Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | 11-May-15 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | ARCA Biopharma, Inc. | |
Entity Central Index Key | 907654 | |
Document Type | 10-Q | |
Amendment Flag | FALSE | |
Document Period End Date | 31-Mar-15 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | ABIO | |
Document Fiscal Year Focus | 2015 | |
Current Fiscal Year End Date | -19 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 21,198,411 |
BALANCE_SHEETS
BALANCE SHEETS (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $12,184 | $15,354 |
Other current assets | 490 | 134 |
Total current assets | 12,674 | 15,488 |
Property and equipment, net | 34 | 36 |
Other assets | 553 | 608 |
Total assets | 13,261 | 16,132 |
Current liabilities: | ||
Accounts payable | 651 | 795 |
Accrued compensation and employee benefits | 123 | 329 |
Accrued expenses and other liabilities | 359 | 264 |
Total current liabilities | 1,133 | 1,388 |
Deferred rent, net of current portion | 1 | 3 |
Total liabilities | 1,134 | 1,391 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value; 100 million shares authorized at March 31, 2015 and December 31, 2014; 21,198,411 and 21,150,486 shares issued and outstanding at March 31, 2015 and December 31, 2014, respectively | 21 | 21 |
Additional paid-in capital | 99,472 | 99,342 |
Accumulated deficit | -87,366 | -84,622 |
Total stockholders’ equity | 12,127 | 14,741 |
Total liabilities and stockholders’ equity | $13,261 | $16,132 |
BALANCE_SHEETS_Parenthetical
BALANCE SHEETS (Parenthetical) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 21,198,411 | 21,150,486 |
Common stock, shares outstanding | 21,198,411 | 21,150,486 |
STATEMENTS_OF_OPERATIONS_AND_C
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (USD $) | 3 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Costs and expenses: | ||
Research and development | $1,707 | $1,308 |
General and administrative | 1,037 | 1,082 |
Total costs and expenses | 2,744 | 2,390 |
Loss from operations | -2,744 | -2,390 |
Interest and other income | 1 | 2 |
Interest expense | -1 | -1 |
Net loss and comprehensive loss | ($2,744) | ($2,389) |
Net loss per share: | ||
Basic and diluted | ($0.13) | ($0.13) |
Weighted average shares outstanding: | ||
Basic and diluted | 21,167,523 | 18,785,418 |
STATEMENTS_OF_STOCKHOLDERS_EQU
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (USD $) | Total | Common stock | Additional Paid-in Capital | Accumulated Deficit |
In Thousands, except Share data | ||||
Beginning Balance at Dec. 31, 2013 | $15,581 | $16 | $90,498 | ($74,933) |
Beginning Balance, shares at Dec. 31, 2013 | 15,685,562 | |||
Issuance of common stock for cash, net of offering costs, shares | 5,116,228 | |||
Issuance of common stock for cash, net of offering costs | 7,866 | 5 | 7,861 | |
Issuance of common stock upon exercise of warrants for cash, shares | 209,025 | |||
Issuance of common stock upon exercise of warrants for cash, value | 338 | 338 | ||
Issuance of common stock upon vesting of Restricted Stock Units, shares | 139,671 | |||
Issuance of common stock upon vesting of Restricted Stock Units, value | -2 | -2 | ||
Share-based compensation | 647 | 647 | ||
Net loss | -9,689 | -9,689 | ||
Ending Balance at Dec. 31, 2014 | 14,741 | 21 | 99,342 | -84,622 |
Ending Balance, shares at Dec. 31, 2014 | 21,150,486 | |||
Issuance of common stock upon vesting of Restricted Stock Units, shares | 47,925 | |||
Share-based compensation | 130 | 130 | ||
Net loss | -2,744 | -2,744 | ||
Ending Balance at Mar. 31, 2015 | $12,127 | $21 | $99,472 | ($87,366) |
Ending Balance, shares at Mar. 31, 2015 | 21,198,411 |
STATEMENTS_OF_CASH_FLOWS
STATEMENTS OF CASH FLOWS (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Cash flows from operating activities: | ||
Net loss | ($2,744) | ($2,389) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 4 | 3 |
Amortization of deferred charges | 31 | |
Share-based compensation | 130 | 158 |
Change in operating assets and liabilities: | ||
Other current assets | -139 | -251 |
Other assets | -698 | |
Accounts payable | -144 | -45 |
Accrued compensation and employee benefits | -206 | -348 |
Accrued expenses and other liabilities | -43 | -117 |
Other | -2 | |
Net cash used in operating activities | -3,113 | -3,687 |
Cash flows from investing activities: | ||
Purchase of property and equipment | -2 | |
Net cash used in investing activities | -2 | |
Cash flows from financing activities: | ||
Proceeds from the issuance of common stock | 9,018 | |
Repayment of principal on vendor finance agreement | -55 | -51 |
Net cash (used in) provided by financing activities | -55 | 8,133 |
Net (decrease) increase in cash and cash equivalents | -3,170 | 4,446 |
Cash and cash equivalents, beginning of period | 15,354 | 16,756 |
Cash and cash equivalents, end of period | 12,184 | 21,202 |
Supplemental cash flow information: | ||
Interest paid | 1 | 1 |
Supplemental disclosure of noncash investing and financing transactions: | ||
Vendor finance agreement | 138 | 128 |
Common stock | ||
Cash flows from financing activities: | ||
Offering costs | ($834) |
The_Company_and_Summary_of_Sig
The Company and Summary of Significant Accounting Policies | 3 Months Ended | |
Mar. 31, 2015 | ||
Accounting Policies [Abstract] | ||
The Company and Summary of Significant Accounting Policies | (1) The Company and Summary of Significant Accounting Policies | |
Description of Business | ||
ARCA biopharma, Inc., or the Company or ARCA, a Delaware corporation, is headquartered in Westminster, Colorado. The Company is a biopharmaceutical company principally focused on developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate, Gencaro™ (bucindolol hydrochloride), is a pharmacologically unique beta-blocker and mild vasodilator that ARCA is evaluating in a clinical trial for the treatment of atrial fibrillation, or AF, in patients with heart failure and left ventricular dysfunction, or HFREF. The Company has identified common genetic variations in receptors in the cardiovascular system that it believes interact with Gencaro’s pharmacology and may predict patient response to the drug. | ||
The Company is testing this hypothesis in a Phase 2B/3 clinical trial of Gencaro, known as GENETIC-AF. The AF indication for Gencaro was chosen based on clinical data from a prior Phase 3 heart failure (HF) trial of Gencaro in 2,708 HF patients, or the BEST trial, which suggested that Gencaro may be successful in reducing or preventing AF. GENETIC-AF is a multi-center, randomized, double-blind clinical trial designed to compare the safety and efficacy of Gencaro to an active comparator in HFREF patients with a current or recent history of paroxysmal (AF episodes lasting 7 days or less) or persistent AF and having a beta-1 389 arginine homozygous genotype, the genotype the Company believes responds most favorably to Gencaro. The primary endpoint of GENETIC-AF is time to recurrent symptomatic AF/atrial flutter (AFL) or all-cause mortality. | ||
ARCA has created an adaptive design for GENETIC-AF and is seeking to enroll approximately 200 HFREF patients in the Phase 2B portion of the study. The GENETIC-AF Data Safety Monitoring Board (DSMB) will analyze certain data from the Phase 2B portion of the trial and recommend, based on a comparison to the pre-trial statistical assumptions, whether the trial should proceed to Phase 3 and enroll an additional 420 patients. The DSMB will make their recommendation based on analysis of certain trial data after 200 patients have completed 24 weeks of follow-up, the period for measuring the primary end-point of the trial. The DSMB interim analysis will focus on available data regarding the primary endpoint, AF/AFL event rates, AF burden, and safety. Should the DSMB interim analysis conclude the data is consistent with the pre-trial statistical assumptions and indicates potential for achieving statistical significance for the Phase 3 endpoint, the DSMB may recommend that the study proceed to Phase 3. The DSMB may also recommend changes to the study design before potentially proceeding to Phase 3, or it may recommend that the study not proceed to Phase 3. The Company, in consultation with the trial’s Steering Committee and the DSMB, will make the final determination on the trial’s development steps. The Company believes the Phase 2B enrollment of 200 patients could be completed by the end of 2016, with the DSMB interim analysis finishing in the first half of 2017. | ||
