Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2021 | May 10, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2021 | |
Document Transition Report | false | |
Entity Registrant Name | DARÉ BIOSCIENCE, INC. | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001401914 | |
Current Fiscal Year End Date | --12-31 | |
Entity Incorporation, State or Country Code | DE | |
Entity File Number | 001-36395 | |
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 | |
City Area Code | 858 | |
Local Phone Number | 926-7655 | |
Entity Address, Postal Zip Code | 92122 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | DARE | |
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 | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 49,350,077 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 7,660,151 | $ 4,669,467 |
Other receivables | 301,835 | 460,168 |
Prepaid expenses | 1,637,089 | 1,854,277 |
Total current assets | 9,599,075 | 6,983,912 |
Property and equipment, net | 31,520 | 37,930 |
Other non-current assets | 887,858 | 528,870 |
Total assets | 10,518,453 | 7,550,712 |
Current liabilities | ||
Accounts payable | 1,471,631 | 1,021,333 |
Accrued expenses | 2,519,925 | 3,359,718 |
Deferred grant funding | 672,430 | 1,564,553 |
Note payable | 0 | 367,285 |
Current portion of contingent consideration | 1,000,000 | 1,000,000 |
Current portion of lease liabilities | 444,448 | 347,712 |
Total current liabilities | 6,108,434 | 7,660,601 |
Deferred license revenue | 1,000,000 | 1,000,000 |
Lease liabilities long-term | 151,786 | 41,844 |
Total liabilities | 7,260,220 | 8,702,445 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity (deficit) | ||
Preferred stock, $0.01 par value, 5,000,000 shares authorized; None issued and outstanding | 0 | 0 |
Common stock, $0.0001 par value; 120,000,000 shares authorized; 47,312,822 and 41,596,253 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 4,731 | 4,159 |
Accumulated other comprehensive loss | (98,229) | (91,388) |
Additional paid-in capital | 82,106,172 | 70,366,293 |
Accumulated deficit | (78,754,441) | (71,430,797) |
Total stockholders' equity (deficit) | 3,258,233 | (1,151,733) |
Total liabilities and stockholders' equity (deficit) | $ 10,518,453 | $ 7,550,712 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2021 | Dec. 31, 2020 |
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) | 47,312,822 | 41,596,253 |
Common stock, shares outstanding (in shares) | 47,312,822 | 41,596,253 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating expenses | ||
General and administrative | $ 1,940,328 | $ 1,861,765 |
Research and development | 5,728,206 | 2,379,804 |
License fees | 25,000 | 12,500 |
Total operating expenses | 7,693,534 | 4,254,069 |
Loss from operations | (7,693,534) | (4,254,069) |
Other income | 3 | 1,821 |
Gain on extinguishment of note payable | 369,887 | 0 |
Net loss | (7,323,644) | (4,252,248) |
Foreign currency translation adjustments | (6,841) | (22,944) |
Comprehensive loss | $ (7,330,485) | $ (4,275,192) |
Loss per common share - basic and diluted (in usd per share) | $ (0.16) | $ (0.18) |
Weighted average number of common shares outstanding: | ||
Basic and diluted (in shares) | 44,502,582 | 23,799,396 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders’ Equity (Deficit) - USD ($) | Total | Common stock | Additional paid-in capital | Accumulated other comprehensive loss | Accumulated deficit |
Beginning balance at Dec. 31, 2019 | $ 440,826 | $ 1,968 | $ 44,564,674 | $ (102,625) | $ (44,023,191) |
Beginning balance (in shares) at Dec. 31, 2019 | 19,683,401 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 160,841 | 160,841 | |||
Issuance of common stock | 5,222,687 | $ 331 | 5,222,356 | ||
Issuance of common stock (in shares) | 3,308,003 | ||||
Issuance of common stock from the exercise of warrants | 1,665,020 | $ 170 | 1,664,850 | ||
Issuance of common stock from the exercise of warrants (in shares) | 1,699,000 | ||||
Stock options exercised | 1 | $ 1 | |||
Stock options exercised (in shares) | 10,149 | ||||
Net loss | (4,252,248) | (4,252,248) | |||
Foreign currency translation adjustments | (22,944) | (22,944) | |||
Ending balance at Mar. 31, 2020 | 3,214,183 | $ 2,470 | 51,612,721 | (125,569) | (48,275,439) |
Ending balance (in shares) at Mar. 31, 2020 | 24,700,553 | ||||
Beginning balance at Dec. 31, 2020 | (1,151,733) | $ 4,159 | 70,366,293 | (91,388) | (71,430,797) |
Beginning balance (in shares) at Dec. 31, 2020 | 41,596,253 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 365,911 | 365,911 | |||
Issuance of common stock | 11,324,140 | $ 567 | 11,323,573 | ||
Issuance of common stock (in shares) | 5,664,069 | ||||
Issuance of common stock from the exercise of warrants | 50,400 | $ 5 | 50,395 | ||
Issuance of common stock from the exercise of warrants (in shares) | 52,500 | ||||
Net loss | (7,323,644) | ||||
Foreign currency translation adjustments | (6,841) | (6,841) | |||
Ending balance at Mar. 31, 2021 | $ 3,258,233 | $ 4,731 | $ 82,106,172 | $ (98,229) | $ (78,754,441) |
Ending balance (in shares) at Mar. 31, 2021 | 47,312,822 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating activities: | ||
Net loss | $ (7,323,644) | $ (4,252,248) |
Non-cash adjustments reconciling net loss to operating cash flows: | ||
Depreciation | 6,410 | 11,949 |
Stock-based compensation | 365,911 | 160,841 |
Non-cash operating lease cost | (24,224) | (55,786) |
Gain on extinguishment of notes payable and accrued interest | (369,887) | 0 |
Changes in operating assets and liabilities: | ||
