Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 10, 2021 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-15070 | |
Entity Registrant Name | REGENERX BIOPHARMACEUTICALS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 52-1253406 | |
Entity Address, Address Line One | 15245 Shady Grove Road – Suite 470 | |
Entity Address, City or Town | Rockville | |
Entity Address, State or Province | MD | |
Entity Address, Postal Zip Code | 20850 | |
City Area Code | 301 | |
Local Phone Number | 208-9191 | |
Title of 12(b) Security | Common | |
Trading Symbol | RGRX | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 143,549,735 | |
Entity Central Index Key | 0000707511 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 1,523,390 | $ 427,898 |
Prepaid expenses and other current assets | 25,817 | 49,909 |
Total current assets | 1,549,207 | 477,807 |
Operating lease right-of-use asset | 38,583 | 68,229 |
Other assets | 5,752 | 5,752 |
Total assets | 1,593,542 | 551,788 |
Current liabilities | ||
Accounts payable | 63,701 | 39,320 |
Unearned revenue | 76,761 | 76,761 |
Accrued expenses | 238,264 | 208,857 |
Promissory note | 0 | 33,856 |
Current portion of operating lease liability | 38,777 | 40,790 |
Total current liabilities | 417,503 | 399,584 |
Long-term liabilities | ||
Unearned revenue | 1,966,993 | 2,024,564 |
Promissory note | 0 | 21,544 |
Operating lease liability | 0 | 27,809 |
Convertible promissory notes, net | 1,077,714 | 902,231 |
Total liabilities | 3,462,210 | 3,375,732 |
Commitments and contingencies | ||
Stockholders' deficit | ||
Preferred stock, $.001 par value per share, 1,000,000 shares authorized; no shares issued | 0 | 0 |
Common stock, par value $.001 per share, 200,000,000 shares authorized, 143,549,735 and 133,441,778 issued and outstanding | 143,550 | 133,442 |
Additional paid-in capital | 108,027,910 | 105,934,572 |
Accumulated deficit | (110,040,128) | (108,891,958) |
Total stockholders' deficit | (1,868,668) | (2,823,944) |
Total liabilities and stockholders' deficit | $ 1,593,542 | $ 551,788 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Condensed Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 1,000,000 | 1,000,000 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 143,549,735 | 133,441,788 |
Common stock, shares, outstanding | 143,549,735 | 133,441,788 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Condensed Statements of Operations | ||||
Revenues | $ 19,190 | $ 19,190 | $ 57,571 | $ 57,571 |
Operating expenses | ||||
Research and development | 5,663 | 482 | 6,638 | 4,433 |
General and administrative | 417,573 | 299,161 | 1,011,842 | 1,056,973 |
Total operating expenses | 423,236 | 299,643 | 1,018,480 | 1,061,406 |
Loss from operations | (404,046) | (280,453) | (960,909) | (1,003,835) |
Other income (expense) | ||||
Gain on forgiveness of PPP loan | 55,400 | 0 | 55,400 | 0 |
Interest income | 114 | 40 | 137 | 3,766 |
Interest expense | (81,313) | (52,186) | (242,798) | (155,424) |
Total other expense | (25,799) | (52,146) | (187,261) | (151,658) |
Loss before taxes | (429,845) | (332,599) | (1,148,170) | (1,155,493) |
Provision for income taxes | 0 | 0 | 0 | 0 |
Net loss | $ (429,845) | $ (332,599) | $ (1,148,170) | $ (1,155,493) |
Basic net loss per common share | $ 0 | $ 0 | $ (0.01) | $ (0.01) |
Diluted net loss per common share | $ 0 | $ 0 | $ (0.01) | $ (0.01) |
Weighted average number of common shares outstanding - basic | 143,482,596 | 133,441,788 | 136,922,152 | 133,328,778 |
Weighted average number of common shares outstanding - diluted | 143,482,596 | 133,441,788 | 136,922,152 | 133,328,778 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Deficit - USD ($) | Common stock [Member] | Additional paid-in capital [Member] | Accumulated deficit [Member] | Total |
Balance at Dec. 31, 2019 | $ 131,507 | $ 104,896,975 | $ (107,368,590) | $ (2,340,108) |
Balance (Shares) at Dec. 31, 2019 | 131,506,494 | |||
Issuance of common stock - warrant exercises (in value) | $ 1,935 | 239,976 | 0 | 241,911 |
Issuance of common stock - warrant exercises (in shares) | 1,935,294 | |||
Stock-based compensation expense | $ 0 | 49,839 | 0 | 49,839 |
Net loss | 0 | 0 | (386,733) | (386,733) |
Balance at Mar. 31, 2020 | $ 133,442 | 105,186,790 | (107,755,323) | (2,435,091) |
Balance (Shares) at Mar. 31, 2020 | 133,441,788 | |||
Balance at Dec. 31, 2019 | $ 131,507 | 104,896,975 | (107,368,590) | (2,340,108) |
Balance (Shares) at Dec. 31, 2019 | 131,506,494 | |||
Net loss | (1,155,493) | |||
Balance at Sep. 30, 2020 | $ 133,442 | 105,407,209 | (108,524,083) | (2,983,432) |
Balance (Shares) at Sep. 30, 2020 | 133,441,788 | |||
Balance at Mar. 31, 2020 | $ 133,442 | 105,186,790 | (107,755,323) | (2,435,091) |
Balance (Shares) at Mar. 31, 2020 | 133,441,788 | |||
Stock-based compensation expense | $ 0 | 146,433 | 0 | 146,433 |
Net loss | 0 | 0 | (436,161) | (436,161) |
Balance at Jun. 30, 2020 | $ 133,442 | 105,333,223 | (108,191,484) | (2,724,819) |
Balance (Shares) at Jun. 30, 2020 | 133,441,788 | |||
Stock-based compensation expense | $ 0 | 73,986 | 0 | 73,986 |
Net loss | 0 | 0 | (332,599) | (332,599) |
Balance at Sep. 30, 2020 | $ 133,442 | 105,407,209 | (108,524,083) | (2,983,432) |
Balance (Shares) at Sep. 30, 2020 | 133,441,788 | |||
Balance at Dec. 31, 2020 | $ 133,442 | 105,934,572 | (108,891,958) | (2,823,944) |
Balance (Shares) at Dec. 31, 2020 | 133,441,788 | |||
Issuance of common stock - option exercises (in value) | $ 105 | 21,945 | 0 | 22,050 |
Issuance of common stock - option exercises (in shares) | 105,000 | |||
Stock-based compensation expense | $ 0 | 61,744 | 0 | 61,744 |
Net loss | 0 | 0 | (379,692) | (379,692) |
Balance at Mar. 31, 2021 | $ 133,547 | 106,018,261 | (109,271,650) | (3,119,842) |
Balance (Shares) at Mar. 31, 2021 | 133,546,788 | |||
Balance at Dec. 31, 2020 | $ 133,442 | 105,934,572 | (108,891,958) | $ (2,823,944) |
Balance (Shares) at Dec. 31, 2020 | 133,441,788 | |||
Issuance of common stock - option exercises (in shares) | 105,000 | |||
Net loss | $ (1,148,170) | |||
Balance at Sep. 30, 2021 | $ 143,550 | 108,027,910 | (110,040,128) | (1,868,668) |
Balance (Shares) at Sep. 30, 2021 | 143,549,735 | |||
Balance at Mar. 31, 2021 | $ 133,547 | 106,018,261 | (109,271,650) | (3,119,842) |
Balance (Shares) at Mar. 31, 2021 | 133,546,788 | |||
Private offering of common stock and warrants, net of issuance costs (in value) | $ 9,900 | 1,833,600 | 0 | 1,843,500 |
Private offering of common stock and warrants, net of issuance costs (in Shares) | 9,900,000 | |||
Stock-based compensation expense | $ 0 | 61,744 | 0 | 61,744 |
Net loss | 0 | 0 | (338,633) | (338,633) |
Balance at Jun. 30, 2021 | $ 143,447 | 107,913,605 | (109,610,283) | (1,553,231) |
Balance (Shares) at Jun. 30, 2021 | 143,446,788 | |||
Issuance of common stock - warrant exercises (in value) | $ 103 | 12,765 | 0 | 12,868 |
Issuance of common stock - warrant exercises (in shares) | 102,947 | |||
Private offering - issuance costs | $ 0 | (84,412) | 0 | (84,412) |
Stock-based compensation expense | 0 | 185,952 | 0 | 185,952 |
Net loss | 0 | 0 | (429,845) | (429,845) |
Balance at Sep. 30, 2021 | $ 143,550 | $ 108,027,910 | $ (110,040,128) | $ (1,868,668) |
