Document_And_Entity_Informatio
Document And Entity Information | 3 Months Ended | |
Mar. 31, 2014 | 14-May-14 | |
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 | ' | 92,983,247 |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 31-Mar-14 | ' |
Document Fiscal Period Focus | 'Q1 | ' |
Document Fiscal Year Focus | '2014 | ' |
Balance_Sheets
Balance Sheets (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
Current assets | ' | ' |
Cash and cash equivalents | $1,299,928 | $6,306 |
Prepaid expenses and other current assets | 49,394 | 26,299 |
Total current assets | 1,349,322 | 32,605 |
Property and equipment, net of accumulated depreciation of $122,643 and $121,727 | 3,457 | 4,373 |
Other assets | 5,752 | 5,752 |
Total assets | 1,358,531 | 42,730 |
Current liabilities | ' | ' |
Accounts payable | 549,847 | 577,211 |
Accrued expenses | 119,489 | 39,049 |
Convertible promisory note, net of discount of $7,513 and $10,854 | 292,487 | 289,146 |
Total current liabilities | 961,823 | 905,406 |
Long-Term liabilities | ' | ' |
Unearned revenue | 400,000 | 400,000 |
Convertible promisory notes, net of derivative liability | 173,476 | 143,399 |
Fair value of derivative liability | 1,986,168 | 215,334 |
Total liabilities | 3,521,467 | 1,664,139 |
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, 92,983,247 and 81,733,247 issued and outstanding | 92,983 | 81,733 |
Additional paid-in capital | 96,919,888 | 95,347,571 |
Accumulated deficit | -99,175,807 | -97,050,713 |
Total stockholders' deficit | -2,162,936 | -1,621,409 |
Total liabilities and stockholders' deficit | $1,358,531 | $42,730 |
Balance_Sheets_Parenthetical
Balance Sheets (Parenthetical) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
Property and equipment, accumulated depreciation (in dollars) | $122,643 | $121,727 |
Convertible promisory note, Discount (in dollars) | $7,513 | $10,854 |
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 | 92,983,247 | 81,733,247 |
Common stock, shares, outstanding | 92,983,247 | 81,733,247 |
Statements_of_Operations
Statements of Operations (USD $) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Sponsored research revenue | $0 | $29,484 |
Operating expenses | ' | ' |
Research and development | 74,700 | 91,489 |
General and administrative | 288,857 | 263,369 |
Total operating expenses | 363,557 | 354,858 |
Loss from operations | -363,557 | -325,374 |
Interest and other income | 3 | 8 |
Interest expense | -45,706 | -7,040 |
Change in fair value of derivative | -1,715,834 | 0 |
Net loss | ($2,125,094) | ($332,406) |
Basic and diluted net loss per common share (in dollars per share) | ($0.03) | $0 |
Weighted average number of common shares outstanding (in shares) | 82,233,247 | 81,733,247 |
Statements_of_Cash_Flows
Statements of Cash Flows (USD $) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Operating activities: | ' | ' |
Net loss | ($2,125,094) | ($332,406) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Depreciation and amortization | 916 | 1,431 |
Share-based compensation | 83,567 | 19,919 |
Non-cash interest expense | 33,418 | 3,341 |
Change in fair value of derivative | 1,715,834 | 0 |
Changes in operating assets and liabilities: | ' | ' |
Grant receivable | 0 | 177,350 |
Prepaid expenses and other current assets | -23,095 | 8,289 |
Other assets | 0 | 0 |
Accounts payable | -27,364 | 9,476 |
Accrued expenses | 80,440 | -19,347 |
Net cash used in operating activities | -261,378 | -131,947 |
Financing activities: | ' | ' |
Proceeds from sale of common stock and issuance of warrants | 1,500,000 | 0 |
Proceeds from issuance of debt | 55,000 | 225,000 |
Cash provided by financing activities | 1,555,000 | 225,000 |
Net increase in cash and cash equivalents | 1,293,622 | 93,053 |
Cash and cash equivalents at beginning of period | 6,306 | 141,905 |
Cash and cash equivalents at end of period | 1,299,928 | 234,958 |
Supplemental Disclosure of Non-Cash Operating and Financing Activities | ' | ' |
Fair value of derivative liability at issuance | $55,000 | $225,000 |
ORGANIZATION_BUSINESS_OVERVIEW
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION | 3 Months Ended | ||
Mar. 31, 2014 | |||
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. | |||