Other receivables | 158,333 | 125,488 |
Prepaid expenses | 217,188 | (2,736,149) |
Other non-current assets | (128,086) | 38,682 |
Accounts payable | 450,298 | 448,314 |
Accrued expenses | (837,191) | (408,027) |
Deferred grant funding | (892,123) | (930,610) |
Deferred license revenue | 0 | 1,000,000 |
Net cash used in operating activities | (8,377,015) | (6,597,546) |
Financing activities: | ||
Net proceeds from issuance of common stock | 11,324,140 | 5,222,687 |
Proceeds from the exercise of common stock warrants | 50,400 | 1,665,020 |
Proceeds from the exercise of stock options | 0 | 1 |
Net cash provided by financing activities | 11,374,540 | 6,887,708 |
Effect of exchange rate changes on cash and cash equivalents | (6,841) | (22,944) |
Net change in cash and cash equivalents | 2,990,684 | 267,218 |
Cash and cash equivalents, beginning of period | 4,669,467 | 4,780,107 |
Cash and cash equivalents, end of period | 7,660,151 | 5,047,325 |
Supplemental disclosure of non-cash operating and financing activities: | ||
Forgiveness of Paycheck Protection Program note payable and accrued interest | 369,887 | 0 |
Operating right-of-use assets obtained in exchange for new operating lease liabilities | $ 308,533 | $ 0 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | ORGANIZATION AND DESCRIPTION OF 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 in one segment. In this report, the “Company” refers collectively to Daré Bioscience, Inc. and its wholly owned subsidiaries, unless otherwise stated or the context otherwise requires. The Company is driven by a mission to identify, develop and bring to market a diverse portfolio of differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health and fertility. The Company's business strategy is to 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 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 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, research and development activities to advance its product candidates through clinical development and regulatory approval. The Company has focused on the advancement of DARE-BV1, Ovaprene, and Sildenafil Cream, 3.6%, and plans to continue to focus its resources on these product candidates for the remainder of 2021 and in 2022. In the first quarter of 2021, the Company also had significant research and development expenses for its DARE-LARC1 program, substantially all of which were supported by a grant from the Bill & Melinda Gates Foundation. 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 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 an evolving and uncertain risk to the Company's business, operating results, financial condition and stock price. Global vaccination efforts to control the pandemic have been underway for the past several months and the number of vaccinated adults in the U.S. is encouraging. However, uncertainty remains regarding the extent, availability and length of time to vaccinate a meaningful portion of the population, as well as the degree of efficacy of such vaccination efforts on the trajectory of the pandemic, including in light of the multiple variants of the virus that causes COVID-19 circulating globally and within the U.S. Challenges to vaccination efforts and other causes of virus spread may require local, state, federal and foreign governments to reimpose restrictions and/or shutdowns in various geographies. To date, neither government-imposed restrictions or other governmental actions nor the Company's remote working arrangements or those of its third-party service providers and contract manufacturers have materially affected the Company's ability to operate its business, and the Company has been able to advance its portfolio of product candidates in meaningful ways during the pandemic, including by commencing and completing a Phase 3 clinical trial of DARE-BV1 during 2020. However, the effects of the pandemic 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 by increasing the anticipated aggregate costs and timelines for the development and marketing approval of the Company's product candidates. Continued uncertainty regarding the duration and impact of the pandemic on the U.S. and global economies, workplace environments and capital markets, preclude any prediction as to the ultimate effect of the pandemic on the Company's business. For example, as it relates to the cost and timelines for the Company's ongoing and planned clinical trials, a spike in hospitalizations in the U.S. due to COVID-19 could cause healthcare industry resources to be diverted from participating in research and development activities for investigational products unrelated to the COVID-19 pandemic or other life threatening diseases and conditions, which could delay the commencement and/or completion of clinical trials for product candidates such as Sildenafil Cream, 3.6% and Ovaprene. Conversely, continued re-opening of the U.S. and global economies may delay enrollment in clinical trials for Sildenafil Cream, 3.6% and Ovaprene as individuals gain more freedom to travel and participate in other activities that have not been available to them since the beginning of the pandemic and may be less inclined to participate in or complete studies that require multiple clinic visits. See also 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, in Part I, ITEM 1A, Risk Factors of the Company's annual report on Form 10-K for the year ended December 31, 2020, or the 2020 10-K, filed with the Securities and Exchange Commission, or SEC, on March 