Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 29, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | DARE | ||
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 | true | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 11,422,161 | ||
Entity Public Float | $ 10,682,000 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current Assets | ||
Cash and cash equivalents | $ 6,805,889 | $ 7,559,846 |
Other receivables | 31,037 | 284,206 |
Prepaid expenses | 403,097 | 311,571 |
Other current assets | 0 | 193,495 |
Total current assets | 7,240,023 | 8,349,118 |
Property and equipment, net | 9,396 | 0 |
Goodwill | 0 | 5,187,519 |
Other non-current assets | 577,968 | 723,191 |
Total assets | 7,827,387 | 14,259,828 |
Current Liabilities | ||
Accounts payable | 459,705 | 308,219 |
Accrued expenses | 631,351 | 658,434 |
Total current liabilities | 1,091,056 | 966,653 |
Deferred rent | 9,711 | 392 |
Total liabilities | 1,100,767 | 967,045 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity | ||
Preferred stock issued | 0 | 0 |
Common stock: $0.0001 par value, 120,000,000 shares authorized, 11,422,161 and 6,047,161 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 1,143 | 605 |
Accumulated other comprehensive loss | (96,728) | (18,080) |
Additional paid-in capital | 35,791,972 | 25,541,210 |
Accumulated deficit | (28,969,767) | (12,230,952) |
Total stockholders' equity | 6,726,620 | 13,292,783 |
Total liabilities and stockholders' equity | $ 7,827,387 | $ 14,259,828 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
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 |
Common stock, par value | $ 0.0001 | $ 0.001 |
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Common stock, shares issued | 11,422,161 | 6,047,161 |
Common stock, shares outstanding | 11,422,161 | 6,047,161 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Operating expenses: | ||
General and administrative | $ 4,655,837 | $ 2,704,853 |
Research and development expenses | 6,413,956 | 984,749 |
License expenses | 625,000 | 0 |
Impairment of goodwill | 5,187,519 | 7,490,886 |
Total operating expenses | 16,882,312 | 11,180,488 |
Loss from operations | (16,882,312) | (11,180,488) |
Other income (expense) | 143,497 | (322,629) |
Net loss | (16,738,815) | (11,503,117) |
Foreign currency translation adjustments, net of tax | (78,648) | (18,080) |
Comprehensive loss | $ (16,817,463) | $ (11,521,197) |
Loss per common share - basic and diluted (in usd per share) | $ (1.57) | $ (3.56) |
Weighted average number of common shares outstanding: | ||
Basic and diluted (in shares) | 10,732,421 | 3,232,278 |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity (Deficit) - USD ($) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2016 | $ (710,621) | $ 91 | $ 17,123 | $ (727,835) | |
Beginning balance, shares at Dec. 31, 2016 | 910,000 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Conversion of convertible notes into common stock | 912,963 | $ 64 | 912,899 | ||
Conversion of convertible notes into common stock (in shares) | 638,805 | ||||
Beneficial conversion feature | 316,805 | 316,805 | |||
Business combination upon merger | 24,279,001 | $ 450 | 24,278,551 | ||
Business combination upon merger (in shares) | 4,498,356 | ||||
Stock-based compensation | 15,832 | 15,832 | |||
Net loss | (11,503,117) | (11,503,117) | |||
Foreign currency translation adjustments | (18,080) | $ (18,080) | |||
Ending balance at Dec. 31, 2017 | 13,292,783 | $ 605 | 25,541,210 | (18,080) | (12,230,952) |
Ending balance, shares at Dec. 31, 2017 | 6,047,161 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net proceeds from issuance of common stock and warrants | 734,235 | $ 38 | 734,197 | ||
Net proceeds from issuance of common stock and warrants (in shares) | 375,000 | ||||
Issuance of common stock via public offering, net | 9,377,717 | $ 500 | 9,377,217 | ||
Issuance of common stock via public offering, net (in shares) | 5,000,000 | ||||
Stock-based compensation | 139,348 | 139,348 | |||
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 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Operating activities: | ||
Net loss | $ (16,738,815) | $ (11,503,117) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 2,440 | 0 |
Stock-based compensation | 139,348 | 15,832 |
Non-cash interest | 0 | 316,805 |
Acquired in-process research and development | 507,000 | 0 |
Impairment of goodwill | 5,187,519 | 7,490,886 |
Changes in operating assets and liabilities, net impact of acquisition: | ||
Other receivables | 253,169 | 662,059 |
Prepaid expenses | (91,526) | (113,021) |
Other current assets | 193,495 | (193,495) |
Other non-current assets and deferred charges | 145,223 | (2,800) |
Accounts payable | 151,486 | 218,267 |
Accrued expenses | (27,083) | 534,831 |
Interest payable | 0 | 33,233 |
Deferred rent | 9,319 | 392 |
Net cash used in operating activities | (10,268,425) | (2,540,128) |
Investing activities: | ||
Cash acquired through merger | 0 | 9,918,440 |
Purchases of property and equipment | (11,836) | 0 |
Acquisition of Pear Tree and Hydra assets | (507,000) | 0 |
Net cash provided by (used in) investing activities | (518,836) | 9,918,440 |
Financing activities: | ||
Net proceeds from issuance of common stock and warrants | 10,111,952 | 0 |
Proceeds from issuance of convertible promissory notes | 0 | 155,000 |
Net cash provided by financing activities | 10,111,952 | 155,000 |
Effect of exchange rate changes on cash and cash equivalents | (78,648) | (18,080) |
Net change in cash and cash equivalents | (753,957) | 7,515,232 |
Cash and cash equivalents, beginning of year | 7,559,846 | 44,614 |
Cash and cash equivalents, end of year | 6,805,889 | 7,559,846 |
Non-cash transactions: | ||
Shares issued in connection of business combination and assumed equity awards | 0 | 24,279,001 |
Conversion of convertible notes into common stock | 0 | 912,962 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | $ 0 | $ 837 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
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 advancement of innovative products for women’s health. Daré Bioscience, Inc. and its wholly owned subsidiaries, Daré Bioscience Operations, Inc., Daré Bioscience Australia Pty LTD, and Pear Tree Pharmaceuticals, Inc., operate in 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 differentiated 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 license or otherwise acquire the rights to differentiated product candidates in women's health, 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. The Company has assembled a portfolio of clinical-stage and pre-clinical-stage candidates addressing unmet needs in women’s health. The Company’s portfolio includes these four clinical-stage candidates: • DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis, or BV; • Ovaprene, a non-hormonal monthly contraceptive intravaginal ring; • Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder, or FSAD; and • DARE-HRT1 (formerly JNP-0201), a combination bio-identical estradiol and progesterone intravaginal ring for hormone replacement therapy following menopause. The Company's portfolio also includes these pre-clinical stage product candidates: • DARE-RH1, a novel approach to non-hormonal contraception for both men and women by targeting the CatSper ion channel; • ORB-204 and ORB-214, 6-month and 12-month formulations of injectable etonogestrel for contraception; • DARE-FRT1 (formerly JNP-0301), an intravaginal ring containing bio-identical progesterone for the prevention of preterm birth and for fertility support as part of an in vitro fertilization, or IVF, treatment plan; • DARE-OAB1 (formerly JNP-0101), an intravaginal ring containing oxybutynin for the treatment of overactive bladder; and • DARE-VVA1 (formerly PT-101), a vaginally delivered formulation of tamoxifen to treat vulvar vaginal atrophy, or VVA, in patients with hormone-receptor positive breast cancer . 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. 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. On July 19, 2017 , the Company completed its business combination with Daré Bioscience Operations, Inc., a privately held Delaware corporation, in accordance with the terms of the Stock Purchase Agreement, dated as of March 19, 2017 , See Note 2, "Acquisitions - Cerulean/Private Daré Stock Purchase Transaction." The operations presented in the Consolidated Financial Statements and accompanying notes (A) for the year ended December 31, 2018 and for the year ended December 31, 2017 that include the period from July 19, 2017 to December 31, 2017, represent the operations of the Company following the Cerulean/Private Daré stock purchase transaction, and (B) for the year ended December 31, 2017 that include the period from January 1, 2017 to July 18, 2017 represent the operations of the Company when it was private, making a comparison between periods difficult. 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. However, as of December 31, 2018 , the Company had an accumulated deficit of approximately $29.0 million and had cash and cash equivalents of approximately $6.8 million. The Company also had negative cash flow from operations of approximately $10.3 million for the year ended December 31, 2018 . 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. During the first quarter of 2018, the Company received gross proceeds of approximately $11.3 million , resulting in net proceeds of approximately $10.1 million , from sales of its securities in registered offerings (see Note 7). During the third and fourth quarter of 2018, the Company received approximately $225,000 from a federal grant. 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 current cash resources, the Company believes its existing resources will be sufficient to fund planned operations into the third quarter of 2019. For the foreseeable future, the Company's ability to continue its operations will depend upon its ability to obtain additional capital. Although the Company has cash and cash equivalents of approximately $6.8 million at December 31, 2018, the Company will need to raise substantial additional capital to continue to fund its operations and to successfully execute its current operating plan, including the development of its current product candidates. 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 and are prepared using U.S. GAAP. These consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Daré Bioscience Operations, Inc., Daré Bioscience Australia Pty LTD, and Pear Tree Pharmaceuticals, Inc. 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 a grant issued by a division of the National Institutes of Health. 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 year ended December 31, 2018 , the Company recognized approximately $225,000 in the statement of operations as a reduction to research and development expense. 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. 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 $ 6.8 million and $7.6 million measured at fair value as of December 31, 2018 and 2017 , respectively, are classified within Level 1. Other receivables 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. 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. 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. Goodwill is not amortized but is tested annually for impairment or more frequently if impairment indicators exist. The Company adopted accounting guidance related to annual and interim goodwill impairment tests which allows the Company to first assess qualitative factors before performing a quantitative assessment of the fair value of a reporting unit. If it is determined on the basis of qualitative factors that the fair value of the reporting unit is more likely than not less than the carrying amount, a quantitative impairment test is required. The Company recorded goodwill of $12.7 million related to the Cerulean/Private Daré stock purchase transaction on July 19, 2017. The Company assessed goodwill at December 31, 2017 and determined there was an impairment and recognized an impairment charge of approximately $7.5 million in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2017 and reduced the carrying value of goodwill from $12.7 million to approximately $5.2 million on its consolidated balance sheet as of December 31, 2017 . The Company reassessed 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 March 31, 2018, the goodwill carrying value on the Company’s consolidated balance sheet was written off in its entirety. See Note 2, “Acquisitions.” 