Dare Bioscience, Inc. 10-K

ITEM 9A. CONTROLS AND PROCEDURES Evaluation of Disclosure Controls and Procedures We maintain disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) designed to provide reasonable assurance that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on an evaluation, performed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) were effective as of December 31, 2022 at the reasonable assurance level. Management’s Report on Internal Control Over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as such term is defined in Rule 13a-15(f) of the Exchange Act). Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles. Because of its inherent limitations, internal controls over financial reporting may not prevent or detect misstatements. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Our management conducted an assessment of the effectiveness of our internal control over financial reporting based on the criteria set forth in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Based on our assessment, management has concluded that our internal control over financial reporting was effective as of December 31, 2022 to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles in the United States. Under SEC rules, because we are a non-accelerated filer, we are not required to provide an auditor attestation report on internal control over financial reporting, nor did we engage our independent registered public accounting firm to perform an audit of our internal control over financial reporting. Changes in Internal Control Over Financial Reporting There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the fourth quarter ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. 112 ITEM 9B. OTHER INFORMATION None. ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS Not applicable. 113 PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE The information required by this item will be included in the Company's 2023 Proxy Statement and is incorporated in this report by reference. ITEM 11. EXECUTIVE COMPENSATION The information required by this item will be included in the Company's 2023 Proxy Statement and is incorporated in this report by reference. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS The information required by this item will be included in the Company's 2023 Proxy Statement and is incorporated in this report by reference. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE The information required by this item will be included in the Company's 2023 Proxy Statement and is incorporated in this report by reference. ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES The information required by this item will be included in the Company's 2023 Proxy Statement and is incorporated in this report by reference. 114 PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES (a) The following documents are filed as part of this annual report on Form 10-K: (1) Financial Statements See “Index to Consolidated Financial Statements” on page F-1. (2) Financial Statement Schedules All financial statement schedules have been omitted, since the required information is not applicable or is not present in amounts sufficient to require submission of the schedule, or because the information required is included in the consolidated financial statements and notes thereto included in this report. (3) Exhibits Exhibits not filed or furnished herewith are incorporated by reference to exhibits previously filed with the SEC, as reflected in the table below. We will furnish a copy of any exhibit to stockholders, without charge upon written request to Daré Bioscience, Inc., 3655 Nobel Drive, Suite 260, San Diego, CA 92122, or by calling 858-926-7655. Incorporated by Reference Exhibit Number Description of Exhibit Form File No. Filing Date Exhibit No. Filed Herewith PLANS OF ACQUISITION 2.1§ Δ Agreement and Plan of Merger, dated as of April 30, 2018, by and among Daré Bioscience, Inc., Daré Merger Sub, Inc., Pear Tree Pharmaceuticals, Inc., and Fred Mermelstein and Stephen C. Rocamboli, as Holders' Representatives 10-Q 001-36395 8/13/2018 10.10 2.2+ Agreement and Plan of Merger, dated November 10, 2019, Dare Bioscience, Inc., MC Merger Sub, Inc., Microchips Biotech, Inc., and Shareholder Representative Services LLC, as the stockholders' representative 8-K 001-36395 11/12/2019 2.1 ARTICLES OF INCORPORATION AND BYLAWS 3.1 Restated Certificate of Incorporation, as amended to date 10-Q 001-36395 08/09/2022 3.1 3.2 Third Amended and Restated By-Laws (as amended through January 24, 2023) 8-K 001-36395 1/27/2023 3.1 INSTRUMENTS DEFINING RIGHTS OF SECURITY HOLDERS 4.1 Specimen stock certificate evidencing the shares of common stock 10-K 001-36395 03/28/2018 4.1 4.2 Warrant Agreement to purchase shares of common stock of the registrant with Aquilo Partners, L.P., entered into as of October 16, 2016. 10-K 001-36395 03/31/2022 4.2 115 4.3(a) Form of Warrant to Purchase Shares of Common Stock (February 2018 Underwritten Offering) 8-K 001-36395 02/13/2018 4.1 4.3(b) Form of Amendment to Warrant to Purchase Common Stock entered into as of June 27, 2018 10-Q 001-36395-181175221 11/13/2018 4.1 4.4 Description of securities of the registrant 10-K 001-36395 03/27/2020 4.6 COMMERCIAL AGREEMENTS 10.1+ Exclusive License Agreement dated March 31, 2022 between Organon International GmbH and Dare Bioscience, Inc., effective as of June 30, 2022 10-Q 001-36395 05/12/2022 10.1 10.2+ Consent, Waiver and Stand-By License Agreement, dated March 30, 2022, by and among TriLogic Pharma, LLC, and MilanaPharm LLC, Dare Bioscience, Inc., and Organon International GmbH. 10-Q 001-36395 05/12/2022 10.2 10.3Δ License and Collaboration Agreement dated February 11, 2018 between Daré Bioscience, Inc., Strategic Science and Technologies-D, LLC and Strategic Science Technologies, LLC 10-K/A 001-36395 04/30/2018 10.1 10.4Δ License Agreement dated March 19, 2017, between Daré Bioscience Operations, Inc. and ADVA-Tec, Inc. 10-Q 001-36395 11/13/2017 10.1 10.5Δ Exclusive License Agreement made as April 24, 2018 by and between Catalent JNP, Inc. (fka Juniper Pharmaceuticals, Inc.), and Daré Bioscience, Inc. 10-Q 001-36395 8/13/2018 10.1 10.6(a)Δ Amended and Restated Exclusive License Agreement for Atrophic Vaginitis Technology , effective as of July 14, 2006, dated August 15, 2007 , by and between Fred Mermelstein, Ph.D. , and Janet Chollet, M.D., and Pear Tree Women’s Health Care, Inc. 10-Q 001-36395 8/13/2018 10.5 10.6(b)Δ Amendment No. 1 to the Amended and Restated Exclusive License Agreement, dated as of October 10, 2007, by and among Fred Mermelstein, Ph.D. and Janet Chollet, M.D., and Pear Tree Pharmaceuticals, Inc. 10-Q 001-36395 8/13/2018 10.6 116 10.6(c)Δ Amendment No. 2 to the Amended and Restated Exclusive License Agreement, dated as of February 13, 2017, by and among Fred Mermelstein, Ph.D., and Janet Chollet, M.D., Pear Tree Pharmaceuticals, Inc. and Bernadette Klamerus 10-Q 001-36395 8/13/2018 10.7 10.6(d)+ Amendment No. 3 to the Amended and Restated Exclusive License Agreement, effective as of February 13, 2017, by and among Fred Mermelstein, Ph.D., and Janet Chollet, M.D., Pear Tree Pharmaceuticals, Inc. and Bernadette Klamerus X 10.6(e)Δ Exclusive License Agreement, dated as of February 13, 2017, by and between GYN Holdings, Inc., a wholly owned subsidiary of Pear Tree Pharmaceuticals, Inc. and Bernadette Klamerus 10-Q 001-36395 8/13/2018 10.8 10.6(f)Δ Exclusive License Agreement, effective as of September 15, 2017, by and between Fred Mermelstein, Ph.D., Janet Chollet, M.D., Pear Tree Pharmaceuticals, Inc., and Stephen C. Rocamboli 10-Q 001-36395 8/13/2018 10.9 10.7(a)Δ Assignment Agreement by and between Daré Bioscience, Inc. and Hammock Pharmaceuticals, Inc. effective as of December 5, 2018 10-K 001-36395 04/01/2019 10.10(a) 10.7(b)Δ First Amendment to the License Agreement effective as of December 5, 2018 by and among Daré Bioscience, Inc., TriLogic Pharma, LLC and MilanaPharm LLC 10-K 001-36395 04/01/2019 10.10(b) 10.7(c) Amendment No. 1 to Assignment Agreement entered into as of December 4, 2019 between Daré Bioscience, Inc. and Hammock Pharmaceuticals, Inc. 10-K 001-36395 03/27/2020 10.10(c) 10.7(d) Amendment No. 2 to the License Agreement entered into as of December 3, 2019 between Daré Bioscience, Inc., TriLogic Pharma, LLC and MilanaPharm LLC 10-K 001-36395 03/27/2020 10.10(d) 10.7(e) Amendment to License Agreement effective as of September 21, 2021 by and among Daré Bioscience, Inc., TriLogic Pharma, LLC and MilanaPharm LLC 10-Q 001-36395 11/10/2021 10.1 117 10.8+ License Agreement dated as of January 10, 2020 between Bayer HealthCare LLC and Daré Bioscience, Inc. 10-K 001-36395 03/27/2020 10.16 10.9+ Grant Agreement between Daré Bioscience, Inc. and the Bill & Melinda Gates Foundation effective as of June 30, 2021 10-Q 001-36395 08/12/2021 10.1 10.10+ Cooperative Research and Development Agreement entered into as of July 8, 2021 between Daré Bioscience, Inc. and the Eunice Kennedy Shriver National Institutes of Child Health and Human Development Institute 10-Q 001-36395 11/10/2021 10.2 MANAGEMENT CONTRACTS AND COMPENSATORY PLANS 10.11(a)* Daré Bioscience, Inc. Amended and Restated 2014 Stock Incentive Plan 8-K 001-36395-18949535 7/12/2018 10.1 10.11(b)* Form of Incentive Stock Option Agreement for grants under the Daré Bioscience, Inc. Amended and Restated 2014 Stock Incentive Plan 10-Q 