What changed in this filing

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Item 1. Business

2026-03-26 compared with 2025-03-31 · 470 added, 397 removed, 1185 unchanged (42% of the section changed)

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Unless otherwise stated, references to particular years, quarters, months or periods refer to our fiscal years ending December 31 and the associated quarters, months and periods of those fiscal years.

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 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.

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.

For decades, women have been told to “wait it out” or “live with it,” while innovations that could improve their quality of life languish in the regulatory or funding pipeline.

With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting.

However, access to real, evidence-based solutions continues to lag.

Daré was founded to change that.

As a female-led health biotech company, we are accelerating the development of credible, science-based solutions that meet the

high standards of clinical rigor – randomized, controlled trials;

validated endpoints;

peer-reviewed publications;

and current Good Manufacturing Practice (cGMP) requirements.

We regularly hear from healthcare providers, researchers, and women themselves about the urgent need for expanded access to evidenced-based and convenient options.

Our goal is to fulfill that need by bringing innovative products to market as soon as practicable, whether as FDA-approved therapies or through alternative regulatory pathways that enable earlier availability, such as Section 503B compounding.

Through a pipeline of investigational products and near-commercial, alternative pathway products, we aim to close persistent gaps in care and deliver clinically meaningful advances that redefine standards in women’s health.

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 outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA), which may compound and distribute certain drugs without patient-specific prescriptions.

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, the first of which, as discussed below, will be our DARE to RESTORE™ product offerings.

In December 2025 we initiated commercialization of DARE to PLAY™ Sildenafil Cream, which we also refer to as DARE to PLAY , a first-of-its-kind, topically applied formulation of sildenafil designed to improve female sexual arousal.

We believe the product’s positioning – science-backed, evidence-driven, and female-focused – sets a new benchmark for credibility in the female sexual wellness category.

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.

The products we plan to bring to market under our DARE to RESTORE offerings align with our broader vision to integrate clinically credible, evidence-based products into women’s health routines, including select consumer health products.

Our near-term commercial initiatives are designed not only to drive revenue but also to create a self-reinforcing ecosystem for growth.

The commercial experience, brand awareness, and provider engagement generated through these products can position us to efficiently introduce additional pipeline candidates, including potential future FDA-approved products.

By pursuing a balanced strategy that integrates short-term commercial execution with long-term R&D investment, we aim to reduce reliance on dilutive capital and build a financially sustainable model for innovation in women’s health.

We are pursuing a capital-efficient path to commercialization that leverages targeted direct-to-consumer and healthcare professional marketing initiatives to build awareness of our women’s health portfolio, including digital campaigns, webinars, social media education, and advocacy programs.

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 third-party manufacturing, market preparation, and strategic partnerships.

Prior to 2025, we were solely pursuing traditional FDA approval pathways to market for our product candidates.

We began assembling our diverse portfolio of assets in 2017 through acquisitions, exclusive in-licenses and other collaborations.

Our portfolio targets product categories we believe represent meaningful opportunities to improve women's health and quality of life.

These include contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health, and menopause.

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

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

XACIATO was approved by the FDA in December 2021 as a single-dose

prescription medication for the treatment of bacterial vaginosis in females 12 years of age and older.

XACIATO was approved by the FDA in December 2021 as a single-dose prescription medication for the treatment of bacterial vaginosis in females 12 years of age and older.

In 2022, we entered into an agreement with an affiliate of Organon & Co., Organon International GmbH, or 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 described below, to provide funding for the development of the product candidates in our pipeline, in April 2024, we entered into an agreement with XOMA (US) LLC, or 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.

In January 2024, Organon announced that XACIATO was available nationwide in the United States.

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 candidates are in various stages of development, from pre-clinical through a pivotal Phase 3 clinical study.

The most 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, whose U.S.

commercial rights are under a license agreement with Bayer;

Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra®, for the treatment of female sexual arousal disorder (FSAD);

and 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.

As discussed in more detail below, because we believe women should not have to wait for needed medical treatment solutions, we are expanding our business strategy to include 503B compounding as a dual-path approach to bring some of our proprietary formulations to market as soon as practicable while we continue to pursue FDA approval of our product candidates.

503B compounding refers to the production and supply of compounded drugs by 503B-registered outsourcing facilities without patient-specific prescriptions in accordance with Section 503B of the FDCA.

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.

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.

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

Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil 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 vasomotor symptoms, also known as hot flashes;

and DARE-HPV, a proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert being developed as a non-surgical, localized, self-administered therapy for clearance of persistent high-risk human papillomavirus (HPV) infection.

Our business strategy is to in-license or otherwise acquire the rights to intellectual property and know-how that enables us to develop and bring to market differentiated evidence-based solutions that we believe can address unmet needs in women’s health and enhance outcomes and convenience, and that represent compelling and meaningful market opportunities.

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We may pursue regulatory approval of a product candidate through clinical development or, if the active pharmaceutical ingredient is on the FDA’s list of bulk drug substances for which there is a clinical need, we may seek to bring it to market under Section 503B of the FDCA.

In certain circumstances, as discussed in more detail below with respect to our proprietary Sildenafil Cream formulation, we may pursue both pathways.

In certain circumstances, as discussed in more detail elsewhere in this "Business" section, we may pursue both pathways.

Additionally, our strategy includes bringing Daré-branded non-prescription products to market, representing another pathway to expand our commercial portfolio and offer additional evidence-based solutions to address gaps in women's health.

We believe having alternative pathways allows us to bring solutions to market as soon as practicable and optimizes access for women in a fiscally responsible manner.

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

We are primarily focused on our existing programs.

However, we also explore opportunities to expand our portfolio through both business development activities that may result in acquiring, or acquiring access to, new intellectual property rights and know-how through in-licensing or other collaborative arrangements, and leveraging platform technology assets we previously acquired or in-licensed from third parties that can be modified with different active pharmaceutical ingredients to address multiple indications.

As with our current portfolio, we seek innovations in women’s health that have (a) attractive market opportunities with the potential to address an unmet need, including through new formulations, manners of application or delivery methods of well-known drug substances that result in novel product candidates customized for women, (b) human proof-of-concept clinical data previously generated by third parties, (c) potential to utilize the FDA's 505(b)(2) pathway, and/or (d) potential to become a first-in-category or first-line product.

We consider a candidate to have potential to become a “first-in-category” product when we believe that, if the candidate were to successfully complete clinical development and receive marketing approval for the use for which it is being developed, or for which we anticipate developing it, the product would address a need in women’s health that is not being met by existing FDA-approved products.

As with our current portfolio, we will opportunistically explore innovations in women’s health that have (a) attractive market opportunities with the potential to address an unmet need, including through new formulations, manners of application or delivery methods of well-characterized drug substances that could result in novel products customized for women, (b) human proof-of-concept clinical data previously generated by third parties, (c) potential to utilize the FDA's 505(b)(2) pathway or be brought to market via Section 503B compounding, and/or (d) potential to become a first-in-category or first-line product.