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 CRO’s, 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. All per share figures have been retroactively adjusted for the Reverse Stock Split. There were stock options exercisable into 584,670 and 539,896 shares of common stock outstanding at December 31, 2018 and 2017 , 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, 2018 , the Company did not record any liabilities for uncertain tax positions. During 2018 , the Company recorded a provision for income taxes of $3,200 . There was no provision for income taxes recorded during 2017. Management evaluated the Company’s tax positions and as of December 31, 2018 has approximately $924,000 of unrecognized benefits. The tax years 2015 to 2018 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, 2018 , 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, 2018 and 2017 , no amounts have been accrued related to such indemnification provisions. Recent Accounting Pronouncements Not Yet Adopted 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 is effective for the Company beginning January 1, 2019 and will be adopted using a modified retrospective approach and the effective date will be as of the initial application. Consequently, financial information will not be updated, and the disclosures required under ASU 2016-02 will not be 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 expects to elect 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 expects to record approximately $241,000 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, and expects no changes to the statement of operations or cash flows as a result of the adoption. Recently Adopted Accounting Standards In May 2014, FASB issued Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers , which impacts the way in which some entities recognize revenue for certain types of transactions. The new standard became effective beginning in 2018 for public companies. Because the Company does not currently have any contracts with customers, the Company’s adoption of this accounting standard did not impact the Company’s consolidated financial statements. In August 2016, FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments, which intended to add or clarify guidance on the classification of certain cash receipts and payments on the statement of cash flows. The new guidance addresses cash flows related to debt prepayment or extinguishment costs, settlement of zero-coupon bonds, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies and bank-owned life insurance policies, distributions received from equity method investees, beneficial interest in securitization transactions, and the application of predominance principle to separately identifiable cash flows. The standard became effective on January 1, 2018. The Company's adoption of this standard on January 1, 2018 did not have a material impact on the Company's consolidated financial statements. In January 2017, FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which intended to clarify the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The standard became effective for the Company on January 1, 2018. The Company’s early adoption of this standard did not have a material impact on the Company’s consolidated financial statements. In January 2017, FASB issued ASU 2017-04, Simplifying the Test for Goodwill Impairment (Topic 350) . The guidance removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. The guidance should be adopted on a prospective basis for the annual or any interim goodwill impairment tests beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company’s adoption of this standard on September 30, 2017 did not have a material impact on the Company’s consolidated financial statements. In May 2017, FASB issued ASU 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting, which intended to provide clarity when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The standard became effective for the Company on January 1, 2018. The Company’s adoption of this standard did not have a material impact on the Company’s consolidated financial statements. In July 2017, FASB issued ASU 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815): (I) Accounting for Certain Financial Instruments with Down Round Features, (II) Replacement for the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. This update was issued to provide additional clarity related to accounting for certain financial instruments that have characteristics of both liabilities and equity. In particular, this update addresses freestanding and embedded financial instruments with down round features and whether they should be treated as a liability or equity instrument. Part II simply replaces the indefinite deferral for certain mandatorily redeemable non-controlling interests and mandatorily redeemable financial instruments of nonpublic entities contained within the ASC Topic 480 with a scope exception and does not impact the accounting for these mandatorily redeemable instruments. For public business entities, the amendments in this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The Company has early adopted ASU 2017-11. As a result, the Company has not recognized the fair value of the warrants containing down round features that were issued in the underwritten offering in February 2018 (see Note 7) as liabilities. |
Acquisitions
Acquisitions | 12 Months Ended |
Dec. 31, 2018 | |
Business Combinations [Abstract] | |
Acquisitions | ACQUISITIONS Cerulean/Private Daré Stock Purchase Transaction On July 19, 2017, the Company completed its business combination with Daré Bioscience Operations, Inc., a privately held Delaware corporation, or Private Daré, in accordance with the terms of the Stock Purchase Agreement dated as of March 19, 2017, or the Daré Stock Purchase Agreement, by and among the Company Private Daré and the holders of capital stock and securities convertible into capital stock of Private Daré named therein, or the Private Daré Stockholders. Pursuant to the Daré Stock Purchase Agreement, each Private Daré Stockholder sold their shares of capital stock in Private Daré 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 because immediately upon completion of the transaction, Private Daré stockholders held a majority of the voting interest of the combined company. 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 is primarily attributable to the cash and cash equivalents at closing 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 unamortized fair value of such stock options relates to an option modification approved on March 19, 2017 that provided for an acceleration of vesting of such options upon a change in control event. Such modification became effective upon the closing of the Cerulean/Private Daré stock purchase transaction. Hence, the unamortized fair value of such stock options is deemed to be part of total purchase consideration and goodwill. Transaction costs associated with the Cerulean/Private Daré stock purchase transaction of $0.96 million are included in general and administrative expense. The total purchase price consideration of approximately $24.3 million represents the fair value of the shares of Cerulean stock issued in connection with the Cerulean/Private Daré stock purchase transaction and the unamortized fair value of the stock options described above, which was allocated as follows: Purchase Consideration (in thousands) Fair value of shares issued $ 20,625 Unamortized fair value of Cerulean options 3,654 Fair value of total consideration $ 24,279 Assets acquired and liabilities assumed Cash and cash equivalents $ 9,918 Prepaid expense and other current assets 1,915 Accounts payable (233 ) Total assets acquired and liabilities assumed 11,600 Goodwill $ 12,679 The final allocation of the purchase price depended on finalizing of the valuation of the fair value of assets acquired and liabilities assumed. The Company retrospectively recorded purchase price adjustments at the acquisition date to increase current liabilities and current assets by $23,609 and $225,778 , respectively, which reduced the original goodwill amount of $12.9 million by $202,169 . The Company tests its goodwill for impairment at least annually as of December 31 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. The Company assessed goodwill at December 31, 2017 , determined there was an impairment, recognized an impairment charge of approximately $7.5 million in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2017 , and reduced the goodwill carrying value from approximately $12.7 million to $5.2 million on its consolidated balance sheet as of December 31, 2017 . 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 Merger On April 30, 2018, the Company entered into an Agreement and Plan of Merger, the Merger Agreement, with Pear Tree Pharmaceuticals, Inc., or Pear Tree, Daré Merger Sub, Inc., a wholly-owned subsidiary of the Company, or Merger Sub, and two individuals in their respective capacities as Pear Tree stockholders’ representatives. The transactions contemplated by the Merger Agreement closed on May 16, 2018, and as a result, Pear Tree became 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 determined that the acquisition of Pear Tree should be accounted for as an asset acquisition instead of a business combination because substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets, and therefore, the asset is not considered a business. Transaction costs of approximately $452,000 associated with the merger are included in the Company’s research and development expense. In accordance with the terms of the Merger Agreement, because the Negative Consideration Amount (as defined below) exceeded the Positive Consideration Amount (as defined below), at the time of the closing of the merger, the excess amount (approximately $132,000 ) will be offset against future payments otherwise due under the Merger Agreement to certain former and continuing Pear Tree service providers and former holders of Pear Tree’s capital stock, or the Holders, including the potential $75,000 payment due on the one -year anniversary of the closing of the merger. Positive Consideration Amount means the sum of $75,000 , and the cash and cash equivalents held by Pear Tree at closing, and Negative Consideration Amount means the sum of (i) certain Pear Tree indebtedness and transaction expenses, (ii) transaction expenses of the stockholders’ representatives, and (iii) amounts payable under Pear Tree’s management incentive plan. Under the Merger Agreement, 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. |
Convertible Promissory Notes