001-36395 8/13/2018 10.3 10.11(c)* Form of Nonstatutory Stock Option Agreement for grants under the Daré Bioscience, Inc. Amended and Restated 2014 Stock Incentive Plan 10-Q 001-36395 8/13/2018 10.4 10.12* 2014 Employee Stock Purchase Plan S-1/A 333-194442 3/31/2014 10.26 10.13(a)* Dar é Bioscience, Inc. 2022 Stock Incentive Plan 8-K 001-36395 6/24/2022 10.1(a) 10.13(b)* Form of Incentive Stock Option Agreement for Grants under the Dar é Bioscience, Inc. 2022 Stock Incentive Plan 8-K 001-36395 6/24/2022 10.1(b) 10.13(c)* For of Nonstatutory Stock Option Agreement for Grants under the Dar é Bioscience, Inc. 2022 Stock Incentive Plan 8-K 001-36395 6/24/2022 10.2(c) 10.14(a)* 2007 Stock Incentive Plan S-1 333-194442 03/10/2014 10.1 10.14(b) Form of Incentive Stock Option Agreement under 2007 Stock Incentive Plan S-1 333-194442 03/10/2014 10.2 10.14(c)* Form of Nonstatutory Stock Option Agreement under 2007 Stock Incentive Plan S-1 333-194442 03/10/2014 10.3 118 10.14(d) Stock Option Agreement and Contingent Consideration Award Agreement, dated March 31, 2013, between Cerulean Pharma, Inc. and Alan Crane S-1 333-194442 03/10/2014 10.24 10.14(e) Amendment to the Stock Option Agreement and Termination of Contingent Consideration Award dated September 16, 2014, by and between Cerulean Pharma, Inc. and Alan Crane 10-Q 001-36395 11/13/2014 10.4 10.15* Daré Bioscience, Inc. Performance Bonus Plan 10-Q 001-36395 11/12/2019 10.1 10.16 Form of indemnification agreement between the registrant and each of its executive officers and directors S-1 333-194442 03/10/2014 10.16 10.17* Amended and Restated Non-Employee Director Compensation Policy (as amended through January 2022) 10-Q 001-36395 5/12/2022 10.3 10.18(a)* Employment Agreement by and between Daré Bioscience, Inc. and Sabrina Martucci Johnson dated as of August 15, 2017 8-K 001-36395 08/18/2017 10.1 10.18(b)* Amendment No. 1 to Employment Agreement between Daré Bioscience, Inc. and Sabrina Martucci Johnson dated as of March 9, 2020 10-Q 001-36395 05/14/2020 10.13(b) 10.19(a)* Employment Agreement by and between Daré Bioscience, Inc. and Lisa Walters-Hoffert dated as of August 15, 2017 8-K 001-36395 08/18/2017 10.2 10.19(b)* Amendment No. 1 to Employment Agreement between Daré Bioscience, Inc. and Lisa Walters-Hoffert dated as of March 9, 2020 10-Q 001-36395 05/14/2020 10.14(b) 10.20* Daré Bioscience, Inc. Employment Offer Letter to John Fair, dated April 24, 2018 S-1 333-251599 01/05/2021 10.19 10.21* Daré Bioscience, Inc. Change in Control Policy (effective October 15, 2019) S-1 333-251599 01/05/2021 10.20 OTHER EXHIBITS 21.1 Subsidiaries of the registrant X 23.1 Consent of Mayer Hoffman McCann P.C. X 31.1 Certification of P rincipal E xecutive O fficer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended X 119 31.2 Certification of P rincipal F inancial O fficer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended X 32.1# Certification of P rincipal E xecutive O fficer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 X 32.2# Certification of P rincipal F inancial O fficer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 X 101.INS XBRL Instance Document X 101.SCH XBRL Taxonomy Extension Schema Document X 101.CAL XBRL Taxonomy Calculation Linkbase Document X 101.DEF XBRL Taxonomy Extension Definition Linkbase Document X 101.LAB XBRL Taxonomy Label Linkbase Document X 101.PRE XBRL Taxonomy Presentation Linkbase Document X 104 Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) X § All schedules (or similar attachments) have been omitted from this filing pursuant to Item 601(b)(2) of Regulation S-K. The registrant will furnish copies of any schedules to the Securities and Exchange Commission upon request. Δ Confidential treatment has been requested or granted to certain confidential information contained in this exhibit. + Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(10). The omitted information is not material and would likely cause competitive harm to the Company if publicly disclosed. * Management contract or compensatory plan or arrangement # Furnished herewith. This certification is being furnished solely to accompany this report pursuant to U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated herein by reference into any filing of the registrant whether made before or after the date hereof, regardless of any general incorporation language in such filing. ITEM 16. FORM 10-K SUMMARY None. 120 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Daré Bioscience, Inc. By: /s/ SABRINA MARTUCCI JOHNSON Date: March 30, 2023 President and Chief Executive Officer Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. Signature Title Date /s/ SABRINA MARTUCCI JOHNSON President and Chief Executive Officer (Principal Executive Officer) and Director March 30, 2023 Sabrina Martucci Johnson /s/ LISA WALTERS-HOFFERT Chief Financial Officer (Principal Financial and Accounting Officer) March 30, 2023 Lisa Walters-Hoffert /s/ WILLIAM H. RASTETTER Chairman of the Board and Director March 30, 2023 William H. Rastetter, Ph.D. /s/ CHERYL R. BLANCHARD Director March 30, 2023 Cheryl R. Blanchard, Ph.D. /s/ JESSICA D. GROSSMAN Director March 30, 2023 Jessica D. Grossman, M.D. /s/ SUSAN L. KELLEY Director March 30, 2023 Susan L. Kelley, M.D. /s/ GREGORY W. MATZ Director March 30, 2023 Gregory W. Matz, CPA /s/ SOPHIA ONONYE-ONYIA Director March 30, 2023 Sophia Ononye-Onyia, Ph.D. /s/ ROBIN STEELE Director March 30, 2023 Robin Steele, J.D., L.L.M. 121 DARÉ BIOSCIENCE, INC. AND SUBSIDIARIES INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm (PCAOB ID 199 ) F- 2 Consolidated Balance Sheets as of December 31, 2022 and 2021 F- 3 Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2022 and 2021 F- 4 Consolidated Statements of Stockholders’ Equity (Deficit) for the years ended December 31, 2022 and 2021 F- 5 Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021 F- 6 Notes to Consolidated Financial Statements F- 7 F-1 Report of Independent Registered Public Accounting Firm To the Board of Directors and Stockholders of Daré Bioscience, Inc. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Daré Bioscience, Inc. and Subsidiaries (“Company”) as of December 31, 2022 and 2021, and the related consolidated statements of operations and comprehensive loss, stockholders’ equity (deficit), and cash flows for each of the two years in the period ended December 31, 2022, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America. The Company's Ability to Continue as a Going Concern The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company had recurring losses from operations, negative cash flow from operations and is dependent on additional financing to fund operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2 to the financial statements. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty. Basis for Opinion These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. Critical Audit Matters Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters. We have served as the Company's auditor since 2017. /s/ Mayer Hoffman McCann P.C. March 30, 2023 San Diego, California F-2 Daré Bioscience, Inc. and Subsidiaries Consolidated Balance Sheets December 31, 2022 2021 Assets Current Assets Cash and cash equivalents $ 34,669,605 $ 51,674,087 Other receivables 1,703,160 1,145,317 Prepaid expenses 6,665,988 2,476,612 Total current assets 43,038,753 55,296,016 Property and equipment, net 64,908 26,041 Other non-current assets 722,722 485,120 Total assets $ 43,826,383 $ 55,807,177 Liabilities and stockholders’ equity Current Liabilities Accounts payable $ 2,027,953 $ 2,103,083 Accrued expenses 10,894,016 3,136,244 Deferred grant funding 18,303,567 10,542,983 Current portion of lease liabilities 398,391 270,546 Total current liabilities 31,623,927 16,052,856 Deferred license revenue 1,000,000 1,000,000 Lease liabilities long-term 90,346 — Total liabilities 32,714,273 17,052,856 Commitments and contingencies (Note 12) Stockholders' equity Preferred stock, $ 0.01 par value, 5,000,000 shares authorized None issued and outstanding — — Common stock: $ 0.0001 par value, 240,000,000 and 120,000,000 shares authorized, 84,825,481 and 83,944,119 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively 8,482 8,394 Accumulated other comprehensive loss ( 351,311 ) ( 154,973 ) Additional paid-in capital 152,529,579 149,027,802 Accumulated deficit ( 141,074,640 ) ( 110,126,902 ) Total stockholders' equity 11,112,110 38,754,321 Total liabilities and stockholders' equity $ 43,826,383 $ 55,807,177 See accompanying notes. F-3 Daré Bioscience, Inc. and Subsidiaries Consolidated Statements of Operations and Comprehensive Loss Years Ended December 31, 2022 2021 Revenue License fee revenue $ 10,000,000 $ — Total revenue 10,000,000 — Operating expenses General and administrative 11,243,271 8,350,945 Research and development 30,042,217 30,617,567 License fee expense 100,000 100,000 Total operating expenses 41,385,488 39,068,512 Loss from operations ( 31,385,488 ) ( 39,068,512 ) Other income 437,750 2,520 Gain on extinguishment of note payable — 369,887 Net loss $ ( 30,947,738 ) $ ( 38,696,105 ) Net loss to common shareholders $ ( 30,947,738 ) $ ( 38,696,105 ) Foreign currency translation adjustments ( 196,338 ) ( 63,585 ) Comprehensive loss $ ( 31,144,076 ) $ ( 38,759,690 ) Loss per common share - basic and diluted $ ( 0.37 ) $ ( 0.63 ) Weighted average number