Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 26, 2020 | Jun. 28, 2019 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Dare Bioscience, Inc. | ||
Entity Central Index Key | 0001401914 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 24,690,404 | ||
Entity Public Float | $ 12,232,000 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Current Assets | ||
Cash and cash equivalents | $ 4,780,107 | $ 6,805,889 |
Other receivables | 555,210 | 31,037 |
Prepaid expenses | 1,108,615 | 403,097 |
Total current assets | 6,443,932 | 7,240,023 |
Property and equipment, net | 63,531 | 9,396 |
Other non-current assets | 935,325 | 577,968 |
Total assets | 7,442,788 | 7,827,387 |
Current Liabilities | ||
Accounts payable | 1,083,183 | 459,705 |
Accrued expenses | 2,098,653 | 631,351 |
Deferred grant funding | 2,019,674 | 0 |
Current portion of lease liabilities | 410,896 | 0 |
Total current liabilities | 5,612,406 | 1,091,056 |
Contingent consideration non-current | 1,000,000 | 0 |
Lease liabilities long-term | 389,556 | 9,711 |
Total liabilities | 7,001,962 | 1,100,767 |
Commitments and contingencies (Note 10) | ||
Stockholders' equity | ||
Preferred stock issued | 0 | 0 |
Common stock: $0.0001 par value, 120,000,000 shares authorized, 19,683,401 and 11,422,161 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively | 1,968 | 1,143 |
Accumulated other comprehensive loss | (102,625) | (96,728) |
Additional paid-in capital | 44,564,674 | 35,791,972 |
Accumulated deficit | 44,023,191 | 28,969,767 |
Total stockholders' equity | 440,826 | 6,726,620 |
Total liabilities and stockholders' equity | $ 7,442,788 | $ 7,827,387 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Common stock, shares issued | 19,683,401 | 11,422,161 |
Common stock, shares outstanding | 19,683,401 | 11,422,161 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating expenses | ||
General and administrative | $ 5,265,438 | $ 4,655,837 |
Research and development expenses | 8,546,108 | 6,413,956 |
License expenses | 533,334 | 625,000 |
Impairment of goodwill | 0 | 5,187,519 |
Total operating expenses | 14,344,880 | 16,882,312 |
Loss from operations | (14,344,880) | (16,882,312) |
Other income | 81,050 | 143,497 |
Net loss | (14,263,830) | (16,738,815) |
Deemed dividend from trigger of round down provision feature | (789,594) | 0 |
Net loss to common shareholders | (15,053,424) | (16,738,815) |
Foreign currency translation adjustments, net of tax | (5,897) | (78,648) |
Comprehensive loss | $ (15,059,321) | $ (16,817,463) |
Loss per common share - basic and diluted (in usd per share) | $ (0.97) | $ (1.57) |
Weighted average number of common shares outstanding: | ||
Basic and diluted (in shares) | 15,578,959 | 10,732,421 |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity (Deficit) - USD ($) | Total | Public Stock Offering | Common Stock | Common StockPublic Stock Offering | Additional Paid-in Capital | Additional Paid-in CapitalPublic Stock Offering | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance at Dec. 31, 2017 | $ 13,292,783 | $ 605 | $ 25,541,210 | $ (18,080) | $ (12,230,952) | |||
Beginning balance, shares at Dec. 31, 2017 | 6,047,161 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock via public offering, net (in shares) | 375,000 | 5,000,000 | ||||||
Issuance of common stock via public offering, net | 734,235 | $ 9,377,717 | $ 38 | $ 500 | 734,197 | $ 9,377,217 | ||
Stock-based compensation | 139,348 | 139,348 | ||||||
Deemed dividend from trigger of round down provision feature | 0 | |||||||
Net loss | (16,738,815) | (16,738,815) | ||||||
Foreign currency translation adjustments | (78,648) | (78,648) | ||||||
Ending balance at Dec. 31, 2018 | $ 6,726,620 | $ 1,143 | 35,791,972 | (96,728) | (28,969,767) | |||
Ending balance, shares at Dec. 31, 2018 | 11,422,161 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock via public offering, net (in shares) | 5,261,250 | |||||||
Issuance of common stock via public offering, net | $ 5,151,702 | $ 525 | $ 5,151,177 | |||||
Equity issued in consideration of acquisition (in shares) | 2,999,990 | |||||||
Equity issued in consideration of acquisition | $ 2,369,992 | $ 300 | 2,369,692 | |||||
Stock-based compensation | 462,239 | 462,239 | ||||||
Deemed dividend from trigger of round down provision feature | (789,594) | 789,594 | (789,594) | |||||
Net loss | (14,263,830) | (14,263,830) | ||||||
Foreign currency translation adjustments | (5,897) | (5,897) | ||||||
Ending balance at Dec. 31, 2019 | $ 440,826 | $ 1,968 | $ 44,564,674 | $ (102,625) | $ (44,023,191) | |||
Ending balance, shares at Dec. 31, 2019 | 19,683,401 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities: | ||
Net loss | $ (14,263,830) | $ (16,738,815) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 11,137 | 2,440 |
Stock-based compensation | 462,239 | 139,348 |
Non-cash operating lease cost | (29,121) | 9,319 |
Acquisition-related IPR&D | (202,096) | 507,000 |
Impairment of goodwill | 0 | 5,187,519 |
Changes in operating assets and liabilities, net of impact of acquisition: | ||
Other receivables | (201,423) | 253,169 |
Prepaid expenses | (322,482) | (91,526) |
Other current assets | 0 | 193,495 |
Other non-current assets and deferred charges | 237,937 | 145,223 |
Accounts payable | 608,650 | 151,486 |
Accrued expenses | 621,618 | (27,083) |
Deferred grant funding | (238,109) | 0 |
Net cash used in operating activities | (13,315,480) | (10,268,425) |
Investing activities: | ||
Acquisition of Microchips cash | 6,143,893 | 0 |
Purchases of property and equipment | 0 | (11,836) |
Acquisition of Pear Tree and Hydra assets | 0 | (507,000) |
Net cash provided by (used in) investing activities | 6,143,893 | (518,836) |
Financing activities: | ||
Net proceeds from issuance of common stock and warrants | 5,151,702 | 10,111,952 |
Net cash provided by financing activities | 5,151,702 | 10,111,952 |
Effect of exchange rate changes on cash and cash equivalents | (5,897) | (78,648) |
Net change in cash and cash equivalents | (2,025,782) | (753,957) |
Cash and cash equivalents, beginning of year | 6,805,889 | 7,559,846 |
Cash and cash equivalents, end of year | 4,780,107 | 6,805,889 |
Supplemental disclosure of non-cash operating, investing and financing activities: | ||
Operating right-of-use assets obtained in exchange for new operating lease liabilities | 583,697 | |
Deemed dividend from trigger of down round provision | 789,594 | 0 |
Microchips acquisition consideration paid in equity | $ 2,369,992 | $ 0 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Organization and Summary of Significant Accounting Policies | ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization and business Daré Bioscience, Inc. is a clinical-stage biopharmaceutical company committed to the acceleration of innovative products for women’s health. Daré Bioscience, Inc. and its wholly owned subsidiaries operate one segment. In this report, the “Company” refers collectively to Daré Bioscience, Inc. and its wholly owned subsidiaries, unless otherwise stated or the context otherwise requires. The Company is driven by a mission to identify, develop and bring to market a diverse portfolio of novel therapies that expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health and fertility. The Company's business strategy is to in-license or otherwise acquire the rights to differentiated product candidates in the Company's areas of focus, some of which have existing clinical proof-of-concept data, and to advance those candidates through clinical development and regulatory approval alone or in collaboration with strategic partners. Since July 2017, the Company has assembled a portfolio of clinical-stage and pre-clinical-stage candidates. While the Company will continue to assess opportunities to expand its portfolio, its current focus is on advancing its existing product candidates through mid- and late stages of clinical development or approval. The Company's global commercialization and development strategy involves partnering with pharmaceutical companies and regional distributors with established marketing and sales capabilities in women's health, including through co-development and promotion agreements, once the Company has advanced a candidate through mid- to late-stage clinical development. The Company's portfolio includes three product candidates in advanced clinical development: • DARE - BV1 , a novel thermosetting bioadhesive hydrogel formulated with clindamycin phosphate 2% to be administered in a single vaginally delivered application , as a first line treatment for bacterial vaginosis , or BV; • Ovaprene® , a hormone-free, monthly vaginal contraceptive; • Sildenafil Cream , 3 . 6% , a proprietary cream formulation of sildenafil for topical administration to the vulva and vagina for treatment of female sexual arousal disorder, or FSAD; The Company's portfolio also includes three product candidates that it believes are Phase 1-ready: • DARE - HRT1 , a combination bio-identical estradiol and progesterone intravaginal ring for the treatment of vasomotor symptoms (VMS) as part of a hormone replacement therapy , or HRT , following menopause; • DARE - VVA1 , a vaginally delivered formulation of tamoxifen to treat vulvar vaginal atrophy , or VVA , in patients with hormone- receptor positive breast cancer; and • DARE - FRT1 , an intravaginal ring containing bio-identical progesterone for the prevention of preterm birth and for fertility support as part of an in vitro fertilization treatment plan . The Company's portfolio also includes these pre-clinical stage product candidates: • A microchip-based, implantable drug delivery system and a contraceptive application of that technology utilizing levonorgestrel that is designed to provide user-controlled, long-acting, reversible contraception • ORB-204 and ORB-214 , 6-month and 12-month formulations of injectable etonogestrel for contraception; and • DARE-RH1 , a novel approach to non - hormonal contraception for both men and women by targeting the CatSper ion channel . The Company’s primary operations have consisted of, and are expected to continue to consist of, product research and development and advancing its portfolio of product candidates through clinical development and regulatory approval. We expect that the majority of our development expenses over the next two years will support the advancement of DARE-BV1, Ovaprene, and Sildenafil Cream, 3.6%. To date, the Company has not obtained any regulatory approvals for any of its product candidates, commercialized any of its product candidates or generated any product revenue. The Company is subject to several risks common to clinical-stage biopharmaceutical companies, including dependence on key individuals, competition from other companies, the need to develop commercially viable products in a timely and cost-effective manner, and the need to obtain adequate additional capital to fund the development of product candidates. The Company is also subject to several risks common to other companies in the industry, including rapid technology change, regulatory approval of products, uncertainty of market acceptance of products, competition from substitute products and larger companies, compliance with government regulations, protection of proprietary technology, dependence on third parties, and product liability. Basis of presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States, or U.S. GAAP as defined by the Financial Accounting Standards Board, or FASB. Going Concern The Company has prepared its consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The Company has a history of losses from operations, expects negative cash flows from its operations will continue for the foreseeable future, and expects that its net losses will continue for at least the next several years as it develops its existing product candidates and seeks to acquire, license or develop additional product candidates. These circumstances raise substantial doubt about the Company's ability to continue as a going concern. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of the Company's ability to continue as a going concern. As of December 31, 2019 , the Company had an accumulated deficit of approximately $44.0 million, had cash and cash equivalents of approximately $ 4.8 million, and working capital was approximately $0.8 million . For the year ended December 31, 2019 , the Company incurred a net loss of $14.3 million and had negative cash flow from operations of approximately $13.3 million. The Company is focused primarily on the development and commercialization of innovative products in women’s health. The Company will continue to incur significant research and development and other expenses related to these activities. If the clinical trials for any of the Company’s product candidates fail to produce successful results such that those product candidates do not advance in clinical development, then the Company’s business and prospects may suffer. Even if the product candidates advance in clinical development, they may fail to gain regulatory approval. Even if the product candidates are approved, they may fail to achieve market acceptance, and the Company may never become profitable. Even if the Company becomes profitable, it may not sustain profitability. Based on the Company's current operating plan estimates, the Company does not have sufficient cash to satisfy its working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying financial statements. The Company needs to raise substantial additional capital to continue to fund its operations and to successfully execute its current operating plan, including to continue the planned development of DARE-BV1, Ovaprene, and Sildenafil Cream, 3.6%. The Company is currently evaluating a variety of capital raising options, including financings, government or other grant funding, collaborations and strategic alliances or other similar types of arrangements to cover its operating expenses, including the development of its product candidates and any future product candidates it may license or otherwise acquire. The amount and timing of the Company's capital needs have been and will continue to depend highly on many factors, including the product development programs the Company chooses to pursue and the pace and results of its clinical development efforts. If the Company raises capital through collaborations, strategic alliances or other similar types of arrangements, it may have to relinquish, on terms that are not favorable to the Company, rights to some of its technologies or product candidates it would otherwise seek to develop or commercialize. There can be no assurances that capital will be available when needed or that, if available, it will be obtained on terms favorable to the Company and its stockholders. Additionally, equity or debt financings may have a dilutive effect on the holdings of the Company's existing stockholders. If the Company cannot raise capital when needed, on favorable terms or at all, the Company will not be able to continue development of its product candidates, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations. If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values at which they are carried on its consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Principles of Consolidation The consolidated financial statements of the Company are stated in U.S. dollars. These consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. One wholly owned subsidiary, Daré Bioscience Australia Pty LTD, operates primarily in Australia. The financial statements of the Company’s wholly owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated Other Comprehensive Loss. All intercompany transactions and accounts have been eliminated in consolidation. Grant Funding The Company receives certain research and development funding through grants issued by a division of the National Institutes of Health and the Bill & Melinda Gates Foundation, or the Gates Foundation. The funding is recognized in the statement of operations as a reduction to research and development expense as the related costs are incurred to meet those obligations over the grant period. The Company adopted this policy in 2018. For the years ended December 31, 2019 and December 31, 2018 , the Company recognized approximately $1.2 million and $225,000 , respectively, in the statement of operations as a reduction to research and development expense. Grant funding payments received in advance of research and development expenses incurred are recorded as deferred grant payments liability in the Company's consolidated balance sheets. Use of Estimates The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the fair value of stock-based compensation, goodwill impairment and purchase accounting. Actual results could differ from those estimates and could materially affect the reported amounts of assets, liabilities and future operating results. Risks and Uncertainties The Company will require approvals from the U.S. Food and Drug Administration, or FDA, or foreign regulatory agencies prior to being able to sell any products. There can be no assurance that the Company’s current or future product candidates will receive the necessary approvals. If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations and its financial position. The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the ability to license product candidates, successfully develop product candidates, raise additional capital, compete with other products, and protect proprietary technology. In the event the Company receives a regulatory approval for a product, the market’s acceptance of the product remains a risk. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success. Cash and Cash Equivalents The Company considers cash and all highly liquid investments with an original maturity of three months or less to be cash and cash equivalents. The Company’s wholly owned subsidiary, Microchips Biotech, Inc., has a $35,903 letter of credit related to the lease of real property that serves as security for future default of lease payments. The letter of credit is collateralized by cash which is unavailable for withdrawal or for usage for general obligations and is included in cash and cash equivalents on the Company's consolidated balance sheet. Concentration of Credit Risk The Company maintains cash balances at various financial institutions and such balances commonly exceed the $250,000 amount insured by the Federal Deposit Insurance Corporation. The Company also maintains money market funds at various financial institutions which are not federally insured although are invested primarily in the U.S. The Company has not experienced any losses in such accounts and management believes that the Company does not have significant risk with respect to such cash and cash equivalents. Fair Value of Financial Instruments U.S. GAAP defines fair value as the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date, and also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available. The three-level hierarchy of valuation techniques established to measure fair value is defined as follows: • Level 1: inputs are unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2: inputs other than level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities. • Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Cash and cash equivalents of $ 4.8 million and $6.8 million measured at fair value as of December 31, 2019 and 2018 , respectively, are classified within Level 1. Other receivables and prepaid expenses are financial assets with carrying values that approximate fair value due to the short-term nature of these assets. Accounts payable and accrued expenses and other liabilities are financial liabilities with carrying values that approximate fair value due to the short-term nature of these liabilities. The estimated fair value of the $1.0 million of contingent consideration potentially payable by the Company related to its acquisition of Microchips Biotech, Inc. is recorded using significant unobservable measures and other fair value inputs and is therefore classified as a Level 3 financial instrument. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use, or ROU, lease assets, current portion of lease obligations, and long-term lease obligations on the Company's balance sheets. ROU lease assets represent the Company's right to use an underlying asset for the lease term. Lease obligations represent the Company's obligation to make lease payments arising from the lease. Operating ROU lease assets and lease obligations are recognized at the commencement date of the applicable lease based on the present value of lease payments over the lease term. If the lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The ROU lease asset includes any lease payments made and excludes lease incentives. The Company's lease terms may include options to extend or terminate the lease and the related payments are only included in the lease liability when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. (See Note 9, Leased Properties.) Business Combinations Assets acquired and liabilities assumed as part of a business acquisition are recorded at their estimated fair value at the date of acquisition. The excess of the total purchase consideration over the fair value of assets acquired and liabilities assumed is recorded as goodwill. Determining fair value of identifiable assets, particularly intangibles, and liabilities acquired also requires management to make estimates, which are based on all available information and, in some cases, assumptions with respect to the timing and amount of future revenue and expenses associated with an asset. Acquired In-Process Research and Development Expense The Company has acquired, and may continue to acquire, the rights to develop new product candidates. Payments to acquire a new product candidate, as well as future milestone payments associated with asset acquisitions which are deemed probable of achievement, are immediately expensed as acquired in-process research and development provided that the product candidate has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. Goodwill The Company records goodwill based on the fair value of the assets acquired. In determining the fair value of the assets acquired, the Company utilizes extensive accounting estimates and judgments to allocate the purchase price to the fair value of the net tangible and intangible assets acquired. The Company uses the discounted cash flow method to estimate the value of intangible assets acquired. The Company tests its goodwill for impairment at least annually as of December 31 st and between annual tests if it becomes aware of an event or change in circumstance that would indicate the carrying value may be impaired. The Company tests goodwill for impairment at the entity level because it operates on the basis of a single reporting unit. A goodwill impairment is the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. When impaired, the carrying value of goodwill is written down to fair value. Any excess of the reporting unit goodwill carrying value over the fair value is recognized as impairment loss. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. Its chief operating decision maker is the chief executive officer. The Company has one operating segment, women’s reproductive health. Research and Development Costs Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses, manufacturing process-development and scale-up activities, fees paid to clinical and regulatory consultants, clinical trial and related clinical trial manufacturing expenses, fees paid to clinical research organizations, or CROs, and investigative sites, transaction expenses incurred in connection with the expansion of the product portfolio through acquisitions and license and option agreements, payments to universities under the Company’s license agreements and other outside expenses. Research and development costs are expensed as incurred. Nonrefundable advance payments, if any, for goods and services used in research and development are recognized as an expense as the related goods are delivered or services are performed. Net Loss Per Share Basic net loss attributable to common stockholders per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive. There were stock options exercisable into 1,889,775 and 1,635,790 shares of common stock outstanding at December 31, 2019 and 2018 , respectively. These securities were not included in the computation of diluted loss per share because they are antidilutive, but they could potentially dilute earnings (loss) per share in future years. Stock-Based Compensation The Company records compensation expense for all stock-based awards granted based on the fair value of the award at the time of grant. The Company uses the Black-Scholes Pricing Model to determine the fair value of each of the awards which considers factors such as expected term, volatility, risk free interest rate and dividend yield. Due to the limited history of the Company, the simplified method was utilized in order to determine the expected term of the awards. Additionally, the Company considered comparable companies in the industry which have available share price history to calculate the volatility. The Company compared U.S. Treasury Bills in determining the risk-free interest rate appropriate given the expected term. Finally, the Company has not established and has no plans to establish a dividend policy or declare any dividends in the foreseeable future and thus no dividend yield was determined necessary in the calculation of fair value. Income Taxes The Company accounts for income taxes using the asset and liability method in accordance with Accounting Standards Codification, or ASC 740, Income Taxes . Under this method deferred income taxes are provided to reflect the tax consequences in future years of differences between the tax basis of assets and liabilities and their financial reporting amounts based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company follows the two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates it is more likely than not, that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount, which is more than 50% likely of being realized upon ultimate settlement. The Company considers many factors when evaluating and estimating the Company's tax positions and tax benefits, which may require periodic adjustments. At December 31, 2019 , the Company did not record any liabilities for uncertain tax positions. During 2019 , the Company recorded no provision for income taxes. During 2018, the Company recorded a provision for income taxes of $3,200 . Management evaluated the Company’s tax positions and, as of December 31, 2019 , the Company has approximately $935,000 of unrecognized benefits. The tax years 2015 to 2019 remain open to examination by federal and state taxing authorities while the statute for net operating losses generated remain open beginning in the year of utilization. Indemnifications As permitted under Delaware law, the Company has entered into indemnification agreements with its officers and directors that provide that the Company will indemnify the directors and officers for certain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by such director or officer in any action or proceeding arising out of their service as a director and/or officer. The term of the indemnification is for the officer’s or director’s lifetime. During the year ended December 31, 2019 , the Company did not experience any losses related to those indemnification obligations. The Company does not expect significant claims related to these indemnification obligations, and consequently, has concluded the fair value of the obligations is not material. Accordingly, as of December 31, 2019 and 2018 , no amounts have been accrued related to such indemnification provisions. Recently Adopted Accounting Standards In February 2016, FASB issued ASU 2016-02, Leases (Topic 842) , which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e., lessees and lessors). The new standard requires lessees to apply a dual approach classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less will be accounted for similar to existing guidance for operating leases. The new standard requires lessors to account for leases using an approach that is substantially equivalent to existing guidance for sales-type leases, direct financing leases and operating leases. The new standard is effective for public companies for fiscal years beginning after December 15, 2018, with early adoption permitted. ASU 2016-02 became effective for the Company on January 1, 2019 and was adopted using a modified retrospective approach and the effective date is as of the initial application. Consequently, financial information was not updated, and the disclosures required under ASU 2016-02 are not provided for dates and periods prior to January 1, 2019. ASU 2016-02 provides a number of optional practical expedients and accounting policy elections. The Company elected the package of practical expedients requiring no reassessment of whether any expired or existing contracts are or contain leases, the lease classification of any expired or existing leases, or initial direct costs for any existing leases. The Company recorded approximately $232,000 right-of-use assets and $241,000 lease liabilities related to its lease of office space as of the adoption date in the consolidated balance sheets. There are no changes to the statement of operations or cash flows as a result of the adoption. |
Acquisitions
Acquisitions | 12 Months Ended |
Dec. 31, 2019 | |
Business Combinations [Abstract] | |
Acquisitions | ACQUISITIONS Cerulean/Private Daré Stock Purchase Transaction In July 2017, the Company completed its business combination with Daré Bioscience Operations, Inc., a privately held Delaware corporation, or Private Daré in which Private Daré stockholders sold their shares to the Company in exchange for newly issued shares of the Company’s common stock, and as a result, Private Daré became a wholly owned subsidiary of the Company and the Private Daré stockholders became majority stockholders of the Company. In connection with the closing of that transaction, the Company changed its name from "Cerulean Pharma Inc." to "Daré Bioscience, Inc." In this report, that transaction is referred to as the Cerulean/Private Daré stock purchase transaction and "Cerulean" refers to Cerulean Pharma Inc. before that transaction closed. The Cerulean/Private Daré stock purchase transaction was accounted for as a reverse merger under the acquisition method of accounting whereby Private Daré was considered to have acquired Cerulean for financial reporting purposes. Pursuant to business combination accounting, the Company applied the acquisition method, which requires the assets acquired and liabilities assumed be recorded at fair value with limited exceptions. The excess of the purchase price over the assets acquired and liabilities assumed represents goodwill. The goodwill was primarily attributable to the cash and cash equivalents at closing of the transaction of approximately $9.9 million and the impact of the unamortized fair value of stock options granted by Cerulean that were outstanding immediately before the transaction closed of approximately $3.7 million . The Company assessed goodwill at March 31, 2018, determined there was an impairment and recognized an impairment charge of approximately $5.2 million in the interim consolidated statement of operations and comprehensive loss for the three months ended March 31, 2018. As of December 31, 2018, the goodwill carrying value on the Company’s consolidated balance sheet was written off in its entirety. Pear Tree Acquisition In May 2018, the Company acquired Pear Tree Pharmaceuticals, Inc., via a merger transaction in which a wholly owned subsidiary the Company, formed for purposes of this transaction, merged with and into Pear Tree, and Pear Tree survived as the Company’s wholly owned subsidiary. The Company acquired Pear Tree to secure the rights to develop DARE-VVA1, a proprietary vaginal formulation of tamoxifen, as a potential treatment for vulvar and vaginal atrophy. The Company accounted for the transaction as an asset acquisition as the purchase primarily related to one asset. Transaction costs of approximately $452,000 associated with the acquisition are included in the Company’s research and development expense. In accordance with the terms of the merger agreement that governed the acquisition, because, at the time of the closing of the merger, the sum of (a) certain Pear Tree indebtedness and transaction expenses, the stockholders’ representatives’ transaction expenses, and amounts payable under Pear Tree’s management incentive plan, exceeded the sum of (b) $75,000 and the cash and cash equivalents held by Pear Tree at the closing, the excess amount (approximately $132,000 ) offset the $75,000 payment due on the one-year anniversary of the closing of the merger to certain former and continuing Pear Tree service providers and former holders of Pear Tree’s capital stock and the balance will offset future payments otherwise due under the merger agreement to such parties. Microchips Acquisition In November 2019, the Company acquired Microchips Biotech, Inc., or Microchips, via a merger transaction in which a wholly owned subsidiary the Company, formed for purposes of this transaction, merged with and into Microchips , and Microchips survived as the Company’s wholly owned subsidiary. Microchips is developing a proprietary, microchip-based, implantable drug delivery system designed to store and precisely deliver numerous therapeutic doses over months and years on a schedule determined by the user and controlled via wireless remote. Microchips’ lead product candidate is a pre-clinical stage contraceptive application of that technology that utilizes levonorgestrel . The Company issued an aggregate of 2,999,990 shares of its common stock to the holders of shares of Microchips' capital stock outstanding immediately prior to the effective time of the merger. The transaction was valued at $2.4 million , based on the fair value of the 2,999,990 shares issued of $0.79 per share, which was the closing price per share of the Company's common stock on the date of closing. The shares were issued in exchange for Microchips’ cash and cash equivalents of $6.1 million , less net liabilities of $3.5 million and transaction costs of $202,000 , which was allocated based on the relative fair value of the assets acquired and liabilities assumed. The Company also agreed to pay (1) contingent consideration based upon the achievement of specified funding, product development and regulatory milestones, and upon the achievement of specified amounts of aggregate net sales of products incorporating the intellectual property the Company acquired in the merger, (2) tiered royalty payments ranging from low single-digit to low double-digit percentages of annual net sales of such products, and (3) a percentage of sublicense revenue related to such products. The Company recorded $1.0 million in contingent consideration associated with milestone payments expected to become payable through 2021. The Company determined the transaction was accounted for as an asset acquisition as there were no outputs or substantive processes in existence as of the acquisition date. Transaction costs of approximately $202,000 associated with the merger are included in the Company’s research and development expense. |
