novel nucleic acid-based immunotherapies and next generation
vaccines and other anti-cancer DNA or RNA therapies. Both are novel synthetic, non-viral vectors with demonstrated capability in nucleic acid cellular
transfection.
IMMUNO-ONCOLOGY Program
On June 20, 2014, the Company completed the acquisition of substantially all of the assets of EGEN, a private company located in Huntsville, Alabama.
Pursuant to the Asset Purchase Agreement, CLSN Laboratories acquired all of EGEN’s right, title and interest in substantially all of the assets of EGEN,
including cash and cash equivalents, patents, trademarks and other intellectual property rights, clinical data, certain contracts, licenses and permits,
equipment, furniture, office equipment, furnishings, supplies and other tangible personal property. A key asset acquired from EGEN was the TheraPlas
technology platform. The first drug candidate developed from this technology platform is GEN-1.
THERAPLAS Technology Platform
TheraPlas is a technology platform for the delivery of DNA and mRNA therapeutics via synthetic non-viral carriers and is capable of providing cell
transfection for double-stranded DNA plasmids and large therapeutic RNA segments such as mRNA. There are two components of the TheraPlas system, a
plasmid DNA or mRNA payload encoding a therapeutic protein, and a delivery system. The delivery system is designed to protect the DNA/mRNA from
degradation and promote trafficking into cells and through intracellular compartments. We designed the delivery system of TheraPlas by chemically
modifying the low molecular weight polymer to improve its gene transfer activity without increasing toxicity. We believe that TheraPlas may be a viable
alternative to current approaches to gene delivery due to several distinguishing characteristics, including enhanced molecular versatility that allows for
complex modifications to potentially improve activity and safety.
The design of the TheraPlas delivery system is based on molecular functionalization of polyethyleneimine (PEI), a cationic delivery polymer with a distinct
ability to escape from the endosomes due to heavy protonation. The transfection activity and toxicity of PEI is tightly coupled to its molecular weight;
therefore, the clinical application of PEI is limited. We have used molecular functionalization strategies to improve the activity of low molecular weight
PEIs without augmenting their cytotoxicity. In one instance, chemical conjugation of a low molecular weight branched BPEI1800 with cholesterol and
polyethylene glycol (PEG) to form PEG-PEI-Cholesterol (PPC) dramatically improved the transfection activity of BPEI1800 following in vivo delivery.
Together, the cholesterol and PEG modifications produced approximately 20-fold enhancement in transfection activity. Biodistribution studies following
intraperitoneal or subcutaneous administration of DNA/PPC nanocomplexes showed DNA delivery localized primarily at the injection site with only small
amount escaping into the systemic circulation. PPC is the delivery component of our lead TheraPlas product, GEN-1, which is in clinical development for
the treatment of ovarian cancer. The PPC manufacturing process has been scaled up from bench scale (1-2 g) to 0.6Kg, and several current Good
Manufacturing Practice (“cGMP”) lots have been produced with reproducible quality.
We believe that TheraPlas has emerged as a viable alternative to current approaches due to several distinguishing characteristics such as strong molecular
versatility that may allow for complex modifications to potentially improve activity and safety with little difficulty. The biocompatibility of these polymers
reduces the risk of adverse immune response, thus allowing for repeated administration. Compared to naked DNA or cationic lipids, TheraPlas is generally
safer, more efficient, and cost effective. We believe that these advantages place Celsion in a strong position to capitalize on this technology platform.
2
Ovarian Cancer Overview
Ovarian cancer is the most lethal of gynecological malignancies among women with an overall five-year survival rate of 45%. This poor outcome is due in
part to the lack of effective prevention and early detection strategies. There were approximately 22,000 new cases of ovarian cancer in the U.S. in 2014
with an estimated 14,000 deaths. Mortality rates for ovarian cancer declined very little in the last forty years due to the unavailability of detection tests and
improved treatments. Most women with ovarian cancer are not diagnosed until Stages III or IV, when the disease has spread outside the pelvis to the
abdomen and areas beyond causing swelling and pain, where the five-year survival rates are 25 - 41 percent and 11 percent, respectively. First-line
chemotherapy regimens are typically platinum-based combination therapies. Although this first line of treatment has an approximate 80 percent response
rate, 55 to 75 percent of women will develop recurrent ovarian cancer within two years and ultimately will not respond to platinum therapy. Patients whose
cancer recurs or progresses after initially responding to surgery and first-line chemotherapy have been divided into one of the two groups based on the time
from completion of platinum therapy to disease recurrence or progression. This time period is referred to as platinum-free interval. The platinum-sensitive
group has a platinum-free interval of longer than six months. This group generally responds to additional treatment with platinum-based therapies. The
platinum-resistant group has a platinum-free interval of shorter than six months and is resistant to additional platinum-based treatments. Pegylated
liposomal doxorubicin, topotecan, and Avastin are the only approved second-line therapies for platinum-resistant ovarian cancer. The overall response rate
for these therapies is 10 to 20 percent with median overall survival (“OS”) of eleven to twelve months. Immunotherapy is an attractive novel approach for
the treatment of ovarian cancer particularly since ovarian cancers are considered immunogenic tumors. IL-12 is one of the most active cytokines for the
induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. The precedence for a
therapeutic role of IL-12 in ovarian cancer is based on epidemiologic and preclinical data.
GEN-1 Immunotherapy
GEN-1 is a DNA-based immunotherapeutic product candidate for the localized treatment of ovarian cancer by intraperitoneally administering an
Interleukin-12 (“IL-12”) plasmid formulated with our proprietary TheraPlas delivery system. In this DNA-based approach, the immunotherapy is combined
with a standard chemotherapy drug, which can potentially achieve better clinical outcomes than with chemotherapy alone. We believe that increases in IL-
12 concentrations at tumor sites for several days after a single administration could create a potent immune environment against tumor activity and that a
direct killing of the tumor with concomitant use of cytotoxic chemotherapy could result in a more robust and durable antitumor response than
chemotherapy alone. We believe the rationale for local therapy with GEN-1 is based on the following:
● Loco-regional production of the potent cytokine IL-12 avoids toxicities and poor pharmacokinetics associated with systemic delivery of
recombinant IL-12;
● Persistent local delivery of IL-12 lasts up to one week and dosing can be repeated; and
● Local therapy is ideal for long-term maintenance therapy.
OVATION I Study. In February 2015, we announced that the U.S. Food and Drug Administration (“FDA”) accepted, without objection, the Phase I dose-
escalation clinical trial of GEN-1 in combination with the standard of care in neoadjuvant ovarian cancer (the “OVATION I Study”). On September 30,
2015, we announced enrollment of the first patient in the OVATION I Study. The OVATION I Study was designed to:
(i)
identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response;
(ii) enroll three to six patients per dose level and evaluate safety and efficacy; and
(iii) attempt to define an optimal dose for a follow-on Phase I/II study.
3
In addition, the OVATION I Study established a unique opportunity to assess how cytokine-based compounds such as GEN-1, directly affect ovarian cancer
cells and the tumor microenvironment in newly diagnosed ovarian cancer patients. The study was designed to characterize the nature of the immune
response triggered by GEN-1 at various levels of the patients’ immune system, including:
● Infiltration of cancer fighting T-cell lymphocytes into primary tumor and tumor microenvironment including peritoneal cavity, which is the
primary site of metastasis of ovarian cancer;
● Changes in local and systemic levels of immuno-stimulatory and immunosuppressive cytokines associated with tumor suppression and growth,
respectively; and
● Expression profile of a comprehensive panel of immune related genes in pre-treatment and GEN-1-treated tumor tissue.
We initiated the OVATION I Study at four clinical sites at the University of Alabama at Birmingham, Oklahoma University Medical Center, Washington
University in St. Louis, and the Medical College of Wisconsin. During 2016 and 2017, we announced data from the first fourteen patients in the OVATION
I Study. On October 3, 2017, we announced final translational research and clinical data from the OVATION I Study.
Key translational research findings from all evaluable patients are consistent with the earlier reports from partial analysis of the data and are summarized
below:
● The intraperitoneal treatment of GEN-1 in conjunction with NACT resulted in dose dependent increases in IL-12 and Interferon-gamma (IFN-γ)
levels that were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients’ systemic circulation. These
and other post-treatment changes including decreases in VEGF levels in peritoneal fluid are consistent with an IL-12 based immune mechanism;
● Consistent with the previous partial reports, the effects observed in the IHC analysis were pronounced decreases in the density of
immunosuppressive T-cell signals (Foxp3, PD-1, PDL-1, IDO-1) and increases in CD8+ cells in the tumor microenvironment;
● The ratio of CD8+ cells to immunosuppressive cells was increased in approximately 75% of patients suggesting an overall shift in the tumor
microenvironment from immunosuppressive to pro-immune stimulatory following treatment with GEN-1. An increase in CD8+ to
immunosuppressive T-cell populations is a leading indicator and believed to be a good predictor of improved OS; and
● Analysis of peritoneal fluid by cell sorting, not reported before, shows a treatment-related decrease in the percentage of immunosuppressive T-cell
(Foxp3+), which is consistent with the reduction of Foxp3+ T-cells in the primary tumor tissue, and a shift in tumor naïve CD8+ cell population to
more efficient tumor killing memory effector CD8+ cells.
The Company also reported positive clinical data from the first fourteen patients who completed treatment in the OVATION I Study. GEN-1 plus standard
chemotherapy produced no dose limiting toxicities and positive dose dependent efficacy signals which correlate well with positive surgical outcomes as
summarized below:
● Of the fourteen patients treated in the entire study, two patients demonstrated a complete response, ten patients demonstrated a partial response
and two patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate and an 86% objective
response rate (“ORR”). Of the five patients treated in the highest dose cohort, there was a 100% ORR with one complete response and four partial
responses;
● Fourteen patients had successful resections of their tumors, with nine patients (64%) having a complete tumor resection (“R0”), which indicates a
microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Seven out of eight (88%) patients in
the highest two dose cohorts experienced a R0 surgical resection. All five patients treated at the highest dose cohort experienced a R0 surgical
resection; and
● All patients experienced a clinically significant decrease in their CA-125 protein levels as of their most recent study visit. CA-125 is used to
monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells.
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On March 2, 2019, the Company announced final progression free survival (“PFS”) results from the OVATION I Study. Median PFS in patients treated per
protocol (n=14) was 21 months and was 17.1 months for the intent-to-treat (“ITT”) population (n=18) for all dose cohorts, including three patients who
dropped out of the study after 13 days or less, and two patients who did not receive full NAC and GEN-1 cycles. Under the current standard of care, in
women with Stage III/IV ovarian cancer undergoing NAC, their disease progresses within about 12 months on average. The results from the OVATION I
Study support continued evaluation of GEN-1 based on promising tumor response, as reported in the PFS data, and the ability for surgeons to completely
remove visible tumor at interval debulking surgery. GEN-1 was well tolerated, and no dose-limiting toxicities were detected. Intraperitoneal administration
of GEN-1 was feasible with broad patient acceptance.
OVATION 2 Study. The Company held an Advisory Board Meeting on September 27, 2017 with the clinical investigators and scientific experts including
those from Roswell Park Cancer Institute, Vanderbilt University Medical School, and M.D. Anderson Cancer Center to review and finalize clinical,
translational research and safety data from the OVATION I Study in order to determine the next steps forward for our GEN-1 immunotherapy program.
On November 13, 2017, the Company filed its Phase I/II clinical trial protocol with the FDA for GEN-1 for the localized treatment of ovarian cancer. The
protocol is designed with a single dose escalation phase to 100 mg/m² to identify a safe and tolerable dose of GEN-1 while maximizing an immune
response. The Phase I portion of the study will be followed by a continuation at the selected dose in approximately 110 patients randomized Phase II study.
In the OVATION 2 Study, patients in the GEN-1 treatment arm will receive GEN-1 plus chemotherapy pre- and post-interval debulking surgery (“IDS”).
The OVATION 2 Study will include up to 110 patients with Stage III/IV ovarian cancer, with 12 to 15 patients in the Phase I portion and up to 95 patients
in Phase II. The study is powered to show a 33% improvement in the primary endpoint, PFS, when comparing GEN-1 with neoadjuvant + adjuvant
chemotherapy versus neoadjuvant + adjuvant chemotherapy alone. The PFS primary analysis will be conducted after at least 80 events have been observed
or after all patients have been followed for at least 16 months, whichever is later.
In March 2020, the Company announced encouraging initial clinical data from the first 15 patients enrolled in the Phase I portion of the OVATION 2 Study
for patients newly diagnosed with Stage III and IV ovarian cancer. The OVATION 2 Study combines GEN-1, the Company’s IL-12 gene-mediated
immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT). Following NACT, patients undergo interval debulking surgery (IDS), followed
by three additional cycles of chemotherapy.
GEN-1 plus standard NACT produced positive dose-dependent efficacy results, with no dose-limiting toxicities, which correlates well with successful
surgical outcomes as summarized below:
● Of the 15 patients treated in the Phase I portion of the OVATION 2 Study, nine patients were treated with GEN-1 at a dose of 100 mg/m² plus
NACT and six patients were treated with NACT only. All 15 patients had successful resections of their tumors, with eight out of nine patients
(88%) in the GEN-1 treatment arm having an R0 resection, which indicates a microscopically margin-negative complete resection in which no
gross or microscopic tumor remains in the tumor bed. Only three out of six patients (50%) in the NACT only treatment arm had a R0 resection.
● When combining these results with the surgical resection rates observed in the Company’s prior Phase Ib dose-escalation trial (the OVATION 1
Study), a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of
adding GEN-1 to the current standard of care NACT:
5
0, 36, 47 mg/m² of GEN-1 plus NACT
61, 79, 100 mg/m² of GEN-1 plus NACT
% of
Patients
with R0
Resections
n=12
n=17
42%
82%
● The ORR as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for the 0, 36, 47 mg/m² dose GEN-1 patients were
comparable, as expected, to the higher (61, 79, 100 mg/m²) dose GEN-1 patients, with both groups demonstrating an approximate 80% ORR.
On March 23, 2020, the Company announced that the European Medicines Agency (the “EMA”) Committee for Orphan Medicinal Products (“COMP”)
has recommended that GEN-1 be designated as an orphan medicinal product for the treatment of ovarian cancer. GEN-1 is an IL-12 DNA plasmid vector
encased in a non-viral nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. GEN-1
previously received orphan designation from the FDA.
On March 26, 2020, the Company announced with Medidata, a Dassault Systèmes company, that examining matched patient data provided by Medidata in
a synthetic control arm (“SCA”) with results from the Company’s completed Phase Ib dose-escalating OVATION I Study showed positive results in
progression-free survival (“PFS”). The hazard ratio (“HR”) was 0.53 in the ITT group, showing strong signals of efficacy. Celsion believes these data may
warrant consideration of strategies to accelerate the clinical development program for GEN-1 in newly diagnosed, advanced ovarian cancer patients by the
FDA. In its March 2019 discussion with Celsion, the FDA noted that preliminary findings from the Phase Ib OVATION I Study were exciting but lacked a
control group to evaluate GEN-1’s independent impact on impressive tumor response, surgical results and PFS. The FDA encouraged the Company to
continue its GEN-1 development program and consult with FDA with new findings that may have a bearing on designations such as Fast Track and
Breakthrough Therapy.
SCAs have the potential to revolutionize clinical trials in certain oncology indications and some other diseases where a randomized control is not ethical or
practical. SCAs are formed by carefully selecting control patients from historical clinical trials to match the demographic and disease characteristics of the
patients treated with the new investigational product. SCAs have been shown to mimic the results of traditional randomized controls so that the treatment
effects of an investigational product can be visible by comparison to the SCA. SCAs can help advance the scientific validity of single arm trials, and in
certain indications, reduce time and cost, and expose fewer patients to placebos or existing standard-of-care treatments that might not be effective for them.
On July 27, 2020, the Company announced the randomization of the first two patients in the Phase II portion of the OVATION 2 Study with GEN-1 in
advanced ovarian cancer. The Company anticipates completing enrollment of up to 110 patients in the second half of 2021. Because this is an open-label
study, the Company intends to provide clinical updates throughout the course of treatment including response rates and surgical resection scores.
On February 22, 2021, the Company announced that it has received Fast Track designation from the FDA for GEN-1, its DNA-mediated IL-12
immunotherapy currently in Phase II development for the treatment of advanced ovarian cancer.
On February 25, 2021, the Company provided an update on the OVATION 2 Study. The Company reported that approximately one-third, or 34 patients, of
the anticipated 110 patients had been enrolled into the OVATION 2 Study, of which 20 are in the treatment arm and 14 are in the control. Currently, 27
patients have had their interval debulking surgery with the following results:
● 12 of 15, or 80%, of patients treated with GEN-1 had a R0 resection, which indicates a microscopically margin-negative complete resection in
which no gross or microscopic tumor remains in the tumor bed.
● 7 of 12 patients, or 58%, of patients in the control arm had an R0 resection.
● This interim data represents a 38% improvement in R0 resection rates for GEN-1 patients compared with control arm patients and is consistent
with the reported improvement in resection scores noted in the encouraging Phase I OVATION I Study, the manuscript of which has been
submitted for peer review publication.
6
The Company further reported that 22 clinical sites in the U.S. and Canada have been initiated, with three more sites expected to be added by the end of the
first quarter. Clinical investigators met in early February 2021 in a virtual meeting and expressed excitement about the potential for GEN-1 to treat
advanced ovarian cancer and, despite the challenges and earlier delays posed by the COVID-19 pandemic, they remain committed to completing
enrollment in the study during the second half of 2021.
PLACCINE DNA VACCINE TECHNOLOGY PLATFORM
In January 2021, the Company announced the filing of a provisional U.S. patent application for a novel DNA-based, investigational vaccine for preventing
or treating infections from a broad range of infectious agents including the coronavirus disease using its PLACCINE DNA vaccine technology platform
(“PLACCINE”). The provisional patent covers a family of novel composition of multi-cistronic vectors and polymeric nanoparticles that comprise the
PLACCINE DNA vaccine platform technology for preventing or treating infectious agents that have the potential for global pandemics, including the
SARS-CoV-2 virus and its variations, using the Company’s platform technology.
Celsion’s PLACCINE DNA vaccine technology platform is characterized by a single multi-cistronic DNA plasmid vector expressing multiple pathogen
antigens along with a potent immune modifier and delivered with a synthetic delivery system. It is easily adaptable to creating vaccines for a multitude of
pathogens, including emerging pathogens leading to pandemics as well as infectious diseases that have yet to be effectively addressed with current vaccine
technologies. This flexible vaccine platform is well supported by an already established supply chain to produce any plasmid vector and its assembly into a
respective vaccine formulation.
PLACCINE is an extension of the Company’s synthetic, non-viral TheraPlas delivery technology currently in a Phase II trial for the treatment of late-stage
ovarian cancer with GEN-1. Celsion’s proprietary multifunctional DNA vaccine technology concept is built on the flexible PLACCINE technology
platform that is amenable to rapidly responding to the SARS-CoV-2 virus, as well as possible future mutations of SARS-CoV-2, other future pandemics,
emerging bioterrorism threats, and novel infectious diseases. Celsion’s extensive experience with TheraPlas suggests that the PLACCINE-based
nanoparticles are stable at storage temperatures of 4oC to 25oC, making vaccines developed on this platform easily suitable for broad world-wide
distribution.
Celsion’s vaccine approach is designed to optimize the quality of the immune response dictating the efficiency of pathogen clearance and patient recovery.
Celsion has taken a multivalent approach in an effort to generate an even more robust immune response that not only results in a strong neutralizing
antibody response, but also a more robust and durable T-cell response. Delivered with Celsion’s synthetic polymeric system, the proprietary DNA plasmid
is protected from degradation and its cellular uptake is facilitated.
COVID-19 Vaccine Overview
Emerging data from the recent literature indicates that the quality of the immune response as opposed to its absolute magnitude is what dictates SARS-
CoV-2 viral clearance and recovery and that an ineffective or non-neutralizing enhanced antibody response might actually exacerbate disease. The first-
generation COVID-19 vaccines were developed for rapid production and deployment and were not optimized for generating cellular responses that result in
effective viral clearance. Though early data has indicated some of these vaccines to be over 95% effective, these first-generation vaccines were primarily
designed to generate a strong antibody response and, while they have been shown to provide prophylactic protection against disease, the durability of this
protection is currently unclear. The vast majority of these vaccines have been specifically developed to target the SARS-CoV-2 Spike (S) protein (antigen),
though it is known that restricting a vaccine to a sole viral antigen creates selection pressure that can serve to facilitate the emergence of viral resistance.
Indeed, even prior to full vaccine rollout, it has been observed that the S protein is a locus for rapid evolutionary and functional change as evidenced by the
D614G, Y453F, 501Y.V2, and VUI-202012/01 mutations/deletions. This propensity for mutation of the S protein leads to future risk of efficacy reduction
over time as these mutations accumulate.
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Our Next Generation Vaccine Initiative
Celsion’s next generation vaccine initiative stands at the confluence of immunotherapy and immunogenicity and envisions delivery, on a single plasmid,
multiple SARS-CoV-2 antigens in conjunction with a potent immune modifier, interleukin-12 (IL-12), which directs a TH-1 immune response, stimulates
T-cell immunity, and also promises the promotion of humoral immunity (antibody response). While most COVID-19 vaccines in late-stage clinical
development are monovalent (S protein antigen only), Celsion has taken this multivalent approach in an effort to generate an even more robust immune
response that not only results in a strong neutralizing antibody response, but also a more robust and durable T-cell response.
Celsion’s vaccine candidate approach comprises a single plasmid vector containing the DNA sequence encoding the cytokine IL-12 and multiple SARS-
CoV-2 antigens, including S antigen in combination with the membrane (M) or nucleocapsid (N) antigen. Delivery will be evaluated intramuscularly,
intradermally, or subcutaneously with a non-viral synthetic DNA delivery carrier that facilitates vector delivery into the cells of the injected tissue and has
potential immune adjuvant properties. Unique designs and formulations of Celsion vaccine candidates may offer several potential key advantages.
● While the antibodies against S antigen would prevent virus entry into cells, the M and N antibodies could help virus clearance through antibody-
mediated opsonization and phagocytosis. The presentation of multiple antigens on the cell surface of vaccine-injected tissue produces a broad
variety of killer T-cells which could potentially produce more efficient viral clearance than a single antigen vaccine.
● Since IL-12 is an essential regulator of the differentiation, proliferation, and maintenance of T helper 1 (TH-1) cells that generate killer T-cells and
memory T-cells against virally infected cells, its simultaneous expression could boost the viral clearance by the vaccine and improve the immune
system’s memory against any future exposure of the same virus.
● Finally, the synthetic polymeric DNA carrier is an important component of the vaccine composition as it has the potential to facilitate the vaccine
immunogenicity by improving vector delivery and, due to potential adjuvant properties, attract professional immune cells to the site of vaccine
delivery.
Future vaccine technology will need to address viral mutations and the challenges of efficient manufacturing, distribution, and storage. We believe an
adaptation of our TheraPlas technology, PLACCINE, has the potential to meet these challenges. Our approach is described in our provisional patent filing
and is summarized as a DNA vaccine technology platform characterized by a single plasmid DNA with multiple coding regions. The plasmid vector is
designed to express multiple pathogen antigens along with a potent immune modifier. It is delivered via a synthetic delivery system and has the potential to
be easily modified to create vaccines against a multitude of infectious diseases, addressing:
● Viral Mutations: PLACCINE may offer broad-spectrum and mutational resistance (variants) by targeting multiple antigens on a single plasmid
vector.
● Enhanced Efficacy: The potent immune modifier IL-12 may improve humoral and cellular responses to viral antigens and can be incorporated in
the plasmid.
● Durable Efficacy: PLACCINE delivers a DNA plasmid-based antigen that can result in durable antigen exposure and a robust vaccine response to
viral antigens.
● Storage & Distribution: PLACCINE allows for stability that is compatible with manageable vaccine storage and distribution.
● Simple Dosing & Administration: PLACCINE is a synthetic delivery system that should require a simple injection that does not require viruses
or special equipment to deliver its payload.
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We are conducting preliminary research associated with our recently announced proprietary DNA vaccine platform provisional patent filing. At the same
time, we are redoubling our efforts and R&D resources in our immuno-oncology and next generation vaccine program.
THERMODOX® - DIRECTED CHEMOTHERAPY
Liposomes are manufactured submicroscopic vesicles consisting of a discrete aqueous central compartment surrounded by a membrane bilayer composed
of naturally occurring lipids. Conventional liposomes have been designed and manufactured to carry drugs and increase residence time, thus allowing the
drugs to remain in the bloodstream for extended periods of time before they are removed from the body. However, the current existing liposomal
formulations of cancer drugs and liposomal cancer drugs under development do not provide for the immediate release of the drug and the direct targeting of
organ specific tumors, two important characteristics that are required for improving the efficacy of cancer drugs such as doxorubicin. A team of research
scientists at Duke University developed a heat-sensitive liposome that rapidly changes its structure when heated to a threshold minimum temperature of
39.5º to 42º Celsius. Heating creates channels in the liposome bilayer that allow an encapsulated drug to rapidly disperse into the surrounding tissue. This
novel, heat-activated liposomal technology is differentiated from other liposomes through its unique low heat-activated release of encapsulated
chemotherapeutic agents. We are able to use several available focused-heat technologies, such as radiofrequency ablation (“RFA”), microwave energy and
high intensity focused ultrasound (“HIFU”), to activate the release of drugs from our novel heat sensitive liposomes.
THERMODOX® for the Treatment of Primary Liver Cancer
Primary Liver Cancer Overview
Hepatocellular carcinoma (“HCC”) is one of the most common and deadliest forms of cancer worldwide. It ranks as the third most common solid tumor
cancer. It is estimated that up to 90% of liver cancer patients will die within five years of diagnosis. The incidence of primary liver cancer is approximately
35,000 cases per year in the U.S., approximately 65,000 cases per year in Europe and is increasing at approximately 2-3% per year worldwide. Global
incidence (per 2017 GLOBALCAN statistics) is reported at 755,000 cases. The World Health Organization (the “WHO”) has projected that HCC will be
the most prevalent form of cancer by 2030. HCC is commonly diagnosed in patients with longstanding hepatic disease and cirrhosis (primarily due to
hepatitis C in the U.S., Japan and Europe and hepatitis B in Asia).
At an early stage, the standard first line treatment for liver cancer is surgical resection of the tumor. Up to 80% of patients are ineligible for surgery or
transplantation at time of diagnosis because early-stage liver cancer generally has few symptoms and when finally detected the tumor frequently is too large
for surgical resection. There are few alternative treatments since radiation therapy and chemotherapy are largely ineffective in treating liver cancer. For
tumors generally up to 5 centimeters in diameter, RFA has emerged as the standard of care treatment which directly destroys the tumor tissue through the
application of high temperatures administered by a probe inserted into the core of the tumor. Local recurrence rates after RFA directly correlate to the size
of the tumor. For tumors 3 cm or smaller in diameter the recurrence rate has been reported to be 10 – 20%; however, for tumors greater than 3 cm, local
recurrence rates of 40% or higher have been observed.
Celsion’s Approach
While RFA uses extremely high temperatures (greater than 90° Celsius) to ablate the tumor, it may fail to treat micro-metastases in the outer margins of the
ablation zone because temperatures in the periphery may not be high enough to destroy cancer cells. Our ThermoDox® treatment approach is designed to
utilize the ability of RFA devices to ablate the center of the tumor while simultaneously thermally activating our ThermoDox® liposome to release its
encapsulated doxorubicin to kill any remaining viable cancer cells throughout the heated region, including the ablation margins. This novel treatment
approach is intended to deliver the drug directly to those cancer cells that survive RFA. This approach is designed to increase the delivery of the
doxorubicin at the desired tumor site while potentially reducing drug exposure distant to the tumor site.
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OPTIMA Study
The OPTIMA Study represents an evaluation of ThermoDox® in combination with a first line therapy, RFA, for newly diagnosed, intermediate stage HCC
patients. The OPTIMA Study was designed to enroll up to 550 patients globally at approximately 65 clinical sites in the U.S., Canada, European Union
(EU), China and other countries in the Asia-Pacific region and will evaluate ThermoDox® in combination with standardized RFA, which will require a
minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone. The
primary endpoint for the OPTIMA Study is OS, and the secondary endpoints are progression free survival and safety. The statistical plan calls for two
interim efficacy analyses by an independent Data Monitoring Committee (“DMC”).
On February 24, 2014, we announced that the FDA provided clearance for the OPTIMA Study, which is a pivotal, double-blind, placebo-controlled Phase
III trial of ThermoDox®, in combination with standardized RFA, for the treatment of primary liver cancer. The trial design of the OPTIMA Study is based
on the comprehensive analysis of data from an earlier Phase III clinical trial called the HEAT Study (the “HEAT Study”). The OPTIMA Study is supported
by a hypothesis developed from an OS analysis of a large subgroup of patients from the HEAT Study.
Post-hoc data analysis from our earlier Phase III HEAT Study suggests that ThermoDox® may substantially improve OS, when compared to the control
group, in patients if their lesions undergo a 45-minute RFA procedure standardized for a lesion greater than 3 cm in diameter. Data from nine OS sweeps
have been conducted since the top line progression free survival PFS data from the HEAT Study were announced in January 2013, with each data set
demonstrating substantial improvement in clinical benefit over the control group with statistical significance. On August 15, 2016, we announced updated
results from its final retrospective OS analysis of the data from the HEAT Study. These results demonstrated that in a large, well bounded, subgroup of
patients with a single lesion (n=285, 41% of the HEAT Study patients), treatment with a combination of ThermoDox® and optimized RFA provided an
average 54% risk improvement in OS compared to optimized RFA alone. The HR at this analysis is 0.65 (95% CI 0.45 - 0.94) with a p-value of 0.02.
Median OS for the ThermoDox® group has been reached which translates into a two-year survival benefit over the optimized RFA group (projected to be
greater than 80 months for the ThermoDox® plus optimized RFA group compared to less than 60 months projection for the optimized RFA only group).
This information should be viewed with caution since it is based on a retrospective analysis of a subgroup.
We also conducted additional analyses that further strengthen the evidence for the HEAT Study subgroup.
● We commissioned an independent computational model at the University of South Carolina Medical School. The results unequivocally indicate
that longer RFA heating times correlate with significant increases in doxorubicin concentration around the RFA treated tissue.
● In addition, we conducted a prospective preclinical study in 22 pigs using two different manufacturers of RFA and human equivalent doses of
ThermoDox® that clearly support the relationship between increased heating duration and doxorubicin concentrations.
On August 13, 2019, the Company announced that results from an independent analysis of the Company’s ThermoDox® HEAT Study conducted by the
National Institutes of Health (NIH) were published in the peer-reviewed publication, Journal of Vascular and Interventional Radiology. The analysis was
conducted by the intramural research program of the NIH and the NIH Center for Interventional Oncology, with the full data set from the Company’s
HEAT Study. The analysis evaluated the full data set to determine if there was a correlation between baseline tumor volume and RFA heating time
(minutes/tumor volume in milliliters), with or without ThermoDox® treatment, for patients with HCC. The NIH analysis was conducted under the direction
of Dr. Bradford Wood, MD, Director, NIH Center for Interventional Oncology and Chief, NIH Clinical Center Interventional Radiology.
The article titled, “RFA Duration Per Tumor Volume May Correlate with Overall Survival in Solitary Hepatocellular Carcinoma Patients Treated with RFA
Plus Lyso-thermosensitive Liposomal Doxorubicin,” discussed the NIH analysis of results from 437 patients in the HEAT Study (all patients with a single
lesion representing 62.4% of the study population). The key finding was that increased RFA heating time per tumor volume significantly improved OS in
patients with single-lesion HCC who were treated with RFA plus ThermoDox®, compared to patients treated with RFA alone. A one-unit increase in RFA
duration per tumor volume was shown to result in about a 20% improvement in OS for patients administered ThermoDox®, compared to RFA alone. The
authors conclude that increasing RFA heating time in combination with ThermoDox® significantly improves OS and establishes an improvement of over
two years versus the control arm when the heating time per milliliter of tumor is greater than 2.5 minutes. This finding was consistent with the Company’s
own results, which defined the optimized RFA procedure as a 45-minute treatment for tumors with a diameter of 3 centimeters. Thus, the NIH analysis lent
support to the hypothesis underpinning the OPTIMA Study.
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In August 2018, the Company announced that the OPTIMA Study was fully enrolled. On August 5, 2019, the Company announced that the prescribed
number of OS events had been reached for the first prespecified interim analysis of the OPTIMA Phase III Study. Following preparation of the data, the
first interim analysis was conducted by the DMC. The DMC’s pre-planned interim efficacy review followed 128 patient events, or deaths, which occurred
in August 2019. On November 4, 2019, the Company announced that the DMC unanimously recommended the OPTIMA Study continue according to
protocol. The recommendation was based on a review of blinded safety and data integrity from 556 patients enrolled in the OPTIMA Study. Data presented
demonstrated that PFS and OS data appeared to be tracking with patient data observed at a similar point in the Company’s subgroup of patients followed
prospectively in the earlier Phase III HEAT Study, upon which the OPTIMA Study was based.
On April 15, 2020, the Company announced that the prescribed minimum number of events of 158 patient deaths had been reached for the second pre-
specified interim analysis of the OPTIMA Phase III Study. The hazard ratio for success at 158 deaths is 0.70, which represents a 30% reduction in the risk
of death compared with RFA alone. On July 13, 2020, the Company announced that it has received a recommendation from the DMC to consider stopping
the global OPTIMA Study. The recommendation was made following the second pre-planned interim safety and efficacy analysis by the DMC on July 9,
2020. The DMC analysis found that the pre-specified boundary for stopping the trial for futility of 0.900 was crossed with an actual value of 0.903.
However, the 2-sided p-value of 0.524 for this analysis provides uncertainty, subsequently, the DMC left the final decision of whether or not to stop the
OPTIMA Study to Celsion. There were no safety concerns noted during the interim analysis. The Company followed the advice of the DMC considered its
options either to stop the study or continue to follow patients after a thorough review of the data, and an evaluation of our probability of success.
On August 4, 2020, the Company issued a press release announcing it would continue following patients for OS, noting that the unexpected and marginally
crossed futility boundary, suggested by the Kaplan-Meier analysis at the second interim analysis on July 9, 2020, may be associated with a data maturity
issue. On October 12, 2020, the Company provided an update on the ongoing data analysis from its Phase III OPTIMA Study with ThermoDox® as well as
growing interest among clinical investigators in conducting studies with ThermoDox® as a monotherapy or in combination with other therapies.
● Celsion engaged a global biometrics contract research organization, with forensic statistical analysis capability that specializes in data
management, statistical consulting, statistical analysis and data sciences, with particular expertise in evaluating unusual data from clinical trials
and experience with associated regulatory issues. The primary objective of the CRO’s work was to determine the basis and reasoning behind
continuing to follow patients for survival, and if there were outside influences that may have impacted the forecast of futility.
● In parallel, the Company submitted all OPTIMA Study clinical trial data to the National Institutes of Health (NIH) and with the expectation of
receiving a report on the following:
○ A Cox Regression Analysis for single solitary lesions including minimum burn time per tumor volume, evaluating similarities to the
hypothesis generated from the NIH paper published in the Journal of Vascular and Interventional Radiology, in which the key finding
was that increased RFA heating time per tumor volume significantly improved OS in patients with single lesion HCC who were treated
with RFA plus ThermoDox®, compared with patients treated with RFA alone.
○ A site-by-site evaluation for RFA heating time-based anomalies that may have contributed to the treatment arm performance.
○ An image-based evaluation comparing results from the OPTIMA Study to the data from the HEAT Study that led to the RFA heating time
hypothesis.
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On February 11, 2021, the Company provided a final update on the Phase III OPTIMA Study and the decision to stop following patients in the Study.
Independent analyses conducted by a global biometrics contract research organization and the NIH, did not find any evidence of significance or factors that
would justify continuing to follow patients for OS. Therefore, the Company notified all clinical sites to discontinue following patients. The OPTIMA Study
database of 556 patients will now be frozen at 185 patient deaths. While the analyses did identify certain patient subgroups that appear to have had a
clinical benefit, the Company concluded that it would not be in its best interest to pursue these retrospective findings as the regulatory hurdles supporting
further discussion will be significant.
Investigator-Sponsored Studies with ThermoDox®
Celsion continues working closely and supporting investigations by others throughout the world in breast cancer, pancreatic cancer and in solid tumors in
children. Following inquiries from the NIH, we intend to renew our Cooperative Research and Development Agreement (CRADA) with the Institute at a
nominal cost, one goal of which is to pursue their interest in a study of ThermoDox® to treat patients with bladder cancer. Importantly, Celsion is
developing a business model to support these investigator-sponsored studies in a manner that will not interfere with the Company’s focus on our GEN-1
program and vaccine development initiative.
Below are summaries of several investigator-sponsored studies using ThermoDox®:
● Oxford University plans to begin enrolling patients in a Phase I pancreatic cancer study with ThermoDox® in combination with High Intensity
Focused Ultrasound (HIFU) in the first half of 2021. The primary objective of this trial, the PanDox Study: Targeted Doxorubicin in Pancreatic
Tumors, is to quantify the enhancement in intratumoral doxorubicin concentration when delivered with ThermoDox® and HIFU, versus
doxorubicin monotherapy. This study is being undertaken pursuant to promising data in a mouse model of pancreatic cancer, which was published
in the International Journal of Hyperthermia in 2018. That preclinical study showed a 23x increase in intratumoral doxorubicin concentration with
ThermoDox® + HIFU, compared with a 2x increase in intratumoral doxorubicin concentration with free doxorubicin plus HIFU.
● Utrecht University in the Netherlands continues to enroll patients in a Phase I breast cancer study to determine the safety, tolerability and
feasibility of ThermoDox® in combination with Magnetic Resonance Guided High Intensity Focused Ultrasound (MR-HIFU) hyperthermia and
cyclophosphamide therapy for the local treatment of the primary tumor in metastatic breast cancer (mBC). This investigator-sponsored study,
which is being funded by the Dutch Cancer Society, the Center for Translational Molecular Medicine (a public-private partnership in the
Netherlands), will be conducted at University Medical Center Utrecht and will enroll up to 12 newly diagnosed mBC patients. Celsion will supply
Thermodox® clinical product for the trial.
● As evidence of the ongoing support Celsion enjoys from the NIH, they have organized a clinical project to evaluate ThermoDox® plus the
chemotherapy drug mitomycin in bladder cancer. Depending on the NIH timelines, this study may commence as early as 2021.
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BUSINESS STRATEGY AND DEVELOPMENT PLAN
We have not generated and do not expect to generate any revenue from product sales in the next several years, if at all. An element of our business strategy
has been to pursue, as resources permit, the research and development of a range of product candidates for a variety of indications. We may also evaluate
licensing products from third parties to expand our current product pipeline. This is intended to allow us to diversify the risks associated with our research
and development expenditures. To the extent we are unable to maintain a broad range of product candidates, our dependence on the success of one or a few
product candidates would increase and results such as those announced in relation to the OPTIMA Study in February 2021 will have a more significant
impact on our financial prospects, financial condition and market value. We may also consider and evaluate strategic alternatives, including investment in,
or acquisition of, complementary businesses, technologies or products. As demonstrated by the HEAT Study and OPTIMA Study results, drug research and
development is an inherently uncertain process and there is a high risk of failure at every stage prior to approval. The timing and the outcome of clinical
results are extremely difficult to predict. The success or failure of any preclinical development and clinical trial can have a disproportionately positive or
negative impact on our results of operations, financial condition, prospects and market value.
Our current business strategy includes the possibility of entering into collaborative arrangements with third parties to complete the development and
commercialization of our product candidates. In the event that third parties take over the clinical trial process for one or more of our product candidates, the
estimated completion date would largely be under the control of that third party rather than us. We cannot forecast with any degree of certainty which
proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole or in part, and how such arrangements would
affect our development plan or capital requirements. We may also apply for subsidies, grants or government or agency-sponsored studies that could reduce
our development costs.
We had $19.0 million in cash, investments, interest receivable and deferred income tax asset as of December 31, 2020. During the first quarter of 2021, we
raised $6.9 million in capital under the Capital on Demand Agreement with JonesTrading, received $1.5 million in gross proceeds from warrant exercises
and $35 million from the January 2021 Registered Direct Offering (as defined below). Given our current development plans, we anticipate our current cash
resources will be sufficient to fund our operations and financial commitments through 2023.
As a result of the risks and uncertainties discussed in this Annual Report, among others, we are unable to estimate the duration and completion costs of our
research and development projects or when, if ever, and to what extent we will receive cash inflows from the commercialization and sale of a product if one
of our product candidates receives regulatory approval for marketing, if at all. Our inability to complete any of our research and development activities,
preclinical studies or clinical trials in a timely manner or our failure to enter into collaborative agreements when appropriate could significantly increase
our capital requirements and could adversely impact our liquidity. While our estimated future capital requirements are uncertain and could increase or
decrease as a result of many factors, including the extent to which we choose to advance our research and development activities, preclinical studies and
clinical trials, or whether we are in a position to pursue manufacturing or commercialization activities, we will need significant additional capital to develop
our product candidates through development and clinical trials, obtain regulatory approvals and manufacture and commercialize approved products, if any.
We do not know whether we will be able to access additional capital when needed or on terms favorable to us or our stockholders. Our inability to raise
additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business. See Item 7 - Management’s
Discussion and Analysis of Financial Condition and Results of Operations for additional information regarding the Company’s financial condition,
liquidity and capital resources.
RESEARCH AND DEVELOPMENT EXPENDITURES
We are engaged in a limited amount of research and development in our own facilities and have sponsored research programs in partnership with various
research institutions, including the NIH, the National Cancer Institute and Duke University. We are currently, with minimal cash expenditures, sponsoring
clinical and pre-clinical research at the University of Oxford, University of Utrecht, and the Children’s Hospital Research Institute. The majority of the
spending in research and development is for the funding of ThermoDox® and GEN-1 clinical trials. Research and development expenses were
approximately $11.3 million and $13.1 million for the years ended December 31, 2020 and 2019, respectively. See Part II, Item 7 - Management’s
Discussion and Analysis of Financial Condition and Results of Operations for additional information regarding expenditures related to our research and
development programs.
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GOVERNMENT REGULATION
Government authorities in the U.S., at the federal, state and local level, and in other countries extensively regulate, among other things, the research,
development, testing, quality control, approval, manufacturing, labeling, post-approval monitoring and reporting, recordkeeping, packaging, promotion,
storage, advertising, distribution, marketing and export and import of pharmaceutical products such as those we are developing. The process of obtaining
regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of
substantial time and financial resources.
Regulation in the U.S.
In the U.S., the FDA regulates drugs and biological products under the Federal Food, Drug, and Cosmetic Act (the “FDCA”), the Public Health Service Act
(the “PHSA”) and implementing regulations. Failure to comply with the applicable FDA requirements at any time pre- or post-approval may result in a
delay of approval or administrative or judicial sanctions. These sanctions could include the FDA’s imposition of a clinical hold on trials, refusal to approve
pending applications, withdrawal of an approval, issuance of warning or untitled letters, product recalls, product seizures, total or partial suspension of
production or distribution, injunctions, fines, civil penalties or criminal prosecution.
Research and Development
The vehicle by which FDA approves a new pharmaceutical product for sale and marketing in the U.S. is a New Drug Application (“NDA”) or a Biologics
License Application (BLA). A new drug or biological product cannot be marketed in the U.S. without FDA’s approval of an NDA/BLA. The steps
ordinarily required before a new drug can be marketed in the U.S. include (a) completion of pre-clinical and clinical studies; (b) submission and FDA
acceptance of an Investigational New Drug application (IND), which must become effective before human clinical trials may commence; (c) completion of
adequate and well-controlled human clinical trials to establish the safety and efficacy of the product to support each of its proposed indications; (d)
submission and FDA acceptance of an NDA/BLA; (e) completion of an FDA inspection and potential audits of the facilities where the drug or biological
product is manufactured to assess compliance with the cGMP and to assure adequate identity, strength, quality, purity, and potency; and (e) FDA review
and approval of the NDA/BLA.
Pre-clinical tests include laboratory evaluations of product chemistry, toxicity, formulation and stability, as well as animal studies, to assess the potential
safety and efficacy of the product. Pre-clinical safety tests must be conducted by laboratories that comply with FDA regulations regarding good laboratory
practice. The results of pre-clinical tests are submitted to the FDA as part of an IND and are reviewed by the FDA before the commencement of human
clinical trials. Submission of an IND will not necessarily result in FDA authorization to commence clinical trials, and the absence of FDA objection to an
IND does not necessarily mean that the FDA will ultimately approve an NDA/BLA or that a product candidate otherwise will come to market.
Clinical trials involve the administration of the investigational product to human subjects under the supervision of a qualified principal investigator.
Clinical trials must be conducted in accordance with good clinical practices under protocols submitted to the FDA as part of an IND and with patient
informed consent. Also, each clinical trial must be approved by an Institutional Review Board (“IRB”) and is subject to ongoing IRB monitoring.
Clinical trials are typically conducted in three sequential phases, but the phases may overlap or be combined. Phase I clinical trials may be conducted in
patients or healthy volunteers to evaluate the product’s safety, dosage tolerance and pharmacokinetics and, if possible, seek to gain an early indication of its
effectiveness. Phase II clinical trials usually involve controlled trials in a larger but still relatively small number of subjects from the relevant patient
population to evaluate dosage tolerance and appropriate dosage; identify possible short-term adverse effects and safety risks; and provide a preliminary
evaluation of the efficacy of the drug for specific indications. Phase III clinical trials are typically conducted in a significantly larger patient population and
are intended to further evaluate safety and efficacy, establish the overall risk-benefit profile of the product, and provide an adequate basis for physician
labeling.
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In certain circumstances, a therapeutic product candidate being studied in clinical trials may be made available for treatment of individual patients.
Pursuant to the 21st Century Cures Act (Cures Act), the manufacturer of an investigational product for a serious disease or condition is required to make
available, such as by posting on its website, its policy on evaluating and responding to requests for individual patient access to such investigational product.
There can be no assurance that any of our clinical trials will be completed successfully within any specified time period or at all. Either the FDA or we may
suspend clinical trials at any time on various grounds, including among other things, if we, the FDA, our independent DMC, or the IRB conclude that
clinical subjects are being exposed to an unacceptable health risk. The FDA inspects and reviews clinical trial sites, informed consent forms, data from the
clinical trial sites (including case report forms and record keeping procedures) and the performance of the protocols by clinical trial personnel to determine
compliance with good clinical practices. The conduct of clinical trials is complex and difficult, and there can be no assurance that the design or the
performance of the pivotal clinical trial protocols of any of our current or future product candidates will be successful.
The results of pre-clinical studies and clinical trials, if successful, are submitted to FDA in the form of an NDA or BLA. Among other things, the FDA
reviews an NDA to determine whether the product is safe and effective for its intended use and reviews a BLA to determine whether the product is safe,
pure, and potent, and in each case, whether the product candidate is being manufactured in accordance with cGMP. The testing, submission, and approval
process requires substantial time, effort, and financial resources, including substantial application user fees and annual product and establishment user fees.
There can be no assurance that any approval will be granted for any product at any time, according to any schedule, or at all. The FDA may refuse to accept
or approve an application if it determines that applicable regulatory criteria are not satisfied. The FDA may also require additional testing for safety and
efficacy. Even, if regulatory approval is granted, the approval will be limited to specific indications. There can be no assurance that any of our current
product candidates will receive regulatory approvals for marketing or, if approved, that approval will be for any or all of the indications that we request.
The FDA has agreed to certain performance goals in the review of NDAs and BLAs. The FDA has 60 days from its receipt of an NDA or BLA to
determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit
substantive review. Once the NDA/BLA is accepted for filing, most standard reviews applications are completed within ten months of filing; most priority
review applications are reviewed within six months of filing. Priority review are applied to a product candidate that the FDA determines has the potential to
treat a serious or life-threatening condition and, if approved, would be a significant improvement in safety or effectiveness compared to available therapies.
The review process for both standard and priority review may be extended by the FDA for three additional months to consider certain late-submitted
information, or information intended to clarify information already provided in the submission.
Section 505(b)(2) NDAs
As an alternative path to FDA approval for modifications to formulations or uses of drugs previously approved by the FDA, an applicant may submit an
NDA under Section 505(b)(2) of the FDCA. Section 505(b)(2) was enacted as part of the Hatch-Waxman Amendments. A Section 505(b)(2) NDA is an
application that contains full reports of investigations of safety and effectiveness, but where at least some of the information required for approval comes
from studies not conducted by, or for, the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom
the investigations were conducted. This type of application permits reliance for such approvals on literature or on an FDA finding of safety, effectiveness or
both for an approved drug product.
As such, under Section 505(b)(2), the FDA may rely, for approval of an NDA, on data not developed by the applicant. The FDA may also require
companies to perform additional studies or measurements, including clinical trials, to support the change from the approved branded reference drug. The
FDA may then approve the new product candidate for the new indication sought by the 505(b)(2) applicant.
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FDA Regulations Specific to Gene-Based Products
The FDA regulates gene-based products as biological products. Biological products intended for therapeutic use may be regulated by either the Center for
Biologics Evaluation & Research (CBER) or the Center for Drug Evaluation & Research (CDER). Gene-based products are subject to extensive regulation
under the FDCA, the PHSA, and their implementing regulations. Each clinical trial of investigational gene therapies must be reviewed and approved by the
Institutional Biosafety Committee (IBC) for each clinical site if they receive any funding whatsoever from the National Institutes of Health (NIH). IBCs
were established under NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to provide local review and oversight of
nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules. The IBC assesses biosafety issues, specifically, safety practices and
containment procedures, related to the investigational product and clinical study. Compliance with the NIH Guidelines is mandatory for investigators at
institutions receiving NIH funds for research involving recombinant DNA, however many companies and other institutions not otherwise subject to the
NIH Guidelines voluntarily follow them. Such trials remain subject to FDA and other clinical trial regulations, and only after FDA, IBC, and other relevant
approvals are in place can these protocols proceed.
Additional Controls for Biological Products
To help reduce the increased risk of the introduction of adventitious agents, the PHSA emphasizes the importance of manufacturing controls for products
whose attributes cannot be precisely defined. The PHSA also provides authority to the FDA to immediately suspend licenses in situations where there
exists a danger to public health, to prepare or procure products in the event of shortages and critical public health needs, and to authorize the creation and
enforcement of regulations to prevent the introduction or spread of communicable diseases in the U.S. and between states.
After a BLA is approved, the biological product may be subject to official lot release as a condition of approval. As part of the manufacturing process, the
manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product is subject to official release
by the FDA, the manufacturer submits samples of each lot of product to the FDA together with a release protocol showing a summary of the history of
manufacture of the lot and the results of all of the manufacturer’s tests performed on the lot. The FDA may also perform certain confirmatory tests on lots
of some products, such as viral vaccines, before releasing the lots for distribution by the manufacturer.
In addition, the FDA conducts laboratory research related to the regulatory standards on the safety, purity, potency, and effectiveness of biological products.
As with drugs, after approval of biological products, manufacturers must address any safety issues that arise, are subject to recalls or a halt in
manufacturing, and are subject to periodic inspection after approval.
Expedited Development and Review Programs
The FDA has various programs, including Fast Track, priority review, accelerated approval and breakthrough therapy, which are intended to expedite or
simplify the process for reviewing product candidates, or provide for the approval of a product candidate on the basis of a surrogate endpoint. In January
2021, the FDA granted Fast Track designation for GEN-1 for the treatment of ovarian cancer.
Even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product candidate no longer meets the
conditions for qualification or that the time period for FDA review or approval will be lengthened. Generally, product candidates that are eligible for these
programs are those for serious or life-threatening conditions, those with the potential to address unmet medical needs and those that offer meaningful
benefits over existing treatments. For example, Fast Track is a process designed to facilitate the development and expedite the review of product candidates
to treat serious or life-threatening diseases or conditions and fill unmet medical needs.
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Although Fast Track and priority review do not affect the standards for approval, the FDA will attempt to facilitate early and frequent meetings with a
sponsor of a Fast-Track designated product candidate and expedite review of the application for a product candidate designated for priority review.
Accelerated approval provides for an earlier approval for a new product candidate that meets the following criteria: is intended to treat a serious or life-
threatening disease or condition, generally provides a meaningful advantage over available therapies and demonstrates an effect on a surrogate endpoint
that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality (IMM) that
is reasonably likely to predict an effect on IMM or other clinical benefit. A surrogate endpoint is a laboratory measurement or physical sign used as an
indirect or substitute measurement representing a clinically meaningful outcome. As a condition of approval, the FDA may require that a sponsor of a
product candidate receiving accelerated approval perform post-marketing clinical trials to verify and describe the predicted effect on irreversible morbidity
or mortality or other clinical endpoint, and the product may be subject to accelerated withdrawal procedures.
A sponsor may seek FDA designation of a product candidate as a “breakthrough therapy” if the product candidate is intended, alone or in combination with
one or more other therapeutics, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the product
candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment
effects observed early in clinical development. A request for Breakthrough Therapy designation should be submitted concurrently with, or as an
amendment to, an IND, but ideally no later than the end of Phase 2 meeting.
Disclosure of Clinical Trial Information
Sponsors of clinical trials of FDA-regulated products are required to register and disclose certain clinical trial information. Information related to the
product, patient population, phase of investigation, trial sites and investigators, and other aspects of the clinical trial is then made public as part of the
registration. Sponsors are also obligated to disclose the results of their clinical trials within one year of completion, although disclosure of the results of
these trials can be delayed in certain circumstances for up to two additional years. Competitors may use this publicly available information to gain
knowledge regarding the progress of development programs.
Orphan Drug Designation
In 2005, the FDA granted orphan drug designation for GEN-1 for the treatment of ovarian cancer. In 2010, the FDA granted orphan drug designation for
ThermoDox® for the treatment of HCC. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and
approval process. However, 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. Orphan drug designation can also provide opportunities for grant funding towards clinical trial costs, tax advantages and FDA user-fee
benefits.
Hatch-Waxman Exclusivity
The FDCA provides a five-year period of non-patent data exclusivity within the U.S. to the first applicant to gain approval of an 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. However, an ANDA or 505(b)(2) NDA referencing the new chemical entity may be submitted after
four years if it contains a certification of patent invalidity or non-infringement.
Biosimilars
The Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”) created an abbreviated approval pathway for biological product candidates
shown to be highly similar to or interchangeable with an FDA licensed reference product. Biosimilarity sufficient to reference a prior FDA-approved
product requires that there be no differences in conditions of use, route of administration, dosage form, and strength, and no clinically meaningful
differences between the biological product candidate and the reference product in terms of safety, purity, and potency. Biosimilarity must be shown through
analytical trials, animal trials, and a clinical trial or trials, unless the Secretary of Health and Human Services waives a required element. A biosimilar
product candidate may be deemed interchangeable with a prior approved product if it meets the higher hurdle of demonstrating that it can be expected to
produce the same clinical results as the reference product and, for products administered multiple times, the biological product and the reference product
may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the
reference product. To date, a handful of biosimilar products and no interchangeable products have been approved under the BPCIA. Complexities
associated with the larger, and often more complex, structures of biological products, as well as the process by which such products are manufactured, pose
significant hurdles to implementation, which is still being evaluated by the FDA.
