Oruka Therapeutics (ORKA) 10-Q 12 Nov 15 2015 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2015	Nov. 10, 2015
Document And Entity Information [Abstract]
Entity Registrant Name	ARCA Biopharma, Inc.
Entity Central Index Key	907,654
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2015
Document Fiscal Period Focus	Q3
Trading Symbol	ABIO
Document Fiscal Year Focus	2,015
Current Fiscal Year End Date	--12-31
Entity Filer Category	Smaller Reporting Company
Entity Common Stock, Shares Outstanding		9,051,217

BALANCE SHEETS (Unaudited)

BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands	Sep. 30, 2015	Dec. 31, 2014
Current assets:
Cash and cash equivalents	$ 41,482	$ 15,354
Other current assets	205	134
Total current assets	41,687	15,488
Property and equipment, net	31	36
Other assets	679	608
Total assets	42,397	16,132
Current liabilities:
Accounts payable	647	795
Accrued compensation and employee benefits	114	329
Accrued expenses and other liabilities	543	264
Total current liabilities	1,304	1,388
Deferred rent, net of current portion		3
Total liabilities	$ 1,304	$ 1,391
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value; 100 million shares authorized at September 30, 2015 and December 31, 2014; 9,049,789 and 3,021,498 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively	$ 9	$ 3
Additional paid-in capital	133,983	99,360
Accumulated deficit	(92,899)	(84,622)
Total stockholders’ equity	41,093	14,741
Total liabilities and stockholders’ equity	$ 42,397	$ 16,132

BALANCE SHEETS (Unaudited) (Par

BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 2015	Dec. 31, 2014
Statement Of Financial Position [Abstract]
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares issued	9,049,789	3,021,498
Common stock, shares outstanding	9,049,789	3,021,498

STATEMENTS OF OPERATIONS AND CO

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Costs and expenses:
Research and development	$ 1,716	$ 1,335	$ 5,170	$ 4,043
General and administrative	1,101	950	3,110	3,038
Total costs and expenses	2,817	2,285	8,280	7,081
Loss from operations	(2,817)	(2,285)	(8,280)	(7,081)
Interest and other income	4	2	7	6
Interest expense	(1)	(1)	(4)	(3)
Net loss and comprehensive loss	$ (2,814)	$ (2,284)	$ (8,277)	$ (7,078)
Net loss per share:
Basic and diluted	$ (0.31)	$ (0.76)	$ (1.54)	$ (2.44)
Weighted average shares outstanding:
Basic and diluted	9,034,016	3,004,163	5,358,629	2,897,568

STATEMENTS OF STOCKHOLDERS' EQU

STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit
Beginning Balance at Dec. 31, 2013	$ 15,581	$ 2	$ 90,512	$ (74,933)
Beginning Balance, shares at Dec. 31, 2013		2,240,794
Issuance of common stock for cash, net of offering costs, shares		730,890
Issuance of common stock for cash, net of offering costs	7,866	$ 1	7,865
Issuance of common stock upon exercise of warrants for cash, shares		29,861
Issuance of common stock upon exercise of warrants for cash, value	338		338
Issuance of common stock upon vesting of Restricted Stock Units, shares		19,953
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	$ 3	99,360	(84,622)
Ending Balance, shares at Dec. 31, 2014	3,021,498	3,021,498
Issuance of common stock for cash, net of offering costs, shares		6,003,082
Issuance of common stock for cash, net of offering costs	$ 34,175	$ 6	34,169
Issuance of common stock upon vesting of Restricted Stock Units, shares		25,241
Issuance of common stock upon vesting of Restricted Stock Units, value	0	$ 0	0	0
Adjustment for fractional shares		(32)
Share-based compensation	454		454
Net loss	(8,277)			(8,277)
Ending Balance at Sep. 30, 2015	$ 41,093	$ 9	$ 133,983	$ (92,899)
Ending Balance, shares at Sep. 30, 2015	9,049,789	9,049,789

