Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 01, 2019 | |
Cover [Abstract] | ||
Entity Registrant Name | ARCA Biopharma, Inc. | |
Entity Central Index Key | 0000907654 | |
Entity Current Reporting Status | Yes | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | ABIO | |
Document Fiscal Year Focus | 2019 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 1,594,070 | |
Entity Shell Company | false | |
Entity File Number | 000-22873 | |
Entity Tax Identification Number | 36-3855489 | |
Entity Address, Address Line One | 11080 CirclePoint Road | |
Entity Address, Address Line Two | Suite 140 | |
Entity Address, City or Town | Westminster | |
Entity Address, State or Province | CO | |
Entity Address, Postal Zip Code | 80020 | |
City Area Code | 720 | |
Local Phone Number | 940-2200 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Entity Interactive Data Current | Yes |
BALANCE SHEETS (Unaudited)
BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 9,645 | $ 6,608 |
Other current assets | 259 | 169 |
Total current assets | 9,904 | 6,777 |
Right-of-use asset - operating | 11 | |
Property and equipment, net | 10 | 24 |
Other assets | 24 | 24 |
Total assets | 9,949 | 6,825 |
Current liabilities: | ||
Accounts payable | 135 | 230 |
Accrued compensation and employee benefits | 158 | 150 |
Accrued expenses and other liabilities | 857 | 413 |
Total current liabilities | 1,150 | 793 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value; 100 million shares authorized at September 30, 2019 and December 31, 2018; 1,594,070 and 773,558 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 2 | 1 |
Additional paid-in capital | 151,987 | 144,965 |
Accumulated deficit | (143,190) | (138,934) |
Total stockholders’ equity | 8,799 | 6,032 |
Total liabilities and stockholders’ equity | $ 9,949 | $ 6,825 |
BALANCE SHEETS (Unaudited) (Par
BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
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 | 1,594,070 | 773,558 |
Common stock, shares outstanding | 1,594,070 | 773,558 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Costs and expenses: | ||||
Research and development | $ 347 | $ 740 | $ 1,449 | $ 3,614 |
General and administrative | 900 | 922 | 3,087 | 2,977 |
Total costs and expenses | 1,247 | 1,662 | 4,536 | 6,591 |
Loss from operations | (1,247) | (1,662) | (4,536) | (6,591) |
Interest and other income | 50 | 40 | 136 | 124 |
Interest expense | (1) | (2) | (7) | (8) |
Loss before income taxes | (1,198) | (1,624) | (4,407) | (6,475) |
Income tax benefit | 42 | 31 | 151 | 31 |
Net loss | (1,156) | (1,593) | (4,256) | (6,444) |
Change in unrealized loss on marketable securities | 2 | |||
Comprehensive loss | $ (1,156) | $ (1,593) | $ (4,256) | $ (6,442) |
Net loss per share: | ||||
Basic and diluted | $ (0.76) | $ (2.06) | $ (3.46) | $ (8.39) |
Weighted average shares outstanding: | ||||
Basic and diluted | 1,521,259 | 773,545 | 1,229,289 | 767,989 |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning Balance at Dec. 31, 2017 | $ 10,275 | $ 1 | $ 141,277 | $ (2) | $ (131,001) |
Beginning Balance, shares at Dec. 31, 2017 | 654,170 | ||||
Issuance of common stock for cash, net of offering costs | 3,415 | 3,415 | |||
Issuance of common stock for cash, net of offering costs, shares | 118,546 | ||||
Issuance of common stock upon vesting of Restricted Stock Units, value | 0 | $ 0 | 0 | 0 | 0 |
Issuance of common stock upon vesting of Restricted Stock Units, shares | 301 | ||||
Share-based compensation | 97 | 97 | |||
Change in unrealized loss on marketable securities | 2 | 2 | |||
Net loss | (2,735) | (2,735) | |||
Ending Balance at Mar. 31, 2018 | 11,054 | $ 1 | 144,789 | (133,736) | |
Ending Balance, shares at Mar. 31, 2018 | 773,017 | ||||
Beginning Balance at Dec. 31, 2017 | 10,275 | $ 1 | 141,277 | (2) | (131,001) |
Beginning Balance, shares at Dec. 31, 2017 | 654,170 | ||||
Change in unrealized loss on marketable securities | 2 | ||||
Net loss | (6,444) | ||||
Ending Balance at Sep. 30, 2018 | 7,463 | $ 1 | 144,907 | (137,445) | |
Ending Balance, shares at Sep. 30, 2018 | 773,545 | ||||
Beginning Balance at Mar. 31, 2018 | 11,054 | $ 1 | 144,789 | (133,736) | |
Beginning Balance, shares at Mar. 31, 2018 | 773,017 | ||||
Issuance of common stock upon vesting of Restricted Stock Units, value | 0 | $ 0 | 0 | 0 | 0 |
Issuance of common stock upon vesting of Restricted Stock Units, shares | 528 | ||||
Share-based compensation | 60 | 60 | |||
Net loss | (2,116) | (2,116) | |||
Ending Balance at Jun. 30, 2018 | 8,998 | $ 1 | 144,849 | (135,852) | |
Ending Balance, shares at Jun. 30, 2018 | 773,545 | ||||
Share-based compensation | 58 | 58 | |||
Net loss | (1,593) | (1,593) | |||
Ending Balance at Sep. 30, 2018 | 7,463 | $ 1 | 144,907 | (137,445) | |
Ending Balance, shares at Sep. 30, 2018 | 773,545 | ||||
Issuance of common stock upon vesting of Restricted Stock Units, value | 0 | $ 0 | 0 | $ 0 | 0 |
Issuance of common stock upon vesting of Restricted Stock Units, shares | 13 | ||||
Share-based compensation | 58 | 58 | |||
Net loss | (1,489) | (1,489) | |||
Ending Balance at Dec. 31, 2018 | $ 6,032 | $ 1 | 144,965 | (138,934) | |
Ending Balance, shares at Dec. 31, 2018 | 773,558 | 773,558 | |||
Issuance of common stock for cash, net of offering costs | $ 2,900 | 2,900 | |||
Issuance of common stock for cash, net of offering costs, shares | 325,304 | ||||
Share-based compensation | 50 | 50 | |||
Adjustment for fractional shares | (49) | ||||
