What changed in this filing

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Item 9A. Controls and Procedures

2023-03-30 compared with 2022-03-31 · 314 added, 347 removed, 695 unchanged (49% of the section changed)

1 unchanged sentence

Evaluation of Disclosure Controls and Procedures

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.

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.

35 unchanged sentences

Filed Herewith

PLANS OF ACQUISITION

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.

3 unchanged sentences

8-K 001-36395 11/12/2019 2.1

3.1 Restated Certificate of Incorporation, as amended by Certificate of Amendment dated July 19, 2017 to effect the Reverse Stock Split effective July 20, 2017, and by Certificate of Amendment dated July 19, 2017 stating the name change effective July 20, 2017

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 Second Amended and Restated By-Laws (as amended through June 1, 2020)

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

1 unchanged sentence

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

4.3(a) Form of Warrant to Purchase Shares of Common Stock (February 2018 Underwritten Offering)

4 unchanged sentences

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

3 unchanged sentences

10-Q 001-36395 11/13/2017 10.1

10.3(a)* Daré Bioscience, Inc.

Amended and Restated 2014 Stock Incentive Plan

8-K 001-36395-18949535 7/12/2018 10.1

10.3(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 08/13/2018 10.3

10.3(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 08/13/2018 10.4

10.4 Form of indemnification agreement between the registrant and each of its executive officers and directors

S-1 333-194442 03/10/2014 10.16

10.5* Non-Employee Director Compensation Policy (as amended through April 9, 2018)

10-Q 001-36395 8/13/2018 10.2

10.5Δ Exclusive License Agreement made as April 24, 2018 by and between Catalent JNP, Inc.

1 unchanged sentence

10-Q 001-36395 8/13/2018 10.1

10.7(a)Δ Amended and Restated Exclusive License Agreement, dated as of July 14, 2006, by and between Fred Mermelstein, Ph.D.

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.

8 unchanged sentences

10-Q 001-36395 8/13/2018 10.7

10.7(d)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.

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

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

10.7(e)Δ Exclusive License Agreement, dated as of September 15, 2017, by and between Fred Mermelstein, Ph.D., Janet Chollet, M.D., Pear Tree Pharmaceuticals, Inc., and Stephen C.

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.

10-Q 001-36395 8/13/2018 10.9

10.8 2014 Employee Stock Purchase Plan

S-1/A 333-194442 03/31/2014 10.26

10.7(a)Δ Assignment Agreement by and between Daré Bioscience, Inc.

13 unchanged sentences

10-Q 001-36395 11/10/2021 10.1

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

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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.

13 unchanged sentences

10.20* Daré Bioscience, Inc.

Performance Bonus Plan

10-Q 001-36395 11/12/2019 10.1

10.14+ 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

10.15* Daré Bioscience, Inc.

Employment Offer Letter to John Fair, dated April 24, 2018

3 unchanged sentences

S-1 333-251599 01/05/2021 10.20

10.17+ 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

10.18+ 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

OTHER EXHIBITS

21.1 Subsidiaries of the registrant

23.1 Consent of Mayer Hoffman McCann P.C.

31.1 Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended

31.2 Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended

32.1# Certification of principal executive officer pursuant to 18 U.S.C.

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

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

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

32.2# Certification of principal financial officer pursuant to 18 U.S.C.

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

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Sabrina Martucci Johnson

/s/ LISA WALTERS-HOFFERT Chief Financial Officer and Secretary

(Principal Financial and Accounting Officer)

March 31, 2022

/s/ LISA WALTERS-HOFFERT Chief Financial Officer

(Principal Financial and Accounting Officer) March 30, 2023

Lisa Walters-Hoffert

27 unchanged sentences

of Daré Bioscience, Inc.

and Subsidiaries

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Daré Bioscience, Inc.

and Subsidiaries (“the Company”) as of December 31, 2021 and 2020, 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, 2021, 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, 2021 and 2020, and the results of their operations and their cash flows for each of the two years in the period ended December 31, 2021, in conformity with accounting principles generally accepted in the United States of America.

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

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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 described in Note 2 to the financial statements.

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.

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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 were no critical audit matters.

We determined that there are no critical audit matters.

We have served as the Company's auditor since 2017.

13 unchanged sentences

Total assets $ 43,826,383 $ 55,807,177

Liabilities and stockholders’ equity (deficit)

Liabilities and stockholders’ equity

Current Liabilities

2 unchanged sentences

Deferred grant funding 18,303,567 10,542,983

Note payable — 367,285

Contingent consideration — 1,000,000

Current portion of lease liabilities 398,391 270,546

4 unchanged sentences

Commitments and contingencies (Note 12)

Stockholders' equity (deficit)

Stockholders' equity

Preferred stock, $ 0.01 par value, 5,000,000 shares authorized

1 unchanged sentence

Common stock:

$ 0.0001 par value, 120,000,000 shares authorized, 83,944,119 and 41,596,253 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively

$ 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

Accumulated other comprehensive loss ( 351,311 ) ( 154,973 )

1 unchanged sentence

Accumulated deficit ( 141,074,640 ) ( 110,126,902 )

Total stockholders' equity (deficit) 38,754,321 ( 1,151,733 )

Total liabilities and stockholders' equity (deficit) $ 55,807,177 $ 7,550,712

Total stockholders' equity 11,112,110 38,754,321

Total liabilities and stockholders' equity $ 43,826,383 $ 55,807,177

See accompanying notes.