of common shares outstanding: Basic and diluted 84,571,805 61,154,157 See accompanying notes. F-4 Daré Bioscience, Inc. and Subsidiaries Consolidated Statements of Stockholders’ Equity (Deficit) Additional Accumulated other Total Common stock paid-in comprehensive Accumulated stockholders' Shares Amount capital loss deficit equity (deficit) Balance at December 31, 2020 41,596,253 $ 4,159 $ 70,366,293 $ ( 91,388 ) $ ( 71,430,797 ) $ ( 1,151,733 ) Stock-based compensation — — 1,599,692 — — 1,599,692 Issuance of common stock, net of issuance costs 41,094,657 4,109 75,309,982 — — 75,314,091 Issuance of common stock from the exercise of warrants 520,985 52 500,094 — — 500,146 Stock options exercised 35,500 4 32,525 — — 32,529 Issuance of common stock in connection with milestone payment 696,724 70 1,219,216 — — 1,219,286 Net loss — — — — ( 38,696,105 ) ( 38,696,105 ) Foreign currency translation adjustments — — — ( 63,585 ) — ( 63,585 ) Balance at December 31, 2021 83,944,119 $ 8,394 $ 149,027,802 $ ( 154,973 ) $ ( 110,126,902 ) $ 38,754,321 Stock-based compensation — — 2,158,511 — — 2,158,511 Issuance of common stock, net of issuance costs 751,040 75 1,218,675 — — 1,218,750 Stock options exercised 130,322 13 124,591 — — 124,604 Net loss — — — — ( 30,947,738 ) ( 30,947,738 ) Foreign currency translation adjustments — — — ( 196,338 ) — ( 196,338 ) Balance at December 31, 2022 84,825,481 $ 8,482 $ 152,529,579 $ ( 351,311 ) $ ( 141,074,640 ) $ 11,112,110 See accompanying notes. F-5 Daré Bioscience, Inc. and Subsidiaries Consolidated Statements of Cash Flows Years Ended December 31, 2022 2021 Cash flows from operating activities Net loss $ ( 30,947,738 ) $ ( 38,696,105 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 24,202 26,413 Stock-based compensation 2,158,511 1,599,692 Non-cash operating lease cost 23,415 ( 96,132 ) Gain on early termination of lease ( 46,477 ) — Non-cash loss on settlement of contingent liability — 44,286 Gain on extinguishment of note payable and accrued interest — ( 369,887 ) Changes in operating assets and liabilities: Other receivables ( 557,842 ) ( 685,149 ) Prepaid expenses ( 4,189,376 ) ( 622,336 ) Other non-current assets 3,650 20,873 Accounts payable ( 75,132 ) 1,081,749 Accrued expenses 7,757,774 ( 45,871 ) Deferred grant funding 7,760,584 8,978,430 Net cash used in operating activities ( 18,088,429 ) ( 28,764,037 ) Cash flows from investing activities Purchases of property and equipment ( 63,069 ) ( 14,524 ) Net cash used in investing activities ( 63,069 ) ( 14,524 ) Cash flows from financing activities Net proceeds from issuance of common stock 1,218,750 75,314,091 Proceeds from the exercise of common stock warrants — 500,146 Proceeds from the exercise of stock options 124,604 32,529 Net cash provided by financing activities 1,343,354 75,846,766 Effect of exchange rate changes on cash and cash equivalents ( 196,338 ) ( 63,585 ) Net change in cash and cash equivalents ( 17,004,482 ) 47,004,620 Cash and cash equivalents, beginning of year 51,674,087 4,669,467 Cash and cash equivalents, end of year $ 34,669,605 $ 51,674,087 Supplemental disclosure of non-cash investing and financing activities: Operating right-of-use assets obtained in exchange for new operating lease liabilities $ 585,942 $ 308,533 Settlement of contingent closing consideration liability with stock issuance in connection with acquisition of business $ — $ 925,000 Milestone payment paid in common stock $ — $ 250,000 See accompanying notes. F-6 Daré Bioscience, Inc. and Subsidiaries Notes to Consolidated Financial Statements 1. ORGANIZATION AND DESCRIPTION OF BUSINESS Organization and 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, vaginal health, reproductive health, menopause, sexual health, and fertility, 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 first 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 an exclusive global 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 $ 10.0 million non-refundable and non-creditable payment due upon the effectiveness of the agreement. 2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States, or U.S. GAAP, as defined by the Financial Accounting Standards Board, or FASB. Going Concern The Company prepared its consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The Company has a history of losses from operations, expects negative cash flows from its operations to continue for the foreseeable future, and expects that its net losses will continue for at least the next several years as it develops and seeks to bring to market its existing product candidates and potentially acquire, license and develop additional product candidates. These circumstances raise substantial doubt about the Company's ability to continue as a going concern. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of the Company's ability to continue as a going concern. At December 31, 2022, the Company had an accumulated deficit of approximately $ 141.1 million, cash and cash equivalents of approximately $ 34.7 million, a deferred grant funding liability of $ 18.3 million (representing grant funds received that may be applied solely toward direct costs and a portion of indirect costs for the development of DARE-LARC1 and DARE-LBT and which are included in cash and cash equivalents), and working capital of approximately $ 11.4 million. For the year ended December 31, 2022, the Company incurred a net loss of $ 30.9 million and had negative cash flow from operations of approximately $ 18.1 million. 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 successfully execute its current strategy. F-7 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. If the Company cannot raise capital when needed, on favorable terms or at all, the Company will not be able to continue development of its product candidates, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations. If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values at which they are carried on its consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock. The Company's consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Principles of Consolidation The consolidated financial statements of the Company are stated in U.S. dollars. These consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. One wholly owned subsidiary, Daré Bioscience Australia Pty LTD, operates primarily in Australia. The financial statements of the Company’s wholly owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated Other Comprehensive Loss. All intercompany transactions and accounts have been eliminated in consolidation. Grant Funding The Company receives certain research and development funding through grants issued by a division of the National Institutes of Health and the Bill & Melinda Gates Foundation, or the Foundation. Under the Foundation grant, which the Company considers to be a research and development contract under FASB Accounting Standards Codification, or ASC, Topic 730 Research and Development , the Company granted the Foundation a Humanitarian License which gives the Foundation the right to make the funded developments accessible at an affordable price to people within developing countries. Grants received by the Company that do not require the transfer of goods or services to a customer are accounted for by analogy to International Accounting Standards 20, Accounting for Grants and Disclosure of Government Assistance , or IAS 20. Under IAS 20, the Company recognizes grant funding in the statements of operations as a reduction to research and development expense as the related costs are incurred to meet those obligations over the grant period. The Company adopted this policy in 2018. For the years ended December 31, 2022 and December 31, 2021, the Company recognized approximately $ 5.6 million and $ 2.5 million, respectively, in the statements of operations as a reduction to research and development expense. Grant funding payments received in advance of research and development expenses incurred are recorded as deferred grant funding liability in the Company's consolidated balance sheets. Use of Estimates The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the fair value of stock-based compensation. Actual results could differ from those estimates and could materially affect the reported amounts of assets, liabilities and future operating results. Risks and Uncertainties The Company will require approvals from the U.S. Food and Drug Administration, or FDA, or foreign regulatory agencies prior to being able to sell any products. The Company received approval from the FDA for its first product, XACIATO™, in December 2021. There can be no assurance that the Company’s current or future product candidates will receive the necessary approvals. If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations and its financial position. The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the ability to license product candidates, successfully develop product candidates, successfully commercialize approved products or enter into strategic relationships with third parties who are able to successfully commercialize approved products, raise additional capital, compete with other products, and protect proprietary technology. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success. F-8 Cash and Cash Equivalents The Company considers cash and all highly liquid investments with an original maturity of three months or less to be cash and cash equivalents. The Company’s wholly owned subsidiary, Dare MB Inc., has a $ 35,000 letter of credit related to the lease of real property that serves as security for future default of lease payments. The letter of credit is collateralized by cash which is unavailable for withdrawal or for usage for general obligations and is included in cash and cash equivalents on the Company's consolidated balance sheets. Concentration of Credit Risk The Company maintains cash balances at various financial institutions and such balances commonly exceed the $ 250,000 amount insured by the Federal Deposit Insurance Corporation. The Company also maintains money market funds at various financial institutions which are not federally insured although are invested primarily in the U.S. The Company has not experienced any losses in such accounts and management believes that the Company does not have significant risk with respect to such cash and cash equivalents. Fair Value of Financial Instruments GAAP defines fair value as the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date, and also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available. The three-level hierarchy of valuation techniques established to measure fair value is defined as follows: • Level 1: inputs are unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2: inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities. • Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The following tables present the classification within the fair value hierarchy of financial assets and liabilities that are remeasured on a recurring basis as of December 31, 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) as of December 31, 2022 . Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at December 31, 2022 Current assets: Cash equivalents (1) $ 33,238,658 $ — $ — $ 33,238,658 Balance at December 31, 2021 Current assets: Cash equivalents (1) $ 49,666,064 $ — $ — $ 49,666,064 (1) Represents cash held in money market funds. F-9 The following table presents a reconciliation of contingent consideration, which was measured at fair value on a recurring basis using significant unobservable inputs (Level 3): Year Ended December 31, 2022 2021 Balance at beginning of period $ — $ 1,000,000 Satisfaction of contingent consideration (1) — ( 1,000,000 ) Balance at end of period $ — $ — (1) In June 2021, the contingent consideration payable by the Company related to an acquisition completed in November 2019 became due. In September 2021, the Company issued approximately 700,000 shares of its common stock in satisfaction of the milestone payments associated with milestones achieved, as described in Note 3. Revenue Recognition Under Accounting Standards Codification Topic 606, or ASC 606, 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 Fee Revenue. 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 F-10 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. Bayer License. In January 2020, the Company entered into a license agreement with Bayer HealthCare LLC, or Bayer, regarding the further development and commercialization of Ovaprene in the U.S. Upon execution of the agreement, the Company received a $ 1.0 million upfront non-refundable license fee payment from Bayer. Bayer, in its sole discretion, has the right to make the license effective by paying the Company an additional $ 20.0 million. The Company concluded that there was one significant performance obligation related to the $ 1.0 million upfront payment: a distinct license to commercialize Ovaprene effective upon the receipt of the $ 20.0 million fee. The $ 1.0 million upfront payment will be recorded as license revenue at the earlier of (1) the point in time the Company receives the $ 20.0 million fee, the license is transferred to Bayer and Bayer is able to use and benefit from the license and (2) the termination of the agreement. As of December 31, 2022, neither of the foregoing had occurred. The $ 1.0 million payment is recorded as deferred license revenue in the Company's consolidated balance sheets at December 31, 2022 and December 31, 2021. The Company will also be entitled to receive (a) milestone payments totaling up to $ 310.0 million related to the commercial sales of Ovaprene, if all such milestones are achieved, (b) tiered royalties starting in the low double digits based on annual net sales of Ovaprene during a calendar year, subject to customary royalty reductions and offsets, and (c) a percentage of sublicense revenue. Potential future payments for variable consideration, such as commercial milestones, will be recognized when it is probable that, if recorded, a significant reversal will not take place. Potential future royalty payments will be recorded as revenue when the associated sales occur. (See Note 3, Strategic Agreements.) Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in other non-current assets as right-of-use, or ROU, lease assets, current portion of lease liabilities, and long-term lease liabilities on the Company's consolidated balance sheets. ROU lease assets represent the Company's right to use an underlying asset for the lease term and lease obligations represent the Company's obligation to make lease payments arising from the lease. Operating ROU lease assets and obligations are recognized at the commencement date based on the present value of lease payments over the lease term. If the lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The ROU lease asset also includes any lease payments made and excludes lease incentives. The Company's lease terms may include options to extend or terminate the lease and the related payments are only included in the lease liability when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. (See Note 11, Leased Properties.) Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. Its chief operating decision maker is the chief executive officer. The Company has one operating segment, women’s health. Australian Research and Development Tax Incentive Program The Company is eligible under the Australian Research and Development Tax Incentive Program, or the Tax Incentive, to receive a cash refund from the Australian Taxation Office for eligible research and development F-11 expenditures. To be eligible, the Company must have revenue of less than AUD $ 20.0 million during the reimbursable period and cannot be controlled by income tax exempt entities. Grants received by the Company that do not require the transfer of goods or services to a customer are accounted for by analogy to IAS 20. Under IAS 20, the Company recognizes the Tax Incentive as a reduction to research and development expense when there is reasonable assurance that the Tax Incentive will be received, the relevant expenditure has been incurred, and the amount can be reliably measured. The Company classifies its estimate for the Tax Incentive as other current assets on its consolidated balance sheets. For the years ended December 31, 2022 and 2021, the Company recognized approximately $ 1.6 million and approximately $ 0.8 million, respectively, as a reduction to research and development expense for expenses incurred that it believes are eligible for the Tax Incentive. At December 31, 2022, the Company recorded a receivable for the estimated Tax Incentive of approximately $ 1.6 million in other current assets on the accompanying consolidated balance sheets. Research and Development Costs Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses, manufacturing process-development and scale-up activities, fees paid to clinical and regulatory consultants, clinical trial and related clinical trial manufacturing expenses, fees paid to contract research organizations, or CROs, and investigative sites, transaction expenses incurred in connection with the expansion of the product portfolio through acquisitions and license and option agreements, milestone payments incurred or probable to be incurred for the Company's in-licensing arrangements, payments to universities under the Company’s license agreements and other outside expenses. Research and development costs are expensed as incurred. Nonrefundable advance payments, if any, for goods and services used in research and development are recognized as an expense as the related goods are delivered or services are performed. Patent Costs The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the consolidated statements of operations. Net Loss Per Share Basic net loss attributable to common stockholders per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive. There were stock options exercisable into 6,612,554 and 4,717,602 shares of common stock outstanding at December 31, 2022 and 2021, respectively. There were warrants exercisable into 1,381,015 shares of common stock outstanding at each December 31, 2022 and 2021. These securities were not included in the computation of diluted loss per share because they are antidilutive, but they could potentially dilute earnings (loss) per share in future years. Stock-Based Compensation The Company records compensation expense for all stock-based awards granted based on the fair value of the award at the time of grant. The Company uses the Black-Scholes Pricing Model to determine the fair value of each of the awards which considers factors such as expected term, estimating the market price volatility of the Company's