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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
⌧ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2021
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: 001-15070
RegeneRx Biopharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware
State or other jurisdiction of
incorporation or organization
15245 Shady Grove Road, Suite 470, Rockville, MD
(Address of principal executive offices)
52-1253406
(I.R.S. Employer
Identification No.)
20850
(zip code)
Registrant’s telephone number, including area code: 301-208-9191
Securities registered pursuant to Section 12(b) of the Act: None.
Title of Each Class
Common
Trading Symbol(s)
RGRX
Name of Each Exchange on which registered
OTC
Common Stock, $0.001 par value, including associated Series A Participating Cumulative Preferred Stock Purchase Rights
Warrants to Purchase Common Stock, $0.001 par value
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ⌧ No
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. ☐ Yes ⌧ No
Securities registered pursuant to Section 12(g) of the Act:
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to
Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). ☒ Yes ☐ No
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not be contained, to the best of
registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☒ Yes ☐ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definitions of “accelerated filer,” “large
accelerated filer " and “smaller reporting company” in Rule 12b-2 of the Securities Exchange Act of 1934. (Check one):
Large accelerated filer ☐
Non- accelerated filer ☒
Emerging growth company ☐
Accelerated filer ☐
Smaller reporting company ☒
If an emerging growth company, indicate by check mark if registrant has elected not to use the extended transition period for complying with any new or revised accounting standards provided
pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). ☐ Yes ☒ No
As of February 25, 2022, the aggregate market value of the voting stock held by non-affiliates of the registrant was approximately $16 million. Such aggregate market value was computed by
reference to the closing price of the Common Stock as quoted on the Over-the-Counter Bulletin Board, or the OTC Bulletin Board, on March 18, 2022.
The number of shares outstanding of the registrant’s common stock as of March 18, 2022 was 143,549,735.
DOCUMENTS INCORPORATED BY REFERENCE
None
Table of Contents
PART I
Item 1. Business
Item 1A. Risk Factors
PART II
TABLE OF CONTENTS
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Securities
Item 6. Selected Financial Data
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation
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
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
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 Accounting Fees and Services
PART IV
Item 15. Exhibits, Financial Statement Schedules
SIGNATURES
INDEX TO FINANCIAL STATEMENTS
EXHIBIT INDEX
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PART I
This Annual Report on Form 10-K, including the section entitled “Management’s Discussion and Analysis of Financial
Condition and Results of Operations,” contains forward-looking statements regarding us and our business, financial condition, results of
operations and prospects within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be
identified by the words “project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “should,” “would,” “could,”
“will,” “may” or other similar expressions. In addition, any statements that refer to projections of our future financial performance or
capital resources, our clinical development programs and schedules, our anticipated growth and trends in our business, the clinical and
pharmaceutical applications of our products, our expectations about our competitive position in the marketplace, potential business
relationships and partnerships, and other characterizations of future events or circumstances are forward-looking statements. We cannot
guarantee that we will achieve the plans, intentions or expectations expressed or implied in our forward-looking statements. There are a
number of important factors that could cause actual results, levels of activity, performance or events to differ materially from those
expressed or implied in the forward-looking statements we make, including those described under “Risk Factors” set forth below. In
addition, any forward-looking statements we make in this report speak only as of the date of this report, and we do not intend to update
any such forward-looking statements to reflect events or circumstances that occur after that date.
Item 1. Business.
General
RegeneRx Biopharmaceuticals, Inc. (“RegeneRx” or the “Company”) (OTCQB:RGRX) is a biopharmaceutical company
focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tß4, for tissue and organ protection, repair, and
regeneration. We have formulated Tß4 into three distinct product candidates in clinical development:
RGN-259, a preservative-free topical eye drop for regeneration of corneal tissues damaged by injury, disease or other pathology;
RGN-352, an injectable formulation to treat cardiovascular diseases, central and peripheral nervous system diseases, and other
medical indications that may be treated by systemic administration; and
RGN-137, a topical gel for dermal wounds and reduction of scar tissue.
We are continuing discussions with government organizations regarding the further clinical development of our product
candidates.
Current Financial Status
On June 30, 2021, we closed a private placement of common stock and warrants with several institutional and accredited
investors, including members of management and the board, and received gross proceeds of $1,980,000. Pursuant to the terms of the
Purchase Agreement, the Company sold an aggregate of 9,900,000 shares of its common stock to investors at a price of $0.20 per share.
Investors also received Series A Warrants to purchase 7,425,000 shares of common stock at an exercise price of $0.24 per share with a
two-year term and Series B Warrants to purchase 7,425,000 Warrant Shares at an exercise price of $0.28 per share with a five-year term.
In connection with the private placement we paid a cash fee to Roth Capital Partners, LLC, our placement agent, and also issued
warrants to purchase up to 1,268,750 shares of common stock on the same terms of the Series B Warrants and Series A Warrants (the
“Roth Warrants”).
In October 2020, we sold a series of convertible promissory notes to management, the Company’s Board of Directors and
accredited investors including Essetifin S.p.A., our largest stockholder (the “2020 Notes”). The sale of the 2020 Notes resulted in gross
proceeds to the Company of $500,000. The 2020 Notes contain a $0.36 conversion price and the purchasers also received a five-year
warrant exercisable at $0.45 to purchase additional shares of common stock equal to 75% of the number of shares into which each note is
initially convertible (the “2020 Warrants”). At present, we believe that we will have sufficient cash to fund planned operations through
the end of 2022.
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Current Clinical Status
In January 2015, we entered into a Joint Venture Agreement with GtreeBNT whereby we created ReGenTree LLC
(“ReGenTree” or “Joint Venture”) jointly owned by us and GtreeBNT, which seeks to commercialize RGN-259 for treatment of dry eye
syndrome (“DES”) and neurotrophic keratitis (“NK), an orphan indication in the United States.
To date, ReGenTree has sponsored a Phase 2/3 clinical trial (“ARISE-1”) and two Phase 3 clinical trials in patients with DES
(“ARISE-2” and “ARISE-3”). In 2020, ReGenTree completed a Phase 3 clinical trial in patients with NK (“SEER-1”). All Phase 3 trials
were conducted in the U.S. In May 2016, we reported the results of the 317-patient ARISE-1 trial and in October 2017, we reported the
results of the ARISE-2 trial. The ARISE-2 study, which was sponsored by ReGenTree and managed by Ora, Inc., demonstrated a number
of statistically significant improvements in both signs and symptoms of DES with 0.1% RGN-259 versus placebo, albeit not in the
designated co-primary endpoints, while showing excellent safety, comfort, and tolerability profiles. The ocular discomfort symptom
showed a statistically significant reduction in the RGN-259-treated group at day 15 as compared to placebo (p=0.0149) in the change
from baseline. For sign, RGN-259 also improved the dry eye patient’s ability to withstand an exacerbated condition in a patient subgroup
with both compromised corneal fluorescein staining and Schirmer’s test at baseline. In this population, RGN-259 showed superiority
over placebo in reducing corneal fluorescein staining in the change from baseline at days 15 and 29 (p=0.0207 and 0.0254, respectively).
RGN-259 confirmed its global effects on dry eye syndrome and fast onset in multiple sign and symptom efficacies with no safety issues
in the ARISE-1 and ARISE-2 studies as well as in the pooled data, although ARISE-2 was not successful in duplicating the results of
ARISE-1 where the study population was limited and less diversified.
Topline results from ARISE-3 were reported on March 18, 2021. Further statistical analysis was performed as part of the
process to fully understand patient data and the effects of RGN-259 compared to placebo by evaluating various subgroups of patients
within ARISE-3 with pooled data from all three ARISE clinical trials. While the trial failed to meet its co-primary sign and symptom
endpoints, the conclusions from these expanded analyses were that the use of RGN-259 has demonstrated statistically significant and
clinically relevant improvements in both signs and symptoms of dry eye syndrome after one and two weeks of treatment when measured
across all three phase 3 clinical trials in over 1,600 patients, while confirming its excellent safety profile. From a regulatory perspective,
the question is whether the combined data from these three trials is sufficient to file for a biologics license (BLA) for marketing approval
in the U.S. ReGenTree has been working with outside FDA regulatory consulting firms to define its regulatory strategy, based on these
analyses, which have been discussed with the FDA at a pre-BLA meeting on February 28, 2022. The ReGenTree team previously
submitted a 150 page pre-BLA dossier to the Agency in anticipation of the meeting, as well as a number of questions. The FDA will
provide to ReGenTree minutes to the meeting by March 28, 2022. When appropriate, RegeneRx will provide information regarding any
additional clinical work that may be required after further discussions with our counterparts at HLB Therapeutics.
The NK trial (SEER-1), a smaller study in an orphan population, enrolled a total of 18 patients. On May 14, 2020, the Company
reported that the trial was closed and reported the results of SEER-1. Six out of 10 patients in the RGN-259 treated group and 1 out of 8
patients in the placebo treated group achieved complete corneal healing in four weeks. In terms of the primary endpoint, “ratio of corneal
wound healed patients after four weeks' administration”, the statistical difference was slightly over 0.05 (p = 0.0656, Fisher's exact test),
due to the limited number of patients in each group. When another statistical analysis method was used to analyze the same primary
endpoint (Chi square test), there was statistical significance, p = 0.0400. In addition, in a pre-specified secondary endpoint evaluating
corneal epithelial healing at day 43 (two weeks post-treatment) and the durability of RGN-259 treatment, we also confirmed a clear
statistical difference using the Fisher's exact test, p = 0.0359. Several other efficacy parameters were either highly significant or strongly
trending toward statistical significance in the RGN-259 group indicating the depth of patient response to RGN-259.
HLB Therapeutics (the parent company of GtreeBNT) has developed the CMC (chemistry, manufacturing and controls) dossier
required for Phase 3 clinical trials and commercialization in the U.S. and in Korea. This comprehensive and critical effort ensures that
final drug product manufacturing, packaging, stability, purity, reproducibility, etc., meets regulatory guidelines and product
specifications. The product of this activity is the current product formulation being utilized in the U.S. trials being conducted by
ReGenTree and will also be utilized in the planned clinical activity to be conducted by HLB under the RGN-259 license agreement for
Pan Asia.
During the past several years, ReGenTree began developing a modified eye drop formulation that it believes will enhance the
efficacy of thymosin beta 4 for NK, improve the patient experience, and allow a proprietary valued orphan product price for this rare
disease. ReGenTree has completed a preliminary formulation for NK patients that will be considered for use in future clinical study.
ReGenTree has not yet determined if it will use this new formulation in the future for NK.
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In February 2017, our licensee for RGN-137, GtreeBNT (now HLB), through its subsidiary, Lenus Therapeutics, LLC, received
permission from the FDA to sponsor a Phase 3 clinical trial using RGN-137 to treat patients with epidermolysis bullosa (“EB”), a genetic
disease that causes severe blistering of the skin and internal organs. In August 2017, the Company amended the agreement for RGN-137
held by GtreeBNT. Under the amendment, the Territory was expanded to include Europe, Canada, South Korea, Australia and Japan. In
December 2018, GtreeBNT initiated a small Phase 2 open trial in patients with EB to evaluate RGN-137 in such patients prior to
sponsoring a larger Phase 3 trial. Three patients have been enrolled in the open clinical trial to date. In August 2019, it was reported that
the first patient had positively responded to RGN-137. However, as of the date of this report, the Company believes that the EB trial has
been put on hold and that Lenus Therapeutics has been dissolved with the rights reverting back to HLB, but the Company has not been
updated by HLB Therapeutics as to any future development plans for RGN-137.
Currently, we have active partnerships in four major territories: North America, Europe, China and Pan Asia. In each case, the
cost of development is being borne by our partners with no financial obligation for the Company. We still have significant clinical assets
to develop, primarily RGN-352 (injectable formulation of Tß4 for cardiac and CNS disorders) in the U.S., most of Asia, and Europe, and
RGN-259 in the EU. In August 2017, we amended the RGN-137 license agreement with GtreeBNT, expanding the territory to include
Europe, Canada, South Korea, Australia and Japan. Regarding RGN-259, our goal is to wait until satisfactory results are obtained from
the current ophthalmic clinical program in the U.S. before moving into the EU. This should allow us to obtain a higher value for the asset
at that time. However, we intend to continue to develop RGN-352, our injectable systemic product candidate for cardiac and central
nervous system indications and for the treatment of severe symptoms resulting from COVID-19 infection, either by obtaining grants to
fund a Phase 2a clinical trial or finding a suitable partner with the resources and capabilities to develop it as we have with RGN-259.
In March 2020, the FDA changed the category under which thymosin beta 4 was regulated. Prior to this change, Tβ4 was
regulated as a new chemical entity. Now it is regulated as a biologic. Further details regarding this change, the impact on the Company,
and its work to date is discussed further in this report (See – “Government Regulation” below). We anticipate incurring additional
operating losses in the future as we continue to explore the potential clinical benefits of Tß4-based product candidates over multiple
indications. To fund further development and clinical trials, we have entered into a series of strategic partnerships under licensing and
joint venture agreements (see “Strategic Partnerships” below) where our partners are responsible for advancing development of our
product candidates with multiple clinical trials.
Overview of Tß4
Tß4 is a synthetic copy of a naturally occurring 43-amino acid peptide that was originally isolated from bovine thymus glands.
It plays a vital role in cell structure and motility and in the protection, regeneration, remodeling and healing of tissues.
Although it is recognized that wound healing and tissue regeneration are complex processes, most companies working to
develop new drugs in this area have focused primarily on the development of growth factors and genetic therapies to stimulate healing
and have, to date, failed to demonstrate dramatic improvements in the healing process. Numerous preclinical animal studies, published
by independent researchers, have identified several important biological activities involving Tß4 that we believe make it potentially
useful as a wound healing, repair and tissue regenerating agent. These activities include:
Progenitor (Stem) Cell Recruitment and Differentiation. Independent research published in the journal Nature in
November 2006 featured the discovery that Tß4 is the key signaling molecule that recruits and triggers adult epicardial
progenitor cells, or EPCs, to differentiate into coronary blood vessels. EPCs are partially differentiated stem cells that can
further differentiate into specific cell types when needed. Confirmatory research published in 2009 in the Journal of
Molecular and Cellular Cardiology concluded that Tß4 is responsible for the initiation of the embryonic coronary
developmental program and EPC differentiation in adult mice. These publications confirm that Tß4’s interaction with EPCs
is necessary for the maintenance of a healthy adult animal heart, as well as for normal embryo and fetal heart development
in mammals. In Neuroscience (2009 and 2010), and the J. Neurosurgery (2010), Tß4 was shown to similarly stimulate
oligodendrogenesis, i.e., the differentiation of oligodendroctye progenitor cells into myelin-producing oligodendrocytes,
whereby restoring functional recovery in animal models of multiple sclerosis, stroke, and traumatic brain injury.
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Actin Regulation. Tß4 regulates actin, which comprises up to 10% of the protein of non-muscle cells in the body and plays
a central role in cell structure and in the movement of cells. Independent research studies have indicated that Tß4 stimulates
the migration of human keratinocytes, or skin cells, as well as corneal epithelial cells that protect the eye, human
endothelial cells and progenitor cells of the heart and brain. Endothelial cells are the major cell type responsible for the
formation of new blood vessels, a process known as angiogenesis. Certain of these studies conducted at the National
Institutes of Health, or NIH, were the first to suggest the role of Tß4 in wound healing. The data from these studies
encouraged us to license the rights to Tß4 from the NIH in 2001 and to launch an initial clinical development program that
targeted the use Tß4 for chronic dermal wounds.
Reduction of Inflammation and Scar Tissue Formation. Uncontrolled inflammation is the underlying basis of many
pathologies and injuries. Independent research has shown that Tß4 is a potent anti-inflammatory agent in skin cells and in
corneal epithelial cells in the eye. Tß4 has also been shown to decrease the levels of inflammatory mediators and to
significantly reduce the influx of inflammatory cells in the reperfused heart of animals. More recent preclinical research
suggests that Tß4 blocks activation of the NFκB pathway, which is involved in DNA activation of inflammatory mediators,
thereby modulating inflammation in the body. This anti-inflammatory activity may explain, in part, the mechanism by
which Tß4 appeared to improve functional outcome in the mouse multiple sclerosis model described above, as well as
promoting repair in the heart and skin. In the skin, it has been shown to reduce scar formation by reduction of infiltration of
myofibroblasts. Identifying a factor such as Tß4 that reduces scarring and blocks activation of NFκB suggests that Tß4
could have additional important therapeutic applications for inflammation-related diseases, such as cancer, osteoarthritis,
rheumatic diseases, autoimmune diseases, inflammatory pulmonary disease and pancreatitis.
Collagen and Laminin-5 Stimulation. Tß4 has a number of additional biological activities shown to reduce inflammation,
stimulate the formation of collagen, and up-regulate the expression of laminin-5, a subepithelial basement membrane
protein. Both collagen and laminin-5 are central to healthy tissue, wound repair and the prevention of disease. Laminin-5
promotes cell migration and maintains cell-cell and cell-matrix contacts for intact tissues which are important for
preventing fluid loss and bacterial infection.
Anti-Apoptosis. Tß4 has been shown to prevent apoptosis, or programmed cell death, in two animal models and in two
tissue types. In the rodent model, corneal apoptosis, or loss of corneal epithelial cells leading to corneal epithelial thinning,
was prevented through topical administration of Tß4 eye drops. In the heart muscle of ischemic animal models, such as in
mice and pigs, cell death was prevented by either local or systemic administration of Tß4.
Tß4 has shown efficacy in heart repair and regeneration in numerous animal models. A 2004 paper in Nature showed that it
could reduce the lesion size, improve cardiac function and promote survival. The 2006 Nature publication mentioned above further
concluded that Tß4’s interaction with EPCs resulted in the formation of cardiomyocytes that repaired damaged myocardium, or heart
tissue, in mice after an induced acute myocardial infarction, or AMI, commonly known as a heart attack. Research published in the
journal Circulation showed Tß4’s cardioprotective effects in a pig ischemic-reperfusion model. This pig model is accepted as an
important model upon which to base human clinical research, as pigs are larger mammals, the anatomy of the pig heart is similar to that
of the human heart, and vascular response processes are completed five to six times faster in pigs than in humans, so that long-term
results can be obtained in a relatively short period of time. This research also identified Tß4’s interaction with EPCs as the underlying
basis of cardioprotection through the differentiation of EPCs into cardiomyocytes, yielding statistically significant cardiac functional
recovery results when compared to the administration of placebo.
Similar research in the area of brain and central nervous system tissues also showed efficacy of repair and regeneration was
published in the journal Neuroscience in 2009. This publication concluded that Tß4 triggered the differentiation of oligodendrocyte
progenitor cells to form myelin-producing oligodendrocytes, which led to the remyelination of axons in the brain of mice with
experimental autoimmune encephalomyelitis, or EAE. This mouse model is an accepted small animal model for the study of multiple
sclerosis. Research published in the Journal of Neurosurgery in 2010 and also in the Journal of Neurological Science in 2014 showed that
Tß4 could improve functional neurological outcome in an animal stroke model. A second study was published in the Journal of
Neurosurgery in 2011 demonstrating that administration of Tß4 can significantly improve histological and functional outcomes in rats
with traumatic brain injury, or TBI, indicating that Tß4 has considerable therapeutic potential for patients with TBI. More recently,
researchers studying Tß4 under a material transfer agreement (MTA) found that Tß4 had beneficial effects in animal models of peripheral
neuropathy, one of the major complications of diabetes. This research was published in the Journal of Neurobiology of Disease in
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December 2012 and appears to corroborate previous findings using Tß4 for repair of central nervous system disorders. A paper in
Neuropharmacology in 2014 found many benefits of Tß4 administration in a rat model of spinal cord injury, including decreased lesion
size at 7 days, increased neural and oligodendrocyte survival, increase levels of myelin basic protein (a marker of mature
oligodendrocytes), decreased ED1 (a marker of activated microglia/macrophages), and decreased proinflammatory cytokines. Thus, Tß4
has efficacy for repair and regeneration in several nervous system injury models including MS, TBI, stroke, peripheral neuropathy, and
spinal cord injury and there will likely be additional applications in this area. We believe that these various biological activities work in
concert to play a vital role in the healing and repair of injured or damaged tissue and suggest that Tß4 is an essential component of the
tissue protection and regeneration process that may lead to many potential medical applications. All of our product candidates utilize Tß4
as the active pharmaceutical ingredient (API), which is manufactured by solid-phase peptide synthesis and is an exact copy of the
naturally occurring peptide. We have created three distinct formulations for various routes of administration and medical indications.
Recently, a scientific paper was published by a multi-institutional team of scientists from eight American research centers
published describing new therapeutic approaches for COVID-19 in which they propose that Thymosin beta 4 (Tβ4), because of its ability
to induce fibrinolysis, among other activities, may be useful in treating patients with the COVID-19 virus. According to the scientific
team, an increase of fibrinolysis could be achieved by administering Tβ4. Fibrinolysis is the breakdown of fibrin in blood clots and Tβ4
has been shown to prevent actin from binding to fibrin, which is a major component of blood clots. Blood clots in the blood stream and
organs of patients with COVID-19 have been shown to lead to extensive morbidity and patient death.
The researchers also found that COVID-19 elevates bradykinin levels in multiple tissues and systems that cause significant
increases in vascular dilation, vascular permeability, and hypotension in infected patients. Previous studies have shown that elevated
bradykinin levels induce pain and cause blood vessels to expand and become leaky, that can lead to swelling and inflammation of the
surrounding tissue. This bradykinin-storm in COVID-19 patients induces leakage of fluid into the lungs and excessive release of
hyaluronic acid preventing oxygen uptake and carbon dioxide release in the lungs of severely affected COVID-19 patients. These
bradykinin-driven outcomes suggest that a bradykinin storm may be responsible for many of the more severe symptoms of COVID.
The researchers also looked at differences in male/female morbidity and mortality and noted a number of interesting points
linked with other studies. It is known that older age and a high number of co-morbidities are associated with increased severity and
mortality in patients with COVID-19 and other similar infectious viruses such as SARS. They reported that age was comparable between
men and women in all data sets. In the case data series, men’s cases tended to be more serious than women’s (P = 0.035). In the public
data set, the number of men who died from COVID-19 is 2.4 times that of women (70.3 vs. 29.7%, P = 0.016). While men and women
have the same prevalence, men with COVID-19 are more at risk for worse outcomes and death, independent of age.
That men with COVID-19 are 2.4 times more likely than women to die from the virus is extremely compelling because the gene
for Thymosin beta 4 resides on the X chromosome. Women have two X chromosomes while men only have one. As the researchers
suggested, this could explain the lower incidence of COVID-19 induced mortality in women because it is found on the X chromosome
and escapes X-inactivation. Women, therefore, would have increased levels of Tβ4 compared to men; thus, the possible explanation why
women have an improved chance of survival. If true, then administering pharmacological levels of Tβ4 to COVID-19 patients may
significantly reduce morbidity and improve survival.
We believe the potential impact of Tβ4 in the treatment of COVID-19 merits further consideration as this, and other published
studies, have shown Tβ4’s ability to not only down-regulate inflammatory chemokines and cytokines and proinflammatory processes
such as the bradykinin storm, but also increase fibrinolysis and accelerate wound repair in the heart, lungs, kidneys and other organs that
are often affected by COVID-19 infection. Moreover, previously published data have demonstrated a significant decrease of Tβ4 in
blood, tears, and saliva with age in humans. Thus, finding a way to control and dampen this "bradykinin storm" may be important to
successfully treating COVID-19 patients, especially in older and more vulnerable patients. Prior to publications addressing the possible
relationship between Tβ4 and COVID-19, the Company filed worldwide patent applications.
In March 2020, the FDA changed the category under which thymosin beta 4 was regulated. Prior to this change, Tβ4 was
regulated as a new chemical entity. Now it is regulated as a biologic. Further details regarding this change, the impact on the Company,
and its work to date is discussed further in this report (See – “Government Regulation” below).
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Our Product Candidates
RGN-259
RGN-259 is our proprietary preservative-free eye drop formulation of Thymosin beta 4. In September 2011, we completed a
Phase 2a exploratory clinical trial evaluating the safety and efficacy of RGN-259 in 72 patients with moderate dry eye syndrome. In
November 2011, we reported preliminary safety and efficacy results from the trial. RGN-259 was deemed safe and well-tolerated, with
no observed drug-related adverse events.
In June 2012, we reported preliminary results from a double-masked, vehicle-controlled, physician-sponsored Phase 2 clinical
trial evaluating RGN-259 for the treatment of nine patients (18 eyes) with severe dry eye. RGN-259 was observed to be safe and well-
tolerated and met key efficacy objectives with statistically significant sign and symptom improvements, compared to vehicle control, at
various time intervals, including 28 days post-treatment.
Consistent with the reduction of ocular discomfort and fluorescein staining at the 28-day follow-up visit, other improvements
seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production. Likewise, these
improvements were seen at other time points in the study. These results were published in Cornea in 2015.
In September 2015, ReGenTree began the Phase 2/3 ARISE-1 clinical trial in patients with DES (and the Phase 3 SEER-1
clinical trial in patients with neurotrophic keratopathy, both in the U.S.). In May 2016, we reported the results of the 317-patient ARISE-
1 dry eye trial. In the trial, RGN-259 demonstrated statistically significant improvements in both signs and symptoms of dry eye with
0.05% and 0.1% RGN-259 compared to placebo in a dose dependent manner during a 28-day dosing period. While the primary outcome
measures were not met, several key related pre-specified endpoints and subgroups of patients with more severe dry eye showed
statistically significant treatment effects. These results confirm the findings from the previous Phase 2 trial providing clear direction for
the clinical regulatory pathway and remaining registration trials for RGN-259. Shortly following the ARISE-1 trial, the FDA approved
ReGenTree’s Phase 3 ARISE-2 dry eye protocol and we initiated the ARISE-2 trial that enrolled approximately 600 patients.
The ARISE-2 study, which was sponsored by ReGenTree and managed by Ora, Inc., demonstrated a number of statistically
significant improvements in both signs and symptoms of DES with 0.1% RGN-259 versus placebo, while showing excellent safety,
comfort, and tolerability profiles. The ocular discomfort symptom showed a statistically significant reduction in the RGN-259-treated
group at day 15 as compared to placebo (p=0.0149) in the change from baseline. For sign, RGN-259 also improved the dry eye patient’s
ability to withstand an exacerbated condition in a patient subgroup with both compromised corneal fluorescein staining and Schirmer’s
test at baseline. In this population, RGN-259 showed superiority over placebo in reducing corneal fluorescein staining in the change from
baseline at days 15 and 29 (p=0.0207 and 0.0254, respectively). RGN-259 confirmed its global effects on DES and fast onset in multiple
sign and symptom efficacies with no safety issues in the ARISE-1 and ARISE-2 studies as well as in the pooled data, although ARISE-2
was not successful in duplicating the results of ARISE-1 where the study population was limited and less diversified.
In February 2019, ReGenTree initiated the 700-patient ARISE-3 trial in patients with dry eye syndrome to confirm the results
observed in ARISE-2. The first patient was enrolled in the second quarter of 2019 and the last patient was enrolled in October 2020.
Topline results from ARISE-3 were reported on March 18, 2021 and further statistical analysis was performed as part of the process to
fully understand patient data and the effects of RGN-259 compared to placebo. We evaluated various subgroups of patients within
ARISE-3 and pooled the data from all three ARISE clinical trials. The conclusions from these expanded analyses are that the use of
RGN-259 has demonstrated statistically significant improvements in both signs and symptoms of dry eye syndrome after one and two
weeks of treatment when measured across three phase 3 clinical trials in over 1,600 patients, while confirming its excellent safety profile.
Strategic Partnerships
Lee’s Pharmaceutical.
We are a party to a license agreement with Lee’s Pharmaceutical for the license of Thymosin Beta 4 in any pharmaceutical form,
including our RGN-259, RGN-352 and RGN-137 product candidates, in China, Hong Kong, Macau and Taiwan. In February 2019, the
License Agreement was assigned by Lee’s to its affiliate, Zhaoke Ophthalmology Pharmaceutical Limited. Prior to 2016, Lee’s filed an
IND with the Chinese FDA to conduct a Phase 2, randomized, double-masked, dose-response clinical trial with RGN-259 in China for
dry-eye syndrome. Lee's subsequently informed us that it received notice from China's FDA declining its IND application for a Phase 2b
dry eye clinical trial because the API was manufactured outside of China. The API was manufactured in the U.S. and
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provided to Lee's by RegeneRx pursuant to a license agreement to develop RGN-259 ophthalmic eye drops in the licensed territory.
However, in mid-2016, we were informed by Lee’s that the CFDA modified its manufacturing regulations and will now allow Chinese
companies to utilize API manufactured outside of China for Phase 1 and 2 clinical trials. Lee’s has assigned the license to its subsidiary
Zhaoke Ophthalmology Pharmaceutical Limited for development of RGN-259 in China. On April 28, 2021, Zhaoke Ophthalmology
completed an initial public offering, raising US$270 million for development of its ophthalmic products, including RGN-259 licensed
from the Company. Zhaoke has established an advanced ophthalmic manufacturing facility and is assembling an experienced marketing
team. RGN-259 is identified as one of their main pipeline drugs and they are planning to submit an IND to the NMPA (the Chinese FDA)
in 2022 and initiate a phase III trial in China in 2023. There are no economic changes to the License Agreement.
GtreeBNT.
We are a party to a license agreement with GtreeBNT for the license of RGN-259 related to certain development and
commercialization rights for RGN-259 in Asia (excluding China, Hong Kong, Macau and Taiwan). Separately, we licensed GtreeBNT
the rights to RGN-137 which was recently amended as discussed above. GtreeBNT is currently our second largest stockholder.
GtreeBNT filed an IND with the Korean Ministry of Food and Drug Safety to conduct a Phase 2/3 study with RGN-259 in patients with
dry eye syndrome and in July 2015, received approval to conduct the trial. In late 2016, GtreeBNT informed us that it believes
marketing approval in the U.S. will allow expedited marketing in Korea, possibly without the need for a clinical trial. At this point, we
are still awaiting marketing approval in the U.S.
U.S. Joint Venture (ReGenTree, LLC).
