Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 07, 2019 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | REGENERX BIOPHARMACEUTICALS INC | |
Entity Central Index Key | 0000707511 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Trading Symbol | RGRX | |
Entity Common Stock, Shares Outstanding | 131,506,494 | |
Entity Emerging Growth Company | false | |
Entity Small Business | true |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash and cash equivalents | $ 662,568 | $ 237,261 |
Prepaid expenses and other current assets | 29,610 | 36,609 |
Total current assets | 692,178 | 273,870 |
Property and equipment, net of accumulated depreciation of $98,587 and $97,921 | 752 | 1,418 |
Operating lease right-of-use asset | 51,682 | 0 |
Other assets | 5,752 | 5,752 |
Total assets | 750,364 | 281,040 |
Current liabilities | ||
Accounts payable | 38,532 | 92,433 |
Unearned revenue | 76,761 | 76,761 |
Accrued expenses | 68,469 | 91,058 |
Convertible promisory notes | 0 | 54,754 |
Current portion of operating lease liability | 48,459 | 0 |
Total current liabilities | 232,221 | 315,006 |
Long-term liabilities | ||
Unearned revenue | 2,158,896 | 2,178,087 |
Convertible promisory notes - net of discount | 307,842 | 0 |
Operating lease liability | 8,146 | 0 |
Total liabilities | 2,707,105 | 2,493,093 |
Commitments and contingencies | ||
Stockholders' deficit | ||
Preferred stock, $.001 par value per share, 1,000,000 shares authorized; no shares issued | 0 | 0 |
Common stock, par value $.001 per share, 200,000,000 shares authorized, 130,506,494 and 128,432,478 issued and outstanding | 130,507 | 128,433 |
Additional paid-in capital | 104,209,546 | 103,541,291 |
Accumulated deficit | (106,296,794) | (105,881,777) |
Total stockholders' deficit | (1,956,741) | (2,212,053) |
Total liabilities and stockholders' deficit | $ 750,364 | $ 281,040 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Stockholders' Equity, Number of Shares, Par Value and Other Disclosures [Abstract] | ||
Property and equipment, accumulated depreciation (in dollars) | $ 98,587 | $ 97,921 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 1,000,000 | 1,000,000 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 130,506,494 | 128,432,478 |
Common stock, shares, outstanding | 130,506,494 | 128,432,478 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenues | $ 19,191 | $ 18,782 |
Operating expenses | ||
Research and development | 15,304 | 18,845 |
General and administrative | 326,748 | 364,071 |
Total operating expenses | 342,052 | 382,916 |
Loss from operations | (322,861) | (364,134) |
Other income (expense) | ||
Inducement expense | 0 | (582,904) |
Interest expense | (9,590) | (38,826) |
Total other income (expense) | (9,590) | (621,730) |
Loss before taxes | (332,451) | (985,864) |
Provision for income taxes | 0 | 0 |
Net loss | (332,451) | (985,864) |
Deemed dividend related to warrants down round provision | (82,566) | 0 |
Net loss attributable to common shareholders | $ (415,017) | $ (985,864) |
Basic net loss per common share (in dollars per share) | $ 0 | $ (0.01) |
Diluted net loss per common share (in dollars per share) | $ 0 | $ (0.01) |
Weighted average number of common shares outstanding - basic (in shares) | 129,578,215 | 111,622,073 |
Weighted average number of common shares outstanding - diluted (in shares) | 129,578,215 | 111,622,073 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Deficit - USD ($) | Total | Common stock [Member] | Additional paid-in capital [Member] | Accumulated deficit [Member] |
Balance at Dec. 31, 2017 | $ (4,116,292) | $ 109,790 | $ 100,333,144 | $ (104,559,226) |
Balance (Shares) at Dec. 31, 2017 | 109,789,703 | |||
Issuance of common stock - note conversions (in value) | 282,032 | $ 4,700 | 277,332 | 0 |
Issuance of common stock - note conversions (in shares) | 4,700,520 | |||
Issuance of common stock - warrant exercises (in value) | 1,029,412 | $ 5,147 | 1,024,265 | 0 |
Issuance of common stock - warrant exercises (in shares) | 5,147,059 | |||
Inducement expense related to warrant reprice | 582,904 | $ 0 | 582,904 | 0 |
Offering expense related to warrant reprice | (85,565) | 0 | (85,565) | 0 |
Culmulative effect adjustment from adoption of ASU 2017-11 at Dec. 31, 2017 | 1,285,169 | 0 | 614,167 | 671,002 |
Share-based compensation expense | 60,168 | 0 | 60,168 | 0 |
Net loss | (985,864) | 0 | 0 | (985,864) |
Balance at Mar. 31, 2018 | (1,948,036) | $ 119,637 | 102,806,415 | (104,874,088) |
Balance (Shares) at Mar. 31, 2018 | 119,637,282 | |||
Balance at Dec. 31, 2018 | (2,212,053) | $ 128,433 | 103,541,291 | (105,881,777) |
Balance (Shares) at Dec. 31, 2018 | 128,432,478 | |||
Issuance of common stock - note conversions (in value) | 68,941 | $ 1,149 | 67,792 | 0 |
Issuance of common stock - note conversions (in shares) | 1,149,016 | |||
Issuance of common stock - warrant exercises (in value) | 115,625 | $ 925 | 114,700 | 0 |
Issuance of common stock - warrant exercises (in shares) | 925,000 | |||
Warrants issued with debt | 174,221 | $ 0 | 174,221 | 0 |
Debt discount related to beneficial conversion feature | 174,221 | 0 | 174,221 | 0 |
Deemed dividend related to warrant reprice | 0 | 0 | 82,566 | (82,566) |
Share-based compensation expense | 54,755 | 0 | 54,755 | 0 |
Net loss | (332,451) | 0 | 0 | (332,451) |
Balance at Mar. 31, 2019 | $ (1,956,741) | $ 130,507 | $ 104,209,546 | $ (106,296,794) |
Balance (Shares) at Mar. 31, 2019 | 130,506,494 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating activities: | ||
Net loss | $ (332,451) | $ (985,864) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 666 | 755 |
Amortization of right-of-use asset | 8,140 | 0 |
Non-cash share-based compensation | 54,755 | 60,168 |
Non-cash interest expense | 6,530 | 29,492 |
Inducement expense | 0 | 582,904 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 6,999 | 12,979 |
Accounts payable | (53,901) | 3,122 |
Accrued expenses and other current liabilites | (3,055) | 13,173 |
Operating lease liability | (8,810) | 0 |
Unearned revenue | (19,191) | 81,218 |
Net cash used in operating activities | (340,318) | (202,053) |
Financing activities: | ||
Payment of offering costs | 0 | (85,565) |
Proceeds from the sale of convertible notes | 650,000 | 0 |
Proceeds from the exercise of stock warrants | 115,625 | 1,029,412 |
