Cover Page
Cover Page - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 29, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-36395 | ||
Entity Registrant Name | DARÉ BIOSCIENCE, INC. | ||
Entity Central Index Key | 0001401914 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-4139823 | ||
Entity Address, Address Line One | 3655 Nobel Drive | ||
Entity Address, Address Line Two | Suite 260 | ||
Entity Address, City or Town | San Diego | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92122 | ||
City Area Code | 858 | ||
Local Phone Number | 926-7655 | ||
Title of 12(b) Security | Common Stock, Par Value $0.0001 Per Share | ||
Trading Symbol | DARE | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 22,800 | ||
Entity Common Stock, Shares Outstanding | 47,312,822 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current Assets | ||
Cash and cash equivalents | $ 4,669,467 | $ 4,780,107 |
Other receivables | 460,168 | 555,210 |
Prepaid expenses | 1,854,277 | 1,108,615 |
Total current assets | 6,983,912 | 6,443,932 |
Property and equipment, net | 37,930 | 63,531 |
Other non-current assets | 528,870 | 935,325 |
Total assets | 7,550,712 | 7,442,788 |
Current Liabilities | ||
Accounts payable | 1,021,333 | 1,083,183 |
Accrued expenses | 3,359,718 | 2,098,653 |
Deferred grant funding | 1,564,553 | 2,019,674 |
Note payable | 367,285 | 0 |
Current portion of contingent consideration | 1,000,000 | 0 |
Current portion of lease liabilities | 347,712 | 410,896 |
Total current liabilities | 7,660,601 | 5,612,406 |
Deferred license revenue | 1,000,000 | 0 |
Contingent consideration, net of current portion | 0 | 1,000,000 |
Lease liabilities long-term | 41,844 | 389,556 |
Total liabilities | 8,702,445 | 7,001,962 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity (deficit) | ||
Preferred stock issued | 0 | 0 |
Common stock: $0.0001 par value, 120,000,000 shares authorized, 41,596,253 and 19,683,401 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively | 4,159 | 1,968 |
Accumulated other comprehensive loss | (91,388) | (102,625) |
Additional paid-in capital | 70,366,293 | 44,564,674 |
Accumulated deficit | (71,430,797) | (44,023,191) |
Total stockholders' equity (deficit) | (1,151,733) | 440,826 |
Total liabilities and stockholders' equity (deficit) | $ 7,550,712 | $ 7,442,788 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in usd per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in usd per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 |
Common stock, shares issued (in shares) | 41,596,253 | 19,683,401 |
Common stock, shares outstanding (in shares) | 41,596,253 | 19,683,401 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating expenses | ||
General and administrative | $ 6,549,508 | $ 5,265,438 |
Research and development | 20,769,416 | 8,546,108 |
License fees | 83,333 | 533,334 |
Total operating expenses | 27,402,257 | 14,344,880 |
Loss from operations | (27,402,257) | (14,344,880) |
Other income | 1,514 | 81,050 |
Net loss | (27,400,743) | (14,263,830) |
Deemed dividend from trigger of round down provision feature | (6,863) | (789,594) |
Net loss to common shareholders | (27,407,606) | (15,053,424) |
Foreign currency translation adjustments, net of tax | 11,237 | (5,897) |
Comprehensive loss | $ (27,396,369) | $ (15,059,321) |
Loss per common share - basic and diluted (in usd per share) | $ (0.91) | $ (0.97) |
Weighted average number of common shares outstanding: | ||
Basic and diluted (in shares) | 30,091,469 | 15,578,959 |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity (Deficit) - USD ($) | Total | Public Stock Offering | Common stock | Common stockPublic Stock Offering | Additional Paid-in Capital | Additional Paid-in CapitalPublic Stock Offering | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2018 | 11,422,161 | |||||||
Beginning balance at Dec. 31, 2018 | $ 6,726,620 | $ 1,143 | $ 35,791,972 | $ (96,728) | $ (28,969,767) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock via public offering, net (in shares) | 5,261,250 | |||||||
Issuance of common stock | $ 5,151,702 | $ 525 | $ 5,151,177 | |||||
Equity issued in consideration of acquisition (in shares) | 2,999,990 | |||||||
Equity issued in consideration of acquisition | 2,369,992 | $ 300 | 2,369,692 | |||||
Stock-based compensation | 462,239 | 462,239 | ||||||
Deemed dividend from trigger of round down provision feature | (789,594) | 789,594 | (789,594) | |||||
Net loss | (14,263,830) | (14,263,830) | ||||||
Foreign currency translation adjustments | (5,897) | (5,897) | ||||||
Ending balance (in shares) at Dec. 31, 2019 | 19,683,401 | |||||||
Ending balance at Dec. 31, 2019 | 440,826 | $ 1,968 | 44,564,674 | (102,625) | (44,023,191) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock via public offering, net (in shares) | 19,791,989 | |||||||
Issuance of common stock | $ 22,977,407 | $ 1,979 | 22,975,428 | |||||
Equity issued in consideration of acquisition (in shares) | 1,825,000 | |||||||
Issuance of common stock from the exercise of warrants | $ 1,785,979 | $ 182 | 1,785,797 | |||||
Stock-based compensation | 742,031 | 742,031 | ||||||
Issuance cost on equity line paid in common stock (in shares) | 285,714 | |||||||
Issuance cost on equity line paid in common stock | 291,529 | $ 29 | 291,500 | |||||
Deemed dividend from trigger of round down provision feature | (6,863) | 6,863 | (6,863) | |||||
Stock options exercised (in shares) | 10,149 | |||||||
Stock options exercised | 1 | $ 1 | ||||||
Net loss | (27,400,743) | (27,400,743) | ||||||
Foreign currency translation adjustments | 11,237 | 11,237 | ||||||
Ending balance (in shares) at Dec. 31, 2020 | 41,596,253 | |||||||
Ending balance at Dec. 31, 2020 | $ (1,151,733) | $ 4,159 | $ 70,366,293 | $ (91,388) | $ (71,430,797) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities: | ||
Net loss | $ (27,400,743) | $ (14,263,830) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 43,227 | 11,137 |
Stock-based compensation | 742,031 | 462,239 |
Non-cash operating lease cost | (162,167) | (29,121) |
Acquisition-related IPR&D | 0 | (202,096) |
Changes in operating assets and liabilities, net of impact of acquisition: | ||
Other receivables | 95,042 | (201,423) |
Prepaid expenses | (454,133) | (322,482) |
Other non-current assets and deferred charges | 157,725 | 237,937 |
Accounts payable | (61,850) | 608,650 |
Accrued expenses | 1,261,065 | 621,618 |
Deferred grant funding | (455,121) | (238,109) |
Deferred license revenue | 1,000,000 | 0 |
Net cash used in operating activities | (25,234,924) | (13,315,480) |
Investing activities: | ||
Acquisition of Microchips cash | 0 | 6,143,893 |
Purchases of property and equipment | (17,625) | 0 |
Net cash provided by (used in) investing activities | (17,625) | 6,143,893 |
Financing activities: | ||
Net proceeds from issuance of common stock | 22,977,407 | 5,151,702 |
Proceeds from the exercise of common stock warrants | 1,785,979 | 0 |
Proceeds from the exercise of stock options | 1 | 0 |
Proceeds from issuance of note payable | 367,285 | 0 |
Net cash provided by financing activities | 25,130,672 | 5,151,702 |
Effect of exchange rate changes on cash and cash equivalents | 11,237 | (5,897) |
Net change in cash and cash equivalents | (110,640) | (2,025,782) |
Cash and cash equivalents, beginning of year | 4,780,107 | 6,805,889 |
Cash and cash equivalents, end of year | 4,669,467 | 4,780,107 |
Supplemental disclosure of non-cash operating, investing and financing activities: | ||
Operating right-of-use assets obtained in exchange for new operating lease liabilities | 0 | 583,697 |
Issuance cost on equity paid in common stock | 291,529 | 0 |
Deemed dividend from trigger of down round provision | 6,863 | 789,594 |
Microchips acquisition consideration paid in equity | $ 0 | $ 2,369,992 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | ORGANIZATION AND DESCRIPTION OF BUSINESS Organization and business Daré Bioscience, Inc. is a clinical-stage biopharmaceutical company committed to advancing innovative products for women’s health. Daré Bioscience, Inc. and its wholly owned subsidiaries operate one segment. In this report, the “Company” refers collectively to Daré Bioscience, Inc. and its wholly owned subsidiaries, unless otherwise stated or the context otherwise requires. The Company is driven by a mission to identify, develop and bring to market a diverse portfolio of 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 in-license or otherwise acquire the rights to differentiated product candidates in the Company's areas of focus, some of which have existing clinical proof-of-concept data, to take those candidates through mid to late-stage clinical development, and to establish and leverage strategic partnerships to achieve commercialization. Since July 2017, the Company has assembled a portfolio of clinical-stage and pre-clinical-stage candidates. While the Company will continue to assess opportunities to expand its portfolio, its current focus is on advancing its existing product candidates through mid and late stages of clinical development or FDA approval. The Company's portfolio includes three product candidates in advanced clinical development: • DARE - BV1 , a novel thermosetting bioadhesive hydrogel formulated with clindamycin phosphate 2% to be administered in a single vaginally delivered application , as a first line treatment for bacterial vaginosis; • Ovaprene® , a hormone-free, monthly vaginal contraceptive; and • Sildenafil Cream , 3 . 6% , a proprietary cream formulation of sildenafil for topical administration to the vulva and vagina for treatment of female sexual arousal disorder; The Company's portfolio also includes three product candidates in Phase 1 clinical development or that it believes are Phase 1-ready: • DARE-HRT1 , a combination bio-identical estradiol and progesterone intravaginal ring for the treatment of menopausal symptoms, including vasomotor symptoms, as part of a hormone therapy following menopause; • DARE - FRT1 , an intravaginal ring containing bio-identical progesterone for the prevention of preterm birth and broader luteal phase support as part of an in vitro fertilization treatment plan; and • DARE - VVA1 , a vaginally delivered formulation of tamoxifen to treat vulvar vaginal atrophy , or VVA , in patients with hormone- receptor positive breast cancer; In addition, the Company's portfolio includes these pre-clinical stage product candidates: • DARE-LARC1 , a combination product designed to provide long-acting, reversible contraception comprising an implantable, user-controlled wireless drug delivery system and levonorgestrel; • ORB-204 and ORB-214 , injectable formulations of etonogestrel designed to provide contraception over 6-month and 12-month periods, respectively; and • DARE-RH1 , a novel approach to non - hormonal contraception for both men and women by targeting the CatSper ion channel . The Company’s primary operations have consisted of, and are expected to continue to consist primarily of, product research and development and advancing its portfolio of product candidates through clinical development and regulatory approval. The Company expects that the majority of its research and development expenses in 2021 and 2022 will support the advancement of DARE-BV1, Ovaprene and Sildenafil Cream, 3.6%. To date, the Company has not obtained any regulatory approvals for any of its product candidates, commercialized any of its product candidates or generated any product revenue. The Company is subject to several risks common to clinical-stage biopharmaceutical companies, including dependence on key individuals, competition from other companies, the need to develop commercially viable products in a timely and cost-effective manner, and the need to obtain adequate additional capital to fund the development of product candidates. The Company is also subject to several risks common to other companies in the industry, including rapid technology change, regulatory approval of products, uncertainty of market acceptance of products, competition from substitute products and larger companies, compliance with government regulations, protection of proprietary technology, dependence on third parties, and product liability. The effect of the COVID-19 pandemic and efforts to reduce the spread of COVID-19 remain a rapidly evolving and uncertain risk to our business, operating results, financial condition and stock price. In November 2020, the U.S. began to experience a substantial surge in cases and hospitalizations and intensive care unit capacity became strained. States and counties across the country imposed or re-imposed stay-at-home orders and shutdowns of non-essential businesses in efforts to reduce spread of the disease. As of March 29, 2021, the U.S. Food and Drug Administration (FDA) had issued emergency use authorizations for three vaccines for the prevention of COVID-19. However, while President Biden recently said that there will be enough vaccine supply for every adult in the U.S. by the end of May 2021, the vaccination effort in the U.S. and elsewhere got off to a bumpy start and continues to face significant, complex challenges, and the timeline for the pandemic and its associated restrictions to end remain uncertain. Given the high level of uncertainty regarding the duration and impact of the pandemic on the U.S. and global economies, workplace environments and capital markets, the Company is unable to assess the full extent of the effects of the pandemic on its business. These effects could have a material adverse impact on the Company's business, operating results and financial condition, including, without limitation, by adversely impacting the Company's ability to raise capital when needed or on terms favorable or acceptable to the Company, and increasing the anticipated aggregate costs and timelines for the development and marketing approval of the Company's product candidates. For further discussion of risks and uncertainties related to the COVID-19 pandemic, see the risk factor titled, The COVID-19 pandemic and efforts to reduce the spread of COVID-19 could negatively impact our business, including by increasing the cost and timelines for our clinical development programs. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES 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 prepared its consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The Company has a history of losses from operations, expects negative cash flows from its operations to continue for the foreseeable future, and expects that its net losses will continue for at least the next several years as it develops and seeks to bring to market its existing product candidates and potentially acquire, license and 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 reclassification 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. At December 31, 2020, the Company had an accumulated deficit of approximately $71.4 million, had cash and cash equivalents of approximately $4.7 million, and a working capital deficit of approximately $0.7 million. For the year ended December 31, 2020, the Company incurred a net loss of $27.4 million and had negative cash flow from operations of approximately $25.2 million. The Company’s primary uses of capital are, and the Company expects will continue to be, staff-related expenses, the cost of clinical trials and regulatory activities related to its product candidates, costs associated with contract manufacturing services and third-party clinical research and development services, payments due under license agreements and its merger agreement with Microchips upon the successful achievement of milestones of the Company’s product candidates, legal expenses, other regulatory expenses and general overhead costs. The Company’s future funding requirements could also include significant costs related to commercialization of its product candidates, if approved, depending on the type and nature of commercial partnerships the Company establishes. The Company expects its expenses, and in particular its research and development expenses, to increase significantly in 2021 compared to 2020 as it continues to develop and seek to bring to market its product candidates, with a focus on DARE-BV1, Ovaprene and Sildenafil Cream, 3.6% To date, the Company has not obtained any regulatory approvals for any of its product candidates, commercialized any of its product candidates or generated any product revenue, and the Company cannot anticipate if or when it will generate any revenue. The Company has devoted significant resources to acquiring its portfolio of product candidates and to research and development activities for its product candidates. The Company must obtain regulatory approvals to market and sell any of its products in the future. The Company will need to generate sufficient safety and efficacy data on its product candidates for them to receive regulatory approvals and to be attractive assets for potential strategic partners to license or for pharmaceutical companies to acquire, and for the Company to generate cash and other license fees related to such product candidates. Based on the Company's current operating plan estimates, the Company does not have sufficient cash to satisfy its working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying financial statements. The Company needs to raise substantial additional capital to continue to fund its operations and to successfully execute its current operating plan, including the development of its product candidates. The Company is currently evaluating a variety of capital raising options, including equity and debt 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, particularly in light of the effects that the COVID-19 pandemic has recently had on the capital markets and investor sentiment. In addition, equity or debt financings may have a dilutive effect on the holdings of the Company's existing stockholders, and debt financings may subject the Company to restrictive covenants, operational restrictions and security interests in our assets. If the Company cannot raise capital when needed, on favorable terms or at all, the Company will not be able to continue development of its product candidates, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations. If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values at which they are carried on its consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Principles of Consolidation The consolidated financial statements of the Company are stated in U.S. dollars. These consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. One wholly owned subsidiary, Daré Bioscience Australia Pty LTD, operates primarily in Australia. The financial statements of the Company’s wholly owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated Other Comprehensive Loss. All intercompany transactions and accounts have been eliminated in consolidation. Grant Funding The Company receives certain research and development funding through grants issued by a division of the National Institutes of Health and the Bill & Melinda Gates Foundation, or the Gates Foundation. The funding is recognized in the statement of operations as a reduction to research and development expense as the related costs are incurred to meet those obligations over the grant period. The Company adopted this policy in 2018. For the years ended December 31, 2020 and December 31, 2019, the Company recognized approximately $3.7 million and $1.3 million, respectively, in the statement of operations as a reduction to research and development expense. Grant funding payments received in advance of research and development expenses incurred are recorded as deferred grant payments liability in the Company's consolidated balance sheets. Use of Estimates The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the fair value of stock-based compensation, and purchase accounting. Actual results could differ from those estimates and could materially affect the reported amounts of assets, liabilities and future operating results. Risks and Uncertainties The Company will require approvals from the U.S. Food and Drug Administration, or FDA, or foreign regulatory agencies prior to being able to sell any products. There can be no assurance that the Company’s current or future product candidates will receive the necessary approvals. If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations and its financial position. The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the ability to license product candidates, successfully develop product candidates, raise additional capital, compete with other products, and protect proprietary technology. In the event the Company receives a regulatory approval for a product, the market’s acceptance of the product remains a risk. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success. Cash and Cash Equivalents The Company considers cash and all highly liquid investments with an original maturity of three months or less to be cash and cash equivalents. The Company’s wholly owned subsidiary, Microchips Biotech, Inc., has a $35,903 letter of credit related to the lease of real property that serves as security for future default of lease payments. The letter of credit is collateralized by cash which is unavailable for withdrawal or for usage for general obligations and is included in cash and cash equivalents on the Company's consolidated balance sheet. Concentration of Credit Risk The Company maintains cash balances at various financial institutions and such balances commonly exceed the $250,000 amount insured by the Federal Deposit Insurance Corporation. The Company also maintains money market funds at various financial institutions which are not federally insured although are invested primarily in the U.S. The Company has not experienced any losses in such accounts and management believes that the Company does not have significant risk with respect to such cash and cash equivalents. Fair Value of Financial Instruments 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. The following tables present the classification within the fair value hierarchy of financial assets and liabilities that are remeasured on a recurring basis as of December 31, 2020 and December 31, 2019. There were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 2) as of December 31, 2020 . Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at December 31, 2020 Current assets: Cash equivalents (1) $ 2,823,099 $ — $ — $ 2,823,099 Current liabilities: Current portion of contingent consideration (2) $ — $ — $ 1,000,000 $ 1,000,000 Balance at December 31, 2019 Current assets: Cash and cash equivalents $ 4,780,107 $ — $ — $ 4,780,107 Other non-current liabilities: Contingent consideration, net of current portion (2) $ — $ — $ 1,000,000 $ 1,000,000 (1) Represents the cash held in money market funds. (2) Represents t he estimated fair value of the contingent consideration potentially payable by the Company related to its acquisition of Microchips Biotech, Inc., as described in Note 4. Revenue Recognition The Company recognizes revenue is accordance with Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers , which applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. The Company recognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligations. At contract inception, the Company assesses the goods or services agreed upon within each contract and assess whether each good or service is distinct and determine those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. In a contract with multiple performance obligations, the Company develops estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation, which determines how the transaction price is allocated among the performance obligations. The estimation of the stand-alone selling price(s) may include estimates regarding forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time. Any change made to estimated progress towards completion of a performance obligation and, therefore, revenue recognized will be recorded as a change in estimate. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. License Fees. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in a contract, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. To date, the Company has not recognized any license fee revenue resulting from any of its collaborative arrangements. Royalties. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its collaborative arrangements. Bayer License. In January 2020, the Company entered into a license agreement with Bayer HealthCare LLC, or Bayer, regarding the further development and commercialization of Ovaprene in the U.S. Upon execution of the agreement, the Company received a $1.0 million upfront non-refundable license fee payment from Bayer. Bayer, in its sole discretion, has the right to make the license effective by paying the Company an additional $20.0 million. The Company concluded that there was one significant performance obligation related to the $1.0 million upfront payment: a distinct license to commercialize Ovaprene effective upon the receipt of the $20.0 million fee. The $1.0 million upfront payment will be recorded as license revenue at the earlier of (1) the point in time the Company receives the $20.0 million fee, the license is transferred to Bayer and Bayer is able to use and benefit from the license and (2) the termination of the agreement. As of December 31, 2020, neither of the foregoing had occurred. The $1.0 million payment is recorded as long term deferred revenue in the Company's consolidated balance sheet at December 31, 2020. The Company will also be entitled to receive (a) milestone payments totaling up to $310.0 million related to the commercial sales of Ovaprene, if all such milestones are achieved, and (b) tiered royalties starting in the low double digits based on annual net sales of Ovaprene during a calendar year, subject to customary royalty reductions and offsets, and (c) a percentage of sublicense revenue. Potential future payments for variable consideration, such as commercial milestones, will be recognized when it is probable that, if recorded, a significant reversal will not take place. Potential future royalty payments will be recorded as revenue when the associated sales occur. (See Note 3, License and Collaboration Agreements.) Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use, or ROU, lease assets, current portion of lease obligations, and long-term lease obligations on the Company's consolidated balance sheets. ROU lease assets represent the Company's right to use an underlying asset for the lease term and lease obligations represent the Company's obligation to make lease payments arising from the lease. Operating ROU lease assets and obligations are recognized at the commencement date based on the present value of lease payments over the lease term. If the lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The ROU lease asset also includes any lease payments made and excludes lease incentives. The Company's lease terms may include options to extend or terminate the lease and the related payments are only included in the lease liability when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. (See Note 11, Leased Properties.) Business Combinations Assets acquired and liabilities assumed as part of a business acquisition are recorded at their estimated fair value at the date of acquisition. The excess of the total purchase consideration over the fair value of assets acquired and liabilities assumed is recorded as goodwill. Determining fair value of identifiable assets, particularly intangibles, and liabilities acquired also requires management to make estimates, which are based on all available information and, in some cases, assumptions with respect to the timing and amount of future revenue and expenses associated with an asset. Acquired In-Process Research and Development Expense The Company has acquired, and may continue to acquire, the rights to develop new product candidates. Payments to acquire a new product candidate, as well as future milestone payments associated with asset acquisitions which are deemed probable of achievement, are immediately expensed as acquired in-process research and development provided that the product candidate has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. 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 CROs and investigative sites, transaction expenses incurred in connection with the expansion of the product portfolio through acquisitions and license and option agreements, milestone payments incurred or probable to be incurred for the Company's in-licensing arrangements, payments to universities under the Company’s license agreements and other outside expenses. Research and development costs are expensed as incurred. Nonrefundable advance payments, if any, for goods and services used in research and development are recognized as an expense as the related goods are delivered or services are performed. Net Loss Per Share Basic net loss attributable to common stockholders per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive. There were stock options exercisable into 2,786,591 and 1,889,775 shares of common stock outstanding at December 31, 2020 and 2019, respectively. There were warrants exercisable into 1,908,643 and 3,750,833 shares of common stock outstanding at December 31, 2020 and 2019, 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, 2020, the Company did not record any liabilities for uncertain tax positions. During each 2020 and 2019, the Company recorded no provision for income taxes. Management evaluated the Company’s tax positions and, as of December 31, 2020, the Company has approximately $1.3 million of unrecognized benefits. The tax years 2016 to 2020 remain open to examination by federal and state taxing authorities while the statute of limitations for U.S. net operating losses generated remain open beginning in the year of utilization. Indemnification Obligations As permitted under Delaware law, the Company has entered into indemnification agreements with its officers and directors that provide that the Company will indemnify its 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, 2020, 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, 2020 and 2019, no amounts have been accrued related to such indemnification provisions. |
License and Collaboration Agree
