Document_And_Entity_Informatio
| Document And Entity Information | 9 Months Ended | |
| Sep. 30, 2013 | Nov. 14, 2013 | |
| Document Information [Line Items] | ' | ' |
| Entity Registrant Name | 'REGENERX BIOPHARMACEUTICALS INC | ' |
| Entity Central Index Key | '0000707511 | ' |
| Current Fiscal Year End Date | '--12-31 | ' |
| Entity Filer Category | 'Smaller Reporting Company | ' |
| Trading Symbol | 'RGRX | ' |
| Entity Common Stock, Shares Outstanding | ' | 81,733,247 |
| Document Type | '10-Q | ' |
| Amendment Flag | 'false | ' |
| Document Period End Date | 30-Sep-13 | ' |
| Document Fiscal Period Focus | 'Q3 | ' |
| Document Fiscal Year Focus | '2013 | ' |
Balance_Sheets
| Balance Sheets (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
| ASSETS | ' | ' |
| Cash and cash equivalents | $176,653 | $141,905 |
| Grant receivable | 0 | 177,350 |
| Prepaid expenses and other current assets | 14,580 | 22,242 |
| Total current assets | 191,233 | 341,497 |
| Property and equipment, net of accumulated depreciation of $120,668 and $116,728 | 5,432 | 9,372 |
| Other assets | 5,752 | 5,752 |
| Total assets | 202,417 | 356,621 |
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ' | ' |
| Accounts payable | 542,196 | 637,102 |
| Accrued expenses | 52,863 | 67,210 |
| Total current liabilities | 595,059 | 704,312 |
| Long-Term liabilities | ' | ' |
| Unearned revenue | 400,000 | 400,000 |
| Convertible promisory note, net of discount $14,269 and $24,402 | 285,731 | 275,598 |
| Convertible promisory notes, net of derivative liability | 115,211 | 0 |
| Fair value of derivative liability | 430,667 | 0 |
| Total liabilities | 1,826,668 | 1,379,910 |
| Commitments | 0 | 0 |
| 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, 81,733,247 issued and outstanding | 81,733 | 81,733 |
| Additional paid-in capital | 95,335,780 | 95,274,348 |
| Accumulated deficit | -97,041,764 | -96,379,370 |
| Total stockholders' deficit | -1,624,251 | -1,023,289 |
| Total liabilities and stockholders' deficit | $202,417 | $356,621 |
Balance_Sheets_Parenthetical
| Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
| Property and equipment, accumulated depreciation (in dollars) | $120,668 | $116,728 |
| Convertible promisory note, discount (in dollars) | $14,269 | $24,402 |
| Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
| Preferred stock, shares authorized | 1,000,000 | 1,000,000 |
| Preferred stock, shares issued | 0 | 0 |
| Common stock, par value (in dollars per share) | $0.00 | $0.00 |
| Common stock, shares authorized | 200,000,000 | 200,000,000 |
| Common stock, shares issued | 81,733,247 | 81,733,247 |
| Common stock, shares, outstanding | 81,733,247 | 81,733,247 |
Statements_of_Operations
| Statements of Operations (USD $) | 3 Months Ended | 9 Months Ended | ||
| Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
| Sponsored research revenue | $0 | $295,360 | $29,484 | $1,061,894 |
| Operating expenses | ' | ' | ' | ' |
| Research and development | 10,807 | 228,554 | 166,194 | 973,702 |
| General and administrative | 150,827 | 161,302 | 596,779 | 837,345 |
| Total operating expenses | 161,634 | 389,856 | 762,973 | 1,811,047 |
| Loss from operations | -161,634 | -94,496 | -733,489 | -749,153 |
| Interest and other income | 1 | 3 | 11 | 15 |
| Interest expense | -29,171 | 0 | -57,416 | 0 |
| Change in fair value of derivative | 91,000 | 0 | 128,500 | 0 |
| Net loss | ($99,804) | ($94,493) | ($662,394) | ($749,138) |
| Basic and diluted net loss per common share (in dollars per share) | $0 | $0 | ($0.01) | ($0.01) |
| Weighted average number of common shares outstanding (in shares) | 81,733,247 | 81,714,995 | 81,733,247 | 81,592,178 |
Statements_of_Cash_Flows
| Statements of Cash Flows (USD $) | 9 Months Ended | |
| Sep. 30, 2013 | Sep. 30, 2012 | |
| Operating activities: | ' | ' |
| Net loss | ($662,394) | ($749,138) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
| Depreciation and amortization | 3,940 | 5,787 |
| Non-cash share-based compensation | 61,432 | 151,543 |
| Non-cash interest expense | 38,511 | 0 |
| Change in fair value of derivative | -128,500 | 0 |
| Changes in operating assets and liabilities: | ' | ' |
| Grant receivable | 177,350 | 173,953 |
| Prepaid expenses and other current assets | 7,662 | 10,842 |
| Accounts payable | -94,906 | 110,609 |
| Accrued expenses | -14,347 | -187,645 |
| Refundable license fee | 0 | 400,000 |
| Net cash used in operating activities | -611,252 | -84,049 |
| Financing activities: | ' | ' |
| Net proceeds from issuance of debt | 646,000 | 0 |
| Net cash provided by financing activities | 646,000 | 0 |
| Net increase (decrease) in cash and cash equivalents | 34,748 | -84,049 |
| Cash and cash equivalents at beginning of period | 141,905 | 116,092 |
| Cash and cash equivalents at end of period | 176,653 | 32,043 |
| Supplemental Disclosure of Non-Cash Operating and Financing Activities | ' | ' |
| Fair value of derivative liability | 559,167 | 0 |
| Issuance of common stock for payment of accounts payable | $0 | $55,182 |
ORGANIZATION_BUSINESS_OVERVIEW
| ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION | 9 Months Ended | ||
| Sep. 30, 2013 | |||
| 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 (“Tβ4”), an amino acid peptide. | |||
| Management Plans to Address Operating Conditions. | |||
