Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Nov. 14, 2018 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | REGENERX BIOPHARMACEUTICALS INC | |
Entity Central Index Key | 707,511 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Trading Symbol | RGRX | |
Entity Common Stock, Shares Outstanding | 128,432,478 | |
Entity Emerging Growth Company | false | |
Entity Small Business | true |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and cash equivalents | $ 396,041 | $ 181,708 |
Prepaid expenses and other current assets | 38,605 | 35,442 |
Total current assets | 434,646 | 217,150 |
Property and equipment, net of accumulated depreciation of $97,255 and $95,168 | 2,084 | 4,171 |
Other assets | 5,752 | 5,752 |
Total assets | 442,482 | 227,073 |
Current liabilities | ||
Accounts payable | 31,819 | 66,461 |
Unearned revenue | 76,761 | 78,893 |
Accrued expenses | 89,141 | 232,365 |
Convertible promissory notes | 51,439 | 591,036 |
Fair value of derivative liabilities | 0 | 1,184,334 |
Total current liabilities | 249,160 | 2,153,089 |
Long-term liabilities | ||
Unearned revenue | 2,197,277 | 2,045,622 |
Convertible promissory notes | 0 | 43,819 |
Fair value of derivative liabilities | 0 | 100,835 |
Total liabilities | 2,446,437 | 4,343,365 |
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, 128,432,478 and 109,789,703 issued and outstanding | 128,433 | 109,790 |
Additional paid-in capital | 103,485,560 | 100,333,144 |
Accumulated deficit | (105,617,948) | (104,559,226) |
Total stockholders' deficit | (2,003,955) | (4,116,292) |
Total liabilities and stockholders' deficit | $ 442,482 | $ 227,073 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Property and equipment, accumulated depreciation (in dollars) | $ 97,255 | $ 95,168 |
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 | 128,432,478 | 109,789,703 |
Common stock, shares, outstanding | 128,432,478 | 109,789,703 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenues | $ 19,190 | $ 13,869 | $ 50,476 | $ 39,281 |
Operating expenses | ||||
Research and development | 26,573 | 39,443 | 64,272 | 108,140 |
General and administrative | 349,924 | 416,606 | 1,049,753 | 1,064,040 |
Total operating expenses | 376,497 | 456,049 | 1,114,025 | 1,172,180 |
Loss from operations | (357,307) | (442,180) | (1,063,549) | (1,132,899) |
Inducement expense | 0 | 0 | (582,904) | 0 |
Interest expense | (18,680) | (43,576) | (83,272) | (129,306) |
Change in fair value of derivative liabilities | 0 | (872,896) | 0 | 131,271 |
Net loss | $ (375,987) | $ (1,358,652) | $ (1,729,725) | $ (1,130,934) |
Basic net loss per common share (in dollars per share) | $ 0 | $ (0.01) | $ (0.01) | $ (0.01) |
Diluted net loss per common share (in dollars per share) | $ 0 | $ (0.01) | $ (0.01) | $ (0.01) |
Weighted average number of common shares outstanding - basic (in shares) | 122,924,921 | 106,882,759 | 118,116,015 | 106,843,751 |
Weighted average number of common shares outstanding - diluted (in shares) | 122,924,921 | 106,882,759 | 118,116,015 | 106,843,751 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Operating activities: | ||
Net loss | $ (1,729,725) | $ (1,130,934) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,087 | 2,292 |
Non-cash share-based compensation | 220,398 | 211,199 |
Non-cash interest expense | 62,584 | 91,872 |
Non-cash inducement expense | 582,904 | 0 |
Change in fair value of derivative liabilities | 0 | (131,271) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (3,163) | 57,753 |
Accounts payable | (34,642) | (25,495) |
Accrued expenses | 20,520 | 70,305 |
Unearned revenue | 149,523 | 260,719 |
Net cash used in operating activities | (729,514) | (593,560) |
Financing activities: | ||
Stock issuance costs | (85,565) | 0 |
Proceeds from the exercise of stock warrants | 1,029,412 | 0 |
Proceeds from exercise of common stock options | 0 | 15,297 |
Net cash provided by financing activities | 943,847 | 15,297 |
Net increase (decrease) in cash and cash equivalents | 214,333 | (578,263) |
Cash and cash equivalents at beginning of period | 181,708 | 769,495 |
Cash and cash equivalents at end of period | 396,041 | 191,232 |
Supplemental Disclosure of Non-Cash Operating and Financing Activities | ||
Conversion of promissory notes to common stock | 646,000 | 0 |
Conversion of accrued interest to common stock | 163,744 | 0 |
Fair value of warrants issued to placement agent | 15,545 | 0 |
Fair value of derivative liabilities reclassified to equity | 1,285,169 | 0 |
Fair value of 2016 Offering warrant reclassified to equity | $ 0 | $ 941,063 |
ORGANIZATION, BUSINESS OVERVIEW
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2018 | |
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. We have a short-term need for additional capital to continue operations beyond the first quarter of 2019. At present, we have sufficient cash that, together with certain cost savings measures, we expect will allow us to continue operating into the first quarter of 2019. However, uncertainty regarding funding by our strategic partners and our ability to raise additional capital raises significant concerns about our ability to continue as a going concern. These issues are addressed in more detail below. 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. Our partners have been moving forward and making progress in each territory. In each case, the cost of development is being borne by our partners with no financial obligation for RegeneRx. 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. This should allow us to obtain a higher value for the asset at that time. However, we intend to continue to develop RGN-352, our injectable systemic product candidate for cardiac and central nervous system indications, 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. In 2004, we entered into a strategic partnership for development and marketing of RGN-137 and RGN-352 for specified fields of use in Europe and other contiguous countries with Sigma-Tau Group, which was subsequently acquired by Alfa Wassermann S.p.A., both Italian pharmaceutical companies. Pursuant to the terms of the license, we notified Alfa Wassermann that the license expired by its terms and we, therefore, reacquired rights to our Tß4-based products in the licensed territory. In August 2017, the Company amended the License Agreement for RGN-137 held by the amendment the Territory was expanded to include Europe, Canada, South Korea, Australia and Japan. Further, we now control the cardiovascular and neurovascular assets (RGN-352) in the EU and are able to consolidate them with similar assets in the U.S. and other territories in Asia to create a worldwide portfolio that we believe will be more attractive to multi-national pharmaceutical companies. Since inception, and through September 30, 2018, we have an accumulated deficit of $106 million and we had cash and cash equivalents of $396,041 as of September 30, 2018. 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 2, 2018 we entered into a warrant reprice, exercise and issuance agreement (the “Reprice Agreement”) with the holders of the warrants issued in the 2016 Offering. Under the terms of the Reprice Agreement, in consideration of the holders exercising in full all of the 2016 Offering warrants the exercise price per share of the warrants was reduced to $0.20 per share. In addition, and as further consideration, we issued to the holders of the 2016 Offering 3,860,294 new warrants with an exercise price of $0.2301 per share. We received gross proceeds of approximately $1,029,000 pursuant to the exercise and issued 5,147,059 shares of common stock. The amendment payments and warrant reprice proceeds plus our year end cash balance will fund planned operations into the first quarter of 2019. We will need to secure additional operating capital to continue operations beyond the first quarter of 2019 as well as 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. 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 U.S. generally accepted accounting principles (“U.S. GAAP”) and with the rules and regulations of the SEC, for interim financial statements. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP. The accounting policies underlying our unaudited interim financial statements are consistent with those underlying our audited annual financial statements, but do not include all disclosures including notes required by U.S. GAAP for complete financial statements. These unaudited interim financial statements should be read in conjunction with the audited annual financial statements as of and for the year ended December 31, 2017, and related notes thereto, included in our Annual Report on Form 10-K for the year ended December 31, 2017 (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 except as described below. The accompanying December 31, 2017 financial information was derived from our audited financial statements included in the Annual Report. Operating results for the three and nine month periods ended September 30, 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2018 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”). Revenue Recognition. Effective January 1, 2018, the Company adopted the new revenue recognition guidance contained in ASC 606, using the modified retrospective method. The adoption of ASC 606 did not result in any material change to how the Company recognizes revenue or to the accounting for costs to obtain and fulfill contracts with customers. As a result, the adoption did not result in a cumulative effect change on the date of adoption. See discussion below for the Company’s revenue recognition policies subsequent to the adoption of the new revenue recognition guidance. Financial Instruments. Effective January 1, 2018, the Company adopted new accounting guidance for financial instruments that contain down round features. As of December 31, 2017, the Company’s existing convertible notes contained embedded conversion features that under previous accounting guidance had been separately accounted for as derivative liabilities due to the presence of down round protection which (which precluded those embedded features from being classified as equity). Upon the adoption of the new guidance, the derivative liabilities were transferred to equity (additional paid in-capital and accumulated deficit) since the presence of those down round features no longer preclude equity treatment. Accordingly, no previously issued financial statements were adjusted as this guidance was applied prospectively. See Note 6 for further discussion of the terms of the convertible notes and embedded conversion features. Use of Estimates. The preparation of financial statements in conformity with U.S. 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 fair value measurements in connection with derivative liabilities, 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. Derivative Financial Instruments. Derivative financial instruments consist of financial instruments or other contracts that contain a notional amount and one or more underlying variables (e.g., interest rate, security price or other variable), which require no initial net investment and permit net settlement. Derivative financial instruments may be free-standing or embedded in other financial instruments. Further, derivative financial instruments are initially, and subsequently, measured at fair value and recorded as liabilities or, in rare instances, assets. The Company does not use derivative financial instruments to hedge exposures to cash-flow, market or foreign-currency risks. However, the Company has issued financial instruments including warrants that are either (i) not afforded equity classification, (ii) embody risks not clearly and closely related to host contracts, or (iii) may be net-cash settled by the counterparty. In certain instances, these instruments are required to be carried as derivative liabilities, at fair value, in the Company’s financial statements. In other instances, these instruments are classified as equity instruments in the Company’s financial statements. The Company estimates the fair value of its derivative financial instrument using the Black-Scholes option pricing model because it embodies all of the requisite assumptions (including trading volatility, estimated terms and risk free rates) necessary to fairly value these instruments. Estimating the fair value of derivative financial instruments requires the development of significant and subjective estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. In addition, option-based techniques are highly volatile and sensitive to changes in the trading market price of the Company’s common stock, which has a high-historical volatility. Since derivative financial instruments are initially and subsequently carried at fair value, the Company’s operating results reflect the volatility in these estimate and assumption changes in each reporting period. Upon the adoption of new accounting guidance on January 1, 2018, the embedded conversion features in the Company’s convertible notes are no longer accounted for as derivative liabilities. Revenue Recognition. Subsequent to the adoption of Accounting Standards Codification Revenue from Contracts with Customers (“ASC 606”) on January 1, 2018 The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers, (ii) identification of distinct performance obligations in the contract, (iii) determination of contract transaction price, (iv) allocation of contract transaction price to the performance obligations and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation. The Company recognizes revenues upon the satisfaction of its performance obligation (upon transfer of control of promised goods or services to our customers) in an amount that reflects the consideration to which it expects to be entitled to in exchange for those goods or services. 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. Revenue associated with licensing agreements consists of non-refundable upfront license fees and milestone payments. Non-refundable upfront license fees received under license agreements, whereby continued performance or future obligations are considered inconsequential to the relevant license technology, are recognized as revenue upon delivery of the technology. 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. If the Company cannot reasonably estimate the level of effort required to complete our performance obligation under an arrangement, the performance obligation is provided on a best-efforts basis and we can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory, then the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over the period we expect to complete our performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date. If the Company cannot reasonably estimate when our performance obligation either ceases or becomes inconsequential and perfunctory, revenue is deferred until we can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. At the inception of each arrangement that includes development milestone payments, the Company evaluates the probability of reaching the milestones and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur in the future, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore revenue recognized is constrained as management is unable to assert that a reversal of revenue would not be possible. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Amounts received prior to satisfying the above revenue recognition criteria are recorded as unearned revenue in our accompanying condensed 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. 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: September 30, 2018 December 31, 2017 Unearned revenue $ 2,274,038 $ 2,124,515 The contract liabilities amount disclosed above as of September 30, 2018, is 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 as of January 1, 2018, during the three and nine months ended September 30, 2018, totaled $2,174 and $41,056, respectively. Revenue is expected to be recognized in the future from contract liabilities as the related performance obligations are satisfied. For details about the Company’s revenue recognition policy prior to the adoption of ASC 606, refer to the Company’s Annual Report. Variable Interest Entities. The Company accounts for the Joint Venture (see Note 7) as a “variable interest entity” and that its equity stake in the Joint Venture is a variable interest, since the total equity investment at risk is not sufficient to permit the Joint Venture to finance its activities without additional subordinated financial support. Further, because of GtreeBNT Co. Ltd.’s, a Korean pharmaceutical company (“GtreeBNT”) and a shareholder of the Company, majority equity stake in the Joint Venture, voting control, control of the board of directors, and substantive management rights, and given that the Company does not have the power to direct the Joint Venture’s activities that most significantly impact its economic performance, the Company determined that it is not the primary beneficiary of the Joint Venture and therefore is not required to consolidate the Joint Venture. The Company reports its equity stake in the Joint Venture using the equity method of accounting because, while it does not control the Joint Venture, the Company can exert significant influence over the Joint Venture’s activities by virtue of its large equity stake and its board representation. Because the Company is not obligated to fund the Joint Venture, and has not provided any financial support to the Joint Venture, the carrying value of its investment in the Joint Venture is zero. 