3 unchanged sentences

Years Ended December 31,

License fee revenue $ 10,000,000 $ —

Total revenue 10,000,000 —

Operating expenses

1 unchanged sentence

Research and development 30,042,217 30,617,567

License fees 100,000 83,333

License fee expense 100,000 100,000

Total operating expenses 41,385,488 39,068,512

3 unchanged sentences

Net loss $ ( 30,947,738 ) $ ( 38,696,105 )

Deemed dividend from trigger of round down provision feature — ( 6,863 )

Net loss to common shareholders $ ( 30,947,738 ) $ ( 38,696,105 )

15 unchanged sentences

Issuance of common stock from the exercise of warrants 520,985 52 500,094 — — 500,146

Issuance cost on equity paid in common stock 285,714 29 291,500 — — 291,529

Stock options exercised 35,500 4 32,525 — — 32,529

Deemed dividend from trigger of down round provision — — 6,863 — ( 6,863 ) —

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 )

3 unchanged sentences

Issuance of common stock, net of issuance costs 751,040 75 1,218,675 — — 1,218,750

Issuance of common stock from the exercise of warrants 520,985 52 500,094 — — 500,146

Stock options exercised 130,322 13 124,591 — — 124,604

Issuance of common stock in connection with milestone payment 696,724 70 1,219,216 — — 1,219,286

Net loss — — — — ( 30,947,738 ) ( 30,947,738 )

6 unchanged sentences

Years Ended December 31,

Operating activities:

Cash flows from operating activities

Net loss $ ( 30,947,738 ) $ ( 38,696,105 )

3 unchanged sentences

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

7 unchanged sentences

Deferred grant funding 7,760,584 8,978,430

Deferred license revenue — 1,000,000

Net cash used in operating activities ( 18,088,429 ) ( 28,764,037 )

Investing activities:

Cash flows from investing activities

Purchases of property and equipment ( 63,069 ) ( 14,524 )

Net cash used in investing activities ( 63,069 ) ( 14,524 )

Financing activities:

Cash flows from financing activities

Net proceeds from issuance of common stock 1,218,750 75,314,091

1 unchanged sentence

Proceeds from the exercise of stock options 124,604 32,529

Proceeds from issuance of note payable — 367,285

Net cash provided by financing activities 1,343,354 75,846,766

7 unchanged sentences

Milestone payment paid in common stock $ — $ 250,000

Issuance cost on equity paid in common stock $ — $ 291,428

Deemed dividend from trigger of down round provision $ — $ 6,863

See accompanying notes.

10 unchanged sentences

and its wholly owned subsidiaries, unless otherwise stated or the context otherwise requires.

The Company is driven by a mission to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health.

The Company's business strategy is to in-license or otherwise acquire the rights to differentiated product candidates in the Company's areas of focus, some of which have existing clinical proof-of-concept data, to take those candidates through mid to late-stage clinical development, and to establish and leverage strategic collaborations to achieve commercialization.

The Company's first product, XACIATO™, which was approved by the FDA in December 2021, is a single-dose vaginal gel prescription product for the treatment of bacterial vaginosis in females 12 years of age and older.

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.

XACIATO is expected to be available commercially in the United States in the fourth quarter of 2022.

The Company began assembling its diverse portfolio of clinical-stage product candidates and pre-clinical programs in 2017 through acquisitions, exclusive in-licenses and other collaborations.

The Company's programs target unmet needs in women's health in the areas of contraception, fertility, and vaginal and sexual health, and aim to expand treatment options, enhance outcomes and improve ease of use for women.

The Company's portfolio includes two product candidates in advanced clinical development:

• Ovaprene® , a hormone-free, monthly contraceptive;

• Sildenafil Cream , 3 .

6% , a proprietary cream formulation of sildenafil for topical administration to the vulva and vagina for treatment of female sexual arousal disorder.

The Company's portfolio also includes four product candidates in Phase 1 clinical development or that the Company believes are Phase 1-ready:

• DARE-HRT1 , a combination bio-identical estradiol and progesterone intravaginal ring for the treatment of menopausal symptoms, including vasomotor symptoms, as part of hormone therapy following menopause;

• DARE - VVA1 , a vaginally delivered formulation of tamoxifen to treat vulvar vaginal atrophy as an option for women with hormone- receptor positive breast cancer;

• DARE - FRT1 , an intravaginal ring containing bio-identical progesterone for broader luteal phase support as part of an in vitro fertilization treatment plan;

• DARE-PTB1 , an intravaginal ring containing bio-identical progesterone for the prevention of preterm birth;

In addition, the Company's portfolio includes these pre-clinical stage potential product candidates:

• DARE-LARC1 , a contraceptive implant delivering levonorgestrel with a woman-centered design that has the potential to be a long-acting, yet convenient and user-controlled contraceptive option;

• ADARE-204 and ADARE-214 , injectable formulations of etonogestrel designed to provide contraception over 6-month and 12-month periods, respectively;

• DARE-RH1 , a novel approach to non-hormonal contraception for both men and women by targeting the CatSper ion channel.

The Company’s primary operations have consisted of, and are expected to continue to consist primarily of, research and development activities to advance its portfolio of product candidates through clinical development and regulatory approval.

The Company has one FDA-approved product, XACIATO, which has not yet been commercially launched.

To date, the Company has not obtained any other regulatory approvals for any of its product candidates, commercialized any of its product candidates or generated any revenue.

The Company is subject to several risks common to biopharmaceutical companies, including dependence on key employees, dependence on third-party collaborators and service providers, competition from other companies, the need to develop commercially viable products in a timely and cost-effective manner, and the need to obtain adequate additional capital to fund the development of product candidates.

The Company is also subject to several risks common to other companies in the industry, including rapid technology change, regulatory approval of products, uncertainty of market acceptance of products, success of third parties in the marketing, sale and distribution of the Company's products, competition from substitute products and larger companies, compliance with government regulations, protection of proprietary technology, and product liability.

The COVID-19 pandemic remains an evolving and uncertain risk to the Company’s business, operating results, financial condition and stock price.

To date, the Company believes the pandemic contributed to a slower than expected initial pace of enrollment in its Phase 2b clinical study of Sildenafil Cream, 3.6% and delays in commencement of clinical studies and nonclinical testing for more than one of its earlier stage clinical programs, but has not had a material adverse effect on its business as a whole.

Continued uncertainty regarding the duration and impact of the pandemic on the U.S.

and global economies, healthcare systems, workplace environments and capital markets, preclude any prediction as to the ultimate effect of the pandemic on the Company’s business.

For further discussion of risks and uncertainties related to the pandemic, see the risk factor in Part I, Item 1A of this report titled, The COVID-19 pandemic has negatively impacted our business and, in the future, may materially and adversely affect our business, financial condition and results and stock price, including by increasing the cost and timelines for our clinical development programs.

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.