On March 28, 2014 we received the proceeds from the first equity purchase in the amount of $1,350,000 from G-treeBNT Co., Ltd. (“G-treeBNT”) formerly known as Digital Aria Co., Ltd., pursuant to the March 2014 execution of two licensing agreements and an associated common stock purchase agreement with G-treeBNT (see Note 7). We had previously received $150,000 earlier in the quarter in connection with these agreements. As of March 31, 2014 we had cash on hand of approximately $1,300,000. With this capital we have resources to continue operations. The operations include the development of RGN-259 for certain ophthalmic indications, including pursuing clinical development for the treatment of dry eye syndrome and neurotrophic keratopathy (NK), for which we received orphan designation at the end of 2013. We believe that we will be able to extend these activities for the next twelve months with the cash on hand plus the proceeds from the second common stock purchase closing with G-treeBNT that is scheduled to occur on or before August 31, 2014. This estimate may change if we are able to accelerate our development efforts or if we discover that we need to undertake additional efforts to support our objectives in which case we would need additional capital in less than 12 months. In addition to the RGN-259 development activities we intend to continue to pursue additional partnering activities, particularly for RGN-352, our injectable systemic product candidate for cardiac and central nervous system indications. | |||
We anticipate incurring additional losses in the future as we continue our RGN-259 development activities while seeking partners to explore the potential clinical benefits of Tβ4-based product candidates over multiple indications. We will need additional funds in order to pursue our current operating objectives substantially beyond the second quarter of 2015. Accordingly, we are in the process of exploring various funding alternatives, including, without limitation, a public or private placement of our securities, debt financing, corporate collaboration and additional licensing arrangements. | |||
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. 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 expect to continue to expend substantial funds to complete our planned product development efforts. Additionally, we continually refine our operating strategy and will continue to evaluate potential orphan indication clinical uses of Tβ4. However, substantial additional resources 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. The accompanying financial 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, 2013, and related notes thereto, included in our Annual Report on Form 10-K for the year ended December 31, 2013 (the “Annual Report”). | |||
The accompanying December 31, 2013 financial information was derived from our audited financial statements included in the Annual Report. Operating results for the three-month period ended March 31, 2014 are not necessarily indicative of the results to be expected for the year ending December 31, 2014 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”). | |||
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. In other instances these instruments are classified as equity instruments 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 quarter ended March 31, 2014 we did not record any grant revenues and for the year ended December 31, 2013, 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. | |||
We did not adopt any new accounting pronouncements during the three months ended March 31, 2014 that had or are expected to have a material impact on our financial statements. | |||
NET_LOSS_PER_COMMON_SHARE
NET LOSS PER COMMON SHARE | 3 Months Ended | ||
Mar. 31, 2014 | |||
Earnings Per Share [Abstract] | ' | ||
Earnings Per Share [Text Block] | ' | ||
2 | Net Loss per Common Share | ||
Net loss per common share for the three-month periods ended March 31, 2014 and 2013, 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 45,641,175 shares and 23,238,500 shares in 2014 and 2013, respectively, reserved for the conversion of convertible debt or exercise of outstanding options, warrants, including 13,833,333 related to G-treeBNT’s second equity purchase and purchase option (see Note 7). | |||
STOCKBASED_COMPENSATION
STOCK-BASED COMPENSATION | 3 Months Ended | |||
Mar. 31, 2014 | ||||
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 $ 83,567 and $ 19,919 in stock-based compensation expense for the three months ended March 31, 2014 and 2013, respectively. We expect to recognize the compensation cost related to non-vested options as of March 31, 2014 of $ 162,131 over the weighted average remaining recognition period of 1.80 years. | ||||