| Our business strategy calls for an “outsourced” business model designed to support development of Tβ4-related products with minimal infrastructure. Beginning in late 2011, we began implementing significant cost-saving measures to conserve capital resources and maintain a minimal level of operations, while seeking additional funding and/or to complete a strategic transaction. As a result of our financial and strategic discussions over the past two years, we have refined our forward-looking strategy to leverage our existing resources into what we believe to be a creative and potentially value-driven path through 2014 and into 2015 provided additional funding is received. There are three potential clinical opportunities that we feel may provide important results in late 2014 or early 2015 that we can support with limited financial resources and our existing infrastructure, these results could be important clinical milestones for us and open or re-open doors for potential strategic and financial partners. The clinical opportunities include two potential investigator-sponsored clinical trials and the anticipated initiation of clinical trials in China by our licensee, Lee’s Pharmaceuticals. While the plans associated with the respective clinical trials are not finalized, we believe that RegeneRx’s support of the trials would be prudent utilization of our resources and funds, if available. We believe this effort can be accomplished with capital of approximately $2.5 million, some of which could potentially come from fees associated with an out-licensing transaction if it were to occur within the next twelve months. If we are able to secure the needed capital, it would be used primarily for drug product in the case of the two U.S. studies, as well as time and consultation by RegeneRx staff, maintaining existing operations such as patent prosecution and maintenance, negotiations with prospective strategic partners, evaluation of any financial or grant opportunities that become available, and maintaining compliance with our SEC reporting obligations through mid-2015. If we are able to secure sufficient capital in the near term, we believe data from these studies would be available in early 2015, and also believe that positive results in any one of the three trials could have a significant effect on the future success of RegeneRx. Therefore, our primary focus will be to leverage our existing resources and capabilities to raise the capital to support this approach and provide as much potential value as possible to our stockholders. | |||
| It is important to note that we will need additional capital before the end of December 2013. If we are unable to raise any additional capital within this timeframe we will be forced to further reduce or cease operations, sell some or all of our assets, or possibly face bankruptcy. | |||
| As of September 30, 2013 we had cash on hand of approximately $177,000. This cash represents the remaining proceeds from the private placement on September 12, 2013 of a fourth series of convertible promissory notes totaling $321,000 with members of management, outside directors, an affiliate and two unaffiliated investors. The loan proceeds will allow us to maintain current operations and continue work on opportunities related to our ophthalmic and cardiac drug candidates, as well as certain strategic financial opportunities. The loan proceeds are expected to fund operations only into December of 2013. As noted above, we continue to evaluate potential strategic options, including the licensing of additional territorial rights to our proprietary clinical programs while maintaining limited operations. Since late 2011 the majority of our research and development staff’s efforts have been directed to work under a grant that we received from the National Institutes of Health (“NIH”). In the first quarter of 2013 we substantially completed all of the work under the grant and have exhausted the grant as a financing source. | |||
| We anticipate incurring additional losses in the future as we continue to explore the potential clinical benefits of Tβ4-based product candidates over multiple indications. We will need substantial additional funds in order to initiate any further preclinical studies or clinical trials, and to fund our operations beyond December 2013. Accordingly, we have an immediate need for financing 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. | |||
| Although we intend to continue to seek additional financing or a strategic partner, 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 the Company. 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, should substantial funding be received, we expect to continue to expend funds to complete our planned product development efforts. Additionally, we continually refine our operating strategy and evaluate alternative clinical uses of Tβ4. However, additional resources to fund this work will be needed before we will be able to achieve sustained profitability. | |||
| 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. | |||
| These factors could significantly limit the ability to continue as a going concern. As noted above, the accompanying financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence. | |||
| 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 (“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 GAAP. The accounting policies underlying our unaudited interim financial statements are consistent with those underlying our audited annual 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, 2012, and related notes thereto, included in our Annual Report on Form 10-K for the year ended December 31, 2012 (the “Annual Report”). | |||
| The accompanying December 31, 2012 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, 2013 are not necessarily indicative of the results to be expected for the year ending December 31, 2013 or any other future period. | |||
| References in this Quarterly Report on Form 10-Q to “authoritative guidance” are to the Accounting Standards Codification issued by the Financial Accounting Standards Board (“FASB”). | |||
| Subsequent events have been evaluated through the filing date of these unaudited financial statements. | |||
| Use of Estimates. | |||
