Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 30, 2020 | |
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, 2020 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | ABIO | |
Document Fiscal Year Focus | 2020 | |
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 | 9,321,470 | |
Entity Shell Company | false | |
Entity File Number | 000-22873 | |
Entity Tax Identification Number | 36-3855489 | |
Entity Address, Address Line One | 10170 Church Ranch Way | |
Entity Address, Address Line Two | Suite 100 | |
Entity Address, City or Town | Westminster | |
Entity Address, State or Province | CO | |
Entity Address, Postal Zip Code | 80021 | |
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, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 51,095 | $ 8,363 |
Other current assets | 841 | 117 |
Total current assets | 51,936 | 8,480 |
Right-of-use asset - operating | 22 | |
Property and equipment, net | 10 | 10 |
Other assets | 36 | 24 |
Total assets | 51,982 | 8,536 |
Current liabilities: | ||
Accounts payable | 761 | 418 |
Accrued compensation and employee benefits | 221 | 129 |
Accrued expenses and other liabilities | 545 | 379 |
Total current liabilities | 1,527 | 926 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value; 100 million shares authorized at September 30, 2020 and December 31, 2019; 9,285,624 and 1,594,070 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 9 | 2 |
Additional paid-in capital | 199,475 | 152,024 |
Accumulated deficit | (149,029) | (144,416) |
Total stockholders’ equity | 50,455 | 7,610 |
Total liabilities and stockholders’ equity | $ 51,982 | $ 8,536 |
BALANCE SHEETS (Unaudited) (Par
BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
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 | 9,285,624 | 1,594,070 |
Common stock, shares outstanding | 9,285,624 | 1,594,070 |
STATEMENTS OF OPERATIONS (Unaud
STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Costs and expenses: | ||||
Research and development | $ 1,051 | $ 347 | $ 1,788 | $ 1,449 |
General and administrative | 939 | 900 | 2,852 | 3,087 |
Total costs and expenses | 1,990 | 1,247 | 4,640 | 4,536 |
Loss from operations | (1,990) | (1,247) | (4,640) | (4,536) |
Interest and other income | 1 | 50 | 27 | 136 |
Interest expense | (2) | (1) | (9) | (7) |
Loss before income taxes | (1,991) | (1,198) | (4,622) | (4,407) |
Income tax benefit | 42 | 9 | 151 | |
Net loss | $ (1,991) | $ (1,156) | $ (4,613) | $ (4,256) |
Net loss per share: | ||||
Basic and diluted | $ (0.33) | $ (0.76) | $ (1.46) | $ (3.46) |
Weighted average shares outstanding: | ||||
Basic and diluted | 6,044,315 | 1,521,259 | 3,154,680 | 1,229,289 |
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, 2018 | $ 6,032 | $ 1 | $ 144,965 | $ (138,934) |
Beginning Balance, shares at Dec. 31, 2018 | 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 | |||
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 | |||
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 | |||
Share-based compensation | 27 | 27 | ||
Other | 10 | 10 | ||
Net loss | (1,226) | (1,226) | ||
Ending Balance at Dec. 31, 2019 | $ 7,610 | $ 2 | 152,024 | (144,416) |
Ending Balance, shares at Dec. 31, 2019 | 1,594,070 | 1,594,070 | ||
Share-based compensation | $ 16 | 16 | ||
Net loss | (1,320) | (1,320) | ||
Ending Balance at Mar. 31, 2020 | 6,306 | $ 2 | 152,040 | (145,736) |
Ending Balance, shares at Mar. 31, 2020 | 1,594,070 | |||
Beginning Balance at Dec. 31, 2019 | $ 7,610 | $ 2 | 152,024 | (144,416) |
Beginning Balance, shares at Dec. 31, 2019 | 1,594,070 | 1,594,070 | ||
Net loss | $ (4,613) | |||
Ending Balance at Sep. 30, 2020 | $ 50,455 | $ 9 | 199,475 | (149,029) |
Ending Balance, shares at Sep. 30, 2020 | 9,285,624 | 9,285,624 | ||
Beginning Balance at Mar. 31, 2020 | $ 6,306 | $ 2 | 152,040 | (145,736) |
Beginning Balance, shares at Mar. 31, 2020 | 1,594,070 | |||
Issuance of common stock and exercise of prefunded warrants for cash,net of offering costs | 5,297 | 5,297 | ||
Issuance of common stock and exercise of prefunded warrants for cash,net of offering costs, shares | 673,500 | |||
Share-based compensation | 4 | 4 | ||
Net loss | (1,302) | (1,302) | ||
Ending Balance at Jun. 30, 2020 | 10,305 | $ 2 | 157,341 | (147,038) |
Ending Balance, shares at Jun. 30, 2020 | 2,267,570 | |||
Issuance of common stock for cash, net of offering costs | 42,136 | $ 7 | 42,129 | |
Issuance of common stock for cash, net of offering costs, shares | 7,018,054 | |||
Share-based compensation | 5 | 5 | ||
Net loss | (1,991) | (1,991) | ||
Ending Balance at Sep. 30, 2020 | $ 50,455 | $ 9 | $ 199,475 | $ (149,029) |