We consider a candidate to have potential to become a “first-in-category” product when we believe that, if the candidate were to successfully complete clinical development and receive FDA marketing approval for the use for which it is being developed, or for which we anticipate developing it, the product would address a need in women’s health that is not being met by existing FDA-approved products.

Key elements of our business strategy are as follows:

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• Advance clinical development of the product candidates in our portfolio through mid- to late-stage clinical development or regulatory approval .

In 2024, we continued to make important progress in the clinical development of our product candidates, including with ongoing enrollment in the pivotal Phase 3 study of Ovaprene.

• Explore opportunities to expand our portfolio, with evidence-based solutions for women’s health as our sole focus .

While simultaneously advancing our current portfolio, we intend to continue to identify other important areas of unmet need in women’s health and to explore opportunities to build our portfolio by acquiring or in-licensing new programs or leveraging assets we previously acquired or in-licensed to create new programs that meet our selection criteria.

In 2025, we continued to make important progress in the clinical development of our product candidates, including with our ongoing pivotal Phase 3 clinical study of Ovaprene.

• Pursue strategic collaborations to fund our business, enhance our development and commercialization capabilities, and/or commercial offerings, optimizing for access in a fiscally responsible manner.

With respect to our product candidates, we intend to develop and maintain strategic relationships with commercial-stage companies that are leaders or emerging leaders in women’s health, as well as with other entities, where we believe such collaborations will help fund our business or accelerate or otherwise improve upon our clinical development and regulatory strengths and/or product manufacturing and commercialization capabilities.

With respect to 503B compounding, we intend to develop and maintain relationships with Section 503B-registered outsourcing facilities to help bring our proprietary formulations to market.

Examples of strategic collaborations to date include our license agreement with Organon to commercialize XACIATO, and our license agreement with Bayer to commercialize Ovaprene, if approved and the license becomes effective.

With respect to 503B compounding, we intend to develop and maintain relationships with Section 503B-registered outsourcing facilities, dispensing pharmacies, telehealth providers, and other third parties to help bring our proprietary formulations to market.

Examples of current strategic collaborations include our license agreement with Organon to commercialize XACIATO, and our arrangements with Bravado Pharmaceuticals, LLC, under which it manufactures DARE to PLAY and fulfills prescription, and Medvantx, a pharmacy services provider, acting as a logistics agent, telehealth platform provider, and dispensing pharmacy for DARE to PLAY.

• Explore opportunities to expand our portfolio, with evidence-based solutions for women’s health as our sole focus .

While simultaneously advancing our current portfolio, we intend to continue to identify other important areas of unmet need in women’s health and to explore opportunities to build our

portfolio by acquiring or in-licensing new programs or leveraging assets we previously acquired or in-licensed to create new programs that meet our selection criteria.

• Seek non-dilutive sources of funding to support product development.

We intend to advance development of our product candidates through a variety of means, including through non-dilutive funding and potential revenue from 503B compounding.

To date, we have received non-dilutive

funding from federal government agencies and/or a private foundation to support various aspects of our research and development activities, from preclinical discovery to a Phase 3 clinical study, for eight of our programs.

We intend to advance development of our product candidates through a variety of means, including through non-dilutive funding and revenue from 503B compounding and non-prescription products.

To date, we have received non-dilutive funding from U.S.

federal government agencies and/or a private foundation to support various aspects of our research and development activities, from preclinical discovery to a Phase 3 clinical study, for eight of our programs.

We intend to continue to explore grants and other forms of non-dilutive funding to support development of our product candidates.

XACIATO (clindamycin phosphate) vaginal gel, a lincosamide antibacterial, received FDA approval in December 2021 for the treatment of bacterial vaginosis in female patients 12 years of age and older.

XACIATO is our first and, to date, only approved product.

Section 503B Compounding

As discussed above, in March 2025, we announced an expansion of our business model to include bringing to market select proprietary formulations as compounded drug products via Section 503B-registered outsourcing facilities.

In assessing which of our proprietary formulations are candidates for Section 503B compounding, in addition to the drug substance(s) being on the FDA’s interim 503B Category 1 list of bulk drug substances, we take into account whether we believe the formulation is ready for cGMP manufacturing at scale to meet potential market demand and that the data from nonclinical and clinical studies of the formulation to date will be compelling to healthcare providers.

Our 503B compounding products are and will be prescription drug products as required by Section 503B of the FDCA.

Section 503B-registered outsourcing facilities must be registered with the FDA, must comply with cGMP requirements, which better ensures quality, strength and consistency of the product, and are subject to FDA inspections.

Compounded drugs are not FDA-approved products.

The FDA does not evaluate compounded drug products for safety or effectiveness.

We do not believe bringing our select proprietary formulations to market via Section 503B compounding will negatively impact the regulatory process or commercial opportunity for an FDA-approved product utilizing the same proprietary formulation.

To execute our Section 503B compounding strategy, among other things, we have entered into and will need to maintain arrangements with one or more FDA-registered Section 503B outsourcing facilities, dispensing pharmacies, telehealth platform providers, and other third parties with marketing, sales or distribution capabilities in the Section 503B market, and we intend to expand our collaborations and vendors as we grow this aspect of our business.

We will oversee the overall brand direction for our 503B compounding products , as well as medical education and awareness, including marketing, advertising, and healthcare provider and patient education.

We intend to focus our resources on provider-to-provider education about disease states and our proprietary formulations, leveraging online resources, including web-based ordering platforms and collaborations with telehealth platforms and other third parties.

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 to bring our proprietary formulations to market under Section 503B.

The DARE Health Hub was created as a branded online platform through which healthcare providers can submit prescriptions for our Section 503B compounded drugs, and to support integrated telehealth services and to provide patient-facing order management and communications.

When we use the term “Section 503B,” “Section 503B compounding,” "503B compounding," or similar terms, we refer to Section 503B of the FDCA and the production and supply of compounded drugs by FDA-registered Section 503B outsourcing facilities without patient-specific prescriptions in accordance with Section 503B of the FDCA.

See "Government Regulation—U.S.

Government Regulation—Regulation of Compounded Drugs” below for additional information regarding compounding under Section 503B of the FDCA.

DARE to PLAY Sildenafil Cream

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

As discussed in more detail below, in 2018, we acquired exclusive, worldwide rights to develop and commercialize this formulation for all indications for women related to female sexual dysfunction and/or female reproductive health under a license and collaboration agreement with Strategic Science & Technologies-D LLC and Strategic Science & Technologies, LLC (referred to collectively as SST), and we have completed a Phase 2b clinical study of this formulation that, to our knowledge, was the first clinical trial specifically evaluating a potential therapy for the treatment of female sexual arousal disorder, for which there currently are no FDA-approved products.