Prepaid Expenses (Notes)
Prepaid Expenses (Notes) | 12 Months Ended |
Dec. 31, 2019 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses | PREPAID EXPENSES Prepaid expenses consisted of the following: As of December 31, 2019 2018 Prepaid clinical expense $ 305,135 $ 14,547 Prepaid insurance expense 417,152 321,546 Prepaid legal and professional expenses 386,328 67,004 Total prepaid expenses $ 1,108,615 $ 403,097 |
Other Non-Current Assets
Other Non-Current Assets | 12 Months Ended |
Dec. 31, 2019 | |
Other Assets, Noncurrent Disclosure [Abstract] | |
Other Non-Current Assets | OTHER NON-CURRENT ASSETS Other non-current assets consisted of the following: As of December 31, 2019 2018 Prepaid insurance, long-term portion $ 404,141 $ 562,266 Deposits 42,904 15,702 Operating lease assets 488,280 — Total other non-current assets $ 935,325 $ 577,968 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2019 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | ACCRUED EXPENSES Accrued expenses consisted of the following: As of December 31, 2019 2018 Accrued compensation and benefits expenses $ 715,201 $ 416,234 Accrued legal and professional expenses 412,584 32,457 Accrued license expense 280,833 — Accrued clinical and related expenses 690,035 182,660 Total accrued expenses $ 2,098,653 $ 631,351 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES The components of loss from continuing operations before provision for income taxes consists of the following (in thousands): Years Ended December 31, 2019 2018 Domestic $ 13,800 $ 16,707 Foreign 464 107 Loss before taxes $ 14,264 $ 16,814 The difference between the provision for income taxes (benefit) and the amount computed by applying the U.S. federal income tax rate for the years ended December 31, 2019 and 2018 are as follows: Years Ended December 31, 2019 2018 Federal statutory rate 21.0 % 21.0 % State income tax, net of federal benefit 7.01 % 2.42 % Permanent differences (0.02 )% 0.31 % Research and development credit 1.46 % 1.24 % Stock compensation (0.44 )% (0.08 )% Other (0.1 )% — % Goodwill impairment — % (6.48 )% Change in valuation allowance (28.94 )% (18.43 )% Effective income tax rate (0.02 )% (0.02 )% The major components of the Company’s deferred tax assets as of December 31, 2019 and 2018 are shown below (in thousands). 2019 2018 Net operating loss carryforwards $ 46,120 $ 40,436 Research and development credit carryforwards 3,669 3,321 Capitalized research and development costs 11,123 13,334 Other 271 11 Stock compensation 1,987 1,941 Total deferred tax assets 63,170 59,043 Valuation allowance (63,170 ) (59,043 ) Net deferred tax assets $ — $ — The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Under applicable accounting standards, management has considered the Company’s history of losses and concluded that it is more likely than not the Company will not recognize the benefits of federal and state deferred tax assets. Accordingly, a valuation allowance of $63.2 million and $59.0 million was established at December 31, 2019 and 2018 respectively, to offset the net deferred tax assets. When and if management determines that it is more likely than not that the Company will be able to utilize the deferred tax assets prior to their expiration, the valuation allowance may be reduced or eliminated. The increase in valuation allowance of approximately $4.1 million for the year ending December 31, 2019 is primarily related to an increase in net operating losses generated during the year. The increase in valuation of approximately $55.6 million for the year ending December 31, 2018 is primarily related to an increase in net operating losses generated during the year. The Company has U.S. federal net operating loss, or NOL, carryforwards available at December 31, 2019 of approximately $174.5 million ( 2018 – $153.8 million ) of which, $135.0 million begin expiring in 2027 unless previously utilized and $39.5 million that do not expire but are limited to 80% of taxable income in a given year. The Company has state NOL carryforwards of $140.1 million ( 2018 – $119.9 million ) that begin expiring in 2032 unless previously utilized. The Company has U.S. federal research credit carryforwards available at December 31, 2019 of approximately $2.5 million ( 2018 – $2.2 million ) that begin expiring in 2027 unless previously utilized. The Company has state research credit carryforwards of $1.2 million ( 2018 – $1.1 million ) that begin expiring in 2022 unless previously utilized. The difference between federal and state NOL carryforwards is primarily due to previously expired state NOL carryforwards. Utilization of the NOL and research and development credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. The Company has not yet completed an evaluation of ownership changes. To the extent an ownership change occurs, the NOL and credit carryforwards and other deferred tax assets may be subject to limitations. On December 22, 2017, President Trump signed into law the “Tax Cuts and Jobs Act,” or TCJA, which significantly reformed the Internal Revenue Code of 1986, as amended. The TCJA, among other things, includes changes to U.S. federal tax rates, imposes significant additional limitations on the deductibility of interest and NOL carryforwards, allows for the expensing of capital expenditures, and puts into effect the migration from a “worldwide” system of taxation to a territorial system. The TCJA permanently lowers the corporate federal income tax rate to 21% from the existing maximum rate of 35% , effective for tax years including or commencing on January 1, 2018. As a result of the reduction of the corporate federal income tax rate to 21% , U.S. GAAP requires companies to revalue their deferred tax assets and deferred tax liabilities as of the date of enactment, with the resulting tax effects accounted for in the reporting period of enactment. This revaluation resulted in a provision of $23.6 million to income tax expense in continuing operations and a corresponding reduction of the Company’s valuation allowance. As a result of the offsetting valuation allowance, there is no impact to the Company’s income statement for the year ended December 31, 2018 from the reduction in federal income tax rates. A reconciliation of the beginning and ending amount of uncertain tax benefits is as follows (in thousands): Years Ended December 31, 2019 2018 Beginning uncertain tax benefits $ 924 $ 846 Current year - increases 83 78 Prior year - reductions (72 ) — Ending uncertain tax benefits $ 935 $ 924 Included in the balance of uncertain tax benefits at December 31, 2019 are $935,000 of tax benefits that, if recognized, would impact the effective tax rate. The Company anticipates that no material amounts of unrecognized tax benefits will be settled within 12 months of the reporting date. The Company’s policy is to record estimated interest and penalties related to uncertain tax benefits as income tax expense. As of December 31, 2019 and 2018 , the Company had no accrued interest or penalties recorded related to uncertain tax positions. The tax years 2015 through 2019 remain open to examination by major taxing jurisdictions to which the Company is subject, which are primarily in the U.S. The statute of limitations for U.S. net operating losses utilized in future years will remain open beginning in the year of utilization. No additional provision has been made for U.S. income taxes related to undistributed foreign earnings of the Company’s wholly owned Australian subsidiary or for unrecognized deferred tax liabilities for temporary differences related to investments in subsidiaries. As such, earnings are expected to be permanently reinvested, the investments are permanent in duration, or the Company has estimated that no additional tax liability will arise as a result of the distribution of such earnings. A liability could arise if amounts are distributed by the subsidiary or if the subsidiary is ultimately disposed. It is not practical to estimate the additional income taxes, if any, related to permanently reinvested earnings. There are no unremitted earnings as of December 31, 2019 . |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY ATM Sales Agreement In January 2018, the Company entered into a common stock sales agreement under which the Company may sell shares of its common stock from time to time in “at-the-market” equity offerings (as defined in Rule 415 promulgated under the Securities Act of 1933, as amended). The Company agreed to pay a commission of up to 3% of the gross proceeds of any common stock sold under this agreement plus certain legal expenses. The common stock sales agreement was amended in August 2018 to refer to the Company’s shelf registration statement on Form S-3 (File No. 333-227019) that was filed to replace the Company’s shelf registration statement on Form S-3 (File No. 333-206396) that expired on August 28, 2018. During 2018, the Company sold 375,000 shares under the common stock sales agreement for gross proceeds of approximately $1.0 million and incurred offering expenses of approximately $338,000 . The Company did not sell any shares under this agreement during 2019. April 2019 Underwritten Public Offering In April 2019, the Company closed an underwritten public offering of 4,575,000 shares of its common stock at a public offering price of $1.10 per share. The Company granted the underwriters a 30 -day over-allotment option to purchase up to an additional 686,250 shares which was exercised in full on April 12, 2019. Including the over-allotment shares, the Company issued a total of 5,261,250 shares in the offering and received gross proceeds of approximately $5.8 million and net proceeds of approximately $5.2 million after deducting underwriting discounts and offering expenses. February 2018 Underwritten Public Offering In February 2018, the Company closed an underwritten public offering of 5.0 million shares of its common stock and warrants to purchase up to 3.5 million shares of its common stock. Each share of common stock was sold with a warrant to purchase up to 0.70 of a share of the Company’s common stock. The Company granted the underwriter a 30 -day overallotment option to purchase up to an additional 750,000 shares of common stock and/or warrants to purchase up to 525,000 shares of common stock. The underwriter exercised the option with respect to warrants to purchase 220,500 shares of common stock. The Company received gross proceeds of approximately $10.3 million , including the proceeds from the sale of the warrants upon exercise of the underwriter’s overallotment option, and net proceeds of approximately $9.4 million . Common Stock Warrants The warrants issued in the February 2018 underwritten offering initially had an exercise price of $3.00 per share and are exercisable through February 2023. The warrants include a price-based anti-dilution provision, which provides that, subject to certain limited exceptions, the exercise price of the warrants will be reduced each time the Company issues or sells (or is deemed to issue or sell) securities for a consideration per share less than the exercise price of those warrants in effect immediately prior to such issuance or sale. In addition, subject to certain exceptions, if the Company issues, sells or enters into any agreement to issue or sell securities at a price which varies or may vary with the market price of the shares of the Company’s common stock, the warrant holders have the right to substitute such variable price for the exercise price of the warrant then in effect. The warrants are exercisable only for cash, unless a registration statement covering the shares issued upon exercise of the warrants is not effective, in which case the warrants may be exercised on a cashless basis. A registration statement covering the shares issued upon exercise of the warrants is currently effective. The Company estimated the fair value of the warrants as of February 15, 2018 to be approximately $3.0 million which has been recorded in equity as of the grant date. The Company early adopted ASU 2017-11 and as a result has recorded the fair value of the warrants as equity. In April 2019, in accordance with the price-based anti-dilution provision discussed above, as a result of the sale of shares in the April 2019 underwritten offering, the exercise price of these warrants was automatically reduced to $0.98 per share. For the year ended December 31, 2019 , the Company recorded $0.8 million to additional paid-in capital as a result of that exercise price reduction. No warrants were exercised during the year ended December 31, 2019 or 2018 . As of December 31, 2019 , the Company had the following warrants outstanding: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 2,906 $ 120.40 December 1, 2021 3,737 $ 120.40 December 6, 2021 17,190 $ 60.50 January 8, 2020 6,500 $ 1.00 April 4, 2026 3,720,500 $ 3.00 February 15, 2023 3,750,833 Common Stock The authorized capital of the Company consists of 120,000,000 shares of common stock with a par value of $0.0001 and 5,000,000 shares of preferred stock with a par value of $0.01 per share at December 31, 2019 . The issued and outstanding common stock of the Company consisted of 19,683,401 and 11,422,161 shares with a par value of $0.0001 as of December 31, 2019 and 2018 , respectively. There were no shares of preferred stock outstanding as of December 31, 2019 or 2018 . Common Stock Reserved for Future Issuance The following table summarizes common stock reserved for future issuance at December 31, 2019 : Common stock reserved for issuance upon exercise of warrants outstanding 3,750,833 Common stock reserved for issuance upon exercise of options outstanding 1,889,775 Common stock reserved for future equity awards (under the Amended 2014 Plan) 634,294 Total 6,274,902 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation | STOCK-BASED COMPENSATION The 2015 Employee, Director and Consultant Equity Incentive Plan Prior to the Cerulean/Private Daré stock purchase transaction, Private Daré maintained the 2015 Employee, Director and Consultant Equity Incentive Plan, or the 2015 Private Daré Plan. Upon closing of the Cerulean/Private Daré stock purchase transaction, the Company assumed the 2015 Private Daré Plan and each then outstanding award granted thereunder, which consisted of options and restricted stock. Based on the exchange ratio for the Cerulean/Private Daré stock purchase transaction and after giving effect to the 1-for-10 reverse stock split effected in connection with the closing of that transaction, the outstanding options and restricted stock awards granted under the 2015 Private Daré Plan were replaced with options to purchase 10,149 shares of the Company’s common stock with a correspondingly adjusted exercise price, all of which were outstanding as of December 31, 2019 and 223,295 shares of the Company’s common stock. Those options are fully vested and expire in December 2025. No further awards may be granted under the 2015 Private Daré Plan following the closing of the Cerulean/Private Daré stock purchase transaction. 