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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

~~x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934~~

~~For~~⌧ ~~the~~ANNUAL ~~fiscal~~REPORT ~~year~~PURSUANT ~~ended~~TO ~~December 31,~~SECTION ~~2020~~13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2021

~~¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934~~

◻	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		52-1253406
State or other jurisdiction of		(I.R.S. Employer
incorporation or organization		Identification No.)

15245 Shady Grove Road, Suite 470, Rockville, MD		20850

(Address of principal executive offices)		(Zip Code)
Delaware		52-1253406
State or other jurisdiction of		(I.R.S. Employer
incorporation or organization		Identification No.)


15245 Shady Grove Road, Suite 470, Rockville, MD		20850
(Address of principal executive offices)		(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 Trading Symbol(s) Name of each exchange on which registered Common RGRX OTC~~

Title of Each Class	Trading Symbol(s)	Name of Each Exchange on which registered
Common	RGRX	OTC

Securities registered pursuant to Section 12(g) of the Act:

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 x No~~

Indicate by check mark if the registrant is ~~not~~a ~~required~~well-known toseasoned ~~file~~issuer, ~~reports~~as ~~pursuant~~defined toin ~~Section~~Rule 13405 ~~or Section 15(d)~~ of the Securities Act. ¨ ◻ Yes x ⌧ No

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. x Yes ¨ No

Indicate by check mark ~~whether~~if the registrant ~~has~~is ~~submitted~~not ~~electronically and posted on its corporate website, if any, every Interactive Data File~~ required to befile ~~submitted~~reports ~~and posted~~ pursuant to ~~Rule~~Section ~~405~~13 ofor ~~Regulation S-T during the preceding 12 months~~ Section 15(ord) of ~~for such shorter period that~~ the ~~registrant was required to submit and post such files)~~Act. ◻ Yes x ⌧ 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. ¨

Indicate by check mark whether the registrant is(1) has afiled ~~large~~all ~~accelerated~~reports ~~filer,~~required anto ~~accelerated~~be ~~filer,~~filed aby ~~non-accelerated~~Section 13 ~~filer~~ or a15 ~~smaller~~(d) of ~~reporting~~the ~~company.~~Securities ~~See definitions~~Exchange Act of ~~“accelerated~~1934 ~~filer,”~~during ~~“large~~the ~~accelerated~~preceding ~~filer”~~12 months ~~and~~(or ~~“smaller~~for ~~reporting~~such ~~company” in~~shorter ~~Rule 12b-2~~period ofthat the ~~Securities~~registrant ~~Exchange~~was ~~Act~~required ofto ~~1934.~~file ~~(Check~~such ~~one~~reports):, and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No

~~Large accelerated filer ¨ Accelerated filer ¨~~

~~Non~~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-~~accelerated filer~~T ~~x Smaller reporting~~during ~~company~~the xpreceding 12 months (or for such shorter period that the registrant was required to submit and post such files). ☒ Yes ☐ No

~~Emerging growth company ¨~~

IfIndicate ~~an emerging growth company, indicate~~ by check mark if ~~registrant~~disclosure ~~has~~of ~~elected~~delinquent ~~not~~filers pursuant to ~~use~~Item 405 ~~the~~of ~~extended~~Regulation S-K ~~transition~~(§ ~~period~~229.405 ~~for~~of ~~complying~~this ~~with~~chapter) ~~any~~is ~~new~~not orcontained ~~revised accounting~~herein, ~~standards~~and ~~provided~~will ~~pursuant~~not be contained, to ~~Section~~the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part ~~13(a)~~ III of ~~the~~this ~~Exchange~~Form 10-K ~~Act.~~or ¨any amendment to this Form 10-K. ☒ Yes ☐ No

~~Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). ¨ Yes x No~~

~~As of~~Indicate ~~February~~by ~~25,~~check ~~2021,~~mark whether the ~~aggregate~~registrant ~~market~~is ~~value~~a oflarge ~~the~~accelerated ~~voting~~filer, ~~stock~~an ~~held~~accelerated byfiler, a non-~~affiliates~~accelerated offiler ~~the~~or ~~registrant~~a ~~was~~smaller ~~approximately $45 million~~reporting company. ~~Such~~See ~~aggregate~~definitions ~~market~~of ~~value~~“accelerated ~~was~~filer,” ~~computed~~“large byaccelerated ~~reference~~filer to" ~~the~~and ~~closing~~“smaller ~~price~~reporting ofcompany” ~~the~~in ~~Common Stock as quoted on the Over~~Rule 12b-~~the-Counter~~2 ~~Bulletin~~of ~~Board, or~~ the ~~OTC~~Securities ~~Bulletin~~Exchange ~~Board,~~Act onof ~~February~~1934. ~~25,~~(Check ~~2021.~~one):

~~The number of shares outstanding of the registrant’s common stock as of February 25, 2021 was 133,546,788.~~

Large accelerated filer ☐	Accelerated filer ☐
Non- accelerated filer ☒	Smaller reporting company ☒
Emerging growth 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.~~

None

Table of Contents

TABLE OF CONTENTS

~~PART I 3~~

	Item 1. Business	3

	Item 1A. Risk Factors	14
PART I		3
	Item 1. Business	3
	Item 1A. Risk Factors	16
PART II		30
	Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Securities	30
	Item 6. Selected Financial Data	30
	Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation	30
	Item 7A. Quantitative and Qualitative Disclosures About Market Risk	38
	Item 8. Financial Statements and Supplementary Data	39
	Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	39
	Item 9A. Controls and Procedures	39
	Item 9B. Other Information	40
	Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
PART III		41
	Item 10. Directors, Executive Officers and Corporate Governance	41
	Item 11. Executive Compensation	43
	Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	46
	Item 13. Certain Relationships and Related Transactions, and Director Independence	48
	Item 14. Principal Accounting Fees and Services	49
PART IV		50
	Item 15. Exhibits, Financial Statement Schedules	50
SIGNATURES		51
INDEX TO FINANCIAL STATEMENTS		F-1
EXHIBIT INDEX		52

PART II		26
	Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Securities	26
	Item 6. Selected Financial Data	27
	Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation	27
	Item 7A. Quantitative and Qualitative Disclosures About Market Risk	34
	Item 8. Financial Statements and Supplementary Data	34
	Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	34
	Item 9A. Controls and Procedures	34
	Item 9B. Other Information	35

PART III		36
	Item 10. Directors, Executive Officers and Corporate Governance	36
	Item 11. Executive Compensation	38
	Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	41
	Item 13. Certain Relationships and Related Transactions, and Director Independence	42
	Item 14. Principal Accounting Fees and Services	45

PART IV		46
	Item 15. Exhibits, Financial Statement Schedules	46

SIGNATURES		47
INDEX TO FINANCIAL STATEMENTS		F-1
EXHIBIT INDEX		49

Table of Contents

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 ~~strategic~~ ~~partnership~~ discussions with ~~biotechnology~~government ~~and~~organizations ~~pharmaceutical companies and the U.S. military~~ regarding the further clinical development of ~~all of~~ our product candidates.

Current Financial Status

InOn ~~October 2020~~June 30, 2021, we ~~sold~~closed a ~~series~~private placement of ~~convertible~~common ~~promissory~~stock ~~notes~~and towarrants ~~management,~~with ~~the~~several ~~Company’s~~institutional ~~Board of Directors~~ and accredited investors ~~including Essetifin S.p.A.~~, ~~our~~including ~~largest~~members ~~stockholder~~of ~~(the~~management ~~“2020~~and ~~Notes”). The sale of~~ the ~~2020~~board, ~~Notes~~and ~~resulted~~received in gross proceeds ~~to the Company~~ of $~~500~~1,980,000. ~~The~~Pursuant ~~2020~~to ~~Notes~~the ~~contain~~terms aof ~~$0.36~~the ~~conversion~~Purchase ~~price~~Agreement, ~~and~~ the ~~purchasers~~Company ~~also~~sold ~~received~~an aaggregate ~~warrant exercisable~~of at9,900,000 ~~$0.45 to purchase additional~~ shares of its common stock ~~equal~~ to ~~75%~~investors ofat ~~the~~a ~~number~~price of ~~shares~~$0.20 ~~into~~per ~~which~~share. ~~each~~Investors ofalso ~~the 2020~~received ~~Notes~~Series isA ~~initially convertible (the “2020~~ Warrants~~”).~~ Onto ~~March 2,~~purchase ~~2018~~7,425,000 weshares ~~entered~~of ~~into~~common ~~the~~stock ~~Reprice~~at ~~Agreement with~~an ~~Sabby~~exercise ~~Healthcare~~price ~~Master~~of ~~Fund, Ltd~~$0.,24 ~~and~~per ~~Sabby~~share ~~Volatility~~with ~~Warrant~~a ~~Master~~two-year ~~Fund, Ltd.~~term ~~(collectively,~~and ~~“Sabby”). In~~Series ~~January 2020,~~B ~~Sabby~~Warrants ~~exercised~~to ~~their~~purchase ~~remaining~~7,425,000 ~~warrants~~Warrant ~~and~~Shares ~~the~~at ~~Company~~an ~~received~~exercise ~~proceeds~~price of $~~241,911~~0.28 Atper ~~present,~~share with ~~the~~ ~~receipt~~a offive-year ~~the~~term. In ~~sale~~connection ~~proceeds~~with ~~from~~ the ~~closing~~private onplacement ~~the 2020 Notes in October 2020,~~ we ~~have~~paid ~~sufficient~~a cash tofee ~~fund planned operations into the second quarter of 2021. We continue~~ to ~~evaluate~~Roth ~~options~~Capital ~~including~~Partners, ~~the~~LLC, ~~licensing of additional rights to commercialize~~ our ~~clinical~~placement ~~products~~agent, asand ~~well~~also asissued ~~raising~~warrants ~~capital through the capital markets. However, our ability~~ to ~~raise~~purchase ~~additional~~up ~~capital raises significant concerns about our ability~~ to ~~continue as a going concern. Since inception~~1, ~~and through December 31~~268,750 ~~2020, we~~shares ~~have an accumulated deficit~~ of ~~$109~~common ~~million~~stock ~~and~~on wethe ~~had~~same ~~cash~~terms ~~and cash equivalents~~ of ~~$427,898 as of December 31, 2020. We anticipate incurring additional operating losses in~~ the ~~future~~Series asB weWarrants ~~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~~Series ~~agreements~~A ~~where~~Warrants ~~our~~(the ~~partners~~“Roth ~~are responsible for advancing development of our product candidates by sponsoring multiple clinical trials~~Warrants”).

~~Current~~In ~~Clinical Status~~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.

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 intends to commercialize RGN-259 for treatment of dry eye syndrome and neurotrophic keratitis, an orphan ophthalmic indication in the United States.

ToTable date ReGenTree has sponsored a Phase 2/3 clinical trial (“ARISE-1”) and Phase 3 clinical trials in patients with DES (“ARISE-2”). Last year ReGenTree completed a Phase 3 clinical trial in patients with neurotrophic keratitis (“NK”) (“SEER-1”), and is currently sponsoring a Phase 3 trial (“ARISE-3”) in patients with DES, both 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. pursuant a contract between the parties, 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 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. ReGenTree is proceeding with its RGN-259 development plan it discussed with the FDA in April 2018. ReGenTree and Ora, Inc. have entered into a contract for management of ARISE-3 study. The first patient was enrolled in the second quarter of 2019 and the last patient was enrolled in October 2020. Due to the COVID-19 pandemic, the completion of ARISE-3 study was delayed from the original timeline but the patent treatment and follow-up was completed in November as ReGenTree previously reported in clinicaltrials.gov. As of the date of this filing, the patient database has been locked and topline results are expected shortly.Contents

~~The~~Current NKClinical trial (SEER-1), a smaller study in an orphan population, enrolled 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.Status

~~GtreeBNT has~~In ~~developed~~January ~~the CMC (chemistry~~2015, ~~manufacturing~~we ~~and~~entered ~~controls)~~into ~~dossier~~a ~~required~~Joint ~~for~~Venture ~~Phase~~Agreement 3with ~~clinical~~GtreeBNT ~~trials~~whereby ~~and~~we ~~commercialization in~~created ~~the~~ReGenTree ~~U.S.~~LLC ~~and~~(“ReGenTree” inor ~~Korea.~~“Joint ~~This~~Venture”) ~~comprehensive~~jointly ~~and~~owned ~~critical~~by ~~effort~~us ~~ensures~~and ~~that final drug product manufacturing~~GtreeBNT, ~~packaging,~~which ~~stability, purity,~~seeks ~~reproducibility, etc.,~~to ~~meets~~commercialize ~~regulatory~~RGN-259 ~~guidelines~~for ~~and~~treatment ~~product specifications. The product~~ of ~~this~~dry ~~activity~~eye issyndrome ~~the current~~(“DES”) ~~product~~and ~~formulation~~neurotrophic ~~being~~keratitis ~~utilized~~(“NK), inan ~~the~~orphan ~~U.S.~~indication ~~trials being conducted by ReGenTree and will also be utilized~~ in the ~~planned clinical~~United ~~activity to be conducted by GtreeBNT under the RGN-259 license agreement for Pan Asia~~States.

~~During~~To ~~the past~~date, ~~several~~ReGenTree ~~years~~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, ~~LLC~~completed ~~began~~a ~~developing~~Phase a3 ~~modified~~clinical ~~eye~~trial ~~drop~~in ~~formulation~~patients ~~that~~with itNK ~~believes~~(“SEER-1”). All ~~will~~Phase ~~enhance~~3 trials were conducted in the ~~efficacy~~ U.S. In May 2016, we reported the results of ~~thymosin~~the ~~beta~~317-patient 4ARISE-1 ~~for~~trial NKand in October 2017, ~~improve~~we reported the ~~patient~~results ~~experience~~of the ARISE-2 trial. The ARISE-2 study, which was sponsored by ReGenTree and ~~allow~~managed by Ora, Inc., demonstrated a ~~proprietary~~number ~~valued~~of ~~orphan~~statistically ~~product~~significant ~~price~~improvements ~~for~~in ~~this~~both ~~rare~~signs ~~disease~~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 ~~Company~~ocular ~~has~~discomfort ~~completed~~symptom showed a ~~preliminary~~statistically ~~formulation~~significant ~~for~~reduction NKin ~~patients~~the ~~that~~RGN-259-treated ~~will~~group beat ~~considered~~day ~~for~~15 ~~use~~as compared to placebo (p=0.0149) in ~~future~~the ~~clinical~~change ~~study~~from baseline. ~~ReGenTree has~~For ~~not~~sign, ~~yet~~RGN-259 ~~determined~~also ifimproved itthe ~~will~~dry ~~use~~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 ~~new~~population, ~~formulation~~RGN-259 showed superiority over placebo in reducing corneal fluorescein staining in the ~~future~~change ~~for~~from NKbaseline 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.

InTopline ~~February 2017, our~~results ~~licensee~~from ~~for RGN~~ARISE-~~137,~~3 ~~GtreeBNT,~~were ~~through~~reported ~~its~~on ~~subsidiary~~March 18, ~~Lenus~~2021. Further ~~Therapeutics,~~statistical ~~LLC,~~analysis ~~received~~was ~~permission~~performed ~~from~~as part of the ~~FDA~~process to ~~sponsor a~~fully ~~Phase~~understand 3patient ~~clinical~~data ~~trial~~and ~~using~~the effects of RGN-~~137~~259 compared to ~~treat~~placebo by evaluating various subgroups of patients ~~with~~within ~~epidermolysis~~ARISE-3 ~~bullosa~~with ~~(“EB”),~~pooled adata ~~genetic~~from ~~disease~~all ~~that causes~~three ~~severe~~ARISE ~~blistering~~clinical oftrials. While the ~~skin~~trial ~~and~~failed ~~internal~~to ~~organs.~~meet Inits ~~August 2017~~co-primary sign and symptom endpoints, the ~~Company~~conclusions ~~amended~~from these expanded analyses were that the ~~agreement~~use ~~for~~of RGN-~~137~~259 ~~held by~~has ~~GtreeBNT.~~demonstrated ~~Under~~statistically ~~the~~significant ~~amendment~~and ~~the~~clinically ~~Territory~~relevant ~~was~~improvements ~~expanded~~in toboth ~~include~~signs ~~Europe~~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 ~~Canada~~patients, ~~South~~while ~~Korea,~~confirming ~~Australia~~its ~~and~~excellent ~~Japan~~safety profile. From Ina ~~December 2018~~regulatory perspective, ~~GtreeBNT~~ ~~initiated~~the aquestion ~~small~~is ~~Phase~~whether 2the ~~open~~combined ~~trial~~data infrom ~~patients~~these ~~with~~three EBtrials is sufficient to ~~evaluate~~file ~~RGN-137~~for a biologics license (BLA) for marketing approval in ~~such~~the ~~patients~~U.S. ReGenTree ~~prior~~has been working with outside FDA regulatory consulting firms to ~~sponsoring~~define aits ~~larger Phase~~regulatory 3strategy, ~~trial.~~based ~~Three~~on ~~patients~~these analyses, which have been ~~enrolled~~discussed inwith the ~~open~~FDA ~~clinical~~at ~~trial~~a topre-BLA ~~date~~meeting on February 28, 2022. The ItReGenTree ~~was~~team ~~reported~~previously submitted a 150 page pre-BLA dossier to the Agency in ~~August 2019,~~anticipation ~~that~~ of the ~~first~~meeting, ~~patient~~as ~~had~~well ~~positively~~as ~~responded~~a tonumber ~~RGN-137~~of questions. The AsFDA ofwill provide to ReGenTree minutes to the ~~date~~meeting ofby ~~this~~March ~~report~~28, ~~the~~2022. ~~Company~~When ~~has~~appropriate, ~~not~~RegeneRx ~~been~~will ~~updated~~provide asinformation toregarding ~~current enrollment~~any ~~status~~additional clinical work that may be required after further discussions with our counterparts at HLB Therapeutics.

~~Currently, we~~The ~~have~~NK ~~active~~trial ~~partnerships~~(SEER-1), ina ~~four~~smaller ~~major~~study ~~territories:~~in ~~North~~an ~~America,~~orphan ~~Europe~~population, ~~China~~enrolled ~~and~~a ~~Pan~~total ~~Asia.~~of ~~Our~~18 ~~partners have been moving forward and making progress in each territory~~patients. InOn ~~each~~May ~~case~~14, 2020, the ~~cost~~Company ofreported ~~development~~that isthe ~~being~~trial ~~borne~~was byclosed ~~our~~and ~~partners~~reported ~~with~~the noresults ~~financial obligation~~of ~~for the Company~~SEER-1. WeSix ~~still~~out ~~have~~of ~~significant~~10 ~~clinical~~patients ~~assets~~in tothe ~~develop, primarily~~ RGN-~~352~~259 ~~(injectable~~treated ~~formulation~~group ~~of Tß4~~and ~~for~~1 ~~cardiac~~out ~~and~~of ~~CNS~~8 ~~disorders)~~patients in the ~~U.S.,~~placebo ~~most~~treated ofgroup ~~Asia,~~achieved ~~and~~complete ~~Europe,~~corneal ~~and~~healing ~~RGN-259~~ in ~~the~~four EUweeks. In ~~August 2017~~terms weof ~~amended~~ the ~~RGN-137~~primary ~~license~~endpoint, ~~agreement~~“ratio ~~with~~of ~~GtreeBNT,~~corneal ~~expanding~~wound ~~the~~healed ~~territory~~patients toafter ~~include~~four ~~Europe,~~weeks' ~~Canada~~administration”, ~~South~~the ~~Korea,~~statistical ~~Australia~~difference ~~and~~was ~~Japan. Regarding~~slightly ~~RGN-259,~~over ~~our~~0.05 ~~goal~~(p is= to0.0656, ~~wait~~Fisher's ~~until~~exact ~~satisfactory~~test), ~~results~~due ~~are~~to ~~obtained from~~ the ~~current~~limited ~~ophthalmic~~number ~~clinical~~of ~~program~~patients in ~~the~~ Ueach group.S. ~~before~~When ~~moving~~another ~~into~~statistical ~~the~~analysis ~~EU.~~method ~~This~~was ~~should~~used ~~allow us~~ to ~~obtain~~analyze athe ~~higher~~same ~~value~~primary ~~for~~endpoint ~~the~~(Chi ~~asset~~square attest), ~~that~~there ~~time.~~was ~~However~~statistical significance, wep ~~intend to~~= ~~continue~~0.0400. toIn ~~develop~~addition, ~~RGN~~in a pre-~~352,~~specified ~~our~~secondary ~~injectable~~endpoint ~~systemic~~evaluating ~~product~~corneal ~~candidate~~epithelial ~~for~~healing ~~cardiac~~at ~~and~~day ~~central~~43 ~~nervous~~(two ~~system~~weeks ~~indications~~post-treatment) and ~~for~~ the ~~treatment~~durability of ~~severe~~RGN-259 ~~symptoms~~treatment, ~~resulting~~we ~~from~~also ~~COVID-19~~confirmed ~~infection~~a clear statistical difference using the Fisher's exact test, ~~either~~p by= ~~obtaining~~0.0359. ~~grants~~Several toother ~~fund~~efficacy aparameters ~~Phase~~were 2aeither ~~clinical trials~~highly significant or ~~finding~~strongly atrending ~~suitable~~toward ~~partner~~statistical ~~with~~significance in the ~~resources~~RGN-259 ~~and~~group ~~capabilities~~indicating tothe ~~develop~~depth itof aspatient weresponse ~~have~~to ~~with~~ 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.

InTable ~~March~~ of ~~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.Contents

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.

· 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.

·Table ~~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.Contents

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 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.

Table of Contents

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 of 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. InFor ~~addition~~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.

7In 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.

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. Patient enrollment and treatment has been completed and the patient database has been locked and topline results are expected shortly.

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 (Greater China)~~. In February 2019, the license was assigned by Lee’s to their affiliate, Zhaoke Ophthalmology Pharmaceutical Limited. Lee’s previously 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 2 dry eye clinical trial because the API was manufactured outside of China. The API was manufactured in the U.S. and provided to Lee's by RegeneRx pursuant to the agreement to develop RGN-259 ophthalmic eye drops in Greater China. However, in mid-2016, we were informed by Lee’s that the CFDA modified its manufacturing regulations and would now allow Chinese companies to utilize API manufactured outside of China for Phase 1 and 2 clinical trials. Recently, we have been in ongoing 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 believe Lee’s intends to await the outcome of the ARISE-3 DES trial prior to initiating clinical trials in China. Lee’s has assigned the license to its subsidiary Zhaoke Ophthalmology Pharmaceutical Limited for development of RGN-259 in China and is in the process of funding this development.

~~GtreeBNT.~~ We are a party to a license agreement with ~~GtreeBNT~~Lee’s Pharmaceutical for the license of ~~RGN-259~~Thymosin ~~related~~Beta to4 ~~certain~~in ~~development~~any ~~and commercialization~~pharmaceutical ~~rights~~form, ~~for~~including our RGN-259, inRGN-352 ~~Asia~~and ~~(excluding~~RGN-137 ~~Greater~~product candidates, in China)., ~~Separately~~Hong Kong, weMacau ~~licensed~~and ~~GtreeBNT~~Taiwan. ~~the~~In ~~rights~~February to2019, ~~RGN-137 which~~the ~~was~~License ~~recently~~Agreement ~~amended~~was asassigned ~~discussed~~by ~~above.~~Lee’s ~~GtreeBNT~~to isits ~~currently~~affiliate, ~~our~~Zhaoke ~~second~~Ophthalmology ~~largest~~Pharmaceutical ~~stockholder~~Limited. ~~GtreeBNT~~Prior to 2016, Lee’s filed an IND with the ~~Korean~~Chinese ~~Ministry~~FDA ~~of Food and Drug Safety~~ to conduct a Phase 2/3, ~~study~~randomized, double-masked, dose-response clinical trial with RGN-259 in ~~patients~~China ~~with~~for dry -eye syndrome ~~and in July 2015 received approval to conduct the trial~~. InLee's ~~late~~subsequently ~~2016 GtreeBNT~~ informed us that it ~~believes~~received ~~marketing~~notice ~~approval~~from ~~in the~~China's ~~U.S.~~FDA ~~will~~declining ~~allow~~its ~~expedited~~IND ~~marketing~~application infor ~~Korea,~~a ~~possibly~~Phase ~~without~~2b dry eye clinical trial because the ~~need~~API ~~for~~was amanufactured ~~clinical~~outside ~~trial~~of ~~and,~~China. ~~therefore,~~The ~~will~~API ~~await~~was ~~marketing approval~~manufactured in the U.S. and

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 (formerly a NDA) for dry eye syndrome in the U.S. In the event ReGenTree is acquired, or a change of control occurs following achievement of n 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 Practices (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 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 numerous 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.

~~Based~~Table ~~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 based on scientific data describe above.Contents

Inprovided ~~March of 2020,~~to Lee's by RegeneRx pursuant to a license agreement to develop RGN-259 ophthalmic eye drops in the ~~FDA~~licensed ~~changed~~territory. However, in mid-2016, we were informed by Lee’s that the ~~category~~CFDA ~~under~~modified ~~which~~its ~~thymosin~~manufacturing ~~beta~~regulations 4and ~~was~~will ~~regulated~~now allow Chinese companies to utilize API manufactured outside of China for Phase 1 and 2 clinical trials. ~~Prior~~Lee’s has assigned the license to ~~this~~its ~~change~~subsidiary Zhaoke Ophthalmology Pharmaceutical Limited for development of RGN-259 in China. On April 28, ~~Tβ4~~2021, ~~was~~Zhaoke ~~regulated~~Ophthalmology ascompleted ~~a new~~an ~~chemical~~initial ~~entity~~public offering, raising US$270 million for development of its ophthalmic products, including RGN-259 licensed from the Company. Zhaoke ~~Now~~has itestablished an advanced ophthalmic manufacturing facility and is ~~regulated~~assembling asan aexperienced ~~biologic~~marketing team. ~~Further~~RGN-259 ~~details~~is ~~regarding~~identified ~~this~~as ~~change~~one ~~the~~of ~~impact~~their onmain ~~the~~pipeline ~~Company~~drugs and ~~its work~~they are planning to ~~date~~submit isan ~~discussed~~IND ~~further~~to the NMPA (the Chinese FDA) in ~~this~~2022 ~~report~~and ~~(See~~initiate –a ~~“Government~~phase ~~Regulation”~~III ~~below)~~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. In February 2017, GtreeBNT, our licensee for RGN-137, 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. While the trial has been ongoing, due to the COVID-19 pandemic, it is unclear when enrollment will resume.

~~Clinical Development —~~Starting ~~Pressure~~in ~~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~~EB. ~~pressure~~EB ~~ulcers,~~is ~~commonly known~~a asgenetic ~~bedsores.In~~disease ~~January 2009,~~of weapproximately ~~reported~~10 ~~final~~gene ~~data~~mutations ~~from~~that ~~this~~results ~~trial~~in fragile skin and other epithelial structures (e.g., ~~RGN-137~~cornea ~~was~~and ~~well-tolerated~~GI tract) that can blister spontaneously or separate at ~~all~~the ~~three~~slightest ~~dose~~trauma ~~levels studied~~or friction, ~~with~~creating noa ~~dose-limiting~~wound ~~adverse~~that ~~events~~at times does not heal or heals poorly. In severe cases, ~~which~~recurrent ~~achieved~~blistering ~~the~~and ~~primary~~tissue ~~objective~~loss ofmay ~~the~~be ~~study~~life threatening. AEB ~~follow-on~~has ~~evaluation,~~been ~~reported at~~designated as an “orphan” indication by the ~~3rd~~FDA’s ~~International~~Office ~~Symposium~~of onOrphan Drugs. We closed the ~~Thymosins~~Phase 2 trial in ~~Health~~late 2011 and ~~Disease~~we submitted the final report to the FDA in ~~March 2012~~2014. Subsequently, ~~showed~~we ~~that~~licensed RGN-137 to GtreeBNT for ~~those~~development ~~pressure~~in ~~ulcer patients’~~the ~~wounds~~U.S. ~~that~~and ~~healed~~EU. In February 2017, GtreeBNT received permission from the U.S. FDA to sponsor a Phase 3 clinical trial using RGN-137 ~~mid~~to ~~dose~~treat (0patients with EB.~~02%~~ Recently, ~~Tβ4~~the ~~gel~~FDA ~~product)~~modified ~~accelerated~~efficacy requirements in EB patients from complete wound ~~closure~~closing ~~with~~to partial wound closing, which has had a ~~median~~positive ~~time to~~impact ~~healing~~on ofclinical 22trial ~~days~~design. Our aslicensee ~~compared~~initiated toa 57Phase ~~days~~2 ~~for~~open clinical trial on EB patients in the ~~placebo~~U.S. ~~Although~~in ~~those~~December ~~results~~2018, ~~were~~and ~~clinically~~3 ~~significant~~of 15 patients have been enrolled to date. Due to the COVID-19 pandemic, ~~they~~it ~~were~~is ~~not statistically~~unclear ~~significant~~when enrollment will resume.

Clinical Development — ~~Venous~~Pressure ~~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.

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 ~~continue~~have toretained ~~control~~ 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 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.

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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 ~~into~~ ~~the~~through ~~second quarter of 2021~~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 ~~note~~and ~~sales~~June 2021 private offerings will only be sufficient to fund our operations ~~into~~through ~~the second quarter of 2021~~2022. ~~Even~~We ~~though we sold the 2020 Notes in October 2020 for proceeds of $500,000, these proceeds are only projected to fund our operations at the current level into the second quarter of 2021; therefore, we~~ will need to secure additional operating capital to continue operations substantially beyond ~~the first quarter of 2021~~2022. We continuously monitor our cash use as well as the clinical timelines. We will need to secure additional operating capital inby early ~~2021~~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;

~~· 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;~~16

·Table ~~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~~Contents

·● the ~~successful~~time ~~commercialization~~required ofto ~~our product candidates~~prosecute, ~~which~~enforce ~~will~~and ~~depend~~defend on our, orintellectual ~~our~~property ~~partners’~~rights, ~~ability~~which todepends ~~either~~on ~~create~~evolving orlegal ~~partner~~regimes ~~with an effective commercialization organization~~ and ~~which~~infringement ~~could~~claims bethat ~~delayed~~may orarise ~~prevented~~between byus ~~the~~and ~~emergence~~third ~~of equal or more effective therapies.~~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, ~~2020~~2021, our accumulated deficit totaled approximately $~~109~~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, ~~2020~~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 ~~the~~securities ~~2020 Notes~~ in ~~October 2020~~June 2021 for proceeds of $~~500~~1,980,000, these proceeds are only projected to fund our operations at the current level ~~into~~through ~~the second quarter of 2021~~2022; therefore, we will need to secure additional operating capital to continue operations substantially beyond ~~the first quarter of 2021~~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.

Risks Related to Our Business and Operations

Public health threats could have an adverse effect on our clinical trials and financial results.

Public health threats could adversely affect our ongoing or planned business operations. In particular, the novel coronavirus (COVID-19) ~~has~~ 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 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.

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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;

· 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;19

·Table ~~clinical trial data is adversely affected by trial conduct or patient withdrawal prior to completion~~ of ~~the trial;~~Contents

·● ~~there~~suitable ~~may~~patients bedo ~~competition~~not ~~with~~enroll ~~ongoing~~in a clinical ~~trials~~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 ~~scheduling~~patients ~~conflicts~~regarding ~~with~~safety, ~~participating~~and ~~clinicians~~the availability of other treatment options;

·● ~~patients~~clinical ~~experience~~trial ~~serious~~data ~~adverse~~is ~~events,~~adversely ~~including~~affected ~~adverse~~by ~~side~~trial ~~effects~~conduct ~~of our drug candidates, for a variety of reasons that may~~ or ~~may~~patient ~~not~~withdrawal beprior ~~related~~ to ~~our~~completion ~~product~~of ~~candidates, including~~ the ~~advanced stage of their disease and other medical problems~~trial;

17● there may be competition with ongoing clinical trials and scheduling conflicts with participating clinicians;

·● patients inexperience ~~the~~serious ~~placebo~~adverse orevents, ~~untreated~~including ~~control~~adverse ~~group~~side ~~exhibit~~effects ~~greater~~of ~~than~~our ~~expected~~drug ~~improvements~~candidates, for a variety of reasons that may or ~~fewer~~may ~~than~~not ~~expected~~be ~~adverse~~related ~~events~~to our product candidates, including the advanced stage of their disease and other medical problems;

·● ~~third-party~~patients ~~clinical~~in ~~investigators do not perform~~ the ~~clinical~~placebo ~~trials on the anticipated schedule~~ or ~~consistent~~untreated ~~with~~control ~~the~~group ~~clinical~~exhibit ~~trial~~greater ~~protocol~~than ~~and~~expected ~~good~~improvements ~~clinical practices,~~ or ~~other~~fewer ~~third-party~~than ~~organizations~~expected doadverse ~~not perform data collection and analysis in a timely or accurate manner~~events;

·● ~~service~~third-party ~~providers,~~clinical ~~collaborators~~investigators ~~or co-sponsors~~ do not ~~adequately~~ perform ~~their~~the ~~obligations~~clinical intrials ~~relation~~on tothe anticipated schedule or consistent with the clinical trial protocol and good clinical practices, or ~~cause~~other ~~the~~third-party ~~trial~~organizations todo benot ~~delayed~~perform data collection and analysis in a timely or ~~terminated~~accurate manner;

·● weservice ~~are~~providers, ~~unable~~collaborators toor ~~obtain~~co-sponsors ado ~~sufficient~~not ~~supply~~adequately ofperform ~~manufactured~~their obligations in relation to the clinical trial ~~materials~~or cause the trial to be delayed or terminated;

·● ~~regulatory~~we ~~inspections~~are ofunable ~~manufacturing~~to ~~facilities,~~obtain ~~which may, among other things, require us or~~ a ~~co-sponsor~~sufficient tosupply ~~undertake~~of ~~corrective~~manufactured ~~action or suspend the~~ clinical ~~trials, such as the clinical hold with respect to our Phase 2 clinical~~ trial ~~of RGN-352~~materials;

·● regulatory inspections of manufacturing facilities, which may, among other things, require us or a co-sponsor to undertake corrective action or suspend the ~~interim~~clinical ~~results~~trials, ofsuch as the clinical ~~trial~~hold ~~are~~with ~~inconclusive~~respect orto ~~negative~~our Phase 2 clinical trial of RGN-352;

·● the ~~clinical~~interim ~~trial,~~results ~~although~~of ~~approved and completed, generates data that is not considered by~~ the ~~FDA~~clinical ortrial ~~others~~are toinconclusive ~~be clinically relevant~~ or ~~sufficient to demonstrate safety and efficacy~~negative; ~~and~~

·● ~~changes~~the inclinical ~~governmental~~trial, ~~regulations~~although orapproved ~~administrative~~and ~~actions~~completed, ~~affect~~generates ~~the~~data ~~conduct~~that ofis not considered by the ~~clinical~~FDA ~~trial~~or others to be clinically relevant or ~~the~~sufficient ~~interpretation~~to ofdemonstrate ~~its~~safety ~~results.~~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:

18● we or our partners do not achieve our objectives under our collaboration agreements;

·● we or our partners doare ~~not~~unable ~~achieve~~to ~~our~~obtain ~~objectives~~patent ~~under~~protection ~~our~~for ~~collaboration~~the ~~agreements~~products or proprietary technologies we develop in our partnerships;

·● we ~~or our partners~~ are unable to ~~obtain~~manage ~~patent~~multiple ~~protection~~simultaneous ~~for~~product ~~the~~development ~~products or proprietary technologies we develop in our~~ partnerships;

·● weour ~~are~~partners ~~unable~~become tocompetitors ~~manage~~of ~~multiple~~ours ~~simultaneous~~or ~~product~~enter ~~development~~into ~~partnerships~~agreements with our competitors;

·● we or our partners ~~become~~encounter ~~competitors~~regulatory ofhurdles ~~ours~~that orprevent ~~enter~~commercialization ~~into~~of ~~agreements with~~ our ~~competitors~~product candidates; or

·● we ordevelop ~~our~~products ~~partners~~and ~~encounter~~processes ~~regulatory~~or ~~hurdles~~enter into additional partnerships that ~~prevent~~conflict ~~commercialization~~with the business objectives of our ~~product~~other ~~candidates; or~~partners.

· 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 ~~they~~it ~~have~~has limited financial resources. ~~They~~It ~~have~~has to continuously raise capital to fund research, development, clinical trials, and operations. Therefore, ~~their~~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.

2023

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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 ~~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.

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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~~ 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 ~~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.~~

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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, ~~2020~~ through ~~March 1~~December 31, 2021, the closing price of our common stock has ranged from $0.1415 to $0.75, with an average daily trading volume of approximately 96118,000 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;

24● technological innovations by us or competitors;

·● ~~technological~~changes ~~innovations~~in bylaws usand orgovernment ~~competitors~~regulations both in the U.S. and overseas;

·● changes in ~~laws~~key ~~and~~personnel ~~government~~at ~~regulations~~our ~~both in the U.S. and overseas~~company;

·● ~~changes~~developments inconcerning ~~key~~proprietary ~~personnel~~rights, atincluding ~~our~~patents ~~company~~and litigation matters;

·● ~~developments~~public ~~concerning~~perception ~~proprietary~~relating ~~rights,~~to ~~including~~the ~~patents~~commercial ~~and~~value ~~litigation~~or ~~matters~~safety of any of our product candidates;

~~· public perception relating to the commercial value or safety of any of our product candidates;~~28

·Table ~~other issuances~~ of ~~our common stock, or securities convertible into or exercisable for our common stock, causing dilution;~~Contents

·● ~~anticipated~~other issuances of our common stock, or ~~unanticipated~~securities ~~changes~~convertible ininto or exercisable for our ~~financial~~common ~~performance~~stock, causing dilution;

·● ~~general~~anticipated ~~trends~~or ~~related~~unanticipated tochanges ~~the~~in ~~biopharmaceutical~~our ~~and~~financial ~~biotechnological industries~~performance; ~~and~~

·● general ~~conditions~~trends inrelated to the ~~stock~~biopharmaceutical ~~market.~~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 ~~48.2~~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 2625.24% of our outstanding common stock and GtreeBNT which owns approximately 1413.76% 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, ~~2020~~ 2021, there were outstanding options to purchase an aggregate of 1112,~~951~~376,250 shares of our common stock under our 2010 and 2018 incentive equity plans at exercise prices ranging from $0.1664 per share to $0.6416 per share and outstanding warrants to purchase 9 25,~~529~~287,~~288~~738 shares of our common stock at a weighted average exercise price of $0.2124 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 ~~shares of our capital stock in connection with collaborations or manufacturing arrangements or in connection with other financing efforts.~~

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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

Our common stock is quoted on the OTC Bulletin Board under the symbol “RGRX.” ~~Our~~ Quotations ~~common~~reported ~~stock~~by ~~last~~the ~~traded~~OTC atBulletin ~~$0.70~~Board onreflect ~~February 25~~inter-dealer prices, ~~2021~~without retail mark-up, mark-down or commission and may not represent actual transactions.

~~The~~We ~~following table~~have ~~sets~~never ~~forth~~declared ~~the~~or ~~high~~paid ~~and~~a ~~low~~cash ~~closing~~dividend ~~prices~~on ~~for~~ our common stock, asand ~~reported~~since byall ~~the~~of ~~OTC~~our ~~Bulletin~~funds ~~Board,~~are ~~for~~committed ~~the~~to ~~periods~~operations ~~indicated. The~~and ~~quotations~~clinical ~~reported~~research, bywe ~~the~~do ~~OTC~~not ~~Bulletin~~anticipate ~~Board~~that ~~reflect~~any ~~inter-dealer~~cash ~~prices,~~dividends ~~without~~will ~~retail~~be ~~mark-up,~~paid ~~mark-down~~on orour ~~commission and~~common ~~may~~stock ~~not~~in ~~represent~~the ~~actual~~foreseeable ~~transactions~~future.

	2020				2019
	High		Low		High		Low
First Quarter	$	0.30	$	0.14	$	0.35	$	0.10
Second Quarter	$	0.34	$	0.19	$	0.24	$	0.17
Third Quarter	$	0.70	$	0.28	$	0.18	$	0.13
Fourth Quarter	$	0.60	$	0.38	$	0.18	$	0.13

As of September 21, 2021, we had 4,037 holders of record of our common stock.

We have never declared or paid a cash dividend on our common stock and since all of our funds are committed to clinical research, we do not anticipate that any cash dividends will be paid on our common stock in the foreseeable future.

In October 2020, we sold the 2020 Notes. The sale of the 2020 Notes resulted in gross proceeds to the Company of $500,000. In January 2020, Sabby exercised their remaining warrants and the Company received proceeds of $241,911. At present, with the receipt of the sale proceeds from the closing on the 2020 Notes in October 2020, we have sufficient cash to fund planned operations into the second quarter of 2021.

InItem ~~February 27, 2019 we sold a series of convertible promissory notes to accredited investors including Essetifin S~~6.~~p.A.,~~ ~~our largest stockholder (the “2019 Notes”)~~Reserved. The sale of in the 2019 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 on May 13, 2019, after the Company provided notice of the enrollment of the first patent in the ARISE-3 clinical trial in patients with dry eye syndrome (“DES”) sponsored by ReGenTree. The 2019 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 January 2019, at note maturity, the holders of the January 2014 Notes elected to convert the note principal and accrued interest into shares of common stock. As a result, the Company issued 1,149,016 shares of common stock.

Item 6. Selected Financial Data.

Not Applicable.

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 Financial Circumstances

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 ~~will~~seeks to commercialize RGN-259 for treatment of dry eye syndrome (“DES”) and neurotrophic keratitis (“NK”), an orphan ~~ophthalmic~~ 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”). ~~Last~~In ~~year~~2020, itReGenTree completed a Phase 3 clinical trial in patients with ~~neurotrophic keratitis (“~~NK”) (“SEER-1”),. All ~~and is currently sponsoring a~~ Phase 3 ~~trial~~trials ~~(ARISE-3)~~were inconducted ~~patients with DES, both~~ 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. ~~pursuant a contract between the parties~~, 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. ReGenTree is proceeding with its RGN-259 development plan as discussed with the FDA in April 2018. ReGenTree and Ora, Inc. have entered into a contract for management of ARISE-3. The first patient was enrolled in the second quarter of 2019 and the last patient was enrolled in October 2020. Due to the COVID-19 pandemic, the completion of ARISE-3 was delayed from the original timeline but the patent treatment and follow-up was completed in November as ReGenTree previously reported in clinicaltrials.gov. As of the date of this filing, the patient database has been locked and topline results are expected shortly.

27Topline 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~~ 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.

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 GtreeBNT under the RGN-259 license agreement for Pan Asia.31

~~During~~Table ~~the past several years, ReGenTree, LLC 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. The Company 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.Contents

Inexact ~~February 2017~~test), ~~our~~ ~~licensee~~due ~~for~~to ~~RGN-137,~~the ~~GtreeBNT,~~limited ~~through~~number ~~its~~of ~~subsidiary,~~patients ~~Lenus~~in ~~Therapeutics,~~each ~~LLC,~~group. ~~received~~When ~~permission~~another ~~from~~statistical ~~the~~analysis ~~FDA~~method towas ~~sponsor a~~used ~~Phase 3 clinical trial using RGN-137~~ to ~~treat~~analyze ~~patients~~the ~~with~~same ~~epidermolysis~~primary ~~bullosa~~endpoint (~~“EB”~~Chi square test), athere ~~genetic~~was ~~disease~~statistical ~~that causes~~significance, ~~severe~~p ~~blistering~~= ~~of the skin and internal organs~~0.0400. In ~~August 2017~~addition, ~~the~~in ~~Company~~a ~~amended~~pre-specified ~~the~~secondary ~~agreement~~endpoint ~~for~~evaluating ~~RGN-137~~corneal ~~held by~~epithelial ~~GtreeBNT.~~healing ~~Under~~at ~~the~~day ~~amendment~~43 ~~the~~(two ~~Territory~~weeks ~~was~~post-treatment) ~~expanded~~and tothe ~~include~~durability ~~Europe,~~of ~~Canada,~~RGN-259 ~~South Korea~~treatment, ~~Australia~~we ~~and~~also ~~Japan.~~confirmed ~~In December 2018, GtreeBNT initiated~~ a ~~small~~clear ~~Phase~~statistical 2difference ~~open~~using ~~trial~~the inFisher’s ~~patients~~exact ~~with~~test, EBp to= ~~evaluate RGN-137 in such patients prior to sponsoring a larger Phase 3 trial~~0.0359. ~~Three~~Several ~~patients~~other ~~have~~efficacy ~~been~~parameters ~~enrolled~~were ineither ~~the~~highly ~~open~~significant ~~clinical~~or ~~trial~~strongly totrending ~~date.~~toward Itstatistical ~~was~~significance ~~reported~~ in ~~August 2019, that~~ the ~~first patient had positively responded to~~ RGN-~~137.~~259 Asgroup ofindicating the ~~date~~depth of ~~this~~patient ~~report,~~response ~~the Company has not been updated as~~ to ~~current enrollment status~~RGN-259.

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.

InOn ~~October 2020~~June 30, we ~~sold~~2021, ~~the~~we ~~2020~~closed ~~Notes.~~a ~~The~~private ~~sale~~placement of ~~the~~common ~~2020~~stock ~~Notes~~and ~~resulted~~warrants inwith ~~gross~~several ~~proceeds~~institutional toand ~~the~~accredited ~~Company of $500~~investors,~~000.~~ Inincluding ~~January 2020, Sabby~~members ~~exercised~~of ~~their~~management ~~remaining warrants~~ and the ~~Company~~board, and received gross proceeds of $~~241~~1,~~911~~980,000. In AtOctober ~~present~~2020, ~~with~~we sold the ~~receipt~~2020 ofNotes. ~~the~~The sale ~~proceeds~~ ~~from~~of the ~~closing~~2020 onNotes resulted in gross proceeds to the ~~2020~~Company ~~Notes~~of in$500,000. ~~October 2020~~At present, we believe that we have sufficient cash to fund planned operations ~~into~~through the ~~second quarter~~end of ~~2021~~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.

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.32

28Table of Contents

GR&~~A costs~~D ~~include~~expenditures ~~outside~~are ~~professional~~subject ~~fees~~to ~~for~~the ~~legal,~~risks ~~business development, audit~~ and ~~accounting~~uncertainties ~~services.~~associated ~~G&A~~with ~~also~~clinical ~~includes~~trials ~~cash~~ and ~~non-cash~~the ~~compensation,~~FDA ~~travel~~review and ~~other~~approval ~~miscellaneous~~process. ~~costs~~As ofa ~~our internal G&A personnel~~result, ~~two~~these inexpenses ~~total,~~could ~~who~~exceed ~~are wholly dedicated to G&A efforts. G&A also includes a proration of~~ our ~~common~~expectations, ~~infrastructure~~possibly ~~costs for office space and communications~~materially. ~~Our~~ ~~G&A~~We ~~expenses~~are ~~also~~uncertain ~~include~~as ~~costs~~ to ~~maintain~~what ~~our intellectual property portfolio. Historically~~ we ~~have~~will ~~expanded~~incur ~~our~~in ~~patent prosecution~~future ~~activities,~~research and indevelopment ~~some~~costs ~~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~~clinical ~~applications in the United States~~studies, ~~Europe~~as ~~and other~~these ~~countries~~amounts ~~with~~are ~~the~~subject ~~advice of outside legal counsel~~ to, ~~determine~~management’s ifcontinuing ~~they~~assessment ~~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~~economics of ~~our~~each ~~intellectual~~individual ~~property~~research ~~portfolio,~~and wedevelopment ~~have~~project and ~~will~~the ~~continue~~internal tocompetition ~~abandon~~for ~~these~~project ~~patent applications in order to reduce our costs of continued prosecution or maintenance~~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.

If the Company cannot reasonably estimate when our performance obligation either ceases or becomes inconsequential and perfunctory, 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.

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:

	December 31
	2020		2019
Unearned revenue	$	2,101,325	$	2,178,086

The contract liabilities amounts disclosed above as of December 31, 2020 and 2019, 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~~The contract liabilities amount disclosed above are primarily related to revenue being recognized on a straight-~~based payment~~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, ~~2020~~2021 and ~~2019~~2020

Revenues. For ~~the year ended December 31~~2021, ~~2020,~~ we recorded revenue in the amount of approximately $77,000 versus $77,000 recorded for ~~the~~ ~~year ended December 31, 2019~~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 ~~the year ended December 31~~2021, ~~2020,~~ our R&D expenditures ~~decreased~~increased by $602,000, or 9240%, to $57,000, from approximately $655,000 in ~~2019~~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 ~~decrease~~2021 inincrease ~~2020~~relates ~~results~~to ~~from~~ the ~~classification~~ retesting of ~~stock~~Tß4 ~~option~~API ~~compensation~~by ~~expense~~our incontract ~~G&A to more accurately reflect the Company’s current operations versus 2019~~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 ~~the year ended December 31~~2021, ~~2020,~~ our G&A expenses increased by approximately $9333,000, or 72%, to $1,~~366~~399,000 from $1,~~274~~366,000 in ~~2019~~2020. Increases are reflected in ~~2020~~2021 expenses for ~~personnel and~~stock ~~related~~option compensation expense (increase of $3966,000), facility and ~~stock~~related ~~option compensation expense~~ (increase of $~~125~~1,000) ,and ~~These~~investor ~~increases~~relations ~~were partially~~related ~~offset~~expenses byincluding ~~decreases~~SEC infiling ~~professional~~compliance ~~fees~~costs ~~(decrease~~and ofa ~~$7,000),~~virtual ~~insurance~~annual ~~(decrease~~shareholders ofmeeting ~~$13,000), sponsorship~~ (~~decrease~~increase of $555,000),. ~~travel~~These ~~(decrease~~increases ofwere ~~$9,000),~~partially ~~investor~~offset ~~relations~~by ~~(decrease~~decreases ofin ~~$25,000),~~personnel ~~facility~~ and related fees and expenses (decrease of $417,000), ~~license~~professional fees (decrease of $213,000) and ~~other~~insurance (decrease of $659,000). We believe that our G&A expenses will remain at current levels as we wait for ~~data~~FDA feedback from the ~~upcoming~~recent ~~clinical~~data ~~trials~~submission ~~being~~completed ~~conducted~~ by ~~our~~ 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 $~~232~~324,~~631~~878 for ~~the~~2021 ~~year ended December 31, 2020~~ versus $~~153~~232,~~410~~631 for ~~the year ended December 31, 2019~~2020. The increase reflects the ~~2019 Notes being outstanding for the full year as well as the~~ issuance of the 2020 Notes in October 2020.

Net Loss. Our statement of operations reflects a net loss of $1,~~523~~597,~~368~~755 for ~~the~~2021 ~~year~~versus ~~ended~~a ~~December 31, 2020 versus~~ net loss of $1,~~404~~523,~~247~~368 for ~~the year ended December 31, 2019~~2020. Losses from operations ~~increased~~ in ~~2020~~2021 ~~versus~~of ~~2019,~~ $1,~~294~~328,~~543 and~~511 increased from the losses in 2020 of $1,~~261~~294,~~881, respectively~~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 ~~addition~~this light, we have primarily financed our operations through the ~~equity or~~ issuance of equity or debt, including the sale of a series of convertible promissory notes through private placements with accredited investors, ~~and~~ the March and August 2014 private placements of common stock with GtreeBNT, asthe ~~well~~October as2020 ~~our~~sale ~~entry~~of ~~into~~$500,000 of the ~~ReGenTree~~2020 ~~joint~~Notes ~~venture~~and inthe ~~early~~June ~~2015.~~2021 ~~The~~private ~~report~~placement of ~~our~~$1,980,000 ~~independent~~of ~~registered public~~common ~~accounting~~stock ~~firm~~and ~~regarding~~warrants ~~our~~with ~~financial~~several ~~statements~~institutional ~~for~~and ~~the~~accredited ~~year ended December 31~~investors, ~~2020~~including ~~contains~~members anof ~~explanatory~~management ~~paragraph regarding~~and ~~our~~the ~~ability~~board. We toalso ~~continue~~saved asadditional acash ~~going~~outlays ~~concern~~by ~~based~~entering ~~upon~~into ~~our~~the ~~history~~ReGenTree ofjoint ~~operating~~venture ~~losses and dependence on future financing~~ in ~~order~~early ~~to meet our planned operating activities~~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.

~~Our~~We ~~statement of~~may ~~operations~~also ~~reflects~~receive afunds ~~net~~from ~~loss~~grants ofor ~~$1,523,368 for~~ the ~~year~~raising ~~ended December 31, 2020. We had cash and cash equivalents~~ of ~~$427,898~~ atadditional ~~December 31,~~capital ~~2020.~~through ~~In October 2020, we sold~~ the ~~2020~~sale ~~Notes, resulting in gross proceeds to the Company~~ of ~~$500,000.~~ Incommon ~~January 2020~~stock, ~~Sabby~~warrants ~~exercised~~or ~~their~~a ~~remaining~~convertible ~~warrants~~instrument ~~and~~if the ~~Company~~market ~~received~~climate ~~proceeds of $241,911~~warrants. ~~At present~~Additionally, ~~with~~ ~~the~~we ~~receipt~~intend ofto ~~the~~continue ~~sale~~to ~~proceeds~~pursue ~~from~~additional ~~the~~partnering ~~closing~~activities, onparticularly ~~the~~for ~~2020 Notes in October 2020~~RGN-352, weour ~~have~~injectable ~~sufficient~~systemic ~~cash~~product tocandidate ~~fund planned~~for ~~operations~~cardiac ~~into~~and ~~the~~central ~~second~~nervous ~~quarter~~system ~~of 2021~~indications.

WeNet ~~may~~Cash ~~also receive~~Used ~~funds~~in ~~from~~Operating ~~grants, new partnerships or the raising of additional capital if the market climate warrants~~Activities. ~~Additionally, we~~Net ~~intend~~cash toused ~~continue~~in tooperating ~~pursue~~activities ~~additional~~was ~~partnering~~approximately ~~activities~~$990,000 ~~particularly~~and ~~for RGN-352~~$1,007,000 ~~our injectable systemic product candidate~~ for ~~cardiac~~2021 and ~~central~~2020, ~~nervous system indications~~respectively. ~~This~~The ~~estimate~~decrease ~~also~~in ~~does~~2021 ~~not~~reflects ~~include~~an ~~receipt~~increase ofin ~~any~~non-cash ~~funds~~expenses ~~from~~related ~~grants,~~to ~~new~~stock ~~partnerships or~~option ~~the~~expense ~~raising~~and ofincreased ~~additional~~interest ~~capital~~accrual ifat ~~the~~December ~~market~~31, ~~climate warrants~~2021. ~~A sale of common stock and warrants~~ Additionally, ~~a convertible instrument or additional partnering of licensed rights are possible sources of operating capital~~ in ~~the future. Additionally~~2021, we ~~intend~~recognized ~~to continue~~a to$55,400 ~~pursue~~gain ~~additional~~related ~~partnering~~to ~~activities,~~the ~~particularly~~forgiveness ~~for~~of ~~RGN-352,~~ our ~~injectable~~SBA ~~systemic~~PPP ~~product~~loan ~~candidate~~in ~~for~~July ~~cardiac and central nervous system indications~~2021.

Net Cash Used in ~~Operating~~Investing Activities. ~~Net~~We ~~cash~~did ~~used~~not inuse ~~operating~~any ~~activities~~cash ~~was $1,007,000 and $1,138,000~~ for ~~the~~investing ~~years ended~~activities ~~December 31, 2020 and 2019, respectively. The decrease is 2020 reflects an increase~~ in ~~accrued~~2021 ~~expenses~~or ~~on the~~ 2020 ~~balance sheet~~.

~~Net Cash Used in Investing Activities. We did not use any cash for investing activities in 2020 or 2019.~~35

~~Net Cash~~Table Provided by Financing Activities. Net cash provided by financing activities totaled $795,000 and $1,541,000 for the years ended December 31, 2020 and 2019, respectively. In 2020, the cash provided by financing activities consisted of ~~the~~ proceeds from the sale of the 2020 Notes of $500,000 and $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 $55,000, while in 2019 the cash provided by financing activities consisted of the proceeds from the sale of the 2019 Notes of $1,300,000 and $241,000 from the exercise of warrants.Contents

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. ~~Our~~ ~~partners have been moving forward and making progress in each territory.~~ 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~~, ARISE-3, ReGenTree’s Phase 3 trial, was initiated and the first patient was enrolled in the second quarter of 2019 and enrollment was completed in November 2020~~. ~~Top line data from ARISE-3 is expected shortly.~~

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 ~~the~~possitive results are obtained from the current ophthalmic clinical ~~trials~~program before moving into the EU with RGN-259. If successful, we believe this should allow us to obtain a higher value for the ~~clinical~~ 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.

~~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; and

32· the progress of our research activities;

· the ~~costs~~number ofand ~~establishing~~scope ~~manufacturing,~~of ~~sales~~our ~~and~~research ~~distribution capabilities.~~programs;

~~Moreover, the~~· ~~duration and~~ the ~~cost~~progress of ~~clinical~~our ~~trials~~preclinical ~~may~~development ~~vary significantly over the life of a project as a result of differences arising during the clinical trial protocol, including, among others, the following:~~activities;

· the ~~number~~costs ofinvolved ~~patients that ultimately participate~~ in ~~the~~preparing, ~~trial;~~filing, ·prosecuting, ~~the~~maintaining, ~~duration~~enforcing ofand ~~patient~~defending ~~follow-up~~patent ~~that seems appropriate in view of the results; · the number of clinical sites included in the trials;~~ and ·other ~~the~~intellectual ~~length~~property ~~of time required to enroll suitable patient subjects.~~claims;

~~Also,~~· ~~we test~~the ~~our~~costs ~~product~~related ~~candidates in numerous preclinical studies~~ to ~~identify~~development ~~indications~~and ~~for~~manufacture ~~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~~preclinical, weclinical ~~may elect~~and tovalidation ~~discontinue~~lots ~~clinical trials~~ for ~~certain~~regulatory ~~product~~purposes ~~candidates~~and orcommercialization ~~for~~of ~~certain~~drug ~~indications~~supply inassociated ~~order~~with ~~to focus~~ our ~~resources on more promising~~ product candidates ~~or indications.~~;

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 ~~June of~~February 2016, we raised $1,520,000 by selling 5,147,059 shares of common stock and warrants to purchase 5,147,059 shares of common stock to Sabby. On March 2, 2018, we entered into a warrant reprice and exercise and issuance agreement with Sabby, which, in consideration of the holders exercising in full all of the 2016 Offering warrants the exercise price per share of the warrants was reduced to $0.20 per share. In addition, and as further consideration, we issued to the holders of the 2016 Offering warrants 3,860,294 new warrants with an exercise price of $0.2301 per share. Pursuant to the terms of the Reprice Agreement the exercise price of the new warrants will be reduced from $0.2301 to $0.125 as a result of the sale of the 2019 ~~Notes. We received gross proceeds of approximately $1~~,~~000,000~~ ~~pursuant the exercise and issued 5,147,059 of common stock. 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 on in 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 notes contain a $0.12 conversion price and are initially convertible into 10,833,333 ~~chares off~~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 ~~their~~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. At present, with the receipt of the sale proceeds from the closing on the 2020 Notes and proceeds from the January 2020 warrant exercises, we will have sufficient cash to fund planned operations into the second quarter of 2021.

WeIn ~~continuously monitor~~October ~~our~~2020, ~~cash~~we ~~use~~sold asthe ~~well~~2020 asNotes resulting in gross proceeds to the ~~clinical~~Company ~~timelines~~of $500,000. WeThe ~~continue~~2020 toNotes ~~evaluate~~were ~~options~~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 ~~licensing~~board, and received gross proceeds of ~~additional~~$1,980,000. ~~rights~~ Pursuant to ~~commercialize~~the ~~our~~terms ~~clinical~~of ~~products~~this aspurchase ~~well~~agreement, asthe ~~raising~~Company ~~capital~~sold ~~through~~an ~~the~~aggregate ~~capital~~of ~~markets~~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.

WeWith ~~have various~~the ~~strategic~~receipt ~~agreements~~of ~~and~~the ~~license~~proceeds ~~agreements~~from ~~with:~~the ~~GtreeBNT,~~closing ~~ReGenTree~~of ~~and~~the ~~Lee’s.~~2021 ~~These~~Private ~~license~~Placement, ~~agreements~~we ~~provide for~~expect ~~the~~to ~~opportunity~~have ~~for~~sufficient uscash to ~~receive~~fund ~~milestone~~our ~~payments~~planned ~~upon~~operations ~~specified~~through ~~commercial~~the ~~events~~end ~~and~~of ~~royalty~~2022. ~~payments~~We incontinuously ~~connection~~monitor ~~with any~~our ~~commercial~~cash ~~sales~~use ofas ~~the~~well ~~licensed~~as ~~products in~~ the ~~respective~~clinical ~~territories~~timelines. ~~However,~~We ~~there~~continue ~~are~~to noevaluate ~~assurances~~options ~~that~~including wethe ~~will~~licensing beof ~~able to~~additional ~~attain~~rights ~~any~~to ~~such~~commercialize ~~milestones~~our orclinical ~~generate~~products ~~any~~as ~~such~~well ~~royalty~~as ~~payments~~raising ~~under~~capital through the ~~agreements~~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 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.

3337

WeTable 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 their affiliate, Zhaoke Ophthalmology Pharmaceutical Limited. There were no economic changes to the agreement.Contents

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.

~~Off-Balance Sheet Arrangements~~

We do not have any off-balance sheet arrangements, as such term is defined in Item 303(a)(4) of Regulation S-K.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

~~Not~~Interest ~~applicable.~~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.

34We 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.

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, 2020 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, 2020.

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.

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, 2020.39

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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, ~~2020~~2021.

Item 9B. Other Information.

None.

35Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

~~PART III~~Not applicable.

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PART III

Item 10. Directors, Executive Officers and Corporate Governance.

Executive Officers and Directors

The following table sets forth as of March 1, ~~2020~~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	Age	Position
Executive Officers:
Mr. J.J. Finkelstein	69	President, Chief Executive Officer and Director
Directors:
Dr. Allan L. Goldstein	83	Founder, Chairman of the Board and Chief Scientific Officer
Mr. R. Don Elsey	67	Director
Mr. Joseph C. McNay	87	Director
Mr. Mauro Bove	65	Director
Dr. Alessandro Noseda	62	Director


Name	Age	Position
Executive Officers
Mr. J.J. Finkelstein	69	President, Chief Executive Officer and Director
Directors
Dr. Allan L. Goldstein	84	Founder, Chairman of the Board and Chief Scientific Officer
Mr. R. Don Elsey	67	Director
Mr. Joseph C. McNay	88	Director
Mr. Mauro Bove	67	Director
Dr. Alessandro Noseda	63	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 ~~committee~~Board believes to be particularly important as we continue our Tß4 development efforts.

3641

~~Mr. Elsey has~~Table ~~served as a member~~ of our Board of Directors since September 2010. Currently Mr. Elsey serves as CFO of Lyra Therapeutics, a private company pioneering a new therapeutic approach to treat debilitating ear, nose and throat diseases. 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.Contents

Mr. ~~McNay~~ Elsey has served as a member of our Board of Directors since ~~2002~~September 2010. HeCurrently, isMr. Elsey ~~currently~~serves ~~Chairman,~~as ~~Chief~~an ~~Investment~~advisor ~~Officer~~to ~~and~~the ~~Managing~~CEO ~~Principal~~ of ~~Essex~~Lyra ~~Investment~~Therapeutics, ~~Management~~a ~~Company,~~private ~~LLC,~~company ~~positions~~pioneering hea ~~has~~new ~~held~~therapeutic ~~since~~approach ~~1976~~to ~~when~~treat hedebilitating ~~founded~~ear, ~~Essex.~~nose Heand ~~has~~throat ~~direct~~diseases. ~~portfolio~~Mr. ~~management responsibilities~~Elsey ~~for~~was athe ~~variety~~CFO of ~~funds~~Lyra ~~and~~until onhis ~~behalf~~retirement ofin ~~private~~December ~~clients~~2020. HePreviously, isMr. Elsey ~~also~~served aas ~~member~~CFO of ~~the~~Senseonics, Inc., ~~firm’s~~from ~~Management~~February 2015 ~~Board~~to February 2019, a medical device company focused on continuous glucose monitoring. ~~Prior~~ toFrom ~~founding~~May 2014 ~~Essex~~until February 2015, Mr. ~~McNay~~Elsey ~~was~~served ~~Executive~~as ~~Vice~~chief ~~President~~financial ~~and~~officer ~~Director~~ of ~~Endowment~~Regado ~~Management &~~Biosciences, ~~Research~~a ~~Corp. from~~public, ~~1967~~late-stage clinical development biopharmaceutical company. ~~Prior~~From December 2012 to ~~that~~February 2014, Mr. ~~McNay~~Elsey ~~was~~served ~~Vice~~as ~~President~~chief ~~and~~financial ~~Senior~~officer ~~Portfolio~~of ~~Manager~~LifeCell, Inc., ata ~~the~~privately ~~Massachusetts~~held ~~Company~~regenerative medicine company. ~~Currently~~ From June 2005 to December 2012, he isserved ~~serving~~in numerous finance capacities, most recently as ~~Trustee~~senior ofvice ~~the~~president ~~Dana~~and ~~Farber~~chief ~~Cancer~~financial ~~Institute~~officer, ~~member~~at ofEmergent BioSolutions Inc., a publicly held biopharmaceutical company. He served as the ~~Children’s~~director ~~Hospital~~of ~~Investment~~finance ~~Committee~~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. ~~McNay~~ Elsey served as director of finance at Applera, a ~~Trustee~~genomics ~~for~~and ~~Brigham~~sequencing company, and ~~Women’s~~in ~~Physicians~~several ~~Organization~~finance ~~from~~positions ~~2000~~at –International ~~2018~~Business Machines, Inc. He received ~~his~~an AM.B.A. ~~degree~~in ~~from Yale~~finance ~~University~~ and ~~his~~a M.B.A. ~~degree~~ in ~~finance~~economics from ~~the~~Michigan ~~Wharton~~State ~~School~~University. ofMr. Elsey ~~the~~is ~~University~~a ofcertified ~~Pennsylvania~~management accountant. The Board believes that Mr. ~~McNay~~Elsey’s ~~extensive~~experience as chief financial ~~experience~~officer of a public company is particularly valuable to our business ~~and~~in ~~also~~that it positions him to contribute to ~~the~~ our board’s and audit committee’s understanding of financial matters.

Mr. ~~Bove~~ McNay has served as a member of our Board of Directors since ~~2004~~2002. ~~and~~He ~~has~~is ~~more~~currently ~~than~~Chairman, 30Chief ~~years~~Investment ofOfficer ~~business~~ and ~~management~~Managing ~~experience within~~Principal ~~the~~of ~~pharmaceutical~~Essex ~~industry.~~Investment ~~Mr. Bove~~Management isCompany, ~~currently~~LLC, ~~based~~positions inhe ~~Hong~~has ~~Kong~~held ~~and~~since in1976 ~~Europe,~~when ~~serving~~he asfounded aEssex. ~~consultant~~He tohas ~~emerging pharmaceutical~~direct ~~companies~~portfolio ~~worldwide.~~management ~~Previously,~~responsibilities ~~Mr. Bove led~~ for ~~more~~a ~~than~~variety 20of ~~years~~funds ~~the~~and ~~Corporate &~~on ~~Business~~behalf ~~Development~~ of ~~Sigma-Tau~~private ~~Finanziaria S~~clients.~~p.A.,~~ ~~formerly~~He ~~the~~is ~~holding~~also ~~company~~a member of ~~Sigma-Tau~~the ~~Group,~~firm’s aManagement ~~leading~~Board. ~~international~~Prior ~~pharmaceutical~~to ~~company (Sigma-Tau~~founding ~~Finanziaria~~Essex, SMr.~~p.A.~~ McNay -was ~~now~~Executive ~~Essetifin~~Vice ~~S.p.A.~~President - and ~~its~~Director ~~affiliates~~of ~~are~~Endowment ~~collectively~~Management & ~~our~~Research ~~largest~~Corp. ~~stockholder)~~from 1967. Prior to that, Mr. ~~Bove, who~~McNay ~~resigned~~was ~~this~~Vice ~~role~~President ~~with~~and ~~Sigma-Tau~~Senior onPortfolio ~~March 31,~~Manager ~~2014,~~at ~~has~~the ~~also~~Massachusetts ~~held~~Company. Currently he is serving as a ~~number~~Trustee of ~~senior~~the ~~positions~~Dana inFarber ~~business,~~Cancer ~~licensing~~ Institute and ~~corporate~~as ~~development~~a ~~within~~member ~~Sigma-Tau~~of ~~Group~~the Children’s Hospital Investment Committee. Mr. ~~Bove~~McNay ~~obtained~~served ~~his~~a ~~law~~Trustee ~~degree~~for atBrigham ~~the~~and ~~University~~Women’s ofPhysicians ~~Parma,~~Organization from 2000 ~~Italy, in~~to ~~1980~~2018. InHe ~~1985,~~received hehis ~~attended~~A.B. ~~the~~degree ~~Academy~~from ofYale ~~American~~University and ~~International~~his ~~Laws~~M.B.A. atdegree in finance from the ~~International~~Wharton ~~and~~School ~~Comparative~~of ~~Law~~the ~~Center,~~University ~~Dallas, Texas~~of Pennsylvania. The Board believes that Mr. ~~Bove~~McNay’s extensive ~~business~~financial ~~and~~experience ~~management~~is ~~experience~~valuable ~~within~~to ~~the~~our ~~pharmaceutical~~business ~~industry allows~~and also positions him to ~~recognize~~contribute ~~and~~to ~~advise~~ the ~~Board~~audit ~~with~~committee’s ~~respect~~understanding toof ~~recent~~financial ~~industry developments~~matters.

DrMr. ~~Noseda is~~Bove ~~the~~has ~~Chief~~served ~~Scientific~~as ~~Officer~~a ~~(CSO)~~member of ~~Leadiant~~our ~~Biosciences~~Board ~~S.p.A.~~of ~~and~~Directors ~~provides~~since ~~scientific~~2004 and ~~medical~~has ~~know-how~~more tothan ~~coordinate and~~30 years ~~manage~~of ~~the~~business ~~scientific~~ and ~~development~~management ~~programs~~experience atwithin ~~a global level as well as to evaluate new opportunities for~~ the ~~Leadiant Group~~pharmaceutical industry. ~~Since September~~Mr. ~~2018~~Bove he is ~~also~~currently ~~Chief~~based ~~Medical~~in ~~Officer~~Hong ofKong ~~Leadiant~~and ~~Biosciences~~in Europe, ~~Inc.~~ ~~After~~serving ~~graduating~~ as a ~~Medical Doctor~~consultant into ~~1984~~emerging atpharmaceutical ~~the~~companies ~~University~~worldwide. ~~of Milan and following a Post Doctorate at Bowman Gray School of medicine (USA)~~Previously, heMr. Bove ~~joined~~led ~~the pharma~~for ~~industry~~more inthan ~~1988~~20 years ~~where he held different managerial positions within~~ the RCorporate &D ~~and~~Business ~~Marketing~~Development ~~organizations~~ of ~~multinational companies.~~Sigma-Tau HeFinanziaria ~~has~~S.p.A., ~~acquired~~formerly athe ~~significant~~holding ~~experience~~company inof ~~R&D~~Sigma-Tau ~~(through the whole development process~~Group, ~~from~~a ~~research~~leading tointernational ~~interaction with~~pharmaceutical ~~Health~~company ~~Authorities for MA submission or HTA assessment) and strategic/business operations. He joined sigma~~(Sigma-~~tau~~Tau inFinanziaria ~~1998 as Director of Scientific Office and Strategic Alliances within the Corporate R&D organization~~S. ~~In this position he managed key R&D projects and contributed to the finalization of important partnerships (e~~p.gA., — ~~with~~now ~~Novartis,~~Essetifin ~~Debiopharm etc~~S.)p.A. — and toits ~~the advancement~~affiliates ofare ~~product~~collectively ~~development~~our ~~(from~~largest ~~research to product registration~~stockholder). HeMr. Bove, ~~has~~who ~~been~~resigned ~~part~~this ofrole ~~the~~with ~~management Team and Board of Directors of biotech companies of the sigma~~Sigma-~~tau~~Tau ~~Group~~on March 31, ~~as Thule Therapeutics~~2014, ~~Metheresis Translational Research and Rostaquo. He~~ has also ~~been~~held ~~Chief~~a ~~Executive~~number ~~Officer~~ of ~~Leadiant~~senior ~~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~~business, ~~(1988-2014)~~licensing and ~~later~~corporate indevelopment ~~Leadiant~~within ~~where he acted as Chief Medical Officer (2014~~Sigma-~~2017)~~Tau ~~before~~Group. ~~becoming the CSO~~Mr. Bove ~~Under~~obtained his ~~management~~law ~~this~~degree ~~company~~at ~~developed~~the ~~and~~University ~~advanced~~of ~~a proprietary technology~~Parma, ~~and~~ Italy, hein ~~guided~~1980. ~~the~~In ~~Company~~1985, ~~through~~he ~~the~~attended ~~process to obtain~~ the ~~authorization~~Academy byof ~~the~~American ~~Swiss Health Authorities to import~~ and ~~release medicinal~~International ~~products,~~Law asat ~~well as~~ the ~~Orpha~~International ~~Drug Designations~~ and ~~registration~~Comparative ofLaw ~~new~~Center, ~~products~~Dallas, (eTexas.~~g.,~~ ~~Chenodeoxycholic~~The ~~Acid~~Board orbelieves ~~CDCA)~~that Mr. He Bove’s ~~worked~~extensive inbusiness ~~several~~and ~~therapeutic~~management ~~(and~~experience ~~diagnostic)~~within ~~areas,~~the ~~but~~pharmaceutical ~~mostly~~industry inallows ~~high~~him ~~unmet~~to ~~medical~~recognize ~~need~~and ~~specialty~~advise ~~areas~~the asBoard ~~cancer,~~with ~~immune-oncology and~~respect ~~rare~~to ~~diseases~~recent industry developments.

37Dr. 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, ~~2020~~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~~ Board of ~~directors~~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~~ Board of ~~directors~~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, ~~2020~~2021 and ~~2019~~2020, compensation awarded to or paid to, or earned by, our chief executive officer who was our only named executive ~~officers~~officer for fiscal ~~2020~~2021. For purposes of this report, we sometimes refer to our chief executive officer as our named executive officer.

										Option		All Other

				Salary(1)			Bonus			Awards(2)		Compensation(3)		Total
						Option	All Other
Name and Principal Position	Year			($)			($)			($)		($)		($)
			Salary(1)	Bonus		Awards(2)	Compensation(3)		Total
J.J. Finkelstein, President and		2020			80,018			--			95,606		3,360		178,984
Name and Principal Position	Year		($)	($)		($)	($)		($)
Chief Executive Officer		2019			81,528			--			103,523		3,360		188,411
J.J. Finkelstein, President and	2021		80,018	--		120,624	3,360		204,002
Chief Executive Officer	2020		80,018	--		95,606	3,360		178,984

(1)		Mr. Finkelstein reduced his 2020 salary to $80,000 and he had previously reduced his 2018 salary from $150,000 to $125,000 in March 2018.
(2)		The 2020 and 2019 amounts reflect the aggregate total grant date fair values (computed in accordance with FASB ASC Topic 718 or ASC Topic 505).
(3)		The 2020 and 2019 amounts reflect payment of life insurance premiums for Mr. Finkelstein in the amount of $3,360

(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.

38(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 ~~has~~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 ~~2020~~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.

Table of Contents

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.

	Number of Shares Underlying Unexercised Options (#)		Number of Shares Underlying Unexercised Options (#)		Option Exercise Price		Option
Name	Exercisable		Unexercisable		($)		Expiration Date		Note
Mr. Finkelstein		125,000		375,000		0.30		6/10/2030		(1)
		325,000		325,000		0.21		5/15/2029		(1)
		200,000		—		0.64		3/17/2023
		187,500		62,500		0.21		7/16/2028		(1)
		500,000		—		0.21		3/25/2021
		500,000		—		0.36		6/30/2022
		150,000		—		0.28		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.


	Number of	Number of
	Shares Underlying	Shares Underlying	Option
	Unexercised Options	Unexercised Options	Exercise Price	Option
Name	(#) Exercisable	(#) Unexercisable	($)	Expiration Date	Note
Mr. Finkelstein	250,000	250,000	0.30	6/10/2030	(1)
	487,500	162,500	0.21	5/15/2029	(1)
	200,000	—	0.64	3/17/2023
	250,000	—	0.21	7/16/2028	(1)
	150,000	450,000	0.28	8/02/2031	(1)
	500,000	—	0.36	6/30/2022
	150,000	—	0.28	9/1/2027	(1)

39(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 ~~2020~~2021 or ~~2019~~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, ~~2020~~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~~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 ~~2020~~2021 or ~~2019~~2020.

In ~~2020~~ 2021, each independent director was granted options to purchase either ~~200~~240,000 or ~~250~~290,000 shares of common stock at an exercise price of $0.3028 per share, which vests in four annual segments pursuant to each director’s continued service. In ~~2019~~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 $0.2130. These option grants ~~vests~~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 ~~2020~~2021 and ~~2019~~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.

~~Director Compensation for Fiscal 2020~~45

	Fees Earned
	or Paid		Option		All Other
	in Cash		Awards		Compensation			Total
Name	($)		($)(1)		($)			($)
Allan Goldstein, Ph.D.		--		76,785		90,000	(2)		166,785
R. Don Elsey		--		47,803		--			47,803
Alessandro Noseda		--		38,424		--			38,424
Joseph McNay		--		47,803		--			47,803
Mauro Bove		--		38,424		--			38,424

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~~(1)~~Director ~~Total~~Compensation ~~Options~~for ~~held~~Fiscal ~~by each Board member as of December 31, 2020, are as follows:~~2021

Allan Goldstein, Ph.D.			2,110,000
R. Don Elsey			1,245,000
Alessandro Noseda			400,000
Joseph McNay			1,245,000
Mauro Bove			1,175,000


	Fees Earned
	or Paid	Option	All Other
	in Cash	Awards	Compensation	Total
Name	($)	($)(1)	($)	($)
Allan Goldstein, Ph.D.	—	96,499	90,000	186,499
R. Don Elsey	—	58,301	—	58,301
Alessandro Noseda	—	48,250	—	48,250
Joseph McNay	—	58,301	—	58,301
Mauro Bove	—	48,250	—	48,250

(21) InTotal ~~addition~~Options toheld ~~being~~by ~~Chairman~~each ~~of our~~ Board ofmember ~~Directors, Dr. Goldstein also serves~~ as ~~our~~of ~~Chief~~December ~~Science Officer. In this capacity~~31, ~~Dr. Goldstein received cash compensation of $90~~2021,~~000~~ inare ~~2020.~~as ~~In 2020 Dr. Goldstein was also granted options to purchase 400,000 shares of common stock.~~follows:


Allan Goldstein, Ph.D.		2,140,000
R. Don Elsey		1,415,000
Alessandro Noseda		640,000
Joseph McNay		1,415,000
Mauro Bove		1,265,000

(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, ~~2021~~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 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 Ownership(1)
Beneficial Owner	Number of Shares			Percent of Total
5% Stockholders:
Entities affiliated previously affiliated with Essetifin S.p.A., Via Sudafrica, 20, Rome, Italy 00144		51,251,189	(2)		34.4	%
GtreeBNT Co., Ltd. 22nd FL, Parkview Tower, 248 Jungjail-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 463-863, Republic of Korea		19,583,333	(3)		14.7	%
Named Executive Officers and Directors:
J.J. Finkelstein		4,038,795	(4)		3.0	%
Allan L. Goldstein		3,152,569	(5)		2.3	%
Joseph C. McNay		7,771,206	(6)		5.8	%
Mauro Bove		1,069,554	(7)		*
R. Don Elsey		1,059,872	(8)		*
Alessandro Noseda		150,000	(9)		*
All directors and executive officers as a group (6 persons)		16,754,496	(10)		12.4	%

*Table ~~Less~~of ~~than one percent.~~Contents

~~(1) This table is based upon information supplied~~ by ~~officers,~~us ~~directors and principal stockholders. Unless otherwise indicated in the footnotes~~ to ~~this~~be ~~table~~beneficial ~~and~~owners ~~subject~~of tomore ~~community~~than ~~property~~five percent ~~laws where applicable, we believe that each~~ of ~~the~~our ~~stockholders~~common ~~named~~stock. inThe ~~this~~address ~~table~~for ~~has~~all ~~sole~~directors ~~voting~~ and ~~investment~~executive ~~power~~officers ~~with~~is ~~respect~~c/o toRegeneRx ~~the shares indicated as beneficially owned~~Biopharmaceuticals, Inc., ~~Applicable~~15245 ~~percentages~~Shady ~~are~~Grove ~~based on 133~~Road,~~546,788~~ ~~shares of common stock outstanding on March 1~~Suite 470, ~~2021~~Rockville, ~~adjusted~~MD ~~as required by rules promulgated by the Securities and Exchange Commission (the “SEC”)~~20850.

(2) Consists of 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, 2021. 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/A filed by Essetifin on October 16, 2020.


	Beneficial Ownership⁽¹⁾
Beneficial Owner	Number of Shares		Percent of Total
5% Stockholders:
Entities affiliated previously affiliated with Essetifin S.p.A., Via Sudafrica, 20, Rome, Italy 00144	55,271,189	⁽²⁾	34.0	%
GtreeBNT Co., Ltd. 22nd FL, Parkview Tower, 248 Jungjail-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 463‑863, Republic of Korea	19,583,333	⁽³⁾	13.6	%

Named Executive Officers and Directors:
J.J. Finkelstein	4,226,295	⁽⁴⁾	2.9	%
Allan L. Goldstein	3,270,069	⁽⁵⁾	2.3	%
Joseph C. McNay	7,798,706	⁽⁶⁾	5.4	%
Mauro Bove	1,129,554	⁽⁷⁾	*
R. Don Elsey	1,087,372	⁽⁸⁾	*
Alessandro Noseda	310,000	⁽⁹⁾	*
All directors and executive officers as a group (6 persons)	17,721,996	⁽¹⁰⁾	12.2	%

~~(3)~~* ~~Consists~~Less ofthan ~~19,583,333~~one ~~shares of common stock held of record by GtreeBNT which were acquired in two equity purchases in March 2014 and August 2014~~percent. ~~The beneficial ownership of GtreeBNT is derived from its Schedule 13D/A filed on April 1, 2015.~~

(41) ~~Consists~~This oftable ~~1,637,991~~is ~~shares~~based ofupon ~~common~~information ~~stock~~supplied ~~held~~by ofofficers, ~~record~~directors byand Mrprincipal stockholders. ~~Finkelstein,~~Unless ~~236,174~~otherwise ~~shares~~indicated ofin ~~common~~the ~~stock~~footnotes ~~issuable~~to ~~upon~~this ~~conversion~~table ofand ~~convertible~~subject ~~promissory~~to ~~notes,~~community ~~177~~property laws where applicable,~~130~~ ~~shares~~we believe that each of ~~common~~the ~~stock~~stockholders ~~issuable~~named ~~upon~~in ~~exercise~~this oftable ~~warrants~~has sole voting and 1investment power with respect to the shares indicated as beneficially owned. Applicable percentages are based on 143,~~987~~549,~~500~~735 shares of common stock ~~issuable~~outstanding ~~upon~~on ~~exercise~~March of1, ~~options~~2022, inadjusted ~~each~~as ~~case~~required ~~exercisable~~by ~~within~~rules 60promulgated ~~days~~by ofthe ~~March~~Securities 1,and ~~2021~~Exchange Commission (the “SEC”).

(52) Consists of 1,~~512~~500,~~793~~000 shares of common stock held of record held by DrAptafin S.p.A. ~~Goldstein~~and 2,250,000 55upon the exercise of warrants,~~586~~ 34,989,080 shares of common stock ~~issuable~~held ~~upon~~of ~~conversion~~record ofheld ~~convertible~~by ~~promissory~~Essetifin ~~notes~~S.p.A. (f/k/a Sigma-Tau Finanziaria, 41S.p.A.) (“Essetifin”),~~690~~ 9,446,920 shares of common stock issuable upon ~~exercise~~conversion of ~~warrants~~a convertible promissory note and 17,~~542~~085,~~500~~189 ~~shares of common stock issuable~~ upon the exercise of ~~options~~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.

(63) Consists of 619,~~524~~583,~~122~~333 shares of common stock held of record by ~~Mr.~~GtreeBNT ~~McNay,~~which ~~208,334~~were ~~shares~~acquired ofin ~~common~~two ~~stock~~equity ~~issuable~~purchases ~~upon~~in ~~conversion~~March of2014 ~~convertible promissory notes, 156,250 shares of common stock issuable upon exercise of warrants~~ and ~~882,500~~August ~~shares~~2014. ofThe ~~common~~beneficial ~~stock~~ownership ~~issuable upon exercise~~ of ~~options,~~GtreeBNT inis ~~each~~derived ~~case~~from ~~exercisable~~its ~~within~~Schedule 6013D/A ~~days~~filed ofon ~~March~~April 1, ~~2021~~2015.

(74) Consists of ~~111~~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, 83289,~~380~~630 shares of common stock issuable upon exercise of warrants and ~~875~~1,~~000~~987,500 shares of common stock issuable upon exercise of options, in each case exercisable within 60 days of March 1, ~~2021~~2022.

(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 882,500 shares of common stock issuable upon exercise of options, in each case exercisable within 60 days of March 1, 2021.
(9)	Consists of 150,000 shares of common stock issuable upon exercise of options within 60 days of March 1, 2021.

(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.

(106) Consists of 96,~~779~~524,~~362~~122 shares of common stock held of record by Mr. McNay, ~~652~~208,~~934~~334 shares of common stock issuable upon conversion of convertible promissory notes, ~~489~~156,~~700~~250 shares of common stock issuable upon exercise of warrants and 5910,~~832,500~~000 shares of common stock issuable upon exercise of options, in each case exercisable within 60 days of March 1, ~~2021~~2022.

~~Equity~~(7) ~~Compensation~~Consists ~~Plan Information~~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.

The following table provides information as of December 31, 2020 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.47

Number of securities

remaining available for

Number of securities to

future issuance under

be issued upon exercise

Weighted-average exercise

equity compensation plans

of outstanding options,

price of outstanding options,

(excluding securities

warrants and rights

reflected in column (a))

Plan Category

(a)

(b)

(c)

Equity compensation plans approved by security holders

11,951,250

0.28

4,148,966

Equity compensation plans not approved by security holders

—

Total

11,951,250

0.28

4,148,966

Table of Contents

(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
			remaining available for
	Number of securities to		future issuance under
	be issued upon exercise	Weighted average exercise	equity compensation plan
	of outstanding options	price of outstanding options	(excluding securities
	warrants and rights	warrants and rights	reflected in column (a))
Plan Category	(a)	(b)	(c)
Equity compensation plans approved by security holders	12,376,250	0.29	4,412,901

Equity compensation plans not approved by security holders	—	—	—

Total	12,376,250	0.29	4,412,901

Related Party Transactions

Described below are transactions and series of similar transactions that have occurred during fiscal ~~2020~~2021 to which we were a party or are a party in which:

42● 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

·● ~~the~~a ~~amounts~~director, ~~involved~~executive ~~exceeded~~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 ~~exceed~~have ~~$120,000;~~a ~~and~~direct or indirect material interest.

·2021 aPrivate 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.Placement

~~2020 Convertible~~In ~~Notes~~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.

InWe ~~October 2020, we~~generally ~~sold~~granted ~~the~~all ~~2020~~investors ~~Notes~~in ~~to management,~~ the ~~Company’s~~private ~~Board~~placement ofa ~~Directors~~right ~~and~~to ~~accredited~~participate ~~investors~~in ~~including Essetifin S.p.A.,~~ our ~~largest~~future ~~stockholder.~~issuances ~~The~~of ~~2020~~equity ~~Notes~~and ~~bear~~debt ~~interest~~securities atfor a ~~rate~~period of ~~five~~12 ~~percent~~months ~~(5%)~~from ~~per~~September ~~annum~~3, ~~and~~2021, ~~are~~the ~~convertible~~effective ~~into~~date ~~shares~~ of ~~our~~a ~~common~~Registration ~~stock~~Statement atwe aagreed ~~conversion~~to ~~price~~and offiled ~~twelve~~with ~~cents~~the ~~($0.36)~~SEC ~~per~~in ~~share~~August ~~(subject~~2021 to ~~adjustment~~register asthe ~~described~~resale inof both the ~~2020~~shares ~~Notes) at~~issued ~~any~~in ~~time~~the ~~prior~~private toplacement ~~repayment,~~and atthose ~~the~~shares ~~election~~issuable upon exercise of the ~~investors~~Warrants. InWe ~~the~~also ~~aggregate~~generally agreed that, during the ~~2020~~30-day ~~Notes~~period ~~issued~~following inthe ~~both~~Registration ~~closings~~Statement’s ~~are convertible~~effective ~~into~~date, upwe towould ~~1,391,382~~not ~~shares~~issue ofor ~~our~~propose ~~common~~to ~~stock~~issue ~~excluding~~any ~~interest~~equity securities.

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.48

InTable ~~connection with the issuance~~ of the 2020 Notes we also issued the 2020 Warrants to each investor. The 2020 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.Contents

The ~~affiliated~~Series ~~investors~~ A and Series B Warrants are exercisable for cash, provided that if during the ~~principal~~term ~~amount~~of the Warrants there is not an effective registration statement under the Securities Act covering the resale of ~~their~~the ~~respective~~shares ~~2020~~issuable ~~Notes~~upon ~~purchase~~exercise ~~are~~of asthe ~~set~~Warrants, ~~forth~~then ~~below:~~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.

Investor	Note Principal
Essetifin S.p.A.	$	400,000
J.J. Finkelstein	$	10,000
Mauro Bove	$	10,000
Allan L. Goldstein	$	5,000

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.

Essetifin S.p.A., our largest stockholder, is currently the holder of all of our securities previously held by Sigma-Tau and its affiliates. 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.

2019 Convertible Notes

In February 2019, we sold the 2019 Notes to management, the Company’s Board of Directors and accredited investors including Essetifin S.p.A., our largest stockholder.”). The sale of the 2019 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 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.

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 the 2019 Warrants to each investor. The 2019 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 affiliated investors and the principal amount of their respective 2019 Notes purchase are as set forth below:

Investor	Note Principal
Essetifin S.p.A.	$	1,000,000
Joseph C. McNay	$	25,000
J.J. Finkelstein	$	25,000
Mauro Bove	$	10,000
Allan L. Goldstein	$	5,000
R. Don Elsey	$	5,000

GtreeBNT

In August 2017, the Company and GtreeBNT reached an agreement to expand the territorial definition of the RGN-137 license agreement in Japan in exchange for a series of payments, two of which were received in 2017 with the remaining two were received in 2018. Under the amendment the Territory was expanded to include Europe, Canada, South Korea, Australia and Japan.

U.S. Joint Venture

On January 28, 2015, we announced that we had entered into a Joint Venture Agreement with GtreeBNT a shareholder of the Company. ReGenTree, LLC was created under the Agreement and is jointly owned by us and GtreeBNT. ReGenTree intends to commercialize RGN-259 for treatment of dry eye and neurotrophic keratitis, an orphan indication in the United States. GtreeBNT will be responsible for funding all product development and commercialization efforts and holds a majority interest in ReGenTree that varies depending on development milestones achieved and eventual commercialization path, if successful. In conjunction with the Joint Venture Agreement, we also entered into a royalty-bearing license with ReGenTree pursuant to which we granted to ReGenTree the right to develop and exclusively commercialize RGN-259 in the United States. We received a total of $1 million in two tranches under the terms of the agreement. The first tranche of $500,000 was received in March 2015 and a second in the amount of $500,000, was received in September 2015. 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.

Our initial ownership interest in ReGenTree was 49% and has been 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 ReGenTree is acquired, or a change of control 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.

In September 2015, ReGenTree began a Phase 2/3 clinical trial in patients with dry eye syndrome (“DES”) and a Phase 3 clinical trial in patients with neurotrophic keratitis (“NK”), both in the U.S. In May 2016, we reported the results of the 317-patient Phase 2/3 trial (ARISE-1). The FDA approved ReGenTree’s Phase 3 protocol for DES in late summer 2016 and we initiated a second Phase 3 trial (ARISE-2) that was completed in approximately 600 patients, the results of which were reported in October 2017. ReGenTree initiated a third Phase 3 trial (ARISE-3), and the first patient was enrolled in the second quarter of 2019 and enrollment is expected to be completed in the summer of 2020.

The NK trial (SEER-1), a smaller study in an orphan population, has enrolled seventeen patients. ReGenTree had previously disclosed that 7 of the 17 patients enrolled in SEER-1 had completely healed. To participate in the trial the patients were required to have a persistent epithelial defect (non-healing corneal wound). While these preliminary observations are encouraging, it should be noted that the patients and treating physicians remain masked while the trial is on-going, so it is not known whether the healed patients are in the RGN-259 group, placebo group, or distributed among both. We expect ReGenTree will report top line data in the next few months.

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~~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~~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.

44Consistent 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.

~~Consistent with~~In ~~these~~determining ~~considerations,~~the ~~after~~independence ~~review~~ of ~~all~~Mr. ~~relevant~~Bove, ~~identified~~the ~~transactions~~Board orof ~~relationships~~Directors ~~between~~considered ~~each~~the ~~director,~~significant orownership ~~any~~ of ~~his family members, and~~ our ~~company,~~common ~~our~~stock ~~senior~~by ~~management~~Essetifin S.p.A. and our ~~independent~~license ~~auditors,~~agreement ~~our~~with ~~board~~Lee’s ~~has~~Pharmaceuticals. ~~determined~~The ~~that~~Board ~~the~~of ~~following three~~Directors ~~directors~~does ~~are~~not ~~independent~~believe ~~directors~~that ~~within~~any ~~the meaning~~ of the ~~applicable~~transactions ~~NYSE~~with ~~Amex~~Lee’s ~~listing~~or ~~standards:~~Essetifin ~~Mr. Elsey, Mr. Bove~~ and ~~Mr. McNay.~~its Inaffiliates ~~making~~described in this ~~determination,~~report ~~the~~has ~~board~~interfered ~~found~~or ~~that~~would ~~none~~reasonably ofbe ~~these~~expected ~~directors~~to ~~had~~interfere ~~a material or other disqualifying relationship~~ with ~~us.~~ Mr. ~~Finkelstein,~~ ~~our~~Bove’s ~~President~~exercise ~~and~~of ~~Chief~~independent ~~Executive~~judgment ~~Officer,~~in ~~and~~carrying ~~Dr. Goldstein~~out ~~our~~his ~~Chief~~responsibilities ~~Scientific Officer,~~as ~~are~~a ~~not~~director ~~independent by virtue~~ of ~~their~~our ~~employment with us~~company.

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, ~~2020~~2021 and ~~2019~~2020 by our independent registered public accounting firm CohnReznick LLP. All such fees described below were approved by the audit committee.

	2020		2019
Audit fees	$	90,000	$	90,000
Tax fees (1)		14,125		15,000
Total fees	$	104,125	$	105,000


	2021		2020
Audit fees	$	103,000	$	90,000
Tax fees ⁽¹⁾		14,800		14,125
Total fees	$	117,800	$	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.

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.

~~SIGNATURES~~50

~~Pursuant to~~Table ~~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.~~Contents

	RegeneRx Biopharmaceuticals, Inc. (Registrant)
Date: March 2, 2021	By:	/s/ J.J. Finkelstein
		J.J. Finkelstein
		President and Chief Executive Officer

SIGNATURES

47Pursuant 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.

POWER OF ATTORNEY


	RegeneRx Biopharmaceuticals, Inc.
	(Registrant)

Date: March 30, 2022	By:	/s/ J.J. Finkelstein
		J.J. Finkelstein
		President and Chief Executive Officer

~~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.~~

InPOWER ~~addition, each~~OF 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.ATTORNEY

Name	Title	Date
/s/ Allan L. Goldstein	Chairman of the Board, Chief Scientific Officer, and Director	March 2, 2021
Allan L. Goldstein
/s/ J.J. Finkelstein	President, Chief Executive Officer, and Director (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)	March 2, 2021
J.J. Finkelstein
/s/ R. Don Elsey	Director	March 2, 2021
R. Don Elsey
/s/ Joseph C. McNay	Director	March 2, 2021
Joseph C. McNay
/s/ Mauro Bove	Director	March 2, 2021
Mauro Bove
/s/ Alessandro Noseda	Director	March 2, 2021
Alessandro Noseda

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.

48In 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.

RegeneRx Biopharmaceuticals, Inc.


Name	Title	Date

/s/ Allan L. Goldstein Allan L. Goldstein	Chairman of the Board, Chief Scientific Officer, and Director	March 30, 2022

/s/ J.J. Finkelstein J.J. Finkelstein	President, Chief Executive Officer, and Director (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)	March 30, 2022

/s/ R. Don Elsey R. Don Elsey	Director	March 30, 2022

/s/ Joseph C. McNay Joseph C. McNay	Director	March 30, 2022

/s/ Mauro Bove Mauro Bove	Director	March 30, 2022

/s/ Alessandro Noseda Alessandro Noseda	Director	March 30, 2022

~~Index to Financial Statements~~

	Page
Report of Independent Registered Public Accounting Firm		F-2
Balance Sheets		F-3
Statements of Operations		F-4
Statements of Changes in Stockholders’ Deficit		F-5
Statements of Cash Flows		F-6
Notes to Financial Statements		F-7

~~Report of Independent Registered Public Accounting Firm~~51

~~The~~Table ~~Board~~ of ~~Directors and Stockholders~~Contents

RegeneRx Biopharmaceuticals, Inc.

~~Opinion~~Index onto ~~the~~ Financial Statements

We have audited the accompanying balance sheets of RegeneRx Biopharmaceuticals, Inc. (the “Company”) as of December 31, 2020 and 2019, 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 referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2020 and 2019, and the results of its operations and its cash flows for 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


	Page
Report of Independent Registered Public Accounting Firm PCAOB ID# 596	F-2

Balance Sheets	F-3

Statements of Operations	F-4

Statements of Changes in Stockholders’ Deficit	F-5

Statements of Cash Flows	F-6

Notes to Financial Statements	F-7

The 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 losses from operations since inception and will need additional capital to fund future operations. These conditions raise substantial doubt about the Company's ability to continue as a going concern. 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 purposes of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding 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.F-1

~~Critical~~Table ~~Audit~~of ~~Matters~~Contents

~~Critical~~REPORT ~~audit~~OF ~~matters~~INDEPENDENT ~~are~~REGISTERED ~~matters arising~~PUBLIC ~~from~~ACCOUNTING 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.FIRM

~~/s/~~To ~~CohnReznick~~the ~~LLP~~Stockholders and Board of Directors of RegeneRx Biopharmaceuticals, Inc.

WeOpinion ~~have~~on ~~served as~~ the ~~Company’s~~Financial ~~auditor since 2012.~~Statements

~~Tysons~~We have audited the accompanying balance sheets of RegeneRx Biopharmaceuticals, Inc. ~~Virginia~~(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.

~~March~~The 2,Company’s ~~2021~~Ability to Continue as a Going Concern

~~F-2~~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.

~~RegeneRx~~Basis ~~Biopharmaceuticals, Inc.~~for Opinion

~~Balance~~These ~~Sheets~~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.

	December 31,
	2020			2019
ASSETS
Current assets
Cash and cash equivalents	$	427,898		$	639,916
Prepaid expenses and other current assets		49,909			41,639
Total current assets		477,807			681,555
Operating lease right-of-use asset		68,229			24,453
Other assets		5,752			5,752
Total assets	$	551,788		$	711,760
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities
Accounts payable	$	39,320		$	43,678
Unearned revenue		76,761			76,761
Accrued expenses		208,857			95,020
Promissory note		33,856			-
Current portion of operating lease liability		40,790			27,014
Total current liabilities		399,584			242,473
Long-term liabilities
Unearned revenue		2,024,564			2,101,325
Promissory note		21,544			-
Operating lease liability		27,809			-
Convertible promissory notes, net		902,231			708,070
Total liabilities		3,375,732			3,051,868
Commitments and contingencies
Stockholders' deficit
Preferred stock, $.001 par value per share, 1,000,000 shares authorized; no shares issued		-			-
Common stock, par value $.001 per share, 200,000,000 shares authorized, 133,441,788 and 131,506,494 issued and outstanding		133,442			131,507
Additional paid-in capital		105,934,572			104,896,975
Accumulated deficit		(108,891,958	)		(107,368,590	)
Total stockholders' deficit		(2,823,944	)		(2,340,108	)
Total liabilities and stockholders' deficit	$	551,788		$	711,760

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.

~~The~~Our ~~accompanying~~audits ~~notes~~included ~~are~~performing anprocedures ~~integral~~to ~~part~~ assess the risks of ~~these~~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.

~~F-3~~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) ~~RegeneRx~~relate ~~Biopharmaceuticals,~~to accounts or disclosures that are material to the financial statements and (2) ~~Inc~~involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.

~~Statements of~~/s/ ~~Operations~~CohnReznick LLP

	Years ended December 31,
	2020			2019
Revenues	$	76,761		$	76,762
Operating expenses
Research and development		4,921			65,107
General and administrative		1,366,383			1,273,536
Total operating expenses		1,371,304			1,338,643
Loss from operations		(1,294,543	)		(1,261,881	)
Other income (expense)
Interest income		3,806			11,044
Interest expense		(232,631	)		(153,410	)
Total other expense		(228,825	)		(142,366	)
Loss before income taxes		(1,523,368	)		(1,404,247	)
Provision for income taxes		-			-
Net loss		(1,523,368	)		(1,404,247	)
Deemed dividend related to warrants down round provision		-			(82,566	)
Net loss attributable to common stockholders	$	(1,523,368	)	$	(1,486,813	)
Basic net loss per common share	$	(0.01	)	$	(0.01	)
Diluted net loss per common share	$	(0.01	)	$	(0.01	)
Weighted average number of common shares outstanding - basic		133,357,185			130,970,754
Weighted average number of common shares outstanding - diluted		133,357,185			130,970,754

~~The~~We ~~accompanying~~have ~~notes are~~served anas ~~integral~~the ~~part~~Company’s ofauditor ~~these~~since ~~financial statements~~2012.

~~F-4~~

~~RegeneRx Biopharmaceuticals~~Tysons, ~~Inc.~~ Virginia

~~Statements~~March 30, ~~of Changes in Stockholders' Deficit~~ 2022

~~Years ended December 31, 2020 and 2019~~

										Total
	Common stock				Additional		Accumulated			stockholders'
		Shares		Amount		paid-in capital		deficit			deficit
Balance, December 31, 2018		128,432,478	$	128,433	$	103,541,291	$	(105,881,777	)	$	(2,212,053	)
Issuance of common stock - note conversions		1,149,016		1,149		67,792		-			68,941
Issuance of common stock - warrant exercises		1,925,000		1,925		238,700		-			240,625
Warrants issued with debt		-		-		348,443		-			348,443
Debt discount related to beneficial conversion feature		-		-		348,443		-			348,443
Deemed dividend related to warrant reprice		-		-		82,566		(82,566	)		-
Share-based compensation expense		-		-		269,740		-			269,740
Net loss		-		-		-		(1,404,247	)		(1,404,247	)
Balance, December 31, 2019		131,506,494		131,507		104,896,975		(107,368,590	)		(2,340,108	)
Issuance of common stock - warrant exercises		1,935,294		1,935		239,976		-			241,911
Warrants issued with debt		-		-		176,573		-			176,573
Debt discount related to beneficial conversion feature		-		-		289,045		-			289,045
Share-based compensation expense		-		-		332,003		-			332,003
Net loss		-		-		-		(1,523,368	)		(1,523,368	)
Balance, December 31, 2020		133,441,788	$	133,442	$	105,934,572	$	(108,891,958	)	$	(2,823,944	)

F-2

~~The~~Table ~~accompanying notes are an integral part~~ of ~~these financial statements.~~Contents

~~F-5~~RegeneRx Biopharmaceuticals, Inc.

~~RegeneRx~~Balance ~~Biopharmaceuticals, Inc.~~ Sheets

~~Statements of Cash Flows~~

	Years ended December 31,

	2020				2019
	December 31,
Operating activities:
	2021			2020
Net loss	$	(1,523,368	)		$	(1,404,247	)

Adjustments to reconcile net loss to net cash used in operating activities:
ASSETS
Depreciation and amortization		-				1,418
Current assets
Non-cash share-based compensation		332,003				269,740
Cash and cash equivalents	$	1,231,608		$	427,898
Non-cash interest expense		162,179				105,202
Prepaid expenses and other current assets		19,932			49,909
Changes in operating assets and liabilities:
Total current assets		1,251,540			477,807
Prepaid expenses and other current assets		(8,270	)			(5,030	)
Operating lease right-of-use asset		27,673			68,229
Accounts payable		(4,358	)			(48,755	)
Other assets		5,752			5,752
Accrued expenses		113,837				23,496
Total assets	$	1,284,965		$	551,788
Operating lease liability		(2,191	)			(3,032	)

Unearned revenue		(76,761	)			(76,762	)
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Net cash used in operating activities		(1,006,929	)			(1,137,970	)
Current liabilities
Financing activities:
Accounts payable	$	63,634		$	39,320
Proceeds from promissory note		55,400				-
Unearned revenue		76,761			76,761
Proceeds from the sale of convertible notes		500,000				1,300,000
Accrued expenses		261,729			208,857
Debt issuance costs		(2,400	)			-
Promissory note		—			33,856
Proceeds from the exercise of stock warrants		241,911				240,625
Current portion of operating lease liability		27,809			40,790
Net cash provided by financing activities		794,911				1,540,625
Total current liabilities		429,933			399,584
Net (decrease) increase in cash and cash equivalents		(212,018	)			402,655

Cash and cash equivalents at beginning of year		639,916				237,261
Long-term liabilities
Cash and cash equivalents at end of year	$	427,898			$	639,916
Unearned revenue		1,947,802			2,024,564
Supplemental Disclosure of Non-Cash Operating and Financing Activities
Promissory note		—			21,544
Conversion of promissory notes to common stock	$	-			$	55,000
Operating lease liability		—			27,809
Conversion of accrued interest to common stock	$	-			$	13,941
Convertible promissory notes, net		1,137,109			902,231
Establishment of right-of-use asset	$	81,980			$	59,822
Total liabilities		3,514,844			3,375,732
Establishment of operating lease liability	$	81,980			$	65,415

Issuance of warrants in conjunction with issuance of convertible notes	$	176,573			$	348,443
Commitments and contingencies
Beneficial conversion feature on issuance of convertible notes	$	289,045			$	348,443

Stockholders’ deficit
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		143,550			133,442
Additional paid-in capital		108,116,284			105,934,572
Accumulated deficit		(110,489,713)			(108,891,958)
Total stockholders’ deficit		(2,229,879)			(2,823,944)
Total liabilities and stockholders’ deficit	$	1,284,965		$	551,788

~~The accompanying notes are an integral part of these financial statements.~~

~~F-6~~The accompanying notes are an integral part of these financial statements.

~~RegeneRx Biopharmaceuticals, Inc.~~

~~Notes to Financial Statements~~F-3

~~December 31,~~Table ~~2020~~of Contents

1.RegeneRx ~~ORGANIZATION AND BUSINESS~~Biopharmaceuticals, Inc.

~~Organization and~~Statements ~~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.


	Years ended December 31,
	2021		2020

Revenues	$	76,761	$	76,761

Operating expenses
Research and development		6,638		4,921
General and administrative		1,398,634		1,366,383
Total operating expenses		1,405,272		1,371,304
Loss from operations		(1,328,511)		(1,294,543)

Other income (expense)
Gain on forgiveness of PPP loan		55,400		—
Interest income		234		3,806
Interest expense		(324,878)		(232,631)
Total other expense		(269,244)		(228,825)
Loss before income taxes		(1,597,755)		(1,523,368)

Provision for income taxes		—		—

Net loss		(1,597,755)		(1,523,368)

Deemed dividend related to warrants down round provision		—		—
Net loss attributable to common stockholders	$	(1,597,755)	$	(1,523,368)

Basic net loss per common share	$	(0.01)	$	(0.01)
Diluted net loss per common share	$	(0.01)	$	(0.01)

Weighted average number of common shares outstanding - basic		138,592,666		133,357,185

Weighted average number of common shares outstanding - diluted		138,592,666		133,357,185

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, 2020, we have an accumulated deficit of $109 million and we had cash and cash equivalents of $427,898 as of December 31, 2020. 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. 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~~accompanying 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 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”). In February 2019, we sold a series of convertible promissory notes toare ~~management,~~an ~~the~~integral ~~Company’s~~part ~~Board~~ of ~~Directors~~these ~~and~~financial ~~accredited investors including Essetifin S~~statements.p.A., our largest stockholder (the “2019 Notes”). The sale of the 2019 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 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 contain a $0.12 conversion price and the purchasers also received a warrant exercisable at $0.18 to purchase additional shares of common stock equal to 75% of the number of shares into which each note is initially convertible (the “2019 Warrants”). 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 their remaining warrants and the Company received proceeds of $241,911. At present, with the receipt of the proceeds the 2020 Notes, we will have sufficient cash to fund planned operations into the second quarter of 2021.

While we successfully secured additional operating capital to continue operations into the second quarter of 2021, we 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, 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.F-4

~~Although we~~Table 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.Contents

~~F-7~~RegeneRx Biopharmaceuticals, Inc.

InStatements ~~addition to our current operational requirements, we continually refine our operating strategy and evaluate alternative clinical uses~~ of ~~Tß4.~~ ~~However,~~Changes ~~substantial~~in ~~additional~~Stockholders’ 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.Deficit

ToYears ~~achieve profitability,~~ended weDecember 31, ~~and/or~~2021 ~~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.2020

~~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.


								Total
	Common stock			Additional		Accumulated		stockholders’
	Shares	Amount		paid-in capital		deficit		deficit
Balance, December 31, 2019	131,506,494	$	131,507	$	104,896,975	$	(107,368,590)	$	(2,340,108)
Issuance of common stock - warrant exercises	1,935,294		1,935		239,976		—		241,911
Warrants issued with debt	—		—		176,573		—		176,573
Debt discount related to beneficial conversion feature	—		—		289,045		—		289,045
Share-based compensation expense	—		—		332,003		—		332,003
Net loss	—		—		—		(1,523,368)		(1,523,368)
Balance, December 31, 2020	133,441,788		133,442		105,934,572		(108,891,958)		(2,823,944)
Private offering of common stock and warrants, net of issuance costs	9,900,000		9,900		1,749,188		—		1,759,088
Issuance of common stock - option exercises	105,000		105		21,945		—		22,050
Issuance of common stock - warrant exercises	102,947		103		12,765		—		12,868
Share-based compensation expense	—		—		397,814		—		397,814
Net loss	—		—		—		(1,597,755)		(1,597,755)
Balance, December 31, 2021	143,549,735	$	143,550	$	108,116,284	$	(110,489,713)	$	(2,229,879)

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~~The ~~Credit~~accompanying ~~Risk.~~notes ~~Financial~~are ~~instruments~~an ~~which~~integral ~~potentially~~part ~~subject the Company to concentrations~~ of ~~credit~~these ~~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~~statements.

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 December 31, 2020. Depreciation expense was $0 and $1,418 for the years ended December 31, 2020 and 2019, respectively.

~~Impairment of Long~~F-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, 2020 and 2019, no impairment losses were recorded.5

~~Convertible Notes~~Table 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.Contents

~~Revenue~~RegeneRx ~~Recognition. The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers~~Biopharmaceuticals, ~~(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 obligationInc. 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.

~~F-8~~Statements of Cash Flows


	Years ended December 31,
	2021		2020

Operating activities:
Net loss	$	(1,597,755)	$	(1,523,368)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash share-based compensation		397,814		332,003
Non-cash interest expense		234,878		162,179
Gain on forgiveness of PPP loan		(55,400)		—
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		29,977		(8,270)
Accounts payable		24,314		(4,358)
Accrued expenses		52,872		113,837
Operating lease liability		(234)		(2,191)
Unearned revenue		(76,762)		(76,761)
Net cash used in operating activities		(990,296)		(1,006,929)

Financing activities:
Proceeds from private offering of common stock and warrants, net of issuance costs		1,759,088		—
Proceeds from the exercise of stock options		22,050		—
Proceeds from promissory note		—		55,400
Proceeds from the sale of convertible notes		—		500,000
Debt issuance costs		—		(2,400)
Proceeds from the exercise of stock warrants		12,868		241,911
Net cash provided by financing activities		1,794,006		794,911
Net increase (decrease) in cash and cash equivalents		803,710		(212,018)

Cash and cash equivalents at beginning of year		427,898		639,916
Cash and cash equivalents at end of year	$	1,231,608	$	427,898

Supplemental Disclosure of Non-Cash Operating and Financing Activities

Establishment of right-of-use asset	$	—	$	81,980

Establishment of operating lease liability	$	—	$	81,980

Issuance of warrants in conjunction with issuance of convertible notes	$	—	$	176,573

Beneficial conversion feature on issuance of convertible notes	$	—	$	289,045

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~~accompanying ~~price~~notes ~~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.~~an Atintegral ~~the~~part ~~end~~ of ~~each~~these ~~subsequent~~financial 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 pricestatements. ~~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 liabilities~~Table ~~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.~~Contents

~~F-9~~RegeneRx Biopharmaceuticals, Inc.

WeNotes to ~~have the~~Financial ~~following amounts recorded for contract liabilities:~~Statements

	December 31
		2020		2019
Unearned revenue	$	2,101,325	$	2,178,086

December 31, 2021

~~The~~1. ORGANIZATION ~~contract liabilities~~AND 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.BUSINESS

~~Revenue recognized~~Organization ~~from contract liabilities during the years ended December 31, 2020~~ and ~~2019,~~Nature ~~totaled~~of ~~$76,761 and $76,762, respectively~~Operations. ~~Revenue is expected to be recognized in the future from contract liabilities as the related performance obligations are satisfied.~~

~~Variable Interest~~RegeneRx ~~Entities~~Biopharmaceuticals, Inc. On ~~January 28~~(“RegeneRx”, ~~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~~“We”, ~~jointly owned by the Company and GtreeBNT~~“Us”, ~~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~~Our”), ~~since~~a ~~the~~Delaware ~~total equity investment at risk is not sufficient to permit the Joint Venture to finance its activities without additional subordinated financial support. Further~~corporation, ~~because of~~was ~~GtreeBNT’s~~incorporated ~~majority equity stake~~ in ~~the~~1982. ~~Joint~~We ~~Venture,~~are ~~voting~~focused ~~control,~~on ~~control of~~ the ~~board~~discovery ~~of directors,~~ and ~~substantive management~~development ~~rights,~~of ~~and~~novel ~~given~~molecules ~~that the Company does not have the power~~ to ~~direct~~accelerate ~~the~~tissue ~~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~~organ ~~is not required to consolidate the Joint Venture~~repair. ~~The~~Our ~~Company~~operations ~~reports~~are ~~its~~confined ~~equity~~to ~~stake~~one inbusiness ~~the~~segment: ~~Joint Venture using~~ the ~~equity~~development ~~method~~and marketing of ~~accounting~~product ~~because,~~candidates ~~while~~based iton ~~does~~Thymosin ~~not~~Beta ~~control~~4 ~~the Joint Venture~~(“Tß4”), ~~the~~an ~~Company~~amino ~~can~~acid ~~exert significant influence over the Joint Venture’s activities by virtue of its board representation~~peptide.

~~Because the~~Management ~~Company~~Plans ~~is not obligated~~ to ~~fund~~Address ~~the~~Operating 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 Decembers 31, 2020 and 2019Conditions. 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, 2020, 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~~Our ~~Development.~~strategy ~~R&D~~is ~~expenditures~~aimed ~~are~~at ~~expensed~~being ascapital ~~incurred~~efficient ~~and~~while ~~are~~leveraging ~~subject~~our toportfolio ~~the~~of ~~risks~~clinical ~~and~~assets ~~uncertainties~~by ~~associated~~ seeking strategic relationships with organizations with clinical ~~trials~~development ~~and~~capabilities ~~the~~including ~~FDA~~development ~~review~~capital. Currently, we have active partnerships in four major territories: North America, Europe, China and ~~approval~~Pan ~~process~~Asia. AsIn aeach ~~result~~case, ~~these~~the ~~expenses~~cost ~~could~~of ~~exceed~~development is being borne by our ~~expectations,~~partners ~~possibly materially~~with no financial obligation for RegeneRx. We ~~are~~still ~~uncertain~~have assignificant clinical assets to ~~what~~develop, weprimarily ~~will~~RGN-352 ~~incur~~(injectable formulation of Tß4 for cardiac and CNS disorders) in ~~future~~the ~~research~~U.S., Pan Asia, and ~~development~~Europe, ~~costs~~and ~~for~~RGN-259 ~~our~~in the EU. Our goal is to wait until satisfactory results are obtained from the current ophthalmic clinical ~~studies~~program in the U.S. before moving into the EU. However, aswe ~~these amounts~~intend ~~are~~to ~~subject~~continue to ~~management's~~develop ~~continuing~~RGN-352, ~~assessment~~our ofinjectable systemic product candidate for cardiac and central nervous system indications, either by obtaining grants to fund a Phase 2a clinical trial in the ~~economics~~cardiovascular ofor ~~each~~central ~~individual~~nervous ~~research~~system ~~and~~fields ~~development~~or ~~project and~~finding a suitable partner with the ~~internal~~resources ~~competition~~and ~~for~~capabilities ~~project~~to ~~funding~~develop it as we have with RGN-259.

~~Patent Costs~~Since inception, and through December 31, 2021, we have an accumulated deficit of $110.5million ~~Costs~~and ~~related~~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 ~~filing~~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 ~~pursuing~~joint ~~patent~~venture ~~applications~~agreements where our partners are ~~recognized~~responsible asfor ~~general~~advancing development of our product candidates by sponsoring multiple clinical trials. On June 30, 2021, we closed a private placement of common stock and ~~administrative~~warrants ~~expenses as~~with ~~incurred~~several ~~since~~institutional ~~recoverability~~investors, including members of ~~such~~management ~~expenditures~~and isthe ~~uncertain~~board, and received gross proceeds of $1,980,000. At present we have sufficient cash to fund planned operations through the end of 2022.

~~Income Taxes.~~We ~~Income~~have ~~taxes~~not ~~are~~reached ~~accounted~~commercialization ~~for under the asset~~ and ~~liability~~therefore ~~method.~~do ~~Deferred~~not ~~tax~~generate ~~assets~~recurring revenue and ~~liabilities~~will ~~are recognized~~need ~~for~~substantial ~~the~~additional ~~estimated~~funds ~~future~~in ~~tax~~order ~~consequences attributable~~ to ~~differences~~significantly ~~between~~advance ~~the~~development ~~financial statement carrying amounts~~ of ~~existing~~our ~~assets~~unlicensed ~~and~~programs. ~~liabilities~~Accordingly, ~~and~~we ~~their~~will ~~respective~~continue ~~tax~~to ~~basis~~evaluate ~~and~~opportunities ~~operating~~to ~~loss~~raise ~~and~~additional ~~tax~~capital ~~credit carryforwards. Deferred tax assets~~ and ~~liabilities~~ are ~~measured using enacted tax rates expected to apply to taxable income~~ in the ~~years~~process inof ~~which~~exploring ~~those~~various ~~temporary differences~~alternatives, ~~are~~including, ~~expected~~without tolimitation, bea ~~recovered~~public or ~~settled.~~private ~~The~~placement ~~effect~~of onour ~~deferred~~securities, ~~tax~~debt ~~assets~~financing, ~~and~~corporate ~~liabilities~~collaboration ofand alicensing ~~change~~arrangements, inmergers, ~~tax~~or ~~rates is~~the ~~recognized~~sale inof ~~income~~our inCompany ~~the~~or ~~period~~certain ~~that~~of ~~includes~~our ~~the~~intellectual ~~enactment~~property ~~date~~rights.

~~The~~These ~~ultimate realization~~factors ofraise ~~deferred~~substantial ~~tax~~doubt ~~assets~~about isour ~~dependent~~ability ~~upon~~to ~~the~~continue ~~generation~~as ofa ~~future~~going ~~taxable income during the periods in which those temporary differences become deductible~~concern. ~~Management~~The ~~considers~~accompanying ~~the~~financial ~~scheduled~~statements ~~reversal~~have ofbeen ~~deferred~~prepared ~~tax~~assuming ~~liabilities,~~that ~~projected~~we ~~future taxable~~will ~~income,~~continue ~~and~~as ~~tax~~a ~~planning~~going ~~strategies~~concern. inThis ~~making~~basis ~~that~~of ~~assessment.~~accounting Wecontemplates ~~recorded~~the arecovery ~~full~~of ~~valuation~~our ~~allowance~~assets ~~against~~and ~~all~~the ~~estimated net~~satisfaction ~~deferred~~of ~~tax~~our ~~assets~~liabilities atin ~~December 31,~~the ~~2020~~normal ~~and~~course ~~2019~~of business.

WeAlthough ~~recognize the~~we ~~effect~~intend ofto ~~income~~continue ~~tax~~to ~~positions~~seek ~~only~~additional iffinancing ~~those~~or ~~positions~~additional ~~are~~strategic ~~more~~partners, ~~likely~~we ~~than~~may not ofbe ~~being~~able ~~sustained.~~to ~~Recognized~~complete ~~income~~a ~~tax~~financing ~~positions are~~or ~~measured~~corporate attransaction, ~~the~~either ~~largest~~on ~~amount~~favorable ~~that~~terms isor ~~greater~~at ~~than~~all. ~~50%~~If ~~likely~~we ofare ~~being~~unable ~~realized.~~to ~~Changes~~complete ina ~~recognition~~financing or ~~measurement~~strategic ~~are reflected~~transaction, inwe ~~the~~may ~~period~~not inbe ~~which~~able ~~the~~to ~~change~~continue inas ~~judgment~~a ~~occurs.~~going ~~Our~~concern ~~policy~~after ~~for~~our ~~recording~~funds ~~interest~~have been exhausted, and ~~penalties~~we ~~associated~~could ~~with audits~~be isrequired ~~that~~to ~~penalties~~significantly curtail or cease operations, file for bankruptcy, or liquidate and ~~interest~~dissolve. ~~expense~~There ~~are~~can ~~recorded~~be inno ~~provision~~assurance ~~for~~that ~~income~~we ~~taxes~~will inbe ~~our~~able to obtain any sources of funding. The financial statements do not include any adjustments relating to the recoverability and classification of ~~operations~~recorded asset amounts and classification of liabilities that might be necessary should we be forced to take any such actions.

F-107

WeTable 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.~~Contents

~~Net Loss~~In ~~Per~~addition ~~Common~~to ~~Share.~~our ~~Basic~~current ~~net~~operational ~~loss~~requirements, ~~per~~we ~~common~~continually ~~share~~refine ~~for~~our ~~2020~~operating strategy and ~~2019~~evaluate isalternative ~~based~~clinical onuses ~~the~~of ~~weighted~~Tß4. ~~average~~However, ~~number~~substantial ~~of shares~~additional ofresources ~~common~~will ~~stock~~be ~~outstanding~~needed ~~during~~before ~~the~~we ~~years.~~will ~~Diluted~~be ~~loss~~able ~~per~~to ~~share~~achieve issustained ~~based~~profitability. onConsequently, ~~the~~we ~~weighted~~continually ~~average~~evaluate ~~number~~alternative ofsources ~~shares~~ of ~~common~~ ~~stock~~financing ~~outstanding~~such ~~during~~as ~~each~~the ~~year~~sharing inof ~~which~~development acosts ~~loss~~through isstrategic ~~incurred;~~collaboration ~~potentially~~agreements. ~~dilutive~~There ~~shares~~can ~~are~~be ~~excluded~~no ~~because~~assurance ~~the~~that ~~effect is~~our ~~antidilutive.~~financing Inefforts ~~years~~will ~~where~~be ~~there~~successful ~~is net income~~and, ~~diluted~~if ~~income~~we ~~per~~are ~~share~~not isable ~~based~~to onobtain ~~the~~sufficient ~~weighted~~levels ~~average~~of ~~number~~financing, ofwe ~~shares of~~would ~~common~~delay ~~stock~~certain ~~outstanding~~clinical ~~plus~~and/or ~~dilutive~~research ~~securities~~activities ~~with~~and aour ~~purchase~~financial orcondition ~~conversion~~would ~~price~~be ~~below~~materially ~~the~~and ~~per~~adversely ~~share~~affected. ~~price~~Even ofif ~~our~~we ~~common stock~~are onable ~~the~~to ~~last~~obtain ~~day~~sufficient offunding, ~~the~~other ~~year.~~factors ~~The~~including ~~potentially~~competition, ~~dilutive~~dependence ~~securities~~on ~~include~~third 33parties,~~705,854~~ ~~shares~~uncertainty ~~and~~regarding 31patents,~~075,178~~ ~~shares~~protection inof ~~2020 and~~proprietary ~~2019~~rights, ~~respectively,~~manufacturing ~~reserved~~of ~~for~~peptides, ~~the~~and ~~conversion~~technology ofobsolescence ~~convertible~~could ~~debt~~have ora ~~exercise~~significant ofimpact ~~outstanding~~on ~~options~~us and ~~warrants~~our operations.

~~Share-Based Compensation.~~To Weachieve ~~measure~~profitability, ~~share-based~~we, ~~compensation~~and/or ~~expense~~a ~~based~~partner, onmust ~~the~~successfully ~~grant~~conduct ~~date~~pre-clinical ~~fair~~studies ~~value~~and ofclinical ~~the~~trials, ~~awards~~obtain ~~which~~required ~~is then~~regulatory ~~recognized~~approvals ~~over~~and ~~the~~successfully ~~period~~manufacture ~~which~~and ~~service~~market isthose ~~required~~pharmaceuticals towe bewish ~~provided~~to commercialize. WeThe ~~estimate~~time ~~the~~required ~~grant~~to ~~date~~reach ~~fair~~profitability ~~value~~is ~~using~~highly ~~the~~uncertain, ~~Black-Scholes option-pricing~~and ~~model~~there ~~(“Black-Scholes”).~~can Webe ~~recognized~~no ~~$332,003~~assurance ~~and~~that ~~$269,740~~we inwill ~~share-based~~be ~~compensation~~able ~~expense~~to ~~for the~~achieve ~~years~~sustained ~~ended December 31~~profitability, ~~2020~~if ~~and~~at ~~2019, respectively~~all.

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.

~~Recently Adopted Accounting Pronouncements~~2. SUMMARY InOF ~~June 2018,~~SIGNIFICANT ~~the~~ACCOUNTING FASB issued Accounting Standards Update (“ASU”) 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees, and as a result, the accounting for share-based payments to non-employees will be substantially aligned. The Company adopted ASU 2018-07 in the first quarter of 2019 and the adoption of this ASU did not have a material impact on its financial statements and related disclosures.POLICIES

InUse ~~February 2016, the~~of ~~FASB~~Estimates. ~~issued~~The ~~ASU~~preparation ~~2016-02,~~of ~~Leases~~financial ~~(Topic~~statements ~~842)~~in conformity with accounting principles generally accepted in the United States of America (“~~ASC~~U.S. ~~842~~GAAP”), ~~which~~requires ~~amends~~management to make certain estimates and assumptions that affect the ~~existing~~reported ~~accounting~~earnings, ~~standards for~~financial ~~leases~~position and various disclosures. ~~The~~Critical ~~new~~accounting ~~standard~~policies ~~requires~~involved ~~lessees~~in toapplying ~~record~~our anaccounting ~~ROU~~policies ~~asset~~are ~~and~~those athat ~~corresponding~~require ~~lease~~management ~~liability~~to onmake ~~the~~assumptions ~~balance~~about ~~sheet~~matters ~~(with the~~that ~~exception~~are ofhighly ~~short-term~~uncertain ~~leases),~~at ~~whereas~~the ~~under~~time ~~prior~~the accounting ~~standards,~~estimate ~~the~~was ~~Company’s~~made ~~lease~~and ~~portfolio~~those ~~consists~~for ~~of an~~which ~~operating~~different ~~lease~~estimates ~~and~~reasonably ~~was~~could ~~not~~have ~~recognized~~been onused ~~its~~for ~~balance~~the ~~sheets~~current period. ~~The~~Critical ~~new~~accounting ~~standard~~estimates are also ~~requires~~those ~~expanded~~which ~~disclosures~~are ~~regarding leasing~~reasonably ~~arrangements.~~likely ~~The~~to ~~new~~change ~~standard~~from ~~was~~period ~~effective~~to ~~for~~period ~~the~~and ~~Company~~would ~~beginning~~have ~~January 1,~~a ~~2019.~~material Inimpact ~~July 2018,~~on the ~~FASB issued~~presentation ~~ASU~~of ~~2018-11,~~our ~~Leases~~financial ~~(Topic 842): Targeted Improvements~~condition, ~~which~~changes ~~provides~~in anfinancial ~~alternative~~condition ~~modified~~or ~~transition~~results ~~method~~of operations. ~~Under~~ ~~this~~Our ~~method,~~most ~~the~~critical ~~cumulative-effect~~accounting ~~adjustment~~estimates relate to ~~the~~accounting ~~opening~~policies ~~balance~~for ofrevenue ~~retained~~recognition, ~~earnings~~discount israte ~~recognized~~used onto calculate the ~~date~~present value of ~~adoption with~~the ~~prior~~future ~~periods~~lease ~~not~~payments ~~restated.~~and ~~The~~share-based ~~guidance~~arrangements. ~~must~~Management bebases ~~adopted~~its estimates on ahistorical ~~modified~~experience ~~retrospective~~and ~~basis~~on ~~and~~various ~~provides~~other ~~for~~assumptions ~~certain~~that ~~practical expedients.~~it Webelieves ~~adopted~~are ~~this~~reasonable ~~guidance~~under ~~effective~~the ~~January 1,~~circumstances. ~~2019,~~Actual ~~using~~results ~~the~~could ~~following~~differ ~~practical~~from ~~expedients:~~these estimates.

•Cash Weand ~~did~~Cash ~~not~~Equivalents. ~~reassess~~Cash ifand ~~any~~cash ~~expired~~equivalents consist of cash and highly liquid investments with original maturities of three months or ~~existing~~less ~~contracts~~when acquired and are, orstated ~~contain,~~at ~~leases~~cost that approximates their fair market value.

•Concentration Weof ~~did~~Credit ~~not~~Risk. ~~reassess~~Financial instruments which potentially subject the ~~classification~~Company to concentrations of ~~any~~credit ~~expired~~risk orconsist ~~existing~~primarily ~~leases~~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.

~~Additionally, we~~Property ~~made~~and ~~ongoing~~Equipment. ~~accounting~~Property ~~policy~~and ~~elections~~equipment ~~whereby~~consist weof ~~(i) do~~office ~~not~~furniture ~~recognize~~and ~~ROU~~equipment ~~assets~~and oris ~~lease~~stated ~~liabilities~~at ~~for~~cost ~~short-term leases~~and ~~(those~~depreciated ~~with~~over ~~original~~the ~~terms~~estimated useful lives of 12the ~~months~~assets or(generally ~~less)~~two ~~and~~to ~~(ii)~~five ~~combine~~years) ~~lease~~using ~~and~~the ~~non~~straight-~~lease~~line ~~elements~~method. Expenditures for maintenance and repairs which do not significantly prolong the useful lives of ~~our~~the ~~operating~~assets ~~leases~~are charged to expense as incurred. All property and equipment is fully depreciated at both December 31, 2021 and 2020.

~~Upon~~Impairment ~~adoption~~ of ~~the~~Long-lived ~~new~~Assets. ~~guidance~~When ~~on January 1, 2019,~~ we ~~recorded~~record along-lived ~~ROU~~assets, ~~asset~~our ofpolicy ~~approximately~~is ~~$60,000~~to ~~(net~~regularly ofperform ~~existing~~reviews ~~deferred~~to ~~rent~~determine ~~liability)~~ if and ~~recognized~~when athe ~~lease~~carrying ~~liability~~value of ~~approximately~~our ~~$65,000,~~long-lived ~~with~~assets nobecomes ~~resulting~~impaired. ~~cumulative~~During ~~effect~~the years ~~adjustment~~ended ~~to accumulated deficit. In June~~December ~~2020~~31, we2021 ~~renewed our office lease for two years~~ and ~~we recorded a ROU asset of approximately $82~~2020,~~000~~ ~~and~~no ~~recognized a~~impairment ~~lease~~losses ~~liability~~were ~~of approximately $82,000~~recorded.

FConvertible Notes with Detachable Warrants. In accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 470-1120, 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.

~~Accounting Standard~~Revenue ~~Not~~Recognition. ~~Yet~~The ~~Adopted.~~Company Inanalyzes ~~December 2019,~~contracts to determine the ~~FASB~~appropriate ~~issued~~revenue ~~ASU~~recognition ~~No. 2019-12, Income~~using ~~Taxes~~the ~~(Topic~~following ~~740)~~steps: ~~Simplifying~~ ~~the~~(i) identification ~~Accounting~~of ~~for~~contracts ~~Income~~with ~~Taxes~~customers, ~~which~~(ii) identification ~~simplifies~~of distinct performance obligations in the ~~accounting~~contract, ~~for~~(iii) determination ~~income~~of ~~taxes.~~contract ~~The~~transaction ~~new~~price, ~~guidance~~(iv) allocation ~~removes certain~~of ~~exceptions~~contract transaction price to the ~~general~~performance ~~principles~~obligations ~~for~~and ~~income~~(v) determination ~~taxes~~of ~~and~~revenue ~~also~~recognition ~~improves~~based ~~consistent~~on ~~application~~timing of ~~accounting~~satisfaction ~~by clarifying~~of orthe ~~amending~~performance ~~existing guidance~~obligation. The ~~new~~Company ~~standard~~recognizes isrevenues ~~effective~~upon ~~for~~the ~~fiscal~~satisfaction ~~years~~of ~~beginning~~its ~~after~~performance ~~December 15, 2020,~~obligation ~~and~~(upon ~~interim~~transfer ~~periods~~of ~~within~~control ~~those~~of ~~years.~~promised Wegoods ~~are~~or ~~currently~~services ~~evaluating~~to ~~the~~our ~~impact~~customers) in an amount that reflects the ~~new~~consideration ~~guidance~~to ~~will~~which ~~have~~it onexpects ~~our financial~~to ~~statements~~be entitled to in exchange for those goods or services. ~~The~~Whenever ~~Company~~we ~~has~~determine ~~evaluated~~that ~~all~~an ~~other~~arrangement ~~issued~~should ~~and~~be ~~unadopted~~accounted ~~ASUs~~for ~~and~~as ~~believes~~a ~~the~~single ~~adoption~~unit of ~~these standards~~accounting, ~~will~~we ~~not~~must ~~have~~determine athe ~~material~~period ~~impact~~over onwhich ~~its~~the ~~results~~performance ofobligations ~~operations~~will be performed, ~~financial~~and ~~position~~revenue orwill ~~cash~~be ~~flows~~recognized. Revenue will be recognized using either a relative

~~3. FAIR VALUE MEASUREMENTS~~F-8

~~The~~Table 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:~~Contents

•performance ~~Level~~or 1straight-line —method. ~~Quoted~~We ~~prices~~recognize inrevenue ~~active~~using ~~markets~~the ~~for~~relative ~~identical~~performance ~~assets~~method provided that we can reasonably estimate the level of effort required to complete our performance obligations under an arrangement and ~~liabilities~~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 ~~Level~~Company’s 2contracts —with ~~Observable~~customers ~~inputs~~may ~~other~~at ~~than~~times ~~quoted~~include ~~prices~~multiple inpromises ~~active~~to ~~markets~~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 ~~identical~~as ~~assets~~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 ~~liabilities~~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 ~~Level~~the 3Company —determines ~~Unobservable~~that ~~inputs~~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.

AsIf ofthe ~~December 31, 2020,~~Company ~~and~~cannot ~~2019,~~reasonably ~~our~~estimate ~~only~~the ~~qualifying~~level ~~assets~~of ~~that~~effort required ~~measurement~~to complete our performance obligation under an arrangement, the ~~foregoing~~performance ~~fair~~obligation ~~value~~is ~~hierarchy~~provided ~~were~~on ~~funds~~a ~~held~~best-efforts ~~in our~~basis ~~Company~~and ~~bank~~we ~~accounts~~can ~~included~~reasonably inestimate ~~cash~~when the performance obligation ceases or the remaining obligations become inconsequential and ~~cash~~perfunctory, ~~equivalents~~then ~~valued~~the attotal ~~$427~~payments under the arrangement,~~898~~ excluding royalties and ~~$639~~payments contingent upon achievement of substantive milestones,~~916,~~ ~~respectively~~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 ~~Level~~the 1straight-line ~~inputs~~basis, as of the period ending date.

4At 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. ~~LICENSES~~If it is probable that a significant revenue reversal would not occur in the future, ~~INTELLECTUAL~~the ~~PROPERTY~~associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, ~~AND~~such ~~RELATED~~as ~~PARTY~~regulatory ~~TRANSACTIONS~~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.

~~We have~~Amounts ~~filed~~received ~~numerous~~prior ~~additional~~to ~~patent~~satisfying ~~applications~~the ~~covering~~above ~~various~~revenue ~~compositions,~~recognition ~~uses,~~criteria ~~formulations~~are ~~and~~recorded ~~other components of Tb4,~~ as ~~well~~unearned asrevenue toin ~~novel peptides resulting from~~ our ~~research~~accompanying ~~efforts.~~balance ~~Some of these patents have been issued, while many patent applications are still pending~~sheets.

WeContract ~~have also~~assets ~~entered~~are ~~into~~generated anwhen ~~agreement~~contractual ~~with~~billing aschedules ~~university~~differ ~~under~~from ~~the~~revenue ~~terms~~recognition oftiming. ~~which~~Contract weassets ~~have~~represent ~~received~~a anconditional ~~exclusive~~right ~~license~~ to ~~technology~~consideration ~~and intellectual~~for ~~property. The~~satisfied ~~agreement,~~performance ~~which~~obligations isthat ~~generally~~becomes ~~cancelable~~a bybilled ~~us,~~receivable ~~provided~~when ~~for~~ the ~~payment~~conditions ofare ~~a license issue fee and/or minimum annual payments~~satisfied. ~~The~~ ~~initial~~There ~~license~~were ~~fee of $25,000 was paid in 2010 and~~ no ~~minimum~~contract ~~fees~~assets ~~were~~as ~~due~~of ~~for the year ended~~ December 31, ~~2011.~~2021 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~~2020. 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~~Contract ~~license fees~~liabilities ~~are~~result ~~included~~from inarrangements ~~Research~~where ~~and~~we ~~Development~~have received payment in advance of performance under the ~~accompanying~~contract. ~~statements~~Changes in contract liabilities are generally due to either receipt of ~~operations~~additional advance payments or our performance under the contract.

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~~following toamounts ~~exclusively~~recorded 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~~contract 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, 2020 and 2019, 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.liabilities:

F-12

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 license agreement for RGN~~F-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.9

~~Under~~Table 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, 2020 and 2019, we have unearned revenue totaling $684,058 and $718,840, respectively, pursuant to this agreement. Revenue will be recognized for future royalty payments as they are earned.Contents

~~Each~~The ~~license agreement~~contract ~~contains~~liabilities ~~diligence~~amount ~~provisions~~disclosed ~~that~~above ~~require~~are ~~the~~primarily ~~initiation~~related 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~~revenue ~~license~~being ~~any~~recognized ~~improvements made by GtreeBNT to our products outside of the licensed territory~~ on a ~~royalty~~straight-line ~~free~~ basis. ~~The~~over ~~two~~periods ~~firms~~ranging ~~have~~from ~~created~~23 ato ~~joint~~30 ~~development~~years, ~~committee~~which, ~~and~~in ~~continue to~~management’s ~~discuss~~judgment, ~~the~~is ~~development of~~ the ~~licensed~~best ~~products~~measure ~~and~~of ~~share~~progress ~~information~~towards ~~relating~~satisfying ~~thereto.~~the ~~Both~~performance ~~companies~~obligations ~~will also share all non-clinical~~ and ~~clinical~~represents ~~data~~the ~~and~~Company’s ~~other~~best ~~information~~estimate ~~related~~of tothe ~~development~~period of the ~~licensed product candidates~~obligation.

OnRevenue ~~January 28, 2015,~~recognized ~~the~~from ~~Company~~contract ~~entered~~liabilities ~~into~~during the years ~~Joint~~ended ~~Venture~~December 31, ~~Agreement~~2021 ~~with~~and ~~GtreeBNT~~2020, atotaled ~~shareholder~~$76,761 inand ~~the~~$76,761, ~~Company~~respectively. ~~The~~Revenue ~~Joint~~is ~~Venture~~expected ~~Agreement provides~~to ~~for~~be ~~the~~recognized ~~creation~~in of the ~~Joint~~future ~~Venture,~~from ~~jointly~~contract ~~owned~~liabilities byas the ~~Company~~related ~~and~~performance ~~GtreeBNT,~~obligations ~~which~~are ~~is commercializing RGN-259 for treatment of dry eye and neurotrophic keratitis in the U~~satisfied.~~S. and Canada.~~

~~GtreeBNT is~~Variable ~~solely~~Interest ~~responsible~~Entities. ~~for~~On ~~funding~~January 28, ~~all~~2015, the ~~product~~Company ~~development~~entered ~~and~~into ~~commercialization~~a ~~efforts of the~~ Joint Venture. ~~GtreeBNT~~Agreement ~~made an~~with ~~initial~~GtreeBNT, ~~contribution~~a ofshareholder ~~$3 million~~ in ~~cash~~the ~~and~~Company. ~~received~~The anJoint ~~initial~~Venture ~~equity~~Agreement ~~stake~~provides offor ~~51%.~~the ~~RegeneRx’s~~operation ~~ownership~~of ~~interest in~~the ~~ReGenTree~~joint ~~was~~venture, ~~reduced~~jointly toowned ~~38.5%~~by ~~when~~ the ~~Clinical~~Company ~~Study~~and ~~Report~~GtreeBNT, ~~was~~which ~~filed~~is commercializing RGN-259 for the ~~Phase~~treatment ~~2/3~~of dry eye ~~clinical trial. Based on when,~~ and ~~if,~~neurotrophic ~~certain~~keratitis ~~additional development milestones are achieved~~ in the U.S. ~~with~~and ~~RGN-259,~~Canada. ~~our~~The ~~equity~~Company ~~ownership~~has ~~may~~determined bethat ~~incrementally reduced~~the toJoint ~~between~~Venture ~~38.5%~~is ~~and~~a ~~25%,~~“variable ~~with~~interest ~~25%~~entity” ~~being~~since the ~~final~~total equity ~~ownership~~investment ~~upon~~at ~~approval~~risk ofis anot ~~BLA~~sufficient ~~for~~to ~~DES~~permit in the ~~U.S.~~Joint InVenture ~~addition~~ to ~~our~~finance ~~equity~~its ~~ownership,~~activities ~~RegeneRx~~without ~~retains~~additional asubordinated ~~royalty~~financial onsupport. ~~net~~Further, ~~sales~~because ~~that~~of ~~varies~~GtreeBNT’s ~~between~~majority ~~single~~equity ~~and~~stake ~~low~~in ~~double~~the ~~digits~~Joint Venture, ~~depending~~voting ~~on whether~~control, ~~commercial~~control ~~sales~~of ~~are~~the ~~made~~board byof ~~ReGenTree~~directors, orand asubstantive ~~licensee.~~management Inrights, and given that the ~~event~~Company ~~ReGenTree~~does isnot ~~acquired~~have orthe ~~there~~power isto adirect ~~change~~the ofJoint ~~control~~ Venture’s activities that ~~occurs~~most ~~following~~significantly ~~achievement~~impact ofits aeconomic ~~BLA~~performance, ~~RegeneRx~~the ~~shall~~Company bedetermined ~~entitled~~that toit ais ~~minimum~~not ofthe ~~40%~~primary beneficiary of ~~all~~the ~~proceeds~~Joint ~~paid~~Venture orand ~~payable~~therefore ~~and will~~is ~~forgo~~not ~~any~~required ~~future~~to ~~royalties~~consolidate the Joint Venture. The Company isreports its equity stake in the Joint Venture using the equity method of accounting because, while it does not ~~required~~control orthe ~~otherwise~~Joint ~~obligated~~Venture, tothe ~~provide~~Company ~~financial~~can ~~support~~exert tosignificant influence over the Joint Venture's activities by virtue of its board representation.

~~F-13~~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.

~~The~~Research ~~Joint Venture is responsible for executing all development~~ and ~~commercialization~~Development. ~~activities~~R&D ~~under~~expenditures ~~the~~are ~~license~~expensed ~~agreement,~~as ~~which~~incurred ~~activities will be directed by a joint development committee comprised of representatives of the Company~~ and ~~GtreeBNT.~~are ~~The~~subject ~~license agreement has a term that extends~~ to the ~~later~~risks ofand ~~the~~uncertainties ~~expiration~~associated ofwith ~~the~~clinical ~~last~~trials ~~patent~~and ~~covered by~~ the ~~agreement~~FDA orreview 25and ~~years~~approval ~~from the first commercial sale under the agreement~~process. ~~The~~As ~~license~~a ~~agreement~~result, ~~may~~these beexpenses ~~earlier~~could ~~terminated~~exceed ifour ~~the Joint Venture fails to meet certain commercialization milestones~~expectations, ifpossibly ~~either~~materially. ~~party~~We ~~breaches~~are ~~the~~uncertain ~~license~~as ~~agreement and fails~~ to ~~cure~~what ~~such~~we ~~breach,~~will asincur ain ~~result~~future ofresearch ~~government~~and ~~action~~development ~~that limits~~costs ~~the~~for ~~ability~~our ofclinical ~~the Joint Venture to commercialize the product~~studies, as athese ~~result~~amounts ofare asubject ~~challenge~~ to amanagement's ~~licensed~~continuing ~~patent,~~assessment ~~following termination~~ of the ~~license~~economics ~~between~~of ~~the~~each ~~Company~~individual research and ~~certain~~development ~~agencies~~project ofand the ~~United~~internal ~~States~~competition ~~federal~~for ~~government,~~project ~~or upon the bankruptcy of either party~~funding.

~~Under~~Patent ~~the license agreement, the Company received $1~~Costs.0 ~~million~~Costs inrelated ~~up-front payments and is entitled~~ to ~~receive~~filing ~~royalties on the Joint Venture’s future sales of products. On April 6, 2016, we received $250,000 from ReGenTree~~ and ~~executed~~pursuing anpatent ~~amendment~~applications toare ~~the~~recognized ~~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 ageneral 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.~~administrative ~~The~~expenses ~~Company~~as ~~evaluated~~incurred ~~the~~since ~~promised~~recoverability ~~goods and services under the license agreements and determined that there was one combined performance obligation representing a series~~ of ~~distinct~~such ~~goods~~expenditures ~~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 obligationuncertain. As of December 31, 2020 and 2019, we have unearned revenue totaling $1,017,267 and $1,059,246, respectively, pursuant to this agreement. Revenue will be recognized for future royalty payments as they are earned.

5Income Taxes. ~~COMPOSITION~~Income OFtaxes ~~CERTAIN~~are ~~FINANCIAL~~accounted ~~STATEMENT~~for ~~CAPTIONS~~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.

~~Prepaid~~The ~~expenses~~ultimate ~~and other~~realization ~~current~~of deferred tax assets ~~are~~is ~~comprised~~dependent upon the generation of future taxable income during the ~~following:~~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.

	December 31,
	2020		2019
Prepaid insurance	$	39,196	$	27,453
Other		10,713		14,186
	$	49,909	$	41,639

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.

~~Accrued expenses are comprised of the following:~~F-10

	December 31,
	2020		2019
Accrued professional fees	$	12,394	$	8,479
Accrued other		48,735		23,000
Accrued compensation		29,300		15,565
Accrued interest - convertible debt		118,428		47,976
	$	208,857	$	95,020

Table of Contents

6We 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. ~~EMPLOYEE~~Use ~~BENEFIT~~of ~~PLANS~~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.

InNet ~~2020~~ Loss Per Common Share. Basic net loss per common share for 2021 and ~~2019~~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 ~~Company~~weighted ~~provided~~average ~~health~~number ~~and~~of ~~dental~~shares ~~insurance~~of tocommon anstock ~~employee~~outstanding ~~under~~plus dilutive securities with a ~~group~~purchase ~~plan~~or conversion price below the per share price of our common stock on the last day of the year. NoThe ~~retirement~~potentially ~~plan~~dilutive ~~was~~securities include 49,889,304 shares and 33,705,854 shares in ~~place~~2021 ~~for~~ and 2020, respectively, reserved for the conversion of convertible debt or ~~2019~~exercise of outstanding options and warrants.

FShare-14Based 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.

7Fair Value of Financial Instruments. ~~CONVERTIBLE~~The ~~NOTES~~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.

~~2014 Convertible~~Adopted ~~Notes~~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.

OnImpact ~~January 7, 2014, we completed a private placement~~ of ~~convertible~~recently ~~notes~~issued ~~raising~~accounting anstandards. ~~aggregate~~In ofJune ~~$55~~2016,~~000~~ inthe ~~gross~~FASB ~~proceeds~~issued ~~(the~~ASU ~~“January 2014 Notes”)~~No. ~~The~~ ~~January 2014 Notes bore interest at a rate of 5% per annum~~2016-13, ~~mature~~Financial ~~sixty~~Instruments ~~(60)~~- ~~months~~Credit ~~after their~~Losses ~~date~~which ofrequires ~~issuance~~financial ~~and~~assets ~~were~~measured ~~convertible~~at ~~into~~amortized ~~shares~~cost ofbasis ~~our~~to ~~common~~be ~~stock~~presented at athe ~~conversion~~net ~~price~~amount ofexpected ~~six~~to ~~cents~~be ~~($0~~collected.~~06)~~ ~~per~~This ~~share (subject~~standard tois ~~adjustment~~effective asfor ~~described~~fiscal inyears ~~the~~beginning ~~January 2014~~after ~~Notes)~~December at15, ~~any~~2022 ~~time~~and ~~prior~~the toCompany ~~repayment,~~is atcurrently evaluating the ~~election~~expected impact of ~~the~~this ~~investor. In the~~ASU ~~aggregate,~~but ~~the~~does ~~January 2014~~not ~~Notes~~expect ~~were~~it ~~initially~~to ~~convertible~~have ~~into~~a upmaterial toimpact ~~916,667~~on ~~shares~~its offinancial ~~our~~statements ~~common~~upon ~~stock~~adoption.

AtIn ~~any~~August ~~time prior~~2020, tothe ~~maturity~~FASB ofissued ~~the~~ASU ~~January 2014~~No. ~~Notes~~2020-06, Debt—Debt with ~~the~~Conversion ~~consent~~and ofOther ~~the~~Options ~~holders~~(Subtopic of470-20) aand ~~majority~~Derivatives inand ~~interest~~Hedging—Contracts ofin ~~the~~Entity’s ~~January 2014 Notes,~~Own weEquity ~~could~~(Subtopic ~~prepay~~815-40): ~~the~~Accounting ~~outstanding~~for ~~principal~~Convertible ~~amount~~Instruments ofand ~~the~~Contracts ~~January 2014~~in ~~Notes~~an ~~plus~~Entity’s ~~unpaid~~Own ~~accrued interest without penalty~~Equity. ~~Upon the~~ ~~commission~~This ofASU ~~any~~simplifies ~~act of bankruptcy by~~ the ~~Company,~~accounting ~~the~~for ~~execution~~convertible byinstruments. ~~the~~This ~~Company~~ASU ofalso arequires ~~general~~entities ~~assignment~~to ~~for~~use the ~~benefit~~if-converted ~~of creditors,~~method ~~the~~for ~~filing~~all byconvertible orinstruments ~~against the Company of a petition~~ in ~~bankruptcy~~calculating ordiluted ~~any~~earnings-per-share. ~~petition~~The ~~for~~ASU ~~relief~~is ~~under~~effective ~~the federal bankruptcy act or the continuation of such petition without dismissal~~ for aannual ~~period~~periods ofbeginning 90after ~~days~~December ~~or more~~15, or2021 ~~the~~with ~~appointment~~early ofadoption apermitted. ~~receiver~~The ~~or trustee~~Company tois ~~take~~currently ~~possession~~evaluating of the ~~property~~impact orthis ~~assets~~standard ofwill ~~the~~have ~~Company, the outstanding principal and all accrued interest~~ on ~~the January 2014~~its ~~Notes~~financial ~~would accelerate and automatically become immediately due and payable~~statements.

The ~~investors in~~Company ~~the~~has ~~offering~~evaluated ~~included~~all ~~two~~other ~~current~~issued and ~~one~~unadopted ~~former~~ASUs ~~member~~and ofbelieves the ~~Board~~adoption of ~~Directors.~~these ~~The~~standards ~~principal~~will ~~amounts~~not ofhave ~~their~~a ~~respective January 2014~~material ~~Notes~~impact ~~were~~on asits ~~set~~results ~~forth~~of ~~below:~~operations, financial position or cash flows.

Investor	Note Principal
Joseph C. McNay	$	25,000
Allan L. Goldstein	$	10,000
L. Thompson Bowles	$	5,000

The Company evaluated the terms of the January 2014 Notes which contain a down round provision under which the conversion price could be decreased as a result of future equity offerings, as defined in the January 2014 Notes. The adjustment would reduce the conversion price of the January 2014 Notes to be equivalent to that of the newly issued stock or stock-related instruments. As a result, the Company concluded that the conversion feature represented an embedded conversion feature for accounting purposes and should be recognized as a derivative liability, requiring a mark-to-market adjustment at the end of each reporting period until the related January 2014 Notes were settled. The bifurcated liability of $55,000 was recorded on the date of issuance which resulted in a residual debt value of $0. The discount related to the embedded feature is being accreted back to debt through the maturity of the notes. The January 2014 Notes matured, and the holders elected to convert the note balances of $55,000 and accrued interest of approximately $14,000 into common stock in January 2019.

~~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~~. FAIR ~~The~~VALUE 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.MEASUREMENTS

AtThe ~~any~~authoritative ~~time prior~~guidance tofor ~~maturity~~fair ofvalue ~~the~~measurements ~~2019~~defines ~~Notes,~~fair ~~with~~value as the ~~consent~~exchange ofprice ~~the~~that ~~holders~~would ofbe received for an asset or paid to transfer a ~~majority~~liability (an exit price) in ~~interest~~the ofprincipal or the ~~2019~~most ~~Notes,~~advantageous wemarket ~~can~~for ~~prepay~~ the ~~outstanding~~asset ~~principal~~or ~~amount~~liability ofin ~~the~~an ~~2019~~orderly ~~Notes~~transaction ~~plus~~between ~~unpaid~~market ~~accrued~~participants ~~interest~~on ~~without~~the ~~penalty~~measurement date. ~~The~~Market ~~outstanding~~participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and ~~all~~ ~~accrued~~(iv) willing ~~interest~~to transact. The guidance describes a fair value hierarchy based on the ~~2019~~levels ~~Notes~~of ~~will~~inputs, ~~accelerate~~of ~~and~~which ~~automatically~~the ~~become~~first ~~immediately~~two ~~due~~are ~~and~~considered ~~payable~~observable ~~upon~~and the ~~occurrence of~~last ~~certain~~unobservable, ~~events~~that ofmay ~~default.~~be used to measure fair value which are the following:

In● ~~connection with~~Level ~~the~~1 ~~issuance~~— ofQuoted ~~the~~prices ~~2019~~in ~~Notes~~active wemarkets ~~also issued warrants to each investor. The warrants are exercisable~~ for anidentical ~~aggregate~~assets 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~~liabilities.~~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 the intrinsic value of that feature to additional paidF-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.11

~~F-15~~Table of Contents

~~The~~● ~~affiliated investors~~Level ~~and~~2 ~~the~~— ~~principal~~Observable ~~amount~~inputs ofother ~~their~~than ~~respective~~quoted ~~2019~~prices ~~Notes~~in ~~purchase~~active ~~are~~markets asfor ~~set~~identical ~~forth~~assets ~~below:~~and liabilities.

Investor	Note Principal
Essetifin S.p.A.	$	1,000,000
Joseph C. McNay	$	25,000
J.J. Finkelstein	$	25,000
Mauro Bove	$	10,000
Allan L. Goldstein	$	5,000
R. Don Elsey	$	5,000

●

Level 3 — Unobservable inputs.

~~Essetifin S.p.A.~~As of December 31, ~~our~~2021 ~~largest~~and ~~stockholder.~~2020, ~~The~~our ~~other~~only ~~listed~~qualifying ~~investors~~assets ~~are~~that ~~members~~required ofmeasurement ~~our~~under ~~Board~~the offoregoing ~~Directors~~fair ~~including~~value ~~Mr. Finkelstein, who~~hierarchy ~~serves~~were asfunds held in our ~~CEO,~~Company ~~and~~bank ~~Dr. Goldstein~~accounts ~~who~~included ~~serves~~in ascash ~~our~~and ~~Chief~~cash ~~Scientific~~equivalents ~~Advisor~~valued at $112,703 and ~~Chairman~~$107,854, ofrespectively, ~~our~~using ~~Board~~Level of1 ~~Directors~~inputs.

~~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~~4.~~p.A.~~ LICENSES, ~~our~~INTELLECTUAL ~~largest stockholder. The sale of the notes resulted in gross proceeds to the Company of $500~~PROPERTY,~~000 (the~~ ~~“2020~~AND ~~Notes”).~~RELATED ~~The~~PARTY 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.TRANSACTIONS

AtWe ~~any~~have ~~time prior~~filed tonumerous ~~maturity~~additional ofpatent ~~the~~applications ~~2020~~covering ~~Notes~~various compositions, ~~with~~uses, ~~the~~formulations ~~consent~~and ofother ~~the~~components ~~holders~~ of ~~a majority in interest of the 2020 Notes~~Tß4, weas ~~can~~well ~~prepay the~~as ~~outstanding~~to ~~principal~~novel ~~amount~~peptides ofresulting ~~the~~from ~~2020~~our ~~Notes~~research ~~plus unpaid accrued interest without penalty~~efforts. ~~The~~Some ~~outstanding~~of ~~principal~~these ~~and all~~patents ~~accrued~~have ~~interest~~been onissued, ~~the~~while ~~2020~~many ~~Notes~~patent ~~will~~applications ~~accelerate~~are ~~and~~still ~~automatically become immediately due and payable upon the occurrence of certain events of default~~pending.

InWe ~~connection~~ have also entered into an agreement with ~~the~~a ~~issuance~~university ofunder the ~~2020~~terms ~~Notes~~of which we ~~also~~have ~~issued~~received ~~warrants~~an exclusive license to ~~each~~technology ~~investor~~and intellectual property. The ~~warrants~~agreement, ~~are~~which ~~exercisable~~is ~~for~~generally ancancelable ~~aggregate~~by ~~of 1~~us,~~043,988~~ ~~shares~~provided for the payment of ~~common~~a ~~stock~~license ~~with~~issue anfee ~~exercise~~and/or ~~price~~minimum ofannual ~~forty-five~~payments. ~~cents~~The (initial license fee of $~~0.45)~~25,000 ~~per~~was ~~share~~paid ~~for~~in a2010 ~~period~~and ofno ~~five~~minimum ~~years~~fees (were due for the year ~~“2020 Warrants”).~~ended ~~The~~December 31, ~~relative~~2011. ~~fair~~Beginning ~~value~~in of2012, ~~the~~minimum ~~2020~~annual ~~Warrants~~maintenance ~~issued~~fees ~~was~~are $~~176~~5,~~573~~000 ~~calculated~~annually ~~using~~which was paid in 2012 but has not been paid since. In addition, the ~~Black-Scholes-Merton~~agreements ~~valuation model~~provide ~~value~~for payments upon the achievement of $0certain milestones in product development.26 The agreement also requires us to fund certain costs associated with anthe ~~expected~~filing and ~~contractual~~prosecution ~~life~~ of ~~five~~patent ~~years~~applications. In February 2013, this agreement was amended to include additional technology and intellectual property. The expanded license does not require payment of an ~~assumed~~initial ~~volatility~~license fee or additional annual maintenance fees but will be subject to payments upon the achievement of ~~74.6%,~~certain ~~and~~milestones for a ~~risk-free~~product ~~interest rate~~developed ofunder ~~0.32%.~~the ~~The~~amended ~~2020~~license ~~Warrants~~of ~~are~~the ~~classified~~additional intechnology ~~equity~~and intellectual property.

~~The~~All ~~Company allocated~~license ~~$176,573~~fees ofare ~~the~~included 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.~~Research ~~The debt discount created by the 2020 Warrants~~ and ~~beneficial conversion~~Development ~~feature~~in ~~is amortized over~~ the ~~term~~accompanying statements of ~~the 2020 Notes as additional interest expense using the effective interest method~~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 ~~affiliated investors~~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 ~~principal~~promised ~~amount~~goods and services under the agreement and determined that there was one combined performance obligation representing a series of ~~their~~distinct ~~respective~~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, ~~Notes~~we ~~purchase~~have ~~are~~unearned revenue totaling $400,000 pursuant to this Agreement. Revenue will be recognized for future royalty payments as ~~set~~they ~~forth~~are ~~below:~~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.

Investor	Note Principal
Essetifin S.p.A.	$	400,000
J.J. Finkelstein	$	10,000
Mauro Bove	$	10,000
Allan L. Goldstein	$	5,000

F-1612

~~The~~Table ~~Company recorded~~of ~~interest expense and discount accretion as set forth below:~~Contents

	For the years ended
	December 31, 2020		December 31, 2019
January 2014 Notes	$	-	$	479
2019 Notes		207,610		152,931
2020 Notes		25,021		-
Total interest expense	$	232,631	$	153,410

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.

8Under 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. ~~STOCKHOLDERS~~(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 ~~EQUITY~~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.

~~Common Stock.~~Each Inlicense ~~January 2019,~~agreement contains diligence provisions that require the ~~January 2014~~initiation ~~Notes~~of ~~matured~~certain clinical trials within certain time periods that, ~~and~~if not met, would result in the ~~holders~~loss ~~elected~~of rights or exclusivity in certain countries. GtreeBNT will pay for all developmental costs associated with each product candidate. We have the right to ~~convert~~exclusively license any improvements made by GtreeBNT to our products outside of the ~~note balances~~licensed ~~and~~territory ~~accrued~~on ~~interest~~a ~~into~~royalty ~~common~~free ~~stock~~basis. AsThe two firms have created a ~~result,~~joint wedevelopment ~~issued~~committee ~~1,149,016~~and ~~shares~~continue to discuss the development of ~~common~~the ~~stock~~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 ~~March~~January 228, ~~2018~~ 2015, wethe Company entered into the ~~Reprice~~Joint Venture Agreement with ~~Sabby Healthcare Master Fund~~GtreeBNT, ~~Ltd.,~~ ~~and~~a ~~Sabby~~shareholder ~~Volatility~~in ~~Warrant Master Fund, Ltd. (collectively, “Sabby”). In connection with that certain securities purchase agreement between~~ the Company. ~~and~~The ~~Sabby~~Joint ~~dated~~Venture ~~June 27, 2016 (the “Purchase~~ Agreement”) weprovides ~~also~~for ~~issued to Sabby warrants to purchase 5,147,059 shares of common stock (~~the ~~“Warrant~~creation ~~Shares”) at an exercise price~~ of ~~$0.51 per share (~~the ~~“Sabby~~Joint ~~Warrants”).~~Venture, ~~Under~~jointly ~~the~~owned ~~terms~~by of the ~~Reprice~~Company ~~Agreement~~and GtreeBNT, inwhich ~~consideration~~is ofcommercializing ~~Sabby~~RGN-259 ~~exercising~~for intreatment ~~full all~~ of ~~the~~ ~~Sabby~~dry ~~Warrants~~eye ~~(the~~and ~~“Warrant~~neurotrophic ~~Exercise”),~~keratitis ~~the~~in ~~exercise price per share of~~ the ~~Sabby Warrants was reduced to $0~~U.~~20 per share~~S. ~~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~~Canada.~~2301 per share, the closing bid price for the Company’s Common Stock on February 28, 2018 (the “March Warrants”).~~

~~The~~GtreeBNT ~~exercise~~is ~~price~~solely ~~under~~responsible for funding all the ~~March Warrants~~product isdevelopment ~~subject~~and tocommercialization aefforts ~~limited~~of ~~anti-dilution provision,~~the ~~such~~Joint ~~that~~Venture. inGtreeBNT ~~the~~made ~~event~~an ~~the~~initial ~~Company~~contribution ~~makes~~of $3 million in cash and received an ~~issuance~~initial equity stake of ~~common~~51%. ~~stock~~RegeneRx’s ~~(subject~~ownership interest in ReGenTree was reduced to ~~customary~~38.5% ~~exceptions)~~when atthe aClinical ~~price per~~Study ~~share~~Report ~~less~~was ~~than~~filed for the ~~applicable~~Phase ~~exercise~~2/3 ~~price~~dry ofeye ~~the~~clinical ~~March Warrants~~trial. Based on when, ~~the~~and ~~exercise~~if, ~~price~~certain ofadditional development milestones are achieved in the ~~March Warrants will~~U.S. with RGN-259, our equity ownership may be incrementally reduced to ~~the~~between ~~price~~38.5% ~~per~~and ~~share~~25%, ~~applicable~~with to25% ~~such~~being ~~new~~the ~~issuance~~final ~~but~~equity ~~will~~ownership ~~not~~upon ~~adjust~~approval toof ana ~~exercise~~BLA ~~price~~for ~~below~~DES $0in the U.~~125~~S. As In addition to our equity ownership, RegeneRx retains a ~~result~~royalty ofon ~~the~~net ~~issuance~~sales ofthat ~~the~~varies ~~2019~~between ~~Notes~~single and ~~Warrants~~low double digits, ~~the~~depending ~~exercise~~on ~~price~~whether ofcommercial ~~the~~sales ~~March~~are ~~Warrants~~made ~~was~~by ~~adjusted~~ReGenTree toor ~~$0.125 per~~a ~~share~~licensee. ~~The~~In ~~estimated~~the ~~fair~~event ~~value~~ReGenTree ofis ~~the~~acquired ~~effect~~or there is a change of ~~the~~control ~~exercise~~that ~~price~~occurs ~~adjustment~~following achievement of ~~$82~~a BLA,~~566~~ isRegeneRx ~~reflected~~shall asbe entitled to a ~~dividend~~minimum of 40% of all proceeds paid or payable and will forgo any future royalties. The Company is not required or otherwise obligated to ~~Sabby~~ ~~for~~provide ~~the~~financial ~~year~~support ~~end~~to ~~December 31,~~the ~~2019~~Joint Venture.

~~Subsequent~~The toJoint ~~the~~Venture ~~reduction~~is ofresponsible for executing all development and commercialization activities under the ~~exercise~~license ~~price~~agreement, which activities will be directed by a joint development committee comprised of representatives of the ~~March Warrants to~~Company $0and GtreeBNT.~~125~~ inThe ~~2019,~~license ~~Sabby~~agreement ~~exercised~~has ~~warrants~~a ~~for~~term ~~925,000~~that ~~shares~~extends to the later of ~~common~~the ~~stock~~expiration ~~and~~of the ~~Company~~last ~~received~~patent ~~exercise~~covered ~~proceeds~~by ~~of $115,625~~the agreement or 25 years from the first commercial sale under the agreement. ~~Sabby~~The ~~exercised~~license ~~additional~~agreement ~~warrants~~may onbe ~~April 23~~earlier terminated if the Joint Venture fails to meet certain commercialization milestones, ~~2019~~if ~~for~~either 1party breaches the license agreement and fails to cure such breach,~~000,000~~ ~~shares~~as a result of ~~common~~government ~~stock~~action ~~and~~that limits the ~~Company received~~ability ~~exercise~~of ~~proceeds~~the ofJoint ~~$125~~Venture to commercialize the product,~~000.~~ ~~Sabby~~as ~~exercised~~a ~~their~~result ~~remaining~~of ~~warrants~~a onchallenge ~~January 17,~~to ~~2020~~a ~~for~~licensed 1patent,~~935,294 shares~~ following termination of ~~common~~the ~~stock~~license ~~and~~between the Company ~~received~~and ~~exercise~~certain ~~proceeds~~agencies of ~~$241~~the United States federal government,~~911~~ or upon the bankruptcy of either party.

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 reF-~~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.~~13

~~The~~Table ~~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.Contents

~~Share-Based Compensation.~~Under Wethe ~~recognized~~license ~~$332~~agreement,~~003~~ ~~and~~the Company received $~~269,740~~1.0 million in ~~stock~~up-~~based~~front ~~compensation~~payments ~~expense~~and ~~for~~is entitled to receive royalties on the ~~years~~Joint ~~ended~~Venture’s ~~December~~future sales of products. On April 316, ~~2020~~ 2016, we received $250,000 from ReGenTree and ~~2019~~executed an amendment to the license agreement on April 28, ~~respectively~~2016. WeUnder ~~expect~~the amendment the territorial rights were expanded to ~~recognize~~include Canada. The Company is accounting for the ~~compensation~~license ~~cost~~agreement ~~related~~with the Joint Venture as a revenue arrangement. Since participation in the joint development committee is required, it was deemed to ~~non~~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-~~vested~~259 ~~options~~and asparticipation in the joint development committee. Revenue is being recognized on a straight-line basis over a period of ~~December~~30 31years, ~~2020~~ ofwhich, ~~$423~~in management’s judgment,~~000~~ ~~over~~is the ~~weighted~~best ~~average~~measure ~~remaining~~of ~~recognition~~progress towards satisfying the performance obligation and represents the Company’s best estimate of the period of 1the obligation.27 As of December ~~years~~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.

~~F-17~~

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. COMPOSITION ~~Pursuant~~OF toCERTAIN ~~this~~FINANCIAL ~~plan~~STATEMENT provision, on July 1, 2020, 2,668,836 additional shares of common stock became available for grant under the 2018 Plan. On July 1, 2019, 2,630,130 additional shares of common stock became available for grant under the 2018 Plan.CAPTIONS

WePrepaid ~~have previously~~expenses ~~adopted two equity incentive plans, known as the 2000 Equity Incentive Plan, or the 2000 Plan,~~ and ~~the~~other ~~2010~~current ~~Equity~~assets ~~Incentive Plan,~~are orcomprised ~~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.following:

~~The following summarizes share-based compensation expense for the years ended December 31, 2020 and 2019, which was allocated as follows:~~

	December 31,

	2020			2019
	December 31,
Research and development	$	-		$	63,207
	2021		2020
General and administrative		332,003			206,533

	$	332,003		$	269,740
Prepaid insurance	$	6,071	$	39,196
Other		13,861		10,713
	$	19,932	$	49,909

~~The following summarizes stock option activity for the years ended December 31, 2020 and 2019:~~

				Options Outstanding
	Shares available for grants				Number of shares			Exercise price range		Weighted average exercise price
December 31, 2018		4,123,142				9,044,825		$	0.14 - 0.64	$	0.28
2018 Plan additions		2,630,130				-			-		-
Grants		(2,415,000	)			2,415,000			0.21		0.21
Expirations		-				(1,638,575	)		0.14 - 0.57		0.21
2010 Plan Expiration		(728,142	)			-			-		-
December 31, 2019		3,610,130				9,821,250			0.16 - 0.64		0.28
2018 Plan additions		2,668,836				-			-		-
Grants		(2,130,000	)			2,130,000			0.30		0.30
Expirations		-				-			-		-
December 31, 2020		4,148,966				11,951,250		$	0.16 - 0.64	$	0.28
Vested and expected to vest at December 31, 2020						11,811,875
Exercisable at December 31, 2020						8,745,500

Accrued expenses are comprised of the following:

~~F-18~~

The following summarizes information about stock options outstanding at December 31, 2020:


	December 31,
	2021		2020

Accrued professional fees	$	2,765	$	12,394
Accrued other		28,951		48,735
Accrued compensation		21,585		29,300
Accrued interest - convertible debt		208,428		118,428
	$	261,729	$	208,857

	Number of Shares		Weighted Average Exercise Price		Weighted Average Remaining Contractual Life	Aggregate Intrinsic Value
Options Outstanding, December 31, 2019		9,821,250	$	0.28
Granted		2,130,000	$	0.30
Exercised		-	$	-
Forfeited		-	$	-
Options Outstanding, December 31, 2020		11,951,250	$	0.28	5.4 years	$	2,189,575
Vested and unvested but expected to vest, December 31, 2020		11,811,875	$	0.28	5.4 years	$	2,164,040
Exercisable at December 31, 2020		8,745,500	$	0.29	4.1 years	$	1,563,850

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, 2020 and 2019:

	2020			2019
Dividend yield		0.0	%		0.0	%
Risk-free rate of return		0.33	%		2.15	%
Expected life in years		5.88			5.88
Volatility		74.57	%		93.59	%
Forfeiture rate		2.6	%		2.6	%

6. EMPLOYEE BENEFIT PLANS

~~Our~~In ~~dividend yield~~2021 ~~assumption is based on the fact that we have never paid cash dividends~~ and do2020, ~~not anticipate paying cash dividends in~~ the ~~foreseeable~~ ~~future.~~Company 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 inhealth ~~the SEC’s Staff Accounting Bulletin (“SAB”) 107~~ and ~~SAB~~dental ~~110,~~insurance ~~using a “simplified” method. The Company has used the simplified method and will continue~~ to ~~use~~an ~~the~~employee ~~simplified~~under ~~method as it does not have sufficient historical exercise data to provide~~ a ~~reasonable~~group ~~basis upon which to estimate an expected term~~plan. No ~~Our~~retirement ~~volatility~~plan 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 ~~$0.19~~ ~~and~~in ~~$0.16~~place for ~~the~~2021 ~~years~~or ~~ended December 31,~~ 2020 ~~and 2019, 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 2020 and 2019:~~

	Warrants Outstanding
	Number of shares			Exercise price range		Weighted average exercise price
December 31, 2018		4,220,594		$	0.23 - 0.37	$	0.24
Issuances		8,125,000			0.18		0.18
Exercises		(1,925,000	)		0.125		0.125
December 31, 2019		10,420,594			0.23 - 0.37		0.24
Issuances		1,043,988			0.45		0.45
Exercises		(1,935,294	)		0.125		0.125
December 31, 2020		9,529,288		$	0.125 - 0.45	$	0.21

7. CONVERTIBLE NOTES

~~F-19~~2019 Convertible Notes

9In 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., ~~INCOME~~our ~~TAXES~~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.

~~The Company’s provision for income taxes consists of the following for the years ended December 31, 2020 and 2019:~~F-14

	2020			2019
Current income tax provision (benefit):
Federal	$	-		$	-
State		-			-
Foreign		-			-
Total		-			-
Deferred income tax provision (benefit):
Federal		(271,000	)		(162,000	)
State		(84,000	)		(51,000	)
Foreign		-			-
Total		(355,000	)		(213,000	)
Change in valuation allowance		355,000			213,000
Total provision (benefit) for income taxes	$	-		$	-

Table of Contents

~~Significant components~~At any time prior to maturity of the ~~Company’s~~2019 ~~deferred~~Notes, ~~tax~~with ~~assets~~the atconsent ~~December 31~~of the holders of a majority in interest of the 2019 Notes, ~~2020~~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 ~~related~~automatically ~~valuation~~become ~~allowances~~immediately ~~are~~due ~~presented below:~~and payable upon the occurrence of certain events of default.

	Year ended December 31,
	2020			2019
Deferred tax assets:
Net operating loss carryforwards	$	14,048,000		$	13,721,000
Research and experimentation credit carryforwards		2,268,000			2,268,000
Charitable contribution carryforwards		4,000			6,000
Accrued expenses, deferred revenue and other		523,000			591,000
Share-based compensation		824,000			774,000
		17,667,000			17,360,000
Less - valuation allowance		(17,667,000	)		(17,360,000	)
Net deferred tax assets	$	-		$	-

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.

~~At December 31~~The Company allocated $348,443 ~~2020~~of the gross proceeds to the warrants, weon ~~had~~a ~~net~~relative ~~operating~~fair ~~loss~~value ~~carryforwards~~basis. In ~~for~~addition, ~~Federal~~because ~~income~~the ~~tax~~effective ~~purposes~~conversion price of ~~approximately~~the ~~$51.1~~2019 ~~million and~~Notes ~~research~~was ~~and~~less ~~research~~than ~~and~~the ~~experimental~~fair ~~tax~~value ~~credit~~of ~~carryforwards~~the ofunderlying ~~approximately~~common ~~$2.3~~stock ~~million~~on the issuance date, ~~which~~we ~~are~~allocated ~~available~~$348,443, the intrinsic value of that feature to ~~offset~~ ~~future~~additional ~~federal~~paid-in ~~income~~capital. ~~Approximately~~The ~~$47.9~~debt ~~million~~discount ofcreated by the ~~net~~2019 ~~operating~~Warrants ~~loss~~and ~~carryforwards,~~beneficial ~~generated~~conversion ~~prior~~feature tois ~~2018,~~amortized ~~expires in~~over ~~increments~~the ~~through~~term ~~2037,~~of ~~while~~the ~~carryforwards~~2019 ~~generated~~Notes inas ~~2018~~additional orinterest ~~later~~expense dousing ~~not~~the ~~expire~~effective interest method.

~~Section 382 of~~The ~~the~~affiliated ~~Internal~~investors ~~Revenue Code imposes substantial restrictions on the utilization of net operating losses~~ and ~~tax credits in~~ the ~~event~~ ofprincipal aamount ~~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.~~their Itrespective ~~was~~2019 ~~determined~~Notes ~~that~~purchase ~~the~~are ~~Company experienced a cumulative change in ownership,~~ as ~~defined~~set byforth 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 loss-es and tax credits presented above may be further reduced as a result of additional ownership changes subsequent to 2009.below:

F-20


Investor	Note Principal
Essetifin S.p.A.	$	1,000,000
Joseph C. McNay	$	25,000
J.J. Finkelstein	$	25,000
Mauro Bove	$	10,000
Allan L. Goldstein	$	5,000
R. Don Elsey	$	5,000

~~The provision for income taxes on earnings subject to income taxes differs from the statutory federal rate for the years ended December 31, 2020 and 2019, due to the following:~~

	2020			2019
US Federal statutory rate		21.00	%		21.00	%
State income tax, net of Federal benefit		6.52	%		6.52	%
Share-based compensation		-2.76	%		-3.10	%
Permanent differences and other		-1.46	%		-9.26	%
Change in valuation allowance		-23.30	%		-15.16	%
		0.00	%		0.00	%

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.

~~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,~~ 2020 ~~and~~Convertible 2019, 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, 2020 and 2019.Notes

~~The~~In ~~2007 through~~October ~~2019~~2020, ~~tax~~we ~~years~~sold ~~generally~~a ~~remain~~series ~~subject~~of convertible promissory notes to ~~examination~~management, bythe ~~federal~~Company’s Board of Directors and ~~most~~accredited ~~state~~investors ~~tax~~including ~~authorities~~Essetifin S.p.A., Inour ~~addition,~~largest westockholder. ~~would remain~~The ~~open~~sale of the notes resulted in gross proceeds to ~~examination~~the ~~for~~Company ~~earlier~~of ~~years~~$500,000 if(the we“2020 ~~were~~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 ~~utilize~~adjustment ~~net~~as ~~operating~~described ~~losses~~in orthe ~~tax~~2020 ~~credit~~Notes) ~~carryforwards~~at ~~that~~any ~~originated~~ time prior to ~~2012~~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.

OnAt ~~March 27, 2020,~~any ~~the~~time ~~Coronavirus~~prior ~~Aid,~~to ~~Relief~~maturity ~~and~~of ~~Economic Security Act (~~the ~~“CARES~~2020 ~~Act”)~~Notes, ~~was~~with ~~signed~~the ~~into~~consent ~~law~~of ~~in response to~~ the ~~COVID-19~~ ~~pandemic.~~holders ~~The~~of ~~CARES~~a ~~Act~~majority ~~provides~~in ~~numerous~~interest ~~tax~~of ~~provisions~~the ~~and~~2020 ~~stimulus measures~~Notes, ~~including~~we ~~temporary~~can ~~changes~~prepay ~~regarding~~ the ~~prior~~outstanding ~~and~~principal ~~future~~amount ~~utilization~~ of ~~net operating losses, temporary changes to~~ the ~~prior~~2020 ~~and~~Notes ~~future~~plus ~~limitations~~unpaid onaccrued interest ~~deductions, and~~without ~~technical corrections from prior tax legislation for tax depreciation of certain qualified improvement property~~penalty. The ~~Company has~~outstanding ~~evaluated~~principal ~~the~~and ~~provisions~~all ofaccrued ~~the~~interest ~~CARES~~on ~~Act~~the ~~relating~~2020 toNotes ~~income taxes which~~ will ~~result~~accelerate inand ~~adjustments~~automatically tobecome ~~certain~~immediately ~~deferred~~due ~~tax assets~~ and ~~liabilities.~~payable ~~Due~~upon to the ~~Company’s~~occurrence ~~U.S.~~of ~~valuation~~certain ~~allowance,~~events ~~the Company noted the provisions~~ of ~~the CARES Act did not have a material impact on its financial statements~~default.

10In connection with the issuance of the 2020 Notes we also issued warrants to each investor. The ~~LEASES~~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.

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, 2020 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.F-15

~~The~~Table ~~following table summarizes the Company’s recognition~~ of ~~its operating lease as of December 31, 2020:~~Contents

	December 31, 2020
Assets
Operating lease right-of-use asset	$	68,229
Total lease assets	$	68,229
Liabilities
Current
Current portion of operating lease liability	$	40,790
Non-current
Operating lease liability		27,809
Total lease liabilities	$	68,599

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.

~~F-21~~The affiliated investors and the principal amount of their respective 2020 Notes purchase are as set forth below:

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, 2020 and 2019 is recorded as general and administrative expense and consisted of the following:

	2020		2019

Operating lease cost	$	50,060	$	48,101
Investor	Note Principal
Variable lease costs		895		4,381
Essetifin S.p.A.	$	400,000
Total lease costs	$	50,955	$	52,482
J.J. Finkelstein	$	10,000
Mauro Bove	$	10,000
Allan L. Goldstein	$	5,000

~~A maturity analysis of our operating lease minimum lease payments follows:~~

2021	$	50,904
2022		29,694
Total		80,598
Discount factor		(11,999	)
Total lease liability	$	68,599

The Company recorded interest expense and discount accretion as set forth below:

~~11. PROMISSORY NOTE~~

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 CARES Act administered by the U.S. Small Business Administration. The principal amount of the Loan is $55,400.


	For the years ended
	December 31, 2021		December 31, 2020
2019 Notes	$	206,274	$	207,610

2020 Notes		118,604		25,021

Total interest expense	$	324,878	$	232,631

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 may apply 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.

Subject to any forgiveness under the PPP, the Loan matures two years following the date of issuance of the Loan and includes a period for the first six months during which time required payments of interest and principal are deferred. In June 2020, the Flexibility Act which amended the CARES Act was signed into law. The Flexibility Act provides that if a borrower does not apply for forgiveness of a loan within 10 months after the last day of the measurement period (“covered period”), the PPP loan is no longer deferred, and the borrower must begin paying principal and interest. In addition, the Flexibility Act extended the length of the covered period from eight weeks to 24 weeks from receipt of proceeds, while allowing borrowers that received PPP loans before June 5, 2020 to determine, at their sole discretion, a covered period of either eight weeks or 24 weeks.

No interest or principal will be due during the deferral period, although interest will continue to accrue over this period. After the deferral period and after taking into account any loan forgiveness applicable to the Note, any remaining principal and accrued interest will be payable in substantially equal monthly installments over the remaining term of the Note. The Loan may be prepaid at any time prior to maturity with no prepayment penalties. The Loan provides for customary events of default, including, among others, those relating to breaches of their obligations under the Loan, including a failure to make payments, any bankruptcy or similar proceedings involving the Company, and certain material effects on the Company’s ability to repay the Loan. The Company did not provide any collateral or guarantees for the Loan.

128. STOCKHOLDERS’ ~~COMMITMENTS~~EQUITY

~~Employment Continuity~~Common ~~Agreements~~Stock. WeAt ~~have~~the ~~entered~~Company’s ~~into~~2021 ~~employment~~Annual ~~contracts~~Meeting ~~with~~on ~~our~~October ~~executive~~27, ~~officers~~2021, ~~which~~the ~~provide~~stockholders ~~for~~adopted ~~severance if~~an ~~the~~amendment ~~executive~~to isthe ~~dismissed~~Company’s ~~without~~Certificate ~~cause~~of orIncorporation ~~under~~to ~~certain~~increase ~~circumstances~~the ~~after~~authorized ashares ~~change~~ of ~~control~~capital instock ~~our~~from ~~ownership. At December 31~~201, ~~2020~~000,000 ~~these~~to ~~obligations~~301,000,000 ~~if triggered~~shares, ~~could~~effective ~~amount~~November ~~to a maximum of approximately $170~~12,~~000~~ 2021.

FOn 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-22year 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.

~~EXHIBIT~~On ~~INDEX~~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”).

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	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)
3.3	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)
3.4	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)
3.5	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	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)
3.7	Amendment to Amended and Restated Bylaws	Exhibit 3.6 to Registration Statement on Form S-8 (File No. 333-152250) (filed July 10, 2008)
4.1	Specimen Common Stock Certificate	Exhibit 4.1 to Registration Statement on Form S-1 (File No. 333-16614

December 31

Unearned revenue

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