Document and Entity Information
Document and Entity Information | 6 Months Ended |
Jun. 30, 2021 | |
Document and Entity Information [Abstract] | |
Document Type | S-1 |
Entity Registrant Name | REGENERX BIOPHARMACEUTICALS, INC. |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Entity Central Index Key | 0000707511 |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Current assets | ||||||||
Cash and cash equivalents | $ 2,025,577 | $ 427,898 | $ 639,916 | |||||
Prepaid expenses and other current assets | 30,415 | 49,909 | 41,639 | |||||
Total current assets | 2,055,992 | 477,807 | 681,555 | |||||
Operating lease right-of-use asset | 48,962 | 68,229 | $ 82,000 | 24,453 | $ 60,000 | |||
Other assets | 5,752 | 5,752 | 5,752 | |||||
Total assets | 2,110,706 | 551,788 | 711,760 | |||||
Current liabilities | ||||||||
Accounts payable | 198,820 | 39,320 | 43,678 | |||||
Unearned revenue | 76,761 | 76,761 | 76,761 | |||||
Accrued expenses | 278,472 | 208,857 | 95,020 | |||||
Promissory note | 33,856 | 33,856 | 0 | |||||
Current portion of operating lease liability | 45,043 | 40,790 | 27,014 | |||||
Total current liabilities | 632,952 | 399,584 | 242,473 | |||||
Long-term liabilities | ||||||||
Unearned revenue | 1,986,183 | 2,024,564 | 2,101,325 | |||||
Promissory note | 21,544 | 21,544 | 0 | |||||
Operating lease liability | 4,172 | 27,809 | 0 | |||||
Convertible promissory notes, net | 1,019,086 | 902,231 | 708,070 | |||||
Total liabilities | 3,663,937 | 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 | 0 | 0 | 0 | |||||
Common stock, par value $.001 per share, 200,000,000 shares authorized, 143,446,788 and 133,441,778 issued and outstanding | 143,447 | 133,442 | 131,507 | |||||
Additional paid-in capital | 107,913,605 | 105,934,572 | 104,896,975 | |||||
Accumulated deficit | (109,610,283) | (108,891,958) | (107,368,590) | |||||
Total stockholders' deficit | (1,553,231) | $ (3,119,842) | (2,823,944) | $ (2,724,819) | $ (2,435,091) | (2,340,108) | $ (2,212,053) | |
Total liabilities and stockholders' deficit | $ 2,110,706 | $ 551,788 | $ 711,760 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Condensed Balance Sheets | |||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 1,000,000 | 1,000,000 | 1,000,000 |
Preferred stock, shares issued | 0 | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 |
Common stock, shares issued | 143,446,788 | 133,441,788 | |
Common stock, shares, outstanding | 133,441,778 | 133,441,788 | 131,506,494 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Condensed Statements of Operations | ||||||||
Revenues | $ 19,191 | $ 19,191 | $ 38,381 | $ 38,381 | $ 76,761 | $ 76,762 | ||
Operating expenses | ||||||||
Research and development | 487 | 3,475 | 975 | 3,951 | 4,921 | 65,107 | ||
General and administrative | 276,151 | 400,951 | 594,269 | 757,813 | 1,366,383 | 1,273,536 | ||
Total operating expenses | 276,638 | 404,426 | 595,244 | 761,764 | 1,371,304 | 1,338,643 | ||
Loss from operations | (257,447) | (385,235) | (556,863) | (723,383) | (1,294,543) | (1,261,881) | ||
Other income (expense) | ||||||||
Interest income | 3 | 693 | 23 | 3,727 | 3,806 | 11,044 | ||
Interest expense | (81,189) | (51,619) | (161,485) | (103,238) | (232,631) | (153,410) | ||
Total other expense | (81,186) | (50,926) | (161,462) | (99,511) | (228,825) | (142,366) | ||
Loss before taxes | (338,633) | (436,161) | (718,325) | (822,894) | (1,523,368) | (1,404,247) | ||
Provision for income taxes | 0 | 0 | 0 | 0 | 0 | 0 | ||
Net loss | $ (338,633) | $ (379,692) | $ (436,161) | $ (386,733) | $ (718,325) | $ (822,894) | (1,523,368) | (1,404,247) |
Deemed dividend related to warrants down round provision | 0 | (82,566) | ||||||
Net loss attributable to common shareholders | $ (1,523,368) | $ (1,486,813) | ||||||
Basic net loss per common share | $ 0 | $ 0 | $ (0.01) | $ (0.01) | $ (0.01) | $ (0.01) | ||
Diluted net loss per common share | $ 0 | $ 0 | $ (0.01) | $ (0.01) | $ (0.01) | $ (0.01) | ||
Weighted average number of common shares outstanding - basic | 133,655,579 | 133,441,788 | 134,329,715 | 133,271,652 | 133,357,185 | 130,970,754 | ||
Weighted average number of common shares outstanding - diluted | 133,655,579 | 133,441,788 | 134,329,715 | 133,271,652 | 133,357,185 | 130,970,754 |
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, 2018 | $ 128,433 | $ 103,541,291 | $ (105,881,777) | $ (2,212,053) |
Balance (Shares) at Dec. 31, 2018 | 128,432,478 | |||
Issuance of common stock - note conversions (in value) | $ 1,149 | 67,792 | 0 | $ 68,941 |
Issuance of common stock - note conversions (in shares) | 1,149,016 | |||
Issuance of common stock - option exercises (in shares) | 1,638,575 | |||
Issuance of common stock - warrant exercises (in value) | $ 1,925 | 238,700 | 0 | $ 240,625 |
Issuance of common stock - warrant exercises (in shares) | 1,925,000 | |||
Warrants issued with debt | $ 0 | 348,443 | 0 | 348,443 |
Debt discount related to beneficial conversion feature | 0 | 348,443 | 0 | 348,443 |
Deemed dividend related to warrant reprice | 0 | 82,566 | (82,566) | 0 |
Stock-based compensation expense | 0 | 269,740 | 0 | 269,740 |
Net loss | 0 | 0 | (1,404,247) | (1,404,247) |
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 | (822,894) | |||
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 | |||
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 - option exercises (in shares) | 0 | |||
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 | |||
Warrants issued with debt | $ 0 | 176,573 | 0 | 176,573 |
Debt discount related to beneficial conversion feature | 0 | 289,045 | 0 | 289,045 |
Stock-based compensation expense | 0 | 332,003 | 0 | 332,003 |
Net loss | 0 | 0 | (1,523,368) | (1,523,368) |
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 | |||
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 | |||
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 | |||
Net loss | (718,325) | |||
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 | |||
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 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities: | ||||
Net loss | $ (718,325) | $ (822,894) | $ (1,523,368) | $ (1,404,247) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Depreciation and amortization | 0 | 1,418 | ||
Non-cash share-based compensation | 123,488 | 196,272 | 332,003 | 269,740 |
Non-cash interest expense | 116,855 | 70,828 | 162,179 | 105,202 |
Changes in operating assets and liabilities: | ||||
Prepaid expenses and other current assets | 19,494 | 18,041 | (8,270) | (5,030) |
Accounts payable | 159,500 | (17,614) | (4,358) | (48,755) |
Accrued expenses | 69,615 | 36,292 | 113,837 | 23,496 |
Operating lease liability | (117) | (2,178) | (2,191) | (3,032) |
Unearned revenue | (38,381) | (38,380) | (76,761) | (76,762) |
Net cash used in operating activities | (267,871) | (559,633) | (1,006,929) | (1,137,970) |
Financing activities: | ||||
Proceeds from private offering of common stock and warrants, net of issuance costs | 1,843,500 | 0 | ||
Proceeds from the exercise of stock options | 22,050 | 0 | ||
Proceeds from promissory note | 0 | 55,400 | 55,400 | 0 |
Proceeds from the sale of convertible notes | 500,000 | 1,300,000 | ||
Debt issuance costs | (2,400) | 0 | ||
Proceeds from the exercise of stock warrants | 0 | 241,911 | 241,911 | 240,625 |
Net cash provided by financing activities | 1,865,550 | 297,311 | 794,911 | 1,540,625 |
Net increase (decrease) in cash and cash equivalents | 1,597,679 | (262,322) | (212,018) | 402,655 |
Cash and cash equivalents at beginning of period | 427,898 | 639,916 | 639,916 | 237,261 |
Cash and cash equivalents at end of period | 2,025,577 | 377,594 | 427,898 | 639,916 |
Supplemental Disclosures of Non-Cash Operating and Financing Activities: | ||||
Conversion of promissory notes to common stock | 0 | 55,000 | ||
Conversion of accrued interest to common stock | 0 | 13,941 | ||
Establish right-of-use asset | 0 | 81,890 | 81,980 | 59,822 |
Establish operating lease liability | $ 0 | $ 81,890 | 81,980 | 65,415 |
Issuance of warrants in conjunction with issuance of convertible notes | 176,573 | 348,443 | ||
Beneficial conversion feature on issuance of convertible notes | $ 289,045 | $ 348,443 |
ORGANIZATION, BUSINESS OVERVIEW
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 June 30, 2021, we have an accumulated deficit of $110 million and we had cash and cash equivalents of $2,025,577 as of June 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 six month periods ended June 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 $34,159 and $45,416 for the three and six months ended June 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 for the three and six months ended June 30, 2020, respectively. | 1. ORGANIZATION AND BUSINESS Organization and Nature of Operations. RegeneRx Biopharmaceuticals, Inc. (“RegeneRx”, the “Company”, “We”, “Us”, “Our”), a Delaware corporation, was incorporated in 1982. We are focused on the discovery and development of novel molecules to accelerate tissue and organ repair. Our operations are confined to one business segment: the development and marketing of product candidates based on Thymosin Beta 4 (“Tß4”), an amino acid peptide. Management Plans to Address Operating Conditions. Our strategy is aimed at being capital efficient while leveraging our portfolio of clinical assets by seeking strategic relationships with organizations with clinical development capabilities including development capital. Currently, we have active partnerships in four major territories: North America, Europe, China and Pan Asia. In each case, the cost of development is being borne by our partners with no financial obligation for RegeneRx. We still have significant clinical assets to develop, primarily RGN-352 (injectable formulation of Tß4 for cardiac and CNS disorders) in the U.S., Pan Asia, and Europe, and RGN-259 in the EU. Our goal is to wait until satisfactory results are obtained from the current ophthalmic clinical program in the U.S. before moving into the EU. However, we intend to continue to develop RGN-352, our injectable systemic product candidate for cardiac and central nervous system indications, either by obtaining grants to fund a Phase 2a clinical trial in the cardiovascular or central nervous system fields or finding a suitable partner with the resources and capabilities to develop it as we have with RGN-259. Since inception, and through December 31, 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 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 to management, the Company’s Board of Directors and accredited investors including Essetifin S.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. 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. |
NET INCOME (LOSS) PER COMMON SH
NET INCOME (LOSS) PER COMMON SHARE | 6 Months Ended |
Jun. 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 six month periods ended June 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 47,547,251 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 | 6 Months Ended |
Jun. 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 $61,744 and $146,433 in stock-based compensation expense for the three months ended June 30, 2021 and 2020. We recognized $123,488 and $196,272 in stock-based compensation expense for the six months ended June 30, 2021 and 2020, respectively. We did not issue stock options to employees, consultants and directors during the six months ended June 30, 2021. We issued 2,130,000 stock options to employees, consultants and directors during the six months ended June 30, 2020. A summary of the Company’s stock options for the six months ended June 30, 2021 is as follows: Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Life Intrinsic Value Options Outstanding, December 31, 2020 11,951,250 $ 0.28 Granted - $ 0.30 Exercised (105,000) $ 0.21 Forfeited (1,915,000) $ 0.21 Options Outstanding, June 30, 2021 9,931,250 $ 0.30 5.9 years $ 283,550 Vested and unvested but expected to vest, June 30, 2021 9,606,260 $ 0.30 5.9 years $ 274,271 Exercisable at June 30, 2021 7,861,250 $ 0.31 5.3 years $ 223,250 The average expected life was determined using historical data. We expect to recognize the compensation cost related to non-vested options as of June 30, 2021 of $299,253 over the weighted average remaining recognition period of 0.93 years. |
INCOME TAXES
INCOME TAXES | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
INCOME TAXES | ||
INCOME TAXES | 4. INCOME TAXES As of June 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 June 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. | 9. INCOME TAXES The Company’s provision for income taxes consists of the following for the years ended December 31, 2020 and 2019: 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 $ - $ - Significant components of the Company’s deferred tax assets at December 31, 2020 and 2019 and related valuation allowances are presented below: 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 $ - $ - At December 31, 2020, we had net operating loss carryforwards for Federal income tax purposes of approximately $51.1 million and research and research and experimental tax credit carryforwards of approximately $2.3 million, which are available to offset future federal income. Approximately $47.9 million of the net operating loss carryforwards, generated prior to 2018, expires in increments through 2037, while carryforwards generated in 2018 or later do not expire. Section 382 of the Internal Revenue Code imposes substantial restrictions on the utilization of net operating losses and tax credits in the event of a corporation’s ownership change. During 2009, the Company completed a preliminary study to compute any limits on the net operating losses and credit carryforwards for purposes of Section 382. It was determined that the Company experienced a cumulative change in ownership, as defined by the regulations, in 2002. This change in ownership triggers an annual limitation on the Company’s ability to utilize certain U.S. federal and state net operating loss carryforwards and research tax credit carryforwards, resulting in the potential loss of approximately $9.8 million of net operating loss carryforwards and $0.2 million in research credit carryforwards. The Company has reduced the deferred tax assets associated with these carryforwards in its balance sheets. The Company believes that the future use of net operating losses and tax credits presented above may be further reduced as a result of additional ownership changes subsequent to 2009. The provision for income taxes on earnings subject to income taxes differs from the statutory federal rate for the years ended December 31, 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 % 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 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. The 2007 through 2019 tax years generally remain subject to examination by federal and most state tax authorities. In addition, we would remain open to examination for earlier years if we were to utilize net operating losses or tax credit carryforwards that originated prior to 2012. On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was signed into law in response to the COVID-19 pandemic. The CARES Act provides numerous tax provisions and stimulus measures, including temporary changes regarding the prior and future utilization of net operating losses, temporary changes to the prior and future limitations on interest deductions, and technical corrections from prior tax legislation for tax depreciation of certain qualified improvement property. The Company has evaluated the provisions of the CARES Act relating to income taxes which will result in adjustments to certain deferred tax assets and liabilities. Due to the Company’s U.S. valuation allowance, the Company noted the provisions of the CARES Act did not have a material impact on its financial statements. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 June 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 $20,067 and $427,898, respectively, using Level 1 inputs. | 3. FAIR VALUE MEASUREMENTS The authoritative guidance for fair value measurements defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or the most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The guidance describes a fair value hierarchy based on the levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following: ● ● ● As of December 31, 2020, and 2019, our only qualifying assets that required measurement under the foregoing fair value hierarchy were funds held in our Company bank accounts included in cash and cash equivalents valued at $427,898 and $639,916, respectively, using Level 1 inputs. |
CONVERTIBLE NOTES