2014 Employee Stock Purchase Plan The Company’s 2014 Employee Stock Purchase Plan, or the ESPP, became effective in April 2014, but no offering period has been initiated thereunder since January 2017 and there was no stock-based compensation related to the ESPP for the years ended December 31, 2019 or December 31, 2018 . Amended and Restated 2014 Stock Incentive Plan The Company maintains the Amended and Restated 2014 Plan, or the Amended 2014 Plan. There were 2,046,885 shares of common stock authorized for issuance under the Amended 2014 Plan when it was approved by the Company's stockholders in July 2018. The number of authorized shares increases annually on the first day of each fiscal year until, and including, the fiscal year ending December 31, 2024 by the least of (i) 2,000,000 , (ii) 4% of the number of outstanding shares of common stock on such date, or (iii) an amount determined by the Company’s board of directors. As a result of the foregoing, the number of shares available under the Amended 2014 Plan increased by 456,886 to 878,130 on January 1, 2019, which increase represented 4% of the number of outstanding shares of common stock on such date. Summary of Stock Option Activity The table below summarizes stock option activity under the Amended 2014 Plan, and related information for the years ended December 31, 2019 and 2018 . The exercise price of all options granted during the years ended December 31, 2019 and 2018 was equal to the market value of the Company’s common stock on the date of grant. As of December 31, 2019 , unamortized stock-based compensation expense of approximately $1.1 million will be amortized over the weighted average period of 2.6 years . As of December 31, 2019 , 634,294 shares of common stock were reserved for future issuance under the Amended 2014 Plan, and options to purchase 1,889,775 shares of the Company’s common stock granted under the Amended 2014 Plan were outstanding. Number of Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Outstanding at December 31, 2017 539,896 $ 31.40 Granted 1,096,050 1.08 Exercised — — Forfeited (156 ) 59.48 Outstanding at December 31, 2018 (1) 1,635,790 $ 11.08 Granted 832,500 0.79 Exercised — — Canceled/forfeited (578,445 ) 28.52 Expired (70 ) 59.48 Outstanding at December 31, 2019 (1) 1,889,775 $ 1.21 8.88 $ 46,599 Options exercisable at December 31, 2019 490,513 $ 1.99 8.63 $ 16,091 Options vested and expected to vest at December 31, 2019 1,889,775 $ 1.21 8.88 $ 46,559 (1) Includes 10,149 shares subject to options granted under the 2015 Private Daré Plan assumed in connection with the Cerulean/Private Daré stock purchase transaction. Compensation Expense Total stock-based compensation expense related to stock options granted to employees and directors recognized in the consolidated statements of operations is as follows: Years Ended December 31, 2019 2018 Research and development $ 107,142 $ 24,929 General and administrative 355,097 114,419 Total $ 462,239 $ 139,348 The assumptions used in the Black-Scholes option-pricing model for stock options granted to employees and to directors in respect of board services during the years ended December 31, 2019 and 2018 is as follows: 2019 2018 Expected life in years 10.0 10.0 Risk-free interest rate 2.44 % 2.52 % Expected volatility 120 % 121 % Forfeiture rate — — Dividend yield — % — % Weighted-average fair value of options granted 0.75 1.03 |
Leased Properties
Leased Properties | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leased Properties | LEASED PROPERTIES The Company's lease for its corporate headquarters ( 3,169 square feet of office space) commenced on July 1, 2018 and terminates on July 31, 2021. The Company has the option to extend the term of the lease for one year . Microchips, which the Company acquired in November 2019, leases general office space in Lexington, Massachusetts and warehouse space in Billerica, Massachusetts. The Lexington lease commenced on July 1, 2013 and terminates on September 30, 2021. The Billerica lease commenced on October 1, 2016 and terminates on March 31, 2022. Under the terms of each lease, the Company pays base annual rent (subject to an annual fixed percentage increase), plus property taxes, and other normal and necessary expenses, such as utilities, repairs, and maintenance. The Company evaluates renewal options at lease inception and on an ongoing basis and includes renewal options that it is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. The leases do not require material variable lease payments, residual value guarantees or restrictive covenants. The leases do not provide an implicit rate, and therefore the Company uses its incremental borrowing rate as the discount rate when measuring operating lease liabilities. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of the lease within a particular currency environment. The Company used an incremental borrowing rate of 7% as of January 1, 2019 for the operating leases that commenced prior to that date. The depreciable lives of operating lease assets and leasehold improvements are limited by the expected lease term. At December 31, 2019 , the Company reported operating lease right of use assets of approximately $488,000 in other non-current assets, and approximately $411,000 and $389,000 , respectively, in current and non-current other liabilities on the consolidated balance sheet. Total operating lease costs were approximately $223,000 for the year ended December 31, 2019 . Operating lease costs consist of monthly lease payments expense, common area maintenance and other repair and maintenance costs and are included in general and administrative expenses in the consolidated statement of operations. Cash paid for amounts included in the measurement of operating lease liabilities was approximately $154,000 for the year ended December 31, 2019 , and these amounts are included in operating activities in the consolidated statement of cash flows. Further, at December 31, 2019 , operating leases had a weighted average remaining lease term of 1.89 years. At December 31, 2019 , future minimum lease payments under the Company's operating leases are as follows: Year ending December 31, 2020 $ 461,000 2021 363,000 2022 42,000 Total future minimum lease payments 866,000 Less: accreted interest (66,000 ) Total operating lease liabilities $ 800,000 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Legal Proceedings From time to time, the Company may be involved in various claims arising in the normal course of business. Management is not aware of any material claims, disputes or unsettled matters that would have a material adverse effect on the Company’s results of operations, liquidity or financial position that the Company has not adequately provided for in the accompanying consolidated financial statements. Employment Agreements Certain executive officers are entitled to payments if they are terminated without cause or as a result of a change in control of the Company. Upon termination without cause, and not as a result of death or disability, each officer is entitled to receive a payment of an amount equal to six to twelve months of base salary and to receive continuing health benefits coverage for periods ranging between six to twelve months following the termination of employment or until such officer is covered under a separate plan from another employer. Upon termination other than for cause or for good reason within three months prior to or twelve months following a change in control of the Company, each officer will be entitled to receive a payment of an amount equal to nine to eighteen months of base salary and target bonus and to receive continuing health benefits coverage for periods ranging between nine to eighteen months following the termination of employment. In addition, upon a change in control of the Company, each officer’s outstanding unvested options will fully vest and accelerate subject to the conditions outlined in such officer’s employment agreement. License and Collaborations ADVA-Tec License Agreement In March 2017, the Company entered into a license agreement with ADVA-Tec, Inc., under which the Company was granted the exclusive right to develop and commercialize Ovaprene for human contraceptive use worldwide. The Company must use commercially reasonable efforts to develop and commercialize Ovaprene. Milestone Payments. The Company will pay to ADVA-Tec: (1) up to $14.6 million in the aggregate based on the achievement of specified development and regulatory milestones; and (2) up to $20 million in the aggregate based on the achievement of certain worldwide net sales milestones. Royalty Payments . After the commercial launch of Ovaprene, the Company will pay to ADVA-Tec royalties based on aggregate annual net sales of Ovaprene in specified regions, at a royalty rate that will vary between 1% and 10% and will increase based on various net sales thresholds. SST License and Collaboration Agreement In February 2018, the Company entered into a license and collaboration agreement with Strategic Science & Technologies-D, LLC and Strategic Science & Technologies, LLC, referred to collectively as SST, under which the Company received an exclusive, royalty-bearing, sublicensable license to develop and commercialize, in all countries and geographic territories of the world, for all indications for women related to female sexual dysfunction and/or female reproductive health, the Licensed Product, which is defined as SST’s topical formulation of Sildenafil Cream, 3.6% as it existed as of the effective date of the agreement, or any other topically applied pharmaceutical product containing sildenafil or a salt thereof as a pharmaceutically active ingredient, alone or with other active ingredients, but specifically excluding any product containing ibuprofen or any salt derivative of ibuprofen. The following is a summary of other terms of this license and collaboration agreement: Invention Ownership. The Company retains rights to inventions made by its employees, SST retains rights to inventions made by its employees, and each party shall own a 50% undivided interest in all joint inventions. Joint Development Committee. The parties will collaborate through a joint development committee that will determine the strategic objectives for, and generally oversee, the development efforts of both parties under the agreement. Development. The Company must use commercially reasonable efforts to develop the Licensed Products in the Field of Use in accordance with a development plan in the agreement, and to commercialize the Licensed Products in the Field of Use. The Company is responsible for all reasonable internal and external costs and expenses incurred by SST in its performance of the development activities it must perform under the agreement. Royalty Payments. SST will be eligible to receive tiered royalties based on percentages of annual net sales of Licensed Products in the single digits to the mid double digits, subject to customary royalty reductions and offsets, and a percentage of sublicense revenue. Milestone Payments. SST will be eligible to receive payments (1) ranging from $0.5 million to $18.0 million in the aggregate on achieving certain clinical and regulatory milestones in the U.S. and worldwide, and (2) between $10.0 million to $100 million in the aggregate upon achieving certain commercial sales milestones. If the Company enters into strategic development or distribution partnerships related to the Licensed Products, additional milestone payments would be due to SST. Orbis Development and Option Agreement In March 2018, the Company entered into an exclusive development and option agreement with Orbis Biosciences, or Orbis, for the development of long-acting injectable etonogestrel contraceptive with 6- and 12-month durations (ORB-204 and ORB-214, respectively). Under this agreement, the Company paid Orbis $300,000 to conduct the first stage of development work, Stage 1, as follows: $150,000 upon signing the agreement, $75,000 at the 50% completion point, not later than 6 months following the date the agreement was signed (which the Company paid in September 2018), and $75,000 upon delivery by Orbis of the 6-month batch, not later than 11 months following the date the agreement was signed (which the Company paid in January 2019). Upon Orbis successfully completing Stage 1 of the development program and achieving the predetermined target milestones for Stage 1, the Company will have 90 days to instruct Orbis whether to commence the second stage of development work, Stage 2. Should the Company execute its option to proceed to Stage 2, it will have to provide additional funding to Orbis for such activities. Pre-clinical studies for the 6- and 12-month formulations have been completed, including establishing pharmacokinetics and pharmacodynamics profiles. The collaboration with Orbis will continue to advance the program through formulation optimization with the goal of achieving sustained release over the target time period. The agreement provides the Company with an option to enter into a license agreement for ORB-204 and ORB-214 should development efforts be successful. Catalent JNP License Agreement In April 2018, the Company entered into an exclusive license agreement with Catalent JNP, Inc. (formerly known as Juniper Pharmaceuticals, Inc., and which the Company refers to as Catalent), under which Catalent granted the Company (a) an exclusive, royalty-bearing worldwide license under certain patent rights, either owned by or exclusively licensed to Catalent, to make, have made, use, have used, sell, have sold, import and have imported products and processes; and (b) a non-exclusive, royalty-bearing worldwide license to use certain technological information owned by Catalent to make, have made, use, have used, sell, have sold, import and have imported products and processes. The Company is entitled to sublicense the rights granted to it under this agreement. Upfront Fee. The Company paid a $250,000 non-creditable upfront license fee to Catalent in connection with the execution of the agreement. Annual Maintenance Fee. The Company will pay an annual license maintenance fee to Catalent on each anniversary of the date of the agreement, the amount of which will be $50,000 for the first two years and $100,000 thereafter, and which will be creditable against royalties and other payments due to Catalent in the same calendar year but may not be carried forward to any other year. Milestone Payments. The Company must make potential future development and sales milestone payments of (1) up to $13.5 million in the aggregate upon achieving certain clinical and regulatory milestones, and (2) up to $30.3 million in the aggregate upon achieving certain commercial sales milestones for each product or process covered by the licenses granted under the agreement. Royalty Payments . During the royalty term, the Company will pay Catalent mid-single-digit to low double-digit royalties based on worldwide net sales of products and processes covered by the licenses granted under the agreement. In lieu of such royalty payments, the Company will pay Catalent a low double-digit percentage of all sublicense income the Company receives for the sublicense of rights under the agreement to a third party. Pear Tree Acquisition In May 2018, the Company completed its acquisition of Pear Tree Pharmaceuticals, Inc., or Pear Tree. The Company acquired Pear Tree to secure the rights to develop DARE-VVA1, a proprietary vaginal formulation of tamoxifen, as a potential treatment for vulvar and vaginal atrophy. Under the merger agreement that governed the acquisition, the Pear Tree former stockholders and their representatives, or the Holders, will be eligible to receive, subject to certain offsets, tiered royalties, including customary provisions permitting royalty reductions and offset, based on percentages of annual net sales of certain products subject to license agreements the Company assumed and a percentage of sublicense revenue. The Company must also make contingent payments to the Holders that are based on achieving certain clinical, regulatory and commercial milestones, which may be paid, in the Company’s sole discretion, in cash or shares of the Company’s common stock. Hammock/MilanaPharm Assignment and License Agreement In December 2018, the Company entered into (a) an Assignment Agreement with Hammock Pharmaceuticals, Inc., or the Assignment Agreement, and (b) a First Amendment to License Agreement with TriLogic Pharma, LLC and MilanaPharm LLC, or the License Amendment. Both agreements relate to the Exclusive License Agreement among Hammock, TriLogic and MilanaPharm dated as of January 9, 2017, or the MilanaPharm License Agreement. Under the Assignment Agreement and the MilanaPharm License Agreement, as amended by the License Amendment, the Company acquired an exclusive, worldwide license under certain intellectual property to, among other things, develop and commercialize products for the diagnosis, treatment and prevention