We did not grant any stock options during the three months ended March 31, 2013. We used the following forward-looking range of assumptions to value the 2,025,000 stock options granted to employees, consultants and directors during the three months ended March 31, 2014: | ||||
Dividend yield | 0 | % | ||
Risk-free rate of return | 1.76 | % | ||
Expected life in years | 5-Apr | |||
Volatility | 91-98 | % | ||
Forfeiture rate | 2.6 | % | ||
INCOME_TAXES
INCOME TAXES | 3 Months Ended | ||
Mar. 31, 2014 | |||
Income Tax Disclosure [Abstract] | ' | ||
Income Tax Disclosure [Text Block] | ' | ||
4 | Income Taxes | ||
As of March 31, 2014, 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, 2014; no changes in settled tax years have occurred through March 31, 2014. Due to the existence of tax attribute carryforwards (which are currently offset by a full valuation allowance), the Company treats all years’ tax positions as unsettled due to the taxing authorities’ ability to modify these attributes. | |||
FAIR_VALUE_MEASUREMENTS
FAIR VALUE MEASUREMENTS | 3 Months Ended | |||||||||||||
Mar. 31, 2014 | ||||||||||||||
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. | |||||||||||||
March 31, 2014 and 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 $1,300,000 and $235,000, respectively, using Level 1 inputs. Our March 31, 2014 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). 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, 2014 using the following assumptions. | ||||||||||||||
March 2013 | July 2013 | Sept 2013 | Jan 2014 | |||||||||||
Dividend yield | 0 | % | 0 | % | 0 | % | 0 | % | ||||||
Risk-free rate of return | 1.73 | % | 1.73 | % | 1.73 | % | 1.73 | % | ||||||
Expected life in years | 4 | 4.25 | 4.45 | 4.75 | ||||||||||
Volatility | 97.6 | % | 94.7 | % | 93.1 | % | 88.2 | % | ||||||
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 period ended March 31, 2014, 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 | March 31, | |||||||||||
2013 | Issuances | Fair Values | 2014 | |||||||||||
Level 3 - | ||||||||||||||
Derivative liabilities from: | ||||||||||||||
Conversion features | ||||||||||||||
Mar-13 | $ | 75,000 | $ | - | $ | 562,500 | $ | 637,500 | ||||||
Jul-13 | 33,334 | - | 250,000 | 283,334 | ||||||||||
Sep-13 | 107,000 | - | 802,500 | 909,500 | ||||||||||
Jan-14 | - | 55,000 | 100,834 | 155,834 | ||||||||||
Derivative instruments | $ | 215,334 | $ | 55,000 | $ | 1,715,834 | $ | 1,986,168 | ||||||
CONVERTIBLE_NOTES
CONVERTIBLE NOTES | 3 Months Ended | |||||||
Mar. 31, 2014 | ||||||||
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 is $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 months ended March 31, 2014 and 2013 totaled $3,341 and $3,341, 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, 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 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 increase the derivative liability by $562,500 was required at March 31, 2014. Non-cash interest expense recorded during the three months ended March 31, 2014 totaled $11,096. 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, Mr. Finkelstein, Dr. Goldstein, Mr. McNay and L. Thompson Bowles, an outside director. The principal amounts of their respective July 2013 Notes are as set forth below: | ||||||||
Investor | Note Principal | |||||||
Joseph C. McNay | $ | 50,000 | ||||||
Allan L. Goldstein | $ | 10,000 | ||||||
J.J. Finkelstein | $ | 5,000 | ||||||
L. Thompson Bowles | $ | 5,000 | ||||||
The 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 an adjustment to increase the derivative liability by $250,000 was required at March 31, 2014. The accretion of the derivative liability recorded as interest expense during the three months ended March 31, 2014 totaled $3,288. 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. | ||||||||
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 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 increase the derivative liability by $802,500 was required at March 31, 2014. The accretion of the derivative liability recorded as interest expense during the three months ended March 31, 2014 totaled $13,192. The discount related to the embedded feature will be accreted back to debt through the maturity of the notes. | ||||||||
2014 Convertible Notes | ||||||||