Convertible Promissory Notes | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Convertible Promissory Notes | CONVERTIBLE PROMISSORY NOTES Prior to the Cerulean/Private Daré stock purchase transaction, Private Daré financed its operations through the sale of convertible promissory notes that entitled the holder to accrued interest at an annual rate of 8% . In the event of a preferred stock financing by Private Daré, all outstanding principal and unpaid interest under the convertible promissory notes would have converted into the shares of Private Daré’s preferred stock issued in such financing at the price per share paid by the purchasers of such shares and an additional number of shares equal to, depending on the time of purchase, 20% to 40% of the outstanding principal and unpaid interest, or the conversion benefit. Private Daré issued a convertible promissory note in the principal amount of $100,000 in February 2017 and issued additional convertible promissory notes in the aggregate principal amount of $55,000 between April 1, 2017 and June 6, 2017. In connection with the Cerulean/Private Daré stock purchase transaction, all outstanding convertible promissory notes were amended to provide that their principal amount plus accrued interest and taking into account their conversion benefit, would convert into shares of Private Daré common stock immediately prior to the closing of the Cerulean/Private Daré stock purchase transaction. The number of shares of Private Daré common stock issued upon conversion of the convertible promissory notes issued before March 31, 2017 was equal to (i) their outstanding principal amount plus accrued interest through March 31, 2017 multiplied by the respective conversion benefit, which ranged from 125% to 140% , divided by (ii) $0.18727 . The number of shares of Private Daré common stock issued upon conversion of the convertible promissory notes issued after March 31, 2017 was equal to (i) 120% of their outstanding principal amount, divided by (ii) $0.38 . In connection with the closing of the Cerulean/Private Daré stock purchase transaction, all the outstanding shares of Private Daré common stock, including the shares issued upon conversion of the above described convertible promissory notes, were exchanged for shares of the Company's common stock at the exchange ratio specified in the Daré Stock Purchase Agreement. The Company recognized interest expense of $ 0 and $ 316,805 as of December 31, 2018 and December 31, 2017 , respectively, relating to the convertible promissory notes. |
Other Non-Current Assets
Other Non-Current Assets | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 Prepaid insurance, long-term portion $ 562,266 $ 720,391 Deposits 15,702 2,800 Total other non-current assets $ 577,968 $ 723,191 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | ACCRUED EXPENSES Accrued expenses consisted of the following: As of December 31, 2018 2017 Accrued compensation and benefits expenses $ 416,234 $ 316,024 Accrued legal and professional expenses 32,457 259,600 Accrued clinical and related expenses 182,660 82,810 Total accrued expenses $ 631,351 $ 658,434 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 Domestic $ 16,707 $ 11,503 Foreign 107 18 Loss before taxes $ 16,814 $ 11,521 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, 2018 and 2017 are as follows: Years Ended December 31, 2018 2017 Federal statutory rate 21.0 % 34.0 % State income tax, net of federal benefit 2.42 % 1.3 % Permanent differences 0.31 % (2.8 )% Research and development credit 1.24 % 1.9 % Stock compensation (0.08 )% (3.4 )% Federal rate reduction under tax reform — % (204.7 )% Goodwill impairment (6.48 )% (22.1 )% Change in valuation allowance (18.43 )% 195.8 % Effective income tax rate (0.02 )% — % The major components of the Company’s deferred tax assets as of December 31, 2018 and 2017 are shown below (in thousands). 2018 2017 Net operating loss carryforwards $ 40,436 $ 32,412 Research and development credit carryforwards 3,321 3,102 Capitalized research and development costs 13,334 15,176 Other amortizable costs 11 3,377 Stock compensation 1,941 1,877 Total deferred tax assets 59,043 55,944 Valuation allowance (59,043 ) (55,944 ) 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 $59.0 million and $55.9 million was established at December 31, 2018 and 2017 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 $3.1 million for the year ending December 31, 2018 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, 2017 is primarily related to acquired deferred tax assets in the transaction with Cerulean Pharma Inc, offset by a reduction in deferred tax assets revalued at the reduced federal tax rate under the U.S. Tax Cuts and Jobs Act enacted in December of 2017. The Company has U.S. federal net operating loss, or NOL, carryforwards available at December 31, 2018 of approximately $153.8 million ( 2017 – $122.5 million ) of which, $135.0 million begin expiring in 2027 unless previously utilized and $18.8 million that do not expire but are limited to 80% of taxable income in a given year. The Company has state NOL carryforwards of $119.9 million ( 2017 – $102.7 million ) that begin expiring in 2032 unless previously utilized. The Company has U.S. federal research credit carryforwards available at December 31, 2018 of approximately $2.2 million ( 2017 – $2.5 million ) that begin expiring in 2027 unless previously utilized. The Company has state research credit carryforwards of $1.1 million ( 2017 – $1.6 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: Years Ended December 31, 2018 2017 Beginning uncertain tax benefits $ 846 $ — Current year - increases 78 65 Current year - purchase accounting increases — 781 Ending uncertain tax benefits $ 924 $ 846 Included in the balance of uncertain tax benefits at December 31, 2018 are $924,000 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, 2018 and 2017 , the Company had no accrued interest or penalties recorded related to uncertain tax positions. The tax years 2015 through 2018 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, 2018 . |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
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 up to an aggregate of $10 million in gross proceeds through the sale of shares of 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 the year ended December 31, 2018 , the Company issued and 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 . All such shares were sold during January and 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 have an exercise price of $3.00 per share and are exercisable immediately and for five years from issuance. 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 adjusted downward if the Company issues or sells (or is deemed to issue or sell) securities at a price that is less than the exercise price in effect immediately prior to such issuance or sale (or deemed issuance or sale). In that case, the exercise price of the warrants will be adjusted to equal the price at which the new securities are issued or sold (or are deemed to have been issued or sold). 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 (see Note 1). No warrants were exercised during the year ended December 31, 2018 or 2017 . During the year ended December 31, 2018 , warrants to purchase 170 shares of the Company’s common stock expired. As of December 31, 2018 , 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 On July 20, 2017, the Company effected a 1-for-10 reverse stock split of its common stock. All share and per share amounts of common stock, options and warrants in this report, including those amounts included in the accompanying consolidated financial statements, have been restated for all periods to give retroactive effect to the reverse stock split. 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, 2018 . The issued and outstanding common stock of the Company consisted of 11,422,161 and 6,047,161 shares with a par value of $0.0001 as of December 31, 2018 and 2017 , respectively. There were no shares of preferred stock outstanding as of December 31, 2018 or 2017 . Common Stock Reserved for Future Issuance The following table summarizes common stock reserved for future issuance at December 31, 2018 and 2017 : As of December 31, 2018 2017 Common stock reserved for issuance upon exercise of warrants outstanding 3,750,833 30,502 Common stock reserved for issuance upon exercise of options outstanding 1,635,790 539,896 Common stock reserved for future equity awards (under the Amended 2014 Plan) 421,244 46,479 Total 5,807,867 616,877 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [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, the 2015 Employee, Director and Consultant Equity Incentive Plan of Private Daré, or the 2015 Private Daré Plan, governed the issuance of equity awards to Private Daré employees, officers, non-employee directors and consultants. Options granted under the 2015 Private Daré Plan have terms of ten years from the date of grant unless earlier terminated and generally vest over a three -year period. Upon closing of the Cerulean/Private Daré stock purchase transaction, the Company assumed the 2015 Private Daré Plan and each outstanding option to acquire Private Daré stock that was not exercised prior to the closing. Options to purchase 50,000 shares of Private Daré stock were assumed. Such options were assumed on the same terms as were applicable to them under the 2015 Private Daré Plan and became an option to purchase such number of shares of the Company’s common stock as was equal to the number of Private Daré shares subject to such option multiplied by the exchange ratio defined in the Daré Stock Purchase Agreement, at a correspondingly adjusted exercise price. Based on the exchange ratio and after giving effect to the reverse stock split effected in connection with the closing of the Cerulean/Private Daré stock purchase transaction, such options were replaced with options to purchase 10,149 shares of the Company’s common stock, all of which were outstanding as of December 31, 2018 . Private Daré issued 900,000 and 200,000 shares of fully vested restricted stock to non-employees under the 2015 Private Daré Plan during 2015 and 2016 , respectively. In connection with the closing of the Cerulean/Private Daré stock purchase transaction, the Company assumed these shares and replaced them with 223,295 restricted shares of the Company’s common stock (after giving effect to the reverse stock split effected in connection with the closing of the Cerulean/Private Daré stock purchase transaction). 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 In March 2014, the Company’s board of directors adopted, and its stockholders approved the 2014 Employee Stock Purchase Plan, or the ESPP, which became effective in April 2014. The ESPP permits eligible employees to enroll in a six-month offering period whereby participants may purchase shares of the Company’s common stock, through payroll deductions, at a price equal to 85% of the closing price of the common stock on the first day of the offering period or on the last day of the offering period, whichever is lower. Purchase dates under the ESPP occur on or about June 30 and December 31 each year. The Company's board of directors decided not to initiate a new offering period beginning January 1, 2017 and no offering period has been initiated since then. There was no stock-based compensation related to the ESPP for the years ended December 31, 2018 and 2017 . Amended and Restated 2014 Stock Incentive Plan The Company maintains the Amended and Restated 2014 Plan, or the Amended 2014 Plan, which was approved by the Company’s stockholders on July 10, 2018. The Amended 2014 Plan was an amendment and restatement of the Company’s 2014 Stock Incentive Plan, or the 2014 Plan. There are 2,046,885 shares of common stock authorized for issuance under the Amended 2014 Plan. The number of authorized shares will increase 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. In March 2017, the Company’s board of directors approved two modifications to outstanding stock options granted under the 2014 Plan to participants providing services to the Company as of that date. One modification extended the exercise period of such stock options to two years after such participant’s termination date, unless the exercise period absent such modification would be longer. The other modification provided for accelerated vesting of such stock options upon a change in control event. These modifications resulted in unamortized fair value expense of approximately $3.7 million and was recorded as part of the total consideration in the Cerulean/Private Daré stock purchase transaction (see Note 2). The two modifications resulted in certain options remaining outstanding that would have otherwise expired. As of December 31, 2018 , 421,244 shares of common stock were reserved for future issuance under the Amended 2014 Plan, and options to purchase 1,635,790 shares of the Company’s common stock granted under the Amended 2014 Plan were outstanding. 