Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 09, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-36395 | |
Entity Registrant Name | DARÉ BIOSCIENCE, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-4139823 | |
Entity Address, Address Line One | 3655 Nobel Drive | |
Entity Address, Address Line Two | Suite 260 | |
Entity Address, City or Town | San Diego | |
Entity Address, State or Province | CA | |
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 | 84,825,481 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001401914 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 40,389,546 | $ 51,674,087 |
Other receivables | 2,292,041 | 1,145,317 |
Prepaid expenses | 6,885,498 | 2,476,612 |
Total current assets | 49,567,085 | 55,296,016 |
Property and equipment, net | 72,833 | 26,041 |
Other non-current assets | 736,514 | 485,120 |
Total assets | 50,376,432 | 55,807,177 |
Current liabilities | ||
Accounts payable | 3,477,192 | 2,103,083 |
Accrued expenses | 4,136,330 | 3,136,244 |
Deferred grant funding | 14,836,416 | 10,542,983 |
Current portion of lease liabilities | 388,135 | 270,546 |
Total current liabilities | 22,838,073 | 16,052,856 |
Deferred license revenue | 1,000,000 | 1,000,000 |
Lease liabilities long-term | 194,587 | 0 |
Total liabilities | 24,032,660 | 17,052,856 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity | ||
Preferred stock, $0.01 par value, 5,000,000 shares authorized; None issued and outstanding | 0 | 0 |
Common stock, $0.0001 par value; 240,000,000 shares authorized; 84,825,481 and 83,944,119 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 8,482 | 8,394 |
Accumulated other comprehensive loss | (530,740) | (154,973) |
Additional paid-in capital | 151,997,447 | 149,027,802 |
Accumulated deficit | (125,131,417) | (110,126,902) |
Total stockholders' equity | 26,343,772 | 38,754,321 |
Total liabilities and stockholders' equity | $ 50,376,432 | $ 55,807,177 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
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) | 240,000,000 | 240,000,000 |
Common stock, shares issued (in shares) | 84,825,481 | 84,825,481 |
Common stock, shares outstanding (in shares) | 83,944,119 | 83,944,119 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Revenue from Contract with Customer, Product and Service [Extensible Enumeration] | License fee revenue | License fee revenue | ||
Revenues [Abstract] | ||||
Total revenue | $ 0 | $ 0 | $ 10,000,000 | $ 0 |
Total revenue | 0 | 0 | 10,000,000 | 0 |
Operating expenses | ||||
General and administrative | 2,651,543 | 2,211,334 | 8,014,424 | 5,949,299 |
Research and development | 4,462,250 | 10,432,603 | 17,065,497 | 23,501,098 |
License fee expense | 25,000 | 25,000 | 75,000 | 75,000 |
Total operating expenses | 7,138,793 | 12,668,937 | 25,154,921 | 29,525,397 |
Loss from operations | (7,138,793) | (12,668,937) | (15,154,921) | (29,525,397) |
Other income | 118,950 | 1,508 | 150,406 | 1,686 |
Gain on extinguishment of note payable | 0 | 0 | 0 | 369,887 |
Net loss | (7,019,843) | (12,667,429) | (15,004,515) | (29,153,824) |
Foreign currency translation adjustments | (230,748) | (63,281) | (375,767) | (79,002) |
Comprehensive loss | $ (7,250,591) | $ (12,730,710) | $ (15,380,282) | $ (29,232,826) |
Loss per common share - basic (in usd per share) | $ (0.08) | $ (0.18) | $ (0.18) | $ (0.45) |
Loss per common share - diluted (in usd per share) | $ (0.08) | $ (0.18) | $ (0.18) | $ (0.45) |
Weighted average number of shares outstanding: | ||||
Basic (in shares) | 84,822,516 | 70,775,508 | 85,553,134 | 64,196,162 |
Diluted (in shares) | 84,822,516 | 70,775,508 | 85,553,134 | 64,196,162 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) - USD ($) | Total | Common stock | Additional paid-in capital | Accumulated other comprehensive loss | Accumulated deficit |
Beginning balance (in shares) at Dec. 31, 2020 | 41,596,253 | ||||
Beginning balance at Dec. 31, 2020 | $ (1,151,733) | $ 4,159 | $ 70,366,293 | $ (91,388) | $ (71,430,797) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 365,911 | 365,911 | |||
Issuance of common stock, net of issuance costs (in shares) | 5,664,069 | ||||
Issuance of common stock, net of issuance costs | 11,324,140 | $ 567 | 11,323,573 | ||
Issuance of common stock from the exercise of warrants (in shares) | 52,500 | ||||
Issuance of common stock from the exercise of warrants | 50,400 | $ 5 | 50,395 | ||
Net income (loss) | (7,323,644) | (7,323,644) | |||
Foreign currency translation adjustments | (6,841) | (6,841) | |||
Ending balance (in shares) at Mar. 31, 2021 | 47,312,822 | ||||
Ending balance at Mar. 31, 2021 | 3,258,233 | $ 4,731 | 82,106,172 | (98,229) | (78,754,441) |
Beginning balance (in shares) at Dec. 31, 2020 | 41,596,253 | ||||
Beginning balance at Dec. 31, 2020 | (1,151,733) | $ 4,159 | 70,366,293 | (91,388) | (71,430,797) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income (loss) | (29,153,824) | ||||
Foreign currency translation adjustments | (79,002) | ||||
Ending balance (in shares) at Sep. 30, 2021 | 76,601,624 | ||||
Ending balance at Sep. 30, 2021 | 31,888,591 | $ 7,660 | 132,635,942 | (170,390) | (100,584,621) |
Beginning balance (in shares) at Mar. 31, 2021 | 47,312,822 | ||||
Beginning balance at Mar. 31, 2021 | 3,258,233 | $ 4,731 | 82,106,172 | (98,229) | (78,754,441) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 405,478 | 405,478 | |||
Issuance of common stock, net of issuance costs (in shares) | 10,096,701 | ||||
Issuance of common stock, net of issuance costs | 13,251,924 | $ 1,010 | 13,250,914 | ||
Net income (loss) | (9,162,751) | (9,162,751) | |||
Foreign currency translation adjustments | (8,880) | (8,880) | |||
Ending balance (in shares) at Jun. 30, 2021 | 57,409,523 | ||||
Ending balance at Jun. 30, 2021 | 7,744,004 | $ 5,741 | 95,762,564 | (107,109) | (87,917,192) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 439,497 | 439,497 | |||
Issuance of common stock, net of issuance costs (in shares) | 18,282,392 | ||||
Issuance of common stock, net of issuance costs | 35,012,048 | $ 1,828 | 35,010,220 | ||
Issuance of common stock from the exercise of warrants (in shares) | 212,985 | ||||
Issuance of common stock from the exercise of warrants | 204,466 | $ 21 | 204,445 | ||
Issuance of common stock in connection with milestone payment (in shares) | 696,724 | ||||
Issuance of common stock in connection with milestone payment | 1,219,286 | $ 70 | 1,219,216 | ||
Net income (loss) | (12,667,429) | (12,667,429) | |||
Foreign currency translation adjustments | (63,281) | (63,281) | |||
Ending balance (in shares) at Sep. 30, 2021 | 76,601,624 | ||||
Ending balance at Sep. 30, 2021 | 31,888,591 | $ 7,660 | 132,635,942 | (170,390) | (100,584,621) |
Beginning balance (in shares) at Dec. 31, 2021 | 83,944,119 | ||||
Beginning balance at Dec. 31, 2021 | 38,754,321 | $ 8,394 | 149,027,802 | (154,973) | (110,126,902) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 532,409 | 532,409 | |||
Net income (loss) | (8,398,670) | (8,398,670) | |||
Foreign currency translation adjustments | (9,150) | (9,150) | |||
Ending balance (in shares) at Mar. 31, 2022 | 83,944,119 | ||||
Ending balance at Mar. 31, 2022 | 30,878,910 | $ 8,394 | 149,560,211 | (164,123) | (118,525,572) |
Beginning balance (in shares) at Dec. 31, 2021 | 83,944,119 | ||||
Beginning balance at Dec. 31, 2021 | $ 38,754,321 | $ 8,394 | 149,027,802 | (154,973) | (110,126,902) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net of issuance costs (in shares) | 751,000 | ||||
Net income (loss) | $ (15,004,515) | ||||
Foreign currency translation adjustments | (375,767) | ||||
Ending balance (in shares) at Sep. 30, 2022 | 84,825,481 | ||||
Ending balance at Sep. 30, 2022 | 26,343,772 | $ 8,482 | 151,997,447 | (530,740) | (125,131,417) |
Beginning balance (in shares) at Mar. 31, 2022 | 83,944,119 | ||||
Beginning balance at Mar. 31, 2022 | 30,878,910 | $ 8,394 | 149,560,211 | (164,123) | (118,525,572) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 537,521 | 537,521 | |||
Issuance of common stock, net of issuance costs (in shares) | 751,040 | ||||
Issuance of common stock, net of issuance costs | 1,218,750 | $ 75 | 1,218,675 | ||
Stock options exercised (in shares) | 125,699 | ||||
Stock options exercised | 120,149 | $ 13 | 120,136 | ||
Net income (loss) | 413,998 | 413,998 | |||
Foreign currency translation adjustments | (135,869) | (135,869) | |||
Ending balance (in shares) at Jun. 30, 2022 | 84,820,858 | ||||
Ending balance at Jun. 30, 2022 | 33,033,459 | $ 8,482 | 151,436,543 | (299,992) | (118,111,574) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 556,448 | 556,448 | |||
Stock options exercised (in shares) | 4,623 | ||||
Stock options exercised | 4,456 | 4,456 | |||
Net income (loss) | (7,019,843) | (7,019,843) | |||
Foreign currency translation adjustments | (230,748) | (230,748) | |||
Ending balance (in shares) at Sep. 30, 2022 | 84,825,481 | ||||
Ending balance at Sep. 30, 2022 | $ 26,343,772 | $ 8,482 | $ 151,997,447 | $ (530,740) | $ (125,131,417) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (15,004,515) | $ (29,153,824) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 13,580 | 19,366 |
Stock-based compensation | 1,626,378 | 1,210,886 |
Non-cash operating lease cost | 29,320 | (69,356) |
Gain on early termination of lease | (46,477) | 0 |
Non-cash loss on settlement of contingent liability | 0 | 44,286 |
Gain on extinguishment of notes payable and accrued interest | 0 | (369,887) |
Changes in operating assets and liabilities: | ||
Other receivables | (1,146,724) | 303,921 |
Prepaid expenses | (4,408,886) | (661,849) |
Other non-current assets | 77,939 | 57,247 |
Accounts payable | 1,374,109 | (415,602) |
Accrued expenses | 1,000,086 | 594,629 |
Deferred grant funding | 4,293,433 | 9,592,045 |
Net cash used in operating activities | (12,191,757) | (18,848,138) |
Cash flows from investing activities | ||
Purchases of property and equipment | (60,372) | (14,524) |
Net cash used in investing activities | (60,372) | (14,524) |
Cash flows from financing activities | ||
Net proceeds from issuance of common stock | 1,218,750 | 59,588,112 |
Proceeds from the exercise of stock options | 124,605 | 254,866 |
Net cash provided by financing activities | 1,343,355 | 59,842,978 |
Effect of exchange rate changes on cash and cash equivalents | (375,767) | (79,002) |
Net change in cash and cash equivalents | (11,284,541) | 40,901,314 |
Cash and cash equivalents, beginning of period | 51,674,087 | 4,669,467 |
Cash and cash equivalents, end of period | 40,389,546 | 45,570,781 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Operating right-of-use assets obtained in exchange for new operating lease liabilities, net | 585,942 | 308,533 |
Forgiveness of Paycheck Protection Program note payable | 0 | 369,887 |
Settlement of contingent closing consideration liability with stock issuance in connection with acquisition of business | 0 | 925,000 |
