Document_And_Entity_Informatio
Document And Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Nov. 05, 2013 | |
Document Information [Line Items] | ' | ' |
Entity Registrant Name | 'Chelsea Therapeutics International, Ltd. | ' |
Entity Central Index Key | '0001333763 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Trading Symbol | 'CHTP | ' |
Entity Common Stock, Shares Outstanding | ' | 70,767,249 |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-13 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Document Fiscal Year Focus | '2013 | ' |
CONDENSED_CONSOLIDATED_BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Assets | ' | ' |
Cash and cash equivalents | $20,881,716 | $28,424,631 |
Prepaid contract research and manufacturing | 908,808 | 175,192 |
Other prepaid expenses and other current assets | 290,804 | 176,181 |
Total current assets | 22,081,328 | 28,776,004 |
Property and equipment, net | 63,676 | 151,544 |
Total Assets | 22,145,004 | 28,927,548 |
Liabilities and Stockholders' Equity | ' | ' |
Accounts payable | 1,204,006 | 788,073 |
Accrued compensation and related expenses | 185,090 | 199,935 |
Accrued restructuring | 394,949 | 841,184 |
Accrued contract research and manufacturing | 467,505 | 496,901 |
Other accrued expenses | 702,180 | 685,305 |
Total current liabilities | 2,953,730 | 3,011,398 |
Commitments | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock, $0.0001 par value, 5,000,000 shares authorized, no shares issued and outstanding | 0 | 0 |
Common stock, $0.0001 par value, 200,000,000 and 100,000,000 shares authorized, respectively; 68,109,960 and 67,075,779 shares issued and outstanding, respectively | 6,811 | 6,708 |
Additional paid-in capital | 245,341,659 | 240,970,852 |
Deficit accumulated during the development stage | -226,157,196 | -215,061,410 |
Total stockholders' equity | 19,191,274 | 25,916,150 |
Total liabilities and stockholders' equity | $22,145,004 | $28,927,548 |
CONDENSED_CONSOLIDATED_BALANCE1
CONDENSED CONSOLIDATED BALANCE SHEETS [Parenthetical] (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized | 200,000,000 | 100,000,000 |
Common stock, shares issued | 68,109,960 | 67,075,779 |
Common stock, shares outstanding | 68,109,960 | 67,075,779 |
CONDENSED_CONSOLIDATED_STATEME
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (USD $) | 3 Months Ended | 9 Months Ended | 138 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | |
Operating expenses: | ' | ' | ' | ' | ' |
Research and development | $2,558,975 | $2,479,471 | $6,420,790 | $15,874,135 | $168,925,636 |
Sales and marketing | 239,083 | 221,399 | 839,506 | 6,943,327 | 25,085,882 |
General and administrative | 1,047,864 | 1,169,157 | 3,849,100 | 4,530,435 | 34,752,258 |
Restructuring | 0 | 2,218,347 | 0 | 2,218,347 | 2,157,795 |
Total operating expenses | 3,845,922 | 6,088,374 | 11,109,396 | 29,566,244 | 230,921,571 |
Operating loss | -3,845,922 | -6,088,374 | -11,109,396 | -29,566,244 | -230,921,571 |
Interest income | 3,239 | 12,076 | 13,610 | 58,444 | 5,022,723 |
Interest expense | 0 | 0 | 0 | 0 | -258,348 |
Net loss | ($3,842,683) | ($6,076,298) | ($11,095,786) | ($29,507,800) | ($226,157,196) |
Net loss per basic and diluted share of common stock (in dollars per share) | ($0.06) | ($0.09) | ($0.17) | ($0.44) | ' |
Weighted average number of basic and diluted common shares outstanding (in shares) | 67,208,361 | 67,040,569 | 67,126,686 | 66,837,516 | ' |
CONDENSED_CONSOLIDATED_STATEME1
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (USD $) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit during Development Stage [Member] |
Balance at Dec. 31, 2012 | $25,916,150 | $6,708 | $240,970,852 | ($215,061,410) |
Balance (in shares) at Dec. 31, 2012 | ' | 67,075,779 | ' | ' |
Stock-based compensation | 1,448,294 | 0 | 1,448,294 | 0 |
Common stock issued pursuant to exercise of stock options | 141,012 | 8 | 141,004 | 0 |
Common stock issued pursuant to exercise of stock options (in shares) | ' | 81,875 | ' | ' |
Common stock issued under at-the-market equity offering program at an average sales price of approximately $3.06 per share | 2,781,604 | 95 | 2,781,509 | 0 |
Common stock issued under at-the-market equity offering program at an average sales price of approximately $3.06 per share (in shares) | ' | 952,306 | ' | ' |
Net loss | -11,095,786 | 0 | 0 | -11,095,786 |
Balance at Sep. 30, 2013 | $19,191,274 | $6,811 | $245,341,659 | ($226,157,196) |
Balance (in shares) at Sep. 30, 2013 | ' | 68,109,960 | ' | ' |
CONDENSED_CONSOLIDATED_STATEME2
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY [parenthetical] (USD $) | 9 Months Ended |
Sep. 30, 2013 | |
Stock Issued During Period Average Sales Price Market Equity Offering Program | $3.06 |
CONDENSED_CONSOLIDATED_STATEME3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 9 Months Ended | 138 Months Ended | |
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | |
Operating activities: | ' | ' | ' |
Net loss | ($11,095,786) | ($29,507,800) | ($226,157,196) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Non-cash stock-based compensation | 1,448,294 | 1,385,400 | 12,267,154 |
Depreciation and amortization | 87,868 | 97,441 | 637,198 |
Stock issued for license agreement | 0 | 0 | 575,023 |
Non-cash interest expense | 0 | 0 | 34,020 |
Gain on disposition of assets | 0 | 37,388 | 22,951 |
Fair value of warrants for finder's agreement | 0 | 0 | 433,750 |
Changes in operating assets and liabilities: | ' | ' | ' |
Prepaid contract research and manufacturing expenses, other prepaid expenses and other assets | -848,239 | 379,203 | -1,199,613 |
Accounts payable, accrued contract research and manufacturing expenses and other accrued expenses | 403,412 | -6,942,266 | 2,373,691 |
Accrued compensation and related expenses | -14,845 | -1,209,676 | 185,090 |
Accrued restructuring | -446,235 | 1,026,931 | 394,949 |
Net cash used in operating activities | -10,465,531 | -34,733,379 | -210,432,983 |
Investing activities: | ' | ' | ' |
Acquisitions of property and equipment | 0 | -25,260 | -739,731 |
Proceeds from sale of assets | 0 | 0 | 15,907 |
Purchases of short-term investments | 0 | 0 | -115,143,906 |
Redemptions and sales of short-term investments | 0 | 4,500,000 | 115,143,906 |
Security deposits | 0 | 38,267 | 0 |
Net cash provided by (used in) investing activities | 0 | 4,513,007 | -723,824 |
Financing activities: | ' | ' | ' |
Proceeds from borrowings from affiliate | 0 | 0 | 1,745,000 |
Proceeds from exercise of stock options | 141,012 | 0 | 228,935 |
Proceeds from exercise of common stock warrants | 0 | 0 | 9,054,546 |
Recapitalization of the Company | 0 | 0 | -400,000 |
Proceeds from sales of equity securities, net of issuance costs | 2,781,604 | 22,151,851 | 221,331,620 |
Receipt of recovery of short-swing profits | 0 | 0 | 73,797 |
Receipt of cash for stock subscription receivable | 0 | 0 | 4,625 |
Net cash provided by financing activities | 2,922,616 | 22,151,851 | 232,038,523 |
Net (decrease) increase in cash and cash equivalents | -7,542,915 | -8,068,521 | 20,881,716 |
Cash and cash equivalents, beginning of period | 28,424,631 | 41,106,301 | 0 |
Cash and cash equivalents, end of period | 20,881,716 | 33,037,780 | 20,881,716 |
Supplemental disclosure of cash flow information: | ' | ' | ' |
Cash paid for interest | $0 | $0 | $224,328 |
CONDENSED_CONSOLIDATED_STATEME4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS [Parenthetical] (USD $) | 1 Months Ended | 12 Months Ended | |||||
Jan. 31, 2007 | 31-May-06 | Feb. 28, 2006 | Feb. 28, 2005 | Dec. 31, 2004 | Dec. 31, 2002 | Dec. 31, 2012 | |
Common stock, shares issued | ' | ' | ' | ' | ' | 5,428,217 | 67,075,779 |
Common stock, subscription receivable | ' | ' | ' | ' | ' | $4,625 | ' |
Loans | ' | ' | ' | ' | 1,745,000 | ' | ' |
Accrued interest | ' | ' | ' | ' | 34,020 | ' | ' |
Common stock issued in conversion of loan | ' | ' | ' | ' | 677,919 | ' | ' |
Common Stock Issued In Lieu Of Repayment Of Loan Per Shares (in dollars per share) | ' | ' | ' | ' | $2.62 | ' | ' |
Common stock, issued in conjunction with merger and recapitalization | ' | ' | ' | 11,911,357 | ' | ' | ' |
Warrants issued to purchase common stock | 0 | 250,000 | 716,666 | 105,516 | 483,701 | ' | ' |
Common stock warrants, purchase price (in dollars per share) | $0 | $4.31 | $3.30 | $2.62 | $2.88 | ' | ' |
Fair Value Of Warrants Granted | $433,750 | $0 | $705,000 | $26,700 | $14,400 | ' | ' |
Warrants Unexercised And Outstanding | ' | ' | ' | ' | ' | ' | 486,766 |
Warrants Exercised Number Of Warrants | ' | ' | ' | ' | ' | ' | 229,900 |
SUMMARY_OF_SIGNIFICANT_ACCOUNT
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NATURE OF OPERATIONS | 9 Months Ended | |
Sep. 30, 2013 | ||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' | |
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Text Block] | ' | |
NOTE 1 | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NATURE OF OPERATIONS | |
The Company | ||
Chelsea Therapeutics International, Ltd. (“Chelsea Ltd.” or the “Company”) is a development stage pharmaceutical company focused on the acquisition, development and commercialization of innovative pharmaceutical products. Specifically, the Company is developing Northera™ (droxidopa), a novel therapeutic agent for the treatment of symptomatic neurogenic orthostatic hypotension, or Neurogenic OH, in patients with primary autonomic failure, dopamine β-hydroxylase, or DBH, deficiency and non-diabetic autonomic neuropathy. On September 4, 2013, the Company announced that the FDA had acknowledged receipt of the Northera NDA resubmission that the Company had filed on August 14, 2013. The FDA has deemed the resubmission a complete response to its March 28, 2012 complete response letter, or CRL, and assigned a new Prescription Drug User Fee Act, or PDUFA, goal date of February 14, 2014. | ||
The Company’s operating subsidiary, Chelsea Therapeutics, Inc. (“Chelsea Inc.”), was incorporated in the State of Delaware on April 3, 2002 as Aspen Therapeutics, Inc., with the name changed in July 2004. In February 2005, Chelsea Inc. merged with a wholly-owned subsidiary of Chelsea Ltd.’s predecessor company, Ivory Capital Corporation (“Ivory”), a Colorado public company with no operations (the “Merger”). The Company reincorporated into the State of Delaware in July 2005, changing its name to Chelsea Therapeutics International, Ltd. | ||