Net cash provided by financing activities | 765,625 | 943,847 |
Net increase in cash and cash equivalents | 425,307 | 741,794 |
Cash and cash equivalents at beginning of period | 237,261 | 181,708 |
Cash and cash equivalents at end of period | 662,568 | 923,502 |
Supplemental Disclosures of Non-Cash Operating and Financing Activities | ||
Conversion of promissory notes to common stock | 55,000 | 225,000 |
Conversion of accrued interest to common stock | 13,941 | 57,032 |
Fair value of warrants issued to placement agent | 0 | 15,545 |
Cumulative effect of adjustment from adoption of ASU 2017-11 | 0 | 1,285,169 |
Establish right-of-use asset | 59,822 | 0 |
Establish operating lease liability | 65,415 | 0 |
Issuance of warrants in conjunction with issuance of convertible notes | 174,221 | 0 |
Beneficial conversion feaure on issuance of convertible notes | $ 174,221 | $ 0 |
ORGANIZATION, BUSINESS OVERVIEW
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | 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”), 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 March 31, 2019, we have an accumulated deficit of $106 million and we had cash and cash equivalents of $662,568 as of March 31, 2019. 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 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 $1,300,000 over two closings. 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, will occur within three days of the Company providing notice of the enrollment of the first patent in the ARISE-3 clinical trial in DES sponsored by ReGenTree (See Note 7). ReGenTree has informed us that they now expect the ARISE-3 clinical trial to occur in the second quarter of 2019. Because the Company does not control the timing of the ARISE-3 clinical trial, we cannot be certain that this timing is correct or that it may not change. 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 $115,625 and $125,000, While we successfully secured additional operating capital to continue operations through the second quarter of 2020, 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 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 condensed 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 and 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 additional funding beyond our current expectations. 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. If we are not able to secure financing beyond our current expectations, we would likely be forced to 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 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 accepted in the United States of America (“GAAP”) and with the rules and regulations of the 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 except as described below. The accompanying December 31, 2018 financial information was derived from our audited financial statements included in the Annual Report. Operating results for the three-month period ended March 31, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 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 (“FASB”). 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, recoverability of long-lived assets 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 , the proceeds received from convertible notes are allocated between the convertible notes and the detachable warrants based on the relative fair value of the convertible notes without the warrants and the relative fair value of the warrants. 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. 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 the 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. Operating lease ROU assets are included in other noncurrent assets and operating lease liabilities are included in other current and non-current liabilities in our consolidated balance sheets. 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. As of March 31, 2019, no impairment was noted. Recently Adopted Accounting Pronouncements. In June 2018, the FASB issued Accounting Standard Update (“ASU”) 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting In February 2016, the FASB issued ASU 2016-02, Leases Leases (Topic 842): Targeted Improvements · We did not reassess if any expired or existing contracts are, or contain, leases. · We did not reassess the classification of any expired or existing leases. 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 an 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 August 2018, the SEC issued a final rule that amends certain disclosure requirements that were duplicative, outdated or superseded. In addition, the final rule expanded the financial reporting requirements for changes in stockholders’ equity for interim reporting periods. The Company adopted the new guidance on January 1, 2019 with no material impact to the condensed financial statements. The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
NET INCOME (LOSS) PER COMMON SH
NET INCOME (LOSS) PER COMMON SHARE | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Earnings Per Share [Text Block] | 2. Net Income (Loss) per Common Share Basic net income (loss) per common share for the three-month periods ended March 31, 2019 and 2018 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 20,869,586 shares and 20,212,715 shares in 2019 and 2018, respectively, reserved for the conversion of convertible debt or exercise of outstanding options and warrants. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 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 $54,755 and $60,168 in stock-based compensation expense for the three months ended March 31, 2019 and 2018. We did not issue stock options to employees, consultants and directors during the three months ended March 31, 2019 or 2018, respectively. A summary of the Company’s stock options for the three months ended March 31, 2019 is as follows: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life Aggregate Intrinsic Value Options Outstanding, December 31, 2018 9,044,825 $ 0.28 Granted - $ - Exercised - $ - Forfeited (950,000 ) $ 0.14 Options Outstanding, March 31, 2019 8,094,825 $ 0.30 4.6 $ 171,550 Vested and unvested but expected to vest, March 31, 2019 8,013,673 $ 0.30 4.6 $ 171,500 Exercisable at March 31, 2019 6,391,075 $ 0.32 3.4 $ 135,428 The average expected life was determined using historical data. We expect to recognize the compensation cost related to non-vested options as of March 31, 2019 of $221,187 over the weighted average remaining recognition period of 1.23 years. |