Ending Balance, shares at Sep. 30, 2020 | 9,285,624 | 9,285,624 |
STATEMENTS OF CASH FLOWS (Unaud
STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (4,613) | $ (4,256) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 6 | 16 |
Amortization of right-of-use asset - operating | 71 | 49 |
Share-based compensation | 25 | 124 |
Change in operating assets and liabilities: | ||
Other current assets | (281) | 259 |
Other assets | (12) | |
Accounts payable | 83 | (95) |
Accrued compensation and employee benefits | 92 | 8 |
Accrued expenses and other liabilities | (101) | 252 |
Net cash used in operating activities | (4,730) | (3,643) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (6) | (2) |
Net cash used in investing activities | (6) | (2) |
Cash flows from financing activities: | ||
Proceeds from the issuance of common stock | 49,644 | 7,281 |
Common stock offering costs | (1,905) | (368) |
Repayment of principal on vendor finance agreement | (271) | (231) |
Net cash provided by financing activities | 47,468 | 6,682 |
Net increase in cash and cash equivalents | 42,732 | 3,037 |
Cash and cash equivalents, beginning of period | 8,363 | 6,608 |
Cash and cash equivalents, end of period | 51,095 | 9,645 |
Supplemental cash flow information: | ||
Interest paid | 7 | 6 |
Income tax refund received | 9 | 151 |
Supplemental disclosure of noncash investing and financing transactions: | ||
Vendor finance agreement | 137 | 118 |
Proceeds receivable from the issuance of common stock | 30 | |
Common stock offering costs accrued but not yet paid | 336 | 14 |
Leased assets obtained in exchange for operating lease liabilities, upon extension and adoption | $ 49 | $ 60 |
The Company and Summary of Sign
The Company and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
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 clinical-stage biopharmaceutical company applying a precision medicine approach to the development and commercialization of genetically targeted therapies for cardiovascular diseases. The Company’s lead product candidates are AB201 (rNAPc2) as a potential treatment for diseases caused by ribonucleic acid, or RNA, viruses, initially focusing on COVID-19, the disease syndrome caused by SARS-CoV-2 virus, and Gencaro™ (bucindolol hydrochloride) for the treatment of atrial fibrillation (AF) in patients with chronic heart failure (HF). AB201 is a protein therapeutic the Company plans to put into clinical development as a potential treatment for patients hospitalized with COVID-19. Based on its unique mechanism of action, its development history and the accumulating clinical evidence from the SARS‑CoV-2 pandemic, the Company believes AB201 has potential to be a beneficial therapy for patients with this viral disease. The Company plans to initiate a Phase 2 clinical trial of AB201 as a potential treatment for patients hospitalized with COVID-19 in the fourth quarter of 2020. The Company has put potential initiation of the PRECISION-AF clinical trial of Gencaro on hold due to the ongoing COVID-19 pandemic and prioritizing the development of AB201. The Company’s other product candidate, AB171, is a thiol-substituted isosorbide mononitrate, which ARCA plans to develop as a genetically-targeted treatment for HF and peripheral arterial disease. In March 2020, the World Health Organization declared the outbreak of COVID-19, a novel strain of Coronavirus, a global pandemic. This outbreak is causing major disruptions to businesses and markets worldwide as the virus spreads. The Company does not expect a material financial effect as a result of the pandemic. However, if the pandemic continues to be a severe worldwide crisis, it could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows. 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 as of September 30, 2020 However, changing circumstances may cause us to consume capital significantly faster or slower than currently anticipated. The Company has based these estimates on assumptions that may prove to be wrong, and the Company could exhaust its available financial resources sooner than the Company currently anticipates. Therefore, the Company may have to raise additional capital for clinical trials of AB201 and will have to raise additional capital for clinical trials of Gencaro. The Company may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of AB201 or 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 AB201, 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, including as a result of the COVID-19 pandemic; • 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. 