In January 2015, we entered into a Joint Venture Agreement with GtreeBNT whereby we created ReGenTree, jointly owned by
us and GtreeBNT, which will commercialize RGN-259 for treatment of dry eye and NK, an orphan indication in the United States. We
are entitled to royalties as a percentage of net sales ranging from single digits to low double digits based on the medical indications
approved and whether the Joint Venture commercializes products directly or through a third party. RegeneRx possesses one of three
board seats of ReGenTree and certain major decisions and transactions within ReGenTree, such as commercialization strategy, mergers,
and acquisitions, require RegeneRx’s board designee’s consent. We currently hold a 38.5% ownership interest in ReGenTree. This
ownership interest may be further reduced to as low as 25% once ReGenTree obtains FDA approval of a BLA for dry eye syndrome in
the U.S. In the event ReGenTree is acquired, or a change of control occurs following achievement of a BLA, RegeneRx shall be entitled
to a minimum of 40% of all proceeds paid or payable and will forgo any future royalties.
RGN-352
During 2009, we completed a Phase 1a and Phase 1b clinical trial evaluating the safety, tolerability and pharmacokinetics of the
intravenous administration of RGN-352 in 60 healthy subjects (40 in each group, 20 of whom participated in both Phases). Based on the
results of these Phase 1 trials and extensive preclinical efficacy data published in peer-reviewed journals, in the second half of 2010, we
began start-up activities for a Phase 2 study to evaluate RGN-352 (Tß4 Injectable Solution) in patients who had suffered an AMI. We
had planned to begin enrolling patients in this clinical trial in the second quarter of 2011. However, in March 2011, we were notified by
the FDA that the trial was placed on clinical hold as a result of our contract manufacturer’s alleged failure to comply with the current
Good Manufacturing Practice (“cGMP”) regulations. The manufacturer has since closed its manufacturing facility. The FDA prohibited
us from using any of the active drug or placebo formulated by this manufacturer in human trials; consequently, we must have study drug
(RGN-352 and RGN-352 placebo) manufactured by a new cGMP-compliant manufacturer in the event we seek to move forward with
this trial. While we have identified a qualified manufacturer for RGN-352, we have elected to postpone activities on this trial until the
requisite funding or a partner is secured.
In addition to the potential application of RGN-352 for the treatment of cardiovascular disease, preclinical research published in
the scientific journals Neuroscience and the Journal of Neurosurgery, among others, indicates that RGN-352 may also prove useful for
patients with multiple sclerosis, or MS, as well as patients suffering a stroke, traumatic brain injury, peripheral neuropathy, or spinal cord
injury. In these preclinical studies, the administration of Tß4 resulted in regeneration of neuronal tissue by promoting remyelination of
axons and stimulating oligodendrogenesis, resulting in improvement of neurological functional activity. In 2012, researchers studying
Tß4 under a material transfer agreement (MTA) found that Tß4 had beneficial effects in animal models of peripheral neuropathy, one of
the major complications of diabetes. This research was published in the Journal of Neurobiology of Disease in 2012 and appears to
corroborate previous findings using Tß4 for repair of central nervous system disorders. We are discussing possible partnership
opportunities with companies interested in developing RGN-352 for this indication.
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Based on our Phase 1 data and the preclinical research discussed above, we are evaluating various opportunities for government
funding for a Phase 2a clinical trial to show proof-of-concept in each case while also talking with prospective strategic partners with the
interest, capabilities and resources to further develop product candidate in these fields. We have also been evaluating the potential of
RGN-352 for the treatment of COVID-19.
RGN-137
Clinical Development — Epidermolysis Bullosa (EB).
Starting in 2005, we began conducting a Phase 2 clinical trial designed to assess the safety and effectiveness of RGN-137 for the
treatment of patients with EB. EB is a genetic disease of approximately 10 gene mutations that results in fragile skin and other epithelial
structures (e.g., cornea and GI tract) that can blister spontaneously or separate at the slightest trauma or friction, creating a wound that at
times does not heal or heals poorly. In severe cases, recurrent blistering and tissue loss may be life threatening. EB has been designated
as an “orphan” indication by the FDA’s Office of Orphan Drugs. We closed the Phase 2 trial in late 2011 and we submitted the final
report to the FDA in 2014. Subsequently, we licensed RGN-137 to GtreeBNT for development in the U.S. and EU. In February 2017,
GtreeBNT received permission from the U.S. FDA to sponsor a Phase 3 clinical trial using RGN-137 to treat patients with EB. Recently,
the FDA modified efficacy requirements in EB patients from complete wound closing to partial wound closing, which has had a positive
impact on clinical trial design. Our licensee initiated a Phase 2 open clinical trial on EB patients in the U.S. in December 2018, and 3 of
15 patients have been enrolled to date. Due to the COVID-19 pandemic, it is unclear when enrollment will resume.
Clinical Development — Pressure Ulcers.
In late 2005, we began conducting a Phase 2 clinical trial designed to assess the safety and effectiveness of RGN-137 for the
treatment of patients with chronic pressure ulcers, commonly known as bedsores.
In January 2009, we reported final data from this trial. RGN-137 was well-tolerated at all three dose levels studied, with no
dose-limiting adverse events, which achieved the primary objective of the study. A follow-on evaluation, reported at the 3rd International
Symposium on the Thymosins in Health and Disease in March 2012, showed that for those pressure ulcer patients’ wounds that healed,
RGN-137 mid dose (0.02% Tβ4 gel product) accelerated wound closure with a median time to healing of 22 days as compared to 57 days
for the placebo. Although those results were clinically significant, they were not statistically significant.
Clinical Development — Venous Stasis Ulcers.
In mid-2006 we began conducting a Phase 2 clinical trial designed to assess the safety and effectiveness of RGN-137 for the
treatment of patients with venous stasis ulcers. Venous stasis ulcers are a common type of chronic wound that develops on the ankle or
lower leg in patients with chronic vascular disease. In these patients’ blood flow in the lower extremities is impaired leading to venous
hypertension, edema (swelling) and mild redness and scaling of the skin that gradually progresses to ulceration. In 2009, we reported
final data from that trial. Those results were both clinically and statistically significant.
Our Strategy
We seek to maximize the value of our product candidates by advancing their clinical development and then identifying suitable
partners for further development, regulatory approval, and marketing. We intend to engage in strategic partnerships with companies with
clinical development and commercialization strengths in desired pharmaceutical therapeutic fields. We are actively seeking partners with
suitable infrastructure, expertise and a long-term initiative in our medical fields of interest. Our ability to locate and engage new strategic
partners has been limited by the global COVID-19 pandemic. Historically, we have entered the licensing and joint ventures discussed
above. We have retained the cardiovascular and neurovascular assets (RGN-352) in the EU and are able to consolidate them with similar
assets in the U.S. and other territories in Asia to create a worldwide portfolio that we believe will be more attractive to multi-national
pharmaceutical companies.
We use a major contract manufacturer to produce bulk Tß4, which is the active pharmaceutical ingredient (API) in our product
candidates by an established and proven manufacturing process known as solid-phase peptide synthesis. While we do not currently have
long-term supply agreements in place, we and ReGenTree intend to establish a long-term supply arrangement with at least one
manufacturer once practicable. No assurance can be given, however, that future agreements by us or our partners will be negotiated on
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favorable terms, or at all. Contractors are selected on the basis of their supply capability, ability to produce a product in accordance with
Current Good Manufacturing Practice, or cGMP, requirements of the FDA and ability to meet our established specifications and quality
requirements. Given our recent licensing and joint venture deals, our partner in Korea and the U.S. are working closely with our current
primary contract manufacturer on the cGMP validation process and consistency runs, among other things, to prepare for the manufacture
of bulk Tß4 for use in future clinical trials and commercialization of our formulated product candidates. Through ReGenTree we are also
identifying and qualifying other potential API manufacturers. We will have access to the data resulting from this endeavor should we
need to use it for purposes outside the licensed territories.
We and our licensees also use a number of outside contract manufacturers to formulate bulk Tß4 into our product candidates,
RGN-137, RGN-259 and RGN-352. We use separate manufacturers for each formulation of Tß4. All of these formulations may require
modifications, along with additional studies, as we advance our clinical development programs through commercialization.
Competition
We are engaged in a business that is highly competitive, and our target medical indications are ones with significant unmet
needs. Consequently, there are many enterprises, both domestic and foreign, pursuing therapies and products that could compete with
ours. Most of these entities have financial and human resources that are substantially greater than ours, specifically with regard to the
conduct of clinical research and development activities, clinical testing and in obtaining the regulatory approvals necessary to market
pharmaceutical products. Brief descriptions of some of these competitive products follow:
RGN-259. Most specialty ophthalmic companies have a number of products on the market that could compete with RGN-259.
There are numerous antibiotics to treat eye infections to promote corneal wound healing and many eye lubrication products that are
soothing to the eye and help eye healing, many of which are sold without prescriptions. Companies also market steroids to treat certain
conditions within our area of interest. Allergan, Inc. markets Restasis®, Ophthalmic Emulsion, an FDA-approved eye drop used to treat
dry eye. Restasis, and other products, have been approved for marketing in certain other countries where we have licensed RGN-259.
Novartis is marketing the recently FDA-approved product, Xiidra®. We believe RGN-259 is different from Restasis® and Xiidra® and
any other product or product candidate available for dry eye in that it actively promotes repair using a multi-faceted approach of
increasing cell migration and laminin-5 production, and decreasing inflammation and apoptosis, without any noted adverse effects.
In 2018, Dompé Farmaceutici S.p.A. announced FDA approval of Oxervate™ to treat patients with neurotrophic keratitis.
Oxervate™ is manufactured using a recombinant form of human nerve growth factor. It is used six times per day for two months
and monthly treatment costs can be as high as $46,760 for one eye according to The Balance, a lifestyle journal covering health care
trends and costs. Patients have reported eye pain, corneal deposits, foreign body sensation and inflammation, among other side effects
associated with Oxervate™. We believe that RGN-259 is different from Oxervate™ in that it is faster acting, shows no adverse effects,
and would likely be far less expensive.
In October 2020, the FDA approved loteprednol etabonate ophthalmic suspension (Eysuvis; Kala Pharmaceuticals) a 0.25%
ocular corticosteroid indicated for dry eye disease. As with other ophthalmic corticosteroids, Eysuvis is contraindicated in most viral
diseases of the cornea and conjunctiva and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Other
warnings on the label include delayed healing and corneal perforation, intraocular pressure (IOP) increase, cataracts, bacterial, viral, and
fungal infections.
RGN-352. Currently, we do not believe there are any approved pharmaceutical products for regenerating cardiac tissue
following a heart attack, nor for regeneration of nervous tissue or for the remyelination of axons of patients with multiple sclerosis or
patients suffering from traumatic brain injury. However, many pharmaceutical companies and research organizations are developing
products, pharmacologic and stem cell therapies and technologies that are intended to prevent cardiac damage, improve cardiac function,
and regenerate cardiac muscle after a heart attack. There are also companies developing products that are purported to remyelinate
neurons and provide functional improvement for patients suffering from multiple sclerosis, stroke, traumatic brain injury, and peripheral
neuropathy. If we, or a partner, were to successfully develop RGN-352 for cardiovascular or central nervous system indications, such
products would have to compete with other drugs or therapies currently being developed or marketed by large pharmaceutical companies
for similar indications.
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RGN-137. There are numerous companies developing new pharmaceutical products for wound healing and for EB, in particular.
Products and therapies such as antibiotics, honey-based ointments, silver-based compounds and low frequency cavitational ultrasound
are also used to treat certain types of dermal wounds. Moreover, dermal wound healing is a large and highly fragmented marketplace that
includes numerous therapeutic products and medical devices for treating acute and chronic dermal wounds. Most recently, various other
companies are attempting to develop genetic therapies to try to heal or prevent serious wound disorders.
Government Regulation
In the United States, the Federal Food, Drug, and Cosmetic Act, as amended, or FFDCA, and the regulations promulgated
thereunder, and other federal and state statutes and regulations govern, among other things, the testing, manufacturing, labeling, storing,
recordkeeping, distribution, advertising and promotion of our product candidates. Regulation by governmental authorities in the United
States and foreign countries will be a significant factor in the manufacturing and potential marketing of our product candidates and in our
ongoing research and product development activities. Any product candidate we develop will require regulatory approval by
governmental agencies prior to commercialization. In particular, human therapeutic products are subject to rigorous preclinical studies,
clinical trials and other approval procedures by the FDA and similar health authorities in foreign countries. The process of obtaining
these approvals and subsequent compliance with appropriate federal and state statutes and regulations requires the expenditure of
substantial resources.
Preclinical studies must ordinarily be conducted to evaluate an investigational new drug’s potential safety by toxicology studies
and potential efficacy by pharmacology studies. The results of these studies, among other things, are submitted to the FDA as part of an
Investigational New Drug Application, or IND, which must be reviewed by the FDA before clinical trials can begin. Typically, clinical
evaluation involves a three-stage process. Phase 1 clinical trials are conducted with a small number of healthy volunteers to determine
the safety profile and the pattern of drug absorption, distribution, metabolism and excretion, and to assess the drug’s effect on the patient.
Phase 2, or therapeutic exploratory, trials are conducted with somewhat larger groups of patients, who are selected by relatively narrow
criteria yielding a more homogenous population that is afflicted with the target disease, in order to determine preliminary efficacy,
optimal dosages and expanded evidence of safety. Phase 2 trials should allow for the determination of the dose to be used in Phase 3
clinical trials. Phase 3, or therapeutic confirmatory, large scale, multi-center, comparative trials are conducted with patients afflicted with
a target disease in order to provide enough data for the statistical proof of safety and efficacy required by the FDA and other regulatory
authorities. The primary objective of Phase 3 clinical trials is to show that the drug confers therapeutic benefit that outweighs any safety
risks. All clinical trials must be registered with a central public database, such as www.clinicaltrials.gov, and once completed, results of
the clinical trials must be entered in the database.
Previously, thymosin beta 4 was regulated as a new chemical entity under the FDA’s Center for Drug Evaluation and Research
(“CDER”). On March 23, 2020, a new requirement under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was
enacted requiring that polypeptides larger than 40 amino acids in length, such as thymosin beta 4 (Tβ4), be regulated as biologics under
the FDA’s Center for Biologics Evaluation and Research (“CBER”). Other such products formerly regulated as drugs, and now as
biologics, include insulin and insulin analogs, human growth hormone, pancreatic enzymes, and reproductive hormones. While the
requirements of a BLA are very similar to those of an NDA, the FDA could require the Company to perform additional non-clinical
testing or even repeat phase 1 in humans under these new regulations.
Unlike the previous five-year exclusive period for new chemical entities approved under an NDA, section 7002 of the Patient
Protection and Affordable Care Act (PPACA) provides 12 years of exclusivity for products approved under a BLA. Biologics can also
receive orphan drug and pediatric exclusivities. Therefore, if RGN-259 receives a license under a BLA, and with the Tβ4 patents already
secured in the U.S, our exclusive market position should be strengthened.
The results of these preclinical studies and clinical trials, along with detailed information on manufacturing, are submitted to the
FDA in the form of a Biologics License Application, or BLA, for approval to commence commercial sales. In responding to a BLA, the
FDA may refuse to file the application if the FDA determines that the application does not satisfy its regulatory approval criteria, request
additional information or grant marketing approval. Therefore, even if we complete Phase 3 clinical trials for our product candidates and
submit a BLA to the FDA, there can be no assurance that the FDA will grant a marketing license, or if granted, that it will be granted on
a timely basis. If the FDA does grant a BLA, it may require, among other things, post-marketing testing, including potentially expensive
Phase 4 trials, which monitor the safety of the drug. In addition, the FDA may in some circumstances impose risk evaluation and
mitigation strategies that may be difficult and expensive to administer. Product approvals may be withdrawn if compliance with
regulatory requirements is not maintained or if problems occur after the product reaches the market.
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Among the conditions for a BLA is the requirement that the applicable clinical, pharmacovigilance, quality control and
manufacturing procedures conform on an ongoing basis with current Good Clinical Practices, Good Laboratory Practices, current Good
Manufacturing Practices, and computer information system validation standards. During the review of a BLA, the FDA will perform a
pre-licensing inspection of select clinical sites, manufacturing facilities and the related quality control records to determine the
applicant’s compliance with these requirements. To assure compliance, applicants must continue to expend time, money and effort in the
area of training, production and quality control. After approval of any product, manufacturers are subject to periodic inspections by the
FDA. If a company fails to comply with FDA regulatory requirements, FDA may pursue a wide range of remedial actions, including
seizure of products, corrective actions, warning letters and fines.
We have received orphan drug designation from the FDA for RGN-137 for the treatment of EB and RGN-259 for the treatment
of neurotrophic keratitis or NK, (now to be developed by ReGenTree). The FDA may designate a product or products as having orphan
drug status to treat a disease or condition that affects less than 200,000 individuals in the United States, or, if patients of a disease number
more than 200,000, the sponsor can establish that it does not realistically anticipate its product sales will be sufficient to recover its costs.
If a product candidate is designated as an orphan drug, then the sponsor may receive incentives to undertake the development and
marketing of the product, including grants for clinical trials, as well as a waiver of the user fees for submission of a BLA.
Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for
which it has such designation, the product is entitled to marketing exclusivity for a period of seven years in the United States and
ten years in the EU. There may be multiple designations of orphan drug status for a given drug and for different indications. Orphan drug
designation does not guarantee that a product candidate will be approved by the FDA for marketing for the designation, and even if a
sponsor of a product candidate for an indication for use with an orphan drug designation is the first to obtain FDA approval of a BLA for
that designation and obtains marketing exclusivity, another sponsor’s application for the same drug product may be approved by the FDA
during the period of exclusivity if the FDA concludes that the competing product is clinically superior. In this instance, the orphan
designation and marketing exclusivity originally granted would be lost in favor of the clinically superior product.
Intellectual Property
We hold worldwide patents and patent applications covering peptide compositions, uses and formulations related to dermal and
ophthalmic indications and other organ and tissue repair activities. In 2001, we entered into a license agreement with the NIH under
which we received an exclusive worldwide license from the NIH for all claims within the scope of the NIH’s patent application, and any
issued patents, covering the use of Tß4 as a tissue repair and regeneration factor. In 2007, patents were issued in Europe and the United
States related to the original NIH patent application. These patents expired in July 2019. Corresponding patents have also been granted in
Hong Kong, Australia and China and certain other territories. The issued European patent was opposed by a third party at the European
Patent Office and, in December 2009, we argued the case before the Opposition Division of the European Patent Office in Munich,
Germany and prevailed with certain amendments to the claims. In exchange for the exclusive license, we agreed to make certain
minimum royalty and milestone payments to the NIH. This license agreement expired with the last of the issued patents. The expiration
of the patents and license has no impact on our current programs.
We hold a U.S. patent relating to the use of Tß4 for the treatment of congestive heart failure. This patent was issued in
January 2012. In 2006, we were issued a patent in China for the use of Tß4 to treat EB. We also hold two patents for the treatment of dry
eye in the U.S. or through our in-license from Henry Ford Hospital System patents for certain neuro disorders, as well as peripheral
neuropathy. Other patent applications for our various product candidates, if issued, will offer protection in the U.S. and certain other
territories through 2033.
We, and our partners, have also filed additional U.S. and international patent applications covering various compositions, uses,
formulations and other components of Tß4, as well as for novel peptides resulting from our research efforts, the latest of which were filed
during 2015. There can be no assurance that these, or any other future patent applications under which we have rights, will result in the
issuance of a patent or that any patent issued will not be subject to challenge or opposition. In the case of a claim of patent infringement
by or against us, there can be no assurance that we will be able to afford the expense of any litigation that may be necessary to enforce
our proprietary rights or that relevant patents will not expire prior to approval of any of our product candidates.
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We continuously evaluate our patents and patent applications in certain territories to determine whether it is cost-effective to
continue to maintain or prosecute them. In some cases, we have determined that the value or potential value of such patents and/or
applications is not worth the continued effort or expense and have either ceased efforts to pursue specific patents or abandoned any that
have short expiries or cover countries of minimal strategic interest to us or our partners. We will continue to evaluate our portfolio and
take such actions from time to time as appropriate.
Material Agreements
Lee’s Pharmaceuticals
On July 15, 2012, we entered into a license agreement with Lee’s Pharmaceutical for the license of Tß4 in any pharmaceutical
formulation, including our RGN-259, RGN-352 and RGN-137 product candidates, in China, Hong Kong, Macau and Taiwan. The terms
of the agreement include aggregate potential milestone payments of up to $3.6 million and royalties ranging from low double digit to
high single digit royalties on commercial sales, if any. Under the agreement, Lee’s is responsible for all developmental costs associated
with each product candidate. We provided Tß4 to Lee’s at no charge for a Phase 2 ophthalmic clinical trial and will provide Tß4 to Lee’s
for all other developmental and clinical work at a price equal to our cost.
Lee’s originally filed an investigational new drug application IND with the Chinese FDA to conduct a Phase 2, randomized,
double-masked, dose-response clinical trial with RGN-259 in China for dry-eye syndrome. Lee’s subsequently informed us that it
received notice from China’s FDA (CFDA) declining its investigational new drug (IND) application for a Phase 2b dry eye clinical trial
because the API (active pharmaceutical ingredient or Tß4) was manufactured outside of China. The API was manufactured in the U.S.
and provided to Lee’s by RegeneRx pursuant to a license agreement to develop RGN-259 ophthalmic eye drops in the licensed territory.
However, in mid-2016, we were informed by Lee’s that the CFDA modified its manufacturing regulations and will now allow Chinese
companies to utilize API manufactured outside of China for Phase 1 and 2 clinical trials. In February 2019, the agreement was amended
and assigned by Lee’s to their affiliate, Zhaoke Ophthalmology Pharmaceutical Limited. There are no economic changes to the
agreement. Recently, we have been in discussions with management of Zhaoke to further refine its development plan for RGN-259. We
have not yet been informed of a projected starting date for Phase 2 trials, but we believe Lee’s is awaiting the outcome of the ARISE-3
DES trial prior to initiating clinical trials in China.
GtreeBNT
On March 7, 2014, we entered into license agreements with GtreeBNT Co., Ltd. The two licensing agreements are for the
license of territorial rights to two of our Thymosin Beta 4-based products candidates, RGN-259 and RGN-137.
Under the agreement for RGN-259, our preservative-free eye drop product candidate, GtreeBNT will have the right to develop
and commercialize RGN-259 in Asia (excluding Greater China). The rights will be exclusive in Korea, Japan, Australia, New Zealand,
Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, Mongolia, Myanmar (Burma), Philippines, Singapore, Thailand, Vietnam, and
Kazakhstan, and semi-exclusive in India, Pakistan, Bangladesh, Bhutan, Maldives, Nepal, Sri Lanka, Kyrgyzstan, Tajikistan,
Turkmenistan and Uzbekistan, collectively, the Territory (the “259 Territory” or Pan Asia). Under the agreement for RGN-259 we are
eligible to receive aggregate potential milestone payments of up to $3.5 million. In addition, we are eligible to receive royalties of a low
double-digit percentage of any commercial sales of the licensed product sold by GtreeBNT in the 259 Territory.
Under the license agreement for RGN-137, our topical dermal gel product candidate, GtreeBNT will have the exclusive right to
develop and commercialize RGN-137 in the U.S. (the “137 Territory”). Under the agreement for RGN-137 we are eligible to receive
aggregate potential milestone payments of up to $3.5 million. In addition, we are eligible to receive royalties of a low double-
digit percentage of any commercial sales of our licensed product sold by GtreeBNT in the 137 Territory. Under an amendment to the
agreement for RGN-137, for which we were compensated, the 137 Territory was expanded to include Europe, Canada, South Korea,
Australia and Japan.
Both the license agreement for RGN-137 and the license agreement for RGN-259 contain diligence provisions that require the
initiation of certain clinical trials within certain time periods that, if not met, would result in the loss of rights or exclusivity in certain
countries. GtreeBNT will pay for all developmental costs associated with each product candidate. We will also have the right to
exclusively license any improvements made by GtreeBNT to our products outside of the licensed territory on a royalty-free basis.
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The two firms have created a joint development committee and continue to discuss and the development of the licensed
products and share information relating thereto. Both companies will also share all non-clinical and clinical data and other information
related to the development of the licensed product candidates.
ReGenTree - U.S. Joint Venture
On January 28, 2015, we entered into the Joint Venture Agreement with GtreeBNT, a shareholder in the Company and licensee
in certain Pan Asian countries. The Joint Venture Agreement provides for the creation of the Joint Venture, ReGenTree, LLC
(“ReGenTree”), jointly owned by the Company and GtreeBNT that will commercialize RGN-259 for treatment of dry eye and
neurotrophic keratitis in the United States, as well as any other relevant ophthalmic indications.
GtreeBNT is solely responsible for funding all of the product development and commercialization efforts of ReGenTree.
GtreeBNT made an initial contribution of $3 million in cash and received an initial equity stake of 51%. RegeneRx received and initial
equity stake of 49% of ReGenTree. GtreeBNT’s equity stake may increase (and RegeneRx’s would proportionally decrease) upon
ReGenTree achieving certain product development milestones (including receipt of a new biologics license application “BLA” by the
U.S. FDA). GtreeBNT has subsequently funded the initial Phase 2b/3 and the ongoing Phase 3 U.S. clinical trials for dry eye syndrome
and neurotrophic keratitis, respectively.
Our initial ownership interest in ReGenTree was 49% and was reduced to 38.5% after filing of the final clinical study report
with the FDA for the Phase 3 trial for Dry Eye Syndrome completed in 2017. Based on when, and if, ReGenTree achieves certain
additional development milestones in the U.S. with RGN-259, our equity ownership may be incrementally reduced to between 38.5%
and 25%, with 25% being the final equity ownership upon FDA approval of an BLA for Dry Eye Syndrome in the U.S. In addition to our
equity ownership, RegeneRx retains a royalty on net sales that varies between single and low double digits, depending on whether
commercial sales are made by ReGenTree or a licensee. In the event the ReGenTree entity is acquired or there is a change of control that
occurs following achievement of an BLA, RegeneRx shall be entitled to a minimum of 40% of all proceeds paid or payable and will
forgo any future royalties.
The Company is not required or otherwise obligated to provide financial support to ReGenTree.
ReGenTree is controlled by a Board of Directors consisting of three members, one of which must be from RegeneRx. Certain
critical matters require unanimous board approval, including merger, consolidation, or sale of the JV, transfer or licensing of any
intellectual property, incurring indebtedness, and entering into any material agreements, among others.
ReGenTree is responsible for executing all development and commercialization activities under the Joint Venture Agreement,
which activities will be directed by a joint development committee comprised of representatives of the Company and GtreeBNT. The
agreement has a term that extends to the later of the expiration of the last patent covered by the agreement or 25 years from the first
commercial sale under the agreement. The agreement may be earlier terminated if the Joint Venture fails to meet certain
commercialization milestones, or if either party breaches the Joint Venture Agreement and fails to cure such breach, or as a result of
government action that limits the ability of the Joint Venture to commercialize the product, as a result of a challenge to a licensed patent,
following termination of the license between the Company and certain agencies of the United States federal government, or upon the
bankruptcy of either party.
Development Agreements
While we are not currently directly engaged in development activities, historically we have entered into agreements with outside
service providers for the manufacture and development of Tß4, the formulation of Tß4 into our product candidates, the conduct of
nonclinical safety, toxicology and efficacy studies in animal models, and the management and execution of clinical trials in humans.
Terms of these agreements vary in that they can last from a few months to more than a year in duration. For additional information
regarding our research and development expenses over the past two years, see “Management’s Discussion and Analysis of Financial
Condition and Results of Operations — Results of Operations” in this report.
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Employees
We currently have three full time employees including our President and CEO and one part time financial, accounting and SEC
compliance consultant. We also retain three independent contractors. We believe that we have good relations with our employees and
contractors.
Corporate Information
We were incorporated in Delaware in 1982 under the name Alpha 1 Biomedicals, Inc. In 2000, we changed our corporate name
to RegeneRx Biopharmaceuticals, Inc. Our principal executive office is located at 15245 Shady Grove Road, Suite 470, Rockville,
Maryland 20850. Our telephone number is (301) 208-9191.
Available Information
Our corporate website is www.regenerx.com. Our electronic filings with the U.S. Securities and Exchange Commission, or
SEC, including our annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and any amendments
to these reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, are available
free of charge through our website as soon as reasonably practicable after we have electronically filed such information with, or
furnished such information to, the SEC.
Item 1A. Risk Factors
Set forth below and elsewhere in this report and in other documents we file with the SEC are risks and uncertainties that could
cause actual results to differ materially from the results contemplated by the forward-looking statements contained in this report. The
descriptions below include any material changes to and supersede the description of the risk factors affecting our business previously
disclosed in “Part II, Item 1A. Risk Factors” of the Annual Report.
Risks Related to Our Liquidity and Need for Financing
Before giving effect to any potential additional sales of our securities, we estimate that our existing capital will only be sufficient to
fund our operations through 2022.
Before giving effect to any potential additional sales of our securities, we estimate that our existing capital resources coupled
with the proceeds from the October 2020 and June 2021 private offerings will only be sufficient to fund our operations through 2022. We
will need to secure additional operating capital to continue operations substantially beyond 2022. We continuously monitor our cash use
as well as the clinical timelines. We will need to secure additional operating capital by early 2022 and are evaluating options including
the licensing of additional rights to commercialize our clinical products as well as raising capital through the capital markets, either of
which could cause a reduction in the trading price of our common stock. The COVID-19 global pandemic, the war in Ukraine and
inflationary concerns may impact our ability to secure additional financing.
We will need substantial additional capital for the continued development of product candidates through marketing approval and for
our longer-term future operations.