of human diseases or conditions in or through any intravaginal or urological applications. The licensed intellectual property relates to the hydrogel drug delivery platform of TriLogic and MilanaPharm known as TRI-726. In DARE-BV1, this proprietary technology is formulated with clindamycin, an antibiotic used to treat certain bacterial infections, including BV, and has been engineered to produce a dual release pattern after vaginal application, providing maximum duration of exposure to clindamycin at the site of infection. In December 2019, the Company entered into amendments to each of the Assignment Agreement and License Amendment. The following is a summary of other terms of the License Amendment, as amended: License Fees. The Company paid MilanaPharm: (1) $25,000 in connection with the execution of the License Amendment; (2) $100,000 on December 5, 2019; and (3) $110,000 on January 31, 2020. Milestone Payments. The Company will pay to MilanaPharm (1) up to $300,000 in the aggregate upon achievement of certain clinical and regulatory development milestones; and (2) up to $1.75 million in the aggregate upon achieving certain commercial sales milestones. Foreign Sublicense Income. The Company will pay MilanaPharm a low double-digit percentage of all income received by the Company or its affiliates in connection with any sublicense granted to a third party for use outside of the United States, subject to certain exclusions. Royalty Payments. During the royalty term, we will pay MilanaPharm high single-digit to low double-digit royalties based on annual worldwide net sales of licensed products and processes. The royalty term, which is determined on a country-by-country basis and licensed product-by-product basis (or process-by-process basis), begins with the first commercial sale of a licensed product or process in a country and terminates on the latest of (1) the expiration date of the last valid claim of the licensed patent rights that cover the method of use of such product or process in such country, or (2) 10 years following the first commercial sale of such product or process in such country. Royalty payments are subject to reduction in certain circumstances, including as a result of generic competition, patent prosecution expenses incurred by us, or payments to third parties for rights or know-how required for us to exercise the licenses granted to it under the MilanaPharm License Agreement or that are strategically important or could add value to a licensed product or process in a manner expected to materially generate or increase sales. Efforts. We must use commercially reasonable efforts and resources to (1) develop and commercialize at least one licensed product or process in the United States and at least one licensed product or process in at least one of Canada, the United Kingdom, France, Germany, Italy or Spain, and (2) continue to commercialize that product or process following the first commercial sale of a licensed product or process in the applicable jurisdiction. Term. Unless earlier terminated, the license term continues until (1) on a licensed product-by-product (or process-by-process basis) and country-by-country basis, the date of expiration of the royalty term with respect to such licensed product in such country, and (2) the expiration of all applicable royalty terms under the MilanaPharm License Agreement with respect to all licensed products and processes in all countries. Upon expiration of the term with respect to any licensed product or process in a country (but not upon earlier termination of the MilanaPharm License Agreement), the licenses granted to us under the MilanaPharm License Agreement will convert automatically to an exclusive, fully paid-up, royalty-free, perpetual, non-terminable and irrevocable right and license under the licensed intellectual property. In addition to customary termination rights for all parties, MilanaPharm may terminate the license granted to us solely with respect to a licensed product or process in a country if, after having launched such product or process in such country, (1) we or our affiliates or sublicensees discontinue the sale of such product or process in such country and MilanaPharm notifies us of such termination within 60 days of having first been notified by us of such discontinuation, or (2) we or our affiliates or sublicensees (A) discontinue all commercially reasonable marketing efforts to sell, and discontinue all sales of, such product or process in such country for nine months or more, (B) fail to resume such commercially reasonable marketing efforts within 120 days of having been notified of such failure by MilanaPharm, (C) fail to reasonably demonstrate a strategic justification for the discontinuation and failure to resume to MilanaPharm, and (D) MilanaPharm gives 90 days’ notice to us. The following is a summary of other terms of the Assignment Agreement, as amended: Assignment; Technology Transfer . Hammock assigned and transferred to the Company all of its right, title and interest in and to the MilanaPharm License Agreement and agreed to cooperate to transfer to the Company all of the data, materials and the licensed technology in its possession pursuant to a technology transfer plan to be agreed upon by the parties, with a goal for the Company to independently practice the licensed intellectual property as soon as commercially practical in order to develop and commercialize the licensed products and processes. Fees . The Company paid Hammock: (1) $250,000 in connection with the execution of the Assignment Agreement; (2) $125,000 on December 5, 2019; and (3) 137,500 on January 31, 2020. Milestone Payments . The Company will pay Hammock up to $1.1 million in the aggregate upon achievement of certain clinical and regulatory development milestones. Term. The Assignment Agreement will terminate upon the later of (1) completion of the parties' technology transfer plan, and (2) payment to Hammock of the last of the milestone payments. Microchips Acquisition On November 20, 2019, the Company completed its acquisition of Microchips Biotech, Inc., or Microchips, pursuant to the Agreement and Plan of Merger, dated as of November 10, 2019. On the closing date of the merger, Microchips became a wholly owned subsidiary of the Company. The Company acquired Microchips to secure the rights to develop user-controlled, long-acting reversible contraception. The Company issued an aggregate of 2,999,990 shares of its common stock to the holders of shares of Microchips' capital stock outstanding immediately prior to the effective time of the merger. The Company also agreed to pay the following contingent consideration: (a) up to $46.5 million contingent upon the achievement of specified funding, product development and regulatory milestones (b) up to $55.0 million contingent upon the achievement of specified amounts of aggregate net sales of products incorporating the intellectual property acquired by Daré in the merger; (c) tiered royalty payments ranging from low single-digit to low double-digit percentages of annual net sales of such products, subject to customary provisions permitting royalty reductions and offset; and (d) a percentage of sublicense revenue related to such products. The Company agreed to use commercially reasonable efforts to achieve specified development and regulatory objectives relating to the implantable contraceptive product in development by Microchips. The Company expects approximately $1.0 million of the contingent consideration payments to become payable through 2021. Employee Benefit – 401(k) Plan The Company has a 401(k) retirement plan, or the 401(k) Plan, covering all qualified employees. The 401(k) Plan allows each participant to contribute a portion of their base wages up to an amount not to exceed an annual statutory maximum. The 401(k) Plan includes a Safe Harbor Plan that provides a Company match up to 4% of salary. The Company made matching contributions of approximately $96,000 and $53,000 during the years ended December 31, 2019 and 2018 , respectively. |
Grant Awards
Grant Awards | 12 Months Ended |
Dec. 31, 2019 | |
Receivables [Abstract] | |
Grant Awards | GRANT AWARDS Eunice Kennedy Shriver National Institute of Child Health and Human Development During 2018 and 2019, the Company received grant funding for clinical development efforts supporting Ovaprene from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, a division of the National Institutes of Health, or the NIH. The NIH issues notices of awards to the Company for a specified amount, and the Company must incur and track expenses eligible for reimbursement under the award and submit a detailed accounting of such expenses to receive payment. If the Company receives payments under the award, the amounts of such payments are recognized in the statement of operations as a reduction to research and development activities as the related costs are incurred to meet those obligations over the period. As of December 31, 2019 , the Company received award payments totaling $1.2 million , approximately $0.2 million of which was received in 2018 and approximately $1.0 million of which was received in 2019. The remaining portion of the award under the grant, approximately $700,000 , is contingent upon, among other matters, assessment of the results of the ongoing post-coital test trial of Ovaprene to satisfy specified requirements set out in the award notice, and the availability of funds. The Company recorded credits to research and development expense for costs related to the NIH award of $1.2 million and $225,000 for the years ended December 31, 2019 and December 31, 2018, respectively. Bill & Melinda Gates Foundation Microchips has a grant agreement with the Bill & Melinda Gates Foundation, or the Foundation, relating to the development of Microchips’ contraceptive program. Expenses eligible for grant funding must be incurred, tracked and reported to the Foundation. In July 2019, Microchips received approximately $2.9 million in grant funding payments. At December 31, 2019, grant funding payments associated with research and development expenses for Microchips’ contraceptive program not yet incurred totaled approximately $2.0 million and are recorded as deferred grant funding liability in the Company's consolidated balance sheet. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTS ATM Sales Between January and March 2020 , the Company sold an aggregate of 3,308,003 shares of common stock in "at-the-market" equity offerings and received aggregate gross proceeds of approximately $5.4 million and incurred sales agent commissions and fees of approximately $204,000 (see Note 7). Exercise of February 2018 Warrants In January 2020, warrants to purchase an aggregate of 1.7 million shares of common stock were exercised at an exercise price of $0.98 per share resulting in gross proceeds to the Company of approximately $1.7 million (see Note 7). Bayer HealthCare License Agreement On January 10, 2020, the Company entered into a license agreement with Bayer HealthCare LLC, or Bayer, regarding the further development and commercialization of Ovaprene in the U.S. Under the agreement, the Company received a $1.0 million upfront payment from Bayer. If Bayer pays an additional $20.0 million to the Company (the “Clinical Trial and Manufacturing Activities Fee”), after Bayer receives and reviews the results of the pivotal clinical trial of Ovaprene, which payment Bayer may elect to make in its sole discretion, the license grant to Bayer to develop and commercialize Ovaprene for human contraception in the U.S. becomes effective. Such license would be exclusive with regard to commercialization and co-exclusive with the Company with regard to development. Under the agreement, the Company would also be entitled to receive (a) a milestone payment in the low double-digit millions upon the first commercial sale of Ovaprene in the U.S. and escalating milestone payments based on annual net sales of Ovaprene during a calendar year, totaling up to $310.0 million if all such milestones, including the first commercial sale, are achieved, (b) tiered royalties starting in the low double digits based on annual net sales of Ovaprene during a calendar year, subject to customary royalty reductions and offsets, and (c) a percentage of sublicense revenue. Under the agreement, the Company will be responsible for the pivotal trial for Ovaprene and for its development and regulatory activities and has product supply obligations. Bayer will support the Company in development and regulatory activities by providing up to two full-time equivalents with expertise in clinical, regulatory, preclinical, commercial, CMC and product supply matters in an advisory capacity. After payment of the Clinical Trial and Manufacturing Activities Fee, Bayer will be responsible for the commercialization of Ovaprene for human contraception in the U.S. The initial term of the agreement, which is subject to automatic renewal terms, continues until the later of (a) the expiration of any valid claim covering the manufacture, use, sale or import of Ovaprene in the U.S.; or (b) 15 years from the first commercial sale of Ovaprene in the U.S. In addition to customary termination rights for both parties, Bayer may terminate the agreement at any time on 90 days days notice and the agreement will automatically terminate if the Company does not receive the Clinical Trial and Manufacturing Activities Fee if and when due. COVID-19 In response to the spread of COVID-19, in March 2020 we implemented work-from-home and restricted travel policies and, subsequently, the governors of California and Massachusetts, where we have operations, issued statewide stay-at-home orders. While we have systems and technologies in place to enable our employees to work from home, productivity may be adversely impacted and challenge our ability to effectively manage and operate our business. In addition, many of our consultants, partners and vendors on which we rely heavily are subject to similar work and travel restrictions that may adversely impact their ability to perform contracted services in a timely manner or at all. The effect of the COVID-19 pandemic and its associated restrictions may increase the anticipated aggregate costs for the development of our product candidates and may adversely impact our anticipated timelines for the development of our product candidates by, among other things, causing disruptions in the supply chain for our clinical supplies, delays in the timing and pace of subject enrollment in our clinical trials and lower than anticipated subject enrollment and completion rates, delays in the review and approval of our regulatory submissions by the FDA and other agencies with respect to our product candidates, and other unforeseen disruptions. The economic impact of the COVID-19 pandemic and its adverse effect on capital markets and investor sentiment may adversely impact our ability to raise capital when needed or on terms favorable to us and our stockholders to fund our development programs and our operations. We do not yet know the full extent of potential delays or impacts on our business, clinical trial activities, ability to access capital or on healthcare systems or the global economy as a whole. However, these effects could have a material adverse impact on our business and financial condition. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States, or U.S. GAAP as defined by the Financial Accounting Standards Board, or FASB. |