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License and Collaboration Agreements | LICENSE AND COLLABORATION AGREEMENTS Out-License Agreements Bayer HealthCare License Agreement On January 10, 2020, the Company entered into a license agreement with Bayer, regarding the further development and commercialization of Ovaprene in the U.S. Under the agreement, the Company received a $1.0 million upfront non-refundable license fee payment from Bayer. If Bayer pays an additional $20.0 million to the Company after Bayer receives and reviews the results of the pivotal clinical trial of Ovaprene, which payment Bayer may elect to make in its sole discretion, the license grant to Bayer to develop and commercialize Ovaprene for human contraception in the U.S. becomes effective. Milestone & Royalty Payments . The Company will be entitled to receive (a) a milestone payment in the low double-digit millions upon the first commercial sale of Ovaprene in the U.S. and escalating milestone payments based on annual net sales of Ovaprene during a calendar year, totaling up to $310.0 million if all such milestones, including the first commercial sale, are achieved, (b) tiered royalties starting in the low double digits based on annual net sales of Ovaprene during a calendar year, subject to customary royalty reductions and offsets, and (c) a percentage of sublicense revenue. Efforts. The Company is responsible for the pivotal trial for Ovaprene and for its development and regulatory activities and has product supply obligations. Bayer is supporting the Company in development and regulatory activities by providing up to two full-time equivalents with expertise in clinical, regulatory, preclinical, commercial, CMC and product supply matters in an advisory capacity. After payment of the $20.0 million fee, Bayer will be responsible for the commercialization of Ovaprene for human contraception in the U.S. Term. The initial term of the agreement, which is subject to automatic renewal terms, continues until the later of (a) the expiration of any valid claim covering the manufacture, use, sale or import of Ovaprene in the U.S.; or (b) 15 years from the first commercial sale of Ovaprene in the U.S. In addition to customary termination rights for both parties, Bayer may terminate the agreement at any time on 90 days' notice and the agreement will automatically terminate if the Company does not receive the $20.0 million fee if and when due. In-License Agreements Hammock/MilanaPharm Assignment and License Agreement In December 2018, the Company entered into (a) an Assignment Agreement with Hammock Pharmaceuticals, Inc., or the Assignment Agreement, and (b) a First Amendment to License Agreement with TriLogic Pharma, LLC and MilanaPharm LLC, or the License Amendment. Both agreements relate to the Exclusive License Agreement among Hammock, TriLogic and MilanaPharm dated as of January 9, 2017, or the MilanaPharm License Agreement. Under the Assignment Agreement and the MilanaPharm License Agreement, as amended by the License Amendment, the Company acquired an exclusive, worldwide license under certain intellectual property to, among other things, develop and commercialize products for the diagnosis, treatment and prevention of human diseases or conditions in or through any intravaginal or urological applications. The licensed intellectual property relates to the hydrogel drug delivery platform of TriLogic and MilanaPharm known as TRI-726. In DARE-BV1, this proprietary technology is formulated with clindamycin for the treatment of bacterial vaginosis. In December 2019, the Company entered into amendments to each of the Assignment Agreement and License Amendment. The following is a summary of other terms of the License Amendment, as amended: License Fees. A total of $235,000 in license fees were payable, and were paid to, MilanaPharm: (1) $25,000 in connection with the execution of the License Amendment; (2) $100,000 in 2019; and (3) $110,000 in 2020. Milestone Payments. The Company will pay to MilanaPharm (1) up to $300,000 in the aggregate upon achievement of certain clinical and regulatory development milestones; $50,000 of which was paid during the second quarter of 2020, 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 (1) the expiration date of the last valid claim of the licensed patent rights that cover the method of use of such product or process in such country, or (2) 10 years following the first commercial sale of such product or process in such country. Royalty payments are subject to reduction in certain circumstances, including as a result of generic competition, patent prosecution expenses incurred by the Company, or payments to third parties for rights or know-how required for us to exercise the licenses granted to it under the MilanaPharm License Agreement or that are strategically important or could add value to a licensed product or process in a manner expected to materially generate or increase sales. Efforts. 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 license term continues until (1) on a licensed product-by-product (or process-by-process basis) and country-by-country basis, the date of expiration of the royalty term with respect to such licensed product in such country, and (2) the expiration of all applicable royalty terms under the MilanaPharm License Agreement with respect to all licensed products and processes in all countries. Upon expiration of the term with respect to any licensed product or process in a country (but not upon earlier termination of the MilanaPharm License Agreement), the licenses granted to 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) discontinue all commercially reasonable marketing efforts to sell, and discontinue all sales of, such product or process in such country for nine months or more, (B) fail to resume such commercially reasonable marketing efforts within 120 days of having been notified of such failure by MilanaPharm, (C) fail to reasonably demonstrate a strategic justification for the discontinuation and failure to resume to MilanaPharm, and (D) MilanaPharm gives 90 days’ notice to the Company. The following is a summary of other terms of the Assignment Agreement, as amended: Assignment; Technology Transfer . Hammock assigned and transferred to the Company all of its right, title and interest in and to the MilanaPharm License Agreement and agreed to cooperate to transfer to the Company all of the data, materials and the licensed technology in its possession pursuant to a technology transfer plan to be agreed upon by the parties, with a goal for the Company to independently practice the licensed intellectual property as soon as commercially practical in order to develop and commercialize the licensed products and processes. Fees. A total of $512,500 in fees were payable, and were paid, to Hammock: (1) $250,000 in connection with the execution of the Assignment Agreement; (2) $125,000 in 2019; and (3) $137,500 in 2020. Milestone Payments. The Company will pay Hammock up to $1.1 million in the aggregate upon achievement of certain clinical and regulatory development milestones. Term. The Assignment Agreement will terminate upon the later of (1) completion of the parties' technology transfer plan, and (2) payment to Hammock of the last of the milestone payments. ADVA-Tec License Agreement In March 2017, the Company entered into a license agreement with ADVA-Tec, Inc., under which the Company was granted the exclusive right to develop and commercialize Ovaprene for human contraceptive use worldwide. The Company must use commercially reasonable efforts to develop and commercialize Ovaprene and must meet certain minimum spending amounts per year, and $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 $20.0 million in the aggregate based on the achievement of certain worldwide net sales milestones. Royalty Payments . After the commercial launch of Ovaprene, the Company will pay to ADVA-Tec royalties based on aggregate annual net sales of Ovaprene in specified regions, at a royalty rate that will vary between 1% and 10% and will increase based on various net sales thresholds. Term . Unless earlier terminated, the license continues on a country-by-country basis until the later of the life of the licensed patents or final 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 to which the Company and ADVA-Tec agree, 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 the Company’s reasonable control. SST License and Collaboration Agreement In February 2018, the Company entered into a license and collaboration agreement with Strategic Science & Technologies-D, LLC and Strategic Science & Technologies, LLC, referred to collectively as SST, under which the Company received an exclusive, royalty-bearing, sublicensable license to develop and commercialize, in all countries and geographic territories of the world, for all indications for women related to female sexual dysfunction and/or female reproductive health, including the treatment of female sexual arousal disorder, or the Field of Use, SST’s topical formulation of Sildenafil Cream, 3.6% as it existed as of the effective date of the agreement, or any other topically applied pharmaceutical product containing sildenafil or a salt thereof as a pharmaceutically active ingredient, alone or with other active ingredients, but specifically excluding any product containing ibuprofen or any salt derivative of ibuprofen, or the Licensed Products. The following is a summary of other terms of this license and collaboration agreement: Invention Ownership. The Company retains rights to inventions made by its employees, SST retains rights to inventions made by its employees, and each party shall own a 50% undivided interest in all joint inventions. Joint Development Committee. The parties will collaborate through a joint development committee that will determine the strategic objectives for, and generally oversee, the development efforts of both parties under the agreement. Development. The Company must use commercially reasonable efforts to develop the Licensed Products in the Field of Use in accordance with a development plan in the agreement, and to commercialize the Licensed Products in the Field of Use. The Company is responsible for all reasonable internal and external costs and expenses incurred by SST in its performance of the development activities it must perform under the agreement. Royalty Payments. SST will be eligible to receive tiered royalties based on percentages of annual net sales of Licensed Products in the single digits to the mid double digits, subject to customary royalty reductions and offsets, and a percentage of sublicense revenue. Milestone Payments. SST will be eligible to receive payments (1) ranging from $0.5 million to $18.0 million in the aggregate on achieving certain clinical and regulatory milestones in the U.S. and worldwide, and (2) between $10.0 million to $100.0 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. Term. The Company’s license 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 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 NDA approval, the Company may terminate the agreement without cause upon 90 days prior written notice; (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 agreement without cause upon 180 days prior written notice; and (3) SST may terminate the agreement with respect to the applicable Licensed Product(s) in the applicable country(ies) upon 30 days’ notice if the Company fails to use commercially reasonable efforts to perform development activities in substantial accordance with the development plan and do not cure such failure within 60 days of receipt of SST's notice thereof. Catalent JNP License Agreement In April 2018, the Company entered into an exclusive license agreement with Catalent JNP, Inc. (formerly known as Juniper Pharmaceuticals, Inc., and which the Company refers to as Catalent), under which Catalent granted the Company (a) an exclusive, royalty-bearing worldwide license under certain patent rights, either owned by or exclusively licensed to Catalent, to make, have made, use, have used, sell, have sold, import and have imported products and processes; and (b) a non-exclusive, royalty-bearing worldwide license to use certain technological information owned by Catalent to make, have made, use, have used, sell, have sold, import and have imported products and processes. The Company is entitled to sublicense the rights granted to it under this agreement. Upfront Fee. The Company paid a $250,000 non-creditable upfront license fee to Catalent in connection with the execution of the agreement. Annual Maintenance Fee. The Company will pay an annual license maintenance fee to Catalent on each anniversary of the date of the agreement, the amount of which will be $50,000 for the first two years and $100,000 thereafter, and which will be creditable against royalties and other payments due to Catalent in the same calendar year but may not be carried forward to any other year. Milestone Payments. The Company must make potential future development and sales milestone payments of (1) up to $13.5 million in the aggregate upon achieving certain clinical and regulatory milestones, and (2) up to $30.3 million in the aggregate upon achieving certain commercial sales milestones for each product or process covered by the licenses granted under the agreement. Royalty Payments . During the royalty term, the Company will pay Catalent mid-single-digit to low double-digit royalties based on worldwide net sales of products and processes covered by the licenses granted under the agreement. In lieu of such royalty payments, the Company will pay Catalent a low double-digit percentage of all sublicense income the Company receives for the sublicense of rights under the agreement to a third party. 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 agreement. Term. Unless earlier terminated, the term of the 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 agreement, the licenses granted thereunder will convert automatically to fully-paid irrevocable licenses. Catalent may terminate the agreement (1) upon 30 days’ notice for the Company’s uncured breach of any payment obligation under the 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 the Company’s other obligations under the agreement. The Company may terminate the 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 Catalent terminates the agreement for the reason described in clause (4) above or if the Company terminates the agreement, Catalent will have full access including the right to use and reference all product data generated during the term of the agreement that is owned by the Company. Adare Development and Option Agreement In March 2018, the Company entered into an exclusive development and option agreement with Adare Pharmaceuticals (formerly known as Orbis Biosciences, and which the Company refers to as Adare), for the development of long-acting injectable etonogestrel contraceptive with 6- and 12-month durations (ORB-204 and ORB-214, respectively). Under this agreement, the Company paid Adare $300,000 to conduct the first stage of development work, Stage 1, as follows: $150,000 upon signing the agreement, $75,000 at the 50% completion point, not later than 6 months following the date the agreement was signed (which the Company paid in September 2018), and $75,000 upon delivery by Adare of the 6-month batch, not later than 11 months following the date the agreement was signed (which the Company paid in January 2019). Upon Adare successfully completing the first stage of development work and achieving the predetermined target milestones for that stage, the Company will have 90 days to instruct Adare whether to commence the second stage of development work. Should the Company execute its option to proceed with the second stage, it will have to provide additional funding to Adare 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 Adare will continue to advance the program through formulation optimization with the goal of achieving sustained release over the target time period. The agreement provides the Company with an option to enter into a license agreement for ORB-204 and ORB-214 should development efforts be successful. Acquired Products Microchips Acquisition As further discussed in Note 4. Acquisition below, in November 2019, the Company acquired Microchips Biotech, Inc., or Microchips. The Company acquired Microchips to secure the rights to develop an implantable, user-controlled, long-acting reversible contraception method, now known as DARE-LARC1. The Company issued an aggregate of 2,999,990 shares of its common stock to the holders of shares of Microchips' capital stock outstanding immediately prior to the effective time of the merger. The Company also agreed to pay the following contingent consideration to the former Microchips stockholders: (a) up to $46.5 million contingent upon the achievement of specified funding, product development and regulatory milestones; (b) up to $55.0 million contingent upon the achievement of specified amounts of aggregate net sales of products incorporating the intellectual property acquired by the Company in the merger; (c) tiered royalty payments ranging from low single-digit to low double-digit percentages of annual net sales of such products, subject to customary provisions permitting royalty reductions and offset; and (d) a percentage of sublicense revenue related to such products. The Company agreed to use commercially reasonable efforts to achieve specified development and regulatory objectives relating to DARE-LARC1. The Company recorded $1.0 million in contingent consideration associated with milestone payments it expects to become payable in the first half of 2021, and if and when they become due and payable, the Company may pay the milestones in cash, shares of the Company's common stock or with some combination of both. Pear Tree Acquisition In May 2018, the Company completed its acquisition of Pear Tree Pharmaceuticals, Inc., or Pear Tree. The Company acquired Pear Tree to secure the rights to develop a proprietary vaginal formulation of tamoxifen, now known as DARE-VVA1, as a potential treatment for vulvar and vaginal atrophy. Milestone Payments . The Company must make contingent payments to the Pear Tree former stockholders and their representatives, or the Holders, that are based on achieving certain clinical, regulatory and commercial |