CONVERTIBLE NOTES | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 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 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 six months ended June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 2019 Notes $ 51,619 $ 51,619 $ 102,671 $ 103,238 2020 Notes 29,570 - 58,814 - Total interest expense $ 81,189 $ 51,619 $ 161,485 $ 103,238 | 7. CONVERTIBLE NOTES 2014 Convertible Notes On January 7, 2014, we completed a private placement of convertible notes raising an aggregate of $55,000 in gross proceeds (the “January 2014 Notes”). The January 2014 Notes bore interest at a rate of 5% per annum, mature sixty (60) months after their date of issuance and were convertible into shares of our common stock at a conversion price of six cents ($0.06) per share (subject to adjustment as described in the January 2014 Notes) at any time prior to repayment, at the election of the investor. In the aggregate, the January 2014 Notes were initially convertible into up to 916,667 shares of our common stock. At any time prior to maturity of the January 2014 Notes, with the consent of the holders of a majority in interest of the January 2014 Notes, we could prepay the outstanding principal amount of the January 2014 Notes plus unpaid accrued interest without penalty. Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the federal bankruptcy act or the continuation of such petition without dismissal for a period of 90 days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the January 2014 Notes would accelerate and automatically become immediately due and payable. The investors in the offering included two current and one former member of the Board of Directors. The principal amounts of their respective January 2014 Notes were as set forth below: 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. 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 warrants to each investor. The warrants are exercisable for an aggregate of 8,125,000 shares of common stock with an exercise price of eighteen cents ($0.18) per share for a period of five years (the “2019 Warrants”). The relative fair value of the 2019 Warrants issued was $348,443 calculated using the Black-Scholes-Merton valuation model value of $0.06 with an expected and contractual life of five years, an assumed volatility of 67.86%, and a risk-free interest rate of 2.49%. The 2019 Warrants are classified in equity. The Company allocated $348,443 of the gross proceeds to the warrants, on a relative fair value basis. In addition, because the effective conversion price of the 2019 Notes was less than the fair value of the underlying common stock on the issuance date, we allocated the intrinsic value of that feature to additional paid-in capital. The debt discount created by the 2019 Warrants and beneficial conversion feature is amortized over the term of the 2019 Notes as additional interest expense using the effective interest method. The affiliated investors and the principal amount of their respective 2019 Notes purchase are as set forth below: Investor 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 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 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 |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 6 Months Ended |
Jun. 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 Joint Venture, jointly owned by the Company and GtreeBNT. ReGenTree will commercialize 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 will be directed by a joint development committee comprised of representatives of the Company and GtreeBNT. The License Agreement has a term that extends to the later of the expiration of the last patent covered by the 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, Australia, New Zealand, Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, Mongolia, Myanmar (Burma), Philippines, Singapore, Thailand, Vietnam, and Kazakhstan, and semi-exclusive in India, Pakistan, Bangladesh, Bhutan, Maldives, Nepal, Sri Lanka, Kyrgyzstan, Tajikistan, Turkmenistan and Uzbekistan, collectively, the Territory (the “259 Territory”). Under the 259 license agreement we are eligible to receive aggregate potential milestone payments of up to $3.5 million. In addition, we are eligible to receive royalties of a low double-digit percentage of any commercial sales of the licensed product sold by GtreeBNT in the 259 Territory. Under the license agreement for RGN-137, our topical dermal gel product candidate, GtreeBNT will have the exclusive right to develop and commercialize RGN-137 in the U.S. (the “137 Territory”). Under the 137 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 complete 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 | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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. The estimated fair value of the effect of the exercise price adjustment of $82,566 is reflected as a dividend to the March 2018 Investor in 2019. 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 1,939,294 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”). | 8. STOCKHOLDERS’ EQUITY Common Stock. On March 2, 2018, we entered into the Reprice Agreement with Sabby Healthcare Master Fund, Ltd., and Sabby Volatility Warrant Master Fund, Ltd. (collectively, “Sabby”). In connection with that certain securities purchase agreement between the Company and Sabby dated June 27, 2016 (the “Purchase Agreement”) we also issued to Sabby warrants to purchase 5,147,059 shares of common stock (the “Warrant Shares”) at an exercise price of $0.51 per share (the “Sabby Warrants”). Under the terms of the Reprice Agreement, in consideration of Sabby exercising in full all of the Sabby Warrants (the “Warrant Exercise”), the exercise price per share of the Sabby Warrants was reduced to $0.20 per share. We received gross proceeds of approximately $1,029,000 from the warrant reprice transaction. In addition, and as further consideration, we issued to Sabby warrants to purchase up to 3,860,294 shares of common stock at an exercise price of $0.2301 per share, the closing bid price for the Company’s Common Stock on February 28, 2018 (the “March Warrants"). 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 Warrants, the exercise price of the March Warrants was adjusted to $0.125 per share. The estimated fair value of the effect of the exercise price adjustment of $82,566 is reflected as a dividend to Sabby for the year ended December 31, 2019. Subsequent to the reduction of the exercise price of the March Warrants to $0.125 in 2019, Sabby exercised warrants for 925,000 shares of common stock and the Company received exercise proceeds of $115,625. Sabby exercised additional warrants on April 23, 2019 for 1,000,000 shares of common stock and the Company received exercise proceeds of $125,000. Sabby exercised their remaining warrants on January 17, 2020 for 1,935,294 shares of common stock and the Company received exercise proceeds of $241,911. Registration Rights Agreements. The Registration Rights Agreements usually require us to pay penalties for any failure or time delay in filing or maintaining the effectiveness of the required registration statements. These penalties are usually expressed as a fixed percentage, per month, of the original amount we received on issuance of the common shares, options or warrants. While to date we have not incurred any penalties under these agreements, if a penalty is determined to be probable, we would recognize the amount as a contingent liability and not as a derivative instrument. Share-Based Compensation. Stock Option and Incentive Plans. We have previously adopted two equity incentive plans, known as the 2000 Equity Incentive Plan, or the 2000 Plan, and the 2010 Equity Incentive Plan, or the 2010 Plan. Both the 2000 Plan and the 2010 Plan have a term of ten years, with the 2000 Plan already expired and the 2010 Plan expired in July 2020. No further awards may be granted under the 2010 Plan with the approval of the 2018 Plan. All outstanding option awards granted under the 2010 Plan will continue to be subject to the terms and conditions as set forth in the agreements evidencing such option awards and the terms of the 2010 Plan. Shares remaining available for issuance under the shares reserved under the 2010 Plan will not be subject to future awards under the 2018 Plan, and shares subject to outstanding awards under the 2010 Plan that are terminated or forfeited in the future will not be subject to future awards under the 2018 Plan. All outstanding option awards granted under the 2000 Plan have expired. The following summarizes share-based compensation expense for the years ended December 31, 2020 and 2019, which was allocated as follows: December 31, 2020 2019 Research and development $ - $ 63,207 General and administrative 332,003 206,533 $ 332,003 $ 269,740 The following summarizes stock option activity for the years ended December 31, 2020 and 2019: Options Outstanding Shares Weighted average available for Number of Exercise price exercise grants shares range 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 The following summarizes information about stock options outstanding at December 31, 2020: Weighted Weighted Average Average Aggregate Number of Exercise Remaining Intrinsic Shares Price Contractual Life 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. 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 % Our dividend yield assumption is based on the fact that we have never paid cash dividends and do not anticipate paying cash dividends in the foreseeable future. Our risk-free interest rate assumption is based on yields of U.S. Treasury notes in effect at the date of grant. Our expected life represents the period of time that options granted are expected to be outstanding and is calculated in accordance with the Securities and Exchange Commission (“SEC”) guidance provided in the SEC’s Staff Accounting Bulletin (“SAB”) 107 and SAB 110, using a “simplified” method. The Company has used the simplified method and will continue to use the simplified method as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate an expected term. Our volatility assumption is based on reviews of the historical volatility of our common stock. Using Black-Scholes and these factors, the weighted average fair value of stock options granted to employees and directors was $0.19 and $0.16 for the years 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 Weighted average Number of Exercise price exercise shares range 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 |
LEASES
LEASES | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 June 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. June 30, 2021 Assets Operating lease right-of-use asset $ 48,962 Total lease assets $ 48,962 Liabilities Current Current portion of operating lease liability $ 45,043 Non-current Operating lease liability 4,172 Total lease liabilities $ 49,215 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 six months ended June 30, 2021 and 2020 is recorded as general and administrative expense and consisted of the following: 2021 2020 Operating lease cost $ 24,542 $ 22,891 Variable lease costs 267 - Total lease costs $ 24,809 $ 22,891 A maturity analysis of our operating lease minimum lease payments follows: 2021 $ 25,452 2022 29,694 Total 55,146 Discount factor (5,931) Total lease liability $ 49,215 | 10. LEASES In June 2020, we amended our office lease agreement, and the term has been extended through July 2022. During the extended term, our rental payments will be approximately $4,200 per month. We had previously amended the office lease to extend through July 2020. Our facility lease is our only existing lease as of December 31, 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. The following table summarizes the Company's recognition of its operating lease as of December 31, 2020: 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 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 Variable lease costs 895 4,381 Total lease costs $ 50,955 $ 52,482 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 |
PROMISSORY NOTE
PROMISSORY NOTE | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 is $55,400. In accordance with the requirements of the CARES Act, the Company used the proceeds from the Loan in accordance with the requirements of the PPP to cover certain qualified expenses, including payroll costs, rent and utility costs. Interest accrues on the Loan at the rate of 1.00% per annum. The Company 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. | 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. 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. |
ORGANIZATION, BUSINESS OVERVI_2
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Policies) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 six month periods ended June 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. | Use of Estimates. |
Convertible Notes with Detachable Warrants. | Convertible Notes with Detachable Warrants. In accordance with ASC 470-20, Debt with Conversion and Other Options | Convertible Notes with Detachable Warrants. Debt with Conversion and Other Options themselves at the time of issuance. The portion of the proceeds allocated to the warrants is recognized as additional paid-in capital and a debt discount. The debt discount related to warrants is accreted into interest expense through maturity of the notes. |
Revenue Recognition. | 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. | Revenue Recognition. The Company’s contracts with customers may at times include multiple promises to transfer products and services. Contracts with multiple promises are analyzed to determine whether the promises, which may include a license together with performance obligations such as providing a clinical supply of product and steering committee services, are distinct and should be accounted for as separate performance obligations or whether they must be accounted for as a single performance obligation. The Company accounts for individual performance obligations separately if they are distinct. Determining whether products and services are considered distinct performance obligations may require significant judgment. If we cannot reasonably estimate when our performance obligation either ceases or becomes inconsequential and perfunctory, then revenue is deferred until we can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. Whenever the Company determines that an arrangement should be accounted for as a combined performance obligation, we must determine the period over which the performance obligation will be performed and when revenue will be recognized. Revenue is recognized using either a relative performance or straight-line method. We recognize revenue using the relative performance method provided that we can reasonably estimate the level of effort required to complete our performance obligation under an arrangement and such performance obligation is provided on a best-efforts basis. Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. If the Company cannot reasonably estimate the level of effort required to complete our performance obligation under an arrangement, the performance obligation is provided on a best-efforts basis and we can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory, then the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over the period we expect to complete our performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date. At the inception of each arrangement that includes development milestone payments, the Company evaluates the probability of reaching the milestones and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur in the future, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore revenue recognized is constrained as management is unable to assert that a reversal of revenue would not be possible. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Amounts received prior to satisfying the above revenue recognition criteria are recorded as unearned revenue in our accompanying balance sheets. Contract assets are generated when contractual billing schedules differ from revenue recognition timing. Contract assets represent a conditional right to consideration for satisfied performance obligations that becomes a billed receivable when the conditions are satisfied. There were no contract assets as of December 31, 2020 and 2019. 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 amount disclosed above are primarily related to revenue being recognized on a straight-line basis over periods ranging from 23 to 30 years, which, in management’s judgment, is the best measure of progress towards satisfying the performance obligations and represents the Company’s best estimate of the period of the obligation. Revenue recognized from contract liabilities during the years ended December 31, 2020 and 2019, totaled $76,761 and $76,762, respectively. Revenue is expected to be recognized in the future from contract liabilities as the related performance obligations are satisfied. |
