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Item 7. Management’s Discussion and Analysis

2026-03-26 compared with 2025-03-31 · 238 added, 257 removed, 208 unchanged (70% of the section changed)

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Business Overview

We are a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority.

We exist to accelerate innovation in women’s health and we believe that innovation does not have to start from scratch.

With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting, but access to real, evidence-based solutions still lags behind.

We continuously hear from healthcare providers, researchers, and women themselves about the urgent need for access to evidence-based treatment options.

Our goal is to fulfill that need by bringing to market as soon as practicable innovative evidence-based treatment solutions that address decades of unmet needs in women’s health and enhance outcomes and convenience, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause - areas in women's health that we believe represent compelling and meaningful market opportunities.

The needed medical treatment solutions we aim to bring to market will primarily be available only with a physician’s prescription – either as an FDA-approved product or as a compounded drug under Section 503B of the FDCA.

We may also bring to market consumer health products that can be obtained without a physician’s prescription.

As discussed in more detail below, we are taking action to utilize 503B compounding to bring our

proprietary Sildenafil Cream formulation to market, and we are targeting to make it available in the fourth quarter of 2025.

See “—Recent Events—Bringing Sildenafil Cream to Market under Section 503B.”

The first FDA-approved product to emerge from our portfolio is XACIATO.

We achieved FDA approval of XACIATO three years after acquiring rights to the program.

In 2022, we entered into an agreement with Organon, whereby Organon licensed exclusive worldwide rights to develop, manufacture and commercialize XACIATO.

Organon commenced U.S.

marketing of XACIATO in the fourth quarter of 2023 and, in January 2024, Organon announced that XACIATO was available nationwide.

As discussed below, to provide funding for the development of the product candidates in our pipeline, in April 2024, we entered into an agreement with XOMA whereby we sold our rights to all royalty and potential milestone payments based on net sales of XACIATO under our agreement with Organon, net of our obligations to certain third parties, until XOMA receives a specified return on its investment, after which we will share equally in the royalty and milestone payments earned on net sales of XACIATO from Organon.

Our product pipeline includes diverse programs that target unmet needs in women's health in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause, and aim to expand treatment options, enhance outcomes and improve ease of use for women.

We are primarily focused on progressing the development of our existing portfolio of product candidates.

However, we also explore opportunities to expand our portfolio and commercial offerings by leveraging assets to which we hold rights or obtaining rights to new assets, with continued focus solely on women's health.

Our current portfolio includes five product candidates in advanced clinical development (Phase 2-ready to Phase 3):

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

• Sildenafil Cream, 3.6% , a proprietary cream formulation of sildenafil for topical administration to the female genitalia on demand for the treatment of female sexual arousal disorder (FSAD);

• DARE-HRT1 , an intravaginal ring designed to deliver combination menopausal hormone therapy, bio-identical 17β-estradiol and progesterone together, continuously over a 28-day period, for the treatment of moderate-to-severe VMS, also known as hot flashes;

• DARE-VVA1 , a proprietary formulation of tamoxifen for intravaginal administration being developed as a hormone-free alternative to estrogen-based therapies for the treatment of moderate-to-severe dyspareunia, or pain during sexual intercourse, a symptom of GSM (formerly called VVA);

• DARE-HPV , a proprietary, fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert, which we plan to develop for the treatment of genital HPV infection in women, treatment of CIN (also known as cervical dysplasia), and other HPV-related pathologies.

Our portfolio also includes six product candidates in Phase 1 clinical development or that we believe are Phase 1-ready:

• DARE-PDM1, a proprietary hydrogel formulation of diclofenac, a nonsteroidal anti-inflammatory drug, for vaginal administration as a treatment for primary dysmenorrhea;

• Casea S , an investigational biodegradable contraceptive implant designed to control release of etonogestrel for a set period of time (18-24 months) before dissolving;

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

• DARE-FRT1 , an intravaginal ring designed to deliver bio-identical progesterone continuously for up to 14 days for luteal phase support as part of an in vitro fertilization treatment plan;

• DARE-PTB1 , an intravaginal ring designed to deliver bio-identical progesterone continuously for up to 14 days for the prevention of preterm birth.

In addition, our portfolio includes the following preclinical stage programs:

• 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;

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

• DARE-PTB2 , a novel approach for the prevention and treatment of idiopathic preterm birth through inhibition of a stress response protein.

We are a purpose-driven health biotech company solely focused on closing the gap in women's health between promising science and real-world solutions.

Every innovation we advance is based in advanced science and backed by rigorous, peer-reviewed research.

From contraception to menopause, pelvic pain to fertility, vaginal health to infectious disease, we’re working to close critical gaps in care using science that serves her needs.

In March 2025, we announced an expansion of our business model to include a dual-path approach to bringing new products to market.

For select proprietary formulations, we are pursuing both traditional FDA approval

and earlier market access via Section 503B compounding.

We believe this strategy allows us to respond to clinician and patient demand for timely access while continuing to generate the data necessary to seek FDA approval and support long-term value creation.

In addition to prescription-based offerings — both FDA-approved products and compounded drugs— we intend to bring to market select consumer health products that do not require a physician’s prescription, where appropriate based on product profile and market opportunity.

Section 503B Compounding

Our proprietary topical cream formulation of sildenafil is our first product to market under Section 503B.

The compounded drug is branded as DARE to PLAY Sildenafil Cream and became available for pre-order fulfillment by prescription in the U.S.

in December 2025.

Prescription fulfillment and payment will occur once the product is available for pharmacy dispensing.

We expect pharmacy dispensing to commence, and to begin recording revenue from sales of DARE to PLAY in the second quarter of 2026.

Because we are in the early stages of executing against our Section 503B compounding strategy and, as an organization, we have no experience in or infrastructure for commercializing products, the amount of potential revenue we may generate during 2026 remains uncertain.

We invested approximately $1.0 million to launch DARE to PLAY in 2025, which has been utilized to support a 503B-registered outsourcing facility with technology-transfer activities specific to DARE to PLAY, activate an awareness campaign, and facilitate access to DARE to PLAY as an option for providers and women.

We are also taking action to bring our estradiol progesterone intravaginal ring to market under Section 503B.

The compounded product will be branded as DARE to RECLAIM.

We are targeting to have DARE to RECLAIM available in early 2027.

There are no FDA-approved products that provide estradiol and progesterone together in a non-oral monthly form.

"BUSINESS," in Part I of this report for additional information regarding our Section 503B compounding strategy.

Consumer Health Products - DARE to RESTORE

The first product in our DARE to RESTORE vaginal probiotic suppositories product line, Flora Sync LF5, is expected to become commercially available in the U.S in the second quarter of 2026.

"BUSINESS," in Part I of this report for additional information regarding our consumer health products strategy.

Our Pipeline:

Clinical Stage and Pre-Clinical Stage Programs

Our product candidates are in various stages of development, from pre-clinical through a pivotal Phase 3 clinical study, and will require review and approval from the FDA, or a comparable foreign regulatory authority, prior to being marketed and sold.

The most clinically advanced product candidates we are developing are:

Ovaprene®, an investigational, hormone-free, monthly intravaginal contraceptive currently being evaluated in a pivotal Phase 3 clinical study.

Sildenafil Cream, 3.6%, or Sildenafil Cream, an investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical administration for the treatment of female sexual arousal disorder, or FSAD;

DARE-HRT1, an intravaginal ring designed to deliver combination menopausal hormone therapy, bio-identical 17β-estradiol and progesterone together, continuously over a 28-day period for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes;

DARE-VVA1, an investigational formulation of tamoxifen in a soft gelatin capsule for intravaginal administration as a hormone-free alternative to estrogen-based therapies for the treatment of moderate-to-severe dyspareunia, or pain during sexual intercourse;

and DARE-HPV, an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment of genital human papillomavirus (HPV) infection in women as well as treatment of cervical intraepithelial neoplasia (also known as cervical dysplasia), and other HPV-related pathologies.

"BUSINESS," in Part I of this report for additional information regarding our product candidates.

Our primary operations consist of research and development activities to advance our portfolio of product candidates through late-stage clinical development and/or regulatory approval.

During 2025, we are also taking action to bring our proprietary Sildenafil Cream formulation to market under Section 503B of the FDCA.

Until we secure additional capital to fund our operating needs, we will focus our resources primarily on advancement of Ovaprene.

In addition, we expect to incur significant research and development expenses for the DARE-LARC1 and DARE-HPV programs, but we also expect such expenses will be supported by non-dilutive funding, with respect to DARE-LARC1, through at least 2026, and with respect to DARE-HPV, through October 2026.

The first FDA-approved product to emerge from our portfolio is XACIATO® (clindamycin phosphate) vaginal gel 2%, or XACIATO (pronounced zah-she-AH-toe).

XACIATO was approved by the FDA in December 2021, three years after we acquired rights to the program, as a single-dose prescription medication for the treatment of bacterial vaginosis in females 12 years of age and older.

In 2022, we licensed exclusive worldwide rights to develop,

manufacture and commercialize XACIATO to Organon.

In January 2024, Organon announced that XACIATO was available nationwide in the U.S.

In April 2024, we sold our rights to all royalty and potential milestone payments based on net sales of XACIATO under our agreement with Organon to XOMA.

See Note 3 “Strategic Agreements” and Note 13 “Royalty Purchase Agreements” to the consolidated financial statements included in this report for information regarding our exclusive license agreement with Organon and our royalty purchase agreements with XOMA, respectively.

Our primary operations consist of research and development activities to advance our portfolio of product candidates through late-stage clinical development and/or regulatory approval, and commercialization activities for the 503B and consumer health products we seek to bring to market.

Until we secure additional capital to fund our operating needs, we will focus our research and development resources primarily on advancement of Ovaprene.