We anticipate that substantial new capital resources will be required to continue our longer-term product development efforts,
including any and all follow-on trials that will result from our current clinical programs beyond those currently contemplated, and to
scale up manufacturing processes for our product candidates. However, the actual amount of funds that we will need will be determined
by many factors, some of which are beyond our control. These factors include, without limitation:
● the scope of our, or our partners’, clinical trials, which is significantly influenced by the quality of clinical data achieved as
trials are completed and the requirements established by regulatory authorities;
● the speed with which we, or our partners, complete our clinical trials, which depends on our ability to attract and enroll
qualifying patients and the quality of the work performed by our clinical investigators and contract research organizations
chosen to conduct the studies or events such as the COVID-19 pandemic;
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● the time required to prosecute, enforce and defend our intellectual property rights, which depends on evolving legal
regimes and infringement claims that may arise between us and third parties;
● the ability to manufacture at scales sufficient to supply commercial quantities of any of our product candidates that receive
regulatory approval, which may require levels of effort not currently anticipated; and
● the successful commercialization of our product candidates, which will depend on our, or our partners’, ability to either
create or partner with an effective commercialization organization and which could be delayed or prevented by the
emergence of equal or more effective therapies.
Emerging biotechnology companies like us may raise capital through corporate collaborations and by licensing intellectual
property rights to other biotechnology or pharmaceutical enterprises. We intend to pursue this strategy, but there can be no assurance that
we will be able to enter into additional license agreements with respect to our intellectual property or product development programs on
commercially reasonable terms, if at all. There are substantial challenges and risks that will make it difficult to successfully implement
any of these alternatives. If we are successful in raising additional capital through such a license or collaboration, we may have to give up
valuable rights to our intellectual property. In addition, the business priorities of a strategic partner may change over time, which creates
the possibility that the interests of the strategic partner in developing our technology may diminish and could have a potentially material
negative impact on the value of our interest in the licensed intellectual property or product candidates.
Further, if we raise additional funds by selling shares of our common stock or securities convertible into our common stock the
ownership interest of our existing stockholders may be significantly diluted. If additional funds are raised through the issuance of
preferred stock or debt securities, these securities are likely to have rights, preferences and privileges senior to our common stock and
may involve significant fees, interest expense, restrictive covenants or the granting of security interests in our assets.
Our failure to successfully address our short-term capital needs and our long-term liquidity requirements would have a material
negative impact on our business, including the possibility of surrendering our rights to some technologies or product opportunities,
delaying our clinical trials or ceasing our operations.
We have incurred losses since inception and expect to incur significant losses in the foreseeable future and may never become
profitable.
We have not commercialized any product candidates to date and incurred net operating losses every year since our inception in
1982. We believe these losses will continue for the foreseeable future, and may increase, as we pursue our product development efforts
related to Tß4. As of December 31, 2021, our accumulated deficit totaled approximately $110.5 million.
As we expand our research and development efforts and seek to obtain regulatory approval of our product candidates to make
them commercially viable, we anticipate substantial and increasing operating losses. Our ability to generate revenues and to become
profitable will depend largely on our ability, alone or through the efforts of third-party licensees and collaborators, to efficiently and
successfully complete the development of our product candidates, obtain necessary regulatory approvals for commercialization, scale-up
commercial quantity manufacturing capabilities either internally or through third-party suppliers, and market our product candidates.
There can be no assurance that we will achieve any of these objectives or that we will ever become profitable or be able to maintain
profitability. Even if we do achieve profitability, we cannot predict the level of such profitability. If we continue to sustain losses over an
extended period of time and are not otherwise able to raise necessary funds to continue our development efforts and maintain our
operations, we may be forced to cease operations.
Our common stock is quoted on the over-the-counter market, which subjects us to the SEC’s penny stock rules and may decrease the
liquidity of our common stock.
Our common stock is traded over-the-counter on the OTC Bulletin Board. Over-the-counter markets are generally considered to
be less efficient than, and not as broad as, a stock exchange. There may be a limited market for our stock now that it is quoted on the
OTC Bulletin Board, trading in our stock may become more difficult and our share price could decrease. Specifically, you may not be
able to resell your shares of common stock at or above the price you paid for such shares or at all.
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In addition, our ability to raise additional capital may be impaired because of the less liquid nature of the over-the-counter
markets. While we cannot guarantee that we would be able to complete an equity financing on acceptable terms, or at all, we believe that
dilution from any equity financing while our shares are quoted on an over-the-counter market would likely be substantially greater than if
we were to complete a financing while our common stock is traded on a national securities exchange. Further, we are unable to use short-
form registration statements on Form S-3 for the registration of our securities, which could impair our ability to raise additional capital as
needed.
Our common stock is also subject to penny stock rules, which impose additional sales practice requirements on broker-dealers
who sell our common stock. The SEC generally defines “penny stock” as an equity security that has a market price of less than $5.00 per
share, subject to certain exceptions. The ability of broker-dealers to sell our common stock and the ability of our stockholders to sell their
shares in the secondary market will be limited and, as a result, the market liquidity for our common stock will likely be adversely
affected. We cannot assure you that trading in our securities will not be subject to these or other regulations in the future.
Further, recently some discount and major brokerage firms have implemented new rules regarding the deposit of penny stock
shares into new or existing accounts where such stocks do not meet minimum price and volume requirements. Such rules may make it
difficult or even prevent stockholders from timely selling their shares through such brokerage firms unless the shares meet such
minimum requirements.
The report of our independent registered public accounting firm contains explanatory language that substantial doubt exists about
our ability to continue as a going concern.
The report of our independent registered public accounting firm on our financial statements for the year ended December 31,
2021 contains explanatory language that substantial doubt exists about our ability to continue as a going concern, without raising
additional capital. As described in this report, even though we sold securities in June 2021 for proceeds of $1,980,000, these proceeds are
only projected to fund our operations at the current level through 2022; therefore, we will need to secure additional operating capital to
continue operations substantially beyond 2022. Therefore, we are seeking sources of capital, but if we are unable to obtain sufficient
financing to support and complete these activities, then we would, in all likelihood, experience severe liquidity problems and may have
to curtail our operations. If we curtail our operations, we may be placed into bankruptcy or undergo liquidation, the result of which will
adversely affect the value of our common shares.
Public health threats could have an adverse effect on our clinical trials and financial results.
Risks Related to Our Business and Operations
Public health threats could adversely affect our ongoing or planned business operations. In particular, the novel coronavirus
(COVID-19) and its variants have resulted in quarantines, restrictions on travel and other business and economic disruptions. We cannot
presently predict the scope and severity of any potential business shutdowns or disruptions, but if we or any of the third parties with
whom we engage, including the partners and other third parties with whom we conduct business, were to experience shutdowns or other
business disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially and
adversely impacted. The COVID-19 pandemic has affected patient accrual in our ARISE-3 clinical trial and with the last patient being
enrolled in October and completed patient treatment and follow-up in November 2020. As of the date of this report, while we do not
specifically foresee additional delays, it is impossible for us to predict further impact the COVID-19 global pandemic may have.
Our planned Phase 2 clinical trial of RGN-352 was placed on clinical hold by the FDA in March 2011 due to non-compliance of
cGMP regulations by a contract manufacturer and we are unsure when, if ever, we will be able to resume this trial.
In the second half of 2010, we implemented the development plans for our Phase 2 clinical trial to evaluate RGN-352 in patients
who have suffered an acute myocardial infarction, or AMI. We had planned to begin enrolling patients near the end of the first quarter of
2011. However, in March 2011, we were notified by the FDA that the trial was placed on clinical hold as a result of our contract
manufacturer’s alleged failure to comply with current Good Manufacturing Practice (“cGMP”) regulations. The FDA has prohibited us
from using any of the active drug or placebo manufactured by this manufacturer in human trials, which will require us to identify a
cGMP-compliant manufacturer and to have new material produced in the event that we seek to resume this trial. We learned that the
contract manufacturer has closed its manufacturing facility and has filed for bankruptcy protection. Significant preparatory time and
procedures will be required before any new suitable manufacturer would be able to manufacture RGN-352 for the AMI trial. Since we
are unable to estimate the length of time that the trial will be on clinical hold, we have elected to cease activities on this trial until the
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FDA clinical hold is resolved and the requisite funding might be secured. Consequently, there can be no assurance that we will be able to
timely initiate trial activities or complete this trial, if at all. As of the date of this report, we have received no new information on that
status of this trial.
All of our drug candidates are based on a single compound.
Our current primary business focus is the development of Tß4, and its analogues, derivatives and fragments, for the regeneration
and accelerated repair of damaged tissue from non-healing dermal and corneal wounds, cardiac injury, central/peripheral nervous system
diseases and other conditions, as well as an improvement in various functions, such as, but not limited to, cardiac and neurological.
Unlike many pharmaceutical companies that have a number of unique chemical entities in development, we are dependent on a single
molecule, formulated for different routes of administration and different clinical indications, for our potential commercial success. As a
result, any common safety or efficacy concerns for Tß4-based products that cross formulations would have a much greater impact on our
business prospects than if our product pipeline were more diversified.
We may never be able to commercialize our product candidates.
Although Tß4 has shown biological activity in in vitro studies and in vivo animal models and while we observed clinical
activity and efficacious outcomes in our recent RGN-259 Phase 2a trial and earlier Phase 2 dermal trials, we cannot assure you that our
product candidates will exhibit activity or importance in humans in large-scale trials. Our drug candidates are still in research and
development, and we do not expect them to be commercially available for the foreseeable future, if at all. Only a small number of
research and development programs ultimately result in commercially successful drugs. Potential products that appear to be promising at
early stages of development may not reach the market for a number of reasons. These include the possibility that the potential products
may:
● be found ineffective or cause harmful side effects during preclinical studies or clinical trials;
● fail to receive necessary regulatory approvals;
● be precluded from commercialization by proprietary rights of third parties;
● be difficult to manufacture on a large scale; or
● be uneconomical or otherwise fail to achieve market acceptance.
If any of these potential problems occurs, we may never successfully market Tß4-based products.
We are subject to intense government regulation, and we may not receive regulatory approvals for our drug candidates.
Our product candidates will require regulatory approvals prior to sale. In particular, therapeutic agents are subject to stringent
approval processes, prior to commercial marketing, by the FDA and by comparable agencies in most foreign countries. The process of
obtaining FDA and corresponding foreign approvals is costly and time-consuming, and we cannot assure you that such approvals will be
granted. Also, the regulations we are subject to change frequently and such changes could cause delays in the development of our
product candidates.
Three of our drug candidates are currently in the clinical development stage, and we cannot be certain that we, or our partners,
will successfully complete the clinical trials necessary to receive regulatory product approvals. The regulatory approval process is
lengthy, unpredictable and expensive. To obtain regulatory approvals in the United States, we or a partner must ultimately demonstrate to
the satisfaction of the FDA that our product candidates are sufficiently safe and effective for their proposed administration to humans.
Many factors, known and unknown, can adversely impact clinical trials and the ability to evaluate a product candidate’s safety and
efficacy, including:
● the FDA or other health regulatory authorities, or institutional review boards, or IRBs, do not approve a clinical trial
protocol or place a clinical trial on hold;
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● suitable patients do not enroll in a clinical trial in sufficient numbers or at the expected rate, for reasons such as the size of
the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the perceptions of
investigators and patients regarding safety, and the availability of other treatment options;
● clinical trial data is adversely affected by trial conduct or patient withdrawal prior to completion of the trial;
● there may be competition with ongoing clinical trials and scheduling conflicts with participating clinicians;
● patients experience serious adverse events, including adverse side effects of our drug candidates, for a variety of reasons
that may or may not be related to our product candidates, including the advanced stage of their disease and other medical
problems;
● patients in the placebo or untreated control group exhibit greater than expected improvements or fewer than expected
adverse events;
● third-party clinical investigators do not perform the clinical trials on the anticipated schedule or consistent with the clinical
trial protocol and good clinical practices, or other third-party organizations do not perform data collection and analysis in a
timely or accurate manner;
● service providers, collaborators or co-sponsors do not adequately perform their obligations in relation to the clinical trial or
cause the trial to be delayed or terminated;
● we are unable to obtain a sufficient supply of manufactured clinical trial materials;
● regulatory inspections of manufacturing facilities, which may, among other things, require us or a co-sponsor to undertake
corrective action or suspend the clinical trials, such as the clinical hold with respect to our Phase 2 clinical trial of RGN-
352;
● the interim results of the clinical trial are inconclusive or negative;
● the clinical trial, although approved and completed, generates data that is not considered by the FDA or others to be
clinically relevant or sufficient to demonstrate safety and efficacy; and
● changes in governmental regulations or administrative actions affect the conduct of the clinical trial or the interpretation of
its results.
There can be no assurance that clinical trials sponsored by our partners will in fact demonstrate, to the satisfaction of the FDA
and others, that our product candidates are sufficiently safe or effective. The FDA or we may also restrict or suspend our clinical trials at
any time if it is believed that subjects participating in the trials are being exposed to unacceptable health risks.
Clinical trials for product candidates such as ours are often conducted with patients who have more advanced forms of a
particular condition or other unrelated conditions. For example, in clinical trials for our product candidate RGN-137, we have studied
patients who are not only suffering from chronic epidermal wounds but who are also older and much more likely to have other serious
adverse conditions. During the course of treatment with our product candidates, patients could die or suffer other adverse events for
reasons that may or may not be related to the drug candidate being tested. Further, and as a consequence that all of our drug candidates
are based on Tß4, crossover risk exists such that a patient in one trial may be adversely impacted by one drug candidate, and that adverse
event may have implications for our other trials and other drug candidates. However, even if unrelated to our product candidates, such
adverse events can nevertheless negatively impact our clinical trials, and our business prospects would suffer.
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These factors, many of which may be outside of our control, may have a negative impact on our business by making it difficult
to advance product candidates or by reducing or eliminating their potential or perceived value. As a consequence, we may need to
perform more or larger clinical trials than planned. Further, if we are forced to contribute greater financial and clinical resources to a
study, valuable resources will be diverted from other areas of our business. If we fail to complete or if we experience material delays in
completing our clinical trials as currently planned, or we otherwise fail to commence or complete, or experience delays in, any of our
other present or planned clinical trials, including as a result of the actions of third parties upon which we rely for these functions, our
ability to conduct our business as currently planned could materially suffer.
We may not successfully establish and maintain development and testing relationships with third-party service providers and
collaborators, which could adversely affect our ability to develop our product candidates.
We have only limited resources, experience with and capacity to conduct requisite testing and clinical trials of our drug
candidates. As a result, we rely and expect to continue to rely on third-party service providers and collaborators, including corporate
partners, licensors and contract research organizations, or CROs, to perform a number of activities relating to the development of our
drug candidates, including the design and conduct of clinical trials, and potentially the obtaining of regulatory approvals. For example,
we currently rely on several third-party contractors to manufacture and formulate Tß4 into the product candidates used in our clinical
trials, develop assays to assess Tß4’s effectiveness in complex biological systems, recruit clinical investigators and sites to participate in
our trials, manage the clinical trial process and collect, evaluate and report clinical results.
We may not be able to maintain or expand our current arrangements with these third parties or maintain such relationships on
favorable terms. Our agreements with these third parties may also contain provisions that restrict our ability to develop and test our
product candidates or that give third parties rights to control aspects of our product development and clinical programs. In addition,
conflicts may arise with our collaborators, such as conflicts concerning the interpretation of clinical data, the achievement of milestones,
the interpretation of financial provisions or the ownership of intellectual property developed during the collaboration. If any conflicts
arise with our existing or future collaborators, they may act in their self-interest, which may be adverse to our best interests. Any failure
to maintain our collaborative agreements and any conflicts with our collaborators could delay or prevent us from developing our product
candidates. We and our collaborators may fail to develop products covered by our present and future collaborations if, among other
things:
● we or our partners do not achieve our objectives under our collaboration agreements;
● we or our partners are unable to obtain patent protection for the products or proprietary technologies we develop in our
partnerships;
● we are unable to manage multiple simultaneous product development partnerships;
● our partners become competitors of ours or enter into agreements with our competitors;
● we or our partners encounter regulatory hurdles that prevent commercialization of our product candidates; or
● we develop products and processes or enter into additional partnerships that conflict with the business objectives of our
other partners.
We also have less control over the timing and other aspects of our clinical trials than if we conducted the monitoring and
supervision entirely on our own. Third parties may not perform their responsibilities for our clinical trials on our anticipated schedule or
consistent with a clinical trial protocol or applicable regulations. We, and our partners, also rely on clinical research organizations to
perform much of our data management and analysis. They may not provide these services as required or in a timely manner. If any of
these parties do not meet deadlines or follow proper procedures, including procedures required by law, the preclinical studies and clinical
trials may take longer than expected, may be delayed or may be terminated, which would have a materially negative impact on our
product development efforts. If we were forced to find a replacement entity to perform any of our preclinical studies or clinical trials, we
may not be able to find a suitable entity on favorable terms or at all. Even if we were able to find a replacement, resulting delays in the
tests or trials may result in significant additional expenditures and delays in obtaining regulatory approval for drug candidates, which
could have a material adverse impact on our results of operations and business prospects.
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GtreeBNT Co., Ltd. has limited drug development experience.
We are a party to several license agreements and a Joint Venture with GtreeBNT. Historically, GtreeBNT’s business focus has
been in the IT software industry in Korea with strong IP positions addressing specific software tools and apps such as optimized
multimedia software for smart phones. GtreeBNT made a strategic decision in November 2013 to expand into the biopharmaceutical
business through selected strategic alliances with biopharmaceutical companies in the U.S. and EU. The collaboration with RegeneRx is
the first strategic investment in this initiative. While GtreeBNT has hired executives and staff with significant pharmaceutical experience,
the company has no internal drug development experience. As a result, GtreeBNT may face more and different challenges in the
development of these product candidates than would more established pharmaceutical companies.
GtreeBNT Co., Ltd. may have different public reporting requirements than RegeneRx and communications between the two
companies may sometimes conflict or be less than clear.
GtreeBNT is a public company traded on the Korean stock market. Certain disclosure requirements may differ from
RegeneRx’s. Moreover, due to different language conventions, translations may be less than 100% accurate. Further, RegeneRx may not
always get material information related to clinical trials or manufacturing development or strategic product development strategy in a
timely or clear manner.
GtreeBNT Co., Ltd. has limited financial resources.
GtreeBNT has informed us that it has limited financial resources. It has to continuously raise capital to fund research,
development, clinical trials, and operations. Therefore, its ability to finance each of these areas is subject to its ability to secured adequate
capital. While GtreeBNT has been able to finance each of these areas, to date, there is no assurance that they will be able to do so in the
future. If GtreeBNT is unable to secure necessary financing to fund clinical trials or operations, it could have a material adverse impact
on RGN-137 and RGN-259 and our ability to continue funding operations while these products are under development.
We are subject to intense competition from companies with greater resources and more mature products, which may result in our
competitors developing or commercializing products before or more successfully than we do.
We are engaged in a business that is highly competitive. Research and development activities for the development of drugs to
treat indications within our focus are being sponsored or conducted by private and public research institutions and by major
pharmaceutical companies located in the United States and a number of foreign countries. Most of these companies and institutions have
financial and human resources that are substantially greater than our own and they have extensive experience in conducting research and
development activities and clinical trials and in obtaining the regulatory approvals necessary to market pharmaceutical products that we
do not have. As a result, they may develop competing products more rapidly that are safer, more effective, or have fewer side effects, or
are less expensive, or they may develop and commercialize products that render our product candidates non-competitive or obsolete.
With respect to our product candidate RGN-259, there are also numerous ophthalmic companies developing drugs for corneal
wound healing and other front-of-the-eye diseases and injuries, including dry eye syndrome. Amniotic membranes have been
successfully used to treat corneal wounds in certain cases, as have topical steroids and antibacterial agents. Most specialty ophthalmic
companies have a number of products on the market that could compete with RGN-259. There are numerous antibiotics to treat eye
infections to promote corneal wound healing and many eye lubrication products that are soothing to the eye and help eye healing, many
of which are sold without prescriptions. Companies also market steroids to treat certain conditions within our area of interest.
Allergan, Inc. markets Restasis™, Ophthalmic Emulsion, which was the only commercially available and FDA-approved eye drop to
treat dry eye. Shire PLC recently received FDA approval to market Xiidra™ for the treatment of dry eye and has launched the product in
the U.S. Restasis. In October 2020, the FDA approved loteprednol etabonate ophthalmic suspension (Eysuvis; Kala Pharmaceuticals) a
0.25% ocular corticosteroid indicated for dry eye disease, and other products, have been approved for marketing in certain other
countries where we have licensed RGN-259.
We have initially targeted our product candidate RGN-352 for cardiovascular indications. We have also been exploring the
potential of RGN-352 for the treatment of COVID-19. Most large pharmaceutical companies and many smaller biomedical companies
are vigorously pursuing the development of therapeutics to treat patients after heart attacks and for other cardiovascular indications.
Numerous biotechnology and pharmaceutical companies are developing products to treat COVID-19.
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With respect to our product candidate RGN-137 for wound healing, Johnson & Johnson has previously marketed Regranex™
for this purpose in patients with diabetic foot ulcers. Other companies, such as Novartis, are developing and marketing artificial skins,
which we believe could also compete with RGN-137. Moreover, wound healing is a large and highly fragmented marketplace attracting
many companies, large and small, to develop products for treating acute and chronic wounds.
We are also interested in developing potential cosmeceutical products, which are loosely defined as products that bridge the gap
between cosmetics and pharmaceuticals, for example, by improving skin texture and reducing the appearance of aging. This industry is
intensely competitive, with potential competitors ranging from large multinational companies to very small specialty companies. New
cosmeceutical products often have a short product life and are frequently replaced with newer products developed to address the latest
trends in appearance and fashion. We may not be able to adapt to changes in the industry as quickly as larger and more experienced
cosmeceutical companies. Further, larger cosmetics companies have the financial and marketing resources to effectively compete with
smaller companies like us in order to sell products aimed at larger markets.
Even if approved for marketing, our technologies and product candidates are unproven, and they may fail to gain market acceptance.
Our product candidates, all of which are based on the molecule Tß4, are new and unproven and there is no guarantee that health
care providers or patients will be interested in our product candidates, even if they are approved for use. If any of our product candidates
are approved by the FDA, our success will depend in part on our ability to demonstrate sufficient clinical benefits, reliability, safety, and
cost effectiveness of our, or our partners’, product candidates relative to other approaches, as well as on our ability to continue to develop
our product candidates to respond to competitive and technological changes. If the market does not accept our product candidates, when
and if we are able to commercialize them, then we may never become profitable. Factors that could delay, inhibit or prevent market
acceptance of our product candidates may include:
● the timing and receipt of marketing approvals;
● the safety and efficacy of the products;
● the emergence of equivalent or superior products;
● the cost-effectiveness of the products; and
● ineffective marketing.
It is difficult to predict the future growth of our business, if any, and the size of the market for our product candidates because
the markets are continually evolving. There can be no assurance that our product candidates will prove superior to products that may
currently be available or may become available in the future or that our research and development activities will result in any
commercially profitable products.
We have no marketing experience, sales force or distribution capabilities. If our product candidates are approved, and we are unable
to recruit key personnel to perform these functions, we may not be able to commercialize them successfully.
Although we do not currently have any marketable products, our ability to produce revenues ultimately depends on our, or our
partners’, ability to sell our product candidates if and when they are approved by the FDA and other regulatory authorities. We currently
have no experience in marketing or selling pharmaceutical products, and we do not have a marketing and sales staff or distribution
capabilities. Developing a marketing and sales force is also time-consuming and could delay the launch of new products or expansion of
existing product sales. In addition, we will compete with many companies that currently have extensive and well-funded marketing and
sales operations. If we fail to establish successful marketing and sales capabilities or fail to enter into successful marketing arrangements
with third parties, our ability to generate revenues will suffer.
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If we enter markets outside the United States our business will be subject to political, economic, legal and social risks in those
markets, which could adversely affect our business.
There are significant regulatory and legal barriers to entering markets outside the United States that must be overcome if we, or
our partners, seek regulatory approval to market our product candidates in countries other than the United States. We would be subject to
the burden of complying with a wide variety of national and local laws, including multiple and possibly overlapping and conflicting
laws. We also may experience difficulties adapting to new cultures, business customs and legal systems. Any sales and operations outside
the United States would be subject to political, economic and social uncertainties including, among others:
● changes and limits in import and export controls;
● increases in custom duties and tariffs;
● changes in currency exchange rates;
● economic and political instability, particular in light of the war in Ukraine and its impact on inflation;
● changes in government regulations and laws;
● absence in some jurisdictions of effective laws to protect our intellectual property rights; and
● currency transfer and other restrictions and regulations that may limit our ability to sell certain product candidates or
repatriate profits to the United States.
Any changes related to these and other factors could adversely affect our business if and to the extent we enter markets outside
the United States. Additionally, we have entered into license agreements with Lee’s Pharmaceutical Limited and GtreeBNT Co, Ltd. for
the development of certain of our product candidates in international markets. As a result, these development activities will be subject to
compliance in all respects with local laws and regulations and may be subject to many of the risks described above.
Governmental and third-party payors may subject any product candidates we develop to sales and pharmaceutical pricing controls
that could limit our product revenues and delay profitability.
The successful commercialization of our product candidates, if they are approved by the FDA, will likely depend on our ability
to obtain reimbursement for the cost of the product and treatment. Government authorities, private health insurers and other
organizations, such as health maintenance organizations, are increasingly seeking to lower the prices charged for medical products and
services. Also, the trend toward managed health care in the United States, the growth of healthcare maintenance organizations, and
recently enacted legislation reforming healthcare and proposals to reform government insurance programs could have a significant
influence on the purchase of healthcare services and products, resulting in lower prices and reducing demand for our product candidates.
The cost containment measures that healthcare providers are instituting, and any healthcare reform could reduce our ability to sell our
product candidates and may have a material adverse effect on our operations. We cannot assure you that reimbursement in the United
States or foreign countries will be available for any of our product candidates, and that any reimbursement granted will be maintained, or
that limits on reimbursement available from third-party payors will not reduce the demand for, or the price of, our product candidates.
The lack or inadequacy of third-party reimbursements for our product candidates would decrease the potential profitability of our
operations. We cannot forecast what additional legislation or regulation relating to the healthcare industry or third-party coverage and
reimbursement may be enacted in the future, or what effect the legislation or regulation would have on our business.
We have no manufacturing or formulation capabilities and are dependent upon third-party suppliers to provide us with our product
candidates. If these suppliers do not manufacture our product candidates in sufficient quantities, at acceptable quality levels and at
acceptable cost, or if we are unable to identify suitable replacement suppliers if needed, our clinical development efforts could be
delayed, prevented or impaired.
We do not own or operate manufacturing facilities and have little experience in manufacturing pharmaceutical products. We
currently rely, and expect to continue to rely, primarily on peptide manufacturers to supply us with Tß4 for further formulation into our
product candidates. We have historically engaged three separate smaller drug formulation contractors for the formulation of clinical
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grade product candidates, one for each of our three product candidates in clinical development, although, as described in this report, the
contractor we engaged to formulate and vial RGN-352 has filed for bankruptcy and closed its manufacturing facility, and our clinical trial
involving RGN-352 has been placed on clinical hold. We currently do not have an alternative source of supply for either Tß4 or the
individual drug candidates. If these suppliers, together or individually, are not able to supply us with either Tß4 or individual product
candidates on a timely basis, in sufficient quantities, at acceptable levels of quality and at a competitive price, or if we are unable to
identify a replacement manufacturer to perform these functions on acceptable terms as needed, our development programs could be
seriously jeopardized.
The clinical hold on our RGN-352 trial will require us to have new material manufactured by a cGMP-compliant manufacturer
in the event that we seek to resume this trial. Significant preparatory time and procedures will be required before any new manufacturer
would be able to manufacture RGN-352 for the AMI trial, due to the time required for revalidation of processes and assays related to
such production that were already in place with the original manufacturer. Since we are unable to estimate the length of time that the trial
will be on clinical hold, we have elected to cease activities on this trial until the FDA clinical hold is resolved and the requisite funding
might be secured.
Other risks of relying solely on single suppliers for each of our product candidates include:
● the possibility that our other manufacturers, and any new manufacturer that we, or our partners, may identify for RGN-352,
may not be able to ensure quality and compliance with regulations relating to the manufacture of pharmaceuticals;
● their manufacturing capacity may not be sufficient or available to produce the required quantities of our product candidates
based on our planned clinical development schedule, if at all;
● they may not have access to the capital necessary to expand their manufacturing facilities in response to our needs;
● commissioning replacement suppliers would be difficult and time-consuming;
● individual suppliers may have used substantial proprietary know-how relating to the manufacture of our product candidates
and, in the event we must find a replacement or supplemental supplier, our ability to transfer this know-how to the new
supplier could be an expensive and/or time-consuming process;
● an individual supplier may experience events, such as a fire or natural disaster, that force it to stop or curtail production for
an extended period;
● an individual supplier could encounter significant increases in labor, capital or other costs that would make it difficult for
them to produce our products cost-effectively; or
● an individual supplier may not be able to obtain the raw materials or validated drug containers in sufficient quantities, at
acceptable costs or in sufficient time to complete the manufacture, formulation and delivery of our product candidates.
Our suppliers may use hazardous and biological materials in their businesses. Any claims relating to improper handling, storage or
disposal of these materials could be time-consuming and costly to us, and we are not insured against such claims.
Our product candidates and processes involve the controlled storage, use and disposal by our suppliers of certain hazardous and
biological materials and waste products. We and our suppliers and other collaborators are subject to federal, state and local regulations
governing the use, manufacture, storage, handling and disposal of materials and waste products. Even if we and these suppliers and
collaborators comply with the standards prescribed by law and regulation, the risk of accidental contamination or injury from hazardous
materials cannot be completely eliminated. In the event of an accident, we could be held liable for any damages that result, and we do not
carry insurance for this type of claim. We may also incur significant costs to comply with current or future environmental laws and
regulations.
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We face the risk of product liability claims, which could adversely affect our business and financial condition.
We, or our partners, may be subject to product liability claims as a result of our testing, manufacturing, and marketing of drugs.
In addition, the use of our product candidates, when and if developed and sold, will expose us to the risk of product liability claims.
Product liability may result from harm to patients using our product candidates, such as a complication that was either not communicated
as a potential side effect or was more extreme than anticipated. We require all patients enrolled in our clinical trials to sign consents,
which explain various risks involved with participating in the trial. However, patient consents provide only a limited level of protection,
and it may be alleged that the consent did not address or did not adequately address a risk that the patient suffered. Additionally, we will
generally be required to indemnify our clinical product manufacturers, clinical trial centers, medical professionals and other parties
conducting related activities in connection with losses they may incur through their involvement in the clinical trials.