Balance (Shares) at Sep. 30, 2021 | 143,549,735 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Operating activities: | ||
Net loss | $ (1,148,170) | $ (1,155,493) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash share-based compensation | 309,440 | 270,258 |
Non-cash interest expense | 175,483 | 106,630 |
Gain on forgiveness of PPP loan | (55,400) | 0 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 24,092 | (16,991) |
Accounts payable | 24,381 | (3,693) |
Accrued expenses | 29,407 | 60,577 |
Operating lease liability | (176) | (2,133) |
Unearned revenue | (57,571) | (57,571) |
Net cash used in operating activities | (698,514) | (798,416) |
Financing activities: | ||
Proceeds from private offering of common stock and warrants, net of issuance costs | 1,759,088 | 0 |
Proceeds from the exercise of stock options | 22,050 | 0 |
Proceeds from promissory note | 0 | 55,400 |
Proceeds from the exercise of stock warrants | 12,868 | 241,911 |
Net cash provided by financing activities | 1,794,006 | 297,311 |
Net increase (decrease) in cash and cash equivalents | 1,095,492 | (501,105) |
Cash and cash equivalents at beginning of period | 427,898 | 639,916 |
Cash and cash equivalents at end of period | 1,523,390 | 138,811 |
Supplemental Disclosures of Non-Cash Operating and Financing Activities: | ||
Establish right-of-use asset | 0 | 81,890 |
Establish operating lease liability | $ 0 | $ 81,890 |
ORGANIZATION, BUSINESS OVERVIEW
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2021 | |
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION | |
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION | 1. ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION Organization and Nature of Operations. RegeneRx Biopharmaceuticals, Inc. (“RegeneRx”, the “Company”, “We”, “Us”, “Our”), a Delaware corporation, was incorporated in 1982. We are focused on the discovery and development of novel molecules to accelerate tissue and organ repair. Our operations are confined to one business segment: the development and marketing of product candidates based on Thymosin Beta 4 (“Tß4”), a 43 amino acid peptide. Management Plans to Address Operating Conditions. Our strategy is aimed at being capital efficient while leveraging our portfolio of clinical assets by seeking strategic relationships with organizations with clinical development capabilities including development capital. Currently, we have active partnerships in four major territories: North America, Europe, China and Pan Asia. In each case, the cost of development is being borne by our partners with no financial obligation for RegeneRx. We still have significant clinical assets to develop, primarily RGN-352 (injectable formulation of Tß4 for cardiac and CNS disorders) in the U.S., Pan Asia, and Europe, and RGN-259 in the EU. Our goal is to wait until satisfactory results are obtained from the current ophthalmic clinical program in the U.S. before moving into the EU. However, we intend to continue to develop RGN-352, our injectable systemic product candidate for cardiac and central nervous system indications, either by obtaining grants to fund a Phase 2a clinical trial in the cardiovascular or central nervous system fields or finding a suitable partner with the resources and capabilities to develop it as we have with RGN-259. Since inception, and through September 30, 2021, we have an accumulated deficit of $110 million and we had cash and cash equivalents of $1,523,390 as of September 30, 2021. We anticipate incurring additional operating losses in the future as we continue to explore the potential clinical benefits of Tß4-based product candidates over multiple indications. We have entered into a series of strategic partnerships under licensing and joint venture agreements where our partners are responsible for advancing development of our product candidates by sponsoring multiple clinical trials. On June 30, 2021, we closed a private placement of common stock and warrants with several institutional and accredited investors, including members of management and the board, and received gross proceeds of $1,980,000. At present we have sufficient cash to fund planned operations through the end of 2022. We have not reached commercialization and therefore do not generate recurring revenue and will need substantial additional funds in order to significantly advance development of our unlicensed programs. Accordingly, we will continue to evaluate opportunities to raise additional capital and are in the process of exploring various alternatives, including, without limitation, a public or private placement of our securities, debt financing, corporate collaboration and licensing arrangements, mergers, or the sale of our Company or certain of our intellectual property rights. These factors raise substantial doubt about our ability to continue as a going concern. The accompanying financial statements have been prepared assuming that we will continue as a going concern. This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities in the normal course of business. Although we intend to continue to seek additional financing or additional strategic partners, we may not be able to complete a financing or corporate transaction, either on favorable terms or at all. If we are unable to complete a financing or strategic transaction, we may not be able to continue as a going concern after our funds have been exhausted, and we could be required to significantly curtail or cease operations, file for bankruptcy or liquidate and dissolve. There can be no assurance that we will be able to obtain any sources of funding. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should we be forced to take any such actions. In addition to our current operational requirements, we continually refine our operating strategy and evaluate alternative clinical uses of Tß4. However, substantial additional resources will be needed before we will be able to achieve sustained profitability. Consequently, we continually evaluate alternative sources of financing such as the sharing of development costs through strategic collaboration agreements. There can be no assurance that our financing efforts will be successful and, if we are not able to obtain sufficient levels of financing, we would delay certain clinical and/or research activities and our financial condition would be materially and adversely affected. Even if we are able to obtain sufficient funding, other factors including competition, dependence on third parties, uncertainty regarding patents, protection of proprietary rights, manufacturing of peptides, and technology obsolescence could have a significant impact on us and our operations. To achieve profitability, we, and/or a partner, must successfully conduct pre-clinical studies and clinical trials, obtain required regulatory approvals and successfully manufacture and market those pharmaceuticals we wish to commercialize. The time required to reach profitability is highly uncertain, and there can be no assurance that we will be able to achieve sustained profitability, if at all. Basis of Presentation. The accompanying unaudited interim condensed financial statements reflect, in the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of our financial