STATEMENTS OF CASH FLOWS (Unaud

STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Cash flows from operating activities:
Net loss	$ (8,277)	$ (7,078)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	14	8
Amortization of deferred charges	133	34
Share-based compensation	454	491
Change in operating assets and liabilities:
Other current assets	147	132
Other assets	(229)	(452)
Accounts payable	(167)	(232)
Accrued compensation and employee benefits	(215)	(360)
Accrued expenses and other liabilities	229	(72)
Other	(3)	2
Net cash used in operating activities	(7,914)	(7,527)
Cash flows from investing activities:
Purchase of property and equipment	(9)	(5)
Net cash used in investing activities	(9)	(5)
Cash flows from financing activities:
Proceeds from the issuance of common stock	37,000	9,038
Common stock offering costs	(2,756)	(834)
Repayment of principal on vendor finance agreement	(193)	(179)
Net cash provided by financing activities	34,051	8,025
Net increase in cash and cash equivalents	26,128	493
Cash and cash equivalents, beginning of period	15,354	16,756
Cash and cash equivalents, end of period	41,482	17,249
Supplemental cash flow information:
Interest paid	4	$ 3
Supplemental disclosure of noncash investing and financing transactions:
Common stock offering costs accrued but not yet paid	$ 69

The Company and Summary of Sign

The Company and Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 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 endpoint 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. If the Company proceeds with the Phase 3 portion of the GENETIC-AF, it will need to raise additional capital to complete the Phase 3 portion of the GENETIC-AF clinical trial and submit for FDA approval. 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 June 2015 and February 2014, the Company raised approximately $34.2 million and $7.9 million in net proceeds, respectively, 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 believes 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 2017. However, in light of the significant uncertainties regarding clinical development timelines and costs for developing drugs such as Gencaro, the Company expects to raise additional capital to finance the completion of GENETIC-AF and the Company’s future 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. Reverse Stock Split On September 3, 2015, the Company completed a 1-for-7 reverse stock split of its common stock. All common shares and per common share amounts in the financial statements and footnotes have been adjusted retroactively to reflect the effects of this action. 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 financial statements. The results of operations for the nine months ended September 30, 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 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 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. . 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

Net Loss Per Share

Net Loss Per Share	9 Months Ended
	Sep. 30, 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 and nine months ended September 30, 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 September 30, 2015, no outstanding warrants were in-the-money and no outstanding stock options were in-the-money, other than the options granted in the first quarter of 2015. See Notes 7 and 8 for further details. September 30, 2015 2014 Potentially dilutive securities, excluded: Outstanding stock options 170,545 148,514 Unvested restricted stock units 71,780 68,702 Warrants to purchase common stock 3,739,948 1,338,715 3,982,273 1,555,931

Fair Value Disclosures

Fair Value Disclosures	9 Months Ended
	Sep. 30, 2015
Fair Value Disclosures [Abstract]
Fair Value Disclosures	(3) Fair Value Disclosures As of September 30, 2015, the Company had $41.4 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 nine month period ended September 30, 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	9 Months Ended
	Sep. 30, 2015
Property Plant And Equipment [Abstract]
Property and Equipment	(4) Property and Equipment Property and equipment consist of the following (in thousands): Estimated Life September 30, 2015 December 31, 2014 Computer equipment 3 years $ 92 $ 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 8 415 418 Accumulated depreciation and amortization (384 ) (382 ) Property and equipment, net $ 31 $ 36 For the nine months ended September 30, 2015 and 2014, depreciation and amortization expense was $14,000 and $8,000, respectively.

Related Party Arrangements

Related Party Arrangements	9 Months Ended
	Sep. 30, 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 nine months ended September 30, 2015 and 2014 was $277,000 and $261,000 respectively.