As a result of the Merger of Ivory and Chelsea Inc. in February 2005, and the reincorporation in Delaware in July 2005, Chelsea Ltd. is the reporting company and is the 100% owner of Chelsea Inc. The separate existence of Ivory ceased in connection with the Delaware reincorporation in July 2005. Except where the context provides otherwise, references to the “Company” and similar terms mean Ivory, Chelsea Ltd. and Chelsea Inc. | ||
Since inception, the Company has focused primarily on organizing and staffing, negotiating in-licensing agreements with partners, acquiring, developing and securing its proprietary technology, participating in regulatory discussions with the United States Food and Drug Administration, or FDA, the European Medicines Agency, or EMA and other regulatory agencies, undertaking preclinical trials and clinical trials of product candidates and raising capital. More recently, the Company has initiated activities to support the commercial launch of Northera, currently planned for the third quarter of 2014 assuming that approval is received from the FDA to market Northera in the United States. The Company plans on limited spending for these activities prior to approval in order to further conserve capital resources. | ||
The Company is a development stage company and has generated no revenue since inception. The Company has sustained operating losses since its inception and expects that such losses could continue for the foreseeable future. Management plans to continue financing the Company’s operations, as necessary, with equity issuances, debt arrangements, strategic alliances or other arrangements of a collaborative nature. If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its research or development programs, delay or scale back certain activities including its commercialization program, or limit or cease operations in which event its business, financial condition and results of operations would be materially harmed. | ||
Management believes that capital resources available at November 5, 2013 will be sufficient to meet the Company’s operating needs into the first quarter of 2015. This estimate includes the planned costs to complete currently ongoing clinical activity and the anticipated costs that will be incurred into the first quarter of 2015 related to a new trial of Northera that could begin patient enrollment as early as the fourth quarter of 2013. In addition to the costs of a new clinical trial, this estimate also assumes various costs related to planning and preparation for the January 2014 meeting of the Cardiovascular and Renal Drug Advisory Committee, or CRDAC. Other than minimal spending for consulting services to assist in the commercialization planning process, the costs of additional activities related to, or subsequent to, a possible approval of Northera, or the commercialization of Northera should it be approved, have not been included in this guidance. | ||
Basis of Presentation | ||
The accompanying condensed consolidated financial statements include the accounts of the Company and its operating subsidiary, which shall collectively be referred to as the “Company”. These statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial reporting and the instructions to Form 10-Q and do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of the Company’s management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results for the interim periods have been included. Operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results for the year ending December 31, 2013 or future periods. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K/A filed on March 14, 2013 and available on the website (www.sec.gov) of the United States Securities and Exchange Commission, or the SEC. The accompanying condensed consolidated balance sheet as of December 31, 2012 has been derived from the audited balance sheet as of that date included in the Form 10-K/A. | ||
Basis of Consolidation | ||
The accompanying financial statements present, on a condensed consolidated basis, the financial position and results of operations of Chelsea Ltd. and its subsidiary. All significant intercompany transactions and balances have been eliminated in consolidation. | ||
Use of Estimates | ||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the financial statements as well as the reported expenses during the reporting periods. On an ongoing basis, management evaluates its estimates and judgments. Management bases estimates on its historical experience and on various other factors that it believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results might differ from these estimates under different assumptions or conditions. | ||
Significant estimates and assumptions are required related to the estimated costs and estimated percentages of completion of research and development activities that are outsourced to third-party contractors, the valuation of assets and stock-based compensation. Some of these judgments can be subjective and complex, and, consequently, actual results may differ from these estimates. For any given individual estimate or assumption made by the Company, there may also be other estimates or assumptions that are reasonable. Although the Company believes that its estimates and assumptions are reasonable, they are based upon information available at the time the estimates and assumptions were made and actual results may differ significantly from such estimates. | ||
Research and Development | ||
Research and development expenditures are expensed based upon the estimated percentage of completion at the financial statement date applied against estimated amounts to complete the project. The Company often contracts with third-party contract research organizations, or CROs, to facilitate, coordinate and perform agreed upon research and development activities. Estimates are calculated, maintained and presented to the Company by CROs and are then subjected to rigorous periodic internal review and analysis to ensure reasonableness of the estimates. Such review includes difficult, subjective and complex judgments, particularly in instances of studying orphan drug candidates where prior clinical activity is limited, providing little or no historical cost information. Given the highly variable nature of the costs involved in the completion of a clinical or pre-clinical trial, fluctuations in costs estimates can occur at any time during the trial or at its conclusion based on a number of factors including, but not limited to, the rate at which investigator sites are identified, the locations of those sites (US versus International), the timing of site activations, the rate at which patients are enrolled into a trial, changes to the number of sites and/or patients that are targeted for the trial, the timelines for trial completion and changes in scope of the actions to be taken by the CROs. | ||
Given that the recognition of expense related to the Company’s contracted research and development activities comprise a significant component of reported expenses during any given period, such fluctuations can be material to the results of operations and/or the carrying value of assets and liabilities. The estimates to complete each contracted project are also used in the determination and disclosure of contractual obligations of the Company providing a snapshot of estimated cash requirements arising from future contractual payment obligations based upon the best information available at the time the financial statements are published. | ||
To ensure that such estimates allow research and development costs to be expensed as incurred, the Company measures expense based on estimated work performed for the underlying contract, typically utilizing a percentage-of-completion approach, and records prepaid assets or accrues expenses on a monthly basis for such activities based on the measurement of liability from expense recognition and the receipt of invoices. Contracts for research and development programs typically call for the payment of fees for services at the initiation of the contract and/or upon the achievement of certain milestones. In the event that the Company prepays fees for future milestones, the Company records the prepayment as a prepaid asset and amortizes the asset into research and development expense over the period of time the contracted research and development services are performed. Most fees are incurred throughout the contract period and are expensed based on their estimated percentage of completion at a particular date. Although such fees may fluctuate during the life of a research and development program, such fluctuations are generally based on changes in or delays in the timelines for study completion. | ||
These contracts generally include pass through fees. Pass through fees include, but are not limited to, regulatory expenses, investigator fees, laboratory fees, travel costs, and other miscellaneous costs including database management, adverse event reporting, shipping and printing fees. Because these fees are incurred at various times during the contract term and they are used throughout the contract term, the Company records a monthly expense estimate to recognize the fees during the contract period. Fees incurred to set up the clinical trial are expensed during the setup period. Estimating the costs of pass-through expenses for a contracted research and development program can be difficult and complex. Judgments used in the development of these estimates are based on a number of considerations, including the input of the CRO, the costs of previous clinical trials, estimates of patient recruitment rates, estimates of drop-out rates and estimates of site identification and activation rates. Estimates of investigator payments, lab costs, database development and management and adverse event reporting are based on parameters such as number of office visits, laboratory requirements, screening failure rates, location of the investigator site and the patient related factors discussed above. Historically, the Company has experienced fluctuations in the estimates of these costs and has implemented rigorous review processes to ensure reliability of estimates. Fluctuations that have occurred previously have been in the range of +/- 5% of total program costs and the Company would anticipate that similar fluctuations could occur in the future. Depending on the size of the trial, the estimated costs to complete and the volume of overall research and development activities during any given period, such fluctuations could be material to the results of operations and financial position (see Note 7). | ||