Going Concern | Going Concern The Company has prepared its consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The Company has a history of losses from operations, expects negative cash flows from its operations will continue for the foreseeable future, and expects that its net losses will continue for at least the next several years as it develops its existing product candidates and seeks to acquire, license or develop additional product candidates. These circumstances raise substantial doubt about the Company's ability to continue as a going concern. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of the Company's ability to continue as a going concern. As of December 31, 2019 , the Company had an accumulated deficit of approximately $44.0 million, had cash and cash equivalents of approximately $ 4.8 million, and working capital was approximately $0.8 million . For the year ended December 31, 2019 , the Company incurred a net loss of $14.3 million and had negative cash flow from operations of approximately $13.3 million. The Company is focused primarily on the development and commercialization of innovative products in women’s health. The Company will continue to incur significant research and development and other expenses related to these activities. If the clinical trials for any of the Company’s product candidates fail to produce successful results such that those product candidates do not advance in clinical development, then the Company’s business and prospects may suffer. Even if the product candidates advance in clinical development, they may fail to gain regulatory approval. Even if the product candidates are approved, they may fail to achieve market acceptance, and the Company may never become profitable. Even if the Company becomes profitable, it may not sustain profitability. Based on the Company's current operating plan estimates, the Company does not have sufficient cash to satisfy its working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying financial statements. The Company needs to raise substantial additional capital to continue to fund its operations and to successfully execute its current operating plan, including to continue the planned development of DARE-BV1, Ovaprene, and Sildenafil Cream, 3.6%. The Company is currently evaluating a variety of capital raising options, including financings, government or other grant funding, collaborations and strategic alliances or other similar types of arrangements to cover its operating expenses, including the development of its product candidates and any future product candidates it may license or otherwise acquire. The amount and timing of the Company's capital needs have been and will continue to depend highly on many factors, including the product development programs the Company chooses to pursue and the pace and results of its clinical development efforts. If the Company raises capital through collaborations, strategic alliances or other similar types of arrangements, it may have to relinquish, on terms that are not favorable to the Company, rights to some of its technologies or product candidates it would otherwise seek to develop or commercialize. There can be no assurances that capital will be available when needed or that, if available, it will be obtained on terms favorable to the Company and its stockholders. Additionally, equity or debt financings may have a dilutive effect on the holdings of the Company's existing stockholders. If the Company cannot raise capital when needed, on favorable terms or at all, the Company will not be able to continue development of its product candidates, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations. If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values at which they are carried on its consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements of the Company are stated in U.S. dollars. These consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. One wholly owned subsidiary, Daré Bioscience Australia Pty LTD, operates primarily in Australia. The financial statements of the Company’s wholly owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated Other Comprehensive Loss. All intercompany transactions and accounts have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the fair value of stock-based compensation, goodwill impairment and purchase accounting. Actual results could differ from those estimates and could materially affect the reported amounts of assets, liabilities and future operating results. |
Risks and Uncertainties | Risks and Uncertainties The Company will require approvals from the U.S. Food and Drug Administration, or FDA, or foreign regulatory agencies prior to being able to sell any products. There can be no assurance that the Company’s current or future product candidates will receive the necessary approvals. If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations and its financial position. The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the ability to license product candidates, successfully develop product candidates, raise additional capital, compete with other products, and protect proprietary technology. In the event the Company receives a regulatory approval for a product, the market’s acceptance of the product remains a risk. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers cash and all highly liquid investments with an original maturity of three months or less to be cash and cash equivalents. The Company’s wholly owned subsidiary, Microchips Biotech, Inc., has a $35,903 letter of credit related to the lease of real property that serves as security for future default of lease payments. The letter of credit is collateralized by cash which is unavailable for withdrawal or for usage for general obligations and is included in cash and cash equivalents on the Company's consolidated balance sheet. |
Concentration of Credit Risk | Concentration of Credit Risk The Company maintains cash balances at various financial institutions and such balances commonly exceed the $250,000 amount insured by the Federal Deposit Insurance Corporation. The Company also maintains money market funds at various financial institutions which are not federally insured although are invested primarily in the U.S. The Company has not experienced any losses in such accounts and management believes that the Company does not have significant risk with respect to such cash and cash equivalents. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments U.S. GAAP defines fair value as the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date, and also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available. The three-level hierarchy of valuation techniques established to measure fair value is defined as follows: • Level 1: inputs are unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2: inputs other than level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities. • Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Cash and cash equivalents of $ 4.8 million and $6.8 million measured at fair value as of December 31, 2019 and 2018 , respectively, are classified within Level 1. Other receivables and prepaid expenses are financial assets with carrying values that approximate fair value due to the short-term nature of these assets. Accounts payable and accrued expenses and other liabilities are financial liabilities with carrying values that approximate fair value due to the short-term nature of these liabilities. The estimated fair value of the $1.0 million of contingent consideration potentially payable by the Company related to its acquisition of Microchips Biotech, Inc. is recorded using significant unobservable measures and other fair value inputs and is therefore classified as a Level 3 financial instrument. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use, or ROU, lease assets, current portion of lease obligations, and long-term lease obligations on the Company's balance sheets. ROU lease assets represent the Company's right to use an underlying asset for the lease term. Lease obligations represent the Company's obligation to make lease payments arising from the lease. Operating ROU lease assets and lease obligations are recognized at the commencement date of the applicable lease based on the present value of lease payments over the lease term. If the lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The ROU lease asset includes any lease payments made and excludes lease incentives. The Company's lease terms may include options to extend or terminate the lease and the related payments are only included in the lease liability when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. (See Note 9, Leased Properties.) |
Business Combinations | Business Combinations Assets acquired and liabilities assumed as part of a business acquisition are recorded at their estimated fair value at the date of acquisition. The excess of the total purchase consideration over the fair value of assets acquired and liabilities assumed is recorded as goodwill. Determining fair value of identifiable assets, particularly intangibles, and liabilities acquired also requires management to make estimates, which are based on all available information and, in some cases, assumptions with respect to the timing and amount of future revenue and expenses associated with an asset. Acquired In-Process Research and Development Expense The Company has acquired, and may continue to acquire, the rights to develop new product candidates. Payments to acquire a new product candidate, as well as future milestone payments associated with asset acquisitions which are deemed probable of achievement, are immediately expensed as acquired in-process research and development provided that the product candidate has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. |
Goodwill | Goodwill The Company records goodwill based on the fair value of the assets acquired. In determining the fair value of the assets acquired, the Company utilizes extensive accounting estimates and judgments to allocate the purchase price to the fair value of the net tangible and intangible assets acquired. The Company uses the discounted cash flow method to estimate the value of intangible assets acquired. The Company tests its goodwill for impairment at least annually as of December 31 st and between annual tests if it becomes aware of an event or change in circumstance that would indicate the carrying value may be impaired. The Company tests goodwill for impairment at the entity level because it operates on the basis of a single reporting unit. A goodwill impairment is the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. When impaired, the carrying value of goodwill is written down to fair value. Any excess of the reporting unit goodwill carrying value over the fair value is recognized as impairment loss. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. Its chief operating decision maker is the chief executive officer. The Company has one operating segment, women’s reproductive health. |
Grant Funding and Research and Development Costs | Research and Development Costs Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses, manufacturing process-development and scale-up activities, fees paid to clinical and regulatory consultants, clinical trial and related clinical trial manufacturing expenses, fees paid to clinical research organizations, or CROs, and investigative sites, transaction expenses incurred in connection with the expansion of the product portfolio through acquisitions and license and option agreements, payments to universities under the Company’s license agreements and other outside expenses. Research and development costs are expensed as incurred. Nonrefundable advance payments, if any, for goods and services used in research and development are recognized as an expense as the related goods are delivered or services are performed. Grant Funding The Company receives certain research and development funding through grants issued by a division of the National Institutes of Health and the Bill & Melinda Gates Foundation, or the Gates Foundation. The funding is recognized in the statement of operations as a reduction to research and development expense as the related costs are incurred to meet those obligations over the grant period. The Company adopted this policy in 2018. |
Net Loss Per Share | Net Loss Per Share Basic net loss attributable to common stockholders per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive. There were stock options exercisable into 1,889,775 and 1,635,790 shares of common stock outstanding at December 31, 2019 and 2018 , respectively. These securities were not included in the computation of diluted loss per share because they are antidilutive, but they could potentially dilute earnings (loss) per share in future years. |
Stock-Based Compensation | Stock-Based Compensation The Company records compensation expense for all stock-based awards granted based on the fair value of the award at the time of grant. The Company uses the Black-Scholes Pricing Model to determine the fair value of each of the awards which considers factors such as expected term, volatility, risk free interest rate and dividend yield. Due to the limited history of the Company, the simplified method was utilized in order to determine the expected term of the awards. Additionally, the Company considered comparable companies in the industry which have available share price history to calculate the volatility. The Company compared U.S. Treasury Bills in determining the risk-free interest rate appropriate given the expected term. Finally, the Company has not established and has no plans to establish a dividend policy or declare any dividends in the foreseeable future and thus no dividend yield was determined necessary in the calculation of fair value. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method in accordance with Accounting Standards Codification, or ASC 740, Income Taxes . Under this method deferred income taxes are provided to reflect the tax consequences in future years of differences between the tax basis of assets and liabilities and their financial reporting amounts based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company follows the two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates it is more likely than not, that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount, which is more than 50% likely of being realized upon ultimate settlement. The Company considers many factors when evaluating and estimating the Company's tax positions and tax benefits, which may require periodic adjustments. At December 31, 2019 , the Company did not record any liabilities for uncertain tax positions. During 2019 , the Company recorded no provision for income taxes. During 2018, the Company recorded a provision for income taxes of $3,200 . Management evaluated the Company’s tax positions and, as of December 31, 2019 , the Company has approximately $935,000 of unrecognized benefits. The tax years 2015 to 2019 remain open to examination by federal and state taxing authorities while the statute for net operating losses generated remain open beginning in the year of utilization. |
Indemnifications | Indemnifications As permitted under Delaware law, the Company has entered into indemnification agreements with its officers and directors that provide that the Company will indemnify the directors and officers for certain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by such director or officer in any action or proceeding arising out of their service as a director and/or officer. The term of the indemnification is for the officer’s or director’s lifetime. During the year ended December 31, 2019 , the Company did not experience any losses related to those indemnification obligations. The Company does not expect significant claims related to these indemnification obligations, and consequently, has concluded the fair value of the obligations is not material. Accordingly, as of December 31, 2019 and 2018 , no amounts have been accrued related to such indemnification provisions. |
Recent Accounting Pronouncements | Recently Adopted Accounting Standards In February 2016, FASB issued ASU 2016-02, Leases (Topic 842) , which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e., lessees and lessors). The new standard requires lessees to apply a dual approach classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less will be accounted for similar to existing guidance for operating leases. The new standard requires lessors to account for leases using an approach that is substantially equivalent to existing guidance for sales-type leases, direct financing leases and operating leases. The new standard is effective for public companies for fiscal years beginning after December 15, 2018, with early adoption permitted. ASU 2016-02 became effective for the Company on January 1, 2019 and was adopted using a modified retrospective approach and the effective date is as of the initial application. Consequently, financial information was not updated, and the disclosures required under ASU 2016-02 are not provided for dates and periods prior to January 1, 2019. ASU 2016-02 provides a number of optional practical expedients and accounting policy elections. The Company elected the package of practical expedients requiring no reassessment of whether any expired or existing contracts are or contain leases, the lease classification of any expired or existing leases, or initial direct costs for any existing leases. The Company recorded approximately $232,000 right-of-use assets and $241,000 lease liabilities related to its lease of office space as of the adoption date in the consolidated balance sheets. There are no changes to the statement of operations or cash flows as a result of the adoption. |
Prepaid Expenses (Tables)
Prepaid Expenses (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure | Prepaid expenses consisted of the following: As of December 31, 2019 2018 Prepaid clinical expense $ 305,135 $ 14,547 Prepaid insurance expense 417,152 321,546 Prepaid legal and professional expenses 386,328 67,004 Total prepaid expenses $ 1,108,615 $ 403,097 |
Other Non-Current Assets (Table
Other Non-Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Other Assets, Noncurrent Disclosure [Abstract] | |