To complete both phases of the GENETIC-AF clinical trial and submit for FDA approval, the Company will need to raise additional capital. If the Company is unable to obtain additional funding or is unable to complete a strategic transaction, it may have to discontinue development activities on Gencaro or discontinue its operations. | ||
On January 27, 2009, the Company completed a business combination, or the Merger, with Nuvelo, Inc. (Nuvelo). Immediately following the Merger, the Company changed its name from Nuvelo, Inc. to ARCA biopharma, Inc. | ||
Liquidity and Going Concern | ||
The Company devotes substantially all of its efforts towards obtaining regulatory approval and raising capital necessary to fund its operations and it is subject to a number of risks associated with clinical research and development, including dependence on key individuals, the development of and regulatory approval of commercially viable products, the need to raise adequate additional financing necessary to fund the development and commercialization of its products, and competition from larger companies. The Company has not generated revenue to date and has incurred substantial losses and negative cash flows from operations since its inception. The Company has historically funded its operations through issuances of common and preferred stock. | ||
In February 2014, the Company completed a public equity offering raising approximately $7.9 million in net proceeds to provide additional funds for the Phase 2B/3 GENETIC-AF trial and the Company’s ongoing operations. The Company is enrolling patients in the Phase 2B portion of the GENETIC-AF trial, and the Company anticipates that its current cash and cash equivalents will be sufficient to fund its operations, at its projected cost structure, through the end of 2015. However, in light of the significant uncertainties regarding clinical development timelines and costs for developing drugs such as Gencaro, the Company expects to need to raise additional capital to finance the completion of GENETIC-AF and the Company’s ongoing operations. If the Company is delayed in completing or is unable to complete additional funding and/or a strategic transaction, the Company may discontinue its development activities or operations. | ||
The Company’s liquidity, and its ability to raise additional capital or complete any strategic transaction, depends on a number of factors, including, but not limited to, the following: | ||
— | progress of GENETIC-AF, including enrollment and any data that may become available; | |
— | the costs and timing for the GENETIC-AF clinical trial in order to gain possible FDA approval for Gencaro; | |
— | the market price of the Company’s stock and the availability and cost of additional equity capital; | |
— | the Company’s ability to retain the listing of its common stock on the Nasdaq Capital Market; | |
— | general economic and industry conditions affecting the availability and cost of capital; | |
— | the Company’s ability to control costs associated with its operations; | |
— | the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and | |
— | the terms and conditions of the Company’s existing collaborative and licensing agreements. | |
The sale of additional equity or convertible debt securities would likely result in substantial additional dilution to the Company’s stockholders. If the Company raises additional funds through the incurrence of indebtedness, the obligations related to such indebtedness would be senior to rights of holders of the Company’s capital stock and could contain covenants that would restrict the Company’s operations. The Company also cannot predict what consideration might be available, if any, to the Company or its stockholders, in connection with any strategic transaction. Should strategic alternatives or additional capital not be available to the Company, or not be available on acceptable terms, the Company may be unable to realize value from its assets and discharge its liabilities in the normal course of business which may, among other alternatives, cause the Company to further delay, substantially reduce or discontinue operational activities to conserve its cash resources. | ||
The significant uncertainties surrounding the clinical development timelines and costs and the need to raise a significant amount of capital raises substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time. These financial statements have been prepared with the assumption that the Company will continue as a going concern and will be able to realize its assets and discharge its liabilities in the normal course of business and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the inability of the Company to continue as a going concern. The Company may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of Gencaro or to otherwise continue operations and may not be able to execute any strategic transaction. | ||
On February 18, 2015, we received notification from Nasdaq of potential delisting of our shares from the Nasdaq Capital Market because the closing bid price of our common stock had not met the minimum closing bid price of $1.00 per share during the preceding 30 days. Nasdaq rules provided us a 180 calendar day grace period from the date of the Notice to regain compliance by meeting the continued listing standard. The continued listing standard would be met if our common stock has a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days during the 180 calendar day grace period. In order to remain compliant with the Nasdaq listing standards, the Company expects to effect a reverse stock split of its common stock to increase the market price of the common stock above the Nasdaq minimum bid price listing standard. However, the effect of a reverse stock Split on the market price of the common stock cannot be predicted with any certainty, and the history of similar stock split combinations for companies in like circumstances is varied. It is possible that the per share price of the Company’s common stock after the reverse stock split will not rise in proportion to the reduction in the number of shares of common stock outstanding resulting from the reverse stock split, effectively reducing the Company’s market capitalization, and there can be no assurance that the market price per post-reverse split share will either exceed or remain in excess of the $1.00 minimum bid price for a sustained period of time. The market price of the Company’s common stock may vary based on other factors that are unrelated to the number of shares outstanding, including the Company’s future performance. | ||
Basis of Presentation | ||