Acquisition
Acquisition | 12 Months Ended |
Dec. 31, 2020 | |
Business Combinations [Abstract] | |
Acquisition | ACQUISITION In November 2019, the Company acquired Microchips Biotech, Inc., or Microchips, via a merger transaction in which a wholly owned subsidiary the Company, formed for purposes of the transaction, merged with and into Microchips , and Microchips survived as the Company’s wholly owned subsidiary. Microchips is developing a proprietary, implantable drug delivery system designed to store and precisely deliver numerous therapeutic doses over months and years on a schedule determined by the user and controlled via wireless remote. Microchips’ lead product candidate is a pre-clinical stage contraceptive application of that technology that utilizes levonorgestrel, now known as DARE-LARC1. The Company issued an aggregate of 2,999,990 shares of its common stock to the holders of shares of Microchips' capital stock outstanding immediately prior to the effective time of the merger. The transaction was valued at $2.4 million, based on the fair value of the 2,999,990 shares issued at $0.79 per share, which was the closing price per share of the Company's common stock on the date of closing. The shares were issued in exchange for Microchips’ cash and cash equivalents of $6.1 million, less net liabilities of $3.5 million and transaction costs of $202,000, which was allocated based on the relative fair value of the assets acquired and liabilities assumed. The Company also agreed to pay contingent consideration payments, tiered royalty payments and a percentage of sublicense revenue as discussed in Note 3, Acquired Products—Microchips Acquisition, above. |
Prepaid Expenses
Prepaid Expenses | 12 Months Ended |
Dec. 31, 2020 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses | PREPAID EXPENSES Prepaid expenses consisted of the following: As of December 31, 2020 2019 Prepaid clinical expense $ 1,288,341 $ 305,135 Prepaid insurance expense 227,298 417,152 Prepaid legal and professional expenses 338,638 386,328 Total prepaid expenses $ 1,854,277 $ 1,108,615 |
Other Non-Current Assets
Other Non-Current Assets | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 2019 Prepaid insurance, long-term portion $ 246,016 $ 404,141 Deposits 43,304 42,904 Operating lease assets 239,550 488,280 Total other non-current assets $ 528,870 $ 935,325 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | ACCRUED EXPENSES Accrued expenses consisted of the following: As of December 31, 2020 2019 Accrued compensation and benefits expenses $ 1,157,074 $ 715,201 Accrued legal and professional expenses 297,395 412,584 Accrued license expense 66,667 280,833 Accrued clinical and related expenses 1,838,582 690,035 Total accrued expenses $ 3,359,718 $ 2,098,653 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 2019 Domestic $ 27,249 $ 13,800 Foreign 152 464 Loss before taxes $ 27,401 $ 14,264 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, 2020 and 2019 are as follows: Years Ended December 31, 2020 2019 Federal statutory rate 21.0 % 21.0 % State income tax, net of federal benefit 8.86 % 7.01 % Permanent differences — % (0.02) % Research and development credit 1.80 % 1.46 % Stock compensation (0.34) % (0.44) % Other (0.40) % (0.1) % Change in valuation allowance (30.93) % (28.94) % Effective income tax rate (0.01) % (0.02) % The major components of the Company’s deferred tax assets as of December 31, 2020 and 2019 are shown below (in thousands). 2020 2019 Net operating loss carryforwards $ 68,437 $ 46,120 Research and development credit carryforwards 4,903 3,669 Capitalized research and development costs 9,398 11,123 Other 376 271 Stock compensation 2,183 1,987 Total deferred tax assets 85,297 63,170 Valuation allowance (85,297) (63,170) 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 $85.3 million and $63.2 million was established at December 31, 2020 and 2019 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 $22.1 million and $4.1 million for the years ending December 31, 2020 and 2019, respectively, is primarily related to an increase in net operating losses generated during the year. The Company has U.S. federal net operating loss, or NOL, carryforwards available at December 31, 2020 of approximately $255.9 million (2019– $174.5 million) of which, $0.2 million begin expiring in 2021 unless previously utilized and $78.1 million that do not expire. The Company has state NOL carryforwards of $221.0 million (2019 – $140.1 million) that begin expiring in 2031 unless previously utilized. The Company has U.S. federal research credit carryforwards available at December 31, 2020 of approximately $4.0 million (2019 – $3.1 million) that begin expiring in 2027 unless previously utilized. The Company has state research credit carryforwards of $2.7 million (2019 – $1.9 million) that begin expiring in 2022 unless previously utilized. These federal and state research and development credits are subject to a 20% reserve under ASC 740. 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. In March 2020, the Coronavirus Aid, Relief and Economic Security (“CARES”) Act was enacted and signed into law and GAAP requires recognition of the tax effects of new legislation during the reporting period that includes the enactment date. The CARES Act includes changes to the tax provisions that benefits business entities, and makes certain technical corrections to the 2017 Tax Cuts and Jobs Act. The tax relief measures for businesses in the CARES Act include a five-year net operating loss carryback for certain net operating losses, suspension of the annual deduction limitation of 80% of taxable income for certain net operating losses, changes in the deductibility of interest, acceleration of alternative minimum tax credit refunds, payroll tax relief, and a technical correction to allow accelerated deductions for qualified improvement property. The CARES Act also provides other non-tax benefits to assist those impacted by the pandemic. The Company evaluated the impact of the CARES Act and determined that there is no material impact to the income tax provision for the year ended December 31, 2020. The Consolidated Appropriation Act (“CAA”) of 2021 was signed into law in December 2020, containing COVID-19 relief provisions as well as many tax provisions including renewals of several popular tax extenders. The Company evaluated the impact of the CAA and determined that there is no material impact to the income tax provision for the year ended December 31, 2020. A reconciliation of the beginning and ending amount of uncertain tax benefits is as follows (in thousands): Years Ended December 31, 2020 2019 Beginning uncertain tax benefits $ 935 $ 924 Current year - increases 237 83 Prior year - additions (reductions) 169 (72) Ending uncertain tax benefits $ 1,341 $ 935 Included in the balance of uncertain tax benefits at December 31, 2020 are $1.3 million 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, 2020 and 2019, the Company had no accrued interest or penalties recorded related to uncertain tax positions. The tax years 2016 through 2020 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 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY 2018 ATM Sales Agreement In January 2018, the Company entered into a common stock sales agreement under which the Company may sell shares of its common stock from time to time in “at the market offerings” of equity securities (as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, the "Securities Act"). The Company will 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 2020, the Company sold 12,577,703 shares of common stock under this agreement for gross proceeds of approximately $15.8 million and incurred offering expenses of approximately $594,000. The Company did not sell any shares under this agreement during 2019. April 2019 Underwritten Public Offering In April 2019, the Company closed an underwritten public offering of 4,575,000 shares of its common stock at a public offering price of $1.10 per share. The Company granted the underwriters a 30-day over-allotment option to purchase up to an additional 686,250 shares which was exercised in full on April 12, 2019. Including the over-allotment shares, the Company issued a total of 5,261,250 shares in the underwritten public offering and received gross proceeds of approximately $5.8 million and net proceeds of approximately $5.2 million after deducting underwriting discounts and offering expenses. Equity Line On April 22, 2020, the Company entered into a purchase agreement, or the Purchase Agreement, and a registration rights agreement with Lincoln Park Capital Fund, LLC, or Lincoln Park. Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $15.0 million of the Company’s common stock. Such sales of common stock by the Company may occur from time to time, at the Company’s sole discretion, subject to certain limitations, until May 19, 2023. On April 22, 2020, in accordance with the Purchase Agreement, the Company issued 285,714 shares of its common stock, or the Commitment Shares, to Lincoln Park in consideration for its commitment to purchase shares under the Purchase Agreement. The Company filed a registration statement on Form S-1 (File No. 333-237954) to register the resale by Lincoln Park of up to 7.5 million shares of the Company's common stock issued or issuable to Lincoln Park under the Purchase Agreement, including the Commitment Shares, and such registration statement was declared effective by the SEC on May 12, 2020. The Company filed a registration statement on Form S-1 (File No. 333-251599) to register the resale by Lincoln Park of up to 6.4 million additional shares of the Company's common stock issued or issuable to Lincoln Park under the Purchase Agreement, and such registration statement was declared effective by the SEC on January 7, 2021. The Company incurred legal, accounting, and other fees related to the Purchase Agreement of approximately $374,000. These costs are amortized and expensed as shares are sold under the Purchase Agreement. As of December 31, 2020, there was approximately $175,000 of unamortized costs recorded as a prepaid in the Company's consolidated balance sheet. During 2020, the Company sold, and Lincoln Park purchased, 7,214,286 shares under the Purchase Agreement for gross proceeds to the Company of approximately $8.0 million and recognized offering expenses of approximately $236,000. Under the Purchase Agreement, on any business day until May 19, 2023, the Company may direct Lincoln Park to purchase up to 200,000 shares of common stock, each, a Regular Purchase. The Company may increase the share amount it directs Lincoln Park to purchase under a Regular Purchase to up to 250,000 shares or up to 300,000 shares if the closing sale price of the Company's common stock is not below $1.50 or $3.00, respectively, on the business day on which the Company initiates the purchase, subject to adjustment for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction as provided in the Purchase Agreement. However, Lincoln Park’s maximum commitment in any single Regular Purchase may not exceed $1.0 million. The purchase price per share for each Regular Purchase will be the lower of (i) the lowest sale price of the Company's common stock on the business day on which the Company initiates the purchase and (ii) the average of the three lowest closing sale prices of the Company's common stock during the 10-business day period immediately preceding the business day on which the Company initiates the purchase. In addition to Regular Purchases, the Company may also direct Lincoln Park to purchase other amounts of common stock as accelerated purchases and as additional accelerated purchases, subject to limits specified in the Purchase Agreement, at a purchase price per share calculated as specified in the Purchase Agreement, but in no case lower than the minimum price per share the Company stipulates in its notice to Lincoln Park initiating these purchases. In addition, under applicable Nasdaq rules, the Company may not issue or sell to Lincoln Park under the Purchase Agreement more than 4,941,089 shares of its common stock, or the Exchange Cap, unless (i) the Company obtains stockholder approval to issue shares in excess of the Exchange Cap or (ii) the average price of all applicable sales of the Company's common stock to Lincoln Park under the Purchase Agreement equals or exceeds $1.0117 (which represents the closing sale price per share of the Company's common stock on the day before the Company entered into the Purchase Agreement, plus an incremental amount). In addition, the Company may not sell shares to Lincoln Park under the Purchase Agreement if such sale would result in Lincoln Park beneficially owning more than 9.99% of the Company's then outstanding shares of common stock. Common Stock Warrants In February 2018, the Company closed an underwritten public offering in connection with which the Company issued to the investors in that offering warrants that initially had an exercise price of $3.00 per share and are exercisable through February 2023. The warrants include a price-based anti-dilution provision, which provides that, subject to certain limited exceptions, the exercise price of the warrants will be reduced each time the Company issues or sells (or is deemed to issue or sell) securities for a net consideration per share less than the exercise price of those warrants in effect immediately prior to such issuance or sale. In addition, subject to certain exceptions, if the Company issues, sells or enters into any agreement to issue or sell securities at a price which varies or may vary with the market price of the shares of the Company’s common stock, the warrant holders have the right to substitute such variable price for the exercise price of the warrant then in effect. These 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 was recorded in equity as of the grant date. The Company early adopted ASU 2017-11 as of January 1, 2018 and recorded the fair value of the warrants as equity. In April 2019 and July 2020, in accordance with the price-based anti-dilution provision discussed above, the exercise price of these warrants was automatically reduced to $0.98 per share and to $0.96 per share, respectively, and as a result of the triggering of the anti-dilution provision, $0.8 million and $6,863, respectively, was recorded to additional paid-in capital. During the year ended December 31, 2020, warrants to purchase an aggregate of 1,825,000 shares