Our ability to reduce our liability exposure for human clinical trials and commercial sales, if any, of Tß4 is dependent in part on
our ability to obtain sufficient product liability insurance or to collaborate with third parties that have adequate insurance. Although we
intend to obtain and maintain product liability insurance coverage if we gain approval to market any of our product candidates, we
cannot guarantee that product liability insurance will continue to be available to us on acceptable terms, or at all, or that its coverage will
be sufficient to cover all claims against us. A product liability claim, even one without merit or for which we have substantial coverage,
could result in significant legal defense costs, thereby potentially exposing us to expenses significantly in excess of our revenues, as well
as harm to our reputation and distraction of our management.
If any of our key employees discontinue their services with us, our efforts to develop our business may be delayed.
We are highly dependent on the principal members of our management team. The loss of our chairman and Chief Scientific
Officer, Allan Goldstein, or chief executive officer, J.J. Finkelstein could prevent or significantly delay the achievement of our goals. We
cannot assure you that Dr. Goldstein or Mr. Finkelstein, or any other key employees or consultants, will not elect to terminate their
employment or consulting arrangements. In addition, we do not maintain a key man life insurance policy with respect to any of our
management personnel. In the future, we anticipate that we will also need to add additional management and other personnel.
Competition for qualified personnel in our industry is intense, and our success will depend in part on our ability to attract and retain
highly skilled personnel. We cannot assure you that our efforts to attract or retain such personnel will be successful.
Mauro Bove, a member of our Board is a consultant to Lee’s Pharmaceuticals, a relationship which could give rise to a conflict of
interest for Mr. Bove.
Mauro Bove is a member of our Board of Directors and currently provides consulting services to Lee’s Pharmaceuticals Group
in Hong Kong. There can be no assurance that we will ever receive any further payments from Lee’s under the current agreement
established between RegeneRx and Lee’s. As a result of Mr. Bove’s relationship with Lee’s, Mr. Bove may have interests that are
different from our other stockholders in connection with our agreement with Lee’s and circumstances may arise that require the exercise
of the Board’s discretion with respect to Lee’s that require the exclusion of Mr. Bove.
Risks Related To Our Intellectual Property
We may not be able to maintain broad patent protection for our product candidates, which could limit the commercial potential of our
product candidates.
Our success will depend in part on our, or our partners’, ability to obtain, defend and enforce patents, both in the United States
and abroad. We have attempted to create a substantial intellectual property portfolio, submitting patent applications for various
compositions of matter, methods of use and fragments and derivatives of Tß4. As described elsewhere in this report, we currently do not
have adequate financial resources to fund our ongoing business activities beyond the third quarter of 2020 without additional funding.
Thus, we continuously evaluate our issued patents and patent applications and may decide to limit their therapeutic and/or geographic
coverage in an effort to enhance our ability to focus on certain medical conditions and countries within our financial constraints. As a
result, we may not be able to protect our intellectual property rights in indications and/or territories that we otherwise would, and,
therefore, our ability to commercialize Tß4, if at all, could be substantially limited, which could have a material adverse impact on our
future results of operations.
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Our patents may expire before any of our product candidates reach commercialization.
Our success will depend in part on our, or our partners’, patents to provide market exclusivity for our product candidates. We
have numerous patent and patent applications in the U.S. and abroad. However, some of our patents are reaching the end of their 20-year
patent exclusivity and, therefore, may expire prior to developing any marketable products or expire shortly after product launch, which
could negatively affect our commercial success.
If we, or our partners, are not able to maintain adequate patent protection for our product candidates, we may be unable to prevent
our competitors from using our technology or technology that we license.
Our success will depend in substantial part on our, or our partners’, abilities to obtain, defend and enforce patents, maintain
trade secrets and operate without infringing upon the proprietary rights of others, both in the United States and abroad. While patents
covering our use of Tß4 have been issued in some countries, we cannot guarantee whether or when corresponding patents will be issued,
or the scope of any patents that may be issued, in other countries. We have attempted to create a substantial intellectual property
portfolio, submitting patent applications for various compositions of matter, methods of use and fragments and derivatives of Tß4. We
have also in-licensed other intellectual property rights from third parties that could be subject to the same risks as our own patents. If any
of these patent applications do not issue, or are not issued in certain countries, or are not enforceable, the ability to commercialize Tß4 in
various medical indications could be substantially limited or eliminated.
In addition, the patent positions of the products being developed by us and our collaborators involve complex legal and factual
uncertainties. As a result, we cannot assure you that any patent applications filed by us, or by others under which we have rights, will
result in patents being issued in the United States or foreign countries. In addition, there can be no assurance that any patents will be
issued from any pending or future patent applications of ours or our partners, that the scope of any patent protection will be sufficient to
provide us with competitive advantages, that any patents obtained by us or our partners will be held valid if subsequently challenged or
that others will not claim rights in or ownership of the patents and other proprietary rights we or our partners may hold. Unauthorized
parties may try to copy aspects of our product candidates and technologies or obtain and use information we consider proprietary.
Policing the unauthorized use of our proprietary rights is difficult. We cannot guarantee that no harm or threat will be made to our or our
partners’ intellectual property. In addition, changes in, or different interpretations of, patent laws in the United States and other countries
may also adversely affect the scope of our patent protection and our competitive situation.
Due to the significant time lag between the filing of patent applications and the publication of such patents, we cannot be certain
that our licensors were the first to file the patent applications we license or, even if they were the first to file, also were the first to invent,
particularly with regards to patent rights in the United States. In addition, a number of pharmaceutical and biotechnology companies and
research and academic institutions have developed technologies, filed patent applications or received patents on various technologies that
may be related to our product candidates. Some of these technologies, applications or patents may conflict with our or our licensors’
technologies or patent applications. A conflict could limit the scope of the patents, if any, that we or our licensors may be able to obtain
or result in denial of our or our licensors’ patent applications. If patents that cover our activities are issued to other companies, we may
not be able to develop or obtain alternative technology.
Additionally, there is certain subject matter that is patentable in the United States but not generally patentable outside of the
United States. Differences in what constitutes patentable subject matter in various countries may limit the protection we can obtain
outside of the United States. For example, methods of treating humans are not patentable in many countries outside of the United States.
These and other issues may prevent us from obtaining patent protection outside of the United States, which would have a material
adverse effect on our business, financial condition and results of operations.
Changes to U.S. patent laws could materially reduce any value our patent portfolio may have.
The value of our patents depends in part on their duration. A shorter period of patent protection could lessen the value of our
rights under any patents that may be obtained and may decrease revenues derived from its patents. For example, the U.S. patent laws
were previously amended to change the term of patent protection from 17 years following patent issuance to 20 years from the earliest
effective filing date of the application. Because the time from filing to issuance of biotechnology applications may be more than
three years depending on the subject matter, a 20-year patent term from the filing date may result in substantially shorter patent
protection. Moreover, a divisional patent that is filed after a parent patent, if granted, would begin its term beginning when the parent
patent was initially filed, thus having an impact on the divisional patent’s practical patent life, Future changes to patent laws could
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shorten our period of patent exclusivity and may decrease the revenues that we might derive from the patents and the value of our patent
portfolio.
We, or our partners, may not have adequate protection for our unpatented proprietary information, which could adversely affect our
competitive position.
In addition to our patents, we, and our partners, also rely on trade secrets, know-how, continuing technological innovations and
licensing opportunities to develop and maintain our competitive position. However, others may independently develop substantially
equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology. To protect our
trade secrets, we may enter into confidentiality agreements with employees, consultants and potential collaborators. However, we may
not have such agreements in place with all such parties and, where we do, these agreements may not provide meaningful protection of
our trade secrets or adequate remedies in the event of unauthorized use or disclosure of such information. Also, our trade secrets or
know-how may become known through other means or be independently discovered by our competitors. Any of these events could
prevent us from developing or commercializing our product candidates.
We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets of former employers.
As is commonplace in the biotechnology industry, we employ now, and may hire in the future, individuals who were previously
employed at other biotechnology or pharmaceutical companies, including competitors or potential competitors. Although there are no
claims currently pending against us, we may be subject to claims that we or certain employees have inadvertently or otherwise used or
disclosed trade secrets or other proprietary information of former employers. Litigation may be necessary to defend against these claims.
Even if we are successful in defending against these claims, litigation could result in substantial costs and would be a significant
distraction to management.
Risks Related To Our Securities
Our common stock price is volatile, our stock is highly illiquid, and any investment in our securities could decline substantially in
value.
For the period from January 1 through December 31, 2021, the closing price of our common stock has ranged from $0.15 to
$0.75, with an average daily trading volume of approximately 118,000 shares. In light of our small size and limited resources, as well as
the uncertainties and risks that can affect our business and industry, our stock price is expected to continue to be highly volatile and can
be subject to substantial drops, with or even in the absence of news affecting our business. The following factors, in addition to the other
risk factors described in this report, and the potentially low volume of trades in our common stock since it is not listed on a national
securities exchange, may have a significant impact on the market price of our common stock, some of which are beyond our control:
● results of pre-clinical studies and clinical trials;
● commercial success of approved products;
● corporate partnerships;
● technological innovations by us or competitors;
● changes in laws and government regulations both in the U.S. and overseas;
● changes in key personnel at our company;
● developments concerning proprietary rights, including patents and litigation matters;
● public perception relating to the commercial value or safety of any of our product candidates;
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● other issuances of our common stock, or securities convertible into or exercisable for our common stock, causing dilution;
● anticipated or unanticipated changes in our financial performance;
● general trends related to the biopharmaceutical and biotechnological industries; and
● general conditions in the stock market, including on account of the COVID-19 pandemic and the war in Ukraine.
The stock market in general has recently experienced relatively large price and volume fluctuations. In particular, the market
prices of securities of smaller biotechnology companies have experienced dramatic fluctuations that often have been unrelated or
disproportionate to the operating results of these companies. Continued market fluctuations could result in extreme volatility in the price
of our common stock, which could cause a decline in its value. You should also be aware that price volatility may be worse if the trading
volume of the common stock remains limited or declines.
Our principal stockholders have significant voting power and may take actions that may not be in the best interests of our other
stockholders.
Our officers, directors and principal stockholders together control approximately 46% of our outstanding common stock.
Included in this group are previous stockholders of Sigma-Tau and their affiliates, which now have consolidated their holding into
Essetifin S.p.A. which holds outstanding shares representing approximately 25.4% of our outstanding common stock and GtreeBNT
which owns approximately 13.6% of our outstanding common stock. These stockholders also hold options, warrants, convertible
promissory notes and stock purchase rights that provide them with the right to acquire significantly more shares of common stock.
Accordingly, if these stockholders acted together, they could control the outcome of all stockholder votes. This concentration of
ownership may have the effect of delaying or preventing a change in control and might adversely affect the market price of our common
stock, and therefore may not be in the best interest of our other stockholders.
If securities or industry analysts do not publish research or reports or publish unfavorable research about our business, the price of
our common stock and other securities and their trading volume could decline.
The trading market for our common stock and other securities will depend in part on the research and reports that securities or
industry analysts publish about us or our business. We currently have research coverage by one securities and industry analyst, and from
time-to-time other independent analysts. If securities or industry analysts do not commence or maintain coverage of us, the trading price
for our common stock and other securities would be negatively affected. In the event one or more of the analysts who covers us
downgrades our securities, the price of our securities would likely decline. If one or more of these analysts ceases to cover us or fails to
publish regular reports on us, interest in the purchase of our securities could decrease, which could cause the price of our common stock
and other securities and their trading volume to decline.
The exercise of options and warrants, conversion of convertible promissory notes, and other issuances of shares of common stock or
securities convertible into common stock will dilute your interest.
As of December 31, 2021, there were outstanding options to purchase an aggregate of 12,376,250 shares of our common stock
under our 2010 and 2018 incentive equity plans at exercise prices ranging from $0.64 per share to $0.16 per share and outstanding
warrants to purchase 25,287,738 shares of our common stock at a weighted average exercise price of $0.24 per share. In October 2020,
we sold a series of convertible promissory notes that will initially be convertible at $0.36 into 1,391,982 shares and we also issued
warrants to purchase 1,043,988 shares with an exercise price $0.45 per share. In February 2019, we sold a series of convertible
promissory notes that will initially be convertible at $0.12 into 10,833,333 shares and also issued warrants to purchase 8,125,000 shares
with an exercise price of $0.18 per share. In June 2021, we closed a private placement of common stock and warrants with several
institutional and accredited investors, including members of management and the board, and received gross proceeds of $1,980,000.
Pursuant to the terms of this purchase agreement, the Company sold an aggregate of 9,900,000 shares of its common stock to investors at
a price of $0.20 per share. Investors also received Series A Warrants to purchase 7,425,000 shares of common stock at an exercise price
of $0.24 per share with a two-year term and Series B Warrants to purchase 7,425,000 Warrant Shares at an exercise price of $0.28 per
share with a five-year term. The exercise of options and warrants or note conversions at prices below the market price of our common
stock could adversely affect the price of shares of our common stock. Additional dilution may result from the issuance of
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shares of our capital stock in connection with collaborations or manufacturing arrangements or in connection with other financing efforts.
Any issuance of our common stock that is not made solely to then-existing stockholders proportionate to their interests, such as
in the case of a stock dividend or stock split, will result in dilution to each stockholder by reducing his, her or its percentage ownership of
the total outstanding shares. Moreover, if we issue options or warrants to purchase our common stock in the future and those options or
warrants are exercised or we issue restricted stock, stockholders may experience further dilution. Holders of shares of our common stock
have no preemptive rights that entitle them to purchase their pro rata share of any offering of shares of any class or series.
Our certificate of incorporation and Delaware law contain provisions that could discourage or prevent a takeover or other change in
control, even if such a transaction would be beneficial to our stockholders, which could affect our stock price adversely and prevent
attempts by our stockholders to replace or remove our current management.
Our certificate of incorporation provides our Board with the power to issue shares of preferred stock without stockholder
approval. In addition, we are subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law. Subject to
specified exceptions, this section provides that a corporation may not engage in any business combination with any interested
stockholder, as defined in that statute, during the three-year period following the time that such stockholder becomes an interested
stockholder. This provision could also have the effect of delaying or preventing a change of control of our company. The foregoing
factors could reduce the price that investors or an acquirer might be willing to pay in the future for shares of our common stock.
We may become involved in securities class action litigation that could divert management’s attention and harm our business and our
insurance coverage may not be sufficient to cover all costs and damages.
The stock market has from time-to-time experienced significant price and volume fluctuations that have affected the market
prices for the common stock of pharmaceutical and biotechnology companies. The current world instability arising from the COVID-19
pandemic, the war in Ukraine, significant price increases due to inflation and global supply chain dysfunctionality has only exacerbated
these fluctuations. These broad market fluctuations may cause the market price of our common stock to decline. In the past, following
periods of volatility in the market price of a particular company’s securities, securities class action litigation has often been brought
against that company. If we experience this sort of volatility, we may become involved in this type of litigation in the future. Litigation
often is expensive and diverts management’s attention and resources, which could hurt our business, operating results and financial
condition.
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Securities.
Our common stock is quoted on the OTC Bulletin Board under the symbol “RGRX.” Quotations reported by the OTC Bulletin
Board reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions.
We have never declared or paid a cash dividend on our common stock and since all of our funds are committed to operations
and clinical research, we do not anticipate that any cash dividends will be paid on our common stock in the foreseeable future.
As of September 21, 2021, we had 4,037 holders of record of our common stock.
Item 6. Reserved.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation.
You should read the following discussion and analysis together with our financial statements and the related notes included
elsewhere in this annual report.
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Business Overview
We are a biopharmaceutical company focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tß4, for
tissue and organ protection, repair, and regeneration. We have formulated Tß4 into three distinct product candidates in clinical
development:
● RGN-259, a preservative-free topical eye drop for regeneration of corneal tissues damaged by injury, disease or other
pathology;
● RGN-352, an injectable formulation to treat cardiovascular diseases, central and peripheral nervous system diseases, and
other medical indications that may be treated by systemic administration; and
● RGN-137, a topical gel for dermal wounds and reduction of scar tissue.
We are continuing strategic partnership discussions with biotechnology and pharmaceutical companies regarding the further
clinical development of all of our product candidates.
Current Clinical Status
In January 2015, we entered into a Joint Venture Agreement with GtreeBNT whereby we created ReGenTree LLC
(“ReGenTree” or “Joint Venture”) jointly owned by us and GtreeBNT, which seeks to commercialize RGN-259 for treatment of dry eye
syndrome (“DES”) and neurotrophic keratitis (“NK”), an orphan indication in the United States.
To date, ReGenTree has sponsored a Phase 2/3 clinical trial (“ARISE-1”) and two Phase 3 clinical trials in patients with DES
(“ARISE-2” and “ARISE-3”). In 2020, ReGenTree completed a Phase 3 clinical trial in patients with NK (“SEER-1”). All Phase 3 trials
were conducted in the U.S. In May 2016, we reported the results of the 317-patient ARISE-1 trial and in October 2017, we reported the
results of the ARISE-2 trial. The ARISE-2 study, which was sponsored by ReGenTree and managed by Ora, Inc., demonstrated a number
of statistically significant improvements in both signs and symptoms of DES with 0.1% RGN-259 versus placebo, albeit not in the
designated co-primary endpoints, while showing excellent safety, comfort, and tolerability profiles. The ocular discomfort symptom
showed a statistically significant reduction in the RGN-259-treated group at day 15 as compared to placebo (p=0.0149) in the change
from baseline. For sign, RGN-259 also improved the dry eye patient’s ability to withstand an exacerbated condition in a patient subgroup
with both compromised corneal fluorescein staining and Schirmer’s test at baseline. In this population, RGN-259 showed superiority
over placebo in reducing corneal fluorescein staining in the change from baseline at days 15 and 29 (p=0.0207 and 0.0254, respectively).
RGN-259 confirmed its global effects on dry eye syndrome and fast onset in multiple sign and symptom efficacies with no safety issues
in the ARISE-1 and ARISE-2 studies as well as in the pooled data, although ARISE-2 was not successful in duplicating the results of
ARISE-1 where the study population was limited and less diversified.
Topline results from ARISE-3 were reported on March 18, 2021. Further statistical analysis was performed as part of the
process to fully understand patient data and the effects of RGN-259 compared to placebo by evaluating various subgroups of patients
within ARISE-3 with pooled data from all three ARISE clinical trials. While the trial failed to meet its co-primary sign and symptom
endpoints, the conclusions from these expanded analyses were that the use of RGN-259 has demonstrated statistically significant and
clinically relevant improvements in both signs and symptoms of dry eye syndrome after one and two weeks of treatment when measured
across all three phase 3 clinical trials in over 1,600 patients, while confirming its excellent safety profile. From a regulatory perspective,
the question is whether the combined data from these three trials is sufficient to file for a biologics license (“BLA”) for marketing
approval in the U.S. ReGenTree has been working with outside FDA regulatory consulting firms to define its regulatory strategy, based
on these analyses, which have been discussed with the FDA at a pre-BLA meeting on February 28, 2022. The ReGenTree team
previously submitted a 150 page pre-BLA dossier to the FDA in anticipation of the meeting as well as a number of questions. The FDA
will provide to ReGenTree minutes to the meeting by March 28, 2022. When appropriate, RegeneRx will provide information regarding
any additional clinical work that may be required after further discussions with our counterparts at HLB Therapeutics.
The NK trial (SEER-1), a smaller study in an orphan population, enrolled a total of 18 patients. On May 14, 2020, the Company
reported that the trial was closed and reported the results of SEER-1. Six out of 10 patients in the RGN-259 treated group and 1 out of 8
patients in the placebo treated group achieved complete corneal healing in four weeks. In terms of the primary endpoint, “ratio of corneal
wound healed patients after four weeks’ administration”, the statistical difference was slightly over 0.05 (p = 0.0656, Fisher’s
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exact test), due to the limited number of patients in each group. When another statistical analysis method was used to analyze the same
primary endpoint (Chi square test), there was statistical significance, p = 0.0400. In addition, in a pre-specified secondary endpoint
evaluating corneal epithelial healing at day 43 (two weeks post-treatment) and the durability of RGN-259 treatment, we also confirmed a
clear statistical difference using the Fisher’s exact test, p = 0.0359. Several other efficacy parameters were either highly significant or
strongly trending toward statistical significance in the RGN-259 group indicating the depth of patient response to RGN-259.
HLB Therapeutics (the parent company of GtreeBNT) has developed the CMC (chemistry, manufacturing and controls) dossier
required for Phase 3 clinical trials and commercialization in the U.S. and in Korea. This comprehensive and critical effort ensures that
final drug product manufacturing, packaging, stability, purity, reproducibility, etc., meets regulatory guidelines and product
specifications. The product of this activity is the current product formulation being utilized in the U.S. trials being conducted by
ReGenTree and will also be utilized in the planned clinical activity to be conducted by HLB under the RGN-259 license agreement for
Pan Asia.
During the past several years, ReGenTree began developing a modified eye drop formulation that it believes will enhance the
efficacy of thymosin beta 4 for NK, improve the patient experience, and allow a proprietary valued orphan product price for this rare
disease. ReGenTree has completed a preliminary formulation for NK patients that will be considered for use in future clinical study.
ReGenTree has not yet determined if it will use this new formulation in the future for NK.
In February 2017, our licensee for RGN-137, GtreeBNT (now HLB), through its subsidiary, Lenus Therapeutics, LLC, received
permission from the FDA to sponsor a Phase 3 clinical trial using RGN-137 to treat patients with epidermolysis bullosa (“EB”), a genetic
disease that causes severe blistering of the skin and internal organs. In August 2017, the Company amended the agreement for RGN-137
held by GtreeBNT. Under the amendment, the Territory was expanded to include Europe, Canada, South Korea, Australia and Japan. In
December 2018, GtreeBNT initiated a small Phase 2 open trial in patients with EB to evaluate RGN-137 in such patients prior to
sponsoring a larger Phase 3 trial. Three patients have been enrolled in the open clinical trial to date. In August 2019, it was reported that
the first patient had positively responded to RGN-137. However, as of the date of this report, the Company believes that the EB trial has
been put on hold and that Lenus Therapeutics has been dissolved with the rights reverting back to GtreeBNT, but the Company has not
been updated by HLB Therapeutics (GtreeBNT) as to any future development plans for RGN-137.
Financial Operations Overview
We have never generated product revenues, and we do not expect to generate product revenues until the FDA approves one of
our product candidates, if ever, and we begin marketing and selling it. We anticipate incurring additional operating losses in the future as
we continue to explore the potential clinical benefits of Tß4-based product candidates over multiple indications. To fund further
development and clinical trials, we have entered into a series of strategic partnerships under licensing and joint venture agreements (see
Note 4 of our financial statements) where our partners are responsible for advancing development of our product candidates with
multiple clinical trials.
On June 30, 2021, we closed a private placement of common stock and warrants with several institutional and accredited
investors, including members of management and the board, and received gross proceeds of $1,980,000. In October 2020, we sold the
2020 Notes. The sale of the 2020 Notes resulted in gross proceeds to the Company of $500,000. At present, we believe that we have
sufficient cash to fund planned operations through the end of 2022. Accordingly, we will continue to evaluate opportunities to raise
additional capital and are in the process of exploring various alternatives, including, without limitation, a public or private placement of
our securities, debt financing, corporate collaboration and licensing arrangements, government grants, or the sale of our company or
certain of our intellectual property rights.
Most of our expenditures to date have been for research and development, or R&D, activities and general and administrative, or
G&A, activities. R&D costs include all of the wholly-allocable costs associated with our various clinical programs passed through to us
by our outsourced vendors. Those costs include manufacturing Tß4 and peptide fragments, formulation of Tß4 into our product
candidates, stability studies for both Tß4, and the various formulations, preclinical toxicology, safety and pharmacokinetic studies,
clinical trial management, medical oversight, laboratory evaluations, statistical data analysis, regulatory compliance, quality assurance
and other related activities. R&D includes cash and non-cash compensation, payroll taxes, travel and other miscellaneous costs of our
internal R&D personnel, three persons in total, who are dedicated on a part-time hourly basis to R&D efforts. R&D also includes a
proration of our common infrastructure costs for office space and communications. We expense our R&D costs as they are incurred.
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R&D expenditures are subject to the risks and uncertainties associated with clinical trials and the FDA review and approval
process. As a result, these expenses could exceed our expectations, possibly materially. We are uncertain as to what we will incur in
future research and development costs for our clinical studies, as these amounts are subject to, management’s continuing assessment of
the economics of each individual research and development project and the internal competition for project funding.
G&A costs include outside professional fees for legal, business development, audit and accounting services. G&A also includes
cash and non-cash compensation, travel and other miscellaneous costs of our internal G&A personnel, two in total, who are wholly
dedicated to G&A efforts. G&A also includes a proration of our common infrastructure costs for office space and communications. Our
G&A expenses also include costs to maintain our intellectual property portfolio. Historically, we have expanded our patent prosecution
activities, and in some cases, we have filed patent applications for non-critical strategic purposes intended to prevent others from filing
similar patent claims. We continue to closely monitor our patent applications in the United States, Europe and other countries with the
advice of outside legal counsel to determine if they will continue to provide strategic benefits. In cases where we believe the benefit has
been realized or it becomes unnecessary due to the issuance of other patents, or for other reasons that will not affect the strength of our
intellectual property portfolio, we have and will continue to abandon these patent applications in order to reduce our costs of continued
prosecution or maintenance.
Critical Accounting Policies
We prepare our financial statements in conformity with accounting principles generally accepted in the United States of
America. Such accounting principles require that our management make estimates and assumptions that affect the amounts reported in
our financial statements and accompanying notes. Our actual results could differ materially from those estimates. The items in our
financial statements that have required us to make significant estimates and judgments are as follows:
Revenue Recognition
The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of
contracts with customers, (ii) identification of distinct performance obligations in the contract, (iii) determination of contract transaction
price, (iv) allocation of contract transaction price to the performance obligations and (v) determination of revenue recognition based on
timing of satisfaction of the performance obligation. The Company recognizes revenues upon the satisfaction of its performance
obligation (upon transfer of control of promised goods or services to our customers) in an amount that reflects the consideration to which
it expects to be entitled to in exchange for those goods or services. Whenever we determine that an arrangement should be accounted for
as a single unit of accounting, we must determine the period over which the performance obligations will be performed, and revenue will
be recognized. Revenue will be recognized using either a relative performance or straight-line method. We recognize revenue using the
relative performance method provided that we can reasonably estimate the level of effort required to complete our performance
obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Revenue recognized is limited
to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the
relative performance method, as of each reporting period.
The Company’s contracts with customers may at times include multiple promises to transfer products and services. Contracts
with multiple promises are analyzed to determine whether the promises, which may include a license together with performance
obligations such as providing a clinical supply of product and steering committee services, are distinct and should be accounted for as
separate performance obligations or whether they must be accounted for as a single performance obligation. The Company accounts for
individual performance obligations separately if they are distinct. Determining whether products and services are considered distinct
performance obligations may require significant judgment. If we cannot reasonably estimate when our performance obligation either
ceases or becomes inconsequential and perfunctory, then revenue is deferred until we can reasonably estimate when the performance
obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance.
Whenever the Company determines that an arrangement should be accounted for as a combined performance obligation, we
must determine the period over which the performance obligation will be performed and when revenue will be recognized. Revenue is
recognized using either a relative performance or straight-line method. We recognize revenue using the relative performance method
provided that we can reasonably estimate the level of effort required to complete our performance obligation under an arrangement and
such performance obligation is provided on a best-efforts basis. Revenue recognized is limited to the lesser of the cumulative amount of
payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each
reporting period.
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If the Company cannot reasonably estimate the level of effort required to complete our performance obligation under an
arrangement, the performance obligation is provided on a best-efforts basis and we can reasonably estimate when the performance
obligation ceases or the remaining obligations become inconsequential and perfunctory, then the total payments under the arrangement,
excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-
line basis over the period we expect to complete our performance obligations. Revenue is limited to the lesser of the cumulative amount
of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending
date.
At the inception of each arrangement that includes development milestone payments, the Company evaluates the probability of
reaching the milestones and estimates the amount to be included in the transaction price using the most likely amount method. If it is
probable that a significant revenue reversal would not occur in the future, the associated milestone value is included in the transaction
price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not
considered probable of being achieved until those approvals are received and therefore revenue recognized is constrained as management
is unable to assert that a reversal of revenue would not be possible. The transaction price is then allocated to each performance obligation
on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the
contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such
development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such
adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.
Amounts received prior to satisfying the above revenue recognition criteria are recorded as unearned revenue in our
accompanying balance sheets.
Contract assets are generated when contractual billing schedules differ from revenue recognition timing. Contract assets
represent a conditional right to consideration for satisfied performance obligations that becomes a billed receivable when the conditions
are satisfied. There were no contract assets as of December 31, 2021 and 2020.
Contract liabilities result from arrangements where we have received payment in advance of performance under the contract.
Changes in contract liabilities are generally due to either receipt of additional advance payments or our performance under the contract.
We have the following amounts recorded for contract liabilities:
Unearned revenue
December 31
2021
2020
$ 2,024,563 $ 2,101,325
The contract liabilities amount disclosed above are primarily related to revenue being recognized on a straight-line basis over
periods ranging from 23 to 30 years, which, in management’s judgment, is the best measure of progress towards satisfying the
performance obligations and represents the Company’s best estimate of the period of the obligation.
Share-based payments
We account for share-based compensation based on the estimated grant date fair value of the award using the Black-Scholes
option-pricing model. The estimated grant date fair value is recognized over the requisite service period.
Determining the appropriate fair value model and calculating the fair value of share-based payment awards require the input of
highly subjective assumptions, including the expected life of the share-based payment awards and stock price volatility. Since our
historical data is limited, the expected life was determined in accordance with SEC Staff Accounting Bulletin No. 107 guidance for
“plain vanilla” options. Since our historical trading volume is relatively low, we estimated the expected volatility based on monthly
closing prices for a period consistent with the expected life of the option.