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

7 unchanged sentences

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, 2021, the Company had an accumulated deficit of approximately $ 110.1 million, cash and cash equivalents of approximately $ 51.7 million, and working capital of approximately $ 39.2 million.

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.

The Company expects its primary uses of capital to be staff-related expenses, the cost of clinical trials and regulatory activities related to its product candidates, costs associated with contract manufacturing services and third-party clinical research and development services, payments due to third-party licensors upon the occurrence of commercial milestones for XACIATO and development milestones for the Company’s product candidates, legal expenses, other regulatory expenses and general overhead costs.

The Company’s future funding requirements could

also include significant costs related to commercialization of its product candidates, if approved, depending on the type, nature and terms of commercial collaborations the Company establishes.

The Company expects its expenses, and in particular its research and development expenses, to increase significantly in 2022 compared to 2021 as the Company continues to develop and seek to bring to market its product candidates, with a focus on its product candidates that have reached the human clinical study development phase.

To date, the Company has one FDA-approved product, XACIATO, which has not yet been commercially launched.

The Company has not obtained any other regulatory approvals for any of its product candidates, commercialized any of its product candidates or generated any revenue.

Commercial launch of XACIATO in the U.S.

by the Company's licensee, Organon, is expected in the fourth quarter of 2022.

Under the terms of its license agreement with Organon, the Company will receive a $ 10.0 million non-refundable and non-creditable payment following the effective date of the license agreement and will be entitled to receive tiered double-digit royalties based on net sales and up to $ 182.5 million in milestone payments as follows:

$ 2.5 million following the first commercial sale of a licensed product in the United States;

and up to $ 180.0 million in tiered commercial sales milestones and regulatory milestones.

The Company has devoted significant resources to building its portfolio of product candidates and to research and development activities related to these product candidates.

The Company or its licensees must obtain regulatory approvals to market and sell any of its product candidates in the future and to market and sell XACIATO anywhere outside the U.S.

The Company will need to generate sufficient safety and efficacy data on each of its product candidates in order to apply for regulatory approvals and for such assets to be attractive assets to potential strategic collaborators to license or to acquire, and for the Company to generate revenue through license fees, royalties on net revenues and commercial milestones related to such product candidates.

Based on the Company's current operating plan estimates, the Company does not have sufficient cash to satisfy its working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying financial statements.

The Company will need to raise substantial additional capital to continue to fund its operations and to successfully execute its current strategy.

The Company will continue to seek to raise capital through the sale of shares of its common stock under its ATM sales agreements, however, when the Company can effect such sales and the amount of shares the Company can sell depends on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of its common stock and its determination as to the appropriate sources of funding for its operations.

For the foreseeable future, the Company will evaluate and may pursue a variety of capital raising options on an on-going basis, including equity and debt financings, government or other grant funding, collaborations and strategic alliances or other similar types of arrangements, to cover its operating expenses, and the cost of any license or other acquisition of new product candidates or technologies.

The amount and timing of the Company's capital needs have been and will continue to depend highly on many factors, including the product development programs the Company chooses to pursue, the pace and results of its clinical development efforts, and the nature and extent of expansion of its product candidate portfolio, if any.

If the Company raises capital through collaborations, strategic alliances or other similar types of arrangements, it may have to relinquish, on terms that are not favorable to the Company, rights to some of its technologies or product candidates the Company would otherwise seek to develop or commercialize.

There can be no assurance that capital will be available when needed or that, if available, it will be obtained on terms favorable to the Company and its stockholders.

In addition, equity or debt financings may have a dilutive effect on the holdings of the Company's existing stockholders, and debt financings may subject the Company to restrictive covenants, operational restrictions and security interests in its assets.

If the Company cannot raise capital when needed, on favorable terms or at all, the Company will not be able to continue development of its product candidates, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations.

If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values at which they are carried on its condensed consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock.

The Company's condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

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

3 unchanged sentences

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.

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.

2 unchanged sentences

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.

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.

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.

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$ 49,666,064 $ — $ — $ 49,666,064

Other non-current liabilities:

Current portion of contingent consideration (2)

$ — $ — $ 1,000,000 $ 1,000,000

(1) Represents cash held in money market funds.

(2) Represented t he estimated fair value of the contingent consideration payable by the Company related to an acquisition completed in November 2019, and which was paid in September 2021, as described in Note 3.

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):

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Revenue Recognition

The Company recognizes revenue in accordance with FASB ASC Topic 606, Revenue from Contracts with Customers , which applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.

The Company recognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services.

revenue recognition for contracts with customers, the Company performs the following five steps:

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;

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and (v) recognize revenue when (or as) the Company satisfies its performance obligations.

At contract inception, the Company assesses the goods or services agreed upon within each contract and 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 that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

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.

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In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.

License Fees.

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 that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees.

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 not recognized any license fee revenue resulting from any of its collaborative arrangements.

Royalties and Commercial Milestones.

For arrangements that include sales-based royalties and milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties and milestones 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 or any commercial milestones resulting from any of its collaborative arrangements.

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.

For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

To date, the Company has not recognized any royalty revenue.

Product Supply.

Arrangements that include a promise for future supply of product for commercial supply at the licensee’s discretion are generally considered as options.

The Company assesses if these options provide a

material right to the licensee and if so, they are accounted for as separate performance obligations.

The Company evaluates whether it is the principal or agent in the arrangement.

The evaluation is based on the degree the Company controls the specified product at any time before transfer to the customer.

Revenues are recognized on a gross basis if the Company is in the capacity of principal and on a net basis if the Company is in the capacity of an agent.

To date, the Company has not recognized any revenue associated with product supply arrangements.

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.

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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

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

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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.

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

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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 and 1,908,643 shares of common stock outstanding at December 31, 2021 and 2020, 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.

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The Company records compensation expense for all stock-based awards granted based on the fair value of the award at the time of grant.

The Company uses the Black-Scholes Pricing Model to determine the fair value of each of the awards which considers factors such as expected term, volatility, risk free interest rate and dividend yield.

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.

Additionally, the Company considered comparable companies in the industry which have available share price history to calculate the volatility.

The Company compared U.S.

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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.