common stock, risk free interest rate, and dividend yield. Due to the limited history of the Company, the simplified method was utilized in order to determine the expected term of the awards. The Company compared U.S. Treasury Bills in determining the risk-free interest rate appropriate given the expected term. The Company has not established and has no plans to establish, a dividend policy, and the Company has not declared, and has no plans to declare dividends in the foreseeable future and thus no dividend yield was determined necessary in the calculation of fair value. Income Taxes The Company accounts for income taxes using the asset and liability method in accordance with FASB ASC 740, Income Taxes . Under this method deferred income taxes are provided to reflect the tax consequences in future years of differences between the tax basis of assets and liabilities and their financial reporting amounts based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect F-12 taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company follows the two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates it is more likely than not, that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount, which is more than 50% likely of being realized upon ultimate settlement. The Company considers many factors when evaluating and estimating the Company's tax positions and tax benefits, which may require periodic adjustments. At December 31, 2022, the Company did not record any liabilities for uncertain tax positions. During each of 2022 and 2021, the Company recorded no provision for income taxes. Management evaluated the Company’s tax positions and, as of December 31, 2022, the Company had approximately $ 2.3 million of unrecognized benefits. The tax years 2018 to 2022 remain open to examination by federal and state taxing authorities while the statute of limitations for U.S. net operating losses generated remain open beginning in the year of utilization. Indemnification Obligations As permitted under Delaware law, the Company has entered into indemnification agreements with its officers and directors that provide that the Company will indemnify its directors and officers for certain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by such director or officer in any action or proceeding arising out of their service as a director and/or officer. The term of the indemnification is for the officer’s or director’s lifetime. During the year ended December 31, 2022, the Company did not experience any losses related to those indemnification obligations. The Company does not expect significant claims related to these indemnification obligations, and consequently, has concluded the fair value of the obligations is not material. Accordingly, as of December 31, 2022 and 2021, no amounts have been accrued related to such indemnification provisions. 3. STRATEGIC AGREEMENTS Strategic Agreement for Product Commercialization Organon Exclusive License Agreement In March 2022, the Company entered into an exclusive license agreement with Organon which became effective in June 2022, whereby Organon licensed 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. In July 2022, the Company received the $ 10.0 million non-refundable and non-creditable payment, which is recorded as license fee revenue in the accompanying consolidated statement of operations. Under the terms of the license agreement, the Company is 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 Company concluded at the inception of the agreement that the transaction price was $ 10.0 million and 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 year ended December 31, 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). The Company is 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. F-13 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. 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. The Company is responsible for the pivotal trial for Ovaprene and for its development and regulatory activities and has product supply obligations. 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 $ 20 million fee. After payment of the $ 20 million fee, Bayer will be responsible for the commercialization of Ovaprene for human contraception in the U.S. Such license would be exclusive as 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 either 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 or the termination of the agreement. As of December 31, 2022, neither of the foregoing had occurred. The $ 1.0 million payment is recorded as long-term deferred license revenue in the Company's consolidated balance sheets at December 31, 2022 and 2021. The Company is entitled to receive (a) a milestone payment in the low double-digit millions upon the first commercial sale of Ovaprene in the U.S. and escalating milestone payments based on annual net sales of Ovaprene during a calendar year, totaling up to $ 310.0 million if all such milestones, including the first commercial sale, are achieved, (b) tiered royalties starting in the low double digits based on annual net sales of Ovaprene during a calendar year, subject to customary royalty reductions and offsets, and (c) a percentage of sublicense revenue. The initial term of the agreement, which is subject to automatic renewal terms, continues until the later of the expiration of any valid claim covering the manufacture, use, sale or import of Ovaprene in the U.S. or 15 years from the first commercial sale of Ovaprene in the U.S. In addition to customary termination rights for both parties, Bayer may terminate the agreement at any time on 90 days' notice and the agreement will automatically terminate if the Company does not receive the $ 20.0 million fee if and when due. Strategic Agreements for Pipeline Development 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. As a result of this license, the Company commenced its DARE-GML. 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. Under the terms of the license agreement, the Company agreed to make potential future payments and sales milestone payments of up to $ 6.25 million in the aggregate upon achieving certain development and regulatory milestones, and of 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. Additionally, Hennepin is eligible to receive tiered royalties in low single-digit to low double-digit percentages based on worldwide net sales of products and processes covered by the licenses granted under the agreement. During the year ended December 31, 2022, no payments were made under this agreement. F-14 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. Under the terms of the merger agreement, the Company agreed to pay 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 the Company acquired in the merger; and (c) tiered royalty payments ranging from low single-digit to low double-digit percentages based on annual net sales of such products sold by the Company (but not by sublicensee) and a percentage of sublicense revenue related to such products. 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. In accordance with the terms of the merger agreement, the Company’s board of directors elected to pay a portion of these milestone payments in shares of the Company’s common stock, and in September 2021, the Company issued approximately 700,000 shares of its common stock to former stockholders of MBI and paid $ 75,000 in cash to the stockholders’ representative in satisfaction of the $ 1.25 million in milestone payments associated with milestones achieved in June 2021. TriLogic and MilanaPharm License Agreement / Hammock Assignment Agreement In December 2018, the Company entered into an Assignment Agreement with Hammock Pharmaceuticals, Inc., or the Assignment Agreement, and 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. In December 2019, the Company entered into amendments to each of the Assignment Agreement and License Amendment. In September 2021, the Company entered into a second amendment to the License Agreement. In March 2022, the Company entered into a consent, waiver and stand-By license Agreement with TriLogic, MilanaPharm and Organon, which further amended the License Agreement. Under the terms of the License Agreement, the Company paid clinical and regulatory development milestones in the aggregate of $ 300,000 to MilanaPharm, the final payment of $ 250,000 was expensed 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 and urological use, and up to $ 250,000 upon the first commercial sale in the United States of each successive licensed products for each vaginal or urological use. In addition, upon achievement of $ 50.0 million in cumulative worldwide net sales of licensed products the Company must pay MilanaPharm $ 1.0 million. MilanaPharm is also eligible to receive (a) 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, and (b) high single-digit to low double-digit royalties based on annual worldwide net sales of licensed products and processes. 