position, results of operations and cash flows for each period presented. These statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and with the rules and regulations of the Securities and Exchange Commission (“SEC”), for interim financial statements. Accordingly, they do not include all the information and footnotes required by GAAP. The accounting policies underlying our unaudited interim condensed financial statements are consistent with those underlying our audited annual financial statements, but do not include all disclosures including notes required by GAAP for complete financial statements. These unaudited interim condensed financial statements should be read in conjunction with the audited annual financial statements as of and for the year ended December 31, 2020, and related notes thereto, included in our Annual Report on Form 10-K for the year ended December 31, 2020 (the “Annual Report”). The Company’s significant accounting policies are included in “Part IV - Item 15 – Exhibits, Financial Statement Schedules. - Note 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES” in the Company’s Annual Report. There have been no changes to these policies. The accompanying December 31, 2020 financial information was derived from our audited financial statements included in the Annual Report. Operating results for the three and nine month periods ended September 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or any other future period. References in this Quarterly Report on Form 10-Q to “authoritative guidance” are to the Accounting Standards Codification (“ASC”) issued by the Financial Accounting Standards Board. Use of Estimates. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. 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 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 those estimates. Convertible Notes with Detachable Warrants. In accordance with ASC 470-20, Debt with Conversion and Other Options Revenue Recognition. 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. Leases. At the inception of a contract we determine if the arrangement is, or contains, a lease. Right-of-use (“ROU”) assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Rent expense is recognized on a straight-line basis over the lease term. We have made certain accounting policy elections whereby we (i) do not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12 months or less) and (ii) combine lease and non-lease elements of our operating leases. ROU Assets. ROU assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. Accounting Standards Updates. The Company has evaluated all issued and unadopted Accounting Standard Updates (“ASU”) and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. Reclassification Stock-based compensation expense of $16,983 and $62,399 for the three and nine months ended September 30, 2020, respectively, has been reclassified from research and development to general and administrative in the unaudited Condensed Statements of Operations to conform to the current period presentation. |
NET INCOME (LOSS) PER COMMON SH
NET INCOME (LOSS) PER COMMON SHARE | 9 Months Ended |
Sep. 30, 2021 | |
NET INCOME (LOSS) PER COMMON SHARE | |
NET INCOME (LOSS) PER COMMON SHARE | 2. NET INCOME (LOSS) PER COMMON SHARE Basic net income (loss) per common share for the three and nine month periods ended September 30, 2021 and 2020 is based on the weighted-average number of shares of common stock outstanding during the periods. Diluted loss per share is based on the weighted-average number of shares of common stock outstanding during each period in which a loss is incurred. Potentially dilutive shares are excluded because the effect is antidilutive. In periods where there is net income, diluted income per share is based on the weighted-average number of shares of common stock outstanding plus dilutive securities with a purchase or conversion price below the per share price of our common stock on the last day of the reporting period. The potentially dilutive securities include 50,049,304 shares and 31,269,884 shares in 2021 and 2020, respectively, reserved for the conversion of convertible debt or exercise of outstanding options and warrants. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2021 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | 3. STOCK-BASED COMPENSATION We measure stock-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 value of our stock option awards on the date of grant using the Black-Scholes option pricing model (“Black-Scholes”) and amortize that cost over the expected term of the grant. We recognized $185,952 and $73,986 in stock-based compensation expense for the three months ended September 30, 2021 and 2020. We recognized $309,440 and $270,258 in stock-based compensation expense for the nine months ended September 30, 2021 and 2020, respectively. We issued 2,605,000 stock options to employees, consultants and directors during the nine months ended September 30, 2021. We issued 2,130,000 stock options to employees, consultants and directors during the nine months ended September 30, 2020. We used the following forward-looking range of assumptions to value the stock options issue in 2021 and 2020: 2021 2020 Dividend yield 0.0 % 0.0 % Risk-free rate of return 0.71 % 0.33 % Expected life in years 5.88 5.88 Volatility 87.68 % 74.57 % Forfeiture rate 2.6 % 2.6 % A summary of the Company’s stock options for the nine months ended September 30, 2021 is as follows: Weighted Weighted Average Number of Average Remaining Aggregate Shares Exercise Price Contractual Life Intrinsic Value Options Outstanding, December 31, 2020 11,951,250 $ 0.28 Granted 2,605,000 $ 0.28 Exercised (105,000) $ 0.21 Forfeited (1,915,000) $ 0.21 Options Outstanding, September 30, 2021 12,536,250 $ 0.29 6.5 years $ 1,350 Vested and unvested but expected to vest, September 30, 2021 12,055,116 $ 0.29 6.5 years $ 1,298 Exercisable at September 30, 2021 8,913,750 $ 0.30 5.5 years $ 1,350 The average expected life was determined using historical data. We expect to recognize the compensation cost related to non-vested options as of September 30, 2021 of $527,327 over the weighted average remaining recognition period of 2.26 years. |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2021 | |
INCOME TAXES | |
INCOME TAXES | 4. INCOME TAXES As of September 30, 2021, there have been no material changes to our uncertain tax positions disclosures as provided in Note 9 of the Annual Report. The tax returns for all years in the Company’s major tax jurisdictions are not settled as of January 1, 2021; no changes in settled tax years have occurred through September 30, 2021. Due to the existence of tax attribute carryforwards (which are currently offset by a full valuation allowance), the Company treats all years’ tax positions as unsettled due to the taxing authorities’ ability to modify these attributes. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2021 | |
FAIR VALUE MEASUREMENTS | |