Milestone payment paid in common stock | $ 0 | $ 250,000 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | ORGANIZATION AND DESCRIPTION OF BUSINESS Daré Bioscience, Inc. is a biopharmaceutical company committed to advancing innovative products for women’s health. Daré Bioscience, Inc. and its wholly owned subsidiaries operate one segment. In this report, the “Company” refers collectively to Daré Bioscience, Inc. and its wholly owned subsidiaries, unless otherwise stated or the context otherwise requires. The Company began assembling its diverse portfolio in 2017 through acquisitions, exclusive in-licenses and other collaborations. The Company's programs target unmet needs in women's health in the areas of contraception, fertility, and vaginal and sexual health, and aim to expand treatment options, enhance outcomes and improve ease of use for women. 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's portfolio includes one FDA-approved product, drug and drug/device product candidates and potential product candidates in various stages of development. The Company's FDA-approved product, XACIATO™ (clindamycin phosphate) vaginal gel, 2%, was approved by the FDA in December 2021, as a single-dose prescription medication for the treatment of bacterial vaginosis in female patients 12 years of age and older. In March 2022, the Company entered into a license agreement with an affiliate of Organon & Co., Organon International GmbH, or Organon, to commercialize XACIATO. That agreement became effective on June 30, 2022, and in July 2022, the Company received the upfront $10.0 million non-refundable and non-creditable payment due under the agreement. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. 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 Company's Annual Report on Form 10-K for the year ended December 31, 2021, or the 2021 10-K. Going Concern The Company prepared its consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. Although the Company reported net income of approximately $0.4 million for its fiscal quarter ended June 30, 2022 as a result of the upfront one-time payment due under its license agreement with Organon to commercialize XACIATO, 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 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 September 30, 2022, the Company had an accumulated deficit of approximately $125.1 million, cash and cash equivalents of approximately $40.4 million, a deferred grant funding liability of $14.8 million (representing grant funds received that may be applied solely for the development of DARE-LARC1 and which are included in cash and cash equivalents), and working capital of approximately $26.7 million. For the nine months ended September 30, 2022, the Company incurred a net loss of approximately $15.0 million and had negative cash flow from operations of approximately $12.2 million. The Company expects its primary uses of capital to be staff-related expenses, the cost of clinical trials and regulatory activities related to its product candidates, costs associated with contract manufacturing services and third-party clinical research and development services, payments due to third-parties under the Company's in-license and acquisition agreements including upon the occurrence of commercial milestones for XACIATO and development milestones for 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, nature and terms of commercial collaborations the Company establishes. The Company has devoted significant resources to building its portfolio of product candidates and to research and development activities related to these product candidates. The Company or its licensees must obtain regulatory approvals to market and sell any of its product candidates in the future and to market and sell XACIATO anywhere outside the U.S. The Company will need to generate sufficient safety and efficacy data on each of its product candidates in order to apply for regulatory approvals and for such assets to be attractive assets to potential strategic collaborators to license or to acquire, and for the Company to generate revenue through license fees, royalties on net revenues and commercial milestones related to such product candidates. Based on the Company's current operating plan estimates, the Company does not have sufficient cash to satisfy its working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying financial statements. The Company will need to raise substantial additional capital to continue to fund its operations and to execute its current strategy. The Company may continue to seek to raise capital through the sale of shares of its common stock under its at-the-market, or ATM, sales agreement or through other types of equity transactions. However, when the Company can effect such sales and the amount of shares the Company can sell depends on a variety of factors including, among others, market conditions, the trading price of its common stock, its determination as to the appropriate sources of funding for its operations, and the number of authorized shares of common stock that are available for issuance. For the foreseeable future, the Company will evaluate and may pursue a variety of capital raising options on an on-going basis, including equity and debt financings, government or other grant funding, collaborations, structured financings, and strategic alliances, or other similar types of arrangements, to cover its operating expenses, and the cost of any license or other acquisition of new product candidates or technologies. The amount and timing of the Company's capital needs have been, and will continue to be, highly dependent on many factors, including the product development programs the Company chooses to pursue, the pace and results of its clinical development efforts, and the nature and extent of the potential expansion of its product candidate portfolio, if any. If the Company raises capital through collaborations, structured financings, strategic alliances or other similar types of arrangements, it may be required to relinquish some or all of its rights to potential revenue or to intellectual property rights for its product candidates on terms that are not favorable to the Company. There can be no assurance that capital will be available when needed or that, if available, it will be obtained on terms favorable to the Company and its stockholders. In addition, equity or debt financings may have a dilutive effect on the holdings of the Company's existing stockholders, and debt financings may subject the Company to restrictive covenants, operational restrictions and security interests in its assets. If the Company cannot raise capital when needed, on favorable terms or at all, the Company will not be able to continue development of its product candidates, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations. If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values at which they are carried on its condensed consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock. The Company's condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company’s significant accounting policies are described in Note 2 to the consolidated financial statements included in the 2021 10-K. Since the date of those consolidated financial statements, there have been no material changes to the Company’s significant accounting policies. 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 September 30, 2022 and December 31, 2021. There were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 2) or using unobservable inputs (Level 3) as of September 30, 2022 or December 31, 2021. Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at September 30, 2022 Current assets: Cash equivalents (1) $ 39,083,471 $ — $ — $ 39,083,471 Balance at December 31, 2021 Current assets: Cash equivalents (1) $ 49,666,064 $ — $ — $ 49,666,064 (1) Represents cash held in money market funds. Revenue Recognition 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, assesses whether each good or service is distinct, and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price 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. Collaboration Revenues . The Company enters into collaboration and licensing agreements under which it out-licenses certain rights to its products or product candidates to third parties. The terms of these arrangements typically include payment of one or more of the following to the Company: non-refundable, up-front license fees; development, regulatory and/or commercial milestone payments; and royalties on net sales of licensed products. To date, the Company has not recognized any collaboration revenues. 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 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 recognized $10.0 million in license fee revenue, all of which represents the upfront payment due under its license agreement for XACIATO. 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. Product Supply. Arrangements that include a promise for future supply of product for commercial supply at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. The Company evaluates whether it is the principal or agent in the arrangement. The evaluation is based on the degree the Company controls the specified product at any time before transfer to the customer. Revenues are recognized on a gross basis if the Company is in the capacity of principal and on a net basis if the Company is in the capacity of an agent. To date, the Company has not recognized any revenue associated with product supply arrangements. Milestones. At the inception of each arrangement in which the Company is a licensor and that includes developmental, regulatory or commercial milestones, the Company evaluates whether achieving the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments not within the Company's control, such as where achievement of the specified milestone depends on activities of a third party or regulatory approval, are not considered probable of being achieved until the specified milestone occurs. To date, the Company has not recognized any milestone revenue. |
Strategic Agreements