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

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The Company received a $ 1.0 million upfront non-refundable license fee payment from Bayer and Bayer agreed to support the Company in development and regulatory activities by providing the equivalent of two experts to advise the Company in clinical, regulatory, preclinical, commercial, CMC and product supply matters.

Bayer, in its sole discretion, has the right to make the license effective by paying the Company an additional $ 20.0 million, referred to as the Clinical Trial and Manufacturing Activities Fee.

Such license would be exclusive with regard to the commercialization of Ovaprene for human contraception in the U.S.

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 following is a summary of the other terms of the Bayer license agreement:

Milestone & Royalty Payments .

The Company will be entitled to receive (a) a milestone payment in the low double-digit millions upon the first commercial sale of Ovaprene in the U.S.

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 Company is responsible for the pivotal trial for Ovaprene and for its development and regulatory activities and has product supply obligations.

After payment of the Clinical Trial and Manufacturing Activities Fee, Bayer will be responsible for the commercialization of Ovaprene for human contraception in the U.S.

The initial term of the agreement, which is subject to automatic renewal terms, continues until the later of (a) the expiration of any valid claim covering the manufacture, use, sale or import of Ovaprene in the U.S.;

or (b) 15 years from the first commercial sale of Ovaprene in the U.S.

In addition to customary termination rights for both parties, Bayer may terminate the agreement at any time on 90 days' notice and the agreement will automatically terminate if the Company does not receive the Clinical Trial and Manufacturing Activities Fee if and when due.

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.

Strategic Agreements for Pipeline Development

Hammock/MilanaPharm Assignment and License Agreement

In December 2018, the Company entered into (a) an Assignment Agreement with Hammock Pharmaceuticals, Inc., or the Assignment Agreement, and (b) a First Amendment to License Agreement with TriLogic Pharma, LLC and MilanaPharm LLC, or the License Amendment.

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.

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.

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In December 2019, the Company entered into amendments to each of the Assignment Agreement and License Amendment.

In September 2021, the Company and Trilogic and MilanaPharm entered into another amendment to the License Agreement.

The following is a summary of other terms of the License Amendment, as amended:

License Fees.

A total of $ 235,000 in license fees were payable to MilanaPharm, the final installment of which was $ 110,000 paid in 2020.

Milestone Payments.

The Company paid MilanaPharm $ 300,000 in the aggregate upon achievement of certain clinical and regulatory development milestones;

$ 50,000 of which was paid in 2020 and $ 250,000 of which was paid in 2021.

The Company may also pay MilanaPharm up to $ 1.75 million in the aggregate upon achieving certain commercial sales milestones.

Foreign Sublicense Income.

The Company will pay MilanaPharm a low double-digit percentage of all income received by the Company or its affiliates in connection with any sublicense granted to a third party for use outside of the United States, subject to certain exclusions.

Royalty Payments.

During the royalty term, the Company will pay MilanaPharm high single-digit to low double-digit royalties based on annual worldwide net sales of licensed products and processes.

The royalty term, which is determined on a country-by-country basis and licensed product-by-product basis (or process-by-process basis), begins with the first commercial sale of a licensed product or process in a country and terminates on the latest of (1) the expiration date of the last valid claim of the licensed patent rights that cover the method of use of such product or process in such country, or (2) 10 years following the first commercial sale of such product or process in such country.

Royalty payments are subject to reduction in certain circumstances, including as a result of generic competition, patent prosecution expenses incurred by the Company, or payments to third parties for rights or know-how required for the Company to exercise the licenses granted to it under the MilanaPharm License Agreement or that are strategically important or could add value to a licensed product or process in a manner expected to materially generate or increase sales.

The Company must use commercially reasonable efforts and resources to (1) develop and commercialize at least one licensed product or process in the United States and at least one licensed product or process in at least one of Canada, the United Kingdom, France, Germany, Italy or Spain, and (2) continue to commercialize that product or process following the first commercial sale of a licensed product or process in the applicable jurisdiction.

Unless earlier terminated, the license term continues until (1) on a licensed product-by-product (or process-by-process basis) and country-by-country basis, the date of expiration of the royalty term with respect to such licensed product in such country, and (2) the expiration of all applicable royalty terms under the MilanaPharm License Agreement with respect to all licensed products and processes in all countries.

Upon expiration of the term with respect to any licensed product or process in a country (but not upon earlier termination of the MilanaPharm License Agreement), the licenses granted to the Company under the MilanaPharm License Agreement will convert automatically to an exclusive, fully paid-up, royalty-free, perpetual, non-terminable and irrevocable right and license under the licensed intellectual property.

In addition to customary termination rights for all parties, MilanaPharm may terminate the license granted to the Company solely with respect to a licensed product or process in a country if, after having launched such product or process in such country, (1) the Company or its affiliates or sublicensees discontinue the sale of such product or

process in such country and MilanaPharm notifies the Company of such termination within 60 days of having first been notified by the Company of such discontinuation, or (2) the Company or its affiliates or sublicensees (A) discontinue all commercially reasonable marketing efforts to sell, and discontinue all sales of, such product or process in such country for nine months or more, (B) fail to resume such commercially reasonable marketing efforts within 120 days of having been notified of such failure by MilanaPharm, (C) fail to reasonably demonstrate a strategic justification for the discontinuation and failure to resume to MilanaPharm, and (D) MilanaPharm gives 90 days’ notice to the Company.

The following is a summary of other terms of the Assignment Agreement, as amended:

Technology Transfer .

Hammock assigned and transferred to the Company all of its right, title and interest in and to the MilanaPharm License Agreement and agreed to cooperate to transfer to the Company all of the data, materials and the licensed technology in its possession pursuant to a technology transfer plan to be agreed upon by the parties, with a goal for the Company to independently practice the licensed intellectual property as soon as commercially practical in order to develop and commercialize the licensed products and processes.

A total of $ 512,500 in fees were payable to Hammock, the final installment of which was $ 137,500 paid in 2020.

Milestone Payments.

The Company will pay Hammock up to $ 1.1 million in the aggregate upon achievement of certain clinical and regulatory development milestones, $ 100,000 of which was paid in 2020 and $ 750,000 of which was paid in 2021.