The accompanying unaudited financial statements of the Company were prepared in accordance with generally accepted accounting principles for interim financial information and instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, these financial statements 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 management, these financial statements include all normal and recurring adjustments considered necessary for a fair presentation of these interim consolidated financial statements. The results of operations for the three months ended March 31, 2015 are not necessarily indicative of results expected for the full year ending December 31, 2015. The Company has generated no revenue to date and its activities have consisted of seeking regulatory approval, research and development, exploring strategic alternatives for further developing and commercializing Gencaro, and raising capital. These unaudited financial statements should be read in conjunction with the audited consolidated financial statements and footnotes thereto for the year ended December 31, 2014 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission. Amounts presented are rounded to the nearest thousand, where indicated, except per share data and par values. | ||
Concentrations of Credit Risk | ||
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company has no off-balance-sheet concentrations of credit risk, such as foreign exchange contracts, option contracts, or foreign currency hedging arrangements. The Company maintains cash and cash equivalent balances in the form of bank demand deposits and money market fund accounts with financial institutions that management believes are creditworthy. Such balances may at times exceed the insured amount. | ||
Accrued Expenses | ||
As part of the process of preparing its financial statements, the Company is required to estimate accrued expenses. This process involves identifying services that third parties have performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for these services as of the balance sheet date. Examples of estimated accrued expenses include contract service fees, such as fees payable to contract manufacturers in connection with the production of materials related to the Company’s drug product, and professional service fees, such as attorneys, consultants, and clinical research organizations. The Company develops estimates of liabilities using its judgment based upon the facts and circumstances known at the time. | ||
Recent Accounting Pronouncements | ||
In June 2014, the Financial Accounting Standards Board (FASB) issued FASB Accounting Standards Update (“ASU”) No. 2014-10, Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation which removes Topic 915 from the FASB Accounting Standards Codification and removes from GAAP the concept of a development stage entity along with the associated incremental financial reporting requirements for development stage entities. The ASU is effective for fiscal years beginning after December 15, 2014, with early adoption being permitted for annual or interim periods for which financial statements have not been issued. The Company adopted this guidance as of June 30, 2014 and as a result, removed references to being a development stage entity and inception-to-date results from these financial statements. | ||
In August 2014, the FASB issued FASB Accounting Standards Update (“ASU No. 2014-15”), Presentation of Financial Statements – Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. ASU No. 2014-15 will be effective for fiscal years and interim periods ending after December 15, 2016, with early adoption being permitted for annual and interim periods for which financial statements have not been issued. ASU 2014-15 requires that management evaluate at each annual and interim reporting period whether there is a substantial doubt about an entity’s ability to continue as a going concern within one year of the date that the financial statements are issued. The significant uncertainties surrounding the clinical development timelines and costs and the need to raise a significant amount of capital raises substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time. The Company does not expect a significant impact on the financial position, results of operations or disclosures upon adoption of this guidance. | ||
In April 2015, the FASB issued Accounting Standards Update No. 2015-05: Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer's Accounting for Fees Paid in a Cloud Computing Arrangement ("ASU 2015-05"). The amendments in this update provide guidance to customers about whether a cloud computing arrangement includes a software license. If a cloud computing arrangement includes a software license, the update specifies that the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. The update further specifies that the customer should account for a cloud computing arrangement as a service contract if the arrangement does not include a software license. ASU 2015-05 will be effective for fiscal years beginning after December 31, 2015. The Company is currently assessing the future impact of this update to the financial statements. |
Net_Loss_Per_Share
Net Loss Per Share | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Earnings Per Share [Abstract] | ||||||||
Net Loss Per Share | (2) Net Loss Per Share | |||||||
The Company calculates basic earnings per share by dividing loss attributable to common stockholders by the weighted average common shares outstanding during the period, excluding common stock subject to vesting provisions. Diluted earnings per share is computed by dividing loss attributable to common stockholders by the weighted average number of common shares outstanding during the period increased to include, if dilutive, the number of additional common shares that would have been outstanding if the potential common shares had been issued. The Company’s potentially dilutive shares include stock options, restricted stock units and warrants for common stock. | ||||||||
Because we reported a net loss for the three months ended March 31, 2015 and 2014, all potentially dilutive shares of common stock have been excluded from the computation of the dilutive net loss per share for all periods presented. As of March 31, 2015, none of the outstanding warrants were in-the-money and no material outstanding stock options were in-the-money, other than the options granted in the first quarter of 2015. Such potentially dilutive shares of common stock consist of the following: | ||||||||
Three Months Ended March 31, | ||||||||
2015 | 2014 | |||||||
Potentially dilutive securities, excluded: | ||||||||
Outstanding stock options | 1,190,112 | 1,043,494 | ||||||
Unvested restricted stock units | 627,024 | 610,700 | ||||||
Warrants to purchase common stock | 9,371,002 | 9,380,127 | ||||||
11,188,138 | 11,034,321 | |||||||
Fair_Value_Disclosures
Fair Value Disclosures | 3 Months Ended | |
Mar. 31, 2015 | ||
Fair Value Disclosures [Abstract] | ||
Fair Value Disclosures | (3) Fair Value Disclosures | |
As of March 31, 2015, the Company had $12.1 million of cash equivalents consisting of money market funds with maturities of 90 days or less. The Company has the ability to liquidate these investments without restriction. The Company determines fair value for these money market funds and equity securities with Level 1 inputs through quoted market prices. There were no transfers of assets between fair value hierarchy levels during the three month period ended March 31, 2015. | ||
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). Inputs used to measure fair value are classified into the following hierarchy: | ||
— | Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities | |
— | Level 2—Unadjusted quoted prices in active markets for similar assets or liabilities; unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active; or inputs other than quoted prices that are observable for the asset or liability | |
— | Level 3—Unobservable inputs for the asset or liability | |
Fair Value of Other Financial Instruments | ||
The carrying amount of other financial instruments, including cash, accounts payable, and short-term notes payable approximated fair value due to their short maturities. |