FAIR VALUE MEASUREMENTS | 5. FAIR VALUE MEASUREMENTS The authoritative guidance for fair value measurements defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or the most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The guidance describes a fair value hierarchy based on the levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following: Level 1 — Quoted prices in active markets for identical assets and liabilities. Level 2 — Observable inputs other than quoted prices in active markets for identical assets and liabilities. Level 3 — Unobservable inputs. As of September 30, 2021 and December 31, 2020, our only qualifying assets that required measurement under the foregoing fair value hierarchy were money market funds included in cash and cash equivalents valued at $54,581 and $427,898, respectively, using Level 1 inputs. |
CONVERTIBLE NOTES
CONVERTIBLE NOTES | 9 Months Ended |
Sep. 30, 2021 | |
CONVERTIBLE NOTES | |
CONVERTIBLE NOTES | 6. CONVERTIBLE NOTES 2019 Convertible Notes On February 27, 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 on February 27, 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 (subject to adjustment as described in the 2019 Notes) 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 warrants to each investor. The warrants are exercisable for an aggregate of 8,125,000 shares of common stock with an exercise price of eighteen cents ($0.18) per share for a period of five years (the “2019 Warrants”). The relative fair value of the 2019 Warrants issued was $348,443 calculated using the Black-Scholes-Merton valuation model value of $0.06 with an expected and contractual life of five years, an assumed volatility of 67.86%, and a risk-free interest rate of 2.49%. The 2019 Warrants are classified in equity. The Company allocated $348,443 of the gross proceeds to the 2019 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 paid-in-capital. The debt discount created by the 2019 Warrants and beneficial conversion feature will be amortized over the term of the 2019 Notes as additional interest expense using the effective interest method. The affiliated investors, and the principal amount of their respective 2019 Notes purchase are as set forth below: Investor 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 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. 2020 Convertible Notes In October 2020, we sold a series of convertible promissory notes to management, the Company’s Board of Directors and accredited investors including Essetifin S.p.A., our largest stockholder. The sale of the notes resulted in gross proceeds to the Company of $500,000 (the “2020 Notes”). The 2020 Notes will mature on October 15, 2025. The 2020 Notes bear interest at a rate of five percent (5%) per annum and are convertible into shares of our common stock at a conversion price of thirty-six cents ($0.36) per share (subject to adjustment as described in the 2020 Notes) at any time prior to repayment, at the election of the investors. In the aggregate, the 2020 Notes are convertible (subject to adjustment as described in the 2020 Notes) into up to 1,391,982 shares of our common stock excluding interest. At any time prior to maturity of the 2020 Notes, with the consent of the holders of a majority in interest of the 2020 Notes, we can prepay the outstanding principal amount of the 2020 Notes plus unpaid accrued interest without penalty. The outstanding principal and all accrued interest on the 2020 Notes will accelerate and automatically become immediately due and payable upon the occurrence of certain events of default. In connection with the issuance of the 2020 Notes we also issued warrants to each investor. The warrants are exercisable for an aggregate of 1,043,988 shares of common stock with an exercise price of forty-five cents ($0.45) per share for a period of five years (the “2020 Warrants”). The relative fair value of the 2020 Warrants issued was $176,573 calculated using the Black-Scholes-Merton valuation model value of $0.26 with an expected and contractual life of five years, an assumed volatility of 74.6%, and a risk-free interest rate of 0.32%. The 2020 Warrants are classified in equity. The Company allocated $176,573 of the gross proceeds to the warrants, on a relative fair value basis. In addition, because the effective conversion price of the 2020 Notes was less than the fair value of the underlying common stock on the issuance date, we allocated $289,045, the intrinsic value of that feature, to additional paid-in capital. The debt discount created by the 2020 Warrants and beneficial conversion feature is amortized over the term of the 2020 Notes as additional interest expense using the effective interest method. The affiliated investors and the principal amount of their respective 2020 Notes purchase are as set forth below: Investor Note Principal Essetifin S.p.A. $ 400,000 J.J. Finkelstein $ 10,000 Mauro Bove $ 10,000 Allan L. Goldstein $ 5,000 The Company recorded interest expense and discount accretion as set forth below: For the three months ended For the nine months ended September 30, 2021 September 30, 2020 September 30, 2021 September 30, 2020 2019 Notes $ 51,418 $ 52,186 $ 154,089 $ 155,424 2020 Notes 29,895 - 88,709 - Total interest expense $ 81,313 $ 52,186 $ 242,798 $ 155,424 |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 9 Months Ended |
Sep. 30, 2021 | |
LICENSE AGREEMENTS | |
LICENSE AGREEMENTS | 7. LICENSE AGREEMENTS Joint Venture Agreement – ReGenTree. On January 28, 2015, the Company entered into the Joint Venture Agreement with GtreeBNT, a stockholder in the Company. The Joint Venture Agreement provides for the creation of the ReGenTree Joint Venture, jointly owned by the Company and GtreeBNT. ReGenTree is commercializing RGN-259 for treatment of dry eye syndrome and neurotrophic keratopathy in the United States and Canada. GtreeBNT is solely responsible for funding all the product development and commercialization efforts of the Joint Venture. GtreeBNT made an initial contribution of $3 million in cash and received an initial equity stake of 51%. RegeneRx’s ownership interest in ReGenTree was reduced from 49% to 38.5% when the Clinical Study Report was filed for the Phase 2/3 dry eye clinical trial. Based on when, and if, certain additional development milestones are achieved in the U.S. with RGN-259, our equity ownership may be incrementally reduced to between 38.5% and 25%, with 25% being the final equity ownership upon approval of a BLA for DES in the U.S. (Tβ4 is now regulated as a biologic rather than as a new drug entity, see page 19). In addition to our equity ownership, RegeneRx retains a royalty on net sales that varies between single and low double digits, depending on whether commercial sales are made by ReGenTree or a licensee. In the event ReGenTree is acquired or there is a change of control that occurs following achievement of a BLA, RegeneRx shall be entitled to a minimum of 40% of all proceeds paid or payable and will forgo any future royalties. The Company is not required or otherwise obligated to provide financial support to the Joint Venture. The Joint Venture is responsible for executing all development and commercialization activities under the License Agreement, which activities are directed by a joint development committee comprised of representatives of the Company and GtreeBNT. The License Agreement has a term that extends to the later of the expiration of the last patent