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, 2018 and 2017 . The exercise price of all options granted during the years ended December 31, 2018 and 2017 was equal to the market value of the Company’s common stock on the date of grant. As of December 31, 2018 , unamortized stock-based compensation expense of $1,035,847 will be amortized over the weighted average period of 3.31 years. Number of Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Outstanding at December 31, 2016 5,000 $ 0.01 Granted 565,372 32.90 Exercised — — Forfeited (30,476 ) 54.25 Outstanding at December 31, 2017 (1) 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 8.77 $ 7,109 Options exercisable at December 31, 2018 584,670 $ 29.03 7.20 $ 7,109 Options vested and expected to vest at December 31, 2018 1,635,790 $ 11.08 8.77 $ 7,109 (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 statement of operations is as follows: Years Ended December 31, 2018 2017 Research and development $ 24,929 $ — General and administrative 114,419 15,832 Total $ 139,348 $ 15,832 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, 2018 and 2017 is as follows: 2018 2017 Expected life in years 10 5.4 Risk-free interest rate 2.52 % 1.85 % Expected volatility 121 % 72 % Forfeiture rate — — Dividend yield — % — % Weighted-average fair value of options granted 1.03 4.46 Restricted Stock After the Cerulean/Private Daré Stock Purchase Transaction The 3.14 million shares of common stock issued in connection with the Cerulean/Private Daré stock purchase transaction to the Private Daré stockholders were not registered with the SEC and may only be sold if registered under the Securities Act of 1933, as amended, or pursuant to an exemption from the registration requirements thereunder. The shares held by non-affiliates became eligible for sale under Rule 144 beginning six months after the closing of the Cerulean/Private Daré stock purchase transaction . |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Operating Lease The Company entered into a facility lease agreement that commenced on July 1, 2018 for 3,169 square feet of office space for its corporate headquarters. The term of the lease is 37 months and terminates on July 31, 2021. The Company has the option to extend the term of the lease for one year . The gross monthly base rent is $8,873 , which will increase approximately 4% per year, subject to certain future adjustments. The base rent was abated during the second month of the lease. Future minimum lease payments at December 31, 2018 total $289,108 . The Company recognizes rent expense by the straight-line method over the lease term. As of December 31, 2018 , deferred rent totaled $9,711 . Future minimum annual lease payments under the Company's facility lease as of December 31, 2018, are as follows: Operating Leases 2019 $ 108,570 2020 112,943 2021 67,595 Total minimum lease payments $ 289,108 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. Risk Management The Company maintains various forms of insurance that the Company’s management believes are adequate to reduce the exposure of these risks to an acceptable level. 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 Research Agreements ADVA-Tec License Agreement In March 2017, the Company entered into a license agreement, or the ADVA-Tec License Agreement, with ADVA-Tec, Inc., or ADVA-Tec, under which the Company was granted the exclusive right to develop and commercialize Ovaprene for human contraceptive use worldwide. ADVA-Tec and its affiliates own issued patents or patent applications covering Ovaprene and control proprietary trade secrets covering the manufacture of Ovaprene. As of the date of this report, this patent portfolio includes nine issued U.S. patents and one pending U.S. patent application, and 59 granted patents and four pending patent applications in other major markets, all of which are exclusively licensed to the Company for the human contraceptive use of Ovaprene as a human contraceptive device. The license continues on a country-by-country basis until the later of the life of the licensed patents or the Company’s last commercial sale of Ovaprene. Under the terms of the ADVA-Tec Agreement, the Company has a right of first refusal to license these patents and patent applications for additional indications. The following is a summary of other terms of the ADVA-Tec License Agreement: Research and Development . ADVA-Tec will conduct certain research and development work as necessary to allow the Company to seek a Premarket Approval, or PMA, from the United States Food and Drug Administration, or the FDA, and will supply the Company with its requirements of Ovaprene for clinical and commercial use on commercially reasonable terms. The Company must use commercially reasonable efforts to develop and commercialize Ovaprene, and must meet certain minimum spending amounts per year, such amounts totaling $5.0 million in the aggregate over the first three years, to cover such activities until a final PMA is filed, or until the first commercial sale of Ovaprene, whichever occurs first. 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. The development and regulatory milestones include: the completion of a successful postcoital clinical study, which is required before the Company can commence a Phase 3 pivotal human clinical trial; approval by the FDA to commence such Phase 3 pivotal human clinical trial; successful completion of such Phase 3 pivotal human clinical trial; the FDA’s acceptance of a PMA filing for Ovaprene; the FDA’s approval of the PMA for Ovaprene; obtaining Conformité Européenne Marking of Ovaprene in at least three designated European countries; obtaining regulatory approval in at least three designated European countries; and obtaining regulatory approval in Japan. Because these milestone payments depend upon the successful progress of the Company’s product development programs, the Company cannot estimate with certainty when these payments will occur, if ever. 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. Termination Rights. Unless earlier terminated, the license the Company received under the ADVA-Tec License Agreement continues on a country-by-country basis until the later of the life of the licensed patents or the Company's last commercial sale of Ovaprene. In addition to customary termination rights for both parties: (A) the Company may terminate the agreement with or without cause in whole or on a country-by-country basis upon 60 days prior written notice; and (B) ADVA-Tec may terminate the agreement if the Company develops or commercializes any non-hormonal ring-based vaginal contraceptive device competitive to Ovaprene or if the Company fails to: (1) in certain limited circumstances, commercialize Ovaprene in certain designated countries within three years of the first commercial sale of Ovaprene, (2) satisfy the annual spending obligation described above, (3) use commercially reasonable efforts to complete all necessary pre-clinical and clinical studies required to support and submit a PMA, (4) conduct clinical trials as set forth in the development plan that is agreed by the Company and ADVA-Tec, and as may be modified by a joint research committee, unless such failure is caused by events outside of the Company’s reasonable control, or (5) enroll a patient in the first non-significant risk medical device study or clinical trial as allowed by an institutional review board within six months of the production and release of Ovaprene, unless such failure is caused by events outside of its reasonable control. For products currently in development, future potential milestone payments based on product development are approximately $14.6 million as of December 31, 2018 . Future potential milestone payments related to commercialization totaled $20 million at December 31, 2018 . There are 1-10% royalties required under the license agreement. The Company is unable to estimate with certainty the timing on when these milestone payments will occur as these payments are dependent upon the progress of the Company’s product development programs. SST License and Collaboration Agreement In February 2018, the Company entered into a license and collaboration agreement, or the SST License Agreement, with Strategic Science & Technologies-D, LLC and Strategic Science & Technologies, LLC, referred to collectively as SST. The SST License Agreement provides the Company with 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, including treatment of female sexual arousal disorder, or the Field of Use, SST’s topical formulation of Sildenafil Cream, 3.6% as it exists as of the effective date of the SST License 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, or the Licensed Products. The following is a summary of other terms of the SST License 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 SST License 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 SST License 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 SST License 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. License Term. The Company’s license received under the SST License Agreement continues on a country-by-country basis until the later of 10 years from the date of the first commercial sale of such Licensed Product or the expiration of the last valid claim of patent rights covering the Licensed Product in the Field of Use. Upon expiration (but not termination) of the SST License Agreement in a particular country, the Company will have a fully paid-up license under the licensed intellectual property to develop and commercialize the applicable Licensed Products in the applicable country on a non-exclusive basis. Termination. In addition to customary termination rights for both parties: (1) prior to receipt of approval by a regulatory authority necessary for commercialization of a Licensed Product in the corresponding jurisdiction, including New Drug Application Approval, or NDA Approval, the Company may terminate the SST License Agreement without cause upon 90 days prior written notice to SST; (2) following receipt of approval by a regulatory authority necessary for commercialization of a Licensed Product in the corresponding jurisdiction, including NDA Approval, the Company may terminate the SST License Agreement without cause upon 180 days prior written notice; and (3) SST may terminate the SST License Agreement with respect to the applicable Licensed Product(s) in the applicable country(ies) upon 30 days ’ notice to the Company if the Company fails to use commercially reasonable efforts to perform development activities in substantial accordance with the development plan and does not cure such failure within 60 days of receipt of SST’s notice thereof. Orbis Development and Option Agreement In March 2018, the Company entered into an exclusive development and option agreement, or the Orbis 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 the Orbis agreement, the Company paid Orbis $300,000 to conduct the first stage of development work, Stage 1, as follows: $150,000 upon signing the Orbis Agreement, $75,000 at the 50% completion point, not later than 6 months following the date the Orbis 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 Orbis 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 Orbis Agreement provides the Company with an option to enter into a license agreement for ORB-204 and ORB-214 should development efforts be successful. Juniper Pharmaceuticals - License Agreement In April 2018, the Company entered into an Exclusive License Agreement, or the Juniper License Agreement, with Juniper Pharmaceuticals, Inc., or Juniper, under which Juniper granted the Company (a) an exclusive, royalty-bearing worldwide license under certain patent rights, either owned by or exclusively licensed to Juniper, 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 Juniper 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 the Juniper License