Document_and_Entity_Informatio
Document and Entity Information | 6 Months Ended | |
Jun. 30, 2014 | Aug. 12, 2014 | |
Document Information [Line Items] | ' | ' |
Entity Registrant Name | 'ARCA Biopharma, Inc. | ' |
Entity Central Index Key | '0000907654 | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Jun-14 | ' |
Document Fiscal Period Focus | 'Q2 | ' |
Document Fiscal Year Focus | '2014 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Smaller Reporting Company | ' |
Entity Common Stock, Shares Outstanding | ' | 21,010,815 |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $19,377 | $16,756 |
Other current assets | 303 | 169 |
Total current assets | 19,680 | 16,925 |
Property and equipment, net | 29 | 29 |
Other assets | 831 | 130 |
Total assets | 20,540 | 17,084 |
Current liabilities: | ' | ' |
Accounts payable | 725 | 597 |
Accrued compensation and employee benefits | 141 | 459 |
Accrued expenses and other liabilities | 351 | 446 |
Total current liabilities | 1,217 | 1,502 |
Deferred rent, net of current portion | 2 | 1 |
Total liabilities | 1,219 | 1,503 |
Commitments and contingencies | ' | ' |
Stockholders’ equity: | ' | ' |
Common stock, $0.001 par value; 100 million shares authorized at June 30, 2014 and December 31, 2013; 21,010,815 and 15,685,562 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively | 21 | 16 |
Additional paid-in capital | 99,027 | 90,498 |
Accumulated deficit | -79,727 | -74,933 |
Total stockholders’ equity | 19,321 | 15,581 |
Total liabilities and stockholders’ equity | $20,540 | $17,084 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 21,010,815 | 15,685,562 |
Common stock, shares outstanding | 21,010,815 | 15,685,562 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations and Comprehensive Loss (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Costs and expenses: | ' | ' | ' | ' |
Research and development | $1,400 | $246 | $2,708 | $427 |
General and administrative | 1,006 | 952 | 2,088 | 1,841 |
Total costs and expenses | 2,406 | 1,198 | 4,796 | 2,268 |
Loss from operations | -2,406 | -1,198 | -4,796 | -2,268 |
Interest and other income | 2 | 1 | 4 | 1 |
Interest and other expense | -1 | -2 | -2 | -3 |
Loss before income taxes | -2,405 | -1,199 | -4,794 | -2,270 |
Benefit from income taxes | ' | ' | ' | ' |
Net loss and comprehensive loss | -2,405 | -1,199 | -4,794 | -2,270 |
Less: Deemed preferred stock dividend | ' | -2,026 | ' | -2,026 |
Net loss available to common stockholders | ($2,405) | ($3,225) | ($4,794) | ($4,296) |
Net loss available to common stockholders per share: | ' | ' | ' | ' |
Basic and diluted | ($0.11) | ($0.65) | ($0.24) | ($1.08) |
Weighted average shares outstanding: | ' | ' | ' | ' |
Basic and diluted | 21,009,712 | 4,944,149 | 19,903,709 | 3,995,921 |
Consolidated_Statements_of_Pre
Consolidated Statements of Preferred Stock and Stockholders' Equity (USD $) | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Convertible Preferred Stock |
In Thousands, except Share data | USD ($) | USD ($) | USD ($) | USD ($) | Preferred Stock |
Beginning Balance, value at Dec. 31, 2012 | $2,907 | $3 | $70,898 | ($67,994) | ' |
Beginning Balance, shares at Dec. 31, 2012 | ' | 2,660,315 | ' | ' | ' |
Issuance of common stock for cash, net of offering costs | 1,421 | ' | 1,421 | ' | ' |
Issuance of common stock for cash, net of offering costs, shares | ' | 521,066 | ' | ' | ' |
Adjustment for fractional shares | ' | -64 | ' | ' | ' |
Issuance of common stock upon exercise of warrants for cash, value | 12 | ' | 12 | ' | ' |
Issuance of common stock upon exercise of warrants for cash, share | ' | 4,245 | ' | ' | ' |
Issuance of Series A convertible preferred stock, net of offering costs | 17,917 | ' | 17,917 | ' | ' |
Issuance of Series A convertible preferred stock, net of offering costs, shares | ' | ' | ' | ' | 125,000 |
Deemed preferred stock dividend for beneficial conversion feature | 2,026 | ' | 2,026 | ' | ' |
Impact of deemed preferred stock dividend for beneficial conversion feature on common stockholders | -2,026 | ' | -2,026 | ' | ' |
Conversion of preferred stock | -20 | 13 | -33 | ' | ' |
Conversion of preferred stock, shares | ' | 12,500,000 | ' | ' | -125,000 |
Share-based compensation | 283 | ' | 283 | ' | ' |
Net loss | -6,939 | ' | ' | -6,939 | ' |
Ending Balance, value at Dec. 31, 2013 | 15,581 | 16 | 90,498 | -74,933 | ' |
Ending Balance, shares at Dec. 31, 2013 | ' | 15,685,562 | ' | ' | ' |
Issuance of common stock for cash, net of offering costs | 7,866 | 5 | 7,861 | ' | ' |
Issuance of common stock for cash, net of offering costs, shares | ' | 5,116,228 | ' | ' | ' |
Issuance of common stock upon exercise of warrants for cash, value | 338 | ' | 338 | ' | ' |
Issuance of common stock upon exercise of warrants for cash, share | ' | 209,025 | ' | ' | ' |
Share-based compensation | 330 | ' | 330 | ' | ' |
Net loss | -4,794 | ' | ' | -4,794 | ' |
Ending Balance, value at Jun. 30, 2014 | $19,321 | $21 | $99,027 | ($79,727) | ' |
Ending Balance, shares at Jun. 30, 2014 | ' | 21,010,815 | ' | ' | ' |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Cash flows from operating activities: | ' | ' |
Net loss | ($4,794) | ($2,270) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Depreciation and amortization | 5 | 19 |
Share-based compensation | 330 | 76 |
Change in operating assets and liabilities: | ' | ' |