On January 7, 2014, we completed a private placement of convertible notes raising an aggregate of $55,000 in gross proceeds (the “January 2014 Notes”). The January 2014 Notes 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. Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the federal bankruptcy act or the continuation of such petition without dismissal for a period of 90 days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the January 2014 Notes will accelerate and automatically become immediately due and payable. | ||||||||
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 Company has evaluated the terms of the January 2014 Notes which contain a down round provision under which the conversion price could be decreased as a result of future equity offerings, as defined in the January 2014 Notes. The adjustment would reduce the conversion price of the January 2014 Notes to be equivalent to that of the newly issued stock or stock-related instruments. As a result, the Company concluded that the conversion feature represented an embedded conversion feature for accounting purposes and should be recognized as a derivative liability, requiring a mark-to-market adjustment at the end of each reporting period until the related January 2014 Notes have been settled. The bifurcated liability of $55,000 was recorded on the date of issuance which resulted in a residual debt value of $0. The Company determined that an adjustment to increase the derivative liability by $100,833 was required at March 31, 2014. The accretion of the derivative liability recorded as interest expense during the three months ended March 31, 2014 totaled $2,501. The discount related to the embedded feature will be accreted back to debt through the maturity of the notes. | ||||||||
STOCKHOLDERS_EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended | |
Mar. 31, 2014 | ||
Stockholders' Equity Note [Abstract] | ' | |
Stockholders' Equity Note Disclosure [Text Block] | ' | |
7 | Stockholders’ Equity | |
On March 7, 2014, the Company signed securities purchase and licensing agreements with G-treeBNT. Under the securities purchase agreement, G-treeBNT invested $1,350,000 for 11,250,000 common shares at $0.12 per share and will invest an additional $1,000,000 for an additional 8,333,333 shares of common stock at $0.12 per share on or before August 31, 2014. Under the terms of the security purchase agreement, G-treeBNT also obtained the option to acquire an additional 5.5 million shares of common stock at $0.15 per share which expires on January 31, 2015. If this option is exercised the Company will receive additional proceeds of $825,000. | ||
The licensing agreements for development and commercialization rights in certain territories to two of the Company’s product development candidates, RGN-259 and RGN-137, included upfront payments of $150,000. | ||
In addition, G-treeBNT agreed to pay the Company milestone payments upon the achievement of certain commercial sales milestones, as well as with royalties on commercial sales. These license rights are conditioned upon the completion of the $1.35 million and $1.0 million security purchases described above and should both security purchases not occur, G-tree BNT will forfeit all license rights. | ||
As the security purchase and licensing agreements were signed in contemplation of each other and the execution of performance under the securities purchase agreement was stipulated as a condition for the retention of the rights granted under the licensing agreements, the three agreements were treated as a multiple-elements arrangement. Following the closing of the agreements, the Company determined that the total consideration received under the three agreements, totaling $1,500,000, should be allocated to identifiable elements within this multiple-elements arrangement (1) the equity investment in the Company’s common shares, including the purchase option and (2) the licensed development and commercialization rights under the two licensing agreements. The fair value of optional investment right is approximately $725,000 which was calculated using the Black Scholes option pricing model at the issuance of this right. As the common shares were issued at a discount to the then market price of the Company’s common stock of $0.20 on the date of closing, all of the proceeds received were allocation to the common shares and the optional investment right leaving no allocation of proceeds to the licensed rights. | ||
ORGANIZATION_BUSINESS_OVERVIEW1