The remaining milestone does not relate to a bacterial vaginosis product.

The Assignment Agreement will terminate upon the later of (1) completion of the parties' technology transfer plan, and (2) payment to Hammock of the last of the milestone payments.

ADVA-Tec License Agreement

In March 2017, the Company entered into a license agreement with ADVA-Tec, Inc., under which the Company was granted the exclusive right to develop and commercialize Ovaprene for human contraceptive use worldwide.

The Company must use commercially reasonable efforts to develop and commercialize Ovaprene and must meet certain minimum spending amounts per year, including $ 2.5 million per year to cover such activities until a final PMA is filed, or until the first commercial sale of Ovaprene, whichever occurs first.

ADVA-Tec will conduct certain research and development work as necessary to allow the Company to seek a PMA from the FDA and will provide the Company with clinical trial and commercial supplies of Ovaprene, either directly or through a CMO, on commercially reasonable terms.

Under the license agreement, in addition to an exclusive license to ADVA-Tec's and its affiliates' intellectual property rights for all uses of Ovaprene as a human contraceptive device, the Company has a right of first refusal to license these patents and patent applications for additional indications.

The following is a summary of other terms of the ADVA-Tec license agreement:

Milestone Payments.

The Company will pay to ADVA-Tec:

(1) up to $ 14.6 million in the aggregate based on the achievement of specified development and regulatory milestones, $ 200,000 of which was paid in 2021;

and (2) up to $ 20.0 million in the aggregate based on the achievement of certain worldwide net sales milestones.

The remaining development and regulatory milestones include:

the FDA's approval to commence a pivotal clinical trial;

successful completion of such pivotal clinical trial;

the FDA's acceptance of a PMA filing for Ovaprene;

the FDA's approval of the PMA for Ovaprene;

CE Marking of Ovaprene in at least three designated European countries;

obtaining regulatory approval in at least three designated European countries;

and obtaining regulatory approval in Japan.

Royalty Payments .

After the commercial launch of Ovaprene, the Company will pay to ADVA-Tec royalties based on aggregate annual net sales of Ovaprene in specified regions, at a royalty rate that will vary between 1 % and 10 % and will increase based on various net sales thresholds.

Unless earlier terminated, the license the Company received under the agreement continues on a country-by-country basis until the later of the life of the licensed patents or the Company's last commercial sale of Ovaprene.

In addition to customary termination rights for both parties:

(A) the Company may terminate the agreement with or without cause in whole or on a country-by-country basis upon 60 days prior written notice;

and (B) ADVA-Tec may terminate the agreement if the Company develops or commercializes any non-hormonal ring-based vaginal contraceptive device competitive to Ovaprene or if the Company fails to:

(1) in certain limited circumstances, commercialize Ovaprene in certain designated countries within three years of the first commercial sale of Ovaprene;

(2) satisfy the annual spending obligation described above, (3) use commercially reasonable efforts to complete all necessary pre-clinical and clinical studies required to support and submit a PMA, (4) conduct clinical trials as set forth in the development plan to which the Company and ADVA-Tec agree, and as may be modified by a joint research committee, unless such failure is caused by events outside of the Company’s reasonable control, or (5) enroll a patient in the first non-significant risk medical device study or clinical trial as allowed by an institutional review board within six months of the production and release of Ovaprene, unless such failure is caused by events outside of the Company’s reasonable control.

SST License and Collaboration Agreement

In February 2018, the Company entered into a license and collaboration agreement with Strategic Science & Technologies-D, LLC and Strategic Science & Technologies, LLC, referred to collectively as SST, under which the Company received an exclusive, royalty-bearing, sublicensable license to develop and commercialize, in all countries and geographic territories of the world, for all indications for women related to female sexual dysfunction and/or female reproductive health, including treatment of female sexual arousal disorder, or the Field of Use, SST’s topical formulation of Sildenafil Cream, 3.6% as it existed as of the effective date of the agreement, or any other topically applied pharmaceutical product containing sildenafil or a salt thereof as a pharmaceutically active ingredient, alone or with other active ingredients, but specifically excluding any product containing ibuprofen or any salt derivative of ibuprofen, or the Licensed Products.

The following is a summary of other terms of the SST license agreement:

Invention Ownership.

The Company retains rights to inventions made by its employees, SST retains rights to inventions made by its employees, and each party owns a 50 % undivided interest in all joint inventions.

Joint Development Committee.

The parties will collaborate through a joint development committee that will determine the strategic objectives for, and generally oversee, the development efforts of both parties under the agreement.

The Company must use commercially reasonable efforts to develop the Licensed Products in the Field of Use in accordance with a development plan in the agreement, and to commercialize the Licensed Products in the Field of Use.

The Company is responsible for all reasonable internal and external costs and expenses incurred by SST in its performance of the development activities it must perform under the agreement.

Royalty Payments.

SST will be eligible to receive tiered royalties based on percentages of annual net sales of Licensed Products in the single digits to the mid double digits, subject to customary royalty reductions and offsets, and a percentage of sublicense revenue.

Milestone Payments.

SST will be eligible to receive payments (1) ranging from $ 0.5 million to $ 18.0 million in the aggregate on achieving certain clinical and regulatory milestones in the U.S.

and worldwide, and (2) between $ 10.0 million to $ 100.0 million in the aggregate upon achieving certain commercial sales milestones.

If the Company enters into strategic development or distribution partnerships related to the Licensed Products, additional milestone payments would be due to SST.

The Company’s license continues on a country-by-country basis until the later of 10 years from the date of the first commercial sale of such Licensed Product or the expiration of the last valid claim of patent rights covering the Licensed Product in the Field of Use.

Upon expiration (but not termination) of the agreement in a particular country, the Company will have a fully paid-up license under the licensed intellectual property to develop and commercialize the applicable Licensed Products in the applicable country on a non-exclusive basis.