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
	Sep. 30, 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 September 30, 2015 (in thousands): Remainder of 2015 $ 21 2016 62 Total future minimum lease payments $ 83 Rent expense for the nine months ended September 30, 2015 and 2014 was $60,000 and $58,000, 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 . 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	9 Months Ended
	Sep. 30, 2015
Equity [Abstract]
Equity Financings and Warrants	(7) Equity Financings and Warrants 2015 Equity Financing Private Investment in Public Entity (PIPE) Transaction On June 16, 2015, the Company sold an aggregate of 6,003,082 security units, made up of an aggregate 6,003,082 shares of the Company’s common stock and warrants to purchase an aggregate of 2,401,233 shares of the Company’s common stock, at a purchase price of $6.1635 per unit, for aggregate net proceeds of approximately of $34.2 million. The warrants will become exercisable on December 13, 2015, expire on June 16, 2022, and have an exercise price of $6.1012 per share. 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. The Company’s Registration Statement on Form S-3 registering the shares of common stock, including the shares of common stock underlying the warrants, issued in the transaction for public resale was declared effective on July 20, 2015. 2014 Equity Financing Registered Direct Offering On February 7, 2014, the Company sold an aggregate of 730,890 shares of the Company’s common stock and warrants to purchase an aggregate of 182,722 shares of the Company’s common stock at a purchase price of $11.90 per share of Common Stock, for aggregate net proceeds of approximately $7.9 million. The warrants were exercisable upon issuance, expire on February 7, 2019, and have an exercise price of $14.875 per share. 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. All outstanding 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 September 30, 2015, these warrants, by year of expiration, are summarized below: Year of Expiration Number of Warrants Weighted Average Exercise Price 2016 82,816 $ 68.19 2017 24,124 17.89 2018 963,153 11.77 2019 224,323 15.73 2020 44,299 15.96 2022 2,401,233 6.10 3,739,948 $ 9.70

Share-based Compensation

Share-based Compensation	9 Months Ended
	Sep. 30, 2015
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]
Share-based Compensation	(8) Share-based Compensation For the three and nine month periods ended September 30, 2015 and 2014, the Company recognized the following non-cash, share-based compensation expense in the statements of operations (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Research and development $ 42 $ 40 $ 132 $ 122 General and administrative 107 121 322 369 Total $ 149 $ 161 $ 454 $ 491 Stock option transactions for the nine month period ended September 30, 2015 under the Company’s stock incentive plans were as follows: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Options outstanding at December 31, 2014 152,584 $ 20.20 8.25 Granted 20,192 4.90 Exercised — — Forfeited and cancelled (2,231 ) 21.72 Options outstanding at September 30, 2015 170,545 $ 18.37 7.74 Options exercisable at September 30, 2015 105,678 $ 23.32 7.32 Options vested and expected to vest 170,367 $ 18.38 7.73 Stock award transactions for the nine month period ended September 30, 2015 under the Company’s stock incentive plans were as follows: Number of Shares Weighted Average Grant Date Fair Value Restricted stock units outstanding at December 31, 2014 67,274 $ 11.33 Granted 30,609 4.76 Vested and released (25,241 ) 10.74 Forfeited and cancelled (862 ) 7.06 Restricted stock units outstanding at September 30, 2015 71,780 $ 8.79

Income Taxes

Income Taxes	9 Months Ended
	Sep. 30, 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 Si16

The Company and Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 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 June 2015 and February 2014, the Company raised approximately $34.2 million and $7.9 million in net proceeds, respectively, 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 believes 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 2017. However, in light of the significant uncertainties regarding clinical development timelines and costs for developing drugs such as Gencaro, the Company expects to raise additional capital to finance the completion of GENETIC-AF and the Company’s future 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.
Reverse Stock Split	Reverse Stock Split On September 3, 2015, the Company completed a 1-for-7 reverse stock split of its common stock. All common shares and per common share amounts in the financial statements and footnotes have been adjusted retroactively to reflect the effects of this action.
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 financial statements. The results of operations for the nine months ended September 30, 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 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 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. . 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

Net Loss Per Share (Tables)

Net Loss Per Share (Tables)	9 Months Ended
	Sep. 30, 2015
Earnings Per Share [Abstract]
Summary of Potentially Dilutive Shares of Common Stock	Because we reported a net loss for the three and nine months ended September 30, 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 September 30, 2015, no outstanding warrants were in-the-money and no outstanding stock options were in-the-money, other than the options granted in the first quarter of 2015. See Notes 7 and 8 for further details. September 30, 2015 2014 Potentially dilutive securities, excluded: Outstanding stock options 170,545 148,514 Unvested restricted stock units 71,780 68,702 Warrants to purchase common stock 3,739,948 1,338,715 3,982,273 1,555,931