Net loss | (1,664) | (1,664) | |||
Ending Balance at Mar. 31, 2019 | 7,318 | $ 1 | 147,915 | (140,598) | |
Ending Balance, shares at Mar. 31, 2019 | 1,098,813 | ||||
Beginning Balance at Dec. 31, 2018 | $ 6,032 | $ 1 | 144,965 | (138,934) | |
Beginning Balance, shares at Dec. 31, 2018 | 773,558 | 773,558 | |||
Net loss | $ (4,256) | ||||
Ending Balance at Sep. 30, 2019 | $ 8,799 | $ 2 | 151,987 | (143,190) | |
Ending Balance, shares at Sep. 30, 2019 | 1,594,070 | 1,594,070 | |||
Beginning Balance at Mar. 31, 2019 | $ 7,318 | $ 1 | 147,915 | (140,598) | |
Beginning Balance, shares at Mar. 31, 2019 | 1,098,813 | ||||
Issuance of common stock for cash, net of offering costs | 3,262 | 3,262 | |||
Issuance of common stock for cash, net of offering costs, shares | 356,743 | ||||
Share-based compensation | 45 | 45 | |||
Net loss | (1,436) | (1,436) | |||
Ending Balance at Jun. 30, 2019 | 9,189 | $ 1 | 151,222 | (142,034) | |
Ending Balance, shares at Jun. 30, 2019 | 1,455,556 | ||||
Issuance of common stock for cash, net of offering costs | 737 | $ 1 | 736 | ||
Issuance of common stock for cash, net of offering costs, shares | 138,514 | ||||
Share-based compensation | 29 | 29 | |||
Net loss | (1,156) | (1,156) | |||
Ending Balance at Sep. 30, 2019 | $ 8,799 | $ 2 | $ 151,987 | $ (143,190) | |
Ending Balance, shares at Sep. 30, 2019 | 1,594,070 | 1,594,070 |
STATEMENTS OF CASH FLOWS (Unaud
STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (4,256) | $ (6,444) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 16 | 17 |
Amortization of right-of-use asset - operating | 49 | |
Amortization of premiums and discounts on marketable securities | 2 | |
Share-based compensation | 124 | 215 |
Change in operating assets and liabilities: | ||
Other current assets | 259 | 522 |
Accounts payable | (95) | (405) |
Accrued compensation and employee benefits | 8 | (573) |
Accrued expenses and other liabilities | 252 | (235) |
Net cash used in operating activities | (3,643) | (6,901) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (2) | (4) |
Proceeds from maturities of marketable securities | 3,050 | |
Net cash (used in) provided by investing activities | (2) | 3,046 |
Cash flows from financing activities: | ||
Proceeds from the issuance of common stock | 7,281 | 3,532 |
Common stock offering costs | (368) | (117) |
Repayment of principal on vendor finance agreement | (231) | (206) |
Net cash provided by financing activities | 6,682 | 3,209 |
Net increase (decrease) in cash and cash equivalents | 3,037 | (646) |
Cash and cash equivalents, beginning of period | 6,608 | 8,702 |
Cash and cash equivalents, end of period | 9,645 | 8,056 |
Supplemental cash flow information: | ||
Interest paid | 6 | 6 |
Income tax refund received | 151 | 31 |
Supplemental disclosure of noncash investing and financing transactions: | ||
Vendor finance agreement | 118 | 105 |
Common stock offering costs accrued but not yet paid | 14 | |
Leased assets obtained in exchange for operating lease liabilities, upon adoption | $ 60 | |
Change in unrealized loss on marketable securities | $ 2 |
The Company and Summary of Sign
The Company and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
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. (the Company or ARCA), a Delaware corporation, is headquartered in Westminster, Colorado. The Company is a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate, Gencaro™ (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator that ARCA is developing for the potential treatment of atrial fibrillation (AF) in certain patients who also have heart failure (HF). In February 2018, the Company completed its Phase 2B clinical superiority trial, known as GENETIC-AF, in which the Company evaluated Gencaro for the treatment of AF in HF patients. In the trial, Gencaro was evaluated against an active comparator, the beta-blocker TOPROL-XL (metoprolol succinate), a drug indicated for the treatment of HF patients that is also prescribed, but not approved, for treating AF. Enrollment in GENETIC-AF was limited to patients that possess the specific genotype that the Company believes enhances Gencaro’s potential therapeutic effects. The planned development program of Gencaro is, in part, based on the results of the Company’s completed GENETIC-AF Phase 2B clinical trial and a prospectively designed DNA substudy of adrenergic receptor polymorphisms in the BEST trial, a previous Phase 3 study of HF patients. GENETIC-AF was a Phase 2B, multi-center, randomized, double-blind, clinical superiority trial comparing the safety and efficacy of Gencaro against TOPROL-XL, that enrolled 267 HF patients. The Company reported top-line Phase 2B trial data in February 2018. Overall, Gencaro demonstrated a similar treatment benefit compared to the active comparator, metoprolol succinate; however, trends for benefit in favor of bucindolol were observed in multiple subpopulations of patients in the trial. Based on these data, the Company believes further clinical development of Gencaro is warranted. Following review of the Phase 2 GENETIC-AF trial results, as well as its alignment with previous Phase 3 pharmacogenetic substudy data from the BEST trial, the FDA stated that data from a single pivotal Phase 3 clinical trial may be sufficient to support approval of Gencaro for the treatment of AF in patients with HF. The Company, in consultation with the FDA, developed key elements of the Phase 3 clinical trial needed to support a potential New Drug Application (NDA), details of which were submitted for evaluation and confirmed via the FDA’s Special Protocol Assessment (SPA) process in 2019. During 2018, ARCA initiated Investigational New Drug enabling development activities with AB171, a thiol-substituted isosorbide mononitrate, as a potential genetically-targeted treatment for peripheral arterial disease and for HF. The Company will need to raise additional capital to fund future operations and any additional development of Gencaro or AB171. 