Agreement. The following is a summary of other terms of the Juniper License Agreement: Upfront Fee. The Company paid a $250,000 non-creditable upfront license fee to Juniper in connection with the execution of the Juniper License Agreement. Annual Maintenance Fee. The Company will pay an annual license maintenance fee to Juniper on each anniversary of the date of the Juniper License 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 Juniper 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 Juniper License Agreement. Royalty Payments . During the royalty term, the Company will pay Juniper mid-single-digit to low double-digit royalties based on worldwide net sales of products and processes covered by the licenses granted under the Juniper License Agreement. In lieu of such royalty payments, the Company will pay Juniper a low double-digit percentage of all sublicense income the Company receives for the sublicense of rights under the Juniper License Agreement to a third party. The royalty term, which is determined on a country-by-country basis and product-by-product basis (or process-by-process basis), begins with the first commercial sale of a product or process in a country and terminates on the latest of (1) the expiration date of the last valid claim within the licensed patent rights with respect to such product or process in such country, (2) 10 years following the first commercial sale of such product or process in such country, and (3) when one or more generic products for such product or process are commercially available in such country, except that if there is no such generic product by the 10th year following the first commercial sale in such country, then the royalty term will terminate on the 10-year anniversary of the first commercial sale in such country. Efforts. The Company must use commercially reasonable efforts to develop and make at least one product or process available to the public, which efforts include achieving specific diligence requirements by specific dates specified in the Juniper License Agreement. Term. Unless earlier terminated, the term of the Juniper License Agreement will continue on a country-by-country basis until the later of (1) the expiration date of the last valid claim within such country, or (2) 10 years from the date of first commercial sale of a product or process in such country. Upon expiration (but not early termination) of the Juniper License Agreement, the licenses granted thereunder will convert automatically to fully-paid irrevocable licenses. Juniper may terminate the Juniper License Agreement (1) upon 30 days ’ notice for the Company’s uncured breach of any payment obligation under the Juniper License Agreement, (2) if the Company fails to maintain required insurance, (3) immediately upon the Company’s insolvency or the making of an assignment for the benefit of the Company’s creditors or if a bankruptcy petition is filed for or against the Company, which petition is not dismissed within 90 days , or (4) upon 60 days ’ notice for any uncured material breach by the Company of any of its other obligations under the Juniper License Agreement. The Company may terminate the Juniper License Agreement on a country-by-country basis for any reason by giving 180 days ’ notice (or 90 days ’ notice if such termination occurs prior to receipt of marketing approval in the United States). If Juniper terminates the Juniper License Agreement for the reason described in clause (4) above or if the Company terminates the Juniper License Agreement, Juniper will have full access including the right to use and reference all product data generated during the term of the Juniper License Agreement that is owned by the Company. Pear Tree Acquisition The Company may be required to make certain royalty and milestone payments under the Merger Agreement (see Note 2). Hammock/MilanaPharm Assignment and License Agreement On December 5, 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. The following is a summary of other terms of the License Amendment: License Fees. The Company paid $25,000 to MilanaPharm in connection with the execution of the License Amendment and must pay $200,000 to MilanaPharm (in the Company's discretion, either in cash or with shares of the Company's common stock) within 15 days of the first to occur of December 5, 2019 or the closing of an equity financing in which the Company raises aggregate proceeds of at least $10.0 million . Milestone Payments. The Company will pay to MilanaPharm (1) up to $300,000 in the aggregate upon achievement of certain 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, the Company 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 (a) 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 (b) 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 the Company, or payments to third parties for rights or know-how that are required for the Company 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 . The Company 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 term of the MilanaPharm License Agreement will continue 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 the Company 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 the Company solely with respect to a licensed product or process in a country if, after having launched such product or process in such country, (1) the Company, or its affiliates or sublicensees, discontinue the sale of such product or process in such country and MilanaPharm notifies the Company of such termination within 60 days of having first been notified by the Company of such discontinuation, or (2) the Company, or its affiliates or sublicensees, (A) discontinues all commercially reasonable marketing efforts to sell, and discontinues all sales of, such product or process in such country for nine months or more, (B) fails to resume such commercially reasonable marketing efforts within 120 days of having been notified of such failure by MilanaPharm, (C) fails to reasonably demonstrate a strategic justification for the discontinuation and failure to resume to MilanaPharm, and (D) MilanaPharm gives 90 days’ notice to the Company. The following is a summary of other terms of the Assignment Agreement with Hammock: 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 $250,000 to Hammock in connection with the execution of the Assignment Agreement and must pay $250,000 to Hammock (in the Company's discretion either in cash or with shares of the Company's common stock) within 15 days of the first to occur of December 5, 2019 or the closing of an equity financing in which the Company raises aggregate proceeds of at least $10.0 million . 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 payments described above, including the milestone payments. 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 $53,252 and $0 during the years ended December 31, 2018 and 2017 , respectively. |
Grant Award
Grant Award | 12 Months Ended |
Dec. 31, 2018 | |
Receivables [Abstract] | |
Grant Award | GRANT AWARD In April 2018, the Company received a Notice of Award for the first $224,665 of the anticipated $1.9 million in grant funding 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 award will be applied to clinical development efforts supporting Ovaprene. The balance of the award is contingent upon, among other matters, assessment of the results of the first phase of the research and availability of funds. The Company must incur and track expenses eligible for reimbursement under the award and submit a detailed accounting of such expenses to receive payment. As of December 31, 2018 , the Company has received payments totaling $224,665 . Such reimbursement 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. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTS Grant Award On March 11, 2019, the Company announced that it received a Notice of Award for an additional $982,851 of the anticipated $1.9 million in grant funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (See Note 10). The second award followed the NIH's review of an interim data analysis and other results of the first phase of the research supporting Ovaprene. The award will be applied to clinical development efforts supporting Ovaprene. The remaining portion of the award under the grant, $730,722 , is contingent upon, among other matters, assessment that the results of the ongoing Ovaprene study satisfy specified requirements set out in the award notice, and the availability of funds. The Company must incur and track expenses eligible for reimbursement under the award and submit a detailed accounting of such expenses to receive payment. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
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. However, as of December 31, 2018 , the Company had an accumulated deficit of approximately $29.0 million and had cash and cash equivalents of approximately $6.8 million. The Company also had negative cash flow from operations of approximately $10.3 million for the year ended December 31, 2018 . 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. During the first quarter of 2018, the Company received gross proceeds of approximately $11.3 million , resulting in net proceeds of approximately $10.1 million , from sales of its securities in registered offerings (see Note 7). During the third and fourth quarter of 2018, the Company received approximately $225,000 from a federal grant. 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 current cash resources, the Company believes its existing resources will be sufficient to fund planned operations into the third quarter of 2019. For the foreseeable future, the Company's ability to continue its operations will depend upon its ability to obtain additional capital. Although the Company has cash and cash equivalents of approximately $6.8 million at December 31, 2018, the Company will need to raise substantial additional capital to continue to fund its operations and to successfully execute its current operating plan, including the development of its current product candidates. 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 and are prepared using U.S. GAAP. These consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Daré Bioscience Operations, Inc., Daré Bioscience Australia Pty LTD, and Pear Tree Pharmaceuticals, Inc. 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 and Research and Development Costs | Grant Funding The Company receives certain research and development funding through a grant issued by a division of the National Institutes of Health. 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. 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 CRO’s, 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. |
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. |
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 $ 6.8 million and $7.6 million measured at fair value as of December 31, 2018 and 2017 , respectively, are classified within Level 1. Other receivables 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. |
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. |
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. Goodwill is not amortized but is tested annually for impairment or more frequently if impairment indicators exist. The Company adopted accounting guidance related to annual and interim goodwill impairment tests which allows the Company to first assess qualitative factors before performing a quantitative assessment of the fair value of a reporting unit. If it is determined on the basis of qualitative factors that the fair value of the reporting unit is more likely than not less than the carrying amount, a quantitative impairment test is required. The Company recorded goodwill of $12.7 million related to the Cerulean/Private Daré stock purchase transaction on July 19, 2017. The Company assessed goodwill at December 31, 2017 and determined there was an impairment and recognized an impairment charge of approximately $7.5 million in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2017 and reduced the carrying value of goodwill from $12.7 million to approximately $5.2 million on its consolidated balance sheet as of December 31, 2017 . The Company reassessed 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 March 31, 2018, the goodwill carrying value on the Company’s consolidated balance sheet was written off in its entirety. See Note 2, “Acquisitions.” |