| The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Critical accounting policies involved in applying our accounting policies are those that require management to make assumptions about matters that are highly uncertain at the time the accounting estimate was made and those for which different estimates reasonably could have been used for the current period. Critical accounting estimates are also those which are reasonably likely to change from period to period, and would have a material impact on the presentation of our financial condition, changes in financial condition or results of operations. Our most critical accounting estimates relate to accounting policies for fair value measurements in connection with derivative liabilities, clinical trial accruals 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 Accounting Standards Codification (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. | |||
| The Company estimates the fair values 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 fair value these instruments. Estimating fair values 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 values, the Company’s operating results reflect the volatility in these estimate and assumption changes in each reporting period. | |||
| Revenue Recognition. | |||
| We recognize revenue in accordance with the authoritative guidance for revenue recognition. We recognize revenue when all of the following criteria are met: (i) persuasive evidence of an arrangement exists, (ii) delivery (or passage of title) has occurred or services have been rendered, (iii) the seller's price to the buyer is fixed or determinable, and (iv) collectability is reasonably assured. We also comply with the authoritative guidance for revenue recognition regarding arrangements with multiple deliverables. Multiple-element arrangements are analyzed to determine whether the deliverables, which may include a license together with performance obligations such as providing a clinical supply of product and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting. 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 we determine that an arrangement should be accounted for as a single unit of accounting, we must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a relative performance or straight-line method. We recognize revenue using the relative performance method provided that the we can reasonably estimate the level of effort required to complete our performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. | |||
| If we cannot reasonably estimate the level of effort required to complete our performance obligations under an arrangement, the performance obligations are 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 we cannot reasonably estimate when our performance obligation either ceases or becomes inconsequential and perfunctory, then revenue is deferred until we can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. | |||
| We recognize consideration that is contingent upon the achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone is substantive in its entirety. A milestone is considered substantive when it meets all of the following criteria: | |||
| · | The consideration is commensurate with either the entity's performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity's performance to achieve the milestone; | ||
| · | The consideration relates solely to past performance; and | ||
| · | The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. | ||
| A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity's performance or on the occurrence of a specific outcome resulting from the entity's performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to us. | |||
| We account for non-refundable grants as “Sponsored research revenues” in the accompanying statements of operations. Revenue from non-refundable grants is recognized when the following criteria are met; persuasive evidence of an arrangement exists, services have been rendered and the underlying costs incurred, the contract price is fixed or determinable, and collectability is reasonably assured. For the nine months ended September 30, 2013 and the year ended December 31, 2012, all of our revenues were received from one NIH grant which was substantially completed during the quarter ended March 31, 2013. No future revenues are expected to be earned from this grant. | |||
| Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in our accompanying balance sheets. | |||
| 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, four persons in total, who are part-time hourly employees dedicated to R&D efforts. R&D also includes a pro-ration of our common infrastructure costs for office space and communications. | |||
| Cost of Preclinical Studies and Clinical Trials. | |||
| We accrue estimated costs for preclinical studies based on estimates of work performed. We estimate expenses incurred for clinical trials that are in process based on patient enrollment and based on clinical data collection and management. Costs based on clinical data collection and management are recognized based on estimates of unbilled goods and services received in the reporting period. We monitor the progress of the trials and their related activities and adjust the accruals accordingly. Adjustments to accruals are charged to expense in the period in which the facts that give rise to the adjustment become known. In the event of early termination of a clinical trial, we would accrue an amount based on estimates of the remaining non-cancelable obligations associated with winding down the clinical trial. | |||
| Recent Accounting Pronouncements. | |||
| For a discussion of recent accounting pronouncements please refer to Note 2, "Summary of Significant Accounting Policies—Recent Accounting Pronouncements," in the Annual Report. We did not adopt any new accounting pronouncements during the three months ended September 30, 2013 that had or are expected to have a material impact on our financial statements. | |||
NET_LOSS_PER_COMMON_SHARE
| NET LOSS PER COMMON SHARE | 9 Months Ended | ||
| Sep. 30, 2013 | |||