Costs related to the acquisition and retention of technology rights and patents for which development work is still in process are expensed as incurred and considered a component of research and development costs. | ||
FAIR_VALUE_MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended | |
Sep. 30, 2013 | ||
Fair Value Disclosures [Abstract] | ' | |
Fair Value Disclosures [Text Block] | ' | |
NOTE 2 | FAIR VALUE MEASUREMENTS | |
In determining fair value, the Company utilizes techniques that optimize the use of observable inputs, when available, and minimize the use of unobservable inputs to the extent possible. At September 30, 2013, assets measured at fair value on a recurring basis consisted of cash and cash equivalents of approximately $20.9 million. Based on the short-term liquid nature of these assets, the fair value, determined using level 1 inputs, is equivalent to the recorded book value. | ||
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] | ' | |||||||||||||
Note 3 | Stock-Based Compensation | |||||||||||||
The Company has a stock incentive plan, as amended (the “Plan”), under which stock options for 10,400,000 shares of the Company’s common stock may be granted. Grants under the Plan may be made to employees (including officers), directors, consultants, advisors or other independent contractors who provide services to the Company or its subsidiary. | ||||||||||||||
The Company’s accounting for stock options or similar equity instruments requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and non-employee directors based on estimated fair values determined using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Company’s statements of operations. | ||||||||||||||
During the three and nine months ended September 30, 2013 and 2012, the Company granted stock options to employees and non-employee directors as follows: | ||||||||||||||
For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||
Options granted during period | n/a | 827,000 | 985,500 | 2,136,000 | ||||||||||
Weighted average exercise price | n/a | $ | 1.14 | $ | 1.1 | $ | 3.26 | |||||||
Weighted average grant date fair value | n/a | $ | 0.81 | $ | 0.77 | $ | 2.21 | |||||||
On April 15, 2013, the Company granted options for the purchase of an aggregate of 200,000 shares of its common stock to non-employee directors that vest only upon a change of control of the Company. Per the Notice of Grant, a change of control is defined as the sale, lease, exchange or other transfer of substantially all of the assets of the Company; or if any person not a shareholder on the date of grant becomes the beneficial owner, directly or indirectly, of 50% or more of the combined voting power of the Company’s outstanding securities other than through a traditional financing transaction; or a merger or consolidation to which the Company is a party should occur resulting in the shareholders of the Company having beneficial ownership of less than 50% of the combined voting power of the surviving company’s outstanding securities immediately following such a transaction. These grants expire on December 31, 2014. The vesting of these options is conditioned upon an event that has not yet occurred. As such, compensation expense for these options will not be recorded unless and until that event occurs and the vesting condition is met. | ||||||||||||||
The fair value of each option award made to employees and directors during the three and nine months ended September 30, 2013 and 2012 was estimated on the date of grant using the Black-Scholes closed-form option valuation model utilizing the following assumptions. To determine the risk-free interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of the Company’s awards. The Company estimated the expected life of the options granted based on anticipated exercises in future periods. The expected dividends reflect the Company’s current and expected future policy for no payment of dividends on its common stock. The Company relies exclusively on the trading and price history of the Company’s stock in order to determine the expected volatility. The Company plans to continue to analyze the expected stock price volatility and expected term assumption at each grant date as more historical data for its common stock becomes available. Given the events of 2012 and the corporate restructuring that occurred in July 2012 that have negatively impacted the Company’s staffing levels, the estimated forfeiture rate was changed to 24% for the first six months of 2012 and the impact of this change in estimate was recognized as a cumulative catch-up and serves to reduce the stock-based compensation costs for the quarter ended June 30, 2012. In January 2013, the Company again reviewed its estimated forfeiture rate, based upon the adjusted staffing levels resulting from attrition in late 2012 and early 2013 and, effective at that date, modified its estimated forfeiture rate to 10%. Due to the limited amount of historical data available to the Company, particularly with respect to stock-price volatility, employee exercise patterns and forfeitures, actual results could differ from the Company’s assumptions. The table below summarizes the assumptions utilized in estimating the fair value of the stock options granted during the three and nine months ended September 30, 2013 and 2012: | ||||||||||||||
For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||
Weighted average risk-free interest rate | n/a | 0.69 | % | 0.69 | % | 0.74 | % | |||||||
Expected life of options | n/a | 5 years | 4.4 years | 5 years | ||||||||||
Expected dividend yield | n/a | 0 | % | 0 | % | 0 | % | |||||||
Weighted average expected volatility | n/a | 95.69 | % | 105.48 | % | 89.73 | % | |||||||
Options granted to employees and non-employee directors during the three and nine months ended September 30, 2013 and 2012, other than those granted to non-employee directors on April 15, 2013 more fully described above, vest as to 25% of the shares on each of the first, second, third and fourth anniversary of the vesting commencement date. Options granted to non-employee directors during the three months ended June 30, 2012 are exercisable and vest only upon a change in control of the Company, as defined above. Following the vesting periods, options are exercisable by employees until the earlier of 90 days after the employee’s termination with the Company or the ten-year anniversary of the initial grant, subject to adjustment under certain conditions and at the discretion of the Board of Directors. Following the vesting periods, options are exercisable by non-employee directors until the earlier of 180 days after they cease to be a member of the Board of Directors or the ten-year anniversary of the initial grant, subject to adjustment under certain conditions and at the discretion of the Board of Directors. As of January 2012, options that are forfeited or cancelled are not returned to the option pool and are, accordingly, no longer eligible for grant under the Plan. | ||||||||||||||
The table below summarizes the compensation expense recorded by the Company for the three and nine months ended September 30, 2013 and 2012 in conjunction with option grants made to employees and non-employee directors: | ||||||||||||||
For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||
Stock-based compensation expense recorded during period | $ | 413,670 | $ | 103,712 | 1,448,294 | $ | 1,385,400 | |||||||
Total unrecognized compensation expense remaining | $ | 3,351,245 | $ | 4,786,963 | $ | 3,351,245 | $ | 4,786,963 | ||||||
Remaining average recognition period (in years) | 2 | 2.65 | 2 | 2.65 | ||||||||||
As a result of the Company’s 2012 restructuring activities, stock-based compensation recorded for the three and nine months ended September 30, 2012 reflects the reversal of stock compensation expense for unvested options that were forfeited during the periods and the impact of option modifications made for former executives and former Board members as a component of their resignations (see Note 8). | ||||||||||||||
The table below summarizes options outstanding, options vested and aggregate intrinsic value as of September 30, 2013: | ||||||||||||||
As of | ||||||||||||||
30-Sep-13 | ||||||||||||||
Total options outstanding under the Plan | 7,156,709 | |||||||||||||
Weighted average remaining contractual life (in years) | 6.01 | |||||||||||||
Weighted average exercise price per share | $ | 3.52 | ||||||||||||
Total options oustanding and vested | 4,708,834 | |||||||||||||
Total in-the-money options oustanding | 3,882,624 | |||||||||||||
Aggregate intrinsic value of in-the-money options outstanding | $ | 4,575,451 | ||||||||||||
Total in-the-money options vested and outstanding | 2,209,999 | |||||||||||||
Aggregate intrinsic value of in-the-money options outstanding and vested | $ | 1,688,606 | ||||||||||||
The aggregate intrinsic value is calculated as the difference between the exercise prices of the underlying awards and the quoted closing price of the common stock of the Company as of September 30, 2013 and only include those awards that have an exercise price below the quoted closing price, or in-the-money options. | ||||||||||||||
During the three and nine months ended September 30, 2013, options for the purchase of 37,500 shares and 81,875 shares, respectively, were exercised at weighted average exercise prices of approximately $1.72 and $1.78 per share, respectively and had an aggregate intrinsic value at the dates of exercise of $28,425 and $49,912, respectively. During the three and nine months ended September 30, 2012, no options were exercised. During the three and nine months ended September 30, 2013, vested and unvested options for 367,500 shares and 822,986 shares, respectively, were forfeited by former employees. During the three and nine months ended September 30, 2012, unvested options for 519,100 and 605,600 shares, respectively, were forfeited by employees that resigned or were terminated during those periods. | ||||||||||||||