30, 2021. Going Concern The Company prepared its condensed 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 to 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 condensed consolidated 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. As of March 31, 2021, the Company had an accumulated deficit of approximately $78.8 million, cash and cash equivalents of approximately $7.7 million, and working capital of approximately $3.5 million. For the three months ended March 31, 2021, the Company incurred a net loss of $7.3 million and had negative cash flow from operations of approximately $8.4 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, preclinical work 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 Biotech, Inc., or 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 or other arrangements 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 its later stage candidates 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 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The Company’s significant accounting policies are described in Note 1 to the consolidated financial statements included in the 2020 10-K. Since the date of those consolidated financial statements, there have been no material changes to the Company’s significant accounting policies. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP, as defined by the Financial Accounting Standards Board, or FASB, for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, the accompanying condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the results of the interim periods presented. Interim financial results are not necessarily indicative of results anticipated for any other interim period or for the full year. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in the 2020 10-K. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in other non-current assets, current portion of lease liabilities, and lease liabilities long-term on the Company's condensed 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 assets 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 6, Leased Properties.) 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 March 31, 2021 and December 31, 2020. There were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 2) as of March 31, 2021 or December 31, 2020. Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at March 31, 2021 Current assets: Cash equivalents (1) $ 6,206,377 $ — $ — $ 6,206,377 Current liabilities: Current portion of contingent consideration (2) $ — $ — $ 1,000,000 $ 1,000,000 Balance at December 31, 2020 Current assets: Cash equivalents (1) $ 2,823,099 $ — $ — $ 2,823,099 Other non-current liabilities: Current portion of contingent consideration (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, as described in Note 3. 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 March 31, 2021, neither of the foregoing had occurred. The $1.0 million payment is recorded as long-term deferred license revenue in the Company's condensed consolidated balance sheet at March 31, 2021 and 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.) |
License and Collaboration Agree
License and Collaboration Agreements | 3 Months Ended |
Mar. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License and Collaboration Agreements | LICENSE AND COLLABORATION AGREEMENTS Out-License Agreements Bayer HealthCare License Agreement In January 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 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 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 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 In November 2019, the Company acquired 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 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 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 milestones, which may be paid, in the Company’s sole discretion, in cash or shares of the Company’s common stock. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION 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. There was no stock-based compensation related to the ESPP for the three months ended March 31, 2021 or March 31, 2020. Amended and Restated 2014 Stock Incentive Plan The Company maintains the Amended and Restated 2014 Plan, or the Amended 2014 Plan, which provides for the grant of options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards to employees, officers and directors, and consultants and advisors. 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. On January 1, 2021, the number of authorized shares increased by 1,663,850 to 2,168,366, 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 three months ended March 31, 2021. The exercise price of all options granted during the three months ended March 31, 2021 was equal to the market value of the Company’s common stock on the date of grant. As of March 31, 2021, unamortized stock-based compensation expense of $4,651,245 will be amortized over a weighted average period of 3.41 years. At March 31, 2021, 643,666 shares of common stock were reserved for future awards granted under the Amended 2014 Plan. Number of Shares Weighted Average Outstanding at December 31, 2020 2,786,591 $ 1.16 Granted 1,524,700 2.59 Exercised — — Canceled/forfeited — — Expired — — Outstanding at March 31, 2021 4,311,291 $ 1.67 Exercisable at March 31, 2021 1,395,046 $ 1.41 Compensation Expense Total stock-based compensation expense related to stock options granted to employees and directors recognized in the condensed consolidated statements of