INCOME TAXES
INCOME TAXES | 3 Months Ended |
Mar. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Tax Disclosure [Text Block] | 4. Income Taxes As of March 31, 2019, 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, 2019; no changes in settled tax years have occurred through March 31, 2019. Due to the existence of tax attribute carryforwards (which are currently offset by a full valuation allowance), the Company treats all years’ tax positions as unsettled due to the taxing authorities’ ability to modify these attributes. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosures [Text Block] | 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 March 31, 2019 and December 31, 2018, 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 $ and $ , respectively, using Level 1 inputs. |
CONVERTIBLE NOTES
CONVERTIBLE NOTES | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Debt Disclosure [Text Block] | 6. Convertible Notes 2012 Convertible Notes On October 19, 2012 we completed a private placement of convertible notes (“2012 Notes”) raising an aggregate of $300,000 in gross proceeds. The 2012 Notes were originally to mature after twenty-four (24) months from issuance. The 2012 Notes bore interest at a rate of five percent ( 5 At any time prior to maturity of the 2012 Notes, with the consent of the holders of a majority in interest of the 2012 Notes, we could prepay the outstanding principal amount of the 2012 Notes plus unpaid accrued interest without penalty. The outstanding principal and all accrued interest on the 2012 Notes would accelerate and automatically become immediately due and payable upon the occurrence of certain events of default. In connection with the issuance of the 2012 Notes we also issued warrants to each Investor. The warrants were exercisable for an aggregate of 400,000 shares of common stock with an exercise price of fifteen cents ($0.15) per share for a period of five years. The relative fair value of the warrants issued was $27,097, calculated using the Black-Scholes-Merton valuation model value of $0.07 with an expected and contractual life of 5 years, an assumed volatility of 74.36%, and a risk-free interest rate of 0.77%. The warrants were recorded as additional paid-in capital and a discount on the 2012 Notes of $27,097. The investors, and the principal amount of their respective 2012 Notes and number of shares of common stock issuable upon exercise of their respective warrants, are as set forth below: Investor Note Principal Warrants Sinaf S.A. $ 200,000 266,667 Joseph C. McNay $ 50,000 66,667 Allan L. Goldstein $ 35,000 46,666 J.J. Finkelstein $ 15,000 20,000 Sinaf S. A. has historically been affiliated with our largest stockholder. The other 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 the Chairman of our Board of Directors. During 2014, the Company, amended the existing October 2012 convertible debt agreement with the holders, solely to extend the due date of the principal and accrued unpaid interest until October 19, 2017. No other terms of the original debt were amended or modified, and the lenders did not reduce the borrowed amount or change the interest rate of the debt. The Company considered the restructuring a troubled debt restructuring as a result of the Company’s financial condition (see Note 1 discussion of “going concern”). At the date of the amendment, all existing debt discounts and deferred financing fees were fully amortized and the amendment did not involve any additional fees paid to the lender or third parties; as such there was no gain recognized as a result of the amendment. The 2012 Notes matured, and the holders elected to convert the note balances of $300,000 and accrued interest of approximately $76,000 into common stock and also exercised the associated warrants in October 2017. 2013 Convertible Notes On March 29, 2013, we completed a private placement of convertible notes (the “March 2013 Notes”) raising an aggregate of $225,000 in gross proceeds. The March 2013 Notes bore interest at a rate of five percent ( 5 At any time prior to maturity of the March 2013 Notes, with the consent of the holders of a majority in interest of the March 2013 Notes, we could prepay the outstanding principal amount of the March 2013 Notes plus unpaid accrued interest without penalty. The outstanding principal and all accrued interest on the March 2013 Notes would accelerate and automatically become immediately due and payable upon the occurrence of certain events of default. The investors in the offering included two members of the Board of Directors, Dr. Goldstein and Joseph C. McNay, an outside director. The principal amounts of their respective March 2013 Notes are as set forth below: Investor Note Principal Joseph C. McNay $ 50,000 Allan L. Goldstein $ 25,000 The March 2013 Notes contained a down round provision under which the conversion price could be decreased as a result of future equity offerings, as defined in the March 2013 Notes. The adjustment would reduce the conversion price of the March 2013 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 March 2013 Notes have been settled prior to the adoption of ASU 2017-11. The bifurcated liability of $225,000 was recorded on the date of issuance which resulted in a residual debt value of $0. The discount related to the embedded feature was accreted back to debt through the maturity of the notes. The March 2013 Notes matured, and the holders elected to convert the note balances of $225,000 and accrued interest of approximately $57,000 into common stock in March 2018. On July 5, 2013, we completed a private placement of convertible notes (the “July 2013 Notes”) raising an aggregate of $100,000 in gross proceeds. The July 2013 Notes bore interest at a rate of five percent ( 5 At any time prior to maturity of the July 2013 Notes, with the consent of the holders of a majority in interest of the July 2013 Notes, we could prepay the outstanding principal amount of the July 2013 Notes plus unpaid accrued interest without penalty. The outstanding principal and all accrued interest on the