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. 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. The Company believes that its current cash and cash equivalents will be sufficient to fund its operations, at its projected cost structure, after giving effect to potential cost reductions, through the end of the third quarter of 2020. In light of the significant uncertainties regarding clinical development timelines and costs for developing drugs such as Gencaro, the Company will need to raise additional capital to finance the Company’s future operations and any additional development of Gencaro or any other product candidates. If the Company is delayed in completing or is unable to complete additional financing and/or a strategic transaction, the Company may discontinue its development activities or operations. Due to the current status of the Gencaro development program, the current amount of cash and cash equivalents held, the anticipated costs to be incurred for existing operations as well as exploring other corporate strategic alternatives, and the uncertainty of the Company’s ability to raise a significant amount of capital, management has determined there is substantial doubt about the Company’s ability to continue as a going concern from one year after the Company’s financial statements have been issued. In May 2019, the Company implemented efforts to reduce personnel costs, including reduction of executive management salaries. The Company could delay or cancel certain planned expenditures related to its drug development programs and/or implement additional cost reduction measures to conserve its cash balances; however, there is no assurance that those measures would be adequate to allow the Company to continue as a going concern for a period beyond one year from the issuance of these financial statements. 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. 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: • the costs and timing for the potential additional clinical trials in order to gain possible regulatory approval for Gencaro or any other product candidate; • the market price of the Company’s stock and the availability and cost of additional equity capital from existing and potential new investors; • 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. Reverse Stock Split On April 3, 2019, the Company completed a 1-for-18 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 pursuant to 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 (GAAP) 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 three and nine months ended September 30, 2019 are not necessarily indicative of results expected for the full year ending December 31, 2019. 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, 2018 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. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use (ROU) asset – operating and lease obligations are included in accrued expenses and other liabilities on the Company’s September 30, 2019 balance sheet. ROU lease assets represent the Company’s right to use an underlying asset for the lease term and lease obligations represent the Company’s obligation to make lease payments arising from the lease. Operating ROU lease assets are recognized at the commencement date based on the present value of lease payments over the lease term. As the Company’s lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Accrued Outsourcing Expenses As part of the process of preparing its financial statements, the Company is required to estimate accrued outsourcing 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 outsourcing 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 service fees from 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 February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updated (ASU) No. 2016-02, Leases (Topic 842) Targeted Improvements In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement The Company reviewed all other recently issued accounting pronouncements and concluded that they were either not applicable or not expected to have a significant impact to the financial statements. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | (2) Net Loss Per Share The Company calculates basic earnings per share by dividing net loss by the weighted average common shares outstanding during the period. Diluted earnings per share is computed by dividing net loss 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 the Company reported a net loss for the three and nine months ended September 30, 2019 and 2018, all potentially dilutive shares of common stock have been excluded from the computation of the dilutive net loss per share for all periods presented. September 30, 2019 2018 Potentially dilutive securities, excluded: Outstanding stock options 32,683 33,518 Unvested restricted stock units — 13 Warrants to purchase common stock 135,862 148,325 168,545 181,856 |
Fair Value Disclosures
Fair Value Disclosures | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosures | (3) Fair Value Disclosures There were no marketable securities as of September 30, 2019 or December 31, 2018. 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. The Company’s Level 1 assets consist of money market investments. The Company does not have any Level 1 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. The Company does not have any Level 2 assets or liabilities. • Level 3—Unobservable inputs for the asset or liability. The Company does not have any Level 3 assets or liabilities. As of September 30, 2019 and December 31, 2018, the Company had $9.6 million and $6.5 million, respectively, of cash equivalents consisting of money market funds with original 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, 2019. Fair Value of Other Financial Instruments The carrying amount of other financial instruments, including accounts payable and notes payable approximated fair value due to their short maturities. |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2019 | |
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, 2019 December 31, 2018 Computer equipment 3 years $ 62 $ 65 Lab equipment 5 years 142 142 Furniture and fixtures 5 years 62 62 Computer software 3 years 66 70 Leasehold improvements Lesser of useful life or life of the lease 59 59 391 398 Accumulated depreciation and amortization (381 ) (374 ) Property and equipment, net $ 10 $ 24 For the nine months ended September 30, 2019 and 2018, depreciation and amortization expense was $16,000 and $17,000, respectively. |
Related Party Arrangements
Related Party Arrangements | 9 Months Ended |
Sep. 30, 2019 | |
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. 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, 2019 and 2018 was $210,000 and $274,000 respectively, of which $69,000 and $111,000 was included in Accrued expenses and other liabilities as of September 30, 2019 and December 31, 2018, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2019 | |
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. Effective March 2, 2016, the lease was renewed for an additional 38 month term beginning October 1, 2016 and expiring on November 30, 2019. Effective October 10, 2019, the lease was renewed for an additional four month term beginning December 1, 2019 and expiring on March 31, 2020 (the October 2019 Amendment). Additional future undiscounted minimum lease payments under the October 2019 Amendment are $34,000. Under the October 2019 Amendment, the Company has no further rights to extend or renew this lease agreement. The lease includes real estate taxes and insurance, which is not a lease component and is not included in the lease obligation. In addition, common area maintenance charges are based on actual costs incurred and are a non-lease component that is not included in the lease obligation. Future minimum lease payments committed for the Company’s facility in Westminster, Colorado as of December 31, 2018 were $83,000. Below is a summary of the future undiscounted minimum lease payments committed for the Company’s facility in Westminster, Colorado as of September 30, 2019 (in thousands): Remainder of 2019 $ 15 Total future minimum lease payments $ 15 Rent expense, which is included in general and administrative expense, for the nine months ended September 30, 2019 and 2018 was $52,000 and $62,000, respectively. Cash paid for amounts included in the measurement of lease liabilities and the operating cash flows from operating leases for the nine months ended September 30, 2019 were $68,000. The weighted-average remaining lease term for the operating lease as of September 30, 2019 is 0.2 years. The weighted-average discount rate for the operating lease is 7.5%. Cardiovascular Pharmacology and Engineering Consultants, LLC ARCA has licensed worldwide rights to all preclinical and clinical data from development of bucindolol through the BEST trial from Cardiovascular Pharmacology and Engineering Consultants, LLC (CPEC), who has licensed rights to this data 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. In October 2017, the Company entered into an agreement with CPEC’s minority owner, Aeolus Pharmaceuticals, Inc. (Aeolus) pursuant to which the Company acquired Aeolus’ minority membership interest in CPEC. The transaction effectively bought out Aeolus’ royalty interest thereby reducing or eliminating the stated milestone and royalty obligations that could be payable by the Company, if Gencaro receives regulatory approval and is commercialized. As a result of this transaction, the Company, together with Endo Pharmaceuticals, Inc., indirectly hold the remaining licensee rights of CPEC to certain Gencaro clinical data, discussed above. The acquisition cost of this interest did not have a material impact on the Company’s financial statements. |
Equity Financings and Warrants
Equity Financings and Warrants | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Equity Financings and Warrants | (7) Equity Financings and Warrants At the Market Equity Financing On January 11, 2017, the Company entered into a Capital on Demand TM Under the amended Sales Agreement, JonesTrading may sell the Shares by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on or through the Nasdaq Capital Market, on any other existing trading market for the Common Stock or to or through a market maker. In addition, under the amended Sales Agreement, JonesTrading may sell the Shares by any other method permitted by law, including in negotiated transactions. The Company may instruct JonesTrading not to sell Shares if the sales cannot be effected at or above the price designated by the Company from time to time. The Company is not obligated to make any sales of the Shares under the amended Sales Agreement. The offering of Shares pursuant to the amended Sales Agreement will terminate upon the earlier of (a) the sale of all of the Shares subject to the amended Sales Agreement or (b) the termination of the amended Sales Agreement by JonesTrading or the Company, as permitted therein. The Company paid JonesTrading a commission rate equal to 3.0% of the aggregate gross proceeds from each sale of Shares and agreed to provide JonesTrading with customary indemnification and contribution rights. The Company will also reimburse JonesTrading for certain specified expenses in connection with entering into and amending the Sales Agreement. Under the amended Sales Agreement, the Company sold an aggregate of 820,561, 118,546 and 148,751 shares of Common Stock, for net proceeds of approximately $6.9 million, $3.4 million and $6.1 million during the nine months ended September 30, 2019 and the years ended December 31, 2018 and 2017, respectively, including initial expenses for executing the “at the market offering” and commissions to the placement agent. As of September 30, 2019, the Company had sold all shares available for this offering under its prospectus to the Company’s registration statement on Form S-3 (No. 333-217459). Warrants Warrants to purchase shares of common stock were previously 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, 2019, these warrants, by year of expiration, are summarized below: Year of Expiration Number of Warrants Weighted Average Exercise Price 2020 2,461 $ 287.28 2022 133,401 109.80 135,862 $ 113.04 |
Share-based Compensation
Share-based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
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, 2019 and 2018, 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, 2019 2018 2019 2018 Research and development $ 14 $ 26 $ 59 $ 92 General and administrative 15 32 65 123 Total $ 29 $ 58 $ 124 $ 215 Stock option transactions for the nine month period ended September 30, 2019 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, 2018 33,503 $ 96.22 7.29 Granted — — Exercised — — Forfeited and cancelled (820 ) 607.30 Options outstanding at September 30, 2019 32,683 $ 83.39 6.25 Options exercisable at September 30, 2019 30,644 $ 86.48 6.18 Options vested and expected to vest 32,682 $ 83.40 6.25 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (9) Income Taxes In accordance with GAAP, 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. Income tax benefit of $151,000 for the nine months ended September 30, 2019 was primarily related to a federal research and experimentation income tax credit related to the Protecting Americans from Tax Hikes Act of 2015 (PATH Act) which allows qualified small businesses to monetize up to $250,000 of research and experimentation tax credits through payroll tax refunds. |
The Company and Summary of Si_2
The Company and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Description of Business | Description of Business ARCA biopharma, Inc. (the Company or ARCA), a Delaware corporation, is headquartered in Westminster, Colorado. The Company is a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate, Gencaro™ (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator that ARCA is developing for the potential treatment of atrial fibrillation (AF) in certain patients who also have heart failure (HF). In February 2018, the Company completed its Phase 2B clinical superiority trial, known as GENETIC-AF, in which the Company evaluated Gencaro for the treatment of AF in HF patients. In the trial, Gencaro was evaluated against an active comparator, the beta-blocker TOPROL-XL (metoprolol succinate), a drug indicated for the treatment of HF patients that is also prescribed, but not approved, for treating AF. Enrollment in GENETIC-AF was limited to patients that possess the specific genotype that the Company believes enhances Gencaro’s potential therapeutic effects. The planned development program of Gencaro is, in part, based on the results of the Company’s completed GENETIC-AF Phase 2B clinical trial and a prospectively designed DNA substudy of adrenergic receptor polymorphisms in the BEST trial, a previous Phase 3 study of HF patients. GENETIC-AF was a Phase 2B, multi-center, randomized, double-blind, clinical superiority trial comparing the safety and efficacy of Gencaro against TOPROL-XL, that enrolled 267 HF patients. The Company reported top-line Phase 2B trial data in February 2018. Overall, Gencaro demonstrated a similar treatment benefit compared to the active comparator, metoprolol succinate; however, trends for benefit in favor of bucindolol were observed in multiple subpopulations of patients in the trial. Based on these data, the Company believes further clinical development of Gencaro is warranted. Following review of the Phase 2 GENETIC-AF trial results, as well as its alignment with previous Phase 3 pharmacogenetic substudy data from the BEST trial, the FDA stated that data from a single pivotal Phase 3 clinical trial may be sufficient to support approval of Gencaro for the treatment of AF in patients with HF. The Company, in consultation with the FDA, developed key elements of the Phase 3 clinical trial needed to support a potential New Drug Application (NDA), details of which were submitted for evaluation and confirmed via the FDA’s Special Protocol Assessment (SPA) process in 2019. During 2018, ARCA initiated Investigational New Drug enabling development activities with AB171, a thiol-substituted isosorbide mononitrate, as a potential genetically-targeted treatment for peripheral arterial disease and for HF. The Company will need to raise additional capital to fund future operations and any additional development of Gencaro or AB171. 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. |
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. The Company believes that its current cash and cash equivalents will be sufficient to fund its operations, at its projected cost structure, after giving effect to potential cost reductions, through the end of the third quarter of 2020. In light of the significant uncertainties regarding clinical development timelines and costs for developing drugs such as Gencaro, the Company will need to raise additional capital to finance the Company’s future operations and any additional development of Gencaro or any other product candidates. If the Company is delayed in completing or is unable to complete additional financing and/or a strategic transaction, the Company may discontinue its development activities or operations. Due to the current status of the Gencaro development program, the current amount of cash and cash equivalents held, the anticipated costs to be incurred for existing operations as well as exploring other corporate strategic alternatives, and the uncertainty of the Company’s ability to raise a significant amount of capital, management has determined there is substantial doubt about the Company’s ability to continue as a going concern from one year after the Company’s financial statements have been issued. In May 2019, the Company implemented efforts to reduce personnel costs, including reduction of executive management salaries. The Company could delay or cancel certain planned expenditures related to its drug development programs and/or implement additional cost reduction measures to conserve its cash balances; however, there is no assurance that those measures would be adequate to allow the Company to continue as a going concern for a period beyond one year from the issuance of these financial statements. 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. 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: • the costs and timing for the potential additional clinical trials in order to gain possible regulatory approval for Gencaro or any other product candidate; • the market price of the Company’s stock and the availability and cost of additional equity capital from existing and potential new investors; • 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. |
Reverse Stock Split | Reverse Stock Split On April 3, 2019, the Company completed a 1-for-18 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 pursuant to 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 (GAAP) 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 three and nine months ended September 30, 2019 are not necessarily indicative of results expected for the full year ending December 31, 2019. 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, 2018 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. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use (ROU) asset – operating and lease obligations are included in accrued expenses and other liabilities on the Company’s September 30, 2019 balance sheet. ROU lease assets represent the Company’s right to use an underlying asset for the lease term and lease obligations represent the Company’s obligation to make lease payments arising from the lease. Operating ROU lease assets are recognized at the commencement date based on the present value of lease payments over the lease term. As the Company’s lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. |
Accrued Outsourcing Expenses | Accrued Outsourcing Expenses As part of the process of preparing its financial statements, the Company is required to estimate accrued outsourcing 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 outsourcing 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 service fees from 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 February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updated (ASU) No. 2016-02, Leases (Topic 842) Targeted Improvements In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement The Company reviewed all other recently issued accounting pronouncements and concluded that they were either not applicable or not expected to have a significant impact to the financial statements. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Summary of Potentially Dilutive Shares of Common Stock | Because the Company reported a net loss for the three and nine months ended September 30, 2019 and 2018, all potentially dilutive shares of common stock have been excluded from the computation of the dilutive net loss per share for all periods presented. September 30, 2019 2018 Potentially dilutive securities, excluded: Outstanding stock options 32,683 33,518 Unvested restricted stock units — 13 Warrants to purchase common stock 135,862 148,325 168,545 181,856 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Property Plant And Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment consist of the following (in thousands): Estimated Life September 30, 2019 December 31, 2018 Computer equipment 3 years $ 62 $ 65 Lab equipment 5 years 142 142 Furniture and fixtures 5 years 62 62 Computer software 3 years 66 70 Leasehold improvements Lesser of useful life or life of the lease 59 59 391 398 Accumulated depreciation and amortization (381 ) (374 ) Property and equipment, net $ 10 $ 24 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Future Minimum Lease Payments | Below is a summary of the future undiscounted minimum lease payments committed for the Company’s facility in Westminster, Colorado as of September 30, 2019 (in thousands): Remainder of 2019 $ 15 Total future minimum lease payments $ 15 |
Equity Financings and Warrants
Equity Financings and Warrants (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Summary of Warrants by Year of Expiration | As of September 30, 2019, these warrants, by year of expiration, are summarized below: Year of Expiration Number of Warrants Weighted Average Exercise Price 2020 2,461 $ 287.28 2022 133,401 109.80 135,862 $ 113.04 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Non-cash, Share-based Compensation Expense | For the three and nine month periods ended September 30, 2019 and 2018, 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, 2019 2018 2019 2018 Research and development $ 14 $ 26 $ 59 $ 92 General and administrative 15 32 65 123 Total $ 29 $ 58 $ 124 $ 215 |
Summary of Stock Option Activities | Stock option transactions for the nine month period ended September 30, 2019 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, 2018 33,503 $ 96.22 7.29 Granted — — Exercised — — Forfeited and cancelled (820 ) 607.30 Options outstanding at September 30, 2019 32,683 $ 83.39 6.25 Options exercisable at September 30, 2019 30,644 $ 86.48 6.18 Options vested and expected to vest 32,682 $ 83.40 6.25 |
The Company and Summary of Si_3
The Company and Summary of Significant Accounting Policies (Details Textual) | Apr. 03, 2019 | Sep. 30, 2019USD ($)Patients | Jan. 01, 2019USD ($) |
Company And Summary Of Significant Accounting Policies Table [Line Items] | |||
Revenues | $ 0 | ||
Concentrations of credit risk | 0 | ||
Right-of-use asset | $ 11,000 | ||
ASU 2016-02 | |||
Company And Summary Of Significant Accounting Policies Table [Line Items] | |||
Lease lability | $ 80,000 | ||
Right-of-use asset | 60,000 | ||
Remaining lease payments | $ 83,000 | ||
Discount rate | 7.50% | ||
Accrued rent | $ 20,000 | ||
Common Stock | |||
Company And Summary Of Significant Accounting Policies Table [Line Items] | |||
Reverse stock split description | 1-for-18 | ||
Reverse stock split conversion ratio1 | 0.056 | ||
Phase 2B | GENETIC-AF Trial | |||
Company And Summary Of Significant Accounting Policies Table [Line Items] | |||
Number of patients enrolled | Patients | 267 |
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, 2019 | Sep. 30, 2018 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 168,545 | 181,856 |
Outstanding stock options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 32,683 | 33,518 |
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 | 13 | |
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 | 135,862 | 148,325 |
Fair Value Disclosures (Details
Fair Value Disclosures (Details Textual) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 0 | $ 0 |
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 and commercial paper | $ 9,600,000 | $ 6,500,000 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Property Plant And Equipment [Line Items] | ||
Property and Equipment, Gross | $ 391 | $ 398 |
Accumulated depreciation and amortization | (381) | (374) |
Property and equipment, net | $ 10 | 24 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | 3 years | |
Property and Equipment, Gross | $ 62 | 65 |
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 | $ 62 | 62 |
Computer Software | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | 3 years | |
Property and Equipment, Gross | $ 66 | 70 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | Lesser of useful life or life of the lease | |
Property and Equipment, Gross | $ 59 | $ 59 |
Property and Equipment (Details
Property and Equipment (Details Textual) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Property Plant And Equipment [Abstract] | ||
Depreciation and amortization expense | $ 16 | $ 17 |
Related Party Arrangements (Det
Related Party Arrangements (Details Textual) - Chief Executive Officer - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Accrued Expenses and Other Liabilities | |||
Related Party Transaction [Line Items] | |||
Total expense | $ 69 | $ 111 | |
Research Grants | |||
Related Party Transaction [Line Items] | |||
Total expense | $ 210 | $ 274 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Textual) $ in Thousands | Oct. 10, 2019USD ($) | Mar. 02, 2016 | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Aug. 01, 2013ft² |
Commitments And Contingencies [Line Items] | ||||||
Area of office facilities taken on lease | ft² | 5,300 | |||||
Additional operating lease term | 38 months | |||||
Lease renewal start date | Oct. 1, 2016 | |||||
Lease expiration date | Nov. 30, 2019 | |||||
Lease renewal option | Under the October 2019 Amendment, the Company has no further rights to extend or renew this lease agreement. | |||||
Future minimum lease payments | $ 15 | |||||
Lessee, operating lease, assumptions and judgments, allocation of lease and nonlease component | The lease includes real estate taxes and insurance, which is not a lease component and is not included in the lease obligation. In addition, common area maintenance charges are based on actual costs incurred and are a non-lease component that is not included in the lease obligation. | |||||
Operating lease, cash paid for measurement of lease liabilities | $ 68 | |||||
Weighted-average remaining lease term | 2 months 12 days | |||||
Weighted-average discount rate | 7.50% | |||||
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% | |||||
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% | |||||
General and Administrative Expense | ||||||
Commitments And Contingencies [Line Items] | ||||||
Rent expense | $ 52 | |||||
Rent expense | $ 62 | |||||
Subsequent Event | ||||||
Commitments And Contingencies [Line Items] | ||||||
Additional operating lease term | 4 months | |||||
Lease renewal start date | Dec. 1, 2019 | |||||
Lease expiration date | Mar. 31, 2020 | |||||
Future undiscounted minimum lease payments | $ 34 | |||||
Lessee, Operating Lease, Existence of Option to Extend [true false] | false | |||||
Westminster, Colorado | ||||||
Commitments And Contingencies [Line Items] | ||||||
Future minimum lease payments | $ 83 |
Commitments and Contingencies -
Commitments and Contingencies - Future Minimum Lease Payments (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
Remainder of 2019 | $ 15 |
Total future minimum lease payments | $ 15 |
Equity Financings and Warrant_2
Equity Financings and Warrants (Details Textual) - USD ($) | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Jun. 28, 2019 | Jan. 11, 2017 | |
Equity Financing And Warrants [Line Items] | |||||
Common stock, par value | $ 0.001 | $ 0.001 | |||
Common stock, shares issued | 1,594,070 | 773,558 | |||
JonesTrading | |||||
Equity Financing And Warrants [Line Items] | |||||
Percentage of selling commission per additional shares sold | 3.00% | ||||
Sales Agreement | |||||
Equity Financing And Warrants [Line Items] | |||||
Common stock, shares issued | 820,561 | 118,546 | 148,751 | ||
Net proceeds from issuance of common stock | $ 6,900,000 | $ 3,400,000 | $ 6,100,000 | ||
Sales Agreement | JonesTrading | |||||
Equity Financing And Warrants [Line Items] | |||||
Common stock, par value | $ 0.001 | ||||
Aggregate offering price of common stock authorized | $ 17,500,000 | $ 7,300,000 |
Equity Financings and Warrant_3
Equity Financings and Warrants - Summary of Warrants by Year of Expiration (Details) | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Class Of Warrant Or Right [Line Items] | |
Number of Warrants | shares | 135,862 |
Weighted Average Exercise Price | $ / shares | $ 113.04 |
2020 | |
Class Of Warrant Or Right [Line Items] | |
Year of Expiration | 2020 |
Number of Warrants | shares | 2,461 |
Weighted Average Exercise Price | $ / shares | $ 287.28 |
2022 | |
Class Of Warrant Or Right [Line Items] | |
Year of Expiration | 2022 |
Number of Warrants | shares | 133,401 |
Weighted Average Exercise Price | $ / shares | $ 109.80 |
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, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total expenses | $ 29 | $ 58 | $ 124 | $ 215 |
Research and development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total expenses | 14 | 26 | 59 | 92 |
General and administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total expenses | $ 15 | $ 32 | $ 65 | $ 123 |
Share-based Compensation - Su_2
Share-based Compensation - Summary of Stock Option Activities (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Number of Stock Options | ||
Number of Options, Options outstanding, beginning of period | 33,503 | |
Number of Options, Forfeited and cancelled | (820) | |
Number of Options, Options outstanding, end of period | 32,683 | 33,503 |
Number of Options, Options exercisable, end of period | 30,644 | |
Number of Options, Options vested and expected to vest | 32,682 | |
Stock Options, Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Options outstanding, beginning of period | $ 96.22 | |
Weighted Average Exercise Price, Forfeited and cancelled | 607.30 | |
Weighted Average Exercise Price, Options outstanding, end of period | 83.39 | $ 96.22 |
Weighted Average Exercise Price, Options exercisable, end of period | 86.48 | |
Weighted Average Exercise Price, Options vested and expected to vest, end of period | $ 83.40 | |
Stock Options, Weighted Average Remaining Contractual Term | ||
Weighted Average Remaining Contractual Term (in years), Options outstanding | 6 years 3 months | 7 years 3 months 14 days |
Weighted Average Remaining Contractual Term (in years), Options exercisable | 6 years 2 months 4 days | |
Weighted Average Remaining Contractual Term (in years), Options vested and expected to vest | 6 years 3 months |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Tax [Line Items] | ||||
Reserve for uncertain tax positions | $ 0 | $ 0 | ||
Income tax benefit | 42,000 | $ 31,000 | 151,000 | $ 31,000 |
Research Tax Credit Carryforward | Federal | Protecting Americans from Tax Hikes Act of 2015 | ||||
Income Tax [Line Items] | ||||
Income tax benefit | 151,000 | |||
Research Tax Credit Carryforward | Federal | Protecting Americans from Tax Hikes Act of 2015 | Maximum | ||||
Income Tax [Line Items] | ||||
Research and experimentation credits | $ 250,000 | $ 250,000 |