operations is as follows: Three Months Ended 2021 2020 Research and development $ 115,625 $ 46,380 General and administrative $ 250,286 $ 114,461 Total $ 365,911 $ 160,841 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 three months ended March 31, 2021 are as follows: Three Months Ended Expected life in years 6.0 Risk-free interest rate 0.58% Expected volatility 122% Forfeiture rate 0.0% Dividend yield 0.0% Weighted-average fair value of options granted $2.25 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY 2018 ATM Sales Agreement In January 2018 the Company entered into a common stock sales agreement with H.C. Wainwright & Co., LLC, or Wainwright, relating to the offering and sale of shares of our common stock from time to time in an "at the market offerings" of equity securities (as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, or the Securities Act) through Wainwright, acting as sales agent. In accordance with the agreement, on March 29, 2021, we provided notice to Wainwright to terminate the agreement. The agreement terminated on April 3, 2021. Under the agreement, Wainwright was entitled to a commission at a fixed commission rate equal to 3.0% of the gross proceeds per share sold under the agreement and we provided Wainwright with customary indemnification rights. During the three months ended March 31, 2021, the Company sold approximately 3.3 million shares of common stock under this agreement for gross proceeds of approximately $7.7 million and incurred offering expenses of approximately $245,000. During the three months ended March 31, 2020, the Company sold approximately 3.3 million shares under this agreement for gross proceeds of approximately $5.4 million and incurred offering expenses of approximately $220,000. Equity Line In April 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 and as of March 31, 2021 there was approximately $76,000 of unamortized costs. During the three months ended March 31, 2021, the Company sold, and Lincoln Park purchased, 2.4 million shares under the Purchase Agreement for gross proceeds to the Company of approximately $4.0 million and recognized offering expenses of approximately $131,000. 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 three months ended March 31, 2021, warrants to purchase an aggregate of 52,500 shares of common stock were exercised for gross proceeds of approximately $50,000. During the three months ended March 31, 2020, warrants to purchase an aggregate of 1,699,000 shares of common stock were exercised for gross proceeds of approximately $1.7 million. As of March 31, 2021, the Company had the following warrants outstanding: Shares Underlying 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 1,843,000 $ 0.96 02/15/2023 1,856,143 |
Leased Properties
Leased Properties | 3 Months Ended |
Mar. 31, 2021 | |
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. In January 2021, the Company exercised its option to extend the term of the lease for one year such that the term now expires July 31, 2022. 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. In January 2021, the Company entered into an amendment to extend the term of the lease for one year such that the term now expires on September 30, 2022. 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 March 31, 2021, the Company reported operating lease ROU assets current portion of lease liabilities lease liabilities long-term Total operating lease costs were approximately $135,000 and $99,000 for the three months ended March 31, 2021 and March 31, 2020, 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 condensed consolidated statements of operations. Cash paid for amounts included in the measurement of operating lease liabilities was approximately $112,000 and $128,000 for the three months ended March 31, 2021 and March 31, 2020, respectively, and these amounts are included in operating activities in the condensed consolidated statements of cash flows. Further, at March 31, 2021, operating leases had a weighted average remaining lease term of 1.31 years. As of March 31, 2021, future minimum lease payments under the Company's operating leases are as follows: Remainder of 2021 $ 349,000 2022 278,000 Total future minimum lease payments 627,000 Less: accreted interest 31,000 Total operating lease liabilities $ 596,000 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
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 condensed consolidated balance sheet at March 31, 2021. The Company may pay the milestones in cash, shares of the Company's common stock or with some combination of both. Note Payable |
Grant Award
Grant Award | 3 Months Ended |
Mar. 31, 2021 | |
Receivables [Abstract] | |
Grant Award | 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 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 an immaterial amount for the three months ended March 31, 2021 and approximately $293,000 for the three months ended March 31, 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 $14,000 during the three months ended March 31, 2021. At March 31, 2021, the Company recorded a receivable of approximately $14,000 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 March 31, 2021, grant funding payments associated with research and development expenses for DARE-LARC1 not yet incurred totaled approximately $0.7 million and are recorded as deferred grant funding liability in the Company's condensed consolidated balance sheet. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NET LOSS PER SHARE The Company computes basic net loss per share using the weighted average number of common shares outstanding during the period. Diluted net income per share is based upon the weighted average number of common shares and potentially dilutive securities (common share equivalents) outstanding during the period. Common share equivalents outstanding, determined using the treasury stock method, are comprised of shares that may be issued under outstanding options and warrants to purchase shares of the Company’s common stock. Common share equivalents are excluded from the diluted net loss per share calculation if their effect is anti-dilutive. The following potentially dilutive outstanding securities were excluded from diluted net loss per common share for the period indicated because of their anti-dilutive effect: Potentially dilutive securities Three Months Ended 2021 2020 Stock options 4,311,291 2,586,626 Warrants 1,856,143 2,034,643 Total 6,167,434 4,621,269 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTS 2021 ATM Sales Agreement In April 2021, the Company entered into a sales agreement with SVB Leerink LLC to sell shares of its common stock from time to time through an ATM equity offering program under which SVB Leerink acts as the Company's agent. Under the sales agreement, the Company may issue and sell up to $50.0 million of shares of its common stock. The Company agreed to pay a commission equal to 3% of the gross proceeds of any common stock sold under the agreement, plus certain legal expenses. Any shares of the Company's common stock sold under the agreement will be issued pursuant to the Company's shelf registration statement on Form S-3 (File No. 333-254862) and the base prospectus included therein, originally filed with the SEC on March 30, 2021, and declared effective on April 7, 2021, and the prospectus supplement dated April 7, 2021 filed with the SEC on April 8, 2021. Sales of Common Stock Between April 1, 2021 and May 10, 2021, the Company sold an aggregate of approximately 1.8 million shares of common stock under its ATM equity offering program and its equity line for aggregate net proceeds of approximately $2.6 million. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP, as defined by the Financial Accounting Standards Board, or FASB, for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, the accompanying condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the results of the interim periods presented. Interim financial results are not necessarily indicative of results anticipated for any other interim period or for the full year. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in the 2020 10-K. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in other non-current assets, current portion of lease liabilities, and lease liabilities long-term on the Company's condensed consolidated balance sheets. |
Fair Value Measurements | 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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
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 March 31, 2021 and December 31, 2020. There were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 2) as of March 31, 2021 or December 31, 2020. Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at March 31, 2021 Current assets: Cash equivalents (1) $ 6,206,377 $ — $ — $ 6,206,377 Current liabilities: Current portion of contingent consideration (2) $ — $ — $ 1,000,000 $ 1,000,000 Balance at December 31, 2020 Current assets: Cash equivalents (1) $ 2,823,099 $ — $ — $ 2,823,099 Other non-current liabilities: Current portion of contingent consideration (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, as described in Note 3. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity for Amended 2014 Plan and Related Information | The table below summarizes stock option activity under the Amended 2014 Plan and related information for the three months ended March 31, 2021. The exercise price of all options granted during the three months ended March 31, 2021 was equal to the market value of the Company’s common stock on the date of grant. As of March 31, 2021, unamortized stock-based compensation expense of $4,651,245 will be amortized over a weighted average period of 3.41 years. At March 31, 2021, 643,666 shares of common stock were reserved for future awards granted under the Amended 2014 Plan. Number of Shares Weighted Average Outstanding at December 31, 2020 2,786,591 $ 1.16 Granted 1,524,700 2.59 Exercised — — Canceled/forfeited — — Expired — — Outstanding at March 31, 2021 4,311,291 $ 1.67 Exercisable at March 31, 2021 1,395,046 $ 1.41 |
Summary of Recognized Stock-Based Compensation Expense Related to Stock Options Granted to Employees and Directors | Total stock-based compensation expense related to stock options granted to employees and directors recognized in the condensed consolidated statements of operations is as follows: Three Months Ended 2021 2020 Research and development $ 115,625 $ 46,380 General and administrative $ 250,286 $ 114,461 Total $ 365,911 $ 160,841 |
Summary of Assumptions Used in Black-Scholes Option-Pricing Model for Stock Options Granted to Employees and 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 three months ended March 31, 2021 are as follows: Three Months Ended Expected life in years 6.0 Risk-free interest rate 0.58% Expected volatility 122% Forfeiture rate 0.0% Dividend yield 0.0% Weighted-average fair value of options granted $2.25 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Schedule of Common Stock Warrants Outstanding | As of March 31, 2021, the Company had the following warrants outstanding: Shares Underlying 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 1,843,000 $ 0.96 02/15/2023 1,856,143 |