covered by the License Agreement or 25 years from the first commercial sale under the License Agreement. The License Agreement may be earlier terminated if the Joint Venture fails to meet certain commercialization milestones, if either party breaches the License Agreement and fails to cure such breach, as a result of government action that limits the ability of the Joint Venture to commercialize the product, as a result of a challenge to a licensed patent, following termination of the license between the Company and certain agencies of the United States federal government, or upon the bankruptcy of either party. Under the License Agreement, the Company received $1.0 million in up-front payments and is entitled to receive royalties on the Joint Venture’s future sales of products. On April 6, 2016, we received $250,000 from ReGenTree in connection with the amendment of the License Agreement in April 2016 to expand the territorial rights to include Canada. The Company is accounting for the License Agreement with the Joint Venture as a revenue arrangement. Since participation in the joint development committee is required, it was deemed to be a material promise. Management has concluded that the participation in the joint development committee is not distinct from other promised goods and services. The Company assessed the license agreements in accordance with ASC 606. The Company evaluated the promised goods and services under the license agreements and determined that there was one combined performance obligation representing a series of distinct goods and services including the license to research, develop and commercialize RGN-259 and participation in the joint development committee. Revenue is being recognized on a straight-line basis over a period of 30 years, which, in management’s judgment, is the best measure of progress towards satisfying the performance obligation and represents the Company’s best estimate of the period of the obligation. Revenue will be recognized for future royalty payments as they are earned. 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 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, Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, Mongolia, Myanmar (Burma), Philippines, Singapore, Thailand andVietnam, and semi-exclusive in India, Pakistan, Bangladesh, Bhutan, Maldives, Nepal, Sri Lanka, Kyrgyzstan, Tajikistan, Turkmenistan and Uzbekistan, collectively, the Territory (the “259 Territory”). Under the 259 license agreement, we are eligible to receive aggregate potential milestone payments of up to $3.5 million. In addition, we are eligible to receive royalties of a low double-digit percentage of any commercial sales of the licensed product sold by GtreeBNT in the 259 Territory. Under the license agreement for RGN-137, our topical dermal gel product candidate, GtreeBNT will have the exclusive right to develop and commercialize RGN-137 in the U.S. (the “137 Territory”). Under the 137 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 Company’s licensed product sold by GtreeBNT in the 137 Territory. In August 2017, we amended the 137 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 assessed the license agreement in accordance with ASC 606. 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. Lee’s Pharmaceutical. We are a party to a license 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 (the “License Agreement”). Prior to 2016, Lee’s filed an IND with the Chinese FDA (“CFDA”) 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 CFDA declining its 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 License Agreement was amended and assigned by Lee’s to their affiliate, Zhaoke Ophthalmology Pharmaceutical Limited. On April 28, 2021, Zhaoke Ophthalmology completed an initial public offering, raising US$270 million for development of its ophthalmic products, including RGN-259 licensed from the Company. Zhaoke has established an advanced ophthalmic manufacturing facility and is assembling an experienced marketing team. RGN-259 is identified as one of their main pipeline drugs and they are planning to submit an IND to the NMPA (the Chinese FDA) in 2022 and initiate a phase III trial in China in 2023. There are no economic changes to the License Agreement. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2021 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | 8. STOCKHOLDERS’ EQUITY On March 2, 2018, the Company entered into a warrant reprice and exercise and issuance agreement with the March 2018 Investor. In connection with the Reprice Agreement, the Company issued to the March 2018 Investor warrants to purchase shares of the Company’s common stock (the “March Warrants”). The exercise price under the March Warrants is subject to a limited anti-dilution provision, such that in the event the Company makes an issuance of common stock (subject to customary exceptions) at a price per share less than the applicable exercise price of the March Warrants, the exercise price of the March Warrants will be reduced to the price per share applicable to such new issuance but will not adjust to an exercise price below $0.125. As a result of the issuance of the 2019 Notes and 2019 Warrants, the exercise price of the March Warrants was adjusted to $0.125 per share. Subsequent to the reduction of the exercise price of the March Warrants to $0.125 in 2019, the March 2018 Investor exercised warrants for 925,000 shares of common stock and the Company received exercise proceeds of $115,625. The March 2018 Investor exercised additional warrants on April 23, 2019, for 1,000,000 shares of common stock and the Company received exercise proceeds of $125,000. In January 2020, the March 2018 Investor exercised warrants for 1,935,294 shares of common stock and the Company received exercise proceeds of $241,911. On June 28, 2021, the Company entered into a securities purchase agreement (the “Purchase Agreement”) and a registration rights agreement (the “Registration Rights Agreement”) with investors and existing stockholders and members of management of the Company (the “Investors”). The Company closed the transactions contemplated under the Purchase Agreement on June 30, 2021. Pursuant to the terms of the Purchase Agreement, the Company sold an aggregate of 9,900,000 shares of its common stock (the “Shares”) to investors at a price of $0.20 per share, for gross proceeds of $1,980,000 before offering expenses (the “Private Placement”). As part of the Private Placement, the Company also issued to investors, for no additional consideration, Series A Warrants to purchase 7,425,000 shares of common stock (the “Warrant Shares”) at an exercise price of $0.24 per share with a two-year term (the “Series A Warrants”) and Series B Warrants to purchase 7,425,000 Warrant Shares 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”). |
LEASES
LEASES | 9 Months Ended |
Sep. 30, 2021 | |
LEASES | |