Strategic Agreements | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Strategic Agreements | STRATEGIC AGREEMENTS Strategic Agreements for Product Commercialization Organon Exclusive License Agreement In March 2022, the Company entered into an exclusive license agreement with Organon pursuant to which Organon will obtain exclusive worldwide rights to develop, manufacture and commercialize XACIATO and other future intravaginal or urological products for human use formulated with clindamycin that rely on intellectual property controlled by the Company. The agreement became effective on June 30, 2022 following the satisfaction of closing conditions. The following is a summary of other terms of the Organon license agreement: Upfront Payment . Upon the effectiveness of the agreement, the Company recorded the transaction price of $10.0 million as license fee revenue in the accompanying condensed consolidated statement of operations. The $10.0 million was received in July 2022. Royalty and Milestone Payments. The Company will be entitled to receive tiered double-digit royalties based on net sales and up to $182.5 million in milestone payments as follows: $2.5 million following the first commercial sale of a licensed product in the United States; and up to $180.0 million in tiered commercial sales milestones and regulatory milestones. Royalty payments will be subject to customary reductions and offsets. The royalty period for each licensed product will continue on a country-by-country basis from the first commercial sale of the licensed product in the country until the expiration of the later of (i) the date that no valid patent claim would be infringed in the absence of the license granted under the agreement by the sale of the licensed product in the country, (ii) 10 years after the end of the month in which the first commercial sale of the licensed product in the country occurred, and (iii) the expiration of regulatory market exclusivity for the licensed product in that country. The Company concluded at the inception of the agreement that the transaction price should not include the variable consideration related to unachieved development, regulatory, commercial milestones and future sales-based royalty payments. This consideration was determined to be constrained as it is probable that the inclusion of such variable consideration could result in a significant reversal in cumulative revenue. The Company re-evaluates the transaction price at each reporting period as uncertain events are resolved and other changes in circumstances occur. For the three and nine months ended September 30, 2022, no adjustments were made to the transaction price. The Company will recognize any consideration related to sales-based payments, including milestones and royalties which relate predominantly to the license granted, at the later of (i) when or as 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). Regulatory Interactions and Product Supply. The Company will be responsible for regulatory interactions and for providing product supply on an interim basis until Organon assumes such responsibilities. Until such time, Organon will purchase all of its product requirements of XACIATO from the Company at a transfer price equal to the Company's manufacturing costs plus a single-digit percentage markup. Term. Unless terminated earlier, the agreement will expire on a product-by-product and country-by-country basis upon expiration of the applicable royalty period for each licensed product. In addition to customary termination rights for both parties, following the first anniversary of the effective date of the agreement, Organon may terminate the agreement in its entirety or on a country-by-country basis at any time in Organon's sole discretion on 120 days' advance written notice. Other . The terms of the agreement provide Organon exclusive worldwide rights of first negotiation for specified potential future products of the Company. 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. The Company received a $1.0 million upfront non-refundable license fee payment from Bayer, and Bayer agreed to support the Company in development and regulatory activities by providing the equivalent of two experts to advise the Company in clinical, regulatory, preclinical, commercial, CMC and product supply matters. Bayer, in its sole discretion, has the right to make the license effective by paying the Company an additional $20.0 million, referred to as the Clinical Trial and Manufacturing Activities Fee. Such license would be exclusive with regard to the commercialization of Ovaprene for human contraception in the U.S. and co-exclusive with the Company with regard to development. The Company concluded 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 September 30, 2022, 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 September 30, 2022 and December 31, 2021. The following is a summary of other terms of the Bayer license agreement: Milestone & Royalty Payments . The Company will be entitled to receive (a) a milestone payment in the low double-digit millions upon the first commercial sale of Ovaprene in the U.S. and escalating milestone payments based on annual net sales of Ovaprene during a calendar year, totaling up to $310.0 million if all such milestones, including first commercial sale, are achieved, (b) tiered royalties starting in the low double digits based on annual net sales of Ovaprene during a calendar year, subject to customary royalty reductions and offsets, and (c) a percentage of sublicense revenue. Efforts. The Company is responsible for the pivotal trial for Ovaprene and for its development and regulatory activities and has product supply obligations. After payment of the Clinical Trial and Manufacturing Activities Fee, Bayer will be responsible for the commercialization of Ovaprene for human contraception in the U.S. 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 Clinical Trial and Manufacturing Activities Fee if and when due. Strategic Agreements for Pipeline Development 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 XACIATO, this proprietary technology is formulated with clindamycin for the treatment of bacterial vaginosis. Each of the Assignment Agreement and License Amendment was amended in December 2019, and the License Agreement was further amended in September 2021 and March 2022. 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 to MilanaPharm, the final installment of which was $110,000 paid in 2020. Milestone Payments. The Company paid MilanaPharm $300,000 in the aggregate upon achievement of certain clinical and regulatory development milestones, $50,000 of which was paid in 2020 and $250,000 of which was paid in 2021. The Company may also pay MilanaPharm up to $500,000 upon the first commercial sale in the United States of the first licensed product for each vaginal use and urological use, and up to $250,000 upon the first commercial sale in the United States of successive licensed products for vaginal or urological use. In addition, upon achievement of $50.0 million in cumulative worldwide net sales of licensed products, the Company must pay $1.0 million to MilanaPharm. 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 the Company to exercise the licenses granted to it under the MilanaPharm License Agreement or that are strategically important or could add value to a licensed product or process in a manner expected to materially generate or increase sales. Efforts. The Company must use commercially reasonable efforts and resources to (1) develop and commercialize at least one licensed product or process in the United States and at least one licensed product or process in at least one of Canada, the United Kingdom, France, Germany, Italy or Spain, and (2) continue to commercialize that product or process following the first commercial sale of a licensed product or process in the applicable jurisdiction. Term. Unless earlier terminated, the 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 to Hammock, the final installment of which was $137,500 paid 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, $100,000 of which was paid in 2020 and $750,000 of which was paid in 2021. The remaining milestone does not relate to a bacterial vaginosis product. 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, including $2.5 million per year to cover such activities until a final premarket approval application, or PMA, is filed, or until the first commercial sale of Ovaprene, whichever occurs first. ADVA-Tec will conduct certain research and development work as necessary to allow the Company to seek a PMA from the FDA and will provide the Company with clinical trial and commercial supplies of Ovaprene, either directly or through a CMO, on commercially reasonable terms. Under the license agreement, in addition to an exclusive license to ADVA-Tec's and its affiliates' intellectual property rights for all uses of Ovaprene as a human contraceptive device, the Company has a right of first refusal to license these patents and patent applications for additional indications. The following is a summary of other terms of the ADVA-Tec license agreement: 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, $200,000 of which was paid in 2021; and (2) up to $20.0 million in the aggregate based on the achievement of certain worldwide net sales milestones. The remaining development and regulatory milestones include: the FDA's approval to commence a pivotal clinical trial; successful completion of such pivotal clinical trial; the FDA's acceptance of a PMA filing for Ovaprene; the FDA's approval of the PMA for Ovaprene; CE Marking of Ovaprene in at least three designated European countries; obtaining regulatory approval in at least three designated European countries; and obtaining regulatory approval in Japan. If the Company sublicenses its rights to Ovaprene, the Company will pay to ADVA-Tec a single digit percentage of the upfront payment or license fee due on or around the effective date of the sublicense. Royalty Payments . The Company will pay to ADVA-Tec tiered royalties of between 1% and 10% based on percentages of annual net sales of Ovaprene by the Company in specified regions. If the Company sublicenses its rights to Ovaprene, in lieu of the foregoing royalties, the Company will pay to ADVA-Tec a low mid-double digit percentage of the royalty revenue the Company receives from the sublicensee. Term . Unless earlier terminated, the license the Company received under the agreement continues on a country-by-country basis until the later of the life of the licensed patents or the Company's last commercial sale of Ovaprene. In addition to customary termination rights for both parties: (A) the Company may terminate the agreement with or without cause in whole or on a country-by-country basis upon 60 days prior written notice; and (B) ADVA-Tec may terminate the agreement if the Company develops or commercializes any non-hormonal ring-based vaginal contraceptive device competitive to Ovaprene or if the Company fails to: (1) in certain limited circumstances, commercialize Ovaprene in certain designated countries within three years of the first commercial sale of Ovaprene; (2) satisfy the annual spending obligation described above, (3) use commercially reasonable efforts to complete all necessary pre-clinical and clinical studies required to support and submit a PMA, (4) conduct clinical trials as set forth in the development plan 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 the SST 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 owns 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 by the Company in the single digits to the low double digits. If the Company sublicenses Licensed Products, SST will be eligible to receive the greater of a low mid-double digit percentage of the sublicense revenue the Company receives from the sublicensee or tiered royalties based on percentages of annual net sales of Licensed Products by the sublicensee in the single digits. In each case, the royalties are subject to customary reductions and offsets. 