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. | Recently Adopted Accounting Pronouncements. Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements restated. The guidance must be adopted on a modified retrospective basis and provides for certain practical expedients. We adopted this guidance effective January 1, 2019, using the following practical expedients: ● ● Additionally, we made ongoing 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. Upon adoption of the new guidance on January 1, 2019, we recorded a ROU asset of approximately $60,000 (net of existing deferred rent liability) and recognized a lease liability of approximately $65,000, with no resulting cumulative effect adjustment to accumulated deficit. In June 2020, we renewed our office lease for two years and we recorded a ROU asset of approximately $82,000 and recognized a lease liability of approximately $82,000. Accounting Standard Not Yet Adopted. Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
Reclassification | Reclassification Stock-based compensation expense of $34,159 and $45,416 for the three and six months ended June 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 for the three and six months ended June 30, 2020, respectively. |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
STOCK-BASED COMPENSATION | ||
Schedule of forward-looking range of assumptions to value the stock options issue | 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 % | |
Schedule of the Company's stock options | A summary of the Company’s stock options for the six months ended June 30, 2021 is as follows: Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Life Intrinsic Value Options Outstanding, December 31, 2020 11,951,250 $ 0.28 Granted - $ 0.30 Exercised (105,000) $ 0.21 Forfeited (1,915,000) $ 0.21 Options Outstanding, June 30, 2021 9,931,250 $ 0.30 5.9 years $ 283,550 Vested and unvested but expected to vest, June 30, 2021 9,606,260 $ 0.30 5.9 years $ 274,271 Exercisable at June 30, 2021 7,861,250 $ 0.31 5.3 years $ 223,250 | The following summarizes information about stock options outstanding at December 31, 2020: Weighted Weighted Average Average Aggregate Number of Exercise Remaining Intrinsic Shares Price Contractual Life 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 |
CONVERTIBLE NOTES (Tables)
CONVERTIBLE NOTES (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 six months ended June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 2019 Notes $ 51,619 $ 51,619 $ 102,671 $ 103,238 2020 Notes 29,570 - 58,814 - Total interest expense $ 81,189 $ 51,619 $ 161,485 $ 103,238 | The Company recorded interest expense and discount accretion as set forth below: 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 |
Schedule of principal amount and number of shares of common stock issuable upon exercise of their respective warrants | The investors in the offering included two current and one former member of the Board of Directors. The principal amounts of their respective January 2014 Notes were as set forth below: Investor Note Principal Joseph C. McNay $ 25,000 Allan L. Goldstein $ 10,000 L. Thompson Bowles $ 5,000 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 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 | |
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) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
LEASES | ||
Schedule of company's recognition of its operating lease | June 30, 2021 Assets Operating lease right-of-use asset $ 48,962 Total lease assets $ 48,962 Liabilities Current Current portion of operating lease liability $ 45,043 Non-current Operating lease liability 4,172 Total lease liabilities $ 49,215 | 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 |
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 six months ended June 30, 2021 and 2020 is recorded as general and administrative expense and consisted of the following: 2021 2020 Operating lease cost $ 24,542 $ 22,891 Variable lease costs 267 - Total lease costs $ 24,809 $ 22,891 | 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 Variable lease costs 895 4,381 Total lease costs $ 50,955 $ 52,482 |
Schedule of maturity operating lease payment | A maturity analysis of our operating lease minimum lease payments follows: 2021 $ 25,452 2022 29,694 Total 55,146 Discount factor (5,931) Total lease liability $ 49,215 | 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 |
ORGANIZATION, BUSINESS OVERVI_3
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)segment | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
ORGANIZATION AND BUSINESS [Line Items] | ||||||
Number of Operating Segments | segment | 1 | |||||
Retained Earnings (Accumulated Deficit) | $ 109,610,283 | $ 109,610,283 | $ 108,891,958 | $ 107,368,590 | ||
Cash and Cash Equivalents, at Carrying Value | 2,025,577 | 2,025,577 | 427,898 | 639,916 | ||
Gross proceeds from private placement | 1,980,000 | |||||
Allocated Share-based Compensation Expense | $ 61,744 | $ 146,433 | $ 123,488 | $ 196,272 | $ 332,003 | $ 269,740 |
Research and development [Member] | ||||||
ORGANIZATION AND BUSINESS [Line Items] | ||||||
Allocated Share-based Compensation Expense | $ 34,159 | $ 45,416 |
NET INCOME (LOSS) PER COMMON _2
NET INCOME (LOSS) PER COMMON SHARE (Details) - shares | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
NET INCOME (LOSS) PER COMMON SHARE | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 47,547,251 | 31,269,884 | 33,705,854 | 31,075,178 |
STOCK-BASED COMPENSATION - Summ
STOCK-BASED COMPENSATION - Summary of the Company's stock options (Details) - USD ($) | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
STOCK-BASED COMPENSATION | |||
Shares available for grant, Beginning | 11,951,250 | 3,610,130 | 4,123,142 |
Number of Shares Granted | 0 | 2,130,000 | 2,415,000 |
Number of Shares Exercised | (105,000) | ||
Number of Shares Forfeited | (1,915,000) | ||
Shares available for grant, Ending | 9,931,250 | 11,951,250 | 3,610,130 |
Vested and unvested but expected to vest, June 30, 2021 | 9,606,260 | 11,811,875 | |
Number of Shares Exercisable | 7,861,250 | 8,745,500 | |
Weighted Average Exercise price, Beginning | $ 0.28 | $ 0.28 | $ 0.28 |
Weighted Average Exercise Price Granted | 0.30 | 0.30 | 0.21 |
Weighted Average Exercise Price Exercised | 0.21 | 0 | 0.21 |
Weighted Average Exercise Price Forfeited | 0.21 | ||
Weighted Average Exercise price, Ending | 0.30 | 0.28 | $ 0.28 |
Weighted Average Exercise Vested and unvested but expected to vest, June 30, 2021 | 0.30 | ||
Weighted Average Exercise Price Exercisable at June 30, 2021 | $ 0.31 | $ 0.29 | |
Weighted Average Remaining Contractual Life Options Outstanding, June 30, 2021 | 5 years 10 months 24 days | 5 years 4 months 24 days | |
Weighted Average Remaining Contractual Life Vested and unvested but expected to vest, June 30, 2021 | 5 years 10 months 24 days | 5 years 4 months 24 days | |
Weighted Average Remaining Contractual Life Exercisable at June 30, 2021 | 5 years 3 months 18 days | 4 years 1 month 6 days | |
Aggregate Intrinsic Value Options Outstanding, June 30, 2021 | $ 283,550 | $ 2,189,575 | |
Aggregate Intrinsic Value Vested and unvested but expected to vest, June 30, 2021 | 274,271 | 2,164,040 | |
Aggregate Intrinsic Value Exercisable at June 30, 2021 | $ 223,250 | $ 1,563,850 |
STOCK-BASED COMPENSATION - Addi
STOCK-BASED COMPENSATION - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment | ||||||
Allocated Share-based Compensation Expense | $ 61,744 | $ 146,433 | $ 123,488 | $ 196,272 | $ 332,003 | $ 269,740 |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 299,253 | $ 299,253 | $ 423,000 | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 11 months 4 days | 1 year 3 months 7 days | ||||
Employees and Consultants and Directors [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment | ||||||
Stock Issued During Period, Shares, New Issues | 2,130,000 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
FAIR VALUE MEASUREMENTS | |||
Cash and Cash Equivalents, Fair Value Disclosure | $ 20,067 | $ 427,898 | $ 639,916 |
CONVERTIBLE NOTES - Schedule of
CONVERTIBLE NOTES - Schedule of principal amount and number of shares of common stock issuable upon exercise of warrants (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
January 2014 [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | $ 55,000 | |
Essetifin SPA [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | $ 1,000,000 | 1,000,000 |
Joseph C. McNay [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 25,000 | 25,000 |
Joseph C. McNay [Member] | January 2014 [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 25,000 | |
J.J. Finkelstein [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 25,000 | 25,000 |
Mauro Bove [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 10,000 | 10,000 |
Allan L. Goldstein [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 5,000 | 5,000 |
Allan L. Goldstein [Member] | January 2014 [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 10,000 | |
R. Don Elsey [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | $ 5,000 | 5,000 |
L. Thompson Bowles [Member] | January 2014 [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 | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Instrument [Line Items] | ||||||
Change in fair value of derivative | $ 81,189 | $ 51,619 | $ 161,485 | $ 103,238 | ||
2019 Notes [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Change in fair value of derivative | 51,619 | 51,619 | 102,671 | 103,238 | $ 207,610 | $ 152,931 |
2020 Notes | ||||||
Debt Instrument [Line Items] | ||||||
Change in fair value of derivative | $ 29,570 | $ 0 | $ 58,814 | $ 0 | 25,021 | 0 |
January 2014 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Change in fair value of derivative | $ 0 | $ 479 |
CONVERTIBLE NOTES - Additional
CONVERTIBLE NOTES - Additional Information (Details) | May 13, 2019USD ($) | Mar. 13, 2019USD ($) | Feb. 27, 2019USD ($)$ / shares | Jan. 07, 2014USD ($)$ / sharesshares | Jan. 07, 2014USD ($)$ / shares | Oct. 31, 2020USD ($)$ / sharesshares | Feb. 28, 2019USD ($) | Feb. 27, 2019USD ($)$ / sharesshares | Feb. 19, 2019USD ($) | Jun. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($) | Mar. 27, 2019 | Jan. 06, 2019shares | Mar. 02, 2018$ / sharesshares |
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Proceeds from Convertible Debt | $ 500,000 | $ 1,300,000 | |||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | $ / shares | $ 0.18 | $ 0.18 | $ 0.2301 | ||||||||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.12 | $ 0.12 | |||||||||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 10,833,333 | ||||||||||||||
Warrants issued with debt | $ 176,573 | $ 348,443 | |||||||||||||
Number of shares of common stock purchased | shares | 8,125,000 | 8,125,000 | 3,860,294 | ||||||||||||
Debt Instrument, Maturity Date, Description | The 2019 Notes will mature on March 1, 2024 | ||||||||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 348,443 | $ 348,443 | |||||||||||||
Fair Value Per Warrant | $ / shares | $ 0.06 | $ 0.06 | |||||||||||||
Measurement Input, Price Volatility [Member] | Black Scholes [Member] | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Warrants and Rights Outstanding, Measurement Input | 67.86 | 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 | 2.49 | 2.49 | |||||||||||||
Note Warrant | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Number of shares of common stock purchased | shares | 1,149,016 | ||||||||||||||
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 | $ 348,443 | |||||||||||||
2020 Notes | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | $ / shares | $ 0.45 | $ 0.45 | |||||||||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 1,391,982 | ||||||||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 176,573 | $ 176,573 | |||||||||||||
January 2014 [Member] | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Debt Instrument, Face Amount | 55,000 | ||||||||||||||
Debt Instrument, Increase, Accrued Interest | 14,000 | ||||||||||||||
Debt Instrument, Term | 60 months | ||||||||||||||
Convertible Notes | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Proceeds from Convertible Debt | $ 1,300,000 | $ 55,000 | $ 500,000 | $ 1,300,000 | $ 1,300,000 | ||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 75.00% | 5.00% | 5.00% | 75.00% | 75.00% | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | $ / shares | $ 0.18 | $ 0.45 | $ 0.18 | ||||||||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.12 | $ 0.06 | $ 0.06 | $ 0.36 | $ 0.12 | ||||||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 916,667 | ||||||||||||||
Convertible Notes | January 2014 [Member] | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Bifurcated Liability | $ 55,000 | $ 55,000 | |||||||||||||
Residual Debt Value | $ 0 | ||||||||||||||
Convertible Notes | February 2019 [Member] | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | 5.00% | 5.00% | ||||||||||||
First Closing | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Proceeds from Convertible Debt | $ 650,000 | $ 650,000 | |||||||||||||
Second Closing | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Proceeds from Convertible Debt | $ 650,000 | $ 650,000 | |||||||||||||
2020 Convertible 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 | ||||||||||||||
Number of shares of common stock purchased | shares | 1,043,988 | 1,043,988 | |||||||||||||
Proceeds from Issuance of Preferred Stock, Preference Stock, and Warrants | $ 176,573 | ||||||||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 176,573 | ||||||||||||||
Fair Value Per Warrant | $ / shares | $ 0.26 | $ 0.26 | |||||||||||||
Intrinsic value of conversion allocated to additional paid up capital | $ 289,045 | $ 289,045 | |||||||||||||
2020 Convertible Notes | 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 | 74.6 | |||||||||||||
2020 Convertible Notes | Measurement Input, Expected Term [Member] | Black Scholes [Member] | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Warrants and Rights Outstanding, Measurement Input | 5 | ||||||||||||||
2020 Convertible Notes | 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 | 0.32 | |||||||||||||
2020 Convertible Notes | 2020 Notes | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) - USD ($) | Apr. 28, 2021 | Apr. 06, 2016 | Jun. 30, 2021 | Dec. 31, 2020 |
License Agreement [Line Items] | ||||
Initial Contribution Received In Related To Joint Venture | $ 3,000,000 | $ 3,000,000 | ||
Initial Equity Stake | 51.00% | 51.00% | ||
Additional Proceeds From License Fees Received | $ 1,000,000 | $ 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. | RegeneRx’s ownership interest in ReGenTree was reduced to 38.5% when the Clinical Study Report was filed for the Phase 2/3 dry eye clinical trial. Based on when, and if, certain additional development milestones are achieved in the U.S. with RGN-259, our equity ownership may be incrementally reduced to between 38.5% and 25%, with 25% being the final equity ownership upon approval of a BLA for DES in the U.S. In addition to our equity ownership, RegeneRx retains a royalty on net sales that varies between single and low double digits, depending on whether commercial sales are made by ReGenTree or a licensee. In the event ReGenTree is acquired or there is a change of control that occurs following achievement of a BLA, RegeneRx shall be entitled to a minimum of 40% of all proceeds paid or payable and will forgo any future royalties. | ||
Revenue, Judgment | Revenue is being recognized on a straight-line basis over a period of 30 years | 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 | $ 3,500,000 | ||
RGN-137 Agreement [Member] | ||||
License Agreement [Line Items] | ||||
Capitalized Contract Cost, Amortization Period | 23 years | |||
Milestone Payments | $ 3,500,000 | $ 3,500,000 | ||
Minimum [Member] | ||||
License Agreement [Line Items] | ||||
Capitalized Contract Cost, Amortization Period | 23 years | 23 years | ||
ReGen Tree [Member] | ||||
License Agreement [Line Items] | ||||
Proceeds from Royalties Received | $ 250,000 | |||
Capitalized Contract Cost, Amortization Period | 30 years |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) | Jun. 28, 2021 | Apr. 23, 2019 | Mar. 02, 2018 | Jan. 31, 2020 | Apr. 23, 2019 | Mar. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 14, 2019 | Mar. 02, 2019 | Jan. 06, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of shares of common stock purchased | 3,860,294 | 8,125,000 | 8,125,000 | ||||||||||
Exercise price | $ 0.2301 | $ 0.18 | $ 0.18 | ||||||||||
Proceeds from the exercise of stock warrants | $ 1,029,000 | $ 0 | $ 241,911 | $ 241,911 | $ 240,625 | ||||||||
Proceeds from Issuance of Private Placement | $ 1,980,000 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 0 | 1,638,575 | |||||||||||