LOSS_PER_SHARE
LOSS PER SHARE | 9 Months Ended | |
Sep. 30, 2013 | ||
Earnings Per Share [Abstract] | ' | |
Earnings Per Share [Text Block] | ' | |
Note 4 | LOSS per share | |
Basic net loss per common share is calculated by dividing net loss by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. For the periods presented, basic and diluted net loss per common share are identical. Potentially dilutive securities from stock options and stock warrants would be antidilutive as the Company incurred a net loss. The number of shares of common stock potentially issuable at September 30, 2013 and 2012 upon exercise or conversion that were not included in the computation of net loss per share totaled 7,156,709 and 9,366,360 shares, respectively. | ||
COMMON_STOCK_WARRANTS
COMMON STOCK WARRANTS | 9 Months Ended | |
Sep. 30, 2013 | ||
Warrants and Rights Note Disclosure [Abstract] | ' | |
Warrants For Common Stock [Text Block] | ' | |
Note 5 | COMMON STOCK WARRANTS | |
No warrants were exercised during the three and nine months ended September 30, 2013 nor did any warrants remain outstanding as of September 30, 2013. | ||
In May 2013, unexercised warrants for the purchase of 250,000 shares of the Company’s stock expired. These warrants had been issued in 2006 in conjunction with and as compensation for activities related to a licensing agreement and under a Finder’s Agreement and permitted the holder to purchase the underlying common shares at $4.31 per share. The exercise of these warrants was conditioned on an event that occurred in January 2007 and, accordingly, the Company recorded a charge based on the warrants’ fair value determined at January 2007. | ||
In March 2013, unexercised warrants for the purchase of 1,286,764 shares of the Company’s stock expired. These warrants had been issued in March 2010 in conjunction with a 2010 sale of equities and permitted the holders to purchase the underlying common shares at $2.79 each or elect a net share settlement and were exercisable in whole at any time, or in part from time to time, during the period commencing six months after the date of issuance and ending three years from the date of issuance. Of the 2,345,000 warrants issued in 2010, warrants for the purchase of 1,058,236 shares had been exercised in previous periods. | ||
In February 2013, unexercised warrants for the purchase of 486,766 shares of the Company’s stock expired. These warrants had been issued in February 2006 in conjunction with a 2006 sale of equities and were exercisable in whole at any time, or in part from time to time, for cash or in a net share settlement, at an exercise price of $3.30 per share, for seven years from the date of issuance. Of the 716,666 warrants issued in 2006, warrants for the purchase of 229,900 shares had been exercised in previous periods. | ||
In February 2012, a warrant holder exercised the right to purchase 57,000 shares of the common stock of the Company, with an exercise price of $3.30 per share, pursuant to a cashless exercise whereby the Company, in a net share settlement, issued 17,148 shares of its common stock to the warrant holder based on the excess of the market price over the exercise price on the date of exercise. | ||
SALE_OF_COMMON_STOCK
SALE OF COMMON STOCK | 9 Months Ended | |
Sep. 30, 2013 | ||
Development Stage Enterprise, Additional Information For Statement Of Stockholders' Equity Disclosure [Abstract] | ' | |
Common Stock Offerings [Text Block] | ' | |
Note 6 | SALES OF COMMON STOCK | |
In November 2012, the Company filed the required documents and became eligible to use an at-the-market common equity sales program, or ATM, for the sale of shares of common stock up to an aggregate offering price of $20,000,000. These shares may be offered, from time to time at market prices under the Company’s 2012 shelf registration statement. During the quarter ended September 30, 2013, the Company sold 952,306 shares under the ATM at an average sales price of approximately $3.07 per share resulting in proceeds, net of expenses, of approximately $2.8 million. In addition, subsequent to September 30, 2013, the Company sold additional shares under the ATM (see Note 9). | ||
On February 8, 2012, the Company amended its shelf registration statement, originally filed on January 26, 2012, with the SEC, under which the Company may offer shares of its common stock and preferred stock, various series of debt securities and/or warrants to purchase any of such securities, either individually or in units, in one or more offerings, up to a total dollar amount of $100,000,000. Such registration statement, as amended, became effective as of February 9, 2012. | ||
On January 11, 2012, the Company raised gross proceeds of approximately $23.7 million through the sale of 4,989,275 shares of its common stock in a publicly-marketed offering. These shares were offered pursuant to the Company’s 2011 shelf registration statement, as amended effective January 5, 2012 pursuant to Rule 462(b) to increase the dollar amount of securities available for sale, filed with the SEC under which the Company could offer shares of its common stock and preferred stock, various series of debt securities and/or warrants to purchase any of such securities, either individually or in units, in one or more offerings, up to a total dollar amount of $63,950,000. Such registration statement became effective as of January 19, 2011. In connection with this offering, the Company paid commissions and other offering-related costs of approximately $1.6 million. | ||
There are no more securities available under the Company’s 2011 shelf registration statement. | ||
COMMITMENTS_AND_CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended | |
Sep. 30, 2013 | ||
Commitments and Contingencies Disclosure [Abstract] | ' | |
Commitments and Contingencies Disclosure [Text Block] | ' | |
Note 7 | commitments and contingencies | |
License Agreements | ||
In March 2004, the Company entered into a license agreement with Dr. M. Gopal Nair, Ph.D., of the University of South Alabama College of Medicine, for the rights to use, produce, distribute and market products derived from an invention by Dr. Nair, claimed in US Patent # 5,912,251, entitled “metabolically inert anti-inflammatory and antitumor antifolates”, designated by the Company as CH-1504 and related compounds. The license provides the Company exclusive rights, excluding India, for CH-1504 and related compounds. The Company made an upfront payment in May 2004 of $150,000 and milestone payments as required by the agreement of $100,000 each in March 2006 and 2005. In April 2007, the Company issued 26,643 shares of its common stock, subject to trading restrictions, at a value of approximately $5.63 per share, in settlement of the $150,000 annual milestone payment liability. In March 2008, the Company made a milestone payment of $100,000 related to patient dosing in a Phase II study as required by the agreement. In April 2008, the Company issued 30,612 shares of its common stock, subject to trading restrictions, at a value of approximately $4.90 per share, in settlement of the 2008 anniversary milestone payment. In April 2009, the Company made the 2009 anniversary milestone payment of $150,000. In September 2010, the Company made a milestone payment of $100,000 related to patient dosing in a Phase II study as required by the agreement. The Company is obligated to pay royalties under the agreement until the later of the expiration of the applicable patent or the applicable last date of market exclusivity after the first commercial sale, on a country-by-country basis. The potential royalty payment under the license agreement is a mid-single-digit percentage of net sales of the commercialized products licensed under the agreement and there are no minimum royalties required under the agreement. The Company is also obligated to make future potential milestone payments based on the achievement of specific development and regulatory approval milestones. Although the Company has no current development activity ongoing for this portfolio of compounds, approximately $1.5 million of payments might become due if specific clinical or regulatory milestones are achieved at a future date, subject to the Company’s right to terminate the license agreement. In addition, should the Company enter into an out-licensing agreement, such payments could be offset by revenue received from the sub-licensee. The agreement remains in effect until the date of the last to expire claim in the patent rights, if not terminated earlier. Currently, the date of the last to expire claim in the patent rights under this agreement is January 17, 2018, without consideration of the potential for patent term extension or the granting of additional patents. The agreement also provides for termination (i) upon material breach, including nonpayment by the Company of any monies due, if such breach remains uncured for a period of sixty days, (ii) for bankruptcy of the Company and (iii) for convenience by the Company upon thirty days’ written notice. | ||