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 September 30, 2018, because it has not provided any financial support and is not obligated to fund the Joint Venture, the Company has no financial exposure as a result of its variable interest in the Joint Venture. Research and Development . Research and development (“R&D”) costs are expensed as incurred and include all of the wholly-allocable costs associated with our various clinical programs passed through to us by our outsourced vendors. Those costs include: manufacturing Tβ4; formulation of Tβ4 into the various product candidates; stability for both Tβ4 and the various formulations; pre-clinical toxicology; safety and pharmacokinetic studies; clinical trial management; medical oversight; laboratory evaluations; statistical data analysis; regulatory compliance; quality assurance; and other related activities. R&D includes cash and non-cash compensation, payroll taxes, travel and other miscellaneous costs of our internal R&D personnel, part-time hourly employees and external consultants dedicated to R&D efforts. R&D also includes a pro-ration of our common infrastructure costs for office space and communications. Recently Adopted Accounting Pronouncements. In May 2014, the FASB issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers , which provides guidance for revenue recognition for contracts, superseding the previous revenue recognition requirements, along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identify the contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. In March 2016, the FASB issued an accounting standard update to clarify the implementation guidance on principal versus agent considerations. In April 2016, the FASB issued an accounting standard update to clarify the identification of performance obligations and the licensing implementation guidance, while retaining the related principles for those areas. In May 2016, the FASB issued an accounting standard update to clarify guidance in certain areas and add some practical expedients to the guidance. The amendments in these 2016 updates do not change the core principle of the previously issued guidance in May 2014. Effective January 1, 2018, the Company adopted ASU 2014-09 (Topic 606) using the modified retrospective method through a cumulative adjustment to equity, which resulted in an immaterial difference and no adjustment to our opening balance of accumulated deficit as of January 1, 2018. In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. Part I of this Update addresses the complexity of accounting for certain financial instruments with down round features. Down round features are features of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings. When determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. Part II of this Update addresses the difficulty of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB Accounting Standards Codification®. For public business entities, the amendments in Part I of this Update are effective for years, beginning after December 15, 2018. Effective January 1, 2018, the Company adopted ASU 2017-11, Distinguishing Liabilities from Equity (Topic 480) . As a result, the December 31, 2017 qualifying liabilities of approximately $1.3 million were reclassified as equity as of January 1, 2018. Accordingly, no previously issued financial statements were adjusted as this guidance was applied prospectively. In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) Scope of Modification Accounting . ASU 2017-09 provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award. This ASU does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if there is a change to the value, vesting conditions, or award classification and would not be required if the changes are considered non-substantive. The Company adopted ASU 2017-09 in the first quarter of 2018 and the adoption of this ASU did not have a material effect on the financial statements. Recent Accounting Pronouncements. In February 2016, the FASB issued ASU 2016-02, Leases , which supersedes ASC Topic 840, Leases , and creates a new topic, ASC Topic 842, Leases . ASU 2016-02 requires lessees to recognize a lease liability and a lease asset for all leases, including operating leases, with a term greater than 12 months on its balance sheet. ASU 2016-02 also expands the required quantitative and qualitative disclosures surrounding leases. ASU 2016-02 is effective for the Company beginning January 1, 2019. Early adoption is permitted. The Company has determined that the adoption of ASU 2016-02 will currently not have a significant impact on its financial statements. In June 2018, the FASB issued ASU 2018-07: Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees, and as a result, the accounting for share-based payments to non-employees will be substantially aligned. ASU 2018-07 is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year, early adoption is permitted but no earlier than an entity’s adoption date of Topic 606. The Company is currently evaluating the impact this new guidance will have on its financial statements and related disclosures. In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification, amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders' equity for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders' equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. This final rule is effective on November 5, 2018. We are evaluating the impact of this guidance on our unaudited condensed consolidated financial statements. |
NET LOSS PER COMMON SHARE
NET LOSS PER COMMON SHARE | 9 Months Ended |
Sep. 30, 2018 | |
Earnings Per Share [Abstract] | |
Earnings Per Share [Text Block] | 2. Net Loss per Common Share Basic net loss per common share for the three and nine month periods ended September 30, 2018 and 2017, 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 14,474,649 shares and 18,576,046 shares in 2018 and 2017, respectively, reserved for the conversion of convertible debt or exercise of outstanding options and warrants. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2018 | |
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 vesting term of the grant. We recognized $100,053 and $96,907 in stock-based compensation expense for the three months ended September 30, 2018 and 2017, respectively. We recognized $220,398 and $211,199 in stock-based compensation expense for the nine months ended September 30, 2018 and 2017, respectively. On June 13, 2018, the stockholders of the Company approved the 2018 Equity Incentive Plan. We issued 1,605,000 stock options to employees, consultants and directors during the nine months ended September 30, 2018. We used the following forward-looking range of assumptions to value these stock options as well as 1,000,000 stock options granted to employees, consultants and directors during the nine months ended September 30, 2017: 2018 2017 Dividend yield 0.0 % 0.0 % Risk-free rate of return 2.76 % 1.73 % Expected life in years 5.88 5.88 Volatility 89 % 90 % Forfeiture rate 2.6 % 2.6 % A summary of the Company’s stock options for the nine months ended September 30, 2018 is as follows: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life Aggregate Intrinsic Value Options Outstanding, December 31, 2017 8,058,788 $ 0.29 Granted 1,605,000 $ 0.21 Exercised - $ - Forfeited (326,400 ) $ 0.22 Options Outstanding, September 30, 2018 9,337,388 $ 0.28 4.4 years $ 56,051 Vested and unvested but expected to vest, September 30, 2018 9,197,771 $ 0.28 4.4 years $ 56,051 Exercisable at September 30, 2018 7,309,888 $ 0.28 3.2 years $ 56,051 The average expected life was determined using historical data. We expect to recognize the compensation cost related to non-vested options as of September 30, 2018 of $328,675 over the weighted average remaining recognition period of 1.27 years. |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Tax Disclosure [Text Block] | 4. Income Taxes As of September 30, 2018, 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, 2018; no changes in settled tax years have occurred through September 30, 2018. Due to the existence of tax attribute carryforwards (which are currently offset by a full valuation allowance), the Company treats all years’ tax positions as unsettled due to the taxing authorities’ ability to modify these attributes. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2018 | |