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 | 1,000,000 | 925,000 | 1,939,294 | 1,000,000 | 1,000,000 | ||||||||
Exercise price | $ 0.125 | $ 0.125 | $ 0.125 | ||||||||||
Proceeds from the exercise of stock warrants | $ 125,000 | $ 115,625 | $ 241,911 | $ 125,000 | |||||||||
Note Warrant | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of shares of common stock purchased | 1,149,016 | ||||||||||||
Private Placement [Member] | Securities Purchase Agreement [Member] | Investor [Member] | |||||||||||||
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 [Member] | Securities Purchase Agreement [Member] | Series A Warrants | Investor [Member] | |||||||||||||
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 [Member] | Securities Purchase Agreement [Member] | Series B Warrants | Investor [Member] | |||||||||||||
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 | $ 0.125 | |||||||||||
Offering Expenses Related To Warrant Reprice | $ 82,566 | $ 82,566 |
LEASES - Company's recognition
LEASES - Company's recognition of its operating lease (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Assets | |||||
Operating lease right-of-use asset | $ 48,962 | $ 68,229 | $ 82,000 | $ 24,453 | $ 60,000 |
Total lease assets | 48,962 | 68,229 | |||
Current | |||||
Current portion of operating lease liability | 45,043 | ||||
Non-current | |||||
Operating lease liability | 4,172 | ||||
Total lease liabilities | $ 49,215 | $ 68,599 | $ 82,000 | $ 65,000 |
LEASES - Minimum operating leas
LEASES - Minimum operating lease payments (Details) - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
LEASES | ||||
Operating lease cost | $ 24,542 | $ 22,891 | $ 50,060 | $ 48,101 |
Variable lease costs | 267 | 0 | 895 | 4,381 |
Total lease costs | $ 24,809 | $ 22,891 | $ 50,955 | $ 52,482 |
LEASES - Maturity operating lea
LEASES - Maturity operating lease payment (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Jan. 01, 2019 |
LEASES | ||||
2021 | $ 25,452 | |||
2022 | 29,694 | |||
2023 | $ 50,904 | |||
2024 | 29,694 | |||
Total | 55,146 | 80,598 | ||
Discount factor | (5,931) | (11,999) | ||
Total lease liabilities | $ 49,215 | $ 68,599 | $ 82,000 | $ 65,000 |
LEASES - Additional information
LEASES - Additional information (Details) - USD ($) | 1 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2020 | |
LEASES | ||
Lease Rent Per Month | $ 4,200 | $ 4,200 |
Lessee, Operating Lease, Discount Rate | 20.00% | 20.00% |
Lease Expiration Term | July 2022 |
PROMISSORY NOTE (Details)
PROMISSORY NOTE (Details) - USD ($) | Aug. 24, 2020 | Apr. 24, 2020 |
Paycheck Protection Program Loan | ||
Debt Instrument [Line Items] | ||
Principal amount of loan | $ 55,400 | $ 55,400 |
Condensed Balance Sheets_2
Condensed Balance Sheets - USD ($) | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Current assets | ||||||||
Cash and cash equivalents | $ 2,025,577 | $ 427,898 | $ 639,916 | |||||
Prepaid expenses and other current assets | 30,415 | 49,909 | 41,639 | |||||
Total current assets | 2,055,992 | 477,807 | 681,555 | |||||
Operating lease right-of-use asset | 48,962 | 68,229 | $ 82,000 | 24,453 | $ 60,000 | |||
Other assets | 5,752 | 5,752 | 5,752 | |||||
Total assets | 2,110,706 | 551,788 | 711,760 | |||||
Current liabilities | ||||||||
Accounts payable | 198,820 | 39,320 | 43,678 | |||||
Unearned revenue | 76,761 | 76,761 | 76,761 | |||||
Accrued expenses | 278,472 | 208,857 | 95,020 | |||||
Promissory note | 33,856 | 33,856 | 0 | |||||
Current portion of operating lease liability | 45,043 | 40,790 | 27,014 | |||||
Total current liabilities | 632,952 | 399,584 | 242,473 | |||||
Long-term liabilities | ||||||||
Unearned revenue | 1,986,183 | 2,024,564 | 2,101,325 | |||||
Promissory note | 21,544 | 21,544 | 0 | |||||
Operating lease liability | 4,172 | 27,809 | 0 | |||||
Convertible promissory notes, net | 1,019,086 | 902,231 | 708,070 | |||||
Total liabilities | 3,663,937 | 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 | 0 | 0 | 0 | |||||
Common stock, par value $.001 per share, 200,000,000 shares authorized, 143,446,788 and 133,441,778 issued and outstanding | 143,447 | 133,442 | 131,507 | |||||
Additional paid-in capital | 107,913,605 | 105,934,572 | 104,896,975 | |||||
Accumulated deficit | (109,610,283) | (108,891,958) | (107,368,590) | |||||
Total stockholders' deficit | (1,553,231) | $ (3,119,842) | (2,823,944) | $ (2,724,819) | $ (2,435,091) | (2,340,108) | $ (2,212,053) | |
Total liabilities and stockholders' deficit | $ 2,110,706 | $ 551,788 | $ 711,760 |
Condensed Balance Sheets (Par_2
Condensed Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Condensed Balance Sheets | |||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 1,000,000 | 1,000,000 | 1,000,000 |
Preferred stock, shares issued | 0 | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 |
Common stock, shares issued | 143,446,788 | 133,441,788 | |
Common stock, shares, outstanding | 133,441,778 | 133,441,788 | 131,506,494 |
Condensed Statements of Opera_2
Condensed Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Condensed Statements of Operations | ||||||||
Revenues | $ 19,191 | $ 19,191 | $ 38,381 | $ 38,381 | $ 76,761 | $ 76,762 | ||
Operating expenses | ||||||||
Research and development | 487 | 3,475 | 975 | 3,951 | 4,921 | 65,107 | ||
General and administrative | 276,151 | 400,951 | 594,269 | 757,813 | 1,366,383 | 1,273,536 | ||
Total operating expenses | 276,638 | 404,426 | 595,244 | 761,764 | 1,371,304 | 1,338,643 | ||
Loss from operations | (257,447) | (385,235) | (556,863) | (723,383) | (1,294,543) | (1,261,881) | ||
Other income (expense) | ||||||||
Interest income | 3 | 693 | 23 | 3,727 | 3,806 | 11,044 | ||
Interest expense | (81,189) | (51,619) | (161,485) | (103,238) | (232,631) | (153,410) | ||
Total other expense | (81,186) | (50,926) | (161,462) | (99,511) | (228,825) | (142,366) | ||
Loss before taxes | (338,633) | (436,161) | (718,325) | (822,894) | (1,523,368) | (1,404,247) | ||
Provision for income taxes | 0 | 0 | 0 | 0 | 0 | 0 | ||
Net loss | $ (338,633) | $ (379,692) | $ (436,161) | $ (386,733) | $ (718,325) | $ (822,894) | (1,523,368) | (1,404,247) |
Deemed dividend related to warrants down round provision | 0 | (82,566) | ||||||
Net loss attributable to common shareholders | $ (1,523,368) | $ (1,486,813) | ||||||
Basic net loss per common share | $ 0 | $ 0 | $ (0.01) | $ (0.01) | $ (0.01) | $ (0.01) | ||
Diluted net loss per common share | $ 0 | $ 0 | $ (0.01) | $ (0.01) | $ (0.01) | $ (0.01) | ||
Weighted average number of common shares outstanding - basic | 133,655,579 | 133,441,788 | 134,329,715 | 133,271,652 | 133,357,185 | 130,970,754 | ||
Weighted average number of common shares outstanding - diluted | 133,655,579 | 133,441,788 | 134,329,715 | 133,271,652 | 133,357,185 | 130,970,754 |
Condensed Statements of Chang_2
Condensed Statements of Changes in Stockholders' Deficit - USD ($) | Common stock [Member] | Additional paid-in capital [Member] | Accumulated deficit [Member] | Total |
Balance at Dec. 31, 2018 | $ 128,433 | $ 103,541,291 | $ (105,881,777) | $ (2,212,053) |
Balance (Shares) at Dec. 31, 2018 | 128,432,478 | |||
Issuance of common stock - note conversions (in value) | $ 1,149 | 67,792 | 0 | $ 68,941 |
Issuance of common stock - note conversions (in shares) | 1,149,016 | |||
Issuance of common stock - option exercises (in shares) | 1,638,575 | |||
Issuance of common stock - warrant exercises (in value) | $ 1,925 | 238,700 | 0 | $ 240,625 |
Issuance of common stock - warrant exercises (in shares) | 1,925,000 | |||
Warrants issued with debt | $ 0 | 348,443 | 0 | 348,443 |
Debt discount related to beneficial conversion feature | 0 | 348,443 | 0 | 348,443 |
Deemed dividend related to warrant reprice | 0 | 82,566 | (82,566) | 0 |
Stock-based compensation expense | 0 | 269,740 | 0 | 269,740 |
Net loss | 0 | 0 | (1,404,247) | (1,404,247) |
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 | (822,894) | |||
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 | |||
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 - option exercises (in shares) | 0 | |||
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 | |||
Warrants issued with debt | $ 0 | 176,573 | 0 | 176,573 |
Debt discount related to beneficial conversion feature | 0 | 289,045 | 0 | 289,045 |
Stock-based compensation expense | 0 | 332,003 | 0 | 332,003 |
Net loss | 0 | 0 | (1,523,368) | (1,523,368) |
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 | |||
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 | |||
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 | |||
Net loss | (718,325) | |||
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 | |||
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 |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities: | ||||
Net loss | $ (718,325) | $ (822,894) | $ (1,523,368) | $ (1,404,247) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Depreciation and amortization | 0 | 1,418 | ||
Non-cash share-based compensation | 123,488 | 196,272 | 332,003 | 269,740 |
Non-cash interest expense | 116,855 | 70,828 | 162,179 | 105,202 |
Changes in operating assets and liabilities: | ||||
Prepaid expenses and other current assets | 19,494 | 18,041 | (8,270) | (5,030) |
Accounts payable | 159,500 | (17,614) | (4,358) | (48,755) |
Accrued expenses | 69,615 | 36,292 | 113,837 | 23,496 |
Operating lease liability | (117) | (2,178) | (2,191) | (3,032) |
Unearned revenue | (38,381) | (38,380) | (76,761) | (76,762) |
Net cash used in operating activities | (267,871) | (559,633) | (1,006,929) | (1,137,970) |
Financing activities: | ||||
Proceeds from private offering of common stock and warrants, net of issuance costs | 1,843,500 | 0 | ||
Proceeds from the exercise of stock options | 22,050 | 0 | ||
Proceeds from promissory note | 0 | 55,400 | 55,400 | 0 |
Proceeds from the sale of convertible notes | 500,000 | 1,300,000 | ||
Debt issuance costs | (2,400) | 0 | ||
Proceeds from the exercise of stock warrants | 0 | 241,911 | 241,911 | 240,625 |
Net cash provided by financing activities | 1,865,550 | 297,311 | 794,911 | 1,540,625 |
Net increase (decrease) in cash and cash equivalents | 1,597,679 | (262,322) | (212,018) | 402,655 |
Cash and cash equivalents at beginning of period | 427,898 | 639,916 | 639,916 | 237,261 |
Cash and cash equivalents at end of period | 2,025,577 | 377,594 | 427,898 | 639,916 |
Supplemental Disclosures of Non-Cash Operating and Financing Activities: | ||||
Conversion of promissory notes to common stock | 0 | 55,000 | ||
Conversion of accrued interest to common stock | 0 | 13,941 | ||
Establish right-of-use asset | 0 | 81,890 | 81,980 | 59,822 |
Establish operating lease liability | $ 0 | $ 81,890 | 81,980 | 65,415 |
Issuance of warrants in conjunction with issuance of convertible notes | 176,573 | 348,443 | ||
Beneficial conversion feature on issuance of convertible notes | $ 289,045 | $ 348,443 |
LEASES_2
LEASES | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 June 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. June 30, 2021 Assets Operating lease right-of-use asset $ 48,962 Total lease assets $ 48,962 Liabilities Current Current portion of operating lease liability $ 45,043 Non-current Operating lease liability 4,172 Total lease liabilities $ 49,215 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 six months ended June 30, 2021 and 2020 is recorded as general and administrative expense and consisted of the following: 2021 2020 Operating lease cost $ 24,542 $ 22,891 Variable lease costs 267 - Total lease costs $ 24,809 $ 22,891 A maturity analysis of our operating lease minimum lease payments follows: 2021 $ 25,452 2022 29,694 Total 55,146 Discount factor (5,931) Total lease liability $ 49,215 | 10. LEASES In June 2020, we amended our office lease agreement, and the term has been extended through July 2022. During the extended term, our rental payments will be approximately $4,200 per month. We had previously amended the office lease to extend through July 2020. Our facility lease is our only existing lease as of December 31, 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. The following table summarizes the Company's recognition of its operating lease as of December 31, 2020: 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 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 Variable lease costs 895 4,381 Total lease costs $ 50,955 $ 52,482 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 |
ORGANIZATION, BUSINESS OVERVI_4
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 June 30, 2021, we have an accumulated deficit of $110 million and we had cash and cash equivalents of $2,025,577 as of June 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 six month periods ended June 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 $34,159 and $45,416 for the three and six months ended June 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 for the three and six months ended June 30, 2020, respectively. | 1. ORGANIZATION AND BUSINESS Organization and Nature of Operations. RegeneRx Biopharmaceuticals, Inc. (“RegeneRx”, the “Company”, “We”, “Us”, “Our”), a Delaware corporation, was incorporated in 1982. We are focused on the discovery and development of novel molecules to accelerate tissue and organ repair. Our operations are confined to one business segment: the development and marketing of product candidates based on Thymosin Beta 4 (“Tß4”), an amino acid peptide. Management Plans to Address Operating Conditions. Our strategy is aimed at being capital efficient while leveraging our portfolio of clinical assets by seeking strategic relationships with organizations with clinical development capabilities including development capital. Currently, we have active partnerships in four major territories: North America, Europe, China and Pan Asia. In each case, the cost of development is being borne by our partners with no financial obligation for RegeneRx. We still have significant clinical assets to develop, primarily RGN-352 (injectable formulation of Tß4 for cardiac and CNS disorders) in the U.S., Pan Asia, and Europe, and RGN-259 in the EU. Our goal is to wait until satisfactory results are obtained from the current ophthalmic clinical program in the U.S. before moving into the EU. However, we intend to continue to develop RGN-352, our injectable systemic product candidate for cardiac and central nervous system indications, either by obtaining grants to fund a Phase 2a clinical trial in the cardiovascular or central nervous system fields or finding a suitable partner with the resources and capabilities to develop it as we have with RGN-259. Since inception, and through December 31, 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 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 to management, the Company’s Board of Directors and accredited investors including Essetifin S.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. 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. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2020 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates. Cash and Cash Equivalents. Concentration of Credit Risk. Property and Equipment. two Impairment of Long-lived Assets. Convertible Notes with Detachable Warrants. Debt with Conversion and Other Options themselves at the time of issuance. The portion of the proceeds allocated to the warrants is recognized as additional paid-in capital and a debt discount. The debt discount related to warrants is accreted into interest expense through maturity of the notes. Revenue Recognition. The Company’s contracts with customers may at times include multiple promises to transfer products and services. Contracts with multiple promises are analyzed to determine whether the promises, which may include a license together with performance obligations such as providing a clinical supply of product and steering committee services, are distinct and should be accounted for as separate performance obligations or whether they must be accounted for as a single performance obligation. The Company accounts for individual performance obligations separately if they are distinct. Determining whether products and services are considered distinct performance obligations may require significant judgment. If we cannot reasonably estimate when our performance obligation either ceases or becomes inconsequential and perfunctory, then revenue is deferred until we can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. Whenever the Company determines that an arrangement should be accounted for as a combined performance obligation, we must determine the period over which the performance obligation will be performed and when revenue will be recognized. Revenue is recognized using either a relative performance or straight-line method. We recognize revenue using the relative performance method provided that we can reasonably estimate the level of effort required to complete our performance obligation under an arrangement and such performance obligation is provided on a best-efforts basis. Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. If the Company cannot reasonably estimate the level of effort required to complete our performance obligation under an arrangement, the performance obligation is provided on a best-efforts basis and we can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory, then the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over the period we expect to complete our performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date. At the inception of each arrangement that includes development milestone payments, the Company evaluates the probability of reaching the milestones and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur in the future, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore revenue recognized is constrained as management is unable to assert that a reversal of revenue would not be possible. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Amounts received prior to satisfying the above revenue recognition criteria are recorded as unearned revenue in our accompanying balance sheets. Contract assets are generated when contractual billing schedules differ from revenue recognition timing. Contract assets represent a conditional right to consideration for satisfied performance obligations that becomes a billed receivable when the conditions are satisfied. There were no contract assets as of December 31, 2020 and 2019. 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 amount disclosed above are primarily related to revenue being recognized on a straight-line basis over periods ranging from 23 to 30 years, which, in management’s judgment, is the best measure of progress towards satisfying the performance obligations and represents the Company’s best estimate of the period of the obligation. Revenue recognized from contract liabilities during the years ended December 31, 2020 and 2019, totaled $76,761 and $76,762, respectively. Revenue is expected to be recognized in the future from contract liabilities as the related performance obligations are satisfied. Variable Interest Entities. 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 Decembers 31, 2020 and 2019. 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 Development Patent Costs. Income Taxes. are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making that assessment. We recorded a full valuation allowance against all estimated net deferred tax assets at December 31, 2020 and 2019. 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. We have significant net operating loss carryforwards to potentially reduce future federal and state taxable income, and research and experimentation tax credit carryforwards available to potentially offset future federal and state income taxes. Use of our net operating loss and research and experimentation credit carryforwards may be limited due to changes in our ownership as defined within Section 382 of the Internal Revenue Code. Net Loss Per Common Share. Share-Based Compensation. Fair Value of Financial Instruments. Recently Adopted Accounting Pronouncements. Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements restated. The guidance must be adopted on a modified retrospective basis and provides for certain practical expedients. We adopted this guidance effective January 1, 2019, using the following practical expedients: ● ● Additionally, we made ongoing 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. Upon adoption of the new guidance on January 1, 2019, we recorded a ROU asset of approximately $60,000 (net of existing deferred rent liability) and recognized a lease liability of approximately $65,000, with no resulting cumulative effect adjustment to accumulated deficit. In June 2020, we renewed our office lease for two years and we recorded a ROU asset of approximately $82,000 and recognized a lease liability of approximately $82,000. Accounting Standard Not Yet Adopted. Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
FAIR VALUE MEASUREMENTS_2
FAIR VALUE MEASUREMENTS | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 June 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 $20,067 and $427,898, respectively, using Level 1 inputs. | 3. FAIR VALUE MEASUREMENTS The authoritative guidance for fair value measurements defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or the most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The guidance describes a fair value hierarchy based on the levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following: ● ● ● As of December 31, 2020, and 2019, our only qualifying assets that required measurement under the foregoing fair value hierarchy were funds held in our Company bank accounts included in cash and cash equivalents valued at $427,898 and $639,916, respectively, using Level 1 inputs. |
LICENSES, INTELLECTUAL PROPERTY
LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2020 | |
LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS | |
LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS | 4. LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS We have filed numerous additional patent applications covering various compositions, uses, formulations and other components of Tβ4, as well as to novel peptides resulting from our research efforts. Some of these patents have been issued, while many patent applications are still pending. We have also entered into an agreement with a university under the terms of which we have received an exclusive license to technology and intellectual property. The agreement, which is generally cancelable by us, provided for the payment of a license issue fee and/or minimum annual payments. The initial license fee of $25,000 was paid in 2010 and no minimum fees were due for the year ended December 31, 2011. Beginning in 2012, minimum annual maintenance fees are $5,000 annually which was paid in 2012 but has not been paid since. In addition, the agreements provide for payments upon the achievement of certain milestones in product development. The agreement also requires us to fund certain costs associated with the filing and prosecution of patent applications. In February 2013, this agreement was amended to include additional technology and intellectual property. The expanded license does not require payment of an initial license fee or additional annual maintenance fees but will be subject to payments upon the achievement of certain milestones for a product developed under the amended license of the additional technology and intellectual property. All license fees are included in Research and Development in the accompanying statements of operations. In 2012, we entered into a license agreement (the “Agreement”) with Lee’s Pharmaceutical (HK) Limited (“Lee’s”), headquartered in Hong Kong, for the license of Thymosin Beta 4 in any pharmaceutical form, including our RGN-259, RGN-352 and RGN-137 product candidates, in China, Hong Kong, Macau and Taiwan. Under the Agreement, we are eligible to receive milestone payments and royalties, ranging from low double digit to high single digit percentages of any commercial sales of the licensed products. Lee’s will pay for all developmental costs associated with each product candidate. We will provide Tß4 to Lee’s at no charge for a Phase 2 ophthalmic clinical trial and will provide Tß4 to Lee’s for all other developmental and clinical work at a price equal to our cost. We will also have the right to exclusively license any improvements made by Lee’s to RegeneRx’s products outside of the licensed territory. Lee’s paid us $200,000 upon signing of a term sheet in March 2012, and Lee’s paid us an additional $200,000 upon signing of the definitive license agreement. The Company is accounting for the license agreement as a revenue arrangement. Since participation in the joint development committee is required it was deemed to be a material promise. Management has concluded that the participation in the joint development committee is not distinct from other promised goods and services. The Company evaluated the promised goods and services under the agreement and determined that there was one combined performance obligation representing a series of distinct goods and services including the license to research, develop and commercialize Tß4 in any pharmaceutical form and participation in the joint development committee. To date, management has not been able to reasonably measure the outcome of the performance obligation, but still expects to recover the costs incurred in satisfying the performance obligation. Accordingly, the Company has deferred all revenue until such time that it can reasonably measure the outcome of the performance obligation or until the performance obligation becomes onerous. As of December 31, 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. 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, Australia, New Zealand, Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, Mongolia, Myanmar (Burma), Philippines, Singapore, Thailand, Vietnam, and Kazakhstan, and semi-exclusive in India, Pakistan, Bangladesh, Bhutan, Maldives, Nepal, Sri Lanka, Kyrgyzstan, Tajikistan, Turkmenistan and Uzbekistan, collectively, the Territory (the “259 Territory”). Under the 259 license agreement, we are eligible to receive aggregate potential milestone payments of up to $3.5 million. In addition, we are eligible to receive royalties of a low double digit percentage of any commercial sales of the licensed product sold by GtreeBNT in the 259 Territory. Under the license agreement for RGN-137, our topical dermal gel product candidate, GtreeBNT will have the exclusive right to develop and commercialize RGN-137 in the U.S. (the “137 Territory”). Under the 137 agreement, we are eligible to receive aggregate potential milestone payments of up to $3.5 million. In addition, we are eligible to receive royalties of a low double digit percentage of any commercial sales of the Company’s licensed product sold by GtreeBNT in the 137 Territory. In August 2017, we amended the license agreement for RGN-137 held by GtreeBNT. Under the amendment, the 137 Territory was expanded to include Europe, Canada, South Korea, Australia and Japan. Under the agreement, the Company received a series of non-refundable payments and is entitled to receive royalties on the future sales of products. The Company is accounting for the license agreement as a revenue arrangement. Since participation in the joint development committee is required, it was deemed to be a material promise. Management has concluded that the participation in the joint development committee is not distinct from other promised goods and services. The Company evaluated the promised goods and services under the agreement and determined that there was one combined performance obligation representing a series of distinct goods and services including the license to research, develop and commercialize RGN-137 and participation in the joint development committee. Revenue is being recognized on a straight-line basis over a period of 23 years, which, in management’s judgment, is the best measure of progress towards satisfying the performance obligation and represents the Company’s best estimate of the period of the obligation. As of December 31, 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. Each license agreement contains diligence provisions that require the initiation of certain clinical trials within certain time periods that, if not met, would result in the loss of rights or exclusivity in certain countries. GtreeBNT will pay for all developmental costs associated with each product candidate. We have the right to exclusively license any improvements made by GtreeBNT to our products outside of the licensed territory on a royalty free basis. The two firms have created a joint development committee and continue to discuss the development of the licensed products and share information relating thereto. Both companies will also share all non-clinical and clinical data and other information related to development of the licensed product candidates. On January 28, 2015, the Company entered into the Joint Venture Agreement with GtreeBNT, a shareholder in the Company. The Joint Venture Agreement provides for the creation of the Joint Venture, jointly owned by the Company and GtreeBNT, which is commercializing RGN-259 for treatment of dry eye and neurotrophic keratitis in the U.S. and Canada. GtreeBNT is solely responsible for funding all the product development and commercialization efforts of the Joint Venture. GtreeBNT made an initial contribution of $3 million in cash and received an initial equity stake of 51%. RegeneRx’s ownership interest in ReGenTree was reduced to 38.5% when the Clinical Study Report was filed for the Phase 2/3 dry eye clinical trial. Based on when, and if, certain additional development milestones are achieved in the U.S. with RGN-259, our equity ownership may be incrementally reduced to between 38.5% and 25%, with 25% being the final equity ownership upon approval of a BLA for DES in the U.S. In addition to our equity ownership, RegeneRx retains a royalty on net sales that varies between single and low double digits, depending on whether commercial sales are made by ReGenTree or a licensee. In the event ReGenTree is acquired or there is a change of control that occurs following achievement of a BLA, RegeneRx shall be entitled to a minimum of 40% of all proceeds paid or payable and will forgo any future royalties. The Company is not required or otherwise obligated to provide financial support to the Joint Venture. The Joint Venture is responsible for executing all development and commercialization activities under the license agreement, which activities will be directed by a joint development committee comprised of representatives of the Company and GtreeBNT. The license agreement has a term that extends to the later of the expiration of the last patent covered by the agreement or 25 years from the first commercial sale under the agreement. The license agreement may be earlier terminated if the Joint Venture fails to meet certain commercialization milestones, if either party breaches the license agreement and fails to cure such breach, as a result of government action that limits the ability of the Joint Venture to commercialize the product, as a result of a challenge to a licensed patent, following termination of the license between the Company and certain agencies of the United States federal government, or upon the bankruptcy of either party. Under the license agreement, the Company received $1.0 million in up-front payments and is entitled to receive royalties on the Joint Venture’s future sales of products. On April 6, 2016, we received $250,000 from ReGenTree and executed an amendment to the license agreement on April 28, 2016. Under the amendment the territorial rights were expanded to include Canada. The Company is accounting for the license agreement with the Joint Venture as a revenue arrangement. Since participation in the joint development committee is required, it was deemed to be a material promise. Management has concluded that the participation in the joint development committee is not distinct from other promised goods and services. The Company evaluated the promised goods and services under the license agreements and determined that there was one combined performance obligation representing a series of distinct goods and services including the license to research, develop and commercialize RGN-259 and participation in the joint development committee. Revenue is being recognized on a straight-line basis over a period of 30 years, which, in management’s judgment, is the best measure of progress towards satisfying the performance obligation and represents the Company’s best estimate of the period of the obligation. As of December 31, 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. |
COMPOSITION OF CERTAIN FINANCIA
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS | 12 Months Ended |
Dec. 31, 2020 | |
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS | |
Composition Of Certain Financial Statement Captions [Text Block] | 5. COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS Prepaid expenses and other current assets are comprised of the following: December 31, 2020 2019 Prepaid insurance $ 39,196 $ 27,453 Other 10,713 14,186 $ 49,909 $ 41,639 Accrued expenses are comprised of the following: 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 |
CONVERTIBLE NOTES_2