Other current assets | 45 | 15 |
Other assets | -701 | 40 |
Accounts payable | 128 | 322 |
Accrued expenses and other liabilities | -464 | 71 |
Deferred rent | 1 | -13 |
Net cash used in operating activities | -5,450 | -1,740 |
Cash flows from investing activities: | ' | ' |
Purchase of property and equipment | -5 | -17 |
Net cash used in investing activities | -5 | -17 |
Cash flows from financing activities: | ' | ' |
Proceeds from the issuance of preferred stock | ' | 20,000 |
Proceeds from the issuance of common stock | 9,038 | 1,741 |
Repayment of principal on vendor finance agreement | -128 | -109 |
Net cash provided by financing activities | 8,076 | 19,211 |
Net increase in cash and cash equivalents | 2,621 | 17,454 |
Cash and cash equivalents, beginning of period | 16,756 | 2,920 |
Cash and cash equivalents, end of period | 19,377 | 20,374 |
Supplemental cash flow information: | ' | ' |
Interest paid | 2 | 3 |
Supplemental disclosure of noncash investing and financing transactions: | ' | ' |
Vendor finance agreement | 128 | 65 |
Preferred Stock | ' | ' |
Cash flows from financing activities: | ' | ' |
Payment of offering costs | ' | -2,083 |
Common Stock | ' | ' |
Cash flows from financing activities: | ' | ' |
Payment of offering costs | ($834) | ($338) |
The_Company_and_Summary_of_Sig
The Company and Summary of Significant Accounting Policies | 6 Months Ended | |
Jun. 30, 2014 | ||
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 and 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 plans to evaluate in a clinical trial for the treatment of atrial fibrillation, or AF, in patients with heart failure and/or 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 prior clinical data from the previously conducted 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 recently diagnosed with persistent AF and having 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. The Company is currently enrolling patients in the Phase 2B portion of the study of approximately 200 HFREF patients. 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 been enrolled and have completed 24 weeks of follow-up, the period for measuring the trial’s primary end-point. The interim analysis will focus on available data regarding the trial’s primary end point, AF 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, then the DSMB may recommend 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 clinical steering committee and the DSMB, will make the final determination on the trial’s development steps. The Company believes the Phase 2B interim analysis will be completed in the second half of 2016. | ||
The Company has been granted patents in the U.S., Europe, and other jurisdictions for methods of treating AF and HF patients with Gencaro based on genetic testing, which the Company believes may provide market exclusivity for these uses of Gencaro into at least 2026 in the U.S. and into 2025 in Europe. In addition, the Company believes that if Gencaro is approved, a Gencaro patent will be eligible for patent term extension based on our current clinical trial plans which, if granted, may provide market exclusivity for Gencaro into 2029 or 2030 in the U.S. and Europe. | ||
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. | ||
Risks, 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. | ||
During 2013, the Company raised approximately $19.3 million, net of offering costs, through sales of its convertible preferred stock, common stock and warrants. 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 at least 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 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 consolidated 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. | ||
Basis of Presentation | ||
The accompanying unaudited consolidated 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 six months ended June 30, 2014 are not necessarily indicative of results expected for the full year ending December 31, 2014. 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 consolidated financial statements should be read in conjunction with the audited consolidated financial statements and footnotes thereto for the year ended December 31, 2013 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, as amended. 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, money market fund accounts and debt securities 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 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 consolidated financial statements. |
Net_Loss_Per_Share
Net Loss Per Share | 6 Months Ended | |||||||||||||||
Jun. 30, 2014 | ||||||||||||||||
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 and warrants for common stock. | ||||||||||||||||
A reconciliation of the numerator and denominator used in the calculation of basic and diluted loss per share follows: | ||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
(In thousands, except shares and per share data) | ||||||||||||||||
Net loss | $ | (2,405 | ) | $ | (1,199 | ) | $ | (4,794 | ) | $ | (2,270 | ) | ||||
Less: Series A Preferred Stock deemed dividend | — | (2,026 | ) | — | (2,026 | ) | ||||||||||
Net loss available to common shareholders | $ | (2,405 | ) | $ | (3,225 | ) | $ | (4,794 | ) | $ | (4,296 | ) | ||||