July 2013 Notes would accelerate and automatically become immediately due and payable upon the occurrence of certain events of default. The investors in the offering included three current and one former member of Board of Directors, Mr. Finkelstein, Dr. Goldstein, Mr. McNay and L. Thompson Bowles, previously an outside director. The principal amounts of their respective July 2013 Notes are as set forth below: Investor Note Principal Joseph C. McNay $ 50,000 Allan L. Goldstein $ 10,000 J.J. Finkelstein $ 5,000 L. Thompson Bowles $ 5,000 The July 2013 Notes contained a down round provision under which the conversion price could be decreased as a result of future equity offerings, as defined in the July 2013 Notes. The adjustment would reduce the conversion price of the July 2013 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 July 2013 Notes have been settled prior to the adoption of ASU 2017-11. The bifurcated liability of $66,667 was recorded on the date of issuance which resulted in a residual debt value of $33,333. The discount related to the embedded feature was accreted back to debt through the maturity of the notes. The July 2013 Notes matured, and the holders elected to convert the note balances of $100,000 and accrued interest of approximately $25,000 into common stock in July 2018. On September 11, 2013, we completed a private placement of convertible notes raising an aggregate of $321,000 in gross proceeds (the “September 2013 Notes”). The September 2013 Notes bore interest at a rate of five percent (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 September 2013 Notes) at any time prior to repayment, at the election of the investor. In the aggregate, the September 2013 Notes were initially convertible into up to 5,350,000 shares of our common stock. At any time prior to maturity of the September 2013 Notes, with the consent of the holders of a majority in interest of the September 2013 Notes, we could prepay the outstanding principal amount of the September 2013 Notes plus unpaid accrued interest without penalty. The outstanding principal and all accrued interest on the September 2013 Notes would accelerate and automatically become immediately due and payable upon the occurrence of certain events of default. The investors in the offering included an affiliate and three current and one former member of the Board of Directors. The principal amounts of their respective September 2013 Notes are as set forth below: Investor Note Principal SINAF S.A. $ 150,000 Joseph C. McNay $ 100,000 Allan L. Goldstein $ 11,000 L. Thompson Bowles $ 5,000 R. Don Elsey $ 5,000 The September 2013 Notes contained a down round provision under which the conversion price could be decreased as a result of future equity offerings, as defined in the September 2013 Notes. The adjustment would reduce the conversion price of the September 2013 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 September 2013 Notes have been settled prior to the adoption of ASU 2017-11. The bifurcated liability of $267,500 was recorded on the date of issuance which resulted in a residual debt value of $53,500. The discount related to the embedded feature was accreted back to debt through the maturity of the notes. The September 2013 Notes matured, and the holders elected to convert the note balances of $321,000 and accrued interest of approximately $81,000 into common stock in September 2018. 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, matured 60 months after their date of issuance and were convertible into shares of our common stock at a conversion price of $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 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. The outstanding principal and all accrued interest on the January 2014 Notes would accelerate and automatically become immediately due and payable upon the occurrence of certain events of default. 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 are as set forth below: Investor Note Principal Joseph C. McNay $ 25,000 Allan L. Goldstein $ 10,000 L. Thompson Bowles $ 5,000 The January 2014 Notes contained 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 have been settled prior to the adoption of ASU 2017-11. 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 was 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 14,000 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 will result 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, will occur within three days of the Company providing notice of the enrollment of the first patent in the ARISE-3 clinical trial in DES sponsored by ReGenTree. This is expected to occur in the second quarter of 2019. The 2019 Notes will mature sixty (60) months from issuance. The 2019 Notes bear interest at a rate of five percent ( 5 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 4,062,500 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 $ 174,221 0.06 5 67.86 2.49 The Company allocated $174,221 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 The affiliated investors, and the principal amount of their respective 2019 Notes purchase commitments 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. is currently the holder of all RegeneRx securities previously held by Sigma-Tau and its affiliates and is our largest stockholder. The other listed investors are members of our Board of Directors including Mr. Finkelstein, who serves as our CEO, and Dr. Goldstein who serves as our Chief Scientific Advisor and Chairman of our Board of Directors. The Company recorded interest expense and discount accretion as set forth below: For the 3 months ended March 31, 2019 March 31, 2018 March 2013 Notes $ - $ 14,192 July 2013 Notes - 4,448 September 2013 Notes - 16,856 January 2014 Notes 479 3,330 2019 Notes 9,111 - Total interest expense $ 9,590 $ 38,826 |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 3 Months Ended |
Mar. 31, 2019 | |
License Agreement [Abstract] | |