The assumptions used in calculating the fair value of share-based payment awards represent management’s best estimates, but
these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use
different assumptions, our stock-based compensation expense could be materially different in the future. See Notes 2 and 8 to the
Financial Statements for a further discussion on stock-based compensation and the relative ranges of our historical, underlying
assumptions.
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Results of Operations
Comparison of years ended December 31, 2021 and 2020
Revenues. For 2021, we recorded revenue in the amount of approximately $77,000 versus $77,000 recorded for 2020. The
revenue reflects the amortization over 30 years of the payments we received under the original joint venture license agreement and the
payment we received for the expansion of the territorial rights to include Canada in April 2016. The payments received under the 2017
RGN-137 license amendment were amortized for revenue over 23 years.
Expenses — Research and development. For 2021, our R&D expenditures increased by $2,000, or 40%, to $7,000, from
approximately $5,000 in 2020. The limited R&D expenditures reflects the shift of our internal R&D efforts as our partners assume full
responsibility for clinical development. The 2021 increase relates to the retesting of Tß4 API by our contract manufacturer. We expect
our R&D expenses will remain at low levels unless we decide to reinitiate internal R&D efforts for our unpartnered programs.
Expenses — General and administrative. For 2021, our G&A expenses increased by approximately $33,000, or 2%, to
$1,399,000 from $1,366,000 in 2020. Increases are reflected in 2021 expenses for stock option compensation expense (increase of
$66,000), facility and related (increase of $1,000) and investor relations related expenses including SEC filing compliance costs and a
virtual annual shareholders meeting (increase of $55,000). These increases were partially offset by decreases in personnel and related
fees and expenses (decrease of $17,000), professional fees (decrease of $13,000) and insurance (decrease of $59,000). We believe that
our G&A expenses will remain at current levels as we wait for FDA feedback from the recent data submission completed by partners. If
we enter into additional partnerships or other business transactions, including anticipated financings required to fund for continued
operations after 2022, we will incur additional legal and transaction related expenses.
Interest Expense. Our statement of operations reflects interest expense of $324,878 for 2021 versus $232,631 for 2020. The
increase reflects the issuance of the 2020 Notes in October 2020.
Net Loss. Our statement of operations reflects a net loss of $1,597,755 for 2021 versus a net loss of $1,523,368 for 2020. Losses
from operations in 2021 of $1,328,511 increased from the losses in 2020 of $1,294,543.
Liquidity and Capital Resources
We have not commercialized any of our product candidates to date and have incurred significant losses since inception,
including a net loss of $1,597,755 for 2021. In this light, we have primarily financed our operations through the issuance of equity or
debt, including the sale of a series of convertible promissory notes through private placements with accredited investors, the March and
August 2014 private placements of common stock with GtreeBNT, the October 2020 sale of $500,000 of the 2020 Notes and the June
2021 private placement of $1,980,000 of common stock and warrants with several institutional and accredited investors, including
members of management and the board. We also saved additional cash outlays by entering into the ReGenTree joint venture in early
2015.
We had cash and cash equivalents of $1,231,608 at December 31, 2021. We believe that this is sufficient cash to fund our
planned operations through the end of 2022. Management has concluded that substantial doubt of our ability to remain a going concern
exists and, as such, the report of our independent registered public accounting firm regarding our financial statements for 2021 contains
an explanatory paragraph regarding our ability to continue as a going concern based upon our history of operating losses and dependence
on future financings in order to meet our planned operating activities.
We may also receive funds from grants or the raising of additional capital through the sale of common stock, warrants or a
convertible instrument if the market climate warrants. Additionally, we intend to continue to pursue additional partnering activities,
particularly for RGN-352, our injectable systemic product candidate for cardiac and central nervous system indications.
Net Cash Used in Operating Activities. Net cash used in operating activities was approximately $990,000 and $1,007,000 for
2021 and 2020, respectively. The decrease in 2021 reflects an increase in non-cash expenses related to stock option expense and
increased interest accrual at December 31, 2021. Additionally, in 2021, we recognized a $55,400 gain related to the forgiveness of our
SBA PPP loan in July 2021.
Net Cash Used in Investing Activities. We did not use any cash for investing activities in 2021 or 2020.
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Net Cash Provided by Financing Activities. Net cash provided by financing activities totaled approximately $1,794,000 and
$795,000 for 2021 and 2020, respectively. In 2021, the cash provided by financing activities consisted of the proceeds from the sale of
common stock and warrants in June 2021 of approximately $1,759,000 and $35,000 from the exercise of stock options and warrants. The
cash provided from financing activities in 2020 consisted of proceeds from the sale of the October 2020 Notes of $500,000, $242,000
from the exercise of warrants and the receipt of a Paycheck Protection Program loan, administered by the U.S. Small Business
Administration, of $55,400.
Future Funding Requirements
The expenditures that will be necessary to execute our business plan are subject to numerous uncertainties that may adversely
affect our liquidity and capital resources. Currently, RegeneRx has active partnerships in four major territories: the U.S., Europe, China
and Pan Asia. In each case, the cost of development is being borne by our partners with no financial obligation for RegeneRx. Patient
accrual, treatment, and follow-up for ophthalmic trials are, in general, relatively fast, as opposed to most other clinical efforts.
We still have significant clinical assets to develop, primarily RGN-352 (injectable formulation of Tß4 for cardiac and CNS
disorders) in the U.S., Pan Asia, and Europe, and RGN-259 in the EU. Our goal is to wait until possitive results are obtained from the
current ophthalmic clinical program before moving into the EU with RGN-259. If successful, we believe this should allow us to obtain a
higher value for the asset at that time. However, we intend to continue to develop RGN-352, either by obtaining grants to fund a Phase
2a clinical trial in the cardiovascular or central nervous system fields or finding a suitable partner with the resources and capabilities to
develop it as we have with RGN-259. We are also continuing to file patent applications for methods of utilizing the asset for certain
medical indications. Our capital resources remain limited; therefore, we will need to secure additional operating capital to continue
operations substantially beyond the end of 2022. A sale of common stock and warrants, a convertible instrument or additional partnering
of licensed rights are possible sources of operating capital in the future. In addition, the length of time required for clinical trials varies
substantially according to the type, complexity, novelty and intended use of a product candidate.
Some of the factors that could impact our liquidity and capital needs include, but are not limited to:
·
·
·
·
·
·
·
·
the progress of our clinical trials;
the progress of our research activities;
the number and scope of our research programs;
the progress of our preclinical development activities;
the costs involved in preparing, filing, prosecuting, maintaining, enforcing and defending patent and other intellectual
property claims;
the costs related to development and manufacture of preclinical, clinical and validation lots for regulatory purposes and
commercialization of drug supply associated with our product candidates;
our ability to enter into corporate collaborations and the terms and success of these collaborations;
the costs and timing of regulatory approvals;
● the costs of establishing manufacturing, sales and distribution capabilities; and
·
the continuing impact of the COVID-19 pandemic, the war in Ukraine and inflation on our activities and those of our
development partners.
In addition, the duration and the cost of clinical trials may vary significantly over the life of a project as a result of differences
arising during the clinical trial protocol, including the continuing impact of the COVID-19 pandemic, the war in Ukraine, inflation and,
among others, the following:
● the number of patients that ultimately participate in the trial;
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● the duration of patient follow-up that seems appropriate in view of the results;
● the number of clinical sites included in the trials; and
● the length of time required to enroll suitable patient subjects.
We also test our product candidates in numerous preclinical studies to identify indications for which they may be efficacious.
We may conduct multiple clinical trials to cover a variety of indications for each product candidate. As we obtain results from trials, we
may elect to discontinue clinical trials for certain product candidates or for certain indications in order to focus our resources on more
promising product candidates or indications.
Our proprietary product candidates have not yet achieved FDA regulatory approval, which is required before we can market
them as therapeutic products. In order to proceed to subsequent clinical trial stages and to ultimately achieve regulatory approval, the
FDA must conclude that our clinical data establish safety and efficacy. Historically, the results from preclinical studies and early clinical
trials have often not been predictive of results obtained in later clinical trials. A number of new drugs and biologics have shown
promising results in clinical trials, but subsequently failed to establish sufficient safety and efficacy data to obtain necessary regulatory
approvals.
Sources of Liquidity
We have not commercialized any of our product candidates to date and have primarily financed our operations through the
issuance of common stock and common stock warrants in private and public financings. In February 2019, we sold a series of convertible
promissory notes to accredited investors including Essetifin S.p.A., our largest shareholder. The sale of the notes resulted in gross
proceeds to the Company of $1,300,000 over two closings. The first closing in the amount of $650,000 occurred in February 2019 and
the second closing, also in the amount of $650,000, occurred in May 2019 after the Company provided notice of the enrollment of the
first patent in the ARISE-3 clinical trial in DES sponsored by ReGenTree. The notes contain a $0.12 conversion price and are initially
convertible into 10,833,333 shares of common stock. The purchasers also received a warrant exercisable at $0.18 to purchase additional
8,125,000 shares of common stock. In addition, we received proceeds of $115,625 pursuant to the exercise of warrants held by Sabby
Management as well as $125,000 for April 2019 warrant exercises. In January 2020, Sabby exercised its remaining warrants and the
Company received proceeds of $241,911.
In October 2020, we sold the 2020 Notes resulting in gross proceeds to the Company of $500,000. The 2020 Notes were
accompanied by 2020 Warrants. In June 2021, we closed a private placement of common stock and warrants with several institutional
and accredited investors, including members of management and the board, and received gross proceeds of $1,980,000. Pursuant to the
terms of this purchase agreement, the Company sold an aggregate of 9,900,000 shares of its common stock to investors at a price of
$0.20 per share. Investors also received Series A Warrants to purchase 7,425,000 shares of common stock at an exercise price of $0.24
per share with a two-year term and Series B Warrants to purchase 7,425,000 Warrant Shares at an exercise price of $0.28 per share with a
five-year term.
With the receipt of the proceeds from the closing of the 2021 Private Placement, we expect to have sufficient cash to fund our
planned operations through the end of 2022. We continuously monitor our cash use as well as the clinical timelines. We continue to
evaluate options including the licensing of additional rights to commercialize our clinical products as well as raising capital through the
capital markets.
We have various strategic agreements and license agreements with GtreeBNT, ReGenTree and Lee’s. These license agreements
provide for the opportunity for us to receive milestone payments upon specified commercial events and royalty payments in connection
with any commercial sales of the licensed products in the respective territories. However, there are no assurances that we will be able to
attain any such milestones or generate any such royalty payments under the agreements.
Licensing Agreements
As noted above, we have entered into two strategic agreements with GtreeBNT. GtreeBNT licensed the development and
commercialization rights for RGN-259 in Asia (excluding China, Hong Kong, Macau and Taiwan) while also licensing the development
and commercialization rights for RGN-137 in the U.S. In August 2017, the Company amended the license agreement for RGN-137 held
by GtreeBNT. Under the amendment, the Territory was expanded to include Europe, Canada, South Korea, Australia and Japan. In
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January 2015, we entered into a joint venture and licensing agreement with GtreeBNT that will commercialize RGN-259 for treatment of
dry eye and neurotrophic keratitis in the United States, as well as any other indications within the field of ophthalmology. The license
agreements provide for the opportunity for us to receive milestone payments upon specified commercial events and royalty payments in
connection with any commercial sales of the licensed products in the respective territories. However, there are no assurances that we will
be able to attain any such milestones or generate any such royalty payments under the agreements.
We also have entered into a license agreement with Lee’s Pharmaceuticals that provides for the opportunity for us to receive
milestone payments upon specified events and royalty payments in connection with any commercial sales of Tß4-based products in
China, Hong Kong, Macau and Taiwan (Greater China). However, there are no assurances that we will be able to attain any such
milestones or generate any such royalty payments under the agreement. In February 2019, the agreement was amended and assigned by
Lee’s to its affiliate, Zhaoke Ophthalmology Pharmaceutical Limited. There were no economic changes to the agreement.
Government Grants
We have pursued, and may continue to pursue, government funding for both RGN-259 and RGN-352. We are not currently
receiving funding under a Government Grant.
Other Financing Sources
Other potential sources of outside capital include entering into additional strategic business relationships, additional issuances of
equity securities or debt financing or other similar financial instruments. If we raise additional capital through a strategic business
relationship, we may have to give up valuable rights to our intellectual property. If we raise funds by selling additional shares of our
common stock or securities convertible into our common stock, the ownership interest of our existing stockholders may be significantly
diluted. In addition, if additional funds are raised through the issuance of preferred stock or debt securities, these securities are likely to
have rights, preferences and privileges senior to our common stock and may involve significant fees, interest expense, restrictive
covenants and the granting of security interests in our assets.
Our failure to successfully address liquidity requirements could have a materially negative impact on our business, including the
possibility of surrendering our rights to some technologies or product opportunities, delaying our clinical trials, or ceasing operations.
There can be no assurance that we will be able to obtain additional capital in sufficient amounts, on acceptable terms, or at all.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk
Our cash, cash equivalents, restricted cash and short-term investments are held in bank deposits, money market funds, U.S.
Treasury and debt securities. Such interest-earning instruments carry a degree of interest rate risk. The goals of our investment policy are
liquidity and capital preservation; we do not enter into investments for trading or speculative purposes and have not used any derivative
financial instruments to manage our interest rate exposure. We believe that we do not have any material exposure to changes in the fair
value of these assets as a result of changes in interest rates due to the short-term nature of our cash, cash equivalents and short-term
investments.
Foreign Currency Exchange Risk
Our expenses are denominated in U.S. dollars. Accordingly, foreign currency transaction gains and losses have not been
material to our financial statements.
Inflation Rate Risk
We do not believe that inflation has had a material effect on our business, financial condition or results of operations.
Nonetheless, if our costs were to become subject to significant inflationary pressures, such as the United States is currently experiencing,
we would not be able to offset such higher costs through price increases, as we have no current source of income from sales. Our
inability or failure to do so could harm our business, financial condition, and results of operations.
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Item 8. Financial Statements and Supplementary Data.
The financial statements required by this item are included beginning on page F-1 of this report.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in
reports that we file or submit under the Exchange Act is recorded, processed, summarized and timely reported as provided in SEC
rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer
who currently serves as both our principal executive officer and our principal financial officer, as appropriate, to allow for timely
decisions regarding required disclosure. We periodically review the design and effectiveness of our disclosure controls and procedures,
including compliance with various laws and regulations that apply to our operations. We make modifications to improve the design and
effectiveness of our disclosure controls and procedures and may take other corrective action if our reviews identify a need for such
modifications or actions. In designing and evaluating the disclosure controls and procedures, we recognize that any controls and
procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control
objectives, and we apply judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design
of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no
assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become
inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the
inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.
We have carried out an evaluation, under the supervision and the participation of our management, including our Chief
Executive Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-
15(e) and 15d-15(e) under the Exchange Act), as of December 31, 2021, the end of the period covered by this report. Based upon that
evaluation, our Chief Executive Officer, in his capacity as principal executive officer and principal financial officer, concluded that our
disclosure controls and procedures were effective as of December 31, 2021.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term
is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with U.S. generally accepted accounting principles. A company’s 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 dispositions 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 generally accepted accounting principles, and that receipts and
expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and
(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 our financial statements.
Because of its inherent limitations, including the possibility of human error and the circumvention or overriding of controls, a
system of internal control over financial reporting can provide only reasonable assurance and may not prevent or detect all
misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial
statement preparation and presentation. Further, because of changes in conditions, effectiveness of internal control over financial
reporting may vary over time.
A significant deficiency is a control deficiency, or combination of control deficiencies, in internal control over financial
reporting that is less severe than a material weakness, yet important enough to merit attention by those responsible for oversight of the
company’s financial reporting. A material weakness is a deficiency, or combination of control deficiencies, in internal control over
financial reporting such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial
statements will not be prevented or detected on a timely basis.
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Under the supervision and with the participation of our management, including our Chief Executive Officer in his capacity as
principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over
financial reporting based on the framework set forth in Internal Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission. Based on our evaluation, management has concluded that our internal control over financial
reporting was effective as of December 31, 2021.
This Annual Report does not include an attestation report of the Company’s independent registered public accounting firm
regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s independent
registered public accounting firm pursuant to the rules of the Securities and Exchange Commission that permit the Company to provide
only management’s report in this Annual Report.
Changes in Internal Control over Financial Reporting
There were no changes to the Company’s Internal Controls over Financial Reporting in the year ended December 31, 2021.
Item 9B. Other Information.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable.
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Item 10. Directors, Executive Officers and Corporate Governance.
Executive Officers and Directors
PART III
The following table sets forth as of March 1, 2022, the name, age and position of each person who serves as an executive officer
or director of our company. There are no family relationships among any of our executive officers or directors, with the exception that
Mr. Finkelstein is the first cousin of Dr. Goldstein’s wife.
We seek to assemble a board that, as a whole, possesses the appropriate balance of professional and industry knowledge,
financial expertise and high-level management experience necessary to oversee and direct our business. To that end, our board intends to
maintain membership of directors who complement and strengthen the skills of other members and who also exhibit integrity,
collegiality, sound business judgment and other qualities that we view as critical to effective functioning of the board. The brief
biographies below include information, as of the date of this report, regarding the specific and particular experience, qualifications,
attributes or skills of each director or nominee that led the board to believe that the director should serve on the board.
Name
Executive Officers
Mr. J.J. Finkelstein
Directors
Dr. Allan L. Goldstein
Mr. R. Don Elsey
Mr. Joseph C. McNay
Mr. Mauro Bove
Dr. Alessandro Noseda
Age
69
84
67
88
67
63
Position
President, Chief Executive Officer and Director
Founder, Chairman of the Board and Chief Scientific Officer
Director
Director
Director
Director
Mr. Finkelstein has served as our President and Chief Executive Officer and a member of our Board of Directors since 2002.
Mr. Finkelstein also served as our Chief Executive Officer from 1984 to 1989 and as the Vice Chairman of our Board of Directors from
1989 to 1991. Mr. Finkelstein has worked as an executive officer and consultant in the bioscience industry for the past 39 years,
including serving from 1989 to 1996 as chief executive officer of Cryomedical Sciences, Inc., a publicly-traded medical device company.
Mr. Finkelstein has significant experience in developing early-stage companies. He has been responsible for the regulatory approval and
marketing of several medical devices in the U.S. and abroad. Mr. Finkelstein has previously served on the executive committee of the
Board of Directors of the Technology Council of Maryland and MdBio, Inc. and formerly chaired the MdBio Foundation (now Learning
Undefeated) for six years, all of which are non-profit entities that support bioscience development and education in the State of
Maryland. Mr. Finkelstein received a business degree in finance from the University of Texas. The Board believes that Mr. Finkelstein’s
history and long tenure as our Chief Executive Officer positions him to contribute to the Board his extensive knowledge of our company
and to provide Board continuity. In addition, the Board believes that his experience at prior companies has provided him with operational
and industry expertise, as well as leadership skills that are important to the Board.
Dr. Goldstein has served as the Chairman of our Board of Directors and our Chief Scientific Officer since he founded our
company in 1982. Dr. Goldstein is Emeritus Professor & former Chairman of the Department of Biochemistry and Molecular Medicine
at the George Washington University School of Medicine and Health Sciences. Dr. Goldstein is a recognized expert in the field of
immunology and protein chemistry, having authored over 435 scientific articles in professional journals. He is also the inventor on over
25 issued and/or pending patents in biochemistry, immunology, cardiology, cancer and wound healing. Dr. Goldstein discovered several
important compounds, including Tα1, which is marketed worldwide, and Tß4, which is the basis for RegeneRx’s clinical program.
Dr. Goldstein served on the Board of Trustees of the Sabin Vaccine Institute from 2000 to 2012 and on the Board of Directors of the
Richard B. and Lynne V. Cheney Cardiovascular Institute from 2006 to 2012. Dr. Goldstein has also done pioneering work in the area of
medical education, developing distance learning programs for the internet entitled “Frontiers in Medicine,” a medical education series
that Dr. Goldstein developed. The Board believes that Dr. Goldstein’s scientific expertise, industry background and prior experience as
our founder all position him to make an effective contribution to the medical and scientific understanding of the Board, which the Board
believes to be particularly important as we continue our Tß4 development efforts.
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Mr. Elsey has served as a member of our Board of Directors since September 2010. Currently, Mr. Elsey serves as an advisor to
the CEO of Lyra Therapeutics, a private company pioneering a new therapeutic approach to treat debilitating ear, nose and throat
diseases. Mr. Elsey was the CFO of Lyra until his retirement in December 2020. Previously, Mr. Elsey served as CFO of
Senseonics, Inc., from February 2015 to February 2019, a medical device company focused on continuous glucose monitoring. From
May 2014 until February 2015, Mr. Elsey served as chief financial officer of Regado Biosciences, a public, late-stage clinical
development biopharmaceutical company. From December 2012 to February 2014, Mr. Elsey served as chief financial officer of
LifeCell, Inc., a privately held regenerative medicine company. From June 2005 to December 2012, he served in numerous finance
capacities, most recently as senior vice president and chief financial officer, at Emergent BioSolutions Inc., a publicly held
biopharmaceutical company. He served as the director of finance and administration at IGEN International, Inc., a publicly held
biotechnology company, and its successor BioVeris Corporation, from April 2000 to June 2005. Prior to joining IGEN, Mr. Elsey served
as director of finance at Applera, a genomics and sequencing company, and in several finance positions at International Business
Machines, Inc. He received an M.B.A. in finance and a B.A. in economics from Michigan State University. Mr. Elsey is a certified
management accountant. The Board believes that Mr. Elsey’s experience as chief financial officer of a public company is particularly
valuable to our business in that it positions him to contribute to our board’s and audit committee’s understanding of financial matters.
Mr. McNay has served as a member of our Board of Directors since 2002. He is currently Chairman, Chief Investment Officer
and Managing Principal of Essex Investment Management Company, LLC, positions he has held since 1976 when he founded Essex. He
has direct portfolio management responsibilities for a variety of funds and on behalf of private clients. He is also a member of the firm’s
Management Board. Prior to founding Essex, Mr. McNay was Executive Vice President and Director of Endowment Management &
Research Corp. from 1967. Prior to that, Mr. McNay was Vice President and Senior Portfolio Manager at the Massachusetts Company.
Currently he is serving as a Trustee of the Dana Farber Cancer Institute and as a member of the Children’s Hospital Investment
Committee. Mr. McNay served a Trustee for Brigham and Women’s Physicians Organization from 2000 to 2018. He received his A.B.
degree from Yale University and his M.B.A. degree in finance from the Wharton School of the University of Pennsylvania. The Board
believes that Mr. McNay’s extensive financial experience is valuable to our business and also positions him to contribute to the audit
committee’s understanding of financial matters.
Mr. Bove has served as a member of our Board of Directors since 2004 and has more than 30 years of business and
management experience within the pharmaceutical industry. Mr. Bove is currently based in Hong Kong and in Europe, serving as a
consultant to emerging pharmaceutical companies worldwide. Previously, Mr. Bove led for more than 20 years the Corporate & Business
Development of Sigma-Tau Finanziaria S.p.A., formerly the holding company of Sigma-Tau Group, a leading international
pharmaceutical company (Sigma-Tau Finanziaria S.p.A. — now Essetifin S.p.A. — and its affiliates are collectively our largest
stockholder). Mr. Bove, who resigned this role with Sigma-Tau on March 31, 2014, has also held a number of senior positions in
business, licensing and corporate development within Sigma-Tau Group. Mr. Bove obtained his law degree at the University of
Parma, Italy, in 1980. In 1985, he attended the Academy of American and International Law at the International and Comparative Law
Center, Dallas, Texas. The Board believes that Mr. Bove’s extensive business and management experience within the pharmaceutical
industry allows him to recognize and advise the Board with respect to recent industry developments.
Dr. Noseda has served as a member of our Board of Directors since 2019. He is the Chief Scientific Officer (CSO) of Leadiant
Biosciences S.p.A. and provides scientific and medical know-how to coordinate and manage the scientific and development programs at
a global level as well as to evaluate new opportunities for the Leadiant Group. Since September 2018, he is also Chief Medical Officer of
Leadiant Biosciences, Inc. After graduating as a Medical Doctor in 1984 at the University of Milan and following a Post Doctorate at
Bowman Gray School of Medicine (USA), he joined the pharma industry in 1988 where he held different managerial positions within the
R&D and Marketing organizations of multinational companies. He has acquired a significant experience in R&D (through the whole
development process, from research to interaction with Health Authorities for MA submission or HTA assessment) and strategic/business
operations. He joined Sigma-Tau in 1998 as Director of Scientific Office and Strategic Alliances within the Corporate R&D organization.
In this position, he managed key R&D projects and contributed to the finalization of important partnerships (e.g., with Novartis,
Debiopharm, etc.) and to the advancement of product development (from research to product registration). He has been part of the
management team and Board of Directors of biotech companies of the Sigma-Tau Group, including Thule Therapeutics, Metheresis
Translational Research and Rostaquo. He has also been Chief Executive Officer of Leadiant Biosciences SA (formerly Sigma-Tau
Research Switzerland) from 2007 to 2017, a position which he held in parallel with his former positions in Sigma-Tau (1988-2014) and
later in Leadiant where he acted as Chief Medical Officer (2014-2017) before becoming the CSO. Under his management, this company
developed and advanced a proprietary technology, and he guided the company through the process to obtain the authorization by the
Swiss Health Authorities to import and release medicinal products, as well as the Orphan Drug Designations and registration of new
products (e.g., Chenodeoxycholic Acid or CDCA). He worked in several therapeutic (and diagnostic) areas, but mostly in high unmet
medical need specialty areas as cancer, immune-oncology and rare diseases.
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Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Exchange Act requires our directors and executive officers, and persons who own more than ten percent of
a registered class of our equity securities, to file with the SEC initial reports of ownership and reports of changes in ownership of
common stock and other equity securities of our company. Officers, directors and greater than ten percent stockholders are required by
SEC regulation 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 such reports furnished to us and written representations of our
directors and officers that no other reports were required, during the fiscal year ended December 31, 2021, all Section 16(a) filing
requirements applicable to our officers, directors and greater than ten percent beneficial owners were complied with.
Corporate Code of Conduct and Ethics
We have adopted a corporate code of conduct and ethics that applies to all of our employees, officers and directors, as well as a
separate code of ethics that applies specifically to our principal executive officer and principal financial officer. The corporate code of
conduct and ethics and the code of ethics for our principal executive and financial officers are available on our corporate website at
www.regenerx.com. If we make any substantive amendments to the corporate code of conduct and ethics or the code of ethics for our
principal executive and financial officers or grant any waivers from a provision of these codes to any executive officer or director, we
will promptly disclose the nature of the amendment or waiver on our website.
Audit Committee and Audit Committee Financial Expert
We have a separately designated standing audit committee established in accordance with Section 3(a)(58)(A) of the Exchange
Act. The members of the audit committee are Messrs. McNay and Elsey. Mr. McNay serves as chairman of the audit committee.
Our Board of Directors periodically reviews the independence of our audit committee members and has determined that all
current members of our audit committee are independent under NYSE Amex listing standards. Although our common stock is no longer
listed on the NYSE Amex exchange, we have determined the independence of our audit committee members using the NYSE Amex
definitions of independence.
Our Board of Directors has also determined that each of Mr. McNay and Mr. Elsey qualifies as an audit committee financial
expert, as defined in applicable SEC rules.
Item 11. Executive Compensation.
Summary Compensation Table
The following table shows, for the fiscal years ended December 31, 2021 and 2020, compensation awarded to or paid to, or
earned by, our chief executive officer who was our only named executive officer for fiscal 2021. For purposes of this report, we
sometimes refer to our chief executive officer as our named executive officer.
Name and Principal Position
J.J. Finkelstein, President and
Chief Executive Officer
Salary(1)
Year
2021
2020
($)
80,018
80,018
Bonus
($)
Option
All Other
Awards(2) Compensation(3)
($)
120,624
95,606
--
--
($)
3,360
3,360
Total
($)
204,002
178,984
(1) Mr. Finkelstein reduced his salary to $80,000 in 2020 and he had previously reduced his 2018 salary from $150,000 to $125,000 in
March 2018.
(2) The 2021 and 2020 amounts reflect the aggregate total grant date fair values (computed in accordance with FASB ASC Topic 718
or ASC Topic 505).
(3) The 2021 and 2020 amounts reflect payment of life insurance premiums for Mr. Finkelstein in the amount of $3,360.
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Employment Agreements; Potential Payments Upon Termination or Change in Control
Employment Agreement with Mr. Finkelstein
We entered into an employment agreement with Mr. Finkelstein on April 16, 2014 for him to serve as our president and chief
executive officer. Mr. Finkelstein’s employment agreement had an initial three-year term, which is automatically renewed for additional
one-year periods unless either we or Mr. Finkelstein elect not to renew it. Mr. Finkelstein’s annual base salary was $125,000, which was
increased to $150,000 on January 1, 2015 and subsequently reduced back to $125,000 in March 2018. Mr. Finkelstein’s salary may not
be adjusted downward without his written consent, except in a circumstance which is part of a general reduction or other concessionary
arrangement affecting all employees or affecting senior executive officers. Effective January 1, 2019, Mr. Finkelstein suggested and
consented that his salary be reduced to $80,000 annually, a level at which it remained in 2021. Mr. Finkelstein is also eligible to receive
an annual bonus in an amount established by the Board and is entitled to participate in and receive all standard employee benefits and to
participate in all of our applicable incentive plans, including stock option, stock, bonus, savings and retirement plans. We also provide
him with $1 million in life insurance.
Mr. Finkelstein is eligible to receive options to purchase common stock under our equity incentive plans. The decision to grant
any such options and the terms of such options are within the discretion of our Board or the compensation committee thereof. All vested
options are exercisable for a period of time following any termination of Mr. Finkelstein’s employment as may be set forth in the
applicable benefit plan or in any option agreement between Mr. Finkelstein and us.