Weighted average shares of common stock outstanding | 21,009,712 | 4,946,932 | 19,903,709 | 3,998,704 | ||||||||||||
Less: Weighted-average shares of unvested common stock | — | (2,783 | ) | — | (2,783 | ) | ||||||||||
Total weighted-average shares used in computing net loss | 21,009,712 | 4,944,149 | 19,903,709 | 3,995,921 | ||||||||||||
per share attributed to common stockholders | ||||||||||||||||
Basic and diluted loss per share | $ | (0.11 | ) | $ | (0.65 | ) | $ | (0.24 | ) | $ | (1.08 | ) | ||||
Potentially dilutive securities representing 11.0 million and 5.2 million weighted average shares of common stock were excluded for the three months ended June 30, 2014 and 2013, respectively, and potentially dilutive securities representing 10.6million and 3.3 million weighted average shares of common stock were excluded for the six months ended June 30, 2014 and 2013, respectively, because including them would have an anti-dilutive effect on net loss per share. |
Fair_Value_Disclosures
Fair Value Disclosures | 6 Months Ended | |
Jun. 30, 2014 | ||
Fair Value Disclosures | ' | |
(3) Fair Value Disclosures | ||
As of June 30, 2014, the Company had $19.0 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 or six month periods ended June 30, 2014. | ||
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 | 6 Months Ended | |||||||||
Jun. 30, 2014 | ||||||||||
Property and Equipment | ' | |||||||||
(4) Property and Equipment | ||||||||||
Property and equipment consist of the following (in thousands): | ||||||||||
Estimated Life | June 30, | December 31, | ||||||||
2014 | 2013 | |||||||||
Computer equipment | 3 years | $ | 99 | $ | 99 | |||||
Lab equipment | 5 years | 142 | 142 | |||||||
Furniture and fixtures | 5 years | 89 | 89 | |||||||
Computer software | 3 years | 91 | 176 | |||||||
Leasehold improvements | Lesser of useful life or life of the lease | 8 | 8 | |||||||
429 | 514 | |||||||||
Accumulated depreciation and amortization | (400 | ) | (485 | ) | ||||||
Property and equipment, net | $ | 29 | $ | 29 | ||||||
For the six months ended June 30, 2014 and 2013, depreciation and amortization expense was $5,000 and $19,000, respectively. |
Commitments_and_Contingencies
Commitments and Contingencies | 6 Months Ended | |||
Jun. 30, 2014 | ||||
Commitments and Contingencies | ' | |||
(5) Commitments and Contingencies | ||||
The Company has or is subject to the following commitments and contingencies: | ||||
Employment Agreements | ||||
The Company maintains employment agreements with several executive employees. Most of these agreements provide for payments to be made under certain conditions related to a change in control of the Company and entitle the employee to wages and certain benefits payments not exceeding one calendar year from the date of termination without cause or by the employee for good reason. The agreements may be terminated at any time by the Company with or without cause upon written notice to the employee. | ||||
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 June 30, 2014 (in thousands): | ||||
Remainder of 2014 | $ | 40 | ||
2015 | 80 | |||
2016 | 62 | |||
Total future minimum lease payments | $ | 182 | ||
Rent expense under these leases for the six months ended June 30, 2014 and 2013 was $39,000 and $27,000, 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 its 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 of the agreement, the Company would be responsible to pay Duke for time and effort incurred through the date of termination. | ||||
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 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 | 6 Months Ended |
Jun. 30, 2014 | |
Equity Financings and Warrants | ' |
(6) Equity Financings and Warrants | |
2013 Equity Financings | |
Private Investment in Public Equity (PIPE) Transaction | |
On January 22, 2013, the Company entered into a Subscription Agreement (the “January 2013 Purchase Agreement”) with various accredited investors and its Chief Executive Officer in connection with a private placement of its common stock and warrants. Pursuant to the January 2013 Purchase Agreement, the Company sold an aggregate of 356,430 shares of its common stock and warrants to purchase up to 249,501 additional shares of its common stock for aggregate gross proceeds of approximately $1 million, before deducting estimated offering expenses payable by the Company. The net proceeds to the Company were approximately $805,000, and the private placement closed on January 25, 2013. | |
The common stock and warrants were sold in units consisting of one share of common stock and a warrant to purchase 0.70 shares of common stock. The purchase price for each unit was $2.81. The warrants were exercisable upon issuance, expire seven years from the date of issuance, and have an exercise price of $2.28 per share, equal to 100% of the closing bid price of ARCA’s common stock on the Nasdaq Capital Market on January 22, 2013. | |
The Company filed a registration statement for the resale of the shares underlying the units sold in the private placement. That registration statement was declared effective by the Securities and Exchange Commission on February 14, 2013. | |