Property and Equipment (Tables)

Property and Equipment (Tables)	9 Months Ended
	Sep. 30, 2015
Property Plant And Equipment [Abstract]
Summary of Property and Equipment	Property and equipment consist of the following (in thousands): Estimated Life September 30, 2015 December 31, 2014 Computer equipment 3 years $ 92 $ 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 8 415 418 Accumulated depreciation and amortization (384 ) (382 ) Property and equipment, net $ 31 $ 36

Commitments and Contingencies (

Commitments and Contingencies (Tables)	9 Months Ended
	Sep. 30, 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 September 30, 2015 (in thousands): Remainder of 2015 $ 21 2016 62 Total future minimum lease payments $ 83

Equity Financings and Warrants

Equity Financings and Warrants (Tables)	9 Months Ended
	Sep. 30, 2015
Equity [Abstract]
Summary of Warrants by Year of Expiration	As of September 30, 2015, these warrants, by year of expiration, are summarized below: Year of Expiration Number of Warrants Weighted Average Exercise Price 2016 82,816 $ 68.19 2017 24,124 17.89 2018 963,153 11.77 2019 224,323 15.73 2020 44,299 15.96 2022 2,401,233 6.10 3,739,948 $ 9.70

Share-based Compensation (Table

Share-based Compensation (Tables)	9 Months Ended
	Sep. 30, 2015
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]
Non-Cash, Share-Based Compensation Expense	For the three and nine month periods ended September 30, 2015 and 2014, the Company recognized the following non-cash, share-based compensation expense in the statements of operations (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Research and development $ 42 $ 40 $ 132 $ 122 General and administrative 107 121 322 369 Total $ 149 $ 161 $ 454 $ 491
Summary of Stock Option and Stock Award Activities	Stock option transactions for the nine month period ended September 30, 2015 under the Company’s stock incentive plans were as follows: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Options outstanding at December 31, 2014 152,584 $ 20.20 8.25 Granted 20,192 4.90 Exercised — — Forfeited and cancelled (2,231 ) 21.72 Options outstanding at September 30, 2015 170,545 $ 18.37 7.74 Options exercisable at September 30, 2015 105,678 $ 23.32 7.32 Options vested and expected to vest 170,367 $ 18.38 7.73
Summary of RSU activity	Stock award transactions for the nine month period ended September 30, 2015 under the Company’s stock incentive plans were as follows: Number of Shares Weighted Average Grant Date Fair Value Restricted stock units outstanding at December 31, 2014 67,274 $ 11.33 Granted 30,609 4.76 Vested and released (25,241 ) 10.74 Forfeited and cancelled (862 ) 7.06 Restricted stock units outstanding at September 30, 2015 71,780 $ 8.79

The Company and Summary of Si22

The Company and Summary of Significant Accounting Policies (Details Textual)	Jun. 16, 2015USD ($)	Feb. 07, 2014USD ($)	Sep. 30, 2015USD ($)Patients
Company And Summary Of Significant Accounting Policies Table [Line Items]
Revenues			$ 0
Reverse stock split			0.143
Concentrations of credit risk			$ 0
Registered Direct Offering
Company And Summary Of Significant Accounting Policies Table [Line Items]
Proceeds from the issuance of security units		$ 7,900,000
Private Investment In Public Entity Transaction
Company And Summary Of Significant Accounting Policies Table [Line Items]
Proceeds from the issuance of security units	$ 34,200,000
Phase 3 heart failure (HF) trial of Gencaro | BEST Trial
Company And Summary Of Significant Accounting Policies Table [Line Items]
Number of patients | Patients			2,708
Phase 3 heart failure (HF) trial of Gencaro | GENETIC-AF Trial
Company And Summary Of Significant Accounting Policies Table [Line Items]
Number of patients company plans to enroll | Patients			420
Phase Two B Heart Failure | GENETIC-AF Trial
Company And Summary Of Significant Accounting Policies Table [Line Items]
Number of patients company plans to enroll | Patients			200
Trail endpoint, term			168 days