In the event that Mr. Finkelstein’s employment is terminated by us without “cause” or by Mr. Finkelstein for “good reason,”
each as defined in his employment agreement, subject to Mr. Finkelstein’s entering into and not revoking a release of claims in a form
acceptable to us, Mr. Finkelstein will be entitled to receive (i) a lump sum payment in an amount equal to one-half of his then annual
base salary if within the first anniversary date of this Agreement; or (ii) a lump sum payment in an amount equal to three-fourths of his
then annual base salary if within the first anniversary date and second anniversary date of this Agreement; or (iii) a lump sum payment in
an amount equal to his then annual base salary if any time after the second anniversary date of this Agreement, less all federal and state
withholdings. In the event of a “change in control,” as defined in his employment agreement, and if Mr. Finkelstein is involuntarily
terminated within 12 months after a change in control event, or if within 12 months after a change in control event, he resigns his
employment for “good reason”, then the Company shall (i) pay Mr. Finkelstein, in a lump sum cash payment, an amount equal to his
annual base salary in effect on the date of his termination from employment, less any applicable federal and state taxes and withholdings.
In addition, in each instance Mr. Finkelstein would also be eligible to receive (i) any earned bonus and accrued vacation pay, and (ii) to
the extent that he is eligible for and participates in a Company sponsored health insurance plan, the Company shall pay or reimburse
Executive for the amount of any insurance premiums for a twelve-month period, but these payments shall be limited to the amount of the
premiums being paid by the Company for Executive’s coverage or the amount being reimbursed for insurance premiums immediately
prior to the date of his termination from employment.
In addition, if Mr. Finkelstein’s employment is terminated without “cause,” or if there is a “change in control” event, in each
case as defined in either the applicable benefit plan or in Mr. Finkelstein’s employment agreement, then the unvested portion of
Mr. Finkelstein’s outstanding options would accelerate in full.
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Outstanding Equity Awards at December 31, 2020
The following table shows certain information regarding outstanding equity awards at December 31, 2020 for the named
executive officer, all of which were stock options granted under our Amended and Restated 2000 Stock Option and Incentive Plan, our
2010 Equity Incentive Plan or our 2018 Equity Incentive Plan.
Name
Mr. Finkelstein
Number of
Number of
Shares Underlying Shares Underlying
Option
Unexercised Options Unexercised Options Exercise Price
(#) Exercisable
(#) Unexercisable
($)
250,000
487,500
200,000
250,000
150,000
500,000
150,000
250,000
162,500
—
—
450,000
—
—
0.30
0.21
0.64
0.21
0.28
0.36
0.28
Option
Expiration Date
6/10/2030
5/15/2029
3/17/2023
7/16/2028
8/02/2031
6/30/2022
Note
(1)
(1)
(1)
(1)
9/1/2027
(1)
(1) These options vest in equal installments upon grant and on the first three anniversaries of the grant date. In each case, these options
were granted ten years prior to the listed expiration dates.
Post-Employment Compensation
We do not maintain any plans providing for payment or other benefits at, following, or in connection with retirement other than
a 401(k) plan which was available to all employees through 2011. The Company did not make any plan contributions in 2021 or 2020. In
addition, we do not maintain any non-qualified deferred compensation plans.
Director Compensation
The following table sets forth certain information for the fiscal year ended December 31, 2021 with respect to the compensation
of our directors. Mr. Finkelstein’s compensation is disclosed in the Summary Compensation Table above, and he does not receive any
additional compensation for his service as a director. Dr. Goldstein is an employee of our Company and his compensation as an employee
is set forth in the table below. He does not receive any additional compensation for his service as a director.
The Company had in effect a non-employee director compensation policy which was suspended in November 2011 by our
Board of Directors elected to help the company preserve capital and consistent with this, certain fees accrued in 2011 were forfeited and
no retainer or meeting fees were paid to non-employee directors in 2021 or 2020.
In 2021, each independent director was granted options to purchase either 240,000 or 290,000 shares of common stock at an
exercise price of $0.28 per share, which vests in four annual segments pursuant to each director’s continued service. In 2020, each
independent director was granted options to purchase either 200,000 or 250,000 shares of common stock with an exercise price per share
of $0.30. These option grants vest in four annual segments pursuant to each director’s continued service. These option grants were the
only compensation received by non-employee directors in 2021 and 2020.
We also reimburse directors for expenses incurred in attending meetings of the board and other events attended on our behalf
and at our request.
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Director Compensation for Fiscal 2021
Name
Allan Goldstein, Ph.D.
R. Don Elsey
Alessandro Noseda
Joseph McNay
Mauro Bove
Fees Earned
or Paid
in Cash
($)
Option
Awards
($)(1)
96,499
58,301
48,250
58,301
48,250
—
—
—
—
—
All Other
Compensation
($)
90,000
—
—
—
—
Total
($)
186,499
58,301
48,250
58,301
48,250
2,140,000
1,415,000
640,000
1,415,000
1,265,000
(1) Total Options held by each Board member as of December 31, 2021, are as follows:
Allan Goldstein, Ph.D.
R. Don Elsey
Alessandro Noseda
Joseph McNay
Mauro Bove
(2) In addition to being Chairman of our Board of Directors, Dr. Goldstein also serves as our Chief Science Officer. In this capacity, Dr.
Goldstein received cash compensation of $90,000 in 2021. In 2021, Dr. Goldstein was also granted ten-year options to purchase
480,000 shares of common stock at an exercise price of $0.28 per share.
We entered into an employment agreement with Dr. Goldstein on April 16, 2014 for him to serve as our Chief Science Officer.
Dr. Goldstein’s employment agreement had an initial one-year term, which has been and will be automatically renewed for
additional one-year periods unless either we or Mr. Goldstein elect not to renew it. Dr. Goldstein’s annual base salary was
$75,000 and was increased to $90,000 on January 1, 2015. Dr. Goldstein’s salary may not be adjusted downward without his
written consent, except in a circumstance which is part of a general reduction or other concessionary arrangement affecting all
employees or affecting senior executive officers. Dr. Goldstein is also eligible to receive an annual bonus in an amount
established by the Board and is entitled to participate in and receive all standard employee benefits and to participate in all of
our applicable incentive plans, including stock option, stock, bonus, savings and retirement plans.
Dr. Goldstein is eligible to receive options to purchase common stock under our equity incentive plans. The decision to grant
any such options and the terms of such options are within the discretion of our Board or the compensation committee thereof.
All vested options are exercisable for a period of time following any termination of Dr. Goldstein’s employment as may be set
forth in the applicable benefit plan or in any option agreement between Dr. Goldstein and us.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The following table sets forth certain information regarding the ownership of our common stock as of March 1, 2022 by (i) each
director; (ii) each named executive officer; (iii) all currently serving executive officers and directors as a group; and (iv) all those known
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by us to be beneficial owners of more than five percent of our common stock. The address for all directors and executive officers is c/o
RegeneRx Biopharmaceuticals, Inc., 15245 Shady Grove Road, Suite 470, Rockville, MD 20850.
Beneficial Owner
5% Stockholders:
Entities affiliated previously affiliated with Essetifin S.p.A., Via Sudafrica, 20, Rome, Italy
00144
GtreeBNT Co., Ltd. 22nd FL, Parkview Tower, 248 Jungjail-ro, Bundang-gu, Seongnam-
si, Gyeonggi-do 463‑863, Republic of Korea
Named Executive Officers and Directors:
J.J. Finkelstein
Allan L. Goldstein
Joseph C. McNay
Mauro Bove
R. Don Elsey
Alessandro Noseda
All directors and executive officers as a group (6 persons)
*
Less than one percent.
Beneficial Ownership(1)
Number of Shares
Percent of Total
55,271,189 (2)
19,583,333 (3)
4,226,295 (4)
3,270,069 (5)
7,798,706 (6)
1,129,554 (7)
1,087,372 (8)
310,000 (9)
17,721,996 (10)
34.0 %
13.6 %
2.9 %
2.3 %
5.4 %
*
*
*
12.2 %
(1) This table is based upon information supplied by officers, directors and principal stockholders. Unless otherwise indicated in the
footnotes to this table and subject to community property laws where applicable, we believe that each of the stockholders named in
this table has sole voting and investment power with respect to the shares indicated as beneficially owned. Applicable percentages
are based on 143,549,735 shares of common stock outstanding on March 1, 2022, adjusted as required by rules promulgated by the
Securities and Exchange Commission (the “SEC”).
(2) Consists of 1,500,000 shares of common stock held of record held by Aptafin S.p.A. and 2,250,000 upon the exercise of warrants,
34,989,080 shares of common stock held of record held by Essetifin S.p.A. (f/k/a Sigma-Tau Finanziaria, S.p.A.) (“Essetifin”),
9,446,920 shares of common stock issuable upon conversion of a convertible promissory note and 7,085,189 upon the exercise of
warrants, in each case exercisable within 60 days of March 1, 2022. Paolo Cavazza and members of his family directly and
indirectly own 38% of Essetifin. The beneficial ownership of Essetifin and its affiliates is derived from the Schedule 13D/A25 filed
by Essetifin on July, 2, 2021.
(3) Consists of 19,583,333 shares of common stock held of record by GtreeBNT which were acquired in two equity purchases in March
2014 and August 2014. The beneficial ownership of GtreeBNT is derived from its Schedule 13D/A filed on April 1, 2015.
(4) Consists of 1,712,991 shares of common stock held of record by Mr. Finkelstein, 236,174 shares of common stock issuable upon
conversion of convertible promissory notes, 289,630 shares of common stock issuable upon exercise of warrants and 1,987,500
shares of common stock issuable upon exercise of options, in each case exercisable within 60 days of March 1, 2022.
(5) Consists of 1,507,793 shares of common stock held of record by Dr. Goldstein, 55,586 shares of common stock issuable upon
conversion of convertible promissory notes, 229,190 shares of common stock issuable upon exercise of warrants and 1,477,500
shares of common stock issuable upon exercise of options, in each case exercisable within 60 days of March 1, 2022.
(6) Consists of 6,524,122 shares of common stock held of record by Mr. McNay, 208,334 shares of common stock issuable upon
conversion of convertible promissory notes, 156,250 shares of common stock issuable upon exercise of warrants and 910,000 shares
of common stock issuable upon exercise of options, in each case exercisable within 60 days of March 1, 2022.
(7) Consists of 111,174 shares of common stock issuable upon conversion of convertible promissory notes, 83,380 shares of common
stock issuable upon exercise of warrants and 835,000 shares of common stock issuable upon exercise of options, in each case
exercisable within 60 days of March 1, 2022.
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(8) Consists of 104,456 shares of common stock held of record, 41,666 shares of common stock issuable upon conversion of convertible
promissory notes, 31,250 shares of common stock issuable upon exercise of warrants and 910,000 shares of common stock issuable
upon exercise of options, in each case exercisable within 60 days of March 1, 2022.
(9) Consists of 310,000 shares of common stock issuable upon exercise of options within 60 days of March 1, 2022.
(10) Consists of 9,849,362 shares of common stock held of record, 652,934 shares of common stock issuable upon conversion of
convertible promissory notes, 789,700 shares of common stock issuable upon exercise of warrants and 6,430,000 shares of common
stock issuable upon exercise of options, in each case exercisable within 60 days of March 1, 2022.
Equity Compensation Plan Information
The following table provides information as of December 31, 2021 about the securities authorized for issuance to our
employees, directors and other eligible participants under our equity compensation plans, consisting of the 2010 Equity Incentive Plan
and the 2018 Equity Incentive Plan.
Number of securities to
be issued upon exercise Weighted average exercise
price of outstanding options
of outstanding options
warrants and rights
warrants and rights
(b)
(a)
12,376,250
Number of securities
remaining available for
future issuance under
equity compensation plan
(excluding securities
reflected in column (a))
(c)
4,412,901
—
4,412,901
0.29
—
0.29
Plan Category
Equity compensation plans approved by security holders
Equity compensation plans not approved by security holders
—
Total
12,376,250
Item 13. Certain Relationships and Related Transactions, and Director Independence.
Related Party Transactions
Described below are transactions and series of similar transactions that have occurred during fiscal 2021 to which we were a party or are
a party in which:
● the amounts involved exceeded or will exceed the lesser of $120,000 or 1% of the average of our total assets at December
31, 2020 and 2021; and
● a director, executive officer, beneficial owner of more than five percent of any class of our voting securities or any member
of their immediate family had or will have a direct or indirect material interest.
2021 Private Placement
In June 2021, J.J. Finkelstein, our President and CEO, Allan L. Goldstein, a director, and Aptafin S.p.A., an affiliate of principal
stockholder Essetifin S.p.A., participated with other investors in a private placement pursuant to which they acquired 75,000, 125,000
and 1,500,000 shares, respectively, of our common stock at a price of $0.20 per share. As part of this private placement, we also issued
them (along with the other investors), for no additional consideration, Series A Warrants to purchase 56,250, 93,750 and 1,125,000
shares, respectively, of our common stock at an exercise price of $0.24 per share with a two-year term and Series B Warrants to purchase
a like number of shares, respectively, of our common stock at an exercise price of $0.28 per share with a five-year term.
We generally granted all investors in the private placement a right to participate in our future issuances of equity and debt
securities for a period of 12 months from September 3, 2021, the effective date of a Registration Statement we agreed to and filed with
the SEC in August 2021 to register the resale of both the shares issued in the private placement and those shares issuable upon exercise
of the Warrants. We also generally agreed that, during the 30-day period following the Registration Statement’s effective date, we would
not issue or propose to issue any equity securities.
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The Series A and Series B Warrants are exercisable for cash, provided that if during the term of the Warrants there is not an
effective registration statement under the Securities Act covering the resale of the shares issuable upon exercise of the Warrants, then the
Warrants may be exercised on a cashless (net exercise) basis. The exercise price under the Warrants is subject to a “full-ratchet” anti-
dilution provision, generally such that in the event we issue common stock at a price per share less than the applicable exercise price of
the Warrants, the exercise price will be reduced to the price per share applicable to such new issuance.
In connection with the private placement, we and some of the investors, including Messrs. Finkelstein and Goldstein, entered
into an agreement restricting them from selling or transferring any of their shares of our common stock for a period of 90 days.
Director Independence
Under NYSE Amex listing standards, a majority of the members of a listed company’s board of directors must qualify as
“independent,” as affirmatively determined by the Board. Although our common stock is no longer listed on the NYSE Amex exchange,
we have determined the independence of our directors using the NYSE Amex definitions of independence. Our Board consults with
counsel to ensure that its determinations are consistent with relevant securities and other laws and regulations regarding the definition of
“independent,” including those set forth in pertinent listing standards of the NYSE Amex, as in effect from time to time.
Consistent with these considerations, after review of all relevant identified transactions or relationships between each director,
or any of his family members, and our Company, our senior management and our independent auditors, our Board has determined that
the following three directors are independent directors within the meaning of the applicable NYSE Amex listing standards: Mr. Elsey,
Mr. Bove and Mr. McNay. In making this determination, the Board found that none of these directors had a material or other
disqualifying relationship with us. Mr. Finkelstein, our President and Chief Executive Officer, and Dr. Goldstein our Chief Scientific
Officer, are not independent by virtue of their employment with us.
In determining the independence of Mr. Bove, the Board of Directors considered the significant ownership of our common stock
by Essetifin S.p.A. and our license agreement with Lee’s Pharmaceuticals. The Board of Directors does not believe that any of the
transactions with Lee’s or Essetifin and its affiliates described in this report has interfered or would reasonably be expected to interfere
with Mr. Bove’s exercise of independent judgment in carrying out his responsibilities as a director of our company.
Item 14. Principal Accounting Fees and Services.
The following table represents aggregate fees billed to us for the fiscal years ended December 31, 2021 and 2020 by our
independent registered public accounting firm CohnReznick LLP. All such fees described below were approved by the audit committee.
Audit fees
Tax fees (1)
Total fees
2021
103,000
14,800
117,800
$
$
2020
90,000
14,125
104,125
$
$
(1) Tax fees include the preparation of our corporate federal and state income tax returns.
Our audit committee has adopted a policy and procedures for the pre-approval of audit and non-audit services rendered by our
independent registered public accounting firm. The policy generally pre-approves specified services in the defined categories of audit
services, audit-related services, and tax services up to specified amounts. Pre-approval may also be given as part of the audit committee’s
approval of the scope of the engagement of the independent registered public accounting firm or on an individual explicit case-by-case
basis before the independent registered public accounting firm is engaged to provide each service. On a periodic basis, the independent
registered public accounting firm reports to the audit committee on the status of actual costs for approved services against the approved
amounts.
The audit committee has determined that the rendering of the services other than audit services by CohnReznick LLP is
compatible with maintaining that firm’s independence.
49
Table of Contents
PART IV
Item 15. Exhibits, Financial Statement Schedules.
See Exhibit Index to Form 10-K following the signature page hereto, which is incorporated herein by reference.
50
Table of Contents
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
Date: March 30, 2022
RegeneRx Biopharmaceuticals, Inc.
(Registrant)
By: /s/ J.J. Finkelstein
J.J. Finkelstein
President and Chief Executive Officer
POWER OF ATTORNEY
Pursuant to the requirements of the Exchange Act, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
In addition, each of the following persons hereby constitutes and appoints J.J. Finkelstein as his true and lawful attorney-in-fact
and agent, with the full power of substitution, for him and in his name, to sign any and all amendments to this report, and to file the
same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting
unto said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be
done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all
that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Name
/s/ Allan L. Goldstein
Allan L. Goldstein
/s/ J.J. Finkelstein
J.J. Finkelstein
/s/ R. Don Elsey
R. Don Elsey
/s/ Joseph C. McNay
Joseph C. McNay
/s/ Mauro Bove
Mauro Bove
/s/ Alessandro Noseda
Alessandro Noseda
Title
Chairman of the Board, Chief Scientific
Officer, and Director
President, Chief Executive Officer, and
Director (Principal Executive Officer,
Principal Financial Officer and Principal
Accounting Officer)
Director
Director
Director
Director
51
Date
March 30, 2022
March 30, 2022
March 30, 2022
March 30, 2022
March 30, 2022
March 30, 2022
Table of Contents
RegeneRx Biopharmaceuticals, Inc.
Index to Financial Statements
Report of Independent Registered Public Accounting Firm PCAOB ID# 596
Balance Sheets
Statements of Operations
Statements of Changes in Stockholders’ Deficit
Statements of Cash Flows
Notes to Financial Statements
F-1
Page
F-2
F-3
F-4
F-5
F-6
F-7
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors of RegeneRx Biopharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of RegeneRx Biopharmaceuticals, Inc. (the “Company”) as of December 31, 2021 and
2020, and the related statements of operations, changes in stockholders’ deficit and cash flows for the years then ended, 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, 2021 and 2020, and the results of its operations and its cash flows for the years
then ended, in conformity with accounting principles generally accepted in the United States of America.
The Company’s Ability to Continue as a Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed
in Note 1 to the financial statements, the Company has incurred recurring losses from operations since inception and has stated that
substantial doubt exists about the Company’s ability to continue as a going concern. Management’s evaluation of the events and
conditions and management’s plans regarding these matters are also described in Note 1. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the
Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting
Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The
Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our
audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an
opinion on the effectiveness of the entity'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
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to
be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and
(2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ CohnReznick LLP
We have served as the Company’s auditor since 2012.
Tysons, Virginia
March 30, 2022
F-2
Table of Contents
RegeneRx Biopharmaceuticals, Inc.
Balance Sheets
ASSETS
Current assets
Cash and cash equivalents
Prepaid expenses and other current assets
Total current assets
Operating lease right-of-use asset
Other assets
Total assets
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities
Accounts payable
Unearned revenue
Accrued expenses
Promissory note
Current portion of operating lease liability
Total current liabilities
Long-term liabilities
Unearned revenue
Promissory note
Operating lease liability
Convertible promissory notes, net
Total liabilities
Commitments and contingencies
Stockholders’ deficit
December 31,
2021
2020
$
$
$
$
$
$
1,231,608
19,932
1,251,540
27,673
5,752
1,284,965
63,634
76,761
261,729
—
27,809
429,933
427,898
49,909
477,807
68,229
5,752
551,788
39,320
76,761
208,857
33,856
40,790
399,584
1,947,802
—
—
1,137,109
3,514,844
2,024,564
21,544
27,809
902,231
3,375,732
Preferred stock, $.001 par value per share, 1,000,000 shares authorized; no shares issued
Common stock, par value $.001 per share, 300,000,000 and 200,000,000 shares authorized,
143,549,735 and 133,441,788 issued and outstanding at Decemebr 31, 2021, respectively
Additional paid-in capital
Accumulated deficit
Total stockholders’ deficit
Total liabilities and stockholders’ deficit
—
—
143,550
108,116,284
(110,489,713)
(2,229,879)
1,284,965
$
133,442
105,934,572
(108,891,958)
(2,823,944)
551,788
$
The accompanying notes are an integral part of these financial statements.
F-3
RegeneRx Biopharmaceuticals, Inc.
Statements of Operations
Table of Contents
Revenues
Operating expenses
Research and development
General and administrative
Total operating expenses
Loss from operations
Other income (expense)
Gain on forgiveness of PPP loan
Interest income
Interest expense
Total other expense
Loss before income taxes
Provision for income taxes
Net loss
Deemed dividend related to warrants down round provision
Net loss attributable to common stockholders
Basic net loss per common share
Diluted net loss per common share
Weighted average number of common shares outstanding - basic
Years ended December 31,
2020
2021
$
76,761
$
76,761
6,638
1,398,634
1,405,272
(1,328,511)
4,921
1,366,383
1,371,304
(1,294,543)
55,400
234
(324,878)
(269,244)
(1,597,755)
—
3,806
(232,631)
(228,825)
(1,523,368)
—
—
(1,597,755)
(1,523,368)
—
$ (1,597,755)
—
$ (1,523,368)
$
$
(0.01)
(0.01)
$
$
(0.01)
(0.01)
138,592,666
133,357,185
Weighted average number of common shares outstanding - diluted
138,592,666
133,357,185
The accompanying notes are an integral part of these financial statements.
F-4
Table of Contents
RegeneRx Biopharmaceuticals, Inc.
Statements of Changes in Stockholders’ Deficit
Years ended December 31, 2021 and 2020
Common stock
Balance, December 31, 2019
Issuance of common stock - warrant exercises
Warrants issued with debt
Debt discount related to beneficial conversion feature
Share-based compensation expense
Net loss
Balance, December 31, 2020
Private offering of common stock and warrants, net
of issuance costs
Issuance of common stock - option exercises
Issuance of common stock - warrant exercises
Share-based compensation expense
Net loss
Balance, December 31, 2021
Shares
131,506,494
1,935,294
—
—
—
—
133,441,788
9,900,000
105,000
102,947
—
—
143,549,735
Amount
131,507
1,935
—
—
—
—
133,442
9,900
105
103
—
—
143,550
$
$
Additional
paid-in capital
$ 104,896,975
239,976
176,573
289,045
332,003
—
105,934,572
Accumulated
deficit
Total
stockholders’
deficit
$ (107,368,590) $ (2,340,108)
241,911
—
176,573
—
289,045
—
332,003
—
(1,523,368)
(1,523,368)
(2,823,944)
(108,891,958)
1,749,188
21,945
12,765
397,814
—
$ 108,116,284
—
—
—
—
(1,597,755)
1,759,088
22,050
12,868
397,814
(1,597,755)
$ (110,489,713) $ (2,229,879)
The accompanying notes are an integral part of these financial statements.
F-5
Table of Contents
RegeneRx Biopharmaceuticals, Inc.
Statements of Cash Flows
Operating activities:
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash share-based compensation
Non-cash interest expense
Gain on forgiveness of PPP loan
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
Accounts payable
Accrued expenses
Operating lease liability
Unearned revenue
Net cash used in operating activities
Financing activities:
Proceeds from private offering of common stock and warrants, net of issuance costs
Proceeds from the exercise of stock options
Proceeds from promissory note
Proceeds from the sale of convertible notes
Debt issuance costs
Proceeds from the exercise of stock warrants
Net cash provided by financing activities
Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of year
Cash and cash equivalents at end of year
Supplemental Disclosure of Non-Cash Operating and Financing Activities
Establishment of right-of-use asset
Establishment of operating lease liability
Issuance of warrants in conjunction with issuance of convertible notes
Beneficial conversion feature on issuance of convertible notes
Years ended December 31,
2020
2021
$ (1,597,755)
$ (1,523,368)
397,814
234,878
(55,400)
29,977
24,314
52,872
(234)
(76,762)
(990,296)
332,003
162,179
—
(8,270)
(4,358)
113,837
(2,191)
(76,761)
(1,006,929)
1,759,088
22,050
—
—
—
12,868
1,794,006
803,710
—
—
55,400
500,000
(2,400)
241,911
794,911
(212,018)
427,898
$ 1,231,608
$
639,916
427,898
$
$
$
$
— $
81,980
— $
81,980
— $
176,573
— $
289,045
The accompanying notes are an integral part of these financial statements.
F-6
Table of Contents
RegeneRx Biopharmaceuticals, Inc.
Notes to Financial Statements
December 31, 2021
1. ORGANIZATION AND BUSINESS
Organization and Nature of Operations.
RegeneRx Biopharmaceuticals, Inc. (“RegeneRx”, the “Company”, “We”, “Us”, “Our”), a Delaware corporation, was
incorporated in 1982. We are focused on the discovery and development of novel molecules to accelerate tissue and organ repair. Our
operations are confined to one business segment: the development and marketing of product candidates based on Thymosin Beta 4
(“Tß4”), an amino acid peptide.
Management Plans to Address Operating Conditions.
Our strategy is aimed at being capital efficient while leveraging our portfolio of clinical assets by seeking strategic relationships
with organizations with clinical development capabilities including development capital. Currently, we have active partnerships in four
major territories: North America, Europe, China and Pan Asia. In each case, the cost of development is being borne by our partners with
no financial obligation for RegeneRx. We still have significant clinical assets to develop, primarily RGN-352 (injectable formulation of
Tß4 for cardiac and CNS disorders) in the U.S., Pan Asia, and Europe, and RGN-259 in the EU. Our goal is to wait until satisfactory
results are obtained from the current ophthalmic clinical program in the U.S. before moving into the EU. However, we intend to continue
to develop RGN-352, our injectable systemic product candidate for cardiac and central nervous system indications, either by obtaining
grants to fund a Phase 2a clinical trial in the cardiovascular or central nervous system fields or finding a suitable partner with the
resources and capabilities to develop it as we have with RGN-259.
Since inception, and through December 31, 2021, we have an accumulated deficit of $110.5million and we had cash and cash
equivalents of $1,231,608 as of December 31, 2021. We anticipate incurring additional operating losses in the future as we continue to
explore the potential clinical benefits of Tß4-based product candidates over multiple indications. We have entered into a series of
strategic partnerships under licensing and joint venture agreements where our partners are responsible for advancing development of our
product candidates by sponsoring multiple clinical trials. On June 30, 2021, we closed a private placement of common stock and
warrants with several institutional investors, including members of management and the board, and received gross proceeds of
$1,980,000. At present we have sufficient cash to fund planned operations through the end of 2022.
We have not reached commercialization and therefore do not generate recurring revenue and will need substantial additional
funds in order to significantly advance development of our unlicensed programs. Accordingly, we will continue to evaluate opportunities
to raise additional capital and are in the process of exploring various alternatives, including, without limitation, a public or private
placement of our securities, debt financing, corporate collaboration and licensing arrangements, mergers, or the sale of our Company or
certain of our intellectual property rights.
These factors raise substantial doubt about our ability to continue as a going concern. The accompanying financial statements
have been prepared assuming that we will continue as a going concern. This basis of accounting contemplates the recovery of our assets
and the satisfaction of our liabilities in the normal course of business.
Although we intend to continue to seek additional financing or additional strategic partners, we may not be able to complete a
financing or corporate transaction, either on favorable terms or at all. If we are unable to complete a financing or strategic transaction, we
may not be able to continue as a going concern after our funds have been exhausted, and we could be required to significantly curtail or
cease operations, file for bankruptcy, or liquidate and dissolve. There can be no assurance that we will be able to obtain any sources of
funding. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset
amounts and classification of liabilities that might be necessary should we be forced to take any such actions.
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In addition to our current operational requirements, we continually refine our operating strategy and evaluate alternative clinical
uses of Tß4. However, substantial additional resources will be needed before we will be able to achieve sustained profitability.
Consequently, we continually evaluate alternative sources of financing such as the sharing of development costs through strategic
collaboration agreements. There can be no assurance that our financing efforts will be successful and, if we are not able to obtain
sufficient levels of financing, we would delay certain clinical and/or research activities and our financial condition would be materially
and adversely affected. Even if we are able to obtain sufficient funding, other factors including competition, dependence on third parties,
uncertainty regarding patents, protection of proprietary rights, manufacturing of peptides, and technology obsolescence could have a
significant impact on us and our operations.
To achieve profitability, we, and/or a partner, must successfully conduct pre-clinical studies and clinical trials, obtain required
regulatory approvals and successfully manufacture and market those pharmaceuticals we wish to commercialize. The time required to
reach profitability is highly uncertain, and there can be no assurance that we will be able to achieve sustained profitability, if at all.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates. The preparation of financial statements in conformity with accounting principles generally accepted in the
United States of America (“U.S. GAAP”) requires management to make certain estimates and assumptions that affect the reported
earnings, financial position and various disclosures. Critical accounting policies involved in applying our accounting policies are those
that require management to make assumptions about matters that are highly uncertain at the time the accounting estimate was made and
those for which different estimates reasonably could have been used for the current period. Critical accounting estimates are also those
which are reasonably likely to change from period to period and would have a material impact on the presentation of our financial
condition, changes in financial condition or results of operations. Our most critical accounting estimates relate to accounting policies for
revenue recognition, discount rate used to calculate the present value of the future lease payments and share-based arrangements.
Management bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the
circumstances. Actual results could differ from these estimates.
Cash and Cash Equivalents. Cash and cash equivalents consist of cash and highly liquid investments with original maturities of
three months or less when acquired and are stated at cost that approximates their fair market value.
Concentration of Credit Risk. Financial instruments which potentially subject the Company to concentrations of credit risk
consist primarily of cash and cash equivalents. We limit our exposure to credit loss by placing our cash and cash equivalents with high
quality financial institutions and, in accordance with our investment policy, in securities that are rated investment grade.