Property_and_Equipment
Property and Equipment | 3 Months Ended | |||||||||
Mar. 31, 2015 | ||||||||||
Property Plant And Equipment [Abstract] | ||||||||||
Property and Equipment | (4) Property and Equipment | |||||||||
Property and equipment consist of the following (in thousands): | ||||||||||
Estimated Life | March 31, | December 31, | ||||||||
2015 | 2014 | |||||||||
Computer equipment | 3 years | $ | 97 | $ | 97 | |||||
Lab equipment | 5 years | 142 | 142 | |||||||
Furniture and fixtures | 5 years | 90 | 89 | |||||||
Computer software | 3 years | 83 | 82 | |||||||
Leasehold improvements | Lesser of useful life or life of the lease | 8 | 8 | |||||||
420 | 418 | |||||||||
Accumulated depreciation and amortization | (386 | ) | (382 | ) | ||||||
Property and equipment, net | $ | 34 | $ | 36 | ||||||
For the three months ended March 31, 2015 and 2014, depreciation and amortization expense was $4,000 and $3,000, respectively. |
Related_Party_Arrangements
Related Party Arrangements | 3 Months Ended |
Mar. 31, 2015 | |
Related Party Transactions [Abstract] | |
Related Party Arrangements | (5) Related Party Arrangements |
Transactions with the Company’s President and Chief Executive Officer | |
The Company has entered into unrestricted research grants with its President and Chief Executive Officer’s academic research laboratory at the University of Colorado, or the Lab. Funding of any unrestricted research grants is contingent upon the Company’s financial condition, and can be deferred or terminated at the Company’s discretion. Total expense under these arrangements for the three months ended March 31, 2015 and 2014 was $90,000 and $85,000 respectively. |
Commitments_and_Contingencies
Commitments and Contingencies | 3 Months Ended | |||
Mar. 31, 2015 | ||||
Commitments And Contingencies Disclosure [Abstract] | ||||
Commitments and Contingencies | ||||
(6) Commitments and Contingencies | ||||
The Company has or is subject to the following commitments and contingencies: | ||||
Employment Agreements | ||||
The Company maintains employment agreements with several key executive employees. The agreements may be terminated at any time by the Company with or without cause upon written notice to the employee, and entitle the employee to wages in lieu of notice for periods not exceeding one calendar year from the date of termination without cause or by the employee for good reason. Certain of these agreements also provide for payments to be made under certain conditions related to a change in control of the Company. | ||||
Operating Lease | ||||
On August 1, 2013 the Company entered into a lease agreement for approximately 5,300 square feet of office facilities in Westminster, Colorado which has served as the Company’s primary business office since October 1, 2013. The lease has a three year term and expires on September 30, 2016. Below is a summary of the future minimum lease payments committed for the Company’s facility in Westminster, Colorado as of March 31, 2015 (in thousands): | ||||
Remainder of 2015 | $ | 61 | ||
2016 | 62 | |||
Total future minimum lease payments | $ | 123 | ||
Rent expense for the three months ended March 31, 2015 and 2014 was $20,000 and $19,000, respectively. | ||||
Duke University | ||||
In November 2013, the Company entered into a clinical research agreement with Duke University (Duke) to serve as the clinical research organization for the Company’s GENETIC-AF clinical study. Under the agreement the Company is responsible to pay Duke for their work managing certain aspects of the clinical study. Upon completion of the clinical study, the agreement will terminate. The agreement can be terminated earlier by the Company for any reason with 90 days written notice to Duke. In the event of an early termination, the Company and Duke would coordinate efforts for an orderly wind-down of the study, and the Company would be responsible to pay Duke for time and effort incurred through the date of termination and through the wind-down period. | ||||
Cardiovascular Pharmacology and Engineering Consultants, LLC, or CPEC | ||||
ARCA has licensed worldwide rights to Gencaro, including all preclinical and clinical data from Cardiovascular Pharmacology and Engineering Consultants, LLC, or CPEC, who has licensed rights in Gencaro from Bristol Myers Squib (BMS). CPEC is a licensing subsidiary of Indevus Pharmaceuticals Inc. (a wholly owned subsidiary of Endo Pharmaceuticals), holding ownership rights to certain clinical trial data of Gencaro. Under the terms of its license agreement with CPEC, the Company will incur milestone and royalty obligations upon the occurrence of certain events. If the FDA grants marketing approval for Gencaro, the license agreement states that the Company will owe CPEC a milestone payment of $8.0 million within six months after FDA approval. The license agreement states that a milestone payment of up to $5.0 million in the aggregate shall be paid upon regulatory marketing approval in Europe and Japan. The license agreement also states that the Company’s royalty obligation ranges from 12.5% to 25% of revenue from the related product based on achievement of specified product sales levels, including a 5% royalty that CPEC is obligated to pay under its original license agreement for Gencaro. The agreement states that the Company has the right to buy down the royalties to a range of 12.5% to 17% by making a payment to CPEC within six months of regulatory approval. |
Equity_Financings_and_Warrants
Equity Financings and Warrants | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Equity [Abstract] | |||||||||
Equity Financings and Warrants | (7) Equity Financings and Warrants | ||||||||
2014 Equity Financing | |||||||||
Registered Direct Offering | |||||||||
On February 3, 2014, the Company agreed to sell to certain investors an aggregate of 5,116,228 shares of the Company’s common stock and warrants to purchase an aggregate of 1,279,057 shares of the Company’s common stock at a purchase price of $1.70 per share of Common Stock, for aggregate gross proceeds of approximately of $8.7 million, before deducting placement agent fees and other offering related expenses. The offering closed on February 7, 2014, and the net proceeds to the Company were approximately $7.9 million. | |||||||||
The common stock and warrants were sold in combination consisting of one share of common stock and a warrant to purchase 0.25 shares of common stock. The warrants were exercisable upon issuance, expire five years from the date of issuance, and have an exercise price of $2.125 per share, equal to 125% of the closing bid price of ARCA’s common stock on the Nasdaq Capital Market on February 3, 2014. The offering was effected as a takedown off the Company’s Registration Statement on Form S-3, as amended, which became effective on April 4, 2011, pursuant to a prospectus supplement filed with the Securities and Exchange Commission on February 4, 2014. The warrants provide for cashless exercise and settlement in unregistered shares if there is no effective registration statement registering, or the prospectus contained therein is not available for the issuance of the shares of common stock underlying the warrants at the time of exercise. | |||||||||
Warrants | |||||||||
Warrants to purchase shares of common stock were granted as part of various financing and business agreements. Warrants were recorded in additional paid-in capital at their estimated fair market value at the date of grant using a Black-Scholes option-pricing model. | |||||||||
As of March 31, 2015, these warrants, by year of expiration, are summarized below: | |||||||||
Year of Expiration | Number | Weighted Average | |||||||
of Warrants | Exercise Price | ||||||||
2016 | 579,712 | $ | 9.74 | ||||||