In connection with this transaction, the Company agreed that, subject to certain exceptions, it would not, while the warrants are outstanding, effect or enter into an agreement to effect any issuance of common stock or securities convertible into, exercisable for or exchangeable for common stock in a “variable rate transaction,” which means a transaction in which the Company issues or sells any convertible securities either (A) at a conversion price, exercise price or exchange rate or other price that is based upon and/or varies with the trading prices of, or quotations for, the shares of common stock at any time after the initial issuance of such convertible securities, or (B) with a conversion, exercise or exchange price that is subject to being reset at some future date after the initial issuance of the convertible securities or upon the occurrence of the specified or contingent events directly or indirectly related to our business or the market for our common stock. In addition, the Company agreed that, subject to certain exceptions, if it issues securities within one year following the closing of the offering, each investor would have the right to purchase its pro rata share of a specified portion of the securities in the future offering on the same terms, conditions and price provided for in the proposed issuance of securities. | |
Registered Direct Offering | |
On January 31, 2013, the Company entered into a subscription agreement with certain institutional investors (the “Investors”) in connection with its Registered Direct public offering, pursuant to which the Company sold an aggregate of 164,636 shares of its common stock and warrants to purchase up to 65,855 additional shares of its common stock to the Investors for aggregate gross proceeds of approximately $730,000, before deducting placement agent fees and other estimated offering expenses payable by the Company. The net proceeds to the Company were approximately $616,000, and the offering closed on February 4, 2013. | |
The common stock and warrants were sold in units consisting of one share of common stock and a warrant to purchase 0.40 shares of common stock. The purchase price for each unit was $4.43. The warrants were exercisable upon issuance, expire five years from the date of issuance, and have an exercise price of $4.13 per share, equal to the closing bid price of ARCA’s common stock on the Nasdaq Capital Market on January 31, 2013. The Offering was effected as a takedown of 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 1, 2013. 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. | |
Public Offering | |
On June 4, 2013, the Company sold shares of its Series A Convertible Preferred Stock (Preferred Stock) and warrants to purchase common stock in a public offering for aggregate gross proceeds of $20.0 million. The Company issued 125,000 shares of Preferred Stock and warrants to purchase up to 6,250,000 shares of common stock at a purchase price of $160 per share of Preferred Stock. The net proceeds, after deducting placement agent fees and other offering expenses payable by the Company, were approximately $17.9 million. ARCA’s Director and Chief Executive Officer participated in the offering, purchasing 781 shares of Preferred Stock and warrants to purchase 39,050 shares of common stock. | |
Each share of Preferred Stock was convertible into 100 shares of the Company’s common stock at any time at the option of the holder. Each share of Preferred Stock had a liquidation preference of $.001 per share. The shares of Preferred Stock had no preferential dividends or redemption rights, and no voting rights except as required by law. During 2013, all of the shares of the Preferred Stock were converted into shares of ARCA common stock. | |
Each purchaser in the offering was issued a warrant to purchase 50 shares of the Company’s common stock for each share of Preferred Stock purchased. The warrants have an exercise price of $1.60 per share, will expire on the five year anniversary of the date of issuance, and were exercisable immediately upon issuance, provided that the holder will be prohibited from exercising the warrants if, as a result of such exercise, the holder, together with its affiliates, would beneficially own more than 9.99% of the total number of shares of common stock then issued and outstanding. | |
The securities were sold pursuant to a placement agreement and have been registered under the Securities Act of 1933 pursuant to the Company’s Registration Statement on Form S-1, as amended (No.333-187508), which was declared effective by the Securities and Exchange Commission on May 29, 2013, and the Preferred Stock and Warrants were offered and sold pursuant to a prospectus dated May 30, 2013. | |
In connection with the Preferred Stock financing, the Company recorded a non-cash dividend of approximately $2.0 million to recognize the intrinsic value of the embedded beneficial conversion feature. Typically, such a deemed dividend would be represented as a reduction in a company’s retained earnings and an increase in additional paid-in capital in recognition of the reapportionment of common shareholder value to the preferred stock purchasers. However, since ARCA has an accumulated deficit, the deemed dividend is recognized by a reapportionment of additional paid-in capital from common shareholders to additional paid-in capital of preferred stock purchasers, which are combined in the Company’s statement of stockholders’ equity. | |
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 | |