In May 2006, the Company entered into an agreement with Dainippon Sumitomo Pharma Co., Ltd. (“DSP”) for an exclusive, sub-licensable license and rights to certain intellectual property and proprietary information (the “DSP Agreement”) relating to L-threo-3,4-dihydroxyphenylserine (“L-DOPS” or “droxidopa”) including, but not limited to all information, formulations, materials, data, drawings, sketches, designs, testing and test results, records and regulatory documentation. Pursuant to the DSP Agreement, DSP reserved rights to market droxidopa in Japan, Korea, China and Taiwan that precludes the Company’s commercialization of droxidopa in those markets. As consideration for these rights, the Company paid DSP $100,000 and issued 63,131 shares of its common stock, with a value of approximately $4.35 per share, or $274,621. As additional consideration, the Company agreed to pay DSP and/or its designees (1) royalties on the sales should any compound be approved for commercial sale, and (2) milestone payments, payable upon achievement of milestones as defined in the DSP Agreement. The potential royalty payment under the license agreement is a mid-single-digit percentage of net sales of the commercialized products licensed under the DSP Agreement. All obligations of the Company to pay royalties under the DSP Agreement expire (i) with respect to North America, which is defined to include the United States, Canada and Mexico, eight years after the First Commercial Sale, as defined in the DSP Agreement, in the United States, and (ii) with respect to the remainder of the territory, eleven years after the First Commercial Sale in either the United Kingdom, France, Italy, Germany or Spain. In February 2008, the Company made a milestone payment under the DSP Agreement of $500,000 related to patient dosing in a Phase III study. In December 2011, the Company made a milestone payment under the DSP Agreement of $750,000 related to submission of an NDA to the FDA and has remaining potential future milestone payments as of September 30, 2013, subject to the Company’s right to terminate the DSP Agreement, totaling $2.5 million, including a potential milestone payment of $1.5 million payable upon approval of an NDA. The DSP Agreement has no fixed term and upon expiration of the relevant royalty term, all of the licenses and rights granted to the Company in the applicable territory under the DSP Agreement shall become irrevocable, perpetual, fully-paid, and royalty-free. Prior to that, the DSP Agreement provides for termination (i) upon material breach by either party if such breach remains uncured for a period of sixty days from the date the breaching party was notified of such breach, (ii) for bankruptcy by either party upon thirty days written notice and (iii) for convenience by the Company upon sixty days written notice. The Company and DSP also initiated, and the Company agreed to fund, activities focused on modifying the manufacturing capabilities of DSP in order to expand capacity and comply with regulations and requirements of the FDA. Final expenses for this work were recognized in the second quarter of 2012 resulting in the Company recording cumulative expense of approximately $3.1 million. | ||
In conjunction with and as consideration for activities related to the execution of the DSP Agreement, the Company entered into a Finder’s Agreement with Paramount BioCapital, Inc. (“Paramount”). In May 2006, pursuant to the Finder’s Agreement, the Company issued warrants for the purchase of 250,000 shares of its common stock at an exercise price of $4.31 per share. The exercise of these warrants was conditioned on an event that occurred in January 2007 and, accordingly, the Company recorded a charge for the fair value of the warrants at January 2007 of $433,750. The Company utilized the Black-Scholes-Merton valuation model for estimating the fair value of the warrants as of the date the condition for exercise occurred, based on a risk-free interest rate of 4.79%, an expected life of three years, an expected dividend yield of 0%, an expected volatility of 66.01% and no estimated forfeitures. Such warrants remained unexercised and expired in May 2013. As additional consideration, the Company agreed to (1) make future milestone payments to Paramount, upon achievement of milestones as defined in the Finder’s Agreement, (2) pay royalties on sales should any licensed compound become available for commercial sale, and (3) compensate a stated third-party consultant for services rendered in the evaluation of the transaction with DSP. The Company has remaining potential future milestone payments under the Finder’s Agreement of $150,000. | ||
Contract Research and Manufacturing Purchase Obligations | ||
The Company often contracts with third parties to facilitate, coordinate and perform agreed upon research and development and manufacturing activities. These contracts typically call for the payment of fees for services at the initiation of the contract and/or upon the achievement of certain milestones. The Company currently intends to continue its research and manufacturing activities for contracts existing as of September 30, 2013. | ||
Additionally, the Company had contracted with a third party for the manufacture of commercial quantities of Northera prior to the date of the then anticipated marketing approval in early 2012 and might perform similar activities for this or other of its product candidates in the future. The scale-up and commercial production of pre-launch inventories involves the risk that such products may not be approved for marketing by the appropriate regulatory agencies on a timely basis, or ever. This risk notwithstanding, the Company initiated such activities with its primary supplier of active pharmaceutical ingredient of Northera in December 2010 and had incurred expenses of approximately $1.2 million related to these activities during 2012. Until final approval to market any of the Company’s product candidates is received from the appropriate regulatory agencies, such costs are expensed to research and development. No such costs have been incurred in 2013. In addition, in October 2011, the Company committed to the purchase of active pharmaceutical ingredient from the manufacturer, to be used in the production of commercial inventory, with a value of approximately $7.2 million, given exchange rates at that time. A small initial shipment of this material was delivered in the first quarter of 2012. In October 2012, the Company obtained a written waiver from the third-party manufacturer wherein the Company was released from its obligation to purchase the remaining material under this agreement. | ||
Legal Proceedings | ||
Following the receipt of the CRL from the FDA regarding the NDA for Northera™ (droxidopa) in March 2012 and the subsequent decline of the price of the Company’s common stock, two purported class action lawsuits were filed on April 4, 2012 and another purported class action lawsuit was filed on May 1, 2012 in the U.S. District Court for the Western District of North Carolina against us and certain of our executive officers. | ||
The complaints generally allege that, during differing class periods, all of the defendants violated Sections 10(b) of the Exchange Act and Rule 10b-5 and the individual defendants violated Section 20(a) of the Exchange Act in making various statements related to the Company’s development of Northera for the treatment of symptomatic neurogenic OH and the likelihood of FDA approval. The complaints seek unspecified damages, interest, attorneys’ fees, and other costs. Following consolidation of the three lawsuits and the appointment of a lead plaintiff, a consolidated complaint was filed on October 5, 2012, on behalf of purchasers of the Company’s common stock from November 3, 2008 through March 28, 2012. On November 16, 2012, the Company and the other defendants moved to dismiss the complaint. On October 10, 2013, the court granted the motion to dismiss with prejudice and entered judgment in favor of the defendants. The plaintiffs have 30 days to file a notice of appeal. The Company and its officers intend to vigorously defend against any appeal but are unable to predict the outcome or reasonably estimate a range of possible loss at this time. | ||
On May 2, 2012, a purported shareholder derivative lawsuit was filed in the Delaware Court of Chancery against the members of the Company’s board of directors as of the date of the lawsuit. The complaint generally alleges that, from at least June 2011 through February 2012, the defendants breached their fiduciary duties and otherwise caused harm to the Company in connection with various statements related to the development of Northera for the treatment of Neurogenic OH and the likelihood of FDA approval. The complaint seeks unspecified damages, attorneys’ fees and other costs. On June 25, 2012, the Court of Chancery entered an Order staying the action until the U.S. District Court for the Western District of North Carolina ruled upon the motion to dismiss that the Company and its officers filed in November 2012 in response to the consolidated complaint in the class action. Although the court granted the motion to dismiss as discussed above, the plaintiffs have 30 days to file a notice of appeal. | ||
Retention Bonus Plans | ||
In April 2013, at the direction of its Board of Directors, the Company implemented an Executive Retention Bonus Plan and an Employee Retention Bonus Plan. Under their respective plans, executives and employees employed by the Company as of April 23, 2013, are eligible to receive a bonus payment should the Company obtain approval from the FDA to market Northera in the U.S. In addition, executives and employees are eligible to receive a bonus payment should the Company enter into a transaction that results in (i) the sale, lease, exchange or other transfer of substantially all of the assets of the Company; (ii) any person not a shareholder on the date of grant becoming the beneficial owner, directly or indirectly, of 50% or more of the combined voting power of the Company’s outstanding securities other than through a traditional financing transaction; or, (iii) a merger or consolidation to which the Company is a party occurring that results in the shareholders of the Company having beneficial ownership of less than 50% of the combined voting power of the surviving company’s outstanding securities immediately following such a transaction. If such approval is obtained and/or should such a transaction occur, the Company would be obligated to make bonus payments of approximately $1.1 million in the aggregate to qualifying executives and employees for each event, calculated based on headcount as of September 30, 2013. As these bonus payments are conditioned on events that have yet to occur, no expense will be recorded by the Company unless and until the conditions for payment have been met. | ||
Other Contractual Obligations | ||