CONVERTIBLE NOTES | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 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 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 six months ended June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 2019 Notes $ 51,619 $ 51,619 $ 102,671 $ 103,238 2020 Notes 29,570 - 58,814 - Total interest expense $ 81,189 $ 51,619 $ 161,485 $ 103,238 | 7. CONVERTIBLE NOTES 2014 Convertible Notes On January 7, 2014, we completed a private placement of convertible notes raising an aggregate of $55,000 in gross proceeds (the “January 2014 Notes”). The January 2014 Notes bore interest at a rate of 5% per annum, mature sixty (60) months after their date of issuance and were convertible into shares of our common stock at a conversion price of six cents ($0.06) per share (subject to adjustment as described in the January 2014 Notes) at any time prior to repayment, at the election of the investor. In the aggregate, the January 2014 Notes were initially convertible into up to 916,667 shares of our common stock. At any time prior to maturity of the January 2014 Notes, with the consent of the holders of a majority in interest of the January 2014 Notes, we could prepay the outstanding principal amount of the January 2014 Notes plus unpaid accrued interest without penalty. Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the federal bankruptcy act or the continuation of such petition without dismissal for a period of 90 days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the January 2014 Notes would accelerate and automatically become immediately due and payable. The investors in the offering included two current and one former member of the Board of Directors. The principal amounts of their respective January 2014 Notes were as set forth below: 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. 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 warrants to each investor. The warrants are exercisable for an aggregate of 8,125,000 shares of common stock with an exercise price of eighteen cents ($0.18) per share for a period of five years (the “2019 Warrants”). The relative fair value of the 2019 Warrants issued was $348,443 calculated using the Black-Scholes-Merton valuation model value of $0.06 with an expected and contractual life of five years, an assumed volatility of 67.86%, and a risk-free interest rate of 2.49%. The 2019 Warrants are classified in equity. The Company allocated $348,443 of the gross proceeds to the warrants, on a relative fair value basis. In addition, because the effective conversion price of the 2019 Notes was less than the fair value of the underlying common stock on the issuance date, we allocated the intrinsic value of that feature to additional paid-in capital. The debt discount created by the 2019 Warrants and beneficial conversion feature is amortized over the term of the 2019 Notes as additional interest expense using the effective interest method. The affiliated investors and the principal amount of their respective 2019 Notes purchase are as set forth below: Investor 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 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 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 |
EMPLOYEE BENEFIT PLANS
EMPLOYEE BENEFIT PLANS | 12 Months Ended |
Dec. 31, 2020 | |
EMPLOYEE BENEFIT PLANS | |
EMPLOYEE BENEFIT PLANS | 6. EMPLOYEE BENEFIT PLANS In 2020 and 2019, the Company provided health and dental insurance to an employee under a group plan. No retirement plan was in place for 2020 or 2019. |
STOCKHOLDERS' EQUITY_2
STOCKHOLDERS' EQUITY | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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. The estimated fair value of the effect of the exercise price adjustment of $82,566 is reflected as a dividend to the March 2018 Investor in 2019. 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 1,939,294 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”). | 8. STOCKHOLDERS’ EQUITY Common Stock. On March 2, 2018, we entered into the Reprice Agreement with Sabby Healthcare Master Fund, Ltd., and Sabby Volatility Warrant Master Fund, Ltd. (collectively, “Sabby”). In connection with that certain securities purchase agreement between the Company and Sabby dated June 27, 2016 (the “Purchase Agreement”) we also issued to Sabby warrants to purchase 5,147,059 shares of common stock (the “Warrant Shares”) at an exercise price of $0.51 per share (the “Sabby Warrants”). Under the terms of the Reprice Agreement, in consideration of Sabby exercising in full all of the Sabby Warrants (the “Warrant Exercise”), the exercise price per share of the Sabby Warrants was reduced to $0.20 per share. We received gross proceeds of approximately $1,029,000 from the warrant reprice transaction. In addition, and as further consideration, we issued to Sabby warrants to purchase up to 3,860,294 shares of common stock at an exercise price of $0.2301 per share, the closing bid price for the Company’s Common Stock on February 28, 2018 (the “March Warrants"). 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 Warrants, the exercise price of the March Warrants was adjusted to $0.125 per share. The estimated fair value of the effect of the exercise price adjustment of $82,566 is reflected as a dividend to Sabby for the year ended December 31, 2019. Subsequent to the reduction of the exercise price of the March Warrants to $0.125 in 2019, Sabby exercised warrants for 925,000 shares of common stock and the Company received exercise proceeds of $115,625. Sabby exercised additional warrants on April 23, 2019 for 1,000,000 shares of common stock and the Company received exercise proceeds of $125,000. Sabby exercised their remaining warrants on January 17, 2020 for 1,935,294 shares of common stock and the Company received exercise proceeds of $241,911. Registration Rights Agreements. The Registration Rights Agreements usually require us to pay penalties for any failure or time delay in filing or maintaining the effectiveness of the required registration statements. These penalties are usually expressed as a fixed percentage, per month, of the original amount we received on issuance of the common shares, options or warrants. While to date we have not incurred any penalties under these agreements, if a penalty is determined to be probable, we would recognize the amount as a contingent liability and not as a derivative instrument. Share-Based Compensation. Stock Option and Incentive Plans. We have previously adopted two equity incentive plans, known as the 2000 Equity Incentive Plan, or the 2000 Plan, and the 2010 Equity Incentive Plan, or the 2010 Plan. Both the 2000 Plan and the 2010 Plan have a term of ten years, with the 2000 Plan already expired and the 2010 Plan expired in July 2020. No further awards may be granted under the 2010 Plan with the approval of the 2018 Plan. All outstanding option awards granted under the 2010 Plan will continue to be subject to the terms and conditions as set forth in the agreements evidencing such option awards and the terms of the 2010 Plan. Shares remaining available for issuance under the shares reserved under the 2010 Plan will not be subject to future awards under the 2018 Plan, and shares subject to outstanding awards under the 2010 Plan that are terminated or forfeited in the future will not be subject to future awards under the 2018 Plan. All outstanding option awards granted under the 2000 Plan have expired. The following summarizes share-based compensation expense for the years ended December 31, 2020 and 2019, which was allocated as follows: December 31, 2020 2019 Research and development $ - $ 63,207 General and administrative 332,003 206,533 $ 332,003 $ 269,740 The following summarizes stock option activity for the years ended December 31, 2020 and 2019: Options Outstanding Shares Weighted average available for Number of Exercise price exercise grants shares range 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 The following summarizes information about stock options outstanding at December 31, 2020: Weighted Weighted Average Average Aggregate Number of Exercise Remaining Intrinsic Shares Price Contractual Life 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. 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 % Our dividend yield assumption is based on the fact that we have never paid cash dividends and do not anticipate paying cash dividends in the foreseeable future. Our risk-free interest rate assumption is based on yields of U.S. Treasury notes in effect at the date of grant. Our expected life represents the period of time that options granted are expected to be outstanding and is calculated in accordance with the Securities and Exchange Commission (“SEC”) guidance provided in the SEC’s Staff Accounting Bulletin (“SAB”) 107 and SAB 110, using a “simplified” method. The Company has used the simplified method and will continue to use the simplified method as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate an expected term. Our volatility assumption is based on reviews of the historical volatility of our common stock. Using Black-Scholes and these factors, the weighted average fair value of stock options granted to employees and directors was $0.19 and $0.16 for the years 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 Weighted average Number of Exercise price exercise shares range 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 |
INCOME TAXES_2
INCOME TAXES | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
INCOME TAXES | ||
INCOME TAXES | 4. INCOME TAXES As of June 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 June 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. | 9. INCOME TAXES The Company’s provision for income taxes consists of the following for the years ended December 31, 2020 and 2019: 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 $ - $ - Significant components of the Company’s deferred tax assets at December 31, 2020 and 2019 and related valuation allowances are presented below: 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 $ - $ - At December 31, 2020, we had net operating loss carryforwards for Federal income tax purposes of approximately $51.1 million and research and research and experimental tax credit carryforwards of approximately $2.3 million, which are available to offset future federal income. Approximately $47.9 million of the net operating loss carryforwards, generated prior to 2018, expires in increments through 2037, while carryforwards generated in 2018 or later do not expire. Section 382 of the Internal Revenue Code imposes substantial restrictions on the utilization of net operating losses and tax credits in the event of a corporation’s ownership change. During 2009, the Company completed a preliminary study to compute any limits on the net operating losses and credit carryforwards for purposes of Section 382. It was determined that the Company experienced a cumulative change in ownership, as defined by the regulations, in 2002. This change in ownership triggers an annual limitation on the Company’s ability to utilize certain U.S. federal and state net operating loss carryforwards and research tax credit carryforwards, resulting in the potential loss of approximately $9.8 million of net operating loss carryforwards and $0.2 million in research credit carryforwards. The Company has reduced the deferred tax assets associated with these carryforwards in its balance sheets. The Company believes that the future use of net operating losses and tax credits presented above may be further reduced as a result of additional ownership changes subsequent to 2009. The provision for income taxes on earnings subject to income taxes differs from the statutory federal rate for the years ended December 31, 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 % 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 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. The 2007 through 2019 tax years generally remain subject to examination by federal and most state tax authorities. In addition, we would remain open to examination for earlier years if we were to utilize net operating losses or tax credit carryforwards that originated prior to 2012. On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was signed into law in response to the COVID-19 pandemic. The CARES Act provides numerous tax provisions and stimulus measures, including temporary changes regarding the prior and future utilization of net operating losses, temporary changes to the prior and future limitations on interest deductions, and technical corrections from prior tax legislation for tax depreciation of certain qualified improvement property. The Company has evaluated the provisions of the CARES Act relating to income taxes which will result in adjustments to certain deferred tax assets and liabilities. Due to the Company’s U.S. valuation allowance, the Company noted the provisions of the CARES Act did not have a material impact on its financial statements. |
PROMISSORY NOTE_2
PROMISSORY NOTE | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 is $55,400. In accordance with the requirements of the CARES Act, the Company used the proceeds from the Loan in accordance with the requirements of the PPP to cover certain qualified expenses, including payroll costs, rent and utility costs. Interest accrues on the Loan at the rate of 1.00% per annum. The Company 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. | 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. 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. |
COMMITMENTS
COMMITMENTS | 12 Months Ended |
Dec. 31, 2020 | |
COMMITMENTS | |
COMMITMENTS | 12. COMMITMENTS Employment Continuity Agreements. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
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. | Use of Estimates. |
Cash and Cash Equivalents. | Cash and Cash Equivalents. | |
Concentration of Credit Risk. | Concentration of Credit Risk. | |
Property and Equipment. | Property and Equipment. two | |
Impairment of Long-lived Assets. | Impairment of Long-lived Assets. | |
Convertible Notes with Detachable Warrants. | Convertible Notes with Detachable Warrants. In accordance with ASC 470-20, Debt with Conversion and Other Options | Convertible Notes with Detachable Warrants. Debt with Conversion and Other Options themselves at the time of issuance. The portion of the proceeds allocated to the warrants is recognized as additional paid-in capital and a debt discount. The debt discount related to warrants is accreted into interest expense through maturity of the notes. |
Revenue Recognition. | 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. | Revenue Recognition. The Company’s contracts with customers may at times include multiple promises to transfer products and services. Contracts with multiple promises are analyzed to determine whether the promises, which may include a license together with performance obligations such as providing a clinical supply of product and steering committee services, are distinct and should be accounted for as separate performance obligations or whether they must be accounted for as a single performance obligation. The Company accounts for individual performance obligations separately if they are distinct. Determining whether products and services are considered distinct performance obligations may require significant judgment. If we cannot reasonably estimate when our performance obligation either ceases or becomes inconsequential and perfunctory, then revenue is deferred until we can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. Whenever the Company determines that an arrangement should be accounted for as a combined performance obligation, we must determine the period over which the performance obligation will be performed and when revenue will be recognized. Revenue is recognized using either a relative performance or straight-line method. We recognize revenue using the relative performance method provided that we can reasonably estimate the level of effort required to complete our performance obligation under an arrangement and such performance obligation is provided on a best-efforts basis. Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. If the Company cannot reasonably estimate the level of effort required to complete our performance obligation under an arrangement, the performance obligation is provided on a best-efforts basis and we can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory, then the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over the period we expect to complete our performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date. At the inception of each arrangement that includes development milestone payments, the Company evaluates the probability of reaching the milestones and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur in the future, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore revenue recognized is constrained as management is unable to assert that a reversal of revenue would not be possible. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Amounts received prior to satisfying the above revenue recognition criteria are recorded as unearned revenue in our accompanying balance sheets. Contract assets are generated when contractual billing schedules differ from revenue recognition timing. Contract assets represent a conditional right to consideration for satisfied performance obligations that becomes a billed receivable when the conditions are satisfied. There were no contract assets as of December 31, 2020 and 2019. 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 amount disclosed above are primarily related to revenue being recognized on a straight-line basis over periods ranging from 23 to 30 years, which, in management’s judgment, is the best measure of progress towards satisfying the performance obligations and represents the Company’s best estimate of the period of the obligation. Revenue recognized from contract liabilities during the years ended December 31, 2020 and 2019, totaled $76,761 and $76,762, respectively. Revenue is expected to be recognized in the future from contract liabilities as the related performance obligations are satisfied. |