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. Hammock is eligible to receive 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. Pear Tree Acquisition In May 2018, the Company acquired Pear Tree Pharmaceuticals, Inc., or Pear Tree, to secure exclusive, sublicensable, worldwide rights under certain patents and know-how to develop and commercialize a proprietary formulation of tamoxifen for vaginal administration. This acquisition led to the Company's DARE-VVA1 program. Under the terms of the merger agreement, the Company agreed to pay the former stockholders of Pear Tree: (a) up to $ 15.5 million in the aggregate upon achieving certain clinical development and regulatory milestones by F-15 licensed products, and (b) up to $ 47.0 million in the aggregate upon achieving certain commercial milestones by licensed products. Additionally, the former stockholders of Pear Tree are eligible to receive tiered royalties based on single-digit to low double-digit percentages of annual net sales of licensed products by the Company or its affiliates, subject to customary reductions and offsets, and a portion of royalties the Company receives from sublicensees. Both the milestone and royalty payments may be made, in the Company's sole discretion, in cash or in shares of its common stock in accordance with the terms of the merger agreement. Under the merger agreement, in addition to customary royalty reductions and offsets, royalty payments and payments based on income received from sublicensees of licensed products made by the Company to Pear Tree's licensors are creditable against all royalty and sublicense revenue share payments payable to the former stockholders of Pear Tree. The Company agreed to pay licensors of Pear Tree (a) up to approximately $ 3.2 million in the aggregate upon achieving certain clinical development, regulatory and commercial milestones by each licensed product, and (b) semi-annual royalties based on a single-digit percentage of net sales of licensed products by the Company or its affiliates, subject to customary reductions and offsets, or a portion of any royalties the Company or its affiliates receives from sublicensees, and a low double-digit percentage of all sublicensing fees or other lump sum payments or compensation the Company receives from sublicensees, subject to customary exclusions. The milestone payments to the licensors of Pear Tree may be made, in the Company's sole discretion, in cash or in shares of its common stock in accordance with the terms of the license agreements. Portions of certain milestone payments made to Pear Tree's licensors may be creditable against royalty payments due to Pear Tree's licensors. 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. Under the terms of the license agreement, the Company paid a $ 250,000 non-creditable upfront license fee to Catalent in connection with the execution of the agreement and will pay a $ 100,000 annual license maintenance fee on each anniversary of the date of the agreement. The annual maintenance fee 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. Catalent is eligible to receive up to (a) $ 13.5 million in the aggregate in payments based on the achievement of specified development and regulatory milestones, $ 1.0 million of which became payable in 2021 and was offset by the $ 100,000 annual maintenance fee, resulting in a net amount of $ 900,000 paid during the year ended December 31, 2021; and (b) up to $ 30.3 million in the aggregate in payments based on the achievement of specified commercial sales milestones for each product or process covered by the licenses granted under the agreement. Additionally, Catalent is eligible to receive 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. Adare Development and Option Agreement In March 2018, the Company entered into an exclusive development and option agreement with Adare Pharmaceuticals USA, Inc. (formerly known as Orbis Biosciences, Inc., and which the Company refers to as Adare), for the development and potential exclusive worldwide license of injectable formulations of etonogestrel for contraceptive protection over 6-month and 12-month periods (which the Company refers to as DARE-204 and DARE-214, respectively). The agreement, as amended, provides the Company with an option to negotiate an exclusive, worldwide, royalty-bearing license, with rights to sublicense, for the programs if the Company funds the conduct of specified development work. The Company has no obligation to exercise its option. 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 treatment of female sexual arousal disorder, or the Field of Use, SST’s topical F-16 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. SST will be eligible to receive payments of up to $ 18.0 million in the aggregate upon achieving certain clinical and regulatory milestones in the U.S. and worldwide, and up to $ 100.0 million in the aggregate upon achieving certain commercial sales milestones. If the Company enters into strategic development or distribution partnerships related to the Licensed Products, additional milestone payments would be due to SST. Additionally, SST is eligible to receive tiered royalties based on percentages of annual net sales of licensed products in the single-digit to mid double-digits subject to customary royalty reductions and offsets, and a percentage of sublicense revenue. ADVA-Tec License Agreement In March 2017, the Company entered into a license agreement with ADVA-Tec, Inc., or ADVA-Tec, under which the Company was granted the exclusive right to develop and commercialize Ovaprene for human contraceptive use worldwide. Under the terms of the license agreement, the Company will pay ADVA-Tec (a) up to $ 14.6 million in the aggregate based on the achievement of specified development and regulatory milestones, $ 1.2 million of which has been paid; and (b) up to $ 20.0 million in the aggregate based on the achievement of certain worldwide net sales milestones. Additionally, ADVA-Tec is eligible to receive royalties based on aggregate annual net sales of Ovaprene in specified regions at a royalty rate that will vary between 1 % and 10 % and will increase based on various net sales thresholds, subject to customary reductions and offsets. If the Company sublicenses its rights under the agreement, in lieu of royalty payments to ADVA-Tec, ADVA-Tec is eligible to receive a double-digit percentage of sublicense revenue received by the Company during the royalty term; provided, however, that for sublicense revenue the Company receives prior to the first commercial sale of a licensed product that represents an upfront payment or license fee due on or around the effective date of the sublicense, ADVA-Tec is eligible to receive a single-digit percentage of that sublicense revenue. 4. PREPAID EXPENSES Prepaid expenses consisted of the following: As of December 31, 2022 2021 Prepaid clinical expense $ 5,928,090 $ 1,728,421 Prepaid insurance expense 502,981 552,354 Prepaid legal and professional expenses 234,917 195,837 Total prepaid expenses $ 6,665,988 $ 2,476,612 5. OTHER NON-CURRENT ASSETS Other non-current assets consisted of the following: As of December 31, 2022 2021 Prepaid insurance, long-term portion $ — $ 87,891 Other non-current assets 115,092 — Deferred financing costs 139,203 143,002 Deposits 10,502 37,554 Operating lease assets 457,925 216,673 Total other non-current assets $ 722,722 $ 485,120 F-17 6. ACCRUED EXPENSES Accrued expenses consisted of the following: As of December 31, 2022 2021 Accrued clinical expense $ 6,665,443 $ 1,242,414 Accrued compensation and benefits 1,720,501 1,533,475 Accrued development expense 2,102,310 158,103 Accrued legal and professional 239,348 129,858 Other accruals 99,747 5,727 Accrued license fee expense 66,667 66,667 Total accrued expenses $ 10,894,016 $ 3,136,244 7. VENDOR CONCENTRATION The Company had a major vendor that accounted for approximately 10 % and 23 % of the Company's research and development expenditures for the years ended December 31, 2022 and 2021, respectively. The same vendor also accounted for approximately 17 % and 4 % of the Company's total accounts payable and accrued expenses as of December 31, 2022 and 2021, respectively. The Company continues to maintain its relationship with this vendor and anticipates incurring significant expenses with this vendor over the next 12 months. 8. INCOME TAXES The components of loss from continuing operations before provision for income taxes consists of the following (in thousands): Years Ended December 31, 2022 2021 Domestic $ 28,391 $ 37,083 Foreign 2,557 1,613 Loss before taxes $ 30,948 $ 38,696 The difference between the provision for income taxes (benefit) and the amount computed by applying the U.S. federal income tax rate for the years ended December 31, 2022 and 2021 are as follows: Years Ended December 31, 2022 2021 Federal statutory rate 21.0 % 21.0 % State income tax, net of federal benefit ( 2.96 ) % 9.64 % State tax rate change ( 9.08 ) % — % Permanent differences ( 0.02 ) % 0.19 % Research and development credit 6.84 % 2.70 % Stock compensation ( 0.57 ) % ( 0.41 ) % Other ( 0.74 ) % 0.25 % Change in valuation allowance ( 14.48 ) % ( 33.38 ) % Effective income tax rate ( 0.01 ) % ( 0.01 ) % F-18 The major components of the Company’s deferred tax assets as of December 31, 2022 and 2021 are shown below (in thousands). 