As of June 30, 2014, warrants to purchase approximately 9.4 million shares of common stock were outstanding at exercise prices ranging from $1.60 to $116.89, with a weighted average exercise price per share of $2.31. These warrants, which were granted as part of various financing and business agreements, expire at various times between April 2016 and January 2020. 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. |
Share_based_Compensation
Share- based Compensation | 6 Months Ended | |||||||||||||||
Jun. 30, 2014 | ||||||||||||||||
Share-based Compensation | ' | |||||||||||||||
(7) Share-based Compensation | ||||||||||||||||
For the three and six month periods ended June 30, 2014 and 2013, the Company recognized the following non-cash, share-based compensation expense in the consolidated statements of operations (in thousands): | ||||||||||||||||
Three Months | Six Months | |||||||||||||||
Ended June 30, | Ended June 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Research and Development | $ | 42 | $ | 14 | $ | 82 | $ | 29 | ||||||||
General and Administrative | 130 | 20 | 248 | 47 | ||||||||||||
Total | $ | 172 | $ | 34 | $ | 330 | $ | 76 | ||||||||
Stock option and stock award transactions for the six month period ended June 30, 2014 under the Company’s stock incentive plans were as follows: | ||||||||||||||||
Number of Options | Weighted Average | Weighted Average Remaining Contractual Term | ||||||||||||||
Exercise | (in years) | |||||||||||||||
Price | ||||||||||||||||
Options outstanding at December 31, 2013 | 843,442 | $ | 3.76 | 8.94 | ||||||||||||
Granted | 200,079 | 1.91 | ||||||||||||||
Exercised | — | — | ||||||||||||||
Forfeited and cancelled | (3,506 | ) | 140.67 | |||||||||||||
Options outstanding at June 30, 2014 | 1,040,015 | $ | 2.94 | 8.71 | ||||||||||||
Options exercisable at June 30, 2014 | 342,333 | $ | 5.66 | 7.51 | ||||||||||||
Options vested and expected to vest | 1,030,851 | $ | 2.95 | 8.7 | ||||||||||||
Number of Shares | Weighted Average Grant Date Fair Value | |||||||||||||||
Restricted stock units outstanding at December 31, 2013 | 419,000 | $ | 1.39 | |||||||||||||
Granted | 191,700 | 1.95 | ||||||||||||||
Vested and released | — | — | ||||||||||||||
Forfeited and cancelled | — | — | ||||||||||||||
Restricted stock units outstanding at June 30, 2014 | 610,700 | $ | 1.57 | |||||||||||||
Income_Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2014 | |
Income Taxes | ' |
(8) 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) | 6 Months Ended | |
Jun. 30, 2014 | ||
Description of Business | ' | |
Description of Business | ||
ARCA biopharma, Inc., or the Company or ARCA, a Delaware corporation, is headquartered in Westminster, Colorado and 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 plans to evaluate in a clinical trial for the treatment of atrial fibrillation, or AF, in patients with heart failure and/or 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 prior clinical data from the previously conducted 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 recently diagnosed with persistent AF and having 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. The Company is currently enrolling patients in the Phase 2B portion of the study of approximately 200 HFREF patients. 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 been enrolled and have completed 24 weeks of follow-up, the period for measuring the trial’s primary end-point. The interim analysis will focus on available data regarding the trial’s primary end point, AF 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, then the DSMB may recommend 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 clinical steering committee and the DSMB, will make the final determination on the trial’s development steps. The Company believes the Phase 2B interim analysis will be completed in the second half of 2016. | ||
The Company has been granted patents in the U.S., Europe, and other jurisdictions for methods of treating AF and HF patients with Gencaro based on genetic testing, which the Company believes may provide market exclusivity for these uses of Gencaro into at least 2026 in the U.S. and into 2025 in Europe. In addition, the Company believes that if Gencaro is approved, a Gencaro patent will be eligible for patent term extension based on our current clinical trial plans which, if granted, may provide market exclusivity for Gencaro into 2029 or 2030 in the U.S. and Europe. | ||
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. | ||
Risks, Liquidity and Going Concern | ' | |
Risks, 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. | ||
During 2013, the Company raised approximately $19.3 million, net of offering costs, through sales of its convertible preferred stock, common stock and warrants. 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 at least 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 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 consolidated 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. | ||
Basis of Presentation | ' | |
Basis of Presentation | ||