Variable Interest Entities. | Variable Interest Entities. 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 Decembers 31, 2020 and 2019. 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 Development. | Research and Development | |
Patent Costs. | Patent Costs. | |
Income Taxes. | Income Taxes. are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making that assessment. We recorded a full valuation allowance against all estimated net deferred tax assets at December 31, 2020 and 2019. 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. We have significant net operating loss carryforwards to potentially reduce future federal and state taxable income, and research and experimentation tax credit carryforwards available to potentially offset future federal and state income taxes. Use of our net operating loss and research and experimentation credit carryforwards may be limited due to changes in our ownership as defined within Section 382 of the Internal Revenue Code. | |
Net Loss Per Common Share. | Net Loss Per Common Share. | |
Share-Based Compensation. | Share-Based Compensation. | |
Fair Value of Financial Instruments. | Fair Value of Financial Instruments. | |
Recently Adopted Accounting Pronouncements. | 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. | Recently Adopted Accounting Pronouncements. Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements restated. The guidance must be adopted on a modified retrospective basis and provides for certain practical expedients. We adopted this guidance effective January 1, 2019, using the following practical expedients: ● ● Additionally, we made ongoing 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. Upon adoption of the new guidance on January 1, 2019, we recorded a ROU asset of approximately $60,000 (net of existing deferred rent liability) and recognized a lease liability of approximately $65,000, with no resulting cumulative effect adjustment to accumulated deficit. In June 2020, we renewed our office lease for two years and we recorded a ROU asset of approximately $82,000 and recognized a lease liability of approximately $82,000. Accounting Standard Not Yet Adopted. Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Summary of contract liabilities | We have the following amounts recorded for contract liabilities: December 31 2020 2019 Unearned revenue $ 2,101,325 $ 2,178,086 |
COMPOSITION OF CERTAIN FINANC_2
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block] | Prepaid expenses and other current assets are comprised of the following: December 31, 2020 2019 Prepaid insurance $ 39,196 $ 27,453 Other 10,713 14,186 $ 49,909 $ 41,639 |
Schedule of Accrued Liabilities [Table Text Block] | Accrued expenses are comprised of the following: 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 |
CONVERTIBLE NOTES (Tables)_2
CONVERTIBLE NOTES (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
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 six months ended June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 2019 Notes $ 51,619 $ 51,619 $ 102,671 $ 103,238 2020 Notes 29,570 - 58,814 - Total interest expense $ 81,189 $ 51,619 $ 161,485 $ 103,238 | The Company recorded interest expense and discount accretion as set forth below: 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 |
Schedule of principal amount and number of shares of common stock issuable upon exercise of their respective warrants | The investors in the offering included two current and one former member of the Board of Directors. The principal amounts of their respective January 2014 Notes were as set forth below: Investor Note Principal Joseph C. McNay $ 25,000 Allan L. Goldstein $ 10,000 L. Thompson Bowles $ 5,000 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 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 | |
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 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
STOCKHOLDERS' EQUITY | ||
Schedule of share-based compensation expense | 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 Research and development $ - $ 63,207 General and administrative 332,003 206,533 $ 332,003 $ 269,740 | |
Summary of stock option activity | The following summarizes stock option activity for the years ended December 31, 2020 and 2019: Options Outstanding Shares Weighted average available for Number of Exercise price exercise grants shares range 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 | |
Schedule of the Company's stock options | A summary of the Company’s stock options for the six months ended June 30, 2021 is as follows: Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Life Intrinsic Value Options Outstanding, December 31, 2020 11,951,250 $ 0.28 Granted - $ 0.30 Exercised (105,000) $ 0.21 Forfeited (1,915,000) $ 0.21 Options Outstanding, June 30, 2021 9,931,250 $ 0.30 5.9 years $ 283,550 Vested and unvested but expected to vest, June 30, 2021 9,606,260 $ 0.30 5.9 years $ 274,271 Exercisable at June 30, 2021 7,861,250 $ 0.31 5.3 years $ 223,250 | The following summarizes information about stock options outstanding at December 31, 2020: Weighted Weighted Average Average Aggregate Number of Exercise Remaining Intrinsic Shares Price Contractual Life 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 |
Schedule of forward-looking range of assumptions to value the stock options issue | 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 % | |
Summary of warrant activity | The following table summarizes our warrant activity for 2020 and 2019: Warrants Outstanding Weighted average Number of Exercise price exercise shares range 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 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
INCOME TAXES | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | The Company’s provision for income taxes consists of the following for the years ended December 31, 2020 and 2019: 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 $ - $ - |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | Significant components of the Company’s deferred tax assets at December 31, 2020 and 2019 and related valuation allowances are presented below: 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 $ - $ - |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | 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 % |
LEASES (Tables)_2
LEASES (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
LEASES | ||
Schedule of company's recognition of its operating lease | June 30, 2021 Assets Operating lease right-of-use asset $ 48,962 Total lease assets $ 48,962 Liabilities Current Current portion of operating lease liability $ 45,043 Non-current Operating lease liability 4,172 Total lease liabilities $ 49,215 | 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 |
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 six months ended June 30, 2021 and 2020 is recorded as general and administrative expense and consisted of the following: 2021 2020 Operating lease cost $ 24,542 $ 22,891 Variable lease costs 267 - Total lease costs $ 24,809 $ 22,891 | 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 Variable lease costs 895 4,381 Total lease costs $ 50,955 $ 52,482 |
Schedule of maturity operating lease payment | A maturity analysis of our operating lease minimum lease payments follows: 2021 $ 25,452 2022 29,694 Total 55,146 Discount factor (5,931) Total lease liability $ 49,215 | 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 |
ORGANIZATION, BUSINESS OVERVI_5
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)segment | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
ORGANIZATION AND BUSINESS [Line Items] | ||||||
Number of Operating Segments | segment | 1 | |||||
Retained Earnings (Accumulated Deficit) | $ 109,610,283 | $ 109,610,283 | $ 108,891,958 | $ 107,368,590 | ||
Cash and Cash Equivalents, at Carrying Value | 2,025,577 | 2,025,577 | 427,898 | 639,916 | ||
Gross proceeds from private placement | 1,980,000 | |||||
Allocated Share-based Compensation Expense | $ 61,744 | $ 146,433 | $ 123,488 | $ 196,272 | $ 332,003 | $ 269,740 |
Research and development [Member] | ||||||
ORGANIZATION AND BUSINESS [Line Items] | ||||||
Allocated Share-based Compensation Expense | $ 34,159 | $ 45,416 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Summary of contract liabilities (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Unearned revenue | $ 2,101,325 | $ 2,178,086 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) - USD ($) | 6 Months Ended | 12 Months Ended | ||||||
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2021 | Mar. 31, 2020 | Jan. 01, 2019 | Dec. 31, 2018 | |
Summary of Significant Accounting Policies [Line Items] | ||||||||
Depreciation | $ 0 | $ 1,418 | ||||||
Impairment losses | 0 | 0 | ||||||
Cumulative effect adjustment from adoption of ASU 2017-11 | $ (1,553,231) | $ (2,724,819) | (2,823,944) | (2,340,108) | $ (3,119,842) | $ (2,435,091) | $ (2,212,053) | |
Contract assets | 0 | 0 | ||||||
Contract with Customer, Liability, Revenue Recognized | 76,761 | 76,762 | ||||||
Investments in joint ventures | $ 0 | $ 0 | ||||||
Percentage Of Joint Venture Operating Loss Used In Share Calculation | 38.50% | |||||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 21.00% | ||||||
Income Tax Examination, Likelihood of Unfavorable Settlement | greater than 50% | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 47,547,251 | 31,269,884 | 33,705,854 | 31,075,178 | ||||
Share-based Compensation | $ 123,488 | $ 196,272 | $ 332,003 | $ 269,740 | ||||
Debt Instrument, Interest Rate, Effective Percentage | 5.00% | |||||||
Lease renewal term | 2 years | |||||||
Operating Lease, Right-of-Use Asset | 48,962 | $ 82,000 | $ 68,229 | $ 24,453 | $ 60,000 | |||
Operating Lease, Liability | $ 49,215 | $ 82,000 | $ 68,599 | $ 65,000 | ||||
Maximum [Member] | ||||||||
Summary of Significant Accounting Policies [Line Items] | ||||||||
Property and Equipment, Useful Life | 5 years | |||||||
Capitalized Contract Cost, Amortization Period | 30 years | |||||||
Minimum [Member] | ||||||||
Summary of Significant Accounting Policies [Line Items] | ||||||||
Property and Equipment, Useful Life | 2 years | |||||||
Capitalized Contract Cost, Amortization Period | 23 years | 23 years |
FAIR VALUE MEASUREMENTS (Deta_2
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
FAIR VALUE MEASUREMENTS | |||
Cash and Cash Equivalents, Fair Value Disclosure | $ 20,067 | $ 427,898 | $ 639,916 |
LICENSES, INTELLECTUAL PROPER_2
LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS (Details) - USD ($) | Apr. 06, 2016 | Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2012 | Dec. 31, 2011 | Dec. 31, 2019 |
LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS [Line Items] | ||||||
Cost of Goods and Services Sold | $ 25,000 | |||||
Annual Maintenance Fees On Technology And Intellectual Property | $ 5,000 | |||||
Deferred Revenue, Noncurrent | $ 1,986,183 | $ 2,024,564 | $ 2,101,325 | |||
Initial Contribution Received In Related To Joint Venture | $ 3,000,000 | $ 3,000,000 | ||||
Initial Equity Stake | 51.00% | 51.00% | ||||
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. | RegeneRx’s ownership interest in ReGenTree was reduced to 38.5% when the Clinical Study Report was filed for the Phase 2/3 dry eye clinical trial. Based on when, and if, certain additional development milestones are achieved in the U.S. with RGN-259, our equity ownership may be incrementally reduced to between 38.5% and 25%, with 25% being the final equity ownership upon approval of a BLA for DES in the U.S. In addition to our equity ownership, RegeneRx retains a royalty on net sales that varies between single and low double digits, depending on whether commercial sales are made by ReGenTree or a licensee. In the event ReGenTree is acquired or there is a change of control that occurs following achievement of a BLA, RegeneRx shall be entitled to a minimum of 40% of all proceeds paid or payable and will forgo any future royalties. | ||||
Additional Proceeds From License Fees Received | $ 1,000,000 | $ 1,000,000 | ||||
Revenue, Judgment | Revenue is being recognized on a straight-line basis over a period of 30 years | Revenue is being recognized on a straight-line basis over a period of 30 years | ||||
Maximum [Member] | ||||||
LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS [Line Items] | ||||||
Capitalized Contract Cost, Amortization Period | 30 years | |||||
Minimum [Member] | ||||||
LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS [Line Items] | ||||||
Capitalized Contract Cost, Amortization Period | 23 years | 23 years | ||||
ReGen Tree [Member] | ||||||
LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS [Line Items] | ||||||
Proceeds from Royalties Received | $ 250,000 | |||||
Deferred Revenue, Noncurrent | $ 1,017,267 | 1,059,246 | ||||
Capitalized Contract Cost, Amortization Period | 30 years | |||||
Percentage of proceeds paid or payable | 40.00% | |||||
RGN-259 Agreement [Member] | ||||||
LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS [Line Items] | ||||||
Milestone Payments | $ 3,500,000 | $ 3,500,000 | ||||
RGN-137 Agreement [Member] | ||||||
LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS [Line Items] | ||||||
Deferred Revenue, Noncurrent | 684,058 | 718,840 | ||||
Milestone Payments | $ 3,500,000 | $ 3,500,000 | ||||
Capitalized Contract Cost, Amortization Period | 23 years | |||||
Lees Pharmaceutical [Member] | ||||||
LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS [Line Items] | ||||||
Proceeds from Royalties Received | 200,000 | |||||
Definitive License Agreement [Member] | ||||||
LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS [Line Items] | ||||||
Proceeds from Royalties Received | $ 200,000 | |||||
Deferred Revenue, Noncurrent | $ 400,000 | $ 400,000 |
COMPOSITION OF CERTAIN FINANC_3
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS - Prepaid Expenses and Other Current Assets (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS | |||
Prepaid insurance | $ 39,196 | $ 27,453 | |
Other | 10,713 | 14,186 | |
Prepaid Expense and Other Assets, Current | $ 30,415 | $ 49,909 | $ 41,639 |
COMPOSITION OF CERTAIN FINANC_4
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS - Accrued Expenses (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS | |||
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 | |
Accrued Liabilities, Current, Total | $ 278,472 | $ 208,857 | $ 95,020 |
CONVERTIBLE NOTES - Schedule _2
CONVERTIBLE NOTES - Schedule of principal amount and number of shares of common stock issuable upon exercise of warrants (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
January 2014 [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | $ 55,000 | |
Essetifin SPA [Member] | 2020 Notes | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | $ 400,000 | 400,000 |
Essetifin SPA [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 1,000,000 | 1,000,000 |
Joseph C. McNay [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 25,000 | 25,000 |
Joseph C. McNay [Member] | January 2014 [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 | 10,000 |
J.J. Finkelstein [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 25,000 | 25,000 |
Mauro Bove [Member] | 2020 Notes | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 10,000 | 10,000 |
Mauro Bove [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 10,000 | 10,000 |
Allan L. Goldstein [Member] | 2020 Notes | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 5,000 | 5,000 |
Allan L. Goldstein [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 5,000 | 5,000 |
Allan L. Goldstein [Member] | January 2014 [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | 10,000 | |
R. Don Elsey [Member] | 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | $ 5,000 | 5,000 |