DARE to PLAY Sildenafil Cream is our branded 503B-compounded drug product utilizing the same formulation of sildenafil citrate evaluated in our completed Phase 2b clinical study.

Sildenafil citrate is on the FDA's interim 503B Category 1 list of bulk drug substances that may be used in compounding.

DARE to PLAY, a topically applied formulation of sildenafil, will address an area of women’s health that has been historically underserved and stigmatized, and will be a first-of-its-kind product in that, to our knowledge, there are no other topical cream sildenafil products manufactured in accordance with cGMP requirements and supported by clinical data demonstrating increased genital blood flow within 10-15 minutes of application and improvements in arousal sensations using clinically validated and FDA-reviewed endpoints.

We believe the product’s positioning – science-backed, evidence-driven, and female-focused – sets a new benchmark for credibility in the female sexual wellness category.

The product currently is available for pre-fulfillment, which means that women may complete a telehealth consultation or in-person clinician visit and have a prescription written and held at the dispensing pharmacy, with prescription fulfillment and payment to 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.

We have entered into an arrangement with a Section 503B-registered outsourcing facility, Bravado Pharmaceuticals, LLC, or Bravado, under which Bravado manufactures DARE to PLAY and fulfills prescription orders through Medvantx, a dispensing pharmacy.

Bravado is responsible for obtaining all state-level pharmacy and outsourcing facility licenses required to fulfill DARE to PLAY prescriptions.

DARE to PLAY’s availability in any given state depends on Bravado's maintenance of the requisite licensure in that state.

We have sublicensed our proprietary topical cream formulation of sildenafil to Bravado for use in manufacturing DARE to PLAY.

Medvantx operates the DARE Health Hub and, on behalf of Bravado, verifies and processes healthcare provider-submitted prescriptions for DARE to PLAY.

Medvantx also manages patient communications and coordinates with Bravado for the shipment and delivery of fulfilled prescriptions to patients.

Medvantx also collects payment from patients at the time of order and, following fulfillment of prescriptions, remits our portion of the revenue to us, after deduction of its fees.

Royalties payable to third parties based upon net sales of DARE to PLAY are paid out of the amounts we receive from Medvantx.

See "Strategic Agreements for Pipeline Development—SST License and Collaboration Agreement" and “Royalty Monetization Transactions—Traditional and Synthetic Royalty Purchase Agreements with XOMA,” below for discussion of such royalties.

DARE to PLAY is currently offered on a cash-pay basis only, and patients pay for the product directly when they place their order.

As a compounded drug, DARE to PLAY is not covered by insurance and is not eligible for reimbursement through government or commercial health plans, including Medicare and Medicaid, or under insurance formularies applicable to FDA-approved prescription drug products.

DARE to RECLAIM™ estradiol progesterone intravaginal ring

We are also taking action to bring our proprietary estradiol progesterone intravaginal ring (DARE-HRT1) to market under Section 503B.

As discussed in more detail below, in 2018, we acquired exclusive, worldwide rights enabling us to develop and commercialize this product via a license agreement with Catalent JNP (formerly known as Juniper Pharmaceuticals, Inc.), and we have completed Phase 1 and Phase 1/2 clinical studies of DARE-HRT1.

The 503B-compounded product will be branded as DARE to RECLAIM estradiol progesterone intravaginal ring, or DARE to RECLAIM.

DARE to RECLAIM will utilize the same formulation of bio-identical 17β-estradiol and bio-identical progesterone and intravaginal ring technology evaluated in our completed Phase 1 and Phase 1/2 clinical studies of DARE-HRT1.

Each of estradiol and progesterone is on the FDA’s interim 503B Category 1 list of bulk drug substances.

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

DARE to RECLAIM, our intravaginal ring formulation of bioidentical 17β-estradiol and bio-identical progesterone will be a non-oral, monthly hormone therapy.

While there are many products on the market targeted to or FDA-approved for the treatment of menopausal symptoms, and both the supplement and compounded hormone therapy markets are very significant, we believe DARE to RECLAIM has the potential to address a preference among some women and healthcare providers for bio-identical hormones delivered in a non-oral route, as well as offer the convenience of an option that is self-administered and does not require daily intervention because each intravaginal ring is meant to be in place for 28 days.

There are no FDA-approved products that provide estradiol and progesterone together in a non-oral monthly form, and, to our knowledge, there are no compounded products that provide estradiol and progesterone together in a self-administrable, non-oral, monthly form.

As with DARE to PLAY, we intend to make DARE to RECLAIM available for prescription fulfillment in the United States through a Section 503B registered outsourcing facility, which will not be the same facility that manufactures DARE to PLAY, and Medvantx as the dispensing pharmacy.

We intend to utilize the DARE Health Hub as the commercial platform through which healthcare provider-submitted prescriptions will be verified and processed, and we expect it will be available on a cash-pay basis only, without insurance coverage or third-party payor reimbursement.

Consumer Health Products - DARE to RESTORE

As part of our expanded business model, in addition to 503B compounding, we are working to bring to market in the United States a line of consumer health products branded as the DARE to RESTORE family of products.

When we use the term “consumer health products,” we refer to consumer health products that can be obtained without a physician's prescription, because they are all classified as cosmetics.

DARE to RESTORE products will be vaginal probiotic suppositories designed to support vaginal microbiome balance.

Our first DARE to RESTORE product, Flora Sync LF5, a vaginal probiotic suppository sourced from Italy, is expected to become commercially available in the U.S.

in the second quarter of 2026.

The formulation, developed by Probiotical S.p.A.

using its proprietary LF5 probiotic strain, is based on scientific research into vaginal microbiome composition and health.

Probiotical will manufacture Flora Sync LF5 exclusively for us in the U.S.

Because of the low regulatory barriers to entry, numerous vaginal probiotic products are marketed directly to consumers as dietary supplements or cosmetics.

Since no clinical studies or evidence of effect on the vaginal microbiome are required for these products to reach market, most lack strain-specific clinical data.

By contrast, Probiotical has invested in research to characterize and clinically evaluate its proprietary LF5 strain, which has been studied in multiple human clinical trials, with findings published in peer-reviewed journals.

We believe that level of evidence distinguishes Flora Sync LF5 from the majority of vaginal probiotic products currently available to consumers.

Probiotical has additional proprietary strains and products that align with the objectives of the DARE to RESTORE brand family, and we expect to continue exploring opportunities to expand the DARE to RESTORE commercial offering through additional collaborations with Probiotical.

Similar to our plans with respect to our Section 503B business strategy, we do not have, and currently do not intend to build, our own marketing, sales or distribution infrastructure to commercialize our DARE to RESTORE products, but rather we plan to utilize a capital-efficient path to market that leverages targeted direct-to-consumer and healthcare professional marketing initiatives to build awareness, including digital campaigns, webinars, social media education, and advocacy programs, as well as strategic agreements and collaborations with third parties with marketing, sales or distribution capabilities in the consumer health products market.