License Agreement [Text Block] | 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 LLC (“ReGenTree” or “Joint Venture”) will commercialize RGN-259 for treatment of dry eye 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 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 an NDA 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 an NDA, 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. In late 2016 GtreeBNT informed us that it believes marketing approval in the U.S. will allow expedited marketing in Korea, possibly without the need for a clinical trial. 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 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 “Lee’s License Agreement”). Lee’s previously filed an IND with the Chinese FDA to conduct a Phase 2, randomized, double-masked, dose-response clinical trial with RGN-259 in China for dry-eye syndrome. Lee's subsequently informed us that it received notice from 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. We have not yet been informed of a projected starting date for Phase 2 trials. 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 License Agreement. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2019 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity Note Disclosure [Text Block] | 8. Stockholders’ Equity On January 6, 2019, the January 2014 Convertible Notes matured, and the holders elected to convert the note balances and accrued interest into common stock. As a result, we issued 1,149,016 On March 2, 2018, the Company entered into a warrant reprice and exercise and issuance agreement (the “Reprice Agreement”) with Sabby Healthcare Master Fund, Ltd., and Sabby Volatility Warrant Master Fund, Ltd. (collectively, “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 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 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 has exercised additional warrants subsequent to March 31, 2019 for 1,000,000 shares of common stock. |
LEASES
LEASES | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Lessee, Operating Lease, Disclosure [Table Text Block] | 9. Leases In February 2017, we amended our office lease agreement and the term was extended through July 2020. During the extended term our rental payments will average approximately $ 4,000 20 Upon adoption the minimum lease payments were: The future minimum rent payments as of January 1, 2019, were as follows: 2019 $ 48,101 2020 28,850 Total $ 76,951 The following table summarizes the Company’s recognition of its operating lease: March 31, 2019 Assets Operating lease right-of-use asset $ 51,682 Total lease assets $ 51,682 Liabilities Current Current portion of operating lease liability $ 48,459 Non-current Operating lease liability 8,146 Total lease liabilities $ 56,605 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 three months ended March 31, 2019 2019 2018 Operating lease cost $ 11,937 $ 11,590 Variable lease costs 1,364 8,571 Total lease costs $ 13,301 $ 20,161 A maturity analysis of our operating lease minimum lease payments follows: 2019 $ 36,163 2020 28,850 Total 65,013 Discount factor (8,408 ) Total lease liabilties 56,605 Amounts due within 12 months (48,459 ) Non-current operating lease liability $ 8,146 |
ORGANIZATION, BUSINESS OVERVI_2
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation. The accompanying unaudited interim 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 accepted in the United States of America (“GAAP”) and with the rules and regulations of the 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 except as described below. The accompanying December 31, 2018 financial information was derived from our audited financial statements included in the Annual Report. Operating results for the three-month period ended March 31, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 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 (“FASB”). |
Use of Estimates, Policy [Policy Text Block] | 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, recoverability of long-lived assets 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 [Policy Text Block] | Convertible Notes with Detachable Warrants. In accordance with ASC 470-20, Debt with Conversion and Other Options , the proceeds received from convertible notes are allocated between the convertible notes and the detachable warrants based on the relative fair value of the convertible notes without the warrants and the relative fair value of the warrants. 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, Policy [Policy Text Block] | 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 the 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. |
Lessee, Leases [Policy Text Block] | 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. Operating lease ROU assets are included in other noncurrent assets and operating lease liabilities are included in other current and non-current liabilities in our consolidated balance sheets. |
Right Of Use Assets [Policy Text Block] | 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. As of March 31, 2019, no impairment was noted. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Adopted Accounting Pronouncements. In June 2018, the FASB issued Accounting Standard Update (“ASU”) 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting In February 2016, the FASB issued ASU 2016-02, Leases Leases (Topic 842): Targeted Improvements · We did not reassess if any expired or existing contracts are, or contain, leases. · We did not reassess the classification of any expired or existing leases. 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 an 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 August 2018, the SEC issued a final rule that amends certain disclosure requirements that were duplicative, outdated or superseded. In addition, the final rule expanded the financial reporting requirements for changes in stockholders’ equity for interim reporting periods. The Company adopted the new guidance on January 1, 2019 with no material impact to the condensed financial statements. The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-based Compensation, Stock Options, Activity [Table Text Block] | A summary of the Company’s stock options for the three months ended March 31, 2019 is as follows: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life Aggregate Intrinsic Value Options Outstanding, December 31, 2018 9,044,825 $ 0.28 Granted - $ - Exercised - $ - Forfeited (950,000 ) $ 0.14 Options Outstanding, March 31, 2019 8,094,825 $ 0.30 4.6 $ 171,550 Vested and unvested but expected to vest, March 31, 2019 8,013,673 $ 0.30 4.6 $ 171,500 Exercisable at March 31, 2019 6,391,075 $ 0.32 3.4 $ 135,428 |