LEASES | 9. LEASES In June 2020, we amended our office lease agreement and the term has been extended through July 2022. During the extended term, our rental payments will be approximately $4,200 per month. We had previously amended the office lease to extend through July 2021. Our facility lease is our only existing lease as of September 30, 2021 and is classified as 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. September 30, 2021 December 31, 2020 Assets Operating lease right-of-use asset $ 38,583 $ 68,229 Total lease assets $ 38,583 $ 68,229 Liabilities Current portion of operating lease liability $ 38,777 $ 40,790 Long-term portion of operating lease liability - 27,809 Total lease liabilities $ 38,777 $ 68,599 Rent expense, consisting of minimum operating lease payments and variable lease payments for pass through items such as common area maintenance and real estate taxes for the nine months ended September 30, 2021 and 2020 is recorded as general and administrative expense and consisted of the following: 2021 2020 Operating lease cost $ 38,003 $ 36,783 Variable lease costs 345 - Total lease costs $ 38,348 $ 36,783 A maturity analysis of our operating lease minimum lease payments follows: 2021 $ 12,726 2022 29,694 Total 42,420 Discount factor (3,643) Total lease liability $ 38,777 |
PROMISSORY NOTE
PROMISSORY NOTE | 9 Months Ended |
Sep. 30, 2021 | |
PROMISSORY NOTE | |
PROMISSORY NOTE | 10. 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 was $55,400. In accordance with the requirements of the CARES Act, the Company used the proceeds from the Loan in accordance with the requirements of the PPP to cover certain qualified expenses, including payroll costs, rent and utility costs. Interest accrues on the Loan at the rate of 1.00% per annum. The Company 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. In April 2021, the Company filed the required documents with the Bank related to forgiveness of the Loan and in July 2021, the Company received a Notice of Paycheck Protection Program Forgiveness Payment stating that the Bank had received payment from the U.S. Small Business Administration on July 9, 2021. |
ORGANIZATION, BUSINESS OVERVI_2
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION | |
Basis of Presentation. | Basis of Presentation. The accompanying unaudited interim condensed financial statements reflect, in the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of our financial position, results of operations and cash flows for each period presented. These statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and with the rules and regulations of the Securities and Exchange Commission (“SEC”), for interim financial statements. Accordingly, they do not include all the information and footnotes required by GAAP. The accounting policies underlying our unaudited interim condensed financial statements are consistent with those underlying our audited annual financial statements, but do not include all disclosures including notes required by GAAP for complete financial statements. These unaudited interim condensed financial statements should be read in conjunction with the audited annual financial statements as of and for the year ended December 31, 2020, and related notes thereto, included in our Annual Report on Form 10-K for the year ended December 31, 2020 (the “Annual Report”). The Company’s significant accounting policies are included in “Part IV - Item 15 – Exhibits, Financial Statement Schedules. - Note 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES” in the Company’s Annual Report. There have been no changes to these policies. The accompanying December 31, 2020 financial information was derived from our audited financial statements included in the Annual Report. Operating results for the three and nine month periods ended September 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or any other future period. References in this Quarterly Report on Form 10-Q to “authoritative guidance” are to the Accounting Standards Codification (“ASC”) issued by the Financial Accounting Standards Board. |
Use of Estimates. | Use of Estimates. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. 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 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 those estimates. |
Convertible Notes with Detachable Warrants. | Convertible Notes with Detachable Warrants. In accordance with ASC 470-20, Debt with Conversion and Other Options |
Revenue Recognition. | Revenue Recognition. 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. |
Leases. | Leases. At the inception of a contract we determine if the arrangement is, or contains, a lease. Right-of-use (“ROU”) assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Rent expense is recognized on a straight-line basis over the lease term. We have made certain accounting policy elections whereby we (i) do not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12 months or less) and (ii) combine lease and non-lease elements of our operating leases. |
ROU Assets. | ROU Assets. ROU assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. |
Accounting Standards Updates. | Accounting Standards Updates. The Company has evaluated all issued and unadopted Accounting Standard Updates (“ASU”) and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
Reclassification | Reclassification Stock-based compensation expense of $16,983 and $62,399 for the three and nine months ended September 30, 2020, respectively, has been reclassified from research and development to general and administrative in the unaudited Condensed Statements of Operations to conform to the current period presentation. |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
STOCK-BASED COMPENSATION | |
Schedule of forward-looking range of assumptions to value the stock options issue | 2021 2020 Dividend yield 0.0 % 0.0 % Risk-free rate of return 0.71 % 0.33 % Expected life in years 5.88 5.88 Volatility 87.68 % 74.57 % Forfeiture rate 2.6 % 2.6 % |
Schedule of the Company's stock options | A summary of the Company’s stock options for the nine months ended September 30, 2021 is as follows: Weighted Weighted Average Number of Average Remaining Aggregate Shares Exercise Price Contractual Life Intrinsic Value Options Outstanding, December 31, 2020 11,951,250 $ 0.28 Granted 2,605,000 $ 0.28 Exercised (105,000) $ 0.21 Forfeited (1,915,000) $ 0.21 Options Outstanding, September 30, 2021 12,536,250 $ 0.29 6.5 years $ 1,350 Vested and unvested but expected to vest, September 30, 2021 12,055,116 $ 0.29 6.5 years $ 1,298 Exercisable at September 30, 2021 8,913,750 $ 0.30 5.5 years $ 1,350 |
CONVERTIBLE NOTES (Tables)
CONVERTIBLE NOTES (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt Instrument [Line Items] | |
Schedule of recorded interest expense and discount accretion | The Company recorded interest expense and discount accretion as set forth below: For the three months ended For the nine months ended September 30, 2021 September 30, 2020 September 30, 2021 September 30, 2020 2019 Notes $ 51,418 $ 52,186 $ 154,089 $ 155,424 2020 Notes 29,895 - 88,709 - Total interest expense $ 81,313 $ 52,186 $ 242,798 $ 155,424 |
2020 Convertible Notes | |
Debt Instrument [Line Items] | |
Schedule of principal amount and number of shares of common stock issuable upon exercise of their respective warrants | The affiliated investors and the principal amount of their respective 2020 Notes purchase are as set forth below: Investor Note Principal Essetifin S.p.A. $ 400,000 J.J. Finkelstein $ 10,000 Mauro Bove $ 10,000 Allan L. Goldstein $ 5,000 |