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 September 30, 2018 and December 31, 2017, 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 $396,041 and $181,708, respectively, using Level 1 inputs. Our December 31, 2017 balance sheet reflects qualifying liabilities resulting from the price protection provision in the convertible promissory notes issued in March, July and September of 2013 and January 2014 (see Note 6). Previously we evaluated the derivative liability embedded in the series of convertible notes using the Black-Scholes model to determine if an adjustment to the carrying value of the liability was required each reporting period. Given the conditions surrounding the trading of the Company’s equity securities, the Company had valued its derivative instruments related to embedded conversion features from the issuance of convertible debentures in accordance with the Level 3 guidelines. Our September 30, 2018 balance sheet no longer reflects these liabilities pursuant to the adoption ASU 2017-11, Distinguishing Liabilities from Equity (Topic 480) . As a result, the December 31, 2017 qualifying liabilities were reclassified as equity. For the nine months ended September 30, 2018, the following table reconciles the beginning and ending balances for financial instruments that are recognized at fair value in these financial statements. Balance at Balance at December 31, New Change in September 30, 2017 Issuances Fair Values Reclassifications 2018 Level 3 - Derivative liabilities from: Conversion features March 2013 $ 412,500 $ - $ - $ (412,500 ) $ - July 2013 183,334 - - (183,334 ) - September 2013 588,500 - - (588,500 ) - January 2014 100,835 - - (100,835 ) - Derivative instruments $ 1,285,169 $ - $ - $ (1,285,169 ) $ - |
CONVERTIBLE NOTES
CONVERTIBLE NOTES | 9 Months Ended |
Sep. 30, 2018 | |
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 (the “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%) per annum and were convertible into shares of our common stock at a conversion price of fifteen cents ($0.15) per share (subject to adjustment as described in the 2012 Notes) at any time prior to repayment, at the election of the Investors. In the aggregate, the 2012 Notes were convertible into up to 2,000,000 shares of our common stock excluding interest. 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 may 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 are 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 is $27,097, calculated using the Black-Scholes 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 also the Chairman of our Board of Directors and Dr. Goldstein who also serves as our Chief Scientific Advisor. During 2014, the Company amended the existing October 2012 convertible debt agreement with the lenders, 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 and accrued interest into common stock and also exercise 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%) 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 March 2013 Notes) at any time prior to repayment, at the election of the investor. In the aggregate, the March 2013 Notes were initially convertible into up to 3,750,000 shares of our common stock. 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 may 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 directors of the Company, 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 and accrued interest 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 bear interest at a rate of five percent (5%) per annum, mature sixty (60) months after their date of issuance and are 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 July 2013 Notes) at any time prior to repayment, at the election of the investor. In the aggregate, the July 2013 Notes are initially convertible into up to 1,666,667 shares of our common stock. 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 may 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 will accelerate and automatically become immediately due and payable upon the occurrence of certain events of default. The investors in the offering included four directors of the Company, Mr. Finkelstein, Dr. Goldstein, Mr. McNay and L. Thompson Bowles, a former 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 contain 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 will be accreted back to debt through the maturity of the notes. The July 2013 Notes matured, and the holders elected to convert the note balances and accrued interest 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 bear interest at a rate of five percent (5%) per annum, mature sixty (60) months after their date of issuance and are 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 are 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 may 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 will 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 four directors of the Company. The principal amounts of the affiliate and directors 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 contain 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 will be accreted back to debt through the maturity of the notes. The September 2013 Notes matured, and the holders elected to convert the note balances and accrued interest 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 will pay interest at a rate of 5% per annum, mature 60 months after their date of issuance and are 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 are 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 may 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 will accelerate and automatically become immediately due and payable upon the occurrence of certain events of default. The Investors in the offering included three directors of the Company. The principal amounts of their respective 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 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 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 will be accreted back to debt through the maturity of the notes. The Company recorded interest expense and discount accretion as set forth below: For the three months ended For the nine months ended September 30, 2018 September 30, 2017 September 30, 2018 September 30, 2017 2012 Notes $ - $ 3,782 $ - $ 11,217 March 2013 Notes - 14,178 14,192 42,072 July 2013 Notes 585 4,621 9,677 13,714 September 2013 Notes 15,172 17,530 49,661 52,020 January 2014 Notes 2,923 3,465 9,742 10,283 Total $ 18,680 $ 43,576 $ 83,272 $ 129,306 The fair value of the derivative liability is as follows: September 30, 2018 December 31, 2017 March 2013 Notes $ - $ 412,500 July 2013 Notes - 183,334 September 2013 Notes - 588,500 January 2014 Notes - 100,835 Total fair value of derivative liability $ - $ 1,285,169 As of January 1, 2018, the Company early adopted ASU 2017-11, which revised the guidance for instruments with down round provisions. In accordance with the guidance presented in the ASU, the fair value of the derivative liability balance as of December 31, 2017 of $1,285,169 was reclassified by means of a cumulative-effect adjustment to equity as of January 1, 2018. The change in fair value of derivative liability is as follows: For the three months ended For the nine months ended September 30, 2018 September 30, 2017 September 30, 2018 September 30, 2017 March 2013 Notes $ - $ 225,000 $ - $ 37,500 July 2013 Notes - 100,000 - 16,666 September 2013 Notes - 321,000 - 53,500 January 2014 Notes - 45,833 - - Warrant liability - 231,063 - (48,937 ) Rights liability - (50,000 ) - (190,000 ) Total change in fair value of derivative $ - $ 872,896 $ - $ (131,271 ) |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 9 Months Ended |
Sep. 30, 2018 | |
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, which is commercializing 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. We are a party to a license agreement with GtreeBNT for the license of RGN-259 related to certain development and commercialization rights for RGN-259, in Asia (excluding China, Hong Kong, Macau and Taiwan). Separately, we licensed GtreeBNT the rights to RGN-137 which was recently amended in exchange for a series of payments the last of which was received in June 2018. GtreeBNT is currently our second largest stockholder. GtreeBNT filed an investigational new drug application (“IND”) with the Korean Ministry of Food and Drug Safety to conduct a Phase 2/3 study with RGN-259 in patients with dry eye syndrome and in July 2015 received approval to conduct the trial. In late 2016 GtreeBNT informed us that it believes marketing approval in the U.S. will allow expedited marketing in Korea, possibly without the need for a clinical trial. Under the license 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 license 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. Revenue will be recognized for future royalty payments as they are earned. 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 (‘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. We have not yet been informed of a projected starting date for Phase 2 trials. Under the license agreement, the Company received $400,000 in 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 license 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-259 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. Revenue will be recognized for future royalty payments as they are earned. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2018 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity Note Disclosure [Text Block] | 8. Stockholders’ Equity 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. 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 “New Warrants”). We received gross proceeds of approximately $1,029,000 from the warrant reprice transaction. The Reprice Agreement was accounted for as an inducement and consequently, we recognized a non-operating expense of $582,904 equal to the fair value of the New Warrants calculated using a customized Monte Carlo simulation. The repricing of the Warrant Shares did not result in any incremental fair value and consequently did not result in any additional expense. In conjunction with the Reprice Agreement we incurred $101,110 of expenses comprised of: (i) 102,947 warrants valued at $15,545 issued to an outside third party as a fee for the transaction and (ii) $85,565 of expenses for professional fees. Such expenses were netted against the proceeds from the transaction. The warrants contained the same terms and conditions as the New Warrants and were valued using the Black-Scholes model. On March 29, 2018, the March 2013 Convertible Notes matured, and the holders elected to convert the note balances and accrued interest into common stock. As a result, we issued 4,700,520 shares of common stock. On July 5, 2018, the July 2013 Convertible Notes matured, and the holders elected to convert the note balances and accrued interest into common stock. As a result, we issued 2,089,120 shares of common stock. On September 13, 2018, the September 2013 Convertible Notes matured, and the holders elected to convert the note balances and accrued interest into common stock. As a result, we issued 6,706,076 shares of common stock. |
COMMITMENTS
COMMITMENTS | 9 Months Ended |
Sep. 30, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies Disclosure [Text Block] | 9. Commitments 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 per month. |
ORGANIZATION, BUSINESS OVERVI_2
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
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 U.S. generally accepted accounting principles (“U.S. GAAP”) and with the rules and regulations of the SEC, for interim financial statements. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP. The accounting policies underlying our unaudited interim financial statements are consistent with those underlying our audited annual financial statements, but do not include all disclosures including notes required by U.S. GAAP for complete financial statements. These unaudited interim financial statements should be read in conjunction with the audited annual financial statements as of and for the year ended December 31, 2017, and related notes thereto, included in our Annual Report on Form 10-K for the year ended December 31, 2017 (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 except as described below. The accompanying December 31, 2017 financial information was derived from our audited financial statements included in the Annual Report. Operating results for the three and nine month periods ended September 30, 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2018 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”). |
Revenue Recognition, Policy [Policy Text Block] | Revenue Recognition. Effective January 1, 2018, the Company adopted the new revenue recognition guidance contained in ASC 606, using the modified retrospective method. The adoption of ASC 606 did not result in any material change to how the Company recognizes revenue or to the accounting for costs to obtain and fulfill contracts with customers. As a result, the adoption did not result in a cumulative effect change on the date of adoption. See discussion below for the Company’s revenue recognition policies subsequent to the adoption of the new revenue recognition guidance. Subsequent to the adoption of Accounting Standards Codification Revenue from Contracts with Customers (“ASC 606”) on January 1, 2018 The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers, (ii) identification of distinct performance obligations in the contract, (iii) determination of contract transaction price, (iv) allocation of contract transaction price to the performance obligations and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation. The Company recognizes revenues upon the satisfaction of its performance obligation (upon transfer of control of promised goods or services to our customers) in an amount that reflects the consideration to which it expects to be entitled to in exchange for those goods or services. 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. Revenue associated with licensing agreements consists of non-refundable upfront license fees and milestone payments. Non-refundable upfront license fees received under license agreements, whereby continued performance or future obligations are considered inconsequential to the relevant license technology, are recognized as revenue upon delivery of the technology. 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. If the Company cannot reasonably estimate the level of effort required to complete our performance obligation under an arrangement, the performance obligation is provided on a best-efforts basis and we can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory, then the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over the period we expect to complete our performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date. If the Company cannot reasonably estimate when our performance obligation either ceases or becomes inconsequential and perfunctory, revenue is deferred until we can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. At the inception of each arrangement that includes development milestone payments, the Company evaluates the probability of reaching the milestones and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur in the future, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore revenue recognized is constrained as management is unable to assert that a reversal of revenue would not be possible. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Amounts received prior to satisfying the above revenue recognition criteria are recorded as unearned revenue in our accompanying condensed 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. 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: September 30, 2018 December 31, 2017 Unearned revenue $ 2,274,038 $ 2,124,515 The contract liabilities amount disclosed above as of September 30, 2018, is 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 as of January 1, 2018, during the three and nine months ended September 30, 2018, totaled $2,174 and $41,056, respectively. Revenue is expected to be recognized in the future from contract liabilities as the related performance obligations are satisfied. For details about the Company’s revenue recognition policy prior to the adoption of ASC 606, refer to the Company’s Annual Report. |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Financial Instruments. Effective January 1, 2018, the Company adopted new accounting guidance for financial instruments that contain down round features. As of December 31, 2017, the Company’s existing convertible notes contained embedded conversion features that under previous accounting guidance had been separately accounted for as derivative liabilities due to the presence of down round protection which (which precluded those embedded features from being classified as equity). Upon the adoption of the new guidance, the derivative liabilities were transferred to equity (additional paid in-capital and accumulated deficit) since the presence of those down round features no longer preclude equity treatment. Accordingly, no previously issued financial statements were adjusted as this guidance was applied prospectively. See Note 6 for further discussion of the terms of the convertible notes and embedded conversion features. |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates. The preparation of financial statements in conformity with U.S. 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 fair value measurements in connection with derivative liabilities, 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. |