Net Loss Per Share (Details Tex

Net Loss Per Share (Details Textual)	9 Months Ended
	Sep. 30, 2015shares
Warrants
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Securities in-the-money	0
Stock options
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Securities in-the-money	0

Net Loss Per Share - Summary of

Net Loss Per Share - Summary of Potentially Dilutive Shares of Common Stock (Details) - shares	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	3,982,273	1,555,931
Outstanding stock options
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	170,545	148,514
Unvested restricted stock units
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	71,780	68,702
Warrants to purchase common stock
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	3,739,948	1,338,715

Fair Value Disclosures (Details

Fair Value Disclosures (Details Textual)	9 Months Ended
	Sep. 30, 2015USD ($)
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Transfers of assets between fair value hierarchy levels	$ 0
Fair Value Measurements, Recurring | Level 1 | Money Market Funds
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash equivalents consisting of money market funds	$ 41,400,000

Property and Equipment - Summar

Property and Equipment - Summary of Property and Equipment (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2015	Dec. 31, 2014
Property Plant And Equipment [Line Items]
Property and Equipment, Gross	$ 415	$ 418
Accumulated depreciation and amortization	(384)	(382)
Property and equipment, net	$ 31	36
Computer Equipment
Property Plant And Equipment [Line Items]
Estimated Life	3 years
Property and Equipment, Gross	$ 92	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 ($) $ in Thousands	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Property Plant And Equipment [Abstract]
Depreciation and amortization expense	$ 14	$ 8

Related Party Arrangements (Det

Related Party Arrangements (Details Textual) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Chief Executive Officer | Research Grants
Related Party Transaction [Line Items]
Total expense	$ 277	$ 261

Commitments and Contingencies29

Commitments and Contingencies (Details Textual) $ in Thousands	9 Months Ended
	Sep. 30, 2015USD ($)	Sep. 30, 2014USD ($)	Aug. 01, 2013ft²
Commitments And Contingencies [Line Items]
Area of office facilities taken on lease | ft²			5,300
Lease term	3 years
Lease expiry date	Sep. 30, 2016
Rent expense	$ 60	$ 58
Royalty buy down due period	6 months
Minimum
Commitments And Contingencies [Line Items]
Percentage of royalty obligation	12.50%
Percentage of range of royalties that can be bought down	12.50%
Maximum
Commitments And Contingencies [Line Items]
Percentage of royalty obligation	25.00%
Percentage of range of royalties that can be bought down	17.00%
Clinincal Research Agreement with Duke University
Commitments And Contingencies [Line Items]
Agreement termination notice period	90 days
Upon Food and Drug Administration Approval
Commitments And Contingencies [Line Items]
Expected milestone payments due upon approval	$ 8,000
Upon Regulatory Marketing Approval
Commitments And Contingencies [Line Items]
Expected milestone payments due upon approval	$ 5,000
CPEC
Commitments And Contingencies [Line Items]
Percentage of royalty obligation	5.00%

Commitments and Contingencies -

Commitments and Contingencies - Future Minimum Lease Payments (Details) $ in Thousands	Sep. 30, 2015USD ($)
Commitments And Contingencies Disclosure [Abstract]
Remainder of 2015	$ 21
2,016	62
Total future minimum lease payments	$ 83

Equity Financings and Warrant31

Equity Financings and Warrants (Details Textual) - USD ($) $ / shares in Units, $ in Millions	Jun. 16, 2015	Feb. 07, 2014	Sep. 30, 2015	Dec. 31, 2014	Feb. 03, 2014
Equity Financing And Warrants [Line Items]
Common stock, shares issued			9,049,789	3,021,498
Private Investment In Public Entity Transaction
Equity Financing And Warrants [Line Items]
Common stock, shares issued	6,003,082
Warrants available to purchase additional commons shares	2,401,233
Purchase price for common stock unit	$ 6.1635
Proceeds from the issuance of security units	$ 34.2
Warrants will become exercisable date			Dec. 13, 2015
Warrants were exercisable upon issuance, expiry date			Jun. 16, 2022
Warrant price per share	$ 6.1012
Private Investment In Public Entity Transaction | Security Units
Equity Financing And Warrants [Line Items]
Common stock, shares issued	6,003,082
Registered Direct Offering
Equity Financing And Warrants [Line Items]
Common stock, shares issued		730,890
Warrants available to purchase additional commons shares		182,722
Purchase price for common stock unit		$ 11.90
Proceeds from the issuance of security units		$ 7.9
Warrants were exercisable upon issuance, expiry date			Feb. 7, 2019
Warrant price per share					$ 14.875

Equity Financings and Warrant32

Equity Financings and Warrants - Summary of Warrants by Year of Expiration (Details)	9 Months Ended
	Sep. 30, 2015$ / sharesshares
Class Of Warrant Or Right [Line Items]
Number of Warrants | shares	3,739,948
Weighted Average Exercise Price	$ 9.70
2,016
Class Of Warrant Or Right [Line Items]
Year of Expiration	2,016
Number of Warrants | shares	82,816
Weighted Average Exercise Price	$ 68.19
2,017
Class Of Warrant Or Right [Line Items]
Year of Expiration	2,017
Number of Warrants | shares	24,124
Weighted Average Exercise Price	$ 17.89
2,018
Class Of Warrant Or Right [Line Items]
Year of Expiration	2,018
Number of Warrants | shares	963,153
Weighted Average Exercise Price	$ 11.77
2,019
Class Of Warrant Or Right [Line Items]
Year of Expiration	2,019
Number of Warrants | shares	224,323
Weighted Average Exercise Price	$ 15.73
2,020
Class Of Warrant Or Right [Line Items]
Year of Expiration	2,020
Number of Warrants | shares	44,299
Weighted Average Exercise Price	$ 15.96
2,022
Class Of Warrant Or Right [Line Items]
Year of Expiration	2,022
Number of Warrants | shares	2,401,233
Weighted Average Exercise Price	$ 6.10

Share-based Compensation - Summ

Share-based Compensation - Summary of Non-cash, Share-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total expenses	$ 149	$ 161	$ 454	$ 491
Research and development
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total expenses	42	40	132	122
General and administrative
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total expenses	$ 107	$ 121	$ 322	$ 369

Share-based Compensation - Su34

Share-based Compensation - Summary of Stock Option Activities (Details) - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2015	Dec. 31, 2014
Number of Stock Options
Options outstanding beginning of period	152,584
Number of Options, Granted	20,192
Number of Options, Forfeited and cancelled	(2,231)
Options outstanding end of the period	170,545	152,584
Options exercisable, end of period, Number of Options	105,678
Options vested and expected to vest, Number of Options	170,367
Stock Options, Weighted Average Exercise Price
Weighted Average exercise Price, Options Outstanding, Beginning of period	$ 20.20
Weighted average exercise price, Granted	4.90
Weighted average exercise price, Forfeited and cancelled	21.72
Weighted Average exercise Price, Options Outstanding, end of period	18.37	$ 20.20
Weighted average exercise price, Options exercisable, end of period	23.32
Weighted Average exercise Price, Options vested and expected to vest, end of period	$ 18.38
Stock Options, Weighted Average Remaining Contractual Term
Weighted Average Remaining Contractual Term (in years) Options Outstanding	7 years 8 months 27 days	8 years 3 months
Options exercisable, Weighted Average Remaining Contractual Term (in years)	7 years 3 months 26 days
Options vested and expected to vest, Weighted Average Remaining Contractual Term (in years)	7 years 8 months 23 days

Share-based Compensation - Su35

Share-based Compensation - Summary of Restricted Stock Units Activity (Details)	9 Months Ended
	Sep. 30, 2015$ / sharesshares
Restricted Stock Awards, Number of Shares
Restricted stock units outstanding, beginning of period | shares	67,274
Granted | shares	30,609
Vested and released | shares	(25,241)
Forfeited and cancelled | shares	(862)
Restricted stock units outstanding, end of period | shares	71,780
Restricted Stock Awards, Weighted Average Grant Date Fair Value
Restricted stock units outstanding, beginning of period	$ 11.33
Granted	4.76
Vested and released	10.74
Forfeited and cancelled	7.06
Restricted stock units outstanding, end of period	$ 8.79