CONVERTIBLE NOTES (Tables)
CONVERTIBLE NOTES (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Convertible Debt [Table Text Block] | The investors, and the principal amount of their respective 2012 Notes and number of shares of common stock issuable upon exercise of their respective warrants, are as set forth below: Investor Note Principal Warrants Sinaf S.A. $ 200,000 266,667 Joseph C. McNay $ 50,000 66,667 Allan L. Goldstein $ 35,000 46,666 J.J. Finkelstein $ 15,000 20,000 The investors in the offering included two members of the Board of Directors, Dr. Goldstein and Joseph C. McNay, an outside director. The principal amounts of their respective March 2013 Notes are as set forth below: Investor Note Principal Joseph C. McNay $ 50,000 Allan L. Goldstein $ 25,000 The investors in the offering included three current and one former member of Board of Directors, Mr. Finkelstein, Dr. Goldstein, Mr. McNay and L. Thompson Bowles, previously an outside director. The principal amounts of their respective July 2013 Notes are as set forth below: Investor Note Principal Joseph C. McNay $ 50,000 Allan L. Goldstein $ 10,000 J.J. Finkelstein $ 5,000 L. Thompson Bowles $ 5,000 The investors in the offering included an affiliate and three current and one former member of the Board of Directors. The principal amounts of their respective September 2013 Notes are as set forth below: Investor Note Principal SINAF S.A. $ 150,000 Joseph C. McNay $ 100,000 Allan L. Goldstein $ 11,000 L. Thompson Bowles $ 5,000 R. Don Elsey $ 5,000 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 are 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 commitments 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 |
Interest Income and Interest Expense Disclosure [Table Text Block] | The Company recorded interest expense and discount accretion as set forth below: For the 3 months ended March 31, 2019 March 31, 2018 March 2013 Notes $ - $ 14,192 July 2013 Notes - 4,448 September 2013 Notes - 16,856 January 2014 Notes 479 3,330 2019 Notes 9,111 - Total interest expense $ 9,590 $ 38,826 |
LEASES (Tables)
LEASES (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | The future minimum rent payments as of January 1, 2019, were as follows: 2019 $ 48,101 2020 28,850 Total $ 76,951 |
Operating Lease Related Assets And Liabilities [Table Text Block] | March 31, 2019 Assets Operating lease right-of-use asset $ 51,682 Total lease assets $ 51,682 Liabilities Current Current portion of operating lease liability $ 48,459 Non-current Operating lease liability 8,146 Total lease liabilities $ 56,605 |
Lease, Cost [Table Text Block] | 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 three months ended March 31, 2019 2019 2018 Operating lease cost $ 11,937 $ 11,590 Variable lease costs 1,364 8,571 Total lease costs $ 13,301 $ 20,161 |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | A maturity analysis of our operating lease minimum lease payments follows: 2019 $ 36,163 2020 28,850 Total 65,013 Discount factor (8,408 ) Total lease liabilties 56,605 Amounts due within 12 months (48,459 ) Non-current operating lease liability $ 8,146 |
ORGANIZATION, BUSINESS OVERVI_3
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Details Textual) - USD ($) | Jan. 07, 2014 | Apr. 30, 2019 | Feb. 27, 2019 | Jul. 05, 2013 | Mar. 29, 2013 | Oct. 19, 2012 | Mar. 31, 2019 | Mar. 31, 2018 | Jan. 01, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
ORGANIZATION AND BUSINESS [Line Items] | |||||||||||
Cash and Cash Equivalents, at Carrying Value | $ 662,568 | $ 923,502 | $ 237,261 | $ 181,708 | |||||||
Proceeds from Warrant Exercises | $ 115,625 | $ 1,029,412 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.18 | ||||||||||
Retained Earnings (Accumulated Deficit) | $ (106,296,794) | (105,881,777) | |||||||||
Debt Instrument, Convertible, Conversion Price | $ 0.12 | $ 0.12 | |||||||||
Debt Instrument, Interest Rate, Stated Percentage | 75.00% | ||||||||||
Operating Lease, Right-of-Use Asset | $ 51,682 | $ 60,000 | $ 0 | ||||||||
Operating Lease, Liability | $ 56,605 | $ 65,000 | |||||||||
Subsequent Event [Member] | |||||||||||
ORGANIZATION AND BUSINESS [Line Items] | |||||||||||
Proceeds from Warrant Exercises | $ 125,000 | ||||||||||
Convertible Notes [Member] | |||||||||||
ORGANIZATION AND BUSINESS [Line Items] | |||||||||||
Proceeds from Convertible Debt | $ 55,000 | $ 1,300,000 | $ 100,000 | $ 225,000 | $ 300,000 | ||||||
Debt Instrument, Convertible, Conversion Price | $ 0.06 | $ 0.06 | $ 0.06 | $ 0.15 | |||||||
First Closing [Member] | |||||||||||
ORGANIZATION AND BUSINESS [Line Items] | |||||||||||
Proceeds from Convertible Debt | 650,000 | ||||||||||
Second Closing [Member] | |||||||||||
ORGANIZATION AND BUSINESS [Line Items] | |||||||||||
Proceeds from Convertible Debt | $ 650,000 |
NET INCOME (LOSS) PER COMMON _2
NET INCOME (LOSS) PER COMMON SHARE (Details Textual) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 20,869,586 | 20,212,715 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) | 3 Months Ended |
Mar. 31, 2019USD ($)$ / sharesshares | |
Number of Shares, Beginning | shares | 9,044,825 |
Number of Shares Granted | shares | 0 |
Number of Shares Exercised | shares | 0 |
Number of Shares Forfeited | shares | (950,000) |
Number of Shares, Ending | shares | 8,094,825 |
Vested and unvested but expected to vest, March 31, 2019 | shares | 8,013,673 |
Number of Shares Exercisable | shares | 6,391,075 |
Weighted-average exercise price, Beginning | $ / shares | $ 0.28 |
Weighted Average Exercise Price Granted | $ / shares | 0 |
Weighted Average Exercise Price Exercised | $ / shares | 0 |
Weighted Average Exercise Price Forfeited | $ / shares | 0.14 |
Weighted-average exercise price, Ending | $ / shares | 0.30 |
Weightd Average Exercise Price Vested and unvested but expected to vest, March 31, 2019 | $ / shares | 0.30 |
Weighted Average Exercise Price Exercisable at March 31, 2019 | $ / shares | $ 0.32 |
Weighted Average Remaining Contractual Life Options Outstanding, September 30, 2018Options Outstanding, March 31, 2019 | 4 years 7 months 6 days |
Weighted Average Remaining Contractual Life Vested and unvested but expected to vest, March 31, 2019 | 4 years 7 months 6 days |