Derivatives, Reporting of Derivative Activity [Policy Text Block] | Derivative Financial Instruments. Derivative financial instruments consist of financial instruments or other contracts that contain a notional amount and one or more underlying variables (e.g., interest rate, security price or other variable), which require no initial net investment and permit net settlement. Derivative financial instruments may be free-standing or embedded in other financial instruments. Further, derivative financial instruments are initially, and subsequently, measured at fair value and recorded as liabilities or, in rare instances, assets. The Company does not use derivative financial instruments to hedge exposures to cash-flow, market or foreign-currency risks. However, the Company has issued financial instruments including warrants that are either (i) not afforded equity classification, (ii) embody risks not clearly and closely related to host contracts, or (iii) may be net-cash settled by the counterparty. In certain instances, these instruments are required to be carried as derivative liabilities, at fair value, in the Company’s financial statements. In other instances, these instruments are classified as equity instruments in the Company’s financial statements. The Company estimates the fair value of its derivative financial instrument using the Black-Scholes option pricing model because it embodies all of the requisite assumptions (including trading volatility, estimated terms and risk free rates) necessary to fairly value these instruments. Estimating the fair value of derivative financial instruments requires the development of significant and subjective estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. In addition, option-based techniques are highly volatile and sensitive to changes in the trading market price of the Company’s common stock, which has a high-historical volatility. Since derivative financial instruments are initially and subsequently carried at fair value, the Company’s operating results reflect the volatility in these estimate and assumption changes in each reporting period. Upon the adoption of new accounting guidance on January 1, 2018, the embedded conversion features in the Company’s convertible notes are no longer accounted for as derivative liabilities. |
Consolidation, Variable Interest Entity, Policy [Policy Text Block] | Variable Interest Entities. The Company accounts for the Joint Venture (see Note 7) as a “variable interest entity” and that its equity stake in the Joint Venture is a variable interest, since the total equity investment at risk is not sufficient to permit the Joint Venture to finance its activities without additional subordinated financial support. Further, because of GtreeBNT Co. Ltd.’s, a Korean pharmaceutical company (“GtreeBNT”) and a shareholder of the Company, majority equity stake in the Joint Venture, voting control, control of the board of directors, and substantive management rights, and given that the Company does not have the power to direct the Joint Venture’s activities that most significantly impact its economic performance, the Company determined that it is not the primary beneficiary of the Joint Venture and therefore is not required to consolidate the Joint Venture. The Company reports its equity stake in the Joint Venture using the equity method of accounting because, while it does not control the Joint Venture, the Company can exert significant influence over the Joint Venture’s activities by virtue of its large equity stake and its board representation. Because the Company is not obligated to fund the Joint Venture, and has not provided any financial support to the Joint Venture, the carrying value of its investment in the Joint Venture is zero. 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 September 30, 2018, because it has not provided any financial support and is not obligated to fund the Joint Venture, the Company has no financial exposure as a result of its variable interest in the Joint Venture. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development . Research and development (“R&D”) costs are expensed as incurred and include all of the wholly-allocable costs associated with our various clinical programs passed through to us by our outsourced vendors. Those costs include: manufacturing Tβ4; formulation of Tβ4 into the various product candidates; stability for both Tβ4 and the various formulations; pre-clinical toxicology; safety and pharmacokinetic studies; clinical trial management; medical oversight; laboratory evaluations; statistical data analysis; regulatory compliance; quality assurance; and other related activities. R&D includes cash and non-cash compensation, payroll taxes, travel and other miscellaneous costs of our internal R&D personnel, part-time hourly employees and external consultants dedicated to R&D efforts. R&D also includes a pro-ration of our common infrastructure costs for office space and communications. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Adopted Accounting Pronouncements. In May 2014, the FASB issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers , which provides guidance for revenue recognition for contracts, superseding the previous revenue recognition requirements, along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identify the contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. In March 2016, the FASB issued an accounting standard update to clarify the implementation guidance on principal versus agent considerations. In April 2016, the FASB issued an accounting standard update to clarify the identification of performance obligations and the licensing implementation guidance, while retaining the related principles for those areas. In May 2016, the FASB issued an accounting standard update to clarify guidance in certain areas and add some practical expedients to the guidance. The amendments in these 2016 updates do not change the core principle of the previously issued guidance in May 2014. Effective January 1, 2018, the Company adopted ASU 2014-09 (Topic 606) using the modified retrospective method through a cumulative adjustment to equity, which resulted in an immaterial difference and no adjustment to our opening balance of accumulated deficit as of January 1, 2018. In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. Part I of this Update addresses the complexity of accounting for certain financial instruments with down round features. Down round features are features of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings. When determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. Part II of this Update addresses the difficulty of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB Accounting Standards Codification®. For public business entities, the amendments in Part I of this Update are effective for years, beginning after December 15, 2018. Effective January 1, 2018, the Company adopted ASU 2017-11, Distinguishing Liabilities from Equity (Topic 480) . As a result, the December 31, 2017 qualifying liabilities of approximately $1.3 million were reclassified as equity as of January 1, 2018. Accordingly, no previously issued financial statements were adjusted as this guidance was applied prospectively. In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) Scope of Modification Accounting . ASU 2017-09 provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award. This ASU does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if there is a change to the value, vesting conditions, or award classification and would not be required if the changes are considered non-substantive. The Company adopted ASU 2017-09 in the first quarter of 2018 and the adoption of this ASU did not have a material effect on the financial statements. Recent Accounting Pronouncements. In February 2016, the FASB issued ASU 2016-02, Leases , which supersedes ASC Topic 840, Leases , and creates a new topic, ASC Topic 842, Leases . ASU 2016-02 requires lessees to recognize a lease liability and a lease asset for all leases, including operating leases, with a term greater than 12 months on its balance sheet. ASU 2016-02 also expands the required quantitative and qualitative disclosures surrounding leases. ASU 2016-02 is effective for the Company beginning January 1, 2019. Early adoption is permitted. The Company has determined that the adoption of ASU 2016-02 will currently not have a significant impact on its financial statements. In June 2018, the FASB issued ASU 2018-07: Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees, and as a result, the accounting for share-based payments to non-employees will be substantially aligned. ASU 2018-07 is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year, early adoption is permitted but no earlier than an entity’s adoption date of Topic 606. The Company is currently evaluating the impact this new guidance will have on its financial statements and related disclosures. In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification, amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders' equity for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders' equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. This final rule is effective on November 5, 2018. We are evaluating the impact of this guidance on our unaudited condensed consolidated financial statements. |