In addition, we expect to incur significant research and development expenses for the DARE-LARC1 and DARE-HPV programs, but we also expect such expenses will be supported by non-dilutive funding, with respect to DARE-LARC1, through December 2027, and with respect to DARE-HPV, through October 2026.

See Note 15, "Grant Awards" to the accompanying consolidated financial statements for additional information.

We do not have sales, marketing or distribution infrastructure, and currently, we do not intend to build our own sales force or marketing and distribution infrastructure.

However, reflecting the shift in our business model, we have been and will be allocating resources to support commercial execution activities, including entering into and maintaining relationships with 503B-registered outsourcing facilities, dispensing pharmacies, telehealth providers and other third parties to help bring our proprietary formulations to market.

As discussed below, we will need to raise substantial additional capital to continue to fund our operations and execute our current business strategy.

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Recent Events

Bringing Sildenafil Cream to Market under Section 503B

We are taking action to bring our proprietary Sildenafil Cream formulation to market under Section 503B of the FDCA, and we expect to begin recording revenue from sales therefrom, in the fourth quarter of 2025.

“BUSINESS–503B Compounding” in Part I of this report for additional information.

Bringing our proprietary Sildenafil Cream formulation to market under Section 503B is part of our dual-path approach to bring some of our proprietary formulations to market as soon as practicable because we believe women should not have to wait for a needed solution while we continue to pursue FDA approval of our product candidates.

In parallel, we will continue to pursue FDA approval of Sildenafil Cream as a treatment for FSAD.

Bringing our proprietary Sildenafil Cream formulation to market via 503B compounding will not impact the regulatory process or commercial opportunity for an FDA-approved Sildenafil Cream product.

Rather, if successful, 503B compounding will be a source of revenue from existing assets that is non-dilutive to our stockholders.

To bring our proprietary Sildenafil Cream formulation to market under Section 503B, among other things, we will need to successfully identify and enter into satisfactory arrangements with one or more 503B-registered outsourcing facilities, and we intend to focus our resources on provider-to-provider education about disease state and our proprietary Sildenafil Cream formulation, leveraging online resources, including web-based ordering platforms and collaborations with telehealth platforms and providers.

We anticipate needing to invest no more than $1.0 million to support a 503B-registered outsourcing facility with technology-transfer activities specific to our Sildenafil Cream formulation, activate an awareness campaign, and facilitate access to our proprietary Sildenafil Cream formulation as an option for providers and women.

We are targeting the second quarter of 2025 to provide an update on the strategic partnerships to achieve these objectives.

Noncompliance with Nasdaq’s Minimum Market Value of Listed Securities Requirement

On August 12, 2024, we received a letter from The Nasdaq Stock Market LLC, or Nasdaq, notifying us that we do not meet the requirement in Nasdaq Listing Rule 5550(b)(2) for continued listing on The Nasdaq Capital Market.

Nasdaq Listing Rule 5550(b)(2) requires a company listed on Nasdaq to maintain a minimum market value of listed securities of $35.0 million, which we refer to as the Minimum MVLS Rule.

We were provided an initial period of 180

calendar days, or until February 10, 2025, to regain compliance with the Minimum MVLS Rule.

On February 13 , 2025, Nasdaq’s Listing Qualifications Department notified us that because the we did not regain compliance with the Minimum MVLS Rule by February 10, 2025, our common stock is subject to delisting from Nasdaq unless we timely requests a hearing before the Nasdaq Hearing Panel, or the Panel.

On February 20, 2025, we requested a hearing before the Panel, which request stayed the delisting of our common stock pending the decision of the Panel following the hearing and the expiration of any extension period that may be granted by the Panel.

The hearing occurred on March 25, 2025.

Pursuant to published Nasdaq guidance, the Panel typically issues its decision within 30 days of the hearing.

There can be no assurance that the Panel will grant us any extension period within which to regain compliance with the Minimum MVLS Rule, or if any extension period is granted, that we will regain compliance with the Minimum MVLS Rule within such extension period, or that we will be successful in otherwise maintaining the listing of our common stock on The Nasdaq Capital Market.

See the risk factor titled, If we fail to regain and maintain compliance with the continued listing requirements of The Nasdaq Capital Market, our common stock could be suspended and delisted, which could, among other things, limit demand for our common stock, substantially impair our ability to raise additional capital and have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock , under "Risks Related to Our Securities" in ITEM 1A .

RISK FACTORS of this report .

NICHD Performance under the CRADA for the Pivotal Phase 3 Study of Ovaprene

“BUSINESS– Our Pipeline:

Clinical-Stage Programs– Ovaprene®– Pivotal Phase 3 Clinical Study” in Part I of this report for a discussion of the impact of executive orders and other actions taken by the new U.S.

presidential administration in the first quarter of 2025 on the Phase 3 clinical study of Ovaprene and NICHD’s ability to carry out its responsibilities under the CRADA.

Theramex Co-Development and Licensing Agreement

“BUSINESS– Strategic Agreements for Pipeline Development– Theramex Co-Development and License Agreement” in Part I of this report for a discussion of the agreement we entered into with Theramex in February 2025.

Receipt of Grant Funding Installment to Support DARE-LARC1

In December 2024, we received a payment of $2.5 million as the latest installment under a grant to advance the development of our investigational contraceptive DARE-LARC1 in nonclinical proof-of-principle studies and other IND-enabling work to allow for the submission of an IND application with the FDA, approval of which will be required to commence testing in humans.

Under the terms of the grant agreement, we may receive a total of up to approximately $49.0 million to support nonclinical development of DARE-LARC1.

As of the filing date of this report, we had received a cumulative total of approximately $31.8 million of such total potential amount under the grant agreement.

Additional payments are conditioned on the program meeting specified development and reporting milestones.

See Note 15, "Grant Awards- Other Non-Dilutive Grant Funding- 2021 DARE-LARC1 Grant Agreement" to the accompanying consolidated financial statements for additional information regarding the grant agreement.

Non-Dilutive Funding Awards for DARE-HPV

In December 2024, we received a notice of award from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the NIH, that we were awarded a $1.0 million grant in support of non-clinical activities for the development of DARE-HPV for an initial project year of December 2024 through November 2025, and that an additional $1.0 million was recommended for a subsequent year, subject to the availability of funds and satisfactory progress of the project, as determined by NIAID.

In October 2024, we entered into a subaward agreement with National Collegiate Inventors and Innovators Alliance, Inc.

d/b/a VentureWell under which we are entitled to receive up to $10.0 million in milestone-based payments subject to our achievement of specified research activities and objectives relating to advancement of our DARE-HPV program, including commencement of a Phase 2 clinical study to evaluate the safety and preliminary efficacy of DARE-HPV for the clearance of high-risk HPV infection in women, over an approximately 24-month period ending in October 2026.

We anticipate that more than half of the award amount will become payable to us during the first 12 months of the performance period under the subaward agreement.

To date, we have received payments totaling $2.5 million.

The subaward agreement was the result of our selection as an awardee by an agency within the HHS.

Grant Agreement to Support the Ovaprene Phase 3 Study and Identification & Development of a New Non-Hormonal Contraceptive Candidate

In November 2024, we entered into a grant agreement with the Foundation, under which we were awarded a new grant of up to approximately $10.7 million to support (i) expansion of the number of study sites in the ongoing Phase 3 clinical trial of Ovaprene, and (ii) activities that will aid in the identification and development of a novel non-hormonal intravaginal contraceptive candidate, suitable for and acceptable to women in low- and middle-income country settings who need or would prefer to use such a product to avoid an unplanned pregnancy.

We received an initial payment under the grant agreement of approximately $5.4 million in November 2024.

Additional payments are contingent upon our achievement of specified development and reporting milestones during the term of the grant agreement, which extends through October 2026.

See Note 15, "Grant Awards--Other Non-Dilutive Grant Funding--2024 Contraceptive Product Candidate Grant Agreement" to the accompanying financial statements for additional information regarding the grant agreement.

In October 2024, we entered into a purchase agreement and registration rights agreement with Lincoln Park Capital Fund, LLC, or Lincoln Park.

Under the terms and subject to the conditions of the purchase agreement, we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $15.0 million in shares of our common stock.

Such sales of our common stock to Lincoln Park, if any, will be subject to certain limitations, and may occur from time to time, at our sole discretion, over the 24-month period commencing on November 27, 2024, which we refer to as the Commencement Date.

From time to time after the Commencement Date, at our sole discretion, on any business day selected by us on which the closing sale price of our common stock is not below $0.50 per share, we may direct Lincoln Park to purchase up to 30,000 shares of our common stock (or up to 35,000 and 40,000 shares if the closing sale price of our common stock on the day on which we initiate a purchase is not below $5.00 or $7.50, respectively, subject to customary adjustments for stock splits and similar transactions) at a purchase price equal to the lower of (i) the lowest sale price of our common stock on the business day on which we initiate the purchase and (ii) the average of the three lowest closing sale prices of our common stock during the 10-business day period immediately preceding the business day on which we initiate the purchase.

However, Lincoln Park’s maximum commitment in any single purchase may not exceed $500,000.

In addition, we may also direct Lincoln Park to purchase other amounts of common stock as accelerated purchases and as additional accelerated purchases, subject to limits specified in the purchase agreement, at a purchase price per share calculated as specified in the purchase agreement, but in no case lower than the minimum price per share we stipulate in our notice to Lincoln Park initiating these purchases.

In addition, under applicable Nasdaq rules, we may not issue or sell to Lincoln Park under the purchase agreement more than 1,711,172 shares of our common stock, which we refer to as the Exchange Cap, unless (i) we obtain stockholder approval to issue shares in excess of the Exchange Cap or (ii) the average price of all applicable sales of our common stock to Lincoln Park under the equity line agreement equals or exceeds $3.59 per share (which represents the lower of (A) the official closing price per share of our common stock on Nasdaq immediately preceding the signing of the purchase agreement and (B) the average official closing price of our common stock on Nasdaq for the five consecutive trading days ending on the trading day immediately preceding the date of the purchase agreement).

We may also not sell shares to Lincoln Park under the purchase agreement if it would result in Lincoln

Park beneficially owning more than 4.99% of our then outstanding shares of common stock, which limitation we refer to as the beneficial ownership cap.

Lincoln Park, upon written notice to us, may increase the beneficial ownership cap to up to 9.99%.

Any increase in the beneficial ownership cap will not be effective until the 61st day after such written notice is delivered to us.

In connection with entering into the purchase agreement, we issued 137,614 shares of our common stock to Lincoln Park in consideration for its commitment to purchase shares thereunder.

Government Policy and Funding and Regulatory Uncertainty

There may be significant future effects on the women's health sector and the pharmaceutical and biopharmaceutical industries as a result of federal policy and regulatory changes under the new U.S.

Receipt of Payment Under October 2024 Grant Award

In February 2026, we received a $2.0 million payment from CMF under the agreement we entered into with CMF in October 2024 to support the development of DARE-HPV.

For a discussion of this agreement, see Note 15, "Grant Awards" to the accompanying consolidated financial statements for additional information.

Taking into account this payment, we have received a cumulative total of approximately $7.5 million of the up to $10.0 million in potential funding under the grant award.

Regulation A Offering

On January 27, 2026, we completed the initial closing of our Regulation A offering of up to 4,854,000 units, each consisting of one share of our Series A convertible preferred stock, which is convertible into two shares of our common stock, and two warrants, each exercisable for one share of our common stock at an exercise price of $4.00 per share.

The offering price of each unit is $5.00.

The offering is being conducted on a “best efforts” basis pursuant to a selling agency agreement, dated January 5, 2026, between us and Digital Offering, LLC, acting as the lead selling agent for the offering.

Digital Offering is not required to sell any specific number or dollar amount of units in the offering.

As of the date of this report, we have issued an aggregate of 65,640 units to investors in the offering, consisting of 65,640 shares of Series A convertible preferred stock and warrants to purchase up to 131,280 shares of our common stock, for gross proceeds of approximately $328,200.

For additional information regarding the Regulation A offering and our agreement with Digital Offering, see Note 17, “Subsequent Events” to the accompanying consolidated financial statements.

Termination of Bayer License Agreement

In January 2020, we entered into a license agreement with Bayer, under which Bayer was supporting the Ovaprene program by providing the equivalent of two experts to advise us in clinical, regulatory, preclinical, commercial, chemistry, manufacturing and controls, and product supply matters, and Bayer had the right to obtain an exclusive license with regard to the commercialization of Ovaprene in the U.S.

for human contraception by paying us an additional $20 million fee.

We received a notice of termination of the license agreement from Bayer in November 2025, and we agreed with Bayer to terminate the license agreement effective December 2, 2025.

Bayer’s election to terminate the license agreement was due to its strategic prioritization.

We do not expect the termination of the license agreement to have a material impact on the ongoing pivotal Phase 3 study of Ovaprene.

If Ovaprene were to receive marketing approval from the FDA, we will need to enter into an agreement with a third party to commercialize Ovaprene, which could delay the commercialization of Ovaprene.

As noted above, we do not have sales, marketing or distribution infrastructure, and we currently do not intend to build such an infrastructure.

Receipt of Grant Funding Installment to Support the Ovaprene Phase 3 Study and Identification & Development of a New Non-Hormonal Contraceptive Candidate

In November 2025, we received a payment of $3.6 million as the latest installment under a grant of up to approximately $10.7 million to support (i) expansion of the number of study sites in the ongoing Phase 3 clinical trial of Ovaprene, and (ii) activities that will aid in the identification and development of a novel non-hormonal intravaginal contraceptive candidate, suitable for and acceptable to women in low- and middle-income country settings who need or would prefer to use such a product to avoid an unplanned pregnancy.

Additional payments are contingent upon our achievement of specified development and reporting milestones during the term of the grant agreement, which extends through March 2027.

See Note 15, "Grant Awards--Other Non-Dilutive Grant Funding--2024 Contraceptive Product Candidate Grant Agreement" to the accompanying consolidated financial statements for additional information regarding the grant agreement.

Nasdaq Listing

On July 24, 2025, we received a letter from the Nasdaq Office of General Counsel confirming that we had demonstrated compliance with the stockholders’ equity requirement in Nasdaq Listing Rule 5550(b)(1) that our stockholders' equity be at least $2.5 million, or the Stockholders’ Equity Rule, and that we are therefore in compliance with the Nasdaq Capital Market's continued listing requirements.

We are subject to a mandatory monitoring period of one-year from July 24, 2025.

If, within that one-year period, the Nasdaq Listing Qualifications Staff determines that we fall out of compliance with the Stockholders' Equity Rule, the Staff will issue a delist determination letter, and we will have an opportunity to request a new hearing with Nasdaq's Hearing Panel.

Notwithstanding Nasdaq Listing Rule 5810(c)(2), we will not be permitted to provide a plan of compliance to the Staff with respect to such non-compliance, the Staff will not be permitted to grant us additional time to regain compliance, and we will not be afforded a cure period pursuant to Nasdaq Listing Rule 5810(c)(3).

We were in compliance with the Stockholders’ Equity Rule as of December 31, 2025.

Based on information currently available to us, our stockholders' equity is expected to be substantially less than $2.5 million as of March 31, 2026.

We are actively pursuing initiatives to increase our stockholders' equity, including through our ongoing Regulation A offering and other potential capital-raising activities.

If we are unable to demonstrate to Nasdaq that we have increased our stockholders’ equity to at least $2.5 million prior to the filing of our quarterly report on Form 10-Q for the quarter ended March 31, 2026, we expect the Staff will issue a delist determination letter.

In that event, we intend to request a new hearing with Nasdaq's Hearing Panel, though there can be no assurance that any such hearing would result in a favorable outcome.

See the risk factor titled, There is no assurance that we will continue satisfying the listing requirements of the Nasdaq Capital Market , in Item 1A of Part II of this report.

Macroeconomic, Political, and Regulatory Environment Considerations

Our business, financial condition, operating results, and our ability to raise additional capital may be adversely affected by the uncertainty in the U.S.

and global macroeconomic, political, and regulatory environments, such as inflation, trade disruptions and restrictive measures, including tariffs, high interest rates, slowed economic growth or recession, uncertainty with respect to the federal budget and debt ceiling, potential or prolonged U.S.

government shutdowns, volatility in financial markets, changes in the regulatory landscape in the U.S., including due to significant reductions in funding and staffing of federal agencies and changes in leadership, and geopolitical factors.

Unstable and unfavorable market and economic conditions may make it more difficult, more costly, and more dilutive to our stockholders to raise additional capital to fund our operations and execute against our business strategy, as well as

adversely impact market demand for the women’s health solutions we bring to market.

Further, the service providers, manufacturers, vendors, and collaborators on which we rely may be adversely affected by the foregoing risks, which could directly impact our ability to achieve our operating goals within planned timelines and budgets.

There may be significant future effects on the women's health sector and the pharmaceutical and biopharmaceutical industries as a result of federal policy and regulatory changes under the current U.S.

presidential administration, including in areas relating to regulatory framework and oversight, research and development funding, drug pricing reform, global trade policy and tariffs, and others.

We continue to monitor these developments, which could result in new opportunities as well as challenges.

The potential effects of these changes on our business could be significant.

Our business strategy has included seeking non-dilutive sources of funding and collaborations to support product development, and we have received federal government grants and awards in support of several of our development programs.

Our pivotal Phase 3 study of Ovaprene and our DARE-HPV program are being significantly supported by federal government funding.

Our pivotal Phase 3 study of Ovaprene is being conducted, in part, under our CRADA with NICHD, and advancement of our DARE-HPV program is being supported by federal government funding under our October 2024 subaward agreement with VentureWell and a December 2024 grant award from NIAID.

Our subaward agreement will automatically terminate if the prime agreement from which the federal government funding flows is terminated and may be terminated for convenience by VentureWell if the prime agreement is materially changed in a way that would materially adversely affect VentureWell financially and, if so terminated, we would be paid only for milestones achieved up to the date of termination.

As discussed in ITEM 1.

"BUSINESS– Our Pipeline:

Clinical-Stage Programs– Ovaprene®– Pivotal Phase 3 Clinical Study" in Part I of this report, executive orders and other actions taken by the U.S.

presidential administration in the first quarter of 2025 have negatively impacted the Phase 3 study and NICHD's ability to carry out its responsibilities under the CRADA, and future developments, including relating to executive orders issued in January 2025, could have a material adverse impact on the study.

Given the high level of uncertainty regarding federal policy and enforcement and regulatory changes under the new U.S.

presidential administration and that circumstances are rapidly evolving, including as a result of legal challenges to federal government actions, we are not able to reasonably predict the potential impact on our business at this time.

Reverse Stock Split

On July 1, 2024, we effected a 1-for-12 reverse split of our issued common stock.

At the effective time of the reverse stock split, every 12 shares of our common stock was automatically reclassified and combined into one share of our common stock.

No fractional shares were issued as a result of the reverse stock split.

Stockholders who would have otherwise been entitled to receive a fractional share instead automatically had their fractional interests rounded up to the next whole share.

All common stock share and per share data presented in this report for prior periods have been retroactively adjusted to reflect the impact of the reverse stock split, without giving effect to whole shares issued in lieu of fractional shares.

See Notes 2 and 9 to the accompanying consolidated financial statements for additional information.

Recent initiatives have resulted in material reductions in staffing levels at the FDA and NIH, including through workforce reductions and reorganizations, and have impacted the agencies’ ability to retain remaining key personnel and hire additional personnel, disrupting their ability to perform routine activities or function in the normal course.

A prolonged federal government shutdown with additional agency staff furloughed or laid off could exacerbate these risks.

With respect to the FDA, this may result in delays or limitations on our ability to obtain guidance from agency staff, slow review times for applications we submit to commence clinical studies and obtain requisite regulatory approvals in the future, and consequently, negatively impact the cost and timelines for developing and obtaining regulatory approval of our product candidates.

Moreover, our business strategy has included seeking non-dilutive sources of funding and collaborations to support product development, and we have benefited significantly from federal government funding through grants and other agreements in support of several of our development programs, including Ovaprene and DARE-HPV.

See Note 15 “Grant Awards” to the accompanying consolidated financial statements.

Beginning in early 2025, the U.S.

presidential administration took actions to freeze or terminate billions of dollars in NIH grants, and the future of the NIH’s budget and research funding remains highly uncertain.

These actions have already begun to adversely affect the broader research and development funding environment, and our business, financial condition and operating results may be significantly adversely affected if existing grants or other arrangements supporting our development programs are frozen or terminated or we are unable to secure additional grants or other federal government funding in the future.

Given the high level of uncertainty regarding federal policy and enforcement and regulatory changes and that circumstances are rapidly evolving, including as a result of legal challenges to recent federal government actions, we are not able to reasonably predict the full extent of the potential impact on our business at this time.

We continue to monitor these evolving developments and conditions and their potential impacts on our business, financial condition, and results of operations, and will attempt to adjust our plans, as appropriate, to mitigate risks.

For additional information, see the risk factors described in Item 1A.

Risk Factors of this report.

Financial Overview

Our revenue reflects payments earned under our license agreement with Organon to commercialize XACIATO.

Pursuant to our traditional royalty purchase agreement with XOMA, from and after April 1, 2024, all of the royalties and potential milestone payments we would otherwise have the right to receive under our license agreement with Organon based on net sales of XACIATO will be paid to XOMA, net of payments made under our exclusive license agreement with third-party licensors TriLogic Pharma, LLC and MilanaPharm LLC and under our royalty interest financing agreement with UiE.

Accordingly, from and after April 1, 2024, any revenue we recognize under our license agreement with Organon based on net sales of XACIATO will be payable to UiE and recognized as non-cash royalty revenue.

In the future, we may generate revenue from license fees, milestone payments, and research and development payments in connection with strategic collaborations, as well as product sales of future products, if any.

Our ability to generate such revenue will depend on the extent to which clinical development of our product

candidates is successful and we or a strategic collaborator receive regulatory approvals to market such product candidates, as well as the eventual commercial success of the approved products.

If we fail to complete the development of our product candidates in a timely manner, or to receive regulatory approval for such product candidates, our ability to generate future revenue and our results of operations would be materially adversely affected.

Our revenue for 2025 primarily relates to the license fee recognized upon termination of our license agreement with Bayer.

Other revenue for 2025 and 2024 were royalties from net sales of XACIATO, which, since April 1, 2024, have been paid to UiE under our royalty interest financing agreement with UiE, and recognized as non-cash royalty revenue.

In the future, we may generate revenue from license fees, milestone payments, and research and development payments in connection with strategic collaborations, and from product sales, including sales of 503B compounded products, consumer health products, and FDA-approved products, if any.

We expect to begin recording revenue from sales of DARE to PLAY and Flora Sync LF5 in the second quarter of 2026.

Our ability to generate such revenue will depend on the extent to which we are successful in executing against our Section 503B and consumer health product business models, the extent to which the clinical development of our product candidates is successful, and whether we or a strategic collaborator receive the regulatory approvals necessary to market such product candidates, as well as the eventual commercial success of any FDA-approved products.

If we fail to successfully achieve any of the foregoing, our ability to generate future revenue and our results of operations would be materially adversely affected.

Cost of Revenues

Cost of revenues primarily represent expenses associated with medical education and consumer awareness related to the commercialization of DARE to PLAY through our 503B business model.

Research and Development Expenses

The majority of our operating expenses during a fiscal year are research and development, or R&D, expenses, a significant portion of which, excluding those funded by non-dilutive grants, are associated with the clinical development for our product candidates that have reached the human clinical study development phase.

We expect our R&D expenses will continue to represent the majority of our operating expenses for at least the next twelve months.

Research and development, or R&D, represents a core operational focus.

We are advancing multiple product candidates through preclinical and clinical development, supported in part by significant non-dilutive grant funding from governmental and non-governmental organizations.

Although our R&D activities remain substantial, as explained in more detail below, grant funding and other financial awards offset a significant portion of our R&D expenses.

As a result, our reported operating expenses may appear to be weighted more heavily toward selling, general and administrative, or SG&A, expenses.

However, this reflects the reduction to R&D expenses (contra R&D expense) as a result of grant funding and other financial awards, rather than a reduction in our commitment to or investment in R&D activities.

We expect our R&D expenses will continue to represent the majority of our operating expenses, on a pre-contra R&D expenses basis, for at least the next twelve months.

R&D expenses consist primarily of:

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• contract manufacturing expenses, primarily for the production of materials for use in our clinical trials and nonclinical studies;

• expenses related to production of select proprietary formulations by 503B-registered outsourcing facilities prior to commercial launch of the product via Section 503B compounding;

• transaction costs related to acquisitions of companies, technologies and related intellectual property, and other assets, and

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Milestone payments to third parties under acquisition, license, and option agreements are recognized as they are incurred or when we deem their incurrence to be probable.

At any one time, we are working on multiple programs at various stages of development.

We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each development program on an ongoing basis based on our cash resources and in response to the results of ongoing and future clinical trials and preclinical studies, regulatory developments, and our ongoing assessments as to the commercial potential of each product candidate.

We generally track direct R&D costs on a specific basis and will present direct costs for our key development programs on a program-by-program basis.

We plan to present direct costs for all other programs on a consolidated basis generally by stage of development.

Specifically, we will present consolidated direct costs for (a) such programs that are in (i) advanced clinical development (Phase 2-ready to Phase 3), (ii) Phase 1 clinical development or that we believe are Phase 1-ready, and (iii) preclinical stage, and (b) other development programs.

We generally track direct R&D costs on a specific basis and present direct costs for our key development programs on a program-by-program basis.

We present direct costs for all other programs on a consolidated basis generally by stage of development.

Specifically, we present consolidated direct costs for (a) such programs that are in (i) advanced clinical development (Phase 2-ready to Phase 3), (ii) Phase 1 clinical development or that we believe are Phase 1-ready, and (iii) preclinical stage, and (b) other development programs.

We do not track indirect costs on a program-by-program basis because those costs generally are deployed across multiple development programs.

Investment in the development of and seeking regulatory approval for our clinical-stage and Phase 1-ready product candidates and the development of any other potential product candidates we may advance into and through clinical trials in the pursuit of regulatory approvals, will increase our R&D expenses.

Activities associated with the foregoing will require a significant increase in investment in regulatory support, clinical supplies, inventory build-up related costs, and the payment of success-based milestones to licensors.

In addition, we continue to evaluate

opportunities to acquire or in-license other product candidates and technologies, which may result in higher R&D expenses due to, among other factors, milestone payments.

Until the first commercial sale of XACIATO, we recognized contract manufacturing expenses associated with producing commercial supplies of XACIATO and costs of regulatory affairs activities related to XACIATO as R&D expenses.

Following the first commercial sale of XACIATO, and during the interim period when we were the NDA holder of XACIATO and provided commercial supplies of XACIATO to Organon, those expenses were recognized as general and administrative expenses.

We recognize the Australian Research and Development Tax Incentive Program, or the Tax Incentive, as a reduction of R&D expenses (contra R&D expense).

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As we incur eligible expenses under those grants or awards, we recognize grant funding in our statements of operations as a reduction to R&D expenses (contra-R&D expense).

For more information, see Note 2, "Basis of Presentation and Summary of Significant Accounting Policies – Grant Funding" to the accompanying consolidated financial statements.

For the years ended December 31, 2024 and 2023, we recognized contra-research and development expense of approximately $8.8 million and $9.3 million, respectively.

For more information, see Note 2, "Basis of Presentation and Summary of Significant Accounting Policies – Grant Funding" to

the accompanying consolidated financial statements.

For the years ended December 31, 2025 and 2024, we recognized contra-R&D expense of approximately $16.4 million and $8.8 million, respectively.

At any one time, we are working on multiple programs at various stages of development.

We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each development program on an ongoing basis based on our cash position and capital resources and in response to the results of ongoing and future clinical trials and preclinical studies, regulatory developments, and our ongoing assessments as to the commercial potential of each product candidate.

In addition, we continue to evaluate opportunities to acquire or in-license other product candidates and technologies, which may result in higher R&D expenses due to, among other factors, milestone payments.

Conducting clinical trials necessary to obtain regulatory approval is costly and time consuming.

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As a result, we cannot accurately determine the duration and completion costs of development projects or if, when and to what extent we will generate revenue from any products we develop.

License Fee Expenses

License fee expenses consist of up-front license fees and annual license fees due under our in-licensing arrangements.

General and Administrative Expenses

General and administrative expenses consist of personnel costs, facility expenses, expenses for outside professional services, including legal, audit and accounting services, commercial-readiness expenses, and milestone expenses.

Selling, General and Administrative Expenses

SG&A expenses consist of personnel costs, facility expenses, expenses for outside professional services, including legal, audit and accounting services, commercial-readiness expenses, including for Section 503B compounded drug products and consumer health products, and milestone expenses.

Personnel costs consist of salaries, benefits and stock-based compensation.

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Recently Issued Accounting Standards

A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations and cash flows is discussed in Note 2 to our audited financial statements included elsewhere in this Annual Report on Form 10-K.

A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations and cash flows is discussed in Note 2 to the accompanying consolidated financial statements.

Critical Accounting Policies and Estimates

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Historically, revisions to our estimates have not resulted in a material change to our financial statements.

While our significant account policies are described in more detail in Note 2 to our consolidated financial statements included herein, we believe that the following accounting policies are most important to the portrayal of our financial condition and results of operations and require management's most difficult, subjective and complex judgments.

financial condition and results of operations and require management's most difficult, subjective and complex judgments.

• Revenue Recognition;

• Stock-Based Compensation;

• Liability Related to the Sale of Future Royalties

• Sale of Future Payments;

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We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.

To date, we have recognized $11.0 million in license fee revenue, all from payments received under our license agreement with Organon to commercialize XACIATO.

estimate the amount to be included in the transaction price using the most likely amount method.

To date, we have recognized $12.8 million in license fee revenue, all of which, other than $1.0 million recognized upon the termination of the license agreement with Bayer, is from payments received under our license agreement with Organon to commercialize XACIATO.

At the inception of each arrangement in which we are a licensor and that includes developmental, regulatory or commercial milestones, we evaluate whether achieving the milestones is considered probable and estimate 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.

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To date, we have recognized $1.8 million of milestone revenue, which represents the $1.8 million milestone payment we received under our license agreement with Organon in connection with the first commercial sale of 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, we recognize 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).

some or all of the royalty has been allocated has been satisfied (or partially satisfied).

To date, we have recognized approximately $26,000 of 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.

We assess if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations.

We evaluate whether we are the principal or agent in the arrangement based on the degree we control the specified product at any time before transfer to the customer.

If we are in the capacity of a principal, revenues are recognized on a gross basis.

If we are in the capacity of an agent, revenues are recognized on a net basis.

To date, we have recognized approximately $205,000 in revenue (and $201,000 in other expense attributed to the cost of revenue) associated with our XACIATO product supply arrangement, which is recorded in other income in our consolidated statements of operations and comprehensive loss.

In connection with the transfer of the NDA for XACIATO to Organon in December 2023, that arrangement was terminated and we will not recognize product supply revenue associated with that arrangement in the future.

Stock-Based Compensation

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Refer to Note 10 to our consolidated financial statements included in this report for more information.

Liability Related to the Sale of Future Royalties

In December 2023, we entered into a royalty interest financing agreement with UiE, pursuant to which we sold to UiE an interest in royalty and milestone payments we receive based on net sales of XACIATO.

We received $5.0 million from UiE in connection with entering into the royalty interest financing agreement.

We account for the sale of future royalties related to the UiE arrangement as debt under ASC 470, Debt.

We recognized the $5.0 million payment received as a liability on our consolidated balance sheet because we agreed to make payments to UiE until such time that UiE has received aggregate payments equaling a 12% internal rate of return on the $5.0 million.

Interest expense for the liability related to the sale of future royalties is recognized using the effective interest rate method over the expected term of the royalty interest financing agreement.

The accounting for this arrangement requires significant judgment in estimating the total amount and timing of future royalty payments expected to be paid over the life of the agreement.

These estimates are based on a combination of internal forecasts and external market data, including assumptions regarding future product sales, market adoption, pricing, and other relevant factors that may impact royalty-generating revenues.

The estimated royalty stream is used to determine the effective interest rate applied to the liability, which drives the recognition of interest expense over the term of the arrangement.

Because the effective interest rate is based on projected royalty payments, changes in the estimated amount or timing of future royalties could materially affect the amount and timing of interest expense recognized in future periods.

We periodically reassess our estimates of expected royalty payments.

If actual results differ from our estimates, or if our expectations regarding future royalty payments change, we prospectively adjust the effective interest rate and the recognition of interest expense over the remaining term of the arrangement.

Refer to Note 12 to our consolidated financial statements included in this report for more information.

Sale of Future Payments

On April 29, 2024, we entered into and closed a traditional royalty purchase agreement and a synthetic royalty purchase agreement with XOMA (US) LLC (“XOMA”) pursuant to which we sold our right, title and interest in the following to XOMA (i) all future net royalty and potential net milestone payments we would otherwise receive from Organon based on net sales of XACIATO, (ii) a portion of future net sales of Ovaprene and a portion of a potential future milestone payment we may receive under our license agreement with Bayer related to Ovaprene, and (iii) a portion of future net sales of Sildenafil Cream.

On April 29, 2024, we entered into and closed a traditional royalty purchase agreement and a synthetic royalty purchase agreement with XOMA pursuant to which we sold our right, title and interest in the following to XOMA (i) all future net royalty and potential net milestone payments we would otherwise receive from Organon based on net sales of XACIATO, (ii) a portion of future net sales of Ovaprene and a portion of the $20.0 million payment that we could have potentially received under our since terminated license agreement with Bayer relating to Ovaprene, and (iii) a portion of future net sales of Sildenafil Cream.

We received $22.0 million from XOMA in connection with entering into the royalty purchase agreements.

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If we earn any such payments, they will be accounted for as variable consideration under ASC 606, Revenue Recognition, and will be recorded as income when such payments are received.

We evaluated the expected cash flows to XOMA from royalties and milestone payments expected to be earned on XACIATO, Ovaprene and Sildenafil Cream over the period that we expect it will take for XOMA to receive total payments of $88.0 million under the royalty purchase agreements, and determined to allocate the $22.0 million we received from XOMA in connection with entering into the royalty purchase agreements, net of transaction costs of approximately $1.6 million, to the traditional royalty purchase agreement for XACIATO, and none of it to the synthetic royalty purchase agreement for Ovaprene and Sildenafil Cream.

Until such time that we are certain of commercialization, the cash flows to XOMA from royalties and milestone payments expected to be earned on Ovaprene and Sildenafil Cream are expected to be de minimis over the period that we expect it will take for XOMA to

receive total payments of $88.0 million under the royalty purchase agreements because, unlike XACIATO, Ovaprene and Sildenafil Cream are not commercial assets at this time.

We determined that the traditional royalty purchase agreement represents a complete sale of a nonfinancial asset (our right, title and interest in and to future payments related to commercial sales of XACIATO) for which XOMA bears all benefit and for which we have no obligations or involvement going forward, and therefore should be accounted for within the scope of Accounting Standards Codification (" ASC") 610-20, Other Income - Gains and Losses from the Derecognition of Nonfinancial Assets .

The $22.0 million net of transaction costs of approximately $1.6 million was recorded as other income on our consolidated statements of operations and comprehensive loss.

We evaluated the expected cash flows to XOMA from royalties and milestone payments expected to be earned on XACIATO, Ovaprene and Sildenafil Cream over the period that we expected it would take for XOMA to receive total payments of $88.0 million under the royalty purchase agreements, and determined to allocate the $22.0 million we received from XOMA in connection with entering into the royalty purchase agreements, net of transaction costs of approximately $1.6 million, to the traditional royalty purchase agreement for XACIATO, and none of it to the synthetic royalty purchase agreement for Ovaprene and Sildenafil Cream.

The cash flows to XOMA from royalties and milestone payments expected to be earned on Ovaprene and Sildenafil Cream were expected to be de

minimis over the period that we expected it would take for XOMA to receive total payments of $88.0 million under the royalty purchase agreements because, unlike XACIATO, Ovaprene and Sildenafil Cream were not commercial assets at the time the evaluation was made.

We determined that the traditional royalty purchase agreement represented a complete sale of a nonfinancial asset (our right, title and interest in and to future payments related to commercial sales of XACIATO) for which XOMA would bear all benefit and for which we had no obligations or involvement going forward, and therefore should be accounted for within the scope of Accounting Standards Codification (" ASC") 610-20, Other Income - Gains and Losses from the Derecognition of Nonfinancial Assets .

The $22.0 million net of transaction costs of approximately $1.6 million was recorded as other income on our consolidated statements of operations and comprehensive loss for the year ended December 31, 2024.

Grant Funding

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2025 2024 $ %

License fee revenue $ — $ 1,000,000 $ (1,000,000) (100) %

Milestone revenue — 1,800,000 (1,800,000) (100) %

Royalty revenue

License fee and other revenue

$ 1,030,193 $ 9,784 $ 1,020,409 10,429 %

Total revenue 1,030,193 9,784 1,020,409 10,429 %

Cost of revenue

295,799 — 295,799 — %

Operating expenses

General and administrative expenses

Selling, general and administrative expenses

8,763,376 9,156,061 (392,685) (4) %

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5,523,352 14,305,208 (8,781,856) (61) %

License fee expenses 100,000 100,000 — — %

Total operating expenses 14,286,728 23,461,269 (9,174,541) (39) %

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Net loss $ (13,399,274) $ (4,053,599) $ (9,345,675) 231 %

Revenues for the years ended December 31, 2024 and 2023 related to our license agreement with Organon to commercialize XACIATO.

For 2023, we recognized $1.0 million in license fee revenue upon execution of the amendment to the license agreement in July 2023, $1.8 million in milestone revenue in connection with the first commercial sale of XACIATO, and approximately $7,900 in royalties from net sales of XACIATO in the fourth quarter.

General and administrative expenses

The decrease of approximately $3.0 million in general and administrative expenses from 2023 to 2024 was primarily attributable to decreases in (i) commercial-readiness expenses of approximately $1.6 million, (ii) personnel costs of approximately $0.6 million due to reduced headcount, (iii) stock-based compensation expense of approximately $0.3 million, (iv) a one-time fraud loss in the first quarter of 2023 of approximately $0.2 million, net of proceeds we received under an insurance policy, related to criminal fraud commonly referred to as "business email compromise fraud" to which we were subject, and (v) professional services expenses of approximately $0.2 million.

The approximately $1.0 million increase in license fee and other revenue was primarily attributable to the $1.0 million of revenue recognized upon the termination of the license agreement with Bayer in December 2025.

Cost of revenues

Cost of revenues relates primarily to expenses associated with medical education and awareness related to the commercialization of DARE to PLAY.

Selling, general and administrative expenses

The decrease of approximately $0.4 million in SG&A expenses from 2024 to 2025 was primarily attributable to decreases in (i) stock-based compensation expense of approximately $0.5 million, (ii) personnel costs of approximately $0.3 million due to reduced compensation expense, and (iii) general corporate overhead expenses of approximately $0.3 million.

Such decreases were partially offset by increases in commercial-readiness expenses of approximately $0.4 million primarily for DARE to PLAY and professional services expenses of approximately $0.3 million.

Research and development expenses

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Sildenafil Cream (2)

1,143,221 2,361,052 (1,217,831) (52) %

Other advanced clinical stage programs 2,805,127 1,421,888 1,383,239 97 %

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Indirect costs:

Personnel-related (including stock compensation) 5,611,057 5,566,016 45,041 1 %

Personnel-related (including stock-based compensation) 4,691,957 5,611,057 (919,100) (16) %

Outside services (including consulting) 21,378 543 20,835 3837 %

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See footnote (3) below.

(2) For 2025, the dollar amount also includes expenses for DARE to PLAY.

(3) These contra R&D expenses were recognized as follows for the years ended December 31, 2025 and 2024:

(a) Ovaprene, $0.2 million, and $0, respectively;

(b) Other advanced clinical stage programs, $0 and $0.1 million, respectively, (c) Phase 1 and Phase 1-ready clinical stage programs, $1.3 million and $0.9 million, respectively;

(a) Ovaprene, $2.5 million, and $0.2 million, respectively;

(b) Other advanced clinical stage programs, $2.9 million and $0, respectively, (c) Phase 1 and Phase 1-ready clinical stage programs, $0.4 million and $1.3 million, respectively;

and (d) Preclinical stage programs, $8.1 million and $6.2 million, respectively.

The decrease of approximately $7.3 million in R&D expenses from 2023 to 2024 was primarily attributable to a decrease in costs related to development activities for Sildenafil Cream as a result of the completion of the Phase 2b RESPOND clinical study completed in June 2023, partially offset by increases in costs related to our ongoing pivotal Phase 3 clinical trial of Ovaprene and manufacturing and regulatory affairs activities for Ovaprene.

Contra-R&D expenses for the years ended December 31, 2024 and 2023 primarily offset direct program costs for DARE-LARC1, one of our preclinical stage programs.

License fee expenses

For each of the years ended December 31, 2024 and December 31, 2023 we accrued or paid $100,000 of the annual license maintenance fee payable under our license agreement related to DARE-HRT1.

For further discussion of this annual license maintenance fee, see Note 3 "Strategic Agreements—Strategic Agreements for Pipeline Development" to the accompanying consolidated financial statements.

The decrease of approximately $8.8 million in R&D expenses from 2024 to 2025 was primarily attributable to (i) an increase in contra-R&D expenses, (ii) a decrease in manufacturing costs related to Ovaprene, (iii) a decrease in costs related to development activities for Sildenafil Cream, (iv) a decrease in personnel costs, and (v) a decrease in costs related to development activities for DARE-HRT1 partially offset by increases in costs related to development activities for (A) our other advanced clinical stage programs —primarily attributable to our DARE-HPV program, (B) our pre-clinical and other development programs —primarily attributable to our DARE-LARC1 program, and (C) our Phase 1 and Phase 1-ready clinical stage programs —primarily attributable to our DARE-PTB1 program.

Contra-R&D expenses for the year ended December 31, 2025 primarily offset direct program costs for DARE-LARC1, DARE-HPV and Ovaprene.

Contra R&D expenses for the year ended December 31, 2024 primarily offset direct program costs for DARE-LARC1.

Other income (expense)

Sale of royalty and milestone rights, net

The $20.4 million of other net income for 2024 represents the $22.0 million payment to us in April 2024 under the Royalty Purchase Agreements, net of approximately $1.6 million in transaction costs.

The $20.4 million of other net income for 2024 represents the $22.0 million payment to us in April 2024 under the royalty purchase agreements we entered into with XOMA, net of approximately $1.6 million in transaction costs.

Other income (expense), net

The decrease of $1.8 million in other income (expense) for 2024 as compared to 2023 was primarily due to a loss on the disposal of a fixed asset of $0.6 million, interest expense related to the Royalty Interest Agreement in 2024 of approximately $0.8 million, and decreased interest earned on cash balances in 2024.

The increase of $1.1 million in other income (expense) for 2025 as compared to 2024 was primarily due to increased interest earned on cash balances in 2025 and the receipt in the current year of approximately $0.3 million of employee retention credits for applications filed during 2023, offset by a loss on the disposal of a fixed asset of $0.6 million in 2024.

Liquidity and Capital Resources

Plan of Operations and Future Funding Requirements

At December 31, 2024, we had an accumulated deficit of approximately $175.3 million, cash and cash equivalents of approximately $15.7 million, and a working capital deficit of approximately $3.2 million.

We will need additional capital to fund our operating needs into the third quarter of 2025 and to meet our current obligations as they become due.

All of our cash and cash equivalents at December 31, 2024 represented funds received under grant agreements that generally may be applied solely toward direct costs of carrying out the respective projects under those grant agreements.

We prepared the accompanying consolidated financial statements on a going concern basis, which assumes that we will realize our assets and satisfy our liabilities in the normal course of business.

We have a history of losses from operations and we expect significant losses from operations, net losses, and negative cash flows from operations for at least the next several years as we continue to develop and seek to bring to market our product candidates.

We are dependent on securing substantial additional capital from one or more third-party sources to satisfy our working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying consolidated financial statements.

These circumstances raise substantial doubt about our ability to continue as a going concern.

The accompanying consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of our ability to remain a going concern.

We are in ongoing discussions with potential third-party sources of additional capital, and we will continue to evaluate and may pursue a variety of capital raising options, including sales of equity (including sales of our common stock under our equity line arrangement and in ATM offerings (see “—Capital Resources,” below)), debt financings, government or other grant funding, collaborations, structured financings, and strategic alliances or other similar types of arrangements.

However, our ability to raise additional capital will depend on a variety of factors, many aspects of which are not entirely within our control, and there can be no assurance that capital will be available when needed or that, if available, it will be obtained on terms favorable to us and our stockholders.

In the near term, we plan to focus primarily on:

(a) our ongoing Ovaprene Phase 3 study;

(b) executing against our Section 503B compounding and consumer health products business strategies, with a focus on DARE to PLAY, DARE to RECLAIM estradiol progesterone intravaginal ring and DARE to RESTORE vaginal probiotics;

and (c) advancing the development of product candidates for which the costs are being supported by non-dilutive grant or other award funding, in particular DARE-LARC1 and DARE-HPV.

We will also continue engagement with the FDA to align on the Phase 3 program for Sildenafil Cream and will continue to work on the development of our other clinical and preclinical-stage programs.

At December 31, 2025, we had cash and cash equivalents of approximately $24.7 million and working capital of approximately $3.4 million.

We will need additional capital to fund our operating needs through the fourth quarter of 2026 and to meet our current obligations as they become due.

Our cash and cash equivalents at December 31, 2025 included funds received under grant agreements that generally may be applied solely toward direct costs for the funded project under those grant agreements other than an approximately 5% to 22% indirect cost allowance, and as of December 31, 2025, our deferred grant funding liability was approximately $19.7 million, substantially all of which consisted of funds intended to support the DARE-LARC1 program, the Ovaprene Phase 3 clinical study, and the DARE-HPV program.

For more information about these grant agreements, see "—Contractual Obligations and Other Commitments—Grant Agreements" below, and Note 2 "Basis of Presentation and Summary of Significant Accounting Policies—Grant Funding" and Note 15 "Grant Awards—Other Non-Dilutive Grant Funding" to the accompanying consolidated financial statements.

In addition to our ongoing Regulation A offering, we will continue to evaluate and may pursue various other capital raising options, including sales of equity, debt financings, government or other grant funding, collaborations, structured financings, and commercial collaborations or other strategic transactions.

Our ability to obtain additional capital, including through our ongoing Regulation A offering, and the timing and terms thereof, depend on various factors, many aspects of which are not entirely within our control, and there can be no assurance that capital will be available when needed or, if available, on terms favorable to us and our stockholders.

Raising additional capital may cause substantial dilution to our stockholders, restrict our operations or require us to relinquish rights in our technologies or product candidates and their future revenue streams.

See the risk factors under “Risks Related to Our Financial Position and Capital Needs” in ITEM 1A.

RISK FACTORS of this report.

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

For example, in recent years, due to our limited capital resources, we have focused our resources primarily on the advancement of Ovaprene and Sildenafil Cream, unless a program has been supported by grant or other non-dilutive funding, and we have delayed R&D activities for other programs.

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

A majority of our operating expenses during a fiscal year are R&D expenses.

Our R&D expenses for 2025, until we secure additional capital to fund our operating needs, will be primarily associated with our ongoing pivotal Phase 3 clinical study of Ovaprene.

However, we plan to continue to advance preclinical development of DARE-LARC1, the costs of which are being supported by grant funding, and, with the support of funding under our October 2024 subaward agreement and the December 2024 NIAID grant award, to advance development of DARE-HPV toward a Phase 2 clinical study.

Assuming we are able to raise the necessary capital to continue our operations, we anticipate our R&D expenses and our general and administrative expenses for 2025 will be similar to the amount of such expenses for 2024.

We expect our operating expenses for the foreseeable future to continue to be R&D expenses and general and administrative expenses consistent with the nature of such expenses described above under “Financial Overview.” Our future expenses could also include significant costs related to commercialization of our product candidates, if approved, depending on the type, nature and terms of commercial collaborations we establish, and in particular, if we determine to engage in commercialization activities directly as opposed to through a third-party collaborator.

Our future capital requirements are difficult to predict because they will depend on many factors that are highly variable and difficult to predict, including, but not limited to, those discussed under “Risks Related to Our Financial Position and Capital Needs” in ITEM 1A.

RISK FACTORS of this report.

We cannot accurately determine the

duration and completion costs of our development programs, or if, when and to what extent we will generate revenue from any products we develop.

If we cannot raise capital when needed, on favorable terms or at all, we will need to reevaluate our planned operations and may need to delay, scale back or eliminate some or all of our product candidate programs and/or reduce expenses.

At December 31, 2025, our accumulated deficit was approximately $188.7 million, and we had a net loss of approximately $13.4 million and negative cash flows from operations of approximately $9.9 million for the year ended December 31, 2025.

Because we are in the early stages of executing against our Section 503B compounding and consumer health products business strategies and, as an organization, we have no experience in or infrastructure for commercializing products, both the timing and amount of potential revenue we may generate remain uncertain.

As a result, we may continue to incur significant losses from operations and negative cash flows from operations for the next several years, and may never generate sufficient revenues to finance our operations or achieve profitability.

Based on our current analysis of the conditions described above, there is substantial doubt about our ability to continue as a going concern within the 12-month period from the issuance date of the accompanying consolidated financial statements.

The accompanying consolidated financial statements were prepared on a going concern basis, which assumes that we will realize our assets and satisfy our liabilities in the normal course of business.

We expect our operating expenses will increase substantially in the future as we continue to develop and seek FDA approval for our product candidates and expand our capabilities to support our 503B compounding and consumer health business strategies.

Our future capital requirements are difficult to predict because they will depend on many factors that are highly variable and difficult to predict, including, but not limited to, those discussed in the risk factors in Part I, Item 1A of this report under “Risks Related to Our Financial Position and Capital Needs.”

Capital Resources

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We have also received a significant amount of cash through non-dilutive grants, strategic collaborations and royalty monetization transactions.

We have an ongoing Regulation A offering in which are offering up to 4,854,000 units, each consisting of one share of our Series A convertible preferred stock, which is convertible into two shares of our common stock, and two warrants, each exercisable for one share of our common stock at an exercise price of $4.00 per share.

The offering price of each unit is $5.00.

We have a sales agreement with Stifel, Nicolaus & Company, Incorporated, or Stifel, to sell shares of our common stock from time to time through an ATM offering under which Stifel acts as our agent.

During 2025, we sold 4,329,116 shares of our common stock under the sales agreement for net proceeds of approximately $17.6 million.

Shares of our common stock sold under the sales agreement will be offered and sold under our shelf registration statement on Form S-3 (File No.

333-278380), declared effective by the SEC on May 10, 2024, the base prospectus included therein and the prospectus supplement thereto dated May 10, 2024 relating to the offering of up to $18.1 million of shares of our common stock, and any subsequent prospectus supplement related to the offering of shares of our common stock under the sales agreement.

We have a purchase agreement with Lincoln Park under which, subject to the conditions thereof, we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $15.0 million in shares of our common stock.

We did not sell any shares of our common stock under this purchase agreement during 2024.

See “—Recent Events—Equity Line,” above.

As discussed above, we are seeking to bring our proprietary Sildenafil Cream formulation to market under Section 503B of the FDCA, and we expect to begin recording revenue from sales therefrom, in the fourth quarter of 2025, however, we do not expect the amount of such revenue, if any, to be material during 2025.

Our royalty purchase agreements with XOMA may be a source of future capital;

however, whether we receive any future payments from XOMA will depend on whether XOMA first receives total payments under those agreements equal to an amount that exceeds $88.0 million, which may not occur and will depend, in part, on the commercial success of XACIATO, which is outside of our control.

Our license agreement with Bayer regarding the further development and commercialization of Ovaprene in the U.S., if approved, may be a future source of capital;

however, whether we receive any future payments from Bayer will depend on whether Bayer, in its sole discretion, exercises its right to make the license effective by paying us $20.0 million after we complete the ongoing pivotal Phase 3 clinical study of Ovaprene, which we do not expect to be completed in 2025.

In addition, a portion of that potential $20.0 million payment from Bayer would be payable to XOMA as discussed under “—Contractual Obligations and Other Commitments—Royalty Purchase Agreements with XOMA,” below.

Deferred Grant Funding

We have received substantial funding under grant agreements with the Foundation, and we generally receive grant funds before we incur the eligible expenses.

Under the terms of such grant agreements, the funds we receive may be applied solely toward direct costs of carrying out the respective projects under those grant agreements, other than approximately 10% of such funds, which may be applied toward general overhead and administration expenses that support our entire operations.

Funds received that have not been spent are recorded both as cash and cash equivalents and as a deferred grant funding liability in our consolidated balance sheets.

Funds received that have been spent but not yet expensed in accordance with GAAP are also recorded as part deferred grant funding liability in our consolidated balance sheets.

As of December 31, 2024, our deferred grant funding liability was approximately $16.6 million, substantially all of which consisted of unspent funds for the DARE-LARC1 program and the Ovaprene Phase 3 clinical study.

For more information about these grant agreements, see Note 2, "Basis of Presentation and Summary of Significant Accounting Policies—Grant Funding," and Note 15, "Grant Awards-Other Non-Dilutive Grant Funding" to the accompanying consolidated financial statements.

Shares of our common stock sold under the sales agreement were offered and sold under our shelf registration statement on Form S-3 (File No.

333-278380), declared effective by the SEC on May 10, 2024.

Because the market value of our outstanding shares of common stock held by non-affiliates, or our public float, is less than $75.0 million, our use of a shelf registration statement is currently limited by what is known as the SEC’s “baby shelf rule” to one-third of our public float in any 12-month period.

Because of the "baby shelf rule" and based on sales of shares of our common stock under our ATM sales agreement, we do not expect to sell any additional shares under our ATM sales agreement during the approximately 12-month period from July 2025, unless and until our public float exceeds approximately $54.0 million, as determined in accordance with SEC rules.

We have a purchase agreement with Lincoln Park Capital Fund, LLC, or Lincoln Park, under which, subject to the conditions thereof, we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $15.0 million in shares of our common stock.

Such sales of our common stock to Lincoln Park, if any, are subject to certain limitations, and may occur from time to time, at our sole discretion, over the 24-month period commencing on November 27, 2024.

We sold 1,470,000 shares of our common stock under this purchase agreement during 2025 for net proceeds of approximately $3.1 million.

As of the filing date of this report, due to the limitations in the purchase agreement on the number of shares we can sell at an average price of less than $3.59, unless we obtain stockholder approval to do so, we do not expect to sell any more shares to Lincoln Park.

See Note 9 "Stockholders’ Equity—Equity Line " to the accompanying consolidated financial statements for additional information regarding these limitations.

We expect to begin recording revenue from sales of our 503B products and consumer health products when such products are commercially available for purchase and are shipped.

Because we are in the early stages of executing against our Section 503B compounding and consumer health products strategy and, as an organization, we have no experience in or infrastructure for commercializing products, the amount of potential revenue we may generate during 2026 remains uncertain.

The following table shows a summary of our cash flows for the periods indicated:

Net cash provided by (used in) operating activities

Net cash (used in) provided by operating activities

$ (9,885,870) $ 5,473,555

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7,186 (67,913)

Net increase (decrease) in cash, cash equivalents and restricted cash

Net increase in cash, cash equivalents and restricted cash

$ 9,013,182 $ 5,187,118

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Cash used in operating activities during the year ended December 31, 2025 included the net loss of $13.4 million, decreased by non-cash stock-based compensation expense of approximately $1.5 million.

Components providing operating cash were a decrease in prepaid expenses of approximately $3.6 million, an increase in deferred grant funding of approximately $2.8 million, a decrease in other receivables of approximately $0.7 million, an increase in interest payable of approximately $0.5 million related to the Royalty Interest Financing Agreement, an increase in accrued expenses of $0.2 million, and a decrease in deposits of $0.4 million.

operating assets and liabilities included a decrease in deferred revenue of $1.0 million related to revenue recognized during the period for amounts previously received, which reduced operating cash.

Components providing operating cash were an increase in deferred grant funding of approximately $3.1 million, a decrease in prepaid expenses of approximately $0.7 million, and an increase in interest payable of approximately $0.6 million related to our royalty interest financing agreement with UiE.

Components reducing operating cash were (i) a decrease in accrued expenses of approximately $2.3 million primarily as a result of prior year accruals not present in the current year including a $1.0 million milestone due under a license agreement, approximately $0.5 million related to the construction of capital equipment, and approximately $0.8 million of accrued bonus expense, (ii) an increase in other receivables of approximately $0.3 million, and (iii) a decrease in accounts payable of approximately $0.3 million.

Cash provided by operating activities during the year ended December 31, 2024 included the net loss of $4.1 million, decreased by non-cash stock-based compensation expense of approximately $2.2 million.

Components providing operating cash were a decrease in prepaid expenses of approximately $3.6 million, an increase in deferred grant funding of approximately $2.8 million, a decrease in other receivables of approximately $0.7 million, an increase in interest payable of approximately $0.5 million related to our royalty interest financing agreement with UiE, an increase in accrued expenses of $0.2 million, and a decrease in deposits of $0.4 million.

Components reducing operating cash were a decrease in accounts payable of approximately $1.9 million and a decrease in other non-current assets of approximately $34,000.

Cash used in operating activities during the year ended December 31, 2023 included the net loss of $30.2 million, decreased by non-cash stock-based compensation expense of approximately $2.5 million.

Components providing operating cash were an increase in accounts payable of approximately $1.4 million, a decrease in other receivables of approximately $0.8 million, and a decrease in prepaid expenses of approximately $0.5 million.

Components reducing operating cash were a decrease in accrued expenses of approximately $8.3 million, a decrease in deferred grant funding of approximately $4.6 million, an increase in deposits of $1.2 million primarily related to deposits paid for the construction of capital equipment, and a decrease in other non-current assets of approximately $10,000.

Net cash used in investing activities

Net cash used in investing activities during the years ended December 31, 2024 and December 31, 2023 was related to purchases of property and equipment of approximately $573,000 and $629,000, respectively.

Net cash used in investing activities during the years ended December 31, 2025 and December 31, 2024 was related to purchases of property and equipment of approximately $0.4 million and $0.6 million, respectively.

Net cash provided by financing activities

Net cash provided by financing activities during the year ended December 31, 2024 was approximately $0.4 million and primarily consisted of proceeds from (i) the sale of our common stock under our ATM sales agreement and (ii) the financing of certain director and officer and other liability insurance premiums, partially offset by payments on the insurance financing payable.

Net cash provided by financing activities during the year ended December 31, 2023 was approximately $15.6 million and consisted of proceeds from (i) the sale of our common stock and warrants in the registered direct offering completed in September 2023 of approximately $7.0 million, (ii) the sale of future royalties of approximately $4.7 million, net, (iii) the sales of our common stock under our ATM sales agreement of approximately $2.3 million, net, (iv) the exercise of warrants of approximately $1.3 million, and (v) the financing of certain director and officer and other liability insurance premiums of approximately $0.6 million net of payments made of approximately $0.3 million.

Net cash provided by financing activities during the year ended December 31, 2025 primarily consisted of net proceeds of approximately $17.6 million and $3.1 million from the sale of our common stock under our ATM sales agreement and our equity line arrangement with Lincoln Park, respectively.

These proceeds were partially offset by (i) principal payments of approximately $1.3 million related to our finance lease obligation, and (ii) payments of approximately $0.3 million for deferred offering costs associated with our capital-raising activities.

Net cash provided by financing activities during the year ended December 31, 2024 primarily consisted of proceeds from (i) the sale of our common stock under our ATM sales agreement and (ii) the financing of certain director and officer and other liability insurance premiums, partially offset by payments on the insurance financing payable.

Contractual Obligations and Other Commitments

License and Royalty Agreements

We have assembled our product pipeline primarily through acquisitions, in-license agreements, and other collaborations.

We agreed to make royalty and milestone payments, and in some cases annual license fee payments, under the license and development agreements related to XACIATO, Ovaprene, and Sildenafil Cream and under other agreements related to our other clinical and preclinical candidates.

The amount and timing of most of these payments are difficult to predict because the timing of milestone payments for pre-commercial programs generally depends on the progress of and success in development of a particular program, which is subject to many risks and uncertainties as discussed elsewhere in this report and difficult to predict, and the timing and amount of royalty and milestone payments related to commercial products generally depends on their commercial success, which may, as it is with XACIATO, be outside of our control.

During 2025, based on our current expectations regarding the progress of development of our product candidates and sales of XACIATO, we expect approximately $0.1 million of such payments to upstream licensors to become payable.

We have assembled our pipeline primarily through acquisitions, in-license agreements, and other collaborations.

We agreed to make royalty and milestone payments, and in some cases annual license fee payments, under the license and development agreements under which we acquired rights to intellectual property from third parties.

For information about these obligations see Note 3 "Strategic Agreements—Strategic Agreements for Pipeline Development" to the accompanying consolidated financial statements.

During 2026, based on our current expectations regarding the progress of development of our product candidates and sales of XACIATO and DARE to PLAY, we expect such payments to upstream licensors to be immaterial.

With respect to our license agreement relating to XACIATO, royalties payable by us to upstream licensors will be funded by royalty payments made by our licensee, Organon.

For further discussion of these potential payments, see Note 3 "Strategic Agreements—Strategic Agreements for Pipeline Development" to the accompanying consolidated financial statements.

With respect to DARE to PLAY, for at least the first twelve months following its market introduction, we anticipate a mid single-digit royalty payment obligation to our upstream licensor on annual net sales.

Grant Agreements

For information regarding our grant agreements with the Foundation, see "--Deferred Grant Funding," above, Note 2, "Basis of Presentation and Summary of Significant Accounting Policies—Grant Funding" and Note 15, "Grant Awards-Other Non-Dilutive Grant Funding" to the accompanying consolidated financial statements.

For information regarding our grant agreements with the Foundation, see "--Deferred Grant Funding," above, and Note 2, "Basis of Presentation and Summary of Significant Accounting Policies—Grant Funding" and Note 15, "Grant Awards-Other Non-Dilutive Grant Funding" to the accompanying consolidated financial statements.

Royalty Purchase Agreements with XOMA

In April 2024, we entered into a traditional royalty purchase agreement and a synthetic royalty purchase agreement with XOMA (which, together, we refer to as the Royalty Purchase Agreements) pursuant to which we sold our right, title and interest in the following to XOMA:

(a) all of the royalties and potential milestone payments we would otherwise have the right to receive from and after April 1, 2024 under our exclusive license agreement with Organon based on net sales of XACIATO, net of our obligations to upstream licensors and UiE (such net amount we refer to as the Purchased Receivables);

(b) a portion of a potential future $20.0 million payment from Bayer under our license agreement relating to Ovaprene and a portion of future net sales of Ovaprene;

and (c) a portion of future net sales of Sildenafil Cream (such amounts described in the foregoing clauses (b) and (c) we collectively refer to as the Revenue Participation Right).

We received $22.0 million from XOMA in connection with entering into the Royalty Purchase Agreements.

If XOMA receives total payments equal to an amount that exceeds $88.0 million, XOMA will pay $11.0 million to us for each successive $22.0 million XOMA receives under the Royalty Purchase Agreements.

Pursuant to the traditional royalty purchase agreement, XOMA, at its sole cost and discretion, may repay in full and retire all of our payment obligations to UiE under our royalty interest financing agreement with UiE.

If XOMA does so, no further amounts in respect of that agreement will be deducted from the net royalties and net milestone payments that XOMA is entitled to receive.

We cannot elect to receive any additional funding from UiE under our royalty interest financing agreement with UiE without XOMA’s prior written consent.

In connection with the synthetic royalty purchase agreement, we granted to XOMA a security interest in certain product assets related to Ovaprene and Sildenafil Cream.

The Royalty Purchase Agreements include covenants that limit or restrict our ability to incur indebtedness or liens related to the Purchased Receivables, the Revenue Participation Right, and certain product assets related to Ovaprene and Sildenafil Cream (except pursuant to a suitable intercreditor agreement).

In April 2024, we entered into a traditional royalty purchase agreement and a synthetic royalty purchase agreement with XOMA pursuant to which, among other things, we sold our right, title and interest in the following to XOMA:

and (b) a portion of future net sales of Ovaprene, Sildenafil Cream and DARE to PLAY.

For more information regarding our contractual obligations to XOMA, see ITEM 1.

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Royalty Interest Financing Agreement

In December 2023, we entered into a royalty interest financing agreement with UiE pursuant to which we sold an interest in the royalty and milestone payments we are entitled to receive in respect of net sales of XACIATO under our license agreement with Organon and received a payment of $5.0 million from UiE.

We have not elected to receive

any of the up to $7.0 million in potential additional payments from UiE under the agreement, and we cannot do so without XOMA’s prior written consent.

As described above, XOMA, at its sole cost and discretion, may repay in full and retire all of our payment obligations to UiE under the royalty interest financing agreement.

In December 2023, we entered into a royalty interest financing agreement with UiE pursuant to which we sold to UiE an interest in the royalty and milestone payments we are entitled to receive in respect of net sales of XACIATO under our license agreement with Organon.

In exchange for any payments to us from UiE under the agreement, we agreed to make payments to UiE out of royalty and milestone payments earned on net sales of XACIATO from Organon, net of our obligations to upstream licensors, until UiE receives a specified return on its investment, or using our other sources of assets or income to complete such payments if UiE has not received the specified return on its investment by the end of 2035.

We have the right to make prepayments on or pay in full and retire all of our payment obligations to UiE.

For more information regarding our contractual obligations to UiE, see ITEM 1.

“BUSINESS— Royalty Monetization Transactions—Royalty Interest Financing Agreement” in Part I of this report and Note 12 “Royalty Interest Financing” to the accompanying consolidated financial statements.

We have two operating leases for our laboratory and office spaces that each expire in 2027.

As of December 31, 2025, we had future minimum lease payments under these leases of $1.2 million, $0.6 million of which is classified as current and $0.6 million of which is classified as long-term, the remainder of which represents future interest payments.

We have one finance lease for our clean room space that expires in 2026.

As of December 31, 2025, we had future minimum lease payments under this lease of $1.5 million, all of which is classified as current, the remainder of which represents future interest payments.

For additional information on our lease obligations, See Note 11 "Leases" to the accompanying consolidated financial statements.

Other Contractual Obligations

We enter into contracts in the normal course of business with various third parties for research studies, clinical trials, testing and other services.

We enter into contracts in the normal course of business with various third parties for research studies, clinical trials, testing and other services, and with Section 503B-registered outsourcing facilities, dispensing pharmacies, telehealth providers, and other third parties to help bring our proprietary formulations to market.

These contracts generally provide for termination upon notice, and we do not believe that our non-cancelable obligations under these agreements are material.

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What changed 10-K

Item 7. Management’s Discussion and Analysis