In addition to customary termination rights for both parties:

(1) prior to receipt of approval by a regulatory authority necessary for commercialization of a Licensed Product in the corresponding jurisdiction, including NDA approval, the Company may terminate the agreement without cause upon 90 days prior written notice;

(2) following receipt of approval by a regulatory authority necessary for commercialization of a Licensed Product in the corresponding jurisdiction, including NDA approval, the Company may terminate the agreement without cause upon 180 days prior written notice;

and (3) SST may terminate the agreement with respect to the applicable Licensed Product(s) in the applicable country(ies) upon 30 days’ notice if the Company fails to use commercially reasonable efforts to perform development activities in substantial accordance with the development plan and do not cure such failure within 60 days of receipt of SST's notice thereof.

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

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

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The Company is entitled to sublicense the rights granted to it under this agreement.

The Company paid a $ 250,000 non-creditable upfront license fee to Catalent in connection with the execution of the agreement.

Annual Maintenance Fee.

The Company will pay an annual license maintenance fee to Catalent on each anniversary of the date of the agreement, the amount of which will be $ 50,000 for the first two years and $ 100,000 thereafter, and which will be creditable against royalties and other payments due to Catalent in the same calendar year but may not be carried forward to any other year.

The Company made the first payments in April 2019.

Milestone Payments.

The Company must make potential future development and sales milestone payments of (1) up to $ 13.5 million in the aggregate upon achieving certain clinical and regulatory milestones, $ 1.0 million of which became payable in the third quarter of 2021, and in accordance with the license agreement, the amount was offset by the $ 100,000 annual maintenance fee, resulting in a net amount of $ 900,000 paid during the third quarter of 2021, and (2) up to $ 30.3 million in the aggregate upon achieving certain commercial sales milestones for each product or process covered by the licenses granted under the agreement.

Royalty Payments .

During the royalty term, the Company will pay Catalent mid-single-digit to low double-digit royalties based on worldwide net sales of products and processes covered by the licenses granted under the agreement.

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.

The royalty term, which is determined on a country-by-country basis and product-by-product basis (or process-by-process basis), begins with the first commercial sale of a product or process in a country and terminates on the latest of (1) the expiration date of the last valid claim within the licensed patent rights with respect to such product or process in such country, (2) 10 years following the first commercial sale of such product or process in such country, and (3) when one or more generic products for such product or process are commercially available in such country, except that if there is no such generic product by the 10th year following the first commercial sale in such country, then the royalty term will terminate on the 10-year anniversary of the first commercial sale in such country.

The Company must use commercially reasonable efforts to develop and make at least one product or process available to the public, which efforts include achieving specific diligence requirements by specific dates specified in the agreement.

Unless earlier terminated, the term of the agreement will continue on a country-by-country basis until the later of (1) the expiration date of the last valid claim within such country, or (2) 10 years from the date of first commercial sale of a product or process in such country.

Upon expiration (but not early termination) of the agreement, the licenses granted thereunder will convert automatically to fully-paid irrevocable licenses.

Catalent may terminate the agreement (1) upon 30 days’ notice for the Company’s uncured breach of any payment obligation under the agreement, (2) if the Company fails to maintain required insurance, (3) immediately upon the Company’s insolvency or the making of an assignment for the benefit of the Company’s creditors or if a bankruptcy petition is filed for or against the Company, which petition is not dismissed within 90 days, or (4) upon 60 days’ notice for any uncured material breach by the Company of any of the Company’s other obligations under the agreement.

The Company may terminate the agreement on a country-by-country basis for any reason by giving 180 days’ notice (or 90 days’ notice if such termination occurs prior to receipt of marketing approval in the United States).

If Catalent terminates the agreement for the reason described in clause (4) above or if the Company terminates the agreement, Catalent will have full access including the right to use and reference all product data generated during the term of the agreement that is owned by the Company.

Adare Development and Option Agreement

In March 2018, the Company entered into an exclusive development and option agreement with Adare Pharmaceuticals (formerly known as Orbis Biosciences, and which the Company refers to as Adare), for the development of long-acting injectable etonogestrel contraceptive with 6- and 12-month durations (now known as

ADARE-204 and ADARE-214, respectively).

The agreement provides the Company with an option to negotiate an exclusive license agreement for the programs if the Company funds the conduct of specified development work by Adare.

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.

At the closing of the acquisition, the Company issued an aggregate of approximately 3.0 million shares of its common stock to the holders of shares of MBI's capital stock outstanding immediately prior to the effective time of the merger.

The transaction was valued at $ 2.4 million, based on the fair value of the approximately 3.0 million shares issued at $ 0.79 per share, which was the closing price per share of the Company's common stock on the date of closing.

The shares were issued in exchange for MBI's cash and cash equivalents of $ 6.1 million, less net liabilities of $ 3.5 million and transaction costs of $ 202,000 , which was allocated based on the relative fair value of the assets acquired and the liabilities assumed.

The Company also agreed to pay the following additional consideration to the former MBI stockholders:

(a) up to $ 46.5 million contingent upon the achievement of specified funding, product development and regulatory milestones;

(b) up to $ 55.0 million contingent upon the achievement of specified amounts of aggregate net sales of products incorporating the intellectual property acquired by the Company in the merger;

(c) tiered royalty payments ranging from low single-digit to low double-digit percentages of annual net sales of such products, subject to customary provisions permitting royalty reductions and offset;

and (d) a percentage of sublicense revenue related to such products.

The Company agreed to use commercially reasonable efforts to achieve specified development and regulatory objectives relating to DARE-LARC1.

In June 2021, a total of $ 1.25 million of that potential additional consideration became payable upon the achievement of certain of the funding and product development milestone events, $ 1.0 million of which was recorded as contingent consideration on the Company's consolidated balance sheets upon the completion of the MBI acquisition and $ 250,000 of which was expensed in 2021.

In July 2021, the Company’s board of directors elected to make these milestone payments in shares of the Company’s common stock, to the extent permissible under the terms of the merger agreement with MBI, and, in September 2021, the Company issued approximately 700,000 shares of its common stock to former stockholders of MBI and paid $ 75,000 in cash to the stockholders’ representative in accordance with the terms of the merger agreement in satisfaction of the $ 1.25 million in milestone payments associated with milestones achieved in June 2021.

Pear Tree Acquisition

In May 2018, the Company completed its acquisition of Pear Tree Pharmaceuticals, Inc., or Pear Tree.