| Earnings Per Share [Abstract] | ' | ||
| Earnings Per Share [Text Block] | ' | ||
| 2 | Net Loss per Common Share | ||
| Net loss per common share for the three and nine month periods ended September 30, 2013 and 2012, respectively, is based on the weighted-average number of shares of common stock outstanding during the periods. Basic and diluted loss per share are identical for all periods presented as potentially dilutive securities have been excluded from the calculation of the diluted net loss per common share because the inclusion of such securities would be antidilutive. The potentially dilutive securities include 30,235,167 shares and 17,173,500 shares in 2013 and 2012, respectively, reserved for the exercise of outstanding options, warrants and convertible notes. | |||
STOCKBASED_COMPENSATION
| STOCK-BASED COMPENSATION | 9 Months Ended | ||||
| Sep. 30, 2013 | |||||
| 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 and amortize that cost over the expected term of the grant. We recognized $21,594 and $26,566 in stock-based compensation expense for the three months and $61,432 and $151,543 for the nine months ended September 30, 2013 and 2012, respectively. We expect to recognize the compensation cost related to non-vested options as of September 30, 2013 of $71,318 over the weighted average remaining recognition period of 1 year. | |||||
| We did not grant any stock options during the three and nine months ended September 30, 2013. We used the following forward-looking range of assumptions to value each stock option granted to employees, consultants and directors during the nine months ended September 30, 2012: | |||||
| 2012 | |||||
| Dividend yield | 0 | % | |||
| Risk-free rate of return | 0.7 | % | |||
| Expected life in years | 4 | ||||
| Volatility | 72 | % | |||
| Forfeiture rate | 2.6 | % | |||
INCOME_TAXES
| INCOME TAXES | 9 Months Ended | ||
| Sep. 30, 2013 | |||
| Income Tax Disclosure [Abstract] | ' | ||
| Income Tax Disclosure [Text Block] | ' | ||
| 4 | Income Taxes | ||
| As of September 30, 2013, there have been no material changes to our uncertain tax positions disclosures as provided in Note 9 of the Annual Report. We do not anticipate that total unrecognized tax benefits will significantly change prior to September 30, 2014. | |||
FAIR_VALUE_MEASUREMENTS
| FAIR VALUE MEASUREMENTS | 9 Months Ended | |||||||||||||
| Sep. 30, 2013 | ||||||||||||||
| 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. | ||||||||||||||
| At September 30, 2013 our only qualifying assets that required measurement under the foregoing fair value hierarchy were money market funds included in Cash and Cash Equivalents valued at $177,000, using Level 1 inputs. Our September 30, 2013 balance sheet reflects qualifying liabilities resulting from the price protection provision in the convertible promissory notes issued in March, July and September of 2013. We evaluated the derivative liability embedded in the series of convertible notes to determine if an adjustment to the carrying value of the liability was required at March 31, June 30 and September 30, 2013 using the following assumptions. | ||||||||||||||
| March | July | September | ||||||||||||
| Dividend yield | 0 | % | 0 | % | 0 | % | ||||||||
| Risk-free rate of return | 1.39 | % | 1.39 | % | 1.39 | % | ||||||||
| Expected life in years | 4.5 | 4.75 | 4.95 | |||||||||||
| Volatility | 62.4 | % | 66.5 | % | 66.1 | % | ||||||||
| Given the conditions surrounding the trading of the Company’s equity securities, the Company values its derivative instruments related to embedded conversion features from the issuance of convertible debentures in accordance with the Level 3 guidelines. For the three month period ended September 30, 2013, 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 | |||||||||||||
| June 30, | New | Change in | September 30, | |||||||||||
| 2013 | Issuances | Fair Values | 2013 | |||||||||||
| Level 3 - | ||||||||||||||
| Derivative liabilities from: | ||||||||||||||
| Conversion features | ||||||||||||||
| Mar-13 | $ | 187,500 | $ | - | $ | -37,500 | $ | 150,000 | ||||||
| Jul-13 | - | 66,667 | - | 66,667 | ||||||||||
| Sep-13 | - | 267,500 | -53,500 | 214,000 | ||||||||||
| Derivative instruments | $ | 187,500 | $ | 334,167 | $ | -91,000 | $ | 430,667 | ||||||
CONVERTIBLE_NOTES
| CONVERTIBLE NOTES | 9 Months Ended | |||||||
| Sep. 30, 2013 | ||||||||
| Debt Disclosure [Abstract] | ' | |||||||
| Debt Disclosure [Text Block] | ' | |||||||
| 6 | Convertible Notes | |||||||
| 2012 Convertible Note | ||||||||
| 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 bear interest at a rate of five percent (5%) per annum, mature twenty-four (24) months after their date of issuance and are 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 are initially convertible into up to 2,000,000 shares of our common stock if held to maturity, 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. Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the federal bankruptcy act or the continuation of such petition without dismissal for a period of ninety (90) days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the 2012 Notes will accelerate and automatically become immediately due and payable. | ||||||||
| 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 was $27,097, calculated using the Black-Scholes-Merton valuation model value of $0.07 with an expected and contractual life of 5 years, an assumed volatility of 74.36%, and a risk-free interest rate of 0.77%. The warrants were recorded as additional paid-in-capital and a discount on the 2012 Notes of $27,097. Non-cash interest expense related to the debt discount during the three and nine months ended September 30, 2013 totaled $3,413 and $10,133, respectively. | ||||||||
| 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. is a direct wholly-owned subsidiary of Aptafin S.p.A., or Aptafin. Aptafin is owned directly by Paolo Cavazza and members of his family, who directly and indirectly own 38% of Sigma-Tau, 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. | ||||||||
| 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 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 March 2013 Notes) at any time prior to repayment, at the election of the investor. In the aggregate, the March 2013 Notes are 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. Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the Federal bankruptcy act or the continuation of such petition without dismissal for a period of ninety (90) days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the March 2013 Notes will accelerate and automatically become immediately due and payable. | ||||||||
| The investors in the offering included two directors of the Company, Allan L. Goldstein, the Company’s chief scientific officer, 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 Company has evaluated the terms of the March 2013 Notes which contain a down round provision under which the conversion price could be decreased as a result of future equity offerings, as defined in the 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. The bifurcated liability of $225,000 was recorded on the date of issuance which resulted in a residual debt value of $0. The Company determined that an adjustment to reduce the derivative liability by $75,000 was required at September 30, 2013. Non-cash interest expense recorded during the three and nine months ended September 30, 2013 totaled $11,342 and $22,562, respectively. The discount related to the embedded feature will be accreted back to debt through the maturity of the notes. | ||||||||
| 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. Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the Federal bankruptcy act or the continuation of such petition without dismissal for a period of ninety (90) days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the July 2013 Notes will accelerate and automatically become immediately due and payable. | ||||||||
| The investors in the offering included four directors of the Company, J.J. Finkelstein, the Company’s chief executive officer, Allan L. Goldstein, the Company’s chief scientific officer, Joseph C. McNay and L. Thompson Bowles, both outside directors. 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 Company has evaluated the terms of the July 2013 Notes which contain a down round provision under which the conversion price could be decreased as a result of future equity offerings, as defined in the 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. The bifurcated liability of $66,667 was recorded on the date of issuance which resulted in a residual debt value of $33,333. The Company determined that no adjustment was needed to adjust the liability at September 30, 2013. The accretion of the derivative liability recorded as interest expense during the quarter ended September 30, 2013 totaled $3,178. The discount related to the embedded feature will be accreted back to debt through the maturity of the notes. | ||||||||
| 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. Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the federal bankruptcy act or the continuation of such petition without dismissal for a period of ninety (90) days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the September 2013 Notes will accelerate and automatically become immediately due and payable. | ||||||||
| Investors. The investors in the offering included an affiliate, four directors of the Company, and two unaffiliated accredited investors. 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 Company has evaluated the terms of the September 2013 Notes which contain a down round provision under which the conversion price could be decreased as a result of future equity offerings, as defined in the 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. The bifurcated liability of $267,500 was recorded on the date of issuance which resulted in a residual debt value of $53,500. The Company determined that an adjustment to reduce the liability by $53,500 was required at September 30, 2013. The accretion of the derivative liability recorded as interest expense during the quarter ended September 30, 2013 totaled $2,638. The discount related to the embedded feature will be accreted back to debt through the maturity of the notes. | ||||||||
STOCKHOLDERS_EQUITY
| STOCKHOLDERS' EQUITY | 9 Months Ended | |
| Sep. 30, 2013 | ||
| Stockholders' Equity Note [Abstract] | ' | |
| Stockholders' Equity Note Disclosure [Text Block] | ' | |
| 7 | Stockholders’ Equity | |
| We did not issue any equity securities during the three or nine months ended September 30, 2013. During the three and nine months ended September 30, 2012, we issued 54,167 and 342,629 shares of our common stock, valued at $7,821 and $54,840, which we expensed as general and administrative (“G&A”) expense upon issuance. The shares were issued pursuant to a consulting agreement with an investor services firm whereby the consultant served as an investment consultant. | ||
ORGANIZATION_BUSINESS_OVERVIEW1
| ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Policies) | 9 Months Ended | ||
| Sep. 30, 2013 | |||
| Organization, Consolidation and Presentation of Financial Statements [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 (“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 GAAP. The accounting policies underlying our unaudited interim financial statements are consistent with those underlying our audited annual 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, 2012, and related notes thereto, included in our Annual Report on Form 10-K for the year ended December 31, 2012 (the “Annual Report”). | |||