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 has entered into strategic development or distribution partnerships related to the Licensed Products at the time certain milestones are achieved, additional milestone payments (1) ranging from $2.0 million to $10.0 million upon achieving certain clinical and regulatory milestones, and (2) ranging from $10.0 million to $125.0 million upon achieving certain commercial sales milestones 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. The Company made the first payments in April 2019. 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, $1.0 million of which became payable in the third quarter of 2021, and in accordance with the license agreement, the amount payable was offset by the $100,000 annual maintenance fee, resulting in a net amount of $900,000 paid during the third quarter of 2021, 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. The royalty term, which is determined on a country-by-country basis and product-by-product basis (or process-by-process basis), begins with the first commercial sale of a product or process in a country and terminates on the latest of (1) the expiration date of the last valid claim within the licensed patent rights with respect to such product or process in such country, (2) 10 years following the first commercial sale of such product or process in such country, and (3) when one or more generic products for such product or process are commercially available in such country, except that if there is no such generic product by the 10th year following the first commercial sale in such country, then the royalty term will terminate on the 10-year anniversary of the first commercial sale in such country. Efforts. The Company must use commercially reasonable efforts to develop and make at least one product or process available to the public, which efforts include achieving specific diligence requirements by specific dates specified in the 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 Pharma Solutions (formerly known as Adare Pharmaceuticals and Orbis Biosciences, and which the Company refers to as Adare), for the development of two long-acting injectable etonogestrel contraceptives with 6- and 12-month durations (now referred to as ADARE-204 and ADARE-214, respectively). The agreement provides the Company with an option to negotiate an exclusive license agreement for the programs if the Company funds the conduct of specified development work by Adare. Hennepin License Agreement In August 2022, the Company entered into a license agreement with Hennepin Life Sciences LLC, or Hennepin, under which the Company acquired the exclusive global rights to develop and commercialize treatments delivering the novel antimicrobial glycerol monolaurate (GML) intravaginally for a variety of health conditions including bacterial, fungal, and viral infections. Under the agreement, the Company received an exclusive, worldwide, royalty-bearing license to research, develop and commercialize the licensed technology. The Company is entitled to sublicense the rights granted to it under the agreement. The following is a summary of other terms of the agreement: Milestone Payments. The Company agreed to make potential future development and sales milestone payments of (1) up to $6.25 million in the aggregate upon achieving certain clinical and regulatory milestones, and (2) up to $45.0 million in the aggregate upon achieving certain commercial sales milestones for each product covered by the licenses granted under the agreement, which may be paid, in the Company’s sole discretion, in cash or shares of the Company’s common stock. Royalty Payments. The Company will pay Hennepin low-single-digit to low double-digit royalties based on worldwide net sales of products and processes covered by the licenses granted under the agreement. Efforts. The Company must use commercially reasonable efforts to develop and introduce to market at least one product. Term. Unless earlier terminated, the term of the agreement shall expire in its entirety upon the last to expire royalty term. In addition to customary termination rights for both parties, the Company may elect to terminate the agreement at any time, with or without cause, on a country-by-country basis and Hennepin may terminate the agreement if the Company does not undertake any development work with respect to the licensed intellectual property for five consecutive years from the date of the agreement. MBI Acquisition In November 2019, the Company acquired Dare MB Inc. (formerly, Microchips Biotech, Inc.), or MBI, to secure the rights to develop a long-acting reversible contraception method that a woman can turn on or off herself, according to her own needs. This candidate is now known as DARE-LARC1. In connection with the MBI acquisition, the Company issued an aggregate of approximately 3.0 million shares of its common stock to the holders of shares of MBI's capital stock outstanding immediately prior to the effective time of the merger and agreed to pay the former MBI 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 the proceeds from annual net sales of such products received by the Company (but not by sublicensees), 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. In June 2021, a total of $1.25 million of the contingent consideration became payable upon the achievement of certain of the funding and product development milestone events, $1.0 million of which was recorded as contingent consideration on the Company's consolidated balance sheets upon the completion of the MBI acquisitio |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY Increase in Authorized Shares of Common Stock In July 2022, following the approval of the Company's stockholders at its annual meeting of stockholders, the Company amended its restated certificate of incorporation to increase the Company's authorized shares of common stock to 240,000,000. October 2021 ATM Sales Agreement In October 2021, the Company entered into a sales agreement with SVB Securities LLC (formerly known as SVB Leerink LLC) to sell shares of its common stock from time to time through an "at-the-market," or ATM, equity offering program under which SVB Leerink acts as the Company's agent. 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. 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 October 13, 2021 relating to the offering of up to $50.0 million in shares of the Company's common stock under this sales agreement, and any subsequent prospectus supplement filed with the SEC related to this ATM equity offering program. During the nine months ended September 30, 2022, the Company sold approximately 751,000 shares of common stock under this agreement for gross proceeds of approximately $1.3 million and incurred offering expenses of approximately $42,000. April 2021 ATM Sales Agreement In April 2021, the Company entered into a sales agreement with SVB Securities LLC to sell shares of its common stock from time to time through an ATM, equity offering program under which SVB Securities 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. During the nine months ended September 30, 2022, the Company sold no shares under this agreement. During the nine months ended September 30, 2021, the Company sold approximately 26.0 million shares of common stock under this agreement for gross proceeds of approximately $46.9 million and incurred offering expenses of approximately $1.6 million. 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 its common stock from time to time in an ATM equity offering program through Wainwright, acting as sales agent. 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. In March 2021, the Company provided notice to Wainwright to terminate the agreement, and the agreement terminated in April 2021. During the nine months ended September 30, 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. 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 had the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park was obligated to purchase up to $15.0 million of the Company’s common stock. The Company incurred legal, accounting, and other fees related to the Purchase Agreement of approximately $374,000. These costs were amortized and expensed as shares were sold under the Purchase Agreement. As of December 31, 2021, the Company had sold and Lincoln Park had purchased $15.0 million of the Company's common stock under the Purchase Agreement, there were no unamortized costs, and no more shares of common stock may be sold by the Company to Lincoln Park under the Purchase Agreement. During the nine months ended September 30, 2021, the Company sold, and Lincoln Park purchased, 4.8 million shares under the Purchase Agreement for gross proceeds to the Company of approximately $7.0 million and recognized offering expenses of approximately $207,000. 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 exercisable through February 2023 and that initially had an exercise price of $3.00 per share. 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 nine months ended September 30, 2022, no warrants were exercised. During the nine months ended September 30, 2021, warrants to purchase 265,485 shares of common stock were exercised for gross proceeds of $254,866. As of September 30, 2022, the Company had the following warrants outstanding: Shares Underlying Exercise Price Expiration Date 6,500 $ 10.00 04/04/2026 1,374,515 $ 0.96 02/15/2023 1,381,015 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