L. Thompson Bowles [Member] | January 2014 [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Face Amount | $ 5,000 |
CONVERTIBLE NOTES - Summary o_2
CONVERTIBLE NOTES - Summary of recorded interest expense and discount accretion (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Instrument [Line Items] | ||||||
Change in fair value of derivative | $ 81,189 | $ 51,619 | $ 161,485 | $ 103,238 | ||
2019 Notes [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Change in fair value of derivative | 51,619 | 51,619 | 102,671 | 103,238 | $ 207,610 | $ 152,931 |
2020 Notes | ||||||
Debt Instrument [Line Items] | ||||||
Change in fair value of derivative | $ 29,570 | $ 0 | $ 58,814 | $ 0 | 25,021 | 0 |
January 2014 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Change in fair value of derivative | $ 0 | $ 479 |
CONVERTIBLE NOTES - Additiona_2
CONVERTIBLE NOTES - Additional Information (Details) | May 13, 2019USD ($) | Mar. 13, 2019USD ($) | Feb. 27, 2019USD ($)$ / shares | Jan. 07, 2014USD ($)$ / sharesshares | Jan. 07, 2014USD ($)$ / shares | Oct. 31, 2020USD ($)$ / sharesshares | Feb. 28, 2019USD ($) | Feb. 27, 2019USD ($)$ / sharesshares | Feb. 19, 2019USD ($) | Jun. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($) | Mar. 27, 2019 | Jan. 06, 2019shares | Mar. 02, 2018$ / sharesshares |
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Proceeds from Convertible Debt | $ 500,000 | $ 1,300,000 | |||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | $ / shares | $ 0.18 | $ 0.18 | $ 0.2301 | ||||||||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.12 | $ 0.12 | |||||||||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 10,833,333 | ||||||||||||||
Warrants issued with debt | $ 176,573 | $ 348,443 | |||||||||||||
Number of shares of common stock purchased | shares | 8,125,000 | 8,125,000 | 3,860,294 | ||||||||||||
Debt Instrument, Maturity Date, Description | The 2019 Notes will mature on March 1, 2024 | ||||||||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 348,443 | $ 348,443 | |||||||||||||
Fair Value Per Warrant | $ / shares | $ 0.06 | $ 0.06 | |||||||||||||
Measurement Input, Price Volatility [Member] | Black Scholes [Member] | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Warrants and Rights Outstanding, Measurement Input | 67.86 | 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 | 2.49 | 2.49 | |||||||||||||
Note Warrant | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Number of shares of common stock purchased | shares | 1,149,016 | ||||||||||||||
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 | $ 348,443 | |||||||||||||
2020 Notes | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | $ / shares | $ 0.45 | $ 0.45 | |||||||||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 1,391,982 | ||||||||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 176,573 | $ 176,573 | |||||||||||||
January 2014 [Member] | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Debt Instrument, Face Amount | 55,000 | ||||||||||||||
Debt Instrument, Increase, Accrued Interest | 14,000 | ||||||||||||||
Debt Instrument, Term | 60 months | ||||||||||||||
Convertible Notes | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Proceeds from Convertible Debt | $ 1,300,000 | $ 55,000 | $ 500,000 | $ 1,300,000 | $ 1,300,000 | ||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 75.00% | 5.00% | 5.00% | 75.00% | 75.00% | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | $ / shares | $ 0.18 | $ 0.45 | $ 0.18 | ||||||||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.12 | $ 0.06 | $ 0.06 | $ 0.36 | $ 0.12 | ||||||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 916,667 | ||||||||||||||
Convertible Notes | January 2014 [Member] | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Bifurcated Liability | $ 55,000 | $ 55,000 | |||||||||||||
Residual Debt Value | $ 0 | ||||||||||||||
Convertible Notes | February 2019 [Member] | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | 5.00% | 5.00% | ||||||||||||
First Closing | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Proceeds from Convertible Debt | $ 650,000 | $ 650,000 | |||||||||||||
Second Closing | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Proceeds from Convertible Debt | $ 650,000 | $ 650,000 | |||||||||||||
2020 Convertible 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 | ||||||||||||||
Number of shares of common stock purchased | shares | 1,043,988 | 1,043,988 | |||||||||||||
Proceeds from Issuance of Preferred Stock, Preference Stock, and Warrants | $ 176,573 | ||||||||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 176,573 | ||||||||||||||
Fair Value Per Warrant | $ / shares | $ 0.26 | $ 0.26 | |||||||||||||
Intrinsic value of conversion allocated to additional paid up capital | $ 289,045 | $ 289,045 | |||||||||||||
2020 Convertible Notes | 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 | 74.6 | |||||||||||||
2020 Convertible Notes | Measurement Input, Expected Term [Member] | Black Scholes [Member] | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Warrants and Rights Outstanding, Measurement Input | 5 | ||||||||||||||
2020 Convertible Notes | 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 | 0.32 | |||||||||||||
2020 Convertible Notes | 2020 Notes | |||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | |||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% |
STOCKHOLDERS' EQUITY - Addition
STOCKHOLDERS' EQUITY - Additional Information (Details) - USD ($) | Apr. 23, 2019 | Mar. 02, 2018 | Mar. 02, 2018 | Jan. 31, 2020 | Apr. 30, 2019 | Apr. 23, 2019 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 17, 2020 | Mar. 14, 2019 | Mar. 02, 2019 | Jan. 06, 2019 | Dec. 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 3,860,294 | 3,860,294 | 8,125,000 | 8,125,000 | 8,125,000 | ||||||||||||
Reduction In Exercise Of Warrants | $ 0.20 | ||||||||||||||||
Proceeds from Warrant Exercises | $ 1,029,000 | $ 0 | $ 241,911 | $ 241,911 | $ 240,625 | ||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.2301 | $ 0.2301 | $ 0.18 | $ 0.18 | $ 0.18 | ||||||||||||
Allocated Share-based Compensation Expense | $ 61,744 | $ 146,433 | $ 123,488 | $ 196,272 | $ 332,003 | $ 269,740 | |||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 299,253 | $ 299,253 | $ 423,000 | ||||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 11 months 4 days | 1 year 3 months 7 days | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 9,931,250 | 9,931,250 | 11,951,250 | 3,610,130 | 4,123,142 | ||||||||||||
Additional Common Stock To Outstanding shares value percent | 2.00% | ||||||||||||||||
Employee and Director [Member] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Grant Date Intrinsic Value | $ 0.19 | $ 0.16 | |||||||||||||||
Stock Option and Incentive Plans [Member] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 5,000,000 | ||||||||||||||||
March Warrants [Member] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,000,000 | 925,000 | 925,000 | 1,939,294 | 1,000,000 | 1,000,000 | |||||||||||
Proceeds from Warrant Exercises | $ 125,000 | $ 115,625 | $ 241,911 | $ 125,000 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.125 | $ 0.125 | $ 0.125 | $ 0.125 | |||||||||||||
Sabby Warrants [Member] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 0.51 | 0.51 | 1,935,294 | ||||||||||||||
Stock Issued During Period, Shares, New Issues | 5,147,059 | ||||||||||||||||
Proceeds from Warrant Exercises | $ 125,000 | $ 241,911 | |||||||||||||||
Warrant | Estimate of Fair Value Measurement [Member] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.125 | $ 0.125 | $ 0.125 | ||||||||||||||
Offering Expenses Related To Warrant Reprice | $ 82,566 | $ 82,566 | |||||||||||||||
Warrant | Sabby Warrants [Member] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Proceeds from Warrant Exercises | $ 115,625 | ||||||||||||||||
Note Warrant | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,149,016 |
STOCKHOLDERS' EQUITY - Summary
STOCKHOLDERS' EQUITY - Summary of share-based Compensation Expense (Details) - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation | $ 123,488 | $ 196,272 | $ 332,003 | $ 269,740 |
Research and development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation | 63,207 | |||
General and administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation | $ 332,003 | $ 206,533 |
STOCKHOLDERS' EQUITY - Summar_2
STOCKHOLDERS' EQUITY - Summary of stock Option Activity (Details) - $ / shares | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares available for grant, Beginning | 11,951,250 | 3,610,130 | 4,123,142 |
Shares available for grant, 2018 plan approved | 2,668,836 | 2,630,130 | |
Shares available for grant, Grants | 0 | (2,130,000) | (2,415,000) |
Shares available for grant, Exercises | 105,000 | ||
Shares available for grant, 2010 Plan Expiration | (728,142) | ||
Shares available for grant, Ending | 9,931,250 | 11,951,250 | 3,610,130 |
Number of shares, Beginning | 11,951,250 | 9,821,250 | 9,044,825 |
Number of shares, Grants | 2,130,000 | 2,415,000 | |
Number of shares, Exercises | 0 | (1,638,575) | |
Number of shares, Ending | 11,951,250 | 9,821,250 | |
Vested and expected to vest at December 31, 2019 | 9,606,260 | 11,811,875 | |
Exercisable at December 31, 2020 | 7,861,250 | 8,745,500 | |
Weighted Average Exercise price, Beginning | $ 0.28 | $ 0.28 | $ 0.28 |
Weighted-average exercise price, Grants | 0.30 | 0.30 | 0.21 |
Weighted-average exercise price, Exercises | 0.21 | 0 | 0.21 |
Weighted Average Exercise price, Ending | 0.30 | 0.28 | 0.28 |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted Average Exercise price, Beginning | 0.16 | 0.16 | 0.14 |
Weighted-average exercise price, Grants | 0.21 | ||
Weighted-average exercise price, Exercises | 0.14 | ||
Weighted Average Exercise price, Ending | 0.16 | 0.16 | |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted Average Exercise price, Beginning | $ 0.64 | 0.64 | 0.64 |
Weighted-average exercise price, Exercises | 0.57 | ||
Weighted Average Exercise price, Ending | $ 0.64 | $ 0.64 |
STOCKHOLDERS' EQUITY - Summar_3
STOCKHOLDERS' EQUITY - Summary of the Company's stock options (Details) - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
STOCKHOLDERS' EQUITY | ||||
Outstanding options, Number of shares Granted | 2,130,000 | 2,415,000 | ||
Outstanding options, Number of shares Exercised | 0 | 1,638,575 | ||
Outstanding options, Number of shares outstanding | 11,951,250 | 9,821,250 | 9,044,825 | |
Vested and unvested but expected to vest, June 30, 2021 | 9,606,260 | 11,811,875 | ||
Weighted Average Exercise Price Granted | $ 0.30 | $ 0.30 | $ 0.21 | |
Weighted Average Exercise Price Exercised | 0.21 | 0 | 0.21 | |
Outstanding options, Weighted-average exercise price | $ 0.30 | $ 0.28 | $ 0.28 | $ 0.28 |
Outstanding options, Weighted-average remaining contractual life (in years) | 5 years 10 months 24 days | 5 years 4 months 24 days | ||
Exercisable options, Number of shares exercisable | 7,861,250 | 8,745,500 | ||
Exercisable options, Weighted-average exercise price | $ 0.31 | $ 0.29 | ||
Options, Vested and Expected to Vest, Outstanding, Weighted-average exercise price | $ 0.28 | |||
Weighted Average Remaining Contractual Life Vested and unvested but expected to vest, June 30, 2021 | 5 years 10 months 24 days | 5 years 4 months 24 days | ||
Exercisable options, Weighted-average remaining contractual life (in years) | 5 years 3 months 18 days | 4 years 1 month 6 days | ||
Outstanding options, Intrinsic value of in-the-money options | $ 283,550 | $ 2,189,575 | ||
Aggregate Intrinsic Value Vested and unvested but expected to vest, June 30, 2021 | 274,271 | 2,164,040 | ||
Exercisable options, Intrinsic value of in-the-money options | $ 223,250 | $ 1,563,850 |
STOCKHOLDERS' EQUITY - Schedule
STOCKHOLDERS' EQUITY - Schedule of forward-looking range of assumptions to value the stock options issue (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
STOCKHOLDERS' EQUITY | ||
Dividend yield | 0.00% | 0.00% |
Risk-free rate of return | 0.33% | 2.15% |
Expected life in years | 5 years 10 months 17 days | 5 years 10 months 17 days |
Volatility | 74.57% | 93.59% |
Forfeiture rate | 2.60% | 2.60% |
STOCKHOLDERS' EQUITY - Summar_4
STOCKHOLDERS' EQUITY - Summary of warrant activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Maximum [Member] | ||
Share Based Compensation Warrant Activity [Line Items] | ||
Weighted Average exercise price, Beginning | $ 0.37 | $ 0.37 |
Weighted Average exercise price, Ending | 0.45 | 0.37 |
Minimum [Member] | ||
Share Based Compensation Warrant Activity [Line Items] | ||
Weighted Average exercise price, Beginning | 0.23 | 0.23 |
Weighted Average exercise price, Ending | $ 0.125 | $ 0.23 |
Warrant | ||
Share Based Compensation Warrant Activity [Line Items] | ||
Number of shares, Beginning | 10,420,594 | 4,220,594 |
Number of shares, Issuances | 1,043,988 | 8,125,000 |
Number of shares, Exercises | (1,935,294) | (1,925,000) |
Number of shares, Ending | 9,529,288 | 10,420,594 |
Weighted Average exercise price, Beginning | $ 0.24 | $ 0.24 |
Weighted Average exercise price, Issuances | 0.45 | 0.18 |
Weighted Average exercise price, Exercises | 0.125 | 0.125 |
Weighted Average exercise price, Ending | $ 0.21 | $ 0.24 |
INCOME TAXES - Schedule of Comp
INCOME TAXES - Schedule of Components of Income Tax Expense (Benefit) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Current income tax provision (benefit): | ||||||
Federal | $ 0 | $ 0 | ||||
State | 0 | 0 | ||||
Foreign | 0 | 0 | ||||
Total | 0 | 0 | ||||
Deferred income tax provision (benefit): | ||||||
Federal | (271,000) | (162,000) | ||||
State | (84,000) | (51,000) | ||||
Foreign | 0 | 0 | ||||
Total | (355,000) | (213,000) | ||||
Change in valuation allowance | 355,000 | 213,000 | ||||
Total provision (benefit) for income taxes | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 |
INCOME TAXES - Schedule of Defe
INCOME TAXES - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 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 carryforward | 4,000 | 6,000 |
Accrued expenses, deferred revenue and other | 523,000 | 591,000 |
Share-based compensation | 824,000 | 774,000 |
Deferred Tax Assets, Gross | 17,667,000 | 17,360,000 |
Less - valuation allowance | (17,667,000) | (17,360,000) |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAXES - Schedule of Effe
INCOME TAXES - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
INCOME TAXES | ||
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%) |
Effective Income Tax Rate Reconciliation, Percent | 0.00% | 0.00% |
INCOME TAXES - Additional infor
INCOME TAXES - Additional information (Details) - USD ($) $ in Millions | Dec. 31, 2020 | Dec. 31, 2018 | Dec. 31, 2009 |
Income Taxes [Line Items] | |||
Operating Loss Carryforwards | $ 51.1 | $ 47.9 | $ 9.8 |
Research Tax Credit Carryforward [Member] | |||
Income Taxes [Line Items] | |||
Tax Credit Carryforward, Amount | $ 2.3 | $ 0.2 |
LEASES - Company's recognitio_2
LEASES - Company's recognition of its operating lease (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Assets | |||||
Operating lease right-of-use asset | $ 48,962 | $ 68,229 | $ 82,000 | $ 24,453 | $ 60,000 |
Total lease assets | 48,962 | 68,229 | |||
Current | |||||
Current portion of operating lease liability | 45,043 | ||||
Non-current | |||||
Operating lease liability | 4,172 | ||||
Total lease liabilities | $ 49,215 | $ 68,599 | $ 82,000 | $ 65,000 |
LEASES - Minimum operating le_2
LEASES - Minimum operating lease payments (Details) - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
LEASES | ||||
Operating lease cost | $ 24,542 | $ 22,891 | $ 50,060 | $ 48,101 |
Variable lease costs | 267 | 0 | 895 | 4,381 |
Total lease costs | $ 24,809 | $ 22,891 | $ 50,955 | $ 52,482 |
LEASES - Maturity operating l_2
LEASES - Maturity operating lease payment (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Jan. 01, 2019 |
LEASES | ||||
2021 | $ 25,452 | |||
2022 | 29,694 | |||
2023 | $ 50,904 | |||
2024 | 29,694 | |||
Total | 55,146 | 80,598 | ||
Discount factor | (5,931) | (11,999) | ||
Total lease liabilities | $ 49,215 | $ 68,599 | $ 82,000 | $ 65,000 |
LEASES - Additional informati_2
LEASES - Additional information (Details) - USD ($) | 1 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2020 | |
LEASES | ||
Lease Rent Per Month | $ 4,200 | $ 4,200 |
Lessee, Operating Lease, Discount Rate | 20.00% | 20.00% |
Lease Expiration Term | July 2022 |
PROMISSORY NOTE (Details)_2
PROMISSORY NOTE (Details) - USD ($) | Aug. 24, 2020 | Apr. 24, 2020 |
Paycheck Protection Program Loan | ||
Debt Instrument [Line Items] | ||
Principal amount of loan | $ 55,400 | $ 55,400 |
COMMITMENTS (Details)
COMMITMENTS (Details) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Commitments [Member] | |
Lessee, Lease, Description [Line Items] | |
Severance Costs | $ 170,000 |