2022 2021 Net operating loss carryforwards $ 81,761 $ 81,817 Research and development credit carryforwards 8,833 7,186 Capitalized research and development costs 10,009 7,417 Other 1,468 801 Stock compensation 2,170 2,540 Total deferred tax assets 104,241 99,761 Valuation allowance ( 104,241 ) ( 99,761 ) Net deferred tax assets $ — $ — The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Under applicable accounting standards, management has considered the Company’s history of losses and concluded that it is more likely than not the Company will not recognize the benefits of federal and state deferred tax assets. Accordingly, a valuation allowance of $ 104.2 million and $ 99.8 million was established at December 31, 2022 and 2021, respectively, to offset the net deferred tax assets. When and if management determines that it is more likely than not that the Company will be able to utilize the deferred tax assets prior to their expiration, the valuation allowance may be reduced or eliminated. The increase in valuation allowance of approximately $ 4.5 million and $ 14.5 million for the years ending December 31, 2022 and 2021, respectively, is primarily related to an increase in net operating losses generated during the year. The Company has U.S. federal net operating loss, or NOL, carryforwards available at December 31, 2022 of approximately $ 295.3 million of which $ 0.9 million begin expiring in 2023 unless previously utilized and $ 117.8 million that do not expire. The Company has state NOL carryforwards of $ 283.4 million that begin expiring in 2031 unless previously utilized. The Company has U.S. federal research credit carryforwards available at December 31, 2022 of approximately $ 8.7 million that begin expiring in 2027 unless previously utilized. The Company has state research credit carryforwards of $ 2.8 million of which $ 0.1 million begin expiring in 2023 unless previously utilized. These federal and state research and development credits are subject to a 20% reserve under FASB ASC 740. The difference between federal and state NOL carryforwards is primarily due to previously expired state NOL carryforwards. Utilization of the NOL and research and development credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. The Company has not yet completed an evaluation of ownership changes. To the extent an ownership change occurs, the NOL and credit carryforwards and other deferred tax assets may be subject to limitations. A reconciliation of the beginning and ending amount of uncertain tax benefits is as follows (in thousands): Years Ended December 31, 2022 2021 Beginning uncertain tax benefits $ 1,909 $ 1,341 Current year - increases $ 427 $ 426 Prior year - additions (reductions) $ ( 20 ) $ 142 Ending uncertain tax benefits $ 2,316 $ 1,909 Included in the balance of uncertain tax benefits at December 31, 2022 are $ 2.3 million of tax benefits that, if recognized, would impact the effective tax rate. The Company anticipates that no material amounts of unrecognized tax benefits will be settled within 12 months of the reporting date. The Company's policy is to record estimated interest and penalties related to uncertain tax benefits as income tax expense. As of December 31, 2022 and 2021, the Company had no accrued interest or penalties recorded related to uncertain tax positions. F-19 The tax years 2018 through 2022 remain open to examination by major taxing jurisdictions to which the Company is subject, which are primarily in the U.S. The statute of limitations for U.S. net operating losses utilized in future years will remain open beginning in the year of utilization. No additional provision has been made for U.S. income taxes related to undistributed foreign earnings of the Company’s wholly owned Australian subsidiary or for unrecognized deferred tax liabilities for temporary differences related to investments in subsidiaries. As such, earnings are expected to be permanently reinvested, the investments are permanent in duration, or the Company has estimated that no additional tax liability will arise as a result of the distribution of such earnings. A liability could arise if amounts are distributed by the subsidiary or if the subsidiary is ultimately disposed. It is not practical to estimate the additional income taxes, if any, related to permanently reinvested earnings. There are no unremitted earnings as of December 31, 2022. 9. 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 240.0 million. 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 Securities 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 the agreement, and any subsequent prospectus supplement filed with the SEC related to this ATM equity offering program. During 2022, the Company sold approximately 751,000 shares of common stock under the agreement for gross proceeds of approximately $ 1.3 million and incurred offering expenses of approximately $ 42,000 . During 2021, the Company sold approximately 7.1 million shares of common stock under the agreement for gross proceeds of approximately $ 16.3 million and incurred offering expenses of approximately $ 537,000 . The Company terminated the agreement in March 2023. (See Note 14, Subsequent Events.) April 2021 ATM Sales Agreement In April 2021, the Company entered into a sales agreement with SVB Securities to sell up to $ 50.0 million of 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. 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 2022, the Company sold no shares of common stock under the agreement. During 2021, the Company sold approximately 26.0 million shares of common stock under the agreement for gross proceeds of approximately $ 46.9 million and incurred offering expenses of approximately $ 1.6 million. The Company terminated the agreement in March 2023. (See Note 14, Subsequent Events.) 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 % of the gross proceeds per share sold under the agreement. In F-20 March 2021, the Company provided notice to Wainwright to terminate the agreement, and the agreement terminated in April 2021. During 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 . Those costs were amortized and expensed as shares were sold under the Purchase Agreement. During 2021, the Company sold, and Lincoln Park purchased, approximately 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 $ 175,000 . As of December 31, 2021, the Company had sold and Lincoln Park had purchased a total of $ 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. 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 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 2022, no warrants were exercised. During 2021, warrants to purchase an aggregate of 520,985 shares of common stock were exercised for gross proceeds of approximately $ 0.5 million. As of December 31, 2022, the Company had the following warrants outstanding: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 6,500 $ 10.00 04/04/2026 1,374,515 $ 0.96 02/15/2023 1,381,015 Common Stock The authorized capital of the Company consists of 240,000,000 shares of common stock with a par value of $ 0.0001 per share and 5,000,000 shares of preferred stock with a par value of $ 0.01 per share. The issued and outstanding common stock of the Company consisted of 84,825,481 and 83,944,119 shares of common stock as of December 31, 2022 and 2021, respectively. There were no shares of preferred stock outstanding as of December 31, 2022 or 2021. F-21 Common Stock Reserved for Future Issuance The following table summarizes common stock reserved for future issuance at December 31, 2022: Common stock reserved for issuance upon exercise of warrants outstanding 1,381,015 Common stock reserved for issuance upon exercise of options outstanding 6,612,554 Common stock reserved for future equity awards 9,576,581 Total 17,570,150 10. 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 and there was no stock-based compensation related to the ESPP for the years ended December 31, 2022 or December 31, 2021. Amended and Restated 2014 Stock Incentive Plan The Company maintains the Amended and Restated 2014 Stock Incentive Plan, or the Amended 2014 Plan. There were 2,046,885 shares of common stock authorized for issuance under the Amended 2014 Plan when it was approved by the Company's stockholders in July 2018. The number of authorized shares increases annually on the first day of each fiscal year until, and including, the fiscal year ending December 31, 2024 by the least of (i) 2,000,000 , (ii) 4 % of the number of outstanding shares of common stock on such date, or (iii) an amount determined by the Company’s board of directors. 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 were or will be granted under the Amended 2014 Plan since that date. 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 years ended December 31, 2022 and 2021. The exercise price of all options granted during the years ended December 31, 2022 and 2021 was equal to the market value of the Company’s common stock on the date of grant. As of December 31, 2022, unamortized stock-based compensation expense of approximately $ 4.1 million will be amortized over the weighted average period of 2.4 years. As of December 31, 2022, 9,576,581 shares of common stock were available for future award grants under the 2022 Plan. F-22 Number of Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Outstanding at December 31, 2020 2,786,591 $ 1.16 Granted 2,052,075 2.31 Exercised ( 35,500 ) 0.92 Canceled/forfeited ( 85,564 ) 1.82 Expired — — 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 December 31, 2022 6,612,554 $ 1.60 7.82 $ 41,679 Options exercisable at December 31, 2022 3,632,467 $ 1.50 7.05 $ 40,102 Options vested and expected to vest at December 31, 2022 6,612,554 $ 1.60 7.82 $ 41,679 Compensation Expense Total stock-based compensation expense related to stock options granted to employees and directors recognized in the consolidated statements of operations is as follows: Years Ended December 31, 2022 2021 Research and development $ 676,645 $ 524,071 General and administrative 1,481,866 1,075,621 Total $ 2,158,511 $ 1,599,692 The assumptions used in the Black-Scholes option-pricing model for stock options granted to employees and to directors in respect of board services during the years ended December 31, 2022 and 2021 is as follows: 2022 2021 Expected life in years 6.0 6.0 Risk-free interest rate 2.00 % 0.67 % Expected volatility 121 % 122 % Dividend yield 0.0 % 0.0 % Weighted-average fair value of options granted $ 1.30 $ 2.01 11. 