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, 2020 are not necessarily indicative of results expected for the full year ending December 31, 2020. 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 AB201 and 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, 2019 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. Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. If the Company had comprehensive gains (losses), they would be reflected in the statement of operations and comprehensive loss and as a separate component in the statement of stockholders’ equity. There were no elements of comprehensive loss during the three and nine months ended September 30, 2020 and 2019. 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, 2020 and December 31, 2019 balance sheets. 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 The Company reviewed 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, 2020 | |
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 and warrants for common stock . Because the Company reported a net loss for the three and nine months ended September 30, 2020 and 2019, 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, 2020 2019 Potentially dilutive securities, excluded: Outstanding stock options 37,138 32,683 Warrants to purchase common stock 133,401 135,862 170,539 168,545 |
Fair Value Disclosures
Fair Value Disclosures | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosures | (3) Fair Value Disclosures There were no marketable securities as of September 30, 2020 or December 31, 2019. 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, 2020 and December 31, 2019, the Company had $51.0 million and $8.3 million, respectively, of cash equivalents consisting of money market funds. The Company has the ability to liquidate these investments without restriction. The Company determines fair value for these money market funds 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, 2020. Fair Value of Other Financial Instruments The carrying amount of other financial instruments, including accounts payable and a vendor finance agreement, which are included in accounts payable and accrued expenses and other liabilities, approximated fair value due to their short maturities. |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2020 | |
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, 2020 December 31, 2019 Computer equipment 3 years $ 25 $ 54 Lab equipment 5 years 146 142 Furniture and fixtures 5 years 38 61 Computer software 3 years 61 61 Leasehold improvements Lesser of useful life or life of the lease — 59 270 377 Accumulated depreciation and amortization (260 ) (367 ) Property and equipment, net $ 10 $ 10 For the nine months ended September 30, 2020 and 2019, depreciation and amortization expense was $6,000 and $16,000, respectively. |
Related Party Arrangements
Related Party Arrangements | 9 Months Ended |
Sep. 30, 2020 | |
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, 2020 and 2019 was $248,000 and $210,000 respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
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 served as the Company’s primary business office from October 1, 2013 until September 30, 2020. In March 2016, October 2019 and February 2020 the lease was amended to extend the lease term. Effective February 24, 2020, the lease was renewed for an additional six month term beginning April 1, 2020 and expired on September 30, 2020 (the February 2020 Amendment). Under the February 2020 Amendment, the Company had no further rights to extend or renew this lease agreement. The lease included real estate taxes and insurance, which was not a lease component and was not included in the lease obligation. In addition, common area maintenance charges were based on actual costs incurred and were a non-lease component that was not included in the lease obligation. As of September 30, 2020 the lease expired and there were no minimum lease payments remaining under this lease. Rent expense, which is included in general and administrative expense, for the nine months ended September 30, 2020 and 2019 was $73,000 and $52,000, respectively. As of September 30, 2020 and December 31, 2019, the lease liability was $0 and $25,000, respectively, and is included in accrued expenses and other liabilities. 