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A reference product is granted 12 years of exclusivity from the time of first licensure of the reference product, and no application for a biosimilar can be
submitted for four years from the date of licensure of the reference product. The first biological product candidate submitted under the abbreviated approval
pathway that is determined to be interchangeable with the reference product has exclusivity against a finding of interchangeability for other biological
products for the same condition of use for the lesser of (i) one year after first commercial marketing of the first interchangeable biosimilar, (ii) 18 months
after the first interchangeable biosimilar is approved if there is no patent challenge, (iii) 18 months after resolution of a lawsuit over the patents of the
reference product in favor of the first interchangeable biosimilar applicant, or (iv) 42 months after the first interchangeable biosimilar’s application has
been approved if a patent lawsuit is ongoing within the 42-month period.
Post-Approval Requirements
After FDA approval of a product is obtained, we and our contract manufacturers are required to comply with various post-approval requirements, including
establishment registration and product listing, record-keeping requirements, reporting of adverse reactions and production problems to the FDA, providing
updated safety and efficacy information for drugs, or safety, purity, and potency for biological products, and complying with requirements concerning
advertising and promotional labeling. As a condition of approval of an NDA/BLA, 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 can also impose other post-marketing
controls on us as well as our products including, but not limited to, restrictions on sale and use, through the approval process, regulations and otherwise.
The FDA also has the authority to require the recall of our products in the event of material deficiencies or defects in manufacture. A governmentally
mandated recall, or a voluntary recall by us, could result from a number of events or factors, including component failures, manufacturing errors, instability
of product or defects in labeling.
In addition, manufacturing establishments in the U.S. and abroad are subject to periodic inspections by the FDA and must comply with cGMP. To maintain
compliance with cGMP, manufacturers must expend funds, time and effort in the areas of production and quality control. The manufacturing process must
be capable of consistently producing quality batches of the product candidate and the manufacturer must develop methods for testing the quality, purity and
potency of the product candidate. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate
that the product candidate does not undergo unacceptable deterioration over its proposed shelf-life.
Foreign Clinical Studies to Support an IND, NDA, or BLA
The FDA will accept as support for an IND, NDA, or BLA a well-designed, well-conducted, non-IND foreign clinical trial if it was conducted in
accordance with good clinical practice (“GCP”) and the FDA is able to validate the data from the trial through an on-site inspection, if necessary. A sponsor
or applicant who wishes to rely on a non-IND foreign clinical trial to support an IND must submit supporting information to the FDA to demonstrate that
the trial conformed to GCP. This information includes the investigator’s qualifications; a description of the research facilities; a detailed summary of the
protocol and trial results and, if requested, case records or additional background data; a description of the drug substance and drug product, including the
components, formulation, specifications, and, if available, the bioavailability of the product candidate; information showing that the trial is adequate and
well controlled; the name and address of the independent ethics committee that reviewed the trial and a statement that the independent ethics committee
meets the required definition; a summary of the independent ethics committee’s decision to approve or modify and approve the trial, or to provide a
favorable opinion; a description of how informed consent was obtained; a description of what incentives, if any, were provided to subjects to participate; a
description of how the sponsor monitored the trial and ensured that the trial was consistent with the protocol; a description of how investigators were
trained to comply with GCP and to conduct the trial in accordance with the trial protocol; and a statement on whether written commitments by investigators
to comply with GCP and the protocol were obtained.
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Regulatory applications based solely on foreign clinical data meeting these criteria may be approved if the foreign data are applicable to the U.S.
population and U.S. medical practice, the trials have been performed by clinical investigators of recognized competence, and the data may be considered
valid without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through
an on-site inspection or other appropriate means. Failure of an application to meet any of these criteria may result in the application not being approvable
based on the foreign data alone.
New Legislation and Regulations
From time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the testing,
approval, manufacturing and marketing of products regulated by the FDA. In addition to new legislation, FDA regulations and policies are often revised or
interpreted by the agency in ways that may significantly affect our business and our products. It is impossible to predict whether further legislative changes
will be enacted or whether FDA regulations, guidance, policies or interpretations will be changed or what the effect of such changes, if any, may be.
Further, with the COVID-19 pandemic, it is possible that Congress and FDA may implement new laws, regulations, or policies that may impact our ability
to continue development programs as planned.
Other regulatory matters
Manufacturing, sales, promotion and other activities of product candidates following product approval, where applicable, or commercialization are also
subject to regulation by numerous regulatory authorities in the U.S. in addition to the FDA, which may include the Centers for Medicare & Medicaid
Services, or CMS, other divisions of the Department of Health and Human Services, or HHS, the Department of Justice, the Drug Enforcement
Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the
Environmental Protection Agency and state and local governments and governmental agencies.
Other healthcare laws
Healthcare providers, physicians, and third-party payors will play a primary role in the recommendation and prescription of any products for which we
obtain marketing approval. Our business operations and any current or future arrangements with third-party payors, healthcare providers and physicians
may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements
and relationships through which we develop, market, sell and distribute any drugs for which we obtain marketing approval. In the U.S., these laws include,
without limitation, state and federal anti-kickback, false claims, physician transparency, and patient data privacy and security laws and regulations,
including but not limited to those described below.
● The federal Anti-Kickback Statute prohibits among other things, persons and entities from knowingly and willfully soliciting, offering, paying,
receiving or providing any remuneration (including any kickback, bribe, or certain rebate), directly or indirectly, overtly or covertly, in cash or in kind,
to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for
which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid. A person or entity need not have
actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation. Violations are subject to
significant civil and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion
from government healthcare programs. In addition, the government may assert that a claim that includes 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.
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● The federal civil and criminal false claims laws, including the civil False Claims Act, or FCA, prohibit individuals or entities from, among other
things, knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false, fictitious or
fraudulent; knowingly making, using, or causing to be made or used, a false statement or record material to a false or fraudulent claim or obligation to
pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing an
obligation to pay money to the federal government. Manufacturers can be held liable under the FCA even when they do not submit claims directly to
government payors if they are deemed to “cause” the submission of false or fraudulent claims. The FCA also permits a private individual acting as a
“whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. When an
entity is determined to have violated the federal civil False Claims Act, the government may impose civil fines and penalties for each false claim, plus
treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs.
● The federal civil monetary penalties laws, which impose civil fines for, among other things, the offering or transfer or remuneration to a Medicare or
state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider,
practitioner, or supplier of services reimbursable by Medicare or a state health care program, unless an exception applies.
● The Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for knowingly and willfully executing
a scheme, or attempting to execute a scheme, to defraud any healthcare benefit program, including private payors, knowingly and willfully embezzling
or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, or 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, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective
implementing regulations, imposes, among other things, specified requirements on covered entities and their business associates relating to the privacy
and security of individually identifiable health information including mandatory contractual terms and required implementation of technical safeguards
of such information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly
applicable to business associates in some cases, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal
courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.
● The Physician Payments Sunshine Act, enacted as part of the Patient Protection and Affordable Care Act (“ACA”), as amended by the Health Care and
Education Reconciliation Act of 2010, or collectively, the ACA, imposed new annual reporting requirements for certain manufacturers of drugs,
devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, for
certain payments and “transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and
teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. In addition, many states also
require reporting of payments or other transfers of value, many of which differ from each other in significant ways, are often not pre-empted, and may
have a more prohibitive effect than the Sunshine Act, thus further complicating compliance efforts. Effective January 1, 2022, these reporting
obligations will extend to include transfers of value made in the previous year to certain non-physician providers such as physician assistants and nurse
practitioners.
● Federal consumer protection and unfair competition laws broadly regulate marketplace activities and activities that potentially harm consumers.
● Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and
claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, and may be broader in
scope than their federal equivalents; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s
voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may
be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of
value to physicians and other healthcare providers and restrict marketing practices or require disclosure of marketing expenditures and pricing
information; and state and foreign laws that govern the privacy and security of health information in some circumstances. These data privacy and
security laws may differ from each other in significant ways and often are not pre-empted by HIPAA, which may complicate compliance efforts.
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The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in
light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions between
healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare
industry. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations or
case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or
any other related governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages,
fines, imprisonment, disgorgement, exclusion from government funded healthcare programs, such as Medicare and Medicaid, reputational harm, additional
oversight and reporting obligations if we become subject to a corporate integrity agreement or similar settlement to resolve allegations of non-compliance
with these laws and the curtailment or restructuring of our operations. If any of the physicians or other healthcare providers or entities with whom we
expect to do business is found to be not in compliance with applicable laws, they may be subject to similar actions, penalties and sanctions. Ensuring
business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time-
and resource-consuming and can divert a company’s attention from its business.
In the U.S., numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws, and
federal and state consumer protection laws, govern the collection, use, disclosure, and protection of health-related and other personal information. For
example, in June 2018, the State of California enacted the California Consumer Privacy Act of 2018 (the “CCPA”), which came into effect on January 1,
2020 and provides new data privacy rights for consumers and new operational requirements for companies, which may increase our compliance costs and
potential liability. The CCPA gives California residents expanded rights to access and delete their personal information, opt out of certain personal
information sharing, and receive detailed information about how their personal information is used. The CCPA provides for civil penalties for violations, as
well as a private right of action for data breaches that is expected to increase data breach litigation. While there is currently an exception for protected
health information that is subject to HIPAA and clinical trial regulations, as currently written, the CCPA may impact certain of our business activities. The
CCPA could mark the beginning of a trend toward more stringent state privacy legislation in the U.S., which could increase our potential liability and
adversely affect our business.
In the event we decide to conduct clinical trials or continue to enroll subjects in our ongoing or future clinical trials, we may be subject to additional
privacy restrictions. The collection, use, storage, disclosure, transfer, or other processing of personal data regarding individuals in the European Economic
Area, or EEA, including personal health data, is subject to the EU General Data Protection Regulation, or GDPR, which became effective on May 25,
2018. The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to
processing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates, providing information to individuals
regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data
breaches, and taking certain measures when engaging third-party processors. The GDPR also imposes strict rules on the transfer of personal data to
countries outside the EEA, including the U.S., and permits data protection authorities to impose large penalties for violations of the GDPR, including
potential fines of up to €20 million or 4% of annual global revenues, whichever is greater. The GDPR also confers a private right of action on data subjects
and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from
violations of the GDPR. In addition, the GDPR includes restrictions on cross-border data transfers. The GDPR may increase our responsibility and liability
in relation to personal data that we process where such processing is subject to the GDPR, and we may be required to put in place additional mechanisms to
ensure compliance with the GDPR, including as implemented by individual countries. Compliance with the GDPR will be a rigorous and time-intensive
process that may increase our cost of doing business or require us to change our business practices, and despite those efforts, there is a risk that we may be
subject to fines and penalties, litigation, and reputational harm in connection with our European activities. Further, the United Kingdom’s decision to leave
the EU, often referred to as Brexit, has created uncertainty with regard to data protection regulation in the United Kingdom. In particular, it is unclear how
data transfers to and from the United Kingdom will be regulated now that the United Kingdom has left the EU.
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Insurance Coverage and Reimbursement
In the U.S. and markets in other countries, patients who are prescribed treatments for their conditions and providers performing the prescribed services
generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Thus, even if a product candidate is approved, sales of the
product will depend, in part, on the extent to which third-party payors, including government health programs in the U.S. such as Medicare and Medicaid,
commercial health insurers and managed care organizations, provide coverage, and establish adequate reimbursement levels for, the product. In the U.S.,
the principal decisions about reimbursement for new medicines are typically made by CMS, an agency within HHS. CMS decides whether and to what
extent a new medicine will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. No uniform policy of
coverage and reimbursement for drug products exists among third-party payors. Therefore, coverage and reimbursement for drug products can differ
significantly from payor to payor. The process for determining whether a third-party 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 are increasingly
challenging the prices charged, examining the medical necessity, and reviewing the cost-effectiveness of medical products and services and imposing
controls to manage costs. Third-party payors may limit coverage to specific products on an approved list, also known as a formulary, which might not
include all of the approved products for a particular indication.
In order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct expensive
pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of the product, in addition to the costs required to obtain
FDA or other comparable regulatory approvals. Additionally, companies may also need to provide discounts to purchasers, private health plans or
government healthcare programs. Nonetheless, product candidates may not be considered medically necessary or cost effective. A decision by a third-party
payor not to cover a product could reduce physician utilization once the product is approved and have a material adverse effect on sales, our operations and
financial condition. Additionally, a third-party payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will
be approved. Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage and
reimbursement for the product, and the level of coverage and reimbursement can differ significantly from payor to payor.
The containment of healthcare costs has become a priority of federal, state and foreign governments, and the prices of products have been a focus in this
effort. Governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement
and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies
in jurisdictions with existing controls and measures, could further limit a company’s revenue generated from the sale of any approved products. Coverage
policies and third-party payor reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or
more products for which a company or its collaborators receive regulatory approval, less favorable coverage policies and reimbursement rates may be
implemented in the future.
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, also called the Medicare Modernization Act, or the MMA, established the
Medicare Part D program to provide a voluntary prescription drug and biologic benefit to Medicare beneficiaries. Under Part D, Medicare beneficiaries
may enroll in prescription drug plans offered by private entities that provide coverage of outpatient prescription drugs and biologics. Unlike Medicare Parts
A and B, Part D coverage is not standardized. Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs and biologics, and
each drug plan can develop its own formulary that identifies which drugs and biologics it will cover, and at what tier or level. However, Part D prescription
drug formularies must include products within each therapeutic category and class of covered Part D drugs, though not necessarily all the drugs and
biologics in each category or class. Any formulary used by a Part D prescription drug plan must be developed and reviewed by a pharmacy and therapeutic
committee. Government payment for some of the costs of prescription drugs and biologics may increase demand for products for which we obtain
marketing approval. Any negotiated prices for any of our products covered by a Part D prescription drug plan will likely be lower than the prices we might
otherwise obtain. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy
and payment limitations in setting their own payment rates. Any reduction in payment that results from the MMA may result in a similar reduction in
payments from non-governmental payors.
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For a drug or biologic product to receive federal reimbursement under the Medicaid or Medicare Part B programs or to be sold directly to U.S. government
agencies, the manufacturer must extend discounts to entities eligible to participate in the 340B drug pricing program. The required 340B discount on a
given product is calculated based on the average manufacturer price, or AMP, and Medicaid rebate amounts reported by the manufacturer. As of 2010, the
Patient Protection and ACA, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively the ACA, expanded the types of
entities eligible to receive discounted 340B pricing, although under the current state of the law these newly eligible entities (with the exception of children’s
hospitals) will not be eligible to receive discounted 340B pricing on orphan drugs. As 340B drug pricing is determined based on AMP and Medicaid rebate
data, the revisions to the Medicaid rebate formula and AMP definition described above could cause the required 340B discount to increase. Changes to
these current laws and state and federal healthcare reform measures that may be adopted in the future may result in additional reductions in Medicare and
other healthcare funding and otherwise affect the prices we may obtain for any product candidates for which we may obtain regulatory approval or the
frequency with which any such product candidate is prescribed or used.
These laws, and future state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions in
Medicare and other healthcare funding and otherwise affect the prices we may obtain for any product candidates for which we may obtain regulatory
approval or the frequency with which any such product candidate is prescribed or used.
Outside the U.S., ensuring coverage and adequate payment for a product also involves challenges, as the pricing of biological products is subject to
governmental control in many countries. For example, in the European Union, pricing and reimbursement schemes vary widely from country to country.
Some countries provide that products may be marketed only after a reimbursement price has been agreed. Some countries may require the completion of
additional studies that compare the cost effectiveness of a particular therapy to currently available therapies or so-called health technology assessments, in
order to obtain reimbursement or pricing approval. Other countries may allow companies to fix their own prices for products but monitor and control
product volumes and issue guidance to physicians to limit prescriptions. Efforts to control prices and utilization of biological products will likely continue
as countries attempt to manage healthcare expenditures.
Current and future healthcare reform legislation
In the U.S. and some foreign jurisdictions, there have been, and likely will continue to be, a number of legislative and regulatory changes and proposed
changes regarding the healthcare system directed at broadening the availability of healthcare, improving the quality of healthcare, and containing or
lowering the cost of healthcare. For example, on May 30, 2018, the Right to Try Act was signed into law. The law, among other things, provides a federal
framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing
investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining
FDA permission under the FDA expanded access program. There is no obligation for a drug manufacturer to make its drug products available to eligible
patients as a result of the Right to Try Act, but the manufacturer must develop an internal policy and respond to patient requests according to that policy.
Also, in March 2010, the U.S. Congress enacted the ACA, which, among other things, includes changes to the coverage and payment for products under
government health care programs. The ACA includes provisions of importance to our potential product candidates that:
● created an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic products,
apportioned among these entities according to their market share in certain government healthcare programs;
● expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with
income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability;
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● expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic
drugs and revising the definition of “average manufacturer price,” or AMP, for calculating and reporting Medicaid drug rebates on outpatient
prescription drug prices;
● addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are
inhaled, infused, instilled, implanted or injected;
● expanded the types of entities eligible for the 340B drug discount program;
● established the Medicare Part D coverage gap discount program by requiring manufacturers to provide point-of-sale-discounts off the negotiated price
of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturers’ outpatient drugs to be covered
under Medicare Part D; and
● created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research,
along with funding for such research.
Some of the provisions of the ACA have yet to be implemented, and there have been judicial and Congressional challenges to certain provisions of the
ACA. While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions of the ACA such as removing
penalties, starting January 1, 2019, for not complying with the ACA’s individual mandate to carry health insurance, delaying the implementation of certain
ACA-mandated fees, and increasing the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D. On
December 14, 2018, a Texas U.S. District Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual mandate” was repealed
by Congress as part of the Tax Cuts and Jobs Act of 2017. Additionally, on December 18, 2019, the U.S. Court of Appeals for the 5th Circuit upheld the
District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining
provisions of the ACA are invalid as well. On March 2, 2020, the U.S. Supreme Court granted the petitions for writs of certiorari to review this case, and
has allotted one hour for oral arguments. The Unites States Supreme Court is expected to rule on the legal challenge to the constitutionality of the ACA in
early 2021. We will continue to evaluate the effect that the ACA and its possible repeal and replacement has on our business. Other legislative changes
have been proposed and adopted in the U.S. since the ACA was enacted.
Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new
payment and delivery models, such as bundled payment models. In addition, recently there has been heightened governmental scrutiny over the manner in
which manufacturers set prices for their commercial products, which has resulted in several Congressional inquiries and proposed and enacted state and
federal legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer
patient programs, and reform government program reimbursement methodologies for pharmaceutical products. For example, the Trump administration
previously released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contained additional proposals to increase drug
manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their
products, and reduce the out-of-pocket costs of drug products paid by consumers. HHS has solicited feedback on some of these measures and has
implemented others under its existing authority. For example, in May 2019, CMS issued a final rule to allow Medicare Advantage Plans the option of using
step therapy, a type of prior authorization, for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was effective
January 1, 2019.
On November 20, 2020, CMS issued an Interim Final Rule implementing the Most Favored Nation, or MFN, Model under which Medicare Part B
reimbursement rates will be calculated for certain drugs and biological products based on the lowest price drug manufacturers receive in other similar
countries. The MFN Model regulations mandate participation by identified Part B providers and will apply in all U.S. states and territories for a seven-year
period beginning January 1, 2021, and ending December 31, 2027. The Interim Final Rule has not been finalized and is subject to revision and challenge.
Additionally, on November 20, 2020, HHS Office of the Inspector General finalized a regulation with the goal of lowering prescription drug prices and out-
of-pocket spending for prescription drugs. Specifically, the final rule clarifies and amends the discount safe harbor under the federal Anti-kickback statute
(AKS) with the effect that rebates paid from drug manufacturers to Medicare Part D prescription drug plan sponsors or their pharmacy benefit managers
(PBMs) are excluded from liability protection under the discount safe harbor. The rule also adds a new safe harbor for point-of-sale reductions in price and
another that protects certain fixed-fee service arrangements between PBMs and drug manufacturers.
Pursuant to the Coronavirus Aid, Relief, and Economic Security Act, also known as the CARES Act, and the 2020 Omnibus Bill, the reductions required
by the Budget Control Act of 2011 are suspended from May 1, 2020 through March 31, 2021 due to the COVID-19 pandemic. As the legislation currently
stands, the reductions will go back into effect April 2021 and will remain in effect through 2030 unless additional Congressional action is taken. Further, it
is possible that the government will take additional steps to address the COVID-19 pandemic. For example, on April 18, 2020, CMS announced that
qualified health plan issuers under the ACA may suspend activities related to the collection and reporting of quality data that would have otherwise been
reported between May and June 2020 because of the challenges healthcare providers are facing responding to the COVID-19 virus.
Although a number of these and other measures may require additional authorization to become effective, and it is unclear whether President Joseph Biden
will work to reverse these measures or pursue similar policy initiatives, Congress has indicated that it will continue to seek new legislative and/or
administrative measures to control drug costs. Any reduction in reimbursement from Medicare and other government programs may result in a similar
reduction in payments from private payers. Moreover, at the state level, legislatures are increasingly passing legislation and implementing regulations
designed to control biopharmaceutical and biologic product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain
product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and
bulk purchasing.
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Regulation Outside of the U.S.
In addition to regulations in the U.S., we will be subject to a variety of regulations of other countries governing, among other things, any clinical trials and
commercial sales and distribution of our product candidates. Whether or not we obtain FDA approval (clinical trial or marketing) for a product, we must
obtain the requisite approvals from regulatory authorities in countries outside of the U.S., such as the EU and China, prior to the commencement of clinical
trials or marketing of the products in those countries. The approval process and requirements governing the conduct of clinical trials, product licensing,
pricing and reimbursement vary greatly from place to place, and the time may be longer or shorter than that required for FDA approval.
In the EU, before starting a clinical trial, a valid request for authorization must be submitted by the sponsor to the competent authority of the EU Member
State(s) in which the sponsor plans to conduct the clinical trial, as well as to an independent national Ethics Committee. A clinical trial may commence
only once the relevant Ethics Committee(s) has (have) issued a favorable opinion and the competent authority of the EU Member State(s) concerned has
(have) not informed the sponsor of any grounds for non-acceptance. Failure to comply with the EU requirements may subject a company to the rejection of
the request and the prohibition to start a clinical trial. Clinical trials conducted in the EU (or used for marketing authorization application in the EU) must
be conducted in accordance with applicable GCP and Good Manufacturing Practice (“GMP”) rules, ICH guidelines and be consistent with ethical
principles. EU Member State inspections are regularly conducted to verify the sponsor’s compliance with applicable rules. The sponsor is required to
record and report to the relevant national competent authorities (and to the Ethics Committee) information about serious unexpected suspected adverse
reactions (“S.U.S.A.Rs”). The way clinical trials are conducted in the EU will undergo a major change when the new EU Clinical Trial Regulation
(Regulation 536/2014) comes into application at the earliest at the beginning of December 2021.
As in the U.S., no medicinal product may be placed on the EU market unless a marketing authorization has been issued. In the EU, medicinal products may
be authorized either via the mutual recognition and decentralized procedure, the national procedure or the centralized procedure. The centralized procedure,
which is compulsory for medicines produced by biotechnology or those medicines intended to treat AIDS, cancer, neurodegenerative disorders or diabetes
and is optional for those medicines that are highly innovative, provides for the grant of a single marketing authorization that is valid for all EU Member
States. Marketing authorizations granted via the centralized procedure are valid for all EU Member States. Products submitted for approval via the
centralized procedure are assessed by the Committee for Medicinal Products for Human Use (the “CHMP”), a committee within the European Medicine
Agency (“EMA”). The CHMP assesses, inter alia, whether a medicine meets the necessary quality, safety and efficacy requirements and whether it has a
positive risk-benefit balance. The requirements for an application dossier for a biological product contain different aspects than that of a chemical
medicinal product.
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In the EU, the requirements for pricing, coverage and reimbursement of any product candidates for which we obtain regulatory approval are provided for
by the national laws of EU Member States. Governments influence the price of pharmaceutical products through their pricing and reimbursement rules and
control of national health care systems that fund a large part of the cost of those products to consumers.
We may seek orphan designations for our product candidates. In the EU, as we understand it, a medicinal product may be designated as an orphan
medicinal product if the sponsor can establish that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating
condition affecting not more than five in 10 thousand persons, or that, for the same purposes, it is unlikely that the marketing of the medicinal product
would generate sufficient return; and that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been
authorized in the EU or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition. Sponsors who
obtain orphan designation benefit from a type of scientific advice specific for designated orphan medicinal products and protocol assistance from the EMA.
Fee reductions are also available depending on the status of the sponsor and the type of service required. Marketing authorization applications for
designated orphan medicinal products must be submitted through the centralized procedure.
The EU Data Protection Directive and Member State implementing legislation may also apply to health-related and other personal information obtained
outside of the U.S. The Directive will be replaced by GDPR in May 2018. The Regulation 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 to ensure compliance with the new EU data protection rules.
MANUFACTURING AND SUPPLY
We do not currently own or operate manufacturing facilities for the production of preclinical, clinical or commercial quantities of any of our product
candidates. We currently contract with third party contract manufacturing organizations (“CMOs”) for our preclinical and clinical trial supplies, and we
expect to continue to do so to meet the preclinical and any clinical requirements of our product candidates. We have agreements for the supply of such drug
materials with manufacturers or suppliers that we believe have sufficient capacity to meet our demands. In addition, we believe that adequate alternative
sources for such supplies exist. However, there is a risk that, if supplies are interrupted, it would materially harm our business. We typically order raw
materials and services on a purchase order basis and do not enter into long-term dedicated capacity or minimum supply arrangements.
Manufacturing is subject to extensive regulations that impose various procedural and documentation requirements, which govern record keeping,
manufacturing processes and controls, personnel, quality control and quality assurance, among others. Our CMOs manufacture our product candidates
under cGMP conditions. cGMP is a regulatory standard for the production of pharmaceuticals that will be used in humans which is recognized by FDA and
many foreign regulatory authorities.
SALES AND MARKETING
Our current focus is on the development of our existing portfolio, the completion of clinical trials and, if and where appropriate, the registration of our
product candidates. We currently do not have marketing, sales and distribution capabilities. If we receive marketing and commercialization approval for
any of our product candidates, we intend to market the product either directly or through strategic alliances and distribution agreements with third parties.
The ultimate implementation of our strategy for realizing the financial value of our product candidates is dependent on the results of clinical trials for our
product candidates, the availability of regulatory approvals and the ability to negotiate acceptable commercial terms with third parties.
PRODUCT LIABILITY AND INSURANCE
Our business exposes us to potential product liability risks that are inherent in the testing, manufacturing and marketing of human therapeutic products. We
presently have product liability insurance limited to $10 million per incident, and if we were to be subject to a claim in excess of this coverage or to a claim
not covered by our insurance and the claim succeeded, we would be required to pay the claim out of our own limited resources.
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COMPETITION
Competition in the discovery and development of new methods for treating and preventing disease is intense. We face, and will continue to face,
competition from pharmaceutical and biotechnology companies, as well as academic and research institutions and government agencies both in the U.S.
and abroad. We face significant competition from organizations pursuing the same or similar technologies used by us in our drug discovery efforts and from
organizations developing pharmaceuticals that are competitive with our product candidates.
Most of our competitors, either alone or together with their collaborative partners, have substantially greater financial resources and larger research and
development staffs than we do. In addition, most of these organizations, either alone or together with their collaborators, have significantly greater
experience than we do in developing products, undertaking preclinical testing and clinical trials, obtaining FDA and other regulatory approvals of products,
and manufacturing and marketing products. Mergers and acquisitions in the pharmaceutical industry may result in even more resources being concentrated
among our competitors. These companies, as well as academic institutions, governmental agencies, and private research organizations, also compete with
us in recruiting and retaining highly qualified scientific personnel and consultants. Our ability to compete successfully with other companies in the
pharmaceutical and biotechnology field also depends on the status of our collaborations and on the continuing availability of capital to us.
GEN-1
Studied indications for GEN-1 currently include stage III/IV ovarian cancer. In evaluating the competitive landscape for this indication, early-stage
indications are treated with chemotherapy (docetaxel, doxil and cisplatinum for ovarian cancer), while later stage ovarian cancer is treated with
Bevacizumab - Avastin®, an anti-angiogenesis inhibitor. Avastin® is currently also being evaluated for early-stage disease.
In product positioning for the ovarian cancer indications, there currently is no direct immunotherapy competitor for GEN-1, which will be studied as an
adjuvant to both chemotherapy standard of care regimens, as well as anti-angiogenesis compounds. To support these cases, we have conducted clinical
studies in combination with chemotherapy for ovarian cancer, and preclinical studies in combination with both temozolomide and Bevacizumab-Avastin®.
ThermoDox®
Although there are many drugs and devices marketed and under development for the treatment of cancer, the Company is not aware of any other heat
activated drug delivery product either being marketed or in human clinical development.
INTELLECTUAL PROPERTY
Patents and Proprietary Rights
For the ThermoDox® technology, we either exclusively license with Duke University for its temperature-sensitive liposome technology that covers the
ThermoDox® formulation or own U.S. and international patents with claims and methods and compositions of matters that cover various aspects of
lysolipid thermally sensitive liposomes technology, with expiration dates ranging from 2018 to 2026. Celsion also has issued patents which pertain
specifically to methods of storing stabilized, temperature-sensitive liposomal formulations and will assist in the protection of global rights. These patents
will extend the overall term of the ThermoDox® patent portfolio to 2026. The patents in this family, include a pending application in the U.S., and issued
patents in Europe and additional key commercial geographies in Asia. This extended patent runway to 2026 allows for the evaluation of future
development activities for ThermoDox® and Celsion’s heat-sensitive liposome technology platform.
For the TheraPlas technology, we own three U.S. and international patents and related applications with claims and methods and compositions of matters
that cover various aspects of TheraPlas and GEN-1 technologies, with expiration dates ranging from 2020 to 2028.
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As mentioned above, the FDA granted orphan drug designation to ThermoDox® for the treatment of HCC and to GEN-1 for the treatment of ovarian
cancer. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. However, 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. Orphan drug
designation can also provide opportunities for grant funding towards clinical trial costs, tax advantages and FDA user-fee benefits.
There can be no assurance that an issued patent will remain valid and enforceable in a court of law through the entire patent term. Should the validity of a
patent be challenged, the legal process associated with defending the patent can be costly and time consuming. Issued patents can be subject to oppositions,
interferences and other third-party challenges that can result in the revocation of the patent or maintenance of the patent in amended form (and potentially
in a form that renders the patent without commercially relevant or broad coverage). Competitors may be able to circumvent our patents. Development and
commercialization of pharmaceutical products can be subject to substantial delays and it is possible that at the time of commercialization any patent
covering the product has expired or will be in force for only a short period of time following commercialization. We cannot predict with any certainty if
any third-party U.S. or foreign patent rights, other proprietary rights, will be deemed infringed by the use of our technology. Nor can we predict with
certainty which, if any, of these rights will or may be asserted against us by third parties. Should we need to defend ourselves and our partners against any
such claims, substantial costs may be incurred. Furthermore, parties making such claims may be able to obtain injunctive or other equitable relief, which
could effectively block our ability to develop or commercialize some or all of our products in the U.S. and abroad and could result in the award of
substantial damages. In the event of a claim of infringement, we or our partners may be required to obtain one or more licenses from a third party. There
can be no assurance that we can obtain a license on a reasonable basis should we deem it necessary to obtain rights to an alternative technology that meets
our needs. The failure to obtain a license may have a material adverse effect on our business, results of operations and financial condition.
In addition to the rights available to us under completed or pending license agreements, we rely on our proprietary know-how and experience in the
development and use of heat for medical therapies, which we seek to protect, in part, through proprietary information agreements with employees,
consultants and others. There can be no assurance that these proprietary information agreements will not be breached, that we will have adequate remedies
for any breach, or that these agreements, even if fully enforced, will be adequate to prevent third-party use of the Company’s proprietary technology. Please
refer to “Part 1, Item 1A, Risk Factors,” including, but not limited to, “We rely on trade secret protection and other unpatented proprietary rights for
important proprietary technologies, and any loss of such rights could harm our business, results of operations and financial condition.” Similarly, we cannot
guarantee that technology rights licensed to us by others will not be successfully challenged or circumvented by third parties, or that the rights granted will
provide us with adequate protection. Please refer to “Part 1, Item 1A, Risk Factors,” including, but not limited to, “Our business depends on license
agreements with third parties to permit us to use patented technologies. The loss of any of our rights under these agreements could impair our ability to
develop and market our products.”
EMPLOYEES
As of March 18, 2021, we employed 27 full-time employees. We also maintain active independent contractor relationships with various individuals, most
of whom have month-to-month or annual consulting agreements. None of our employees are covered by a collective bargaining agreement, and we
consider our relationship with our employees to be good.
COMPANY INFORMATION
Celsion was founded in 1982 and is a Delaware corporation. Our principal executive offices are located at 997 Lenox Drive, Suite 100, Lawrenceville, NJ
08648. Our telephone number is (609) 896-9100. The Company’s website is www.celsion.com. The information contained in, or that can be accessed
through, our website is not part of, and is not incorporated in, this Annual Report.
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AVAILABLE INFORMATION
We make available free of charge through our website, www.celsion.com, our Annual Report, Quarterly Reports on Form 10-Q, Current Reports on Form
8-K, and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with or furnished to the Securities and
Exchange Commission (the “SEC”). In addition, our website includes other items related to corporate governance matters, including, among other things,
our corporate governance principles, charters of various committees of the Board of Directors, and our code of business conduct and ethics applicable to all
employees, officers and directors. We intend to disclose on our internet website any amendments to or waivers from our code of business conduct and
ethics as well as any amendments to its corporate governance principles or the charters of various committees of the Board of Directors. Copies of these
documents may be obtained, free of charge, from our website. The SEC also maintains an internet site that contains reports, proxy and information
statements and other information regarding issuers that file periodic and other reports electronically with the Securities and Exchange Commission. The
address of that site is www.sec.gov. The information available on or through our website is not a part of this Annual Report and should not be relied upon.
RECENT EVENTS
On January 26, 2021, the Company issued and sold 25,925,925 shares of common stock to several institutional in a registered direct offering for gross
proceeds of approximately $35 million before the deduction of placement agent fees and offering expenses (the “January 2021 Offering”). In connection
with the January 2021 Offering, the Company paid the placement agents a cash fee equal to 7% of the aggregate gross proceeds raised from the sale of the
securities sold in the January 2021 Offering and reimbursed them for certain expenses.
ITEM 1A. RISK FACTORS
We are providing the following cautionary discussion of risk factors and uncertainties that we believe are relevant to our business. These are factors that,
individually or in the aggregate, we think could cause our actual results to differ materially from expected or historical results and our forward-looking
statements. We note these factors for investors as permitted by Section 21E of the Securities Exchange Act, and Section 27A of the Securities Act. You
should understand that it is not possible to predict or identify all such factors. Consequently, you should not consider the following to be a complete
discussion of all potential risks or uncertainties that may impact our business. Moreover, we operate in a competitive and rapidly changing environment.
New factors emerge from time to time, and it is not possible to predict the impact of all of these factors on our business, financial condition or results of
operations. We undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events, or otherwise.
Risk Factors Summary
The following is a summary of some of the Company’s most important risks and uncertainties that could materially adversely affect our business, financial
condition, and results of operations. You should read this summary together with the more detailed description of each risk factor. Additional discussion of
the risks summarized in this Risk Factors Summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be
carefully considered, together with other information in this Form 10-K and our other filings with the SEC, before making an investment in our securities.
Risk Related to Our Business and Operations
● We have a history of significant losses from operations and expect to continue to incur significant losses for the foreseeable future.
● Drug development is an inherently uncertain process with a high risk of failure at every stage of development. Our lead drug candidate failed to
meet its primary endpoint in our earlier Phase III clinical trial.
● We will need to raise additional capital to fund our planned future operations, and we may be unable to secure such capital without dilutive
financing transactions. If we are not able to raise additional capital, we may not be able to complete the development, testing and
commercialization of our product candidates.
● If we do not obtain or maintain FDA and foreign regulatory approvals for our drug candidates on a timely basis, or at all, or if the terms of any
approval impose significant restrictions or limitations on use, we will be unable to sell those products and our business, results of operations and
financial condition will be negatively affected.
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● The outbreak duration and severity of the novel coronavirus disease, COVID-19, pandemic could adversely impact our business, including our
preclinical studies and clinical trials.
● If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely
affected.
● We rely on third parties to conduct all of our clinical trials. If these third parties are unable to carry out their contractual duties in a manner that is
consistent with our expectations, comply with budgets and other financial obligations or meet expected deadlines, we may not receive certain
development milestone payments or be able to obtain regulatory approval for or commercialize our product candidates in a timely or cost-effective
manner.
● The success of our products may be harmed if the government, private health insurers and other third-party payers do not provide sufficient
coverage or reimbursement.
● The commercial potential of a drug candidate in development is difficult to predict. If the market size for a new drug is significantly smaller than
we anticipate, it could significantly and negatively impact our revenue, results of operations and financial condition.
● Technologies for the treatment of cancer are subject to rapid change, and the development of treatment strategies that are more effective than our
technologies could render our technologies obsolete.
● Our success will depend in part on our ability to grow and diversify, which in turn will require that we manage and control our growth effectively.
● We face intense competition and the failure to compete effectively could adversely affect our ability to develop and market our products.
● We or the third parties upon whom we depend on may be adversely affected by earthquakes, global pandemics or other natural disasters and our
business continuity and disaster recovery plans may not adequately protect us from a serious disaster, including earthquakes, outbreak of disease
or other natural disasters.
● Pandemics such as the COVID-19 coronavirus could have an adverse impact on our developmental programs and our financial condition.
Risks Related to Intellectual Property
● If any of our pending patent applications do not issue, or are deemed invalid following issuance, we may lose valuable intellectual property
protection.
Risks Related to Our Securities
● The market price of our common stock has been, and may continue to be volatile and fluctuate significantly, which could result in substantial
losses for investors and subject us to securities class action litigation.
● We may be unable to maintain compliance with The Nasdaq Marketplace Rules which could cause our common stock to be delisted from The
Nasdaq Capital Market. This could result in the lack of a market for our common stock, cause a decrease in the value of an investment in us, and
adversely affect our business, financial condition, and results of operations.
● Adverse capital and credit market conditions could affect our liquidity.
● We have never paid cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future.
RISKS RELATED TO OUR BUSINESS AND OPERATIONS
We have a history of significant losses from operations and expect to continue to incur significant losses for the foreseeable future.
Since our inception, our expenses have substantially exceeded our revenue, resulting in continuing losses and an accumulated deficit of $312 million at
December 31, 2020. For the years ended December 31, 2020 and 2019, we incurred net losses of $21.5 million and $16.9 million, respectively. We
currently have no product revenue and do not expect to generate any product revenue for the foreseeable future. Because we are committed to continuing
our product research, development, clinical trial and commercialization programs, we will continue to incur significant operating losses unless and until we
complete the development of GEN-1 and other new product candidates and these product candidates have been clinically tested, approved by the U.S. FDA
and successfully marketed. The amount of future losses is uncertain. Our ability to achieve profitability, if ever, will depend on, among other things, us or
our collaborators successfully developing product candidates, obtaining regulatory approvals to market and commercialize product candidates,
manufacturing any approved products on commercially reasonable terms, establishing a sales and marketing organization or suitable third-party alternatives
for any approved product and raising sufficient funds to finance business activities. If we or our collaborators are unable to develop and commercialize one
or more of our product candidates or if sales revenue from any product candidate that receives approval is insufficient, we will not achieve profitability,
which could have a material adverse effect on our business, financial condition, results of operations and prospects.
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We do not expect to generate revenue for the foreseeable future.
We have devoted our resources to developing a new generation of products and will not be able to market these products until we have completed clinical
trials and obtain all necessary governmental approvals. Our product candidates, including GEN-1, are still in various stages of development and trials and
cannot be marketed until we have completed clinical testing and obtained necessary governmental approval. Following our announcement on February 11,
2021 that the Company’s Phase III OPTIMA Study failed to meet its primary endpoint of OS, we do not expect to generate revenue from ThermoDox® for
the foreseeable future. GEN-1 is currently in a Phase II trial for the treatment of ovarian cancer. Our delivery technology platforms, TheraPlas and
TheraSilence, are in preclinical stages of development. Accordingly, our revenue sources are, and will remain, extremely limited until our product
candidates are clinically tested, approved by the FDA or foreign regulatory agencies and successfully marketed. We cannot guarantee that any of our
product candidates will be approved by the FDA or any foreign regulatory agency or marketed, successfully or otherwise, at any time in the foreseeable
future or at all.
Drug development is an inherently uncertain process with a high risk of failure at every stage of development. Our lead drug candidate,
ThermoDox®, failed to meet its primary endpoint in two Phase III clinical trials.
On January 31, 2013, we announced that ThermoDox® in combination with RFA failed to meet the primary endpoint of the Phase III clinical trial for
primary liver cancer, known as the HEAT study. On July 13, 2020, the Company announced that it has received a recommendation from the independent
DMC to consider stopping the global Phase III OPTIMA Study of ThermoDox® in combination with RFA for the treatment of HCC, or primary liver
cancer. The recommendation was made following the second pre-planned interim safety and efficacy analysis by the DMC on July 9, 2020. The DMC’s
analysis found that the pre-specified boundary for stopping the trial for futility of 0.900 was crossed with an actual value of 0.903. The Company followed
the advice of the DMC and considered its options to either stop the study or continue to follow patients after a thorough review of the data, and an
evaluation of the probability of success. On February 11, 2021, the Company issued a letter to shareholders stating the Company was notifying all clinical
sites to discontinue following patients in the OPTIMA Study.
Preclinical testing and clinical trials are long, expensive, and highly uncertain processes and failure can unexpectedly occur at any stage of clinical
development, as evidenced by the failure of ThermoDox® to meet its primary endpoint in the HEAT Study and the OPTIMA Study. Drug development is
inherently risky and clinical trials take us several years to complete. 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 comparator drug or required prior therapy, clinical outcomes including insufficient efficacy, safety concerns, or
our own financial constraints. The results from preclinical testing or early clinical trials of a product candidate may not predict the results that will be
obtained in later phase clinical trials of the product candidate. We, the FDA, or other applicable regulatory authorities may suspend clinical trials of a
product candidate at any time for various reasons, including a belief that subjects participating in such trials are being exposed to unacceptable health risks
or adverse side effects. We may not have the financial resources to continue development of, or to enter into collaborations for, a product candidate if we
experience any problems or other unforeseen events that delay or prevent regulatory approval of, or our ability to commercialize, product candidates. The
failure of one or more of our drug candidates or development programs could have a material adverse effect on our business, financial condition, and
results of operations.
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We will need to raise additional capital to fund our planned future operations, and we may be unable to secure such capital without dilutive
financing transactions. If we are not able to raise additional capital, we may not be able to complete the development, testing and
commercialization of our product candidates.
We have not generated significant revenue and have incurred significant net losses in each year since our inception. For the year ended December 31, 2020,
we incurred a net loss of $21.5 million. We have incurred approximately $312 million of cumulative net losses. As of December 31, 2020, we had cash and
cash equivalents of $17.2 million.
We have substantial future capital requirements to continue our research and development activities and advance our product candidates through various
development stages. We are unable to estimate the duration and completion costs of our research and development projects or when, if ever, and to what
extent we will receive cash inflows from the commercialization and sale of a product.. Our inability to complete any of our research and development
activities, preclinical studies or clinical trials in a timely manner or our failure to enter into collaborative agreements when appropriate could significantly
increase our capital requirements and could adversely impact our liquidity. While our estimated future capital requirements are uncertain and could increase
or decrease as a result of many factors, including the extent to which we choose to advance our research, development activities, preclinical studies and
clinical trials, or if we are in a position to pursue manufacturing or commercialization activities, we will need significant additional capital to develop our
product candidates through development and clinical trials, obtain regulatory approvals and manufacture and commercialize approved products, if any. We
do not know whether we will be able to access additional capital when needed or on terms favorable to us or our stockholders. Our inability to raise
additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business.
If we do not obtain or maintain FDA and foreign regulatory approvals for our drug candidates on a timely basis, or at all, or if the terms of any
approval impose significant restrictions or limitations on use, we will be unable to sell those products and our business, results of operations and
financial condition will be negatively affected.
To obtain regulatory approvals from the FDA and foreign regulatory agencies, we must conduct clinical trials demonstrating that our products are safe and
effective. We may need to amend ongoing trials, or the FDA and/or foreign regulatory agencies may require us to perform additional trials beyond those we
planned. The testing and approval process requires substantial time, effort and resources, and generally takes a number of years to complete. The time to
complete testing and obtaining approvals is uncertain, and the FDA and foreign regulatory agencies have substantial discretion, at any phase of
development, to terminate clinical studies, require additional clinical studies or other testing, delay or withhold approval, and mandate product withdrawals,
including recalls. In addition, our drug candidates may have undesirable side effects or other unexpected characteristics that could cause us or regulatory
authorities to interrupt, delay or halt clinical trials and could result in a more restricted label or the delay or denial of regulatory approval by regulatory
authorities.
Even if we receive regulatory approval of a product, the approval may limit the indicated uses for which the drug may be marketed. The failure to obtain
timely regulatory approval of product candidates, the imposition of marketing limitations, or a product withdrawal would negatively impact our business,
results of operations and financial condition. Even if we receive approval, we will be subject to ongoing regulatory obligations and continued regulatory
review, which may result in significant additional expense and subject us to restrictions, withdrawal from the market, or penalties if we fail to comply with
applicable regulatory requirements or if we experience unanticipated problems with our product candidates, when and if approved. Finally, even if we
obtain FDA approval of any of our product candidates, we may never obtain approval or commercialize such products outside of the U.S., given that we
may be subject to additional or different regulatory burdens in other markets. This could limit our ability to realize their full market potential.
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Our industry is highly regulated by the FDA and comparable foreign regulatory agencies. We must comply with extensive, strictly enforced
regulatory requirements to develop, obtain, and maintain marketing approval for any of our product candidates.
Securing FDA or comparable foreign regulatory approval requires the submission of extensive preclinical and clinical data and supporting information for
each therapeutic indication to establish the product candidate’s safety and efficacy for its intended use. It takes years to complete the testing of a new drug
or biological product and development delays and/or failure can occur at any stage of testing. Any of our present and future clinical trials may be delayed,
halted, not authorized, or approval of any of our products may be delayed or may not be obtained due to any of the following:
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factors related to the COVID-19 pandemic, including regulators or institutional review boards, or IRBs, or ethics committees may not authorize us
or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
any preclinical test or clinical trial may fail to produce safety and efficacy results satisfactory to the FDA or comparable foreign regulatory
authorities;
preclinical and clinical data can be interpreted in different ways, which could delay, limit, or prevent marketing approval;
negative or inconclusive results from a preclinical test or clinical trial or adverse events during a clinical trial could cause a preclinical study or
clinical trial to be repeated or a development program to be terminated, even if other studies relating to the development program are ongoing or
have been completed and were successful;
the FDA or comparable foreign regulatory authorities can place a clinical hold on a trial if, among other reasons, it finds that subjects enrolled in
the trial are or would be exposed to an unreasonable and significant risk of illness or injury;
the facilities that we utilize, or the processes or facilities of third-party vendors, including without limitation the contract manufacturers who will
be manufacturing drug substance and drug product for us or any potential collaborators, may not satisfactorily complete inspections by the FDA or
comparable foreign regulatory authorities; and
we may encounter delays or rejections based on changes in FDA policies or the policies of comparable foreign regulatory authorities during the
period in which we develop a product candidate, or the period required for review of any final marketing approval before we are able to market
any product candidate.
In addition, information generated during the clinical trial process is susceptible to varying interpretations that could delay, limit, or prevent marketing
approval at any stage of the approval process. Moreover, early positive preclinical or clinical trial results may not be replicated in later clinical trials. As
more product candidates within a particular class of drugs proceed through clinical development to regulatory review and approval, the amount and type of
clinical data that may be required by regulatory authorities may increase or change. Failure to demonstrate adequately the quality, safety, and efficacy of
any of our product candidates would delay or prevent marketing approval of the applicable product candidate. We cannot assure you that if clinical trials
are completed, either we or our potential collaborators will submit applications for required authorizations to manufacture or market potential products or
that any such application will be reviewed and approved by appropriate regulatory authorities in a timely manner, if at all.
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The outbreak, duration and severity of the novel coronavirus disease, COVID-19, pandemic could adversely impact our business, including our
preclinical studies and clinical trials.
In January 2020, the WHO declared COVID-19 a global pandemic, and the U.S. Department of Health and Human Services declared a public health
emergency to aid the U.S. healthcare community in responding to COVID-19. Governments and businesses around the world have taken unprecedented
actions to mitigate the spread of COVID-19, including, but not limited to, shelter-in-place orders, quarantines, and significant restrictions on travel, as well
as restrictions that prohibit many employees from going to work. Uncertainty with respect to the economic impacts of the pandemic has introduced
significant volatility in the financial markets. The Company did not observe significant impacts on its business or results of operations for the year ended
December 31, 2020 due to the global emergence of COVID-19. While the extent to which COVID-19 impacts the Company’s future results will depend on
future developments, the pandemic and associated economic impacts could result in a material impact to the Company’s future financial condition, results
of operations and cash flows.
The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions
to, and volatility in, financial markets in the U.S. and worldwide resulting from the ongoing COVID-19 pandemic.
The disruptions caused by COVID-19 may also disrupt preclinical studies, the clinical trials process and enrollment of patients. This may delay
commercialization efforts. The Company is currently monitoring its operating activities in light of these events and it is reasonably possible that the virus
could have a negative effect on the Company’s financial condition and results of operations. The specific impact is not readily determinable as of the date
of this report.
While, as of the date of this report, we have not experienced any material disruptions to the execution of the clinical trials and the research and
development activities that we currently have underway, as a result of the pandemic we may experience disruptions that could severely impact research and
development timelines and outcomes, including, but not limited to:
● delays or difficulties in enrolling patients in our clinical trials;
● delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
● diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and
hospital staff supporting the conduct of our clinical trials;
● interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal,
state or foreign governments, employers and others or interruption of clinical trial subject visits and study procedures (such as procedures that are
deemed non-essential under law, regulation or institutional policies), which may impact the integrity of subject data and clinical study endpoints;
● interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;
● interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages,
production slowdowns or stoppages and disruptions in delivery systems;
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● interruptions in preclinical studies due to restricted or limited operations at our contracted research facilities;
● unforeseen costs we may incur as a result of the impact of the COVID-19 pandemic, including the costs of mitigation efforts;
● deterioration of worldwide credit and financial markets that could limit our ability to obtain external financing to fund our operations and capital
expenditures;
● investment-related risks, including difficulties in liquidating investments due to current market conditions and adverse investment performance;
● limitations on employee resources that would otherwise be focused on the conduct of our research and development activities, including because of
sickness of employees or their families or the desire of employees to avoid contact with large groups of people; or
● interruptions or limitations of the types described affecting our service providers and collaboration partners, including contract research organizations
running clinical trials and collaboration partners sponsoring clinical trials in which we are supplying our product candidates or otherwise participating.
In addition, the trading prices for common stock of other biopharmaceutical companies have been highly volatile as a result of the COVID-19 pandemic.
The COVID-19 pandemic continues to rapidly evolve. The extent to which the pandemic impacts our business, preclinical studies and clinical trials will
depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease,
the duration of the pandemic, travel restrictions and social distancing in the U.S. and other countries, business closures or business disruptions and the
effectiveness of actions taken in the U.S. and other countries to diagnose, contain and treat the disease. If we or any of the third parties with whom we
engage were to experience shutdowns or other business disruptions, our ability to conduct our business and development activities in the manner and on the
timelines presently planned could be materially and negatively impacted. There can be no assurance that any such disruptions or delays will not materially
adversely impact our business, results of operations, access to financial resources and our financial condition.
New gene-based products for therapeutic applications are subject to extensive regulation by the FDA and comparable agencies in other countries.
The precise regulatory requirements with which we will have to comply, now and in the future, are uncertain due to the novelty of the gene-based
products we are developing.
The regulatory approval process for novel product candidates such as ours can be significantly more expensive and take longer than for other, better known
or more extensively studied product candidates. Limited data exist regarding the safety and efficacy of DNA-based therapeutics compared with
conventional therapeutics, and government regulation of DNA-based therapeutics is evolving. Regulatory requirements governing gene and cell therapy
products have changed frequently and may continue to change in the future. The FDA has established the Office of Cellular, Tissue and Gene Therapies
within its Center for Biologics Evaluation and Research (CBER), to consolidate the review of gene therapy and related products, and has established the
Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER in its review. It is difficult to determine how long it will take or how much it will
cost to obtain regulatory approvals for our product candidates in either the U.S. or the European Union or how long it will take to commercialize our
product candidates.
Adverse events or the perception of adverse events in the field of gene therapy generally, or with respect to our product candidates specifically, may have a
particularly negative impact on public perception of gene therapy and result in greater governmental regulation, including future bans or stricter standards
imposed on gene-based therapy clinical trials, stricter labeling requirements and other regulatory delays in the testing or approval of our potential products.
For example, if we were to engage an NIH-funded institution to conduct a clinical trial, we may be subject to review by the NIH Office of Biotechnology
Activities’ Recombinant DNA Advisory Committee (the RAC). If undertaken, RAC can delay the initiation of a clinical trial, even if the FDA has
reviewed the trial design and details and approved its initiation. Conversely, the FDA can put an IND application on a clinical hold even if the RAC has
provided a favorable review or an exemption from in-depth, public review. Such committee and advisory group reviews and any new guidelines they
promulgate may lengthen the regulatory review process, require us to perform additional studies, increase our development costs, lead to changes in
regulatory positions and interpretations, delay or prevent approval and commercialization of our product candidates or lead to significant post-approval
limitations or restrictions. Any increased scrutiny could delay or increase the costs of our product development efforts or clinical trials.
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Even if our products receive regulatory approval, they may still face future development and regulatory difficulties. Government regulators may impose
significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies. This
governmental oversight may be particularly strict with respect to gene-based therapies.
Serious adverse events, undesirable side effects or other unexpected properties of our product candidates may be identified during development or
after approval, which could lead to the discontinuation of our clinical development programs, refusal by regulatory authorities to approve our
product candidates or, if discovered following marketing approval, revocation of marketing authorizations or limitations on the use of our product
candidates thereby limiting the commercial potential of such product candidate.