We intend to distribute DARE to RESTORE products through the DARE Health Hub, consistent with the commercial infrastructure being built around DARE to PLAY.

The dispensing pharmacy's role for DARE to RESTORE product offerings is expected to include online order management, payment processing, and fulfillment logistics, similar to its role in connection with DARE to PLAY, though the absence of a prescription requirement simplifies certain aspects of the fulfillment process for DARE to RESTORE product offerings.

We may also pursue additional distribution channels for DARE to RESTORE product offerings, including direct-to-consumer e-commerce and consumer retail.

The DARE to RESTORE vaginal probiotic products are intended to be complementary to our Section 503B prescription offerings.

For example, healthcare providers may recommend DARE to RESTORE products in conjunction with DARE to PLAY as part of a comprehensive approach to women's vaginal and sexual health.

We intend to build awareness of the DARE to RESTORE products among the consumer and the healthcare provider community that is already engaged with the DARE Health Hub in connection with DARE to PLAY.

XACIATO (clindamycin phosphate) vaginal gel, a lincosamide antibacterial, received FDA approval in December 2021 as a single-dose prescription medication for the treatment of bacterial vaginosis in female patients 12 years of age and older.

XACIATO is our first, and to date, our only product with FDA approval for marketing.

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

We commenced and completed a successful pivotal clinical study, prepared and filed a new drug application, or NDA, with the FDA and received notification from the FDA of U.S.

marketing approval, all during the COVID-19 pandemic.

In 2022, we licensed to Organon exclusive worldwide rights to develop, manufacture and commercialize XACIATO.

See "Strategic Agreements for Product Commercialization" below for further discussion of the terms of our agreement with Organon.

We remained the NDA holder of XACIATO until December 2023, at which time the NDA was transferred by the FDA to Organon, and Organon assumed all manufacturing responsibilities, regulatory and compliance matters.

Organon is also responsible for commercializing, promoting, determining pricing, and negotiating reimbursement matters related to XACIATO.

Organon commenced U.S.

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

As described below, to provide funding for the development of the product candidates in our pipeline, in April 2024, we sold to XOMA 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.

See below under "Royalty Monetization Transactions" for additional details.

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

See "Organon Exclusive License Agreement," below for further discussion of the terms of our license agreement with Organon.

XACIATO previously received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for the treatment of bacterial vaginosis in women.

As a result of the QIDP designation, XACIATO was eligible to receive a five-year extension of the three years of data exclusivity in the U.S.

As a result of the QIDP designation, XACIATO was

eligible to receive a five-year extension of the three years of data exclusivity in the U.S.

available to the product based on the submission of new clinical data that were essential to its approval.

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Ovaprene is a novel, investigational hormone-free monthly intravaginal contraceptive designed to be worn conveniently over multiple weeks (one menstrual cycle) that currently is being evaluated in a pivotal Phase 3 clinical study.

Based on the results of our pre-pivotal postcoital test, or PCT, clinical trial, as discussed below, we believe Ovaprene has the potential to achieve “typical use” contraceptive efficacy in the range of approximately 86% to 91% at 6-months, which approaches the approximately 93% typical use efficacy at 12-months of current FDA-approved non-implanted, non-injected hormonal contraceptive methods (pills, patches and vaginal rings).

Based on the results of our pre-pivotal postcoital test, or PCT, clinical trial, as discussed below, we believe Ovaprene has the potential to achieve “typical use” contraceptive efficacy in the range of approximately 86% to 91% during the first six months of use, which approaches the approximately 93% typical use efficacy rate expected during the first year of use of current FDA-approved non-implanted, non-injected hormonal contraceptive methods (pills, patches and vaginal rings).

Typical use contraceptive efficacy refers to the expected rate of pregnancy prevention during the first year of actual use of a method, including sometimes using the method in a way that is not correct or not consistent.

Ovaprene features a proprietary knitted polymer barrier to physically block sperm from entering the cervical canal within a silicone-reinforced ring that releases non-hormonal agent ferrous gluconate to impede sperm motility.

Unlike current FDA-approved monthly intravaginal contraceptives, Ovaprene does not contain hormones, but, consistent with those monthly intravaginal contraceptives, including Merck’s NuvaRing®, Ovaprene is designed to be a “one size fits most”

monthly, self-administered product.

If approved, Ovaprene could be the first hormone-free, monthly contraceptive option for women.

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Pivotal Phase 3 Clinical Study

In December 2023, we announced commencement of the multi-center, single arm, non-comparative, pivotal Phase 3 clinical study of Ovaprene to evaluate its effectiveness as a contraceptive along with its safety and acceptability (ClinicalTrials.gov ID:

Enrollment is ongoing in our pivotal Phase 3 multi-center, single arm, non-comparative clinical study of Ovaprene to evaluate its effectiveness as a contraceptive along with its safety and acceptability (ClinicalTrials.gov ID:

NCT06127199).

The study aims to enroll sufficient participants across approximately 20 study sites in the U.S.

to have approximately 250 participants complete approximately 12 months (13 menstrual cycles) of use.

Based on typical dropout rates for contraceptive efficacy studies, we will seek to enroll more than double the number of subjects we target to complete 13 menstrual cycles of use.

Twenty clinical research sites from within the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD) Contraceptive Clinical Trials Network (CCTN) were trained on the protocol and were initiated to start screening and enrolling participants in late 2023 and early 2024.

Currently, there are 15 active NICHD CCTN sites following enrolled participants in the study.

Enrollment is currently proceeding at five study sites that were initiated in 2025, funded by a grant we received in 2024 from the Gates Foundation, or the Foundation, to accelerate the overall study timeline.

We anticipate that approximately 125 women, which is half of our target number of participants to complete the study, will complete approximately six months of Ovaprene use by the end of the second quarter of 2025.

This is a designated check point for review of interim data by the study's data safety monitoring board, or DSMB, an independent group of experts which evaluates the safety and integrity of the study.

The study aims to enroll sufficient participants to have approximately 250 participants complete approximately 12 months (13 menstrual cycles) of use.

Based on typical dropout rates for contraceptive efficacy studies, we may seek to enroll more than double the number of subjects we target to complete 13 menstrual cycles of use.

Participants are being recruited and enrolled at five study sites in the U.S.

that were initiated in 2025 with the support of grant funding we received in November 2024.

We do not anticipate initiating additional study sites.

The primary objective of the study is to assess the typical use pregnancy rate over 13 menstrual cycles, or the estimated Pearl Index for Ovaprene.

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If successful, we expect the study to support the submission of a premarket approval application for Ovaprene to the FDA, as well as regulatory filings in Europe and other countries worldwide, to allow for marketing approvals of Ovaprene.

We currently anticipate enrollment will be completed in 2026, and plan to provide further updates regarding anticipated enrollment and study completion targets in the second half of this year.