Leased Properties (Tables)
Leased Properties (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Future Minimum Lease Payments | As of March 31, 2021, future minimum lease payments under the Company's operating leases are as follows: Remainder of 2021 $ 349,000 2022 278,000 Total future minimum lease payments 627,000 Less: accreted interest 31,000 Total operating lease liabilities $ 596,000 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Potential Dilutive Outstanding Securities Excluded From Diluted Net Loss Per Common Share | The following potentially dilutive outstanding securities were excluded from diluted net loss per common share for the period indicated because of their anti-dilutive effect: Potentially dilutive securities Three Months Ended 2021 2020 Stock options 4,311,291 2,586,626 Warrants 1,856,143 2,034,643 Total 6,167,434 4,621,269 |
Organization and Description _2
Organization and Description of Business - Additional Information (Details) | 3 Months Ended | |||
Mar. 31, 2021USD ($)segment | Mar. 31, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Number of operating segments | segment | 1 | |||
Accumulated deficit | $ 78,754,441 | $ 71,430,797 | ||
Cash and cash equivalents | 7,660,151 | $ 5,047,325 | $ 4,669,467 | $ 4,780,107 |
Working capital | 3,500,000 | |||
Net loss | 7,323,644 | $ 4,252,248 | ||
Cash flow from operations | $ 8,400,000 | |||
Period of insufficient cash and liquidity requirements | 12 months |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Financial Assets and Liabilities Remeasured on a Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 6,206,377 | $ 2,823,099 |
Current portion of contingent consideration | 1,000,000 | |
Current portion of contingent consideration | 1,000,000 | |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 6,206,377 | 2,823,099 |
Current portion of contingent consideration | 0 | |
Current portion of contingent consideration | 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 | |
Current portion of contingent consideration | 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 | |
Current portion of contingent consideration | $ 1,000,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) - Bayer Healthcare License Agreement $ in Millions | 1 Months Ended |
Jan. 31, 2020USD ($)obligation | |
Significant Accounting Policies [Line Items] | |
Upfront license fee paid | $ 1 |
Number of significant performance obligations | obligation | 1 |
Revenue from grant for notice of award | $ 20 |
Milestone payments, contingent amount | $ 310 |
License and Collaboration Agr_2
License and Collaboration Agreements - Additional Information (Details) - USD ($) | Dec. 05, 2019 | Jan. 31, 2020 | Dec. 31, 2019 | Nov. 30, 2019 | Apr. 30, 2018 | Mar. 31, 2018 | Feb. 28, 2018 | Mar. 31, 2017 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
License fee | $ 25,000 | $ 12,500 | |||||||||||
Microchips Biotech, Inc. | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Business acquisition transaction value | $ 2,400,000 | ||||||||||||
Business combination shares issued (in usd per share) | $ 0.79 | ||||||||||||
Cash and cash equivalents | $ 6,100,000 | ||||||||||||
Contingent consideration, liability | 3,500,000 | ||||||||||||
Current portion of contingent consideration | 1,000,000 | 1,000,000 | |||||||||||
Microchips Biotech, Inc. | Research and development | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Business acquisition transaction value | $ 202,000 | ||||||||||||
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 | ||||||||||||
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 award | 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 fee | $ 235,000 | ||||||||||||
License fee to be paid upon contingency | 25,000 | $ 110,000 | $ 100,000 | ||||||||||
License agreement termination periodic discontinued sale of product | 60 days | ||||||||||||
License agreement termination period due to performance failure | 120 days | ||||||||||||
Certain clinical and regulatory development milestone payments | 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 | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Milestone payments, contingent amount | $ 50,000 | ||||||||||||
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 fee | $ 512,500 | ||||||||||||
Assignment Agreement | Hammock Pharmaceuticals, Inc | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
License fee | $ 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 | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | |||||||||||||
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 | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | Maximum | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Milestone payments, contingent amount | $ 18,000,000 | ||||||||||||
License and Collaboration Agreement | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | 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 | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | 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 | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | 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 | |||||||||||||
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 | |||||||||||||
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 | |||||||||||||