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. |
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. All per share figures have been retroactively adjusted for the Reverse Stock Split. There were stock options exercisable into 584,670 and 539,896 shares of common stock outstanding at December 31, 2018 and 2017 , 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, 2018 , the Company did not record any liabilities for uncertain tax positions. During 2018 , the Company recorded a provision for income taxes of $3,200 . There was no provision for income taxes recorded during 2017. Management evaluated the Company’s tax positions and as of December 31, 2018 has approximately $924,000 of unrecognized benefits. The tax years 2015 to 2018 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, 2018 , 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, 2018 and 2017 , no amounts have been accrued related to such indemnification provisions. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Not Yet Adopted 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 is effective for the Company beginning January 1, 2019 and will be adopted using a modified retrospective approach and the effective date will be as of the initial application. Consequently, financial information will not be updated, and the disclosures required under ASU 2016-02 will not be 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 expects to elect 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 expects to record approximately $241,000 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, and expects no changes to the statement of operations or cash flows as a result of the adoption. Recently Adopted Accounting Standards In May 2014, FASB issued Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers , which impacts the way in which some entities recognize revenue for certain types of transactions. The new standard became effective beginning in 2018 for public companies. Because the Company does not currently have any contracts with customers, the Company’s adoption of this accounting standard did not impact the Company’s consolidated financial statements. In August 2016, FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments, which intended to add or clarify guidance on the classification of certain cash receipts and payments on the statement of cash flows. The new guidance addresses cash flows related to debt prepayment or extinguishment costs, settlement of zero-coupon bonds, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies and bank-owned life insurance policies, distributions received from equity method investees, beneficial interest in securitization transactions, and the application of predominance principle to separately identifiable cash flows. The standard became effective on January 1, 2018. The Company's adoption of this standard on January 1, 2018 did not have a material impact on the Company's consolidated financial statements. In January 2017, FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which intended to clarify the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The standard became effective for the Company on January 1, 2018. The Company’s early adoption of this standard did not have a material impact on the Company’s consolidated financial statements. In January 2017, FASB issued ASU 2017-04, Simplifying the Test for Goodwill Impairment (Topic 350) . The guidance removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. The guidance should be adopted on a prospective basis for the annual or any interim goodwill impairment tests beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company’s adoption of this standard on September 30, 2017 did not have a material impact on the Company’s consolidated financial statements. In May 2017, FASB issued ASU 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting, which intended to provide clarity when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The standard became effective for the Company on January 1, 2018. The Company’s adoption of this standard did not have a material impact on the Company’s consolidated financial statements. In July 2017, FASB issued ASU 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815): (I) Accounting for Certain Financial Instruments with Down Round Features, (II) Replacement for the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. This update was issued to provide additional clarity related to accounting for certain financial instruments that have characteristics of both liabilities and equity. In particular, this update addresses freestanding and embedded financial instruments with down round features and whether they should be treated as a liability or equity instrument. Part II simply replaces the indefinite deferral for certain mandatorily redeemable non-controlling interests and mandatorily redeemable financial instruments of nonpublic entities contained within the ASC Topic 480 with a scope exception and does not impact the accounting for these mandatorily redeemable instruments. For public business entities, the amendments in this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The Company has early adopted ASU 2017-11. As a result, the Company has not recognized the fair value of the warrants containing down round features that were issued in the underwritten offering in February 2018 (see Note 7) as liabilities. |
Acquisitions (Tables)
Acquisitions (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Business Combinations [Abstract] | |
Schedule of Purchase Price Consideration Allocation | The total purchase price consideration of approximately $24.3 million represents the fair value of the shares of Cerulean stock issued in connection with the Cerulean/Private Daré stock purchase transaction and the unamortized fair value of the stock options described above, which was allocated as follows: Purchase Consideration (in thousands) Fair value of shares issued $ 20,625 Unamortized fair value of Cerulean options 3,654 Fair value of total consideration $ 24,279 Assets acquired and liabilities assumed Cash and cash equivalents $ 9,918 Prepaid expense and other current assets 1,915 Accounts payable (233 ) Total assets acquired and liabilities assumed 11,600 Goodwill $ 12,679 |
Other Non-Current Assets (Table
Other Non-Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Other Assets, Noncurrent Disclosure [Abstract] | |
Schedule of Other Non-Current Assets | Other non-current assets consisted of the following: As of December 31, 2018 2017 Prepaid insurance, long-term portion $ 562,266 $ 720,391 Deposits 15,702 2,800 Total other non-current assets $ 577,968 $ 723,191 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accrued expenses consisted of the following: As of December 31, 2018 2017 Accrued compensation and benefits expenses $ 416,234 $ 316,024 Accrued legal and professional expenses 32,457 259,600 Accrued clinical and related expenses 182,660 82,810 Total accrued expenses $ 631,351 $ 658,434 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 Domestic $ 16,707 $ 11,503 Foreign 107 18 Loss before taxes $ 16,814 $ 11,521 |
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, 2018 and 2017 are as follows: Years Ended December 31, 2018 2017 Federal statutory rate 21.0 % 34.0 % State income tax, net of federal benefit 2.42 % 1.3 % Permanent differences 0.31 % (2.8 )% Research and development credit 1.24 % 1.9 % Stock compensation (0.08 )% (3.4 )% Federal rate reduction under tax reform — % (204.7 )% Goodwill impairment (6.48 )% (22.1 )% Change in valuation allowance (18.43 )% 195.8 % Effective income tax rate (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, 2018 and 2017 are shown below (in thousands). 2018 2017 Net operating loss carryforwards $ 40,436 $ 32,412 Research and development credit carryforwards 3,321 3,102 Capitalized research and development costs 13,334 15,176 Other amortizable costs 11 3,377 Stock compensation 1,941 1,877 Total deferred tax assets 59,043 55,944 Valuation allowance (59,043 ) (55,944 ) 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: Years Ended December 31, 2018 2017 Beginning uncertain tax benefits $ 846 $ — Current year - increases 78 65 Current year - purchase accounting increases — 781 Ending uncertain tax benefits $ 924 $ 846 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Schedule of Common Stock Outstanding Warrant to Purchase Shares | As of December 31, 2018 , 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, 2018 and 2017 : As of December 31, 2018 2017 Common stock reserved for issuance upon exercise of warrants outstanding 3,750,833 30,502 Common stock reserved for issuance upon exercise of options outstanding 1,635,790 539,896 Common stock reserved for future equity awards (under the Amended 2014 Plan) 421,244 46,479 Total 5,807,867 616,877 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [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, 2018 and 2017 . The exercise price of all options granted during the years ended December 31, 2018 and 2017 was equal to the market value of the Company’s common stock on the date of grant. As of December 31, 2018 , unamortized stock-based compensation expense of $1,035,847 will be amortized over the weighted average period of 3.31 years. Number of Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Outstanding at December 31, 2016 5,000 $ 0.01 Granted 565,372 32.90 Exercised — — Forfeited (30,476 ) 54.25 Outstanding at December 31, 2017 (1) 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 8.77 $ 7,109 Options exercisable at December 31, 2018 584,670 $ 29.03 7.20 $ 7,109 Options vested and expected to vest at December 31, 2018 1,635,790 $ 11.08 8.77 $ 7,109 (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 statement of operations is as follows: Years Ended December 31, 2018 2017 Research and development $ 24,929 $ — General and administrative 114,419 15,832 Total $ 139,348 $ 15,832 |
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, 2018 and 2017 is as follows: 2018 2017 Expected life in years 10 5.4 Risk-free interest rate 2.52 % 1.85 % Expected volatility 121 % 72 % Forfeiture rate — — Dividend yield — % — % Weighted-average fair value of options granted 1.03 4.46 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases | Future minimum annual lease payments under the Company's facility lease as of December 31, 2018, are as follows: Operating Leases 2019 $ 108,570 2020 112,943 2021 67,595 Total minimum lease payments $ 289,108 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | ||||
Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($)Segment | Jan. 01, 2019USD ($) | Jul. 19, 2017USD ($) | Dec. 31, 2016USD ($) | |
Significant Accounting Policies [Line Items] | ||||||
Number of operating segments | Segment | 1 | |||||
Accumulated deficit | $ 28,969,767 | $ 12,230,952 | ||||
Cash and cash equivalents | 6,805,889 | 7,559,846 | $ 44,614 | |||
Cash flow from operations | 10,300,000 | |||||
Gross proceeds from sales of securities in registered offerings | $ 11,300,000 | |||||
Net proceeds from sales of securities in registered offerings | 10,100,000 | |||||
Cash received from federal grant | 224,665 | |||||
Grant funding recognized during period | 225,000 | |||||
Goodwill | 0 | 5,187,519 | $ 12,700,000 | |||
Goodwill impairment charge | $ 5,200,000 | 5,187,519 | 7,490,886 | |||
Income tax provision | 3,200 | 0 | ||||
Unrecognized tax benefits | 924,000 | 846,000 | $ 0 | |||
Fair Value, Measurements, Recurring [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Cash and cash equivalents | 6,800,000 | $ 7,600,000 | ||||
Minimum [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Cash balance of financial institutions insured by federal deposits insurance corporation | $ 250,000 | |||||