2017 | 168,866 | 2.56 | |||||||
2018 | 6,742,068 | 1.68 | |||||||
2019 | 1,570,262 | 2.25 | |||||||
2020 | 310,094 | 2.28 | |||||||
9,371,002 | $ | 2.31 | |||||||
Sharebased_Compensation
Share-based Compensation | 3 Months Ended | |||||||||||
Mar. 31, 2015 | ||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||||||||||
Share-based Compensation | (8) Share-based Compensation | |||||||||||
For the three month periods ended March 31, 2015 and 2014, the Company recognized the following non-cash, share-based compensation expense in the consolidated statements of operations (in thousands): | ||||||||||||
Three Months | ||||||||||||
Ended March 31, | ||||||||||||
2015 | 2014 | |||||||||||
Research and development | $ | 42 | $ | 40 | ||||||||
General and administrative | 88 | 118 | ||||||||||
Total | $ | 130 | $ | 158 | ||||||||
Stock option transactions for the three month period ended March 31, 2015 under the Company’s stock incentive plans were as follows: | ||||||||||||
Number | Weighted Average Exercise Price | Weighted | ||||||||||
of Options | Average | |||||||||||
Remaining | ||||||||||||
Contractual | ||||||||||||
Term | ||||||||||||
(in years) | ||||||||||||
Options outstanding at December 31, 2014 | 1,068,515 | $ | 2.89 | 8.25 | ||||||||
Granted | 121,780 | 0.67 | ||||||||||
Exercised | — | — | ||||||||||
Forfeited and cancelled | (183 | ) | 0.36 | |||||||||
Options outstanding at March 31, 2015 | 1,190,112 | $ | 2.66 | 8.2 | ||||||||
Options exercisable at March 31, 2015 | 576,567 | $ | 3.95 | 7.52 | ||||||||
Options vested and expected to vest | 1,188,716 | $ | 2.66 | 8.19 | ||||||||
Stock award transactions for the three month period ended March 31, 2015 under the Company’s stock incentive plans were as follows: | ||||||||||||
Number | Weighted | |||||||||||
of Shares | Average | |||||||||||
Grant Date | ||||||||||||
Fair Value | ||||||||||||
Restricted stock units outstanding at December 31, 2014 | 471,029 | $ | 1.62 | |||||||||
Granted | 203,920 | 0.67 | ||||||||||
Vested and released | (47,925 | ) | 1.95 | |||||||||
Forfeited and cancelled | — | — | ||||||||||
Restricted stock units outstanding at March 31, 2015 | 627,024 | $ | 1.29 | |||||||||
Income_Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (9) Income Taxes |
In accordance with United States Generally Accepted Accounting Principles, a valuation allowance should be provided if it is more likely than not that some or all of the Company’s deferred tax assets will not be realized. The Company’s ability to realize the benefit of its deferred tax assets will depend on the generation of future taxable income. Due to the uncertainty of future profitable operations and taxable income, the Company has recorded a full valuation allowance against its net deferred tax assets. The Company believes its tax filing positions and deductions related to tax periods subject to examination will be sustained upon audit and, therefore, has no reserve for uncertain tax positions. |
The_Company_and_Summary_of_Sig1
The Company and Summary of Significant Accounting Policies (Policies) | 3 Months Ended | |
Mar. 31, 2015 | ||
Accounting Policies [Abstract] | ||
Liquidity and Going Concern | Liquidity and Going Concern | |
The Company devotes substantially all of its efforts towards obtaining regulatory approval and raising capital necessary to fund its operations and it is subject to a number of risks associated with clinical research and development, including dependence on key individuals, the development of and regulatory approval of commercially viable products, the need to raise adequate additional financing necessary to fund the development and commercialization of its products, and competition from larger companies. The Company has not generated revenue to date and has incurred substantial losses and negative cash flows from operations since its inception. The Company has historically funded its operations through issuances of common and preferred stock. | ||
In February 2014, the Company completed a public equity offering raising approximately $7.9 million in net proceeds to provide additional funds for the Phase 2B/3 GENETIC-AF trial and the Company’s ongoing operations. The Company is enrolling patients in the Phase 2B portion of the GENETIC-AF trial, and the Company anticipates that its current cash and cash equivalents will be sufficient to fund its operations, at its projected cost structure, through the end of 2015. However, in light of the significant uncertainties regarding clinical development timelines and costs for developing drugs such as Gencaro, the Company expects to need to raise additional capital to finance the completion of GENETIC-AF and the Company’s ongoing operations. If the Company is delayed in completing or is unable to complete additional funding and/or a strategic transaction, the Company may discontinue its development activities or operations. | ||
The Company’s liquidity, and its ability to raise additional capital or complete any strategic transaction, depends on a number of factors, including, but not limited to, the following: | ||
— | progress of GENETIC-AF, including enrollment and any data that may become available; | |
— | the costs and timing for the GENETIC-AF clinical trial in order to gain possible FDA approval for Gencaro; | |
— | the market price of the Company’s stock and the availability and cost of additional equity capital; | |
— | the Company’s ability to retain the listing of its common stock on the Nasdaq Capital Market; | |
— | general economic and industry conditions affecting the availability and cost of capital; | |
— | the Company’s ability to control costs associated with its operations; | |
— | the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and | |
— | the terms and conditions of the Company’s existing collaborative and licensing agreements. | |
The sale of additional equity or convertible debt securities would likely result in substantial additional dilution to the Company’s stockholders. If the Company raises additional funds through the incurrence of indebtedness, the obligations related to such indebtedness would be senior to rights of holders of the Company’s capital stock and could contain covenants that would restrict the Company’s operations. The Company also cannot predict what consideration might be available, if any, to the Company or its stockholders, in connection with any strategic transaction. Should strategic alternatives or additional capital not be available to the Company, or not be available on acceptable terms, the Company may be unable to realize value from its assets and discharge its liabilities in the normal course of business which may, among other alternatives, cause the Company to further delay, substantially reduce or discontinue operational activities to conserve its cash resources. | ||
The significant uncertainties surrounding the clinical development timelines and costs and the need to raise a significant amount of capital raises substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time. These financial statements have been prepared with the assumption that the Company will continue as a going concern and will be able to realize its assets and discharge its liabilities in the normal course of business and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the inability of the Company to continue as a going concern. The Company may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of Gencaro or to otherwise continue operations and may not be able to execute any strategic transaction. | ||