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 | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Milestone payments | $ 75,000 |
Stock Based Compensation - Addi
Stock Based Compensation - Additional Information (Details) - USD ($) | Jan. 01, 2020 | Jul. 10, 2018 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Jul. 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unamortized stock-based compensation expense | $ 4,651,245 | |||||
Weighted Average Amortization Period | 3 years 4 months 28 days | |||||
Employee Stock Option | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock options outstanding (in shares) | 2,000,000 | |||||
Stock-based compensation expense | $ 365,911 | $ 160,841 | ||||
Options to purchase number of outstanding shares of common stock | 2,046,885 | |||||
Annual percentage increase in outstanding number of common stock | 4.00% | 4.00% | ||||
Increase in number of shares authorized | 1,663,850 | |||||
Common stock reserved for future issuance (in shares) | 2,168,366 | |||||
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 | Employee Stock Option | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock options outstanding (in shares) | 4,311,291 | 2,786,591 | ||||
Common stock reserved for future issuance (in shares) | 643,666 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity for Amended 2014 Plan and Related Information (Details) - Amended and Restated Two Thousand Fourteen Stock Incentive Plan - Employee Stock Option | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Number of Shares | |
Outstanding beginning balance (in shares) | shares | 2,786,591 |
Granted (in shares) | shares | 1,524,700 |
Exercised (in shares) | shares | 0 |
Canceled/forfeited (in shares) | shares | 0 |
Expired (in shares) | shares | 0 |
Outstanding ending balance (in shares) | shares | 4,311,291 |
Exercisable (in shares) | shares | 1,395,046 |
Weighted Average Exercise Price | |
Outstanding beginning balance (in usd per share) | $ / shares | $ 1.16 |
Granted (in usd per share) | $ / shares | 2.59 |
Exercised (in usd per share) | $ / shares | 0 |
Canceled/forfeited (in usd per share) | $ / shares | 0 |
Expired (in usd per share) | $ / shares | 0 |
Outstanding ending balance (in usd per share) | $ / shares | 1.67 |
Exercisable (in usd per share) | $ / shares | $ 1.41 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Recognized Stock-Based Compensation Expense Related to Stock Options Granted to Employees and Directors (Details) - Employee Stock Option - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 365,911 | $ 160,841 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 115,625 | 46,380 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 250,286 | $ 114,461 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Assumptions Used in Black-Scholes Option-Pricing Model for Stock Options Granted to Employees and Directors (Details) | 3 Months Ended |
Mar. 31, 2021$ / shares | |
Share-based Payment Arrangement [Abstract] | |
Expected life in years | 6 years |
Risk-free interest rate | 0.58% |
Expected volatility | 122.00% |
Forfeiture rate | 0.00% |
Dividend yield | 0.00% |
Weighted-average fair value of options granted (in usd per share) | $ 2.25 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | Jan. 07, 2021 | May 12, 2020 | Jul. 31, 2020 | Apr. 30, 2020 | Apr. 30, 2019 | Mar. 31, 2021 | Mar. 31, 2020 | Apr. 22, 2020 | Feb. 28, 2018 | Feb. 15, 2018 |
Stockholders Equity [Line Items] | ||||||||||
Stock registered for resale (in shares) | 6,400,000 | 7,500,000 | ||||||||
Exercise price (in usd per share) | $ 3 | |||||||||
Warrant, exercise price, decrease (in usd per share) | $ 0.96 | $ 0.98 | ||||||||
Anti-dilution provision | $ 6,863 | $ 800,000 | $ 369,887 | $ 0 | ||||||
Warrants exercised (in shares) | 52,500 | 1,699,000 | ||||||||
Warrant exercises, gross | $ 50,000 | $ 1,700,000 | ||||||||
Accounting Standards Update 2017-11 | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Estimated fair value of warrants recorded in equity | $ 3,000,000 | |||||||||
Lincoln Park | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Obligation to purchase common stock | $ 15,000,000 | |||||||||
ATM Sales Agreement | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Common stock, shares issued and sold | 3,300,000 | 3,300,000 | ||||||||
Aggregate net proceeds on sales of shares of common stock | $ 7,700,000 | $ 5,400,000 | ||||||||
Offering expenses | 245,000 | $ 220,000 | ||||||||
Purchase Agreement | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Common stock, shares issued and sold | 285,714 | |||||||||
Legal, accounting and other fees related to Purchase Agreement | $ 374,000 | |||||||||
Unamortized costs related to legal, accounting, and other fees | $ 76,000 | |||||||||
Purchase Agreement | Lincoln Park | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Common stock, shares issued and sold | 2,400,000 | |||||||||
Aggregate net proceeds on sales of shares of common stock | $ 4,000,000 | |||||||||
Offering expenses | $ 131,000 | |||||||||
Regular purchase, common stock issuable (in shares) (up to) | 200,000 | |||||||||
Regular purchase, common stock issuable, maximum amount (in shares) | 1,000,000 | |||||||||
Exchange cap (in shares) | 4,941,089 | |||||||||
Closing price of the Company's common stock (in usd per share) | $ 1.0117 | |||||||||
Exchange cap, percentage | 9.99% | |||||||||
Purchase Agreement | Lincoln Park | Minimum | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Stock sale price (in usd per share) | $ 1.50 | |||||||||