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 nine months ended September 30, 2022 or September 30, 2021. Amended and Restated 2014 Stock Incentive Plan The Amended and Restated 2014 Stock Incentive Plan, or the Amended 2014 Plan, provided 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 increased annually on the first day of each fiscal year 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, 2022, the number of authorized shares increased by 2,000,000 to 2,201,855. On June 23, 2022, the Amended 2014 Plan was superseded by the 2022 Plan (as defined below), and no further awards will be granted under the Amended 2014 Plan. Awards outstanding under the Amended 2014 Plan will continue to remain outstanding pursuant to their terms and conditions. 2022 Stock Incentive Plan In April 2022, the Company's board of directors approved the Daré Bioscience, Inc. 2022 Stock Incentive Plan, or the 2022 Plan, which was subsequently approved by the Company's stockholders on June 23, 2022, and became effective as of that date. The 2022 Plan provides for the grant of stock-based incentive awards to employees, consultants, advisors, and directors. The number of shares of common stock authorized for issuance under the 2022 Plan is (a) 10,117,305; plus (b) up to 6,144,682 shares subject to awards granted under the Amended 2014 Plan or the 2007 Stock Incentive Plan that expire, terminate or are otherwise forfeited on or after June 23, 2022. Summary of Stock Option Activity The table below summarizes stock option activity under the Company's stock incentive plans and related information for the nine months ended September 30, 2022. The exercise price of all options granted during the nine months ended September 30, 2022 was equal to the market value of the Company’s common stock on the date of grant. As of September 30, 2022, unamortized stock-based compensation expense of approximately $4.7 million will be amortized over a weighted average period of 2.56 years. At September 30, 2022, 9,576,581 shares of common stock were available for future awards granted under the 2022 Plan. Number of Shares Weighted Average Outstanding at December 31, 2021 4,717,602 $ 1.65 Granted 2,346,692 1.50 Exercised (130,322) 0.96 Canceled/forfeited (321,418) 1.94 Expired — — Outstanding at September 30, 2022 6,612,554 $ 1.60 Exercisable at September 30, 2022 3,337,063 $ 1.49 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 Nine Months Ended 2022 2021 2022 2021 Research and development $ 168,323 $ 144,876 $ 514,875 $ 389,913 General and administrative $ 388,125 $ 294,621 $ 1,111,504 $ 820,973 Total $ 556,448 $ 439,497 $ 1,626,379 $ 1,210,886 |
Leased Properties
Leased Properties | 9 Months Ended |
Sep. 30, 2022 | |
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 February 2022, the Company entered into an amendment to extend the term of the lease for two years such that the term now expires on August 31, 2024. MBI, a wholly owned subsidiary the Company acquired in November 2019, leases general office space in Lexington, Massachusetts. The lease for that space commenced on July 1, 2013. In February 2022, the Company entered into an amendment to extend the term of the lease for three years to December 31, 2025, subject to the landlord's right to terminate the lease on December 31, 2023. The extension of the lease in February 2022 resulted in an increase in operating lease liabilities and ROU assets of approximately $1.0 million. In September 2022, the landlord exercised its option to terminate the lease, resulting in the new term ending on December 31, 2023. The termination of the lease resulted in a reduction of operating lease liabilities and ROU assets of approximately $504,000 and $458,000, respectively, and a $46,000 gain on the modification of the lease which is included as a reduction to research and development expense for the three and nine months ended September 30, 2022. MBI previously leased warehouse space in Billerica, Massachusetts, under a lease that commenced on October 1, 2016 and terminated 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 consisting of the current prime rate plus 200 basis points 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 September 30, 2022, the Company reported operating lease ROU assets Total operating lease costs were approximately $116,000 and $134,000 for the three months ended September 30, 2022 and September 30, 2021, respectively, and $469,000 and $420,000 for the nine months ended September 30, 2022 and September 30, 2021, 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 $81,000 and $117,000 for the three months ended September 30, 2022 and September 30, 2021, respectively, and $231,000 and $343,000 for the nine months ended September 30, 2022 and September 30, 2021, respectively. These amounts are included in operating activities in the condensed consolidated statements of cash flows. At September 30, 2022, operating leases had a weighted average remaining lease term of 1.58 years. As of September 30, 2022, future minimum lease payments under the Company's operating leases are as follows: Remainder of 2022 $ 105,000 2023 422,000 2024 93,000 Total future minimum lease payments 620,000 Less: accreted interest 37,000 Total operating lease liabilities $ 583,000 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES CRADA with NICHD for the Pivotal Phase 3 Study of Ovaprene In July 2021, the Company entered into a Cooperative Research and Development Agreement, or the CRADA, with the U.S. Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, for the conduct of a multi-center, non-comparative, pivotal Phase 3 clinical study of Ovaprene, or the Ovaprene Phase 3. The Ovaprene Phase 3 will be conducted within NICHD’s Contraceptive Clinical Trial Network with NICHD's selected contract research organization providing clinical coordination and data collection and management services for the Ovaprene Phase 3. The Company and NICHD will each provide medical oversight and final data review and analysis for the Ovaprene Phase 3 and will work together to prepare the final report of the results of the Ovaprene Phase 3. The Company is responsible for providing clinical supplies of Ovaprene, coordinating interactions with the FDA, preparing and submitting supportive regulatory documentation, and providing a total of $5.5 million to NICHD to be applied toward the costs of conducting the Ovaprene Phase 3. NICHD will be responsible for the other costs related to the conduct of the Ovaprene Phase 3. In accordance with the payment schedule under the CRADA, the Company has paid $5.0 million of the total amount payable to NICHD, $3.5 million of which was paid during the first quarter of 2022. At September 30, 2022, the remaining amount of the Company's payment obligation under the CRADA was $0.5 million, which is due in the second quarter of 2023. Contingent Consideration As discussed in Note 3 above, in connection with the acquisition of MBI, the Company agreed to pay additional consideration of up to $46.5 million to the former stockholders of MBI contingent upon the achievement of specified funding, product development and regulatory milestones. In June 2021, $1.25 million of that additional consideration became payable upon the achievement of certain of the funding and product development milestone events, $1.0 million of which was previously recorded as contingent consideration on the Company's consolidated balance sheets upon the completion of the MBI acquisition and $250,000 of which was expensed in 2021. In July 2021, the Company’s board of directors elected to make these milestone payments in shares of the Company’s common stock, to the extent permissible under the terms of the merger agreement with MBI, and, in September 2021, the Company issued approximately 700,000 shares of its common stock to former stockholders of MBI and paid $75,000 to the stockholders’ representative in accordance with the terms of the merger agreement in satisfaction of the $1.25 million in milestone payments associated with milestones achieved in June 2021. Note Payable |
Grant Awards
Grant Awards | 9 Months Ended |
Sep. 30, 2022 | |
Receivables [Abstract] | |
Grant Awards | GRANT AWARDS NICHD Non-Dilutive Grant Funding The Company has received notices of awards and non-dilutive grant funding from NICHD to support the development of Ovaprene, DARE-PTB1, DARE-LARC1, and ADARE-204/214. NICHD 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 statements of operations as a reduction to research and development activities as the related costs are incurred to meet those obligations over the period. Ovaprene From 2018 through 2021, the Company received approximately $1.9 million of non-dilutive grant funding from NICHD for clinical development efforts supporting Ovaprene. All funds under the final notice of award had been disbursed as of December 31, 2021. DARE-PTB1 In August 2020, the Company received a notice of award of a grant from NICHD to support the development of DARE-PTB1. The award in the amount of $300,000 was for the "Phase I" segment of the project outlined in the Company's grant application, which is ongoing. 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 NICHD award of approximately $500 and $20,000 during the three and nine months ended September 30, 2022, respectively. DARE-LARC1 In September 2021, the Company received a notice of award of a grant from NICHD to support the development of DARE-LARC1. The award in the amount of approximately $300,000 is to be used to explore device insertion and removal in non-clinical studies, which is ongoing. The Company recorded credits to research and development expense of approximately $3,000 and $196,000 for costs related to the NICHD award during the three and nine months ended September 30, 2022, respectively. At September 30, 2022, the Company recorded a receivable of approximately $2,000 for expenses incurred through such date that it believes are eligible for reimbursement under the grant. ADARE-204 and ADARE-214 In May 2022, the Company received a notice of award of a grant from NICHD of approximately $249,000 to support end-user research to better understand women's preferences for a long-acting injectable contraceptive method. The findings from the research will inform the Company's target product profile and guide its development priorities for ADARE-204 and ADARE-214. The Company recorded credits to research and development expense of approximately $65,000 for costs related to the NICHD award during both the three and nine months ended September 30, 2022. At September 30, 2022, the Company recorded a receivable of approximately $65,000 for expenses incurred through such date that it believes is eligible for reimbursement under the grant. DARE-LARC1 Non-Dilutive Grant Funding MBI Grant Agreement The Company's wholly-owned subsidiary, MBI, was awarded $5.4 million to support the development of DARE-LARC1 under a grant agreement with the Bill & Melinda Gates Foundation, or the Foundation. The funding period under this agreement ended on June 30, 2021. Expenses eligible for funding were incurred, tracked and reported to the Foundation. MBI received aggregate payments under this agreement of approximately $5.4 million. At June 30, 2021, all payments under this agreement associated with research and development expenses for DARE-LARC1 had been incurred and reported to the Foundation. 2021 DARE-LARC1 Grant Agreement In June 2021, the Company entered into an agreement with the Foundation, or the 2021 DARE-LARC1 Grant Agreement, under which the Company was awarded up to $48.95 million to support the development of DARE-LARC1. The 2021 DARE-LARC1 Grant Agreement will support technology development and preclinical activities over the period of June 30, 2021 to November 1, 2026, to advance DARE-LARC1 in non-clinical proof of principle studies. Under the 2021 DARE-LARC1 Grant Agreement, the Company receives funding in advance and tracks and reports eligible expenses incurred to the Foundation. Any unspent funds are recorded as a deferred grant funding liability in the Company's condensed consolidated balance sheet. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NET LOSS PER SHARE The Company computes basic net loss per share, or EPS, using the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents. Diluted EPS is based upon the weighted average number of common shares and potentially dilutive securities (common share equivalents) outstanding during the period. Dilutive securities include the dilutive effect of in-the-money options and warrants, which is calculated based on the average share price for each period using the treasury stock method. Under the treasury stock method, the exercise price of an option or warrant, the amount of compensation cost, if any, for future service that the Company has not yet recognized, and the amount of estimated tax benefits that would be recorded in paid-in capital, if any, when the option or warrant is exercised are assumed to be used to repurchase shares in the current period . Dilutive securities are excluded from the diluted EPS calculation if their effect is anti-dilutive. The following potentially dilutive outstanding securities were excluded from diluted EPS for the period indicated because of their anti-dilutive effect: Potentially dilutive securities Three Months Ended Nine Months Ended 2022 2021 2022 2021 Stock options 6,612,554 4,802,666 6,612,554 4,802,666 Warrants 1,381,015 1,643,158 1,381,015 1,643,158 Total 7,993,569 6,445,824 7,993,569 6,445,824 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTS Ovaprene IDE Application Approval On October 10, 2022, the FDA approved the Company's Investigational Device Exemption, or IDE, application for a single arm, open-label pivotal contraceptive efficacy study of Ovaprene and provided the Company with recommended additional study design considerations. Implementing such study design considerations will further position the study to collect safety and effectiveness data to enable the preparation of, and to support the submission of, a PMA application. The Company expects to make a $1.0 million milestone payment as a result. Receipt of Australia Research and Development Cash Credit On October 3, 2022, the Company received a research and development rebate from the government of Australia in the amount of approximately $786,000 for clinical work performed in Australia in 2021. The rebate is accounted for as an offset to research and development expense. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
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 U.S. 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 Company's Annual Report on Form 10-K for the year ended December 31, 2021, or the 2021 10-K. |
Going Concern | Going Concern The Company prepared its consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. Although the Company reported net income of approximately $0.4 million for its fiscal quarter ended June 30, 2022 as a result of the upfront one-time payment due under its license agreement with Organon to commercialize XACIATO, 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 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 September 30, 2022, the Company had an accumulated deficit of approximately $125.1 million, cash and cash equivalents of approximately $40.4 million, a deferred grant funding liability of $14.8 million (representing grant funds received that may be applied solely for the development of DARE-LARC1 and which are included in cash and cash equivalents), and working capital of approximately $26.7 million. For the nine months ended September 30, 2022, the Company incurred a net loss of approximately $15.0 million and had negative cash flow from operations of approximately $12.2 million. The Company expects its primary uses of capital to be staff-related expenses, the cost of clinical trials and regulatory activities related to its product candidates, costs associated with contract manufacturing services and third-party clinical research and development services, payments due to third-parties under the Company's in-license and acquisition agreements including upon the occurrence of commercial milestones for XACIATO and development milestones for 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, nature and terms of commercial collaborations the Company establishes. The Company has devoted significant resources to building its portfolio of product candidates and to research and development activities related to these product candidates. The Company or its licensees must obtain regulatory approvals to market and sell any of its product candidates in the future and to market and sell XACIATO anywhere outside the U.S. The Company will need to generate sufficient safety and efficacy data on each of its product candidates in order to apply for regulatory approvals and for such assets to be attractive assets to potential strategic collaborators to license or to acquire, and for the Company to generate revenue through license fees, royalties on net revenues and commercial milestones related to such product candidates. Based on the Company's current operating plan estimates, the Company does not have sufficient cash to satisfy its working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying financial statements. The Company will need to raise substantial additional capital to continue to fund its operations and to execute its current strategy. The Company may continue to seek to raise capital through the sale of shares of its common stock under its at-the-market, or ATM, sales agreement or through other types of equity transactions. However, when the Company can effect such sales and the amount of shares the Company can sell depends on a variety of factors including, among others, market conditions, the trading price of its common stock, its determination as to the appropriate sources of funding for its operations, and the number of authorized shares of common stock that are available for issuance. For the foreseeable future, the Company will evaluate and may pursue a variety of capital raising options on an on-going basis, including equity and debt financings, government or other grant funding, collaborations, structured financings, and strategic alliances, or other similar types of arrangements, to cover its operating expenses, and the cost of any license or other acquisition of new product candidates or technologies. The amount and timing of the Company's capital needs have been, and will continue to be, highly dependent on many factors, including the product development programs the Company chooses to pursue, the pace and results of its clinical development efforts, and the nature and extent of the potential expansion of its product candidate portfolio, if any. If the Company raises capital through collaborations, structured financings, strategic alliances or other similar types of arrangements, it may be required to relinquish some or all of its rights to potential revenue or to intellectual property rights for its product candidates on terms that are not favorable to the Company. There can be no assurance that capital will be available when needed or that, if available, it will be obtained on terms favorable to the Company and its stockholders. In addition, equity or debt financings may have a dilutive effect on the holdings of the Company's existing stockholders, and debt financings may subject the Company to restrictive covenants, operational restrictions and security interests in its assets. If the Company cannot raise capital when needed, on favorable terms or at all, the Company will not be able to continue development of its product candidates, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations. If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values at which they are carried on its condensed consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock. The Company's condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company’s significant accounting policies are described in Note 2 to the consolidated financial statements included in the 2021 10-K. Since the date of those consolidated financial statements, there have been no material changes to the Company’s significant accounting policies. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments GAAP defines fair value as the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date, and also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available. The three-level hierarchy of valuation techniques established to measure fair value is defined as follows: • Level 1: inputs are unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2: inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities. • Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue 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, assesses whether each good or service is distinct, and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price 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. Collaboration Revenues . The Company enters into collaboration and licensing agreements under which it out-licenses certain rights to its products or product candidates to third parties. The terms of these arrangements typically include payment of one or more of the following to the Company: non-refundable, up-front license fees; development, regulatory and/or commercial milestone payments; and royalties on net sales of licensed products. To date, the Company has not recognized any collaboration revenues. 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 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 recognized $10.0 million in license fee revenue, all of which represents the upfront payment due under its license agreement for XACIATO. 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. Product Supply. Arrangements that include a promise for future supply of product for commercial supply at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. The Company evaluates whether it is the principal or agent in the arrangement. The evaluation is based on the degree the Company controls the specified product at any time before transfer to the customer. Revenues are recognized on a gross basis if the Company is in the capacity of principal and on a net basis if the Company is in the capacity of an agent. To date, the Company has not recognized any revenue associated with product supply arrangements. Milestones. At the inception of each arrangement in which the Company is a licensor and that includes developmental, regulatory or commercial milestones, the Company evaluates whether achieving the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments not within the Company's control, such as where achievement of the specified milestone depends on activities of a third party or regulatory approval, are not considered probable of being achieved until the specified milestone occurs. To date, the Company has not recognized any milestone revenue. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022 and December 31, 2021. There were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 2) or using unobservable inputs (Level 3) as of September 30, 2022 or December 31, 2021. Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at September 30, 2022 Current assets: Cash equivalents (1) $ 39,083,471 $ — $ — $ 39,083,471 Balance at December 31, 2021 Current assets: Cash equivalents (1) $ 49,666,064 $ — $ — $ 49,666,064 (1) Represents cash held in money market funds. |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Schedule of Common Stock Warrants Outstanding | As of September 30, 2022, the Company had the following warrants outstanding: Shares Underlying Exercise Price Expiration Date 6,500 $ 10.00 04/04/2026 1,374,515 $ 0.96 02/15/2023 1,381,015 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 Company's stock incentive plans and related information for the nine months ended September 30, 2022. The exercise price of all options granted during the nine months ended September 30, 2022 was equal to the market value of the Company’s common stock on the date of grant. As of September 30, 2022, unamortized stock-based compensation expense of approximately $4.7 million will be amortized over a weighted average period of 2.56 years. At September 30, 2022, 9,576,581 shares of common stock were available for future awards granted under the 2022 Plan. Number of Shares Weighted Average Outstanding at December 31, 2021 4,717,602 $ 1.65 Granted 2,346,692 1.50 Exercised (130,322) 0.96 Canceled/forfeited (321,418) 1.94 Expired — — Outstanding at September 30, 2022 6,612,554 $ 1.60 Exercisable at September 30, 2022 3,337,063 $ 1.49 |