Accounting Standards Update 2016-02 [Member] | Subsequent Event [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Right-of-use asset | $ 241,000 | |||||
Lease liability | $ 241,000 |
Acquisitions - Additional Infor
Acquisitions - Additional Information (Detail) - USD ($) | May 16, 2018 | Jul. 19, 2017 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Business Combination Reverse Merger [Line Items] | |||||
Goodwill impairment charge | $ 5,200,000 | $ 5,187,519 | $ 7,490,886 | ||
Goodwill | $ 12,700,000 | $ 0 | $ 5,187,519 | ||
Cerulean Private Dare Stock Purchase Transaction [Member] | |||||
Business Combination Reverse Merger [Line Items] | |||||
Cash and cash equivalents | 9,918,000 | ||||
Unamortized fair value of Cerulean stock options | 3,654,000 | ||||
Transaction costs | 960,000 | ||||
Total purchase price consideration | 24,279,000 | ||||
Purchase price adjustments increase to current liabilities | 23,609 | ||||
Purchase price adjustments increase in current assets | 225,778 | ||||
Original goodwill amount acquired | 12,900,000 | ||||
Reduction to original goodwill | 202,169 | ||||
Goodwill | $ 12,679,000 | ||||
Pear Tree Pharmaceuticals, Inc. [Member] | |||||
Business Combination Reverse Merger [Line Items] | |||||
Consideration amount | $ 132,000 | ||||
Potential cash payment to acquire business | $ 75,000 | ||||
Period of potential cash payment | 1 year | ||||
Pear Tree Pharmaceuticals, Inc. [Member] | Research and Development Expense [Member] | |||||
Business Combination Reverse Merger [Line Items] | |||||
Transaction costs | $ 452,000 |
Acquisitions - Schedule of Purc
Acquisitions - Schedule of Purchase Price Consideration Allocation (Detail) - USD ($) | Jul. 19, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Assets acquired and liabilities assumed | |||
Goodwill | $ 12,700,000 | $ 0 | $ 5,187,519 |
Cerulean Private Dare Stock Purchase Transaction [Member] | |||
Business Combination Reverse Merger [Line Items] | |||
Fair value of shares issued | 20,625,000 | ||
Unamortized fair value of Cerulean options | 3,654,000 | ||
Fair value of total consideration | 24,279,000 | ||
Assets acquired and liabilities assumed | |||
Cash and cash equivalents | 9,918,000 | ||
Prepaid expense and other current assets | 1,915,000 | ||
Accounts payable | (233,000) | ||
Total assets acquired and liabilities assumed | 11,600,000 | ||
Goodwill | $ 12,679,000 |
Convertible Promissory Notes -
Convertible Promissory Notes - Additional Information (Detail) - USD ($) | Feb. 17, 2017 | May 31, 2017 | Jun. 06, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Debt Conversion [Line Items] | ||||||
Convertible promissory notes issued | $ 0 | $ 155,000 | ||||
Convertible notes issued, per share | $ 0.38 | $ 0.18727 | ||||
Minimum [Member] | ||||||
Debt Conversion [Line Items] | ||||||
Percentage of conversion benefit on preferred stock financing | 20.00% | |||||
Percentage of conversion benefit | 125.00% | |||||
Maximum [Member] | ||||||
Debt Conversion [Line Items] | ||||||
Percentage of conversion benefit on preferred stock financing | 40.00% | |||||
Percentage of conversion benefit | 140.00% | |||||
Convertible Notes Payable [Member] | ||||||
Debt Conversion [Line Items] | ||||||
Note annual interest rate | 8.00% | |||||
Convertible promissory notes issued | $ 100,000 | $ 55,000 | ||||
Conversion percentage | 120.00% | |||||
Expense recognized from beneficial conversion feature | $ 0 | $ 316,805 |
Other Non-Current Assets - Sche
Other Non-Current Assets - Schedule of Other Non-Current Assets (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Other Assets, Noncurrent Disclosure [Abstract] | ||
Prepaid insurance, long-term portion | $ 562,266 | $ 720,391 |
Deposits | 15,702 | 2,800 |
Total other non-current assets | $ 577,968 | $ 723,191 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Accrued compensation and benefits expenses | $ 416,234 | $ 316,024 |
Accrued legal and professional expenses | 32,457 | 259,600 |
Accrued clinical and related expenses | 182,660 | 82,810 |
Total accrued expenses | $ 631,351 | $ 658,434 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating Loss Carryforwards [Line Items] | |||
Deferred tax valuation allowance | $ 59,043,000 | $ 55,944,000 | |
Deferred tax assets, increase in valuation allowance | 3,100,000 | $ 55,600,000 | |
Operating loss carryforward, subject to expiration | 135,000,000 | ||
Operating loss carryforwards not subject to expiration | $ 18,800,000 | ||
Federal statutory rate | 21.00% | 34.00% | |
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 | 924,000 | 846,000 | $ 0 |
Unremitted earnings | 0 | ||
Federal [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 153,800,000 | 122,500,000 | |
Net operating loss carryforwards expiration year | 2027 | ||
Federal [Member] | Research Credit Carryforwards [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Research credit carryforwards | $ 2,200,000 | 2,500,000 | |
Research credit carryforwards expiration year | 2027 | ||
State [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 119,900,000 | 102,700,000 | |
Net operating loss carryforwards expiration year | 2032 | ||
State [Member] | Research Credit Carryforwards [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Research credit carryforwards | $ 1,100,000 | $ 2 | |
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, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Domestic | $ 16,707 | $ 11,503 |
Foreign | 107 | 18 |
Loss before taxes | $ 16,814 | $ 11,521 |
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, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory rate | 21.00% | 34.00% |
State income tax, net of federal benefit | 2.42% | 1.30% |
Permanent differences | 0.31% | (2.80%) |
Research and development credit | 1.24% | 1.90% |
Stock compensation | (0.08%) | (3.40%) |
Federal rate reduction under tax reform | 0.00% | (204.70%) |
Goodwill impairment | (6.48%) | (22.10%) |
Change in valuation allowance | (18.43%) | 195.80% |
Effective income tax rate | (0.02%) | 0.00% |
Income Taxes - Summary of Major
Income Taxes - Summary of Major Components of Company's Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 40,436 | $ 32,412 |
Research and development credit carryforwards | 3,321 | 3,102 |
Capitalized research and development costs | 13,334 | 15,176 |
Other amortizable costs | 11 | 3,377 |
Stock compensation | 1,941 | 1,877 |
Total deferred tax assets | 59,043 | 55,944 |
Valuation allowance | (59,043) | (55,944) |
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, 2018 | Dec. 31, 2017 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Beginning uncertain tax benefits | $ 846 | $ 0 |
Current year - increases | 78 | 65 |
Current year - purchase accounting increases | 0 | 781 |
Ending uncertain tax benefits | $ 924 | $ 846 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) | Jul. 20, 2017 | Feb. 28, 2018USD ($)$ / sharesshares | Jan. 31, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Feb. 15, 2018USD ($) |
Class of Stock [Line Items] | |||||||
Gross proceeds from sales of securities in registered offerings | $ | $ 11,300,000 | ||||||
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 | $ | $ 10,111,952 | $ 0 | |||||
Warrants exercised (in shares) | 0 | ||||||
Number of securities expired (in shares) | 170 | ||||||
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 | |||||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.001 | |||||
Common stock, shares issued | 11,422,161 | 6,047,161 | |||||
Common stock, shares outstanding (in shares) | 11,422,161 | 6,047,161 | |||||
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 | 1-for-10 | ||||||
Reverse stock split, conversion ratio | 0.1 | ||||||
ATM Sales Agreement [Member] | |||||||
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 | ||||||
Underwritten Offering [Member] | |||||||
Class of Stock [Line Items] | |||||||
Warrants to purchase common stock (in shares) | 220,500 | ||||||
Underwriters option to purchase additional shares of common stock and warrants period | 30 days | ||||||
Gross proceeds from offering of warrrants | $ | $ 10,300,000 | ||||||
Net proceeds from issuance of common stock and warrants | $ | $ 9,400,000 | ||||||
Exercise price (in usd per share) | $ / shares | $ 3 | ||||||
Class of warrant or right exercisable period | 5 years | ||||||
Maximum [Member] | |||||||
Class of Stock [Line Items] | |||||||
Warrants to purchase common stock (in shares) | 3,500,000 | ||||||
Maximum [Member] | ATM Sales Agreement [Member] | |||||||
Class of Stock [Line Items] | |||||||
Gross proceeds from sales of securities in registered offerings | $ | $ 10,000,000 | ||||||
Aggregate commission rate | 3.00% | ||||||
Maximum [Member] | Underwritten Offering [Member] | |||||||
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 [Member] | |||||||
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, 2018$ / sharesshares |
Class of Stock [Line Items] | |
Shares underlying outstanding warrants (in shares) | 3,750,833 |
Warrants Expiring on December 1, 2021 [Member] | |
Class of Stock [Line Items] | |
Shares underlying outstanding warrants (in shares) | 2,906 |
Exercise price (in usd per share) | $ / shares | $ 120.40 |
Warrants Expiring on December 6, 2021 [Member] | |
Class of Stock [Line Items] | |
Shares underlying outstanding warrants (in shares) | 3,737 |
Exercise price (in usd per share) | $ / shares | $ 120.40 |
Warrants Expiring on January 8, 2020 [Member] | |
Class of Stock [Line Items] | |
Shares underlying outstanding warrants (in shares) | 17,190 |
Exercise price (in usd per share) | $ / shares | $ 60.50 |
Warrants Expiring on April 4, 2026 [Member] | |
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 [Member] | |
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, 2018 | Dec. 31, 2017 |
Class of Stock [Line Items] | ||
Common stock reserved for issuance (in shares) | 5,807,867 | 616,877 |
Exercise of Warrants Outstanding [Member] | ||
Class of Stock [Line Items] | ||
Common stock reserved for issuance (in shares) | 3,750,833 | 30,502 |
Exercise of Options Outstanding [Member] | ||
Class of Stock [Line Items] | ||
Common stock reserved for issuance (in shares) | 1,635,790 | 539,896 |
2014 Stock Incentive Plan [Member] | ||
Class of Stock [Line Items] | ||
Common stock reserved for issuance (in shares) | 46,479 |
Stock-based compensation - Addi
Stock-based compensation - Additional Information (Detail) - USD ($) | Jul. 01, 2018 | Jul. 19, 2017 | Mar. 31, 2017 | Mar. 31, 2014 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock, shares outstanding (in shares) | 11,422,161 | 6,047,161 | ||||||
Stock-based compensation expense | $ 139,348 | $ 15,832 | ||||||
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 | ||||||
Common stock reserved for future issuance (in shares) | 5,807,867 | 616,877 | ||||||
Unamortized stock-based compensation expense | $ 1,035,847 | |||||||
Amortized weighted average period | 3 years 3 months 22 days | |||||||
Common stock, shares issued | 11,422,161 | 6,047,161 | ||||||
Stock Purchase Transaction [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock, shares issued | 3,140,000 | |||||||
2015 Stock Incentive Plan [Member] | Stock Options [Member] | Private Dare [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock options grant period | 10 years | |||||||
Stock options vesting period | 3 years | |||||||
Stock options outstanding (in shares) | 50,000 | 10,149 | 10,149 | |||||
2015 Stock Incentive Plan [Member] | Restricted Stock [Member] | Private Dare [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares issued to non-employees (in shares) | 200,000 | 900,000 | ||||||
Common stock, shares outstanding (in shares) | 223,295 | |||||||
2014 Employee Stock Purchase Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Purchase price as percentage of stock price on offering period | 85.00% | |||||||
Stock-based compensation expense | $ 0 | $ 0 | ||||||
Offering period | 6 months | |||||||