Regular purchase, common stock issuable, increase amount (in shares) | 250,000 | |||||||||
Purchase Agreement | Lincoln Park | Maximum | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Stock sale price (in usd per share) | $ 3 | |||||||||
Regular purchase, common stock issuable, increase amount (in shares) | 300,000 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Common Stock Warrants Outstanding (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2021 | Feb. 28, 2018 | |
Class of Warrant or Right [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 1,856,143 | |
Exercise price (in usd per share) | $ 3 | |
Warrants Expiring on December 1, 2021 | ||
Class of Warrant or Right [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 2,906 | |
Exercise price (in usd per share) | $ 120.40 | |
Expiration Date | Dec. 1, 2021 | |
Warrants Expiring on December 6, 2021 | ||
Class of Warrant or Right [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 3,737 | |
Exercise price (in usd per share) | $ 120.40 | |
Expiration Date | Dec. 6, 2021 | |
Warrants Expiring on April 4, 2026 | ||
Class of Warrant or Right [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 6,500 | |
Exercise price (in usd per share) | $ 10 | |
Expiration Date | Apr. 4, 2026 | |
Warrants Expiring on February 15, 2023 | ||
Class of Warrant or Right [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 1,843,000 | |
Exercise price (in usd per share) | $ 0.96 | |
Expiration Date | Feb. 15, 2023 |
Leased Properties - Additional
Leased Properties - Additional Information (Details) | 3 Months Ended | |||||
Mar. 31, 2021USD ($) | Mar. 31, 2020USD ($) | Jan. 31, 2021 | Dec. 31, 2020USD ($) | Dec. 31, 2018 | Jul. 01, 2018ft² | |
Lessee, Lease, Description [Line Items] | ||||||
Square footage of office space | ft² | 3,169 | |||||
Renewal term of operating lease | 1 year | |||||
Incremental borrowing rate | 7.00% | |||||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Other non-current assets | |||||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | |||||
Current portion of lease liabilities | $ 444,448 | $ 347,712 | ||||
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesNoncurrent | |||||
Lease liabilities long-term | $ 151,786 | $ 41,844 | ||||
Non-cash lease expenses | 135,000 | $ 99,000 | ||||
Cash paid for measurement of operating lease liabilities | $ 112,000 | $ 128,000 | ||||
Operating lease weighted average remaining lease term | 1 year 3 months 21 days | |||||
Other Current Assets | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Right of use asset | $ 470,000 |
Leased Properties - Future Mini
Leased Properties - Future Minimum Lease Payments (Details) | Mar. 31, 2021USD ($) |
Leases [Abstract] | |
Remainder of 2021 | $ 349,000 |
2022 | 278,000 |
Total future minimum lease payments | 627,000 |
Less: accreted interest | 31,000 |
Total operating lease liabilities | $ 596,000 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) | 1 Months Ended | ||
Apr. 30, 2020 | Mar. 31, 2021 | Nov. 30, 2019 | |
Commitments And Contingencies [Line Items] | |||
Loan under Paycheck Protection Program | $ 367,285 | ||
Notes payable including accrued interest | $ 369,887 | ||
Microchips Biotech, Inc. | |||
Commitments And Contingencies [Line Items] | |||
Current portion of contingent consideration | $ 1,000,000 | $ 1,000,000 |
Grant Award - Narrative (Detail
Grant Award - Narrative (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Aug. 31, 2020 | Apr. 30, 2020 | Jul. 31, 2019 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2018 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||||
Amount awarded for grant | $ 731,000 | $ 1,900,000 | |||||
Deferred grant funding | $ 672,430 | $ 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 | $ 293,000 | ||||||
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 | 14,000 | ||||||
Additional potential grant funding | $ 2,000,000 | ||||||
Receivable for expenses eligible for reimbursement | $ 14,000 | ||||||
Grant | Bill And Melinda Gates Foundation | |||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||||
Revenue from grant for notice of award | $ 2,900,000 | $ 2,500,000 |
Net Loss Per Share - Potential
Net Loss Per Share - Potential Dilutive Outstanding Securities Excluded From Diluted Net Loss Per Common Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (shares) | 6,167,434 | 4,621,269 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (shares) | 4,311,291 | 2,586,626 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (shares) | 1,856,143 | 2,034,643 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | |||
May 10, 2021 | Apr. 30, 2021 | Apr. 30, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
ATM Sales Agreement | |||||
Subsequent Event [Line Items] | |||||
Issuance of common stock (in shares) | 3,300,000 | 3,300,000 | |||
Aggregate net proceeds on sales of shares of common stock | $ 7.7 | $ 5.4 | |||
Purchase Agreement | |||||
Subsequent Event [Line Items] | |||||
Issuance of common stock (in shares) | 285,714 | ||||
Subsequent Event | ATM Sales Agreement | |||||
Subsequent Event [Line Items] | |||||
Authorized amount | $ 50 | ||||
Subsequent Event | ATM Sales Agreement | Maximum | |||||
Subsequent Event [Line Items] | |||||
Aggregate commission rate | 3.00% | ||||
Subsequent Event | At-the-Market Equity Offerings | |||||
Subsequent Event [Line Items] | |||||
Issuance of common stock (in shares) | 1,800,000 | ||||
Subsequent Event | Purchase Agreement | |||||
Subsequent Event [Line Items] | |||||
Aggregate net proceeds on sales of shares of common stock | $ 2.6 |