During 2011 and early 2012, the Company contracted with various third parties to facilitate, coordinate and perform agreed upon commercialization support activities in anticipation of receiving approval from the FDA of Northera in 2012. These contracts typically called for the payment of fees for services at the initiation of the contract and/or upon the achievement of certain milestones. In the event that the Company prepaid fees for future milestones, it would have recorded the prepayment as a prepaid asset and amortized the asset into sales and marketing expense over the period of time the contracted services were performed. Most fees were incurred throughout the contract period and were expensed based on the percentage of completion at a particular date. During the second quarter of 2012, the Company successfully curtailed these activities and cancelled the associated contracts given the receipt of the CRL from the FDA on March 28, 2012. The Company did incur a cancellation penalty on one of these contracts and, during the second quarter of 2012, recorded $100,000 of sales and marketing expense related to that penalty. | ||
Business activities performed under these contracts included, but were not limited to, market research, marketing and advertising planning and development, contracted Medical Science Liaison professionals, sales territory mapping, publication planning, sales force recruiting, sales operations support and planning, messaging and website development, public relations and information technology support and planning. | ||
RESTRUCTURING
RESTRUCTURING | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Restructuring and Related Activities [Abstract] | ' | ||||||||||||||||
Restructuring and Related Activities Disclosure [Text Block] | ' | ||||||||||||||||
NOTE 8 RESTRUCTURING | |||||||||||||||||
In July 2012, the Company, at the direction of its Board of Directors, conducted a corporate restructuring under which the number of employees was significantly reduced, retaining only those employees necessary to continue the Company’s efforts to obtain marketing approval for Northera in the United States. This reduction in force primarily, but not exclusively, impacted those positions that had been filled in 2011 and 2012 to support the planned commercialization of Northera in the United States. In addition, the Company’s Chief Executive Officer, or CEO, and its Vice President of Sales and Marketing left the Company. The Company’s Vice President of Operations was appointed Interim President and CEO as the Board evaluates candidates for that position. At the Board level, the Chairman of the Board stepped down, but remains a director, while another existing director assumed the role of Chairman. The former CEO and two other directors also resigned from the Board. | |||||||||||||||||
Other than severance payments that continue to be made to its former CEO per the terms of his severance agreement, the Company has completed all other severance payments related to the reduction in force as of September 30, 2013. As a component of the former CEO’s departure, the Company accelerated the vesting of all unvested options that had been previously granted to its former CEO and extended the period in which those options could be exercised from 90 days from the date of termination of July 10, 2012, to two years from that date. For the directors that resigned from the Board, the Company accelerated the vesting of all unvested options that had been previously granted and extended the period in which those options can be exercised from 180 days from the date of separation of July 9, 2012, to one year from that date. As of September 30, 2013, those former directors had exercised options for the purchase of 65,000 shares and options for the purchase of 335,000 shares remained unexercised and have expired (see Note 3). For the former Vice President of Sales and Marketing, the Company agreed that options would continue to vest and could be exercised until the end of his severance period plus 90 days. As of September 30, 2013, all options that had been issued to the former Vice President of Sales and Marketing remained unexercised and have expired (see Note 3). For purposes of determining the accounting impact of these modifications, it is assumed that the original grants are cancelled and new grants are issued. The calculation based upon such assumptions resulted in adjustments being recorded to true-up stock-based compensation expense recorded for those options in 2012 based upon an adjusted fair value. | |||||||||||||||||
During 2012, the Company established a reserve related to the costs of the restructuring totaling approximately $2.5 million. As of September 30, 2013, the Company had made cash payments of approximately $2.0 million related to this reserve and had made other non-cash adjustments of approximately $0.1 million. The activity associated with the reserve established by the Company for restructuring charges associated with these actions as of September 30, 2013 are as follows: | |||||||||||||||||
Restructuring | Adjustments, | Restructuring | |||||||||||||||
Liabilities as of | Non-cash items | Liabilities as of | |||||||||||||||
December 31, | Charges to the | Cash | and Changes | September 30, | |||||||||||||
2012 | Reserve | Payments | to Estimates | 2013 | |||||||||||||
Employee related costs: | |||||||||||||||||
Severance, salary continuation and related costs | $ | 841,184 | $ | - | $ | -446,235 | $ | - | $ | 394,949 | |||||||
Other costs | - | - | - | - | - | ||||||||||||
Totals | $ | 841,184 | $ | - | $ | -446,235 | $ | - | $ | 394,949 | |||||||
SUBSEQUENT_EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2013 | |
Subsequent Events [Abstract] | ' |
Subsequent Events [Text Block] | ' |
NOTE 9 SUBSEQUENT EVENTS | |
Sales of Common Stock | |
Subsequent to September 30, 2013, the Company sold 2,657,289 shares of its common stock under its ATM at an average sales price of approximately $3.00 per share resulting in proceeds, net of expenses, of approximately $7.6 million. Cumulatively during 2013, the Company has sold 3,609,595 shares under the program at an average sales price of $3.02 per share resulting in proceeds, net of expenses, of approximately $10.4 million (See Note 6). On November 1, 2013, the Company provided notice to the bank of its intent to terminate the sales agreement related to the ATM, effective November 11, 2013 and no further sales will be made under its ATM. | |
SUMMARY_OF_SIGNIFICANT_ACCOUNT1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NATURE OF OPERATIONS (Policies) | 9 Months Ended |
Sep. 30, 2013 | |
Accounting Policies [Abstract] | ' |
Basis of Accounting, Policy [Policy Text Block] | ' |
Basis of Presentation | |
The accompanying condensed consolidated financial statements include the accounts of the Company and its operating subsidiary, which shall collectively be referred to as the “Company”. These statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial reporting and the instructions to Form 10-Q and do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of the Company’s management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results for the interim periods have been included. Operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results for the year ending December 31, 2013 or future periods. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K/A filed on March 14, 2013 and available on the website (www.sec.gov) of the United States Securities and Exchange Commission, or the SEC. The accompanying condensed consolidated balance sheet as of December 31, 2012 has been derived from the audited balance sheet as of that date included in the Form 10-K/A. | |
Consolidation, Policy [Policy Text Block] | ' |
Basis of Consolidation | |
The accompanying financial statements present, on a condensed consolidated basis, the financial position and results of operations of Chelsea Ltd. and its subsidiary. All significant intercompany transactions and balances have been eliminated in consolidation. | |
Use of Estimates, Policy [Policy Text Block] | ' |
Use of Estimates | |
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the financial statements as well as the reported expenses during the reporting periods. On an ongoing basis, management evaluates its estimates and judgments. Management bases estimates on its historical experience and on various other factors that it believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results might differ from these estimates under different assumptions or conditions. | |
Significant estimates and assumptions are required related to the estimated costs and estimated percentages of completion of research and development activities that are outsourced to third-party contractors, the valuation of assets and stock-based compensation. Some of these judgments can be subjective and complex, and, consequently, actual results may differ from these estimates. For any given individual estimate or assumption made by the Company, there may also be other estimates or assumptions that are reasonable. Although the Company believes that its estimates and assumptions are reasonable, they are based upon information available at the time the estimates and assumptions were made and actual results may differ significantly from such estimates. | |
Research and Development Expense, Policy [Policy Text Block] | ' |
Research and Development | |
Research and development expenditures are expensed based upon the estimated percentage of completion at the financial statement date applied against estimated amounts to complete the project. The Company often contracts with third-party contract research organizations, or CROs, to facilitate, coordinate and perform agreed upon research and development activities. Estimates are calculated, maintained and presented to the Company by CROs and are then subjected to rigorous periodic internal review and analysis to ensure reasonableness of the estimates. Such review includes difficult, subjective and complex judgments, particularly in instances of studying orphan drug candidates where prior clinical activity is limited, providing little or no historical cost information. Given the highly variable nature of the costs involved in the completion of a clinical or pre-clinical trial, fluctuations in costs estimates can occur at any time during the trial or at its conclusion based on a number of factors including, but not limited to, the rate at which investigator sites are identified, the locations of those sites (US versus International), the timing of site activations, the rate at which patients are enrolled into a trial, changes to the number of sites and/or patients that are targeted for the trial, the timelines for trial completion and changes in scope of the actions to be taken by the CROs. | |