As we continue our development of our product candidates and initiate clinical trials of our additional product candidates, serious adverse events,
undesirable side effects or unexpected characteristics may emerge causing us to abandon these product candidates or limit their development to more
narrow uses or subpopulations in which the serious adverse events, undesirable side effects or other characteristics are less prevalent, less severe or more
acceptable from a risk-benefit perspective.
Even if our product candidates initially show promise in these early clinical trials, the side effects of drugs are frequently only detectable after they are
tested in large, Phase 3 clinical trials or, in some cases, after they are made available to patients on a commercial scale after approval. Sometimes, it can be
difficult to determine if the serious adverse or unexpected side effects were caused by the product candidate or another factor, especially in oncology
subjects who may suffer from other medical conditions and be taking other medications. If serious adverse or unexpected side effects are identified during
development and are determined to be attributed to our product candidate, we may be required to develop a Risk Evaluation and Mitigation Strategy
(REMS) to mitigate those serious safety risks, which could impose significant distribution and use restrictions on our products.
In addition, drug-related side effects could also affect subject recruitment or the ability of enrolled subjects to complete the trial, result in potential product
liability claims, reputational harm, withdrawal of approvals, a requirement to include additional warnings on the label or to create a medication guide
outlining the risks of such side effects for distribution to patients. It can also result in patient harm, liability lawsuits, and reputational harm. Any of these
occurrences could prevent us from achieving or maintaining market acceptance and may harm our business, financial condition, and prospects significantly.
If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely
affected.
We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance
with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. The
enrollment of patients depends on many factors, including:
● the patient eligibility and exclusion criteria defined in the protocol;
● the size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying patients;
● delays in our research programs resulting from factors related to the COVID-19 pandemic;
● the willingness or availability of patients to participate in our trials;
● the proximity of patients to trial sites;
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● the design of the trial;
● our ability to recruit clinical trial investigators with the appropriate competencies and experience;
● clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available
therapies, including any new products that may be approved for the indications we are investigating;
● the availability of competing commercially available therapies and other competing drug candidates’ clinical trials;
● our ability to obtain and maintain patient informed consents; and
● the risk that patients enrolled in clinical trials will drop out of the trials before completion.
In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates,
and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may
instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to
conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are
available for our clinical trials in such clinical trial site. Certain of our planned clinical trials may also involve invasive procedures, which may lead some
patients to drop out of trials to avoid these follow-up procedures.
Further, timely enrollment in clinical trials is reliant on clinical trial sites which may be adversely affected by global health matters, including, among other
things, pandemics. For example, our clinical trial sites may be located in regions currently being affected by the COVID-19 coronavirus. Some factors from
the COVID-19 coronavirus pandemic or any future pandemics that we believe may adversely affect enrollment in our trials include:
● the diversion of healthcare resources away from the conduct of clinical trial matters to focus on pandemic concerns, including the attention of
infectious disease physicians serving as our clinical trial investigators, hospitals serving as our clinical trial sites and hospital staff supporting the
conduct of our clinical trials;
● patients who would otherwise be candidates for enrollment in our clinical trials, may become infected with the COVID-19 coronavirus, which
may kill some patients and render others too ill to participate, limiting the available pool of participants for our trials;
● limitations on travel that interrupt key trial activities, such as clinical trial site initiations and monitoring;
● interruption in global shipping affecting the transport of clinical trial materials, such as investigational drug product and comparator drugs used in
our trials; and
● employee furlough days that delay necessary interactions with local regulators, ethics committees and other important agencies and contractors.
These and other factors arising from the COVID-19 coronavirus could worsen in countries that are already afflicted with the virus or could continue to
spread to additional countries, each of which may further adversely impact our clinical trials. The global pandemic of the COVID-19 coronavirus continues
to evolve and the conduct of our trials may continue to be adversely affected, despite efforts to mitigate this impact.
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We may not successfully engage in future strategic transactions, which could adversely affect our ability to develop and commercialize product
candidates, impact our cash position, increase our expense and present significant distractions to our management.
In the future, we may consider strategic alternatives intended to further the development of our business, which may include acquiring businesses,
technologies, or products, out- or in-licensing product candidates or technologies or entering into a business combination with another company. Any
strategic transaction may require us to incur non-recurring or other charges, increase our near- and long-term expenditures and pose significant integration
or implementation challenges or disrupt our management or business. These transactions would entail numerous operational and financial risks, including
exposure to unknown liabilities, disruption of our business and diversion of our management’s time and attention in order to manage a collaboration or
develop acquired products, product candidates or technologies, incurrence of substantial debt or dilutive issuances of equity securities to pay transaction
consideration or costs, higher than expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment charges,
increased amortization expenses, difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired business,
impairment of relationships with key suppliers, manufacturers or customers of any acquired business due to changes in management and ownership and the
inability to retain key employees of any acquired business. Accordingly, although there can be no assurance that we will undertake or successfully complete
any transactions of the nature described above, any transactions that we do complete may be subject to the foregoing or other risks and have a material
adverse effect on our business, results of operations, financial condition and prospects. Conversely, any failure to enter any strategic transaction that would
be beneficial to us could delay the development and potential commercialization of our product candidates and have a negative impact on the
competitiveness of any product candidate that reaches market.
Strategic transactions, such as acquisitions, partnerships, and collaborations, including the EGEN asset acquisition, involve numerous risks, including:
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the failure of markets for the products of acquired businesses, technologies, or product lines to develop as expected;
uncertainties in identifying and pursuing acquisition targets;
the challenges in achieving strategic objectives, cost savings and other benefits expected from acquisitions;
the risk that the financial returns on acquisitions will not support the expenditures incurred to acquire such businesses or the capital
expenditures needed to develop such businesses;
difficulties in assimilating the acquired businesses, technologies, or product lines;
the failure to successfully manage additional business locations, including the additional infrastructure and resources necessary to support and
integrate such locations;
the existence of unknown product defects related to acquired businesses, technologies or product lines that may not be identified due to the
inherent limitations involved in the due diligence process of an acquisition;
the diversion of management’s attention from other business concerns;
risks associated with entering markets or conducting operations with which we have no or limited direct prior experience;
risks associated with assuming the legal obligations of acquired businesses, technologies, or product lines;
risks related to the effect that internal control processes of acquired businesses might have on our financial reporting and management’s report
on our internal control over financial reporting;
the potential loss of key employees related to acquired businesses, technologies, or product lines; and
the incurrence of significant exit charges if products or technologies acquired in business combinations are unsuccessful.
We may never realize the perceived benefits of the EGEN asset acquisition or potential future transactions. We cannot assure you that we will be successful
in overcoming problems encountered in connection with any transactions, and our inability to do so could significantly harm our business, results of
operations and financial condition. These transactions could dilute a stockholder’s investment in us and cause us to incur debt, contingent liabilities and
amortization/impairment charges related to intangible assets, all of which could materially and adversely affect our business, results of operations and
financial condition. In addition, our effective tax rate for future periods could be negatively impacted by the EGEN asset acquisition or potential future
transactions.
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We rely on third parties to conduct all of our clinical trials. If these third parties are unable to carry out their contractual duties in a manner that
is consistent with our expectations, comply with budgets and other financial obligations or meet expected deadlines, we may not receive certain
development milestone payments or be able to obtain regulatory approval for or commercialize our product candidates in a timely or cost-
effective manner.
We do not independently conduct clinical trials for our drug candidates. We rely, and expect to continue to rely, on third-party clinical investigators, clinical
research organizations (CROs), clinical data management organizations and consultants to design, conduct, supervise and monitor our clinical trials.
Because we do not conduct our own clinical trials, we must rely on the efforts of others and have reduced control over aspects of these activities, including,
the timing of such trials, the costs associated with such trials and the procedures that are followed for such trials. We do not expect to significantly increase
our personnel in the foreseeable future and may continue to rely on third parties to conduct all of our future clinical trials. If we cannot contract with
acceptable third parties on commercially reasonable terms or at all, if these third parties are unable to carry out their contractual duties or obligations in a
manner that is consistent with our expectations or meet expected deadlines, if they do not carry out the trials in accordance with budgeted amounts, if the
quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical protocols or for other reasons, or if they fail
to maintain compliance with applicable government regulations and standards, our clinical trials may be extended, delayed or terminated or may become
significantly more expensive, we may not receive development milestone payments when expected or at all, and we may not be able to obtain regulatory
approval for or successfully commercialize our product candidates.
Despite our reliance on third parties to conduct our clinical trials, we are ultimately responsible for ensuring that each of our clinical trials is conducted in
accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires clinical trials to be conducted in accordance with
good clinical practices for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate
and that the rights, integrity and confidentiality of clinical trial participants are protected. We also are required to register ongoing clinical trials and post the
results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines,
adverse publicity and civil and criminal sanctions. Our reliance on third parties that we do not control does not relieve us of these responsibilities and
requirements. If we or a third party we rely on fails to meet these requirements, we may not be able to obtain, or may be delayed in obtaining, marketing
authorizations for our drug candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our drug candidates. This
could have a material adverse effect on our business, financial condition, results of operations and prospects.
Because we rely on third party manufacturing and supply partners, our supply of research and development, preclinical and clinical development
materials may become limited or interrupted or may not be of satisfactory quantity or quality.
We rely on third party supply and manufacturing partners to supply the materials and components for, and manufacture, our research and development,
preclinical and clinical trial drug supplies. We do not own manufacturing facilities or supply sources for such components and materials. There can be no
assurance that our supply of research and development, preclinical and clinical development drugs and other materials will not be limited, interrupted,
restricted in certain geographic regions or of satisfactory quality or continue to be available at acceptable prices. Suppliers and manufacturers must meet
applicable manufacturing requirements and undergo rigorous facility and process validation tests required by FDA and foreign regulatory authorities in
order to comply with regulatory standards, such as current cGMP. In the event that any of our suppliers or manufacturers fails to comply with such
requirements or to perform its obligations to us in relation to quality, timing or otherwise, or if our supply of components or other materials becomes
limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves, for which we currently do not have the capabilities or
resources, or enter into an agreement with another third party, which we may not be able to do on reasonable terms, if at all.
Our business is subject to numerous and evolving state, federal and foreign regulations and we may not be able to secure the government
approvals needed to develop and market our products.
Our research and development activities, pre-clinical tests and clinical trials, and ultimately the manufacturing, marketing and labeling of our products, are
all subject to extensive regulation by the FDA and foreign regulatory agencies. Pre-clinical testing and clinical trial requirements and the regulatory
approval process typically take years and require the expenditure of substantial resources. Additional government regulation may be established that could
prevent or delay regulatory approval of our product candidates. Delays or rejections in obtaining regulatory approvals would adversely affect our ability to
commercialize any product candidates and our ability to generate product revenue or royalties.
The FDA and foreign regulatory agencies require that the safety and efficacy of product candidates be supported through adequate and well-controlled
clinical trials. If the results of pivotal clinical trials do not establish the safety and efficacy of our product candidates to the satisfaction of the FDA and
other foreign regulatory agencies, we will not receive the approvals necessary to market such product candidates. Even if regulatory approval of a product
candidate is granted, the approval may include significant limitations on the indicated uses for which the product may be marketed.
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We are subject to the periodic inspection of our clinical trials, facilities, procedures and operations and/or the testing of our products by the FDA to
determine whether our systems and processes, or those of our vendors and suppliers, are in compliance with FDA regulations. Following such inspections,
the FDA may issue notices on Form 483 and warning letters that could cause us to modify certain activities identified during the inspection.
Failure to comply with the FDA and other governmental regulations can result in fines, unanticipated compliance expenditures, recall or seizure of
products, total or partial suspension of production and/or distribution, suspension of the FDA’s review of product applications, enforcement actions,
injunctions and criminal prosecution. Under certain circumstances, the FDA also has the authority to revoke previously granted product approvals.
Although we have internal compliance programs, if these programs do not meet regulatory agency standards or if our compliance is deemed deficient in
any significant way, it could have a material adverse effect on the Company.
We are also subject to recordkeeping and reporting regulations. These regulations require, among other things, the reporting to the FDA of adverse events
alleged to have been associated with the use of a product or in connection with certain product failures. Labeling and promotional activities also are
regulated by the FDA. We must also comply with record keeping requirements as well as requirements to report certain adverse events involving our
products. The FDA can impose other post-marketing controls on us as well as our products including, but not limited to, restrictions on sale and use,
through the approval process, regulations and otherwise.
Many states in which we do or may do business, or in which our products may be sold, if at all, impose licensing, labeling or certification requirements that
are in addition to those imposed by the FDA. There can be no assurance that one or more states will not impose regulations or requirements that have a
material adverse effect on our ability to sell our products.
In many of the foreign countries in which we may do business or in which our products may be sold, we will be subject to regulation by national
governments and supranational agencies as well as by local agencies affecting, among other things, product standards, packaging requirements, labeling
requirements, import restrictions, tariff regulations, duties and tax requirements. There can be no assurance that one or more countries or agencies will not
impose regulations or requirements that could have a material adverse effect on our ability to sell our products.
We have obtained Orphan Drug Designation for GEN-1 ThermoDox® and may seek Orphan Drug Designation for other product candidates, but
we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market
exclusivity.
GEN-1 has been granted orphan drug designation for ovarian cancer in both the U.S. and Europe. ThermoDox® has been granted orphan drug designation
for primary liver cancer in both the U.S. and Europe. Regulatory authorities in some jurisdictions, including the U.S. and Europe, may designate drugs for
relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug as an orphan drug if it is a drug 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., or a patient
population greater than 200,000 in the U.S. where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the
U.S.
Even though we have obtained Orphan Drug Designation for GEN-1 and ThermoDox® and may obtain such designation for other product candidates in
specific indications, we may not be the first to obtain marketing approval of these product candidates for the orphan-designated indication due to the
uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights in the U.S. may be limited if we seek approval
for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially
defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.
Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different
drugs with different active moieties can be approved for the same condition. Even after an orphan product is approved, the FDA can subsequently approve
the same drug with the same active moiety for the same condition if the FDA concludes that the later drug is safer, more effective or makes a major
contribution to patient care. Orphan Drug Designation neither shortens the development time or regulatory review time of a drug nor gives the drug any
advantage in the regulatory review or approval process.
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Fast Track designation may not actually lead to a faster development or regulatory review or approval process.
Both GEN-1 and ThermoDox® have received U.S. FDA Fast Track Designation in 2021 and 2010, respectively. However, we may not experience a faster
development process, review, or approval compared to conventional FDA procedures. The FDA may withdraw our Fast-Track designation if the FDA
believes that the designation is no longer supported by data from our clinical or pivotal development program. Our Fast-Track designation does not
guarantee that we will qualify for or be able to take advantage of the FDA’s expedited review procedures or that any application that we may submit to the
FDA for regulatory approval will be accepted for filing or ultimately approved.
Our relationships with healthcare providers and physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse
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.
Healthcare providers, physicians and third-party payors in the U.S. and elsewhere play a primary role in the recommendation and prescription of
biopharmaceutical products. Arrangements with third-party payors and customers can expose biopharmaceutical manufacturers to broadly applicable fraud
and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act,
which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute biopharmaceutical
products. In particular, the research of our product candidates, as well as the promotion, sales and marketing of healthcare items and services, as well as
certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive
practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and
commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper
use of information obtained in the course of patient recruitment for clinical trials. The applicable federal, state and foreign healthcare laws and regulations
laws that may affect our ability to operate include, but are not limited to:
● the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any
remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in
return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which
payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A person or entity
can be found guilty of violating the statute without actual knowledge of the statute or specific intent to violate it. In addition, a claim submitted for
payment to any federal health care program that includes items or services that were made as a result of a violation of the federal Anti-Kickback
Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act, or FCA. The Anti-Kickback Statute has been
interpreted to apply to arrangements between biopharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary
managers, among others, on the other. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities
from prosecution;
● the federal civil and criminal false claims laws, including the FCA, and civil monetary penalty laws which prohibit, among other things,
individuals or entities from knowingly presenting, or causing to be presented, false, fictious or fraudulent claims for payment to, or approval by
Medicare, Medicaid, or other federal healthcare programs; knowingly making, using or causing to be made or used a false record or statement
material to a false or fraudulent claim or an obligation to pay or transmit money or property to the federal government; or knowingly concealing or
knowingly and improperly avoiding or decreasing or concealing an obligation to pay money to the federal government. A claim that includes
items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim under the FCA.
Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause”
the submission of false or fraudulent claims. The FCA also permits a private individual acting as a “whistleblower” to bring qui tam actions on
behalf of the federal government alleging violations of the FCA and to share in any monetary recovery;
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● the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal statutes that prohibit
knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or
fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare
benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or
device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or
services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA
without actual knowledge of the statute or specific intent to violate it;
● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective
implementing regulations, which impose, among other things, requirements relating to the privacy, security and transmission of individually
identifiable health information on certain covered healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, as
well as their respective “business associates,” those independent contractors or agents of covered entities that perform services for covered entities
that involve the creation, use, receipt, maintenance or disclosure of individually identifiable health information. HITECH also created new tiers of
civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys
general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees
and costs associated with pursuing federal civil actions;
● the federal Physician Payments Sunshine Act, created under the ACA, and its implementing regulations, which require some manufacturers of
drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance
Program (with certain exceptions) to report annually to CMS information related to payments or other transfers of value made to physicians
(defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment
interests held by physicians and their immediate family members. Effective January 1, 2022, these reporting obligations will extend to include
transfers of value made in the previous year to certain non-physician providers such as physician assistants and nurse practitioners;
● federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm
consumers; and
● analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing
arrangements and claims involving healthcare items or services reimbursed by third-party payors, including private insurers, and may be broader
in scope than their federal equivalents; state and foreign laws that require biopharmaceutical companies to comply with the biopharmaceutical
industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict
payments that may be made to healthcare providers and other potential referral sources; state and foreign laws that require drug manufacturers to
report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or drug
pricing; state and local laws that require the registration of biopharmaceutical sales representatives; and state and foreign laws governing the
privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not
preempted by HIPAA, thus complicating compliance efforts.
The distribution of biopharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage
and security requirements intended to prevent the unauthorized sale of biopharmaceutical products.
The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in
light of the lack of applicable precedent and regulations. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to
possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from the business.
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It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes,
regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and we
are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of
significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, reputational harm, possible exclusion from
participation in federal and state funded healthcare programs, contractual damages and the curtailment or restricting of our operations, as well as additional
reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance
with these laws. Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in
compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government
funded healthcare programs. Any action for violation of these laws, even if successfully defended, could cause a biopharmaceutical manufacturer to incur
significant legal expenses and divert management’s attention from the operation of the business. Prohibitions or restrictions on sales or withdrawal of future
marketed products could materially affect business in an adverse way.
Ongoing legislative and regulatory changes affecting the healthcare industry could have a material adverse effect on our business.
Political, economic and regulatory influences are subjecting the healthcare industry to potential fundamental changes that could substantially affect our
results of operations by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the
recall or discontinuation of our products; or (iv) additional record-keeping requirements.
In the U.S., there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the ACA was
passed, which substantially changed the way health care is financed by both governmental and private insurers, and significantly impacted the U.S.
biopharmaceutical industry. The ACA, among other things, addressed a new methodology by which rebates owed by manufacturers under the Medicaid
Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by
manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations,
established annual fees and taxes on manufacturers of certain branded prescription drugs, and created a new Medicare Part D coverage gap discount
program, in which manufacturers must agree to offer certain point-of-sale discounts off negotiated prices of applicable brand 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.
Since its enactment, some of the provisions of the ACA have yet to be fully implemented, while certain provisions have been subject to judicial,
congressional, and executive challenges. While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain
provisions of the ACA such as removing penalties, starting January 1, 2019, for not complying with the ACA’s individual mandate to carry health
insurance, delaying the implementation of certain ACA-mandated fees, and increasing the point-of-sale discount that is owed by pharmaceutical
manufacturers who participate in Medicare Part D. On December 14, 2018, a Texas U.S. District Court Judge ruled that the ACA is unconstitutional in its
entirety because the “individual mandate” was repealed by Congress as part of the Tax Cuts and Jobs Act of 2017. Additionally, on December 18, 2019, the
U.S. Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to
the District Court to determine whether the remaining provisions of the ACA are invalid as well. On March 2, 2020, the U.S. Supreme Court granted the
petitions for writs of certiorari to review this case, and has allotted one hour for oral arguments. The United States Supreme Court is expected to rule on the
legal challenge to the constitutionality of the ACA in early 2021. We cannot predict what affect further changes to the ACA would have on our business.
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Other legislative changes have been proposed and adopted in the U.S. since the ACA was enacted, affecting among other matters, Medicare payments to
providers.
Moreover, increasing efforts by governmental and third-party payors in the U.S. and abroad to cap or reduce healthcare costs may cause such organizations
to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for
our product candidates. There has been increasing legislative and enforcement interest in the U.S. with respect to specialty drug pricing practices.
Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other
things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and
manufacturer patient programs, and reform government program reimbursement methodologies for drugs. Several states have adopted price transparency
requirements and those as well as any future federal price transparency requirements that may be implemented in the future could have a negative effect on
our business. Additionally, we expect to experience pricing pressures in connection with the sale of any future approved product candidates due to the trend
toward managed healthcare, the increasing influence of health maintenance organizations, cost containment initiatives and additional legislative changes.
Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payers. In
addition, individual states in the U.S. have also increasingly passed legislation and implemented regulations designed to control pharmaceutical product
pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and
transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
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At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control biopharmaceutical and biologic product
pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and
transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
We cannot predict what healthcare reform initiatives may be adopted in the future. Further, federal and state legislative and regulatory developments are
likely, and we expect ongoing initiatives in the U.S. to increase pressure on drug pricing. Such reforms could have an adverse effect on anticipated revenues
any product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition
and ability to develop product candidates.
We may fail to comply with evolving European and other privacy laws.
Since we conduct clinical trials in the European Economic Area (“EEA”), we are subject to additional European data-privacy laws. The General Data
Protection Regulation, (EU) 2016/679 (“GDPR”) became effective on May 25, 2018 and deals with the processing of personal data and on the free
movement of such data. The GDPR imposes a broad range of strict requirements on companies subject to the GDPR, including requirements relating to
having legal bases for processing personal information relating to identifiable individuals and transferring such information outside the EEA, including to
the U.S., providing details to those individuals regarding the processing of their personal information, keeping personal information secure, having data
processing agreements with third parties who process personal information, responding to individuals’ requests to exercise their rights in respect of their
personal information, reporting security breaches involving personal data to the competent national data protection authority and affected individuals,
appointing data protection officers, conducting data protection impact assessments, and record-keeping. The GDPR increases substantially the penalties to
which we could be subject in the event of any non-compliance, including fines of up to 10,000,000 Euros or up to 2% of our total worldwide annual
turnover for certain comparatively minor offenses, or up to 20,000,000 Euros or up to 4% of our total worldwide annual turnover for more serious offenses.
Given the limited enforcement of the GDPR to date, we face uncertainty as to the exact interpretation of the new requirements on our trials and we may be
unsuccessful in implementing all measures required by data protection authorities or courts in interpretation of the new law.
In particular, national laws of member states of the EU are in the process of being adapted to the requirements under the GDPR, thereby implementing
national laws which may partially deviate from the GDPR and impose different obligations from country to country, so that we do not expect to operate in a
uniform legal landscape in the EEA. Also, as it relates to processing and transfer of genetic data, the GDPR specifically allows national laws to impose
additional and more specific requirements or restrictions, and European laws have historically differed quite substantially in this field, leading to additional
uncertainty. Further, the United Kingdom’s decision to leave the EU, often referred to as Brexit, has created uncertainty with regard to data protection
regulation in the United Kingdom. In particular, it is unclear how data transfers to and from the United Kingdom will be regulated now that the United
Kingdom has left the EU.
In the event we continue to conduct clinical trials in the EEA, we must also ensure that we maintain adequate safeguards to enable the transfer of personal
data outside of the EEA, in particular to the U.S., in compliance with European data protection laws. We expect that we will continue to face uncertainty as
to whether our efforts to comply with our obligations under European privacy laws will be sufficient. If we are investigated by a European data protection
authority, we may face fines and other penalties. Any such investigation or charges by European data protection authorities could have a negative effect on
our existing business and on our ability to attract and retain new clients or pharmaceutical partners. We may also experience hesitancy, reluctance, or
refusal by European or multi-national clients or pharmaceutical partners to continue to use our products and solutions due to the potential risk exposure as a
result of the current (and, in particular, future) data protection obligations imposed on them by certain data protection authorities in interpretation of current
law, including the GDPR. Such clients or pharmaceutical partners may also view any alternative approaches to compliance as being too costly, too
burdensome, too legally uncertain, or otherwise objectionable and therefore decide not to do business with us. Any of the foregoing could materially harm
our business, prospects, financial condition and results of operations.
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The success of our products may be harmed if the government, private health insurers and other third-party payers do not provide sufficient
coverage or reimbursement.
Our ability to commercialize our new cancer treatment systems successfully will depend in part on the extent to which reimbursement for the costs of such
products and related treatments will be available from third-party payors, which include government authorities such as Medicare, Medicaid, TRICARE,
and the Veterans Administration, managed care providers, private health insurers, and other organizations. Patients who are provided medical treatment for
their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Coverage and adequate
reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance.
Patients are unlikely to use our product candidates unless coverage is provided, and reimbursement is adequate to cover a significant portion of the cost.
The reimbursement status of newly approved medical products is subject to significant uncertainty We cannot be sure that coverage and reimbursement will
be available for, or accurately estimate the potential revenue from, our product candidates or assure that coverage and reimbursement will be available for
any product that we may develop.
Government authorities and other third-party payors decide which drugs and treatments they will cover and the amount of reimbursement. In the U.S., the
principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency
within the U.S. Department of Health and Human Services. CMS decides whether and to what extent a new medicine will be covered and reimbursed under
Medicare and private payors tend to follow CMS to a substantial degree. No uniform policy of coverage and reimbursement for drug products exists among
third-party payors. Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor. The process for determining
whether a third-party 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. Coverage and reimbursement by a third-party payor may depend upon a number of factors, including
the third-party payor’s determination that use of a product is:
● a covered benefit under its health plan;
● safe, effective, and medically necessary;
● appropriate for the specific patient;
● cost-effective; and
● neither experimental nor investigational.
In order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct expensive
pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of the product, in addition to the costs required to obtain
FDA or other comparable regulatory approvals. Additionally, companies may also need to provide discounts to purchasers, private health plans or
government healthcare programs. Nonetheless, product candidates may not be considered medically necessary or cost effective. A decision by a third-party
payor not to cover a product could reduce physician utilization once the product is approved and have a material adverse effect on sales, our operations and
financial condition.
Government, private health insurers and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the
level of reimbursement for new therapeutic products approved for marketing by the FDA. For example, Congress passed the ACA in 2010 which enacted a
number of reforms to expand access to health insurance while also reducing or constraining the growth of healthcare spending, enhancing remedies against
fraud and abuse, adding new transparency requirements for healthcare industries, and imposing new taxes on fees on healthcare industry participants,
among other policy reforms. Federal agencies, Congress and state legislatures have continued to show interest in implementing cost containment programs
to limit the growth of health care costs, including price controls, price disclosures, restrictions on reimbursement and other fundamental changes to the
healthcare delivery system. In addition, in recent years, Congress has enacted various laws seeking to reduce the federal debt level and contain healthcare
expenditures, and the Medicare and other healthcare programs are frequently identified as potential targets for spending cuts. New government legislation
or regulations related to pricing or other fundamental changes to the healthcare delivery system as well as a government or third-party payer decision not to
approve pricing for, or provide adequate coverage or reimbursement of, our product candidates hold the potential to severely limit market opportunities of
such products. Accordingly, even if coverage and reimbursement are provided by government, private health insurers and third-party payors for uses of our
products, market acceptance of these products would be adversely affected if the reimbursement available proves to be unprofitable for health care
providers.
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Our products may not achieve sufficient acceptance by the medical community to sustain our business.
The commercial success of our products will depend upon their acceptance by the medical community and third-party payors as clinically useful, cost
effective and safe. Any of our drug candidates or similar product candidates being investigated by our competitors may prove not to be effective in trial or
in practice, cause adverse events or other undesirable side effects. Our testing and clinical practice may not confirm the safety and efficacy of our product
candidates or even if further testing and clinical practice produce positive results, the medical community may view these new forms of treatment as
effective and desirable or our efforts to market our new products may fail. Market acceptance depends upon physicians and hospitals obtaining adequate
reimbursement rates from third-party payors to make our products commercially viable. Any of these factors could have an adverse effect on our business,
financial condition and results of operations.
The commercial potential of a drug candidate in development is difficult to predict. If the market size for a new drug is significantly smaller than
we anticipate, it could significantly and negatively impact our revenue, results of operations and financial condition.
It is very difficult to predict the commercial potential of product candidates due to important factors such as safety and efficacy compared to other available
treatments, including potential generic drug alternatives with similar efficacy profiles, changing standards of care, third party payor reimbursement
standards, patient and physician preferences, the availability of competitive alternatives that may emerge either during the long drug development process
or after commercial introduction, and the availability of generic versions of our successful product candidates following approval by government health
authorities based on the expiration of regulatory exclusivity or our inability to prevent generic versions from coming to market by asserting our patents. If
due to one or more of these risks the market potential for a drug candidate is lower than we anticipated, it could significantly and negatively impact the
revenue potential for such drug candidate and would adversely affect our business, financial condition and results of operations.
Several of our current clinical trials are being conducted outside the U.S., and the FDA may not accept data from trials conducted in foreign
locations.
Several of our current clinical trials are being conducted outside the U.S. Although the FDA may accept data from clinical trials conducted outside the
U.S., acceptance of these data is subject to certain conditions imposed by the FDA. For example, the clinical trial must be well designed and conducted and
performed by qualified investigators in accordance with ethical principles. The trial population must also adequately represent the U.S. population, and the
data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. In general, the patient
population for any clinical trials conducted outside of the U.S. must be representative of the population for whom we intend to label the product in the U.S.
In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will be dependent upon its determination that the
trials also complied with all applicable U.S. laws and regulations. We cannot assure you that the FDA will accept data from trials conducted outside of the
U.S. If the FDA does not accept the data from such clinical trials, it would likely result in the need for additional trials, which would be costly and time-
consuming and delay or permanently halt our development of our product candidates.
We have no internal sales or marketing capability. If we are unable to create sales, marketing and distribution capabilities or enter into alliances
with others possessing such capabilities to perform these functions, we will not be able to commercialize our products successfully.
We currently have no sales, marketing, or distribution capabilities. We intend to market our products, if and when such products are approved for
commercialization by the FDA and foreign regulatory agencies, either directly or through other strategic alliances and distribution arrangements with third
parties. If we decide to market our products directly, we will need to commit significant financial and managerial resources to develop a marketing and
sales force with technical expertise and with supporting distribution, administration, and compliance capabilities. If we rely on third parties with such
capabilities to market our products, we will need to establish and maintain partnership arrangements, and there can be no assurance that we will be able to
enter into third-party marketing or distribution arrangements on acceptable terms or at all. To the extent that we do enter into such arrangements, we will be
dependent on our marketing and distribution partners. In entering into third-party marketing or distribution arrangements, we expect to incur significant
additional expenses and there can be no assurance that such third parties will establish adequate sales and distribution capabilities or be successful in
gaining market acceptance for our products and services.
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Technologies for the treatment of cancer are subject to rapid change, and the development of treatment strategies that are more effective than our
technologies could render our technologies obsolete.
Various methods for treating cancer currently are, and in the future, are expected to be, the subject of extensive research and development. Many possible
treatments that are being researched, if successfully developed, may not require, or may supplant, the use of our technologies. The successful development
and acceptance of any one or more of these alternative forms of treatment could render our technology obsolete as a cancer treatment method.
We may not be able to hire or retain key officers or employees that we need to implement our business strategy and develop our product
candidates and business, including those purchased in the EGEN asset acquisition.
Our success depends significantly on the continued contributions of our executive officers, scientific and technical personnel and consultants, including
those retained in the EGEN acquisition, and on our ability to attract additional personnel as we seek to implement our business strategy and develop our
product candidates and businesses. Our operations associated with the EGEN acquisition are located in Huntsville, Alabama. Key employees may depart if
we fail to successfully manage this additional business location or in relation to any uncertainties or difficulties of integration with Celsion. We cannot
guarantee that we will retain key employees to the same extent that we and EGEN retained each of our own employees in the past, which could have a
negative impact on our business, results of operations and financial condition. Our integration of EGEN and ability to operate in the fields we acquired
from EGEN may be more difficult if we lose key employees. Additionally, during our operating history, we have assigned many essential responsibilities to
a relatively small number of individuals. However, as our business and the demands on our key employees expand, we have been, and will continue to be,
required to recruit additional qualified employees. The competition for such qualified personnel is intense, and the loss of services of certain key personnel
or our inability to attract additional personnel to fill critical positions could adversely affect our business. Further, we do not carry “key man” insurance on
any of our personnel. Therefore, loss of the services of key personnel would not be ameliorated by the receipt of the proceeds from such insurance.
Our success will depend in part on our ability to grow and diversify, which in turn will require that we manage and control our growth effectively.
Our business strategy contemplates growth and diversification. Our ability to manage growth effectively will require that we continue to expend funds to
improve our operational, financial and management controls, reporting systems and procedures. In addition, we must effectively expand, train and manage
our employees. We will be unable to manage our business effectively if we are unable to alleviate the strain on resources caused by growth in a timely and
successful manner. There can be no assurance that we will be able to manage our growth and a failure to do so could have a material adverse effect on our
business.
We face intense competition and the failure to compete effectively could adversely affect our ability to develop and market our products.
There are many companies and other institutions engaged in research and development of various technologies for cancer treatment products that seek
treatment outcomes similar to those that we are pursuing. We believe that the level of interest by others in investigating the potential of possible
competitive treatments and alternative technologies will continue and may increase. Potential competitors engaged in all areas of cancer treatment research
in the U.S. and other countries include, among others, major pharmaceutical, specialized technology companies, and universities and other research
institutions. Most of our current and potential competitors have substantially greater financial, technical, human and other resources, and may also have far
greater experience than do we, both in pre-clinical testing and human clinical trials of new products and in obtaining FDA and other regulatory approvals.
One or more of these companies or institutions could succeed in developing products or other technologies that are more effective than the products and
technologies that we have been or are developing, or which would render our technology and products obsolete and non-competitive. Furthermore, if we
are permitted to commence commercial sales of any of our products, we will also be competing, with respect to manufacturing efficiency and marketing,
with companies having substantially greater resources and experience in these areas.
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We may be subject to significant product liability claims and litigation.
Our business exposes us to potential product liability risks inherent in the testing, manufacturing and marketing of human therapeutic products. We
presently have product liability insurance limited to $10 million per incident and $10 million annually. If we were to be subject to a claim in excess of this
coverage or to a claim not covered by our insurance and the claim succeeded, we would be required to pay the claim with our own limited resources, which
could have a severe adverse effect on our business. Whether or not we are ultimately successful in any product liability litigation, such litigation would
harm the business by diverting the attention and resources of our management, consuming substantial amounts of our financial resources and by damaging
our reputation. Additionally, we may not be able to maintain our product liability insurance at an acceptable cost, if at all.
We or the third parties upon whom we depend on may be adversely affected by earthquakes, global pandemics or other natural disasters and our
business continuity and disaster recovery plans may not adequately protect us from a serious disaster, including earthquakes or other natural
disasters.
Our current operations are located in our facilities in Lawrenceville, New Jersey. Any unplanned event, such as flood, fire, explosion, earthquake, extreme
weather condition, power shortage, telecommunication failure or other natural or manmade accidents or incidents that result in us being unable to fully
utilize our facilities, or the manufacturing facilities of our third-party contract manufacturers, may have a material and adverse effect on our ability to
operate our business, particularly on a daily basis, and have significant negative consequences on our financial and operating conditions. Loss of access to
these facilities may result in increased costs, delays in the development of our product candidates or interruption of our business operations. Earthquakes or
other natural disasters could further disrupt our operations and have a material and adverse effect on our business, financial condition, results of operations
and prospects. If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that
damaged critical infrastructure, such as our research facilities or the manufacturing facilities of our third-party contract manufacturers, or that otherwise
disrupted operations, it may be difficult or, in certain cases, impossible, for us to continue our business for a substantial period of time. Please see the risk
factor titled “The outbreak, severity and duration of the novel coronavirus disease, COVID-19, pandemic could adversely impact our business, including
our preclinical studies and clinical trials” for information regarding the COVID-19 pandemic.
The disaster recovery and business continuity plan we have in place may prove inadequate in the event of a serious disaster or similar event. We may incur
substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which, could have a material adverse effect on
our business. As part of our risk management policy, we maintain insurance coverage at levels that we believe are appropriate for our business. However, in
the event of an accident or incident at these facilities, we cannot assure you that the amounts of insurance will be sufficient to satisfy any damages and
losses. If our facilities, or the manufacturing facilities of our third-party contract manufacturers, are unable to operate because of an accident or incident or
for any other reason, even for a short period of time, any or all of our research and development programs may be harmed.
Our internal computer systems, or those of our CROs or other contractors or consultants, may fail or suffer security breaches, which could result
in a material disruption of our product development programs.
Despite the implementation of security measures, our internal computer systems and those of our CROs and other contractors and consultants are
vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Such
events could cause interruptions of our operations. For instance, the loss of preclinical data or data from any clinical trial involving our product candidates
could result in delays in our development and regulatory filing efforts and significantly increase our costs. To the extent that any disruption or privacy or
security breach were to result in a loss of, or damage to, our data, or inappropriate disclosure of confidential or proprietary information, we could be subject
to reputational harm, monetary fines, civil suits, civil penalties or criminal sanctions and requirements to disclose the breach, and other forms of liability
and the development of our product candidates could be delayed.
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Pandemics such as the COVID-19 coronavirus could have an adverse impact on our developmental programs and our financial condition.
In December 2019, a novel strain of the COVID-19 coronavirus was first identified in Wuhan, Hubei Province, China. Any outbreak of contagious
diseases, or other adverse public health developments, could have a material and adverse effect on our business operations. These could include disruptions
or restrictions on our ability to travel, pursue partnerships and other business transactions, conduct clinical trials, make shipments of biologic materials, as
well as be impacted by the temporary closure of the facilities of suppliers and clinical trial sites. Any disruption of suppliers, clinical trial sites or access to
patients would likely impact our clinical trial enrollment progress and rates as well as our ability to access capital through the financial markets. The extent
to which the COVID-19 coronavirus impacts our business will depend on future developments, which are highly uncertain and cannot be predicted,
including new information which may emerge concerning the severity of the COVID-19 coronavirus and the actions to contain the COVID-19 coronavirus
or treat its impact, among others.
RISKS RELATED TO OUR INTELLECTUAL PROPERTY
Our business depends on license agreements with third parties to permit us to use patented technologies. The loss of any of our rights under these
agreements could impair our ability to develop and market our products.
Our success will depend, in a substantial part, on our ability to maintain our rights under license agreements granting us rights to use patented technologies.
For instance, we are party to license agreements with Duke University, under which we have exclusive rights to commercialize medical treatment products
and procedures based on Duke’s thermo-sensitive liposome technology. The Duke University license agreement contains a license fee, royalty and/or
research support provisions, testing and regulatory milestones, and other performance requirements that we must meet by certain deadlines. If we breach
any provisions of the license and research agreements, we may lose our ability to use the subject technology, as well as compensation for our efforts in
developing or exploiting the technology. Any such loss of rights and access to technology could have a material adverse effect on our business.
Further, we cannot guarantee that any patent or other technology rights licensed to us by others will not be challenged or circumvented successfully by third
parties, or that the rights granted will provide adequate protection. We may be required to alter any of our potential products or processes or enter into a
license and pay licensing fees to a third party or cease certain activities. There can be no assurance that we can obtain a license to any technology that we
determine we need on reasonable terms, if at all, or that we could develop or otherwise obtain alternate technology. If a license is not available on
commercially reasonable terms or at all, our business, results of operations, and financial condition could be significantly harmed, and we may be
prevented from developing and commercializing the product. Litigation, which could result in substantial costs, may also be necessary to enforce any
patents issued to or licensed by us or to determine the scope and validity of another’s claimed proprietary rights.
If any of our pending patent applications do not issue, or are deemed invalid following issuance, we may lose valuable intellectual property
protection.
The patent positions of pharmaceutical and biotechnology companies, such as ours, are uncertain and involve complex legal and factual issues. We own
various U.S. and international patents and have pending U.S. and international patent applications that cover various aspects of our technologies. There can
be no assurance that patents that have issued will be held valid and enforceable in a court of law through the entire patent term. Even for patents that are
held valid and enforceable, the legal process associated with obtaining such a judgment is time-consuming and costly. Additionally, issued patents can be
subject to opposition, interferences or other proceedings that can result in the revocation of the patent or maintenance of the patent in amended form (and
potentially in a form that renders the patent without commercially relevant or broad coverage). Further, our competitors may be able to circumvent and
otherwise design around our patents. Even if a patent is issued and enforceable because development and commercialization of pharmaceutical products
can be subject to substantial delays, patents may expire early and provide only a short period of protection, if any, following the commercialization of
products encompassed by our patents. We may have to participate in interference proceedings declared by the U.S. Patent and Trademark Office, which
could result in a loss of the patent and/or substantial cost to us.
We have filed patent applications, and plan to file additional patent applications, covering various aspects of our technologies and our proprietary product
candidates. There can be no assurance that the patent applications for which we apply would actually issue as patents or do so with commercially relevant
or broad coverage. The coverage claimed in a patent application can be significantly reduced before the patent is issued. The scope of our claim coverage
can be critical to our ability to enter into licensing transactions with third parties and our right to receive royalties from our collaboration partnerships.
Since publication of discoveries in scientific or patent literature often lags behind the date of such discoveries, we cannot be certain that we were the first
inventor of inventions covered by our patents or patent applications. In addition, there is no guarantee that we will be the first to file a patent application
directed to an invention.
An adverse outcome in any judicial proceeding involving intellectual property, including patents, could subject us to significant liabilities to third parties,
require disputed rights to be licensed from or to third parties or require us to cease using the technology in dispute. In those instances where we seek an
intellectual property license from another, we may not be able to obtain the license on a commercially reasonable basis, if at all, thereby raising concerns on
our ability to freely commercialize our technologies or products.
We rely on trade secret protection and other unpatented proprietary rights for important proprietary technologies, and any loss of such rights
could harm our business, results of operations and financial condition.
We rely on trade secrets and confidential information that we seek to protect, in part, by confidentiality agreements with our corporate partners,
collaborators, employees and consultants. We cannot assure you that these agreements are adequate to protect our trade secrets and confidential information
or will not be breached or, if breached, we will have adequate remedies. Furthermore, others may independently develop substantially equivalent
confidential and proprietary information or otherwise gain access to our trade secrets or disclose such technology. Any loss of trade secret protection or
other unpatented proprietary rights could harm our business, results of operations and financial condition.
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Our products may infringe patent rights of others, which may require costly litigation and, if we are not successful, could cause us to pay
substantial damages or limit our ability to commercialize our products.
Our commercial success depends on our ability to operate without infringing the patents and other proprietary rights of third parties. There may be third
party patents that relate to our products and technology. We may unintentionally infringe upon valid patent rights of third parties. Although we currently are
not involved in any material litigation involving patents, a third-party patent holder may assert a claim of patent infringement against us in the future.
Alternatively, we may initiate litigation against the third-party patent holder to request that a court declare that we are not infringing the third party’s patent
and/or that the third party’s patent is invalid or unenforceable. If a claim of infringement is asserted against us and is successful, and therefore we are found
to infringe, we could be required to pay damages for infringement, including treble damages if it is determined that we knew or became aware of such a
patent and we failed to exercise due care in determining whether or not we infringed the patent. If we have supplied infringing products to third parties or
have licensed third parties to manufacture, use or market infringing products, we may be obligated to indemnify these third parties for damages they may
be required to pay to the patent holder and for any losses they may sustain.
We can also be prevented from selling or commercializing any of our products that use the infringing technology in the future unless we obtain a license
from such third party. A license may not be available from such third party on commercially reasonable terms or may not be available at all. Any
modification to include a non-infringing technology may not be possible, or if possible, may be difficult or time-consuming to develop, and require
revalidation, which could delay our ability to commercialize our products. Any infringement action asserted against us, even if we are ultimately successful
in defending against such action, would likely delay the regulatory approval process of our products, harm our competitive position, be expensive and
require the time and attention of our key management and technical personnel.
RISKS RELATED TO OUR SECURITIES
The market price of our common stock has been, and may continue to be volatile and fluctuate significantly, which could result in substantial
losses for investors and subject us to securities class action litigation.
The trading price for our common stock has been, and we expect it to continue to be, volatile. The price at which our common stock trades depends upon a
number of factors, including our historical and anticipated operating results, our financial situation, announcements of technological innovations or new
products by us or our competitors, our ability or inability to raise the additional capital we may need and the terms on which we raise it, and general market
and economic conditions. Some of these factors are beyond our control. Broad market fluctuations may lower the market price of our common stock and
affect the volume of trading in our stock, regardless of our financial condition, results of operations, business or prospect.
The closing price of our common stock as reported on NASDAQ had a high price of $2.47 and a low price of $1.08 in the 52-week period ended December
31, 2019, a high price of $5.26 and a low price of $0.47 in the 52-week period ended December 31, 2020, and a high price of $2.81 and a low price of
$0.79 from January 1, 2021 through March 18, 2021.
Among the factors that may cause the market price of our common stock to fluctuate are the risks described in this “Risk Factors” section and other factors,
including:
● results of preclinical and clinical studies of our product candidates or those of our competitors;
● regulatory or legal developments in the U.S. and other countries, especially changes in laws and regulations applicable to our product candidates;
● actions taken by regulatory agencies with respect to our product candidates, clinical studies, manufacturing process or sales and marketing terms;
● introductions and announcements of new products by us or our competitors, and the timing of these introductions or announcements;
● announcements by us or our competitors of significant acquisitions or other strategic transactions or capital commitments;
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● fluctuations in our quarterly operating results or the operating results of our competitors;
● variance in our financial performance from the expectations of investors;
● changes in the estimation of the future size and growth rate of our markets;
● changes in accounting principles or changes in interpretations of existing principles, which could affect our financial results;
● failure of our products to achieve or maintain market acceptance or commercial success;
● conditions and trends in the markets we serve;
● changes in general economic, industry and market conditions;
● success of competitive products and services;
● changes in market valuations or earnings of our competitors;
● changes in our pricing policies or the pricing policies of our competitors;
● changes in legislation or regulatory policies, practices or actions;
● the commencement or outcome of litigation involving our company, our general industry or both;
● recruitment or departure of key personnel;
● changes in our capital structure, such as future issuances of securities or the incurrence of additional debt;
● actual or anticipated changes in earnings estimates or changes in stock market analyst recommendations regarding our common stock, other
comparable companies or our industry generally;
● actual or expected sales of our common stock by our stockholders;
● acquisitions and financings, including the EGEN acquisition; and
● the trading volume of our common stock.
In addition, the stock markets, in general, The Nasdaq Capital Market and the market for pharmaceutical companies in particular, may experience a loss of
investor confidence. Such loss of investor confidence may result in extreme price and volume fluctuations in our common stock that are unrelated or
disproportionate to the operating performance of our business, financial condition or results of operations. These broad market and industry factors may
materially harm the market price of our common stock and expose us to securities class action litigation. Such litigation, even if unsuccessful, could be
costly to defend and divert management’s attention and resources, which could further materially harm our financial condition and results of operations.
We may be unable to maintain compliance with The Nasdaq Marketplace Rules which could cause our common stock to be delisted from The
Nasdaq Capital Market. This could result in the lack of a market for our common stock, cause a decrease in the value of an investment in us, and
adversely affect our business, financial condition, and results of operations.
Our common stock is currently listed on The Nasdaq Capital Market. To maintain the listing of our common stock on The Nasdaq Capital Market, we are
required to meet certain listing requirements, including, among others, a minimum closing bid price of $1.00 per share.
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On October 13, 2020, we received notice from The Nasdaq Stock Market (“Nasdaq”) that the closing bid price for our common stock had been below $1.00
per share for the previous 30 consecutive business days, and that we are therefore not in compliance with the minimum bid price requirement for continued
inclusion on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Rule”). Nasdaq’s notice had no immediate effect on the listing or
trading of our common stock on The Nasdaq Capital Market. The notice indicated that we would have 180 calendar days, until April 12, 2021, to regain
compliance with this requirement. To regain compliance with the $1.00 minimum bid listing requirement, the closing bid price of our common stock must
be at least $1.00 per share for a minimum of ten (10) consecutive business days during the 180-day compliance period.
On February 3, 2021, the Company received written notice from the Listing Qualifications Staff of Nasdaq notifying the Company that, for the previous ten
(10) consecutive business days, from January 20, 2021 to February 2, 2021, the closing bid price for the Company’s common stock was $1.00 per share or
greater. Accordingly, the written notice stated that the Company has regained compliance with the minimum bid price listing requirement set forth under
the Rule. If in the future we are unable to comply with one or more of the Nasdaq listing standards, we could receive a notice of non-compliance and, if we
are not able to regain compliance within the requisite time period, Nasdaq could take action to delist us.
Future sales of our common stock in the public market could cause our stock price to fall.
Sales of a substantial number of shares of our common stock in the public market, or the perception that these sales might occur, could depress the market
price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. As of March 18, 2021, we had
75,011,774 shares of common stock outstanding, all of which, other than shares held by our directors and certain officers, were eligible for sale in the
public market, subject in some cases to compliance with the requirements of Rule 144, including the volume limitations and manner of sale requirements.
In addition, all of the shares of common stock issuable upon exercise of warrants will be freely tradable without restriction or further registration upon
issuance.
Our stockholders may experience significant dilution as a result of future equity offerings or issuances and exercise of outstanding options and
warrants.
In order to raise additional capital or pursue strategic transactions, we may in the future offer, issue or sell additional shares of our common stock or other
securities convertible into or exchangeable for our common stock, including the issuance of common stock in relation to the achievement, if any, of
milestones triggering our payment of earn-out consideration in connection with the EGEN acquisition. Our stockholders may experience significant
dilution as a result of future equity offerings or issuances. Investors purchasing shares or other securities in the future could have rights superior to existing
stockholders. As of March 18, 2021, we have the following number of securities convertible into, or allowing the purchase of, our common stock, including
2,636,899 shares of common stock issuable upon exercise of warrants outstanding, 6,586,435 options to purchase shares of our common stock and
restricted stock awards outstanding, and 59,493 shares of common stock reserved for future issuance under our stock incentive plan.
Changes in tax law could adversely affect our financial condition and results of operations.
The rules dealing with U.S. federal, state, and local income taxation are constantly under review by persons involved in the legislative process and by the
Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect
us or holders of our common stock. In recent years, many such changes have been made and changes are likely to continue to occur in the future. For
example, on March 27, 2020, former President Trump signed into law the “Coronavirus Aid, Relief, and Economic Security Act” or the CARES Act, which
included certain changes in tax law intended to stimulate the U.S. economy in light of the COVID-19 coronavirus pandemic, including temporary
beneficial changes to the treatment of net operating losses, interest deductibility limitations and payroll tax matters. Future changes in tax laws could have a
material adverse effect on our business, cash flow, financial condition or results of operations. We urge investors to consult with their legal and tax advisers
regarding the implications of potential changes in tax laws on an investment in our common stock.
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The adverse capital and credit market conditions could affect our liquidity.
Adverse capital and credit market conditions could affect our ability to meet liquidity needs, as well as our access to capital and cost of capital. The capital
and credit markets have experienced extreme volatility and disruption in recent years. Our results of operations, financial condition, cash flows and capital
position could be materially adversely affected by continued disruptions in the capital and credit markets.
Our ability to use net operating losses to offset future taxable income are subject to certain limitations.
On December 22, 2017, the then President of the U.S. signed into law the Tax Reform Act. The Tax Reform Act significantly changes U.S. tax law by,
among other things, lowering corporate income tax rates, implementing a quasi-territorial tax system, providing a one-time transition toll charge on foreign
earnings, creating a new limitation on the deductibility of interest expenses and modifying the limitation on officer compensation. The Tax Reform Act
permanently reduces the U.S. corporate income tax rate from a maximum of 35% to a flat 21% rate, effective January 1, 2018. We currently have
significant net operating losses (NOLs) that may be used to offset future taxable income. In general, under Section 382 of the Internal Revenue Code of
1986, as amended (the “Code”), a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change NOLs to
offset future taxable income. During 2020, 2019 and years prior, we performed analyses to determine if there were changes in ownership, as defined by
Section 382 of the Internal Revenue Code that would limit our ability to utilize certain net operating loss and tax credit carry forwards. We determined we
experienced ownership changes, as defined by Section 382, in connection with certain common stock offerings in 2011, 2013, 2015, 2017, 2018 and 2020.
As a result, the utilization of our federal tax net operating loss carry-forwards generated prior to the ownership changes is limited. Future changes in our
stock ownership, some of which are outside of our control, could result in an ownership change under Section 382 of the Code, which would significantly
limit our ability to utilize NOLs to offset future taxable income. Future changes in tax laws could also impair our corporate tax rate and/or our ability to
utilize our NOLs.
We have never paid cash dividends on our common stock in the past and do not anticipate paying cash dividends on our common stock in the
foreseeable future.
We have never declared or paid cash dividends on our common stock. We do not anticipate paying any cash dividends on our common stock in the
foreseeable future. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business. As a
result, capital appreciation, if any, of our common stock will be the sole source of gain for the foreseeable future for holders of our common stock.
Anti-takeover provisions in our charter documents and Delaware law could prevent or delay a change in control.
Our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition that a stockholder may consider favorable by
authorizing the issuance of “blank check” preferred stock. This preferred stock may be issued by our Board of Directors on such terms as it determines,
without further stockholder approval. Therefore, our Board of Directors may issue such preferred stock on terms unfavorable to a potential bidder in the
event that our Board of Directors opposes a merger or acquisition. In addition, our staggered Board of Directors may discourage such transactions by
increasing the amount of time necessary to obtain majority representation on our Board of Directors. Certain other provisions of our bylaws and of
Delaware law may also discourage, delay or prevent a third party from acquiring or merging with us, even if such action were beneficial to some, or even a
majority, of our stockholders.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2.
PROPERTIES
In July 2011, we entered into a lease with Brandywine Operating Partnership, L.P., a Delaware limited partnership for a 10,870 square foot premises
located in Lawrenceville, New Jersey in connection with the relocation of our offices from Columbia, Maryland. Under the terms of the current lease,
which was amended effective May 1, 2017, we reduced the size of the premises to 7,565 square feet and are paying a monthly rent that ranges from
approximately $18,900 in the first year to approximately $20,500 in the final year of the amendment. On February 1, 2019, we amended the current terms
of the lease to increase the size of the premises by 2,285 square feet to 9,850 square feet and also extended the lease term by one year to September 1, 2023.