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 lease 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 year ended December 31, 2022. MBI previously leased warehouse space in Billerica, Massachusetts, under a lease that commenced on October 1, 2016 and terminated on March 31, 2022. F-23 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 December 31, 2022, the Company reported operating lease right of use assets of approximately $ 458,000 in other non-current assets, approximately $ 398,000 in current liabilities, and approximately $ 90,000 in long-term liabilities on the consolidated balance sheets. Total operating lease costs were approximately $ 602,000 and $ 561,000 for the years ended December 31, 2022 and 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 consolidated statements of operations. Cash paid for amounts included in the measurement of operating lease liabilities was approximately $ 346,000 and $ 462,000 for the years ended December 31, 2022 and 2021, respectively, and these amounts are included in operating activities in the consolidated statements of cash flows. At December 31, 2022, operating leases had a weighted average remaining lease term of 1.33 years. At December 31, 2022, future minimum lease payments under the Company's operating leases are as follows: Year ending December 31, 2023 $ 422,000 2024 $ 93,000 Total future minimum lease payments 515,000 Less: accreted interest 26,000 Total operating lease liabilities $ 489,000 12. 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 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 in payments 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 made aggregate F-24 payments of $ 1.5 million to NICHD in 2021 and a payment of $ 3.5 million to NICHD in 2022. The Company's remaining obligation under the CRADA at December 31, 2022 is $ 0.5 million. Note Payable In April 2020, due to the economic uncertainty resulting from the impact of the COVID-19 pandemic on the Company's operations and to support its ongoing operations and retain all employees, the Company applied for and received a loan of $ 367,285 under the Paycheck Protection Program of the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, administered by the U.S. Small Business Administration, or the SBA. In January 2021, the Company was notified that the principal balance of the loan and all accrued interest, which together totaled $ 369,887 , were fully forgiven by the SBA. The Company recorded a gain on extinguishment of note payable and debt forgiveness income with respect to such loan forgiveness in the first quarter of 2021. Legal Proceedings From time to time, the Company may be involved in various claims arising in the normal course of business. Management is not aware of any material claims, disputes or unsettled matters that would have a material adverse effect on the Company’s results of operations, liquidity or financial position that the Company has not adequately provided for in the accompanying consolidated financial statements. Employment Agreements Certain executive officers of the Company are entitled to payments if their employment is terminated by the Company without cause, if they resign for good reason, if their employment agreements are not renewed, or if their employment is terminated by the Company without cause or if they resign for good reason, in each case, within three months prior to or 12 months following a change in control of the Company. Upon termination by the Company without cause, if they resign for good reason, if their employment agreements are not renewed, such executives are entitled to receive a payment of an amount equal to either nine or twelve months of base salary and to receive continuing health benefits coverage for periods equal to either nine or twelve months following the termination of employment or until such officer is covered under a separate plan from another employer. If their employment is terminated by the Company without cause or if they resign for good reason, in each case, within three months prior to or 12 months following a change in control of the Company, such executives will be entitled to receive a payment of an amount equal to either twelve or eighteen months of base salary and target bonus and to receive continuing health benefits coverage for periods ranging between twelve and eighteen months following the termination of employment. In addition, upon a change in control of the Company, each officer’s outstanding unvested options will fully vest and accelerate subject to the conditions outlined in such officer’s employment agreement. Employee Benefit – 401(k) Plan The Company has a 401(k) retirement plan, or the 401(k) Plan, covering all qualified employees. The 401(k) Plan allows each participant to contribute a portion of their base wages up to an amount not to exceed an annual statutory maximum. The 401(k) Plan includes a Safe Harbor Plan that provides a Company match up to 4 % of salary. The Company made matching contributions of approximately $ 200,000 and $ 160,000 during the years ended December 31, 2022 and 2021, respectively. 13. 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 DARE-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. F-25 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 notices of awards received by the Company 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 what is referred to as 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 of approximately $ 20,000 and $ 65,000 for costs related to the NICHD award for the years ended December 31, 2022 and 2021, 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 nonclinical studies, which is ongoing. The Company recorded credits to research and development expense of approximately $ 239,000 and $ 7,400 for costs related to the NICHD award for the year ended December 31, 2022 and 2021, respectively. The Company recorded receivables of approximately $ 33,000 and $ 7,400 for expenses incurred through such date that it believes is eligible for reimbursement under the grant at December 31, 2022 and 2021, respectively. DARE-204 and DARE-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 DARE-204 and DARE-214. The Company recorded credits to research and development expense of approximately $ 116,000 for costs related to the NICHD award for the year ended December 31, 2022. At December 31, 2022, the Company recorded a receivable of approximately $ 24,000 for expenses incurred through such date that it believes is eligible for reimbursement under the grant. Other Non-Dilutive Grant Funding MBI Grant Agreement for DARE-LARC1 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 and no future funding has been or will be received under this agreement. 2021 DARE-LARC1 Grant Agreement In June 2021, the Company entered into an agreement with the Foundation under which the Company was awarded up to $ 49.0 million to support the development of DARE-LARC1. The agreement supports technology development and preclinical activities over the period of June 30, 2021 to November 1, 2026, to advance DARE-LARC1 in nonclinical proof of principle studies. Under the 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 consolidated balance sheets. The Company received an initial payment of $ 11.5 million in July 2021, approximately $ 8.0 million in July 2022 and approximately $ 4.4 million in December 2022. As of December 31, 2022, the Company has received an F-26 aggregate of approximately $ 23.9 million in non-dilutive funding under the agreement and recorded approximately $ 17.7 million of deferred grant funding in the Company's consolidated balance sheets. Additional payments are contingent upon the DARE-LARC1 program’s achievement of specified development and reporting milestones. 2022 DARE-LBT Grant Agreement In November 2022, the Company entered into an agreement with the Foundation under which the Company was awarded $ 585,000 to support the development of DARE-LBT. Under the 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 consolidated balance sheets. The Company received the full amount of the award in November 2022. As of December 31, 2022, the Company has recorded approximately $ 573,000 of deferred grant funding in the Company's consolidated balance sheets. 14. SUBSEQUENT EVENTS Termination of ATM Sales Agreements Effective March 30, 2023, the Company terminated its ATM equity offering program sales agreements with SVB Securities LLC (see Note 9). Exercise of February 2018 Warrants In January and February 2023, warrants to purchase an aggregate of 1,353,515 shares of common stock were exercised at an exercise price of $ 0.96 per share resulting in gross proceeds to the Company of approximately $ 1.3 million (see Note 9). F-27