On February 18, 2015, we received notification from Nasdaq of potential delisting of our shares from the Nasdaq Capital Market because the closing bid price of our common stock had not met the minimum closing bid price of $1.00 per share during the preceding 30 days. Nasdaq rules provided us a 180 calendar day grace period from the date of the Notice to regain compliance by meeting the continued listing standard. The continued listing standard would be met if our common stock has a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days during the 180 calendar day grace period. In order to remain compliant with the Nasdaq listing standards, the Company expects to effect a reverse stock split of its common stock to increase the market price of the common stock above the Nasdaq minimum bid price listing standard. However, the effect of a reverse stock Split on the market price of the common stock cannot be predicted with any certainty, and the history of similar stock split combinations for companies in like circumstances is varied. It is possible that the per share price of the Company’s common stock after the reverse stock split will not rise in proportion to the reduction in the number of shares of common stock outstanding resulting from the reverse stock split, effectively reducing the Company’s market capitalization, and there can be no assurance that the market price per post-reverse split share will either exceed or remain in excess of the $1.00 minimum bid price for a sustained period of time. The market price of the Company’s common stock may vary based on other factors that are unrelated to the number of shares outstanding, including the Company’s future performance. | ||
Basis of Presentation | Basis of Presentation | |
The accompanying unaudited financial statements of the Company were prepared in accordance with generally accepted accounting principles for interim financial information and instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, these financial statements 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 management, these financial statements include all normal and recurring adjustments considered necessary for a fair presentation of these interim consolidated financial statements. The results of operations for the three months ended March 31, 2015 are not necessarily indicative of results expected for the full year ending December 31, 2015. The Company has generated no revenue to date and its activities have consisted of seeking regulatory approval, research and development, exploring strategic alternatives for further developing and commercializing Gencaro, and raising capital. These unaudited financial statements should be read in conjunction with the audited consolidated financial statements and footnotes thereto for the year ended December 31, 2014 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission. Amounts presented are rounded to the nearest thousand, where indicated, except per share data and par values. | ||
Concentrations of Credit Risk | Concentrations of Credit Risk | |
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company has no off-balance-sheet concentrations of credit risk, such as foreign exchange contracts, option contracts, or foreign currency hedging arrangements. The Company maintains cash and cash equivalent balances in the form of bank demand deposits and money market fund accounts with financial institutions that management believes are creditworthy. Such balances may at times exceed the insured amount. | ||
Accrued Expenses | Accrued Expenses | |
As part of the process of preparing its financial statements, the Company is required to estimate accrued expenses. This process involves identifying services that third parties have performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for these services as of the balance sheet date. Examples of estimated accrued expenses include contract service fees, such as fees payable to contract manufacturers in connection with the production of materials related to the Company’s drug product, and professional service fees, such as attorneys, consultants, and clinical research organizations. The Company develops estimates of liabilities using its judgment based upon the facts and circumstances known at the time. | ||
Recent Accounting Pronouncements | Recent Accounting Pronouncements | |
In June 2014, the Financial Accounting Standards Board (FASB) issued FASB Accounting Standards Update (“ASU”) No. 2014-10, Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation which removes Topic 915 from the FASB Accounting Standards Codification and removes from GAAP the concept of a development stage entity along with the associated incremental financial reporting requirements for development stage entities. The ASU is effective for fiscal years beginning after December 15, 2014, with early adoption being permitted for annual or interim periods for which financial statements have not been issued. The Company adopted this guidance as of June 30, 2014 and as a result, removed references to being a development stage entity and inception-to-date results from these financial statements. | ||
In August 2014, the FASB issued FASB Accounting Standards Update (“ASU No. 2014-15”), Presentation of Financial Statements – Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. ASU No. 2014-15 will be effective for fiscal years and interim periods ending after December 15, 2016, with early adoption being permitted for annual and interim periods for which financial statements have not been issued. ASU 2014-15 requires that management evaluate at each annual and interim reporting period whether there is a substantial doubt about an entity’s ability to continue as a going concern within one year of the date that the financial statements are issued. The significant uncertainties surrounding the clinical development timelines and costs and the need to raise a significant amount of capital raises substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time. The Company does not expect a significant impact on the financial position, results of operations or disclosures upon adoption of this guidance. | ||
In April 2015, the FASB issued Accounting Standards Update No. 2015-05: Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer's Accounting for Fees Paid in a Cloud Computing Arrangement ("ASU 2015-05"). The amendments in this update provide guidance to customers about whether a cloud computing arrangement includes a software license. If a cloud computing arrangement includes a software license, the update specifies that the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. The update further specifies that the customer should account for a cloud computing arrangement as a service contract if the arrangement does not include a software license. ASU 2015-05 will be effective for fiscal years beginning after December 31, 2015. The Company is currently assessing the future impact of this update to the financial statements. |
Net_Loss_Per_Share_Tables
Net Loss Per Share (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Earnings Per Share [Abstract] | ||||||||
Summary of Potentially Dilutive Shares of Common Stock | Because we reported a net loss for the three months ended March 31, 2015 and 2014, all potentially dilutive shares of common stock have been excluded from the computation of the dilutive net loss per share for all periods presented. As of March 31, 2015, none of the outstanding warrants were in-the-money and no material outstanding stock options were in-the-money, other than the options granted in the first quarter of 2015. Such potentially dilutive shares of common stock consist of the following: | |||||||
Three Months Ended March 31, | ||||||||
2015 | 2014 | |||||||
Potentially dilutive securities, excluded: | ||||||||
Outstanding stock options | 1,190,112 | 1,043,494 | ||||||
Unvested restricted stock units | 627,024 | 610,700 | ||||||
Warrants to purchase common stock | 9,371,002 | 9,380,127 | ||||||