In July 2025, the study’s data safety monitoring board (DSMB), an independent group of experts which evaluates the safety and integrity of the study, conducted a planned interim analysis and recommended the study continue without modification.

No new safety or tolerability concerns were identified.

At the time of the interim analysis, approximately 9% of the women treated in the study had experienced a pregnancy.

Approximately 17% of participants discontinued the study due to vaginal odor, the most commonly reported product-related adverse event.

No serious safety concerns were identified, and overall tolerability was favorable.

As of the interim analysis, approximately 115 participants were ongoing or had completed the study.

In accordance with the Investigational Device Exemption for Ovaprene, we provided an annual report to the FDA with data collected from the study through September 15, 2025 regarding safety, tolerability and pregnancy experiences.

Such data was consistent with the data analyzed by the DSMB during the July 2025 planned interim analysis.

The Phase 3 study is being conducted, in part, under our Cooperative Research and Development Agreement, or CRADA, with the U.S.

Department of Health and Human Services (HHS), as represented by the NICHD, part of the U.S.

National Institutes of Health (NIH), and within the CCTN.

Under the CRADA, we and NICHD each provide medical oversight and final data review and analysis for the study at these sites and will work together to prepare the final report of the results of the study from these sites.

We are responsible for providing clinical supplies of Ovaprene, coordinating interactions with the FDA, preparing and submitting supportive regulatory documentation, and providing a total of $5.5 million to NICHD to be applied toward the costs of conducting the Phase 3 study, all of which had been paid as of September 30, 2024.

NICHD is responsible for the other costs related to the conduct of the Phase 3 study and for managing the payment of expenses to the contract research organization for the study, the clinical sites, and other parties involved with the study.

Executive orders and other actions taken by the new 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.

In particular, the NICHD process to enter into contract modifications with the CCTN sites participating in the study in the same manner as it would ordinarily do to provide additional funding to those sites within the current budget under the CRADA has been impacted and remains uncertain.

As a result, to help ensure the CCTN sites remain active for continued follow-up with existing study participants, we and NICHD agreed to pause recruitment of new participants at the CCTN sites.

This pause in recruitment at the CCTN sites does not effect the anticipated timing for reaching the designated check point for DSMB review.

Depending on its duration, it could adversely impact the overall enrollment rate for the study and increase the time and cost to us to complete the study.

In addition, most of the CCTN sites participating in the study are part of colleges or universities, and the federal government recently has terminated or threatened to terminate grants and contracts with colleges and universities, including clinical study contracts with at least one university that is a CCTN site in our study.

To date, these developments have not materially impacted the study, however, if NICHD is unable to enter into new contracts or contract modifications with CCTN sites for a prolonged period, or terminates its contracts with CCTN sites in our study before the study follow-up visits with existing participants are completed or before the study is completed, we may determine to contract directly with those sites to enable them to restart recruitment and enrollment of new participants and/or ensure they remain active sites to continue follow-up with existing participants, which could increase the time and cost to us to complete the study.

There is a high level of uncertainty relating to U.S.

government contracts and funding and regulation of research and development, as well as the functioning and funding of many federal government departments and agencies in general, and future developments may significantly delay or jeopardize the completion of the Phase 3 study and significantly increase the cost of the study to us.

Further, depending on the duration of the enrollment period and number of subjects enrolled in the Phase 3 study, there may be future costs associated with the study that are not reflected in the current budget under the CRADA for the CCTN sites.

We and NICHD have been in discussions regarding the CRADA, which are continuing and which may include discussing a mechanism to potentially provide for additional future payments by us in support of the Phase 3 study for the CCTN sites to complete subjects already enrolled, in the event that the currently budgeted CRADA funds are insufficient.

As discussed above, we have contracted directly with five new study sites, which began recruiting in the

first quarter of 2025, with the support of grant funding we received from the Foundation.

At this time, due to the uncertainty regarding the CCTN sites and because the five new study sites only recently began participant recruitment, we cannot reasonably predict the enrollment rate for the remainder of the study or an estimated time for completion of enrollment.

We are collaborating with ADVA-Tec, Inc., or ADVA-Tec, and Bayer HealthCare LLC, or Bayer, for the development and commercialization of Ovaprene as part of two strategic collaborations announced in March 2017 and January 2020, respectively.

See "Strategic Agreements for Pipeline Development" and "Strategic Agreements for Product Commercialization" below for discussion of the terms of e ach collaboration.

Department of Health and Human Services (HHS), as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD), part of the U.S.

National Institutes of Health (NIH).

Twenty clinical research sites from within NICHD's Contraceptive Clinical Trials Network (CCTN) were trained on the protocol and were initiated to start screening and enrolling participants in late

2023 and early 2024.

In the first quarter of 2025, in connection with the change in U.S.

presidential administrations and due to uncertainty regarding the future NICHD budget for the CRADA following U.S.

federal policy changes and executive orders, we and NICHD agreed to pause recruitment of new participants at all 15 of the CCTN study sites then following enrolled participants to help ensure the CCTN sites would remain active for continued follow-up with those participants.

We will not resume recruitment of participants at the CCTN sites.

CCTN sites with ongoing subjects are expected to remain open to complete follow-up visits with those participants.

The CRADA will expire in accordance with its terms in July 2026.

We do not expect the expiration of the CRADA to have a negative impact on the Phase 3 study.

See "Strategic Agreements for Pipeline Development—Cooperative Research and Development Agreement with NICHD, below for additional information regarding the CRADA.

We are collaborating with ADVA-Tec, Inc., or ADVA-Tec, for the development and commercialization of Ovaprene as part of a strategic collaboration announced in March 2017.

See "Strategic Agreements for Pipeline Development" below for discussion of the terms of the collaboration.

We previously were also collaborating on Ovaprene with Bayer Healthcare LLC, or Bayer, under a license agreement entered into in January 2020.

Under the license agreement, 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.

Sildenafil Cream, 3.6%

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Based on data from the Phase 2b RESPOND study and feedback from the FDA, we are preparing to advance Sildenafil Cream into a Phase 3 clinical study for the treatment of FSAD.

A second confirmatory Phase 3 study will be required to support an NDA submission.

Based on prior communications with the FDA, we currently believe a second confirmatory Phase 3 study will be required to support an NDA submission.

We plan to leverage the existing data and established safety profile of sildenafil and the Viagra® brand to utilize the FDA’s 505(b)(2) pathway to obtain marketing approval of Sildenafil Cream in the U.S.