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 Nine Months Ended 2022 2021 2022 2021 Research and development $ 168,323 $ 144,876 $ 514,875 $ 389,913 General and administrative $ 388,125 $ 294,621 $ 1,111,504 $ 820,973 Total $ 556,448 $ 439,497 $ 1,626,379 $ 1,210,886 |
Leased Properties (Tables)
Leased Properties (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Schedule of Future Minimum Lease Payments | As of September 30, 2022, future minimum lease payments under the Company's operating leases are as follows: Remainder of 2022 $ 105,000 2023 422,000 2024 93,000 Total future minimum lease payments 620,000 Less: accreted interest 37,000 Total operating lease liabilities $ 583,000 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Potential Dilutive Outstanding Securities Excluded From Diluted Net Loss Per Common Share | The following potentially dilutive outstanding securities were excluded from diluted EPS for the period indicated because of their anti-dilutive effect: Potentially dilutive securities Three Months Ended Nine Months Ended 2022 2021 2022 2021 Stock options 6,612,554 4,802,666 6,612,554 4,802,666 Warrants 1,381,015 1,643,158 1,381,015 1,643,158 Total 7,993,569 6,445,824 7,993,569 6,445,824 |
Organization and Description _2
Organization and Description of Business (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jul. 31, 2022 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) segment | Sep. 30, 2021 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Number of operating segments | segment | 1 | ||||
License and collaboration revenue | $ 0 | $ 0 | $ 10,000,000 | $ 0 | |
License fee revenue | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
License and collaboration revenue | $ 10,000,000 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Significant Accounting Policies [Line Items] | ||||||||||
Net income (loss) | $ (7,019,843) | $ 413,998 | $ (8,398,670) | $ (12,667,429) | $ (9,162,751) | $ (7,323,644) | $ (15,004,515) | $ (29,153,824) | ||
Accumulated deficit | (125,131,417) | (125,131,417) | $ (110,126,902) | |||||||
Cash and cash equivalents | 40,389,546 | 45,570,781 | 40,389,546 | 45,570,781 | 51,674,087 | $ 4,669,467 | ||||
Deferred grant funding | 14,836,416 | 14,836,416 | $ 10,542,983 | |||||||
Working capital | 26,700,000 | 26,700,000 | ||||||||
Cash flow from operations | $ (12,200,000) | |||||||||
Period of insufficient cash and liquidity requirements | 12 months | |||||||||
License and collaboration revenue | $ 0 | $ 0 | $ 10,000,000 | $ 0 | ||||||
License fee revenue | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
License and collaboration revenue | $ 10,000,000 |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Financial Assets and Liabilities Remeasured on a Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 39,083,471 | $ 49,666,064 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 39,083,471 | 49,666,064 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 0 | $ 0 |
Strategic Agreements (Details)
Strategic Agreements (Details) - USD ($) shares in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||
Aug. 31, 2022 | Jul. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Jan. 31, 2020 | Dec. 31, 2019 | Nov. 30, 2019 | Apr. 30, 2018 | Feb. 28, 2018 | Mar. 31, 2017 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | $ 0 | $ 250,000 | ||||||||||||||
Total revenue | $ 0 | $ 0 | 10,000,000 | 0 | ||||||||||||
License fee | 25,000 | 25,000 | 75,000 | 75,000 | ||||||||||||
Accrued expenses | 4,136,330 | 4,136,330 | $ 3,136,244 | |||||||||||||
Microchips Biotech, Inc. | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Asset acquisition, contingent consideration | $ 50,000 | |||||||||||||||
Common stock issued to microchips capital stock holders (in shares) | 700 | |||||||||||||||
Current portion of contingent consideration | $ 1,000,000 | $ 1,000,000 | ||||||||||||||
Potential additional consideration payable | 1,250,000 | |||||||||||||||
Accrued expenses | 250,000 | 250,000 | 250,000 | |||||||||||||
Cash paid to stockholders' representative | $ 75,000 | |||||||||||||||
Payment of additional consideration | $ 1,250,000 | 46,500,000 | ||||||||||||||
Microchips Biotech, Inc. | Common stock | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Common stock issued to microchips capital stock holders (in shares) | 3,000 | |||||||||||||||
Microchips Biotech, Inc. | Upon Achievement of Specified Development and Regulatory Milestones | ||||||||||||||||
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 | Upon Achievement of Specified Development and Regulatory Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payments | $ 2,500,000 | |||||||||||||||
Maximum | ADVA Tec Agreement | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Percentage of royalty rate | 10% | |||||||||||||||
Maximum | ADVA Tec Agreement | Upon Achievement of Specified Development and Regulatory Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payments | $ 14,600,000 | |||||||||||||||
Minimum | ADVA Tec Agreement | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Percentage of royalty rate | 1% | |||||||||||||||
MilanaPharm | Upon Achievement of Specified Development and Regulatory Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | $ 50,000,000 | |||||||||||||||
Bayer Healthcare License Agreement | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | $ 310,000,000 | |||||||||||||||
Upfront license fee paid | 1,000,000 | |||||||||||||||
Total revenue | $ 20,000,000 | |||||||||||||||
Initial term of license agreement | 15 years | |||||||||||||||
Licensing Agreements | ADVA Tec Agreement | Upon Reaching Certain Worldwide Net Sales Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payments term | 3 years | |||||||||||||||
Milestone payments | $ 20,000,000 | |||||||||||||||
Licensing Agreements | MilanaPharm | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | 1,000,000 | 250,000 | ||||||||||||||
License fee | $ 235,000 | |||||||||||||||
License fee to be paid upon contingency | 110,000 | |||||||||||||||
Royalty agreement term | 10 years | |||||||||||||||
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 | MilanaPharm | Upon Achieving Certain Development Milestones | Maximum | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | $ 300,000 | |||||||||||||||
Licensing Agreements | MilanaPharm | Upon Achieving Certain Commercial Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | 750,000 | 100,000 | ||||||||||||||
Licensing Agreements | MilanaPharm | Upon Achieving Certain Commercial Milestones | Upon Achievement of Specified Development and Regulatory Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | $ 200,000 | |||||||||||||||
Licensing Agreements | MilanaPharm | Upon Achieving Certain Commercial Milestones | Maximum | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | $ 500,000 | |||||||||||||||
Licensing Agreements | MilanaPharm | Licensed Product or Process for Vaginal or Urological Use | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | 250,000 | |||||||||||||||
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 to be paid upon contingency | $ 137,500 | |||||||||||||||
Assignment Agreement | Hammock Pharmaceuticals, Inc | Upon Achieving Certain Clinical and Regulatory Development Milestones | Maximum | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | $ 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% | |||||||||||||||
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 payment paid in common stock | $ 18,000,000 | |||||||||||||||
Milestone additional payments, contingent amount | 10,000,000 | |||||||||||||||
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 payment paid in common stock | 500,000 | |||||||||||||||
Milestone additional payments, contingent amount | 2,000,000 | |||||||||||||||
License and Collaboration Agreement | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | Upon Achieving Certain Commercial Milestones | Maximum | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | 100,000,000 | |||||||||||||||
Milestone additional payments, contingent amount | 125,000,000 | |||||||||||||||
License and Collaboration Agreement | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | Upon Achieving Certain Commercial Milestones | Minimum | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | 10,000,000 | |||||||||||||||
Milestone additional 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 | |||||||||||||||
Hennepin License Agreement | Clinical and Regulatory Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Maximum potential milestone payments | $ 6,250,000 | |||||||||||||||
Hennepin License Agreement | Sales Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Maximum potential milestone payments | $ 45,000,000 | |||||||||||||||
Organon | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Upfront license fee paid | $ 10,000,000 | |||||||||||||||
Milestone payment paid in common stock | 182,500,000 | |||||||||||||||
First commercial sale amount | 2,500,000 | |||||||||||||||
Sales based milestones amount | $ 180,000,000 | $ 180,000,000 | ||||||||||||||
Milestone payments term | 10 years | |||||||||||||||
Catalent and MilanaPharm | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Annual maintenance fee | 100,000 | |||||||||||||||
Net amount payable | $ 900,000 | 900,000 | $ 900,000 | |||||||||||||