| The accompanying December 31, 2012 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, 2013 are not necessarily indicative of the results to be expected for the year ending December 31, 2013 or any other future period. | |||
| References in this Quarterly Report on Form 10-Q to “authoritative guidance” are to the Accounting Standards Codification issued by the Financial Accounting Standards Board (“FASB”). | |||
| Subsequent events have been evaluated through the filing date of these unaudited financial statements. | |||
| Use of Estimates, Policy [Policy Text Block] | ' | ||
| Use of Estimates. | |||
| The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Critical accounting policies involved in applying our accounting policies are those that require management to make assumptions about matters that are highly uncertain at the time the accounting estimate was made and those for which different estimates reasonably could have been used for the current period. Critical accounting estimates are also those which are reasonably likely to change from period to period, and would have a material impact on the presentation of our financial condition, changes in financial condition or results of operations. Our most critical accounting estimates relate to accounting policies for fair value measurements in connection with derivative liabilities, clinical trial accruals 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 Accounting Standards Codification (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. | |||
| The Company estimates the fair values 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 fair value these instruments. Estimating fair values 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 values, the Company’s operating results reflect the volatility in these estimate and assumption changes in each reporting period. | |||
| Revenue Recognition, Policy [Policy Text Block] | ' | ||
| Revenue Recognition. | |||
| We recognize revenue in accordance with the authoritative guidance for revenue recognition. We recognize revenue when all of the following criteria are met: (i) persuasive evidence of an arrangement exists, (ii) delivery (or passage of title) has occurred or services have been rendered, (iii) the seller's price to the buyer is fixed or determinable, and (iv) collectability is reasonably assured. We also comply with the authoritative guidance for revenue recognition regarding arrangements with multiple deliverables. Multiple-element arrangements are analyzed to determine whether the deliverables, which may include a license together with performance obligations such as providing a clinical supply of product and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting. 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 we determine that an arrangement should be accounted for as a single unit of accounting, we must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a relative performance or straight-line method. We recognize revenue using the relative performance method provided that the we can reasonably estimate the level of effort required to complete our performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. | |||
| If we cannot reasonably estimate the level of effort required to complete our performance obligations under an arrangement, the performance obligations are 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 we cannot reasonably estimate when our performance obligation either ceases or becomes inconsequential and perfunctory, then revenue is deferred until we can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. | |||
| We recognize consideration that is contingent upon the achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone is substantive in its entirety. A milestone is considered substantive when it meets all of the following criteria: | |||
| ⋅ | The consideration is commensurate with either the entity's performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity's performance to achieve the milestone; | ||
| ⋅ | The consideration relates solely to past performance; and | ||
| ⋅ | The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. | ||
| A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity's performance or on the occurrence of a specific outcome resulting from the entity's performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to us. | |||
| We account for non-refundable grants as “Sponsored research revenues” in the accompanying statements of operations. Revenue from non-refundable grants is recognized when the following criteria are met; persuasive evidence of an arrangement exists, services have been rendered and the underlying costs incurred, the contract price is fixed or determinable, and collectability is reasonably assured. For the nine months ended September 30, 2013 and the year ended December 31, 2012, all of our revenues were received from one NIH grant which was substantially completed during the quarter ended March 31, 2013. No future revenues are expected to be earned from this grant. | |||
| Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in our accompanying balance sheets. | |||
| 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, four persons in total, who are part-time hourly employees dedicated to R&D efforts. R&D also includes a pro-ration of our common infrastructure costs for office space and communications. | |||
| Preclinical Studies and Clinical Trials [Policy Text Block] | ' | ||
| Cost of Preclinical Studies and Clinical Trials. | |||
| We accrue estimated costs for preclinical studies based on estimates of work performed. We estimate expenses incurred for clinical trials that are in process based on patient enrollment and based on clinical data collection and management. Costs based on clinical data collection and management are recognized based on estimates of unbilled goods and services received in the reporting period. We monitor the progress of the trials and their related activities and adjust the accruals accordingly. Adjustments to accruals are charged to expense in the period in which the facts that give rise to the adjustment become known. In the event of early termination of a clinical trial, we would accrue an amount based on estimates of the remaining non-cancelable obligations associated with winding down the clinical trial. | |||
| New Accounting Pronouncements, Policy [Policy Text Block] | ' | ||
| Recent Accounting Pronouncements. | |||
| For a discussion of recent accounting pronouncements please refer to Note 2, "Summary of Significant Accounting Policies—Recent Accounting Pronouncements," in the Annual Report. We did not adopt any new accounting pronouncements during the three months ended September 30, 2013 that had or are expected to have a material impact on our financial statements. | |||
STOCKBASED_COMPENSATION_Tables
| STOCK-BASED COMPENSATION (Tables) | 9 Months Ended | ||||
| Sep. 30, 2013 | |||||
| Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | ||||
| Schedule of Share-based Payment Award, Employee Stock Purchase Plan, Valuation Assumptions [Table Text Block] | ' | ||||
| We used the following forward-looking range of assumptions to value each stock option granted to employees, consultants and directors during the nine months ended September 30, 2012: | |||||
| 2012 | |||||
| Dividend yield | 0 | % | |||
| Risk-free rate of return | 0.7 | % | |||
| Expected life in years | 4 | ||||
| Volatility | 72 | % | |||
| Forfeiture rate | 2.6 | % | |||
FAIR_VALUE_MEASUREMENTS_Tables
| FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended | |||||||||||||
| Sep. 30, 2013 | ||||||||||||||
| Fair Value Disclosures [Abstract] | ' | |||||||||||||
| Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | ' | |||||||||||||
| We evaluated the derivative liability embedded in the series of convertible notes to determine if an adjustment to the carrying value of the liability was required at March 31, June 30 and September 30, 2013 using the following assumptions. | ||||||||||||||
| March | July | September | ||||||||||||
| Dividend yield | 0 | % | 0 | % | 0 | % | ||||||||
| Risk-free rate of return | 1.39 | % | 1.39 | % | 1.39 | % | ||||||||
| Expected life in years | 4.5 | 4.75 | 4.95 | |||||||||||
| Volatility | 62.4 | % | 66.5 | % | 66.1 | % | ||||||||
| Fair Value Measurement Derivative Liabilities Disclosure [Table Text Block] | ' | |||||||||||||
| For the three month period ended September 30, 2013, 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 | |||||||||||||
| June 30, | New | Change in | September 30, | |||||||||||
| 2013 | Issuances | Fair Values | 2013 | |||||||||||
| Level 3 - | ||||||||||||||
| Derivative liabilities from: | ||||||||||||||
| Conversion features | ||||||||||||||
| Mar-13 | $ | 187,500 | $ | - | $ | -37,500 | $ | 150,000 | ||||||
| Jul-13 | - | 66,667 | - | 66,667 | ||||||||||
| Sep-13 | - | 267,500 | -53,500 | 214,000 | ||||||||||
| Derivative instruments | $ | 187,500 | $ | 334,167 | $ | -91,000 | $ | 430,667 | ||||||
CONVERTIBLE_NOTES_Tables
| CONVERTIBLE NOTES (Tables) | 9 Months Ended | |||||||
| Sep. 30, 2013 | ||||||||
| Debt Disclosure [Abstract] | ' | |||||||
| Schedule of Convertible Note Principal and Exercise of Warrant [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, Allan L. Goldstein, the Company’s chief scientific officer, 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, J.J. Finkelstein, the Company’s chief executive officer, Allan L. Goldstein, the Company’s chief scientific officer, Joseph C. McNay and L. Thompson Bowles, both outside directors. 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, four directors of the Company, and two unaffiliated accredited investors. 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 | ||||||
ORGANIZATION_BUSINESS_OVERVIEW2
| ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Details Textual) (USD $) | Sep. 30, 2013 | Sep. 12, 2013 |
| Management, Outside Director and Two Unaffiliated Investors [Member] | ||
| Capital Required for Capital Adequacy | $2,500,000 | ' |
| Cash | 177,000 | ' |
| Convertible Notes Payable | ' | $321,000 |
NET_LOSS_PER_COMMON_SHARE_Deta
| NET LOSS PER COMMON SHARE (Details Textual) | 9 Months Ended | |
| Sep. 30, 2013 | Sep. 30, 2012 | |
| Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 30,235,167 | 17,173,500 |
STOCKBASED_COMPENSATION_Detail
| STOCK-BASED COMPENSATION (Details) | 9 Months Ended |
| Sep. 30, 2012 | |
| Dividend yield | 0.00% |
| Risk-free rate of return | 0.70% |
| Expected life in years | '4 years |
| Volatility | 72.00% |
| Forfeiture rate | 2.60% |
STOCKBASED_COMPENSATION_Detail1
| STOCK-BASED COMPENSATION (Details Textual) (USD $) | 3 Months Ended | 9 Months Ended | ||
| Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
| Allocated Share-based Compensation Expense | $21,594 | $26,566 | $61,432 | $151,543 |
| Employee Service Share-based Compensation, Nonvested Awards, Total Compensation Cost Not yet Recognized, Stock Options | $71,318 | ' | $71,318 | ' |
| Employee Service Share-based Compensation, Nonvested Awards, Total Compensation Cost Not yet Recognized, Period for Recognition | ' | ' | '1 year | ' |
FAIR_VALUE_MEASUREMENTS_Detail
| FAIR VALUE MEASUREMENTS (Details ) | 3 Months Ended | ||
| Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | |
| Dividend yield | 0.00% | 0.00% | 0.00% |
| Risk-free rate of return | 1.39% | 1.39% | 1.39% |
| Expected life in years | '4 years 11 months 12 days | '4 years 9 months | '4 years 6 months |
| Volatility | 66.10% | 66.50% | 62.40% |
FAIR_VALUE_MEASUREMENTS_Detail1
| FAIR VALUE MEASUREMENTS (Details 1) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 |
| Conversion Features [Member] | Conversion Features [Member] | Conversion Features [Member] | Derivative Instruments [Member] | |||
| Fair Value, Inputs, Level 3 [Member] | Fair Value, Inputs, Level 3 [Member] | Fair Value, Inputs, Level 3 [Member] | Fair Value, Inputs, Level 3 [Member] | |||
| March 2013 [Member] | July 2013 [Member] | September 2013 [Member] | ||||
| Derivative liabilities, Beginning Balance | $430,667 | $0 | $187,500 | $0 | $0 | $187,500 |
| Derivative liabilities, New Issuances | ' | ' | 0 | 66,667 | 267,500 | 334,167 |
| Derivative liabilities, Change in Fair Values | ' | ' | -37,500 | 0 | -53,500 | -91,000 |
| Derivative liabilities, Ending Balance | $430,667 | $0 | $150,000 | $66,667 | $214,000 | $430,667 |
FAIR_VALUE_MEASUREMENTS_Detail2
| FAIR VALUE MEASUREMENTS (Details Textual) (Fair Value, Inputs, Level 1 [Member], USD $) | Sep. 30, 2013 |
| Fair Value, Inputs, Level 1 [Member] | ' |
| Cash and Cash Equivalents, Fair Value Disclosure | $177,000 |
CONVERTIBLE_NOTES_Details
| CONVERTIBLE NOTES (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
| SINAF S.A. [Member] | ' | ' |
| Debt Instrument, Face Amount | $150,000 | $200,000 |
| Class of Warrant or Right, Outstanding | ' | 266,667 |
| Joseph C. McNay [Member] | ' | ' |
| Debt Instrument, Face Amount | 100,000 | 50,000 |
| Class of Warrant or Right, Outstanding | ' | 66,667 |
| Joseph C. McNay [Member] | March 2013 [Member] | ' | ' |
| Debt Instrument, Face Amount | 50,000 | ' |
| Joseph C. McNay [Member] | July 2013 [Member] | ' | ' |
| Debt Instrument, Face Amount | 50,000 | ' |
| Allan L. Goldstein [Member] | ' | ' |
| Debt Instrument, Face Amount | 11,000 | 35,000 |
| Class of Warrant or Right, Outstanding | ' | 46,666 |
| Allan L. Goldstein [Member] | March 2013 [Member] | ' | ' |
| Debt Instrument, Face Amount | 25,000 | ' |
| Allan L. Goldstein [Member] | July 2013 [Member] | ' | ' |
| Debt Instrument, Face Amount | 10,000 | ' |
| J.J. Finkelstein [Member] | ' | ' |
| Debt Instrument, Face Amount | ' | 15,000 |
| Class of Warrant or Right, Outstanding | ' | 20,000 |
| J.J. Finkelstein [Member] | July 2013 [Member] | ' | ' |
| Debt Instrument, Face Amount | 5,000 | ' |
| L. Thompson Bowles [Member] | ' | ' |
| Debt Instrument, Face Amount | 5,000 | ' |
| L. Thompson Bowles [Member] | July 2013 [Member] | ' | ' |
| Debt Instrument, Face Amount | 5,000 | ' |
| R. Don Elsey [Member] | ' | ' |
| Debt Instrument, Face Amount | $5,000 | ' |
CONVERTIBLE_NOTES_Details_Text
| CONVERTIBLE NOTES (Details Textual) (USD $) | 1 Months Ended | 9 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||
| Jul. 05, 2013 | Mar. 29, 2013 | Oct. 19, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 11, 2013 | Jul. 05, 2013 | Mar. 29, 2013 | Oct. 19, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | Dec. 31, 2012 | |
| Convertible Notes [Member] | Convertible Notes [Member] | Convertible Notes [Member] | Convertible Notes [Member] | Convertible Notes [Member] | Convertible Notes [Member] | Convertible Notes [Member] | Convertible Notes [Member] | Convertible Notes [Member] | Warrant [Member] | Warrant [Member] | Warrant [Member] | Sigma Tau [Member] | ||||||
| March 2013 [Member] | July 2013 [Member] | September 2013 [Member] | ||||||||||||||||
| Proceeds from Convertible Debt | ' | ' | ' | ' | ' | $321,000 | $100,000 | $225,000 | $300,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
| Debt Conversion, Converted Instrument, Warrants or Options Issued | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 400,000 | ' |
| Debt Instrument, Interest Rate, Stated Percentage | ' | ' | ' | ' | ' | 5.00% | 5.00% | 5.00% | 5.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' |
| Warrant Exercise Price | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $0.15 | ' |
| Debt Instrument, Maturity Date, Description | '60 months | '60 months | '24 months | '60 months | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 'five years | ' |
| StockAndWarrantsIssuedDuringPeriodValuePreferredStockAndWarrants | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 27,097 | ' |
| Debt Instrument, Convertible, Conversion Price | ' | ' | ' | ' | ' | $0.06 | $0.06 | $0.06 | $0.15 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
| Debt Conversion, Converted Instrument, Shares Issued | ' | ' | ' | ' | ' | 5,350,000 | 1,666,667 | 3,750,000 | 2,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
| Noncontrolling Interest, Ownership Percentage by Noncontrolling Owners | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 38.00% |
| 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 | ' | ' | ' | ' | '4 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '5 years | ' |
| Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | ' | ' | ' | ' | 72.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 74.36% | ' |
| Share-Based Compensation Arrangement By Share-Based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | ' | ' | ' | ' | 0.70% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0.77% | ' |
| Adjustments to Additional Paid in Capital, Warrant Issued | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 27,097 | ' |
| Derivative Credit Risk Valuation Adjustment, Derivative Liabilities | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 75,000 | 0 | 53,500 | ' | ' | ' | ' |
| Non-cash interest expense | ' | ' | ' | 38,511 | 0 | ' | ' | ' | ' | 11,342 | 22,562 | ' | ' | ' | 3,413 | 10,133 | ' | ' |
| Bifurcated Liability | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 225,000 | 66,667 | 267,500 | ' | ' | ' | ' |
| Residual Debt Value | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | 33,333 | 53,500 | ' | ' | ' | ' |
| Interest Expense, Debt | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $3,178 | $2,638 | ' | ' | ' | ' |
STOCKHOLDERS_EQUITY_Details_Te
| STOCKHOLDERS' EQUITY (Details Textual) (USD $) | 3 Months Ended | 9 Months Ended |
| Sep. 30, 2012 | Sep. 30, 2012 | |
| Stock Issued During Period, Shares, Issued for Services | 54,167 | 342,629 |
| Stock Issued During Period, Value, Issued for Services | $7,821 | $54,840 |