Schedule of Other Non-Current Assets | Other non-current assets consisted of the following: As of December 31, 2019 2018 Prepaid insurance, long-term portion $ 404,141 $ 562,266 Deposits 42,904 15,702 Operating lease assets 488,280 — Total other non-current assets $ 935,325 $ 577,968 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accrued expenses consisted of the following: As of December 31, 2019 2018 Accrued compensation and benefits expenses $ 715,201 $ 416,234 Accrued legal and professional expenses 412,584 32,457 Accrued license expense 280,833 — Accrued clinical and related expenses 690,035 182,660 Total accrued expenses $ 2,098,653 $ 631,351 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Summary of Components of Loss from Continuing Operations Before Provision for Income Taxes | The components of loss from continuing operations before provision for income taxes consists of the following (in thousands): Years Ended December 31, 2019 2018 Domestic $ 13,800 $ 16,707 Foreign 464 107 Loss before taxes $ 14,264 $ 16,814 |
Difference Between Provision for Income Taxes (Benefit) and the Amount Computed by Applying U.S. Federal Income Tax Rate | The difference between the provision for income taxes (benefit) and the amount computed by applying the U.S. federal income tax rate for the years ended December 31, 2019 and 2018 are as follows: Years Ended December 31, 2019 2018 Federal statutory rate 21.0 % 21.0 % State income tax, net of federal benefit 7.01 % 2.42 % Permanent differences (0.02 )% 0.31 % Research and development credit 1.46 % 1.24 % Stock compensation (0.44 )% (0.08 )% Other (0.1 )% — % Goodwill impairment — % (6.48 )% Change in valuation allowance (28.94 )% (18.43 )% Effective income tax rate (0.02 )% (0.02 )% |
Summary of Major Components of Company's Deferred Tax Assets | The major components of the Company’s deferred tax assets as of December 31, 2019 and 2018 are shown below (in thousands). 2019 2018 Net operating loss carryforwards $ 46,120 $ 40,436 Research and development credit carryforwards 3,669 3,321 Capitalized research and development costs 11,123 13,334 Other 271 11 Stock compensation 1,987 1,941 Total deferred tax assets 63,170 59,043 Valuation allowance (63,170 ) (59,043 ) Net deferred tax assets $ — $ — |
Schedule of Reconciliation of the Beginning and Ending Amount of Uncertain Tax Benefits | A reconciliation of the beginning and ending amount of uncertain tax benefits is as follows (in thousands): Years Ended December 31, 2019 2018 Beginning uncertain tax benefits $ 924 $ 846 Current year - increases 83 78 Prior year - reductions (72 ) — Ending uncertain tax benefits $ 935 $ 924 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Schedule of Common Stock Outstanding Warrant to Purchase Shares | As of December 31, 2019 , the Company had the following warrants outstanding: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 2,906 $ 120.40 December 1, 2021 3,737 $ 120.40 December 6, 2021 17,190 $ 60.50 January 8, 2020 6,500 $ 1.00 April 4, 2026 3,720,500 $ 3.00 February 15, 2023 3,750,833 |
Summary of Common Stock Reserved for Future Issuance | The following table summarizes common stock reserved for future issuance at December 31, 2019 : Common stock reserved for issuance upon exercise of warrants outstanding 3,750,833 Common stock reserved for issuance upon exercise of options outstanding 1,889,775 Common stock reserved for future equity awards (under the Amended 2014 Plan) 634,294 Total 6,274,902 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity for 2015 Plan and Current Plan and Related Information | The table below summarizes stock option activity under the Amended 2014 Plan, and related information for the years ended December 31, 2019 and 2018 . The exercise price of all options granted during the years ended December 31, 2019 and 2018 was equal to the market value of the Company’s common stock on the date of grant. As of December 31, 2019 , unamortized stock-based compensation expense of approximately $1.1 million will be amortized over the weighted average period of 2.6 years . As of December 31, 2019 , 634,294 shares of common stock were reserved for future issuance under the Amended 2014 Plan, and options to purchase 1,889,775 shares of the Company’s common stock granted under the Amended 2014 Plan were outstanding. Number of Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Outstanding at December 31, 2017 539,896 $ 31.40 Granted 1,096,050 1.08 Exercised — — Forfeited (156 ) 59.48 Outstanding at December 31, 2018 (1) 1,635,790 $ 11.08 Granted 832,500 0.79 Exercised — — Canceled/forfeited (578,445 ) 28.52 Expired (70 ) 59.48 Outstanding at December 31, 2019 (1) 1,889,775 $ 1.21 8.88 $ 46,599 Options exercisable at December 31, 2019 490,513 $ 1.99 8.63 $ 16,091 Options vested and expected to vest at December 31, 2019 1,889,775 $ 1.21 8.88 $ 46,559 (1) Includes 10,149 shares subject to options granted under the 2015 Private Daré Plan assumed in connection with the Cerulean/Private Daré stock purchase transaction. |
Schedule of Stock-Based Compensation Expense | Total stock-based compensation expense related to stock options granted to employees and directors recognized in the consolidated statements of operations is as follows: Years Ended December 31, 2019 2018 Research and development $ 107,142 $ 24,929 General and administrative 355,097 114,419 Total $ 462,239 $ 139,348 |
Summary of Assumptions Used in Black-Scholes Option-Pricing Model for Stock Options Granted to Employees, and Non-Employee Directors | The assumptions used in the Black-Scholes option-pricing model for stock options granted to employees and to directors in respect of board services during the years ended December 31, 2019 and 2018 is as follows: 2019 2018 Expected life in years 10.0 10.0 Risk-free interest rate 2.44 % 2.52 % Expected volatility 120 % 121 % Forfeiture rate — — Dividend yield — % — % Weighted-average fair value of options granted 0.75 1.03 |
Leased Properties (Tables)
Leased Properties (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Future Minimum Lease Payment | At December 31, 2019 , future minimum lease payments under the Company's operating leases are as follows: Year ending December 31, 2020 $ 461,000 2021 363,000 2022 42,000 Total future minimum lease payments 866,000 Less: accreted interest (66,000 ) Total operating lease liabilities $ 800,000 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | |||
Dec. 31, 2019USD ($)Segmentshares | Dec. 31, 2018USD ($)shares | Jul. 10, 2018shares | Dec. 31, 2017USD ($)shares | |
Significant Accounting Policies [Line Items] | ||||
Number of operating segments | Segment | 1 | |||
Accumulated deficit | $ 44,023,191 | $ 28,969,767 | ||
Working capital increase | 800,000 | |||
Operating income (loss) | (14,344,880) | (16,882,312) | ||
Letter of credit related to lease of real property | $ 35,903 | |||
Period of insufficient cash and liquidity requirements | 12 months | |||
Cash flow from operations | $ 13,300,000 | |||
Grant funding recognized during period | 1,200,000 | 225,000 | ||
Income tax provision | 0 | 3,200 | ||
Unrecognized tax benefits | 935,000 | 924,000 | $ 846,000 | |
Lease liability | 800,000 | |||
Accrued indemnification P\provisions | 0 | 0 | ||
Fair Value, Inputs, Level 1 | ||||
Significant Accounting Policies [Line Items] | ||||
Cash and cash equivalents | 4,800,000 | |||
Fair Value, Inputs, Level 3 | ||||
Significant Accounting Policies [Line Items] | ||||
Contingent consideration | 1,000,000 | |||
Fair Value, Measurements, Recurring | Fair Value, Inputs, Level 1 | ||||
Significant Accounting Policies [Line Items] | ||||
Cash and cash equivalents | $ 6,800,000 | |||
Minimum | ||||
Significant Accounting Policies [Line Items] | ||||
Cash balance of financial institutions insured by federal deposits insurance corporation | $ 250,000 | |||
Stock Options | ||||
Significant Accounting Policies [Line Items] | ||||
Stock options outstanding (in shares) | shares | 2,000,000 | |||
Amended And Restated Two Thousand Fourteen Stock Incentive Plan | Stock Options | ||||
Significant Accounting Policies [Line Items] | ||||
Stock options outstanding (in shares) | shares | 1,889,775 | 539,896 | ||
Stock options exercisable | shares | 490,513 | 1,635,790 | ||
Lease of Office Space | ||||
Significant Accounting Policies [Line Items] | ||||
Right-of-use asset | $ 232,000 | |||
Lease liability | $ 241,000 |
Acquisitions - Additional Infor
Acquisitions - Additional Information (Detail) - USD ($) | May 16, 2018 | Jul. 18, 2017 | May 31, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 30, 2019 | Nov. 20, 2019 | Jul. 19, 2017 |
Business Combination Reverse Merger [Line Items] | |||||||||
Cash and cash equivalents | $ 9,900,000 | ||||||||
Unamortized fair value of Cerulean stock options | $ 3,700,000 | ||||||||
Goodwill impairment charge | $ 5,200,000 | $ 0 | $ 5,187,519 | ||||||
Equity issued in consideration of acquisition | $ 2,369,992 | $ 0 | |||||||
Common stock issued to Microchips capital stock holders (in shares) | 2,999,990 | ||||||||
Reverse stock split | 1-for-10 | ||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | |||||||
Common stock, shares issued | 19,683,401 | 11,422,161 | |||||||
Pear Tree Pharmaceuticals Inc. | |||||||||
Business Combination Reverse Merger [Line Items] | |||||||||
Equity issued in consideration of acquisition | $ 132,000 | ||||||||
Potential cash payment to acquire business | $ 75,000 | ||||||||
Pear Tree Pharmaceuticals Inc. | Research and Development Expense | |||||||||
Business Combination Reverse Merger [Line Items] | |||||||||
Transaction costs | $ 452,000 | ||||||||
Microchips Biotech, Inc. | |||||||||
Business Combination Reverse Merger [Line Items] | |||||||||
Cash and cash equivalents | $ 6,100,000 | ||||||||
Business acquisition transaction value | $ 2,400,000 | ||||||||
Business combination shares issued (dollars per share) | $ 0.79 | ||||||||
Contingent consideration, liability | $ 3,500,000 | ||||||||
Contingent consideration | 1,000,000 | $ 1,000,000 | |||||||
Microchips Biotech, Inc. | Research and Development Expense | |||||||||
Business Combination Reverse Merger [Line Items] | |||||||||
Business acquisition transaction value | $ 202,000 |
Prepaid Expenses (Details)
Prepaid Expenses (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid clinical expense | $ 305,135 | $ 14,547 |
Prepaid insurance expense | 417,152 | 321,546 |
Prepaid legal and professional expenses | 386,328 | 67,004 |
Total prepaid expenses | $ 1,108,615 | $ 403,097 |
Other Non-Current Assets - Sche
Other Non-Current Assets - Schedule of Other Non-Current Assets (Detail) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Other Assets, Noncurrent Disclosure [Abstract] | ||
Prepaid insurance, long-term portion | $ 404,141 | $ 562,266 |
Deposits | 42,904 | 15,702 |
Operating lease assets | 488,280 | |
Total other non-current assets | $ 935,325 | $ 577,968 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Detail) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Accrued compensation and benefits expenses | $ 715,201 | $ 416,234 |
Accrued legal and professional expenses | 412,584 | 32,457 |
Accrued license expense | 280,833 | 0 |
Accrued clinical and related expenses | 690,035 | 182,660 |
Total accrued expenses | $ 2,098,653 | $ 631,351 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | |||
Deferred tax valuation allowance | $ 63,170,000 | $ 59,043,000 | |
Deferred tax assets, increase in valuation allowance | 4,100,000 | $ 55,600,000 | |
Operating loss carryforward, subject to expiration | 135,000,000 | ||
Operating loss carryforwards not subject to expiration | $ 39,500,000 | ||
Federal statutory rate | 21.00% | 21.00% | |
Tax cuts and jobs act of 2017, incomplete accounting, provision to income tax expense in continuing operations | $ 23,600,000 | ||
Accrued interest or penalties recorded related to uncertain tax positions | $ 0 | 0 | |
Unrecognized tax benefits | 935,000 | 924,000 | $ 846,000 |
Unremitted earnings | 0 | ||
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 174,500,000 | 153,800,000 | |
Net operating loss carryforwards expiration year | 2027 | ||
Federal | Research Credit Carryforwards | |||
Operating Loss Carryforwards [Line Items] | |||
Research credit carryforwards | $ 2,500,000 | 2,200,000 | |
Research credit carryforwards expiration year | 2027 | ||
State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 140,100,000 | 119,900,000 | |
Net operating loss carryforwards expiration year | 2032 | ||
State | Research Credit Carryforwards | |||
Operating Loss Carryforwards [Line Items] | |||
Research credit carryforwards | $ 1,200,000 | $ 1,100,000 | |
Research credit carryforwards expiration year | 2022 |
Income Taxes - Summary of Compo
Income Taxes - Summary of Components of Loss from Continuing Operations Before Provision for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Domestic | $ 13,800 | $ 16,707 |
Foreign | 464 | 107 |
Loss before taxes | $ 14,264 | $ 16,814 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Provision for Income Taxes (Benefit) and Amount Computed by Applying U.S. Federal Income Tax Rate (Detail) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory rate | 21.00% | 21.00% |
State income tax, net of federal benefit | 7.01% | 2.42% |
Permanent differences | (0.02%) | 0.31% |
Research and development credit | 1.46% | 1.24% |
Stock compensation | (0.44%) | (0.08%) |
Other | (0.09%) | 0.00% |
Goodwill impairment | 0.00% | (6.48%) |
Change in valuation allowance | (28.94%) | (18.43%) |
Effective income tax rate | (0.02%) | (0.02%) |
Income Taxes - Summary of Major
Income Taxes - Summary of Major Components of Company's Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 46,120 | $ 40,436 |
Research and development credit carryforwards | 3,669 | 3,321 |
Capitalized research and development costs | 11,123 | 13,334 |
Other | 271 | 11 |
Stock compensation | 1,987 | 1,941 |
Total deferred tax assets | 63,170 | 59,043 |
Valuation allowance | (63,170) | (59,043) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of Beginning and Ending Amount of Uncertain Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Beginning uncertain tax benefits | $ 924 | $ 846 |
Current year - increases | 83 | 78 |
Prior year - reductions | (72) | 0 |
Ending uncertain tax benefits | $ 935 | $ 924 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) | Apr. 12, 2019USD ($)shares | Jul. 20, 2017 | Apr. 30, 2019$ / sharesshares | Feb. 28, 2018USD ($)$ / sharesshares | Jan. 31, 2018 | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Feb. 15, 2018USD ($) |
Class of Stock [Line Items] | ||||||||
Issuance of common stock via public offering, net (in shares) | 5,000,000 | |||||||
Conversion of common stock | 0.70 | |||||||
Net proceeds from issuance of common stock and warrants | $ | $ 5,151,702 | $ 10,111,952 | ||||||
Warrant, exercise price, decrease | $ / shares | $ 0.98 | |||||||
Deemed dividend from trigger of down round provision | $ | $ 789,594 | $ 0 | ||||||
Warrants exercised (in shares) | 0 | 0 | ||||||
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 | ||||||
Common stock, shares issued | 19,683,401 | 11,422,161 | ||||||
Common stock, shares outstanding (in shares) | 19,683,401 | 11,422,161 | ||||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | ||||||
Preferred stock, par value | $ / shares | $ 0.01 | $ 0.01 | ||||||
Preferred stock, shares outstanding | 0 | 0 | ||||||
Reverse stock split, conversion ratio | 0.1 | |||||||
ATM Sales Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Gross proceeds from sales of securities in registered offerings | $ | $ 1,000,000 | |||||||
Issuance of common stock via public offering, net (in shares) | 375,000 | |||||||
Offering expenses | $ | $ 338,000 | |||||||
Public Stock Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Issuance of common stock via public offering, net (in shares) | 4,575,000 | |||||||
Public offering price | $ / shares | $ 1.10 | |||||||
Underwritten Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Issuance of common stock via public offering, net (in shares) | 5,261,250 | |||||||
Net proceeds from sale of stock offering | $ | $ 5,200,000 | |||||||
Warrants to purchase common stock (in shares) | 220,500 | |||||||
Underwriters option to purchase additional shares of common stock and warrants period | 30 days | 30 days | ||||||
Underwriters option to purchase additional shares (in shares) | 686,250 | |||||||
Gross proceeds from offering of warrants | $ | $ 5,800,000 | $ 10,300,000 | ||||||
Net proceeds from issuance of common stock and warrants | $ | $ 9,400,000 | |||||||
Exercise price (in usd per share) | $ / shares | $ 3 | |||||||
Maximum | ||||||||
Class of Stock [Line Items] | ||||||||
Warrants to purchase common stock (in shares) | 3,500,000 | |||||||
Maximum | ATM Sales Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Aggregate commission rate | 3.00% | |||||||