Catalent and MilanaPharm | Licensing Agreements | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | $ 1,000,000 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | 1 Months Ended | 9 Months Ended | ||||||||||
Oct. 31, 2021 | Apr. 30, 2021 | Jul. 31, 2020 | Apr. 30, 2019 | Jan. 31, 2018 | Sep. 30, 2022 | Sep. 30, 2021 | Jul. 31, 2022 | Dec. 31, 2021 | Apr. 30, 2020 | Feb. 28, 2018 | Feb. 15, 2018 | |
Stockholders Equity [Line Items] | ||||||||||||
Common stock, shares authorized (in shares) | 240,000,000 | 240,000,000 | ||||||||||
Commission percent | 3% | 3% | 3% | |||||||||
Issues shares | $ 8,482 | $ 8,394 | ||||||||||
Issuance of common stock, net of issuance costs (in shares) | 751,000 | |||||||||||
Aggregate net proceeds on sales of shares of common stock | $ 1,300,000 | $ 7,000,000 | ||||||||||
Offering Expenses | $ 42,000 | |||||||||||
Unamortized costs related to legal, accounting, and other fees | $ 0 | |||||||||||
Offering expenses | $ 207,000 | |||||||||||
Exercise price (in usd per share) | $ 3 | |||||||||||
Warrant, exercise price, decrease (in usd per share) | $ 0.96 | $ 0.98 | ||||||||||
Deemed dividend from trigger of down round provision feature | $ 6,863 | $ 800,000 | ||||||||||
Number Of Common Stock Warrants Exercised | 0 | 265,485 | ||||||||||
Warrant exercises, gross | $ 254,866 | |||||||||||
Maximum | ||||||||||||
Stockholders Equity [Line Items] | ||||||||||||
Common stock, shares authorized (in shares) | 240,000,000 | |||||||||||
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 | |||||||||||
April 2021 At The Market Sales Agreement | ||||||||||||
Stockholders Equity [Line Items] | ||||||||||||
Issues shares | $ 50,000,000 | |||||||||||
Issuance of common stock, net of issuance costs (in shares) | 26,000,000 | |||||||||||
Aggregate net proceeds on sales of shares of common stock | $ 46,900,000 | |||||||||||
Offering Expenses | $ 1,600,000 | |||||||||||
2018 At The Market Sales Agreement | ||||||||||||
Stockholders Equity [Line Items] | ||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 3,300,000 | |||||||||||
Aggregate net proceeds on sales of shares of common stock | $ 7,700,000 | |||||||||||
Offering Expenses | $ 245,000 | |||||||||||
Purchase Agreement | ||||||||||||
Stockholders Equity [Line Items] | ||||||||||||
Legal, accounting and other fees related to purchase agreement | $ 374,000 | |||||||||||
Purchase Agreement | Lincoln Park | ||||||||||||
Stockholders Equity [Line Items] | ||||||||||||
Regular purchase, common stock issuable (in shares) (up to) | 4,800,000 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Common Stock Warrants Outstanding (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Feb. 28, 2018 | |
Class of Warrant or Right [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 1,381,015 | |
Exercise price (in usd per share) | $ 3 | |
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. 04, 2026 | |
Warrants Expiring on February 15, 2023 | ||
Class of Warrant or Right [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 1,374,515 | |
Exercise price (in usd per share) | $ 0.96 | |
Expiration Date | Feb. 15, 2023 |
Stock Based Compensation - Addi
Stock Based Compensation - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Jan. 01, 2021 | Jul. 31, 2018 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Jun. 23, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Unamortized stock-based compensation expense | $ 4,700,000 | $ 4,700,000 | ||||||
Weighted average amortization period | 2 years 6 months 21 days | |||||||
Employee Stock Option | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | $ 556,448 | $ 439,497 | $ 1,626,379 | $ 1,210,886 | ||||
Options to purchase number of outstanding shares of common stock (in shares) | 2,046,885 | |||||||
Stock options outstanding (in shares) | 2,000,000 | |||||||
Annual percentage increase in outstanding number of common stock | 4% | |||||||
Increase in number of shares authorized (in shares) | 2,000,000 | |||||||
Common stock reserved for future issuance (in shares) | 2,201,855 | |||||||
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) | 6,612,554 | 6,612,554 | 4,717,602 | |||||
Common stock reserved for future issuance (in shares) | 9,576,581 | 9,576,581 | ||||||
Amended and Restated Two Thousand Fourteen Stock Incentive Plan | 2022 Stock Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Options to purchase number of outstanding shares of common stock (in shares) | 10,117,305 | |||||||
Common stock reserved for future issuance (in shares) | 6,144,682 |
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 - $ / shares | 9 Months Ended |
Sep. 30, 2022 | |
Number of Shares | |
Outstanding beginning balance (in shares) | 4,717,602 |
Granted (in shares) | 2,346,692 |
Exercised (in shares) | (130,322) |
Canceled/forfeited (in shares) | (321,418) |
Expired (in shares) | 0 |
Outstanding ending balance (in shares) | 6,612,554 |
Exercisable (in shares) | 3,337,063 |
Weighted Average Exercise Price | |
Outstanding beginning balance (in usd per share) | $ 1.65 |
Granted (in usd per share) | 1.50 |
Exercised (in usd per share) | 0.96 |
Canceled/forfeited (in usd per share) | 1.94 |
Expired (in usd per share) | 0 |
Outstanding ending balance (in usd per share) | 1.60 |
Exercisable (in usd per share) | $ 1.49 |
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 | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | $ 556,448 | $ 439,497 | $ 1,626,379 | $ 1,210,886 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | 168,323 | 144,876 | 514,875 | 389,913 |
General and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | $ 388,125 | $ 294,621 | $ 1,111,504 | $ 820,973 |
Leased Properties - Additional
Leased Properties - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Feb. 28, 2022 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Jul. 01, 2018 ft² | |
Lessee, Lease, Description [Line Items] | |||||||
Square footage of office space | ft² | 3,169 | ||||||
Renewal term of operating lease | 2 years | ||||||
Increase (decrease) operating lease liability | $ (504,000) | ||||||
Decrease in operating lease ROU assets | $ 458,000 | ||||||
Gain on early termination of lease | $ 46,000 | $ 46,477 | $ 0 | ||||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Other non-current assets | Other non-current assets | |||||
Right of use asset | $ 546,000 | $ 546,000 | |||||
Current portion of lease liabilities | 388,135 | 388,135 | $ 270,546 | ||||
Lease liabilities long-term | 194,587 | 194,587 | $ 0 | ||||
Non-cash lease expenses | 116,000 | $ 134,000 | 469,000 | 420,000 | |||
Cash paid for measurement of operating lease liabilities | $ 81,000 | $ 117,000 | $ 231,000 | $ 343,000 | |||
Operating lease weighted average remaining lease term | 1 year 6 months 29 days | 1 year 6 months 29 days | |||||
Maximum | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Incremental borrowing rate, amount over prime rate | 0.0200 | 0.0200 | |||||
MBI | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Renewal term of operating lease | 3 years | ||||||
Increase (decrease) operating lease liability | $ 1,000,000 |
Leased Properties - Future Mini
Leased Properties - Future Minimum Lease Payments (Details) | Sep. 30, 2022 USD ($) |
Leases [Abstract] | |
Remainder of 2022 | $ 105,000 |
2023 | 422,000 |
2024 | 93,000 |
Total future minimum lease payments | 620,000 |
Less: accreted interest | 37,000 |
Total operating lease liabilities | $ 583,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) shares in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2021 | Jul. 31, 2021 | Jun. 30, 2021 | Apr. 30, 2020 | Mar. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | Jan. 31, 2021 | Nov. 30, 2019 | |
Commitments And Contingencies [Line Items] | |||||||||
Accrued expenses | $ 4,136,330 | $ 3,136,244 | |||||||
Loan under paycheck protection program | $ 367,285 | ||||||||
Notes payable including accrued interest | $ 369,887 | ||||||||
Microchips Biotech, Inc. | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Payment of additional consideration | $ 1,250,000 | 46,500,000 | |||||||
Potential additional consideration payable | 1,250,000 | ||||||||
Current portion of contingent consideration | $ 1,000,000 | $ 1,000,000 | |||||||
Accrued expenses | 250,000 | $ 250,000 | |||||||
Common stock issued to microchips capital stock holders (in shares) | 700 | ||||||||
Cash paid to stockholders' representative | $ 75,000 | ||||||||
NICHD | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Total payment | $ 5,500,000 | ||||||||
Other cost | $ 5,000,000 | $ 3,500,000 | |||||||
CRADA | |||||||||
Commitments And Contingencies [Line Items] | |||||||||
Remaining performance obligation, amount | $ 500,000 |
Grant Awards (Details)
Grant Awards (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 48 Months Ended | ||||
Jun. 30, 2021 | Jul. 31, 2022 | May 31, 2022 | Sep. 30, 2021 | Aug. 31, 2020 | Sep. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||
Amount awarded for grant | $ 19,400,000 | $ 1,900,000 | ||||||
Deferred grant funding | $ 14,836,416 | 14,836,416 | $ 10,542,983 | |||||
Grant, DARE-FRT1 | ||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||
Amount awarded for grant | $ 300,000 | |||||||
Additional potential grant funding | $ 2,000,000 | |||||||
Initial payment | $ 48,950,000 | |||||||
Grant, DARE-PTB1 | ||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||
Credits recorded to research and development expense for costs related to award | 500 | 20,000 | ||||||
DARE-LARC1 | ||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||
Amount awarded for grant | $ 8,000,000 | $ 300,000 | ||||||
Credits recorded to research and development expense for costs related to award | 3,000 | 196,000 | ||||||
Receivable for expenses eligible for reimbursement | 2,000 | 2,000 | ||||||
Business development | $ 5,400,000 | |||||||
Grant, ADARE-204 and ADARE-214 | ||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||
Amount awarded for grant | $ 249,000 | |||||||
Credits recorded to research and development expense for costs related to award | 65,000 | 65,000 | ||||||
Receivable for expenses eligible for reimbursement | $ 65,000 | $ 65,000 |
Net Loss Per Share - Potential
Net Loss Per Share - Potential Dilutive Outstanding Securities Excluded From Diluted Net Income (Loss) Per Common Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (in shares) | 7,993,569 | 6,445,824 | 7,993,569 | 6,445,824 |
Stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (in shares) | 6,612,554 | 4,802,666 | 6,612,554 | 4,802,666 |
Warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (in shares) | 1,381,015 | 1,643,158 | 1,381,015 | 1,643,158 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 9 Months Ended | |||
Oct. 10, 2022 | Oct. 03, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | |
Subsequent Event [Line Items] | ||||
Milestone payment paid in common stock | $ 0 | $ 250,000 | ||
Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Milestone payment paid in common stock | $ 1,000,000 | |||
Research and development rebate | $ 786,000 |