of common stock were exercised for gross proceeds of approximately $1.8 million. No warrants were exercised during the year ended 2019. As of December 31, 2020, the Company had the following warrants outstanding: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 2,906 $ 120.40 12/01/2021 3,737 $ 120.40 12/06/2021 6,500 $ 10.00 04/04/2026 1,895,500 $ 0.96 02/15/2023 1,908,643 Common Stock The authorized capital of the Company consists of 120,000,000 shares of common stock with a par value of $0.0001 and 5,000,000 shares of preferred stock with a par value of $0.01 per share. The issued and outstanding common stock of the Company consisted of 41,596,253 and 19,683,401 shares of common stock as of December 31, 2020 and 2019, respectively. There were no shares of preferred stock outstanding as of December 31, 2020 or 2019. Common Stock Reserved for Future Issuance The following table summarizes common stock reserved for future issuance at December 31, 2020: Common stock reserved for issuance upon exercise of warrants outstanding 1,908,643 Common stock reserved for issuance upon exercise of options outstanding 2,786,591 Common stock reserved for future equity awards (under the Amended 2014 Plan) 504,516 Total 5,199,750 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation | STOCK-BASED COMPENSATION The 2015 Employee, Director and Consultant Equity Incentive Plan In connection with the business combination transaction in July 2017 between the Company and Daré Bioscience Operations, Inc., a privately held Delaware corporation, or Private Daré, the Company assumed the Private Daré 2015 Employee, Director and Consultant Equity Incentive Plan, or the 2015 Private Daré Plan and each then outstanding award granted thereunder, which consisted of options and restricted stock. Based on the exchange ratio for the business combination transaction and after giving effect to the reverse stock split effected in connection with the closing of that transaction, the outstanding options and restricted stock awards granted under the 2015 Private Daré Plan were replaced with options to purchase 10,149 shares of the Company’s common stock with a correspondingly adjusted exercise price and 223,295 shares of the Company’s common stock. All of the options that were assumed were exercised as of December 31, 2020. No awards may be granted under the 2015 Private Daré Plan following the closing of the business combination transaction. 2014 Employee Stock Purchase Plan The Company’s 2014 Employee Stock Purchase Plan, or the ESPP, became effective in April 2014, but no offering period has been initiated thereunder since January 2017 and there was no stock-based compensation related to the ESPP for the years ended December 31, 2020 or December 31, 2019. Amended and Restated 2014 Stock Incentive Plan The Company maintains the Amended and Restated 2014 Plan, or the Amended 2014 Plan. There were 2,046,885 shares of common stock authorized for issuance under the Amended 2014 Plan when it was approved by the Company's stockholders in July 2018. The number of authorized shares increases annually on the first day of each fiscal year until, and including, the fiscal year ending December 31, 2024 by the least of (i) 2,000,000, (ii) 4% of the number of outstanding shares of common stock on such date, or (iii) an amount determined by the Company’s board of directors. As a result of the foregoing, the number of shares available under the Amended 2014 Plan increased by 787,336 to 1,411,481 on January 1, 2020, which increase represented 4% of the number of outstanding shares of common stock on such date. Summary of Stock Option Activity The table below summarizes stock option activity under the Amended 2014 Plan, and related information for the years ended December 31, 2020 and 2019. The exercise price of all options granted during the years ended December 31, 2020 and 2019 was equal to the market value of the Company’s common stock on the date of grant. As of December 31, 2020, unamortized stock-based compensation expense of approximately $1.3 million will be amortized over the weighted average period of 2.2 years. As of December 31, 2020, 504,516 shares of common stock were reserved for future issuance under the Amended 2014 Plan. Number of Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Outstanding at December 31, 2018 1,635,790 $ 11.08 Granted 832,500 0.79 Exercised — — Forfeited (578,445) 28.52 Expired (70) 59.48 Outstanding at December 31, 2019 (1) 1,889,775 $ 1.21 Granted 906,965 1.06 Exercised (10,149) — Canceled/forfeited — — Expired — — Outstanding at December 31, 2020 (1) 2,786,591 $ 1.16 8.33 $ 993,981 Options exercisable at December 31, 2020 1,199,857 $ 1.40 8.01 $ 427,931 Options vested and expected to vest at December 31, 2020 2,786,591 $ 1.16 8.33 $ 993,981 (1) Includes 10,149 shares subject to options granted under the 2015 Private Daré Plan assumed in connection with the Cerulean/Private Daré stock purchase transaction. Compensation Expense Total stock-based compensation expense related to stock options granted to employees and directors recognized in the consolidated statements of operations is as follows: Years Ended December 31, 2020 2019 Research and development $ 225,579 $ 107,142 General and administrative 516,452 355,097 Total $ 742,031 $ 462,239 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, 2020 and 2019 is as follows: 2020 2019 Expected life in years 10.0 10.0 Risk-free interest rate 0.82 % 2.44 % Expected volatility 120 % 120 % Forfeiture rate 0.0 % 0.0 % Dividend yield 0.0 % 0.0 % Weighted-average fair value of options granted $ 1.00 $ 0.75 |
Leased Properties
Leased Properties | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leased Properties | LEASED PROPERTIES The Company's lease for its corporate headquarters (3,169 square feet of office space) commenced on July 1, 2018 and terminates on July 31, 2021. The lease provides the Company with an option to extend the term of the lease for one year. Microchips, which the Company acquired in November 2019, leases general office space in Lexington, Massachusetts and warehouse space in Billerica, Massachusetts. The Lexington lease commenced on July 1, 2013 and terminates on September 30, 2021. The Billerica lease commenced on October 1, 2016 and terminates on March 31, 2022. Under the terms of each lease, the lessee pays base annual rent (subject to an annual fixed percentage increase), plus property taxes, and other normal and necessary expenses, such as utilities, repairs, and maintenance. The Company evaluates renewal options at lease inception and on an ongoing basis and includes renewal options that it is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. The leases do not require material variable lease payments, residual value guarantees or restrictive covenants. The leases do not provide an implicit rate, and therefore the Company uses its incremental borrowing rate as the discount rate when measuring operating lease liabilities. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of the lease within a particular currency environment. The Company uses an incremental borrowing rate of 7% for operating leases that commenced prior to January 2019 (and all of the Company's operating leases commenced prior to such date). The depreciable lives of operating leases and leasehold improvements are limited by the expected lease term. At December 31, 2020, the Company reported operating lease right of use assets of approximately $240,000 in other non-current assets, and approximately $347,000 and $42,000, respectively, in current and non-current other liabilities on the consolidated balance sheet. Total operating lease costs were approximately $303,800 and $223,000 for the years ended December 31, 2020 and 2019, respectively. Operating lease costs consist of monthly lease payments expense, common area maintenance and other repair and maintenance costs and are included in general and administrative expenses in the consolidated statement of operations. Cash paid for amounts included in the measurement of operating lease liabilities was approximately $461,000 for the year ended December 31, 2020, and these amounts are included in operating activities in the consolidated statement of cash flows. Further, at December 31, 2020, operating leases had a weighted average remaining lease term of 0.86 years. At December 31, 2020, future minimum lease payments under the Company's operating leases are as follows: Year ending December 31, 2021 $ 363,000 2022 42,000 Total future minimum lease payments 405,000 Less: accreted interest 16,000 Total operating lease liabilities $ 389,000 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Contingent Consideration In connection with the acquisition of Microchips, the Company agreed to pay contingent consideration based upon the achievement of specified funding, product development and regulatory milestones. The Company recorded $1.0 million in contingent consideration liability associated with milestone payments expected to become payable in the first half of 2021 in its consolidated balance sheet at December 31, 2020. Note Payable In April 2020, due to the economic uncertainty resulting from the impact of the COVID-19 pandemic on the Company's operations and to support its ongoing operations and retain all employees, the Company applied for a loan under the Paycheck Protection Program, or the PPP, of the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, administered by the U.S. Small Business Administration, or the SBA. The Company received a loan of approximately $367,000. Under the terms of the PPP, the loan proceeds could be used for "qualifying expenses" and, subject to specified limitations in the CARES Act and under the terms of the PPP, certain amounts of the loan, including accrued interest, may be forgiven if used for qualifying expenses. Qualifying expenses include payroll costs, costs used to continue group health care benefits, mortgage interest payments, rent payments, utility payments, and interest payments on other debt obligations. In September 2020, the Company submitted its forgiveness application. The Company recorded a note payable plus accrued interest for the loan in the amount of approximately $369,600 in its consolidated balance sheet at December 31, 2020. In January 2021, the Company was notified that the principal balance of the PPP loan and all accrued interest was fully forgiven by the SBA. See Note 14. Subsequent Events. Legal Proceedings From time to time, the Company may be involved in various claims arising in the normal course of business. Management is not aware of any material claims, disputes or unsettled matters that would have a material adverse effect on the Company’s results of operations, liquidity or financial position that the Company has not adequately provided for in the accompanying consolidated financial statements. Employment Agreements Certain executive officers are entitled to payments if they are terminated without cause or as a result of a change in control of the Company. Upon termination without cause, and not as a result of death or disability, each officer is entitled to receive a payment of an amount equal to six six nine nine Employee Benefit – 401(k) Plan The Company has a 401(k) retirement plan, or the 401(k) Plan, covering all qualified employees. The 401(k) Plan allows each participant to contribute a portion of their base wages up to an amount not to exceed an annual statutory maximum. The 401(k) Plan includes a Safe Harbor Plan that provides a Company match up to 4% of salary. The Company made matching contributions of approximately $136,000 and $96,000 during the years ended December 31, 2020 and 2019, respectively. |
Grant Awards
Grant Awards | 12 Months Ended |
Dec. 31, 2020 | |
Receivables [Abstract] | |
Grant Awards | GRANT AWARDS NIH Grant Funding The Company has received notices of awards and grant funding from the National Institutes of Health, or the NIH, to support the development of Ovaprene and DARE-FRT1. The NIH issues notices of awards to the Company for a specified amount, and the Company must incur and track expenses eligible for reimbursement under the award and submit a detailed accounting of such expenses to receive payment. If the Company receives payments under the award, the amounts of such payments are recognized in the statement of operations as a reduction to research and development activities as the related costs are incurred to meet those obligations over the period. Ovaprene Since 2018, the Company has received approximately $1.9 million of grant funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, a division of the NIH, for clinical development efforts supporting Ovaprene. The most recent and final notice of award the Company received was for approximately $731,000 in April 2020, substantially all of which has been funded to date. The Company recorded credits to research and development expense for costs related to the NIH award of approximately $595,000 and $1.2 million for the years ended December 31, 2020 and December 31, 2019, respectively. At December 31, 2020, the Company recorded a receivable of approximately $12,000 for expenses incurred through such date that it believes are eligible for reimbursement under the final notice of award received in April 2020. DARE-FRT1 In August 2020, the Company received a notice of award of a grant from the NIH to support the development of DARE-FRT1. The award in the amount of $300,000 was for what is referred to as the "Phase I" segment of the project outlined in the Company's grant application, which is to occur during the period of August 2020 through July 2021. Additional potential funding of up to approximately $2.0 million for the "Phase II" segment of the project outlined in the grant application is contingent upon satisfying specified requirements, including, assessment of the results of the Phase I segment, determination that the Phase I goals were achieved, and availability of funds. There is no guarantee the Company will receive any Phase II award. The Company recorded credits to research and development expense for costs related to the NIH award of approximately $131,000 for the year ended December 31, 2020. At December 31, 2020, the Company recorded a receivable of approximately $128,000 for expenses incurred through such date that it believes are eligible for reimbursement under the grant. Bill & Melinda Gates Foundation The Company's wholly-owned subsidiary, Microchips, has a grant agreement with the Bill & Melinda Gates Foundation, or the Foundation, relating to the development of the pre-clinical stage contraceptive candidate, DARE-LARC1. Expenses eligible for grant funding must be incurred, tracked and reported to the Foundation. Microchips received grant funding payments of approximately $2.9 million in 2019 and $2.5 million in 2020. At December 31, 2020, grant funding payments associated with research and development expenses for DARE-LARC1 not yet incurred totaled approximately $1.6 million and are recorded as deferred grant funding liability in the Company's consolidated balance sheet. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTS ATM Sales Between January and March 2021, the Company sold an aggregate of 3,264,069 shares of common stock in at the market offerings through a sales agent and received aggregate gross proceeds of approximately $7.7 million and incurred sales agent commissions and fees of approximately $245,000 (see Note 9). Equity Line Between January and March 2021, the Company sold an aggregate of 2,400,000 shares of common stock to Lincoln Park under the Purchase Agreement and received aggregate net proceeds of approximately $3.9 million. Exercise of February 2018 Warrants In February 2021, warrants to purchase an aggregate of 52,500 shares of common stock were exercised at an exercise price of $0.96 per share resulting in gross proceeds to the Company of approximately $50,000 (see Note 9). PPP Loan Forgiveness In January 2021, the Company was notified that the principal balance of its PPP loan and all accrued interest was fully forgiven by the SBA. The Company will record a gain contingency and debt forgiveness income with respect to such loan forgiveness in the first quarter of 2021. Leased Properties On January 7, 2021, the Company exercised its option to extend the term of the lease for its corporate headquarters in San Diego, California for a year. The extended term begins August 1, 2021 and expires July 31, 2022. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