11,188,138 | 11,034,321 | |||||||
Property_and_Equipment_Tables
Property and Equipment (Tables) | 3 Months Ended | |||||||||
Mar. 31, 2015 | ||||||||||
Property Plant And Equipment [Abstract] | ||||||||||
Summary of Property and Equipment | Property and equipment consist of the following (in thousands): | |||||||||
Estimated Life | March 31, | December 31, | ||||||||
2015 | 2014 | |||||||||
Computer equipment | 3 years | $ | 97 | $ | 97 | |||||
Lab equipment | 5 years | 142 | 142 | |||||||
Furniture and fixtures | 5 years | 90 | 89 | |||||||
Computer software | 3 years | 83 | 82 | |||||||
Leasehold improvements | Lesser of useful life or life of the lease | 8 | 8 | |||||||
420 | 418 | |||||||||
Accumulated depreciation and amortization | (386 | ) | (382 | ) | ||||||
Property and equipment, net | $ | 34 | $ | 36 | ||||||
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 3 Months Ended | |||
Mar. 31, 2015 | ||||
Commitments And Contingencies Disclosure [Abstract] | ||||
Future Minimum Lease Payments | Below is a summary of the future minimum lease payments committed for the Company’s facility in Westminster, Colorado as of March 31, 2015 (in thousands): | |||
Remainder of 2015 | $ | 61 | ||
2016 | 62 | |||
Total future minimum lease payments | $ | 123 | ||
Equity_Financings_and_Warrants1
Equity Financings and Warrants (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Equity [Abstract] | |||||||||
Summary of Warrants by Year of Expiration | As of March 31, 2015, these warrants, by year of expiration, are summarized below: | ||||||||
Year of Expiration | Number | Weighted Average | |||||||
of Warrants | Exercise Price | ||||||||
2016 | 579,712 | $ | 9.74 | ||||||
2017 | 168,866 | 2.56 | |||||||
2018 | 6,742,068 | 1.68 | |||||||
2019 | 1,570,262 | 2.25 | |||||||
2020 | 310,094 | 2.28 | |||||||
9,371,002 | $ | 2.31 | |||||||
Sharebased_Compensation_Tables
Share-based Compensation (Tables) | 3 Months Ended | |||||||||||
Mar. 31, 2015 | ||||||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||||||||||
Non-Cash, Share-Based Compensation Expense | For the three month periods ended March 31, 2015 and 2014, the Company recognized the following non-cash, share-based compensation expense in the consolidated statements of operations (in thousands): | |||||||||||
Three Months | ||||||||||||
Ended March 31, | ||||||||||||
2015 | 2014 | |||||||||||
Research and development | $ | 42 | $ | 40 | ||||||||
General and administrative | 88 | 118 | ||||||||||
Total | $ | 130 | $ | 158 | ||||||||
Summary of Stock Option and Stock Award Activities | Stock option transactions for the three month period ended March 31, 2015 under the Company’s stock incentive plans were as follows: | |||||||||||
Number | Weighted Average Exercise Price | Weighted | ||||||||||
of Options | Average | |||||||||||
Remaining | ||||||||||||
Contractual | ||||||||||||
Term | ||||||||||||
(in years) | ||||||||||||
Options outstanding at December 31, 2014 | 1,068,515 | $ | 2.89 | 8.25 | ||||||||
Granted | 121,780 | 0.67 | ||||||||||
Exercised | — | — | ||||||||||
Forfeited and cancelled | (183 | ) | 0.36 | |||||||||
Options outstanding at March 31, 2015 | 1,190,112 | $ | 2.66 | 8.2 | ||||||||
Options exercisable at March 31, 2015 | 576,567 | $ | 3.95 | 7.52 | ||||||||
Options vested and expected to vest | 1,188,716 | $ | 2.66 | 8.19 | ||||||||
Summary of RSU activity | ||||||||||||
Stock award transactions for the three month period ended March 31, 2015 under the Company’s stock incentive plans were as follows: | ||||||||||||
Number | Weighted | |||||||||||
of Shares | Average | |||||||||||
Grant Date | ||||||||||||
Fair Value | ||||||||||||
Restricted stock units outstanding at December 31, 2014 | 471,029 | $ | 1.62 | |||||||||
Granted | 203,920 | 0.67 | ||||||||||
Vested and released | (47,925 | ) | 1.95 | |||||||||
Forfeited and cancelled | — | — | ||||||||||
Restricted stock units outstanding at March 31, 2015 | 627,024 | $ | 1.29 | |||||||||
The_Company_and_Summary_of_Sig2
The Company and Summary of Significant Accounting Policies (Details) (USD $) | 0 Months Ended | 3 Months Ended | 0 Months Ended | 1 Months Ended | |
Feb. 18, 2015 | Mar. 31, 2015 | Mar. 31, 2014 | Feb. 03, 2014 | Feb. 28, 2014 | |
Company Basis of Presentation (Textual) [Abstract] | |||||
Revenues | $0 | ||||
Proceeds from the issuance of common stock | 9,018,000 | ||||
Notification for delisting of shares | On February 18, 2015, we received notification from Nasdaq of potential delisting of our shares from the Nasdaq Capital Market because the closing bid price of our common stock had not met the minimum closing bid price of $1.00 per share during the preceding 30 days. Nasdaq rules provided us a 180 calendar day grace period from the date of the Notice to regain compliance by meeting the continued listing standard. The continued listing standard would be met if our common stock has a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days during the 180 calendar day grace period. In order to remain compliant with the Nasdaq listing standards, the Company expects to effect a reverse stock split of its common stock to increase the market price of the common stock above the Nasdaq minimum bid price listing standard. However, the effect of a reverse stock Split on the market price of the common stock cannot be predicted with any certainty, and the history of similar stock split combinations for companies in like circumstances is varied. It is possible that the per share price of the Company’s common stock after the reverse stock split will not rise in proportion to the reduction in the number of shares of common stock outstanding resulting from the reverse stock split, effectively reducing the Company’s market capitalization, and there can be no assurance that the market price per post-reverse split share will either exceed or remain in excess of the $1.00 minimum bid price for a sustained period of time. The market price of the Company’s common stock may vary based on other factors that are unrelated to the number of shares outstanding, including the Company’s future performance. | ||||
Minimum closing bid price of common stock | $1 | ||||
Number of grace days provided by NASDAQ to meet continued listing standard | 180 days | ||||
Concentrations of credit risk | 0 | ||||
Registered Direct Offering | |||||
Company Basis of Presentation (Textual) [Abstract] | |||||
Proceeds from the issuance of common stock | $8,700,000 | $7,900,000 | |||
Phase 3 heart failure (HF) trial of Gencaro | BEST Trial | |||||
Company Basis of Presentation (Textual) [Abstract] | |||||
Number of patients | 2,708 | ||||
Phase 3 heart failure (HF) trial of Gencaro | GENETIC-AF Trial | |||||
Company Basis of Presentation (Textual) [Abstract] | |||||
Number of patients company plans to enroll | 420 | ||||
Phase Two B Heart Failure | GENETIC-AF Trial | |||||
Company Basis of Presentation (Textual) [Abstract] | |||||
Number of patients company plans to enroll | 200 |
Net_Loss_Per_Share_Details_Tex
Net Loss Per Share (Details Textual) | 3 Months Ended |
Mar. 31, 2015 | |
Stock options | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |
Securities in-the-money | 0 |
Warrant | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |
Securities in-the-money | 0 |
Net_Loss_Per_Share_Details_1
Net Loss Per Share (Details 1) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Earnings Per Share Basic [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 11,188,138 | 11,034,321 |
Outstanding stock options | ||
Earnings Per Share Basic [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,190,112 | 1,043,494 |
Unvested restricted stock units | ||
Earnings Per Share Basic [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 627,024 | 610,700 |
Warrants to purchase common stock | ||