The accompanying unaudited consolidated 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 six months ended June 30, 2014 are not necessarily indicative of results expected for the full year ending December 31, 2014. 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 consolidated financial statements should be read in conjunction with the audited consolidated financial statements and footnotes thereto for the year ended December 31, 2013 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, as amended. 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, money market fund accounts and debt securities 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 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 consolidated financial statements. |
Net_Loss_Per_Share_Tables
Net Loss Per Share (Tables) | 6 Months Ended | |||||||||||||||
Jun. 30, 2014 | ||||||||||||||||
Summary of Basic and Diluted Loss Per Share | ' | |||||||||||||||
A reconciliation of the numerator and denominator used in the calculation of basic and diluted loss per share follows: | ||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
(In thousands, except shares and per share data) | ||||||||||||||||
Net loss | $ | (2,405 | ) | $ | (1,199 | ) | $ | (4,794 | ) | $ | (2,270 | ) | ||||
Less: Series A Preferred Stock deemed dividend | — | (2,026 | ) | — | (2,026 | ) | ||||||||||
Net loss available to common shareholders | $ | (2,405 | ) | $ | (3,225 | ) | $ | (4,794 | ) | $ | (4,296 | ) | ||||
Weighted average shares of common stock outstanding | 21,009,712 | 4,946,932 | 19,903,709 | 3,998,704 | ||||||||||||
Less: Weighted-average shares of unvested common stock | — | (2,783 | ) | — | (2,783 | ) | ||||||||||
Total weighted-average shares used in computing net loss | 21,009,712 | 4,944,149 | 19,903,709 | 3,995,921 | ||||||||||||
per share attributed to common stockholders | ||||||||||||||||
Basic and diluted loss per share | $ | (0.11 | ) | $ | (0.65 | ) | $ | (0.24 | ) | $ | (1.08 | ) | ||||
Property_and_Equipment_Tables
Property and Equipment (Tables) | 6 Months Ended | |||||||||
Jun. 30, 2014 | ||||||||||
Summary of Property and Equipment | ' | |||||||||
Property and equipment consist of the following (in thousands): | ||||||||||
Estimated Life | June 30, | December 31, | ||||||||
2014 | 2013 | |||||||||
Computer equipment | 3 years | $ | 99 | $ | 99 | |||||
Lab equipment | 5 years | 142 | 142 | |||||||
Furniture and fixtures | 5 years | 89 | 89 | |||||||
Computer software | 3 years | 91 | 176 | |||||||
Leasehold improvements | Lesser of useful life or life of the lease | 8 | 8 | |||||||
429 | 514 | |||||||||
Accumulated depreciation and amortization | (400 | ) | (485 | ) | ||||||
Property and equipment, net | $ | 29 | $ | 29 | ||||||
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 6 Months Ended | |||
Jun. 30, 2014 | ||||
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 June 30, 2014 (in thousands): | ||||
Remainder of 2014 | $ | 40 | ||
2015 | 80 | |||
2016 | 62 | |||
Total future minimum lease payments | $ | 182 | ||
Sharebased_Compensation_Tables
Share-based Compensation (Tables) | 6 Months Ended | |||||||||||||||
Jun. 30, 2014 | ||||||||||||||||
Non-Cash, Share-Based Compensation Expense | ' | |||||||||||||||
For the three and six month periods ended June 30, 2014 and 2013, the Company recognized the following non-cash, share-based compensation expense in the consolidated statements of operations (in thousands): | ||||||||||||||||
Three Months | Six Months | |||||||||||||||
Ended June 30, | Ended June 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Research and Development | $ | 42 | $ | 14 | $ | 82 | $ | 29 | ||||||||
General and Administrative | 130 | 20 | 248 | 47 | ||||||||||||
Total | $ | 172 | $ | 34 | $ | 330 | $ | 76 | ||||||||
Summary of Stock Option Activities | ' | |||||||||||||||
Stock option and stock award transactions for the six month period ended June 30, 2014 under the Company’s stock incentive plans were as follows: | ||||||||||||||||
Number of Options | Weighted Average | Weighted Average Remaining Contractual Term | ||||||||||||||
Exercise | (in years) | |||||||||||||||
Price | ||||||||||||||||
Options outstanding at December 31, 2013 | 843,442 | $ | 3.76 | 8.94 | ||||||||||||
Granted | 200,079 | 1.91 | ||||||||||||||
Exercised | — | — | ||||||||||||||
Forfeited and cancelled | (3,506 | ) | 140.67 | |||||||||||||
Options outstanding at June 30, 2014 | 1,040,015 | $ | 2.94 | 8.71 | ||||||||||||
Options exercisable at June 30, 2014 | 342,333 | $ | 5.66 | 7.51 | ||||||||||||
Options vested and expected to vest | 1,030,851 | $ | 2.95 | 8.7 | ||||||||||||
Summary of RSU activity | ' | |||||||||||||||
Number of Shares | Weighted Average Grant Date Fair Value | |||||||||||||||
Restricted stock units outstanding at December 31, 2013 | 419,000 | $ | 1.39 | |||||||||||||
Granted | 191,700 | 1.95 | ||||||||||||||
Vested and released | — | — | ||||||||||||||
Forfeited and cancelled | — | — | ||||||||||||||
Restricted stock units outstanding at June 30, 2014 | 610,700 | $ | 1.57 | |||||||||||||
The_Company_and_Summary_of_Sig2
The Company and Summary of Significant Accounting Policies (Details) (USD $) | 6 Months Ended | 12 Months Ended | 1 Months Ended | 6 Months Ended | |
Jun. 30, 2014 | Jun. 30, 2013 | Dec. 31, 2013 | Feb. 28, 2014 | Jun. 30, 2014 | |
Patients | Two Zero One Four Equity Financings | Phase 3 heart failure (HF) trial of Gencaro | |||
Registered Direct Offering | Patients | ||||
Company Basis of Presentation | ' | ' | ' | ' | ' |
Number of patients | ' | ' | ' | ' | 2,708 |