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 prepared its consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The Company has a history of losses from operations, expects negative cash flows from its operations to continue for the foreseeable future, and expects that its net losses will continue for at least the next several years as it develops and seeks to bring to market its existing product candidates and potentially acquire, license and 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 reclassification 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. At December 31, 2020, the Company had an accumulated deficit of approximately $71.4 million, had cash and cash equivalents of approximately $4.7 million, and a working capital deficit of approximately $0.7 million. For the year ended December 31, 2020, the Company incurred a net loss of $27.4 million and had negative cash flow from operations of approximately $25.2 million. The Company’s primary uses of capital are, and the Company expects will continue to be, staff-related expenses, the cost of clinical trials and regulatory activities related to its product candidates, costs associated with contract manufacturing services and third-party clinical research and development services, payments due under license agreements and its merger agreement with Microchips upon the successful achievement of milestones of the Company’s product candidates, legal expenses, other regulatory expenses and general overhead costs. The Company’s future funding requirements could also include significant costs related to commercialization of its product candidates, if approved, depending on the type and nature of commercial partnerships the Company establishes. The Company expects its expenses, and in particular its research and development expenses, to increase significantly in 2021 compared to 2020 as it continues to develop and seek to bring to market its product candidates, with a focus on DARE-BV1, Ovaprene and Sildenafil Cream, 3.6% To date, the Company has not obtained any regulatory approvals for any of its product candidates, commercialized any of its product candidates or generated any product revenue, and the Company cannot anticipate if or when it will generate any revenue. The Company has devoted significant resources to acquiring its portfolio of product candidates and to research and development activities for its product candidates. The Company must obtain regulatory approvals to market and sell any of its products in the future. The Company will need to generate sufficient safety and efficacy data on its product candidates for them to receive regulatory approvals and to be attractive assets for potential strategic partners to license or for pharmaceutical companies to acquire, and for the Company to generate cash and other license fees related to such product candidates. Based on the Company's current operating plan estimates, the Company does not have sufficient cash to satisfy its working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying financial statements. The Company needs to raise substantial additional capital to continue to fund its operations and to successfully execute its current operating plan, including the development of its product candidates. The Company is currently evaluating a variety of capital raising options, including equity and debt 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 |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements of the Company are stated in U.S. dollars. These consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. One wholly owned subsidiary, Daré Bioscience Australia Pty LTD, operates primarily in Australia. The financial statements of the Company’s wholly owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated Other Comprehensive Loss. All intercompany transactions and accounts have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the fair value of stock-based compensation, 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 EquivalentsThe Company considers cash and all highly liquid investments with an original maturity of three months or less to be cash and cash equivalents. The Company’s wholly owned subsidiary, Microchips Biotech, Inc., has a $35,903 letter of credit related to the lease of real property that serves as security for future default of lease payments. The letter of credit is collateralized by cash which is unavailable for withdrawal or for usage for general obligations and is included in cash and cash equivalents on the Company's consolidated balance sheet. |
Concentration of Credit Risk | Concentration of Credit Risk The Company maintains cash balances at various financial institutions and such balances commonly exceed the $250,000 amount insured by the Federal Deposit Insurance Corporation. The Company also maintains money market funds at various financial institutions which are not federally insured although are invested primarily in the U.S. The Company has not experienced any losses in such accounts and management believes that the Company does not have significant risk with respect to such cash and cash equivalents. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments 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. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue is accordance with Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers , which applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. The Company recognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligations. At contract inception, the Company assesses the goods or services agreed upon within each contract and assess whether each good or service is distinct and determine those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. In a contract with multiple performance obligations, the Company develops estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation, which determines how the transaction price is allocated among the performance obligations. The estimation of the stand-alone selling price(s) may include estimates regarding forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time. Any change made to estimated progress towards completion of a performance obligation and, therefore, revenue recognized will be recorded as a change in estimate. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. License Fees. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in a contract, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. To date, the Company has not recognized any license fee revenue resulting from any of its collaborative arrangements. Royalties. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its collaborative arrangements. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use, or ROU, lease assets, current portion of lease obligations, and long-term lease obligations on the Company's consolidated balance sheets. ROU lease assets represent the Company's right to use an underlying asset for the lease term and lease obligations represent the Company's obligation to make lease payments arising from the lease. Operating ROU lease assets and obligations are recognized at the commencement date based on the present value of lease payments over the lease term. If the lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The ROU lease asset also includes any lease payments made and excludes lease incentives. The Company's lease terms may include options to extend or terminate the lease and the related payments are only included in the lease liability when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. (See Note 11, Leased Properties.) |
Business Combinations | Business Combinations Assets acquired and liabilities assumed as part of a business acquisition are recorded at their estimated fair value at the date of acquisition. The excess of the total purchase consideration over the fair value of assets acquired and liabilities assumed is recorded as goodwill. Determining fair value of identifiable assets, particularly intangibles, and liabilities acquired also requires management to make estimates, which are based on all available information and, in some cases, assumptions with respect to the timing and amount of future revenue and expenses associated with an asset. Acquired In-Process Research and Development Expense The Company has acquired, and may continue to acquire, the rights to develop new product candidates. Payments to acquire a new product candidate, as well as future milestone payments associated with asset acquisitions which are deemed probable of achievement, are immediately expensed as acquired in-process research and development provided that the product candidate has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. |
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. |
Research and Development Costs | Research and Development Costs Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses, manufacturing process-development and scale-up activities, fees paid to clinical and regulatory consultants, clinical trial and related clinical trial manufacturing expenses, fees paid to CROs and investigative sites, transaction expenses incurred in connection with the expansion of the product portfolio through acquisitions and license and option agreements, milestone payments incurred or probable to be incurred for the Company's in-licensing arrangements, 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 | Net Loss Per ShareBasic 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. |
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, 2020, the Company did not record any liabilities for uncertain tax positions. During each 2020 and 2019, the Company recorded no provision for income taxes. Management evaluated the Company’s tax positions and, as of December 31, 2020, the Company has approximately $1.3 million of unrecognized benefits. The tax years 2016 to 2020 remain open to examination by federal and state taxing authorities while the statute of limitations for U.S. net operating losses generated remain open beginning in the year of utilization. |
Indemnifications | Indemnification Obligations As permitted under Delaware law, the Company has entered into indemnification agreements with its officers and directors that provide that the Company will indemnify its 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, 2020, 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, 2020 and 2019, no amounts have been accrued related to such indemnification provisions. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Financial Assets and Liabilities Remeasured on a Recurring Basis | The following tables present the classification within the fair value hierarchy of financial assets and liabilities that are remeasured on a recurring basis as of December 31, 2020 and December 31, 2019. There were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 2) as of December 31, 2020 . Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at December 31, 2020 Current assets: Cash equivalents (1) $ 2,823,099 $ — $ — $ 2,823,099 Current liabilities: Current portion of contingent consideration (2) $ — $ — $ 1,000,000 $ 1,000,000 Balance at December 31, 2019 Current assets: Cash and cash equivalents $ 4,780,107 $ — $ — $ 4,780,107 Other non-current liabilities: Contingent consideration, net of current portion (2) $ — $ — $ 1,000,000 $ 1,000,000 (1) Represents the cash held in money market funds. (2) Represents t he estimated fair value of the contingent consideration potentially payable by the Company related to its acquisition of Microchips Biotech, Inc., as described in Note 4. |
Prepaid Expenses (Tables)
Prepaid Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure | Prepaid expenses consisted of the following: As of December 31, 2020 2019 Prepaid clinical expense $ 1,288,341 $ 305,135 Prepaid insurance expense 227,298 417,152 Prepaid legal and professional expenses 338,638 386,328 Total prepaid expenses $ 1,854,277 $ 1,108,615 |
Other Non-Current Assets (Table
Other Non-Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Other Assets, Noncurrent Disclosure [Abstract] | |
Schedule of Other Non-Current Assets | Other non-current assets consisted of the following: As of December 31, 2020 2019 Prepaid insurance, long-term portion $ 246,016 $ 404,141 Deposits 43,304 42,904 Operating lease assets 239,550 488,280 Total other non-current assets $ 528,870 $ 935,325 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accrued expenses consisted of the following: As of December 31, 2020 2019 Accrued compensation and benefits expenses $ 1,157,074 $ 715,201 Accrued legal and professional expenses 297,395 412,584 Accrued license expense 66,667 280,833 Accrued clinical and related expenses 1,838,582 690,035 Total accrued expenses $ 3,359,718 $ 2,098,653 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 2019 Domestic $ 27,249 $ 13,800 Foreign 152 464 Loss before taxes $ 27,401 $ 14,264 |
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, 2020 and 2019 are as follows: Years Ended December 31, 2020 2019 Federal statutory rate 21.0 % 21.0 % State income tax, net of federal benefit 8.86 % 7.01 % Permanent differences — % (0.02) % Research and development credit 1.80 % 1.46 % Stock compensation (0.34) % (0.44) % Other (0.40) % (0.1) % Change in valuation allowance (30.93) % (28.94) % Effective income tax rate (0.01) % (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, 2020 and 2019 are shown below (in thousands). 2020 2019 Net operating loss carryforwards $ 68,437 $ 46,120 Research and development credit carryforwards 4,903 3,669 Capitalized research and development costs 9,398 11,123 Other 376 271 Stock compensation 2,183 1,987 Total deferred tax assets 85,297 63,170 Valuation allowance (85,297) (63,170) Net deferred tax assets $ — $ — |
Schedule of Reconciliation of the Beginning and Ending Amount of Uncertain Tax Benefits | A reconciliation of the beginning and ending amount of uncertain tax benefits is as follows (in thousands): Years Ended December 31, 2020 2019 Beginning uncertain tax benefits $ 935 $ 924 Current year - increases 237 83 Prior year - additions (reductions) 169 (72) Ending uncertain tax benefits $ 1,341 $ 935 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Schedule of Common Stock Outstanding Warrant to Purchase Shares | As of December 31, 2020, the Company had the following warrants outstanding: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 2,906 $ 120.40 12/01/2021 3,737 $ 120.40 12/06/2021 6,500 $ 10.00 04/04/2026 1,895,500 $ 0.96 02/15/2023 1,908,643 |