Maximum | Underwritten Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Warrants to purchase common stock (in shares) | 525,000 | |||||||
Underwriters option to purchase additional shares (in shares) | 750,000 | |||||||
Accounting Standards Update 2017-11 | ||||||||
Class of Stock [Line Items] | ||||||||
Estimated fair value of warrants | $ | $ 3,000,000 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Common Stock Warrants Outstanding (Details) | Dec. 31, 2019$ / sharesshares |
Class of Stock [Line Items] | |
Shares underlying outstanding warrants (in shares) | 3,750,833 |
Warrants Expiring on December 1, 2021 | |
Class of Stock [Line Items] | |
Shares underlying outstanding warrants (in shares) | 2,906 |
Exercise price (in usd per share) | $ / shares | $ 120.4 |
Warrants Expiring on December 6, 2021 | |
Class of Stock [Line Items] | |
Shares underlying outstanding warrants (in shares) | 3,737 |
Exercise price (in usd per share) | $ / shares | $ 120.4 |
Warrants Expiring on January 8, 2020 | |
Class of Stock [Line Items] | |
Shares underlying outstanding warrants (in shares) | 17,190 |
Exercise price (in usd per share) | $ / shares | $ 60.5 |
Warrants Expiring on April 4, 2026 | |
Class of Stock [Line Items] | |
Shares underlying outstanding warrants (in shares) | 6,500 |
Exercise price (in usd per share) | $ / shares | $ 1 |
Warrants Expiring On February 15, 2023 | |
Class of Stock [Line Items] | |
Shares underlying outstanding warrants (in shares) | 3,720,500 |
Exercise price (in usd per share) | $ / shares | $ 3 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Common Stock Reserved for Future Issuance (Detail) - shares | Dec. 31, 2019 | Jan. 01, 2019 |
Class of Stock [Line Items] | ||
Common stock reserved for issuance (in shares) | 6,274,902 | |
Exercise of Warrants Outstanding | ||
Class of Stock [Line Items] | ||
Common stock reserved for issuance (in shares) | 3,750,833 | |
Exercise of Options Outstanding | ||
Class of Stock [Line Items] | ||
Common stock reserved for issuance (in shares) | 1,889,775 | |
Stock Options | ||
Class of Stock [Line Items] | ||
Common stock reserved for issuance (in shares) | 878,130 | |
Amended And Restated Two Thousand Fourteen Stock Incentive Plan | Stock Options | ||
Class of Stock [Line Items] | ||
Common stock reserved for issuance (in shares) | 634,294 |
Stock-based compensation - Addi
Stock-based compensation - Additional Information (Detail) | Jan. 01, 2019shares | Jul. 10, 2018shares | Jul. 20, 2017 | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($)shares | Dec. 31, 2017shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock-based compensation expense | $ | $ 462,239 | $ 139,348 | |||||
Reverse stock split | 1-for-10 | ||||||
Reverse stock split, conversion ratio | 0.1 | ||||||
Common stock, shares outstanding (in shares) | 19,683,401 | 11,422,161 | |||||
Common stock reserved for future issuance (in shares) | 6,274,902 | ||||||
Unamortized stock-based compensation expense | $ | $ 1,100,000 | ||||||
Amortized weighted average period | 2 years 6 months 26 days | ||||||
Stock Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options outstanding (in shares) | 2,000,000 | ||||||
Annual percentage increase in outstanding number of common stock | 4.00% | 4.00% | |||||
Number of authorized shares, period increase | 456,886 | ||||||
Common stock reserved for future issuance (in shares) | 878,130 | ||||||
Options to purchase number of outstanding shares of common stock (in shares) | 2,046,885 | ||||||
2015 Stock Incentive Plan | Stock Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options outstanding (in shares) | 10,149 | ||||||
2015 Stock Incentive Plan | Stock Options | Private Dare | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options outstanding (in shares) | 10,149 | ||||||
2015 Stock Incentive Plan | Restricted Stock | Private Dare | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Common stock, shares outstanding (in shares) | 223,295 | ||||||
2014 Employee Stock Purchase Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock-based compensation expense | $ | $ 0 | $ 0 | |||||
Amended And Restated Two Thousand Fourteen Stock Incentive Plan | Stock Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options outstanding (in shares) | 1,889,775 | 539,896 | |||||
Common stock reserved for future issuance (in shares) | 634,294 | ||||||
Options to purchase number of outstanding shares of common stock (in shares) | 1,889,775 |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of Stock Option Activity (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Shares | ||
Forfeited (in shares) | (578,445) | |
Amended And Restated Two Thousand Fourteen Stock Incentive Plan | Stock Options | ||
Number of Shares | ||
Outstanding beginning balance (in shares) | 539,896 | |
Granted (in shares) | 832,500 | 1,096,050 |
Exercised (in shares) | 0 | 0 |
Forfeited (in shares) | (156) | |
Expired (in shares) | (70) | |
Outstanding ending balance (in shares) | 1,889,775 | |
Options exercisable at December 31, 2018 (in shares) | 490,513 | 1,635,790 |
Options vested and expected to vest at December 31, 2018 (in shares) | 1,889,775 | |
Weighted- Average Exercise Price | ||
Outstanding beginning balance (in usd per share) | $ 11.08 | $ 31.40 |
Granted (in usd per share) | 0.79 | 1.08 |
Exercised (in usd per share) | 0 | 0 |
Expired (in usd per share) | 59.48 | |
Forfeited (in usd per share) | 28.52 | 59.48 |
Outstanding ending balance (in usd per share) | 1.21 | $ 11.08 |
Options exercisable at December 31, 2018 (in usd per share) | 1.99 | |
Options vested and expected to vest at December 31, 2018 (in usd per share) | $ 1.21 | |
Weighted- Average Remaining Contractual Life (Years) | ||
Outstanding at December 31, 2018 | 8 years 10 months 18 days | |
Options exercisable at December 31, 2018 | 8 years 7 months 17 days | |
Options vested and expected to vest at December 31, 2018 | 8 years 10 months 18 days | |
Aggregate Intrinsic Value | ||
Outstanding at December 31, 2018 | $ 46,599 | |
Options exercisable at December 31, 2018 | 16,091 | |
Options vested and expected to vest at December 31, 2018 | $ 46,559 |
Stock-based Compensation - Comp
Stock-based Compensation - Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 462,239 | $ 139,348 |
Research and Development Expense | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 107,142 | 24,929 |
General and Administrative Expense | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 355,097 | $ 114,419 |
Stock-based Compensation - Su_2
Stock-based Compensation - Summary of Assumptions Used in Black-Scholes Option-Pricing Model for Stock Options Granted to Employees and Non-Employee Directors (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement [Abstract] | ||
Expected life in years | 10 years | 10 years |
Risk-free interest rate | 2.44% | 2.52% |
Expected volatility | 120.00% | 121.00% |
Forfeiture rate | 0.00% | 0.00% |
Dividend yield | 0.00% | 0.00% |
Weighted-average fair value of options granted (in usd per share) | $ 0.75 | $ 1.03 |
Leased Properties (Details)
Leased Properties (Details) | 12 Months Ended | |||
Dec. 31, 2019USD ($) | Jan. 01, 2019 | Dec. 31, 2018USD ($) | Jul. 01, 2018ft² | |
Lessee, Lease, Description [Line Items] | ||||
Square feet of office space | ft² | 3,169 | |||
Renewal term of operating lease | 1 year | |||
Operating lease discount rate | 7.00% | |||
Current portion of lease liabilities | $ 410,896 | $ 0 | ||
Operating lease, liability, noncurrent | $ 389,000 | |||
Operating lease cost | 223,000 | |||
Operating lease, payments | $ 154,000 | |||
Operating lease weighted average remaining lease term | 1 year 10 months 21 days | |||
Other Current Assets | ||||
Lessee, Lease, Description [Line Items] | ||||
Right-of-use asset | $ 488,000 | |||
Lease of Office Space | ||||
Lessee, Lease, Description [Line Items] | ||||
Right-of-use asset | $ 232,000 |
Leased Properties Leased Proper
Leased Properties Leased Properties- Future Minimum Lease Payment (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Leases [Abstract] | |
2020 | $ 461 |
2021 | 363 |
2022 | 42 |
Total future minimum lease payments | 866 |
Less: accreted interest | (66) |
Total operating lease liabilities | $ 800 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | Jan. 31, 2020 | Dec. 05, 2019 | Nov. 20, 2019 | Apr. 30, 2018 | Mar. 31, 2018 | Feb. 28, 2018 | Mar. 31, 2017 | Mar. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 30, 2019 | Jul. 01, 2018 |
Commitments And Contingencies [Line Items] | ||||||||||||
Renewal term of operating lease | 1 year | |||||||||||
Common stock issued to Microchips capital stock holders (in shares) | 2,999,990 | |||||||||||
License fee | $ 533,334 | $ 625,000 | ||||||||||
Defined contribution plan, employer matching contribution, percent of match | 4.00% | |||||||||||
Defined contribution plan, employer matching contributions | $ 96,000 | $ 53,000 | ||||||||||
ADVA Tec Agreement | Minimum | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Percentage of royalty rate | 1.00% | |||||||||||
ADVA Tec Agreement | Maximum | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Percentage of royalty rate | 10.00% | |||||||||||
Juniper Pharmaceuticals, Inc. | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Upfront license fee paid | $ 250,000 | |||||||||||
Potential annual license maintenance fee, payments in year one | 50,000 | |||||||||||
Potential annual license maintenance fee payments, thereafter | 100,000 | |||||||||||
Juniper Pharmaceuticals, Inc. | Clinical And Regulatory Milestones | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Maximum potential milestone payments | 13,500,000 | |||||||||||
Juniper Pharmaceuticals, Inc. | Sales Milestones | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Maximum potential milestone payments | $ 30,300,000 | |||||||||||
Upon Achievement Of Specified Development And Regulatory Milestones | ADVA Tec Agreement | Maximum | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments | $ 14,600,000 | |||||||||||
Upon Reaching Certain Worldwide Net Sales Milestones | Licensing Agreements | ADVA Tec Agreement | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments | $ 20,000,000 | |||||||||||
Microchips Biotech, Inc. | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Contingent consideration | $ 1,000,000 | $ 1,000,000 | ||||||||||
Microchips Biotech, Inc. | Upon Achievement Of Specified Development And Regulatory Milestones | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments | 46,500,000 | |||||||||||
Contingent consideration | $ 55,000,000 | |||||||||||
SST | License And Collaboration Agreement | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Percentage of rights to inventions by employees under license agreement | 50.00% | |||||||||||
SST | License And Collaboration Agreement | Minimum | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments, contingent amount | $ 500,000 | |||||||||||
SST | License And Collaboration Agreement | Maximum | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments, contingent amount | 18,000,000 | |||||||||||
SST | Upon Achieving Certain Commercial Milestones | License And Collaboration Agreement | Minimum | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments, contingent amount | 10,000,000 | |||||||||||
SST | Upon Achieving Certain Commercial Milestones | License And Collaboration Agreement | Maximum | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments, contingent amount | $ 100,000,000 | |||||||||||
Orbis | Development And Option Agreement | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments | $ 300,000 | |||||||||||
Commencement period for stage two upon achievement of stage one | 90 days | |||||||||||
Orbis | Upon Signing Of Development And Option Agreement | Development And Option Agreement | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments | $ 150,000 | |||||||||||
Orbis | Upon Completion Of Fifty Percent Development Not Later Than Six Months | Development And Option Agreement | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Percentage of rights to inventions by employees under license agreement | 50.00% | |||||||||||
Milestone payments | $ 75,000 | |||||||||||
Orbis | Upon Delivery Of Six Month Batch Development Not Later Than Eleven Months | Development And Option Agreement | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments | $ 75,000 | |||||||||||
MilanaPharm | Licensing Agreements | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
License Agreement Termination Periodic Discontinued Sale Of Product | 60 days | |||||||||||
License agreement, termination period due to performance failure | 120 days | |||||||||||
License agreement, notice period of termination | 90 days | |||||||||||
License fee | $ 25,000 | |||||||||||
License fee to be paid upon contingency | 100,000 | |||||||||||
MilanaPharm | Upon Achieving Certain Commercial Milestones | Licensing Agreements | Maximum | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments, contingent amount | 1,750,000 | |||||||||||
MilanaPharm | Upon Achieving Certain Development Milestones | Licensing Agreements | Maximum | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments, contingent amount | 300,000 | |||||||||||
Hammock Pharmaceuticals, Inc. | Assignment Agreement | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
License fee | 250,000 | |||||||||||
License fee to be paid upon contingency | $ 125,000 | |||||||||||
Hammock Pharmaceuticals, Inc. | Upon Achieving Certain Clinical And Regulatory Development Milestones | Assignment Agreement | Maximum | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payments, contingent amount | $ 1,100,000 | |||||||||||
Common Stock | Microchips Biotech, Inc. | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Common stock issued to Microchips capital stock holders (in shares) | 2,999,990 | |||||||||||
Subsequent Event | MilanaPharm | Licensing Agreements | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
License fee to be paid upon contingency | $ 110,000 | |||||||||||
Subsequent Event | Hammock Pharmaceuticals, Inc. | Assignment Agreement | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
License fee to be paid upon contingency | $ 138,000 |
Grant Awards - Additional Infor
Grant Awards - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Jul. 31, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Deferred grant funding awards | $ 2,019,674 | $ 0 | |
National Institutes Of Health | Grant Awards | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Cash received from federal grant awards | 1,200,000 | 225,000 | |
Deferred grant funding awards | 2,000,000 | ||
Eunice Kennedy Shriver National Institute Of Child Health And Human Development | National Institutes Of Health | Grant Awards | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Revenue from grant for notice of awards | 1,200,000 | ||
Bill And Melinda Gates Foundation | Grant Awards | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Revenue from grant for notice of awards | $ 2,900,000 | ||
First Phase Of Research And Availability Of Funds | Eunice Kennedy Shriver National Institute Of Child Health And Human Development | National Institutes Of Health | Grant Awards | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Revenue from grant for notice of awards | $ 200,000 | ||
Second Phase Of Research And Availability Of Funds | Eunice Kennedy Shriver National Institute Of Child Health And Human Development | National Institutes Of Health | Grant Awards | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Revenue from grant for notice of awards | 1,000,000 | ||
Remaining Portion Of Research And Availability Of Funds | Eunice Kennedy Shriver National Institute Of Child Health And Human Development | National Institutes Of Health | Grant Awards | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Revenue from grant for notice of awards | $ 700,000 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jan. 10, 2020 | Jan. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Subsequent Event [Line Items] | |||||
Common stock, shares issued | 19,683,401 | 11,422,161 | |||
Warrants to purchase shares | 3,750,833 | ||||
Subsequent Event | Warrant | |||||
Subsequent Event [Line Items] | |||||
Warrants to purchase shares | 1,700,000 | ||||
Exercise price (in usd per share) | $ 0.98 | ||||
Gross proceeds from offering of warrants | $ 1,700 | ||||
ATM Sales | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Common stock, shares issued | 3,308,003 | ||||
Proceeds from issuance of common stock | $ 5,400 | ||||
Sales commissions and fees | $ 204 | ||||
Bayer Healthcare License Agreement | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Revenue from grant for notice of awards | $ 20,000 | ||||
Upfront license fee paid | 1,000 | ||||
Milestone payments, contingent amount | $ 310,000 | ||||
Period from first commercial sale | 15 years | ||||
License agreement, notice period of termination | 90 days |