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Policies) | 3 Months Ended | ||
Mar. 31, 2014 | |||
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 (“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, 2013, and related notes thereto, included in our Annual Report on Form 10-K for the year ended December 31, 2013 (the “Annual Report”). | |||
The accompanying December 31, 2013 financial information was derived from our audited financial statements included in the Annual Report. Operating results for the three-month period ended March 31, 2014 are not necessarily indicative of the results to be expected for the year ending December 31, 2014 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”). | |||
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. In other instances these instruments are classified as equity instruments 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 quarter ended March 31, 2014 we did not record any grant revenues and for the year ended December 31, 2013, 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. | |||
We did not adopt any new accounting pronouncements during the three months ended March 31, 2014 that had or are expected to have a material impact on our financial statements. | |||
STOCKBASED_COMPENSATION_Tables
STOCK-BASED COMPENSATION (Tables) | 3 Months Ended | |||
Mar. 31, 2014 | ||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | |||
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | ' | |||
We used the following forward-looking range of assumptions to value the 2,025,000 stock options granted to employees, consultants and directors during the three months ended March 31, 2014: | ||||
Dividend yield | 0 | % | ||
Risk-free rate of return | 1.76 | % | ||
Expected life in years | 5-Apr | |||
Volatility | 91-98 | % | ||
Forfeiture rate | 2.6 | % | ||
FAIR_VALUE_MEASUREMENTS_Tables
FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended | |||||||||||||
Mar. 31, 2014 | ||||||||||||||
Fair Value Disclosures [Abstract] | ' | |||||||||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [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, 2014 using the following assumptions. | ||||||||||||||
March 2013 | July 2013 | Sept 2013 | Jan 2014 | |||||||||||
Dividend yield | 0 | % | 0 | % | 0 | % | 0 | % | ||||||
Risk-free rate of return | 1.73 | % | 1.73 | % | 1.73 | % | 1.73 | % | ||||||
Expected life in years | 4 | 4.25 | 4.45 | 4.75 | ||||||||||
Volatility | 97.6 | % | 94.7 | % | 93.1 | % | 88.2 | % | ||||||
Fair Value Measurement Derivative Liabilities Disclosure [Table Text Block] | ' | |||||||||||||
For the period ended March 31, 2014, 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 | March 31, | |||||||||||
2013 | Issuances | Fair Values | 2014 | |||||||||||
Level 3 - | ||||||||||||||
Derivative liabilities from: | ||||||||||||||
Conversion features | ||||||||||||||
Mar-13 | $ | 75,000 | $ | - | $ | 562,500 | $ | 637,500 | ||||||
Jul-13 | 33,334 | - | 250,000 | 283,334 | ||||||||||
Sep-13 | 107,000 | - | 802,500 | 909,500 | ||||||||||
Jan-14 | - | 55,000 | 100,834 | 155,834 | ||||||||||
Derivative instruments | $ | 215,334 | $ | 55,000 | $ | 1,715,834 | $ | 1,986,168 | ||||||
CONVERTIBLE_NOTES_Tables
CONVERTIBLE NOTES (Tables) | 3 Months Ended | |||||||
Mar. 31, 2014 | ||||||||
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, 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, an outside director. The principal amounts of their respective July 2013 Notes are as set forth below: | ||||||||
Investor | Note Principal | |||||||
Joseph C. McNay | $ | 50,000 | ||||||
Allan L. Goldstein | $ | 10,000 | ||||||
J.J. Finkelstein | $ | 5,000 | ||||||
L. Thompson Bowles | $ | 5,000 | ||||||
The investors in the offering included an affiliate and 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 | ||||||
ORGANIZATION_BUSINESS_OVERVIEW2
ORGANIZATION, BUSINESS OVERVIEW AND BASIS OF PRESENTATION (Details Textual) (USD $) | 3 Months Ended |
Mar. 31, 2014 | |
ORGANIZATION AND BUSINESS [Line Items] | ' |
Cash | $1,300,000 |
Proceeds from Issuance Initial Public Offering | 1,350,000 |
Amount Received Under Purchase Agreement | $150,000 |
NET_LOSS_PER_COMMON_SHARE_Deta
NET LOSS PER COMMON SHARE (Details Textual) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 45,641,175 | 23,238,500 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 13,833,333 | ' |
STOCKBASED_COMPENSATION_Detail
STOCK-BASED COMPENSATION (Details) | 3 Months Ended |