Summary of Common Stock Reserved for Future Issuance | The following table summarizes common stock reserved for future issuance at December 31, 2020: Common stock reserved for issuance upon exercise of warrants outstanding 1,908,643 Common stock reserved for issuance upon exercise of options outstanding 2,786,591 Common stock reserved for future equity awards (under the Amended 2014 Plan) 504,516 Total 5,199,750 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity for 2015 Plan and Current Plan and Related Information | The table below summarizes stock option activity under the Amended 2014 Plan, and related information for the years ended December 31, 2020 and 2019. The exercise price of all options granted during the years ended December 31, 2020 and 2019 was equal to the market value of the Company’s common stock on the date of grant. As of December 31, 2020, unamortized stock-based compensation expense of approximately $1.3 million will be amortized over the weighted average period of 2.2 years. As of December 31, 2020, 504,516 shares of common stock were reserved for future issuance under the Amended 2014 Plan. Number of Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Outstanding at December 31, 2018 1,635,790 $ 11.08 Granted 832,500 0.79 Exercised — — Forfeited (578,445) 28.52 Expired (70) 59.48 Outstanding at December 31, 2019 (1) 1,889,775 $ 1.21 Granted 906,965 1.06 Exercised (10,149) — Canceled/forfeited — — Expired — — Outstanding at December 31, 2020 (1) 2,786,591 $ 1.16 8.33 $ 993,981 Options exercisable at December 31, 2020 1,199,857 $ 1.40 8.01 $ 427,931 Options vested and expected to vest at December 31, 2020 2,786,591 $ 1.16 8.33 $ 993,981 (1) Includes 10,149 shares subject to options granted under the 2015 Private Daré Plan assumed in connection with the Cerulean/Private Daré stock purchase transaction. |
Schedule of Stock-Based Compensation Expense | Total stock-based compensation expense related to stock options granted to employees and directors recognized in the consolidated statements of operations is as follows: Years Ended December 31, 2020 2019 Research and development $ 225,579 $ 107,142 General and administrative 516,452 355,097 Total $ 742,031 $ 462,239 |
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, 2020 and 2019 is as follows: 2020 2019 Expected life in years 10.0 10.0 Risk-free interest rate 0.82 % 2.44 % Expected volatility 120 % 120 % Forfeiture rate 0.0 % 0.0 % Dividend yield 0.0 % 0.0 % Weighted-average fair value of options granted $ 1.00 $ 0.75 |
Leased Properties (Tables)
Leased Properties (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Future Minimum Lease Payment | At December 31, 2020, future minimum lease payments under the Company's operating leases are as follows: Year ending December 31, 2021 $ 363,000 2022 42,000 Total future minimum lease payments 405,000 Less: accreted interest 16,000 Total operating lease liabilities $ 389,000 |
Organization and Description _2
Organization and Description of Business (Details) | 12 Months Ended |
Dec. 31, 2020segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of operating segments | 1 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | Jan. 10, 2020 | Jan. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2020 | Dec. 31, 2018 | Jul. 10, 2018 |
Significant Accounting Policies [Line Items] | |||||||
Accumulated deficit | $ 71,430,797 | $ 44,023,191 | |||||
Working capital increase | (700,000) | ||||||
Operating income (loss) | (27,402,257) | (14,344,880) | |||||
Cash flow from operations | $ 25,200,000 | ||||||
Period of insufficient cash and liquidity requirements | 12 months | ||||||
Grant funding recognized during period | $ 3,700,000 | 1,300,000 | |||||
Letter of credit related to lease of real property | $ 35,903 | ||||||
Common stock reserved for issuance (in shares) | 5,199,750 | ||||||
Income tax provision | $ 0 | 0 | |||||
Unrecognized tax benefits | 1,341,000 | 935,000 | $ 924,000 | ||||
Accrued indemnification P\provisions | 0 | $ 0 | |||||
Bayer Healthcare License Agreement | |||||||
Significant Accounting Policies [Line Items] | |||||||
Upfront license fee paid | $ 1,000,000 | ||||||
Revenue from grant for notice of awards | $ 20,000,000 | ||||||
Milestone payments, contingent amount | $ 310,000,000 | ||||||
Level 1 | |||||||
Significant Accounting Policies [Line Items] | |||||||
Cash and cash equivalents | 4,700,000 | ||||||
Minimum | |||||||
Significant Accounting Policies [Line Items] | |||||||
Cash balance of financial institutions insured by federal deposits insurance corporation | $ 250,000 | ||||||
Stock Options | |||||||
Significant Accounting Policies [Line Items] | |||||||
Stock options outstanding (in shares) | 2,000,000 | ||||||
Common stock reserved for issuance (in shares) | 1,411,481 | ||||||
Exercise of Warrants Outstanding | |||||||
Significant Accounting Policies [Line Items] | |||||||
Common stock reserved for issuance (in shares) | 1,908,643 | 3,750,833 | |||||
Amended And Restated Two Thousand Fourteen Stock Incentive Plan | Stock Options | |||||||
Significant Accounting Policies [Line Items] | |||||||
Stock options outstanding (in shares) | 2,786,591 | 1,889,775 | 1,635,790 | ||||
Common stock reserved for issuance (in shares) | 504,516 |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Financial Assets and Liabilities Remeasured on a Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 2,823,099 | $ 4,780,107 |
Current portion of contingent consideration | 1,000,000 | |
Contingent consideration, net of current portion | 1,000,000 | |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 2,823,099 | 4,780,107 |
Current portion of contingent consideration | 0 | |
Contingent consideration, net of current portion | 0 | |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Current portion of contingent consideration | 0 | |
Contingent consideration, net of current portion | 0 | |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Current portion of contingent consideration | $ 1,000,000 | |
Contingent consideration, net of current portion | $ 1,000,000 |
License and Collaboration Agr_2
License and Collaboration Agreements - Additional Information (Details) - USD ($) | Jan. 10, 2020 | Nov. 30, 2019 | Jan. 31, 2020 | Dec. 31, 2019 | Apr. 30, 2018 | Mar. 31, 2018 | Feb. 28, 2018 | Mar. 31, 2017 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
License fees | $ 83,333 | $ 533,334 | |||||||||
Common stock issued to microchips capital stock holders (in shares) | 1,825,000 | ||||||||||
Microchips Biotech, Inc. | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Contingent consideration | $ 50,000 | ||||||||||
Current portion of contingent consideration | $ 1,000,000 | ||||||||||
Microchips Biotech, Inc. | Common stock | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Common stock issued to microchips capital stock holders (in shares) | 2,999,990 | ||||||||||
Upon Achievement Of Specified Development And Regulatory Milestones | Microchips Biotech, Inc. | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments | $ 46,500,000 | $ 100,000 | |||||||||
Contingent consideration | $ 110,000 | ||||||||||
Current portion of contingent consideration | $ 55,000,000 | ||||||||||
ADVA Tec Agreement | Maximum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Percentage of royalty rate | 10.00% | ||||||||||
ADVA Tec Agreement | Minimum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Percentage of royalty rate | 1.00% | ||||||||||
ADVA Tec Agreement | Upon Achievement Of Specified Development And Regulatory Milestones | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments | $ 5,000,000 | ||||||||||
ADVA Tec Agreement | Upon Achievement Of Specified Development And Regulatory Milestones | Maximum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments | 14,600,000 | ||||||||||
Bayer Healthcare License Agreement | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Upfront license fee paid | $ 1,000,000 | ||||||||||
Revenue from grant for notice of awards | $ 20,000,000 | ||||||||||
Milestone payments, contingent amount | $ 310,000,000 | ||||||||||
Licensing Agreements | ADVA Tec Agreement | Upon Reaching Certain Worldwide Net Sales Milestones | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments | $ 20,000,000 | ||||||||||
Licensing Agreements | MilanaPharm | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
License fees | 235,000 | ||||||||||
License fee to be paid upon contingency | $ 25,000 | ||||||||||
License agreement termination periodic discontinued sale of product | 60 days | ||||||||||
License agreement, termination period due to performance failure | 120 days | ||||||||||
License agreement, notice period of termination | 90 days | ||||||||||
Licensing Agreements | Upon Achieving Certain Development Milestones | MilanaPharm | Maximum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments, contingent amount | $ 300,000 | ||||||||||
Licensing Agreements | Upon Achieving Certain Commercial Milestones | MilanaPharm | Maximum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments, contingent amount | $ 1,750,000 | ||||||||||
Assignment Agreement | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
License fees | 512,500 | ||||||||||
Assignment Agreement | Hammock Pharmaceuticals, Inc. | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
License fees | 250,000 | ||||||||||
License fee to be paid upon contingency | $ 137,500 | $ 125,000 | |||||||||
Assignment Agreement | Upon Achieving Certain Clinical And Regulatory Development Milestones | Hammock Pharmaceuticals, Inc. | Maximum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments, contingent amount | $ 1,100,000 | ||||||||||
License And Collaboration Agreement | SST | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Percentage of rights to inventions by employees under license agreement | 50.00% | ||||||||||
License And Collaboration Agreement | SST | Maximum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments, contingent amount | $ 18,000,000 | ||||||||||
License And Collaboration Agreement | SST | Minimum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments, contingent amount | 500,000 | ||||||||||
License And Collaboration Agreement | Upon Achieving Certain Commercial Milestones | SST | Maximum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments, contingent amount | 100,000,000 | ||||||||||
License And Collaboration Agreement | Upon Achieving Certain Commercial Milestones | SST | Minimum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments, contingent amount | $ 10,000,000 | ||||||||||
Juniper Pharmaceuticals, Inc. | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Upfront license fee paid | $ 250,000 | ||||||||||
Potential annual license maintenance fee, payments in year one | 50,000 | ||||||||||
Potential annual license maintenance fee payments, thereafter | 100,000 | ||||||||||
Juniper Pharmaceuticals, Inc. | Clinical And Regulatory Milestones | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Maximum potential milestone payments | 13,500,000 | ||||||||||
Juniper Pharmaceuticals, Inc. | Sales Milestones | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Maximum potential milestone payments | $ 30,300,000 | ||||||||||
Development And Option Agreement | Adare Pharmaceuticals | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments | $ 300,000 | ||||||||||
Commencement period for stage two upon achievement of stage one | 90 days | ||||||||||
Development And Option Agreement | Upon Signing Of Development And Option Agreement | Adare Pharmaceuticals | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments | $ 150,000 | ||||||||||
Development And Option Agreement | Upon Completion Of Fifty Percent Development Not Later Than Six Months | Adare Pharmaceuticals | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments | $ 75,000 | ||||||||||
Percentage of rights to inventions by employees under license agreement | 50.00% | ||||||||||
Development And Option Agreement | Upon Delivery Of Six Month Batch Development Not Later Than Eleven Months | Adare Pharmaceuticals | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Milestone payments | $ 75,000 |
Acquisition - Additional Inform
Acquisition - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Nov. 30, 2019 | Dec. 31, 2020 |
Business Combination Reverse Merger [Line Items] | ||
Common stock issued to microchips capital stock holders (in shares) | 1,825,000 | |
Microchips Biotech, Inc. | ||
Business Combination Reverse Merger [Line Items] | ||
Business acquisition transaction value | $ 2,400 | |
Business combination shares issued (in usd per share) | $ 0.79 | |
Cash and cash equivalents | $ 6,100 | |
Contingent consideration, liability | 3,500 | |
Microchips Biotech, Inc. | Research and development | ||
Business Combination Reverse Merger [Line Items] | ||
Business acquisition transaction value | $ 202 | |
Microchips Biotech, Inc. | Common stock | ||
Business Combination Reverse Merger [Line Items] | ||
Common stock issued to microchips capital stock holders (in shares) | 2,999,990 |
Prepaid Expenses (Details)
Prepaid Expenses (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid clinical expense | $ 1,288,341 | $ 305,135 |
Prepaid insurance expense | 227,298 | 417,152 |
Prepaid legal and professional expenses | 338,638 | 386,328 |
Total prepaid expenses | $ 1,854,277 | $ 1,108,615 |
Other Non-Current Assets - Sche
Other Non-Current Assets - Schedule of Other Non-Current Assets (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Other Assets, Noncurrent Disclosure [Abstract] | ||
Prepaid insurance, long-term portion | $ 246,016 | $ 404,141 |
Deposits | 43,304 | 42,904 |
Operating lease assets | 239,550 | 488,280 |
Total other non-current assets | $ 528,870 | $ 935,325 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accrued compensation and benefits expenses | $ 1,157,074 | $ 715,201 |
Accrued legal and professional expenses | 297,395 | 412,584 |
Accrued license expense | 66,667 | 280,833 |
Accrued clinical and related expenses | 1,838,582 | 690,035 |
Total accrued expenses | $ 3,359,718 | $ 2,098,653 |
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, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Domestic | $ 27,249 | $ 13,800 |
Foreign | 152 | 464 |
Loss before taxes | $ 27,401 | $ 14,264 |
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, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory rate | 21.00% | 21.00% |
State income tax, net of federal benefit | 8.86% | 7.01% |
Permanent differences | 0.00% | (0.02%) |
Research and development credit | 1.80% | 1.46% |
Stock compensation | (0.34%) | (0.44%) |
Other | (0.40%) | (0.10%) |
Change in valuation allowance | (30.93%) | (28.94%) |
Effective income tax rate | (0.01%) | (0.02%) |
Income Taxes - Summary of Major
Income Taxes - Summary of Major Components of Company's Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 68,437 | $ 46,120 |
Research and development credit carryforwards | 4,903 | 3,669 |
Capitalized research and development costs | 9,398 | 11,123 |
Other | 376 | 271 |
Stock compensation | 2,183 | 1,987 |
Total deferred tax assets | 85,297 | 63,170 |
Valuation allowance | (85,297) | (63,170) |
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, 2020 | Dec. 31, 2019 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Beginning uncertain tax benefits | $ 935 | $ 924 |
Current year - increases | 237 | 83 |
Prior year - additions | 169 | |
Prior year - (reductions) | (72) | |
Ending uncertain tax benefits | $ 1,341 | $ 935 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating Loss Carryforwards [Line Items] | |||
Deferred tax valuation allowance | $ 85,297,000 | $ 63,170,000 | |
Deferred tax assets, increase in valuation allowance | 22,100,000 | 4,100,000 | |
Operating loss carryforward, subject to expiration | 200,000 | ||
Operating loss carryforwards not subject to expiration | 78,100,000 | ||
Unrecognized tax benefits | 1,341,000 | 935,000 | $ 924,000 |
Accrued interest or penalties recorded related to uncertain tax positions | 0 | 0 | |
Unremitted earnings | 0 | ||
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 255,900,000 | 174,500,000 | |
Net operating loss carryforwards expiration year | 2021 | ||
Federal | Research Credit Carryforwards | |||
Operating Loss Carryforwards [Line Items] | |||
Research credit carryforwards | $ 4,000,000 | 3,100,000 | |
Research credit carryforwards expiration year | 2027 | ||