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, 2020 and 2019 were $76,000 and $68,000, respectively. On August 29, 2020 the Company entered into a lease agreement for approximately 5,200 square feet of office facilities in Westminster, Colorado which serves as the Company’s primary business office effective October 1, 2020 (October 2020 Lease). The lease term is 42 months beginning October 1, 2020 and includes an option to renew for an additional 36 month term at the then prevailing rental rate. The exercise of the lease renewal option is at the Company’s sole discretion. The lease term for the operating lease assumes exercise of the renewal option. The discount rate for the operating lease is 7%. Future minimum commitments due under the October 2020 Lease agreement as of October 1, 2020 are as follows (in thousands): Remainder of 2020 $ — 2021 71 2022 88 2023 90 2024 93 Thereafter 221 Present value adjustment (121 ) Present value of lease payments $ 442 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, 2020 | |
Equity [Abstract] | |
Equity Financings and Warrants | (7) Equity Financings and Warrants Registered Direct Financing On June 3, 2020, the Company closed a registered direct offering with certain institutional and accredited investors of 348,000 shares of the Company’s common stock, at a purchase price of $9.00 per share, and pre-funded warrants to purchase 325,500 shares of common stock at a purchase price of $8.999 per warrant. All warrants were exercised by the closing date. No pre-funded warrants are outstanding as of September 30, 2020. The net proceeds were approximately $5.3 million, after deducting placement agent fees and other offering expenses. The Company paid JonesTrading a placement agent fee equal to 8.0% of the aggregate gross proceeds and agreed to provide JonesTrading with customary indemnification and contribution rights. 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 In July 2020, the Company sold an aggregate of 2,214,301 shares of Common Stock, for net proceeds of approximately $14.3 million under the Sales Agreement. This sales agreement terminated in July 2020. On July 22, 2020, the Company entered into a new Capital on Demand TM As of September 30, 2020, the Company has $25.3 million available for this offering under its prospectus to the Company’s registration statement on Form S-3 (No. 333-238067). 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, 2020, these warrants, by year of expiration, are summarized below: Year of Expiration Number of Warrants Weighted Average Exercise Price 2022 133,401 $ 109.80 |
Share-based Compensation
Share-based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
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, 2020 and 2019, 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, 2020 2019 2020 2019 Research and development $ 5 $ 14 $ 18 $ 59 General and administrative — 15 7 65 Total $ 5 $ 29 $ 25 $ 124 Stock option transactions for the nine month period ended September 30, 2020 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, 2019 31,136 $ 84.50 6.26 Granted 6,250 5.96 Exercised — — Forfeited and cancelled (248 ) 610.46 Options outstanding at September 30, 2020 37,138 $ 67.77 6.29 Options exercisable at September 30, 2020 31,013 $ 80.37 5.58 Options vested and expected to vest 37,138 $ 67.77 6.29 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2020 | |
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 $9,000 for the nine months ended September 30, 2020 was related to realization of alternative minimum tax carryforwards. Income tax benefit of $42,000 and $151,000 for the three and nine months ended September 30, 2019 primarily was related to the reduction in the recorded valuation allowance as a result of the realization of research and experimentation credit carryforwards under the Protecting Americans from Tax Hikes Act of 2015 (PATH Act). As of December 31, 2019, the Company had realized the full amount available under the PATH Act. |
The Company and Summary of Si_2
The Company and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
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 clinical-stage biopharmaceutical company applying a precision medicine approach to the development and commercialization of genetically targeted therapies for cardiovascular diseases. The Company’s lead product candidates are AB201 (rNAPc2) as a potential treatment for diseases caused by ribonucleic acid, or RNA, viruses, initially focusing on COVID-19, the disease syndrome caused by SARS-CoV-2 virus, and Gencaro™ (bucindolol hydrochloride) for the treatment of atrial fibrillation (AF) in patients with chronic heart failure (HF). AB201 is a protein therapeutic the Company plans to put into clinical development as a potential treatment for patients hospitalized