Number of patients company plans to enroll | 200 | ' | ' | ' | 420 |
Fund raised through sale of convertible preferred and common stock | ' | ' | $19,300,000 | ' | ' |
Proceeds from the issuance of common stock | $9,038,000 | $1,741,000 | ' | $7,900,000 | ' |
Net_Loss_Per_Share_Details
Net Loss Per Share (Details) (USD $) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Dec. 31, 2013 |
Summary of basic and diluted loss per share | ' | ' | ' | ' | ' |
Net loss | ($2,405) | ($1,199) | ($4,794) | ($2,270) | ($6,939) |
Less: Deemed preferred stock dividend | ' | -2,026 | ' | -2,026 | 2,026 |
Net loss available to common stockholders | ($2,405) | ($3,225) | ($4,794) | ($4,296) | ' |
Weighted average shares of common stock outstanding | 21,009,712 | 4,946,932 | 19,903,709 | 3,998,704 | ' |
Less: Weighted-average shares of unvested common stock | ' | -2,783 | ' | -2,783 | ' |
Total weighted-average shares used in computing net loss per share attributed to common stockholders | 21,009,712 | 4,944,149 | 19,903,709 | 3,995,921 | ' |
Basic and diluted loss per share | ($0.11) | ($0.65) | ($0.24) | ($1.08) | ' |
Net_Loss_Per_Share_Details_Tex
Net Loss Per Share (Details Textual) | 3 Months Ended | 6 Months Ended | ||
In Millions, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Earnings (Loss) Per Share (Textual) [Abstract] | ' | ' | ' | ' |
Potentially dilutive shares | 11 | 5.2 | 10.6 | 3.3 |
Fair_Value_Disclosures_Details
Fair Value Disclosures (Details) (USD $) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2014 | Jun. 30, 2014 | |
Fair Value Disclosures (Textual) [Abstract] | ' | ' |
Transfers of assets between fair value hierarchy levels | $0 | $0 |
Money Market Funds | ' | ' |
Fair Value Disclosures (Textual) [Abstract] | ' | ' |
Cash equivalents consisting of money market funds | $19,000,000 | $19,000,000 |
Maximum | ' | ' |
Fair Value Disclosures (Textual) [Abstract] | ' | ' |
Cash equivalents consisting of money market funds, maturity period | ' | '90 days |
Property_and_Equipment_Details
Property and Equipment (Details) (USD $) | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 |
Components of Property and equipment | ' | ' |
Property and Equipment, Gross | $429 | $514 |
Accumulated depreciation and amortization | -400 | -485 |
Property and equipment, net | 29 | 29 |
Computer Equipment | ' | ' |
Components of Property and equipment | ' | ' |
Estimated Life | '3 years | ' |
Property and Equipment, Gross | 99 | 99 |
Lab Equipment | ' | ' |
Components of Property and equipment | ' | ' |
Estimated Life | '5 years | ' |
Property and Equipment, Gross | 142 | 142 |
Furniture and Fixtures | ' | ' |
Components of Property and equipment | ' | ' |
Estimated Life | '5 years | ' |
Property and Equipment, Gross | 89 | 89 |
Computer Software | ' | ' |
Components of Property and equipment | ' | ' |
Estimated Life | '3 years | ' |
Property and Equipment, Gross | 91 | 176 |
Leasehold Improvements | ' | ' |
Components of Property and equipment | ' | ' |
Estimated Life | 'Lesser of useful life or life of the lease | ' |
Property and Equipment, Gross | $8 | $8 |
Property_and_Equipment_Details1
Property and Equipment (Details Textual) (USD $) | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Property and Equipment (Textual) [Abstract] | ' | ' |
Depreciation and amortization | $5 | $19 |
Commitments_and_Contingencies_1
Commitments and Contingencies (Details Textual) (USD $) | 3 Months Ended | 6 Months Ended | 3 Months Ended | ||
Mar. 31, 2014 | Jun. 30, 2014 | Jun. 30, 2013 | Mar. 31, 2014 | Aug. 01, 2013 | |
Westminster, Colorado | Westminster, Colorado | ||||
sqft | |||||
Commitments and Contingencies (Textual) [Abstract] | ' | ' | ' | ' | ' |
Area of office facilities taken on lease | ' | ' | ' | ' | 5,300 |
Lease term | ' | ' | ' | '3 years | ' |
Lease expiry period | ' | ' | ' | 30-Sep-16 | ' |
Rent expense | ' | $39,000 | $27,000 | ' | ' |
Clinical research agreement with Duke University, termination notice period | '90 days | ' | ' | ' | ' |
Expected milestone payments upon approval | ' | 8,000,000 | ' | ' | ' |
Another expected milestone payments 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 buy down | ' | 12.50% | ' | ' | ' |
Maximum percentage of range of royalties that can be buy down | ' | 17.00% | ' | ' | ' |
Milestone payment due period | ' | '6 months | ' | ' | ' |
Commitments_and_Contingencies_2
Commitments and Contingencies (Details) (USD $) | Jun. 30, 2014 |
In Thousands, unless otherwise specified | |
Commitments And Contingencies [Line Items] | ' |
Remainder of 2014 | $40 |
2015 | 80 |
2016 | 62 |
Total future minimum lease payments | $182 |
Equity_Financings_and_Warrants1
Equity Financings and Warrants (Details Textual) (USD $) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2014 | Dec. 31, 2013 | |
Equity financings and warrants (Textual) [Abstract] | ' | ' |
Number of warrants outstanding | 9,400,000 | ' |
Class of warrant or rights expiration date earliest. | '2016-04 | ' |
Class of warrant or rights expiration date latest | '2020-01 | ' |
Minimum | ' | ' |
Equity financings and warrants (Textual) [Abstract] | ' | ' |
Warrant price per share | $1.60 | ' |
Maximum | ' | ' |
Equity financings and warrants (Textual) [Abstract] | ' | ' |
Warrant price per share | $116.89 | ' |
Weighted Average | ' | ' |
Equity financings and warrants (Textual) [Abstract] | ' | ' |