Property and Equipment. Property and equipment consist of office furniture and equipment and is stated at cost and depreciated
over the estimated useful lives of the assets (generally two to five years) using the straight-line method. Expenditures for maintenance
and repairs which do not significantly prolong the useful lives of the assets are charged to expense as incurred. All property and
equipment is fully depreciated at both December 31, 2021 and 2020.
Impairment of Long-lived Assets. When we record long-lived assets, our policy is to regularly perform reviews to determine if
and when the carrying value of our long-lived assets becomes impaired. During the years ended December 31, 2021 and 2020, no
impairment losses were recorded.
Convertible Notes with Detachable Warrants. In accordance with the Financial Accounting Standards Board (“FASB”)
Accounting Standards Codification (“ASC”) 470-20, Debt with Conversion and Other Options, the proceeds received from convertible
notes are allocated to the instruments based on the relative fair values of the convertible notes without the warrants and of the warrants
themselves at the time of issuance. The portion of the proceeds allocated to the warrants is recognized as additional paid-in capital and a
debt discount. The debt discount related to warrants is accreted into interest expense through maturity of the notes.
Revenue Recognition. The Company analyzes contracts to determine the appropriate revenue recognition using the following
steps: (i) identification of contracts with customers, (ii) identification of distinct performance obligations in the contract,
(iii) determination of contract transaction price, (iv) allocation of contract transaction price to the performance obligations and
(v) determination of revenue recognition based on timing of satisfaction of the performance obligation. The Company recognizes
revenues upon the satisfaction of its performance obligation (upon transfer of control of promised goods or services to our customers) in
an amount that reflects the consideration to which it expects to be entitled to in exchange for those goods or services. Whenever we
determine that an arrangement should be accounted for as a single unit of accounting, we must determine the period over which the
performance obligations will be performed, and revenue will be recognized. Revenue will be recognized using either a relative
F-8
Table of Contents
performance or straight-line method. We recognize revenue using the relative performance method provided that we can reasonably
estimate the level of effort required to complete our performance obligations under an arrangement and such performance obligations are
provided on a best-efforts basis. Revenue recognized is limited to the lesser of the cumulative amount of payments received or the
cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period.
The Company’s contracts with customers may at times include multiple promises to transfer products and services. Contracts
with multiple promises are analyzed to determine whether the promises, which may include a license together with performance
obligations such as providing a clinical supply of product and steering committee services, are distinct and should be accounted for as
separate performance obligations or whether they must be accounted for as a single performance obligation. The Company accounts for
individual performance obligations separately if they are distinct. Determining whether products and services are considered distinct
performance obligations may require significant judgment. If we cannot reasonably estimate when our performance obligation either
ceases or becomes inconsequential and perfunctory, then revenue is deferred until we can reasonably estimate when the performance
obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance.
Whenever the Company determines that an arrangement should be accounted for as a combined performance obligation, we
must determine the period over which the performance obligation will be performed and when revenue will be recognized. Revenue is
recognized using either a relative performance or straight-line method. We recognize revenue using the relative performance method
provided that we can reasonably estimate the level of effort required to complete our performance obligation under an arrangement and
such performance obligation is provided on a best-efforts basis. Revenue recognized is limited to the lesser of the cumulative amount of
payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each
reporting period.
If the Company cannot reasonably estimate the level of effort required to complete our performance obligation under an
arrangement, the performance obligation is provided on a best-efforts basis and we can reasonably estimate when the performance
obligation ceases or the remaining obligations become inconsequential and perfunctory, then the total payments under the arrangement,
excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-
line basis over the period we expect to complete our performance obligations. Revenue is limited to the lesser of the cumulative amount
of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending
date.
At the inception of each arrangement that includes development milestone payments, the Company evaluates the probability of
reaching the milestones and estimates the amount to be included in the transaction price using the most likely amount method. If it is
probable that a significant revenue reversal would not occur in the future, the associated milestone value is included in the transaction
price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not
considered probable of being achieved until those approvals are received and therefore revenue recognized is constrained as management
is unable to assert that a reversal of revenue would not be possible. The transaction price is then allocated to each performance obligation
on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the
contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such
development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such
adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.
Amounts received prior to satisfying the above revenue recognition criteria are recorded as unearned revenue in our
accompanying balance sheets.
Contract assets are generated when contractual billing schedules differ from revenue recognition timing. Contract assets
represent a conditional right to consideration for satisfied performance obligations that becomes a billed receivable when the conditions
are satisfied. There were no contract assets as of December 31, 2021 and 2020.
Contract liabilities result from arrangements where we have received payment in advance of performance under the contract.
Changes in contract liabilities are generally due to either receipt of additional advance payments or our performance under the contract.
We have the following amounts recorded for contract liabilities:
Unearned revenue
December 31
2021
$ 2,024,563
2020
$
2,101,325
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The contract liabilities amount disclosed above are primarily related to revenue being recognized on a straight-line basis over
periods ranging from 23 to 30 years, which, in management’s judgment, is the best measure of progress towards satisfying the
performance obligations and represents the Company’s best estimate of the period of the obligation.
Revenue recognized from contract liabilities during the years ended December 31, 2021 and 2020, totaled $76,761 and $76,761,
respectively. Revenue is expected to be recognized in the future from contract liabilities as the related performance obligations are
satisfied.
Variable Interest Entities. On January 28, 2015, the Company entered into a Joint Venture Agreement with GtreeBNT, a
shareholder in the Company. The Joint Venture Agreement provides for the operation of the joint venture, jointly owned by the Company
and GtreeBNT, which is commercializing RGN-259 for the treatment of dry eye and neurotrophic keratitis in the U.S. and Canada. The
Company has determined that the Joint Venture is a “variable interest entity” since the total equity investment at risk is not sufficient to
permit the Joint Venture to finance its activities without additional subordinated financial support. Further, because of GtreeBNT’s
majority equity stake in the Joint Venture, voting control, control of the board of directors, and substantive management rights, and given
that the Company does not have the power to direct the Joint Venture’s activities that most significantly impact its economic
performance, the Company determined that it is not the primary beneficiary of the Joint Venture and therefore is not required to
consolidate the Joint Venture. The Company reports its equity stake in the Joint Venture using the equity method of accounting because,
while it does not control the Joint Venture, the Company can exert significant influence over the Joint Venture's activities by virtue of its
board representation.
Because the Company is not obligated to fund the Joint Venture and has not provided any financial support and has no
commitment to provide financial support in the future to the Joint Venture, the carrying value of its investment in the Joint Venture is
zero at both December 31, 2021 and 2020. As a result, the Company is not recognizing its share (38.5%) of the Joint Venture’s operating
losses and will not recognize any such losses until the Joint Venture produces net income (as opposed to net losses) and at that point the
Company will reduce its share of the Joint Venture’s net income by its share of previously suspended net losses. As of December 31,
2021, because it has not provided any financial support, the Company has no financial exposure as a result of its variable interest in the
Joint Venture.
Research and Development. R&D expenditures are expensed as incurred and are subject to the risks and uncertainties associated
with clinical trials and the FDA review and approval process. As a result, these expenses could exceed our expectations, possibly
materially. We are uncertain as to what we will incur in future research and development costs for our clinical studies, as these amounts
are subject to management's continuing assessment of the economics of each individual research and development project and the
internal competition for project funding.
Patent Costs. Costs related to filing and pursuing patent applications are recognized as general and administrative expenses as
incurred since recoverability of such expenditures is uncertain.
Income Taxes. Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are
recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of
existing assets and liabilities and their respective tax basis and operating loss and tax credit carryforwards. 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 assets and liabilities of a change in tax rates is recognized in income in the
period that includes the enactment date.
The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in
which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected
future taxable income, and tax planning strategies in making that assessment. We recorded a full valuation allowance against all
estimated net deferred tax assets at December 31, 2021 and 2020.
We recognize the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized
income tax positions are measured at the largest amount that is greater than 50% likely of being realized. Changes in recognition or
measurement are reflected in the period in which the change in judgment occurs. Our policy for recording interest and penalties
associated with audits is that penalties and interest expense are recorded in provision for income taxes in our statements of operations.
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We have significant net operating loss carryforwards to potentially reduce future federal and state taxable income, and research
and experimentation tax credit carryforwards available to potentially offset future federal and state income taxes. Use of our net
operating loss and research and experimentation credit carryforwards may be limited due to changes in our ownership as defined within
Section 382 of the Internal Revenue Code.
Net Loss Per Common Share. Basic net loss per common share for 2021 and 2020 is based on the weighted average number of
shares of common stock outstanding during the years. Diluted loss per share is based on the weighted average number of shares of
common stock outstanding during each year in which a loss is incurred; potentially dilutive shares are excluded because the effect is
antidilutive. In years where there is net income, diluted income per share is based on the weighted average number of shares of common
stock outstanding plus dilutive securities with a purchase or conversion price below the per share price of our common stock on the last
day of the year. The potentially dilutive securities include 49,889,304 shares and 33,705,854 shares in 2021 and 2020, respectively,
reserved for the conversion of convertible debt or exercise of outstanding options and warrants.
Share-Based Compensation. We measure share-based compensation expense based on the grant date fair value of the awards
which is then recognized over the period which service is required to be provided. We estimate the grant date fair value using the Black-
Scholes option-pricing model (“Black-Scholes”). We recognized $397,814 and $332,003 in share-based compensation expense for
the years ended December 31, 2021 and 2020, respectively.
Fair Value of Financial Instruments. The carrying amounts of our financial instruments, as reflected in the accompanying
balance sheets, approximate fair value. Financial instruments consist of cash and cash equivalents, accounts payable, and convertible
debt and accrued interest. Because the convertible debt with an interest rate of 5% is with related parties, it was not practicable to
estimate the effect of subjective risk factors, which might influence the value of the debt. The most significant of these risk factors
include the lack of collateralization.
Adopted accounting standards. In December 2019, the FASB issued Accounting Standards Update (“ASU”) No. 2019-12,
Simplifying the Accounting for Income Taxes, which removes certain exceptions related to the approach for intra-period tax allocation,
the methodology for calculating income taxes in an interim period, the recognition of deferred tax liabilities for outside basis differences
and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The Company adopted ASU 2019-12 on
January 1, 2021. The impact of adopting ASU 2019-12 did not have a material impact on the Company’s financial statements.
Impact of recently issued accounting standards. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments -
Credit Losses which requires financial assets measured at amortized cost basis to be presented at the net amount expected to be collected.
This standard is effective for fiscal years beginning after December 15, 2022 and the Company is currently evaluating the expected
impact of this ASU but does not expect it to have a material impact on its financial statements upon adoption.
In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and
Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts
in an Entity’s Own Equity. This ASU simplifies the accounting for convertible instruments. This ASU also requires entities to use the if-
converted method for all convertible instruments in calculating diluted earnings-per-share. The ASU is effective for annual periods
beginning after December 15, 2021 with early adoption permitted. The Company is currently evaluating the impact this standard will
have on its financial statements.
The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a
material impact on its results of operations, financial position or cash flows.
3. FAIR VALUE MEASUREMENTS
The authoritative guidance for fair value measurements defines fair value as the exchange price that would be received for an
asset or paid to transfer a liability (an exit price) in the principal or the most advantageous market for the asset or liability in an orderly
transaction between market participants on the measurement date. Market participants are buyers and sellers in the principal market that
are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The guidance describes a fair value hierarchy
based on the levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair
value which are the following:
● Level 1 — Quoted prices in active markets for identical assets and liabilities.
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● Level 2 — Observable inputs other than quoted prices in active markets for identical assets and liabilities.
● Level 3 — Unobservable inputs.
As of December 31, 2021 and 2020, our only qualifying assets that required measurement under the foregoing fair value
hierarchy were funds held in our Company bank accounts included in cash and cash equivalents valued at $112,703 and $107,854,
respectively, using Level 1 inputs.
4. LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS
We have filed numerous additional patent applications covering various compositions, uses, formulations and other components
of Tß4, as well as to novel peptides resulting from our research efforts. Some of these patents have been issued, while many patent
applications are still pending.
We have also entered into an agreement with a university under the terms of which we have received an exclusive license to
technology and intellectual property. The agreement, which is generally cancelable by us, provided for the payment of a license issue fee
and/or minimum annual payments. The initial license fee of $25,000 was paid in 2010 and no minimum fees were due for the year ended
December 31, 2011. Beginning in 2012, minimum annual maintenance fees are $5,000 annually which was paid in 2012 but has not been
paid since. In addition, the agreements provide for payments upon the achievement of certain milestones in product development. The
agreement also requires us to fund certain costs associated with the filing and prosecution of patent applications. In February 2013, this
agreement was amended to include additional technology and intellectual property. The expanded license does not require payment of an
initial license fee or additional annual maintenance fees but will be subject to payments upon the achievement of certain milestones for a
product developed under the amended license of the additional technology and intellectual property.
All license fees are included in Research and Development in the accompanying statements of operations.
In 2012, we entered into a license agreement (the “Agreement”) with Lee’s Pharmaceutical (HK) Limited (“Lee’s”),
headquartered in Hong Kong, for the license of Thymosin Beta 4 in any pharmaceutical form, including our RGN-259, RGN-352 and
RGN-137 product candidates, in China, Hong Kong, Macau and Taiwan. Under the Agreement, we are eligible to receive milestone
payments and royalties, ranging from low double digit to high single digit percentages of any commercial sales of the licensed products.
Lee’s will pay for all developmental costs associated with each product candidate. We will provide Tß4 to Lee’s at no charge for a Phase
2 ophthalmic clinical trial and will provide Tß4 to Lee’s for all other developmental and clinical work at a price equal to our cost. We
will also have the right to exclusively license any improvements made by Lee’s to RegeneRx’s products outside of the licensed territory.
Lee’s paid us $200,000 upon signing of a term sheet in March 2012, and Lee’s paid us an additional $200,000 upon signing of the
definitive license agreement. The Company is accounting for the license agreement as a revenue arrangement. Since participation in the
joint development committee is required it was deemed to be a material promise. Management has concluded that the participation in the
joint development committee is not distinct from other promised goods and services. The Company evaluated the promised goods and
services under the agreement and determined that there was one combined performance obligation representing a series of distinct goods
and services including the license to research, develop and commercialize Tß4 in any pharmaceutical form and participation in the joint
development committee. To date, management has not been able to reasonably measure the outcome of the performance obligation, but
still expects to recover the costs incurred in satisfying the performance obligation. Accordingly, the Company has deferred all revenue
until such time that it can reasonably measure the outcome of the performance obligation or until the performance obligation becomes
onerous. As of December 31, 2021 and 2020, we have unearned revenue totaling $400,000 pursuant to this Agreement. Revenue will be
recognized for future royalty payments as they are earned. In February 2019, the license agreement was amended and assigned by Lee’s
to their affiliate, Zhaoke Ophthalmology Pharmaceutical Limited. There are no economic changes to the Agreement.
On March 7, 2014, we entered into license agreements with GtreeBNT Co., Ltd. The two Licensing Agreements are for the
license of territorial rights to two of our Thymosin Beta 4-based products candidates, RGN-259 and RGN-137.
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Under the license agreement for RGN-259, our preservative-free eye drop product candidate, GtreeBNT will have the right to
develop and commercialize RGN-259 in Asia (excluding China, Hong Kong, Taiwan, and Macau). The rights will be exclusive in Korea,
Japan, Australia, New Zealand, Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, Mongolia, Myanmar (Burma), Philippines,
Singapore, Thailand, Vietnam, and Kazakhstan, and semi-exclusive in India, Pakistan, Bangladesh, Bhutan, Maldives, Nepal, Sri Lanka,
Kyrgyzstan, Tajikistan, Turkmenistan and Uzbekistan, collectively, the Territory (the “259 Territory”). Under the 259 license agreement
we are eligible to receive aggregate potential milestone payments of up to $3.5 million. In addition, we are eligible to receive royalties of
a low double digit percentage of any commercial sales of the licensed product sold by GtreeBNT in the 259 Territory.
Under the license agreement for RGN-137, our topical dermal gel product candidate, GtreeBNT will have the exclusive right to
develop and commercialize RGN-137 in the U.S. (the “137 Territory”). Under the 137 agreement we are eligible to receive aggregate
potential milestone payments of up to $3.5 million. In addition, we are eligible to receive royalties of a low double digit percentage of
any commercial sales of the Company’s licensed product sold by GtreeBNT in the 137 Territory. In August 2017, we amended the
license agreement for RGN-137 held by GtreeBNT. Under the amendment, the 137 Territory was expanded to include Europe, Canada,
South Korea, Australia and Japan. Under the agreement, the Company received a series of non-refundable payments and is entitled to
receive royalties on the future sales of products. The Company is accounting for the license agreement as a revenue arrangement. Since
participation in the joint development committee is required, it was deemed to be a material promise. Management has concluded that the
participation in the joint development committee is not distinct from other promised goods and services. The Company evaluated the
promised goods and services under the agreement and determined that there was one combined performance obligation representing a
series of distinct goods and services including the license to research, develop and commercialize RGN-137 and participation in the joint
development committee. Revenue is being recognized on a straight-line basis over a period of 23 years, which, in management’s
judgment, is the best measure of progress towards satisfying the performance obligation and represents the Company’s best estimate of
the period of the obligation. As of December 31, 2021 and 2020, we have unearned revenue totaling $649,275 and $684,058,
respectively, pursuant to this agreement. Revenue will be recognized for future royalty payments as they are earned.
Each license agreement contains diligence provisions that require the initiation of certain clinical trials within certain time
periods that, if not met, would result in the loss of rights or exclusivity in certain countries. GtreeBNT will pay for all developmental
costs associated with each product candidate. We have the right to exclusively license any improvements made by GtreeBNT to our
products outside of the licensed territory on a royalty free basis. The two firms have created a joint development committee and continue
to discuss the development of the licensed products and share information relating thereto. Both companies will also share all non-
clinical and clinical data and other information related to development of the licensed product candidates.
On January 28, 2015, the Company entered into the Joint Venture Agreement with GtreeBNT, a shareholder in the Company.
The Joint Venture Agreement provides for the creation of the Joint Venture, jointly owned by the Company and GtreeBNT, which is
commercializing RGN-259 for treatment of dry eye and neurotrophic keratitis in the U.S. and Canada.
GtreeBNT is solely responsible for funding all the product development and commercialization efforts of the Joint Venture.
GtreeBNT made an initial contribution of $3 million in cash and received an initial equity stake of 51%. RegeneRx’s ownership interest
in ReGenTree was reduced to 38.5% when the Clinical Study Report was filed for the Phase 2/3 dry eye clinical trial. Based on when,
and if, certain additional development milestones are achieved in the U.S. with RGN-259, our equity ownership may be incrementally
reduced to between 38.5% and 25%, with 25% being the final equity ownership upon approval of a BLA for DES in the U.S. In addition
to our equity ownership, RegeneRx retains a royalty on net sales that varies between single and low double digits, depending on whether
commercial sales are made by ReGenTree or a licensee. In the event ReGenTree is acquired or there is a change of control that occurs
following achievement of a BLA, RegeneRx shall be entitled to a minimum of 40% of all proceeds paid or payable and will forgo any
future royalties. The Company is not required or otherwise obligated to provide financial support to the Joint Venture.
The Joint Venture is responsible for executing all development and commercialization activities under the license agreement,
which activities will be directed by a joint development committee comprised of representatives of the Company and GtreeBNT. The
license agreement has a term that extends to the later of the expiration of the last patent covered by the agreement or 25 years from the
first commercial sale under the agreement. The license agreement may be earlier terminated if the Joint Venture fails to meet certain
commercialization milestones, if either party breaches the license agreement and fails to cure such breach, as a result of government
action that limits the ability of the Joint Venture to commercialize the product, as a result of a challenge to a licensed patent, following
termination of the license between the Company and certain agencies of the United States federal government, or upon the bankruptcy of
either party.
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Under the license agreement, the Company received $1.0 million in up-front payments and is entitled to receive royalties on the
Joint Venture’s future sales of products. On April 6, 2016, we received $250,000 from ReGenTree and executed an amendment to the
license agreement on April 28, 2016. Under the amendment the territorial rights were expanded to include Canada. The Company is
accounting for the license agreement with the Joint Venture as a revenue arrangement. Since participation in the joint development
committee is required, it was deemed to be a material promise. Management has concluded that the participation in the joint development
committee is not distinct from other promised goods and services. The Company evaluated the promised goods and services under the
license agreements and determined that there was one combined performance obligation representing a series of distinct goods and
services including the license to research, develop and commercialize RGN-259 and participation in the joint development committee.
Revenue is being recognized on a straight-line basis over a period of 30 years, which, in management’s judgment, is the best measure of
progress towards satisfying the performance obligation and represents the Company’s best estimate of the period of the obligation. As of
December 31, 2021 and 2020, we have unearned revenue totaling $975,288 and $1,017,267, respectively, pursuant to this agreement.
Revenue will be recognized for future royalty payments as they are earned.
5. COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS
Prepaid expenses and other current assets are comprised of the following:
Prepaid insurance
Other
Accrued expenses are comprised of the following:
Accrued professional fees
Accrued other
Accrued compensation
Accrued interest - convertible debt
6. EMPLOYEE BENEFIT PLANS
December 31,
2021
2020
6,071
13,861
19,932
$
$
39,196
10,713
49,909
December 31,
2021
2020
2,765
28,951
21,585
208,428
261,729
$
$
12,394
48,735
29,300
118,428
208,857
$
$
$
$
In 2021 and 2020, the Company provided health and dental insurance to an employee under a group plan. No retirement plan
was in place for 2021 or 2020.
7. CONVERTIBLE NOTES
2019 Convertible Notes
In February 2019, we sold a series of convertible promissory notes to management, the Company’s Board of Directors and
accredited investors including Essetifin S.p.A., our largest stockholder. The sale of the notes resulted in gross proceeds to the Company
of $1,300,000 over two closings (the “2019 Notes”). The first closing in the amount of $650,000 occurred in February 2019 and the
second closing, also in the amount of $650,000, occurred on May 13, 2019 after the Company provided notice of the enrollment of the
first patent in the ARISE-3 clinical trial in DES sponsored by ReGenTree. The 2019 Notes will mature on March 1, 2024. The 2019
Notes bear interest at a rate of five percent (5%) per annum and are convertible into shares of our common stock at a conversion price of
twelve cents ($0.12) per share (subject to adjustment as described in the 2019 Notes) at any time prior to repayment, at the election of the
investors. In the aggregate, the 2019 Notes issued in both closings are convertible into up to 10,833,333 shares of our common stock
excluding interest.
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At any time prior to maturity of the 2019 Notes, with the consent of the holders of a majority in interest of the 2019 Notes, we
can prepay the outstanding principal amount of the 2019 Notes plus unpaid accrued interest without penalty. The outstanding principal
and all accrued interest on the 2019 Notes will accelerate and automatically become immediately due and payable upon the occurrence of
certain events of default.
In connection with the issuance of the 2019 Notes we also issued warrants to each investor. The warrants are exercisable for an
aggregate of 8,125,000 shares of common stock with an exercise price of eighteen cents ($0.18) per share for a period of five years (the
“2019 Warrants”). The relative fair value of the 2019 Warrants issued was $348,443 calculated using the Black-Scholes-Merton
valuation model value of $0.06 with an expected and contractual life of five years, an assumed volatility of 67.86%, and a risk-free
interest rate of 2.49%. The 2019 Warrants are classified in equity.
The Company allocated $348,443 of the gross proceeds to the warrants, on a relative fair value basis. In addition, because the
effective conversion price of the 2019 Notes was less than the fair value of the underlying common stock on the issuance date, we
allocated $348,443, the intrinsic value of that feature to additional paid-in capital. The debt discount created by the 2019 Warrants and
beneficial conversion feature is amortized over the term of the 2019 Notes as additional interest expense using the effective interest
method.
The affiliated investors and the principal amount of their respective 2019 Notes purchase are as set forth below:
Investor
Essetifin S.p.A.
Joseph C. McNay
J.J. Finkelstein
Mauro Bove
Allan L. Goldstein
R. Don Elsey
Note Principal
$ 1,000,000
25,000
$
25,000
$
10,000
$
5,000
$
5,000
$
Essetifin S.p.A., our largest stockholder. The other listed investors are members of our Board of Directors including Mr.
Finkelstein, who serves as our CEO, and Dr. Goldstein who serves as our Chief Scientific Advisor and Chairman of our Board of
Directors.
2020 Convertible Notes
In October 2020, we sold a series of convertible promissory notes to management, the Company’s Board of Directors and
accredited investors including Essetifin S.p.A., our largest stockholder. The sale of the notes resulted in gross proceeds to the Company
of $500,000 (the “2020 Notes”). The 2020 Notes will mature on October 15, 2025. The 2020 Notes bear interest at a rate of five percent
(5%) per annum and are convertible into shares of our common stock at a conversion price of thirty-six cents ($0.36) per share (subject
to adjustment as described in the 2020 Notes) at any time prior to repayment, at the election of the investors. In the aggregate, the 2020
Notes are convertible into up to 1,391,982 shares of our common stock excluding interest.
At any time prior to maturity of the 2020 Notes, with the consent of the holders of a majority in interest of the 2020 Notes, we
can prepay the outstanding principal amount of the 2020 Notes plus unpaid accrued interest without penalty. The outstanding principal
and all accrued interest on the 2020 Notes will accelerate and automatically become immediately due and payable upon the occurrence of
certain events of default.
In connection with the issuance of the 2020 Notes we also issued warrants to each investor. The warrants are exercisable for an
aggregate of 1,043,988 shares of common stock with an exercise price of forty-five cents ($0.45) per share for a period of five years (the
“2020 Warrants”). The relative fair value of the 2020 Warrants issued was $176,573 calculated using the Black-Scholes-Merton
valuation model value of $0.26 with an expected and contractual life of five years, an assumed volatility of 74.6%, and a risk-free
interest rate of 0.32%. The 2020 Warrants are classified in equity.
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The Company allocated $176,573 of the gross proceeds to the warrants, on a relative fair value basis. In addition, because the
effective conversion price of the 2020 Notes was less than the fair value of the underlying common stock on the issuance date, we
allocated $289,045, the intrinsic value of that feature to additional paid-in capital. The debt discount created by the 2020 Warrants and
beneficial conversion feature is amortized over the term of the 2020 Notes as additional interest expense using the effective interest
method.
The affiliated investors and the principal amount of their respective 2020 Notes purchase are as set forth below:
Investor
Essetifin S.p.A.
J.J. Finkelstein
Mauro Bove
Allan L. Goldstein
The Company recorded interest expense and discount accretion as set forth below:
Note Principal
400,000
10,000
10,000
5,000
$
$
$
$
For the years ended
2019 Notes
2020 Notes
Total interest expense
8. STOCKHOLDERS’ EQUITY
December 31, 2021 December 31, 2020
207,610
206,274
$
$
118,604
25,021
$
324,878
$
232,631
Common Stock. At the Company’s 2021 Annual Meeting on October 27, 2021, the stockholders adopted an amendment to the
Company’s Certificate of Incorporation to increase the authorized shares of capital stock from 201,000,000 to 301,000,000 shares,
effective November 12, 2021.
On June 28, 2021, the Company entered into a securities purchase agreement (the “Purchase Agreement”) and a registration
rights agreement (the “Registration Rights Agreement”) with investors and existing stockholders and members of management of the
Company (the “Investors”). The Company closed the transactions contemplated under the Purchase Agreement on June 30, 2021.
Pursuant to the terms of the Purchase Agreement, the Company sold an aggregate of 9,900,000 shares of its common stock (the
“Shares”) to investors at a price of $0.20 per share, for gross proceeds of $1,980,000 before offering expenses (the “Private Placement”).
As part of the Private Placement, the Company also issued to investors, for no additional consideration, Series A Warrants to purchase
7,425,000 shares of common stock (the “Warrant Shares”) at an exercise price of $0.24 per share with a two-year term (the “Series A
Warrants”) and Series B Warrants to purchase 7,425,000 shares of common stock at an exercise price of $0.28 per share with a five-year
term (the “Series B Warrants,” together with the Series A Warrants, the “Warrants”). In addition, Series A Warrants to purchase 634,375
shares of common stock at an exercise price of $0.24 per share with a two-year term and Series B Warrants to purchase 634,375 shares of
common stock at an exercise price of $0.28 per share with a five-year term were issued to the placement agent.
On March 2, 2018, we entered into the Reprice Agreement with Sabby Healthcare Master Fund, Ltd., and Sabby Volatility
Warrant Master Fund, Ltd. (collectively, “Sabby”). In connection with that certain securities purchase agreement between the Company
and Sabby dated June 27, 2016 (the “Purchase Agreement”) we also issued to Sabby warrants to purchase 5,147,059 shares of common
stock (the “Warrant Shares”) at an exercise price of $0.51 per share (the “Sabby Warrants”). Under the terms of the Reprice Agreement,
in consideration of Sabby exercising in full all of the Sabby Warrants (the “Warrant Exercise”), the exercise price per share of the Sabby
Warrants was reduced to $0.20 per share. We received gross proceeds of approximately $1,029,000 from the warrant reprice transaction.
In addition, and as further consideration, we issued to Sabby warrants to purchase up to 3,860,294 shares of common stock at an exercise
price of $0.2301 per share, the closing bid price for the Company’s Common Stock on February 28, 2018 (the “March Warrants”).
Subsequent to the reduction of the exercise price of the March Warrants to $0.125 in 2019, Sabby exercised warrants for
925,000 shares of common stock and the Company received exercise proceeds of $115,625. Sabby exercised additional warrants on April
23, 2019 for 1,000,000 shares of common stock and the Company received exercise proceeds of $125,000. Sabby exercised their
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remaining warrants on January 17, 2020 for 1,935,294 shares of common stock and the Company received exercise proceeds of
$241,911.
Registration Rights Agreements. In connection with the sale of certain equity instruments, we have entered into Registration
Rights Agreements. Generally, these Agreements required us to file registration statements with the Securities and Exchange
Commission to register common shares to permit re-sale of common shares previously sold under an exemption from registration or to
register common shares that may be issued on exercise of outstanding warrants.