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Clinical Data

In a Phase 1 clinical study conducted by our licensor Strategic Science and Technologies, LLC, or SST, of three escalating doses of topical sildenafil cream (1 g cream with 35 mg sildenafil;

In a Phase 1 clinical study conducted by our licensor SST of three escalating doses of topical sildenafil cream (1 g cream with 50 mg sildenafil;

2 g cream with 100 mg sildenafil;

and 4 g cream with 142 mg sildenafil) in 20 healthy postmenopausal women using a crossover study design, topical sildenafil cream demonstrated significantly lower systemic exposure to sildenafil compared to a 50 mg oral sildenafil dose, and topical sildenafil cream was well tolerated at clinically relevant doses (1-2 g cream).

and 4 g cream with 200 mg sildenafil) in 20 healthy postmenopausal women using a crossover study design, Sildenafil Cream (then known as SST-6007) demonstrated significantly lower systemic exposure to sildenafil compared to a 100 mg oral sildenafil dose administered to men in a separate clinical study, and was well tolerated at clinically relevant doses (1-2 g cream).

Study subjects reported favorable product characteristics:

easy to use and readily absorbed.

In a Phase 2a, single center, single-dose, double-blind, placebo-controlled, 2-way crossover study conducted by SST, women with FSAD, ages 21 to 60, received a single 2 g dose of Sildenafil Cream.

Specifically, the geometric mean maximum plasma concentration of sildenafil in the postmenopausal women in the Phase 1 stucy, after exposure to the 200 mg dose, was 5,262 pg/mL compared to the maximum plasma concentration of sildenafil of 450,000 pg/ML, after exposure to a 100 mg oral dose administered to men in the separate clinical study.

Therefore, systemic exposure after the administration of topical sildenafil to postmenopausal women was almost two orders of magnitude lower than seen with oral administration in that separate study.

All treatment emergent adverse events were mild, with the most common event being headache, followed by a mild genital burning sensation with product application.

In a Phase 2a, single center, single-dose, double-blind, placebo-controlled, 2-way crossover study conducted by SST, women with FSAD, ages 21 to 60, received a single 2 g dose of Sildenafil Cream (then known as SST 6007).

Of the 35 women enrolled, 31 (15 premenopausal and 16 postmenopausal) completed the study.

The primary objective was to evaluate the efficacy of Sildenafil Cream compared to placebo cream assessed by participant-reported levels of subjective

cognitive sexual arousal and by physiological genital arousal response.

Sildenafil Cream demonstrated increases in measurable blood flow to the genital tissue compared to placebo (mean change in vaginal pulse amplitude analysis) using a vaginal photoplethysmograph approximately 30 minutes post-dosing.

The co-primary objectives were (1) to evaluate the preliminary efficacy of Sildenafil Cream compared to placebo cream in women with FSAD assessed by participant-reported levels of subjective sexual arousal measured continuously by the Arousometer, and (2) to evaluate the effect of Sildenafil Cream compared to a placebo cream on physiological genital response in women with FSAD assessed using the vaginal photoplethysmography amplitude (VPP) and by physiological genital arousal response.

Each participant was randomized to the order of use of the placebo cream and Sildenafil Cream in a cross over design.

There was a 4-8 day washout between treatments.

For each treatment, participants had Arousometer and VPP data collected while viewing a 3-minute neutral, non-erotic film.

After the neutral film, the study product was applied and after 5-11 minutes, the participant viewed a 6-minute erotic film with collection of Arousometer and VPP data.

There were two different 6-minute erotic films so that the participant did not view the same erotic film with both study product treatments.

The VPP data was used to calculate vaginal pulse amplitude (VPA) as a more objective measure of arousal.

For the intent to treat population, there was no significant difference in the VPA while viewing the erotic film when participants used Sildenafil Cream versus when they used placebo cream.

There was also no significant differences in the VPA when the per protocol population was analyzed by menopausal status (pre versus postmenopausal).

Similarly, for the subjective arousal response, measured by the Arousometer, for the intent to treat population, the Arousometer scores were similar when patients viewed the erotic film using Sildenafil Cream versus when they viewed the other erotic film using placebo cream.

The results remained not significant when the data was analyzed based on the per protocol population or by menopausal status.

Treatment with a single dose of 2 grams of Sildenafil Cream (71 mg sildenafil) applied intravaginally and externally to the labia minora and clitoris in study participants was well tolerated.

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In June 2023, we announced topline results from our exploratory Phase 2b RESPOND clinical study of Sildenafil Cream in premenopausal women with FSAD, and in July and November 2023, we announced additional findings based on further analyses of data from the study.

In 2024, several peer-reviewed journal articles were published on the study, including efficacy findings in Obstetrics & Gynecology , the official journal of the American College of Obstetricians and Gynecologists (ACOG), and safety findings in The Journal of Sexual Medicine , the official journal of the International Society for the Study of Women’s Sexual Health (ISSWHS).

In 2024, several peer-reviewed journal articles were published on the study, including efficacy findings in Obstetrics & Gynecology (2024 Aug 144(2):p 144-152), the official journal of the American College of Obstetricians and Gynecologists (ACOG), and safety findings in The Journal of Sexual Medicine (2024 Sep 3;21(9):793-799), the official journal of the International Society for the Study of Women’s Sexual Health (ISSWHS).

In February 2024, we presented additional findings from the study at the Annual Meeting of ISSWHS.

In addition, efficacy findings from the study were the featured topic of ACOG Green Room Gynecology Podcast in August 2024.

During the multi-center, double-blind, randomized, placebo-controlled study, subjects used Sildenafil Cream and placebo cream in their home setting over 12 weeks following a 4-week non-drug run-in period and a 4-week, single-blind placebo run-in period.

During the multi-center, double-blind, randomized, placebo-controlled study (ClinicalTrials.gov ID:

NCT04948151), subjects used Sildenafil Cream and placebo cream in their home setting over 12 weeks following a 4-week non-drug run-in period and a 4-week, single-blind placebo run-in period.

A total of 252 subjects were enrolled in the 4-week single-blind placebo run-in period and a total of 200 subjects were randomized to the 12-week double-blind dosing period.

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There were no differences in the number of treatment-related TEAEs among Sildenafil Cream versus placebo cream users (p>0.99).

Four Sildenafil Cream participants and three placebo cream participants discontinued the study due to TEAEs involving application site discomfort (p>0.99).

Four Sildenafil Cream participants and three placebo cream participants

discontinued the study due to TEAEs involving application site discomfort (p>0.99).

There were 9 TEAEs reported by 7 of 91 sexual partners exposed to Sildenafil Cream versus 4 TEAEs reported by 4 of 84 sexual partners exposed to placebo cream (p=0.54).

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Consistent with the Phase 2b RESPOND study, the planned Phase 3 study will include a 12-week, double-blind treatment period evaluating Sildenafil Cream compared to placebo cream in patients with FSAD with or without concomitant decreased desire.

The currently planned Phase 3 study will have co-primary efficacy endpoints- one assessing arousal sensations and one assessing associated distress, which will be the same co-primary endpoints for arousal sensations and associated distress used in the Phase 2b RESPOND study.

The currently planned Phase 3 study will have co-primary efficacy endpoints- one assessing arousal sensations and one assessing associated distress.