State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 221,000,000 | 140,100,000 | |
Net operating loss carryforwards expiration year | 2031 | ||
State | Research Credit Carryforwards | |||
Operating Loss Carryforwards [Line Items] | |||
Research credit carryforwards | $ 2,700,000 | $ 1,900,000 | |
Research credit carryforwards expiration year | 2022 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | Jan. 07, 2021 | May 01, 2020 | Apr. 22, 2020 | Apr. 12, 2019 | Jul. 31, 2020 | Apr. 30, 2019 | Jan. 31, 2018 | Mar. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Apr. 21, 2020 | Feb. 28, 2018 | Feb. 15, 2018 |
Class of Stock [Line Items] | |||||||||||||
Net proceeds from issuance of common stock | $ 22,977,407 | $ 5,151,702 | |||||||||||
Registered amount | 7,500,000 | ||||||||||||
Unamortized costs | 175,000 | ||||||||||||
Issuance of common stock | 22,977,407 | ||||||||||||
Exercise price (in usd per share) | $ 3 | ||||||||||||
Warrant, exercise price, decrease | $ 0.96 | $ 0.98 | |||||||||||
Deemed dividend from trigger of down round provision | $ 6,863 | $ 800,000 | $ 6,863 | $ 789,594 | |||||||||
Warrants exercised (in shares) | 1,825,000 | 0 | |||||||||||
Proceeds from warrant exercises | $ 1,800,000 | ||||||||||||
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 | |||||||||||
Common stock, par value (in usd per share) | $ 0.0001 | $ 0.0001 | |||||||||||
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 | |||||||||||
Preferred stock, par value (in usd per share) | $ 0.01 | $ 0.01 | |||||||||||
Common stock, shares issued (in shares) | 41,596,253 | 19,683,401 | |||||||||||
Common stock, shares outstanding (in shares) | 41,596,253 | 19,683,401 | |||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||||||
Subsequent Event | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Registered amount | 6,400,000 | ||||||||||||
Lincoln Park | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Purchase obligation | $ 15,000,000 | ||||||||||||
ATM Sales Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Issuance of common stock via public offering, net (in shares) | 12,577,703 | ||||||||||||
Net proceeds from issuance of common stock | $ 15,800,000 | ||||||||||||
Offering expenses | $ 594,000 | ||||||||||||
Public Stock Offering | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Issuance of common stock via public offering, net (in shares) | 4,575,000 | ||||||||||||
Public offering price | $ 1.10 | ||||||||||||
Issuance of common stock | $ 5,151,702 | ||||||||||||
Underwritten Offering | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Issuance of common stock via public offering, net (in shares) | 5,261,250 | ||||||||||||
Underwriters option to purchase additional shares of common stock and warrants period | 30 days | ||||||||||||
Underwriters option to purchase additional shares (in shares) | 686,250 | ||||||||||||
Gross proceeds from offering of warrants | $ 5,800,000 | ||||||||||||
Net proceeds from sale of stock offering | $ 5,200,000 | ||||||||||||
Purchase Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Issuance of common stock via public offering, net (in shares) | 285,714 | 7,214,286 | |||||||||||
Purchase agreement | $ 374,000 | ||||||||||||
Issuance of common stock | $ 8,000,000 | ||||||||||||
Recognized offering expenses | $ 236,000 | ||||||||||||
Purchase Agreement | Lincoln Park | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Regular Repurchase | 200,000 | ||||||||||||
Regular purchase, maximum amount | 1,000,000 | ||||||||||||
Common stock, exchange cap | 4,941,089 | ||||||||||||
Convertible notes issued, per share | $ 1.0117 | ||||||||||||
Common stock, exchange cap, percentage | 9.99% | ||||||||||||
Purchase Agreement | Lincoln Park | Subsequent Event | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Issuance of common stock via public offering, net (in shares) | 2,400,000 | ||||||||||||
Net proceeds from issuance of common stock | $ 3,900,000 | ||||||||||||
Maximum | ATM Sales Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Aggregate commission rate | 3.00% | ||||||||||||
Maximum | Purchase Agreement | Lincoln Park | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Public offering price | $ 3 | ||||||||||||
Regular purchase | 300,000 | ||||||||||||
Minimum | Purchase Agreement | Lincoln Park | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Public offering price | $ 1.50 | ||||||||||||
Regular purchase | 250,000 | ||||||||||||
Accounting Standards Update 2017-11 | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Estimated fair value of warrants | $ 3,000,000 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Common Stock Warrants Outstanding (Details) - $ / shares | Dec. 31, 2020 | Feb. 28, 2018 |
Class of Stock [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 1,908,643 | |
Exercise price (in usd per share) | $ 3 | |
Warrants Expiring on December 1, 2021 | ||
Class of Stock [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 2,906 | |
Exercise price (in usd per share) | $ 120.40 | |
Warrants Expiring on December 6, 2021 | ||
Class of Stock [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 3,737 | |
Exercise price (in usd per share) | $ 120.40 | |
Warrants Expiring on April 4, 2026 | ||
Class of Stock [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 6,500 | |
Exercise price (in usd per share) | $ 10 | |
Warrants Expiring On February 15, 2023 | ||
Class of Stock [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 1,895,500 | |
Exercise price (in usd per share) | $ 0.96 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Common Stock Reserved for Future Issuance (Detail) - shares | Dec. 31, 2020 | Jan. 01, 2020 | Dec. 31, 2019 |
Class of Stock [Line Items] | |||
Common stock reserved for issuance (in shares) | 5,199,750 | ||
Exercise of Warrants Outstanding | |||
Class of Stock [Line Items] | |||
Common stock reserved for issuance (in shares) | 1,908,643 | 3,750,833 | |
Exercise of Options Outstanding | |||
Class of Stock [Line Items] | |||
Common stock reserved for issuance (in shares) | 2,786,591 | ||
Stock Options | |||
Class of Stock [Line Items] | |||
Common stock reserved for issuance (in shares) | 1,411,481 | ||
Amended And Restated Two Thousand Fourteen Stock Incentive Plan | Stock Options | |||
Class of Stock [Line Items] | |||
Common stock reserved for issuance (in shares) | 504,516 |
Stock-based compensation - Addi
Stock-based compensation - Additional Information (Detail) | Jan. 01, 2020shares | Jul. 10, 2018shares | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($)shares | Dec. 31, 2018shares | Jul. 31, 2018shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock, shares outstanding (in shares) | 41,596,253 | 19,683,401 | ||||
Stock-based compensation expense | $ | $ 742,031 | $ 462,239 | ||||
Common stock reserved for future issuance (in shares) | 5,199,750 | |||||
Unamortized stock-based compensation expense | $ | $ 1,300,000 | |||||
Amortized weighted average period | 2 years 2 months 12 days | |||||
Reverse stock split, conversion ratio | 0.1 | |||||
Stock Options | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock options outstanding (in shares) | 2,000,000 | |||||
Options to purchase number of outstanding shares of common stock (in shares) | 2,046,885 | |||||
Annual percentage increase in outstanding number of common stock | 4.00% | |||||
Number of authorized shares, period increase | 787,336 | |||||
Common stock reserved for future issuance (in shares) | 1,411,481 | |||||
2015 Stock Incentive Plan | Stock Options | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock options outstanding (in shares) | 10,149 | |||||
2015 Stock Incentive Plan | Stock Options | Private Dare | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock options outstanding (in shares) | 10,149 | |||||
2015 Stock Incentive Plan | Restricted Stock | Private Dare | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock, shares outstanding (in shares) | 223,295 | |||||
2014 Employee Stock Purchase Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ | $ 0 | $ 0 | ||||
Amended And Restated Two Thousand Fourteen Stock Incentive Plan | Stock Options | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock options outstanding (in shares) | 2,786,591 | 1,889,775 | 1,635,790 | |||
Common stock reserved for future issuance (in shares) | 504,516 |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of Stock Option Activity (Detail) - Amended And Restated Two Thousand Fourteen Stock Incentive Plan - Stock Options - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Shares | ||
Outstanding beginning balance (in shares) | 1,889,775 | 1,635,790 |
Granted (in shares) | 906,965 | 832,500 |
Exercised (in shares) | (10,149) | 0 |
Forfeited (in shares) | 0 | (578,445) |
Expired (in shares) | 0 | (70) |
Outstanding ending balance (in shares) | 2,786,591 | 1,889,775 |
Options exercisable at December 31, 2020 (in shares) | 1,199,857 | |
Options vested and expected to vest at December 31, 2020 (in shares) | 2,786,591 | |
Weighted- Average Exercise Price | ||
Outstanding beginning balance (in usd per share) | $ 1.21 | $ 11.08 |
Granted (in usd per share) | 1.06 | 0.79 |
Exercised (in usd per share) | 0 | 0 |
Expired (in usd per share) | 0 | 59.48 |
Forfeited (in usd per share) | 0 | 28.52 |
Outstanding ending balance (in usd per share) | 1.16 | $ 1.21 |
Options exercisable at December 31, 2020 (in usd per share) | 1.40 | |
Options vested and expected to vest at December 31, 2020 (in usd per share) | $ 1.16 | |
Weighted- Average Remaining Contractual Life (Years) | ||
Outstanding at December 31, 2020 | 8 years 3 months 29 days | |
Options exercisable at December 31, 2020 | 8 years 3 days | |
Options vested and expected to vest at December 31, 2020 | 8 years 3 months 29 days | |
Aggregate Intrinsic Value | ||
Outstanding at December 31, 2020 | $ 993,981 | |
Options exercisable at December 31, 2020 | 427,931 | |
Options vested and expected to vest at December 31, 2020 | $ 993,981 |
Stock-based Compensation - Comp
Stock-based Compensation - Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 742,031 | $ 462,239 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 225,579 | 107,142 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 516,452 | $ 355,097 |
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, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | ||
Expected life in years | 10 years | 10 years |
Risk-free interest rate | 0.82% | 2.44% |
Expected volatility | 120.00% | 120.00% |
Forfeiture rate | 0.00% | 0.00% |
Dividend yield | 0.00% | 0.00% |
Weighted-average fair value of options granted (in usd per share) | $ 1 | $ 0.75 |
Leased Properties - Additional
Leased Properties - Additional Information (Details) | 12 Months Ended | |||
Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018 | Jul. 01, 2018ft² | |
Lessee, Lease, Description [Line Items] | ||||
Square feet of office space | ft² | 3,169 | |||
Renewal term of operating lease | 1 year | |||
Operating lease discount rate | 7.00% | |||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Other non-current assets | |||
Current portion of lease liabilities | $ 347,712 | $ 410,896 | ||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | |||
Operating lease, liability, noncurrent | $ 42,000 | |||
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease liabilities long-term | |||
Operating lease cost | $ 303,800 | $ 223,000 | ||
Operating lease, payments | $ 461,000 | |||
Operating lease weighted average remaining lease term | 10 months 9 days | |||
Other Current Assets | ||||
Lessee, Lease, Description [Line Items] | ||||
Right-of-use asset | $ 240,000 |
Leased Properties Leased Proper
Leased Properties Leased Properties- Future Minimum Lease Payment (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Leases [Abstract] | |
2021 | $ 363 |
2022 | 42 |
Total future minimum lease payments | 405 |
Less: accreted interest | 16 |
Total operating lease liabilities | $ 389 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Nov. 30, 2019 | |
Commitments And Contingencies [Line Items] | ||||
Loan under Paycheck Protection Program | $ 367,000 | |||
Notes payable including accrued interest | $ 369,600 | |||
Defined contribution plan, employer matching contribution, percent of match | 4.00% | |||
Defined contribution plan, employer matching contributions | $ 136,000 | $ 96,000 | ||
Minimum | ||||
Commitments And Contingencies [Line Items] | ||||
Payment to be received upon termination without cause | 6 months | |||
Health coverage to be received upon termination without cause | 6 months | |||
Change in control of company, termination for cause or for good reason | 3 months | |||
Payment to be received upon termination for cause or for good reason | 9 months | |||
Health coverage to be received upon termination for cause or for good reason | 9 months | |||
Maximum | ||||
Commitments And Contingencies [Line Items] | ||||
Payment to be received upon termination without cause | 12 months | |||
Health coverage to be received upon termination without cause | 12 months | |||
Change in control of company, termination for cause or for good reason | 12 months | |||
Payment to be received upon termination for cause or for good reason | 18 months | |||
Health coverage to be received upon termination for cause or for good reason | 18 months | |||
Microchips Biotech, Inc. | ||||
Commitments And Contingencies [Line Items] | ||||
Current portion of contingent consideration | $ 1,000,000 |
Grant Awards - Additional Infor
Grant Awards - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | 36 Months Ended | ||
Aug. 31, 2020 | Apr. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2020 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Amount awarded for grant | $ 731,000 | $ 1,900,000 | |||
Grants Receivable | $ 12,000 | 12,000 | |||
Deferred grant funding | 1,564,553 | $ 2,019,674 | 1,564,553 | ||
Grant, Ovaprene | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Credits recorded to research and development expense for costs related to award | 595,000 | 1,200,000 | |||
Grant, DARE-FRT1 | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Amount awarded for grant | $ 300,000 | ||||
Credits recorded to research and development expense for costs related to award | 131,000 | ||||
Additional potential grant funding | $ 2,000,000 | ||||
Receivable for expenses eligible for reimbursement | 128,000 | $ 128,000 | |||
Grant Awards | Bill And Melinda Gates Foundation | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Revenue from grant for notice of awards | $ 2,500,000 | $ 2,900,000 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) | Apr. 22, 2020 | Feb. 28, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Feb. 28, 2018 |
Subsequent Event [Line Items] | ||||||
Net proceeds from issuance of common stock | $ 22,977,407 | $ 5,151,702 | ||||
Warrants to purchase shares | 1,908,643 | |||||
Exercise price (in usd per share) | $ 3 | |||||
Purchase Agreement | ||||||
Subsequent Event [Line Items] | ||||||
Issuance of common stock (in shares) | 285,714 | 7,214,286 | ||||
Subsequent Event | Purchase Agreement | Lincoln Park | ||||||
Subsequent Event [Line Items] | ||||||
Issuance of common stock (in shares) | 2,400,000 | |||||
Net proceeds from issuance of common stock | $ 3,900,000 | |||||
Subsequent Event | Warrant | ||||||
Subsequent Event [Line Items] | ||||||
Warrants to purchase shares | 52,500 | |||||
Exercise price (in usd per share) | $ 0.96 | |||||
Gross proceeds from offering of warrants | $ 50,000 | |||||
ATM Sales | Subsequent Event | ||||||
Subsequent Event [Line Items] | ||||||
Sales commissions and fees | $ 245,000 | |||||
ATM Sales | Subsequent Event | At-the-Market Equity Offerings | ||||||
Subsequent Event [Line Items] | ||||||
Issuance of common stock (in shares) | 3,264,069 | |||||
Net proceeds from issuance of common stock | $ 7,700,000 |