Weighted Average Remaining Contractual Life Exercisable at March 31, 2019 | 3 years 4 months 24 days |
Aggregate Intrinsic Value Options Outstanding, March 31, 2019 | $ | $ 171,550 |
Aggregate Intrinsic Value Vested and unvested but expected to vest, March 31, 2019 | $ | 171,500 |
Aggregate Intrinsic Value Exercisable at March 31, 2019 | $ | $ 135,428 |
STOCK-BASED COMPENSATION (Det_2
STOCK-BASED COMPENSATION (Details Textual) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated Share-based Compensation Expense | $ 54,755 | $ 60,168 |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 221,187 | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 2 months 23 days |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details Textual) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash and Cash Equivalents, Fair Value Disclosure | $ 662,568 | $ 237,261 |
CONVERTIBLE NOTES (Details)
CONVERTIBLE NOTES (Details) | Mar. 31, 2019USD ($)shares |
March 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | $ 225,000 |
July 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 100,000 |
September 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 321,000 |
2012 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 300,000 |
Sinaf S.A. [Member] | September 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 150,000 |
Sinaf S.A. [Member] | 2012 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | $ 200,000 |
Class of Warrant or Right, Outstanding | shares | 266,667 |
Essetifin SPA [Member] | 2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | $ 1,000,000 |
Joseph C. McNay [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 25,000 |
Joseph C. McNay [Member] | March 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 50,000 |
Joseph C. McNay [Member] | July 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 50,000 |
Joseph C. McNay [Member] | September 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 100,000 |
Joseph C. McNay [Member] | 2012 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | $ 50,000 |
Class of Warrant or Right, Outstanding | shares | 66,667 |
Joseph C. McNay [Member] | 2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | $ 25,000 |
J.J. Finkelstein [Member] | July 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 5,000 |
J.J. Finkelstein [Member] | 2012 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | $ 15,000 |
Class of Warrant or Right, Outstanding | shares | 20,000 |
J.J. Finkelstein [Member] | 2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | $ 25,000 |
Mauro Bove [Member] | 2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 10,000 |
Allan L. Goldstein [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 10,000 |
Allan L. Goldstein [Member] | March 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 25,000 |
Allan L. Goldstein [Member] | July 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 10,000 |
Allan L. Goldstein [Member] | September 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 11,000 |
Allan L. Goldstein [Member] | 2012 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | $ 35,000 |
Class of Warrant or Right, Outstanding | shares | 46,666 |
Allan L. Goldstein [Member] | 2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | $ 5,000 |
R. Don Elsey [Member] | September 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 5,000 |
R. Don Elsey [Member] | 2019 Notes [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 5,000 |
L. Thompson Bowles [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 5,000 |
L. Thompson Bowles [Member] | July 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | 5,000 |
L. Thompson Bowles [Member] | September 2013 [Member] | |
Debt Instrument [Line Items] | |
Debt Instrument, Face Amount | $ 5,000 |
CONVERTIBLE NOTES (Details 1)
CONVERTIBLE NOTES (Details 1) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Debt Instrument [Line Items] | ||
Change in fair value of derivative | $ 9,590 | $ 38,826 |
March 2013 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Change in fair value of derivative | 0 | 14,192 |
July 2013 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Change in fair value of derivative | 0 | 4,448 |
September 2013 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Change in fair value of derivative | 0 | 16,856 |
January 2014 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Change in fair value of derivative | 479 | 3,330 |
2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Change in fair value of derivative | $ 9,111 | $ 0 |
CONVERTIBLE NOTES (Details Text
CONVERTIBLE NOTES (Details Textual) - USD ($) | Jan. 07, 2014 | Feb. 27, 2019 | Sep. 11, 2013 | Jul. 05, 2013 | Mar. 29, 2013 | Oct. 19, 2012 | Mar. 31, 2019 | Dec. 31, 2012 |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Debt Instrument, Interest Rate, Stated Percentage | 75.00% | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.18 | |||||||
Debt Instrument, Convertible, Conversion Price | $ 0.12 | $ 0.12 | ||||||
Debt Conversion, Converted Instrument, Shares Issued | 5,416,667 | |||||||
Adjustments to Additional Paid in Capital, Warrant Issued | $ 174,221 | |||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 4,062,500 | |||||||
Debt Instrument, Maturity Date, Description | The 2019 Notes will mature sixty (60) months from issuance | |||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 174,221 | |||||||
Fair Value Per Warrant | $ 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 | |||||||
Measurement Input, Expected Term [Member] | Black Scholes [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Warrants and Rights Outstanding, Measurement Input | 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 | |||||||
Note Warrant [Member] | 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 | $ 174,221 | |||||||
Notes 2012 [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Debt Instrument, Face Amount | 300,000 | |||||||
Debt Instrument, Increase, Accrued Interest | 76,000 | |||||||
March 2013 [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Debt Instrument, Face Amount | 225,000 | |||||||
Debt Instrument, Increase, Accrued Interest | 57,000 | |||||||
July 2013 [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Debt Instrument, Face Amount | 100,000 | |||||||