Mar. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' |
Dividend yield | 0.00% |
Risk-free rate of return | 1.76% |
Volatility (Minimum) | 91.00% |
Volatility (Maximum) | 98.00% |
Forfeiture rate | 2.60% |
Maximum [Member] | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' |
Expected life in years | '5 years |
Minimum [Member] | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' |
Expected life in years | '4 years |
STOCKBASED_COMPENSATION_Detail1
STOCK-BASED COMPENSATION (Details Textual) (USD $) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Share Based Payment Award Stock Options Valuation Assumptions [Line Items] | ' | ' |
Allocated Share-based Compensation Expense, Total | $83,567 | $19,919 |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $162,131 | ' |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | '1 year 9 months 18 days | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Net of Forfeitures, Total | 2,025,000 | ' |
FAIR_VALUE_MEASUREMENTS_Detail
FAIR VALUE MEASUREMENTS (Details) | 3 Months Ended |
Mar. 31, 2014 | |
March 2013 [Member] | ' |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ' |
Dividend yield | 0.00% |
Risk-free rate of return | 1.73% |
Expected life in years | '4 years |
Volatility | 97.60% |
July 2013 [Member] | ' |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ' |
Dividend yield | 0.00% |
Risk-free rate of return | 1.73% |
Expected life in years | '4 years 3 months |
Volatility | 94.70% |
September 2013 [Member] | ' |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ' |
Dividend yield | 0.00% |
Risk-free rate of return | 1.73% |
Expected life in years | '4 years 5 months 12 days |
Volatility | 93.10% |
Jan 2014 [Member] | ' |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ' |
Dividend yield | 0.00% |
Risk-free rate of return | 1.73% |
Expected life in years | '4 years 9 months |
Volatility | 88.20% |
FAIR_VALUE_MEASUREMENTS_Detail1
FAIR VALUE MEASUREMENTS (Details 1) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2014 |
Conversion Features [Member] | 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] | Fair Value, Inputs, Level 3 [Member] | |||
March 2013 [Member] | July 2013 [Member] | September 2013 [Member] | January 2014 [Member] | ||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ' | ' | ' | ' | ' | ' | ' |
Derivative liabilities, Beginning Balance | $1,986,168 | $215,334 | $75,000 | $33,334 | $107,000 | $0 | $215,334 |
Derivative liabilities, New Issuances | ' | ' | 0 | 0 | 0 | 55,000 | 55,000 |
Derivative liabilities, Change in Fair Values | ' | ' | 562,500 | 250,000 | 802,500 | 100,834 | 1,715,834 |
Derivative liabilities, Ending Balance | $1,986,168 | $215,334 | $637,500 | $283,334 | $909,500 | $155,834 | $1,986,168 |
FAIR_VALUE_MEASUREMENTS_Detail2
FAIR VALUE MEASUREMENTS (Details Textual) (Fair Value, Inputs, Level 1 [Member], USD $) | Mar. 31, 2014 | Mar. 31, 2013 |
Fair Value, Inputs, Level 1 [Member] | ' | ' |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ' | ' |
Cash and Cash Equivalents, Fair Value Disclosure | $1,300,000 | $235,000 |
CONVERTIBLE_NOTES_Details
CONVERTIBLE NOTES (Details) (USD $) | Mar. 31, 2014 |
Sinaf S.A. [Member] | September 2013 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | $150,000 |
Sinaf S.A. [Member] | Notes 2012 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 200,000 |
Class of Warrant or Right, Outstanding | 266,667 |
Joseph C. McNay [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 25,000 |
Joseph C. McNay [Member] | March 2013 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 50,000 |
Joseph C. McNay [Member] | July 2013 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 50,000 |
Joseph C. McNay [Member] | September 2013 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 100,000 |
Joseph C. McNay [Member] | Notes 2012 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 50,000 |
Class of Warrant or Right, Outstanding | 66,667 |
Allan L. Goldstein [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 10,000 |
Allan L. Goldstein [Member] | March 2013 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 25,000 |
Allan L. Goldstein [Member] | July 2013 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 10,000 |
Allan L. Goldstein [Member] | September 2013 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 11,000 |
Allan L. Goldstein [Member] | Notes 2012 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 35,000 |