with COVID-19. Based on its unique mechanism of action, its development history and the accumulating clinical evidence from the SARS‑CoV-2 pandemic, the Company believes AB201 has potential to be a beneficial therapy for patients with this viral disease. The Company plans to initiate a Phase 2 clinical trial of AB201 as a potential treatment for patients hospitalized with COVID-19 in the fourth quarter of 2020. The Company has put potential initiation of the PRECISION-AF clinical trial of Gencaro on hold due to the ongoing COVID-19 pandemic and prioritizing the development of AB201. The Company’s other product candidate, AB171, is a thiol-substituted isosorbide mononitrate, which ARCA plans to develop as a genetically-targeted treatment for HF and peripheral arterial disease. In March 2020, the World Health Organization declared the outbreak of COVID-19, a novel strain of Coronavirus, a global pandemic. This outbreak is causing major disruptions to businesses and markets worldwide as the virus spreads. The Company does not expect a material financial effect as a result of the pandemic. However, if the pandemic continues to be a severe worldwide crisis, it could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows. |
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 as of September 30, 2020 However, changing circumstances may cause us to consume capital significantly faster or slower than currently anticipated. The Company has based these estimates on assumptions that may prove to be wrong, and the Company could exhaust its available financial resources sooner than the Company currently anticipates. Therefore, the Company may have to raise additional capital for clinical trials of AB201 and will have to raise additional capital for clinical trials of Gencaro. The Company may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of AB201 or 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 AB201, 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, including as a result of the COVID-19 pandemic; • 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. |
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, 2020 are not necessarily indicative of results expected for the full year ending December 31, 2020. 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 AB201 and 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, 2019 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. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. If the Company had comprehensive gains (losses), they would be reflected in the statement of operations and comprehensive loss and as a separate component in the statement of stockholders’ equity. There were no elements of comprehensive loss during the three and nine months ended September 30, 2020 and 2019. |
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, 2020 and December 31, 2019 balance sheets. 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 The Company reviewed 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, 2020 | |
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, 2020 and 2019, 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, 2020 2019 Potentially dilutive securities, excluded: Outstanding stock options 37,138 32,683 Warrants to purchase common stock 133,401 135,862 170,539 168,545 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Property Plant And Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment consist of the following (in thousands): Estimated Life September 30, 2020 December 31, 2019 Computer equipment 3 years $ 25 $ 54 Lab equipment 5 years 146 142 Furniture and fixtures 5 years 38 61 Computer software 3 years 61 61 Leasehold improvements Lesser of useful life or life of the lease — 59 270 377 Accumulated depreciation and amortization (260 ) (367 ) Property and equipment, net $ 10 $ 10 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Future Minimum Commitments due Under October 2020 Lease Agreement | Future minimum commitments due under the October 2020 Lease agreement as of October 1, 2020 are as follows (in thousands): Remainder of 2020 $ — 2021 71 2022 88 2023 90 2024 93 Thereafter 221 Present value adjustment (121 ) Present value of lease payments $ 442 |
Equity Financings and Warrants
Equity Financings and Warrants (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Summary of Warrants by Year of Expiration | As of September 30, 2020, these warrants, by year of expiration, are summarized below: Year of Expiration Number of Warrants Weighted Average Exercise Price 2022 133,401 $ 109.80 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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, 2020 and 2019, 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, 2020 2019 2020 2019 Research and development $ 5 $ 14 $ 18 $ 59 General and administrative — 15 7 65 Total $ 5 $ 29 $ 25 $ 124 |