The Company acquired Pear Tree to secure the rights to develop a proprietary vaginal formulation of tamoxifen, now known as DARE-VVA1, as a potential treatment for vulvar and vaginal atrophy.

Milestone Payments .

The Company must make contingent payments to the Pear Tree former stockholders or their representatives, or the Holders, that become payable upon achievement of specified clinical, regulatory and commercial milestones, which may be paid, in the Company’s sole discretion, in cash or shares of the Company’s common stock.

Royalty Payments .

The Holders will be eligible to receive, subject to certain offsets, tiered royalties, including customary provisions permitting royalty reductions and offset, based on percentages of annual net sales of certain products subject to license agreements the Company assumed and a percentage of sublicense revenue.

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

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.

PREPAID EXPENSES

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Prepaid insurance, long-term portion $ — $ 87,891

Other non-current assets 115,092 —

Deferred financing costs 139,203 143,002

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As of December 31,

Accrued compensation and benefits expenses $ 1,533,475 $ 1,157,074

Accrued legal and professional expenses 293,688 297,395

Accrued license expense 66,667 66,667

Accrued clinical and related expenses 1,242,414 1,838,582

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

VENDOR CONCENTRATION

The Company had a major vendor that accounted for approximately 23 % and 20 % of the research and development expenditures for one of the Company's late-stage product candidates for the years ended December 31, 2021 and 2020, respectively.

The same vendor also accounted for approximately 4 % and 23 % of the total accounts payable and vendor-related accrued expenses as of December 31, 2021 and 2020, respectively.

The Company continues to maintain this vendor relationship and anticipates incurring significant expenses with this vendor over the next 12 months.

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.

The components of loss from continuing operations before provision for income taxes consists of the following (in thousands):

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State income tax, net of federal benefit ( 2.96 ) % 9.64 %

State tax rate change ( 9.08 ) % — %

Permanent differences ( 0.02 ) % 0.19 %

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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 Leerink LLC to sell shares of its common stock from time to time through an "at-the-market," or ATM, equity offering program under which SVB Leerink acts as the Company's agent.

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 this sales agreement, and any subsequent prospectus supplement filed with the SEC related to this ATM equity offering program.

During 2021, the Company sold approximately 7.1 million shares of common stock under this agreement for gross proceeds of approximately $ 16.3 million and incurred offering expenses of approximately $ 537,000 .

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 Leerink to sell shares of its common stock from time to time through an ATM equity offering program under which SVB Leerink acts as the Company's agent.

Under the sales agreement, the Company may issue and sell up to $50.0 million of shares of its common stock.

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.

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During 2021, the Company sold approximately 26.0 million shares of common stock under this agreement for gross proceeds of approximately $ 46.9 million and incurred offering expenses of approximately $ 1.6 million.

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

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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.

In March 2021, the Company provided notice to Wainwright to terminate the agreement, and the agreement terminated in April 2021.

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.

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 .

March 2021, the Company provided notice to Wainwright to terminate the agreement, and the agreement terminated in April 2021.

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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, and as of December 31, 2021 there were no unamortized costs.

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 .

Those costs were amortized and expensed as shares were sold under the Purchase Agreement.

As of December 31, 2021, the Company had sold and Lincoln Park had purchased a total of $ 15.0 million of the Company's common stock under the Purchase Agreement, and no more shares of common stock may be sold by the Company to Lincoln Park under the Purchase Agreement.

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

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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 2021, warrants to purchase an aggregate of 520,985 shares of common stock were exercised for gross proceeds of approximately $ 0.5 million.

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.

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1,374,515 $ 0.96 02/15/2023

The authorized capital of the Company consists of 120,000,000 shares of common stock with a par value of $ 0.0001 and 5,000,000 shares of preferred stock with a par value of $ 0.01 per share.

The 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.

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Common stock reserved for issuance upon exercise of options outstanding 6,612,554

Common stock reserved for future equity awards (under the Amended 2014 Plan) 201,855

Common stock reserved for future equity awards 9,576,581

Total 17,570,150

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The number of authorized shares increases annually on the first day of each fiscal year until, and including, the fiscal year ending December 31, 2024 by the least of (i) 2,000,000 , (ii) 4 % of the number of outstanding shares of common stock on such date, or (iii) an amount determined by the Company’s board of directors.

As a result of the foregoing, the number of shares available under the Amended 2014 Plan increased by 1,663,850 to 2,168,366 on January 1, 2021, which increase represented 4 % of the number of outstanding shares of common stock on such date.

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 Amended 2014 Plan and related information for the years ended December 31, 2021 and 2020.

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, 2021, 201,855 shares of common stock were available for future award grants under the Amended 2014 Plan.

As of December 31, 2022, 9,576,581 shares of common stock were available for future award grants under the 2022 Plan.

Outstanding at December 31, 2020 2,786,591 $ 1.16

1,889,775 $ 1.21

Granted 2,052,075 2.31

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Options vested and expected to vest at December 31, 2022 6,612,554 $ 1.60 7.82 $ 41,679

(1) Includes 10,149 shares subject to options granted under an equity incentive plan assumed in connection with an acquisition.

Compensation Expense

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Expected volatility 121 % 122 %

Forfeiture rate 0.0 % 0.0 %

Dividend yield 0.0 % 0.0 %

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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.

(See Note 14, Subsequent Events.)

MBI, a wholly owned subsidiary the Company acquired in November 2019, leases general office space in Lexington, Massachusetts and warehouse space in Billerica, Massachusetts.

The Lexington lease commenced on July 1, 2013.

In February 2022, the Company entered into an amendment to extend the term of the lease for three years such that the term now expires on December 31, 2025.

(See Note 14, Subsequent Events.) The Billerica lease commenced on October 1, 2016 and terminates on March 31, 2022.

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.

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.

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The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of the lease within a particular currency environment.

The Company uses an incremental borrowing rate of 7 % for operating leases that commenced prior to January 2019 (and all of the Company's operating leases commenced prior to such date).

The 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, 2021, the Company reported operating lease right of use assets of approximately $ 216,700 in other non-current assets and approximately $ 270,500 in current liabilities on the consolidated balance sheet.