Given that the recognition of expense related to the Company’s contracted research and development activities comprise a significant component of reported expenses during any given period, such fluctuations can be material to the results of operations and/or the carrying value of assets and liabilities. The estimates to complete each contracted project are also used in the determination and disclosure of contractual obligations of the Company providing a snapshot of estimated cash requirements arising from future contractual payment obligations based upon the best information available at the time the financial statements are published. | |
To ensure that such estimates allow research and development costs to be expensed as incurred, the Company measures expense based on estimated work performed for the underlying contract, typically utilizing a percentage-of-completion approach, and records prepaid assets or accrues expenses on a monthly basis for such activities based on the measurement of liability from expense recognition and the receipt of invoices. Contracts for research and development programs typically call for the payment of fees for services at the initiation of the contract and/or upon the achievement of certain milestones. In the event that the Company prepays fees for future milestones, the Company records the prepayment as a prepaid asset and amortizes the asset into research and development expense over the period of time the contracted research and development services are performed. Most fees are incurred throughout the contract period and are expensed based on their estimated percentage of completion at a particular date. Although such fees may fluctuate during the life of a research and development program, such fluctuations are generally based on changes in or delays in the timelines for study completion. | |
These contracts generally include pass through fees. Pass through fees include, but are not limited to, regulatory expenses, investigator fees, laboratory fees, travel costs, and other miscellaneous costs including database management, adverse event reporting, shipping and printing fees. Because these fees are incurred at various times during the contract term and they are used throughout the contract term, the Company records a monthly expense estimate to recognize the fees during the contract period. Fees incurred to set up the clinical trial are expensed during the setup period. Estimating the costs of pass-through expenses for a contracted research and development program can be difficult and complex. Judgments used in the development of these estimates are based on a number of considerations, including the input of the CRO, the costs of previous clinical trials, estimates of patient recruitment rates, estimates of drop-out rates and estimates of site identification and activation rates. Estimates of investigator payments, lab costs, database development and management and adverse event reporting are based on parameters such as number of office visits, laboratory requirements, screening failure rates, location of the investigator site and the patient related factors discussed above. Historically, the Company has experienced fluctuations in the estimates of these costs and has implemented rigorous review processes to ensure reliability of estimates. Fluctuations that have occurred previously have been in the range of +/- 5% of total program costs and the Company would anticipate that similar fluctuations could occur in the future. Depending on the size of the trial, the estimated costs to complete and the volume of overall research and development activities during any given period, such fluctuations could be material to the results of operations and financial position (see Note 7). | |
Costs related to the acquisition and retention of technology rights and patents for which development work is still in process are expensed as incurred and considered a component of research and development costs. | |
STOCKBASED_COMPENSATION_Tables
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended | |||||||||||||
Sep. 30, 2013 | ||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | |||||||||||||
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award [Table Text Block] | ' | |||||||||||||
During the three and nine months ended September 30, 2013 and 2012, the Company granted stock options to employees and non-employee directors as follows: | ||||||||||||||
For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||
Options granted during period | n/a | 827,000 | 985,500 | 2,136,000 | ||||||||||
Weighted average exercise price | n/a | $ | 1.14 | $ | 1.1 | $ | 3.26 | |||||||
Weighted average grant date fair value | n/a | $ | 0.81 | $ | 0.77 | $ | 2.21 | |||||||
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | ' | |||||||||||||
The table below summarizes the assumptions utilized in estimating the fair value of the stock options granted during the three and nine months ended September 30, 2013 and 2012: | ||||||||||||||
For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||
Weighted average risk-free interest rate | n/a | 0.69 | % | 0.69 | % | 0.74 | % | |||||||
Expected life of options | n/a | 5 years | 4.4 years | 5 years | ||||||||||
Expected dividend yield | n/a | 0 | % | 0 | % | 0 | % | |||||||
Weighted average expected volatility | n/a | 95.69 | % | 105.48 | % | 89.73 | % | |||||||
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | ' | |||||||||||||
The table below summarizes the compensation expense recorded by the Company for the three and nine months ended September 30, 2013 and 2012 in conjunction with option grants made to employees and non-employee directors: | ||||||||||||||
For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||
Stock-based compensation expense recorded during period | $ | 413,670 | $ | 103,712 | 1,448,294 | $ | 1,385,400 | |||||||
Total unrecognized compensation expense remaining | $ | 3,351,245 | $ | 4,786,963 | $ | 3,351,245 | $ | 4,786,963 | ||||||
Remaining average recognition period (in years) | 2 | 2.65 | 2 | 2.65 | ||||||||||
Schedule of Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding [Table Text Block] | ' | |||||||||||||
The table below summarizes options outstanding, options vested and aggregate intrinsic value as of September 30, 2013: | ||||||||||||||
As of | ||||||||||||||
30-Sep-13 | ||||||||||||||
Total options outstanding under the Plan | 7,156,709 | |||||||||||||
Weighted average remaining contractual life (in years) | 6.01 | |||||||||||||
Weighted average exercise price per share | $ | 3.52 | ||||||||||||
Total options oustanding and vested | 4,708,834 | |||||||||||||
Total in-the-money options oustanding | 3,882,624 | |||||||||||||
Aggregate intrinsic value of in-the-money options outstanding | $ | 4,575,451 | ||||||||||||
Total in-the-money options vested and outstanding | 2,209,999 | |||||||||||||
Aggregate intrinsic value of in-the-money options outstanding and vested | $ | 1,688,606 | ||||||||||||
RESTRUCTURING_Tables
RESTRUCTURING (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Restructuring and Related Activities [Abstract] | ' | ||||||||||||||||
Schedule of Restructuring and Related Costs [Table Text Block] | ' | ||||||||||||||||
The activity associated with the reserve established by the Company for restructuring charges associated with these actions as of September 30, 2013 are as follows: | |||||||||||||||||
Restructuring | Adjustments, | Restructuring | |||||||||||||||
Liabilities as of | Non-cash items | Liabilities as of | |||||||||||||||
December 31, | Charges to the | Cash | and Changes | September 30, | |||||||||||||
2012 | Reserve | Payments | to Estimates | 2013 | |||||||||||||
Employee related costs: | |||||||||||||||||
Severance, salary continuation and related costs | $ | 841,184 | $ | - | $ | -446,235 | $ | - | $ | 394,949 | |||||||
Other costs | - | - | - | - | - | ||||||||||||
Totals | $ | 841,184 | $ | - | $ | -446,235 | $ | - | $ | 394,949 | |||||||
SUMMARY_OF_SIGNIFICANT_ACCOUNT2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NATURE OF OPERATIONS (Details Textual) | Jul. 31, 2005 |
Noncontrolling Interest, Ownership Percentage by Parent | 100.00% |
FAIR_VALUE_MEASUREMENTS_Detail
FAIR VALUE MEASUREMENTS (Details Textual) (USD $) | Sep. 30, 2013 |
In Millions, unless otherwise specified | |
Cash and Cash Equivalents, Fair Value Disclosure | $20.90 |
STOCKBASED_COMPENSATION_Detail
STOCK-BASED COMPENSATION (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Options granted during period (in shares) | ' | 827,000 | 985,500 | 2,136,000 |
Weighted average exercise price (in dollars per share) | ' | $1.14 | $1.10 | $3.26 |
Weighted average grant date fair value (in dollars per share) | ' | $0.81 | $0.77 | $2.21 |
STOCKBASED_COMPENSATION_Detail1
STOCK-BASED COMPENSATION (Details 1) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Weighted average risk-free interest rate | ' | 0.69% | 0.69% | 0.74% |
Expected life of options | ' | '5 years | '4 years 4 months 24 days | '5 years |
Expected dividend yield | ' | 0.00% | 0.00% | 0.00% |
Weighted average expected volatility | ' | 95.69% | 105.48% | 89.73% |
STOCKBASED_COMPENSATION_Detail2
STOCK-BASED COMPENSATION (Details 2) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Stock-based compensation expense recorded during period | $413,670 | $103,712 | $1,448,294 | $1,385,400 |
Total unrecognized compensation expense remaining | $3,351,245 | $4,786,963 | $3,351,245 | $4,786,963 |
Remaining average recognition period (in years) | '2 years | '2 years 7 months 24 days | '2 years | '2 years 7 months 24 days |
STOCKBASED_COMPENSATION_Detail3
STOCK-BASED COMPENSATION (Details 3) (USD $) | 9 Months Ended |
Sep. 30, 2013 | |
Options outstanding under the plan: | ' |
Total options outstanding under the Plan | 7,156,709 |
Weighted average remaining contractual life (in years) | '6 years 4 days |
Weighted average exercise price per share | $3.52 |
Total options outstanding and vested | 4,708,834 |
Total in-the-money options outstanding | 3,882,624 |
Aggregate intrinsic value of in-the-money options outstanding | $4,575,451 |
Total in-the-money options vested and outstanding | 2,209,999 |
Aggregate intrinsic value of in-the-money options outstanding and vested | $1,688,606 |
STOCKBASED_COMPENSATION_Detail4