Summary of Stock Option Activities | Stock option transactions for the nine month period ended September 30, 2020 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, 2019 31,136 $ 84.50 6.26 Granted 6,250 5.96 Exercised — — Forfeited and cancelled (248 ) 610.46 Options outstanding at September 30, 2020 37,138 $ 67.77 6.29 Options exercisable at September 30, 2020 31,013 $ 80.37 5.58 Options vested and expected to vest 37,138 $ 67.77 6.29 |
The Company and Summary of Si_3
The Company and Summary of Significant Accounting Policies (Details Textual) | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Accounting Policies [Abstract] | |
Revenues | $ 0 |
Concentrations of credit risk | $ 0 |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Potentially Dilutive Shares of Common Stock (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 170,539 | 168,545 | 170,539 | 168,545 |
Outstanding stock options | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 37,138 | 32,683 | 37,138 | 32,683 |
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 | 133,401 | 135,862 | 133,401 | 135,862 |
Fair Value Disclosures (Details
Fair Value Disclosures (Details Textual) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | |
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 | $ 51,000,000 | $ 8,300,000 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | |
Property Plant And Equipment [Line Items] | ||
Property and Equipment, Gross | $ 270 | $ 377 |
Accumulated depreciation and amortization | (260) | (367) |
Property and equipment, net | $ 10 | 10 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | 3 years | |
Property and Equipment, Gross | $ 25 | 54 |
Lab Equipment | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | 5 years | |
Property and Equipment, Gross | $ 146 | 142 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | 5 years | |
Property and Equipment, Gross | $ 38 | 61 |
Computer Software | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | 3 years | |
Property and Equipment, Gross | $ 61 | 61 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | Lesser of useful life or life of the lease | |
Property and Equipment, Gross | $ 59 |
Property and Equipment (Details
Property and Equipment (Details Textual) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Property Plant And Equipment [Abstract] | ||
Depreciation and amortization expense | $ 6 | $ 16 |
Related Party Arrangements (Det
Related Party Arrangements (Details Textual) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Chief Executive Officer | Research Grants | ||
Related Party Transaction [Line Items] | ||
Total expense | $ 248 | $ 210 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Textual) $ in Thousands | Aug. 29, 2020ft² | Feb. 24, 2020 | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Aug. 01, 2013ft² |
Commitments And Contingencies [Line Items] | ||||||
Area of office facilities taken on lease | ft² | 5,200 | 5,300 | ||||
Additional operating lease term | 36 months | 6 months | ||||
Lease renewal start date | Apr. 1, 2020 | |||||
Lease expiration date | Sep. 30, 2020 | |||||
Lease renewal option | option to renew for an additional 36 month term at the then prevailing rental rate. | Under the February 2020 Amendment, the Company had no further rights to extend or renew this lease agreement. | ||||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | false | ||||
Lessee, operating lease, assumptions and judgments, allocation of lease and nonlease component | The lease included real estate taxes and insurance, which was not a lease component and was not included in the lease obligation. In addition, common area maintenance charges were based on actual costs incurred and were a non-lease component that was not included in the lease obligation. | |||||
Operating lease, cash paid for measurement of lease liabilities | $ 76 | $ 68 | ||||
Lease liability | $ 0 | $ 25,000 | ||||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherAccruedLiabilitiesCurrent | us-gaap:OtherAccruedLiabilitiesCurrent | ||||
Operating lease term | 42 months | |||||
Weighted-average discount rate | 7.00% | |||||
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 | $ 73 | $ 52 |
Commitments and Contingencies -
Commitments and Contingencies - Future Minimum Commitments due Under October 2020 Lease Agreement (Details) $ in Thousands | Oct. 01, 2020USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2021 | $ 71 |
2022 | 88 |
2023 | 90 |
2024 | 93 |
Thereafter | 221 |
Present value adjustment | (121) |
Present value of lease payments | $ 442 |
Equity Financings and Warrant_2
Equity Financings and Warrants (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Jun. 03, 2020 | Jul. 31, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Jul. 22, 2020 | Jul. 14, 2020 | Jan. 11, 2017 |
Equity Financing And Warrants [Line Items] | ||||||||
Net proceeds from issuance of common stock | $ 49,644 | $ 7,281 | ||||||
Common stock, par value | $ 0.001 | $ 0.001 | ||||||
Common stock, shares issued | 9,285,624 | 1,594,070 | ||||||
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] | ||||||||
Net proceeds from issuance of common stock | $ 14,300 | $ 14,300 | ||||||
Common stock, shares issued | 820,561 | |||||||
Net proceeds from issuance of common stock | $ 6,900 | |||||||
Sale of common stock | 2,214,301 | 2,214,301 | ||||||
Sales Agreement | JonesTrading | ||||||||
Equity Financing And Warrants [Line Items] | ||||||||
Common stock, par value | $ 0.001 | |||||||
Aggregate offering price of common stock authorized | $ 32,400 | $ 7,300 | ||||||
2020 Sales Agreement | ||||||||
Equity Financing And Warrants [Line Items] | ||||||||
Net proceeds from issuance of common stock | $ 27,800 | |||||||
Aggregate offering price of common stock authorized | $ 25,300 | $ 54,000 | ||||||
Sale of common stock | 4,803,753 | |||||||
Direct Offering | ||||||||
Equity Financing And Warrants [Line Items] | ||||||||
Common stock issued | 348,000 | 348,000 | ||||||
Purchase price per share | $ 9 | $ 9 | ||||||
Pre-funded warrants to purchase shares of common stock | 325,500 | 325,500 | ||||||
Purchase price per warrant | $ 8.999 | $ 8.999 | ||||||
Pre-funded warrants outstanding | 0 | 0 | ||||||
Net proceeds from issuance of common stock | $ 5,300 | $ 5,300 | ||||||
Percentage of selling commission per additional shares sold | 8.00% | 8.00% |
Equity Financings and Warrant_3
Equity Financings and Warrants - Summary of Warrants by Year of Expiration (Details) - 2020 | 9 Months Ended |
Sep. 30, 2020$ / sharesshares | |
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, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total expenses | $ 5 | $ 29 | $ 25 | $ 124 |
Research and development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total expenses | $ 5 | 14 | 18 | 59 |
General and administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total expenses | $ 15 | $ 7 | $ 65 |
Share-based Compensation - Su_2
Share-based Compensation - Summary of Stock Option Activities (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Number of Stock Options | ||
Number of Options, Options outstanding, beginning of period | 31,136 | |
Number of Options, Granted | 6,250 | |
Number of Options, Forfeited and cancelled | (248) | |
Number of Options, Options outstanding, end of period | 37,138 | 31,136 |
Number of Options, Options exercisable, end of period | 31,013 | |
Number of Options, Options vested and expected to vest | 37,138 | |
Stock Options, Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Options outstanding, beginning of period | $ 84.50 | |
Weighted Average Exercise Price, Granted | 5.96 | |
Weighted Average Exercise Price, Forfeited and cancelled | 610.46 | |
Weighted Average Exercise Price, Options outstanding, end of period | 67.77 | $ 84.50 |
Weighted Average Exercise Price, Options exercisable, end of period | 80.37 | |
Weighted Average Exercise Price, Options vested and expected to vest, end of period | $ 67.77 | |
Stock Options, Weighted Average Remaining Contractual Term | ||
Weighted Average Remaining Contractual Term (in years), Options outstanding | 6 years 3 months 14 days | 6 years 3 months 3 days |
Weighted Average Remaining Contractual Term (in years), Options exercisable | 5 years 6 months 29 days | |
Weighted Average Remaining Contractual Term (in years), Options vested and expected to vest | 6 years 3 months 14 days |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Tax [Line Items] | |||
Reserve for uncertain tax positions | $ 0 | ||
Income tax benefit | $ 42,000 | 9,000 | $ 151,000 |
Alternative Minimum Tax | Federal | Protecting Americans from Tax Hikes Act of 2015 | |||
Income Tax [Line Items] | |||
Income tax benefit | $ 9,000 | ||
Research Tax Credit Carryforward | Federal | Protecting Americans from Tax Hikes Act of 2015 | |||
Income Tax [Line Items] | |||
Income tax benefit | $ 42,000 | $ 151,000 |