The Registration Rights Agreements usually require us to pay penalties for any failure or time delay in filing or maintaining the
effectiveness of the required registration statements. These penalties are usually expressed as a fixed percentage, per month, of the
original amount we received on issuance of the common shares, options or warrants. While to date we have not incurred any penalties
under these agreements, if a penalty is determined to be probable, we would recognize the amount as a contingent liability and not as a
derivative instrument.
Share-Based Compensation. We recognized $397,814 and $332,003 in share-based compensation expense for the years ended
December 31, 2021 and 2020, respectively. We expect to recognize the compensation cost related to non-vested options as of
December 31, 2021 of $646,000 over the weighted average remaining recognition period of 1.53 years.
Stock Option and Incentive Plans. On June 13, 2018, at our Annual Meeting of Stockholders, our stockholders approved the
2018 Equity Incentive Plan (the “2018 Plan”). The terms of the 2018 Plan provide for the discretionary grant of incentive stock options,
nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance stock awards,
other stock awards and performance cash awards to our employees, directors and consultants. The total number of shares of our common
stock reserved for issuance under the 2018 Plan was initially 5,000,000 shares of common stock with additional shares being available
for grant under the plan annually in an amount equal to 2% of the then outstanding shares of common stock on July 1 of each
calendar year. Pursuant to this plan provision, on July 1, 2021, 2,868,936 additional shares of common stock became available for grant
under the 2018 Plan. On July 1, 2020, 2,668,836 additional shares of common stock became available for grant under the 2018 Plan.
We have previously adopted two equity incentive plans, known as the 2000 Equity Incentive Plan, or the 2000 Plan, and the
2010 Equity Incentive Plan, or the 2010 Plan. Both the 2000 Plan and the 2010 Plan have a term of ten years, with the 2000 Plan already
expired and the 2010 Plan expired in July 2020. No further awards may be granted under the 2010 Plan with the approval of the 2018
Plan. All outstanding option awards granted under the 2010 Plan will continue to be subject to the terms and conditions as set forth in the
agreements evidencing such option awards and the terms of the 2010 Plan. Shares remaining available for issuance under the shares
reserved under the 2010 Plan will not be subject to future awards under the 2018 Plan, and shares subject to outstanding awards under
the 2010 Plan that are terminated or forfeited in the future will not be subject to future awards under the 2018 Plan. All outstanding
option awards granted under the 2000 Plan have expired.
The following summarizes share-based compensation expense for the years ended December 31, 2021 and 2020, which was
allocated as follows:
General and administrative
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December 31,
2021
2020
$ 397,814
$ 397,814
$ 332,003
$ 332,003
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The following summarizes stock option activity for the years ended December 31, 2021 and 2020:
Shares available for
grants
Number of shares Exercise price range
Weighted average
exercise
price
Options Outstanding
December 31, 2019
2018 Plan additions
Grants
Expirations
December 31, 2020
2018 Plan additions
Grants
Exercises
Expirations 2010 Plan
December 31, 2021
Vested and expected to vest at December 31, 2021
Exercisable at December 31, 2021
3,610,130
2,668,836
(2,130,000)
—
4,148,966
2,868,936
(2,605,000)
—
4,412,902
9,821,250
—
2,130,000
—
11,951,250
—
2,605,000
(105,000)
(2,075,000)
12,376,250
11,890,234
8,753,750
0.16 - 0.64
—
0.30
—
0.16 - 0.64
—
0.28
0.21
0.16 - 0.21
0.19 - 0.64 $
$
0.28
—
0.30
0.00
0.28
—
0.28
0.21
0.21
0.29
The following summarizes information about stock options outstanding at December 31, 2021:
Options Outstanding, December 31, 2020
Granted
Exercised
Forfeited
Options Outstanding, December 31, 2021
Vested and unvested but expected to vest, December 31, 2021
Exercisable at December 31, 2021
Weighted Average
Exercise Price
Weighted
Average
Remaining
Contractual Life
Aggregate
Intrinsic Value
0.28
0.28
0.21
0.21
0.29
0.29
0.30
6.4 years
6.4 years
5.3 years
$
$
$
—
—
—
Number of Shares
11,951,250
$
$
2,605,000
(105,000) $
(2,075,000) $
12,376,250
$
$
11,890,234
$
8,753,750
Determining the Fair Value of Options. We use the Black-Scholes valuation model to estimate the fair value of options granted.
Black-Scholes considers a number of factors, including the market price and volatility of our common stock. We used the following
forward-looking range of assumptions to value each stock option granted to employees, directors and consultants during the years ended
December 31, 2021 and 2020:
Dividend yield
Risk-free rate of return
Expected life in years
Volatility
Forfeiture rate
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2021
2020
0.0 %
0.71 %
5.88
87.68 %
2.6 %
0.0 %
0.33 %
5.88
74.57 %
2.6 %
Table of Contents
Our dividend yield assumption is based on the fact that we have never paid cash dividends and do not anticipate paying cash
dividends in the foreseeable future. Our risk-free interest rate assumption is based on yields of U.S. Treasury notes in effect at the date of
grant. Our expected life represents the period of time that options granted are expected to be outstanding and is calculated in accordance
with the Securities and Exchange Commission (“SEC”) guidance provided in the SEC’s Staff Accounting Bulletin (“SAB”) 107 and
SAB 110, using a “simplified” method. The Company has used the simplified method and will continue to use the simplified method as it
does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate an expected term. Our volatility
assumption is based on reviews of the historical volatility of our common stock. Using Black-Scholes and these factors, the weighted
average fair value of stock options granted to employees and directors was $0.20 and $0.19 for the years ended December 31, 2021 and
2020, respectively. We do not record tax-related effects on stock-based compensation given our historical and anticipated operating
experience and offsetting changes in our deferred income tax valuation allowance which fully reserves against our deferred tax assets.
The following table summarizes our warrant activity for 2021 and 2020:
December 31, 2019
Issuances
Exercises
December 31, 2020
Issuances
Exercises
Forfeitures
December 31, 2021
9. INCOME TAXES
Warrants Outstanding
Number of
shares
Exercise price
range
Weighted
average
exercise
price
10,420,594
1,043,988
(1,935,294)
9,529,288
16,118,750
(102,947)
(257,353)
25,287,738
0.125 - 0.37
0.45
0.125
0.125 - 0.45
0.24 - 0.28
0.13
0.37
$ 0.18 - 0.45
0.17
0.45
0.125
0.21
0.26
0.13
0.37
$ 0.24
The Company’s provision for income taxes consists of the following for the years ended December 31, 2021 and 2020:
Current income tax provision (benefit):
Federal
State
Foreign
Total
Deferred income tax provision (benefit):
Federal
State
Foreign
Total
2021
2020
$
— $
—
—
—
—
—
—
—
(202,000)
(63,000)
—
(265,000)
(271,000)
(84,000)
—
(355,000)
Change in valuation allowance
Total provision (benefit) for income taxes
265,000
$
— $
355,000
—
F-19
Table of Contents
Significant components of the Company’s deferred tax assets at December 31, 2021 and 2020 and related valuation allowances
are presented below:
Deferred tax assets:
Net operating loss carryforwards
Research and experimentation credit carryforwards
Charitable contribution carryforwards
Accrued expenses, deferred revenue and other
Share-based compensation
Less - valuation allowance
Net deferred tax assets
Year ended December 31,
2020
2021
$ 14,266,000
2,269,000
3,000
547,000
847,000
17,932,000
$ 14,048,000
2,268,000
4,000
523,000
824,000
17,667,000
(17,932,000)
$
— $
(17,667,000)
—
At December 31, 2021, we had net operating loss carryforwards for Federal income tax purposes of approximately $51.8
million and research and research and experimental tax credit carryforwards of approximately $2.3 million, which are available to offset
future federal income. Approximately $47.9 million of the net operating loss carryforwards, generated prior to 2018, expires in
increments through 2037, while carryforwards generated in 2018 or later do not expire.
Section 382 of the Internal Revenue Code imposes substantial restrictions on the utilization of net operating losses and tax
credits in the event of a corporation’s ownership change. During 2009, the Company completed a preliminary study to compute any
limits on the net operating losses and credit carryforwards for purposes of Section 382. It was determined that the Company experienced
a cumulative change in ownership, as defined by the regulations, in 2002. This change in ownership triggers an annual limitation on the
Company’s ability to utilize certain U.S. federal and state net operating loss carryforwards and research tax credit carryforwards,
resulting in the potential loss of approximately $9.8 million of net operating loss carryforwards and $0.2 million in research credit
carryforwards. The Company has reduced the deferred tax assets associated with these carryforwards in its balance sheets. The Company
believes that the future use of net operating losses and tax credits presented above may be further reduced as a result of additional
ownership changes subsequent to 2009.
The provision for income taxes on earnings subject to income taxes differs from the statutory federal rate for the years ended
December 31, 2021 and 2020, due to the following:
US Federal statutory rate
State income tax, net of Federal benefit
Share-based compensation
Permanent differences and other
Change in valuation allowance
2021
21.00 %
6.52 %
-5.27%
-5.68%
-16.57%
2020
21.00 %
6.52 %
-2.76%
-1.46%
-23.30%
0.00 %
0.00 %
As discussed in Note 2, we recognize the effect of income tax positions only if those positions are more likely than not of being
sustained. At December 31, 2021 and 2020, we had no gross unrecognized tax benefits. We do not expect any significant changes in
unrecognized tax benefits over the next 12 months. In addition, we did not recognize any interest or penalties related to uncertain tax
positions at December 31, 2021 and 2020.
The 2007 through 2021 tax years generally remain subject to examination by federal and most state tax authorities. In addition,
we would remain open to examination for earlier years if we were to utilize net operating losses or tax credit carryforwards that
originated prior to 2012.
F-20
Table of Contents
10. LEASES
In June 2020, we amended our office lease agreement, and the term has been extended through July 2022. During the extended
term, our rental payments will be approximately $4,200 per month. We had previously amended the office lease to extend through July
2020. Our facility lease is our only existing lease as of December 31, 2021 and is classified as an operating lease. The discount rate used
in the calculation of our lease liability is approximately 20%, which is based on our estimate of the rate of interest that we would have to
pay to borrow on a collateralized basis over a similar term and amount equal to the lease payments in a similar economic environment as
the lease does not provide an implicit rate.
The following table summarizes the Company's recognition of its operating lease as of December 31, 2021 and 2020:
Assets
Operating lease right-of-use asset
Total lease assets
Liabilities
Current portion of operating lease liability
Long-term portion of operating lease liability
Total lease liabilities
December 31, 2021 December 31, 2020
$
$
$
$
27,673 $
27,673 $
68,229
68,229
27,809 $
—
27,809 $
40,790
27,809
68,599
Rent expense, consisting of minimum operating lease payments and variable lease payments for pass through items such as
common area maintenance and real estate taxes for the years ended December 31, 2021 and 2020 is recorded as general and
administrative expense and consisted of the following:
Operating lease cost
Variable lease costs
Total lease costs
A maturity analysis of our operating lease minimum lease payments follows:
2022
Total
Discount factor
Total lease liability
11. PROMISORY NOTE
$
2021
50,671
1,216
$
2020
50,060
895
$
51,887
$
50,955
$
29,694
29,694
(1,885)
27,809
$
On April 24, 2020, the Company entered into a Promissory Note (the “Loan”) with PNC Bank (the “Bank”) pursuant to the
Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) administered by
the U.S. Small Business Administration. The principal amount of the Loan is $55,400.
In accordance with the requirements of the CARES Act, the Company used the proceeds from the Loan in accordance with the
requirements of the PPP to cover certain qualified expenses, including payroll costs, rent and utility costs. Interest accrues on the Loan at
the rate of 1.00% per annum. The Company applied for forgiveness of amount due under the Loan, in an amount equal to the sum of
qualified expenses under the PPP, which include payroll costs, rent obligations, and covered utility payments incurred during the
forgiveness period following disbursement of the Loan.
In April 2021, the Company filed the required documents with the Bank related to forgiveness of the Loan and in July 2021, the
Company received a Notice of Paycheck Protection Program Forgiveness Payment stating that the Bank had received payment from the
U.S. Small Business Administration on July 9, 2021.
F-21
Table of Contents
12. COMMITMENTS
Employment Continuity Agreements. We have entered into employment contracts with our executive officers which provide for
severance if the executive is dismissed without cause or under certain circumstances after a change of control in our ownership. At
December 31, 2021, these obligations, if triggered, could amount to a maximum of approximately $170,000.
F-22
Table of Contents
EXHIBIT INDEX
Exhibit
No.
Description of Exhibit
Reference*
3.1
Restated Certificate of Incorporation
Exhibit 3.1 to Registration Statement on Form S-1 (File No.
333-166146) (filed April 16, 2010)
3.2
3.3
3.4
3.5
Certificate of Amendment to Restated Certificate of
Incorporation
Exhibit 3.2 to Registration Statement on Form S-1 (File No.
333-166146) (filed April 16, 2010)
Certificate of Amendment to Restated Certificate of
Incorporation
Exhibit 3.3 to Registration Statement on Form S-1 (File No.
333-166146) (filed April 16, 2010)
Certificate of Amendment of Restated Certificate of
Incorporation
Exhibit 3.4 to Registration Statement on Form S-8 (File No.
333-168252) (filed July 21, 2010)
Certificate of Designation of Series A Participating
Cumulative Preferred Stock
Exhibit 3.4 to Registration Statement on Form S-1 (File No.
333-166146) (filed April 16, 2010)
3.6
Amended and Restated Bylaws
3.7
Amendment to Amended and Restated Bylaws
Exhibit 3.4 to Quarterly Report on Form 10-Q (File No. 001-
15070) for the quarter ended June 30, 2006 (filed August 14,
2006)
Exhibit 3.6 to Registration Statement on Form S-8 (File No.
333-152250) (filed July 10, 2008)
3.8
Certificate of Amendment of Restated Certificate of
Incorporation
Exhibit 3.1 to Current Report on Form 8-K (File No. 001-
15070) (filed November 15, 2021)
4.1
Specimen Common Stock Certificate
4.2
Specimen Rights Certificate
Rights Agreement, dated April 29, 1994, between the
Company and American Stock Transfer & Trust Company,
as Rights Agent
Amendment No. 1 to Rights Agreement, dated March 4,
2004, between the Company and American Stock Transfer
& Trust Company, as Rights Agent
4.3
4.4
4.5
Exhibit 4.1 to Registration Statement on Form S-1 (File No.
333-166146) (filed April 16, 2010)
Exhibit 4.2 to Registration Statement on Form S-1 (File No.
333-166146) (filed April 16, 2010)
Exhibit 4.3 to Registration Statement on Form S-1 (File No.
333-166146) (filed April 16, 2010)
Exhibit 4.4 to Registration Statement on Form S-1 (File No.
333-166146) (filed April 16, 2010)
Warrant Agreement, dated May 21, 2010, between the
Company and American Stock Transfer & Trust Company,
as Warrant Agent
Exhibit 4.1 to Current Report on Form 8-K (File No. 001-
15070) (filed May 21, 2010)
4.6
Form of Warrant Certificate
Exhibit 4.6 to Amendment No. 1 to Registration Statement on
Form S-1 (File No. 333-166146) (filed May 17, 2010)
10.1˄
Amended and Restated 2000 Stock Option and Incentive
Plan, as amended
Annex A to the Company’s Proxy Statement on Schedule
14A (File No. 001-15070) (filed May 9, 2008)
52
Table of Contents
10.2˄
2010 Equity Incentive Plan
Exhibit 10.1 to Current Report on Form 8-K (File No. 001-
15070) (filed July 20, 2010)
10.3
10.4
10.5
10.6
10.7
10.8
Form of Stock Option Grant Notice and Stock Option
Agreement under the 2010 Equity Incentive Plan
Patent License Agreement — Exclusive, dated January 24,
2001, between the Company and the U.S. Public Health
Service
Exhibit 10.2 to Current Report on Form 8-K (File No. 001-
15070) (filed July 20, 2010)
Exhibit B to Exhibit 10.1 to Amendment No. 1 to Quarterly
Report on Form 10-Q for the quarter ended September 30,
2012 (File No. 001-15070) (filed January 16, 2013)
Thymosin Beta 4 License and Supply Agreement, dated
January 21, 2004, between the Company and Defiante
Farmaceutica S.A.
Lease, by and between the Company and The Realty
Associates Fund V, L.P., dated December 10, 2009
Exhibit 10.10 to Registration Statement on Form SB-2 (File
No. 333-113417) (filed March 9, 2004)**
Exhibit 10.25 to Annual Report on Form 10-K for the year
ended December 31, 2009 (File No. 001-15070) (filed March
31, 2010)
Form of Warrant to Purchase Common Stock dated April
30, 2009
Exhibit 10.1 to Current Report on Form 8-K (File No. 001-
15070) (filed April 16, 2009)
Form of Common Stock Purchase Warrant, dated October
5, 2009
Exhibit 4.1 to Current Report on Form 8-K (File No. 001-
15070) (filed September 30, 2009)
10.9
Form of Warrant, dated October 15, 2009
Exhibit 4.1 to Current Report on Form 8-K (File No. 001-
15070) (filed October 5, 2009)
10.10
Representative’s Warrant to Purchase Common Stock,
dated May 21, 2010
Exhibit 4.3 to Current Report on Form 8-K (File No. 001-
15070) (filed May 21, 2010)
10.11
Registration Rights Agreement, dated January 4, 2011
Exhibit 10.3 to Current Report on Form 8-K (File No. 001-
15070) (filed January 7, 2011)
10.12
10.13
10.14˄
10.15˄
Warrant to Purchase Common Stock, dated January 7,
2011, issued to Lincoln Park Capital
Exhibit 4.1 to Current Report on Form 8-K (File No. 001-
15070) (filed January 7, 2011)
Form of Warrant to Purchase Common Stock, dated
January 7, 2011, issued to the Sigma-Tau Purchasers
Exhibit 4.2 to Current Report on Form 8-K (File No. 001-
15070) (filed January 7, 2011)
Amended and Restated Change in Control Agreement
between the Company and J.J. Finkelstein, dated July 2,
2012
Amended and Restated Change in Control Agreement
between the Company and Allan L. Goldstein, dated July
2, 2012
Exhibit 10.8 to Current Report on Form 10-Q (File No. 001-
15070) (filed August 14, 2012)
Exhibit 10.12 to Current Report on Form 10-Q (File No. 001-
15070) (filed August 14, 2012)
10.16
Form of Convertible Promissory Note
10.17
Form of Warrant
10.18
Convertible Note and Warrant Purchase Agreement
Exhibit 4.1 to Current Report on Form 8-K (File No. 001-
15070) (filed October 24, 2012)
Exhibit 4.2 to Current Report on Form 8-K (File No. 001-
15070) (filed October 24, 2012)
Exhibit 10.1 to Current Report on Form 8-K (File No. 001-
15070) (filed October 24, 2012)
53
Table of Contents
10.19
License Agreement with Lee’s Pharmaceutical (HK)
Limited
10.20
Form of Convertible Promissory Note
10.21
Convertible Note Purchase Agreement
10.22
Form of Convertible Promissory Note
10.23
Convertible Note Purchase Agreement
Exhibit 10.1 to Amendment No. 1 to Form 10-Q (File No.
001-15070) for the quarter ended September 30, 2012 (filed
January 16, 2013)**
Exhibit 4.1 to Current Report on Form 8-K (File No. 001-
15070) (filed April 2, 2013)
Exhibit 10.1 to Current Report on Form 8-K (File No. 001-
15070) (filed April 2, 2013)
Exhibit 4.1 to Current Report on Form 8-K (File No. 001-
15070) (filed July 11, 2013)
Exhibit 10.1 to Current Report on Form 8-K (File No. 001-
15070) (filed July 11, 2013)
10.24˄
10.25˄
Letter Agreement between the Company and J.J.
Finkelstein, dated July 5, 2013
Exhibit 10.2 to Current Report on Form 8-K (File No. 001-
15070) (filed July 11, 2013)
Letter Agreement between the Company and Allan L.
Goldstein, dated July 5, 2013
Exhibit 10.4 to Current Report on Form 8-K (File No. 001-
15070) (filed July 11, 2013)
10.26
Form of Convertible Promissory Note
10.27
Convertible Note Purchase Agreement
10.28
Form of Convertible Promissory Note
10.29
Convertible Note Purchase Agreement
Exhibit 4.1 to Current Report on Form 8-K (File No. 001-
15070) (filed September 19, 2013)
Exhibit 10.1 to Current Report on Form 8-K (File No. 001-
15070) (filed September 19, 2013)
Exhibit 4.1 to Current Report on Form 8-K (File No. 001-
15070) (filed January 9, 2014)
Exhibit 10.1 to Current Report on Form 8-K (File No. 001-
15070) (filed January 9, 2014)
10.30˄
Letter Agreement between the Company and J.J.
Finkelstein, dated January 7, 2014
Exhibit 10.2 to Current Report on Form 8-K (File No. 001-
15070) (filed January 9, 2014)
10.31
Letter Agreement between the Company and Allan L.
Goldstein, dated January 7, 2014
Exhibit 10.3 to Quarterly Report on Form10-Q (File No. 001-
15070) (filed January 9, 2014)
10.32
Securities Purchase Agreement
Exhibit 10.5 to Quarterly Report on Form10-Q (File No. 001-
15070) (filed May 15, 2014)
10.33
10.34
10.35˄
10.36˄
License Agreement RGN-259 dated March 7, 2014 with
GtreeBNT (formerly Digital Aria)
Exhibit 10.6 to Quarterly Report on Form10-Q (File No. 001-
15070) (filed May 15, 2014)**
License Agreement RGN-137 dated March 7, 2014 with
GtreeBNT (formerly Digital Aria)
Exhibit 10.7 to Quarterly Report on Form10-Q (File No. 001-
15070) (filed May 15, 2014)**
Executive Employment Agreement between the Company
and J.J. Finkelstein dated April 16, 2014
Exhibit 10.1 to Quarterly Report on Form10-Q (File No. 001-
15070) (filed August 14, 2014)
Executive Employment Agreement between the Company
and Allan L. Goldstein dated April 16, 2014
Exhibit 10.2 to Quarterly Report on Form10-Q (File No. 001-
15070) (filed August 14, 2014)
54
Table of Contents
10.37˄
10.38
10.39
10.40
Executive Employment Agreement between the Company
and Dane Saglio dated April 16, 2014
Exhibit 10.3 to Quarterly Report on Form10-Q (File No. 001-
15070) (filed August 14, 2014)
Form of First Amendment to Promissory Note dated
October 3, 2014
Exhibit 10.1 to Current Report on Form 8-K (File No. 001-
15070) (filed October 9, 2014)
Joint Venture Agreement between the Company and
GtreeBNT Co., Ltd. dated January 28, 2015
License Agreement between the Company and
ReGenTree, LLC dated January 28, 2015
Exhibit 10.1 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed May 15, 2015)
Exhibit 10.2 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed May 15, 2015)
10.41
2014 Amendment to Lease Agreement
Exhibit 10.41 to Annual Report on Form 10-K (File No. 001-
15070) (filed April 11, 2016)
10.42
10.43
10.44
10.45
10.46
Securities Purchase Agreement between the Company and
Purchasers identified therein dated June 27, 2016.
Exhibit 10.1 to Current Report on Form 8-K (File No. 001-
15070) (filed July 1, 2016).
Registration Rights Agreement between the Company and
Purchasers identified therein dated June 27, 2016.
Exhibit 10.2 to Current Report on Form 8-K (File No. 001-
15070) (filed July 1, 2016).
Amendment No. 2 to the RGN-259 License Agreement
between the Company and ReGenTree, LLC dated April
28, 2016.
Amendment No. 2. to Joint Venture Agreement between
the Company and GtreeBNT Co., Ltd. dated May 11,
2016.
Exhibit 10.1 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed August 22, 2016)
Exhibit 10.2 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed August 22, 2016)
Amendment No 2. Dated as of August 28, 2017, REN-137
License Agreement between the Company and GTreeBNT
Co., LTD, dated March 7, 2014
Exhibit 10.1 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed November 14, 2017)**
10.47
Warrant Reprice Agreement between the Company and the
Purchasers identified therein dated March 2, 2018
Exhibit 10.47 to Annual Report (File No. 001-15070) (filed
March 29, 2018)
10.48
Form of Common Stock Warrant
10.49
2018 Equity Incentive Plan dated June 13, 2018
Exhibit 10.48 to Annual Report (File No. 001-15070) (filed
March 29, 2018)
Exhibit 10.49 to Annual Report on Form 10-K (File No. 001-
15070) (filed March 29, 2019)
10.50
Form of Convertible Note Purchase Agreement February
2019
Exhibit 10.1 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed May 15, 2019)
10.51
Form of Convertible Promissory Note February 2019
10.52
Form of Stock Warrant February 2019
10.53
Amendment N. 1 to License Agreement dated February
25, 2019 between the Company and Lee’s Pharmaceutical
(HK) Limited
Exhibit 10.2 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed May 15, 2019)
Exhibit 10.3 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed May 15, 2019)
Exhibit 10.1 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed November 14, 2019)
55
Table of Contents
10.54
Amendment No. 1 to RGN-259 License (PAN ASIA)
dated September 17, 2019 between Company and
GtreeBNT Co., Ltd.
Exhibit 10.2 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed November 14, 2019)
10.55
Form of Convertible Note Purchase Agreement October
2020
Exhibit 10.1 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed November 13, 2020)
10.56
Form of Convertible Promissory Note October 2020
10.57
Form of Common Stock Warrant October 2020
Exhibit 10.3 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed November 13, 2020)
Exhibit 10.3 to Quarterly Report on Form 10-Q (File No.
001-15070) (filed November 13, 2020)
10.58
10.59
10.60
10.61
10.62
Securities Purchase Agreement between the Company and
Various Investors Dated June 28, 2021
Exhibit 10.1 to Quarterly Report on Form 10-Q (File No. 001-
15070) (filed November 15, 2021)
Registration Rights Agreement between the Company and
Various Investors Dated June 28, 2021
Exhibit 10.2 to Quarterly Report on Form 10-Q (File No. 001-
15070) (filed November 15, 2021)
Form of Series A Common Stock Purchase Warrant Dated June
30, 2021
Exhibit 10.3 to Quarterly Report on Form 10-Q (File No. 001-
15070) (filed November 15, 2021)
Form of Series B Common Stock Purchase Warrant Dated June
30, 2021
Exhibit 10.4 to Quarterly Report on Form 10-Q (File No. 001-
15070) (Filed November 15, 2021)
Lock-Up Agreement Between Company and Various Investors
Dated June 30, 2021
Exhibit 10.5 to Quarterly Report on Form 10-Q (File No. 001-
15070) (Filed November 15, 2021)
23.1
Consent of CohnReznick LLP
Filed herewith
24.1
Powers of Attorney
Included on signature page
31.1
32.1
101
Certification of Principal Executive Officer and Principal
Financial Officer pursuant to Rules 13a-14 and 15d-14
promulgated under the Securities Exchange Act of 1934
Filed herewith
Filed herewith***
Filed herewith
Certification of Principal Executive Officer and Principal
Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
The following materials from the Registrant’s Annual
Report on Form 10-K for the year ended December 31,
2021, formatted in iXBRL (eXtensible Business Reporting
Language): (i) Balance Sheets at December 31, 2021 and
2020; (ii) Statements of Operations for the years ended
December 31, 2021 and 2020; (iii) Statements of Changes
in Stockholders’ Deficit; (iv) Statements of Cash Flows for
the years ended December 31, 2021 and 2020; and (v)
Notes to Financial Statements.
104
Cover Page Interactive Data File (Embedded within the
Inline XBRL document and included in Exhibit).
56
Table of Contents
*
Except where noted, the exhibits referred to in this column have heretofore been filed with the Securities and Exchange
Commission as exhibits to the documents indicated and are hereby incorporated by reference thereto. The Registration
Statements referred to are Registration Statements of the Company.
** The registrant has been granted confidential treatment with respect to certain portions of this exhibit (indicated by asterisks),
which have been filed separately with the Securities and Exchange Commission.
*** This certification is being furnished solely to accompany this annual report pursuant to 18 U.S.C. Section 1350, is not being
filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not to be incorporated by reference into any
filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such
filing.
˄
Compensatory plan, contract or arrangement.
57
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in Registration Statements on Form S-8 (Registration Nos. 333-168252, 333-152250, and
333-111386) of RegeneRx Biopharmaceuticals, Inc. (“the Company”) of our report, which includes an explanatory paragraph relating to
the Company’s ability to continue as a going concern, dated March 30, 2022, on our audits of the financial statements of RegeneRx
Biopharmaceuticals, Inc. as of December 31, 2021 and 2020 and for the years then ended, included in this Annual Report on Form 10-K
for the year ended December 31, 2021.
EXHIBIT 23.1
/s/ CohnReznick LLP
Tysons, Virginia
March 30, 2022
I, J.J. Finkelstein, certify that:
I have reviewed this annual report on Form 10-K of RegeneRx Biopharmaceuticals, Inc.;
CERTIFICATION
EXHIBIT 31.1
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;
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;
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:
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;
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;
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
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
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):
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
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 30, 2022
/s/ J.J. Finkelstein
J.J. Finkelstein
President and Chief Executive Officer
(Principal Executive Officer, Principal
Financial Officer)
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
EXHIBIT 32.1
In connection with the Annual Report of RegeneRx Biopharmaceuticals, Inc. (the "Company") on Form 10-K for the fiscal year ended
December 31, 2021, as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, J.J. Finkelstein, Chief
Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-
Oxley Act of 2002, that, to the best of my knowledge:
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
The information contained in the Report fairly presents, in all material respects, the financial condition and results of
operations of the Company as of and for the periods presented in this report.
This certification accompanies this Report to which it relates, shall not be deemed "filed" with the Securities and Exchange Commission
and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities
Exchange Act of 1934, as amended (whether made before or after the date of the Report), irrespective of any general incorporation
language contained in such filing.
Date: March 30, 2022
/s/ J.J. Finkelstein
J.J. Finkelstein
President and Chief Executive Officer
(Principal Executive Officer, Principal
Financial Officer)