In conjunction with the February 1, 2019 lease amendment, we agreed to modify our one-time option to cancel the lease as of the 36th month after the May
1, 2017 lease commencement date.
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In connection with the Asset Purchase Agreement with EGEN in June 2014, we assumed the existing lease with another landlord for an 11,500 square foot
premises located in Huntsville, Alabama. In January 2018, we entered into a new 60-month lease agreement for 9,049 square feet with rent payments of
approximately $18,100 per month.
Following is a table of future payments and maturity of our operating lease liabilities as of December 31, 2020:
2021
2022
2023 and thereafter
Subtotal future lease payments
Less imputed interest
Total lease liabilities
Weighted average remaining life
Weighted average discount rate
For the
year ending
December 31,
530,734
535,579
233,117
1,299,430
(155,712)
1,143,718
2.46 years
9.98%
$
For 2020, operating lease expense was $522,380 and cash paid for operating leases included in operating cash flows was $525,809. For 2019, operating
lease expense was $522,380 and cash paid for operating leases included in operating cash flows was $485,848.
We believe our existing facilities are suitable and adequate to conduct our business.
ITEM 3.
LEGAL PROCEEDINGS
On September 20, 2019, a purported stockholder of the Company filed a derivative and putative class action lawsuit against the Company and certain
officers and directors (the “Shareholder Action”). The Company was a defendant in this derivative and putative class action lawsuit in the Superior Court of
New Jersey, Chancery Division, filed by a shareholder against the Company (as both a class action defendant and nominal defendant), and certain of its
officers and directors (the “Individual Defendants”), with the caption O’Connor v. Braun et al., Docket No. MER-C-000068-19 (the “Shareholder Action”).
The Shareholder Action alleged breaches of the defendants’ fiduciary duties based on allegations that the defendants omitted or made improper statements
when seeking shareholder approval of the 2018 Stock Incentive Plan. The Shareholder Action sought, among other things, any damages sustained by the
Company as a result of the defendants’ alleged wrongdoing, a declaratory judgment against all defendants invalidating the 2018 Stock Incentive Plan and
declaring any awards made under the Plan invalid, rescinded, and subject to disgorgement, an order disgorging the equity awards granted to the Individual
Defendants under the 2018 Stock Incentive Plan, and attorneys’ fees and costs.
On April 24, 2020, the Company, the Individual Defendants, and the plaintiff (the “Parties”) entered into a Settlement Agreement and Release (the
“Settlement Agreement”), which memorializes the terms of the Parties’ settlement of the Shareholder Action (the “Settlement”). The Settlement calls for
repricing of certain stock options and payment of plaintiff legal fees of $187,500. On July 24, 2020, the Court issued an order approving the Parties’
proposed form of notice to shareholders regarding the Settlement. A hearing was held on September 8, 2020 whereby the Court issued a final approval
approving the Settlement. Pursuant to the Settlement, the Company paid $187,500 on October 1, 2020. Without admitting the validity of any of the claims
asserted in the Shareholder Action, or any liability with respect thereto, and expressly denying all allegations of wrongdoing, fault, liability, or damage
against the Company and the Individual Defendants arising out of any of the conduct, statements, acts or omissions alleged, or that could have been
alleged, in the Shareholder Action, the Company and the Individual Defendants concluded that it was desirable that the claims be settled on the terms and
subject to the conditions set forth in the Settlement Agreement. The Company and the Individual Defendants entered into the Settlement Agreement for
settlement purposes only and solely to avoid the cost and disruption of further litigation.
On October 29, 2020, a putative securities class action was filed against the Company and certain of its officers and directors (the “Spar Individual
Defendants”) in the U.S. District Court for the District of New Jersey, captioned Spar v. Celsion Corporation, et al., Case No. 1:20-cv-15228. The plaintiff
alleges that the Company and Individual Defendants made false and misleading statements regarding one of the Company’s product candidates,
ThermoDox®, and brings claims for damages under Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder against all Defendants, and
under Section 20(a) of the Exchange Act of 1934 against the Spar Individual Defendants. The Company believes that the case is without merit and intends
to defend it vigorously.
In February 2021, a derivative shareholder lawsuit was filed against the Company, as the nominal defendant, and certain of its directors and officers as
defendants in the U.S. District Court for the District of New Jersey, captioned Fidler v. Michael H. Tardugno et al., Case No. 3:21-cv-02662. The plaintiff
alleges breach of fiduciary duty and other claims arising out of alleged statements made by certain of the Company’s directors and/or officers regarding
ThermoDox®. The Company believes it has meritorious defenses to these claims and intends to vigorously contest this suit.
ITEM 4. MINE SAFETY DISCLOSURES
Not Applicable.
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ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF
PART II
EQUITY SECURITIES
Market for Our Common Stock
Our common stock trades on The Nasdaq Capital Market under the symbol “CLSN”.
Record Holders
As of March 18, 2021, there were approximately 55,000 stockholders of record of our common stock. The actual number of stockholders may be greater
than this number of record stockholders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other
nominees. This number of stockholders of record also does not include stockholders whose shares may be held in trust by other entities.
Dividend Policy
We have never declared or paid any cash dividends on our common stock. We currently anticipate that we will retain all of our future earnings for use in the
operation of our business and to fund future growth and do not anticipate paying any cash dividends in the foreseeable future. Any future determination to
declare cash dividends will be made at the discretion of our Board of Directors, subject to applicable law, and will depend on our financial condition,
results of operations, capital requirements, general business conditions and other factors that our Board of Directors may deem relevant.
Securities Authorized for Issuance Under Equity Compensation Plans
See “Part III, Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matter-Equity Compensation
Plan Information”.
Unregistered Shares of Equity Securities
None.
Issuer Purchases of Equity Securities
None.
ITEM 6.
SELECTED FINANCIAL DATA
Not required.
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ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussions should be read in conjunction with our financial statements and related notes thereto included in this Annual Report. The
following discussion contains forward-looking statements made pursuant to the safe harbor provisions of Section 27A of the Securities Act and Section
21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs and
expectations about future outcomes and are subject to risks and uncertainties that could cause actual results to differ materially from anticipated results.
Factors that could cause or contribute to such differences include those described under “Part I, Item 1A - Risk Factors” appearing in this Annual Report
and factors described in other cautionary statements, cautionary language and risk factors set forth in other documents that we file with the Securities and
Exchange Commission. We undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or
otherwise.
Overview
Celsion Corporation (“Celsion” and the “Company”) is a fully integrated, clinical stage biotechnology company focused on advancing a portfolio of
innovative treatments including DNA-based immunotherapies, next generation vaccines and directed chemotherapies through clinical trials and eventual
commercialization. The Company’s product pipeline includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer and
ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently under investigator-sponsored development for several cancer
indications. Celsion has two feasibility stage platform technologies for the development of novel nucleic acid-based immunotherapies and next generation
vaccines and other anti-cancer DNA or RNA therapies. Both are novel synthetic, non-viral vectors with demonstrated capability in nucleic acid cellular
transfection.
IMMUNO-ONCOLOGY Program
On June 20, 2014, the Company completed the acquisition of substantially all of the assets of EGEN, a private company located in Huntsville, Alabama.
Pursuant to the Asset Purchase Agreement, CLSN Laboratories acquired all of EGEN’s right, title and interest in substantially all of the assets of EGEN,
including cash and cash equivalents, patents, trademarks and other intellectual property rights, clinical data, certain contracts, licenses and permits,
equipment, furniture, office equipment, furnishings, supplies and other tangible personal property. A key asset acquired from EGEN was the TheraPlas
technology platform. The first drug candidate developed from this technology platform is GEN-1.
THERAPLAS Technology Platform
TheraPlas is a technology platform for the delivery of DNA and mRNA therapeutics via synthetic non-viral carriers and is capable of providing cell
transfection for double-stranded DNA plasmids and large therapeutic RNA segments such as mRNA. There are two components of the TheraPlas system, a
plasmid DNA or mRNA payload encoding a therapeutic protein, and a delivery system. The delivery system is designed to protect the DNA/mRNA from
degradation and promote trafficking into cells and through intracellular compartments. We designed the delivery system of TheraPlas by chemically
modifying the low molecular weight polymer to improve its gene transfer activity without increasing toxicity. We believe that TheraPlas may be a viable
alternative to current approaches to gene delivery due to several distinguishing characteristics, including enhanced molecular versatility that allows for
complex modifications to potentially improve activity and safety.
The design of the TheraPlas delivery system is based on molecular functionalization of polyethyleneimine (PEI), a cationic delivery polymer with a distinct
ability to escape from the endosomes due to heavy protonation. The transfection activity and toxicity of PEI is tightly coupled to its molecular weight;
therefore the clinical application of PEI is limited. We have used molecular functionalization strategies to improve the activity of low molecular weight
PEIs without augmenting their cytotoxicity. In one instance, chemical conjugation of a low molecular weight branched BPEI1800 with cholesterol and
polyethylene glycol (PEG) to form PEG-PEI-Cholesterol (PPC) dramatically improved the transfection activity of BPEI1800 following in vivo delivery.
Together, the cholesterol and PEG modifications produced approximately 20-fold enhancement in transfection activity. Biodistribution studies following
intraperitoneal or subcutaneous administration of DNA/PPC nanocomplexes showed DNA delivery localized primarily at the injection site with only small
amount escaping into the systemic circulation. PPC is the delivery component of our lead TheraPlas product, GEN-1, which is in clinical development for
the treatment of ovarian cancer. The PPC manufacturing process has been scaled up from bench scale (1-2 g) to 0.6Kg, and several current Good
Manufacturing Practice (“cGMP”) lots have been produced with reproducible quality.
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We believe that TheraPlas has emerged as a viable alternative to current approaches due to several distinguishing characteristics such as strong molecular
versatility that may allow for complex modifications to potentially improve activity and safety with little difficulty. The biocompatibility of these polymers
reduces the risk of adverse immune response, thus allowing for repeated administration. Compared to naked DNA or cationic lipids, TheraPlas is generally
safer, more efficient, and cost effective. We believe that these advantages place Celsion in a strong position to capitalize on this technology platform.
Ovarian Cancer Overview
Ovarian cancer is the most lethal of gynecological malignancies among women with an overall five-year survival rate of 45%. This poor outcome is due in
part to the lack of effective prevention and early detection strategies. There were approximately 22,000 new cases of ovarian cancer in the U.S. in 2014
with an estimated 14,000 deaths. Mortality rates for ovarian cancer declined very little in the last forty years due to the unavailability of detection tests and
improved treatments. Most women with ovarian cancer are not diagnosed until Stages III or IV, when the disease has spread outside the pelvis to the
abdomen and areas beyond causing swelling and pain, where the five-year survival rates are 25 - 41 percent and 11 percent, respectively. First-line
chemotherapy regimens are typically platinum-based combination therapies. Although this first line of treatment has an approximate 80 percent response
rate, 55 to 75 percent of women will develop recurrent ovarian cancer within two years and ultimately will not respond to platinum therapy. Patients whose
cancer recurs or progresses after initially responding to surgery and first-line chemotherapy have been divided into one of the two groups based on the time
from completion of platinum therapy to disease recurrence or progression. This time period is referred to as platinum-free interval. The platinum-sensitive
group has a platinum-free interval of longer than six months. This group generally responds to additional treatment with platinum-based therapies. The
platinum-resistant group has a platinum-free interval of shorter than six months and is resistant to additional platinum-based treatments. Pegylated
liposomal doxorubicin, topotecan, and Avastin are the only approved second-line therapies for platinum-resistant ovarian cancer. The overall response rate
for these therapies is 10 to 20 percent with median overall survival (“OS”) of eleven to twelve months. Immunotherapy is an attractive novel approach for
the treatment of ovarian cancer particularly since ovarian cancers are considered immunogenic tumors. IL-12 is one of the most active cytokines for the
induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. The precedence for a
therapeutic role of IL-12 in ovarian cancer is based on epidemiologic and preclinical data.
GEN-1 Immunotherapy
GEN-1 is a DNA-based immunotherapeutic product candidate for the localized treatment of ovarian cancer by intraperitoneally administering an
Interleukin-12 (“IL-12”) plasmid formulated with our proprietary TheraPlas delivery system. In this DNA-based approach, the immunotherapy is combined
with a standard chemotherapy drug, which can potentially achieve better clinical outcomes than with chemotherapy alone. We believe that increases in IL-
12 concentrations at tumor sites for several days after a single administration could create a potent immune environment against tumor activity and that a
direct killing of the tumor with concomitant use of cytotoxic chemotherapy could result in a more robust and durable antitumor response than
chemotherapy alone. We believe the rationale for local therapy with GEN-1 is based on the following:
● Loco-regional production of the potent cytokine IL-12 avoids toxicities and poor pharmacokinetics associated with systemic delivery of
recombinant IL-12;
● Persistent local delivery of IL-12 lasts up to one week and dosing can be repeated; and
● Local therapy is ideal for long-term maintenance therapy.
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OVATION I Study. In February 2015, we announced that the U.S. Food and Drug Administration (“FDA”) accepted, without objection, the Phase I dose-
escalation clinical trial of GEN-1 in combination with the standard of care in neoadjuvant ovarian cancer (the “OVATION I Study”). On September 30,
2015, we announced enrollment of the first patient in the OVATION I Study. The OVATION I Study was designed to:
(i)
identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response;
(ii) enroll three to six patients per dose level and evaluate safety and efficacy; and
(iii) attempt to define an optimal dose for a follow-on Phase I/II study.
In addition, the OVATION I Study established a unique opportunity to assess how cytokine-based compounds such as GEN-1, directly affect ovarian cancer
cells and the tumor microenvironment in newly diagnosed ovarian cancer patients. The study was designed to characterize the nature of the immune
response triggered by GEN-1 at various levels of the patients’ immune system, including:
● Infiltration of cancer fighting T-cell lymphocytes into primary tumor and tumor microenvironment including peritoneal cavity, which is the
primary site of metastasis of ovarian cancer;
● Changes in local and systemic levels of immuno-stimulatory and immunosuppressive cytokines associated with tumor suppression and growth,
respectively; and
● Expression profile of a comprehensive panel of immune related genes in pre-treatment and GEN-1-treated tumor tissue.
We initiated the OVATION I Study at four clinical sites at the University of Alabama at Birmingham, Oklahoma University Medical Center, Washington
University in St. Louis, and the Medical College of Wisconsin. During 2016 and 2017, we announced data from the first fourteen patients in the OVATION
I Study. On October 3, 2017, we announced final translational research and clinical data from the OVATION I Study.
Key translational research findings from all evaluable patients are consistent with the earlier reports from partial analysis of the data and are summarized
below:
● The intraperitoneal treatment of GEN-1 in conjunction with NACT resulted in dose dependent increases in IL-12 and Interferon-gamma (IFN-γ)
levels that were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients’ systemic circulation. These
and other post-treatment changes including decreases in VEGF levels in peritoneal fluid are consistent with an IL-12 based immune mechanism;
● Consistent with the previous partial reports, the effects observed in the IHC analysis were pronounced decreases in the density of
immunosuppressive T-cell signals (Foxp3, PD-1, PDL-1, IDO-1) and increases in CD8+ cells in the tumor microenvironment;
● The ratio of CD8+ cells to immunosuppressive cells was increased in approximately 75% of patients suggesting an overall shift in the tumor
microenvironment from immunosuppressive to pro-immune stimulatory following treatment with GEN-1. An increase in CD8+ to
immunosuppressive T-cell populations is a leading indicator and believed to be a good predictor of improved OS; and
● Analysis of peritoneal fluid by cell sorting, not reported before, shows a treatment-related decrease in the percentage of immunosuppressive T-cell
(Foxp3+), which is consistent with the reduction of Foxp3+ T-cells in the primary tumor tissue, and a shift in tumor naïve CD8+ cell population to
more efficient tumor killing memory effector CD8+ cells.
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The Company also reported positive clinical data from the first fourteen patients who completed treatment in the OVATION I Study. GEN-1 plus standard
chemotherapy produced no dose limiting toxicities and positive dose dependent efficacy signals which correlate well with positive surgical outcomes as
summarized below:
● Of the fourteen patients treated in the entire study, two patients demonstrated a complete response, ten patients demonstrated a partial response
and two patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate and an 86% objective
response rate (“ORR”). Of the five patients treated in the highest dose cohort, there was a 100% ORR with one complete response and four partial
responses;
● Fourteen patients had successful resections of their tumors, with nine patients (64%) having a complete tumor resection (“R0”), which indicates a
microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Seven out of eight (88%) patients in
the highest two dose cohorts experienced a R0 surgical resection. All five patients treated at the highest dose cohort experienced a R0 surgical
resection; and
● All patients experienced a clinically significant decrease in their CA-125 protein levels as of their most recent study visit. CA-125 is used to
monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells.
On March 2, 2019, the Company announced final progression free survival (“PFS”) results from the OVATION I Study. Median PFS in patients treated per
protocol (n=14) was 21 months and was 17.1 months for the intent-to-treat (“ITT”) population (n=18) for all dose cohorts, including three patients who
dropped out of the study after 13 days or less, and two patients who did not receive full NAC and GEN-1 cycles. Under the current standard of care, in
women with Stage III/IV ovarian cancer undergoing NAC, their disease progresses within about 12 months on average. The results from the OVATION I
Study support continued evaluation of GEN-1 based on promising tumor response, as reported in the PFS data, and the ability for surgeons to completely
remove visible tumor at interval debulking surgery. GEN-1 was well tolerated, and no dose-limiting toxicities were detected. Intraperitoneal administration
of GEN-1 was feasible with broad patient acceptance.
OVATION 2 Study. The Company held an Advisory Board Meeting on September 27, 2017 with the clinical investigators and scientific experts including
those from Roswell Park Cancer Institute, Vanderbilt University Medical School, and M.D. Anderson Cancer Center to review and finalize clinical,
translational research and safety data from the OVATION I Study in order to determine the next steps forward for our GEN-1 immunotherapy program.
On November 13, 2017, the Company filed its Phase I/II clinical trial protocol with the FDA for GEN-1 for the localized treatment of ovarian cancer. The
protocol is designed with a single dose escalation phase to 100 mg/m² to identify a safe and tolerable dose of GEN-1 while maximizing an immune
response. The Phase I portion of the study will be followed by a continuation at the selected dose in approximately 110 patients randomized Phase II study.
In the OVATION 2 Study, patients in the GEN-1 treatment arm will receive GEN-1 plus chemotherapy pre- and post-interval debulking surgery (“IDS”).
The OVATION 2 Study will include up to 110 patients with Stage III/IV ovarian cancer, with 12 to 15 patients in the Phase I portion and up to 95 patients
in Phase II. The study is powered to show a 33% improvement in the primary endpoint, PFS, when comparing GEN-1 with neoadjuvant + adjuvant
chemotherapy versus neoadjuvant + adjuvant chemotherapy alone. The PFS primary analysis will be conducted after at least 80 events have been observed
or after all patients have been followed for at least 16 months, whichever is later.
In March 2020, the Company announced encouraging initial clinical data from the first 15 patients enrolled in the Phase I portion of the OVATION 2 Study
for patients newly diagnosed with Stage III and IV ovarian cancer. The OVATION 2 Study combines GEN-1, the Company’s IL-12 gene-mediated
immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT). Following NACT, patients undergo interval debulking surgery (IDS), followed
by three additional cycles of chemotherapy.
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GEN-1 plus standard NACT produced positive dose-dependent efficacy results, with no dose-limiting toxicities, which correlates well with successful
surgical outcomes as summarized below:
● Of the 15 patients treated in the Phase I portion of the OVATION 2 Study, nine patients were treated with GEN-1 at a dose of 100 mg/m² plus
NACT and six patients were treated with NACT only. All 15 patients had successful resections of their tumors, with eight out of nine patients
(88%) in the GEN-1 treatment arm having an R0 resection, which indicates a microscopically margin-negative complete resection in which no
gross or microscopic tumor remains in the tumor bed. Only three out of six patients (50%) in the NACT only treatment arm had a R0 resection.
● When combining these results with the surgical resection rates observed in the Company’s prior Phase Ib dose-escalation trial (the OVATION 1
Study), a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of
adding GEN-1 to the current standard of care NACT:
0, 36, 47 mg/m² of GEN-1 plus NACT
61, 79, 100 mg/m² of GEN-1 plus NACT
% of
Patients
with R0
Resections
n=12
n=17
42%
82%
● The ORR as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for the 0, 36, 47 mg/m² dose GEN-1 patients were
comparable, as expected, to the higher (61, 79, 100 mg/m²) dose GEN-1 patients, with both groups demonstrating an approximate 80% ORR.
On March 23, 2020, the Company announced that the European Medicines Agency (the “EMA”) Committee for Orphan Medicinal Products (“COMP”)
has recommended that GEN-1 be designated as an orphan medicinal product for the treatment of ovarian cancer. GEN-1 is an IL-12 DNA plasmid vector
encased in a non-viral nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. GEN-1
previously received orphan designation from the FDA.
On March 26, 2020, the Company announced with Medidata, a Dassault Systèmes company, that examining matched patient data provided by Medidata in
a synthetic control arm (“SCA”) with results from the Company’s completed Phase Ib dose-escalating OVATION I Study showed positive results in
progression-free survival (“PFS”). The hazard ratio (“HR”) was 0.53 in the ITT group, showing strong signals of efficacy. Celsion believes these data may
warrant consideration of strategies to accelerate the clinical development program for GEN-1 in newly diagnosed, advanced ovarian cancer patients by the
FDA. In its March 2019 discussion with Celsion, the FDA noted that preliminary findings from the Phase Ib OVATION I Study were exciting but lacked a
control group to evaluate GEN-1’s independent impact on impressive tumor response, surgical results and PFS. The FDA encouraged the Company to
continue its GEN-1 development program and consult with FDA with new findings that may have a bearing on designations such as Fast Track and
Breakthrough Therapy.
SCAs have the potential to revolutionize clinical trials in certain oncology indications and some other diseases where a randomized control is not ethical or
practical. SCAs are formed by carefully selecting control patients from historical clinical trials to match the demographic and disease characteristics of the
patients treated with the new investigational product. SCAs have been shown to mimic the results of traditional randomized controls so that the treatment
effects of an investigational product can be visible by comparison to the SCA. SCAs can help advance the scientific validity of single arm trials, and in
certain indications, reduce time and cost, and expose fewer patients to placebos or existing standard-of-care treatments that might not be effective for them.
On July 27, 2020, the Company announced the randomization of the first two patients in the Phase II portion of the OVATION 2 Study with GEN-1 in
advanced ovarian cancer. The Company anticipates completing enrollment of up to 110 patients in the second half of 2021. Because this is an open-label
study, the Company intends to provide clinical updates throughout the course of treatment including response rates and surgical resection scores.
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On February 22, 2021, the Company announced that it has received Fast Track designation from the FDA for GEN-1, its DNA-mediated IL-12
immunotherapy currently in Phase II development for the treatment of advanced ovarian cancer.
On February 25, 2021, the Company provided an update on the OVATION 2 Study. The Company reported that approximately one-third, or 34 patients, of
the anticipated 110 patients had been enrolled into the OVATION 2 Study, of which 20 are in the treatment arm and 14 are in the control. Currently, 27
patients have had their interval debulking surgery with the following results:
● 12 of 15, or 80%, of patients treated with GEN-1 had a R0 resection, which indicates a microscopically margin-negative complete resection in
which no gross or microscopic tumor remains in the tumor bed.
● 7 of 12 patients, or 58%, of patients in the control arm had an R0 resection.
● This interim data represents a 38% improvement in R0 resection rates for GEN-1 patients compared with control arm patients and is consistent
with the reported improvement in resection scores noted in the encouraging Phase I OVATION I Study, the manuscript of which has been
submitted for peer review publication.
The Company further reported that 22 clinical sites in the U.S. and Canada have been initiated, with three more sites expected to be added by the end of the
first quarter. Clinical investigators met in early February 2021 in a virtual meeting and expressed excitement about the potential for GEN-1 to treat
advanced ovarian cancer and, despite the challenges and earlier delays posed by the COVID-19 pandemic, they remain committed to completing
enrollment in the study during the second half of 2021.
PLACCINE DNA VACCINE TECHNOLOGY PLATFORM
In January 2021, the Company announced the filing of a provisional U.S. patent application for a novel DNA-based, investigational vaccine for preventing
or treating infections from a broad range of infectious agents including the coronavirus disease using its PLACCINE DNA vaccine technology platform
(“PLACCINE”). The provisional patent covers a family of novel composition of multi-cistronic vectors and polymeric nanoparticles that comprise the
PLACCINE DNA vaccine platform technology for preventing or treating infectious agents that have the potential for global pandemics, including the
SARS-CoV-2 virus and its variations, using the Company’s platform technology.
Celsion’s PLACCINE DNA vaccine technology platform is characterized by a single multi-cistronic DNA plasmid vector expressing multiple pathogen
antigens along with a potent immune modifier and delivered with a synthetic delivery system. It is easily adaptable to creating vaccines for a multitude of
pathogens, including emerging pathogens leading to pandemics as well as infectious diseases that have yet to be effectively addressed with current vaccine
technologies. This flexible vaccine platform is well supported by an already established supply chain to produce any plasmid vector and its assembly into a
respective vaccine formulation.
PLACCINE is an extension of the Company’s synthetic, non-viral TheraPlas delivery technology currently in a Phase II trial for the treatment of late-stage
ovarian cancer with GEN-1. Celsion’s proprietary multifunctional DNA vaccine technology concept is built on the flexible PLACCINE technology
platform that is amenable to rapidly responding to the SARS-CoV-2 virus, as well as possible future mutations of SARS-CoV-2, other future pandemics,
emerging bioterrorism threats, and novel infectious diseases. Celsion’s extensive experience with TheraPlas suggests that the PLACCINE-based
nanoparticles are stable at storage temperatures of 4oC to 25oC, making vaccines developed on this platform easily suitable for broad world-wide
distribution.
Celsion’s vaccine approach is designed to optimize the quality of the immune response dictating the efficiency of pathogen clearance and patient recovery.
Celsion has taken a multivalent approach in an effort to generate an even more robust immune response that not only results in a strong neutralizing
antibody response, but also a more robust and durable T-cell response. Delivered with Celsion’s synthetic polymeric system, the proprietary DNA plasmid
is protected from degradation and its cellular uptake is facilitated.
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COVID-19 Vaccine Overview
Emerging data from the recent literature indicates that the quality of the immune response as opposed to its absolute magnitude is what dictates SARS-
CoV-2 viral clearance and recovery and that an ineffective or non-neutralizing enhanced antibody response might actually exacerbate disease. The first-
generation COVID-19 vaccines were developed for rapid production and deployment and were not optimized for generating cellular responses that result in
effective viral clearance. Though early data has indicated some of these vaccines to be over 95% effective, these first-generation vaccines were primarily
designed to generate a strong antibody response and, while they have been shown to provide prophylactic protection against disease, the durability of this
protection is currently unclear. The vast majority of these vaccines have been specifically developed to target the SARS-CoV-2 Spike (S) protein (antigen),
though it is known that restricting a vaccine to a sole viral antigen creates selection pressure that can serve to facilitate the emergence of viral resistance.
Indeed, even prior to full vaccine rollout, it has been observed that the S protein is a locus for rapid evolutionary and functional change as evidenced by the
D614G, Y453F, 501Y.V2, and VUI-202012/01 mutations/deletions. This propensity for mutation of the S protein leads to future risk of efficacy reduction
over time as these mutations accumulate.
Our Next Generation Vaccine Initiative
Celsion’s next generation vaccine initiative stands at the confluence of immunotherapy and immunogenicity and envisions delivery, on a single plasmid,
multiple SARS-CoV-2 antigens in conjunction with a potent immune modifier, interleukin-12 (IL-12), which directs a TH-1 immune response, stimulates
T-cell immunity, and also promises the promotion of humoral immunity (antibody response). While most COVID-19 vaccines in late-stage clinical
development are monovalent (S protein antigen only), Celsion has taken this multivalent approach in an effort to generate an even more robust immune
response that not only results in a strong neutralizing antibody response, but also a more robust and durable T-cell response.
Celsion’s vaccine candidate approach comprises a single plasmid vector containing the DNA sequence encoding the cytokine IL-12 and multiple SARS-
CoV-2 antigens, including S antigen in combination with the membrane (M) or nucleocapsid (N) antigen. Delivery will be evaluated intramuscularly,
intradermally, or subcutaneously with a non-viral synthetic DNA delivery carrier that facilitates vector delivery into the cells of the injected tissue and has
potential immune adjuvant properties. Unique designs and formulations of Celsion vaccine candidates may offer several potential key advantages.
● While the antibodies against S antigen would prevent virus entry into cells, the M and N antibodies could help virus clearance through antibody-
mediated opsonization and phagocytosis. The presentation of multiple antigens on the cell surface of vaccine-injected tissue produces a broad
variety of killer T-cells which could potentially produce more efficient viral clearance than a single antigen vaccine.
● Since IL-12 is an essential regulator of the differentiation, proliferation, and maintenance of T helper 1 (TH-1) cells that generate killer T-cells and
memory T-cells against virally infected cells, its simultaneous expression could boost the viral clearance by the vaccine and improve the immune
system’s memory against any future exposure of the same virus.
● Finally, the synthetic polymeric DNA carrier is an important component of the vaccine composition as it has the potential to facilitate the vaccine
immunogenicity by improving vector delivery and, due to potential adjuvant properties, attract professional immune cells to the site of vaccine
delivery.
Future vaccine technology will need to address viral mutations and the challenges of efficient manufacturing, distribution, and storage. We believe an
adaptation of our TheraPlas technology, PLACCINE, has the potential to meet these challenges. Our approach is described in our provisional patent filing
and is summarized as a DNA vaccine technology platform characterized by a single plasmid DNA with multiple coding regions. The plasmid vector is
designed to express multiple pathogen antigens along with a potent immune modifier. It is delivered via a synthetic delivery system and has the potential to
be easily modified to create vaccines against a multitude of infectious diseases, addressing:
● Viral Mutations: PLACCINE may offer broad-spectrum and mutational resistance (variants) by targeting multiple antigens on a single plasmid
vector.
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● Enhanced Efficacy: The potent immune modifier IL-12 may improve humoral and cellular responses to viral antigens and can be incorporated in
the plasmid.
● Durable Efficacy: PLACCINE delivers a DNA plasmid-based antigen that can result in durable antigen exposure and a robust vaccine response to
viral antigens.
● Storage & Distribution: PLACCINE allows for stability that is compatible with manageable vaccine storage and distribution.
● Simple Dosing & Administration: PLACCINE is a synthetic delivery system that should require a simple injection that does not require viruses
or special equipment to deliver its payload.
We are conducting preliminary research associated with our recently announced proprietary DNA vaccine platform provisional patent filing. At the same
time, we are redoubling our efforts and R&D resources in our immuno-oncology and next generation vaccine program.
THERMODOX® - DIRECTED CHEMOTHERAPY
Liposomes are manufactured submicroscopic vesicles consisting of a discrete aqueous central compartment surrounded by a membrane bilayer composed
of naturally occurring lipids. Conventional liposomes have been designed and manufactured to carry drugs and increase residence time, thus allowing the
drugs to remain in the bloodstream for extended periods of time before they are removed from the body. However, the current existing liposomal
formulations of cancer drugs and liposomal cancer drugs under development do not provide for the immediate release of the drug and the direct targeting of
organ specific tumors, two important characteristics that are required for improving the efficacy of cancer drugs such as doxorubicin. A team of research
scientists at Duke University developed a heat-sensitive liposome that rapidly changes its structure when heated to a threshold minimum temperature of
39.5º to 42º Celsius. Heating creates channels in the liposome bilayer that allow an encapsulated drug to rapidly disperse into the surrounding tissue. This
novel, heat-activated liposomal technology is differentiated from other liposomes through its unique low heat-activated release of encapsulated
chemotherapeutic agents. We are able to use several available focused-heat technologies, such as radiofrequency ablation (“RFA”), microwave energy and
high intensity focused ultrasound (“HIFU”), to activate the release of drugs from our novel heat sensitive liposomes.
THERMODOX® for the Treatment of Primary Liver Cancer
Primary Liver Cancer Overview
Hepatocellular carcinoma (“HCC”) is one of the most common and deadliest forms of cancer worldwide. It ranks as the third most common solid tumor
cancer. It is estimated that up to 90% of liver cancer patients will die within five years of diagnosis. The incidence of primary liver cancer is approximately
35,000 cases per year in the U.S., approximately 65,000 cases per year in Europe and is increasing at approximately 2-3% per year worldwide. Global
incidence (per 2017 GLOBALCAN statistics) is reported at 755,000 cases. The World Health Organization (the “WHO”) has projected that HCC will be
the most prevalent form of cancer by 2030. HCC is commonly diagnosed in patients with longstanding hepatic disease and cirrhosis (primarily due to
hepatitis C in the U.S., Japan and Europe and hepatitis B in Asia).
At an early stage, the standard first line treatment for liver cancer is surgical resection of the tumor. Up to 80% of patients are ineligible for surgery or
transplantation at time of diagnosis because early-stage liver cancer generally has few symptoms and when finally detected the tumor frequently is too large
for surgical resection. There are few alternative treatments since radiation therapy and chemotherapy are largely ineffective in treating liver cancer. For
tumors generally up to 5 centimeters in diameter, RFA has emerged as the standard of care treatment which directly destroys the tumor tissue through the
application of high temperatures administered by a probe inserted into the core of the tumor. Local recurrence rates after RFA directly correlate to the size
of the tumor. For tumors 3 cm or smaller in diameter the recurrence rate has been reported to be 10 – 20%; however, for tumors greater than 3 cm, local
recurrence rates of 40% or higher have been observed.
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Celsion’s Approach
While RFA uses extremely high temperatures (greater than 90° Celsius) to ablate the tumor, it may fail to treat micro-metastases in the outer margins of the
ablation zone because temperatures in the periphery may not be high enough to destroy cancer cells. Our ThermoDox® treatment approach is designed to
utilize the ability of RFA devices to ablate the center of the tumor while simultaneously thermally activating our ThermoDox® liposome to release its
encapsulated doxorubicin to kill any remaining viable cancer cells throughout the heated region, including the ablation margins. This novel treatment
approach is intended to deliver the drug directly to those cancer cells that survive RFA. This approach is designed to increase the delivery of the
doxorubicin at the desired tumor site while potentially reducing drug exposure distant to the tumor site.
OPTIMA Study
The OPTIMA Study represents an evaluation of ThermoDox® in combination with a first line therapy, RFA, for newly diagnosed, intermediate stage HCC
patients. The OPTIMA Study was designed to enroll up to 550 patients globally at approximately 65 clinical sites in the U.S., Canada, European Union
(EU), China and other countries in the Asia-Pacific region and will evaluate ThermoDox® in combination with standardized RFA, which will require a
minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone. The
primary endpoint for the OPTIMA Study is OS, and the secondary endpoints are progression free survival and safety. The statistical plan calls for two
interim efficacy analyses by an independent Data Monitoring Committee (“DMC”).
On February 24, 2014, we announced that the FDA provided clearance for the OPTIMA Study, which is a pivotal, double-blind, placebo-controlled Phase
III trial of ThermoDox®, in combination with standardized RFA, for the treatment of primary liver cancer. The trial design of the OPTIMA Study is based
on the comprehensive analysis of data from an earlier Phase III clinical trial called the HEAT Study (the “HEAT Study”). The OPTIMA Study is supported
by a hypothesis developed from an OS analysis of a large subgroup of patients from the HEAT Study.
Post-hoc data analysis from our earlier Phase III HEAT Study suggests that ThermoDox® may substantially improve OS, when compared to the control
group, in patients if their lesions undergo a 45-minute RFA procedure standardized for a lesion greater than 3 cm in diameter. Data from nine OS sweeps
have been conducted since the top line progression free survival PFS data from the HEAT Study were announced in January 2013, with each data set
demonstrating substantial improvement in clinical benefit over the control group with statistical significance. On August 15, 2016, we announced updated
results from its final retrospective OS analysis of the data from the HEAT Study. These results demonstrated that in a large, well bounded, subgroup of
patients with a single lesion (n=285, 41% of the HEAT Study patients), treatment with a combination of ThermoDox® and optimized RFA provided an
average 54% risk improvement in OS compared to optimized RFA alone. The HR at this analysis is 0.65 (95% CI 0.45 - 0.94) with a p-value of 0.02.
Median OS for the ThermoDox® group has been reached which translates into a two-year survival benefit over the optimized RFA group (projected to be
greater than 80 months for the ThermoDox® plus optimized RFA group compared to less than 60 months projection for the optimized RFA only group).
This information should be viewed with caution since it is based on a retrospective analysis of a subgroup.
We also conducted additional analyses that further strengthen the evidence for the HEAT Study subgroup.
● We commissioned an independent computational model at the University of South Carolina Medical School. The results unequivocally indicate
that longer RFA heating times correlate with significant increases in doxorubicin concentration around the RFA treated tissue.
● In addition, we conducted a prospective preclinical study in 22 pigs using two different manufacturers of RFA and human equivalent doses of
ThermoDox® that clearly support the relationship between increased heating duration and doxorubicin concentrations.
On August 13, 2019, the Company announced that results from an independent analysis of the Company’s ThermoDox® HEAT Study conducted by the
National Institutes of Health (NIH) were published in the peer-reviewed publication, Journal of Vascular and Interventional Radiology. The analysis was
conducted by the intramural research program of the NIH and the NIH Center for Interventional Oncology, with the full data set from the Company’s
HEAT Study. The analysis evaluated the full data set to determine if there was a correlation between baseline tumor volume and RFA heating time
(minutes/tumor volume in milliliters), with or without ThermoDox® treatment, for patients with HCC. The NIH analysis was conducted under the direction
of Dr. Bradford Wood, MD, Director, NIH Center for Interventional Oncology and Chief, NIH Clinical Center Interventional Radiology.
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The article titled, “RFA Duration Per Tumor Volume May Correlate with Overall Survival in Solitary Hepatocellular Carcinoma Patients Treated with RFA
Plus Lyso-thermosensitive Liposomal Doxorubicin,” discussed the NIH analysis of results from 437 patients in the HEAT Study (all patients with a single
lesion representing 62.4% of the study population). The key finding was that increased RFA heating time per tumor volume significantly improved OS in
patients with single-lesion HCC who were treated with RFA plus ThermoDox®, compared to patients treated with RFA alone. A one-unit increase in RFA
duration per tumor volume was shown to result in about a 20% improvement in OS for patients administered ThermoDox®, compared to RFA alone. The
authors conclude that increasing RFA heating time in combination with ThermoDox® significantly improves OS and establishes an improvement of over
two years versus the control arm when the heating time per milliliter of tumor is greater than 2.5 minutes. This finding was consistent with the Company’s
own results, which defined the optimized RFA procedure as a 45-minute treatment for tumors with a diameter of 3 centimeters. Thus, the NIH analysis lent
support to the hypothesis underpinning the OPTIMA Study.
In August 2018, the Company announced that the OPTIMA Study was fully enrolled. On August 5, 2019, the Company announced that the prescribed
number of OS events had been reached for the first prespecified interim analysis of the OPTIMA Phase III Study. Following preparation of the data, the
first interim analysis was conducted by the DMC. The DMC’s pre-planned interim efficacy review followed 128 patient events, or deaths, which occurred
in August 2019. On November 4, 2019, the Company announced that the DMC unanimously recommended the OPTIMA Study continue according to
protocol. The recommendation was based on a review of blinded safety and data integrity from 556 patients enrolled in the OPTIMA Study. Data presented
demonstrated that PFS and OS data appeared to be tracking with patient data observed at a similar point in the Company’s subgroup of patients followed
prospectively in the earlier Phase III HEAT Study, upon which the OPTIMA Study was based.
On April 15, 2020, the Company announced that the prescribed minimum number of events of 158 patient deaths had been reached for the second pre-
specified interim analysis of the OPTIMA Phase III Study. The hazard ratio for success at 158 deaths is 0.70, which represents a 30% reduction in the risk
of death compared with RFA alone. On July 13, 2020, the Company announced that it has received a recommendation from the DMC to consider stopping
the global OPTIMA Study. The recommendation was made following the second pre-planned interim safety and efficacy analysis by the DMC on July 9,
2020. The DMC analysis found that the pre-specified boundary for stopping the trial for futility of 0.900 was crossed with an actual value of 0.903.
However, the 2-sided p-value of 0.524 for this analysis provides uncertainty, subsequently, the DMC has left the final decision of whether or not to stop the
OPTIMA Study to Celsion. There were no safety concerns noted during the interim analysis. The Company followed the advice of the DMC and
considered its options either to stop the study or continue to follow patients after a thorough review of the data, and an evaluation of our probability of
success. Timing for this decision is made less urgent by the fact that the OPTIMA Study has been fully enrolled since August 2018 and that the vast
majority of the trial expenses have already been incurred.
On August 4, 2020, the Company issued a press release announcing it would continue following patients for OS, noting that the unexpected and marginally
crossed futility boundary, suggested by the Kaplan-Meier analysis at the second interim analysis on July 9, 2020, may be associated with a data maturity
issue. On October 12, 2020, the Company provided an update on the ongoing data analysis from its Phase III OPTIMA Study with ThermoDox® as well as
growing interest among clinical investigators in conducting studies with ThermoDox® as a monotherapy or in combination with other therapies.
● Celsion engaged a global biometrics contract research organization, with forensic statistical analysis capability that specializes in data
management, statistical consulting, statistical analysis and data sciences, with particular expertise in evaluating unusual data from clinical trials
and experience with associated regulatory issues. The primary objective of the CRO’s work was to determine the basis and reasoning behind
continuing to follow patients for survival, and if there were outside influences that may have impacted the forecast of futility.
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● In parallel, the Company submitted all OPTIMA Study clinical trial data to the National Institutes of Health (NIH) with the expectation of
receivings a report on the following:
○ A Cox Regression Analysis for single solitary lesions including minimum burn time per tumor volume, evaluating similarities to the
hypothesis generated from the NIH paper published in the Journal of Vascular and Interventional Radiology, in which the key finding was
that increased RFA heating time per tumor volume significantly improved OS in patients with single lesion HCC who were treated with RFA
plus ThermoDox®, compared with patients treated with RFA alone.
○ A site-by-site evaluation for RFA heating time-based anomalies that may have contributed to the treatment arm performance.
○ An image-based evaluation comparing results from the OPTIMA Study to the data from the HEAT Study that led to the RFA heating time
hypothesis.
On February 11, 2021, the Company provided a final update on the Phase III OPTIMA Study and the decision to stop following patients in the Study.
Independent analyses conducted by a global biometrics contract research organization and the NIH, did not find any evidence of significance or factors that
would justify continuing to follow patients for OS. Therefore, the Company notified all clinical sites to discontinue following patients. The OPTIMA Study
database of 556 patients will now be frozen at 185 patient deaths. While the analyses did identify certain patient subgroups that appear to have had a
clinical benefit, the Company concluded that it would not be in its best interest to pursue these retrospective findings as the regulatory hurdles supporting
further discussion will be significant.
Investigator-Sponsored Studies with ThermoDox®
Celsion continues working closely and supporting investigations by others throughout the world in breast cancer, pancreatic cancer and in solid tumors in
children. Following inquiries from the NIH, we intend to renew our Cooperative Research and Development Agreement (CRADA) with the Institute at a
nominal cost, one goal of which is to pursue their interest in a study of ThermoDox® to treat patients with bladder cancer. Importantly, Celsion is
developing a business model to support these investigator-sponsored studies in a manner that will not interfere with the Company’s focus on our GEN-1
program and vaccine development initiative.
Below are summaries of several investigator-sponsored studies using ThermoDox®:
● Oxford University plans to begin enrolling patients in a Phase I pancreatic cancer study with ThermoDox® in combination with High Intensity
Focused Ultrasound (HIFU) in the first half of 2021. The primary objective of this trial, the PanDox Study: Targeted Doxorubicin in Pancreatic
Tumors, is to quantify the enhancement in intratumoral doxorubicin concentration when delivered with ThermoDox® and HIFU, versus
doxorubicin monotherapy. This study is being undertaken pursuant to promising data in a mouse model of pancreatic cancer, which was published
in the International Journal of Hyperthermia in 2018. That preclinical study showed a 23x increase in intratumoral doxorubicin concentration with
ThermoDox® + HIFU, compared with a 2x increase in intratumoral doxorubicin concentration with free doxorubicin plus HIFU.
● Utrecht University in the Netherlands continues to enroll patients in a Phase I breast cancer study to determine the safety, tolerability and
feasibility of ThermoDox® in combination with Magnetic Resonance Guided High Intensity Focused Ultrasound (MR-HIFU) hyperthermia and
cyclophosphamide therapy for the local treatment of the primary tumor in metastatic breast cancer (mBC). This investigator-sponsored study,
which is being funded by the Dutch Cancer Society, the Center for Translational Molecular Medicine (a public-private partnership in the
Netherlands), will be conducted at University Medical Center Utrecht and will enroll up to 12 newly diagnosed mBC patients. Celsion will supply
Thermodox® clinical product for the trial.
● As evidence of the ongoing support Celsion enjoys from the NIH, they have organized a clinical project to evaluate ThermoDox® plus the
chemotherapy drug mitomycin in bladder cancer. Depending on the NIH timelines, this study may commence as early as 2021.
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Because of the risks and uncertainties discussed in this Annual Report, among others, we are unable to estimate the duration and completion costs of our
research and development projects or when, if ever, and to what extent we will receive cash inflows from the commercialization and sale of a product. Our
inability to complete any of our research and development activities, preclinical studies or clinical trials in a timely manner or our failure to enter into
collaborative agreements when appropriate could significantly increase our capital requirements and could adversely impact our liquidity. While our
estimated future capital requirements are uncertain and could increase or decrease as a result of many factors, including the extent to which we choose to
advance our research, development activities, preclinical studies and clinical trials, or if we are in a position to pursue manufacturing or commercialization
activities, we will need significant additional capital to develop our product candidates through development and clinical trials, obtain regulatory approvals
and manufacture and commercialize approved products, if any. We do not know whether we will be able to access additional capital when needed or on
terms favorable to us or our stockholders. Our inability to raise additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the
future success of our business.
Covenant Not to Compete (CNTC)
Pursuant to the EGEN Purchase Agreement, EGEN provided certain covenants (“Covenant Not to Compete”) to the Company whereby EGEN agreed,
during the period ending on the seventh anniversary of the closing date of the acquisition on June 20, 2014, not to enter into any business, directly or
indirectly, which competes with the business of the Company nor will it contact, solicit or approach any of the employees of the Company for purposes of
offering employment.
Business Plan
As a clinical stage biopharmaceutical company, our business and our ability to execute our strategy to achieve our corporate goals are subject to numerous
risks and uncertainties. Material risks and uncertainties relating to our business and our industry are described in “Part I, Item 1A. Risk Factors” in this
Annual Report on Form 10-K.
Since inception, the Company has incurred substantial operating losses, principally from expenses associated with the Company’s research and
development programs, clinical trials conducted in connection with the Company’s product candidates, and applications and submissions to the U.S. FDA.
The Company has not generated significant revenue and has incurred significant net losses in each year since our inception. As of December 31, 2020, the
Company has incurred approximately $312 million of cumulative net losses and we had approximately $17.2 million in cash and cash equivalents. We have
substantial future capital requirements to continue our research and development activities and advance our product candidates through various
development stages. The Company believes these expenditures are essential for the commercialization of its technologies.
The Company expects its operating losses to continue for the foreseeable future as it continues its product development efforts, and when it undertakes
marketing and sales activities. The Company’s ability to achieve profitability is dependent upon its ability to obtain governmental approvals, manufacture,
and market and sell its new product candidates. There can be no assurance that the Company will be able to commercialize its technology successfully or
that profitability will ever be achieved. The operating results of the Company have fluctuated significantly in the past.
The actual amount of funds the Company will need to operate is subject to many factors, some of which are beyond the Company’s control. These factors
include the following:
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the progress of research activities;
the number and scope of research programs;
the progress of preclinical and clinical development activities;
the progress of the development efforts of parties with whom the Company has entered into research and development agreements;
the costs associated with additional clinical trials of product candidates;
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the ability to maintain current research and development licensing arrangements and to establish new research and development and licensing
arrangements;
the ability to achieve milestones under licensing arrangements;
the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and
the costs and timing of regulatory approvals.
On July 13, 2020, the Company announced that it has received a recommendation from the independent DMC to consider stopping the global Phase III
OPTIMA Study of ThermoDox® in combination with RFA for the treatment of HCC, or primary liver cancer. The recommendation was made following
the second pre-planned interim safety and efficacy analysis by the DMC on July 9, 2020. The DMC’s analysis found that the pre-specified boundary for
stopping the trial for futility of 0.900 was crossed with an actual value of 0.903. The Company followed the advice of the DMC and considered its options
to either stop the study or continue to follow patients after a thorough review of the data, and an evaluation of the probability of success. On February 11,
2021, the Company issued a letter to shareholders stating that the Company was notifying all clinical sites to discontinue following patients in the OPTIMA
Study.
As more fully discussed below, in June 2020 and as updated in September 2020, the Company filed an application with the New Jersey Economic
Development Authority to sell substantially all of its remaining State of New Jersey net operating losses totaling $2.0 million available under the program.
On February 12, 2021, the New Jersey Economic Development Authority approved the full amount of the Company’s application. In February 2021, the
Company entered into an agreement to sell the net operating losses from the 2020 application and expects to receive net proceeds of approximately $1.85
million by the end of the first quarter of 2021.
As more fully discussed in Note 10 to our Consolidated Financial Statements contained in this Form 10-K, during 2021 through the date of the filing of this
Annual Report on Form 10-K, the Company has raised $6.9 million in gross proceeds from the use of its JonesTrading Capital on DemandTM financing
facility, $35 million in gross proceeds from a registered direct financing completed in January 2021 and approximately $1.5 million in net proceeds through
warrant exercises.
With $17.2 million in cash and cash equivalents, coupled with approximately $43 million of gross proceeds received from the sale of equity thus far in
2021 and up to $1.85 million in expected net proceeds from the sale of its State of New Jersey net operating losses it applied for in 2020, the Company
believes it has sufficient capital resources to fund its operations through 2023.
The Company has based its estimates on assumptions that may prove to be wrong. The Company may need to obtain additional funds sooner or in greater
amounts than it currently anticipates. Potential sources of financing include strategic relationships, public or private sales of the Company’s shares or debt,
the sale of the Company’s State of New Jersey net operating losses and other sources. If the Company raises funds by selling additional shares of common
stock or other securities convertible into common stock, the ownership interest of existing stockholders may be diluted.
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Financing Overview
Equity, Debt and Other Forms of Financing
During 2020, 2019 and 2018, the Company submitted applications to sell a portion of the Company’s State of New Jersey net operating losses as part of the
Technology Business Tax Certificate Program sponsored by The New Jersey Economic Development Authority. Under the program, emerging
biotechnology companies with unused NOLs and unused research and development credits are allowed to sell these benefits to other New Jersey-based
companies. In 2018 and 2019, the Company sold NOLs totaling $13 million receiving net proceeds of $12.2 million. In June 2020 and as updated in
September 2020, the Company filed an application with the New Jersey Economic Development Authority to sell substantially all of its remaining State of
New Jersey net operating losses totaling $2.0 million available under the program. On February 12, 2021, the New Jersey Economic Development
Authority approved the full amount of the Company’s application. In February of 2021, the Company entered into an agreement to sell the net operating
losses from the 2020 application and expects to receive net proceeds of approximately $1.85 million by the end of the first quarter of 2021. Beginning in
2021, the New Jersey State Legislature increased the maximum lifetime benefit per company from $15 million to $20 million, which will allow the
Company to participate in this innovative funding program in future years.
In June 2018, the Company entered into a Credit Agreement with Horizon Technology Finance Corporation (“Horizon”) that provided $10 million in
capital (the “Horizon Credit Agreement”). The obligations under the Horizon Credit Agreement are secured by a first-priority security interest in
substantially all assets of Celsion other than intellectual property assets. Payments under the loan agreement are interest only (calculated based on one-
month LIBOR plus 7.625%) for the first twenty-four (24) months through July 2020, followed by a 24-month amortization period of principal and interest
starting on August 1, 2020 and ending through the scheduled maturity date. On August 28, 2020, in connection with an Amendment to the Horizon Credit
Agreement, Celsion repaid $5 million of the $10 million loan and $0.2 million in related end of term charges, and the remaining $5 million in obligations
were restructured as more fully discussed in Note 8 to our Consolidated Financial Statements contained in this Form 10-K.
During 2019 and 2020, we issued a total of 21.1 million shares of common stock as discussed below for an aggregate $32.8 million in gross proceeds.
During the first quarter of 2021, the Company issued an additional 34.3 million shares of common stock for an aggregate of $43.4 million in gross proceeds
as discussed in more detail below.
● On October 28, 2019, Company, entered into the 2019 Aspire Purchase Agreement with Aspire Capital. The terms and conditions pursuant to the
2019 Aspire Purchase Agreement are substantially similar to the 2018 Aspire Purchase Agreement. Pursuant to the new 2019 Aspire Purchase
Agreement, Aspire Capital is committed to purchase up to an aggregate of $10.0 million of shares of the Company’s common stock over the 24-
month term of the 2019 Aspire Purchase Agreement. Concurrently with entering into the 2019 Aspire Purchase Agreement, the Company also
entered into a registration rights agreement with Aspire Capital (the “Registration Rights Agreement”), in which the Company agreed to file one
or more registration statements, as permissible and necessary to register under the Securities Act of 1933, as amended (the “Securities Act”),
registering the sale of the shares of the Company’s common stock that have been and may be issued to Aspire Capital under the 2019 Aspire
Purchase Agreement. In consideration for entering into the 2019 Aspire Purchase Agreement, the Company issued to Aspire Capital an additional
100,000 Commitment Shares. On November 8, 2019, the Company filed with the SEC a Registration Statement on Form S-1 registering all the
shares of common stock that may be offered to Aspire Capital from time to time under the 2019 Aspire Purchase Agreement. During 2019, the
Company sold 0.5 million shares of common stock under the 2019 Aspire Purchase Agreement, receiving approximately $0.7 million in gross
proceeds. On March 5, 2020, the Company delivered notice to Aspire Capital terminating the 2019 Aspire Purchase Agreement effective as of
March 6, 2020. During the first quarter of 2020, the Company sold 1.0 million shares of common stock under the 2019 Aspire Purchase
Agreement and received $1.6 million in gross proceeds.
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● On December 4, 2018, the Company entered into a new Capital on DemandTM Sales Agreement (the “Capital on Demand Agreement”) with
JonesTrading Institutional Services LLC, as sales agent (“JonesTrading”), pursuant to which the Company may offer and sell, from time to time,
through JonesTrading shares of common stock having an aggregate offering price of up to $16.0 million. The Company intends to use the net
proceeds from the offering, if any, for general corporate purposes, including research and development activities, capital expenditures and working
capital. The Company is not obligated to sell any Common Stock under the Capital on Demand Agreement and, subject to the terms and
conditions of the Capital on Demand Agreement, JonesTrading will use commercially reasonable efforts, consistent with its normal trading and
sales practices and applicable state and federal law, rules and regulations and the rules of The Nasdaq Capital Market, to sell common stock from
time to time based upon Celsion’s instructions, including any price, time or size limits or other customary parameters or conditions the Company
may impose. Under the Capital on Demand Agreement, JonesTrading may sell common stock by any method deemed to be an “at the market
offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. The Capital on Demand Agreement will terminate
upon the earlier of (i) the sale of all shares of our common stock subject to the Sales Agreement, and (ii) the termination of the Capital on Demand
Agreement by JonesTrading or Celsion. The Capital on Demand Agreement may be terminated by JonesTrading or the Company at any time upon
10 days’ notice to the other party, or by JonesTrading at any time in certain circumstances, including the occurrence of a material adverse change
in the Company. The Company did not sell any shares under the Capital on Demand Agreement during 2018. During 2019, 2020 and thus far in
2021, the Company sold 0.5 million, 5.2 million and 7.2 million shares of common stock under the Capital on Demand Agreement, respectively,
receiving gross proceeds of approximately $1.0 million, $6.2 million and $6.9 million, respectively.
● On February 27, 2020, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with several institutional investors, pursuant
to which we agreed to issue and sell, in a registered direct offering (the “February 2020 Offering”), an aggregate of 4,571,428 shares (the
“Shares”) of our common stock at an offering price of $1.05 per share for gross proceeds of approximately $4.8 million before the deduction of
the Placement Agent fees and offering expenses. The Shares were offered by the Company pursuant to a registration statement on Form S-3 (File
No. 333-227236). The Purchase Agreement contains customary representations, warranties and agreements by the Company and customary
conditions to closing. In a concurrent private placement (the “Private Placement”), the Company agreed to issue to the investors that participated
in the Offering, for no additional consideration, warrants, to purchase up to 2,971,428 shares of Common Stock (the “Original Warrants”). The
Original Warrants were initially exercisable six months following their issuance and were set to expire on the five-year anniversary of such initial
exercise date. The Warrants had an exercise price of $1.15 per share subject to adjustment as provided therein. On March 12, 2020, the Company
entered into private exchange agreements (the “Exchange Agreements”) with holders the Warrants. Pursuant to the Exchange Agreements, in
return for a higher exercise price of $1.24 per share of Common Stock, the Company issued new warrants to the Investors to purchase up to
3,200,000 shares of Common Stock (the “Exchange Warrants”) in exchange for the Original Warrants. The Exchange Warrants, like the Original
Warrants, are initially exercisable six months following their issuance (the “Initial Exercise Date”) and expire on the five-year anniversary of their
Initial Exercise Date. Other than having a higher exercise price, different issue date, Initial Exercise Date and expiration date, the terms of the
Exchange Warrants are identical to those of the Original Warrants. On July 31, 2020, the Company filed a Form S-3 Registration Statement to
register the shares of Common Stock issuable under the Exchange Warrants; the Registration Statement was declared effective by the SEC on
August 13, 2020. No Exchange Warrants were exercised during 2020. During 2021 thus far, the Company has issued 1.2 million shares pursuant
to investors exercising Exchange Warrants, receiving approximately $1.5 million in gross proceeds.
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● On September 8, 2020, the Company entered into a purchase agreement (the “LPC Purchase Agreement”) and a Registration Rights Agreement
(the “Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which, upon the terms and subject to
the conditions and limitations set forth therein, the Company has the right to sell to Lincoln Park up to $26.0 million of shares of the Company’s
Common Stock at the Company’s discretion as described below (the “ LPC Offering”). Over the 36-month term of the LPC Purchase Agreement,
we have the right, but not the obligation, from time to time, in our sole discretion and subject to certain conditions, including that the closing price
of our Common Stock is not below $0.25 per share, to direct Lincoln Park to purchase up to an aggregate amount of $26.0 million (subject to
certain limitations) of shares of Common Stock. Under the Purchase Agreement, on any business day selected by us, we may direct Lincoln Park
to purchase up to 400,000 shares (the “Regular Purchase Share Limit”) of our Common Stock (each such purchase, a “Regular Purchase”).
Lincoln Park’s maximum obligation under any single Regular Purchase will not exceed $1,500,000 unless we mutually agree to increase the
maximum amount of such Regular Purchase. The purchase price for shares of Common Stock to be purchased by Lincoln Park under a Regular
Purchase will be the equal to the lower of (in each case, subject to the adjustments described in the LPC Purchase Agreement): (i) the lowest sale
price for our Common Stock on The Nasdaq Capital Market on the applicable purchase date, and (ii) the arithmetic average of the three lowest
sale prices for our Common Stock on The Nasdaq Capital Market during the ten trading days prior to the purchase date. If we direct Lincoln Park
to purchase the maximum number of shares of Common Stock we then may sell in a Regular Purchase, then in addition to such Regular Purchase,
and subject to certain conditions and limitations in the LPC Purchase Agreement, we may direct Lincoln Park to make an “accelerated purchase”
of an additional amount of Common Stock that may not exceed the lesser of (i) 300% of the number of shares purchased pursuant to the
corresponding Regular Purchase and (ii) 30% of the total number of shares of our Common Stock traded on The Nasdaq Capital Market during a
specified period on the applicable purchase date as set forth in the Purchase Agreement. Under certain circumstances and in accordance with the
Purchase Agreement, the Company may direct Lincoln Park to purchase shares in multiple accelerated purchases on the same trading day. The
Purchase Agreement prohibits us from issuing or selling to Lincoln Park under the Purchase Agreement: (i) in excess of 6,688,588 shares of our
Common Stock (the “Exchange Cap”), unless we obtain stockholder approval to issue shares in excess of the Exchange Cap or the average price
of all applicable sales of our Common Stock to Lincoln Park under the LPC Purchase Agreement equal or exceed the lower of (a) the Nasdaq
Official Closing Price (as defined in the Purchase Agreement) immediately preceding the execution of the LPC Purchase Agreement or (b) the
average of the five Nasdaq Official Closing Prices for the Common Stock immediately preceding the execution of the LPC Purchase Agreement,
as adjusted in accordance with the rules of The Nasdaq Capital Market, and (ii) any shares of our Common Stock if those shares, when aggregated
with all other shares of our Common Stock then beneficially owned by Lincoln Park and its affiliates would result in Lincoln Park and its affiliates
having beneficial ownership of more than 9.99% of the then total outstanding shares of our Common Stock. The LPC Purchase Agreement does
not limit our ability to raise capital from other sources at our sole discretion, except that we may not enter into any equity line or similar
transaction for 36 months, other than an “at-the-market” offering. The LPC Purchase Agreement and the Registration Rights Agreement contain
customary representations, warranties and agreements of us and Lincoln Park, indemnification rights and other obligations of the parties. We have
the right to terminate the Purchase Agreement at any time on one business days’ notice to Lincoln Park, at no cost to us. As consideration for
entering into the Purchase Agreement, we issued 437,828 shares of our Common Stock to Lincoln Park (the “LPC Commitment Shares”). We will
not receive any cash proceeds from the issuance of the LPC Commitment Shares. Also pursuant to the Purchase Agreement, Lincoln Park agreed
to an initial purchase of 1,000,000 shares of our Common Stock for an aggregate purchase price of $1,000,000 or $1.00 per share. Lincoln Park
has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of our shares of Common Stock.
The Offering is being made pursuant to our effective Registration Statement on Form S-3 (File No. 333-227236) (the “Registration Statement”),
which was previously filed with the SEC on September 7, 2018, and declared effective by the SEC on October 12, 2018, and the prospectus
supplement related to the Offering filed with the SEC on September 8, 2020. During 2020 the Company sold and issued an aggregate of 3.3
million shares, including the LPC Commitment Shares, under the LPC Purchase Agreement, receiving approximately $2.2 million in gross
proceeds. During 2020, the Company sold and issued an aggregate of 3.3 million shares, including the LPC Commitment Shares, under the LPC
Purchase Agreement, receiving approximately $2.2 million in gross proceeds. During the first quarter of 2021, the Company sent a letter to
Lincoln Park terminating the LPC Offering effective January 21, 2021. The Company did not sell any shares under the LPC Purchase Agreement
during 2021.
● On January 22, 2021, the Company entered into a Securities Purchase Agreement (the “January 2021 Purchase Agreement”) with several
institutional investors, pursuant to which the Company agreed to issue and sell, in a registered direct offering (the “January 2021 Offering”), an
aggregate of 25,925,925 shares of the Company’s common stock at an offering price of $1.35 per share for gross proceeds of approximately $35
million before the deduction of Placement Agents fees and offering expenses. The shares were offered by the Company pursuant to a registration
statement on Form S-3 (File No. 333-227236) (the “Registration Statement”) and a registration statement on Form S-3 (File No. 333-252320) filed
pursuant to Rule 462 under the Securities Act of 1933, as amended (the “Securities Act”). The January 2021 Purchase Agreement contains
customary representations, warranties and agreements by the Company and customary conditions to closing. The closing of the January 2021
Offering occurred on January 26, 2021.
In connection with the January 2021 Offering, the Company entered into a placement agent agreement (the “January 2021 Placement Agent
Agreement”) with A.G.P./Alliance Global Partners (together with Brookline Capital Markets, the “January 2021 Placement Agents”) pursuant to
which the Company agreed to pay the January 2021 Placement Agents a cash fee equal to 7% of the aggregate gross proceeds raised from the sale
of the securities sold in the January 2021 Offering and reimburse the January 2021 Placement Agents for certain of their expenses in an amount
not to exceed $82,500.
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The January 2021 Placement Agent Agreement contains customary representations, warranties and agreements by the Company, customary
conditions to closing, indemnification obligations of the Company and the January 2021 Placement Agents, including for liabilities under the
Securities Act, other obligations of the parties and termination provisions. Under the January 2021 Purchase Agreement and January 2021
Placement Agent Agreement, the Company and its subsidiary are prohibited, for a period of 90 days after the closing, from issuing, entering into
any agreement to issue or announcing the issuance or proposed issuance of any shares of common stock or any other securities that are at any time
convertible into, or exercisable or exchangeable for, or otherwise entitle the holder thereof to receive common stock, without the prior written
consent of the placement agents or the investors participating in the offering, subject to specific exceptions.
Please refer to Note 2 to our Consolidated Financial Statements contained in this Form 10-K. Also refer to Part II, Item IA, Risk Factors, including,
but not limited to, “We will need to raise substantial additional capital to fund our planned future operations, and we may be unable to secure such capital
without dilutive financing transactions. If we are not able to raise additional capital, we may not be able to complete the development, testing and
commercialization of our product candidates.”
Critical Accounting Policies and Estimates
Our financial statements, which appear at Part II, Item 8. Financial Statements and Supplementary Data have been prepared in accordance with
accounting principles generally accepted in the U.S., which require that we make certain assumptions and estimates and, in connection therewith, adopt
certain accounting policies. Our significant accounting policies are set forth in Note 1 to our Consolidated Financial Statements contained in this Form
10-K. Of those policies, we believe that the policies discussed below may involve a higher degree of judgment and may be more critical to an accurate
reflection of our financial condition and results of operations.
In-Process Research and Development, Other Intangible Assets and Goodwill
During 2014, the Company acquired certain assets of EGEN, Inc. As more fully described in Note 5 to our Consolidated Financial Statements
contained in this Form 10-K., the acquisition was accounted for under the acquisition method of accounting which required the Company to perform an
allocation of the purchase price to the assets acquired and liabilities assumed. Under the acquisition method of accounting, the total purchase price is
allocated to net tangible and intangible assets and liabilities based on their estimated fair values as of the acquisition date.
Lease Accounting
In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases” - Topic 842 (ASC Topic 842), which requires that
lessees recognize assets and liabilities for leases with lease terms greater than twelve months in the statement of financial position. Leases will be classified
as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. This update also requires improved
disclosures to help users of financial statements better understand the amount, timing and uncertainty of cash flows arising from leases. The update became
effective for fiscal years beginning after December 15, 2018, including interim reporting periods within that reporting period. The FASB subsequently
issued the following amendments to ASC Topic 842, which have the same effective date and transition date of January 1, 2019:
● ASU No. 2018-10, Codification Improvements to Topic 842, Leases, which amends certain narrow aspects of the guidance issued in ASU No.
2016-02; and
● ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, which allows for a transition approach to initially apply ASU No. 2016-02 at the
adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption as well as an
additional practical expedient for lessors to not separate non-lease components from the associated lease component.
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We adopted Accounting Standards Codification (“ASC”) Topic 842 effective January 1, 2019 and elected to apply the available practical expedients and
implement internal controls to enable the preparation of financial information on adoption. We have identified all of our leases which consist of the New
Jersey corporate office lease and the Alabama lab facility lease and we estimate the adoption of this standard will result in the recognition of right-of-use
assets of approximately $1.4 million, related operating lease liabilities of $1.5 million and reduced other liabilities by approximately $0.1 million on the
consolidated balance sheets as of January 1, 2019 of approximately $1.5 million related to our operating lease commitments, with no material impact to the
opening balance of retained earnings. See Note 15 to our Consolidated Financial Statements contained in this Form 10-K for further discussions
regarding the adoption of ASC Topic 842.
In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement: Disclosure Framework – Changes to the Disclosure Requirements for Fair
Value Measurement, which adds and modifies certain disclosure requirements for fair value measurements. Under the new guidance, entities will no longer
be required to disclose the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, or valuation processes for Level 3
fair value measurements. However, public companies will be required to disclose the range and weighted average of significant unobservable inputs used to
develop Level 3 fair value measurements, and related changes in unrealized gains and losses included in other comprehensive income. This update is
effective for annual periods beginning after December 15, 2019, and interim periods within those periods. The adoption of this standard did not have an
impact on the Company’s condensed consolidated financial statements.
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740). The standard simplifies the accounting for incomes taxes by removing
certain exceptions to the general principles in Topic 740 related to the approach for intra-period tax allocation and the recognition of deferred tax liabilities
for outside basis differences. The standard also clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The standard
also improves consistent application of and simplifies GAAP for other areas of Topic 740 by clarifying and amending existing guidance. The amendment is
effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption is permitted. The Company does
not believe the adoption of this standard will have a material impact on its condensed consolidated financial statements.
We review our financial reporting and disclosure practices and accounting policies on an ongoing basis to ensure that our financial reporting and disclosure
system provides accurate and transparent information relative to the current economic and business environment. As part of the process, the Company
reviews the selection, application and communication of critical accounting policies and financial disclosures. The preparation of our financial statements
in conformity with accounting principles generally accepted in the U.S. requires that our management make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts
of revenues and expenses during the reporting period. We review our estimates and the methods by which they are determined on an ongoing basis.
However, actual results could differ from our estimates.
Results of Operations
Comparison of Fiscal Year Ended December 31, 2020 and Fiscal Year Ended December 31, 2019.
For the year ended December 31, 2020, our net loss was $21.5 million compared to a net loss of $16.9 million for the year ended December 31, 2019. The
Company recognized $1.85 million and $1.82 million in tax benefits from the sale of its New Jersey net operating losses under the Technology Business
Tax Certificate Program in each of the fourth quarters of 2020 and 2019, respectively. With $17.2 million in cash and cash equivalents, coupled with
approximately $43 million of gross proceeds received from the sale of equity in the first quarter of 2021 and up to $1.85 million in expected proceeds from
the sale of the State of New Jersey net operating losses it applied for in 2020, the Company believes it has sufficient capital resources to fund its operations
through 2023.
Technology Development and Licensing Revenue
In January 2013, we entered into a technology development contract with Hisun, pursuant to which Hisun paid us a non-refundable technology transfer fee
of $5.0 million to support our development of ThermoDox® in the China territory. The $5.0 million received as a non-refundable payment from Hisun in
the first quarter 2013 has been recorded to deferred revenue and will be amortized over the ten-year term of the agreement; therefore, we recognized
revenue of $500,000 in each of the years 2020 and 2019.
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Research and Development Expenses
Research and development (“R&D”) expenses decreased $1.8 million from $13.1 million in 2019 to $11.3 million in 2020. Costs associated with the Phase
III OPTIMA Study were $2.2 million in 2020 compared to $4.1 million in 2019. In July 2020, the Company unblinded the OPTIMA Study at the
recommendation of the DMC to halt the study due to futility. Costs associated with the OVATION 2 Study were $1.3 million in 2020 compared to $0.6
million in 2019 as the Company initiated enrollment in the Phase 2 portion of the study during the third quarter of 2020. Regulatory costs were $0.6 million
in 2020 compared to $1.1 million in 2019. Other clinical costs were $2.0 million in 2020 compared to $2.5 million in 2019. Costs associated with the
production of ThermoDox® were $2.1 million during 2020 compared to $1.5 million in 2019. R&D costs associated with the development of GEN-1 to
support the OVATION program decreased by $0.2 million to $3.1 million in 2020 compared to $3.3 million in 2019.
General and Administrative Expenses
General and administrative expenses decreased $0.4 million to $7.6 million in 2020 compared to $8.0 million in 2019. This decrease is primarily
attributable to lower personnel costs of approximately $0.5 million which included a $0.3 million decrease in non-cash stock compensation expense.
Change in Earn-out Milestone Liability
The total aggregate purchase price for the acquisition of assets from EGEN included potential future earn-out payments contingent upon achievement of
certain milestones. The difference between the aggregate $30.4 million in future earn-out payments and the $13.9 million included in the fair value of the
acquisition consideration at June 20, 2014 was based on the Company’s risk-adjusted assessment of each milestone and utilizing a discount rate based on
the estimated time to achieve the milestone. These milestone payments are fair valued at the end of each quarter and any change in their value is recognized
in our Consolidated Financial Statements contained in this Form 10-K.
On March 28, 2019, the Company and EGWU, Inc, entered into an amendment to the Asset Purchase Agreement discussed in Note 8 to our Consolidated
Financial Statements contained in this Form 10-K. Pursuant to the Amended Asset Purchase Agreement, payment of the earnout milestone liability
related to the Ovarian Cancer Indication of $12.4 million has been modified. The Company has the option to make the payment as follows:
● $7.0 million in cash within 10 business days of achieving the milestone; or
● $12.4 million in cash, common stock of the Company, or a combination of either, within one year of achieving the milestone.
The Company provided EGWU, Inc. 200,000 warrants to purchase common stock at a strike price of $0.01 per warrant share as consideration for entering
into the amended agreement. These warrants shares have no expiration and were fair valued at $2.00 using the closing price of a share of Celsion stock on
the date of issuance offset by the exercise price and recorded $0.4 million as an expense in the income statement and were classified as equity on the
balance sheet during 2019. In October of 2020, EGWU, Inc elected to receive 197,260 shares through a non-cash conversion exercised of all 200,000
warrant shares.
At December 31, 2020, the Company fair valued the earn-out milestone liability at $7.0 million and recognized a non-cash charge of $1.3 million during
2020 as a result of the change in the fair value of earn-out milestone liability of $5.7 million at December 31, 2019. In assessing the earnout milestone
liability at December 31, 2020, the Company fair valued each of the two payment options per the Amended Asset Purchase Agreement and weighted them
at 50% and 50% probability for the $7.0 million and the $12.4 million payments, respectively.
At December 31, 2019, the Company fair valued the earn-out milestone liability at $5.7 million and recognized a non-cash gain of $3.2 million during 2019
as a result of the change in the fair value of earn-out milestone liability of $8.9 million at December 31, 2018. In assessing the earnout milestone liability at
December 31, 2019, the Company fair valued each of the two payment options per the Amended Asset Purchase Agreement and weighted them at 80% and
20% probability for the $7.0 million and the $12.4 million payments, respectively.
75
Impairment of IPR&D
IPR&D is reviewed for impairment at least annually as of our third quarter ended September 30 by assessing if any events or changes in circumstances
have occurred which indicate that the carrying value of the assets might not be recoverable. At September 30, 2020, after our assessment of the totality of
the events that could impair IPR&D, the Company determined certain IPR&D assets related to the development of its GBM product candidate may be
impaired. To arrive at this determination, the Company assessed the status of studies in GBM conducted by its competitors and the Company’s strategic
commitment of resources to its studies in primary liver cancer and ovarian cancer. The Company concluded that the GBM asset, valued at $2.4 million, was
fully impaired and wrote off the GBM asset, incurring a non-cash charge of $2.4 million in the third quarter of 2020. During 2019, the Company concluded
no IPR&D asset was impaired during that period.
Investment income and interest expense
The Company realized $0.1 million and $0.5 million of investment income from its short-term investments during 2020 and 2019, respectively. In
connection with the Horizon Credit Agreement, the Company incurred $1.3 million and $1.4 million in interest expense in 2020 and 2019, respectively.
Income Tax Benefit
Annually, the State of New Jersey enables approved technology and biotechnology businesses with New Jersey net operating tax losses the opportunity to
sell these losses through the Technology Business Tax Certificate Program (the “NOL Program”), thereby providing cash to companies to help fund their
research and development and business operations. During the fourth quarter of 2018, the Company received eligibility from the New Jersey Economic
Development Authority to sell, and did sell, $11.1 million of its unused New Jersey net operating losses under the Technology Business Tax Certificate
Program, receiving $10.4 million of non-dilutive funding. The Company received approval from the New Jersey Economic Development Authority to sell
$1.9 million of its New Jersey net operating losses recognizing a tax benefit for the year ended December 31, 2019 for the net proceeds (approximately
$1.8 million) by reducing the deferred income tax valuation allowance.
In early 2020, the Company entered into an agreement to sell these net operating losses and received net proceeds of approximately $1.82 million in the
second quarter of 2020. In June 2020 and as updated in September 2020, the Company filed an application with the New Jersey Economic Development
Authority to sell substantially all of its remaining State of New Jersey net operating losses totaling $2.0 million available under the program. On February
12, 2021, the New Jersey Economic Development Authority approved the full amount of the Company’s application. In February of 2021, the Company
entered into an agreement to sell the net operating losses from the 2020 application and expects to receive net proceeds of approximately $1.85 million by
the end of the first quarter of 2021. During 2021, the New Jersey State Legislature increased the maximum lifetime benefit per company from $15 million
to $20 million, which will allow the Company to participate in this innovative funding program in future years.
Inflation
We do not believe that inflation has had a material adverse impact on our revenue or operations in any of the past three years.
Financial Condition, Liquidity and Capital Resources
Since inception we have incurred significant losses and negative cash flows from operations. We have financed our operations primarily through the net
proceeds from the sales of equity, credit facilities and amounts received under our product licensing agreement with Yakult and our technology
development agreement with Hisun. The process of developing ThermoDox®, GEN-1 and other product candidates and technologies requires significant
research and development work and clinical trial studies, as well as significant manufacturing and process development efforts. We expect these activities,
together with our general and administrative expenses to result in significant operating losses for the foreseeable future. Our expenses have significantly
and regularly exceeded our revenue, and we had an accumulated deficit of $312 million at December 31, 2020.
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At December 31, 2020 we had total current assets of $18.8 million (including cash and cash equivalents of $17.2 million) and current liabilities of $6.8
million, resulting in net working capital of $12.0 million. At December 31, 2019 we had total current assets of $16.2 million (including cash, cash
equivalents, short-term investments and interest receivable of $14.9 million) and current liabilities of $7.9 million, resulting in net working capital of $8.3
million. We have substantial future capital requirements to continue our research and development activities and advance our product candidates through
various development stages. The Company believes these expenditures are essential for the commercialization of its technologies.
Net cash used in operating activities for 2020 was $15.6 million. Our net loss of $21.5 million for 2020 included the following non-cash transactions: (i)
$1.9 million in non-cash stock-based compensation expense, (ii) $2.4 million non-cash charge from the write-off of the IPR&D assets related to the
development of its GBM product candidate, (iii) $0.4 million in non-cash interest expense and (iv) $1.3 non-cash charge based on the change in the earn-
out milestone liability. The $15.6 million net cash used in operating activities was funded from cash and cash equivalents, short term investments, and cash
proceeds received in equity financings during 2020. At December 31, 2020, we had cash and cash equivalents of $17.2 million and coupled with
approximately $42 million of gross proceeds received from the sale of equity thus far in 2021 and up to $1.85 million in expected net proceeds from the
sale of the State of New Jersey net operating losses it applied for in 2020, the Company believes it has sufficient capital resources to fund its operations
through 2023. See Financing Overview as wells as Notes 8, 9 and 10 to our Consolidated Financial Statements contained in this Form 10-K.
The Company may seek additional capital through further public or private equity offerings, debt financing, additional strategic alliance and licensing
arrangements, collaborative arrangements, or some combination of these financing alternatives. If we raise additional funds through the issuance of equity
securities, the percentage ownership of our stockholders could be significantly diluted, and the newly issued equity securities may have rights, preferences,
or privileges senior to those of the holders of our common stock. If we raise funds through the issuance of debt securities, those securities may have rights,
preferences, and privileges senior to those of our common stock. If we seek strategic alliances, licenses, or other alternative arrangements, such as
arrangements with collaborative partners or others, we may need to relinquish rights to certain of our existing or future technologies, product candidates, or
products we would otherwise seek to develop or commercialize on our own, or to license the rights to our technologies, product candidates, or products on
terms that are not favorable to us. The overall status of the economic climate could also result in the terms of any equity offering, debt financing, or
alliance, license, or other arrangement being even less favorable to us and our stockholders than if the overall economic climate were stronger. We also will
continue to look for government sponsored research collaborations and grants to help offset future anticipated losses from operations and, to a lesser extent,
interest income.
If adequate funds are not available through either the capital markets, strategic alliances, or collaborators, we may be required to delay or, reduce the scope
of, or terminate our research, development, clinical programs, manufacturing, or commercialization efforts, or effect additional changes to our facilities or
personnel, or obtain funds through other arrangements that may require us to relinquish some of our assets or rights to certain of our existing or future
technologies, product candidates, or products on terms not favorable to us.
Off-Balance Sheet Arrangements
We do not utilize off-balance sheet financing arrangements as a source of liquidity or financing.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The primary objective of our cash investment activities is to preserve principal while at the same time maximizing the income we receive from our
investments without significantly increasing risk. Some of the securities that we invest in may be subject to market risk. This means that a change in
prevailing interest rates may cause the principal amount of the investment to fluctuate. For example, if we hold a security that was issued with a fixed
interest rate at the then-prevailing rate and the interest rate later rises, the principal amount of our investment will probably decline. A hypothetical 50 basis
point increase in interest rates reduces the fair value of our available-for-sale securities at December 31, 2020 by an immaterial amount. To minimize this
risk in the future, we intend to maintain our portfolio of cash equivalents and marketable securities in a variety of securities, including commercial paper,
government and non-government debt securities and/or money market funds that invest in such securities. We have no holdings of derivative financial or
commodity instruments. As of December 31, 2020, our investments consisted of investments in government backed notes and obligations or in money
market accounts and checking funds with variable market rates of interest. We believe our credit risk is immaterial.
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ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The financial statements, supplementary data and report of independent registered public accounting firm are filed as part of this report on pages F-1
through F-32 and incorporated herein by reference.
ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
(a)
Disclosure Controls and Procedures
We have conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) under the supervision, and with the
participation, of our management, including our principal executive officer and principal financial officer. Based on that evaluation, our principal executive
officer and principal financial officer concluded that as of December 31, 2020, which is the end of the period covered by this Annual Report, our disclosure
controls and procedures are effective.
(b)
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-
15(f) under the Securities Exchange Act of 1934. Our internal control over financial reporting is a process designed by, or under the supervision of, our
chief executive officer and chief financial officer, or persons performing similar functions, and effected by our Board of Directors, management and other
personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with accounting principles generally accepted in the U.S. of America (GAAP). Our internal control over financial reporting includes those
policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and disposition
of the assets of the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in
accordance with GAAP and that receipts and expenditures of the Company are being made only in accordance with authorization of management and
directors of the Company; and (iii) 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.
Management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2020. In making this assessment,
management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in the 2013 Internal Control-
Integrated Framework. Based on its evaluation, management has concluded that the Company’s internal control over financial reporting is effective as of
December 31, 2020.
Pursuant to Regulation S-K Item 308(b), this Annual Report does not include an attestation report of our company’s registered public accounting firm
regarding internal control over financial reporting.
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. A control system, no matter how well designed and operated can provide only reasonable, but
not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their cost.
(c)
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting in the fiscal year ended December 31, 2020, which were identified in
connection with our management’s evaluation required by paragraph (d) of rules 13a-15 and 15d-15 under the Exchange Act, that have materially affected,
or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
None.
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ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
PART III
Our board of directors, or our Board, currently consists of seven members and is divided into three classes of directors serving staggered three-year terms.
Directors for each class are elected at the annual meeting of stockholders held in the year in which the term for their class expires and hold office for a
three-year term and until their successors are duly elected and qualified, or their earlier death, resignation or removal. In accordance with our amended and
restated certificate of incorporation and bylaws, our Board may fill any vacancy on the Board by appointment.
Set forth below is certain information regarding our Company’s current directors, as well as our non-director executive officers.
NAME
AGE
POSITION(S)
CLASS
Michael H. Tardugno
Robert W. Hooper
Alberto R. Martinez, M.D.
Augustine Chow, Ph.D.
Frederick J. Fritz
Donald P. Braun, Ph.D.
Andreas Voss, M.D.
Khursheed Anwer, Ph.D. MBA
Nicholas Borys, M.D.
Jeffrey W. Church
Directors
70
74
71
68
70
71
62
61
61
64
Chairman, President and Chief Executive Officer
Director
Director (Retired December 31, 2020)
Director
Director
Director
Director
Executive Vice President and Chief Scientific Officer
Executive Vice President and Chief Medical Officer
Executive Vice President and Chief Financial Officer
III
II
II
I
I
III
III
Mr. Michael H. Tardugno. Mr. Tardugno was appointed President and Chief Executive Officer of the Company on January 3, 2007 and was elected to the
Board of Directors on January 22, 2007. In October of 2014, Mr. Tardugno was appointed by our Board of Directors as our Chairman. Prior to joining the
Company and for the period from February 2005 to December 2006, Mr. Tardugno served as Senior Vice President and General Manager of Mylan
Technologies, Inc., a subsidiary of Mylan Inc. From 1998 to 2005, Mr. Tardugno was Executive Vice President of Songbird Hearing, Inc., a medical device
company spun out of Sarnoff Corporation. From 1996 to 1998, he was Senior Vice President of Technical Operations worldwide for a division of Bristol-
Myers Squibb, and from 1977 to 1995, he held increasingly senior executive positions including Senior Vice President of Worldwide Technology
Development with Bausch & Lomb and Abbott Laboratories. Mr. Tardugno holds a B.S. degree from St. Bonaventure University and completed the
Harvard Business School Program for Management Development.
Mr. Robert W. Hooper. Mr. Hooper has served as a member of our Board of Directors since July 2010. He is currently President of Crows Nest Ventures,
Inc. a privately held company, which provides advisory and consulting services to the healthcare industry. From 1997 to 2001, Mr. Hooper served as
President North America for IMS Health Incorporated, a healthcare information and market research company listed on The New York Stock Exchange.
From 1993 to 1997, he served as President of Abbott Laboratories Canada. From 1989 to 1993, he served as Managing Director, Australia/Asia for Abbott
Laboratories. Prior to that, he held increasingly senior positions at E.R. Squibb and Sterling Winthrop Labs. Mr. Hooper holds a bachelor’s degree in
biology from Wilkes University.
Dr. Alberto R. Martinez. Dr. Martinez served as a member of our Board of Directors from December 2010 until his retirement from the Board of
Directors effective December 31, 2020. He has been a consultant to the healthcare industry since 2008. From 2007 to 2008, Dr. Martinez served as the
President and Chief Operating Officer of Talecris Biotherapeutics, Inc., a publicly traded life science company. Prior to that, Dr. Martinez served as
Talecris’ President and Chief Executive Officer from October 2005 until June 2007. Prior to that, he held increasingly senior positions as Executive Vice
President of Worldwide Commercial Operations at ZLB Behring (subsequently renamed CSL Behring). Prior to ZLB Behring, Dr. Martinez served in
various international positions at Sandoz Pharmaceuticals (currently the generic pharmaceuticals division of Novartis) in Brazil, Switzerland, Spain and the
U.S. for eighteen years. Dr. Martinez completed his undergraduate and graduate studies at the University of Sao Paulo and received his medical degree
from the University of Sao Paulo in 1973. After completing his residency in Pediatrics in 1975, he studied Business and Marketing Administration at the
Fundacao Getulio Vargas in Sao Paulo, Brazil.
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Dr. Augustine Chow. Dr. Chow was appointed to our Board of Directors in March 2007. Dr. Chow is the chairman of Harmony Asset Management
Limited in Hong Kong, serving in such capacity since 2015. He also serves as a director of Medifocus Inc. (TSX Venture: MFS). From 1996 to 2015, Dr.
Chow was the Chief Executive Officer of Harmony Asset Limited, a Hong Kong listed investment company, and from 2008 to 2016 he served as Executive
Director of Kaisun Energy Group Limited. From 1990 to 1998, Dr. Chow was the Chief Executive Officer of Allied Group of Companies based in Hong
Kong which include several publicly listed companies spanning across various industries. Prior to this, Dr. Chow held a senior position with Brunswick
Corporation and Outboard Marine Corporation and was responsible for all business activities in South East Asia and China. Dr. Chow has extensive
experience in managing publicly listed companies that are involved in manufacturing, marketing and financial services and specializes in mergers and
acquisitions. Dr. Chow’s qualifications include a number of Bachelors, Masters and Doctoral degrees. Among them include a MSc from London Business
School and a Ph.D. in Biology from City University of Hong Kong.
Mr. Frederick J. Fritz. Mr. Fritz was appointed to our Board of Directors in July 2011. Mr. Fritz has served as CEO and Founder of NeuroDx, a
development stage diagnostic device company focused on the neurosurgery market, since 2006. Mr. Fritz joined NeuroDx from Valeo Medical, a
biotechnology company he founded in 2003 to develop the world’s first non-invasive diagnostic test for endometriosis. Prior to that, Mr. Fritz was
President and CEO of Songbird Hearing, Inc., a medical device company spun out of Sarnoff Corporation. Mr. Fritz began his career in marketing
management and new product development. He joined Schering Plough’s Wesley Jessen in 1985 as VP Marketing and Sales in 1986. He was promoted to
general manager of Schering’s Over the Counter pharmaceutical business in 1988 and of the podiatric products business in 1990. He was President of
Coleman North America from 1995 to 1997. Mr. Fritz holds a bachelor’s degree in engineering (summa cum laude) from University of Illinois and an
MBA degree from Harvard University.
Dr. Donald P. Braun. Dr. Braun has over 35 years of research experience in oncology, cancer immunology, cancer immunotherapy, and inflammatory
diseases. He is the author of more than 120 published peer-reviewed manuscripts, 25 reviews and book chapters, and co-editor of a book on the role of
prostaglandins and other COX 2 metabolites in cancer patient immunity and immunotherapy. He served from 2006 to 2014 as Vice President Clinical
Research and after which he served as Vice President Translational Research and Chief Science Officer at the Cancer Treatment Centers of America until
his retirement in May 2016. Prior to this role, he was the Scientific Director of the Cancer Center and Professor of Medicine and Immunology at Rush
Medical College in Chicago from 1978 to 1999, and the Administrative Director of the Cancer Institute and a Professor of Surgery with tenure at the
Medical College of Ohio from 1999 to 2006. Dr. Braun has been appointed to and served on more than a dozen federal government and public advisory
committees on oncology and immunology. He received his Ph.D. in Immunology and Microbiology from the University of Illinois at the Medical Center in
Chicago. Dr. Braun has served as an advisor to numerous public agencies and private corporations concerned with cancer therapeutics and diagnostics. At
the National Cancer Institute, Dr. Braun served as a member of the Experimental Therapeutics Study Section; the Small Business Innovation Grant Review
Study Section; and the Experimental Therapy program for “Molecular Targets in Lung Cancer”. He served as a member of the Immunology and
Immunotherapy Study Section of the American Cancer Society-National Division; as a Member of the Ohio Cancer Incidence Surveillance System; as a
Member of the Biomedical Research Technology Transfer Commission for the State of Ohio; and as an advisor to the State of Arizona’s Disease Research
Control Commission. Dr. Braun has also served as a consultant to numerous Pharmaceutical and Biotechnology Companies developing cancer treatments
and diagnostics including Pfizer Pharmaceuticals, Sterling Winthrop, Abbott Laboratories, Boehringer Mannheim, Serono Corporation, Biomira Inc,
Centocor and Merck KGA.
Andreas Voss, MD. Dr Voss is the founder of AMEDIX GmbH providing a broad range of services to life science companies since July 2020. He served
as Chief Operating Officer at Swissrockets AG in Basel from August 2019 to June 2020. Before that Dr. Voss was General Manager of Caris Life Sciences
International, implementing personalized medicine in oncology through market leading tumor profiling services. Prior to joining Caris in September 2010,
he was responsible for global clinical development of Avastin® and a member of the Corporate Drug Safety Board at F. Hoffmann-La Roche AG (June
2006 to July 2010). Dr. Voss was responsible for the Lung Cancer Disease Area at AstraZeneca from May 2003 to May 2006 and Medical Director at
Bayer GmbH (October 2000 to April 2003) and at Asta Medica AG before that (December 1996 to September 2000). He received his MD from the
University of Hamburg Medical School and was a postdoctoral fellow in the department of cellular immunology at the University of California at San
Diego. He is board certified in internal medicine and joined the board of directors at Celsion Corporation in 2015.
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Executive Officers
Mr. Michael H. Tardugno. Mr. Tardugno’s biographical information appears above under the heading “Directors”.
Khursheed Anwer, Ph.D., M.B.A. Dr. Anwer joined us in June 2014 as Executive Vice President and Chief Scientific Officer, in connection with our
acquisition of all the assets of EGWU, Inc. (formerly known as Egen, Inc.), an Alabama corporation (or “EGEN”). Before joining Celsion, Dr. Anwer
served as EGEN’s President and Chief Scientific Officer, a position he held since 2009. He joined EGEN in July 2002 as Vice President of Research and
Development and directed EGEN’s clinical and research and development functions. Before joining EGEN, Dr. Anwer was Director of Pre-Clinical
Development at Valentis, Inc. from July 2000 to June 2002. From 1993 to 1999, he served in several positions at GeneMedicine, Inc., where he led several
research projects in the area of non-viral gene therapy. He has authored more than 40 publications in the area of non-viral gene therapy, resulting from his
active career in research and development. Dr. Anwer holds a Ph.D. in physiology/pharmacology from Ohio University and received post-doctoral training
from the University of Texas Health Science Center at Houston. Dr. also has a Master’s in Business Administration from University of Alabama.
Nicholas Borys, M.D. Dr. Borys joined us in October 2007 as Vice President and Chief Medical Officer of the Company and was promoted to Senior Vice
President in June 2014 and to Executive Vice President in February 2019. In this position, Dr. Borys manages the clinical development and regulatory
programs for Celsion. Dr. Borys has over 25 years of experience in all phases of pharmaceutical development with a focus on oncology. Immediately prior
to joining Celsion, Dr. Borys served as Chief Medical Officer of Molecular Insight Pharmaceuticals, Inc., a molecular imaging and nuclear oncology
pharmaceutical company, from 2004 until 2007. From 2002 until 2004, he served as the Vice President and Chief Medical Officer of Taiho Pharma USA, a
Japanese start-up oncology therapeutics company. Prior to that he held increasingly senior positions at Cytogen Corporation, Anthra Pharmaceuticals, Inc.,
Amersham Healthcare, Inc. and Hoffmann La-Roche Inc. Dr. Borys obtained his premedical degree from Rutgers University and holds an M.D. degree
from American University of the Caribbean.
Mr. Jeffrey W. Church. Mr. Church joined us in July 2010 as Vice President, Chief Financial Officer and Corporate Secretary. Mr. Church was appointed
as our Senior Vice President, Corporate Strategy and Investor Relations in July 2011. In July 2013, Mr. Church was reappointed as Senior Vice President
and Chief Financial Officer. In December 2018, Mr. Church was promoted to Executive Vice President. Immediately prior to joining us, Mr. Church served
as Chief Financial Officer and Corporate Secretary of Alba Therapeutics Corporation, a privately held life science company from 2007 until 2010. From
2006 until 2007, he served as Vice President, Chief Financial Officer and Corporate Secretary for Novavax, Inc., a vaccine development company listed on
The Nasdaq Global Select Market. From 1998 until 2006, he served as Vice President, CFO and Corporate Secretary for GenVec, Inc., a biotechnology
company listed on The Nasdaq Capital Market. Prior to that, he held senior financial positions at BioSpherics Corporation and Meridian Medical
Technologies, both publicly traded companies. He started his career with Price Waterhouse from 1979 until 1986. Mr. Church holds a B.S. degree in
accounting from the University of Maryland.
CODE OF ETHICS
The Company has adopted a Code of Ethics and Business Conduct (the “Code of Ethics”) applicable to its directors, officers, including the Chief Executive
Officer, Chief Financial Officer, Chief Accounting Officer and other officers performing similar functions, and employees. This Code of Ethics constitutes
a code of ethics applicable to senior financial officers within the meaning of the Sarbanes-Oxley Act of 2002 and SEC rules. A copy of the Code of Ethics
is available on the Company’s website at http://www.celsion.com and any stockholder may obtain a copy by making a written request to the Company’s
Corporate Secretary, 997 Lenox Drive, Suite 100, Lawrenceville, NJ 08648. In the event of any amendments to or waivers of the terms of the Code of
Ethics, such matters will be posted promptly to the Company’s website in lieu of disclosure on Form 8-K in accordance with Item 5.05(c) of Form 8-K.
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BOARD LEADERSHIP STRUCTURE AND ROLE IN RISK OVERSIGHT
Board Leadership
Our Board of Directors believes that it is important to select our Chairman of the Board and our Chief Executive Officer in the manner it considers in our
best interests. The members of our Board of Directors possess considerable business experience and in-depth knowledge of the issues we face and are
therefore in the best position to evaluate our needs and how best to organize and adopt our leadership structure to meet those needs. Accordingly, our
Chairman and the Chief Executive Officer may be filled by one individual or by two different individuals, and our Chairman may be a Company insider or
an independent director. Mr. Tardugno serves as Chairman of our Board of Directors, President and Chief Executive Officer. Currently all the other
directors of our Board of Directors are independent under applicable SEC and NASDAQ rules. Our Board of Directors believes that the Company and its
stockholders have been well served by the current leadership structure due to Mr. Tardugno’s experience and in-depth knowledge of the Company and the
industry.
Board Oversight of Risk
Our Board of Directors is responsible for oversight of the various risks we face. In this regard, the Board of Directors seeks to understand and oversee the
most critical risks relating to our business and operations, allocate responsibilities for the oversight of risks among the full Board of Directors and its
committees, and see that management has in place effective systems and processes for managing risks we face. Overseeing risk is an ongoing process, and
risk is inherently tied to our strategy and to strategic decisions. Accordingly, our Board of Directors considers risk throughout the year and with respect to
specific proposed actions. Our Board of Directors recognizes that it is neither possible nor prudent to eliminate all risk. Indeed, purposeful and appropriate
risk-taking is essential for us to be competitive and to achieve its business objectives.
While our Board of Directors oversees risk, management is charged with identifying and managing risk. We have robust internal processes and a strong
internal control environment to identify and manage risks and to communicate information about risk to the Board of Directors. Management
communicates routinely with our Board of Directors, Board Committees (as defined below) and individual directors on the significant risks identified and
how they are being managed. Our directors are free to, and indeed often do, communicate directly with senior management.
Our Board of Directors implements its risk oversight function both as a whole and through delegation to various committees (the “Board Committees”).
These Board Committees meet regularly and report back to our full Board of Directors. Our Audit Committee oversees the management of financial,
accounting, internal controls, disclosure controls and the engagement arrangement and regular oversight of the independent auditors. Our Compensation
Committee is responsible for the design and oversight of our compensation programs. Based on a review of our company-wide compensation programs,
including the compensation programs for our executive officers, our Compensation Committee has concluded that these programs do not create risks that
are likely to have a material adverse effect on us. Our Nominating and Governance Committee periodically reviews our corporate governance practices,
including the risks that those practices are intended to address. It also periodically reviews the composition of our Board of Directors to help ensure that a
diversity of skills and experiences is represented by the members of our Board of Directors taking into account the stage of our growth and strategic
direction. Our Science and Technology Committee assists our Board of Directors in monitoring the state of science and technology capabilities within the
Company and associated risks and overseeing the development of key technologies and major science and medicine-driven innovation initiatives essential
to our long-term success.
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COMMITTEES OF OUR BOARD OF DIRECTORS
Our Board of Directors presently maintains separately designated Audit, Compensation, Nominating and Governance, and Science and Technology
Committees.
Good Governance Practices
Our Board of Directors has a commitment to strong and sustainable corporate governance. As such, we continuously review our practices to ensure
effective collaboration of management and our Board of Directors. Highlights of our Board of Directors’ best practices are:
● Five of the six Board directors are independent;
● Our Board of Directors has adopted and published committee charters (charters are available at www.celsion.com);
● Our Board of Directors conducts an annual review of Board Independence;
● Our Board Committees conduct annual self-evaluations that are reviewed by our Nominating and Governance Committee and Board of Directors;
● New directors participate in an orientation program and receive a current state briefing before their first Board meeting;
● We have stock ownership and stock retention guidelines for our directors;
● We have policies and practices to specifically align executive compensation with long-term stockholder interests;
● We have a policy prohibiting hedging and pledging, short sales, purchases or sales of puts or calls, and other derivative transactions of our stock
(including any transaction that provides the economic equivalent of ownership) by our executive officers and directors;
● An executive compensation claw back policy was adopted by our Board of Directors in 2014;
● Our Board of Directors reviews management talent and succession annually with our chief executive officer; and
● There is no automatic enhancement of executive incentive compensation upon a change-in-control.
Audit Committee
Our Audit Committee consists of Mr. Frederick J. Fritz, (Chairman), Dr. Augustine Chow and Dr. Donald Braun. Our Audit Committee operates under a
written charter as amended and restated effective May 4, 2007. A copy of that charter, as may be amended from time to time, is available on our web site,
located at http://www.celsion.com. Additional copies of the charter are available upon written request to us.
Our Audit Committee assists our Board of Directors in fulfilling its responsibility to oversee management’s implementation of our financial reporting
process. In discharging its oversight role, the Audit Committee reviewed and discussed the audited financial statements contained in our 2020 Annual
Report on Form 10-K with our management and independent registered public accounting firm. Management is responsible for the financial statements and
the reporting process, including the system of internal controls. Our independent registered public accounting firm is responsible for expressing an opinion
on the conformity of those financial statements with accounting principles generally accepted in the U.S.
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Our Board has determined that all members of the Audit Committee meet the independence standards established by the SEC and Nasdaq. Our Board has
determined that Mr. Fritz is qualified to serve as the “audit committee financial expert” as defined by Item 407(d)(5) of Regulation S-K and that Drs. Chow
and Braun meet the financial literacy requirements under applicable NASDAQ rules.
Compensation Committee
Our Compensation Committee is responsible for establishing and administering the compensation policies applicable to our directors, officers and key
personnel, for determining the compensation arrangements to our Chairman, President and Chief Executive Officer and for evaluating the performance of
senior management. Our Compensation Committee operates under a written charter effective as of December 24, 2003. A copy of that charter, as may be
amended from time to time, is available on our web site, located at www.celsion.com. Additional copies of the charter are available upon written request to
us. Our Compensation Committee does not delegate the authority to approve compensation policies and actions affecting our named executive officers or
directors. Our Compensation Committee applies discretion in determining compensation for our executives. Our Compensation Committee has not
established any equity or other security ownership requirements or guidelines in respect of its executive officers. Our Chairman, President and Chief
Executive Officer assists our Compensation Committee in evaluating the performance of other executive officers and by providing information to directors
as and when requested, such as salary surveys and compensation paid by our competitors, to the extent such information is publicly available. Members of
our Compensation Committee undertake to verify such information prior to referring to it in determining executive compensation. The compensation of our
Chairman, President and Chief Executive Officer is determined by our Compensation Committee based on our Compensation Committee’s evaluation of
his performance and with reference to such external or competitive data as they consider necessary. The compensation of the other named executive
officers is determined by our Compensation Committee based on its evaluation of their individual performance and the recommendations of our Chairman,
President and Chief Executive Officer.
Mr. Hooper (Chairman), and Dr. Chow currently comprise our Compensation Committee. Our Board has determined that all members of our Compensation
Committee are independent under the applicable Nasdaq rules.
Nominating and Governance Committee
Our Nominating and Governance Committee is responsible for identifying and recruiting new members of our Board of Directors when vacancies arise,
identifying and recruiting nominees for election as directors, reconsideration of incumbent directors in connection with nominations for elections of
directors and ensuring that our Board of Directors is properly constituted to meet its corporate governance obligations. Our Nominating and Governance
Committee operates under a written charter effective as of December 24, 2003 and amended on February 27, 2006. A copy of that charter, as may be
amended from time to time, is available on our web site, located at www.celsion.com. The current member of our Nominating and Governance Committee
is Mr. Fritz. Our Board has determined that Mr. Fritz is deemed to be independent under applicable Nasdaq rules.
Science and Technology Committee
The primary purpose of our Science and Technology Committee is to assist our Board of Directors in monitoring the state of science and technology
capabilities within our Company and associated risks and overseeing the development of key technologies and major science and medicine-driven
innovation initiatives essential to our long-term success. Our Science and Technology Committee’s responsibilities includes reviewing technologies and
technology programs of significance to us, with special focus on major external initiatives, observing the evolution of science and medicine outside the
Company, participating in the development of metrics to assess the state of our science and technology in subject areas including, but not limited to, patent
estate, freedom to operate, productivity, capability and external benchmarks, providing guidance for our external science and technology alliances, and
providing guidance on the direction of our science and technology activities, as appropriate. The current members of our Science and Technology
Committee are Dr. Voss and Dr. Braun.
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MEETINGS OF THE BOARD AND BOARD COMMITTEES
During the year ended December 31, 2020, there were a total of four (4) regular meetings of our Board of Directors. All of our directors attended all of the
meetings of our Board of Directors and the Board committees on which they served that were held during the period for which they were a director or
committee member, respectively. During the year ended December 31, 2020, our Audit Committee met four (4) times, our Compensation Committee met
one (1) time and our Science and Technology Committee did not meet during 2020. Our Nominating and Governance Committee did not meet during 2020.
DELINQUENT SECTION 16(A) REPORTS
Section 16(a) of the Exchange Act requires our executive officers, directors and persons who own more than 10% of our common stock to file reports of
ownership and reports of changes in ownership of common stock and other equity securities of the Company with the SEC. Executive officers, directors
and greater than 10% stockholders are required by SEC regulations to furnish us with copies of all Section 16(a) forms they file.
To our knowledge, based solely on a review of the copies of reports furnished to us, we believe that during the year ended December 31, 2020, our
executive officers, directors and greater than 10% stockholders complied with all Section 16(a) filing requirements.
ITEM 11. EXECUTIVE COMPENSATION
COMPENSATION DISCUSSION AND ANALYSIS
This section describes the material elements of compensation awarded to, earned by, or paid to the following Executive Officers of the Company:
○ Michael H. Tardugno, our Chairman, President and Chief Executive Officer
○ Nicholas Borys, M.D., our Executive Vice President and Chief Medical Officer
○ Khursheed Anwer, Ph.D., our Executive Vice President and Chief Science Officer
○ Jeffrey W. Church, our Executive Vice President and Chief Financial Officer
These individuals are listed in the 2020 Summary Compensation Table below and are referred to in this discussion as the “Named Executive Officers.”
2020 SUMMARY COMPENSATION TABLE
The following table sets forth information regarding the total compensation for services rendered in all capacities during the years ended December 31,
2020 and 2019, awarded to, paid to or earned by each named executive officers serving as of December 31, 2020. All compensation awarded to, earned by,
or paid to Celsion’s named executive officers are included in the table below for the years ended December 31, 2020 and 2019:
Name and Principal Position
Year
Salary Bonus
Stock
Awards
(1)(2)
Option
Awards
(1)
Non-Equity
Incentive
Plan
Compensation
(2)
All Other
Compensation
(3)
Total
($)
Michael H. Tardugno (4)
Chairman, President & CEO
2020 $ 557,222 $
2019 $ 547,342 $
– $ 426,600 $
– $
– $ 179,800 $ 284,926 $
400,001 $
192,572 $
45,250 $ 1,429,073
47,000 $ 1,251,640
Nicholas Borys (5)
Executive VP & CMO
2020 $ 417,097 $
2019 $ 409,999 $
– $
– $ 173,800 $
– $ 58,000 $ 136,727 $
138,395 $
67,182 $
26,750 $ 756,042
28,800 $ 700,708
Khursheed Anwer (6)
Executive VP & CSO
2020 $ 335,852 $
2019 $ 325,442 $
– $
– $ 158,000 $
– $ 46,400 $ 194,977 $
122,147 $
54,797 $
26,750 $ 756,042
29,082 $ 650,698
Jeffrey Church (7)
Executive VP & CFO
2020 $ 382,246 $
2019 $ 377,593 $
– $ 173,800 $
– $
– $ 54,520 $ 136,727 $
126,127 $
61,827 $
14,250 $ 696,423
16,500 $ 647,167
(1) The value reported for option awards is the aggregate grant date fair value of stock options granted to the Named Executive Officers in the years
shown, determined in accordance with FASB ASC Topic 718, disregarding adjustments for forfeiture assumptions. The assumptions for making
the valuation determinations are set forth in Note 11 to the financial statements included in this 2020 Annual Report on Form 10-K.
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(2) Executives’ bonuses under our annual incentive program are based on the achievement of specific performance measures established at the
beginning of the fiscal year by our Compensation Committee. Historically, our Compensation Committee has awarded the annual incentive bonus
for each year in the first quarter of the following year. In the first quarter of 2021, our Compensation Committee approved the amount and the
payment of the incentive bonus for 2020 for each of the Named Executive Officers in the form of stock awards and Non-Equity (Cash) Incentive
Plan Compensation. In connection with a portion of the 2019 bonuses earned by its Named Executive Officers, the Company issued stock awards
totaling 292,000 common shares in lieu of cash.
(3) This column includes other compensation as indicated below and matching and discretionary contributions made by the Company for the Named
Executive Officers under our 401(k) plan. Our matching contribution is equal to 50% of the employee’s deferrals under the plan up to 6% of the
employee’s compensation, subject to applicable IRS limitations, and are made in shares of our common stock. The 2020 discretionary contribution
is 5.0% of eligible salary of each employee which was contributed in January 2021.
(4) For Mr. Tardugno, “All Other Compensation” for 2020 consists of $18,000 for discretionary spending allowance, a 401(k)-plan matching
contribution of $13,000 in our common stock and a $14,250 discretionary 401(k) contribution.
(5) For Dr. Borys, “All Other Compensation” for 2020 consists of a 401(k)-plan matching contribution of $14,250 in our common stock and a
$14,250 discretionary 401(k) contribution.
(6) For Dr. Anwer, “All Other Compensation” for 2020 consists of $6,0062 for discretionary spending allowance, a 401(k)-plan matching contribution
of $7,593 in our common stock and a $14,250 discretionary 401(k) contribution.
(7) For Mr. Church, “All Other Compensation” for 2020 consists of a $12,500 discretionary 401(k) contribution.
NARRATIVE DISCLOSURE TO SUMMARY COMPENSATION TABLE
Introduction
We are a fully integrated, clinical stage biotechnology company focused on advancing a portfolio of innovative treatments including DNA-based
immunotherapies, next generation vaccines and directed chemotherapies through clinical trials and eventual commercialization. The Company’s product
pipeline includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer and ThermoDox®, a proprietary heat-activated
liposomal encapsulation of doxorubicin, currently under investigator-sponsored development for several cancer indications. Celsion has two feasibility
stage platform technologies for the development of novel nucleic acid-based immunotherapies and next generation vaccines and other anti-cancer DNA or
RNA therapies. Both are novel synthetic, non-viral vectors with demonstrated capability in nucleic acid cellular transfection.
As a result of our drug development status, it is unlikely, in the short term, to generate revenues and income sufficient to cover product development costs.
As a result, our executive compensation philosophy is to align the interests of management and stockholders by emphasizing rewards for Company
performance, while remaining competitive with compensation paid by other clinical stage biotechnology companies.
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The compensation practices that we have outlined below have been implemented because we believe that they are consistent with our stockholders’
interests:
What we do:
● A significant portion of our executive compensation is based on actual Company performance compared to absolute and relative measures and is
therefore “at risk”;
● Performance shares in our long-term and annual incentive programs are subject to both time and performance vesting requirements;
● Multiple performance metrics between the annual and long-term incentive plans discourage excessive risk-taking by removing any incentive to
focus on a single performance goal to the detriment of the Company;
● Balance between annual and long-term compensation to discourage short-term risk taking at the expense of long-term results;
● Our executives are encouraged to acquire and maintain meaningful ownership positions in our Company’s common stock;
● Use relevant competitive compensation information compiled from compensation surveys; and
● Provide reasonable, double trigger change in control arrangements.
Following is a list of compensation practices that we have not engaged in because we do not believe that they are consistent with our stockholders’
interests:
What we don’t do:
● Re-pricing or backdating of stock options;
● Hedging or engaging in the following transactions that include shares of common stock: collars, short sales and other derivative transactions for
NEOs or directors;
● Excessive perquisites for executives;
● Single trigger or modified single trigger cash severance benefits followed by a change in control; and
● Provisions for excise tax gross-ups in employment contracts issued.
Stockholder Say-on-Pay Votes
We provide our stockholders with the opportunity to cast an advisory vote annually to approve our executive compensation program (referred to as a “say-
on-pay proposal”). At the Annual Meeting of Stockholders held on June 15, 2020, approximately 86.1% of the votes cast on the say-on-pay proposal at that
meeting were voted in favor of our executive compensation program. The Compensation Committee believes these results affirmed stockholders’ support
of our approach to the executive compensation program. In general, the Compensation Committee did not change its approach in 2020 and believes the
program in place, as in prior years, includes a number of features that further the goals of the Company’s executive compensation program. The
Compensation Committee will continue to consider the outcome of the Company’s say-on-pay proposals when making future compensation decisions for
the Named Executive Officers.
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The Compensation Committee has adopted the following executive compensation approaches, which the Company believes help to achieve the objectives
for the executive compensation program and are generally favored by stockholders:
● A significant amount of the executives’ compensation is at-risk. For fiscal year 2020, 57.8% of Mr. Tardugno’s target total direct compensation
was performance-based (annual cash incentive awards) and/or linked to the value of our stock price (long-term equity incentive awards). As used
in this discussion, the term “total direct compensation” means:
1. Aggregate amount of the executive’s base salary (39%),
2. Annual cash incentive awards (28%),
3. Long-term equity incentive (option and restricted stock) awards based on the grant-date fair value of such awards as determined under the
accounting principles used in the Company’s audited financial statements (30%), and
4. Other Compensation (3%).
● Executives’ bonuses under our annual incentive program are principally based on the achievement of specific performance objectives established
at the beginning of the fiscal year by the Compensation Committee. Historically the Compensation Committee has awarded the annual incentive
bonus for each year in the first quarter of the following year.
● Executives’ 2020 annual equity awards were granted in the form of stock option awards. We believe the grant of stock option awards further
aligns the executives’ interests with those of stockholders as the awards will not have value unless the Company’s stock price appreciates after the
award is granted. The stock option awards also provide a retention incentive as they vest over a multi-year period.
● Executives are also granted stock option and restricted stock awards at the time they join the Company as these provide the same incentives as
annual equity awards. These stock option grants and restricted stock awards generally vest over a three or four-year period beginning on the first-
year anniversary of the date of grant.
The following table provides the components of Mr. Tardugno’s compensation for the last two years:
(in 000’s)
Base Salary
Cash Incentive Awards
Option and Stock Awards
All Other Compensation
Total
2020
Change
2019
Change
$
$
557
400
427
45
1,429
2% $
108%
(8)%
(4)%
14% $
547
193
465
47
1,252
3%
(48)%
(77)%
-%
(58)%
Executive Compensation Philosophy and Procedures
The Compensation Committee attempts to design executive compensation programs to achieve three principal objectives.
● The program is intended to attract, motivate and retain talented executives with total compensation that is competitive within the drug
development and broader pharmaceutical and biotechnology industry;
● The program is intended to create an alignment of interests between our executives and stockholders such that a significant portion of each
executive’s compensation varies with business performance and is dependent on stock price appreciation; and
● The program is designed to award behavior which results in optimizing the commercial potential of our development program.
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The Compensation Committee’s philosophy is to pay competitive total compensation, comprised of annual salaries, annual cash incentives and long-term
equity awards (primarily stock options), with a significant percentage of total compensation directly linked with the Company’s performance. The
Compensation Committee considers the elements of the compensation package to be reflective of compensation packages given to executives of companies
of similar size in our industry. Compensation packages generally are designed to pay competitive salaries at the median of the industry compensation
surveys as described below, reward superior annual performance through incentive compensation awards and allow executives to participate in increases in
stockholder value through stock option and other stock-based grants.
In determining executives’ compensation levels, the Compensation Committee relies primarily on its experience and judgment to provide a package that it
believes appropriately balances the need to attract and retain key executive talent with the creation of incentives that will (i) enhance the growth of the
Company, (ii) align the interests of management and stockholders by emphasizing rewards for Company performance, while remaining competitive with
compensation paid by other clinical stage biotechnology companies and (iii) provide value for stockholders.
As part of its decision-making process, the Compensation Committee takes into account the role and experience of each executive and reviews industry
surveys (specifically, the Radford Global Life Sciences Survey, which covers a broad cross-section of the biotechnology, pharmaceuticals and life science
industries and in which the Company participates) for information on the compensation paid to executive officers by companies in our industry that are
similar in size, breadth, stage of development or complexity to the Company. The Compensation Committee also reviews custom surveys comparing
executive compensation with that of specific peer groups (for example, pre-commercial biopharma public companies, biopharma companies with under 50
employees, biopharma companies with a market cap above $100 million and biopharma companies with a market cap below $100 million).
In 2021, the Compensation Committee retained Mercer as its independent compensation advisor to compare the Company’s executive and non-employee
director 2020 compensation levels, policies, practices and procedures to a set of peer companies selected by the Compensation Committee with input from
Mercer. Mercer reported directly to the Compensation Committee and performed no work for management that was not under the Compensation
Committee’s purview. The Compensation Committee assessed the independence of Mercer pursuant to the relevant SEC rules and the Nasdaq Listing Rules
and concluded that no conflicts of interest exist. The Compensation Committee and Mercer reviewed the compensation surveys as summarized above as it
relates to elements of yearly performance and compensation of all members of the executive management team. As part of their engagement, Mercer
prepared and submitted to the Compensation Committee a report on the audit of the Company’s current compensation benchmarking practices and its
recommendations relating to executive and non-employee director compensation. Mercer concluded that the Company uses appropriate market data sources
to evaluate the competitive positioning of the top executives’ and the Board of Directors’ compensation packages and market positioning relative to those
data sources is reasonable.
The Compensation Committee believes that an appropriate level of input from our Chief Executive Officer provides a necessary and valuable perspective
in helping the Compensation Committee formulate its own independent views on compensation. The Compensation Committee takes measures to ensure
its independence with respect to our Chief Executive Officer’s compensation, excusing him from portions of meetings to freely discuss his and the other
Named Executive Officers performance and compensation. The Compensation Committee made all final determinations on the compensation levels for all
Named Executive Officers in 2020 and 2019.
Annual Salaries
We participate in an ongoing industry survey as described above. The Compensation Committee compares base salary for our executives with the levels
provided to similarly situated executives and generally targets base salaries at levels in the median of the survey data.
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In 2020, the Compensation Committee reviewed each executive’s job responsibilities, individual performance, our corporate performance, competitive
market data, our total compensation expense and the base salaries of Mr. Tardugno, Dr. Borys, Dr. Anwer and Mr. Church and approved the following
salary adjustments for each Named Executive Officer:
Named Executive Officer
Michael H. Tardugno
Nicholas Borys
Khursheed Anwer
Jeffrey W. Church
Incentive Compensation
Fiscal 2020
Salary
Fiscal 2019
Salary
Change from
Previous Year
$
$
$
$
557,222 $
417,097 $
335,852 $
382,246 $
547,342
409,999
325,442
377,593
1.8%
1.7%
3.2%
1.2%
We have an incentive compensation plan in which all members of our senior management participate. The plan is performance-driven based on Company
and individual personal operational objectives established at the beginning of the year by the Compensation Committee in consultation with our Chief
Executive Officer. These operational objectives include the completion of certain development projects, capital raising, cost controls, business development
and profit and loss goals, which we believe are ultimately linked to creating stockholder value. These objectives are designed to achieve timely and
efficient product development including completion of clinical studies and regulatory approvals. Each member of senior management is individually
evaluated based on the achievement of the Company’s overall operational objectives and each individual’s personal performance against these objectives.
This component of compensation is provided, among other reasons, to create incentives for members of senior management to meet short- and medium-
term performance goals of the Company, without regard to stock price. Objectives are weighted in terms of overall importance to meeting the Company’s
operating plan.
The total annual incentive compensation a member of senior management can earn is based on his level within management, with more senior members of
management eligible to earn a higher percentage of their base salary as incentive compensation than less senior members. We believe it is appropriate for
executives to have a greater percentage of their compensation “at-risk” based on performance as they generally have a greater role in the achievement of
objectives that we believe promote the growth of the Company and the creation of value for stockholders. The actual amount of incentive compensation
paid to any member of senior management is determined on a sliding scale dependent on how successful such member of senior management was in
achieving the objectives upon which his or her incentive compensation was targeted and the relative importance to the Company of the objectives achieved.
The Compensation Committee retains complete discretion to adjust any incentive compensation down and retains discretion as to whether to grant any
incentive compensation to any individual member of senior management at all.
Under the incentive compensation plan for 2020, the Compensation Committee established a number of annual corporate goals identified below that
include research and development, regulatory, manufacturing, organizational and financial goals which we believe are essential to building stockholder
value. The relative weighting of these corporate goals is based upon our assessment of the importance of each goal in creating value for the Company and
our stockholders. Each corporate goal was established so that significant levels of achievement were required to meet the goal. Following the conclusion of
the annual performance period, the level of achievement for each corporate goal was assessed by the Compensation Committee. The Compensation
Committee determined whether each corporate goal had been met, exceeded, or not satisfied. In addition, in assessing corporate performance, the
Compensation Committee had the discretion to factor in other significant corporate events that occurred during the performance period, which could have
resulted in an upward or downward adjustment in the determination of corporate performance. After considering the level of attainment of each corporate
goal and other appropriate corporate performance factors, the Compensation Committee assigned the overall corporate performance rating, which could
have ranged from 0% to 130%. A maximum bonus pool is established by multiplying the overall corporate performance rating by the aggregate target
bonuses for all individuals in the incentive plan. Certain individual downward adjustments may be made at the discretion of the Compensation Committee.
The aggregate of all individual bonuses awarded under the policy cannot exceed the maximum bonus pool available such that the cost of bonuses
ultimately reflects our overall performance and is not inflated by any individual performance rating.
After the corporate performance rating is determined by the Compensation Committee, the individual performance of each Named Executive Officer is
reviewed by the Compensation Committee in consultation with Mr. Tardugno in order to determine the appropriate annual performance percentage rating to
be assigned to the executive for the performance period. Each Named Executive Officer’s actual annual performance-based incentive compensation
payment is based on a combination of our corporate performance rating and his or her individual performance rating. The actual annual performance bonus
compensation award for each Named Executive Officer is determined in the Compensation Committee’s sole discretion, and the maximum payout for each
Named Executive Officer could be up to 130% of his target annual performance-based compensation target.
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The Named Executive Officers were each assigned a target annual incentive for 2020 ranging from 45% to 100% of base salary. The table below shows the
target annual incentive assigned to each Named Executive Officer for 2020 both as a dollar amount and as a percentage of base salary.
Name
Michael H. Tardugno
Nicholas Borys
Khursheed Anwer
Jeffrey W. Church
Target Annual
Incentive
for 2020
Target Annual
Incentive for 2020 (%
of Base Salary)
Annual Incentive
Awarded
for 2020
Annual Incentive
Awarded for 2020 (%
of Base Salary)
$
557,222
187,694
167,926
172,011
100% $
45%
50%
45%
400,001
138,395
122,147
126,127
71,8%
33.2%
36.4%
33.0%
The following 2020 corporate objectives and relative weightings assigned to each objective include the completion of certain development projects, capital
raising, cost controls, business development and profit and loss goals, which we believe are ultimately linked to creating stockholder value. These
objectives are designed to achieve timely and efficient product development including completion of clinical studies and regulatory approvals and in total
represent a potential payout at 130% of the executive’s bonus target if all objectives are achieved.
1. Research and Development Objectives to file a New Drug Application (NDA) within 6 months of positive data from the OPTIMA Study
and establish a global commercialization plan for ThermoDox® which includes (i) completion of U.S. marketing plan and pricing studies by
the third quarter of 2020, (ii) establish a China commercial structure by the fourth quarter of 2020 and (iii) enter into confidential discussions
with three or more potential European license partners by the fourth quarter of 2020 (30%)
5% of 30% OF OBJECTIVES MET
2. Research and Development Objectives to enroll 12 patients in the phase I portion of the OVATION 2 Study by November 30, 2020 and
15% of 20% OF OBJECTIVES
establish twenty (20) new investigator sites for the phase II portion of the OVATION 2 Study (20%)
MET
3. Research and Development Objective to reduce GEN-1 manufacturing costs and expand GEN-1 manufacturing capacity in support of the
phase II portion of the OVATION 2 Study (10%)
OBJECTIVES MET
4. Financial Objectives to manage cash and operating expenses, ensure cash flows are within 10% of plan and maintain sufficient levels of cash
no less than 16 months operating cash at year end 2020 (25%)
OBJECTIVES MET
5. Corporate Development Objectives to expand senior management team to support commercialization of ThermoDox® and renegotiate the
milestone payment for the GEN-1 ovarian cancer product candidate reducing the near-term exposure of the $12.2 million milestone payment
(15%)
7.5% of 15% OF OBJECTIVES MET
6. Bonus Objectives to develop bold and differentiating plans so as to achieve a market cap consistent with a share price of 80% of the current
analysts’ average target price for Celsion and complete a commercial license of significant value with a Pharma partner for either GEN-1 or
ThermoDox® by year-end 2019 (30%). *
* Following the recommendation by the DMC on July 9, 2021 to terminate the Phase III OPTIMA Study for futility, the Compensation
Committee reassessed the Bonus Objectives with a four-point action plan for the second half of 2020 designed to stabilize the Company and
insure its future. (15%)
OBJECTIVES MET
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The plan consisted of the following:
● Stabilize and reposition the Company by reducing operating costs by $8 million and by raising additional capital to strengthen the
balance sheet;
● Pivot the clinical focus to GEN-1 and accelerate the Phase II portion of the OVATION 2 Study;
● Complete the independent failure analysis of the Phase III OPTIMA Study and determine whether the study should continue to follow
patients or be terminated; and
● Evaluate the Company’s options going forward
Stock-Based Compensation
We grant long-term equity awards to its executives and other employees that are designed to align the interests our Company employees and stockholders,
encouraging participants to maintain and increase their ownership our Company common stock with the opportunity to benefit from our long-term
performance. Our equity program has generally consisted of grants of stock options and occasional grants of stock awards. Because the exercise price of
the options is based on the market price of our common stock on the date of grant, the Compensation Committee believes that options help to align the
interests of our executives with those of its stockholders as the options will not have value unless there is appreciation in our stock price. The options also
serve as a retention tool since they generally vest over a three to four-year period following the grant date. This approach is designed to focus key
employees on sustainable growth of the Company and the creation of stockholder value over the long term.
Annual grants to the Named Executive Officers are generally made during the first half of the fiscal year. Annual grants are determined by the
Compensation Committee based on review of each individual’s past performance as well as their potential impact on the Company’s future performance.
Grants may also be made at other times during the fiscal year in certain circumstances (such as a grant in connection with the hiring or promotion of an
executive or other special circumstance as deemed appropriate by the Compensation Committee).
Material Terms of Option Grants During 2020
Each of the stock options awarded to the Named Executive Officers in 2020 and reported in the 2020 Grants of Plan-Based Awards Table below was
granted under, and is subject to, the terms of the 2018 Plan. The 2018 Plan is administered by the Compensation Committee, which has authority to
interpret the plan provisions and make all required determinations under the plan. This authority includes making required proportionate adjustments to
outstanding awards upon the occurrence of certain corporate events such as reorganizations, mergers and stock splits, and making provision to ensure that
any tax withholding obligations incurred in respect of awards are satisfied. Awards granted under the plan are generally only transferable to a beneficiary of
a Named Executive Officer upon his death. Under the terms of the 2018 Plan, if there is a change in control of the Company, each Named Executive
Officer’s outstanding awards granted under the plan will generally terminate, unless the Compensation Committee provides for the substitution,
assumption, exchange or other continuation or settlement (in cash, securities or property) of the outstanding awards. The Compensation Committee has
discretion to provide for outstanding awards to become vested in connection with a change in control.
Each option granted to the Named Executive Officers in 2020 was granted with a per-share exercise price equal to the closing price of our common stock
on the grant date. Each option is scheduled to vest in three installments, with one-third vesting on the date of grant and the balance vesting in equal annual
installments over each of the next two years, subject in each case to the executive’s continued employment through the applicable vesting date and has a
maximum term of ten years. However, vested options may terminate earlier in connection with a change in control transaction or a termination of the
Named Executive Officer’s employment. Subject to any accelerated vesting that may apply in the circumstances, the unvested portion of the option will
immediately terminate upon a termination of the Named Executive Officer’s employment.
92
2020 Grants of Plan-Based Awards Table
The following table presents information regarding the incentive awards granted to the Named Executive Officers during 2020. Each of the equity awards
reported in the table below was granted under the 2018 Plan.
Estimated
Future
Payouts
Under Non-
Equity
Incentive
Plan Awards
Target
($) (1)
All other
Stock Awards:
Number of
Shares or
Units of
Stock
(#)
All Other
Option
Awards:
Number of
Securities
Under- lying
Options
(#) (2)
Exercise or
Base Price
of Option
Awards
($/Share)
(3)
Grant Date
Fair Value
of Stock
and Option
Awards
($/Share)
(3)
566,710
190,890
168,479
173,968
135,000 $
3.66 $
3.16
55,000 $
3.66 $
3.16
50,000 $
3.66 $
3.16
55,000 $
3.66 $
3.16
Name
Michael H. Tardugno
Nicholas Borys
Khursheed Anwer
Jeffrey W. Church
Grant Date
N/A
6/15/2020
N/A
6/15/2020
N/A
6/15/2020
N/A
6/15/2020
$
$
$
$
(1) The amounts reported in this column represent the target bonus opportunity under the Company’s annual bonus program. See “Compensation
Discussion and Analysis – Incentive Compensation” above for information on the terms of these bonuses.
(2) The amounts reported in this column represented stock option awards granted under the 2018 Plan. Each option granted to each Named
Executive Officer is scheduled to vest in three installments, with one-half vesting on the date of grant and the balance vesting in annual
installments over each of the next two years, subject in each case to the executive’s continued employment through the applicable vesting date
and has a maximum term of ten years.
(3) The value reported for stock and option awards is the aggregate grant date fair value of stock options granted to the Named Executive Officers
in 2020, determined in accordance with FASB ASC Topic 718, disregarding adjustments for forfeiture assumptions. The assumptions for
making the valuation determinations are set forth in Note 11 to the financial statements in this 2020 Annual Report on Form 10-K.
2020 Option Exercises and Stock Vested
During 2020, Dr Anwer exercised 29,132 stock options with a weighted average strike price of $2.48 per share and Dr Borys exercised 74,643 stock
options with a weighted average of $2.65 per share. No other Named Executive Officers exercised any of their stock options that vested during 2020. No
officers were awarded shares of stock during 2020.
93
2020 Outstanding Equity Awards at Year-End
The following table summarizes the unexercised stock options held by each of the Named Executive Officers as of December 31, 2020. None of the Named
Executive Officers held any other outstanding stock awards as of December 31, 2020.
Name
Michael H. Tardugno
Nicholas Borys
Khursheed Anwer
Jeffrey W. Church
Option Awards
No. of Securities
Underlying
Unexercised
Options (#)
Exercisable
No. of Securities
Underlying
Unexercised
Options (#)
Unexercisable
Option
Exercise
Price ($)
10,714
8,928
176,429
850,000
16,667
16,667
21,667
–
3,571
2,905
223,948
6,667
8,333
11,667
–
2,857
18,154
82,500
7,667
7,667
14,167
–
4,285
2,095
48,571
250,000
6,667
8,333
11,667
–
$
–
$
–
$
–
$
–
33,333(1) $
33,333(1) $
43,333(1) $
135,000(1) $
$
–
$
–
$
–
13,333(1) $
16,667(1) $
23,333(1) $
55,000(1) $
$
–
$
–
$
–
23,333(1) $
23,333(1) $
28,333(1) $
50,000(1) $
$
–
$
–
$
–
$
–
13,333(1) $
16,667(1) $
23,333(1) $
55,000(1) $
18.62
17.08
2.69
2.58
2.18
2.14
1.72
3.66
18.62
17.08
2.58
2.18
2.14
1.72
3.66
18.62
2.69
2.58
2.18
2.14
1.72
3.66
18.62
17.08
2.69
2.58
2.18
2.14
1.72
3.66
Option
Expiration
Date
2/2/2026
9/6/2026
5/30/2027
5/30/2028
2/19/2029
5/14/2029
10/3/2029
6/15/2030
2/2/2026
9/6/2026
5/30/2028
2/19/2029
5/14/2029
10/3/2029
6/15/2030
2/2/2026
5/30/2027
5/30/2028
2/19/2029
5/14/2029
10/3/2029
6/15/2030
2/2/2026
9/6/2026
5/30/2027
5/30/2028
2/19/2029
5/14/2029
10/3/2029
6/15/2030
Grant Date
2/2/2016
9/6/2016
5/30/2017
5/15/2018
2/19/2019
5/14/2019
10/3/2019
6/15/2020
2/2/2016
9/6/2016
5/15/2018
2/19/2019
5/14/2019
10/3/2019
6/15/2020
2/2/2016
5/30/2017
5/15/2018
2/19/2019
5/14/2019
10/3/2019
6/15/2020
2/2/2016
9/6/2016
5/30/2017
5/15/2018
2/19/2019
5/14/2019
10/3/2019
6/15/2020
(1) Each of these stock option grants vest in three equal installments, with one-third of the grant vesting each on the first, second and third
anniversary of the date of grant.
94
Other Compensation
Executive officers are eligible to participate in our medical and other welfare benefit plans and for other benefits, in each case on generally the same basis
as other employees. We maintain a 401(k) plan for our employees. Other than the 401(k) plan, we do not offer any of our employees a pension plan,
retirement plan or other forms of compensation paid out upon retirement. The Company matches up to 50% of the first 6% of employee contributions. Mr.
Tardugno and Dr Anwer receive $18,000 and $6,006, respectively, as a discretionary spending allowance.
COMPENSATION COMMITTEE REPORT ON EXECUTIVE COMPENSATION
Our Compensation Committee has certain duties and powers as described in its charter. Our Compensation Committee is currently composed of the three
non-employee directors named at the end of this report, each of whom our Board of Directors has determined is independent under the applicable Nasdaq
rules.
Our Compensation Committee has reviewed and discussed with management the disclosures contained in the Compensation Discussion and Analysis
section of this Proxy Statement. Based upon this review and discussion, our Compensation Committee recommended to our Board of Directors that the
Compensation Discussion and Analysis section be included in this Proxy Statement and the Company’s Annual Report on Form 10-K for the year ended
December 31, 2020, as amended.
Compensation Committee of the Board of Directors
Mr. Robert W. Hooper (Chairman)
Dr. Augustine Chow
95
POST-EMPLOYMENT OBLIGATIONS
We believe that severance protections, particularly in the context of a change in control transaction, can play a valuable role in attracting and retaining key
executive officers. Under their employment agreements, each of the Named Executive Officers would be entitled to severance benefits in the event of a
termination of employment by the Company without cause. We have determined that it is appropriate to provide the executives with severance benefits
under these circumstances in light of their positions with us and as part of their overall compensation package.
We believe that the occurrence, or potential occurrence, of a change in control transaction will create uncertainty regarding the continued employment of
our executive officers as many change in control transactions result in significant organizational changes, particularly at the senior executive level. In order
to encourage the Company’s executive officers to remain employed with us during an important time when their prospects for continued employment
following the transaction may be uncertain, we provide Mr. Tardugno, Mr. Church and Dr. Borys with enhanced severance benefits if his employment is
actually or constructively terminated by the Company without cause in connection with a change in control.
Employment Agreement with Michael H. Tardugno
In March 2016, the Company and Mr. Tardugno entered into an employment agreement, effective March 30, 2016, which superseded the previous
employment agreements with Mr. Tardugno. The amended and restated employment agreement generally maintained the same terms as set forth in his
previous December 2014 agreement, but removed the modified single-trigger provision included in that agreement. Under that provision, Mr. Tardugno
was eligible to receive severance following a change in control if Mr. Tardugno elected to terminate his employment for any reason or no reason
commencing with the sixth and ending with the twelfth month following the change in control. In accordance with commonly viewed best practices, the
parties agreed to remove this provision so that it is no longer operative, effective March 30, 2016. The following narrative describes the terms of Mr.
Tardugno’s employment agreement, as in effect on December 31, 2019 (the “March 2016 Agreement”).
Subject to earlier termination pursuant to the terms of the March 2016 Agreement, the initial term of the agreement ends on January 31, 2018, with
automatic one-year renewals thereafter, unless either party provides a notice of non-renewal. Mr. Tardugno’s March 2016 Agreement provides for an
annual base salary of $547,342 subject to annual adjustment by our Board of Directors of the Company or the Compensation Committee. Mr. Tardugno is
also eligible for an annual performance bonus from the Company, pursuant to the Company’s management incentive bonus program in effect from time to
time. The amount of such bonus will be determined by our Board of Directors or the Compensation Committee in its sole and absolute discretion and will
not exceed 100% of the then-current base salary except pursuant to a specific finding by our Board of Directors or the Compensation Committee that a
higher percentage is appropriate. Under the March 2016 Agreement, we agreed to grant to Mr. Tardugno, at the time of its usual annual grant to employees,
annual stock options to purchase shares of our common stock as our Board of Directors or the Compensation Committee shall determine.
96
In the event of Mr. Tardugno’s termination due to death or disability during the employment term, Mr. Tardugno’s legal representatives shall be entitled to
receive his base salary through the date which is ninety (90) days after his death and a pro rata annual performance bonus based on actual performance and
the time served during the performance year. Upon Mr. Tardugno’s death or termination due to disability, previously granted and vested stock options will
remain fully exercisable through their respective original maximum terms (subject to earlier termination in connection with a change in control of the
Company and similar events as provided in the applicable plan and/or award agreement) and all other stock options and stock awards (and similar equity
rights) that have not vested prior to the date of termination will be forfeited.
In the event, (A) that we terminate the agreement other than for “cause” (as defined in the agreement) or (B) Mr. Tardugno terminates the agreement upon
the occurrence of: (i) a material adverse change in his duties or authority; (ii) a situation in which he is no longer at least one of the President or the Chief
Executive Officer of the Company; (iii) a bankruptcy filing or similar action by or against us; or (iv) another material breach of the agreement by us (each,
a “Triggering Event”), or (C) the agreement terminates for nonrenewal, Mr. Tardugno will be entitled to receive a severance payment equal to his base
annual salary at the time of termination (the “Severance Amount”), payable in accordance with our normal payroll practices, COBRA premiums for up to
twelve months and may generally exercise any vested options through the remainder of their original terms.
In the event of termination of his employment upon a Triggering Event within two years following a “change in control” (as described below), or, if within
such two-year period (i) there is a material adverse change in his compensation or benefits, or (ii) any successor to the Company does not assume our
obligations under the agreement, and he terminates his employment, Mr. Tardugno is entitled to a lump sum severance payment equal to the Severance
Amount and any previously unvested options granted to Mr. Tardugno and covered by the employment agreement shall immediately vest and remain fully
exercisable through the remainder of their original maximum terms and otherwise in accordance with their respective original terms.
In the event of termination of his employment upon a Triggering Event during the period commencing six months prior to a change in control (“CIC”) (as
described below) and ending on the 2nd anniversary of the CIC (i) there is a material adverse change in his duties or responsibilities, (ii) there is a material
adverse change in his compensation or benefits, or (iii) any successor to the Company does not assume our obligations under the agreement, and he
terminates his employment, Mr. Tardugno is entitled to a lump sum severance payment equal to the Severance Amount and any previously unvested
options granted to Mr. Tardugno and covered by the employment agreement shall immediately vest and remain fully exercisable through the remainder of
their original maximum terms and otherwise in accordance with their respective original terms. A “change in control” is deemed to occur: (i) if any person
becomes the direct or indirect beneficial owner of more than 50% of the combined voting power of our then-outstanding securities; (ii) there is a change in
a majority of the directors in office during any twenty-four (24) month period; (iii) we engage in a recapitalization, reorganization, merger, consolidation or
similar transaction after which the holders of our voting securities before the transaction do not continue to hold at least 50% of the voting securities of the
Company or its successor after the transaction; or (iv) upon our complete liquidation or dissolution of the Company or the sale or other disposition of
substantially all of our assets after which the holders of our voting securities before such sale or disposition do not continue to hold at least 50% of the
voting securities of the Company or its successor after such sale or disposition.
In the event that Mr. Tardugno is terminated for cause or is receiving severance payments contemplated under the employment agreement, Mr. Tardugno
shall, among other things, not provide any services, directly or indirectly, to any other business or commercial entity in the Company’s “Field of Interest”
(as such term is defined in his employment agreement), solicit any customers or suppliers of the Company, directly or indirectly, or employ or seek to
employ an employee of the Company for a period of two years following the date of termination. In addition, at no time during the term of the employment
agreement or thereafter will Mr. Tardugno knowingly make any written or oral untrue statement that disparages the Company. Mr. Tardugno is also subject
to confidentiality provisions in his employment agreement.
97
Employment Agreements with Other Named Executed Officers
Nicholas Borys
The Company and Dr. Borys entered into an employment offer letter on August 23, 2007, pursuant to which Dr. Borys agreed to serve as our Vice President
and Chief Medical Officer. Dr. Borys’ employment with us is “at-will”; however, subject to a retention agreement the Company provided to Dr. Borys on
February 19, 2013, if we terminate Dr. Borys’ employment for any reason other than just cause, we will pay Dr. Borys a salary continuation and COBRA
premiums for up to twelve months. The salary and COBRA premiums will cease at the end of the twelve-month period or, if he finds new employment
prior to the end of the twelve-month period, the benefit will be reduced by the amount of compensation which he will receive from any new employer.
Jeffrey Church
The Company and Mr. Church entered into an employment offer letter on June 15, 2010. Mr. Church’s employment is “at-will”; however, if we terminate
Mr. Church’s employment for any reason other than just cause, we will pay Mr. Church a salary continuation and COBRA premiums for up to twelve
months. The salary and COBRA premiums will cease at the end of the twelve-month period or if he finds new employment prior to the twelve-month
period, the benefit will be reduced by the amount of compensation which he will receive from any new employer.
Khursheed Anwer
The Company and Dr. Anwer entered into an employment offer letter effective as of June 20, 2014. Dr. Anwer’s employment with us is “at-will”; however,
subject to the retention and severance agreement between the Company and Dr. Anwer dated as of May 28, 2014, if we terminate Dr. Anwer’s employment
without cause (as such term is defined in the retention and severance agreement), he will be entitled to receive cash severance equal to 12 months of his
base salary and reimbursement of his COBRA premiums for up to 12 months. Dr. Anwer’s right to receive these severance benefits is subject to his
providing a release of claims in favor of the Company.
Change in Control Agreements
In September 2016, we entered into amended and restated change in control severance agreements (CIC Agreements) with each of the Named Executive
Officers (other than Dr. Anwer who is not subject to such an agreement) to provide severance benefits to these executives should their employment
terminate in certain circumstances in connection with a change in control of the Company.
Under the amended and restated CIC Agreements, in the event that we terminate the executive’s employment without cause or in the event that the
executive terminates his employment for good reason, in either case on or within two years after a change in control of the Company, the executive would
be entitled to receive a cash lump sum payment equal to two (2) times the sum of (1) the executive’s annual base salary and (2) the executive’s target
annual bonus for the fiscal year in which the termination occurs. (For these purposes, the terms “cause,” “good reason” and “change in control” are each
defined in the CIC Agreement.) In addition, we will pay or reimburse the executive for the cost of COBRA premiums and life insurance coverage for the
executive and his eligible dependents, in each case for a period of up to two years following the termination. The executive would also be entitled to full
acceleration of his then-outstanding equity awards granted to him by us. However, as to any equity award agreement that is subject to performance-based
vesting requirements, the vesting of such award will continue to be governed by its terms. In the case of options or similar awards, the award would
generally remain exercisable for the remainder of the original term of the award (or, in the case of awards that vested after the date of the change in control,
for the lesser of 12 months following the last day such award would have been exercisable under the applicable award agreement and the remainder of the
original term). The benefits provided under the CIC Agreement are in addition to, and not in lieu of, any severance benefits the executive may be entitled to
receive in connection with the termination of his employment under any other agreement with the Company. The executive’s right to benefits under the
CIC Agreement is subject to his executing a release of claims in favor of the Company upon the termination of his employment.
98
Potential Payments Upon Termination or Change In Control
As described above under “Narrative Disclosure to Executive Compensation Tables,” the Company has entered into agreements with each of the Named
Executive Officers currently employed by the Company that provide benefits that may become payable to the executives in connection with a termination
of their employment. The Company has also entered into agreements with Mr. Tardugno, Mr. Church and Dr. Borys that provides benefits that may become
payable to the executives in connection with a termination of employment following a change in control of the Company. If in the event the Named
Executive Officer is entitled to receive severance benefits in connection with a termination of employment under both their severance agreement and their
change in control agreement, the executive shall be entitled to receive the benefits from both agreements. The first table below indicates the benefits that
would be payable to each executive if a termination of employment in the circumstances described above had occurred on December 31, 2020 outside of a
change in control. The second table below indicates the benefits that would be payable to each executive if a change in control of the Company and such a
termination of employment had occurred on that date.
Severance Benefits (Outside of a Change in Control)
Name
Michael H. Tardugno
Nicholas Borys
Khursheed Anwer
Jeffrey W. Church
Change of Control Severance Benefits
Name
Michael H. Tardugno
Nicholas Borys
Jeffrey W. Church
2020 DIRECTOR COMPENSATION TABLE
Cash
Severance
Continuation
of Health/Life
Benefit
Equity
Acceleration
Total
566,710
212,100
336,958
193,298
$
$
$
$
17,940
12,924
17,940
8,970
– $
– $
– $
– $
584,650
225,024
354,898
202,268
Cash
Severance
Continuation
of Health/Life
Benefit
Equity
Acceleration
Total
2,266,840
1,230,177
1,121,126
$
$
$
35,880
51,696
35,880
– $
– $
– $
2,302,720
1,281,873
1,157,006
$
$
$
$
$
$
$
The following table sets forth the cash and noncash compensation paid to the Company’s directors who are not employed by the Company or any of its
subsidiaries (“Non-Employee Directors”) for the year ended December 31, 2020. Other than as set forth in the table, we did not pay any compensation,
make any equity awards or non-equity awards to, or pay any other compensation to any of the non-employee members of our Board in 2020. The
compensation paid to any director who was also one of our employees during fiscal year 2020 is presented in the “2020 Summary Compensation Table”
and the information that follows that table. Such employee directors do not receive separate compensation for service on the Board of Directors or any of
its committees.
Name
Augustine Chow
Robert W. Hooper
Alberto R. Martinez (2)
Frederick J. Fritz
Donald P. Braun
Andreas Voss
Fees Earned
($)
Option Awards
($) (1)
Total
($)
$
$
41,000
46,000
41,000
99,900
35,900
90,900
23,010 $
23,010
23,010
23,010
23,010
23,010
64,010
69,010
64,010
122,910
58,910
133,910
(1) The value reported for Option Awards is the aggregate grant date fair value of stock options granted to each Director in 2020, determined in
accordance with FASB ASC Topic 718. The assumptions for making the valuation determinations are set forth in Note 11 in the financial
statements in this Annual Report on Form 10-K filed. As of December 31, 2020, Dr. Chow had 143,689 option awards outstanding; Mr. Hooper
had 139,737 option awards outstanding; Dr. Martinez had 105,880 option awards outstanding; Mr. Fritz had 140,118 option awards outstanding;
and Dr. Braun and Dr. Voss each had 111,357 option awards outstanding.
(2) Dr. Martinez retired from the Board of Directors effective December 31, 2020.
99
The following table sets forth stock option grants awarded to the Company’s Non-Employee Directors for the year ended December 31, 2020. The stock
option grants to any director who was also one of our employees during fiscal year 2020 is presented in the “2020 Grants of Plan-Based Awards Table” and
the information that follows that table. Employee directors do not receive separate equity awards for service on the Board of Directors or any of the Board
committees.
Name
Augustine Chow
Robert W. Hooper
Alberto R. Martinez
Frederick J. Fritz
Donald P. Braun
Andreas Voss
Non-Employee Director Stock Option and Grant Awards Table
Number of
Options
Granted (#) (1)
6,000
4,000
6,000
4,000
6,000
4,000
6,000
4,000
6,000
4,000
6,000
4,000
Exercise
Price ($)
1.16
3.66
1.16
3.66
1.16
3.66
1.16
3.66
1.16
3.66
1.16
3.66
$
$
$
$
$
$
$
$
$
$
$
$
Grant
Date
2/25/2020
6/15/2020
Expiration
Date
2/25/2020 $
6/15/2020 $
2/25/2020
6/15/2020
2/25/2020
6/15/2020
2/25/2020
6/15/2020
2/25/2020
6/15/2020
2/25/2020
6/15/2020
2/25/2020 $
6/15/2020 $
2/25/2020 $
6/15/2020 $
2/25/2020 $
6/15/2020 $
2/25/2020 $
6/15/2020 $
2/25/2020 $
6/15/2020 $
Grant
Date
Fair
Value ($)
3.1600
1.0125
3.1600
1.0125
3.1600
1.0125
3.1600
1.0125
3.1600
1.0125
3.1600
1.0125
(1) Each of these stock option grants vest in three equal installments, with one-third of the grant vesting on the date of grant and one third of the grant
vesting on each of the first and second anniversary of the date of grant, subject to the applicable director’s continued service as a member of our
Board through each applicable vesting date.
NARRATIVE DISCLOSURE TO DIRECTOR COMPENSATION TABLE
During the year ended December 31, 2020, each Non-Employee Director of the Company received annual cash compensation in the amount of $28,500
payable in quarterly installments, and an additional $1,850 for attendance, in person or telephonically, at regular meetings of the Board of Directors and
each meeting of a committee of the Board of Directors that was not held in conjunction with a meeting of the Board of Directors. Each Non-Employee
director is reimbursed for the out-of-pocket costs of attending meetings of the Board of Directors and of committees of the Board of Directors. In 2020, the
Chairman of the Audit Committee received an additional annual cash fee of $12,000, the Chairman of the Compensation Committee received an additional
annual cash fee of $9,000.
100
Acting on behalf of the Board of Directors, Mr. Fritz also received fees totaling $48,000 in 2020 for his role as a Board Liaison to our Board of Directors.
Mr. Fritz’s responsibilities as Board Liaison include the following: (i) serve as an initial sounding board for our management regarding issues, matters, or
communications to be brought or potentially to be brought before the Board of Directors; (ii) provide input and feedback to management regarding strategic
matters, business matters, major scientific, clinical, collaboration, or corporate development matters, key personnel matters, or other items of significance
regarding which management would like to obtain initial or further Board guidance, including, but not limited to, guidance regarding timing and content of
communications regarding such matters or items with the full Board or any of its committees; (iii) remain accessible to management to provide guidance on
business or strategy issues or other issues of significance on an as-needed basis; (iv) participate in meetings and relevant discussions as requested by
management; (v) conduct general advisory or liaison services to the Board, including relaying to management requests from other members of the Board
regarding desired additional information or clarification or suggestions or feedback regarding improvement in Board processes or communications; (vi)
serve as a conduit for informal communications between management and the Board; and (vii) any other such services established by the Board from time
to time.
Acting on behalf of our Board of Directors, Dr. Voss also received fees totaling $48,000 in 2020 for his role as a strategic advisor to our Chief Executive
Officer. Dr. Voss’ responsibilities as a strategic advisor include the following: (i) provide strategic and tactical advice to our Chief Executive Officer; (ii)
evaluate international subsidiary options; (iii) develop strategies to secure business relationships other than in the U.S.; and (iv) having done both (ii) and
(iii), develop high potential ex-US market strategies that address the objectives for broad and profitable sales of its commercial products.
COMPENSATION COMMITTEE INTERLOCKS AND INSIDER PARTICIPATION
Mr. Hooper and Drs. Chow and Martinez (until his retirement from the Board of Directors on December 31, 2020) each served on the Compensation
Committee of our Board of Directors for 2020. No director who served on our Compensation Committee at any time during 2020 is or was a current or
former executive officer or employee of the Company, or had any relationships requiring disclosure by the Company under the SEC’s rules requiring
disclosure of certain relationships and related party transactions. None of the members of the Compensation Committee during fiscal year 2020 was, or has
ever been, an officer or employee of the Company, and, during fiscal year 2020, no executive officer of the Company served on the board and/or
compensation committee of any company that employed as an executive officer any member of the Company’s Board and/or Compensation Committee.
STOCK OWNERSHIP GUIDELINES FOR NON-EMPLOYEE AND EXECUTIVE DIRECTORS
Our Board of Directors believes that, as a matter of sound corporate governance, non-employee and executive directors should have a significant personal
financial stake in our performance. Consequently, in February 2011, our Board of Directors adopted stock ownership guidelines for non-employee and
executive directors. Our corporate governance guidelines require that each non-employee director acquire and hold shares of our common stock having an
aggregate value equal to two times the director’s total compensation in the first year of service and that our executive director acquire and hold shares of
our common stock having an aggregate value equal to the executive director’s total compensation in the first year of service. Each director is expected to
satisfy the applicable ownership guideline within three years after his or her appointment to the Board.
Shares of our common stock that count toward satisfaction of these ownership guidelines include, unless beneficial ownership therein is disclaimed: (i)
shares owned outright by the director or executive officer or their immediate family members residing in the same household, whether held individually or
jointly; (ii) shares held in a trust, family limited partnership or similar entity solely for the benefit of the director or executive officer and/or their immediate
family members; (iii) shares of restricted stock and restricted stock units awarded under our equity incentive plans, including vested and unvested awards;
and (iv) shares acquired upon stock option exercise, but not shares underlying unexercised stock options.
101
ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS
BENEFICIAL OWNERSHIP OF COMMON STOCK
The following table sets forth certain information known to the Company regarding the beneficial ownership of the Company’s common stock as of March
18, 2021 by:
● each person or group known by us to own beneficially more than five percent of the outstanding common stock;
● each of our directors and the director nominees, as well as each executive officer named in the Summary Compensation Table appearing under the
heading “Executive Compensation”; and
● our directors and executive officers as a group.
We determine beneficial ownership in accordance with the rules of the SEC. Under SEC rules, beneficial ownership for purposes of this table takes into
account shares as to which the individual has voting or investment power as well as shares that may be acquired within 60 days. Shares of common stock
subject to options that are currently exercisable or that become exercisable within 60 days of March 18, 2021 are treated as outstanding and beneficially
owned by the holder of such options. However, these shares are not treated as outstanding for purposes of computing the percentage ownership of any other
person. Unless otherwise indicated or as to the interests of spouses, the persons included in the table have sole voting and investment power with respect to
all shares beneficially owned thereby.
NUMBER OF SHARES OF COMMON STOCK BENEFICIALLY OWNED
NAME OF BENEFICIAL OWNER
Ayrton Capital, LLC (3)
Altium Capital Management, LP (4)
CVI Investments, Inc. (5)
Augustine Chow* (6)
Robert W. Hooper* (7)
Alberto Martinez* (8)
Frederick J. Fritz* (9)
Donald P. Braun* (10)
Andreas Voss* (11)
Michael H. Tardugno* (12)
Nicholas Borys* (13)
Khursheed Anwer* (14)
Jeffrey W. Church* (15)
Directors and Executive Officers as a group (10 persons)
NUMBER OF
SHARES OF
COMMON
STOCK
BENEFICIALLY
OWNED
(1)
PERCENT OF
SHARES OF
COMMON
STOCK
OUTSTANDING
(2)
5,555,555
5,555,555
5,555,555
120,466
140,758
150,880
166,943
85,976
92,226
1,538,771
356,848
282,534
492,583
3,427,985
7.41%
7.41%
7.41%
**
**
**
**
**
**
2.05%
**
**
**
4.57%
*
The address of each of the individuals named is c/o Celsion Corporation, 997 Lenox Drive, Suite 100, Lawrenceville, NJ 08648.
**
Less than one percent.
(1) Beneficial Ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to
securities. Except as indicated by footnote, and subject to community property laws where applicable, the persons named in the table above
have sole voting and investment power with respect to all shares of common stock shown as beneficially owned by them.
102
(2) Based on 75,011,774 shares of common stock outstanding as of March 18, 2021.
(3) Based on the Schedule 13G filed by Ayrton Capital, LLC (“Ayrton Capital”) on January 29, 2021, reporting beneficial ownership as of January
22, 2021. The Schedule 13G provides information only as of January 22, 2021, and, consequently, the beneficial ownership of the above-
mentioned reporting person may have changed between January 22, 2021 and March 18, 2021. Shares reported herein were held by Alto
Opportunity Master Fund, SPC— Segregated Master Portfolio B (the “Fund”), a Cayman Islands exempted company. The Fund is a private
investment vehicle for which Ayrton Capital LLC serves as the investment manager and Waqas Khatri serves as the managing member of the
Ayrton Capital LLC. The address of the principal business and office of Ayrton Capital LLC and its affiliates is 222 Broadway 19th Floor, New
York, New York, 10038.
(4) Based on the Schedule 13G filed by Altium Capital Management, LLC (“Altium Capital”) on January 29, 2021, reporting beneficial ownership
as of January 22, 2021. The Schedule 13G provides information only as of January 22, 2021, and, consequently, the beneficial ownership of
the above-mentioned reporting person may have changed between January 22, 2021 and March 18, 2021. This statement is jointly filed by and
on behalf of each of Altium Growth Fund, LP (the “Fund”), Altium Capital Management, LLC, and Altium Growth GP, LLC. The Fund is the
record and direct beneficial owner of the securities covered by this statement. Altium Capital Management, LP is the investment adviser of,
and may be deemed to beneficially own securities, owned by, the Fund. Altium Growth GP, LLC is the general partner of, and may be deemed
to beneficially own securities owned by the Fund. The address of the principal business office of each of the reporting persons is 152 West 57
Street, FL 20, New York, NY 10019.
(5) Based on the Schedule 13G filed by CVI Investments Inc. (“CVI”) and Heights Capital Management (“Heights”) on January 29, 2021,
reporting beneficial ownership as of January 22, 2021. The Schedule 13G provides information only as of January 22, 2021, and, consequently,
the beneficial ownership of the above-mentioned reporting person may have changed between January 22, 2021 and March 18, 2021. Heights
which serves as the investment manager to CVI may be deemed to be the beneficial owner of all shares owned by Martin Kobinger, in his
capacity as Investment Manager of Heights Capital Management, Inc., may also be deemed to have investment discretion and voting power
over the shares held by CVI. Each of Heights, CVI and Mr. Kobinger hereby disclaims any beneficial ownership of any such shares, except for
their pecuniary interest therein. CVI Investments Inc.’s address is P.O. Box 309GT, Ugland House, South Church Street, George Town, Grand
Cayman KY1-1104 Cayman Islands and Heights Capital Management’s address is 101 California Street, Suite 3250, San Francisco, California
94111.
(6)
Includes 119,023 shares of common stock underlying options currently exercisable or exercisable within 60 days of March 18, 2021.
(7)
Includes 115,071 shares of common stock underlying options currently exercisable or exercisable within 60 days of March 18, 2021.
(8)
Includes 105,880 shares of common stock underlying options currently exercisable or exercisable within 60 days of March 18, 2021.
103
(9)
Includes 115,452 shares of common stock underlying options currently exercisable or exercisable within 60 days of March 18, 2021.
(10)
Includes 85,619 shares of common stock underlying options currently exercisable or exercisable within 60 days of March 18, 2021.
(11)
Includes 85,619 shares of common stock underlying options currently exercisable or exercisable within 60 days of March 18, 2021.
(12)
Includes 1,351,071 shares of common stock underlying options currently exercisable or exercisable within 60 days of March 18, 2021.
(13)
Includes 305,424 shares of common stock underlying options currently exercisable or exercisable within 60 days of March 18, 2021.
(14)
Includes 239,677 shares of common stock underlying options currently exercisable or exercisable within 60 days of March 18, 2021.
(15)
Includes 438,285 shares of common stock underlying options currently exercisable or exercisable within 60 days of March 18, 2021.
Equity Compensation Plan Information as of December 31, 2020
Plan Category
Equity compensation plans approved by security
holders
Equity compensation plans not approved by security
holders
Total
Number of securities
to be issued upon
exercise of
outstanding
options, warrants
and rights (a)
Weighted-
average exercise price
of outstanding
options,
warrants and
rights (b)
Number of
Securities remaining
available for
future issuance
under equity compensation
plans (excluding securities
reflected in
column (a)) (c)
4,487,471(1) $
140,004(3)
4,624,725
$
2.86
2.48
2.77
2,018,453(2)
–
2,018,453
(1) Includes both vested and unvested options to purchase common stock and unvested stock grants under the 2018 Plan. These awards have a
weighted average remaining term of 7.5 years.
(2) Represents shares available for award grant purposes under the 2018 Plan. Subject to certain express limits of the plan, shares available under
the plan generally may be used for any type of award authorized under that plan including options, stock appreciation rights, restricted stock
and other forms of awards granted or denominated in shares of our common stock or units of our common stock.
(3) Includes both vested and unvested options to purchase common stock and unvested stock grants under inducement grants provided certain
employees as an inducement to accept employment with the Company. These awards have a weighted average remaining term of 8.5 years.
These grants are similar to those granted under the 2018 Plan and is more fully discussed in Note 11 to the financial statements in this 2020
Annual Report on Form 10-K filed.
104
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Related Party Transactions
None
Director Independence
In addition, in accordance with the rules of the SEC and NASDAQ, the Company requires that at least a majority of the directors serving at any time on the
Board of Directors be independent, that at least three directors satisfy the financial literacy requirements for service on the Audit Committee and that at
least one member of the Audit Committee qualify as an “audit committee financial expert” under those rules.
The Board of Directors has determined that Mr. Fritz is qualified to serve as the “audit committee financial expert” as defined by Item 407(d)(5) of
Regulation S-K and that Mr. Fritz and Drs. Chow and Braun meet the financial literacy requirements under applicable SEC and NASDAQ rules. The Board
of Directors determined that of the six currently serving directors, five directors (Drs. Augustine Chow, Donald P. Braun, Andreas Voss and Messrs. Robert
W. Hooper and Frederick J. Fritz) are independent under applicable SEC and NASDAQ rules. Mr. Fritz acts as the chairman of our Audit Committee.
ITEM 14.
PRINCIPAL ACCOUNTANT FEES AND SERVICES
Our Audit Committee has appointed Withum as the independent registered public accounting firm of the Company to audit our financial statements for the
fiscal year ending December 31, 2020, and our Board requests stockholder ratification of such selection. Withum has served as our independent
accountants since 2017 and has advised us that neither Withum nor any of its members has, or has had in the past three years, any financial interest in the
Company or any relation to the Company other than as auditors and accountants.
FEES
The following table presents fees as invoiced for professional audit services rendered for the audit of our annual financial statements included in the
Company’s Form 10-K and review of quarterly financial statements included in the Company’s Forms 10-Q for the fiscal years ended December 31, 2020
and December 31, 2019, and fees for other services rendered during those periods:
FEE CATEGORY
Audit Fees
Audit Related Fees
Tax Fees
All Other Fees
Total Fees
2020
2019
$
AMOUNT
101,000
69,000
9,000
–
$
179,000 $
105
%
OF TOTAL
56% $
39
5
–
100% $
AMOUNT
98,500
20,800
8,900
–
128,200
%
OF TOTAL
77%
16
7
–
100%
Audit fees consist of fees for professional services rendered by Withum for the audits of our annual financial statements in our Form 10-K and for reviews
of the quarterly financial statements included in the Company’s Forms 10-Q. Audit related fees pertain to the work performed during our equity offerings in
2020 and 2019. Tax fees consist of fees for preparation of the Company’s federal and state tax returns. All other fees consist of fees for attendance at the
Company’s annual meetings, review of registration statements and similar matters.
SERVICES BY EMPLOYEES OF WITHUM
No part of Withum’s engagement to audit the Company’s financial statements for the years ended December 31, 2020 and 2019 was attributable to work
performed by persons other than Withum’s full-time, permanent employees.
AUDIT COMMITTEE POLICY ON APPROVAL OF AUDIT AND NON-AUDIT SERVICES
It is the policy of the Audit Committee to pre-approve all audit and permissible non-audit services provided by our independent accountants, in accordance
with rules prescribed by the SEC. These services may include audit services, audit-related services, tax services, and other services. Pre-approval is based
on a written proposal, accompanied by a cost estimate and estimated budget. The Audit Committee has delegated to its Chairman the authority to pre-
approve audit and non-audit services with an estimated cost of up to $25,000, provided the exercise of such authority is reported to the Audit Committee at
its next regular meeting. The Audit Committee reserves the right, from time to time, to delegate pre-approval authority to other of its members, so long as
such members are independent directors. All audit and permissible non-audit services during 2020 and 2019 were approved by the Audit Committee in
accordance with its pre-approval policy and the approval requirements of the SEC.
106
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) The following documents are filed as part of this Annual Report:
1. FINANCIAL STATEMENTS
PART IV
The following is a list of the consolidated financial statements of Celsion Corporation filed with this Annual Report, together with the reports of our
independent registered public accountants and Management’s Report on Internal Control over Financial Reporting.
REPORTS
Reports of Independent Registered Public Accounting Firms
FINANCIAL STATEMENTS
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Comprehensive Loss
Consolidated Statements of Cash Flows
Consolidated Statements of Changes in Stockholders’ Equity
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
2. FINANCIAL STATEMENT SCHEDULES
Page
F-1
F-2
F-4
F-5
F-6
F-8
F-10
All financial statement schedules are omitted because the information is inapplicable or presented in the notes to the consolidated financial statements.
3. EXHIBITS
The following documents are included as exhibits to this report:
EXHIBIT
NO.
DESCRIPTION
2.1*
Asset Purchase Agreement dated as of June 6, 2014, by and between Celsion Corporation and EGEN, Inc., incorporated herein by reference
to Exhibit 2.1 to the Quarterly Report on Form 10-Q of the Company for the quarter ended June 30, 2014.
3.1
Certificate of Incorporation of Celsion, as amended, incorporated herein by reference to Exhibit 3.1 to the Quarterly Report on Form 10-Q
of the Company for the quarter ended June 30, 2004.
3.2
Certificate of Ownership and Merger of Celsion Corporation (a Maryland Corporation) into Celsion (Delaware) Corporation (inter alia,
changing the Company’s name to “Celsion Corporation” from “Celsion (Delaware) Corporation”), incorporated herein by reference to
Exhibit 3.1.3 to the Annual Report of the Company for the year ended September 30, 2000.
3.3
Certificate of Amendment of the Certificate of Incorporation effective and filed on February 27, 2006, incorporated therein by reference to
Exhibit 3.1 to the Current Report on Form 8-K of the Company filed on March 1, 2006.
107
3.4
Certificate of Amendment to Certificate of Incorporation effective October 28, 2013, incorporated herein by reference to Exhibit 3.1 to the
Current Report on Form 8-K of the Company filed on October 29, 2013.
3.5
Certificate of Amendment to Certificate of Incorporation effective June 15, 2016, incorporated herein by reference to Exhibit 3.1 to the
Current Report on Form 8-K of the Company, filed on June 15, 2016.
3.6
Certificate of Amendment to Certificate of Incorporation, effective May 26, 2017, incorporated herein by reference to Exhibit 3.1 to the
Current Report on Form 8-K of the Company, filed on May 26, 2017.
3.7
Amended and Restated By-laws of the Company dated June 16, 2020, incorporated by reference to Exhibit 3.1 to the Quarterly Report of
the Company for the quarter ended June 30, 2020.
4.1
Form of Common Stock Certificate, par value $0.01, incorporated herein by reference to Exhibit 4.1 to the Annual Report of the Company
for the year ended September 30, 2000.
4.2
Form of Representative’s Common Stock Purchase Warrant, incorporated herein by reference to Exhibit 4.2 to the Current Report on Form
8-K of the Company, filed on October 31, 2017.
4.3
Form of Placement Agent Common Stock Purchase Warrant incorporated herein by reference to Exhibit 4.4 to the Current Report on Form
8-K of the Company, filed on July 11, 2017.
4.4
Form of Series AA Warrant, incorporated herein by reference to Exhibit 4.26 to the Registration Statement to the Registration Statement on
Form S-1 of the Company, filed on February 13, 2017.
4.5
Form of Amended and Restated Warrant (issued under First Amendment of Venture Loan and Security Agreement, dated as of August 1,
2020, by and among Celsion Corporation, Horizon Funding I, LLC, Horizon Funding Trust 2019-1, and Horizon Technology Finance
Corporation, as Collateral Agent), incorporated herein by reference to Exhibit 4.1 to the Current Report on Form 8-K of the Company, filed
on September 4, 2020.
4.6
Form of Exchange Warrant, incorporated herein by reference to Exhibit 4.1 to the Current Report on Form 8-K of the Company, filed on
March 13, 2020.
4.7
Description of Securities of the Registrant, incorporated herein by reference to Exhibit 4.5 to the Annual Report on Form 10-K of the
Company, filed on March 25, 2020.
10.1***
Celsion Corporation 2007 Stock Incentive Plan, as amended, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form
8-K of the Company, filed on May 16, 2017.
10.2
Form Inducement Offer to Exercise Common Stock Purchase Warrants, incorporated herein by reference to exhibit 10.3 to the Quarterly
Report on Form 10-Q of the Company for the quarter ended September 30, 2017.
10.3***
Celsion Corporation 2018 Stock Incentive Plan, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K of the
Company filed May 15, 2018.
10.4***
First Amendment to the Celsion Corporation 2018 Stock Incentive Plan, incorporated by reference to Exhibit 10.1 to the Current Report on
Form 8-K of the Company, filed on May 15, 2020.
10.5***
Second Amendment to the Celsion Corporation 2018 Stock Incentive Plan, incorporated by reference to Exhibit 10.1 to the Current Report
on Form 8-K of the Company, filed on June 16, 2020.
108
10.6***
Amended and Restated Employment Agreement, effective March 30, 2016, between Celsion Corporation and Mr. Michael H. Tardugno,
incorporated by reference to Exhibit 10.8 to the Annual Report of the Company filed on March 30, 2016.
10.7***
Employment Offer Letter, entered into on June 15, 2010, between the Company and Jeffrey W. Church, incorporated herein by reference to
Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on June 18, 2010.
10.8*
Patent License Agreement between the Company and Duke University dated November 10, 1999, incorporated herein by reference to
Exhibit 10.9 to the Annual Report of the Company for the year ended September 30, 1999.
10.9*
License Agreement dated July 18, 2003, between the Company and Duke University, incorporated herein by reference to Exhibit 10.1 to the
Registration Statement on Form S-3 (File No. 333-108318) filed on August 28, 2003.
10.10*
10.11*
Development, Product Supply and Commercialization Agreement, effective December 5, 2008, by and between the Company and Yakult
Honsha Co., Ltd., incorporated herein by reference to Exhibit 10.15 to the Annual Report of the Company for the year ended December 31,
2008.
The 2nd Amendment to The Development, Product Supply and Commercialization Agreement, effective January 7, 2011, by and between
the Company and Yakult Honsha Co., Ltd. incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the
Company filed on January 18, 2011.
10.12
Lease Agreement, executed July 21, 2011, by and between Celsion Corporation and Brandywine Operating Partnership, L.P., incorporated
herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on July 25, 2011.
10.13
First Amendment to Lease Agreement, executed April 20, 2017, by and between Celsion Corporation and Lenox Drive Office Park, LLC,
incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 10-Q of the Company filed on November 14, 2017.
10.14*
10.15*
Technology Development Agreement effective as of May 7, 2012, by and between Celsion Corporation and Zhejiang Hisun Pharmaceutical
Co. Ltd., incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of the Company for the quarter ended June
30, 2012.
Technology Development Contract dated as of January 18, 2013, by and between Celsion Corporation and Zhejiang Hisun Pharmaceutical
Co. Ltd., incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q of the Company for the quarter ended
March 31, 2013.
10.16***
Employment Offer Letter effective as of June 2, 2014, between the Company and Khursheed Anwer incorporated herein by reference to
Exhibit 10.27 to the Annual Report of the Company for the year ended December 31, 2014.
10.17***
10.18***
10.19***
Amended and Restated Change in Control Agreement dated as of September 6, 2016, by and between the Company and Michael H.
Tardugno, incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q of the Company for the quarter ended
September 30, 2016.
Amended and Restated Change in Control Agreement dated as of September 6, 2016, by and between the Company and Nicholas Borys,
M.D., incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of the Company for the quarter ended
September 30, 2016.
Amended and Restated Change in Control Agreement dated as of September 6, 2016, by and between the Company and Jeffrey W. Church,
incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30,
2016.
109
10.20*** Amended and Restated Change in Control Agreement dated as of September 6, 2016, by and between the Company and Timothy J.
Tumminello, incorporated herein by reference to Exhibit 10.4 to the Quarterly Report on Form 10-Q of the Company for the quarter ended
September 30, 2016.
10.21
Form of Securities Purchase Agreement incorporated herein by reference to Exhibit 10.33 to the Registration Statement on Form S-1 of the
Company filed on February 13, 2017.
10.22
10.23
10.24
Lease Agreement dated January 15, 2018, by and between Celsion Corporation and HudsonAlpha Institute of Biotechnology for office and
lab space located in Huntsville, Alabama incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q of the
Company for the quarter ended March 31, 2018.
Venture Loan and Security Agreement dated June 27, 2018, by and between Celsion Corporation and Horizon Technology Finance
Corporation incorporated herein by reference to Exhibit 10.0 to the Quarterly Report on Form 10-Q of the Company for the quarter ended
June 30, 2018.
First Amendment of Venture Loan and Security Agreement, dated as of August 1, 2020, by and among Celsion Corporation, Horizon
Funding I, LLC, Horizon Funding Trust 2019-1, and Horizon Technology Finance Corporation, as Collateral Agent, incorporated herein by
reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed with the SEC on September 4, 2020
10.25
Common Stock Purchase Agreement, dated August 31, 2018 between Celsion Corporation and Aspire Capital Fund, LLC incorporated by
reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on September 4, 2018.
10.26
Capital on DemandTM Sales Agreement, dated December 4, 2018, between Celsion Corporation and JonesTrading Institutional Services
LLC incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on December 4, 2018.
10.27
Common Stock Purchase Agreement, dated October 28, 2019 between Celsion Corporation and Aspire Capital Fund, LLC incorporated by
reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on October 28, 2019.
10.28
Placement Agent Agreement, dated January 22, 2021, between Celsion Corporation and A.G.P./Alliance Global Partners, incorporated by
reference to Exhibit 1.1 to the Current Report on Form 8-K of the Company, filed on January 25, 2021.
10.29
Form of Securities Purchase Agreement between Celsion Corporation and the investors therein, dated January 22, 2021, incorporated by
reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company, filed on January 5, 2021.
10.30
Form of Securities Purchase Agreement between Celsion Corporation and the investors therein, dated February 27, 2020, incorporated by
reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company, filed on March 3, 2020.
10.31
Settlement Agreement and Release, by and between the plaintiff to the shareholder action captioned O’Connor v. Braun, et al., N.J. Super.,
Dkt. No. MERC-00068-19, William J. O’Connor, derivatively on behalf of Celsion Corporation and individually on behalf of himself and
all other similarly situated stockholders of Celsion Corporation and defendants, incorporated herein by reference to Exhibit 10.2 to the
Current Report on Form 8-K of the Company, filed on June 16, 2020.
10.32
Form of Exercise Agreement, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company, filed on March
13, 2020.
21.1+
Subsidiaries of Celsion Corporation
110
23.1+
Consent of WithumSmith+Brown, PC, independent registered public accounting firm for the Company.
31.1+
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2+
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1^
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.
32.2^
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.
101**
The following materials from the Company’s Annual Report for the fiscal year ended December 31, 2019, formatted in XBRL (Extensible
Business Reporting Language): (i) the audited Consolidated Balance Sheets, (ii) the audited Consolidated Statements of Operations, (iii) the
audited Consolidated Statements of Comprehensive Loss, (iv) the audited Consolidated Statements of Cash Flows, (v) the audited
Consolidated Statements of Changes in Stockholders’ Equity and (vi) Notes to Consolidated Financial Statements.
*
Portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act
of 1934, amended, and the omitted material has been separately filed with the Securities and Exchange Commission.
+
^
**
***
Filed herewith.
Furnished herewith.
XBRL information is filed herewith.
Management contract or compensatory plan or arrangement.
ITEM 16. FORM 10-K SUMMARY
None.
111
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its
behalf by the undersigned thereunto duly authorized.
SIGNATURES
March 19, 2021
March 19, 2021
CELSION CORPORATION
Registrant
By: /s/ MICHAEL H. TARDUGNO
Michael H. Tardugno
Chairman of the Board, President and Chief Executive Officer
By: /s/ JEFFREY W. CHURCH
Jeffrey W. Church
Executive Vice President and
Chief Financial Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant
and in the capacities and on the dates indicated:
Name
Position
/s/ MICHAEL H. TARDUGNO
(Michael H. Tardugno)
/s/ JEFFREY W. CHURCH
(Jeffrey W. Church)
/s/ TIMOTHY J. TUMMINELLO
(Timothy J. Tumminello)
/s/ AUGUSTINE CHOW
(Augustine Chow, Ph.D.)
/s/ FREDERICK J. FRITZ
(Frederick J. Fritz)
/s/ ROBERT W. HOOPER
(Robert W. Hooper)
/s/ DONALD BRAUN
(Donald Braun, Ph.D.)
/s/ ANDREAS VOSS
(Andreas Voss, M.D.)
Chairman of the Board, President and
Chief Executive Officer
(Principal Executive Officer)
Executive Vice President and Chief
Financial Officer (Principal Financial Officer)
Date
March 19, 2021
March 19, 2021
Controller and Chief Accounting Officer
March 19, 2021
Director
Director
Director
Director
Director
112
March 19, 2021
March 19, 2021
March 19, 2021
March 19, 2021
March 19, 2021
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
Celsion Corporation:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Celsion Corporation (the “Company”) as of December 31, 2020 and 2019, the related
consolidated statements of operations, comprehensive loss, changes in stockholders’ equity, and cash flows for each of the two years in the period ended
December 31, 2020 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, 2020 and 2019, and the results of its operations and its cash flows for each of
the two years in the period ended December 31, 2020, in conformity with accounting principles generally accepted in the United States of America.
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 audits 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.
Our 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.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or
required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2)
involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion
on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion
on the critical audit matter or on the accounts or disclosures to which they relate.
Fair Value Calculations
Description of the Matter:
At December 31, 2020, the Company’s goodwill was $1,976,101 and indefinite lived in-process research and development assets (IPR&D) was
$13,366,234. As discussed in Note 5 to the consolidated financial statements, goodwill and indefinite lived IPR&D are tested at least annually for
impairment or when events or changes in circumstances indicate it is more likely than not that the carrying amount of such assets may not be recoverable.
To determine the estimated fair value of reporting unit and the intangible assets, management considers both market and income valuation approaches.
At December 31, 2020, the Company’s Earn-out milestone liability was $7,018,000. As discussed in Note 12 to the consolidated financial statements, the
Earn-out milestone liability is remeasured at fair value, with changes in fair value reported in earnings.
Auditing management’s impairment tests for the goodwill, intangible assets, and the earn-out milestone liability was complex and judgmental due to the
subjectivity required when identifying triggering events and the evaluation of significant, unobservable assumptions used in the fair value calculations.
How We Addressed the Matter in Our Audit:
We obtained an understanding of controls over the Company’s annual goodwill and intangible asset impairment review process and the recurring fair value
measurement of the earn-out milestone liability.
To test the estimated fair value of the reporting unit, intangible assets and estimated fair value earn-out milestone liability, we performed audit procedures
that included, among others, assessing methodologies and testing the significant assumptions and the underlying data used by the Company in its analyses.
We compared the significant assumptions used by management to current market and economic trends and other relevant factors. We involved valuation
specialists to assist with assessing the methodologies and evaluating certain significant assumptions. We performed sensitivity analyses on significant
assumptions to evaluate the changes in the fair value that would result from changes in the assumptions.
The Company’s business plan and going concern considerations
Description of Matter
The Company’s financial statements include disclosure of their business plan, including sources and uses of cash.
Auditing management’s conclusions about whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a
going concern within one year after the financial statements are issued is subjective and requires significant judgement.
How We Addressed the Matter in Our Audit
We obtained an understanding of controls over the Company’s process for determining their ability to continue as a going concern.
To test the Company’s conclusion about their ability to continue as a going concern, we obtained information about their plans and considered the
likelihood of whether the Company would be unable to fund operations and meet their financial obligations as they become due for a reasonable period of
time and whether such plans could be effectively implemented.
/s/ WithumSmith+Brown, PC
WithumSmith+Brown, PC
We have served as the Company’s auditor since 2017.
Princeton, New Jersey
March 19, 2021
F-1
CELSION CORPORATION
CONSOLIDATED BALANCE SHEETS
ASSETS
Current assets:
Cash and cash equivalents
Investment in debt securities - available for sale, at fair value
Accrued interest receivable on investment securities
Advances and deposits on clinical programs and other current assets
Total current assets
December 31,
2020
2019
$
17,164,177 $
–
–
1,660,695
18,824,872
6,875,273
7,985,886
21,369
1,352,670
16,235,198
Property and equipment (at cost, less accumulated depreciation and amortization)
294,551
405,363
Other assets:
Deferred income tax asset
In-process research and development, net
Goodwill
Operating lease right-of-use assets, net
Other intangible assets, net
Deposits and other assets
Total other assets
Total assets
1,845,823
13,366,234
1,976,101
1,047,336
113,660
58,761
18,407,915
1,819,324
15,736,491
1,976,101
1,431,640
340,976
333,274
21,637,806
$
37,527,338 $
38,278,367
See accompanying notes to the consolidated financial statements.
F-2
CELSION CORPORATION
CONSOLIDATED BALANCE SHEETS
(Continued)
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable – trade
Other accrued liabilities
Notes payable – current portion, net of deferred financing costs
Operating lease liability - current portion
Deferred revenue - current portion
Total current liabilities
Earn-out milestone liability
Notes payable – non-current portion, net of deferred financing costs
Operating lease liability - non-current portion
Deferred revenue - non-current portion
Total liabilities
Commitments and contingencies
Stockholders’ equity:
Preferred Stock - $0.01 par value (100,000 shares authorized, and no shares issued or
outstanding at December 31, 2020 and 2019)
Common stock - $0.01 par value (112,500,000 shares authorized; 40,701,356 and 23,256,152
shares issued at December 31, 2020 and 2019, respectively, and 40,701,022 and 23,255,818
shares outstanding at December 31, 2020 and 2019, respectively)
Additional paid-in capital
Accumulated other comprehensive gain
Accumulated deficit
Total stockholders’ equity before treasury stock
Treasury stock, at cost (334 shares at December 31, 2020 and 2019)
Total stockholders’ equity
$
December 31,
2020
2019
2,244,847 $
2,458,532
1,116,663
433,413
500,000
6,753,455
7,018,000
3,934,497
710,305
500,000
18,916,257
–
–
407,014
330,289,596
–
(312,000,341)
18,696,269
(85,188)
18,611,081
2,862,949
2,303,547
1,840,228
387,733
500,000
7,894,457
5,717,709
7,963,449
1,143,717
1,000,000
23,719,332
–
–
232,562
304,885,663
42,778
(290,516,780)
14,644,223
(85,188)
14,559,035
Total liabilities and stockholders’ equity
$
37,527,338 $
38,278,367
See accompanying notes to the consolidated financial statements.
F-3
CELSION CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
Year ended December 31,
2020
2019
Technology development and licensing revenue
$
500,000 $
500,000
Operating expenses:
Research and development
General and administrative
Total operating expenses
Loss from operations
Other income (expense):
(Loss) gain from change in earn-out milestone liability
Fair value of warrants issued in connection with amendment to modify GEN-1 earn-out
milestone payments
Impairment of in-process research and development
Investment income, net
Interest expense
Other income
Total other (expense) income
Loss before income tax benefit
Income tax benefit
Net loss
Net loss per common share - basic and diluted
11,344,819
7,641,593
18,986,412
13,065,309
8,000,164
21,065,473
(18,486,412)
(20,565,473)
(1,300,291)
3,189,955
–
(2,370,257)
119,907
(1,292,338)
7
(4,842,972)
(400,000)
–
500,882
(1,393,400)
29
1,897,466
(23,329,384)
(18,668,007)
1,845,823
1,816,474
(21,483,561) $
(16,851,533)
(0.67) $
(0.77)
$
$
Weighted average common shares outstanding - basic and diluted
31,961,248
21,832,932
See accompanying notes to the consolidated financial statements.
F-4
CELSION CORPORATION
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
Net loss
Changes in:
Realized (gain) on investment securities recognized in investment income, net
Unrealized gain on investment securities
Other comprehensive (loss) income
Comprehensive loss
Year Ended December 31,
2020
2019
(21,483,561) $
(16,851,533)
(53,354)
10,576
(42,778)
(57,895)
70,801
12,906
(21,526,339) $
(16,838,627)
$
$
See accompanying notes to the consolidated financial statements.
F-5
CELSION CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year ended December 31,
2020
2019
$
(21,483,561) $
(16,851,533)
Cash flows from operating activities:
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
Change in fair value of earn-out milestone liability
Fair value of warrants issued in connection with amendment to modify the GEN-1 earn-out
milestone payments
Fair value of warrants issued in exchange for services
Stock-based compensation
Shares issued upon vesting of stock awards
Change in deferred income tax asset
Impairment of in-process research and development
Amortization of deferred finance charges and debt discount associated with note payable
Net changes in:
Accrued interest receivable on investment securities
Advances and deposits on clinical programs and other current assets
Other assets
Accounts payable – trade
Deferred revenue
Other accrued liabilities
Net cash used in operating activities
Cash flows from investing activities:
Purchases of investment in debt securities
Proceeds from sale and maturity of investment in debt securities
Purchases of property and equipment
Net cash provided by investing activities
Cash flows from financing activities:
Proceeds from issuance of common stock equity, net of issuance costs
Proceeds from issuance of common stock upon exercise of stock options
Payments on notes payable including end-of-term fees
Proceeds from Paycheck Protection Program (“PPP”) loans
Repayments on PPP loans
Net cash provided by financing activities
741,524
1,300,291
–
44,798
1,851,391
–
(26,499)
2,370,257
447,483
21,369
(308,025)
274,513
(618,102)
(500,000)
265,885
(15,618,676)
(9,956,892)
17,900,000
(19,092)
7,924,016
22,811,669
371,895
(5,200,000)
1,324,750
(1,324,750)
17,983,564
721,665
(3,189,955)
400,000
–
2,286,388
5,350
(1,819,324)
–
386,640
46,940
(901,377)
(74,341)
(157,689)
(500,000)
(611,746)
(20,258,982)
(23,829,982)
30,115,000
(349,158)
5,935,860
7,844,852
–
–
–
–
7,844,852
(6,478,270)
13,353,543
6,875,273
Increase (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of year
Cash and cash equivalents at end of year
10,288,904
6,875,273
17,164,177 $
$
See accompanying notes to the consolidated financial statements.
F-6
CELSION CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS (continued)
Supplemental disclosures of cash flow information:
Cash (paid for) received from:
Interest
Cash paid for amounts included in measurement of lease liabilities:
Operating cash flows from lease payments
Non-cash financing and investing activities
Common stock issued to settle accrued bonuses
Fair value of warrants issued in connection with the debt facility, net of cancelled warrants
Realized and unrealized (gains) and losses, net, on investment in debt securities
Year ended December 31,
2020
2019
$
$
$
$
$
(844,278) $
(1,006,760)
525,809 $
485,848
498,632 $
81,102 $
—
—
(42,778) $
12,906
See accompanying notes to the consolidated financial statements.
F-7
CELSION CORPORATION
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
YEAR ENDED DECEMBER 31, 2019
Common Stock
Outstanding
Shares
Amount
Additional
Paid-in
Capital
Treasury Stock
Shares Amount
Accum.
Other
Compr. Accumulated
Income
Deficit
Total
Balance at January 1, 2019
Net loss
Sale of equity through equity
financing facilities
Common stock warrants issued
in connection with amendment to
modify GEN-1 earn-out
milestone payments
Realized and unrealized gains
and losses, net, on investment
securities
Stock-based compensation
expense
Issuance of restricted stock
Balance at December 31, 2019
18,831,834 $ 188,322 $ 294,393,313
-
-
-
334 $ (85,188) $ 29,872 $ (273,665,247) $ 20,861,072
(16,851,533)
(16,851,533)
-
-
-
4,385,984
43,860
7,800,992
-
-
-
-
7,844,852
-
-
-
-
400,000
-
-
-
-
-
-
400,000
-
12,906
-
12,906
-
38,000
2,286,388
4,970
23,255,818 $ 232,562 $ 304,885,663
-
380
-
-
2,286,388
5,350
334 $ (85,188) $ 42,778 $ (290,516,780) $ 14,559,035
-
-
-
-
-
-
See accompanying notes to the consolidated financial statements.
F-8
CELSION CORPORATION
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (continued)
YEAR ENDED DECEMBER 31, 2020
Common Stock
Outstanding
Shares
Amount
Additional
Paid-in
Capital
Treasury Stock
Shares Amount
Accum.
Other
Compr. Accumulated
Income
Deficit
Total
Balance at January 1, 2020
23,255,818 $ 232,562 $ 304,885,663
334 $ (85,188) $ 42,778 $ (290,516,780) $ 14,559,035
Net loss
-
-
-
16,674,225
166,741
22,644,928
-
-
-
-
-
(21,483,561)
(21,483,561)
-
-
22,811,669
Sale of equity through equity
financing facilities
Issuance of common stock upon
exercise of options and vesting
of stock awards
Issuance of common stock upon
exercise of common stock
warrants
Common stock issued to settle
accrued bonuses
Common stock warrants issued
in exchange for services
Stock-based compensation
expense
Realized and unrealized gains
and losses, net, on investment
securities
Balance at December 31, 2020
143,864
1,439
370,456
-
-
-
-
371,895
-
-
-
-
-
-
-
498,632
-
44,798
-
1,851,391
197,260
1,973
(1,973)
429,855
4,299
494,333
-
-
-
44,798
-
1,851,391
-
40,701,022 $ 407,014 $ 330,289,596
-
-
-
-
-
-
-
-
-
-
-
-
See accompanying notes to the consolidated financial statements.
F-9
334 $ (85,188) $
(42,778)
(42,778)
-
- $ (312,000,341) $ 18,611,081
CELSION CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2020 AND 2019
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Description of Business
Celsion Corporation (“Celsion” and the “Company”) is a fully integrated, clinical stage biotechnology company focused on advancing a portfolio of
innovative treatments including DNA-based immunotherapies, next generation vaccines and directed chemotherapies through clinical trials and eventual
commercialization. The Company’s product pipeline includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer and
ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently under investigator-sponsored development for several cancer
indications. Celsion has two feasibility stage platform technologies for the development of novel nucleic acid-based immunotherapies and next generation
vaccines and other anti-cancer DNA or RNA therapies. Both are novel synthetic, non-viral vectors with demonstrated capability in nucleic acid cellular
transfection.
Basis of Presentation
The accompanying consolidated financial statements of Celsion have been prepared in accordance with generally accepted accounting principles
(“GAAP”) in the U.S. and include the accounts of the Company and CLSN Laboratories, Inc. All significant intercompany balances and transactions have
been eliminated in consolidation. The preparation of financial statements in conformity with GAAP requires management to make judgments, estimates,
and assumptions that affect the amount reported in the Company’s financial statements and accompanying notes. Actual results could differ materially from
these estimates.
Events and conditions arising subsequent to the most recent balance sheet date through the date of the issuance of these consolidated financial statements
have been evaluated for their possible impact on the financial statements and accompanying notes. No events and conditions would give rise to any
information that required accounting recognition or disclosure in the financial statements other than those arising in the ordinary course of business.
Use of Estimates
The preparation of financial statements in conformity with US GAAP requires the Company to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of
expenses during the reporting period.
On an ongoing basis, the Company evaluates its estimates using historical experience and other factors, including the current economic environment.
Significant items subject to such estimates are assumptions used for purposes of determining stock-based compensation, the fair value of the earn-out
milestone liabilities, estimates for contingent liabilities, if any, and accounting for valuation of in-process research and development assets and goodwill
evaluation. Management believes its estimates to be reasonable under the circumstances. Actual results could differ significantly from those estimates.
Significant estimates in these financials are the valuation of options granted and valuation methods used to determine the recoverability of goodwill and
other intangible assets.
Revenue Recognition
The Company’s sole revenue stream is related to the Hisun agreement described in Note 18. There were no accounts receivable as of December 31, 2020 or
2019. Contract liabilities from the Hisun agreement amounted to $1,000,000 and $1,500,000 at December 31, 2020 and 2019, respectively. Contract
liabilities values represent the value of cash received before the services were provided.
F-10
Cash and Cash Equivalents
Cash and cash equivalents include cash on hand and investments purchased with an original maturity of three months or less. A portion of these funds are
not covered by FDIC insurance.
Fair Value of Financial Instruments
The carrying values of investment securities approximate their respective fair values. Management believes that the carrying amounts of the Company’s
investment securities, including cash and cash equivalents, accounts payable and accrued expenses, approximate fair value due to the short-term nature of
those instruments. Short-term investments are recorded at their estimated fair value.
Short Term Investments
The Company classifies its investments in debt securities with readily determinable fair values as investments available-for-sale in accordance with
Accounting Standards Codification (“ASC”) 320, Investments - Debt and Equity Securities. Available-for-sale securities consist of debt securities not
classified as trading securities or as securities to be held to maturity. The Company has classified all of its investments as available-for-sale. Unrealized
holding gains and losses on available-for-sale securities are reported as a net amount in accumulated other comprehensive gain or loss in stockholders’
equity until realized. Gains and losses on the sale of available-for-sale securities are determined using the specific identification method. The Company’s
short-term investments consist of corporate bonds.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is provided over the estimated useful lives of the
related assets, ranging from three to seven years, using the straight-line method. Amortization is recognized over the lesser of the life of the asset or the
lease term. Major renewals and improvements are capitalized at cost and ordinary repairs and maintenance are charged against operating expenses as
incurred. Depreciation expense was approximately $130,000 and $128,500 for the years ended December 31, 2020 and 2019, respectively.
The Company reviews property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset
may not be recoverable. An asset is considered impaired if its carrying amount exceeds the future net undiscounted cash flows that the asset is expected to
generate. If such asset is considered to be impaired, the impairment recognized is the amount by which the carrying amount of the asset, if any, exceeds its
fair value determined using a discounted cash flow model. There was no impairment of property or equipment during 2020 or 2019.
Deposits
Deposits include real property security deposits and other deposits which are contractually required and of a long-term nature.
In-Process Research and Development, Other Intangible Assets and Goodwill
During 2014, the Company acquired certain assets of EGEN, Inc. As more fully described in Note 5, the acquisition was accounted for under the
acquisition method of accounting which required the Company to perform an allocation of the purchase price to the assets acquired and liabilities assumed.
Under the acquisition method of accounting, the total purchase price is allocated to net tangible and intangible assets and liabilities based on their estimated
fair values as of the acquisition date.
Impairment or Disposal of Long-Lived Assets
The Company assesses the impairment of its long-lived assets under accounting standards for the impairment or disposal of long-lived assets whenever
events or changes in circumstances indicate that the carrying value may not be recoverable. For long-lived assets to be held and used, the Company
recognizes an impairment loss only if its carrying amount is not recoverable through its undiscounted cash flows and measures the impairment loss based
on the difference between the carrying amount and fair value. See Note 5 for information on impairment losses of its in-process research and development.
F-11
Comprehensive Income (Loss)
ASC 220, Comprehensive Income, establishes standards for the reporting and display of comprehensive income (loss) and its components in the Company’s
consolidated financial statements. The objective of ASC 220 is to report a measure of comprehensive income (loss) of all changes in equity of an enterprise
that result from transactions and other economic events in a period other than transactions with owners. Comprehensive gains (losses) result from changes
in unrealized gains and losses from investment in debt securities.
Research and Development
Research and development costs are expensed as incurred. Equipment and facilities acquired for research and development activities that have alternative
future uses are capitalized and charged to expense over their estimated useful lives.
Net Loss Per Common Share
Basic and diluted net loss per common share was computed by dividing net loss for the year by the weighted average number of shares of common stock
outstanding, both basic and diluted, during each period. The impact of common stock equivalents has been excluded from the computation of diluted
weighted average common shares outstanding in periods where there is a net loss, as their effect is anti-dilutive.
For the years ended December 31, 2020 and 2019, the total number of shares of common stock issuable upon exercise of warrants and equity awards is
8,481,041 and 4,766,990, respectively. Warrants with an exercise price of $0.01 (as more fully described in Note 13 of these financial statements)
exercisable for 200,000 shares of common stock issued in March 2019 and exercised for 197,260 shares of stock through a cashless conversion in October
2020, were considered issued in calculating basic loss per share for each year. For the year ended December 31, 2020 and 2019, diluted loss per common
share is the same as basic loss per common share as all options and all other warrants that were convertible into shares of the Company’s common stock
were excluded from the calculation of diluted earnings attributable to common stockholders per common share as their effect would be anti-dilutive.
Income Taxes
Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the future tax
consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases
and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income
in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax asset and liabilities of a change in tax
rates is recognized in results of operations in the period that the tax rate change occurs. Valuation allowances are established, when necessary, to reduce
deferred tax assets to the amount expected to be realized. In accordance with ASC 740, Income Taxes, a tax position is recognized as a benefit only if it is
“more likely than not” that the tax position taken would be sustained in a tax examination, presuming that a tax examination will occur. The Company
recognizes interest and/or penalties related to income tax matters in the income tax expense category.
As more fully discussed in Note 9, on February 12, 2021, the Company received approval from the New Jersey Economic Development Authority to sell
$2.0 million of its New Jersey net operating losses recognizing a tax benefit for the year ended December 31, 2020 for the net proceeds (approximately
$1.85 million) by reducing the deferred income tax valuation allowance. In February of 2021, the Company entered into an agreement to sell these net
operating losses and expects to receive net proceeds of approximately $1.85 million by the end of the first quarter of 2021. During 2019 and 2018, the
Company submitted applications to sell a portion of the Company’s State of New Jersey net operating losses as part of the Technology Business Tax
Certificate Program sponsored by The New Jersey Economic Development Authority. Under the program, emerging biotechnology companies with unused
NOLs and unused research and development credits are allowed to sell these benefits to other New Jersey-based companies. In 2019 and 2018, the
Company sold NOLs totaling $13 million, receiving net proceeds of $1.8 million and $10.4 million, respectively. During 2021, the New Jersey State
Legislature increased the maximum lifetime benefit per company from $15 million to $20 million, which will allow the Company to participate in this
innovative funding program in future years.
F-12
Stock-Based Compensation
In March 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-09, Compensation-Stock Compensation, which simplifies various
aspects of accounting for share-based payments. The areas for simplification involve several aspects of the accounting for share-based payment
transactions, including the income tax consequences and classification on the statements of cash flows. The Company recognizes the effect of forfeitures in
compensation cost when they occur.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) and are adopted by us as of the
specified effective date. Unless otherwise discussed, we believe that the impact of recently issued accounting pronouncements will not have a material
impact on the Company’s consolidated financial position, results of operations, and cash flows, or do not apply to our operations.
In February 2016, the FASB issued ASU No. 2016-02, “Leases” - Topic 842 (ASC Topic 842), which requires that lessees recognize assets and liabilities
for leases with lease terms greater than twelve months in the balance sheet. Leases will be classified as either finance or operating, with classification
affecting the pattern of expense recognition in the income statement. This update also requires improved disclosures to help users of financial statements
better understand the amount, timing and uncertainty of cash flows arising from leases. The update became effective for fiscal years beginning after
December 15, 2018, including interim reporting periods within that reporting period. We adopted ASC Topic 842 effective January 1, 2019 and elected to
apply the available practical expedients and implement internal controls to enable the preparation of financial information on adoption. We identified two
of our leases consisting of the New Jersey corporate office lease and the Alabama lab facility lease as being subject to ASC Topic 842. The adoption of this
standard resulted in the recognition of right-of-use assets of approximately $1.4 million, related operating lease liabilities of $1.5 million and reduced other
liabilities by approximately $0.1 million on the consolidated balance sheets as of January 1, 2019 with no material impact to the opening balance of
retained earnings. See Note 15 for further discussions regarding the adoption of ASC Topic 842.
In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments”, which modifies the measurement of expected credit losses on certain financial instruments. The Company expects to adopt ASU 2016-13 in
its first quarter of 2021 utilizing the modified retrospective transition method. Based on the composition of the Company’s investment portfolio and current
market conditions, the adoption of ASU 2016-13 is not expected to have a material impact on its consolidated financial statements.
In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement: Disclosure Framework – Changes to the Disclosure Requirements for Fair
Value Measurement, which adds and modifies certain disclosure requirements for fair value measurements. Under the new guidance, entities will no longer
be required to disclose the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, or valuation processes for Level 3
fair value measurements. However, public companies will be required to disclose the range and weighted average of significant unobservable inputs used to
develop Level 3 fair value measurements, and related changes in unrealized gains and losses included in other comprehensive income. This update is
effective for annual periods beginning after December 15, 2019, and interim periods within those periods. The adoption of this standard did not have a
significant impact on the Company’s condensed consolidated financial statements.
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740). The standard simplifies the accounting for incomes taxes by removing
certain exceptions to the general principles in Topic 740 related to the approach for intraperiod tax allocation and the recognition of deferred tax liabilities
for outside basis differences. The standard also clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The standard
also improves consistent application of and simplifies GAAP for other areas of Topic 740 by clarifying and amending existing guidance. The amendment is
effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption is permitted. The Company does
not believe that the adoption of this standard will have an impact on its consolidated financial statements.
F-13
2. FINANCIAL CONDITION
Since inception, the Company has incurred substantial operating losses, principally from expenses associated with the Company’s research and
development programs, clinical trials conducted in connection with the Company’s product candidates, and applications and submissions to the U.S. Food
and Drug Administration. The Company has not generated significant revenue and has incurred significant net losses in each year since our inception. As
of December 31, 2020, the Company has incurred approximately $312 million of cumulative net losses and we had approximately $17.2 million in cash
and cash equivalents. We have substantial future capital requirements to continue our research and development activities and advance our product
candidates through various development stages. The Company believes these expenditures are essential for the commercialization of its technologies.
The Company expects its operating losses to continue for the foreseeable future as it continues its product development efforts, and when it undertakes
marketing and sales activities. The Company’s ability to achieve profitability is dependent upon its ability to obtain governmental approvals, manufacture,
and market and sell its new product candidates. There can be no assurance that the Company will be able to commercialize its technology successfully or
that profitability will ever be achieved. The operating results of the Company have fluctuated significantly in the past.
In January 2020, the WHO declared an outbreak of coronavirus, COVID-19, to be a “Public Health Emergency of International Concern,” and the U.S.
Department of Health and Human Services declared a public health emergency to aid the U.S. healthcare community in responding to COVID-19. This
virus has spread to over 100 countries, including the U.S. Governments and businesses around the world have taken unprecedented actions to mitigate the
spread of COVID-19, including, but not limited to, shelter-in-place orders, quarantines, significant restrictions on travel, as well as restrictions that prohibit
many employees from going to work. Uncertainty with respect to the economic impacts of the pandemic has introduced significant volatility in the
financial markets. The Company did not observe significant impacts on its business or results of operations during 2020 due to the global emergence of
COVID-19. While the extent to which COVID-19 impacts the Company’s future results will depend on future developments, the pandemic and associated
economic impacts could result in a material impact to the Company’s future financial condition, results of operations and cash flows.
The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions
to, and volatility in, financial markets in the U.S. and worldwide resulting from the ongoing COVID-19 pandemic. The disruptions caused by COVID-19
may also disrupt the clinical trials process and enrolment of patients. This may delay commercialization efforts. The Company continues to monitor its
operating activities in light of these events, and it is reasonably possible that the virus could have a negative effect on the Company’s financial condition
and results of operations. The specific impact, if any, is not readily determinable as of the date of these financial statements.
The actual amount of funds the Company will need to operate is subject to many factors, some of which are beyond the Company’s control. These factors
include the following:
●
●
●
●
●
the progress of research activities;
the number and scope of research programs;
the progress of preclinical and clinical development activities;
the progress of the development efforts of parties with whom the Company has entered into research and development agreements;
the costs associated with additional clinical trials of product candidates;
F-14
●
●
●
●
the ability to maintain current research and development licensing arrangements and to establish new research and development and licensing
arrangements;
the ability to achieve milestones under licensing arrangements;
the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and
the costs and timing of regulatory approvals.
On July 13, 2020, the Company announced that it has received a recommendation from the independent DMC to consider stopping the global Phase III
OPTIMA Study of ThermoDox® in combination with RFA for the treatment of HCC, or primary liver cancer. The recommendation was made following
the second pre-planned interim safety and efficacy analysis by the DMC on July 9, 2020. The DMC’s analysis found that the pre-specified boundary for
stopping the trial for futility of 0.900 was crossed with an actual value of 0.903. The Company followed the advice of the DMC and considered its options
to either stop the study or continue to follow patients after a thorough review of the data, and an evaluation of the probability of success. On February 11,
2021, the Company issued a letter to shareholders stating that the Company was notifying all clinical sites to discontinue following patients in the OPTIMA
Study.
During 2020, 2019 and 2018, the Company submitted applications to sell a portion of the Company’s State of New Jersey net operating losses as part of the
Technology Business Tax Certificate Program sponsored by The New Jersey Economic Development Authority. Under the program, emerging
biotechnology companies with unused NOLs and unused research and development credits are allowed to sell these benefits to other New Jersey-based
companies. In 2018 and 2019, the Company sold NOLs totaling $13 million receiving net proceeds of $12.2 million. In June 2020 and as updated in
September 2020, the Company filed an application with the New Jersey Economic Development Authority to sell substantially all of its remaining State of
New Jersey net operating losses totaling $2.0 million available under the program. On February 12, 2021, the New Jersey Economic Development
Authority approved the full amount of the Company’s application. In February of 2021, the Company entered into an agreement to sell the net operating
losses from the 2020 application and expects to receive net proceeds of approximately $1.85 million by the end of the first quarter of 2021. During 2021,
the New Jersey State Legislature increased the maximum lifetime benefit per company from $15 million to $20 million, which will allow the Company to
participate in this innovative funding program in future years.
In June 2018, the Company entered into a Credit Agreement with Horizon Technology Finance Corporation (“Horizon”) that provided $10 million in
capital (the “Horizon Credit Agreement”). The obligations under the Horizon Credit Agreement are secured by a first-priority security interest in
substantially all assets of Celsion other than intellectual property assets. Payments under the loan agreement are interest only (calculated based on one-
month LIBOR plus 7.625%) for the first twenty-four (24) months through July 2020, followed by a 24-month amortization period of principal and interest
starting on August 1, 2020 and ending through the scheduled maturity date. On August 28, 2020, in connection with an Amendment to the Horizon Credit
Agreement, Celsion repaid $5 million of the $10 million loan and $0.2 million in related end of term charges, and the remaining $5 million in obligations
were restructured as more fully discussed in Note 8 to these financial statements.
As more fully discussed in Note 10, during 2021 through the date of the filing of this Annual Report on Form 10-K, the Company has raised approximately
$6.9 million in gross proceeds from the use of its JonesTrading Capital on DemandTM financing facility, $35 million dollars from a registered direct
financing completed in January 2021 and $1.5 million from warrant exercises. With $17.2 million in cash and cash equivalents at December 31, 2020,
coupled with approximately $43 million of gross proceeds received from the sale of equity thus far in 2021 and up to $1.85 million in expected proceeds
from the sale of the State of New Jersey net operating losses it applied for in 2020, the Company believes it has sufficient capital resources to fund its
operations through the end of 2023.
F-15
The Company has based its estimates on assumptions that may prove to be wrong. The Company may need to obtain additional funds sooner or in greater
amounts than it currently anticipates. Potential sources of financing include strategic relationships, public or private sales of the Company’s shares or debt,
the sale of the Company’s State of New Jersey net operating losses and other sources. If the Company raises funds by selling additional shares of common
stock or other securities convertible into common stock, the ownership interest of existing stockholders may be diluted.
3. INVESTMENTS IN DEBT SECURITIES AVAILABLE FOR SALE
Investments in debt securities available for sale with a fair value of $7,985,886 as of December 31, 2019 consisted of corporate debt securities. These
investments are valued at estimated fair value, with unrealized gains and losses reported as a separate component of stockholders’ equity in accumulated
other comprehensive loss. The Company only had investments in cash and cash equivalents at December 31, 2020.
Investments in debt securities available for sale are evaluated periodically to determine whether a decline in their value is other than temporary. The term
“other than temporary” is not intended to indicate a permanent decline in value. Rather, it means that the prospects for near term recovery of value are not
necessarily favorable, or that there is a lack of evidence to support fair values equal to, or greater than, the carrying value of the security. Management
reviews criteria such as the magnitude and duration of the decline, as well as the reasons for the decline, to predict whether the loss in value is other than
temporary. Once a decline in value is determined to be other than temporary, the value of the security is reduced and a corresponding charge to earnings is
recognized.
A summary of the cost, fair value and maturities of the Company’s short-term investments is as follows:
Short-term investments
Corporate debt securities
Total
Short-term investment maturities
Within 3 months
Between 3-12 months
Total
December 31, 2020
December 31, 2019
Cost
Fair Value
Cost
Fair Value
-
-
$
$
- $
- $
7,943,108 $
7,943,108 $
7,985,886
7,985,886
December 31, 2020
December 31, 2019
Cost
Fair Value
Cost
Fair Value
-
-
-
$
$
- $
-
- $
7,943,108 $
-
7,943,108 $
7,985,886
-
7,985,886
$
$
$
$
The following table shows the Company’s investment in debt securities available for sale gross unrealized gains (losses) and fair value by investment
category and length of time that individual securities have been in a continuous unrealized loss position at December 31, 2020 and 2019. The Company has
reviewed individual securities to determine whether a decline in fair value below the amortizable cost basis is other than temporary.
December 31, 2020
December 31, 2019
Available for sale securities (all unrealized holding gains and
losses are less than 12 months at date of measurement)
Investments in debt securities with unrealized gains
Investments in debt securities with unrealized losses
Total
Fair Value
$
$
F-16
-
-
-
$
Unrealized
Holding
Gains (Losses)
$
Fair Value
- $
-
- $
7,985,886 $
-
7,985,886 $
Unrealized
Holding
Gains (Losses)
42,778
-
42,778
Investment income, which includes net realized losses on sales of available for sale securities and investment income interest and dividends, is summarized
as follows:
Interest and dividends accrued and paid
Realized gains
Investment income net
4. FAIR VALUES OF FINANCIAL INSTRUMENTS
2020
2019
66,553 $
53,354
119,907 $
442,987
57,895
500,882
$
$
FASB ASC Section 820, Fair Value Measurements and Disclosures establishes a three-level hierarchy for fair value measurements which requires an entity
to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The three levels of inputs that may be
used to measure fair value are as follows:
Level 1: Quoted prices (unadjusted) or identical assets or liabilities in active markets that the entity has the ability to access as of the measurement
date;
Level 2: Significant other observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in
markets that are not active; or other inputs that are observable or can be corroborated by observable market data; and
Level 3: Significant unobservable inputs that reflect a reporting entity’s own assumptions that market participants would use in pricing an asset or
liability.
Cash and cash equivalents, other current assets, accounts payable and other accrued liabilities are reflected in the condensed consolidated balance sheet at
their approximate estimated fair values primarily due to their short-term nature. The fair values of securities available for sale is determined by relying on
the securities’ relationship to other benchmark quoted securities and classified its investments as Level 2 items in both 2020 and 2019. There were no
transfers of assets or liabilities between Level 1 and Level 2 and no transfers in or out of Level 3 during the years ended December 31, 2020 and 2019. The
changes in Level 3 liabilities were the result of changes in the fair value of the earn-out milestone liability included in earnings and in-process R&D. The
earnout milestone liability is valued using a risk-adjusted assessment of the probability of payment of each milestone, discounted to present value using an
estimated time to achieve the milestone (see Note 12).
Assets and liabilities measured at fair value are summarized below:
Assets:
Recurring items as of December 31, 2020
Corporate debt securities, available for sale
Non-recurring items as of December 31, 2020
In-process R&D (Note 5)
Recurring items as of December 31, 2019
Corporate debt securities, available for sale
Non-recurring items as of December 31, 2019
In-process R&D (Note 5)
Liabilities:
Recurring items as of December 31, 2020
Earn-out milestone liability (Note 12)
Recurring items as of December 31, 2019
Earn-out milestone liability (Note 12)
Quoted Prices in
Active Markets for
Identical
Assets/Liabilities
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Total Fair Value
$
$
$
$
$
$
–
$
– $
– $
–
13,366,234
$
– $
– $
13,366,234
7,985,886
$
– $
7,985,886 $
–
15,736,491
$
– $
– $
15,736,491
7,018,000
$
– $
– $
7,017,000
5,717,709
$
– $
– $
5,717,709
F-17
5. INTANGIBLE ASSETS
In June 2014, we completed the acquisition of substantially all of the assets of EGEN, Inc., an Alabama corporation, which has changed its company name
to EGWU, Inc. after the closing of the acquisition (“EGEN”). We acquired all of EGEN’s right, title and interest in and to substantially all of the assets of
EGEN, including cash and cash equivalents, patents, trademarks and other intellectual property rights, clinical data, certain contracts, licenses and permits,
equipment, furniture, office equipment, furnishings, supplies and other tangible personal property. In addition, CLSN Laboratories assumed certain
specified liabilities of EGEN, including the liabilities arising out of the acquired contracts and other assets relating to periods after the closing date.
Acquired In-process Research and Development.
Acquired in-process research and development (IPR&D) consists of EGEN’s drug technology platforms: TheraPlas and TheraSilence. The fair value of the
IPR&D drug technology platforms was estimated to be $24.2 million as of the acquisition date. As of the closing of the acquisition, the IPR&D was
considered indefinite lived intangible assets and will not be amortized. IPR&D is reviewed for impairment at least annually as of our third quarter ended
September 30, and whenever events or changes in circumstances indicate that the carrying value of the assets might not be recoverable. The Company’s
IPR&D consisted of three core elements, its RNA delivery system, its glioblastoma multiforme cancer (GBM) product candidate and its ovarian cancer
indication.
The Company’s ovarian cancer indication, with original value of $13.3 million, has not been impaired since its acquisition. At September 30, 2020, the
Company evaluated its IPR&D of the ovarian cancer indication and concluded that it is not more likely than not that the asset is impaired. As no other
indicators of impairment existed during the fourth quarter of 2020 or 2019, no impairment charges were recorded during 2020 or 2019.
The Company’s GBM candidate, with original value of $9.4 million had cumulative impairments through 2018 of $7 million, with remaining carrying
value of $2.4 million at December 31, 2019. On September 30, 2020, the Company evaluated its IPR&D for the (GBM) product candidate and concluded
that it is more likely than not that the asset is further impaired. After this assessment on September 30, 2020, the Company wrote off the remaining $2.4
million of this asset, thereby recognizing a non-cash charge of $2.4 million in the third quarter of 2020.
Covenants Not to Compete
Pursuant to the EGEN Purchase Agreement, EGEN provided certain covenants (“Covenant Not To Compete”) to the Company whereby EGEN agreed,
during the period ending on the seventh anniversary of the closing date of the acquisition on June 20, 2014, not to enter into any business, directly or
indirectly, which competes with the business of the Company nor will it contact, solicit or approach any of the employees of the Company for purposes of
offering employment. The Covenant Not to Compete which was valued at approximately $1.6 million at the date of the EGEN acquisition has a definitive
life and is amortized on a straight-line basis over its life of 7 years. The Company recognized amortization expense of $227,316 in 2020 and 2019. The
carrying value of the Covenant Not to Compete was $113,660, net of $1,477,554 accumulated amortization, as of December 31, 2020 and $340,976, net of
$1,250,238 accumulated amortization as of December 31, 2019. The Covenant Not to Compete will be fully amortized by the end of the second quarter of
2021.
F-18
Goodwill
The purchase price exceeded the estimated fair value of the net assets acquired by approximately $2.0 million which was recorded as Goodwill. Goodwill
represents the difference between the total purchase price for the net assets purchased from EGEN and the aggregate fair values of tangible and intangible
assets acquired, less liabilities assumed. Goodwill is reviewed for impairment at least annually as of our third quarter ended September 30 or sooner if we
believe indicators of impairment exist. As of September 30, 2020, we concluded that the Company’s fair value exceeded its carrying value therefore “it is
not more likely than not” that the Goodwill was impaired. As no other indicators of impairment existed during the fourth quarters of 2020 or 2019, the
Company concluded it is “not more likely than not” Goodwill was impaired.
Following is a summary of the net fair value of the assets acquired in the EGEN acquisition for the two years ended December 31, 2020:
Balance at January 1, 2019, net
Amortization
Impairment charge
Balance at December 31, 2019, net
Amortization
Impairment charge
Balance at December 31, 2020, net
6. PROPERTY AND EQUIPMENT
Property and equipment at December 31, 2020 and 2019 consist of the following:
Machinery and equipment (5-7 year life)
Furniture and fixtures (3-5 year life)
Leasehold improvements (5-7 year life)
Less accumulated depreciation and amortization
Total
7. OTHER ACCRUED LIABILITIES
Other accrued liabilities at December 31, 2020 and 2019 include the following:
Amounts due to contract research organizations and other contractual agreements
Accrued payroll and related benefits
Accrued professional fees
Other
Total
F-19
IPR&D
Goodwill
Covenant Not to
Compete
$
$
15,736,491
-
-
15,736,491
-
(2,370,257)
13,366,234
$
$
1,976,101
-
-
1,976,101
-
-
1,976,101 $
568,292
(227,316)
-
340,976
(227,316)
-
113,660
December 31,
2020
2019
2,832,995 $
344,939
343,202
3,521,136
(3,226,585)
2,831,564
327,278
343,202
3,502,044
(3,096,681)
294,551 $
405,363
December 31,
2020
2019
636,000 $
1,736,271
66,850
19,411
2,458,532 $
475,440
1,604,541
204,155
19,411
2,303,547
$
$
$
$
8. NOTES PAYABLE
Horizon Credit Agreement
On June 27, 2018, the Company entered into a loan agreement with Horizon Technology Finance Corporation (“Horizon”) that provided $10 million in
new capital (the “Horizon Credit Agreement”). The Company drew down $10 million upon closing of the Horizon Credit Agreement on June 27, 2018. On
August 28, 2020, Horizon and the Company amended the Horizon Credit Agreement (the “Amendment”) whereby Celsion repaid $5 million of the $10
million loan and $0.2 million in related end of term charges, and the remaining $5 million in obligations were restructured as set forth below.