Amended And Restated 2014 Stock Incentive Plan [Member] | Stock Options [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock options outstanding (in shares) | 2,000,000 | 1,635,790 | 539,896 | 5,000 | ||||
Common stock, shares authorized (in shares) | 2,046,885 | |||||||
Annual percentage increase in outstanding number of common stock | 4.00% | |||||||
Exercise period for stock options after termination date | 2 years | |||||||
Unamortized fair value expense | $ 3,700,000 | |||||||
Common stock reserved for future issuance (in shares) | 421,244 | |||||||
Options to purchase number of outstanding shares of common stock (in shares) | 1,635,790 |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of Stock Option Activity (Detail) - Amended And Restated 2014 Stock Incentive Plan [Member] - Stock Options [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Number of Shares | ||
Outstanding beginning balance (in shares) | 539,896 | 5,000 |
Granted (in shares) | 1,096,050 | 565,372 |
Exercised (in shares) | 0 | 0 |
Forfeited (in shares) | (156) | (30,476) |
Outstanding ending balance (in shares) | 1,635,790 | 539,896 |
Options exercisable at December 31, 2018 (in shares) | 584,670 | |
Options vested and expected to vest at December 31, 2018 (in shares) | 1,635,790 | |
Weighted- Average Exercise Price | ||
Outstanding beginning balance (in usd per share) | $ 31.40 | $ 0.01 |
Granted (in usd per share) | 1.08 | 32.90 |
Exercised (in usd per share) | 0 | 0 |
Forfeited (in usd per share) | 59.48 | 54.25 |
Outstanding ending balance (in usd per share) | 11.08 | $ 31.40 |
Options exercisable at December 31, 2018 (in usd per share) | 29.03 | |
Options vested and expected to vest at December 31, 2018 (in usd per share) | $ 11.08 | |
Weighted- Average Remaining Contractual Life (Years) | ||
Outstanding at December 31, 2018 | 8 years 9 months 8 days | |
Options exercisable at December 31, 2018 | 7 years 2 months 11 days | |
Options vested and expected to vest at December 31, 2018 | 8 years 9 months 8 days | |
Aggregate Intrinsic Value | ||
Outstanding at December 31, 2018 | $ 7,109 | |
Options exercisable at December 31, 2018 | 7,109 | |
Options vested and expected to vest at December 31, 2018 | $ 7,109 |
Stock-based Compensation - Comp
Stock-based Compensation - Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 139,348 | $ 15,832 |
Research and Development Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 24,929 | 0 |
General and Administrative Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 114,419 | $ 15,832 |
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, 2018 | Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Expected life in years | 10 years | 5 years 4 months 24 days |
Risk-free interest rate | 2.52% | 1.85% |
Expected volatility | 121.00% | 72.00% |
Forfeiture rate | 0.00% | 0.00% |
Dividend yield | 0.00% | 0.00% |
Weighted-average fair value of options granted (in usd per share) | $ 1.03 | $ 4.46 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | Dec. 05, 2018USD ($) | Jul. 01, 2018USD ($)ft² | Apr. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Feb. 28, 2018USD ($) | Mar. 31, 2017USD ($)Patent | Mar. 31, 2017USD ($)Patent | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($)Country |
Commitments And Contingencies [Line Items] | |||||||||
Square footage of office space | ft² | 3,169 | ||||||||
Term of operating lease | 37 months | ||||||||
Renewal term of operating lease | 1 year | ||||||||
Gross monthly base rent | $ 8,873 | ||||||||
Percentage of increase in annual base rent, each year | 4.00% | ||||||||
Future minimum lease payments | $ 289,108 | ||||||||
Deferred rent | 9,711 | $ 392 | |||||||
License fee | $ 625,000 | 0 | |||||||
Defined contribution plan, employer matching contribution, percent of match | 4.00% | ||||||||
Defined contribution plan, employer matching contributions | $ 53,252 | $ 0 | |||||||
ADVA Tec Agreement [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Number of patents issued | Patent | 9 | 9 | |||||||
Number of pending US patent applications | Patent | 1 | 1 | |||||||
Number of patents granted | Patent | 59 | 59 | |||||||
Number of patent applications in other major markets | Patent | 4 | 4 | |||||||
ADVA Tec Agreement [Member] | Ovaprene [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Prior written notice period for termination of agreement for both parties | 60 days | ||||||||
Agreement termination on failing to enroll patient within months of production and release | 6 months | ||||||||
ADVA Tec Agreement [Member] | Minimum [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Number of designated European countries | Country | 3 | ||||||||
Percentage of royalty rate | 1.00% | ||||||||
ADVA Tec Agreement [Member] | Maximum [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Percentage of royalty rate | 10.00% | ||||||||
Licensing Agreements [Member] | ADVA Tec Agreement [Member] | Minimum [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Percentage of royalty rate | 1.00% | ||||||||
Licensing Agreements [Member] | ADVA Tec Agreement [Member] | Minimum [Member] | Ovaprene [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Minimum spending amounts per year | $ 5,000,000 | $ 5,000,000 | |||||||
Licensing Agreements [Member] | ADVA Tec Agreement [Member] | Maximum [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Percentage of royalty rate | 10.00% | ||||||||
Juniper Pharmaceuticals, Inc. [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
License agreement, termination period prior to receipt of approval | 90 days | ||||||||
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 | ||||||||
License agreement, period of continuation from date of first commercial sale of product or process | 10 years | ||||||||
License agreement notice period of termination for breach of payment obligation | 30 days | ||||||||
Period of dismissal of bankruptcy petition | 90 days | ||||||||
License agreement notice period of termination for breach of other obligation | 60 days | ||||||||
License agreement, notice period of termination | 180 days | ||||||||
Juniper Pharmaceuticals, Inc. [Member] | Clinical And Regulatory Milestones [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Maximum potential milestone payments | $ 13,500,000 | ||||||||
Juniper Pharmaceuticals, Inc. [Member] | Sales Milestones [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Maximum potential milestone payments | $ 30,300,000 | ||||||||
SST [Member] | License And Collaboration Agreement [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Percentage of rights to inventions by employees under license agreement | 50.00% | ||||||||
License agreement, expiration period | 10 years | ||||||||
License agreement, termination period prior to receipt of approval | 90 days | ||||||||
License agreement, termination period after receipt of approval | 180 days | ||||||||
License agreement, termination period for applicable license products of applicable countries | 30 days | ||||||||
License agreement, termination period due to performance failure | 60 days | ||||||||
SST [Member] | License And Collaboration Agreement [Member] | Minimum [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments, contingent amount | $ 500,000 | ||||||||
SST [Member] | License And Collaboration Agreement [Member] | Maximum [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments, contingent amount | 18,000,000 | ||||||||
Orbis [Member] | Development And Option Agreement [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments | $ 300,000 | ||||||||
Commencement period for stage two upon achievement of stage one | 90 days | ||||||||
MilanaPharm [Member] | Licensing Agreements [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
License fee | $ 25,000 | ||||||||
License fee to be paid upon contingency | 200,000 | ||||||||
Proceeds raised from equity financing | 10,000,000 | ||||||||
Hammock Pharmaceuticals, Inc. [Member] | Assignment Agreement [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
License fee | 250,000 | ||||||||
License fee to be paid upon contingency | 250,000 | ||||||||
Proceeds raised from equity financing | 10,000,000 | ||||||||
Upon Achieving Certain Commercial Milestones [Member] | SST [Member] | License And Collaboration Agreement [Member] | Minimum [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments, contingent amount | 10,000,000 | ||||||||
Upon Achieving Certain Commercial Milestones [Member] | SST [Member] | License And Collaboration Agreement [Member] | Maximum [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments, contingent amount | $ 100,000,000 | ||||||||
Upon Achieving Certain Commercial Milestones [Member] | MilanaPharm [Member] | Licensing Agreements [Member] | Maximum [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments, contingent amount | 1,750,000 | ||||||||
Upon Signing Of Development And Option Agreement [Member] | Orbis [Member] | Development And Option Agreement [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments | $ 150,000 | ||||||||
Upon Completion Of Fifty Percent Development Not Later Than Six Months [Member] | Orbis [Member] | Development And Option Agreement [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments | 75,000 | ||||||||
Upon Delivery Of Six Month Batch Development Not Later Than Eleven Months [Member] | Orbis [Member] | Development And Option Agreement [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments | $ 75,000 | ||||||||
Upon Achieving Certain Development Milestones [Member] | MilanaPharm [Member] | Licensing Agreements [Member] | Maximum [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments, contingent amount | 300,000 | ||||||||
Upon Achieving Certain Clinical And Regulatory Development Milestones [Member] | Hammock Pharmaceuticals, Inc. [Member] | Assignment Agreement [Member] | Maximum [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments, contingent amount | $ 1,100,000 | ||||||||
Upon Achievement Of Specified Development And Regulatory Milestones [Member] | ADVA Tec Agreement [Member] | Maximum [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments | 14,600,000 | 14,600,000 | |||||||
Upon Reaching Certain Worldwide Net Sales Milestones [Member] | ADVA Tec Agreement [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments | $ 20,000,000 | ||||||||
Upon Reaching Certain Worldwide Net Sales Milestones [Member] | Licensing Agreements [Member] | ADVA Tec Agreement [Member] | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Milestone payments | $ 20,000,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Rental Payments (Details) | Dec. 31, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2019 | $ 108,570 |
2020 | 112,943 |
2021 | 67,595 |
Total minimum lease payments | $ 289,108 |
Grant Awards - Additional Infor
Grant Awards - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended |
Apr. 30, 2018 | Dec. 31, 2018 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Grants receivable | $ 1,900,000 | |
Cash received from federal grant | $ 224,665 | |
First Phase Of Research And Availability Of Funds [Member] | Eunice Kennedy Shriver National Institute Of Child Health And Human Development [Member] | National Institutes Of Health [Member] | Grant [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Revenue from grant for notice of award | $ 224,665 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) | Mar. 11, 2019 | Apr. 30, 2018 |
Subsequent Event [Line Items] | ||
Grants receivable | $ 1,900,000 | |
Grant [Member] | Eunice Kennedy Shriver National Institute Of Child Health And Human Development [Member] | Second Phase Of Research And Availability Of Funds [Member] | National Institutes Of Health [Member] | Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Revenue from grant for notice of award | $ 982,851 | |
Grant [Member] | Eunice Kennedy Shriver National Institute Of Child Health And Human Development [Member] | Remaining Portion Of Research And Availability Of Funds [Member] | National Institutes Of Health [Member] | Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Revenue from grant for notice of award | $ 730,722 |