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 $ 462,000 for the year ended December 31, 2021, and these amounts are included in operating activities in the consolidated statements of cash flows.

Further, at December 31, 2021, operating leases had a weighted average remaining lease term of 0.56 years.

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:

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2023 $ 422,000

2024 $ 93,000

Total future minimum lease payments 515,000

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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 contractor Health Decisions Inc., a contract research organization, providing clinical coordination and data collection and management services for 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.

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NICHD will be responsible for the other costs related to the conduct of the Ovaprene Phase 3.

In 2021, in accordance with the payment schedule under the CRADA, the Company made aggregate payments of $ 1.5 million of the total amount payable to NICHD.

In accordance with the payment schedule under the CRADA, the Company made aggregate

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.

Contingent Consideration

As discussed in Note 3 above, in connection with the acquisition of MBI, the Company agreed to pay additional consideration of up to $ 46.5 million to the former stockholders of MBI contingent upon the achievement of specified funding, product development and regulatory milestones.

In June 2021, a total of $1.25 million of that potential additional consideration became payable upon the achievement of certain of the funding and product development milestone events, $ 1.0 million of which was previously recorded as contingent consideration on the Company's consolidated balance sheets upon the completion of the MBI acquisition and $250,000 of which was

expensed in 2021.

In July 2021, the Company’s board of directors elected to make these milestone payments in shares of the Company’s common stock, to the extent permissible under the terms of the merger agreement with MBI, and, in September 2021, the Company issued approximately 700,000 shares of its common stock to former stockholders of MBI and paid $75,000 to the stockholders’ representative in accordance with the terms of the merger agreement in satisfaction of the $1.25 million in milestone payments associated with milestones achieved in June 2021.

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, or the PPP, of the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, administered by the U.S.

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.

Under the terms of the PPP, the loan proceeds could be used for "qualifying expenses" and, subject to specified limitations in the CARES Act and under the terms of the PPP, certain amounts of the loan, including accrued interest, may be forgiven if used for qualifying expenses.

In January 2021, the Company was notified that the principal balance of its PPP loan and all accrued interest, which together totaled $ 369,887 , were fully forgiven by 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.

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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 and DARE-LARC1.

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.

Since 2018, the Company has received approximately $ 1.9 million of non-dilutive grant funding from NICHD for clinical development efforts supporting Ovaprene.

The final notice of award the Company received was for approximately $ 731,000 in April 2020, all of which has been funded to date.

The Company recorded credits to research and development expense for costs related to the NICHD award of an immaterial amount the year ended December 31, 2021, and approximately $ 595,000 for the year ended December 31, 2020.

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.

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.

In August 2020, the Company received a notice of award of a grant from NICHD to support the development of DARE-PTB1.

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There is no guarantee the Company will receive any Phase II award.

The Company recorded credits to research and development expense for costs related to the NICHD award of approximately $ 65,000 for the year ended December 31, 2021.

At December 31, 2021, the Company recorded a receivable of approximately $ 9,600 for expenses incurred through such date that it believes are eligible for reimbursement under the grant.

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.

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 to occur during the period of September 2021 through August 2022.

The Company recorded credits to research and development expense of approximately $ 7,400 for costs related to the NICHD award during the year ended December 31, 2021.

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.

DARE-LARC1 Non-Dilutive Grant Funding

MBI Grant Agreement

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 June 30, 2021.

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 payments under this agreement of approximately $ 2.5 million in 2020.

At December 31, 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 will be received under this agreement.

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, or the 2021 DARE-LARC1 Grant Agreement, under which the Company was awarded up to $ 48.95 million to support the development of DARE-LARC1.

The 2021 DARE-LARC1 Grant Agreement will support technology development and preclinical activities over the period of June 30, 2021 to November 1, 2026, to advance DARE-LARC1 in nonclinical proof of principle studies.

The Company received an initial payment of $ 11.45 million in July 2021.

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

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.

At December 31, 2021, approximately $ 10.5 million of deferred grant funding liability under this agreement was recorded in the Company's consolidated balance sheet.

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.

SUBSEQUENT EVENTS

Exclusive License Agreement with Organon to Commercialize XACIATO

On March 31, 2022, the Company entered into an exclusive license agreement with Organon pursuant to which Organon will obtain exclusive worldwide rights to develop, manufacture and commercialize XACIATO and other future intravaginal or urological products for human use formulated with clindamycin that rely on intellectual property controlled by the Company.

Under the agreement, the Company will receive a $ 10.0 million non-refundable and non-creditable payment following the effective date of the agreement and will be entitled to receive tiered double-digit royalties based on net sales and up to $ 182.5 million in milestone payments as follows:

$ 2.5 million following the first commercial sale of a licensed product in the United States;

and up to $ 180.0 million in tiered commercial sales milestones and regulatory milestones.

Royalty payments will be subject to customary reductions and offsets.

The royalty period for each licensed product will continue on a country-by-country basis from the first commercial sale of the licensed product in the country until the expiration of the later of (i) the date that no valid patent claim would be infringed in the absence of the license granted under the agreement by the sale of the licensed product in the country, (ii) 10 years after the end of the month in which the first commercial sale of the licensed product in the country occurred, and (iii) the expiration of regulatory market exclusivity for the licensed product in that country.

Under the agreement, the Company will be responsible for regulatory interactions and for providing product supply on an interim basis until Organon assumes such responsibilities.

The effective date of the agreement will occur following the satisfaction of closing conditions that include receipt of all applicable approvals, or the expiration or termination of all applicable waiting periods, required under applicable antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

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.

The agreement includes customary representations and warranties, covenants and indemnification obligations of each party.

In addition, the terms of the agreement provide Organon exclusive worldwide rights of first negotiation for specified potential future products of the Company.

Leased Properties

On February 4, 2022, the Company entered into an amendment to extend the term of the lease for its corporate headquarters in San Diego, California for two years .

The extended term begins August 1, 2022 and expires August 31, 2024.

On February 14, 2022, the Company entered into an amendment to extend the term of the lease for its office space in Lexington, Massachusetts for three years .

The extended term begins October 1, 2022 and expires December 31, 2025.

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).

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures