Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 22, 2019 | Jun. 29, 2018 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | ARCA Biopharma, Inc. | ||
Entity Central Index Key | 907,654 | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ABIO | ||
Document Fiscal Year Focus | 2,018 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 7,650,869 | ||
Entity Common Stock, Shares Outstanding | 18,355,111 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 6,608 | $ 8,702 |
Marketable securities | 3,050 | |
Other current assets | 169 | 547 |
Total current assets | 6,777 | 12,299 |
Property and equipment, net | 24 | 42 |
Other assets | 24 | 24 |
Total assets | 6,825 | 12,365 |
Current liabilities: | ||
Accounts payable | 230 | 622 |
Accrued compensation and employee benefits | 150 | 757 |
Accrued expenses and other liabilities | 413 | 691 |
Total current liabilities | 793 | 2,070 |
Deferred rent, net of current portion | 20 | |
Total liabilities | 793 | 2,090 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 5 million shares authorized; no shares issued or outstanding at December 31, 2018 and 2017 | ||
Common stock, $0.001 par value; 100 million shares authorized at December 31, 2018 and 2017; 13,924,058 and 11,775,062 shares issued and outstanding at December 31, 2018 and 2017, respectively | 14 | 12 |
Additional paid-in capital | 144,952 | 141,266 |
Accumulated other comprehensive loss | (2) | |
Accumulated deficit | (138,934) | (131,001) |
Total stockholders’ equity | 6,032 | 10,275 |
Total liabilities and stockholders’ equity | $ 6,825 | $ 12,365 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 13,924,058 | 11,775,062 |
Common stock, shares outstanding | 13,924,058 | 11,775,062 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Costs and expenses: | ||
Research and development | $ 4,239 | $ 14,076 |
General and administrative | 3,879 | 4,636 |
Total costs and expenses | 8,118 | 18,712 |
Loss from operations | (8,118) | (18,712) |
Interest and other income | 162 | 167 |
Interest expense | (8) | (6) |
Loss before income taxes | (7,964) | (18,551) |
Income tax benefit | 31 | 61 |
Net loss | (7,933) | (18,490) |
Change in unrealized loss on marketable securities | 2 | 17 |
Comprehensive loss | $ (7,931) | $ (18,473) |
Net loss per share: | ||
Basic and diluted | $ (0.57) | $ (1.77) |
Weighted average shares outstanding: | ||
Basic and diluted | 13,849,055 | 10,431,391 |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning Balance at Dec. 31, 2016 | $ 22,194 | $ 9 | $ 134,715 | $ (19) | $ (112,511) |
Beginning Balance, shares at Dec. 31, 2016 | 9,082,366 | ||||
Issuance of common stock for cash, net of offering costs | 6,096 | $ 3 | 6,093 | ||
Issuance of common stock for cash, net of offering costs, shares | 2,677,525 | ||||
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 | 15,171 | ||||
Share-based compensation | 458 | 458 | |||
Change in unrealized loss on marketable securities | 17 | 17 | |||
Net loss | (18,490) | (18,490) | |||
Ending Balance at Dec. 31, 2017 | $ 10,275 | $ 12 | 141,266 | (2) | (131,001) |
Ending Balance, shares at Dec. 31, 2017 | 11,775,062 | 11,775,062 | |||
Issuance of common stock for cash, net of offering costs | $ 3,415 | $ 2 | 3,413 | ||
Issuance of common stock for cash, net of offering costs, shares | 2,133,828 | ||||
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 | 15,168 | ||||
Share-based compensation | 273 | 273 | |||
Change in unrealized loss on marketable securities | 2 | $ 2 | |||
Net loss | (7,933) | (7,933) | |||
Ending Balance at Dec. 31, 2018 | $ 6,032 | $ 14 | $ 144,952 | $ (138,934) | |
Ending Balance, shares at Dec. 31, 2018 | 13,924,058 | 13,924,058 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (7,933) | $ (18,490) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 22 | 27 |
Amortization of other assets | 329 | |
Amortization of premiums and discounts on marketable securities | 2 | 119 |
Share-based compensation | 273 | 458 |
Change in operating assets and liabilities: | ||
Other current assets | 689 | 437 |
Accounts payable | (392) | (583) |
Accrued compensation and employee benefits | (607) | 38 |
Accrued expenses and other liabilities | (298) | 193 |
Net cash used in operating activities | (8,244) | (17,472) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (4) | (3) |
Purchases of marketable securities | (5,471) | |
Proceeds from maturities of marketable securities | 3,050 | 18,400 |
Net cash provided by investing activities | 3,046 | 12,926 |
Cash flows from financing activities: | ||
Proceeds from the issuance of common stock | 3,532 | 6,551 |
Common stock offering costs | (117) | (448) |
Repayment of principal on vendor finance agreement | (311) | (256) |
Net cash provided by financing activities | 3,104 | 5,847 |
Net (decrease) increase in cash and cash equivalents | (2,094) | 1,301 |
Cash and cash equivalents, beginning of year | 8,702 | 7,401 |
Cash and cash equivalents, end of year | 6,608 | 8,702 |
Supplemental cash flow information: | ||
Interest paid | 8 | 6 |
Income tax refund received | 54 | 38 |
Supplemental disclosure of noncash investing and financing transactions: | ||
Common stock offering costs accrued but not yet paid | 7 | |
Change in unrealized loss on marketable securities | $ 2 | $ 17 |
The Company and Summary of Sign
The Company and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
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 patients with heart failure with reduced left ventricular ejection fraction (HFrEF) and mid-range left ventricle ejection fraction (HFmrEF) against an active comparator, the beta-blocker TOPROL-XL (metoprolol succinate), a drug indicated for treating HFrEF that is also prescribed, but not approved, for treating AF in patients with HFrEF. 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 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. Based on 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 February 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 cash and cash equivalents as of December 31, 2018 , together with the $2.4 million of net proceeds raised in 2019 from sales of its common stock, 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. The Company could delay or cancel certain planned expenditures related to its drug development programs and/or implement 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. On April 11, 2018, the Company received notification from Nasdaq of potential delisting of its shares from the Nasdaq Capital Market because the closing bid price of its common stock had not met the minimum closing bid price of $1.00 per share during the preceding 30 days. On October 9, 2018, ARCA received a written notification from NASDAQ granting an additional 180 calendar day period, until April 8, 2019, to regain compliance with the minimum bid price requirement. The minimum bid price requirement will be met if the Common Stock has a closing bid of at least $1.00 per share for a minimum of 10 consecutive business days during the 180 day period. If the Company is not able to regain compliance with the closing bid requirement in such period, the Company may be subject to delisting from the Nasdaq Capital Market. If delisted, it could substantially impact the Company’s access to the capital markets, and any limitation on market liquidity or reduction in the price of the common stock as a result of that delisting could adversely affect the Company’s ability to raise capital on acceptable terms, or at all. On October 18, 2018, the Company held a special meeting of its stockholders, at which stockholders authorized the Company’s board of directors to amend the Company’s restated certificate of incorporation, as amended, to effect a reverse split of the Company’s outstanding common stock, if, in the judgment of the Company’s board of directors, it is deemed necessary to maintain NASDAQ compliance or for other reasons. The Company’s board of directors has not selected a ratio for the reverse split. Basis of Presentation The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) and include all adjustments necessary for the fair presentation of our financial position, results of operations and cash flows for the periods presented. Management has performed an evaluation of the Company’s activities through the date of filing of this Annual Report on Form 10-K, and the subsequent events are disclosed in Note 11. Recent Accounting Pronouncements In January 2016, Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities In February 2016, the FASB issued 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. Accounting Estimates in the Preparation of Financial Statements The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The Company bases estimates on various assumptions that are believed to be reasonable under the circumstances. The Company believes significant judgment was involved in estimating the clinical trial accruals, and in estimating other accrued liabilities, stock-based compensation, and income taxes. Management is continually evaluating and updating these estimates, and it is possible that these estimates will change in the future or that actual results may differ from these estimates. Cash Equivalents Cash equivalents generally consist of money market funds and debt securities with maturities of 90 days or less at the time of purchase. The Company invests its excess cash in securities with strong ratings and has established guidelines relative to diversification and maturity with the objective of maintaining safety of principal and liquidity. Marketable Securities The Company has designated its marketable securities as available-for-sale securities and accounted for them at their respective fair values. Marketable securities are classified as short-term or long-term based on the nature of the securities and their availability to meet current operating requirements. Marketable securities that are readily available for use in current operations are classified as short-term available-for-sale securities and are reported as current marketable securities in the accompanying balance sheets. Marketable securities that are not considered available for use in current operations are classified as long-term available-for-sale securities and are reported as a component of long-term assets in the accompanying balance sheets. Securities that are classified as available-for-sale are measured at fair value, including accrued interest, with temporary unrealized gains and losses reported as a component of stockholders' equity until their disposition. The Company reviews all available-for-sale securities at each period end to determine if they remain available-for-sale based on the Company’s then current intent and ability to sell the security if it is required to do so. All of the Company’s marketable securities are subject to a periodic impairment review. The Company recognizes an impairment charge when a decline in the fair value of its investments below the cost basis is judged to be other-than-temporary. Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents and marketable securities. 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. Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Cost includes expenditures for equipment, leasehold improvements, replacements, and renewals. Maintenance and repairs are charged to expense as incurred. When assets are sold, retired, or otherwise disposed of, the cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is reflected in operations. The cost of property and equipment is depreciated using the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized over the shorter of the life of the lease or the estimated useful life of the assets. 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. Segments The Company operates in one segment. Management uses one measure of profitability and does not segment its business for internal reporting. Research and Development Research and development costs are expensed as incurred. These consist primarily of salaries, contract services, and supplies. Costs related to clinical trial and drug manufacturing activities are based upon estimates of the services received and related expenses incurred by contract research organizations (CROs), clinical study sites, drug manufacturers, collaboration partners, laboratories, consultants, or otherwise. Related contracts vary significantly in length, and could be for a fixed amount, a variable amount based on actual costs incurred, capped at a certain limit, or for a combination of these elements. Activity levels are monitored through communications with the vendors, including detailed invoices and task completion review, analysis of expenses against budgeted amounts, and pre-approval of any changes in scope of the services to be performed. Certain significant vendors may also provide an estimate of costs incurred but not invoiced on a periodic basis. Expenses related to the CROs and clinical studies, as well as contract drug manufacturers, are primarily based on progress made against specified milestones or targets in each period. In accordance with certain research and development agreements, we are obligated to make certain upfront payments upon execution of the agreement. We record these upfront payments as prepaid research and development expenses, which are included in Other current assets or Other assets in the accompanying Balance Sheets. Such payments are recorded to research and development expense as services are performed. We evaluate on a quarterly basis whether events and circumstances have occurred that may indicate impairment of remaining prepaid research and development expenses. Stock-Based Compensation The Company’s stock-based compensation cost recognized is based on the estimated grant date fair value. The Company recognizes compensation costs for its stock-based awards on a straight-line basis over the requisite service period for the entire award, as adjusted for expected forfeitures. Income Taxes The current benefit for income taxes represents actual or estimated amounts payable or refundable on tax returns filed or to be filed each year. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that includes the enactment date. The overall change in deferred tax assets and liabilities for the period measures the deferred tax expense or benefit for the period. The measurement of deferred tax assets may be reduced by a valuation allowance based on judgmental assessment of available evidence if deemed more likely than not that some or all of the deferred tax assets will not be realized. The Company has recorded a valuation allowance against all of its deferred tax assets, as management has concluded that it is more likely than not that the net deferred tax asset will not be realized through future taxable income, based primarily on the Company’s history of operating losses. The Company has not performed an Internal Revenue Code Section 382 limitation study. Depending on the outcome of such a study, the gross amount of net operating losses recognizable in future tax periods could be limited. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | (2) Net Loss Per Share The Company calculates basic loss per share by dividing net loss by the weighted average common shares outstanding during the period. Diluted loss 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 years ended December 31, 2018 and 2017, all potentially dilutive shares of common stock have been excluded from the computation of the dilutive net loss per share for all periods presented. Such potentially dilutive shares of common stock consist of the following: Years Ended December 31, 2018 2017 Potentially dilutive securities, excluded: Outstanding stock options 604,003 611,975 Unvested restricted stock units — 15,168 Warrants to purchase common stock 2,669,855 3,633,008 3,273,858 4,260,151 |
Marketable Securities and Fair
Marketable Securities and Fair Value Disclosures | 12 Months Ended |
Dec. 31, 2018 | |
Marketable Securities And Fair Value Disclosures [Abstract] | |
Marketable Securities and Fair Value Disclosures | (3) Marketable Securities and Fair Value Disclosures There were no marketable securities as of December 31, 2018. Marketable securities consisted of the following as of December 31, 2017 (in thousands): December 31, 2017 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Short-term available-for-sale securities: Corporate bonds $ 3,052 $ — $ (2 ) $ 3,050 Total $ 3,052 $ — $ (2 ) $ 3,050 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’s Level 2 assets consist of corporate bonds and commercial paper securities. The Company does not have any Level 2 liabilities. • Level 3—Unobservable inputs for the asset or liability. The Company does not have any Level 3 assets or liabilities. The following table identifies the Company’s assets that were measured at fair value on a recurring basis (in thousands): Balance Level 1 Level 2 Level 3 December 31, 2018 Money market $ 6,529 $ 6,529 $ — $ — Total $ 6,529 $ 6,529 $ — $ — December 31, 2017 Money market $ 8,189 $ 8,189 $ — $ — Corporate bonds 3,725 — 3,725 — Total $ 11,914 $ 8,189 $ 3,725 $ — As of December 31, 2018 and 2017, the Company had $6.5 million and $8.9 million, respectively, of cash equivalents consisting of money market funds, and corporate bonds in 2017, 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 between any fair value hierarchy levels in 2018 or 2017. Fair Value of Other Financial Instruments The carrying amount of other financial instruments, including accounts payable, approximated fair value due to their short maturities. As of December 31, 2018 and 2017, the Company did not have any debt outstanding. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | (4) Property and Equipment Property and equipment consist of the following (in thousands): Estimated Life December 31, 2018 December 31, 2017 Computer equipment 3 years $ 65 $ 74 Lab equipment 5 years 142 142 Furniture and fixtures 5 years 62 83 Computer software 3 years 70 85 Leasehold improvements Lesser of useful life or life of the lease 59 59 398 443 Accumulated depreciation and amortization (374 ) (401 ) Property and equipment, net $ 24 $ 42 For the years ended December 31, 2018 and 2017, depreciation and amortization expense was $22,000 and $27,000, respectively. |
Related Party Arrangements
Related Party Arrangements | 12 Months Ended |
Dec. 31, 2018 | |
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 years ended December 31, 2018 and 2017 was $325,000 and $418,000, respectively, of which $111,000 was unpaid and included in accrued expenses and other liabilities as of December 31, 2018. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
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 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. Below is a summary of the future minimum lease payments committed for the Company’s facility in Westminster, Colorado as of December 31, 2018 (in thousands): 2019 $ 83 Total future minimum lease payments $ 83 Rent expense under these leases for the years ended December 31, 2018 and 2017 was $82,000 and $82,000, respectively. 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 buys-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, as discussed above. The acquisition cost of this interest did not have a material impact on the Company’s annual financial statements. |
Equity Financings and Warrants
Equity Financings and Warrants | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Equity Financings and Warrants | (7) Equity Financings and Warrants 2017 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 2,133,828 and 2,677,525 shares of Common Stock pursuant to the terms of such Sales Agreement, as amended, for net proceeds of approximately $3.4 million and $6.1 million during 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. See Note 11 for subsequent sales under the Sales Agreement. Warrants Warrants to purchase shares of common stock were granted as part of various financing and business agreements. All outstanding warrants were recorded in additional paid-in capital at their estimated fair market value at the date of grant using a Black-Scholes option-pricing model. As of December 31, 2018, these warrants, by year of expiration, are summarized below: Year of Expiration Number of Warrants Weighted Average Exercise Price 2019 224,323 $ 15.73 2020 44,299 15.96 2022 2,401,233 6.10 2,669,855 $ 7.07 |
Share-based Compensation
Share-based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-based Compensation | (8) Share-based Compensation Stock Plans The Company’s equity incentive plan, the 2013 Equity Incentive Plan The Equity Plan provides for the granting of stock options (including indexed options), restricted stock units, stock appreciation rights, restricted stock purchase rights, restricted stock bonuses, performance shares, performance units and deferred stock units. Under the Equity Plan, awards may be granted to employees, directors and consultants of ARCA, except for incentive stock options, which may be granted only to employees. As of December 31, 2018, options and awards for 597,342 shares were outstanding under the Equity Plan, and 615,976 shares were reserved for future awards. In general, the Equity Plan authorizes the grant of stock options that vest at rates set by the Board of Directors or the Compensation Committee thereof. Generally, stock options granted by ARCA under the equity incentive plans become exercisable ratably for a period of three to four years from the date of grant and have a maximum term of ten years. The exercise prices of stock options under the equity incentive plan generally meet the following criteria: the exercise price of incentive stock options must be at least 100% of the fair market value on the grant date and exercise price of options granted to 10% (or greater) stockholders must be at least 110% of the fair market value on the grant date. In conjunction with the adoption of the Equity Plan, the Company discontinued grants under its previous plan, the Amended and Restated ARCA biopharma, Inc. 2004 Equity Incentive Plan The Company granted options for 40,000 and 469,600 shares of common stock in the years ended December 31, 2018 and 2017, respectively. The fair values of employee stock options granted in the years ended December 31, 2018 and 2017 were estimated at the date of grant using the Black-Scholes model with the following assumptions and had the following estimated weighted average grant date fair value per share: Years Ended December 31, 2018 2017 Expected term 5.3 years 5.8 years Expected volatility 90 % 73 % Risk-free interest rate 2.59 % 1.99 % Expected dividend yield 0 % 0 % Weighted-average grant date fair value per share $ 0.52 $ 1.60 A summary of ARCA’s stock option activities for the years ended December 31, 2018 and 2017, and related information as of December 31, 2018, is as follows: Options Outstanding Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value (in thousands) Options outstanding - December 31, 2016 629,629 $ 6.30 Granted 469,600 2.54 Exercised — — Forfeited and cancelled (487,254 ) 3.05 Options outstanding - December 31, 2017 611,975 $ 6.00 8.14 $ — Granted 40,000 0.72 Exercised — — Forfeited and cancelled (47,972 ) 9.51 Options outstanding - December 31, 2018 604,003 $ 5.37 7.29 $ — Options exercisable - December 31, 2018 486,420 $ 6.04 7.13 $ — Options vested and expected to vest - December 31, 2018 603,842 $ 5.38 7.29 $ — The aggregate intrinsic value in the table above represents the total intrinsic value, based on our closing price as of December 31 of the respective year, which would have been received by the option holders had all the option holders with in-the-money options exercised as of that date. As of December 31, 2018, the unrecognized compensation expense related to unvested options, excluding estimated forfeitures, was $186,000 which is expected to be recognized over a weighted average period of 1.1 years. The Company recognizes compensation costs for its share-based awards on a straight-line basis over the requisite service period for the entire award, as adjusted for expected forfeitures. Restricted Stock Units The Company began granting restricted stock units (RSUs) to employees during 2013 in conjunction with the adoption of the Equity Plan. The fair value of RSU awards is the closing price of the Company’s common stock on the date of grant and was recognized as compensation expense on a straight-line basis over the respective vesting period. The stock awards granted had a requisite service period between three and four years with annual vesting on the grant anniversary date. A summary of RSU activity for the years ended December 31, 2018 and 2017 is presented below: Restricted Stock Units Outstanding Number of Shares Weighted Average Grant Date Fair Value RSUs outstanding - December 31, 2016 30,739 $ 7.91 Granted — — Vested and released (15,171 ) 7.94 Forfeited and cancelled (400 ) 6.03 RSUs outstanding - December 31, 2017 15,168 $ 7.94 Granted — — Vested and released (15,168 ) 7.94 Forfeited and cancelled — — RSUs outstanding - December 31, 2018 — $ — As of December 31, 2018, all compensation cost related to stock awards was recognized. Non-cash Stock-based Compensation For the years ended December 31, 2018 and 2017, the Company recognized the following non-cash, share-based compensation expense (in thousands): Years Ended December 31, 2018 2017 Research and development $ 117 $ 169 General and administrative 156 289 Total $ 273 $ 458 Stock-based compensation expense related to non-employees was negligible in 2018 and 2017. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2018 | |
Compensation And Retirement Disclosure [Abstract] | |
Employee Benefit Plans | (9) Employee Benefit Plans The Company has a 401(k) plan and makes a matching contribution equal to 100% of the employee’s first 3% of the employee’s contributions and 50% of the employee’s next 2% of contributions. The Company adopted the plan in 2006 and contributed $115,000 and $135,000 for the years ended December 31, 2018 and 2017, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | ( 10) Income Taxes Effective June 1, 2005, the Company changed from an S-Corporation to a C-Corporation. As an S-Corporation, the net operating loss carryforwards were distributed to the Company’s stockholders; such amounts were not significant. As of December 31, 2018, the Company has net operating loss carryforwards of approximately $165.2 million, and approximately $1.8 million of research and development credits that may be used to offset future taxable income. The Company’s net operating loss carryforwards through December 31, 2017 will expire beginning 2025 through 2037. The net operating loss carryforwards beginning in 2018, have no expiration, but are limited to 80% of taxable income. Utilization of net operating losses and tax credits, including those acquired as a result of the Merger, will be subject to an annual limitation due to ownership change limitations provided by Internal Revenue Code Section 382. The Company believes that an ownership change limitation as defined under Section 382 of the U.S. Internal Revenue Code occurred as a result of its various historical financing transactions, and its offering of common stock completed in June 2015. Future utilization of the federal net operating losses and tax credit carryforwards accumulated from June 2005 to the change in ownership date will be subject to annual limitations to offset future taxable income. The annual limitation may result in the expiration of the net operating losses and credits before utilization. As such, a portion of the Company’s net operating loss carryforwards may be limited. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the period in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. Due primarily to the Company’s history of operating losses, management is unable to conclude that it is more likely than not that the Company will realize the benefits of these deductible differences, and accordingly has provided a valuation allowance against the entire net deferred tax asset of approximately $43.5 million at December 31, 2018, reflecting an increase of approximately $1.9 million from December 31, 2017. During 2017, deferred tax assets decreased $20.1million related to the remeasurement of the deferred tax assets from 34% to the new 2018 U.S. Federal corporate income tax rate of 21%. The deferred tax assets are primarily comprised of net operating loss carryforwards and research and experimentation credit carryforwards. As of December 31, 2018, the Company has not performed an Internal Revenue Code Section 382 limitation study. Depending on the outcome of such a study, the gross amount of net operating losses recognizable in future tax periods could be limited. A limitation in the carryforwards would decrease the carrying amount of the gross amount of the net operating loss carryforwards, with a corresponding decrease in the valuation allowance recorded against these gross deferred tax assets. Income tax benefit for the years ended December 31, 2018 and 2017 were related to a federal research and experimentation income tax credits related to the Protecting Americans from Tax Hikes Act of 2015, or PATH Act, which allows qualified small businesses to monetize up to $250,000 of research and experimentation tax credits through payroll tax refunds. Income tax benefit attributable to our loss from operations before income taxes differs from the amounts computed by applying the U.S. federal statutory income tax rate of 21% for 2018 and 34% for 2017, as a result of the following (in thousands): Years ended December 31, 2018 2017 U.S. federal income tax benefit at statutory rates $ (1,666 ) $ (6,286 ) State income tax benefit, net of federal benefit (290 ) (565 ) Research and experimentation credits (144 ) (303 ) Change in tax rate — 20,085 Deferred tax asset adjustment 34 37 Other 134 122 Change in valuation allowance 1,901 (13,151 ) Income tax benefit $ (31 ) $ (61 ) Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting and the amounts used for income tax purposes, as well as operating loss and tax credit carryforwards. The income tax effects of temporary differences and carryforwards that give rise to significant portions of the Company’s net deferred tax assets consisted of the following (in thousands): As of December 31, 2018 2017 Net operating loss carryforwards $ 40,742 $ 38,566 Charitable contribution carryforwards 433 455 Research and experimentation credits 1,796 1,682 Capitalized intangibles 409 608 Stock-based compensation 127 148 Depreciation and amortization 1 1 Accrued compensation 20 168 Other 1 — Total deferred tax assets 43,529 41,628 Valuation allowance (43,529 ) (41,628 ) Net deferred tax assets $ — $ — Since the Company is in a loss carryforward position, the Company is generally subject to U.S. federal and state income tax examinations by tax authorities for all years for which a loss carryforward is available. Thus, the Company’s open tax years extend back to 2009. The Company believes that its tax filing positions and deductions related to tax periods subject to examination will be sustained upon audit and does not anticipate any adjustment will result in a material adverse effect on the Company’s financial condition, result of operations, or cash flow. For the years ended December 31, 2018 and 2017, the Company has no reserve for uncertain tax positions. The Company does not expect that the total amounts of unrecognized tax benefits will significantly increase or decrease within the subsequent twelve months. In the event the Company concludes it is subject to interest or penalties arising from uncertain tax positions, the Company will record interest and penalties as a component of other income and expense. No interest or penalties were recognized in the financial statements for the years ended December 31, 2018 and 2017. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Event | (11) Subsequent Event In January 2019, the Company amended the Sales Agreement to increase the maximum aggregate value of shares which it may issue and sell from time to time under the Sales Agreement by approximately $2.5 million, from $10.2 million to $12.7 million. Subsequent to December 31, 2018, the Company sold an aggregate of 4,431,053 shares of its Common Stock pursuant to the terms of the Sales Agreement, as amended, for aggregate gross proceeds of approximately $2.5 million. Net proceeds received in the period were approximately $2.4 million, after deducting initial expenses for executing the “at the market offering” and commissions paid to the placement agent. As of February 22, 2019, the Company has sold all shares available under its current prospectus to the Company’s registration statement on Form S-3 (No. 333-217450). |
The Company and Summary of Si_2
The Company and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
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 patients with heart failure with reduced left ventricular ejection fraction (HFrEF) and mid-range left ventricle ejection fraction (HFmrEF) against an active comparator, the beta-blocker TOPROL-XL (metoprolol succinate), a drug indicated for treating HFrEF that is also prescribed, but not approved, for treating AF in patients with HFrEF. 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 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. Based on 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 February 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 cash and cash equivalents as of December 31, 2018 , together with the $2.4 million of net proceeds raised in 2019 from sales of its common stock, 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. The Company could delay or cancel certain planned expenditures related to its drug development programs and/or implement 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. On April 11, 2018, the Company received notification from Nasdaq of potential delisting of its shares from the Nasdaq Capital Market because the closing bid price of its common stock had not met the minimum closing bid price of $1.00 per share during the preceding 30 days. On October 9, 2018, ARCA received a written notification from NASDAQ granting an additional 180 calendar day period, until April 8, 2019, to regain compliance with the minimum bid price requirement. The minimum bid price requirement will be met if the Common Stock has a closing bid of at least $1.00 per share for a minimum of 10 consecutive business days during the 180 day period. If the Company is not able to regain compliance with the closing bid requirement in such period, the Company may be subject to delisting from the Nasdaq Capital Market. If delisted, it could substantially impact the Company’s access to the capital markets, and any limitation on market liquidity or reduction in the price of the common stock as a result of that delisting could adversely affect the Company’s ability to raise capital on acceptable terms, or at all. On October 18, 2018, the Company held a special meeting of its stockholders, at which stockholders authorized the Company’s board of directors to amend the Company’s restated certificate of incorporation, as amended, to effect a reverse split of the Company’s outstanding common stock, if, in the judgment of the Company’s board of directors, it is deemed necessary to maintain NASDAQ compliance or for other reasons. The Company’s board of directors has not selected a ratio for the reverse split. |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) and include all adjustments necessary for the fair presentation of our financial position, results of operations and cash flows for the periods presented. Management has performed an evaluation of the Company’s activities through the date of filing of this Annual Report on Form 10-K, and the subsequent events are disclosed in Note 11. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In January 2016, Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities In February 2016, the FASB issued 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. |
Accounting Estimates in the Preparation of Financial Statements | Accounting Estimates in the Preparation of Financial Statements The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The Company bases estimates on various assumptions that are believed to be reasonable under the circumstances. The Company believes significant judgment was involved in estimating the clinical trial accruals, and in estimating other accrued liabilities, stock-based compensation, and income taxes. Management is continually evaluating and updating these estimates, and it is possible that these estimates will change in the future or that actual results may differ from these estimates. |
Cash Equivalents | Cash Equivalents Cash equivalents generally consist of money market funds and debt securities with maturities of 90 days or less at the time of purchase. The Company invests its excess cash in securities with strong ratings and has established guidelines relative to diversification and maturity with the objective of maintaining safety of principal and liquidity. |
Marketable Securities | Marketable Securities The Company has designated its marketable securities as available-for-sale securities and accounted for them at their respective fair values. Marketable securities are classified as short-term or long-term based on the nature of the securities and their availability to meet current operating requirements. Marketable securities that are readily available for use in current operations are classified as short-term available-for-sale securities and are reported as current marketable securities in the accompanying balance sheets. Marketable securities that are not considered available for use in current operations are classified as long-term available-for-sale securities and are reported as a component of long-term assets in the accompanying balance sheets. Securities that are classified as available-for-sale are measured at fair value, including accrued interest, with temporary unrealized gains and losses reported as a component of stockholders' equity until their disposition. The Company reviews all available-for-sale securities at each period end to determine if they remain available-for-sale based on the Company’s then current intent and ability to sell the security if it is required to do so. All of the Company’s marketable securities are subject to a periodic impairment review. The Company recognizes an impairment charge when a decline in the fair value of its investments below the cost basis is judged to be other-than-temporary. |
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 and marketable securities. 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. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Cost includes expenditures for equipment, leasehold improvements, replacements, and renewals. Maintenance and repairs are charged to expense as incurred. When assets are sold, retired, or otherwise disposed of, the cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is reflected in operations. The cost of property and equipment is depreciated using the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized over the shorter of the life of the lease or the estimated useful life of the assets. |
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. |
Segments | Segments The Company operates in one segment. Management uses one measure of profitability and does not segment its business for internal reporting. |
Research and Development | Research and Development Research and development costs are expensed as incurred. These consist primarily of salaries, contract services, and supplies. Costs related to clinical trial and drug manufacturing activities are based upon estimates of the services received and related expenses incurred by contract research organizations (CROs), clinical study sites, drug manufacturers, collaboration partners, laboratories, consultants, or otherwise. Related contracts vary significantly in length, and could be for a fixed amount, a variable amount based on actual costs incurred, capped at a certain limit, or for a combination of these elements. Activity levels are monitored through communications with the vendors, including detailed invoices and task completion review, analysis of expenses against budgeted amounts, and pre-approval of any changes in scope of the services to be performed. Certain significant vendors may also provide an estimate of costs incurred but not invoiced on a periodic basis. Expenses related to the CROs and clinical studies, as well as contract drug manufacturers, are primarily based on progress made against specified milestones or targets in each period. In accordance with certain research and development agreements, we are obligated to make certain upfront payments upon execution of the agreement. We record these upfront payments as prepaid research and development expenses, which are included in Other current assets or Other assets in the accompanying Balance Sheets. Such payments are recorded to research and development expense as services are performed. We evaluate on a quarterly basis whether events and circumstances have occurred that may indicate impairment of remaining prepaid research and development expenses. |
Stock-Based Compensation | Stock-Based Compensation The Company’s stock-based compensation cost recognized is based on the estimated grant date fair value. The Company recognizes compensation costs for its stock-based awards on a straight-line basis over the requisite service period for the entire award, as adjusted for expected forfeitures. |
Income Taxes | Income Taxes The current benefit for income taxes represents actual or estimated amounts payable or refundable on tax returns filed or to be filed each year. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that includes the enactment date. The overall change in deferred tax assets and liabilities for the period measures the deferred tax expense or benefit for the period. The measurement of deferred tax assets may be reduced by a valuation allowance based on judgmental assessment of available evidence if deemed more likely than not that some or all of the deferred tax assets will not be realized. The Company has recorded a valuation allowance against all of its deferred tax assets, as management has concluded that it is more likely than not that the net deferred tax asset will not be realized through future taxable income, based primarily on the Company’s history of operating losses. The Company has not performed an Internal Revenue Code Section 382 limitation study. Depending on the outcome of such a study, the gross amount of net operating losses recognizable in future tax periods could be limited. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Summary of Potentially Dilutive Shares of Common Stock | Because the Company reported a net loss for the years ended December 31, 2018 and 2017, all potentially dilutive shares of common stock have been excluded from the computation of the dilutive net loss per share for all periods presented. Such potentially dilutive shares of common stock consist of the following: Years Ended December 31, 2018 2017 Potentially dilutive securities, excluded: Outstanding stock options 604,003 611,975 Unvested restricted stock units — 15,168 Warrants to purchase common stock 2,669,855 3,633,008 3,273,858 4,260,151 |
Marketable Securities and Fai_2
Marketable Securities and Fair Value Disclosures (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Marketable Securities And Fair Value Disclosures [Abstract] | |
Summary of Marketable Securities | There were no marketable securities as of December 31, 2018. Marketable securities consisted of the following as of December 31, 2017 (in thousands): December 31, 2017 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Short-term available-for-sale securities: Corporate bonds $ 3,052 $ — $ (2 ) $ 3,050 Total $ 3,052 $ — $ (2 ) $ 3,050 |
Summary of Assets Measured at Fair Value on Recurring Basis | The following table identifies the Company’s assets that were measured at fair value on a recurring basis (in thousands): Balance Level 1 Level 2 Level 3 December 31, 2018 Money market $ 6,529 $ 6,529 $ — $ — Total $ 6,529 $ 6,529 $ — $ — December 31, 2017 Money market $ 8,189 $ 8,189 $ — $ — Corporate bonds 3,725 — 3,725 — Total $ 11,914 $ 8,189 $ 3,725 $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment consist of the following (in thousands): Estimated Life December 31, 2018 December 31, 2017 Computer equipment 3 years $ 65 $ 74 Lab equipment 5 years 142 142 Furniture and fixtures 5 years 62 83 Computer software 3 years 70 85 Leasehold improvements Lesser of useful life or life of the lease 59 59 398 443 Accumulated depreciation and amortization (374 ) (401 ) Property and equipment, net $ 24 $ 42 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Future Minimum Lease Payments | Below is a summary of the future minimum lease payments committed for the Company’s facility in Westminster, Colorado as of December 31, 2018 (in thousands): 2019 $ 83 Total future minimum lease payments $ 83 |
Equity Financings and Warrants
Equity Financings and Warrants (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Summary of Warrants by Year of Expiration | As of December 31, 2018, these warrants, by year of expiration, are summarized below: Year of Expiration Number of Warrants Weighted Average Exercise Price 2019 224,323 $ 15.73 2020 44,299 15.96 2022 2,401,233 6.10 2,669,855 $ 7.07 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Estimated Weighted Average Grant Date Fair Value per Share | The Company granted options for 40,000 and 469,600 shares of common stock in the years ended December 31, 2018 and 2017, respectively. The fair values of employee stock options granted in the years ended December 31, 2018 and 2017 were estimated at the date of grant using the Black-Scholes model with the following assumptions and had the following estimated weighted average grant date fair value per share: Years Ended December 31, 2018 2017 Expected term 5.3 years 5.8 years Expected volatility 90 % 73 % Risk-free interest rate 2.59 % 1.99 % Expected dividend yield 0 % 0 % Weighted-average grant date fair value per share $ 0.52 $ 1.60 |
Summary of Stock Option Activities | A summary of ARCA’s stock option activities for the years ended December 31, 2018 and 2017, and related information as of December 31, 2018, is as follows: Options Outstanding Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value (in thousands) Options outstanding - December 31, 2016 629,629 $ 6.30 Granted 469,600 2.54 Exercised — — Forfeited and cancelled (487,254 ) 3.05 Options outstanding - December 31, 2017 611,975 $ 6.00 8.14 $ — Granted 40,000 0.72 Exercised — — Forfeited and cancelled (47,972 ) 9.51 Options outstanding - December 31, 2018 604,003 $ 5.37 7.29 $ — Options exercisable - December 31, 2018 486,420 $ 6.04 7.13 $ — Options vested and expected to vest - December 31, 2018 603,842 $ 5.38 7.29 $ — |
Summary of RSU Activity | A summary of RSU activity for the years ended December 31, 2018 and 2017 is presented below: Restricted Stock Units Outstanding Number of Shares Weighted Average Grant Date Fair Value RSUs outstanding - December 31, 2016 30,739 $ 7.91 Granted — — Vested and released (15,171 ) 7.94 Forfeited and cancelled (400 ) 6.03 RSUs outstanding - December 31, 2017 15,168 $ 7.94 Granted — — Vested and released (15,168 ) 7.94 Forfeited and cancelled — — RSUs outstanding - December 31, 2018 — $ — |
Summary of Non-cash, Share-based Compensation Expense | For the years ended December 31, 2018 and 2017, the Company recognized the following non-cash, share-based compensation expense (in thousands): Years Ended December 31, 2018 2017 Research and development $ 117 $ 169 General and administrative 156 289 Total $ 273 $ 458 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Tax Benefit Attributable to Our Loss from Operations | Income tax benefit attributable to our loss from operations before income taxes differs from the amounts computed by applying the U.S. federal statutory income tax rate of 21% for 2018 and 34% for 2017, as a result of the following (in thousands): Years ended December 31, 2018 2017 U.S. federal income tax benefit at statutory rates $ (1,666 ) $ (6,286 ) State income tax benefit, net of federal benefit (290 ) (565 ) Research and experimentation credits (144 ) (303 ) Change in tax rate — 20,085 Deferred tax asset adjustment 34 37 Other 134 122 Change in valuation allowance 1,901 (13,151 ) Income tax benefit $ (31 ) $ (61 ) |
Net Deferred Tax Assets | Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting and the amounts used for income tax purposes, as well as operating loss and tax credit carryforwards. The income tax effects of temporary differences and carryforwards that give rise to significant portions of the Company’s net deferred tax assets consisted of the following (in thousands): As of December 31, 2018 2017 Net operating loss carryforwards $ 40,742 $ 38,566 Charitable contribution carryforwards 433 455 Research and experimentation credits 1,796 1,682 Capitalized intangibles 409 608 Stock-based compensation 127 148 Depreciation and amortization 1 1 Accrued compensation 20 168 Other 1 — Total deferred tax assets 43,529 41,628 Valuation allowance (43,529 ) (41,628 ) Net deferred tax assets $ — $ — |
The Company and Summary of Si_3
The Company and Summary of Significant Accounting Policies (Details Textual) | Oct. 09, 2018$ / shares | Apr. 11, 2018$ / shares | Feb. 22, 2019USD ($) | Dec. 31, 2018USD ($)PatientsSegment | Dec. 31, 2017USD ($) |
Company And Summary Of Significant Accounting Policies Table [Line Items] | |||||
Revenues | $ 0 | ||||
Concentrations of credit risk | $ 0 | ||||
Number of segments | Segment | 1 | ||||
Nasdaq Capital Market | |||||
Company And Summary Of Significant Accounting Policies Table [Line Items] | |||||
Common stock not met minimum closing bid price, preceding days | 30 days | ||||
Minimum consecutive business days | 10 days | ||||
Additional granted days for common stock to meet minimum bid price | 180 days | ||||
Common stock bid price, description | On April 11, 2018, the Company received notification from Nasdaq of potential delisting of its shares from the Nasdaq Capital Market because the closing bid price of its common stock had not met the minimum closing bid price of $1.00 per share during the preceding 30 days. On October 9, 2018, ARCA received a written notification from NASDAQ granting an additional 180 calendar day period, until April 8, 2019, to regain compliance with the minimum bid price requirement. The minimum bid price requirement will be met if the Common Stock has a closing bid of at least $1.00 per share for a minimum of 10 consecutive business days during the 180 day period. | ||||
Nasdaq Capital Market | Minimum | |||||
Company And Summary Of Significant Accounting Policies Table [Line Items] | |||||
Minimum closing bid price | $ / shares | $ 1 | $ 1 | |||
Sales Agreement | |||||
Company And Summary Of Significant Accounting Policies Table [Line Items] | |||||
Net proceeds from issuance of common stock | $ 3,400,000 | $ 6,100,000 | |||
Subsequent Event | Sales Agreement | |||||
Company And Summary Of Significant Accounting Policies Table [Line Items] | |||||
Net proceeds from issuance of common stock | $ 2,400,000 | ||||
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 | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 3,273,858 | 4,260,151 |
Outstanding stock options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 604,003 | 611,975 |
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 | 15,168 | |
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 | 2,669,855 | 3,633,008 |
Marketable Securities and Fai_3
Marketable Securities and Fair Value Disclosures (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 0 | |
Transfers of assets between fair value hierarchy levels | 0 | $ 0 |
Debt outstanding | 0 | 0 |
Fair Value Measurements, Recurring | Level 1 | Money Market Funds | Commercial paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents consisting of money market funds and commercial paper | $ 6,500,000 | $ 8,900,000 |
Marketable Securities and Fai_4
Marketable Securities and Fair Value Disclosures - Summary of Marketable securities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Schedule of Available-for-sale Securities [Line Items] | ||
Fair Value | $ 0 | |
Short-term available-for-sale securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 3,052,000 | |
Gross Unrealized Losses | (2,000) | |
Fair Value | 3,050,000 | |
Short-term available-for-sale securities | Corporate bonds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 3,052,000 | |
Gross Unrealized Losses | (2,000) | |
Fair Value | $ 3,050,000 |
Marketable Securities and Fai_5
Marketable Securities and Fair Value Disclosures - Summary of Assets Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | $ 6,529 | $ 11,914 |
Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 3,725 | |
Money market | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 6,529 | 8,189 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 6,529 | 8,189 |
Level 1 | Money market | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | $ 6,529 | 8,189 |
Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 3,725 | |
Level 2 | Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | $ 3,725 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property Plant And Equipment [Line Items] | ||
Property and Equipment, Gross | $ 398 | $ 443 |
Accumulated depreciation and amortization | (374) | (401) |
Property and equipment, net | $ 24 | 42 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | 3 years | |
Property and Equipment, Gross | $ 65 | 74 |
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 | 83 |
Computer Software | ||
Property Plant And Equipment [Line Items] | ||
Estimated Life | 3 years | |
Property and Equipment, Gross | $ 70 | 85 |
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 | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property Plant And Equipment [Abstract] | ||
Depreciation and amortization expense | $ 22 | $ 27 |
Related Party Arrangements (Det
Related Party Arrangements (Details Textual) - Chief Executive Officer - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Accrued Expenses and Other Liabilities | ||
Related Party Transaction [Line Items] | ||
Unpaid expense | $ 111 | |
Research Grants | ||
Related Party Transaction [Line Items] | ||
Total expense | $ 325 | $ 418 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Textual) $ in Thousands | Mar. 02, 2016 | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | 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 | |||
Rent expense | $ 82 | $ 82 | ||
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% |
Commitments and Contingencies -
Commitments and Contingencies - Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2,019 | $ 83 |
Total future minimum lease payments | $ 83 |
Equity Financings and Warrant_2
Equity Financings and Warrants (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Feb. 22, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 25, 2019 | Jan. 11, 2017 | |
Equity Financing And Warrants [Line Items] | |||||
Common stock, par value | $ 0.001 | $ 0.001 | |||
Common stock, shares issued | 13,924,058 | 11,775,062 | |||
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] | |||||
Aggregate offering price of common stock authorized | $ 10,200,000 | ||||
Common stock, shares issued | 2,133,828 | 2,677,525 | |||
Net proceeds from issuance of common stock | $ 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 | $ 7,300,000 | ||||
Subsequent Event | Sales Agreement | |||||
Equity Financing And Warrants [Line Items] | |||||
Aggregate offering price of common stock authorized | $ 12,700,000 | ||||
Common stock, shares issued | 4,431,053 | ||||
Net proceeds from issuance of common stock | $ 2,400,000 | ||||
Subsequent Event | Sales Agreement | JonesTrading | |||||
Equity Financing And Warrants [Line Items] | |||||
Aggregate offering price of common stock authorized | $ 12,700,000 |
Equity Financings and Warrant_3
Equity Financings and Warrants - Summary of Warrants by Year of Expiration (Details) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Class Of Warrant Or Right [Line Items] | |
Number of Warrants | shares | 2,669,855 |
Weighted Average Exercise Price | $ / shares | $ 7.07 |
2,019 | |
Class Of Warrant Or Right [Line Items] | |
Year of Expiration | 2,019 |
Number of Warrants | shares | 224,323 |
Weighted Average Exercise Price | $ / shares | $ 15.73 |
2,020 | |
Class Of Warrant Or Right [Line Items] | |
Year of Expiration | 2,020 |
Number of Warrants | shares | 44,299 |
Weighted Average Exercise Price | $ / shares | $ 15.96 |
2,022 | |
Class Of Warrant Or Right [Line Items] | |
Year of Expiration | 2,022 |
Number of Warrants | shares | 2,401,233 |
Weighted Average Exercise Price | $ / shares | $ 6.10 |
Share-based Compensation (Detai
Share-based Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of shares outstanding under Equity plan | 604,003 | 611,975 | 629,629 | |
Stock options award, expiration | 10 years | |||
Weighted Average exercise Price of Options Outstanding | $ 5.37 | $ 6 | $ 6.30 | |
Employee Stock Option | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Unrecognized compensation expense related to unvested options | $ 186 | |||
Maturity period of weighted average period of compensation expenses | 1 year 1 month 6 days | |||
Minimum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock options award, vesting period | 3 years | |||
Percentage holding for stock options exercise price | 10.00% | |||
Minimum | Incentive Stock Option | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Percentage of exercise price of stock option | 100.00% | |||
Minimum | Incentive Stock Option | Stockholders | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Percentage of exercise price of stock option | 110.00% | |||
Minimum | Restricted Stock Units (RSUs) | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Restricted Stock Units award, requisite service period | 3 years | |||
Maximum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock options award, vesting period | 4 years | |||
Maximum | Restricted Stock Units (RSUs) | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Restricted Stock Units award, requisite service period | 4 years | |||
2013 Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Increase in number of shares reserve for issuance under amended Equity Plan | 1,000,000 | |||
Number of shares issuable under Equity plan | 1,321,428 | |||
Number of shares outstanding under Equity plan | 597,342 | |||
Shares reserved for future | 615,976 | |||
Options granted | 40,000 | 469,600 | ||
Two Thousand And Four Stock Option Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of shares outstanding under Equity plan | 5,383 | |||
Weighted Average exercise Price of Options Outstanding | $ 102.16 | |||
Other Stock Option Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of shares outstanding under Equity plan | 1,278 | |||
Weighted Average exercise Price of Options Outstanding | $ 233.94 |
Share-based Compensation - Esti
Share-based Compensation - Estimated Weighted Average Grant Date Fair Value Per Share (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Estimated weighted average grant date fair value per share | ||
Expected term | 5 years 3 months 18 days | 5 years 9 months 18 days |
Expected volatility | 90.00% | 73.00% |
Risk-free interest rate | 2.59% | 1.99% |
Expected dividend yield | 0.00% | 0.00% |
Weighted-average grant date fair value per share | $ 0.52 | $ 1.60 |
Share-based Compensation - Summ
Share-based Compensation - Summary of Stock Option Activities (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Number of Stock Options | ||
Number of Options, Options outstanding, beginning of period | 611,975 | 629,629 |
Number of Options, Granted | 40,000 | 469,600 |
Number of Options, Forfeited and cancelled | (47,972) | (487,254) |
Number of Options, Options outstanding, end of period | 604,003 | 611,975 |
Number of Options, Options exercisable, end of period | 486,420 | |
Number of Options, Options vested and expected to vest | 603,842 | |
Stock Options, Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Options outstanding, beginning of period | $ 6 | $ 6.30 |
Weighted Average Exercise Price, Granted | 0.72 | 2.54 |
Weighted Average Exercise Price, Forfeited and cancelled | 9.51 | 3.05 |
Weighted Average Exercise Price, Options outstanding, end of period | 5.37 | $ 6 |
Weighted Average Exercise Price, Options exercisable, end of period | 6.04 | |
Weighted Average Exercise Price, Options vested and expected to vest, end of period | $ 5.38 | |
Stock Options, Weighted Average Remaining Contractual Term | ||
Weighted Average Remaining Contractual Term (in years), Options outstanding | 7 years 3 months 14 days | 8 years 1 month 20 days |
Weighted Average Remaining Contractual Term (in years), Options exercisable | 7 years 1 month 17 days | |
Weighted Average Remaining Contractual Term (in years), Options vested and expected to vest | 7 years 3 months 14 days |
Share-based Compensation - Su_2
Share-based Compensation - Summary of RSU Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Restricted Stock Awards, Number of Shares | ||
Restricted stock units outstanding, beginning of period | 15,168 | 30,739 |
Vested and released | (15,168) | (15,171) |
Forfeited and cancelled | (400) | |
Restricted stock units outstanding, end of period | 15,168 | |
Restricted Stock Awards, Weighted Average Grant Date Fair Value | ||
Restricted stock units outstanding, beginning of period | $ 7.94 | $ 7.91 |
Vested and released | $ 7.94 | 7.94 |
Forfeited and cancelled | 6.03 | |
Restricted stock units outstanding, end of period | $ 7.94 |
Share-based Compensation - Su_3
Share-based Compensation - Summary of Non-cash, Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total expenses | $ 273 | $ 458 |
Research and development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total expenses | 117 | 169 |
General and administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total expenses | $ 156 | $ 289 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Defined Contribution Plan Disclosure [Line Items] | ||
Matching contribution | matching contribution equal to 100% of the employee’s first 3% of the employee’s contributions and 50% of the employee’s next 2% of contributions. | |
Company's contribution | $ 115 | $ 135 |
First 3% of pay contributed | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Benefit Plan, Percentage of Match | 100.00% | |
Employer matching contribution percentage | 3.00% | |
Next 2% of pay contributed | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Benefit Plan, Percentage of Match | 50.00% | |
Employer matching contribution percentage | 2.00% |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax [Line Items] | ||
Net operating loss carryforwards | $ 165,200,000 | |
Tax Credit Carryforward, Description | The net operating loss carryforwards beginning in 2018, have no expiration, but are limited to 80% of taxable income. | |
Percentage limited to taxable income on operating loss carryforward | 80.00% | |
Valuation allowance | $ 43,529,000 | $ 41,628,000 |
Increase net deferred tax asset | $ 1,900,000 | |
Remeasurement of deferred tax assets | $ 20,100,000 | |
Federal statutory income tax rate | 21.00% | 34.00% |
Reserve for uncertain tax positions | $ 0 | $ 0 |
Interest or penalties recognized | $ 0 | 0 |
Open tax year | 2,009 | |
Research Tax Credit Carryforward | ||
Income Tax [Line Items] | ||
Research and experimentation credits | $ 1,800,000 | |
Operating loss carryforwards, limitations on use | Utilization of net operating losses and tax credits, including those acquired as a result of the Merger, will be subject to an annual limitation due to ownership change limitations provided by Internal Revenue Code Section 382. The Company believes that an ownership change limitation as defined under Section 382 of the U.S. Internal Revenue Code occurred as a result of its various historical financing transactions, and its offering of common stock completed in June 2015. Future utilization of the federal net operating losses and tax credit carryforwards accumulated from June 2005 to the change in ownership date will be subject to annual limitations to offset future taxable income. The annual limitation may result in the expiration of the net operating losses and credits before utilization. As such, a portion of the Company’s net operating loss carryforwards may be limited | |
Tax credit carryforward, limitations on use | Utilization of net operating losses and tax credits, including those acquired as a result of the Merger, will be subject to an annual limitation due to ownership change limitations provided by Internal Revenue Code Section 382. The Company believes that an ownership change limitation as defined under Section 382 of the U.S. Internal Revenue Code occurred as a result of its various historical financing transactions, and its offering of common stock completed in June 2015. Future utilization of the federal net operating losses and tax credit carryforwards accumulated from June 2005 to the change in ownership date will be subject to annual limitations to offset future taxable income. The annual limitation may result in the expiration of the net operating losses and credits before utilization. As such, a portion of the Company’s net operating loss carryforwards may be limited | |
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 |
Earliest Tax Year | ||
Income Tax [Line Items] | ||
Operating loss carryforwards expiration year | 2,025 | |
Latest Tax Year | ||
Income Tax [Line Items] | ||
Operating loss carryforwards expiration year | 2,037 |
Income Taxes - Income Tax Benef
Income Taxes - Income Tax Benefit Attributable to Our Loss from Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | ||
U.S. federal income tax benefit at statutory rates | $ (1,666) | $ (6,286) |
State income tax benefit, net of federal benefit | (290) | (565) |
Research and experimentation credits | (144) | (303) |
Change in tax rate | 20,085 | |
Deferred tax asset adjustment | 34 | 37 |
Other | 134 | 122 |
Change in valuation allowance | 1,901 | (13,151) |
Income tax benefit | $ (31) | $ (61) |
Income Taxes - Net deferred tax
Income Taxes - Net deferred tax assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 40,742 | $ 38,566 |
Charitable contribution carryforwards | 433 | 455 |
Research and experimentation credits | 1,796 | 1,682 |
Capitalized intangibles | 409 | 608 |
Stock-based compensation | 127 | 148 |
Depreciation and amortization | 1 | 1 |
Accrued compensation | 20 | 168 |
Other | 1 | |
Total deferred tax assets | 43,529 | 41,628 |
Valuation allowance | (43,529) | (41,628) |
Net deferred tax assets | $ 0 | $ 0 |
Subsequent Event (Details Textu
Subsequent Event (Details Textual) - USD ($) $ in Thousands | Jan. 25, 2019 | Feb. 22, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Subsequent Event [Line Items] | ||||
Common stock, shares issued | 13,924,058 | 11,775,062 | ||
Proceeds from the issuance of common stock | $ 3,532 | $ 6,551 | ||
Sales Agreement | ||||
Subsequent Event [Line Items] | ||||
Aggregate offering price of common stock authorized | $ 10,200 | |||
Common stock, shares issued | 2,133,828 | 2,677,525 | ||
Net proceeds from issuance of common stock | $ 3,400 | $ 6,100 | ||
Subsequent Event | Sales Agreement | ||||
Subsequent Event [Line Items] | ||||
Aggregate offering price of common stock additional authorized offering amount under agreement to sell | $ 2,500 | |||
Aggregate offering price of common stock authorized | $ 12,700 | |||
Common stock, shares issued | 4,431,053 | |||
Proceeds from the issuance of common stock | $ 2,500 | |||
Net proceeds from issuance of common stock | $ 2,400 |