STOCK-BASED COMPENSATION (Details Textual) (USD $) | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Jun. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 10,400,000 | ' | ' | 10,400,000 | ' |
Share Based Compensation Arrangement By Share Based Payment Award Vesting Percentage | ' | ' | ' | 25.00% | 25.00% |
Share Based Compensation Arrangement Share Based Payment Award Unvested Options Forfeitures In Period | 367,500 | 519,100 | ' | 822,986 | 605,600 |
Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price | $1.72 | ' | ' | $1.78 | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $28,425 | ' | ' | $49,912 | ' |
Share Based Compensation Arrangement Share Based Payment Award Estimated Forfeiture Rate | ' | ' | 24.00% | 10.00% | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Net of Forfeitures, Total | ' | 827,000 | ' | 985,500 | 2,136,000 |
Employees [Member] | ' | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 37,500 | ' | ' | 81,875 | ' |
Non Employee Directors [Member] | ' | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Net of Forfeitures, Total | ' | ' | ' | 200,000 | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | ' | ' | ' | 50.00% | ' |
LOSS_PER_SHARE_Details_Textual
LOSS PER SHARE (Details Textual) (Contingently Issuable Shares [Member]) | 9 Months Ended | |
Sep. 30, 2013 | Sep. 30, 2012 | |
Contingently Issuable Shares [Member] | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 7,156,709 | 9,366,360 |
COMMON_STOCK_WARRANTS_Details_
COMMON STOCK WARRANTS (Details Textual) (USD $) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
31-May-13 | Mar. 31, 2013 | Feb. 28, 2013 | Feb. 29, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2010 | Dec. 31, 2006 | |
Unexercised Warrants To Purchase Common Stock Expired | 250,000 | 1,286,764 | 486,766 | ' | ' | ' | ' | ' |
Development Stage Entities, Equity Issuance, Per Share Amount | ' | ' | ' | ' | ' | ' | $2.79 | $4.31 |
Warrants Issued To Purchase Common Stock Shares | ' | ' | ' | ' | ' | ' | 2,345,000 | 716,666 |
Warrants Exercised During Period | ' | ' | ' | 57,000 | 0 | 0 | 1,058,236 | 229,900 |
Warrants Exercise Price | ' | ' | $3.30 | $3.30 | ' | ' | ' | ' |
Stock Issued During Period Shares Pursuant To Net Share Exercises Of Common Stock Warrants | ' | ' | ' | 17,148 | ' | ' | ' | ' |
Class of Warrant or Right, Outstanding | ' | ' | ' | ' | 0 | 0 | ' | ' |
SALE_OF_COMMON_STOCK_Details_T
SALE OF COMMON STOCK (Details Textual) (USD $) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2013 | Dec. 31, 2012 | Jan. 05, 2012 | |
Aggregate Offering Price Of Shares To Be Issued | ' | $20,000,000 | ' |
Stock Authorized Under Shelf Registration Statement | ' | 100,000,000 | 63,950,000 |
Proceeds from Issuance of Common Stock | ' | 23,700,000 | ' |
Payments of Stock Issuance Costs | ' | 1,600,000 | ' |
Stock Issued During Period Average Sales Price Market Equity Offering Program | $3.06 | ' | ' |
Stock Issued During Period Value Market Equity Offering Program | 2,781,604 | ' | ' |
Common Stock [Member] | ' | ' | ' |
Common stock issued during period, shares | ' | 4,989,275 | ' |
Stock Issued During Period, Shares, Market Equity Offering Program | 952,306 | ' | ' |
Stock Issued During Period Value Market Equity Offering Program | $95 | ' | ' |
COMMITMENTS_AND_CONTINGENCIES_
COMMITMENTS AND CONTINGENCIES (Details Textual) (USD $) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | 12 Months Ended | 12 Months Ended | 3 Months Ended | 12 Months Ended | 12 Months Ended | ||||||||||||||||||
Jan. 31, 2007 | 31-May-06 | Feb. 28, 2006 | Feb. 28, 2005 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2004 | Apr. 23, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Dec. 31, 2010 | Dec. 31, 2009 | Dec. 31, 2008 | Dec. 31, 2007 | Dec. 31, 2006 | Dec. 31, 2005 | Dec. 31, 2004 | Jun. 30, 2012 | Dec. 31, 2011 | Dec. 31, 2008 | Dec. 31, 2006 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2006 | Sep. 30, 2013 | |
Contract Research and Manufacturing Purchase Obligations [Member] | Contract Research and Manufacturing Purchase Obligations [Member] | License Agreement With Gopal Nair [Member] | License Agreement With Gopal Nair [Member] | License Agreement With Gopal Nair [Member] | License Agreement With Gopal Nair [Member] | License Agreement With Gopal Nair [Member] | License Agreement With Gopal Nair [Member] | License Agreement With Gopal Nair [Member] | License Agreement With Dainippon Sumitomo Pharma [Member] | License Agreement With Dainippon Sumitomo Pharma [Member] | License Agreement With Dainippon Sumitomo Pharma [Member] | License Agreement With Dainippon Sumitomo Pharma [Member] | License Agreement With Dainippon Sumitomo Pharma [Member] | License Agreement With Dainippon Sumitomo Pharma [Member] | Finders Agreement [Member] | Finders Agreement [Member] | |||||||||||
Use Rights [Member] | Use Rights [Member] | Use Rights [Member] | Use Rights [Member] | Use Rights [Member] | Use Rights [Member] | Use Rights [Member] | Use Rights [Member] | Use Rights [Member] | Use Rights [Member] | Use Rights [Member] | Use Rights [Member] | Use Rights [Member] | Warrant [Member] | Warrant [Member] | |||||||||||||
N D A [Member] | |||||||||||||||||||||||||||
Initial Payment Towards Use Of Rights As Per License Agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $150,000 | ' | ' | ' | $100,000 | ' | ' | ' | ' |
Value Of Common Stock Issued During Period Towards Milestone Payment | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 150,000 | 100,000 | 100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common Stock Shares Issued During Period To wards Milestone Payment | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 30,612 | 26,643 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Fair Value Of Common Stock Issued During Period Towards Milestone Payment | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $4.90 | $5.63 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone Payment Made During Period | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 100,000 | 150,000 | 100,000 | ' | ' | ' | ' | ' | 750,000 | 500,000 | ' | ' | ' | ' | ' |
Potential Future Milestone Payments | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2,500,000 | 1,500,000 | ' | 150,000 |
Common Stock Shares Issued During Period Towards Right To Use Intellectual Property | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 63,131 | ' | ' | ' | ' |
Fair Value Of Common Stock Issued During Period Towards Right To Use Intellectual Property | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $4.35 | ' | ' | ' | ' |
Value Of Common Stock Issued During Period Towards Right To Use Intellectual Property | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 274,621 | ' | ' | ' | ' |
Research and Development Expense (Excluding Acquired in Process Cost) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,200,000 | ' | ' | ' | ' | ' | ' | ' | ' | 3,100,000 | ' | ' | ' | ' | ' | ' | ' |
Warrants issued to purchase common stock | 0 | 250,000 | 716,666 | 105,516 | ' | ' | ' | ' | 483,701 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock warrants, purchase price (in dollars per share) | $0 | $4.31 | $3.30 | $2.62 | ' | ' | ' | ' | $2.88 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Fair Value Of Warrants Granted | 433,750 | 0 | 705,000 | 26,700 | ' | ' | ' | ' | 14,400 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted average risk-free interest rate | ' | ' | ' | ' | ' | 0.69% | 0.69% | 0.74% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 4.79% | ' |
Weighted-average expected life of options | ' | ' | ' | ' | ' | '5 years | '4 years 4 months 24 days | '5 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '3 years | ' |
Expected dividend yield | ' | ' | ' | ' | ' | 0.00% | 0.00% | 0.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0.00% | ' |
Weighted average expected volatility | ' | ' | ' | ' | ' | 95.69% | 105.48% | 89.73% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 66.01% | ' |
Beneficial Ownership Percentage | ' | ' | ' | ' | ' | ' | ' | ' | ' | 50.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Commitment And Contingencies, Bonus Payments Obligation | ' | ' | ' | ' | 1,100,000 | ' | 1,100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Purchase Obligation, Total | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $7,200,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
RESTRUCTURING_Details
RESTRUCTURING (Details) (USD $) | 9 Months Ended |
Sep. 30, 2013 | |
Restructuring Liabilities as of December 31, 2012 | $841,184 |
Charges to the Reserve | 0 |
Cash Payments | -446,235 |
Adjustments, Non-cash items and Changes to Estimates | 0 |
Restructuring Liabilities as of June 30, 2013 | 394,949 |
Employee Related Costs Severance and Salary Continuation [Member] | ' |
Restructuring Liabilities as of December 31, 2012 | 841,184 |
Charges to the Reserve | 0 |
Cash Payments | -446,235 |
Adjustments, Non-cash items and Changes to Estimates | 0 |
Restructuring Liabilities as of June 30, 2013 | 394,949 |
Other costs [Member] | ' |
Restructuring Liabilities as of December 31, 2012 | 0 |
Charges to the Reserve | 0 |
Cash Payments | 0 |
Adjustments, Non-cash items and Changes to Estimates | 0 |
Restructuring Liabilities as of June 30, 2013 | $0 |
RESTRUCTURING_Details_Textual
RESTRUCTURING (Details Textual) (USD $) | 9 Months Ended | 12 Months Ended |
In Millions, except Share data, unless otherwise specified | Sep. 30, 2013 | Dec. 31, 2012 |
Restructuring Charges To Reserve Total | ' | $2.50 |
Cash Payments Related To Restructuring Reserves | 2 | ' |
Restructuring Reserve Accrual Adjustment Total | $0.10 | ' |
Director [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 65,000 | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Expirations in Period | 335,000 | ' |
SUBSEQUENT_EVENTS_Details_Text
SUBSEQUENT EVENTS (Details Textual) (USD $) | 12 Months Ended | 9 Months Ended | |
In Millions, except Share data, unless otherwise specified | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 |
Subsequent Event [Member] | Cumulative Sales [Member] | ||
Stock Issued During Period, Shares, New Issues | ' | 2,657,289 | 3,609,595 |
Proceeds From Equity Issuance Per Share Amount | ' | $3 | $3.02 |
Proceeds From Issuance Of Common Stock | $23.70 | $7.60 | $10.40 |