Class of Warrant or Right, Outstanding | 46,666 |
J.J. Finkelstein [Member] | July 2013 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 5,000 |
J.J. Finkelstein [Member] | Notes 2012 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 15,000 |
Class of Warrant or Right, Outstanding | 20,000 |
L. Thompson Bowles [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 5,000 |
L. Thompson Bowles [Member] | July 2013 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 5,000 |
L. Thompson Bowles [Member] | September 2013 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | 5,000 |
R. Don Elsey [Member] | September 2013 [Member] | ' |
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' |
Debt Instrument, Face Amount | $5,000 |
CONVERTIBLE_NOTES_Details_Text
CONVERTIBLE NOTES (Details Textual) (USD $) | 3 Months Ended | 0 Months Ended | 1 Months Ended | 3 Months Ended | ||||||||||
Mar. 31, 2014 | Mar. 31, 2013 | Jan. 07, 2014 | Sep. 11, 2013 | Jul. 05, 2013 | Mar. 29, 2013 | Oct. 19, 2012 | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | |
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] | Sigma Tau [Member] | |||
March 2013 [Member] | July 2013 [Member] | September 2013 [Member] | January 2014 [Member] | |||||||||||
Convertible Note Principal And Exercise Of Warrant [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds from Convertible Debt | ' | ' | $55,000 | $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% | 5.00% | ' | ' | ' | ' | ' | ' | ' |
Warrant Exercise Price | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $0.15 | ' | ' |
Debt Instrument, Maturity Date, Description | ' | ' | '60 months | '(60) months | '(60) months | '(60) months | '(24) months | ' | ' | ' | ' | 'five years | ' | ' |
StockAndWarrantsIssuedDuringPeriodValuePreferredStockAndWarrants | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 27,097 | ' | ' |
Debt Instrument, Convertible, Conversion Price | ' | ' | $0.06 | $0.06 | $0.06 | $0.06 | $0.15 | ' | ' | ' | ' | ' | ' | ' |
Debt Conversion, Converted Instrument, Shares Issued | ' | ' | 916,667 | 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 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '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 | 1.76% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0.77% | ' | ' |
Adjustments to Additional Paid in Capital, Warrant Issued | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 27,097 | ' | ' |
Derivative Credit Risk Valuation Adjustment, Derivative Liabilities | ' | ' | ' | ' | ' | ' | ' | 562,500 | 250,000 | 802,500 | 100,833 | ' | ' | ' |
Non-cash interest expense | 33,418 | 3,341 | ' | ' | ' | ' | ' | 11,096 | ' | ' | ' | 3,341 | 3,341 | ' |
Bifurcated Liability | ' | ' | ' | ' | ' | ' | ' | 225,000 | 66,667 | 267,500 | 55,000 | ' | ' | ' |
Residual Debt Value | ' | ' | ' | ' | ' | ' | ' | 0 | 33,333 | 53,500 | 0 | ' | ' | ' |
Interest Expense, Debt | ' | ' | ' | ' | ' | ' | ' | ' | $3,288 | $13,192 | $2,501 | ' | ' | ' |
STOCKHOLDERS_EQUITY_Details_Te
STOCKHOLDERS' EQUITY (Details Textual) (USD $) | 3 Months Ended | 1 Months Ended | 3 Months Ended | ||
Mar. 31, 2014 | Mar. 31, 2013 | Mar. 07, 2014 | Mar. 31, 2014 | Mar. 31, 2014 | |
Securities Purchase Agreement [Member] | Securities Purchase Agreement [Member] | Licence Agreement [Member] | |||
Stock Holders Equity [Line Items] | ' | ' | ' | ' | ' |
Common Stock Purchased By Agreement Party | ' | ' | $1,350,000 | ' | ' |
Common Stock Shares Purchased By Agreement Party | ' | ' | 11,250,000 | ' | ' |
Common Stock Purchase Price | ' | ' | $0.12 | ' | ' |
Additional Common Stock Purchased By Agreement Party | ' | ' | ' | 1,000,000 | ' |
Additional Common Stock Shares Purchased By Agreement Party | ' | ' | ' | 8,333,333 | ' |
Additional Common Stock Purchase Price | ' | ' | ' | $0.12 | ' |
Additional Common Stock Purchase Date | ' | ' | ' | 'on or before August 31, 2014 | ' |
Common Stock, Option To Purchase Additional Shares | ' | ' | ' | 825,000 | ' |
Common Stock Shares, Option To Purchase Additional Shares | ' | ' | ' | 5,500,000 | ' |
Additional Common Stock Option To Purchase Price | ' | ' | ' | $0.15 | ' |
Additional Common Stock option To Purchase Expire date | ' | ' | ' | 31-Jan-15 | ' |
Upfront Payments | ' | ' | ' | ' | 150,000 |
Proceeds from Issuance of Common Stock | 1,500,000 | 0 | ' | ' | ' |
Investment Owned, at Fair Value | $725,000 | ' | ' | ' | ' |
Market Price of Common Stock | $0.20 | ' | ' | ' | ' |