Earnings Per Share Basic [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 9,371,002 | 9,380,127 |
Fair_Value_Disclosures_Details
Fair Value Disclosures (Details) (USD $) | 3 Months Ended |
Mar. 31, 2015 | |
Fair Value Disclosures (Textual) [Abstract] | |
Transfers of assets between fair value hierarchy levels | $0 |
Fair Value Measurements, Recurring | Level 1 | Money Market Funds | |
Fair Value Disclosures (Textual) [Abstract] | |
Cash equivalents consisting of money market funds | $12,100,000 |
Summary_of_Property_and_Equipm
Summary of Property and Equipment (Details) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Dec. 31, 2014 |
Property Plant And Equipment [Line Items] | ||
Property and Equipment, Gross | $420 | $418 |
Accumulated depreciation and amortization | -386 | -382 |
Property and equipment, net | 34 | 36 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | 3 years | |
Property and Equipment, Gross | 97 | 97 |
Lab Equipment | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | 5 years | |
Property and Equipment, Gross | 142 | 142 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | 5 years | |
Property and Equipment, Gross | 90 | 89 |
Computer Software | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | 3 years | |
Property and Equipment, Gross | 83 | 82 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | Lesser of useful life or life of the lease | |
Property and Equipment, Gross | $8 | $8 |
Property_and_Equipment_Details
Property and Equipment (Details Textual) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Property Plant And Equipment [Abstract] | ||
Depreciation and amortization expense | $4 | $3 |
Related_Party_Arrangements_Det
Related Party Arrangements (Details) (Chief Executive Officer, Research Grants, USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Chief Executive Officer | Research Grants | ||
Related Party Transaction [Line Items] | ||
Total expense | $90 | $85 |
Commitments_and_Contingencies_1
Commitments and Contingencies (Details Textual) (USD $) | 3 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Aug. 01, 2013 | |
sqft | |||
Commitments And Contingencies (Textual) [Abstract] | |||
Rent expense | $20,000 | $19,000 | |
Clinical research agreement with Duke University, termination notice period | 90 days | ||
Expected milestone payments due upon approval | 8,000,000 | ||
Another expected milestone payments due upon approval | $5,000,000 | ||
Minimum percentage of royalty obligation | 12.50% | ||
Maximum percentage of royalty obligation | 25.00% | ||
Product sales levels royalty | 5.00% | ||
Minimum percentage of range of royalties that can be bought down | 12.50% | ||
Maximum percentage of range of royalties that can be bought down | 17.00% | ||
Royalty buy down due period | 6 months | ||
Westminster, Colorado | |||
Commitments And Contingencies (Textual) [Abstract] | |||
Area of office facilities taken on lease | 5,300 | ||
Lease term | 3 years | ||
Lease expiry date | 30-Sep-16 |
Future_Minimum_Lease_Payments_
Future Minimum Lease Payments (Details) (USD $) | Mar. 31, 2015 |
In Thousands, unless otherwise specified | |
Commitments And Contingencies Disclosure [Abstract] | |
Remainder of 2015 | $61 |
2016 | 62 |
Total future minimum lease payments | $123 |
Equity_Financings_and_Warrants2
Equity Financings and Warrants (Details Textual) (USD $) | 3 Months Ended | 0 Months Ended | 1 Months Ended | 3 Months Ended | ||
Mar. 31, 2014 | Feb. 07, 2014 | Feb. 03, 2014 | Feb. 28, 2014 | Mar. 31, 2015 | Dec. 31, 2014 | |
Equity Financings And Warrants (Textual) [Abstract] | ||||||
Common stock, shares issued | 21,198,411 | 21,150,486 | ||||
Proceeds from the issuance of common stock | $9,018,000 | |||||
Registered Direct Offering | ||||||
Equity Financings And Warrants (Textual) [Abstract] | ||||||
Common stock, shares issued | 5,116,228 | |||||
Warrants available to purchase additional commons shares | 1,279,057 | |||||
Purchase price for common stock unit | $1.70 | |||||
Proceeds from the issuance of common stock | 8,700,000 | 7,900,000 | ||||
Proceeds from issuance of common stock, net of financing costs | $7,900,000 | |||||
Closing bid price date | 3-Feb-14 | |||||
Public Equity Offering Close Date | 7-Feb-14 | |||||
Warrant coverage ratio | 0.25 | |||||
Warrants were exercisable upon issuance, expiry year | 5 years | |||||
Warrant price per share | $2.13 | |||||
Closing bid price of the common stock | 125.00% |
Summary_of_Warrants_by_Year_of
Summary of Warrants by Year of Expiration (Details) (USD $) | 3 Months Ended |
Mar. 31, 2015 | |
Class Of Warrant Or Right [Line Items] | |
Number of Warrants | 9,371,002 |
Weighted Average Exercise Price | $2.31 |
2016 | |
Class Of Warrant Or Right [Line Items] | |
Year of Expiration | 2016 |
Number of Warrants | 579,712 |
Weighted Average Exercise Price | $9.74 |
2017 | |
Class Of Warrant Or Right [Line Items] | |
Year of Expiration | 2017 |
Number of Warrants | 168,866 |
Weighted Average Exercise Price | $2.56 |
2018 | |
Class Of Warrant Or Right [Line Items] | |
Year of Expiration | 2018 |
Number of Warrants | 6,742,068 |
Weighted Average Exercise Price | $1.68 |
2019 | |
Class Of Warrant Or Right [Line Items] | |
Year of Expiration | 2019 |
Number of Warrants | 1,570,262 |
Weighted Average Exercise Price | $2.25 |
2020 | |
Class Of Warrant Or Right [Line Items] | |
Year of Expiration | 2020 |
Number of Warrants | 310,094 |
Weighted Average Exercise Price | $2.28 |
NonCash_ShareBased_Compensatio
Non-Cash, Share-Based Compensation Expense (Details) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total expenses | $130 | $158 |
Research and development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total expenses | 42 | 40 |
General and administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total expenses | $88 | $118 |
Summary_of_Stock_Option_and_St
Summary of Stock Option and Stock Award Activities (Details) (USD $) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2015 | Dec. 31, 2014 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Options outstanding beginning of period | 1,068,515 | |
Number of Options, Granted | 121,780 | |
Number of Options, Forfeited and cancelled | -183 | |
Options outstanding end of the period | 1,190,112 | 1,068,515 |
Options exercisable, end of period, Number of Options | 576,567 | |
Options vested and expected to vest, Number of Options | 1,188,716 | |
Weighted Average exercise Price, Options Outstanding, Beginning of period | $2.89 | |
Weighted average exercise price, Granted | $0.67 | |
Weighted average exercise price, Forfeited and cancelled | $0.36 | |
Weighted Average exercise Price, Options Outstanding, end of period | $2.66 | $2.89 |
Weighted average exercise price, Options exercisable, end of period | $3.95 | |
Weighted Average exercise Price, Options vested and expected to vest, end of period | $2.66 | |
Weighted Average Remaining Contractual Term (in years) Options Outstanding | 8 years 2 months 12 days | 8 years 3 months |
Options exercisable, Weighted Average Remaining Contractual Term (in years) | 7 years 6 months 7 days | |
Options vested and expected to vest, Weighted Average Remaining Contractual Term (in years) | 8 years 2 months 9 days |
Summary_of_RSU_Activity_Detail
Summary of RSU Activity (Details) (USD $) | 3 Months Ended |
Mar. 31, 2015 | |
Restricted Stock Awards, Number of Shares | |
Restricted stock units outstanding, beginning of period | 471,029 |
Granted | 203,920 |
Vested and released | -47,925 |
Restricted stock units outstanding, end of period | 627,024 |
Restricted Stock Awards, Weighted Average Grant Date Fair Value | |
Restricted stock units outstanding, beginning of period | $1.62 |
Granted | $0.67 |
Vested and released | $1.95 |
Restricted stock units outstanding, end of period | $1.29 |