The SFQ28 Arousal Sensation Domain endpoint used in the Phase 2b RESPOND study will also be used in the planned Phase 3 study.

The question used to assess distress is anticipated to be from the same FSDS-DAO questionnaire used in the Phase 2b RESPOND study, but may be a different question about interpersonal difficulty.

In addition, secondary efficacy endpoints to assess improvement in orgasm, desire, and distress and interpersonal difficulties will be included in the Phase 3 study, as they were in the Phase 2b RESPOND study.

We plan to submit the protocol and statistical analysis plan for an adequate and well-controlled Phase 3 clinical study, reflecting the FDA’s recommendations, to the FDA in the second quarter of 2025, pending review of additional forthcoming recommendations from the FDA that impact our statistical analysis plan.

We are targeting 2025 for commencement of the Phase 3 study pending the forthcoming FDA recommendations.

We do not plan to conduct the Phase 3 study until after we secure additional capital.

A second confirmatory Phase 3 study will be required to support the NDA submission.

We anticipate that each

Phase 3 study will be approximately $15.0 million in direct R&D costs (as defined below).

We are developing Sildenafil Cream with Strategic Science & Technologies-D LLC and Strategic Science & Technologies, LLC (which we refer to collectively as SST) under our license and collaboration agreement announced in February 2018.

Based on prior communications with the FDA, we currently believe a second confirmatory Phase 3 study will be required to support an NDA submission.

In April 2025, we received additional input and information requests from the FDA regarding our patient reported outcomes (PRO) psychometrics for the Phase 3 study.

The PRO psychometrics analysis has bearing on efficacy endpoint selection and the statistical analysis plan for the Phase 3 study.

We submitted additional requested information to the FDA in the second quarter of 2025 related to the FSDS-DAO questions.

Pending additional feedback from the FDA, the timing of which is uncertain, and alignment with the FDA on the protocol and statistical analysis plan, we cannot determine whether our prior estimate of capital required to conduct the Phase 3 studies is appropriate.

We do not plan to conduct the Phase 3 study until after we achieve alignment with the FDA on the protocol and statistical analysis plan and secure the capital required to conduct the Phase 3 study based on such protocol and statistical analysis plan.

We do not anticipate initiating the first Phase 3 study in 2026 and cannot at this time reasonably predict when the study will commence.

We are developing Sildenafil Cream with SST under our license and collaboration agreement announced in February 2018.

See “Strategic Agreements for Pipeline Development” below for discussion of the terms of this collaboration.

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of DARE-HRT1 for the treatment of moderate-to-severe VMS due to menopause in women with intact uteri.

Based on pre-IND communications with the FDA and the topline PK data from our Phase 1/2 clinical trial of DARE-HRT1, which is discussed below, we believe FDA approval of DARE-HRT1 for that indication is achievable via the FDA's 505(b)(2) pathway supported by a single, placebo-controlled Phase 3 clinical trial of DARE-HRT1, with safety evaluations out to 12 months, and a scientifically justified PK “bridge” (via a relative bioavailability trial) between DARE-HRT1 and the selected listed estradiol and progesterone drugs.

Based on pre-IND communications with the FDA and the PK data from our Phase 1/2 clinical trial of DARE-HRT1, which is discussed below, we believe FDA approval of DARE-HRT1 for that indication is achievable via the FDA's 505(b)(2) pathway supported by a single, placebo-controlled Phase 3 clinical trial of DARE-

HRT1, with safety evaluations out to 12 months, and a scientifically justified PK “bridge” (via a relative bioavailability trial) between DARE-HRT1 and the selected listed estradiol and progesterone drugs.

We are conducting activities necessary to enable submission of an IND application to the FDA for a pivotal Phase 3 clinical study of DARE-HRT1.

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In January 2023, data from our Phase 1 clinical trial of DARE-HRT1 conducted by our wholly owned subsidiary in Australia were published in Menopause:

The Journal of The North American Menopause Society, or the Menopause journal, in an article entitled, “Evaluation of 28-day estradiol and progesterone vaginal rings in a phase 1 clinical pharmacokinetic study.” We previously announced positive topline results from the study in June 2021.

We previously announced positive topline results from the study in June 2021.

The randomized, open-label, three-arm, parallel group trial evaluated the PK and safety of DARE-HRT1 in approximately 30 healthy, postmenopausal women with intact uteri, and was conducted by our wholly-owned Australian subsidiary at two specialty women's health sites in Australia.

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DARE-HRT1 has also been evaluated in a Phase 1/2 clinical trial conducted by our wholly owned subsidiary in Australia.

The randomized, open-label, two-arm, parallel group Phase 1/2 study of DARE-HRT1 was designed to

evaluate the PK of the same two versions of DARE-HRT1 as were evaluated in our earlier Phase 1 clinical study, the 80/4 IVR and the 160/8 IVR, in approximately 20 healthy, postmenopausal women with intact uteri.

The randomized, open-label, two-arm, parallel group Phase 1/2 study of DARE-HRT1 was designed to evaluate the PK of the same two versions of DARE-HRT1 as were evaluated in our earlier Phase 1 clinical study, the 80/4 IVR and the 160/8 IVR, in approximately 20 healthy, postmenopausal women with intact uteri.

In the study, women were randomized (1:1) to either the 80/4 IVR or the 160/8 IVR and used DARE-HRT1 for three 28-day cycles, inserting a new IVR monthly.

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All TEAEs were mild or moderate and were distributed similarly among the 80/4 IVR and the 160/8 IVR users.

The second article ( Menopause 30(9):p 940-946, September 2023) found that (a) preliminary local GSM treatment efficacy was supported by significant decreases in vaginal pH and percentage (%) parabasal cells, and significant increases in the overall VMI and % superficial cells for both DARE-HRT1 groups (all P values <0.01) and (b) preliminary VMS efficacy was supported by significant decreases in all domains of the MENQOL questionnaire from baseline for both dosing groups (all P values <0.01).

values <0.01) and (b) preliminary VMS efficacy was supported by significant decreases in all domains of the MENQOL questionnaire from baseline for both dosing groups (all P values <0.01).

Both articles concluded that data from the Phase 1/2 study support further development of DARE-HRT1 for the treatment of menopausal symptoms.

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See “Strategic Agreements for Pipeline Development” below for discussion of the terms of that agreement.

DARE-HPV (formerly referred to as R-131-2 and DARE-CIN) is an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert, which we plan to develop for the treatment of genital human papillomavirus (HPV) infection in women as well as treatment of cervical intraepithelial neoplasia, or CIN (also known as cervical dysplasia), and other HPV-related pathologies.

CIN is a precancerous condition in women strongly linked to HPV infection, the most common sexually transmitted infection in the U.S.

Disease severity is classified on a scale from one to three based on how much epithelial tissue in the cervix has abnormal cells.