ORGANIZATION, BUSINESS OVERVI_3
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Contract with Customer, Asset and Liability [Table Text Block] | We have the following amounts recorded for contract liabilities: September 30, 2018 December 31, 2017 Unearned revenue $ 2,274,038 $ 2,124,515 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | On June 13, 2018, the stockholders of the Company approved the 2018 Equity Incentive Plan. We issued 1,605,000 stock options to employees, consultants and directors during the nine months ended September 30, 2018. We used the following forward-looking range of assumptions to value these stock options as well as 1,000,000 stock options granted to employees, consultants and directors during the nine months ended September 30, 2017: 2018 2017 Dividend yield 0.0 % 0.0 % Risk-free rate of return 2.76 % 1.73 % Expected life in years 5.88 5.88 Volatility 89 % 90 % Forfeiture rate 2.6 % 2.6 % |
Share-based Compensation, Stock Options, Activity [Table Text Block] | A summary of the Company’s stock options for the nine months ended September 30, 2018 is as follows: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life Aggregate Intrinsic Value Options Outstanding, December 31, 2017 8,058,788 $ 0.29 Granted 1,605,000 $ 0.21 Exercised - $ - Forfeited (326,400 ) $ 0.22 Options Outstanding, September 30, 2018 9,337,388 $ 0.28 4.4 years $ 56,051 Vested and unvested but expected to vest, September 30, 2018 9,197,771 $ 0.28 4.4 years $ 56,051 Exercisable at September 30, 2018 7,309,888 $ 0.28 3.2 years $ 56,051 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement Derivative Liabilities Disclosure [Table Text Block] | For the nine months ended September 30, 2018, the following table reconciles the beginning and ending balances for financial instruments that are recognized at fair value in these financial statements. Balance at Balance at December 31, New Change in September 30, 2017 Issuances Fair Values Reclassifications 2018 Level 3 - Derivative liabilities from: Conversion features March 2013 $ 412,500 $ - $ - $ (412,500 ) $ - July 2013 183,334 - - (183,334 ) - September 2013 588,500 - - (588,500 ) - January 2014 100,835 - - (100,835 ) - Derivative instruments $ 1,285,169 $ - $ - $ (1,285,169 ) $ - |
CONVERTIBLE NOTES (Tables)
CONVERTIBLE NOTES (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
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 directors of the Company, 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 four directors of the Company, Mr. Finkelstein, Dr. Goldstein, Mr. McNay and L. Thompson Bowles, a former 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 four directors of the Company. The principal amounts of the affiliate and directors 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 three directors of the Company. The principal amounts of their respective Notes are as set forth below: Investor Note Principal Joseph C. McNay $ 25,000 Allan L. Goldstein $ 10,000 L. Thompson Bowles $ 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 three months ended For the nine months ended September 30, 2018 September 30, 2017 September 30, 2018 September 30, 2017 2012 Notes $ - $ 3,782 $ - $ 11,217 March 2013 Notes - 14,178 14,192 42,072 July 2013 Notes 585 4,621 9,677 13,714 September 2013 Notes 15,172 17,530 49,661 52,020 January 2014 Notes 2,923 3,465 9,742 10,283 Total $ 18,680 $ 43,576 $ 83,272 $ 129,306 |
Schedule of Derivative Liabilities at Fair Value [Table Text Block] | The fair value of the derivative liability is as follows: September 30, 2018 December 31, 2017 March 2013 Notes $ - $ 412,500 July 2013 Notes - 183,334 September 2013 Notes - 588,500 January 2014 Notes - 100,835 Total fair value of derivative liability $ - $ 1,285,169 |
Schedule Of Change In Fair Value Of The Derivative Liability [Table Text Block] | The change in fair value of derivative liability is as follows: For the three months ended For the nine months ended September 30, 2018 September 30, 2017 September 30, 2018 September 30, 2017 March 2013 Notes $ - $ 225,000 $ - $ 37,500 July 2013 Notes - 100,000 - 16,666 September 2013 Notes - 321,000 - 53,500 January 2014 Notes - 45,833 - - Warrant liability - 231,063 - (48,937 ) Rights liability - (50,000 ) - (190,000 ) Total change in fair value of derivative $ - $ 872,896 $ - $ (131,271 ) |
ORGANIZATION, BUSINESS OVERVI_4
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Details) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Unearned revenue | $ 2,274,038 | $ 2,124,515 |
ORGANIZATION, BUSINESS OVERVI_5
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Details Textual) - USD ($) | Mar. 02, 2018 | Sep. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 |
ORGANIZATION AND BUSINESS [Line Items] | ||||||
Cash and Cash Equivalents, at Carrying Value | $ 396,041 | $ 396,041 | $ 191,232 | $ 181,708 | $ 769,495 | |
Stock Issued During Period, Shares, New Issues | 5,147,059 | |||||
Percentage Of Joint Venture Operating Loss Used In Share Calculation | (38.50%) | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 3,860,294 | |||||
Proceeds from Warrant Exercises | $ 1,029,000 | $ 1,029,412 | $ 0 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.2301 | |||||
Stockholders' Equity Attributable to Parent | (2,003,955) | (2,003,955) | (4,116,292) | |||
Contract with Customer, Liability, Revenue Recognized | 2,174 | 41,056 | ||||
Retained Earnings (Accumulated Deficit) | $ (105,617,948) | $ (105,617,948) | (104,559,226) | |||
Maximum [Member] | ||||||
ORGANIZATION AND BUSINESS [Line Items] | ||||||
Capitalized Contract Cost, Amortization Period | 30 years | 30 years | ||||
Minimum [Member] | ||||||
ORGANIZATION AND BUSINESS [Line Items] | ||||||
Capitalized Contract Cost, Amortization Period | 23 years | 23 years | ||||
Accounting Standards Update 2017-11 [Member] | ||||||
ORGANIZATION AND BUSINESS [Line Items] | ||||||
Stockholders' Equity Attributable to Parent | $ 1,300,000 | |||||
New Warrants [Member] | ||||||
ORGANIZATION AND BUSINESS [Line Items] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | 0.2301 | |||||
Revised Sabby Warrants [Member] | ||||||
ORGANIZATION AND BUSINESS [Line Items] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.20 |
NET LOSS PER COMMON SHARE (Deta
NET LOSS PER COMMON SHARE (Details Textual) - shares | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 14,474,649 | 18,576,046 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Dividend yield | 0.00% | 0.00% |
Risk-free rate of return | 2.76% | 1.73% |
Expected life in years | 5 years 10 months 17 days | 5 years 10 months 17 days |
Volatility | 89.00% | 90.00% |
Forfeiture rate | 2.60% | 2.60% |
STOCK-BASED COMPENSATION (Det_2
STOCK-BASED COMPENSATION (Details 1) | 9 Months Ended |
Sep. 30, 2018USD ($)$ / sharesshares | |
Number of Shares, Beginning | shares | 8,058,788 |
Number of Shares Granted | shares | 1,605,000 |
Number of Shares Exercised | shares | 0 |
Number of Shares Forfeited | shares | (326,400) |
Number of Shares, Ending | shares | 9,337,388 |
Vested and unvested but expected to vest, September 30, 2018 | shares | 9,197,771 |
Number of Shares Exercisable | shares | 7,309,888 |
Weighted-average exercise price, Beginning | $ / shares | $ 0.29 |
Weighted Average Exercise Price Granted | $ / shares | 0.21 |
Weighted Average Exercise Price Exercised | $ / shares | 0 |
Weighted Average Exercise Price Forfeited | $ / shares | 0.22 |
Weighted-average exercise price, Ending | $ / shares | 0.28 |
Weightd Average Exercise Price Vested and unvested but expected to vest, September 30, 2018 | $ / shares | 0.28 |
Weighted Average Exercise Price Exercisable at September 30, 2018 | $ / shares | $ 0.28 |
Weighted Average Remaining Contractual Life Options Outstanding, September 30, 2018 | 4 years 4 months 24 days |
Weighted Average Remaining Contractual Life Vested and unvested but expected to vest, September 30, 2018 | 4 years 4 months 24 days |
Weighted Average Remaining Contractual Life Exercisable at September 30, 2018 | 3 years 2 months 12 days |
Aggregate Intrinsic Value Options Outstanding, September 30, 2018 | $ | $ 56,051 |
Aggregate Intrinsic Value Vested and unvested but expected to vest, September 30, 2018 | $ | 56,051 |
Aggregate Intrinsic Value Exercisable at September 30, 2018 | $ | $ 56,051 |
STOCK-BASED COMPENSATION (Det_3
STOCK-BASED COMPENSATION (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated Share-based Compensation Expense | $ 100,053 | $ 96,907 | $ 220,398 | $ 211,199 |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 328,675 | $ 328,675 | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 3 months 7 days | |||
Employees Consultants And Directors [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, Gross | 1,605,000 | 1,000,000 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Derivative liabilities, Beginning Balance | $ 100,835 |
Derivative liabilities, Ending Balance | 0 |
Conversion Features [Member] | Fair Value, Inputs, Level 3 [Member] | March 2013 [Member] | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Derivative liabilities, Beginning Balance | 412,500 |
Derivative liabilities, New Issuances | 0 |
Derivative liabilities, Change in Fair Values | 0 |
Derivative Liabilities, Reclassifications | (412,500) |
Derivative liabilities, Ending Balance | 0 |
Conversion Features [Member] | Fair Value, Inputs, Level 3 [Member] | July 2013 [Member] | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Derivative liabilities, Beginning Balance | 183,334 |
Derivative liabilities, New Issuances | 0 |
Derivative liabilities, Change in Fair Values | 0 |
Derivative Liabilities, Reclassifications | (183,334) |
Derivative liabilities, Ending Balance | 0 |
Conversion Features [Member] | Fair Value, Inputs, Level 3 [Member] | September 2013 [Member] | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Derivative liabilities, Beginning Balance | 588,500 |
Derivative liabilities, New Issuances | 0 |
Derivative liabilities, Change in Fair Values | 0 |
Derivative Liabilities, Reclassifications | (588,500) |
Derivative liabilities, Ending Balance | 0 |
Conversion Features [Member] | Fair Value, Inputs, Level 3 [Member] | January 2014 [Member] | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Derivative liabilities, Beginning Balance | 100,835 |
Derivative liabilities, New Issuances | 0 |
Derivative liabilities, Change in Fair Values | 0 |
Derivative Liabilities, Reclassifications | (100,835) |
Derivative liabilities, Ending Balance | 0 |
Derivative Instruments [Member] | Fair Value, Inputs, Level 3 [Member] | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Derivative liabilities, Beginning Balance | 1,285,169 |
Derivative liabilities, New Issuances | 0 |
Derivative liabilities, Change in Fair Values | 0 |
Derivative Liabilities, Reclassifications | (1,285,169) |
Derivative liabilities, Ending Balance | $ 0 |
FAIR VALUE MEASUREMENTS (Deta_2
FAIR VALUE MEASUREMENTS (Details Textual) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash and Cash Equivalents, Fair Value Disclosure | $ 396,041 | $ 181,708 |
CONVERTIBLE NOTES (Details)
CONVERTIBLE NOTES (Details) | Sep. 30, 2018USD ($)shares |
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 |
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 |
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 |
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 |
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 |
R. Don Elsey [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 | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Debt Instrument [Line Items] | ||||
Total interest expense | $ 18,680 | $ 43,576 | $ 83,272 | $ 129,306 |
2012 Notes [Member] | ||||
Debt Instrument [Line Items] | ||||
Total interest expense | 0 | 3,782 | 0 | 11,217 |
March 2013 Notes [Member] | ||||
Debt Instrument [Line Items] | ||||
Total interest expense | 0 | 14,178 | 14,192 | 42,072 |
July 2013 Notes [Member] | ||||
Debt Instrument [Line Items] | ||||
Total interest expense | 585 | 4,621 | 9,677 | 13,714 |
September 2013 Notes [Member] | ||||
Debt Instrument [Line Items] | ||||
Total interest expense | 15,172 | 17,530 | 49,661 | 52,020 |
January 2014 Notes [Member] | ||||
Debt Instrument [Line Items] | ||||
Total interest expense | $ 2,923 | $ 3,465 | $ 9,742 | $ 10,283 |
CONVERTIBLE NOTES (Details 2)
CONVERTIBLE NOTES (Details 2) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Debt Instrument [Line Items] | ||
Total Fair value of derivative liability | $ 0 | $ 1,285,169 |
March 2013 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Total Fair value of derivative liability | 0 | 412,500 |
July 2013 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Total Fair value of derivative liability | 0 | 183,334 |
September 2013 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Total Fair value of derivative liability | 0 | 588,500 |
January 2014 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Total Fair value of derivative liability | $ 0 | $ 100,835 |
CONVERTIBLE NOTES (Details 3)
CONVERTIBLE NOTES (Details 3) - USD ($) | Jan. 02, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 |
Debt Instrument [Line Items] | |||||
Change in fair value of derivative | $ (1,285,169) | $ 0 | $ 872,896 | $ 0 | $ (131,271) |
Warrant liability [Member] | |||||
Debt Instrument [Line Items] | |||||
Change in fair value of derivative | 0 | 231,063 | 0 | (48,937) | |
Rights liability [Member] | |||||
Debt Instrument [Line Items] | |||||
Change in fair value of derivative | 0 | (50,000) | 0 | (190,000) | |
March 2013 Notes [Member] | |||||
Debt Instrument [Line Items] | |||||
Change in fair value of derivative | 0 | 225,000 | 0 | 37,500 | |
July 2013 Notes [Member] | |||||
Debt Instrument [Line Items] | |||||
Change in fair value of derivative | 0 | 100,000 | 0 | 16,666 | |
September 2013 Notes [Member] | |||||
Debt Instrument [Line Items] | |||||
Change in fair value of derivative | 0 | 321,000 | 0 | 53,500 | |
January 2014 Notes [Member] | |||||
Debt Instrument [Line Items] | |||||
Change in fair value of derivative | $ 0 | $ 45,833 | $ 0 | $ 0 |
CONVERTIBLE NOTES (Details Text
CONVERTIBLE NOTES (Details Textual) - USD ($) | Sep. 13, 2018 | Jul. 05, 2018 | Jan. 02, 2018 | Jan. 07, 2014 | Sep. 11, 2013 | Jul. 05, 2013 | Mar. 29, 2013 | Oct. 19, 2012 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2012 | Mar. 02, 2018 |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.2301 | |||||||||||||
Debt Conversion, Converted Instrument, Shares Issued | 6,706,076 | 2,089,120 | 4,700,520 | 85,565 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 5 years 10 months 17 days | 5 years 10 months 17 days | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 89.00% | 90.00% | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 2.76% | 1.73% | ||||||||||||
Derivative, Gain (Loss) on Derivative, Net | $ 1,285,169 | $ 0 | $ (872,896) | $ 0 | $ 131,271 | |||||||||
Convertible Notes [Member] | ||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||||||||
Proceeds from Convertible Debt | $ 55,000 | $ 100,000 | $ 225,000 | $ 300,000 | ||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | 5.00% | 5.00% | 5.00% | ||||||||||
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] | March 2013 [Member] | ||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||||||||
Bifurcated Liability | 225,000 | 225,000 | ||||||||||||
Residual Debt Value | 0 | 0 | ||||||||||||
Convertible Notes [Member] | July 2013 [Member] | ||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||||||||
Bifurcated Liability | 66,667 | 66,667 | ||||||||||||
Residual Debt Value | 33,333 | 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 | 267,500 | ||||||||||||
Residual Debt Value | 53,500 | 53,500 | ||||||||||||
Convertible Notes [Member] | January 2014 [Member] | ||||||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ||||||||||||||
Bifurcated Liability | 55,000 | 55,000 | ||||||||||||
Residual Debt Value | 0 | 0 | ||||||||||||
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 | |||||||||||||
Derivative, Gain (Loss) on Derivative, Net | $ 0 | $ (231,063) | $ 0 | $ 48,937 |
LICENSE AGREEMENTS (Details Tex
LICENSE AGREEMENTS (Details Textual) - USD ($) | Apr. 06, 2016 | Sep. 30, 2018 |
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. | |
Lees Pharmaceutical HK Limited [Member] | ||
License Agreement [Line Items] | ||
Proceeds from License Fees Received | $ 400,000 | |
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 ($) | Sep. 13, 2018 | Jul. 05, 2018 | Mar. 02, 2018 | Mar. 29, 2013 | Sep. 30, 2018 | Sep. 30, 2017 | 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 | 3,860,294 | ||||||
Stock Issued During Period, Shares, New Issues | 5,147,059 | ||||||
Other Nonoperating Expense | $ 582,904 | $ 0 | |||||
Fair Value Adjustment of Warrants | 15,545 | 0 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.2301 | ||||||
Proceeds from Warrant Exercises | $ 1,029,000 | $ 1,029,412 | $ 0 | ||||
Reduction in Exercise Of Warrants | $ 0.20 | ||||||
Debt Conversion, Converted Instrument, Shares Issued | 6,706,076 | 2,089,120 | 4,700,520 | 85,565 | |||
SabbyWarrants [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 | ||||||
Stock Issued During Period, Shares, New Issues | 5,147,059 | ||||||
Warrant [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 | 102,947 | ||||||
Reprice Agreement expenses | $ 101,110 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.15 |
COMMITMENTS (Details Textual)
COMMITMENTS (Details Textual) | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Operating Leased Assets [Line Items] | |
Operating Leases, Rent Expense, Net | $ 4,000 |