Warrant price per share | $2.31 | ' |
PIPE Transaction | ' | ' |
Equity financings and warrants (Textual) [Abstract] | ' | ' |
Aggregate common stock sold | ' | 356,430 |
Warrants available to purchase additional commons shares | ' | 249,501 |
Aggregate gross proceeds | ' | $1,000,000 |
Proceeds from the issuance of common stock | ' | 805,000 |
Public Equity Offering Close Date | ' | 25-Jan-13 |
Subscription agreement date | ' | 22-Jan-13 |
Purchase price for common stock unit | ' | $2.81 |
Warrant coverage ratio | ' | 0.7 |
Warrant price per share | ' | $2.28 |
Closing bid price of the common stock | ' | 100.00% |
Warrants were exercisable upon issuance, expiry year | ' | '7 years |
Closing bid price date | ' | 22-Jan-13 |
Registered Direct Offering | ' | ' |
Equity financings and warrants (Textual) [Abstract] | ' | ' |
Aggregate common stock sold | 5,116,228 | 164,636 |
Warrants available to purchase additional commons shares | 1,279,057 | 65,855 |
Aggregate gross proceeds | 8,700,000 | 730,000 |
Proceeds from the issuance of common stock | 7,900,000 | 616,000 |
Public Equity Offering Close Date | 7-Feb-14 | 4-Feb-13 |
Subscription agreement date | ' | 31-Jan-13 |
Purchase price for common stock unit | $1.70 | $4.43 |
Warrant coverage ratio | 0.25 | 0.4 |
Warrant price per share | $2.13 | $4.13 |
Closing bid price of the common stock | 125.00% | ' |
Warrants were exercisable upon issuance, expiry year | '5 years | '5 years |
Closing bid price date | 3-Feb-14 | 31-Jan-13 |
Public Offering | Series A Convertible Preferred Stock | ' | ' |
Equity financings and warrants (Textual) [Abstract] | ' | ' |
Aggregate common stock sold | ' | 125,000 |
Warrants available to purchase additional commons shares | ' | 6,250,000 |
Aggregate gross proceeds | ' | 20,000,000 |
Proceeds from the issuance of common stock | ' | 17,900,000 |
Purchase price for common stock unit | ' | $160 |
Warrant coverage ratio | ' | 50 |
Warrant price per share | ' | $1.60 |
Warrants were exercisable upon issuance, expiry year | ' | '5 years |
Common stock shares issued upon conversion of each share of convertible preferred stock | ' | 100 |
Preferred stock liquidation preference per share | ' | $0.00 |
Percentage of total number of shares of common stock then issued and outstanding limit on beneficial ownership | ' | 9.99% |
Intrinsic value of embedded beneficial conversion feature | ' | $2,000,000 |
Public Offering | Director and Chief Executive Officer | ' | ' |
Equity financings and warrants (Textual) [Abstract] | ' | ' |
Warrants available to purchase additional commons shares | ' | 39,050 |
Preferred Stock Purchased by Officer | ' | 781 |
Sharebased_Compensation_Detail
Share-based Compensation (Details) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Non-cash, share-based compensation expense | ' | ' | ' | ' |
Total expenses | $172 | $34 | $330 | $76 |
Research and Development | ' | ' | ' | ' |
Non-cash, share-based compensation expense | ' | ' | ' | ' |
Total expenses | 42 | 14 | 82 | 29 |
General and Administrative | ' | ' | ' | ' |
Non-cash, share-based compensation expense | ' | ' | ' | ' |
Total expenses | $130 | $20 | $248 | $47 |
Sharebased_Compensation_Detail1
Share-based Compensation (Details 1) (USD $) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2014 | Dec. 31, 2013 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ' | ' |
Options outstanding beginning of period | 843,442 | ' |
Number of Options, Granted | 200,079 | ' |
Issuance of common stock upon exercise of stock options, for cash, shares | ' | ' |
Number of Options Forfeited, cancelled or expired | -3,506 | ' |
Options outstanding end of the period | 1,040,015 | 843,442 |
Options exercisable, end of period, Number of Options | 342,333 | ' |
Options vested and expected to vest, Number of Options | 1,030,851 | ' |
Weighted Average exercise Price, Options Outstanding, Beginning of period | $3.76 | ' |
Weighted average exercise price, Granted | $1.91 | ' |
Weighted average exercise price, Exercised | ' | ' |
Weighted average exercise price, Forfeited, cancelled or expired | $140.67 | ' |
Weighted Average exercise Price, Options Outstanding, end of period | $2.94 | $3.76 |
Weighted average exercise price, Options exercisable, end of period | $5.66 | ' |
Weighted Average exercise Price, Options vested and expected to vest, end of period | $2.95 | ' |
Weighted Average Remaining Contractual Term (in years) Options Outstanding | '8 years 8 months 16 days | '8 years 11 months 9 days |
Options exercisable at March 31, 2014, Weighted Average Remaining Contractual Term (in years) | '7 years 6 months 4 days | ' |
Options vested and expected to vest, Weighted Average Remaining Contractual Term (in years) | '8 years 8 months 12 days | ' |
Sharebased_Compensation_Detail2
Share-based Compensation (Details 2) (USD $) | 6 Months Ended |
Jun. 30, 2014 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ' |
Restricted stock units outstanding at December 31, 2013 | 419,000 |
Granted | 191,700 |
Vested and released | ' |
Forfeited and cancelled | ' |
Restricted stock units outstanding at June 30, 2014 | 610,700 |
Restricted Stock Awards | ' |
Restricted stock units outstanding at December 31, 2013 | $1.39 |
Granted | $1.95 |
Vested and released | ' |
Forfeited and cancelled | ' |
Restricted stock units outstanding at June 30, 2014 | $1.57 |