Debt Instrument, Increase, Accrued Interest | 25,000 | |||||||
September 2013 [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Debt Instrument, Face Amount | 321,000 | |||||||
Debt Instrument, Increase, Accrued Interest | 81,000 | |||||||
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 | |||||||
Convertible Notes [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Proceeds from Convertible Debt | $ 55,000 | $ 1,300,000 | $ 100,000 | $ 225,000 | $ 300,000 | |||
Debt Instrument, Convertible, Conversion Price | $ 0.06 | $ 0.06 | $ 0.06 | $ 0.15 | ||||
Debt Conversion, Converted Instrument, Shares Issued | 916,667 | 1,666,667 | 3,750,000 | 2,000,000 | ||||
Convertible Notes [Member] | Notes 2012 [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | |||||||
Convertible Notes [Member] | March 2013 [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | |||||||
Bifurcated Liability | 225,000 | |||||||
Residual Debt Value | 0 | |||||||
Convertible Notes [Member] | July 2013 [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | |||||||
Bifurcated Liability | 66,667 | |||||||
Residual Debt Value | 33,333 | |||||||
Convertible Notes [Member] | September 2013 [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Proceeds from Convertible Debt | $ 321,000 | |||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | |||||||
Debt Instrument, Convertible, Conversion Price | $ 0.06 | |||||||
Debt Conversion, Converted Instrument, Shares Issued | 5,350,000 | |||||||
Bifurcated Liability | 267,500 | |||||||
Residual Debt Value | 53,500 | |||||||
Convertible Notes [Member] | January 2014 [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | |||||||
Bifurcated Liability | 55,000 | |||||||
Residual Debt Value | $ 0 | |||||||
Convertible Notes [Member] | February 2019 [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | |||||||
First Closing [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Proceeds from Convertible Debt | $ 650,000 | |||||||
Second Closing [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Proceeds from Convertible Debt | $ 650,000 | |||||||
Warrant [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Debt Conversion, Converted Instrument, Warrants or Options Issued | 400,000 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.15 | |||||||
Stock and Warrants Issued During Period, Value, Preferred Stock and Warrants | $ 27,097 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price | $ 0.07 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 5 years | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 74.36% | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 0.77% | |||||||
Adjustments to Additional Paid in Capital, Warrant Issued | $ 27,097 | |||||||
Warrant [Member] | Estimate of Fair Value Measurement [Member] | ||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.125 |
LICENSE AGREEMENTS (Details Tex
LICENSE AGREEMENTS (Details Textual) - USD ($) | Apr. 06, 2016 | Mar. 31, 2019 |
License Agreement [Line Items] | ||
Initial Contribution Received In Related To Joint Venture | $ 3,000,000 | |
Initial Equity Stake | 51.00% | |
Additional Proceeds From License Fees Received | $ 1,000,000 | |
Description of Equity Ownership Interest | RegeneRx’s ownership interest in ReGenTree was reduced 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 an NDA 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 an NDA, 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 | |
RGN-259 Agreement [Member] | ||
License Agreement [Line Items] | ||
Milestone Payments | $ 3,500,000 | |
RGN-137 Agreement [Member] | ||
License Agreement [Line Items] | ||
Milestone Payments | $ 3,500,000 | |
Minimum [Member] | ||
License Agreement [Line Items] | ||
Capitalized Contract Cost, Amortization Period | 23 years | |
ReGen Tree [Member] | ||
License Agreement [Line Items] | ||
Proceeds from Royalties Received | $ 250,000 |
STOCKHOLDERS' EQUITY (Details T
STOCKHOLDERS' EQUITY (Details Textual) - USD ($) | Mar. 02, 2018 | Apr. 30, 2019 | Mar. 31, 2019 | Mar. 31, 2018 | Apr. 15, 2019 | Jan. 06, 2019 | Dec. 31, 2012 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 4,062,500 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.18 | ||||||
Offering Expenses Related To Warrant Reprice | $ (85,565) | ||||||
Proceeds from Warrant Exercises | $ 115,625 | $ 1,029,412 | |||||
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 | 925,000 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.125 | ||||||
Proceeds from Warrant Exercises | $ 115,625 | ||||||
Subsequent Event [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Proceeds from Warrant Exercises | $ 125,000 | ||||||
Subsequent Event [Member] | 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 | ||||||
Note Warrant [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1,149,016 | ||||||
Warrant [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.15 | ||||||
Warrant [Member] | 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 | ||||||
Offering Expenses Related To Warrant Reprice | $ 82,566 |
LEASES (Details)
LEASES (Details) | Jan. 01, 2019USD ($) |
Operating Leased Assets [Line Items] | |
2019 | $ 48,101 |
2020 | 28,850 |
Total | $ 76,951 |
LEASES (Details 1)
LEASES (Details 1) - USD ($) | Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Assets | |||
Operating lease right-of-use asset | $ 51,682 | $ 60,000 | $ 0 |
Total lease assets | 51,682 | ||
Current | |||
Current portion of operating lease liability | 48,459 | 0 | |
Non-current | |||
Operating lease liability | 8,146 | $ 0 | |
Total lease liabilities | $ 56,605 | $ 65,000 |
LEASES (Details 2)
LEASES (Details 2) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating lease cost | $ 11,937 | $ 11,590 |
Variable lease costs | 1,364 | 8,571 |
Total lease costs | $ 13,301 | $ 20,161 |
LEASES (Details 3)
LEASES (Details 3) - USD ($) | Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
2019 | $ 36,163 | ||
2020 | 28,850 | ||
Total | 65,013 | ||
Discount factor | (8,408) | ||
Total lease liabilties | 56,605 | $ 65,000 | |
Amounts due within 12 months | (48,459) | $ 0 | |
Non-current operating lease liability | $ 8,146 | $ 0 |
LEASES (Details Textual)
LEASES (Details Textual) | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Lease Rent Per Month | $ 4,000 |
Lessee, Operating Lease, Discount Rate | 20.00% |