Pursuant to the Amendment, the remaining $5 million in obligations of Celsion under the Initial Horizon Credit Agreement are secured by a first-priority
security interest in substantially all assets of Celsion other than intellectual property assets. The obligations bear interest at a rate calculated based an
amount by which the one-month LIBOR exceeds 2% plus 7.625%. In no event shall the interest rate be less than 9.625%. Payments pursuant to the
Amendment are interest only for the first twelve (12) months after August 1, 2020, followed by a 21-month amortization period of principal and interest
through the scheduled maturity date. In addition, the remaining $5 million in obligations is subject to an end of term fee equal, in the aggregate, to
$275,000, which amount shall be payable upon the maturity of the obligations or upon the date of final payment or default, as applicable. In connection
with the Amendment, Celsion agreed to a liquidity covenant which provides that, at all times, Celsion shall maintain unrestricted cash and/or cash
equivalents on deposit in accounts over which the applicable Lenders maintain an account control agreement in an amount not less than $2.5 million. In
addition, pursuant to the Amendment, Celsion has agreed to provide evidence to Horizon on or before March 31, 2021, that it has received aggregate cash
proceeds of not less than $5 million from the sale of equity, debt, its New Jersey net operating losses, or a combination thereof, subsequent to the date of
the Amendment. The Company met this requirement during the fourth quarter of 2020.
In connection with the Horizon Credit Agreement, the Company incurred financing fees and expenses totaling $175,000 which were recorded and
classified as debt discount. In addition, the Company paid loan origination fees of $100,000 which were recorded and classified as debt discount. These
debt discount amounts totaling $782,116 were being amortized as interest expense using the effective interest method over the life of the loan. Also, in
connection with each of the Horizon Credit Agreements, the Company is required to pay an end of term charge equal to 4.0% of the original loan amount at
time of maturity. Therefore, these amounts totaling $400,000 were being amortized as interest expense using the effective interest method over the life of
the loan.
As a fee in connection with the Horizon Credit Agreement, Celsion issued Horizon warrants exercisable for a total of 190,114 shares of Celsion’s common
stock (the “Existing Warrants”) at a per share exercise price of $2.63. The Horizon Warrants were immediately exercisable for cash or by net exercise from
the date of grant and will expire after ten years from the date of grant. The Company valued the Horizon Warrants issued using the Black-Scholes option
pricing model and recorded a total of $507,116 as a direct deduction from the debt liability, consistent with the presentation of debt discounts, and are being
amortized as interest expense using the effective interest method over the life of the loan. Pursuant to the Amendment, one-half of the aggregate Existing
Warrants, exercisable for a total of 95,057 shares of Celsion’s common stock, have been canceled, and, in connection with the Amendment, Celsion issued
Horizon new warrants exercisable at a per share exercise price equal to $1.01 for a total of 247,525 shares of Celsion’s common stock (the “New Warrants”
and, together with the Existing Warrants, the “Warrants”). The remaining 95,057 Existing Warrants issued in connection with the Initial Horizon Credit
Agreement remain outstanding at a per share exercise price of $2.63.
The New Warrants are immediately exercisable for cash or by net exercise from the date of grant and will expire after ten years from the date of grant.
Effective October 27, 2020. The Horizon Credit Agreement contains customary representations, warranties and affirmative and negative covenants
including, among other things, covenants that limit or restrict Celsion’s ability to grant liens, incur indebtedness, make certain restricted payments, merge,
or consolidate and make dispositions of assets.
The Amendment was evaluated in accordance with FASB ASC 470-50, Debt-Modifications and Extinguishments, for debt modification and extinguishment
accounting. We accounted for the $5 million we repaid as a debt extinguishment thereby reducing the principal obligations accordingly. Also, in connection
with the $5 million repayment, we recognized as interest expense, approximately $0.2 million of unamortized debt discount, deferred financing and end of
term fees related to the repaid obligation in August 2020.
F-20
We accounted for the remaining $5 million of obligation under the Amendment as a debt modification to the initial agreement with respect to the minor
changes in cash flows. Also, in connection with the $5 million remaining obligations, we recorded $5,000 of financing fees and the New Warrant fair value
of $247,548 as additional debt discount on the $5 million remaining obligation. Therefore, approximately $109,706 of unamortized debt discount will be
amortized over the remaining life of the new obligations. The $275,000 of end of term fees, net of previously amortized end of term fees totaling $142,605
previously accrued on the original note associated with the $5 million remaining obligation, will be amortized as interest expense over the remaining life of
the new obligations.
During 2020, the Company incurred $808,899 in interest expense and amortized $483,439 as interest expense for debt discounts and end of term charges in
connection with the Horizon Credit Agreement. During 2019, the Company incurred $1,006,760 in interest expense and amortized $386,640 as interest
expense for debt discounts and end of term charges in connection with the Horizon Credit Agreement.
Following is a schedule of future principal payments, net of unamortized debt discounts and amortized end of term charges, due on the Horizon Credit
Agreement:
2021
2022
2023 and thereafter
Subtotal of future principal payments
Unamortized debt issuance costs, net
Total
Paycheck Protection Program
For the year ending
December 31,
1,190,475
2,857,140
952,385
5,000,000
51,160
5,051,160
$
$
On April 23, 2020, we entered into a loan agreement with Silicon Valley Bank (the “April PPP Loan”), pursuant to the Paycheck Protection Program (the
“PPP”), established pursuant to the recently enacted Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) and administered by the U.S.
Small Business Administration (“SBA”). We thereafter received proceeds of $632,220 under the April PPP Loan. The April PPP Loan application required
Celsion to certify that there was economic uncertainty surrounding the Company and that, as such, the April PPP Loan was necessary to support our
ongoing operations. Celsion made this certification in good faith after analyzing, among other things, its financial situation and access to alternative forms
of capital and believed that the Company satisfied all eligibility criteria for the April PPP Loan, and that our receipt of the April PPP Loan proceeds was
consistent with the broad objectives of the PPP of the CARES Act. The certification given with respect to the April PPP Loan did not contain any objective
criteria and was subject to interpretation. Considering subsequent guidance issued by the SBA in consultation with the U.S. Department of the Treasury at
that time, out of an abundance of caution we returned the proceeds of the PPP Loan in full on May 13, 2020.
Shortly after the April PPP Loan was repaid, the SBA provided further guidance with respect to these certifications providing a safe harbor under which
companies such as Celsion with PPP loans of less than $2 million will be deemed to have made these certifications in good faith. Therefore, as the
Company continued to believe it qualifies for a loan under the PPP, it reapplied for and eventually received the new PPP Loan for $692,530 on May 26,
2020 (the “May PPP Loan”). The May PPP Loan was guaranteed by the SBA and evidenced by a promissory note of the Company dated May 26, 2020
(the “Note”) in the principal amount of $692,530 payable to the lender. Pursuant to the terms of the Note, was payable in part or in full, at any time, without
penalty. On June 22, 2020, as disclosed in the Company’s Current Report on Form 8-K filed on the same date, the Company commenced an offering of
2,666,667 shares of its common stock which closed on June 24, 2020 (Note 10) and received net proceeds of approximately $9.1 million. In light of the
proceeds received from this equity offering, the Company elected to repay the May PPP Loan in full (including interest accrued of $577) on June 24, 2020,
terminating all obligations of the Company under the Note.
F-21
9. INCOME TAXES
The income tax provision (benefit) for the years ended December 31, 2020 and 2019 consists of the following:
Federal
Current
Deferred
State and Local
Current
Deferred
Total
2020
2019
$
$
- $
-
-
-
(1,845,823)
(1,845,823) $
-
-
-
-
(1,816,474)
(1,816,474)
A reconciliation of the Company’s statutory tax rate to the effective rate for the years ended December 31, 2020 and 2019 is as follows:
Federal statutory rate
State taxes, net of federal tax benefit
Permanent differences
Other
Change in valuation allowance and deferred rate change, net
Effective tax rate
The components of the Company’s deferred tax asset as of December 31, 2020 and 2019 are as follows:
Net operating loss carryforwards
Other Deferred tax assets, net
Subtotal
Valuation allowance
Total deferred tax asset
2020
2019
21.0%
7.8
(5.3)
–
(15.5)
8.0%
21.0%
9.8
(2.6)
1.1
(19.6)
9.7%
December 31,
2020
60,446,000 $
5,182,000
65,628,000
(63,782,177)
1,845,823 $
2019
58,243,000
254,000
58,497,000
(56,677,676)
1,819,324
$
$
The evaluation of the realizability of such deferred tax assets in future periods is made based upon a variety of factors that affect the Company’s ability to
generate future taxable income, such as intent and ability to sell assets and historical and projected operating performance. As of December 31, 2020, the
Company has established a valuation reserve for its deferred income tax assets other than those related to its New Jersey NOLs. At December 31, 2020,
after its evaluation of its New Jersey NOLs as discussed more fully below, the Company reduced the valuation reserve and recognized $1.8 million as a
deferred income tax asset. Such tax assets are available to be recognized and benefit future periods. As of December 31, 2020, the Company had federal net
operating loss carryforwards of approximately $274 million, net of net operating losses utilized in prior years of which $225 million, if unused, will expire
starting in 2022 through 2037. The Federal net operating loss generated for the years ended December 31, 2018, 2019 and 2020 of approximately $45
million can be carried forward indefinitely. However, the deduction for net operating losses incurred in tax years beginning after January 1, 2018 is limited
to 80% of annual taxable income. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was enacted in response to
the COVID-19 pandemic. The CARES Act provides for economic and cash liquidity stimulus through various means including payroll tax credits, payroll
tax deferral, short term changes in tax deductibility of interest expenses among other things. The Act also permits NOL carryovers and carrybacks to offset
100% of taxable income for taxable years beginning before 2021. Previously, NOLs generated after December 31, 2017 were limited to 80% of taxable
income in future years. In addition, the CARES Act allows NOLs incurred in 2018, 2019 and 2020 to be carried back to each of the five preceding tax
years. The Company evaluated the various aspects of the Act and determined that there was no material effect on the Financial Statements. As of December
31, 2020, the Company had state net operating loss carryforwards of approximately $39 million, net of net operating losses utilized in prior years, and, if
unused, will expire starting in 2029 through 2040.
F-22
During 2020, 2019 and in prior years, the Company performed analyses to determine if there were changes in ownership, as defined by Section 382 of the
Internal Revenue Code that would limit its ability to utilize certain net operating loss and tax credit carry forwards. The Company determined that it
experienced ownership changes, as defined by Section 382, in connection with certain common stock offerings in July 2011, February 2013, June 2013,
June 2015, February 2017, June 2017, October 2017, August 2018 and February 2020. As a result, the utilization of the Company’s federal tax net
operating loss carry forwards generated prior to the ownership changes are limited. As of December 31, 2020, the Company has net operating loss carry
forwards for U.S. federal and state tax purposes of approximately $266 million, before excluding net operating losses that have been limited as a result of
Section 382 limitations. The annual limitation due to Section 382 for net operating loss carry forward utilization is approximately $4.2 million per year for
approximately $90 million in net operating loss carry forwards existing at the ownership change occurring in July 2011, approximately $1.4 million per
year for approximately $34 million of additional net operating losses occurring from July 2011 to the ownership change that occurred in February 2013,
approximately $1.5 million per year for approximately $4 million of additional net operating losses occurring from February 2013 to the ownership change
that occurred in June 2013, approximately $1.6 million per year for approximately $40 million of additional net operating losses occurring from June 2013
to the ownership change that occurred in June 2015, approximately $0.3 million per year for approximately $35 million of additional net operating losses
occurring from June 2015 to the ownership change that occurred in February 2017, approximately $0.3 million per year for approximately $7 million of
additional net operating losses occurring from February 2017 to the ownership change that occurred in June 2017, approximately $0.8 million per year for
approximately $5 million of additional net operating losses occurring from June 2017 to the ownership change that occurred in October 2017, and
approximately $1.5 million per year for approximately $30 million of additional net operating losses occurring from October 2017 to the ownership change
that occurred in August 2018, approximately $0.8 million per year for approximately $15 million of additional net operating losses occurring from August
2018 to the ownership change that occurred in February 2020. The utilization of these net operating loss carry forwards may be further limited if the
Company experiences future ownership changes as defined in Section 382 of the Internal Revenue Code.
Sale of New Jersey Net Operating Losses
During 2020 and 2019, the Company applied for and received approval to sell a portion of the Company’s New Jersey NOLs as part of the Technology
Business Tax Certificate Program sponsored by The New Jersey Economic Development Authority. Under the program, emerging biotechnology
companies with unused NOLs and unused research and development credits are allowed to sell these benefits to other companies.
During the first quarter of 2021, the Company entered into an agreement to sell the approved portion of the New Jersey NOLs applied for in 2020 for $1.85
million. At December 31, 2020, the Company evaluated the valuation reserve for its tax net operating losses associated with its New Jersey NOLs and
reduced the valuation reserve and recognized $1.85 million as a deferred income tax asset and an income tax benefit. The Company expects to complete the
sale of these net operating losses by the end of the first quarter of 2021.
During the first quarter of 2020, the Company entered into an agreement to sell the approved portion of the New Jersey NOLs applied for in 2019 for $1.8
million. At December 31, 2019, the Company evaluated the valuation reserve for its tax net operating losses associated with its New Jersey NOLs and
reduced the valuation reserve and recognized $1.8 million as a deferred income tax asset and an income tax benefit. The Company completed the sale of
these net operating losses in the second quarter of 2020.
10. STOCKHOLDERS’ EQUITY
In September 2018, the Company filed with the SEC a $75 million shelf registration statement on Form S-3 (the 2018 Shelf Registration Statement) that
allows the Company to issue any combination of common stock, preferred stock or warrants to purchase common stock or preferred stock. This shelf
registration was declared effective on October 12, 2018 and during January 2021, has been fully utilized.
Capital on DemandTM Sales Agreement
On December 4, 2018, the Company entered into the Capital on Demand Agreement with JonesTrading, pursuant to which the Company may offer and
sell, from time to time, through JonesTrading shares of Common Stock having an aggregate offering price of up to $16.0 million.
During 2019, the Company sold and issued an aggregate of 0.5 million shares under the Capital on Demand Agreement, receiving approximately $1.0
million in gross proceeds. During 2020, the Company sold and issued an aggregate of 5.2 million shares under the Capital on Demand Agreement,
receiving approximately $6.2 million in gross proceeds. During 2021 through the date of this Annual Report on Form 10K, the Company has sold 7.2
million shares under the Capital on Demand Agreement, receiving approximately $6.9 million in gross proceeds under the Capital on Demand Agreement.
F-23
February 2020 Registered Direct Offering
On February 27, 2020, we entered into a Securities Purchase Agreement (the “February 2020 Purchase Agreement”) with several institutional investors,
pursuant to which we agreed to issue and sell, in a registered direct offering (the “February 2020 Offering”), an aggregate of 4,571,428 shares (the
“Shares”) of our common stock at an offering price of $1.05 per Share for gross proceeds of approximately $4.8 million before the deduction of the
Placement Agent fees and offering expenses. The February 2020 Purchase Agreement contained customary representations, warranties and agreements by
the Company and customary conditions to closing. In a concurrent private placement (the “Private Placement”), the Company issued to the investors that
participated in the February 2020 Offering, for no additional consideration, warrants, to purchase up to 2,971,428 shares of Common Stock (the “Original
Warrants”). The Original Warrants were initially exercisable six months following their date of issue and were set to expire on the five-year anniversary of
such initial exercise date. The Original Warrants had an exercise price of $1.15 per share subject to adjustment as provided therein. On March 12, 2020, the
Company entered into private exchange agreements (the “Exchange Agreements”) with holders of the Original Warrants. Pursuant to the Exchange
Agreements, in return for a higher exercise price of $1.24 per share of Common Stock, the Company issued new warrants to the Investors to purchase up to
3,200,000 shares of Common Stock (the “Exchange Warrants”) in exchange for the Original Warrants. The Exchange Warrants, like the Original Warrants,
are initially exercisable six months following their issuance (the “Initial Exercise Date”) and expire on the five-year anniversary of their Initial Exercise
Date. Other than having a higher exercise price, different issue date, Initial Exercise Date and expiration date, the terms of the Exchange Warrants are
identical to those of the Original Warrants. On July 31, 2020, the Company filed a Form S-3 Registration Statement to register the shares of Common Stock
issuable under the Exchange Warrants; the Registration Statement was declared effective by the SEC on August 13, 2020. No Exchange Warrants were
exercised during 2020. During 2021 thus far, the Company has issued 1.2 million shares pursuant to investors exercising Exchange Warrants, receiving
approximately $1.5 million.
Underwritten Offering
On June 22, 2020, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Oppenheimer & Co. Inc. (the
“Underwriter”), relating to the issuance and sale (the “Underwritten Offering”) of 2,666,667 shares of the Company’s common stock. Pursuant to the terms
of the Underwriting Agreement, the Underwriter agreed to purchase the shares at a price of $3.4875 per share. The Underwriter offered the shares at a
public offering price of $3.75 per share, reflecting an underwriting discount equal to $0.2625, or 7.0% of the public offering price. The net proceeds to the
Company from the Underwritten Offering, after deducting the underwriting discount and estimated offering expenses payable by the Company, were
approximately $9.1 million.
The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing,
indemnification obligations of the Company and the Underwriter including for liabilities under the Securities Act, other obligations of the parties, and
termination provisions. Pursuant to the Underwriting Agreement, until December 31, 2020, the Underwriter shall have a right of first refusal to act as sole
underwriter, initial purchaser, placement/selling agent, or arranger, as the case may be, on any new financing for the Company (excluding equipment lease
financings, loans or grants from governmental authorities or in connection with government programs and financings relating to or sales of tax attributes)
during such period. The Underwriter shall have the sole right to determine whether or not any other broker dealer shall have the right to participate in any
such offering and the economic terms of any such participation. Pursuant to the Underwriting Agreement, subject to certain exceptions, the Company and
certain of the Company’s executive officers and directors have agreed that, without the prior written consent of the Underwriter and subject to certain
negotiated exceptions, they will not, for a period of 60 days, in either case, following the date of the final prospectus supplement, sell or otherwise dispose
of any of the Company’s securities held by them.
LPC Purchase Agreement
On September 8, 2020, the Company entered into a purchase agreement (the “LPC Purchase Agreement”) and a Registration Rights Agreement (the
“Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which, upon the terms and subject to the conditions
and limitations set forth therein, the Company has the right to sell to Lincoln Park up to $26.0 million of shares of the Company’s Common Stock at the
Company’s discretion as described below (the “LPC Offering”).
F-24
Over the 36-month term of the LPC Purchase Agreement, we have the right, but not the obligation, from time to time, in our sole discretion and subject to
certain conditions, including that the closing price of our Common Stock is not below $0.25 per share, to direct Lincoln Park to purchase up to an aggregate
amount of $26.0 million (subject to certain limitations) of shares of Common Stock. Under the Purchase Agreement, on any business day selected by us,
we may direct Lincoln Park to purchase up to 400,000 shares (the “Regular Purchase Share Limit”) of our Common Stock (each such purchase, a “Regular
Purchase”). Lincoln Park’s maximum obligation under any single Regular Purchase will not exceed $1,500,000 unless we mutually agree to increase the
maximum amount of such Regular Purchase. The purchase price for shares of Common Stock to be purchased by Lincoln Park under a Regular Purchase
will be the equal to the lower of (in each case, subject to the adjustments described in the LPC Purchase Agreement): (i) the lowest sale price for our
Common Stock on The Nasdaq Capital Market on the applicable purchase date, and (ii) the arithmetic average of the three lowest sale prices for our
Common Stock on The Nasdaq Capital Market during the ten trading days prior to the purchase date.
If we direct Lincoln Park to purchase the maximum number of shares of Common Stock we then may sell in a Regular Purchase, then in addition to such
Regular Purchase, and subject to certain conditions and limitations in the LPC Purchase Agreement, we may direct Lincoln Park to make an “accelerated
purchase” of an additional amount of Common Stock that may not exceed the lesser of (i) 300% of the number of shares purchased pursuant to the
corresponding Regular Purchase and (ii) 30% of the total number of shares of our Common Stock traded on The Nasdaq Capital Market during a specified
period on the applicable purchase date as set forth in the Purchase Agreement. Under certain circumstances and in accordance with the Purchase
Agreement, the Company may direct Lincoln Park to purchase shares in multiple accelerated purchases on the same trading day.
The Purchase Agreement prohibits us from issuing or selling to Lincoln Park under the Purchase Agreement: (i) in excess of 6,688,588 shares of our
Common Stock (the “Exchange Cap”), unless we obtain stockholder approval to issue shares in excess of the Exchange Cap or the average price of all
applicable sales of our Common Stock to Lincoln Park under the LPC Purchase Agreement equal or exceed the lower of (a) the Nasdaq Official Closing
Price (as defined in the Purchase Agreement) immediately preceding the execution of the LPC Purchase Agreement or (b) the average of the five Nasdaq
Official Closing Prices for the Common Stock immediately preceding the execution of the LPC Purchase Agreement, as adjusted in accordance with the
rules of The Nasdaq Capital Market, and (ii) any shares of our Common Stock if those shares, when aggregated with all other shares of our Common Stock
then beneficially owned by Lincoln Park and its affiliates would result in Lincoln Park and its affiliates having beneficial ownership of more than 9.99% of
the then total outstanding shares of our Common Stock.
The LPC Purchase Agreement does not limit our ability to raise capital from other sources at our sole discretion, except that we may not enter into any
equity line or similar transaction for 36 months, other than an “at-the-market” offering. The LPC Purchase Agreement and the Registration Rights
Agreement contain customary representations, warranties and agreements of us and Lincoln Park, indemnification rights and other obligations of the
parties. We have the right to terminate the Purchase Agreement at any time on one business day’s notice to Lincoln Park, at no cost to us.
As consideration for entering into the Purchase Agreement, we issued 437,828 shares of our Common Stock to Lincoln Park (the “LPC Commitment
Shares”). We will not receive any cash proceeds from the issuance of the LPC Commitment Shares. Also pursuant to the LPC Purchase Agreement,
Lincoln Park agreed to an initial purchase of 1,000,000 shares of our Common Stock for an aggregate purchase price of $1,000,000 or $1.00 per share.
Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of our shares of Common
Stock.
During 2020, the Company sold and issued an aggregate of 3.3 million shares, including the LPC Commitment Shares, under the LPC Purchase
Agreement, receiving approximately $2.2 million in gross proceeds. The Company sent a letter to Lincoln Park terminating the LPC Offering effective
January 21, 2021. The Company did not sell any shares under the LPC Purchase Agreement in 2021.
F-25
Aspire Purchase Agreement
On August 31, 2018, the Company entered into a common stock purchase agreement (the “2018 Aspire Purchase Agreement”) with Aspire Capital Fund,
LLC (“Aspire Capital”) which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital was committed to
purchase up to an aggregate of $15.0 million of shares of the Company’s common stock over the 24-month term of the 2019 Aspire Purchase Agreement.
During 2018, the Company sold and issued an aggregate of 0.1 million shares under the 2018 Aspire Purchase Agreement, receiving approximately $0.2
million. During 2019, the Company sold and issued an aggregate of 3.3 million shares under the 2018 Aspire Purchase Agreement, receiving
approximately $6.3 million. As a result of the Company and Aspire entering into a new purchase agreement on October 28, 2019 (the “2019 Aspire
Purchase Agreement”) discussed in the next paragraph, the 2018 Aspire Purchase Agreement was terminated.
The 2019 Aspire Purchase Agreement provided that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital was
committed to purchase up to an aggregate of $10.0 million of shares of the Company’s common stock over the 24-month term of the 2019 Aspire Purchase
Agreement. During 2019, the Company sold and issued an aggregate of 0.5 million shares under the 2019 Aspire Purchase Agreement, receiving
approximately $0.7 million. During the first quarter of 2020 through March 5, 2020 when the Company delivered notice to Aspire terminating the 2019
Aspire Purchase Agreement, the Company sold 1.0 million shares of common stock under the Aspire Purchase Agreement, receiving approximately $1.6
million in additional gross proceeds.
January 2021 Registered Direct Offering
On January 22, 2021, the Company entered into a Securities Purchase Agreement (the “January 2021 Purchase Agreement”) with several institutional
investors, pursuant to which the Company agreed to issue and sell, in a registered direct offering (the “January 2021 Offering”), an aggregate of 25,925,925
shares of the Company’s common stock at an offering price of $1.35 per share for gross proceeds of approximately $35 million before the deduction of the
Placement Agents (as defined below) fee and offering expenses. The January 2021 Purchase Agreement contains customary representations, warranties and
agreements by the Company and customary conditions to closing. The closing of the January 2021 Offering occurred on January 26, 2021.
In connection with the January 2021 Offering, the Company entered into a placement agent agreement (the “January 2021 Placement Agent Agreement”)
with A.G.P./Alliance Global Partners (together with Brookline Capital Markets, the “January 2021 Placement Agents”) pursuant to which the Company
agreed to pay the January 2021 Placement Agents a cash fee equal to 7% of the aggregate gross proceeds raised from the sale of the securities sold in the
January 2021 Offering and reimburse the January 2021 Placement Agents for certain of their expenses in an amount not to exceed $82,500.
The January 2021 Placement Agent Agreement contains customary representations, warranties and agreements by the Company, customary conditions to
closing, indemnification obligations of the Company and the January 2021 Placement Agents, including for liabilities under the Securities Act, other
obligations of the parties and termination provisions. Under the January 2021 Purchase Agreement and January 2021 Placement Agent Agreement, the
Company and its subsidiary are prohibited, for a period of 90 days after the closing, from issuing, entering into any agreement to issue or announcing the
issuance or proposed issuance of any shares of common stock or any other securities that are at any time convertible into, or exercisable or exchangeable
for, or otherwise entitle the holder thereof to receive common stock, without the prior written consent of the placement agents or the investors participating
in the offering, subject to specific exceptions.
11. STOCK-BASED COMPENSATION
The Company has long-term compensation plans that permit the granting of equity-based awards in the form of stock options, restricted stock, restricted
stock units, stock appreciation rights, other stock awards, and performance awards.
F-26
At the 2018 Annual Stockholders Meeting of the Company held on May 15, 2018, stockholders approved the Celsion Corporation 2018 Stock Incentive
Plan (the “2018 Plan”). The 2018 Plan, as adopted, permits the granting of 2,700,000 shares of Celsion common stock as equity awards in the form of
incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights, other stock awards, performance
awards, or in any combination of the foregoing. At the 2019 Annual Stockholders Meeting of the Company held on May 14, 2019, stockholders approved
an amendment to the 2018 Plan whereby the Company increased the number of common stock shares available by 1,200,000 to a total of 3,900,000 under
the 2018 Plan, as amended. Prior to the adoption of the 2018 Plan, the Company had maintained the Celsion Corporation 2007 Stock Incentive Plan (the
“2007 Plan”). At the 2020 Annual Stockholders Meeting of the Company held on June 15, 2020, stockholders approved an amendment to the 2018 Plan, as
previously amended, whereby the Company increased the number of shares of common stock available by 2,500,000 to a total of 6,400,000 under the 2018
Plan, as amended.
The Company has issued stock awards to employees and directors in the form of stock options and restricted stock. Options are generally granted with
strike prices equal to the fair market value of a share of Celsion common stock on the date of grant. Incentive stock options may be granted to purchase
shares of common stock at a price not less than 100% of the fair market value of the underlying shares on the date of grant, provided that the exercise price
of any incentive stock option granted to an eligible employee owning more than 10% of the outstanding stock of Celsion must be at least 110% of such fair
market value on the date of grant. Only officers and key employees may receive incentive stock options.
Option and restricted stock awards vest upon terms determined by the Compensation Committee of the Board of Directors and are subject to accelerated
vesting in the event of a change of control or certain terminations of employment. The Company issues new shares to satisfy its obligations from the
exercise of options or the grant of restricted stock awards.
On September 28, 2018, and again on February 19, 2019, the Compensation Committee of the Board of Directors approved the grant of (i) inducement
stock options (the “Inducement Option Grants”) to purchase a total of 164,004 and 140,004 shares of Celsion common stock, respectively and (ii)
inducement restricted stock awards (the “Inducement Stock Grants”) totaling 19,000 and 13,000 shares of Celsion common stock to five new employees
collectively. Each award has a grant date of the date of grant. Each Inducement Option Grant has an exercise price per share equal to $2.77 and $2.18
which represents the closing price of Celsion’s common stock as reported by Nasdaq on September 28, 2018 and February 19, 2019, respectively. Each
Inducement Option Grant will vest over three years, with one-third vesting on the one-year anniversary of the employee’s first day of employment with the
Company and one-third vesting on the second and third anniversaries thereafter, subject to the new employee’s continued service relationship with the
Company on each such date. Each Inducement Option Grant has a ten-year term and is subject to the terms and conditions of the applicable stock option
agreement. Each of Inducement Stock Grant vested on the one-year anniversary of the employee’s first day of employment with the Company is subject to
the new employee’s continued service relationship with the Company through such date and is subject to the terms and conditions of the applicable
restricted stock agreement.
As of December 31, 2020, there were a total of 6,505,924 shares of Celsion common stock reserved for issuance under the 2018 Plan, which were
comprised of 4,484,721 shares of Celsion common stock subject to equity awards previously granted under the 2018 Plan and 2007 Plan and 2,018,453
shares of Celsion common stock available for future issuance under the 2018 Plan. As of December 31, 2020, there were a total of 140,004 shares of
Celsion common stock subject to outstanding inducement awards.
Total compensation cost related to stock options and restricted stock awards was approximately $1.9 million and $2.3 million during 2020 and 2019,
respectively. Of these amounts, $0.8 million and $0.9 million was charged to research and development expenses during 2020 and 2019, respectively, and
$1.1 million and $1.4 million was charged to general and administrative expenses during 2020 and 2019, respectively. In connection with the Company’s
annual 2019 bonus program, the Company issued 429,855 shares of common stock from the 2018 Stock Incentive Plan in lieu of paying cash for 50% of
the annual bonus awards. These amounts were fully accrued for in the consolidated financial statements for the year ended December 31, 2019.
F-27
A summary of stock option awards as of December 31, 2020 and changes during the two-year period ended December 31, 2020 is presented below:
Stock Options
Outstanding at January 1, 2019
Options granted
Options canceled or expired
Outstanding at December 31, 2019
Options granted
Options exercised
Options canceled or expired
Outstanding at December 31, 2020
Exercisable at December 31, 2020
Number
Outstanding
Weighted
Average Exercise
Price
Weighted
Average
Remaining
Contractual
Term (years)
Aggregate
Intrinsic Value
3,148,743
1,250,754
(67,355)
4,332,142
670,250
(140,864)
(236,803)
4,624,725
3,351,086
$
$
$
$
$
$
$
$
$
2.67
2.00
2.50
2.63
3.41
2.12
2.14
2.77
2.80
7.8 $
5,882
7.4 $
750
A summary of the status of the Company’s non-vested restricted stock awards as of December 31, 2020 and changes during the two-year period ended
December 31, 2020, is presented below:
Restricted Stock
Non-vested stock awards outstanding at January 1, 2019
Granted
Vested and issued
Forfeited
Non-vested stock awards outstanding at December 31, 2019
Granted
Vested and issued
Forfeited
Non-vested stock awards outstanding at December 31, 2020
Number
Outstanding
Weighted
Average
Grant Date
Fair Value
22,500 $
29,250 $
(5,000) $
(38,000) $
8,750 $
431,605 $
(434,105) $
(3,500) $
2,750 $
2.72
1.99
2.14
2.48
1.59
1.16
1.16
1.59
0.98
A summary of stock options outstanding at December 31, 2020 by price range is as follows:
Options Outstanding
Options Exercisable
Range of Exercise Prices
Number
(in years)
Weighted
Average
Remaining
Contractual
Term
Weighted
Average
Remaining
Contractual
Term
Number
(in years)
Weighted
Average
Exercise
Price
Weighted
Average
Exercise
Price
Up to $2.00
$2.00 to $5.00
Above $5.00 to $81.90
429,667
4,130,723
64,335
4,624,725
8.8 $
7.7 $
5.2 $
1.64
2.64
18.81
147,276
3,139,475
64,335
3,351,086
8.8 $
7.3 $
5.2 $
1.66
2.53
18.81
F-28
The fair values of stock options granted were estimated at the date of grant using the Black-Scholes option pricing model. The Black-Scholes model was
originally developed for use in estimating the fair value of traded options, which have different characteristics from Celsion’s stock options. The model is
also sensitive to changes in assumptions, which can materially affect the fair value estimate. The Company used the following assumptions for determining
the fair value of options granted under the Black-Scholes option pricing model:
Risk-free interest rate
Expected volatility
Expected life (in years)
Expected dividend yield
Year Ended December 31,
2020
0.65% to 1.33%
100.4% to 109.1%
7.5 to 10.0
0.0%
2019
2.82 to 3.02%
101.3 to 106.2%
7.5 to 9.3
0.0%
Expected volatilities utilized in the model are based on historical volatility of the Company’s stock price. As of December 31, 2020, there was $1.4 million
of total unrecognized compensation cost related to non-vested stock-based compensation arrangements. That cost is expected to be recognized over a
weighted-average period of 1.1 years.
12. EARN-OUT MILESTONE LIABILITY
The total aggregate purchase price for the EGEN Acquisition included potential future Earn-out Payments contingent upon achievement of certain
milestones. The difference between the aggregate $30.4 million in future Earn-out Payments and the $13.9 million included in the fair value of the
acquisition consideration at June 20, 2014 was based on the Company’s risk-adjusted assessment of each milestone (10% to 67%) and utilizing a discount
rate based on the estimated time to achieve the milestone (1.5 to 2.5 years). The earn-out milestone liability will be fair valued at the end of each quarter
and any change in their value will be recognized in the financial statements.
On March 28, 2019, the Company and EGWU, Inc, entered into the Amended Asset Purchase Agreement. Pursuant to the Amended Asset Purchase
Agreement, payment of the earnout milestone liability related to the Ovarian Cancer Indication of $12.4 million has been modified. The Company has the
option to make the payment as follows:
$7.0 million in cash within 10 business days of achieving the milestone; or
a)
b) $12.4 million in cash, common stock of the Company, or a combination of either, within one year of achieving the milestone.
The Company provided EGWU, Inc. 200,000 warrants to purchase common stock at a strike price of $0.01 per warrant share as consideration for entering
into this amended agreement. The warrant shares have no expiration and were fair valued at $2.00 using the closing price of a share of Celsion stock on the
date of issuance offset by the exercise price and recorded as a non-cash expense in the income statement and were classified as equity on the balance sheet.
In October of 2020, EGWU, Inc. elected to receive 197,260 shares through a non-cash conversion exercised all 200,000 warrant shares.
At December 31, 2020, the Company fair valued the earn-out milestone liability at $7.0 million and recognized a non-cash charge of $1.3 million during
2020 as a result of the change in the fair value of earn-out milestone liability of $5.7 million at December 31, 2019. In assessing the earnout milestone
liability at December 31, 2020, the Company fair valued each of the two payment options per the Amended Asset Purchase Agreement and weighted them
at 50% and 50% probability for the $7.0 million and the $12.4 million payments, respectively.
At December 31, 2019, the Company fair valued the earn-out milestone liability at $5.7 million and recognized a non-cash gain of $3.2 million during 2019
as a result of the change in the fair value of earn-out milestone liability of $8.9 million at December 31, 2018. In assessing the earnout milestone liability at
December 31, 2019, the Company fair valued each of the two payment options per the Amended Asset Purchase Agreement and weighted them at 80% and
20% probability for the $7.0 million and the $12.4 million payments, respectively.
F-29
The following is a summary of the changes in the earn-out milestone liability for 2019 and 2020:
Balance at January 1, 2019
Non-cash gain from the adjustment for the change in fair value included in 2019 net loss
Balance at December 31, 2019
Non-cash loss from the adjustment for the change in fair value included in 2020 net loss
Balance at December 31, 2020
13. WARRANTS
Following is a summary of all warrant activity for the two years ended December 31, 2020:
Warrants
Warrants outstanding at January 1, 2019
Warrants issued during 2019 (see Note 12)
Warrants expired during 2019
Warrants outstanding at December 31, 2019
Warrants issued during 2020
Warrants exercised during 2020 (see Note 12)
Warrants cancelled during 2020
Warrants outstanding and exercisable at December 31, 2020
Aggregate intrinsic value of outstanding warrants at December 31, 2020
$
Weighted average remaining contractual terms (years)
$
$
8,907,664
(3,189,955)
5,717,709
1,300,291
7,018,000
Number of
Warrants
Issued
Weighted
Average
Exercise
Price
5.36
0.01
6.32
1.87
1.21
0.01
2.63
1.35
1,593,162 $
200,000 $
(1,167,064) $
626,098 $
3,522,525 $
(200,000) $
(95,057) $
3,853,566 $
-0-
4.8
In connection with the February 2020 Registered Direct financing (Note 10), the Company issued warrants to purchase 3.2 million shares of common stock
in February 2020. In connection with the Horizon Credit Agreement Amendment, the Company cancelled warrants to purchase 95,057 shares of common
stock and issued warrants to purchase 247,525 shares of common stock in August 2020. Pursuant to a consulting agreement dated September 21, 2020, the
Company issued warrants to purchase 75,000 shares of common stock vesting immediately and having a 4-year term. The shares underlying these warrants
are unregistered and have a strike price of $0.79 per share. The Company fair valued these warrants $0.60 per share, recognizing $45,000 as professional
fee expense. Warrants to purchase 1,167,064 shares of common stock expired during 2019.
14. CELSION EMPLOYEE BENEFIT PLANS
Celsion maintains a defined-contribution plan under Section 401(k) of the Internal Revenue Code. The plan covers substantially all employees over the age
of 21. Participating employees may defer a portion of their pretax earnings, up to the IRS annual contribution limit. The Company makes a matching
contribution up to a maximum of 3% of an employee’s annual salary. The Company’s total matching contributions for the years ended December 31, 2020
and 2019 was $111,000 and $106,000, respectively. During 2020, the Company also provided a discretionary contribution totaling $178,000 which
represented 6% of each eligible participant’s annual salary in 2020. This amount was paid in January 2021.
F-30
15. LEASES
In 2011, the Company executed a lease (the “Lease”) with Brandywine Operating Partnership, L.P. (Brandywine), a Delaware limited partnership for a
10,870 square foot premises located in Lawrenceville, New Jersey and relocated its offices to Lawrenceville, New Jersey from Columbia, Maryland. The
Lease had an initial term of 66 months. In late 2015, Lenox Drive Office Park LLC, purchased the real estate and office building and assumed the Lease.
This Lease was set to expire on April 30, 2017. In April 2017, the Company and the landlord amended the Lease effective May 1, 2017. The 1st Lease
Amendment extended the term of the agreement for an additional 64 months, reduced the premises to 7,565 square feet, reduced the monthly rent and
provided four months free rent. The monthly rent ranged from approximately $18,900 in the first year to approximately $20,500 in the final year of the 1st
Lease Amendment. The Company also had a one-time option to cancel the lease as of the 40th month after the commencement date of the 1st Lease
Amendment and must provide the landlord notice by the 28th month of the lease. Effective January 9, 2019, the Company amended the current terms of the
1st Lease Amendment to increase the size of the premises by 2,285 square feet to 9,850 square feet and also extended the lease term by one year to
September 1, 2023. In conjunction with this 2nd Lease Amendment, we agreed to modify our one-time option to cancel the lease as of the end of August
2021 and we must provide notice to the landlord by the end of August 2020. The monthly rent will range from approximately $25,035 in the first year to
approximately $27,088 in the final year of the 2nd Lease Amendment.
In connection with the EGEN Asset Purchase Agreement in June 2014, the Company assumed the existing lease with another landlord for an 11,500 square
foot premises located in Huntsville Alabama. In January 2018, the Company and the Huntsville landlord entered into a new 60-month lease which reduced
the premises to 9,049 square feet with rent payments of approximately $18,100 per month.
As previously mentioned in Note 4, we adopted ASC Topic 842 on January 1, 2019 using the modified retrospective transition method for all lease
arrangements at the beginning of the period of adoption. Results for reporting periods beginning January 1, 2019 are presented under ASC Topic 842, while
prior period amounts were not adjusted and continue to be reported in accordance with our historic accounting under Topic 840, Leases. The standard had a
material impact on our Consolidated Condensed Balance Sheet but had no impact on our consolidated net earnings and cash flows. The most significant
impact of adopting ASC Topic 842 was the recognition of the right-of-use (ROU) asset and lease liabilities for operating leases, which are presented in the
following three-line items on the Consolidated Condensed Balance Sheet: (i) operating lease right-of-use asset; (ii) current operating lease liabilities; and
(iii) operating lease liabilities. Therefore, on date of adoption of ASC Topic 842, the Company recognized a ROU asset of $1.4 million, operating lease
liabilities, current and non-current collectively, of $1.5 million and reduced other liabilities by approximately $0.1 million. We elected the package of
practical expedients for leases that commenced before the effective date of ASC Topic 842 whereby we elected to not reassess the following: (i) whether
any expired or existing contracts contain leases; (ii) the lease classification for any expired or existing leases; and (iii) initial direct costs for any existing
leases. In addition, we have lease agreements with lease and non-lease components, and we have elected the practical expedient for all underlying asset
classes and account for them as a single lease component. We have no finance leases. We determine if an arrangement is a lease at inception. We have
operating leases for office space and research and development facilities. Neither of our leases include options to renew, however, one contains an option
for early termination. We considered the option of early termination in measurement of right-of-use assets and lease liabilities and we determined it is not
reasonably certain to be terminated. In connection with the 2nd Lease Amendment for the New Jersey office lease in January 2019, the Company
considered this as one modified lease and not as two separate leases. Therefore, in January 2019, the Company determined this lease was an operating lease
and remeasured the ROU asset and lease liability. Therefore, the Company increased the ROU asset and operating lease liabilities by $0.4 million to $1.8
million and $1.9 million, respectively. Following is a table of the lease payments and maturity of our operating lease liabilities as of December 31, 2020:
2021
2022
2023 and thereafter
Subtotal future lease payments
Less imputed interest
Total lease liabilities
Weighted average remaining life
Weighted average discount rate
F-31
$
$
For the
year ending
December 31,
530,734
535,579
233,117
1,299,430
(155,712)
1,143,718
2.46 years
9.98%
For 2020, operating lease expense was $522,380 and cash paid for operating leases included in operating cash flows was $525,809. For 2019, operating
lease expense was $522,380 and cash paid for operating leases included in operating cash flows was $485,848.
16. COMMITMENTS AND CONTINGENCIES
On September 20, 2019, a purported stockholder of the Company filed a derivative and putative class action lawsuit against the Company and certain
officers and directors (the “Shareholder Action”). The Company was a defendant in this derivative and putative class action lawsuit in the Superior Court of
New Jersey, Chancery Division, filed by a shareholder against the Company (as both a class action defendant and nominal defendant), and certain of its
officers and directors (the “Individual Defendants”), with the caption O’Connor v. Braun et al., Docket No. MER-C-000068-19 (the “Shareholder Action”).
The Shareholder Action alleged breaches of the defendants’ fiduciary duties based on allegations that the defendants omitted or made improper statements
when seeking shareholder approval of the 2018 Stock Incentive Plan. The Shareholder Action sought, among other things, any damages sustained by the
Company as a result of the defendants’ alleged wrongdoing, a declaratory judgment against all defendants invalidating the 2018 Stock Incentive Plan and
declaring any awards made under the Plan invalid, rescinded, and subject to disgorgement, an order disgorging the equity awards granted to the Individual
Defendants under the 2018 Stock Incentive Plan, and attorneys’ fees and costs.
On April 24, 2020, the Company, the Individual Defendants, and the plaintiff (the “Parties”) entered into a Settlement Agreement and Release (the
“Settlement Agreement”), which memorializes the terms of the Parties’ settlement of the Shareholder Action (the “Settlement”). The Settlement calls for
repricing of certain stock options and payment of plaintiff legal fees of $187,500. On July 24, 2020, the Court issued an order approving the Parties’
proposed form of notice to shareholders regarding the Settlement. A hearing was held on September 8, 2020 whereby the Court issued a final approval
approving the Settlement. Pursuant to the Settlement, the Company paid $187,500 on October 1, 2020. Without admitting the validity of any of the claims
asserted in the Shareholder Action, or any liability with respect thereto, and expressly denying all allegations of wrongdoing, fault, liability, or damage
against the Company and the Individual Defendants arising out of any of the conduct, statements, acts or omissions alleged, or that could have been
alleged, in the Shareholder Action, the Company and the Individual Defendants concluded that it was desirable that the claims be settled on the terms and
subject to the conditions set forth in the Settlement Agreement. The Company and the Individual Defendants entered into the Settlement Agreement for
settlement purposes only and solely to avoid the cost and disruption of further litigation.
On October 29, 2020, a putative securities class action was filed against the Company and certain of its officers and directors (the “Spar Individual
Defendants”) in the U.S. District Court for the District of New Jersey, captioned Spar v. Celsion Corporation, et al., Case No. 1:20-cv-15228. The plaintiff
alleges that the Company and Individual Defendants made false and misleading statements regarding one of the Company’s product candidates,
ThermoDox®, and brings claims for damages under Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder against all Defendants, and
under Section 20(a) of the Exchange Act of 1934 against the Spar Individual Defendants. The Company believes that the case is without merit and intends
to defend it vigorously. Due to the early stage of the case neither the likelihood that a loss, if any, will be realized, nor an estimate of possible loss or range
of loss, if any, can be determined.
In February 2021, a derivative shareholder lawsuit was filed against the Company, as the nominal defendant, and certain of its directors and officers as
defendants in the U.S. District Court for the District of New Jersey, captioned Fidler v. Michael H. Tardugno et al., Case No. 3:21-cv-02662. The plaintiff
alleges breach of fiduciary duty and other claims arising out of alleged statements made by certain of the Company’s directors and/or officers regarding
ThermoDox®. The Company believes it has meritorious defenses to these claims and intends to vigorously contest this suit. Due to the early stage of the
case neither the likelihood that a loss, if any, will be realized, nor an estimate of possible loss or range of loss, if any, can be determined.
17. LICENSES OF INTELLECTUAL PROPERTY AND PATENTS
On November 10, 1999, the Company entered into a license agreement with Duke University (“Duke”) under which the Company received worldwide
exclusive rights (subject to certain exceptions) to commercialize and use Duke’s thermally sensitive liposome technology. The license agreement contains
annual royalty and minimum payment provisions due on net sales. The agreement also required milestone-based royalty payments measured by various
events, including product development stages, FDA applications and approvals, foreign marketing approvals and achievement of significant sales.
However, in lieu of such milestone-based cash payments, Duke agreed to accept shares of the Company’s common stock to be issued in installments at the
time each milestone payment is due, with each installment of shares to be calculated at the average closing price of the common stock during the 20 trading
days prior to issuance.
F-32
The total number of shares issuable to Duke under these provisions is subject to adjustment in certain cases, and Duke has piggyback registration rights for
public offerings taking place more than one year after the effective date of the license agreement. On January 31, 2003, the Company issued 253,691 shares
of common stock to Duke University valued at $2.2 million as payment for milestone-based royalties under this license agreement. An amendment to the
Duke license agreement contains certain development and regulatory milestones, and other performance requirements that the Company has met with
respect to the use of the licensed technologies. The Company will be obligated to make royalty payments based on sales to Duke upon commercialization,
until the last of the Duke patents expire. For the years ended December 31, 2020 and 2019, the Company has not incurred any expense under this
agreement and will not incur any future liabilities until commercial sales commence.
Under the November 1999 license agreement with Duke, the Company has rights to the thermally sensitive liposome technology, including Duke’s U.S.
patents covering the technology as well as all foreign counterparts and related pending applications. Foreign counterpart applications have been issued in
the EU, Hong Kong, Australia and Canada and have been allowed in Japan. The EU patent has been validated in Austria, Belgium, France, Germany, Great
Britain, Italy, Luxembourg, Monaco, Spain and Switzerland. In addition, the Duke license agreement provides the Company with rights to multiple issued
U.S. patents related to the formulation, method of making and use of heat sensitive liposomes. The Company’s rights under the license agreement with
Duke extend for the life of the last-to-expire of the licensed patents.
In addition to the rights available to the Company under completed or pending license agreements, the Company is actively pursuing patent protection for
technologies developed by the Company. Among these patents is a family of a pending US, and international issued patents, which seek to protect the
Company’s proprietary method of storing ThermoDox® which is critical for worldwide distribution channels.
Finally, through proprietary information agreements with employees, consultants and others, the Company seeks to protect its own proprietary know-how
and trade secrets. The Company cannot offer assurances that these confidentiality agreements will not be breached, that the Company will have adequate
remedies for any breach, or that these agreements, even if fully enforced, will be adequate to prevent third-party use of the Company’s proprietary
technology. Similarly, the Company cannot guarantee that technology rights licensed to it by others will not be successfully challenged or circumvented by
third parties, or that the rights granted will provide the Company with adequate protection.
18. TECHNOLOGY DEVELOPMENT AND LICENSING AGREEMENTS
On May 7, 2012, the Company entered into a long-term commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. (Hisun) for the
production of ThermoDox® in the China territory. In accordance with the terms of the agreement, Hisun will be responsible for providing all of the
technical and regulatory support services, including the costs of all technical transfer, registration and bioequivalence studies, technical transfer costs,
Celsion consultative support costs and the purchase of any necessary equipment and additional facility costs necessary to support capacity requirements for
the manufacture of ThermoDox®. Celsion will repay Hisun for the aggregate amount of these development costs and fees commencing on the successful
completion of three registration batches of ThermoDox®. Hisun is also obligated to certain performance requirements under the agreement. The agreement
will initially be limited to a percentage of the production requirements of ThermoDox® in the China territory with Hisun retaining an option for additional
global supply after local regulatory approval in the China territory. In addition, Hisun will collaborate with Celsion around the regulatory approval
activities for ThermoDox® with the China State Food and Drug Administration (CHINA FDA).
On January 18, 2013, we entered into a technology development contract with Hisun, pursuant to which Hisun paid us a non-refundable research and
development fee of $5 million to support our development of ThermoDox® in mainland China, Hong Kong and Macau (the China territory). Following our
announcement on January 31, 2013 that the HEAT study failed to meet its primary endpoint, Celsion and Hisun have agreed that the Technology
Development Contract entered into on January 18, 2013 will remain in effect while the parties continue to collaborate and are evaluating the next steps in
relation to ThermoDox®, which include the sub-group analysis of patients in the Phase III HEAT Study for the HCC clinical indication and other activities
to further the development of ThermoDox® for the Greater China market. The $5.0 million received as a non-refundable payment from Hisun in the first
quarter 2013 has been recorded to deferred revenue and will continue to be amortized over the 10 -year term of the agreement, until such time as the parties
find a mutually acceptable path forward on the development of ThermoDox® based on findings of the ongoing post-study analysis of the HEAT Study data.
19. SUBSEQUENT EVENTS
The Company has evaluated events subsequent to the date of the balance sheet through the date of these financial statements. As more fully discussed in
Note 2, the Company issued a letter to shareholders on February 11, 2021 stating that the Company will be notifying all clinical sites to discontinue
following patients in the OPTIMA Study. As more fully discussed in Note 10, the Company collectively has sold 34.3 million shares of common stock for
gross proceeds of $43.4 million in 2021 through the date that these statements are made available.
F-33
Subsidiaries of Celsion Corporation
Name
CLSN Laboratories, Inc.
Exhibit 21.1
Jurisdiction of
Incorporation
Delaware
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements of Celsion Corporation on Form S-1 (333-221543, 333-219414, 333-
217156, 333-214353 and 333-234603), Form S-3 (Nos. 333-174960, 333-183286, 333-198786, 333-193936, 333-205608, 333-206789 and 333-227236)
and on Form S-8 (Nos. 33 139784, 333-145680, 333-183288, 333-207864) of our report dated March 19, 2021, relating to the consolidated financial
statements, which appears in this Form 10-K.
We also consent to the reference to us under the caption “Experts” in these Registration Statements.
Exhibit 23.1
/s/ WithumSmith+Brown, PC
Princeton, New Jersey
March 19, 2021
CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER PURSUANT TO
SECURITIES EXCHANGE ACT OF 1934 RULES 13a-14(a) AND 15d-14(a)
AS ADOPTED PURSUANT TO §302 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 31.1
I, Michael H. Tardugno, certify that:
1.
I have reviewed this Annual Report of Celsion Corporation;
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 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 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 19, 2021
/s/ Michael H. Tardugno
Michael H. Tardugno
President and Chief Executive Officer
CERTIFICATION OF THE CHIEF FINANCIAL OFFICER PURSUANT TO
SECURITIES EXCHANGE ACT OF 1934 RULES 13a-14(a) AND 15d-14(a)
AS ADOPTED PURSUANT TO §302 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 31.2
I, Jeffrey W. Church, certify that:
1.
I have reviewed this Annual Report of Celsion Corporation;
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 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 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 19, 2021
/s/ Jeffrey W. Church
Jeffrey W. Church
Executive Vice President and Chief Financial Officer
CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER
PURSUANT TO 18 UNITED STATES CODE § 1350
AS ADOPTED PURSUANT TO
§ 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with the Annual Report of Celsion Corporation (the “Company”) for the year ended December 31, 2020, as filed with the Securities and
Exchange Commission on or about March 19, 2021 (the “Report”), I, Michael H. Tardugno, President and Chief Executive Officer of the Company, certify,
pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: March 19, 2021
/s/ Michael H. Tardugno
Michael H. Tardugno
President and Chief Executive Officer
This certification accompanies each Report pursuant to §906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by the
Sarbanes-Oxley Act of 2002, be deemed filed by the Company for purposes of §18 of the Securities Exchange Act of 1934, as amended.
A signed original of this written statement required by §906 has been provided to the Company and will be retained by the Company and furnished to the
Securities and Exchange Commission or its staff upon request.
CERTIFICATION OF THE CHIEF FINANCIAL OFFICER
PURSUANT TO 18 UNITED STATES CODE § 1350
AS ADOPTED PURSUANT TO
§ 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.2
In connection with the Annual Report of Celsion Corporation (the “Company”) for the year ended December 31, 2020, as filed with the Securities and
Exchange Commission on or about March Date: March 19, 2021 (the “Report”), I, Jeffrey W. Church, Executive Vice President and Chief Financial Officer
of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: March 19, 2021
/s/ Jeffrey W. Church
Jeffrey W. Church
Executive Vice President and Chief Financial Officer
This certification accompanies each Report pursuant to §906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by the
Sarbanes-Oxley Act of 2002, be deemed filed by the Company for purposes of §18 of the Securities Exchange Act of 1934, as amended.
A signed original of this written statement required by §906 has been provided to the Company and will be retained by the Company and furnished to the
Securities and Exchange Commission or its staff upon request.