2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Schedule of principal amount and number of shares of common stock issuable upon exercise of their respective warrants | 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 |
LEASES (Tables)
LEASES (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
LEASES | |
Schedule of company's recognition of its operating lease | September 30, 2021 December 31, 2020 Assets Operating lease right-of-use asset $ 38,583 $ 68,229 Total lease assets $ 38,583 $ 68,229 Liabilities Current portion of operating lease liability $ 38,777 $ 40,790 Long-term portion of operating lease liability - 27,809 Total lease liabilities $ 38,777 $ 68,599 |
Schedule of minimum operating lease payments | 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 nine months ended September 30, 2021 and 2020 is recorded as general and administrative expense and consisted of the following: 2021 2020 Operating lease cost $ 38,003 $ 36,783 Variable lease costs 345 - Total lease costs $ 38,348 $ 36,783 |
Schedule of maturity operating lease payment | A maturity analysis of our operating lease minimum lease payments follows: 2021 $ 12,726 2022 29,694 Total 42,420 Discount factor (3,643) Total lease liability $ 38,777 |
ORGANIZATION, BUSINESS OVERVI_3
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Details) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)segment | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | |
ORGANIZATION AND BUSINESS [Line Items] | |||||
Number of Operating Segments | segment | 1 | ||||
Retained Earnings (Accumulated Deficit) | $ 110,040,128 | $ 110,040,128 | $ 108,891,958 | ||
Cash and Cash Equivalents, at Carrying Value | 1,523,390 | 1,523,390 | $ 427,898 | ||
Gross proceeds from private placement | 1,980,000 | ||||
Allocated Share-based Compensation Expense | $ 185,952 | $ 73,986 | $ 309,440 | $ 270,258 | |
General and administrative | |||||
ORGANIZATION AND BUSINESS [Line Items] | |||||
Allocated Share-based Compensation Expense | $ 16,983 | $ 62,399 |
NET INCOME (LOSS) PER COMMON _2
NET INCOME (LOSS) PER COMMON SHARE (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
NET INCOME (LOSS) PER COMMON SHARE | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 50,049,304 | 31,269,884 |
STOCK-BASED COMPENSATION - Fair
STOCK-BASED COMPENSATION - Fair value assumptions (Details) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
STOCK-BASED COMPENSATION | ||
Dividend yield | 0.00% | 0.00% |
Risk-free rate of return | 0.71% | 0.33% |
Expected life in years | 5 years 10 months 17 days | 5 years 10 months 17 days |
Volatility | 87.68% | 74.57% |
Forfeiture rate | 2.60% | 2.60% |
STOCK-BASED COMPENSATION - Summ
STOCK-BASED COMPENSATION - Summary of the Companys stock options (Details) | 9 Months Ended |
Sep. 30, 2021USD ($)$ / sharesshares | |
STOCK-BASED COMPENSATION | |
Number of shares, Beginning | shares | 11,951,250 |
Number of shares, Grants | shares | 2,605,000 |
Number of shares, Exercises | shares | (105,000) |
Number of shares, Forfeitures | shares | (1,915,000) |
Number of shares, Ending | shares | 12,536,250 |
Vested and unvested but expected to vest, June 30, 2021 | shares | 12,055,116 |
Number of Shares Exercisable | shares | 8,913,750 |
Weighted Average Exercise price, Beginning | $ / shares | $ 0.28 |
Weighted Average Exercise Price Granted | $ / shares | 0.28 |
Weighted Average Exercise Price Exercised | $ / shares | 0.21 |
Weighted Average Exercise Price Forfeited | $ / shares | 0.21 |
Weighted Average Exercise price, Ending | $ / shares | 0.29 |
Weighted Average Exercise Vested and unvested but expected to vest, June 30, 2021 | $ / shares | 0.29 |
Weighted Average Exercise Price Exercisable at June 30, 2021 | $ / shares | $ 0.30 |
Weighted Average Remaining Contractual Life Options Outstanding, June 30, 2021 | 6 years 6 months |
Weighted Average Remaining Contractual Life Vested and unvested but expected to vest, June 30, 2021 | 6 years 6 months |
Weighted Average Remaining Contractual Life Exercisable at June 30, 2021 | 5 years 6 months |
Aggregate Intrinsic Value Options Outstanding, June 30, 2021 | $ | $ 1,350 |
Aggregate Intrinsic Value Vested and unvested but expected to vest, June 30, 2021 | $ | 1,298 |
Aggregate Intrinsic Value Exercisable at June 30, 2021 | $ | $ 1,350 |
STOCK-BASED COMPENSATION - Addi
STOCK-BASED COMPENSATION - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment | ||||
Allocated Share-based Compensation Expense | $ 185,952 | $ 73,986 | $ 309,440 | $ 270,258 |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 527,327 | $ 527,327 | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 3 months 3 days | |||
Employees and Consultants and Directors [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment | ||||
Stock Issued During Period, Shares, New Issues | 2,605,000 | 2,130,000 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
FAIR VALUE MEASUREMENTS | ||
Cash and Cash Equivalents, Fair Value Disclosure | $ 54,581 | $ 427,898 |
CONVERTIBLE NOTES - Schedule of
CONVERTIBLE NOTES - Schedule of principal amount and number of shares of common stock issuable upon exercise of warrants (Details) | Sep. 30, 2021USD ($) |
Essetifin SPA [Member] | 2020 Notes | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | $ 400,000 |
Essetifin SPA [Member] | 2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 1,000,000 |
Joseph C. McNay [Member] | 2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 25,000 |
J.J. Finkelstein [Member] | 2020 Notes | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 10,000 |
J.J. Finkelstein [Member] | 2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 25,000 |
Mauro Bove [Member] | 2020 Notes | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 10,000 |
Mauro Bove [Member] | 2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 10,000 |
Allan L. Goldstein [Member] | 2020 Notes | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 5,000 |
Allan L. Goldstein [Member] | 2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 5,000 |
R. Don Elsey [Member] | 2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | $ 5,000 |
CONVERTIBLE NOTES - Summary of
CONVERTIBLE NOTES - Summary of recorded interest expense and discount accretion (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Debt Instrument [Line Items] | ||||
Change in fair value of derivative | $ 81,313 | $ 52,186 | $ 242,798 | $ 155,424 |
2019 Notes [Member] | ||||
Debt Instrument [Line Items] | ||||
Change in fair value of derivative | 51,418 | 52,186 | 154,089 | 155,424 |
2020 Notes | ||||
Debt Instrument [Line Items] | ||||
Change in fair value of derivative | $ 29,895 | $ 0 | $ 88,709 | $ 0 |
CONVERTIBLE NOTES - Additional
CONVERTIBLE NOTES - Additional Information (Details) | May 13, 2019USD ($) | Oct. 31, 2020USD ($)$ / sharesshares | Feb. 27, 2019USD ($)$ / sharesshares |
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||
Class of warrant or right, Exercise price of warrants or rights | $ / shares | $ 0.45 | $ 0.18 | |
Number of shares of common stock purchased | shares | 1,043,988 | 8,125,000 | |
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 176,573 | $ 348,443 | |
Fair Value Per Warrant | $ / shares | $ 0.26 | $ 0.06 | |
Intrinsic value of conversion allocated to additional paid up capital | $ 289,045 | ||
Measurement Input, Price Volatility [Member] | Black Scholes [Member] | |||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||
Warrants and Rights Outstanding, Measurement Input | 74.6 | 67.86 | |
Measurement Input, Expected Term [Member] | Black Scholes [Member] | |||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||
Warrants and Rights Outstanding, Measurement Input | 5 | 5 | |
Measurement Input, Risk Free Interest Rate [Member] | Black Scholes [Member] | |||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||
Warrants and Rights Outstanding, Measurement Input | 0.32 | 2.49 | |
Note Warrant | Estimate of Fair Value Measurement [Member] | |||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||
Proceeds from Issuance of Preferred Stock, Preference Stock, and Warrants | $ 348,443 | ||
Convertible Notes [Member] | February 2019 [Member] | |||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||
Proceeds from Convertible Debt | $ 1,300,000 | ||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | ||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.12 | ||
Debt Conversion, Converted Instrument, Shares Issued | shares | 10,833,333 | ||
Debt Instrument, Maturity Date, Description | The 2019 Notes will mature on March 1, 2024 | ||
First Closing | February 2019 [Member] | |||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||
Proceeds from Convertible Debt | $ 650,000 | ||
Second Closing | February 2019 [Member] | |||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||
Proceeds from Convertible Debt | $ 650,000 | ||
2020 Convertible Notes [Member] | 2020 Notes | |||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||
Proceeds from Convertible Debt | $ 500,000 | ||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | ||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.36 | ||
Debt Conversion, Converted Instrument, Shares Issued | shares | 1,391,982 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) - USD ($) | Apr. 28, 2021 | Apr. 06, 2016 | Sep. 30, 2021 |
License Agreement [Line Items] | |||
Initial Contribution Received In Related To Joint Venture | $ 3,000,000 | ||
Initial Equity Stake | 51.00% | ||
Additional Proceeds From License Fees Received | $ 1,000,000 | ||
Description of Equity Ownership Interest | RegeneRx’s ownership interest in ReGenTree was reduced from 49% to 38.5% when the Clinical Study Report was filed for the Phase 2/3 dry eye clinical trial. Based on when, and if, certain additional development milestones are achieved in the U.S. with RGN-259, our equity ownership may be incrementally reduced to between 38.5% and 25%, with 25% being the final equity ownership upon approval of a BLA for DES in the U.S. (Tβ4 is now regulated as a biologic rather than as a new drug entity, see page 19). In addition to our equity ownership, RegeneRx retains a royalty on net sales that varies between single and low double digits, depending on whether commercial sales are made by ReGenTree or a licensee. In the event ReGenTree is acquired or there is a change of control that occurs following achievement of a BLA, RegeneRx shall be entitled to a minimum of 40% of all proceeds paid or payable and will forgo any future royalties. | ||
Revenue, Judgment | Revenue is being recognized on a straight-line basis over a period of 30 years | ||
IPO [Member] | |||
License Agreement [Line Items] | |||
Gross proceeds | $ 270,000,000 | ||
RGN-259 Agreement [Member] | |||
License Agreement [Line Items] | |||
Milestone Payments | $ 3,500,000 | ||
RGN-137 Agreement [Member] | |||
License Agreement [Line Items] | |||
Milestone Payments | $ 3,500,000 | ||
Minimum [Member] | |||
License Agreement [Line Items] | |||
Capitalized Contract Cost, Amortization Period | 23 years | ||
ReGen Tree [Member] | |||
License Agreement [Line Items] | |||
Proceeds from Royalties Received | $ 250,000 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) | Jun. 28, 2021 | Mar. 02, 2018 | Jan. 31, 2020 | Apr. 23, 2019 | Mar. 31, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Oct. 31, 2020 | Feb. 27, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of shares of common stock purchased | 1,043,988 | 8,125,000 | ||||||||
Exercise price | $ 0.45 | $ 0.18 | ||||||||
Proceeds from the exercise of stock warrants | $ 12,868 | $ 241,911 | ||||||||
Proceeds from Issuance of Private Placement | $ 1,980,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 105,000 | |||||||||
Stock Issued During Period, Value, Stock Options Exercised | $ 22,050 | |||||||||
March Warrants [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of shares of common stock purchased | 925,000 | 1,935,294 | 1,000,000 | |||||||
Exercise price | $ 0.125 | |||||||||
Proceeds from the exercise of stock warrants | $ 115,625 | $ 241,911 | $ 125,000 | |||||||
Private Placement | Securities purchase agreement | Investors | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Aggregate shares sold | 9,900,000 | |||||||||
Share price | $ 0.20 | |||||||||
Gross proceeds | $ 1,980,000 | |||||||||
Private Placement | Securities purchase agreement | Series A Warrants | Investors | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of shares of common stock purchased | 7,425,000 | |||||||||
Exercise price | $ 0.24 | |||||||||
Term of warrant | 2 years | |||||||||
Private Placement | Securities purchase agreement | Series B Warrants | Investors | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of shares of common stock purchased | 7,425,000 | |||||||||
Exercise price | $ 0.28 | |||||||||
Term of warrant | 5 years | |||||||||
Warrant | Estimate of Fair Value Measurement [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Exercise price | $ 0.125 |
LEASES - Company's recognition
LEASES - Company's recognition of its operating lease (Details) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Assets | ||
Operating lease right-of-use asset | $ 38,583 | $ 68,229 |
Total lease assets | 38,583 | 68,229 |
Current | ||
Current portion of operating lease liability | 38,777 | 40,790 |
Non-current | ||
Long-term portion of operating lease liability | 0 | 27,809 |
Total lease liabilities | $ 38,777 | $ 68,599 |
LEASES - Minimum operating leas
LEASES - Minimum operating lease payments (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
LEASES | ||
Operating lease cost | $ 38,003 | $ 36,783 |
Variable lease costs | 345 | 0 |
Total lease costs | $ 38,348 | $ 36,783 |
LEASES - Maturity operating lea
LEASES - Maturity operating lease payment (Details) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
LEASES | ||
2021 | $ 12,726 | |
2022 | 29,694 | |
Total | 42,420 | |
Discount factor | (3,643) | |
Total lease liabilities | $ 38,777 | $ 68,599 |
LEASES - Additional information
LEASES - Additional information (Details) | 1 Months Ended |
Jun. 30, 2020USD ($) | |
LEASES | |
Lease Rent Per Month | $ 4,200 |
Lessee, Operating Lease, Discount Rate | 20.00% |
PROMISSORY NOTE (Details)
PROMISSORY NOTE (Details) | Apr. 24, 2020USD ($) |
Paycheck Protection Program Loan | |
Debt Instrument [Line Items] | |
Principal amount of loan | $ 55,400 |