Essentially all cervical cancers worldwide are caused by infection with one of 14 carcinogenic, or “high-risk” HPV types.

While HPV vaccination continues to be a key tool, we believe HPV treatments will also continue to be a key pillar in cervical cancer prevention due to suboptimal vaccine uptake and because the vaccine doesn’t cover all strains of high-risk HPV.

While most HPV infections resolve spontaneously, millions of women experience persistent high-risk HPV infection.

There is no FDA-approved treatment for HPV infection and no non-surgical pharmaceutical intervention to treat CIN2 or CIN3 (collectively referred to as CIN2+).

Today, the standard of care does not treat the virus.

Instead, women with persistent high-risk HPV infection are monitored through repeated screening.

Intervention typically occurs only after late-stage cervical lesions develop, often requiring surgical procedures such as excisional or ablative treatments of cervical tissue.

Current surgical procedures to treat cervical dysplasia are invasive and can adversely impact future pregnancies.

We believe a non-surgical, self-administered localized pharmaceutical approach that targets the virus itself rather than waiting for cellular changes to develop has the potential to redefine the treatment paradigm in cervical disease prevention.

In October 2024, we announced that we were selected by the Advanced Research Projects Agency for Health (ARPA-H), part of HHS, to receive up to $10 million in milestone-based payments over approximately two years to support the development of DARE-HPV, 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.

For more information about this funding, see Note 15, “Grant Awards," to our consolidated financial statements included in this report.

To date, we have received $7.5 million of the ARPA-H award.

In February 2026, we announced FDA clearance of our IND application for a Phase 2 clinical study of DARE-HPV to evaluate the safety and antiviral activity of DARE-HPV in women with persistent high-risk HPV infection.

The planned Phase 2 study is expected to be supported by ARPA-H award funding.

We will provide additional details regarding the Phase 2 study design and anticipated timelines for study initiation, which we are preparing for 2026, in the coming months.

Clinical Data

An earlier non-optimized formulation of the same two active pharmaceutical ingredients in DARE-HPV was previously evaluated in 23 non-pregnant, healthy, premenopausal, HIV un-infected Kenyan women with CIN2 or CIN3 in an open-label, proof-of-concept clinical study with all women receiving a 4:1 (133 mg lopinavir and 33 mg ritonavir) oral tablet (Lopimune) which is FDA approved for the treatment of human immunodeficiency virus (HIV), but dosed vaginally twice daily for 14 days in this study.

There were no SAEs.

The most common TEAEs were headache (3/23, 13%) followed by vaginal irritation (2/23, 8.7%);

nausea (2/23, 8.7%);

feeling faint/dizziness (2/23, 8.7%), abnormal vaginal discharge (2/23 8.7%);

and abdominal pains (1/23 4.3%).

In total, 5/23 or 21.7% of study subjects experienced some form of minor complaint within the first month of taking Lopimune as described.

The results demonstrated its potential as a self-applied therapy for HPV infection and related cervical lesions.

The proof-of-concept study is published in the Public Library of Science (PLoS) One.

DARE-HPV was also previously evaluated in 12 healthy, non-pregnant, premenopausal women without high-risk HPV or CIN.

Participants inserted one tablet vaginally daily for 21 days.

Participants reported the amount of vaginal or vulvar irritation they experienced daily using a Likert scale ranging from 0 (none) to 1 (mild, does not require medical attention) to 2 (moderate, requires medical attention) to 3 (severe, requires medical attention and results in study medication being stopped).

The mean daily vaginal irritation score was 1.47 ± 1.29 for active product users (n=8) versus 1.40 ± 0.9 for placebo product users (n=4).

We are developing DARE-HPV under our license agreement with Douglas Pharmaceuticals, Limited.

See "Strategic Agreements for Pipeline Development" below for discussion of the terms of that agreement.

DARE-VVA1 is a proprietary investigational formulation of tamoxifen in a soft gelatin capsule for intravaginal administration.

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At the conclusion of our development program, if successful, we intend to leverage the existing safety and efficacy data for tamoxifen to utilize the FDA’s 505(b)(2) pathway to obtain marketing approval of DARE-VVA1 in the U.S.

We do not plan to conduct the Phase 2 study until after we secure additional capital.

Clinical Data

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Fourteen participants completed the study.

The primary endpoints of the study evaluated the safety and tolerability of DARE-VVA1 by vaginal administration and determined the plasma PK of DARE-VVA1 after intravaginal application.

The primary endpoints of the study evaluated the safety and tolerability of DARE-VVA1 by vaginal administration and determined the plasma PK of DARE-VVA1 after intravaginal

Secondary endpoints evaluated preliminary efficacy and PD of DARE-VVA1 in terms of the most bothersome vaginal symptom and changes in vaginal cytology and pH.

In November 2022, we announced topline results from the Phase 1/2 study of DARE-VVA1.

In 2023, data from the study were published in Climacteric, the official journal of the International Menopause Society, in an article entitled, “Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1:

a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy.” The article concluded that DARE-VVA1 resulted in minimal systemic exposure to tamoxifen.

Data from the study were published in Climacteric, the official journal of the International Menopause Society, in an article entitled, “Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1:

a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy” (2023, 26(5), 479-488).

The article concluded that DARE-VVA1 resulted in minimal systemic exposure to tamoxifen.

Adverse events were mild to moderate in severity and distributed similarly among the DARE-VVA1 and placebo groups.

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We acquired the DARE-VVA1 program through our acquisition of Pear Tree Pharmaceuticals in 2018.

See "Strategic Agreements for Pipeline Development" below for discussion of that merger agreement.

CIN is a precancerous condition in women strongly linked to HPV infection, the most common sexually transmitted infection in the U.S.

Disease severity is classified on a scale from one to three based on how much epithelial tissue in the cervix has abnormal cells.

There is no FDA-approved treatment for HPV infection and no non-surgical pharmaceutical intervention to treat CIN2 or CIN3 (collectively referred to as CIN2+).

Current surgical procedures to treat cervical dysplasia are invasive and can adversely impact future pregnancies.

We believe a non-surgical pharmaceutical approach could provide women with an important alternative to surgical procedures to treat cervical dysplasia.

We are conducting activities necessary to enable submission of an IND application to the FDA for a Phase 2 clinical study of DARE-HPV as a treatment for genital persistent HPV infection with high risk strains.

The IND enabling activities, IND submission, and the Phase 2 study are expected to be supported by non-dilutive funding under awards granted by the federal government in 2024.

"MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS–Recent Events–Non-Dilutive Funding Awards for DARE-HPV," below.

Clinical Data

There were no SAEs.

The most common TEAEs were headache (3/23, 13%) followed by vaginal irritation (2/23, 8.7%);

nausea (2/23, 8.7%);

feeling faint/dizziness (2/23, 8.7%), abnormal vaginal discharge (2/23 8.7%);

and abdominal pains (1/23 4.3%).

In total, 5/23 or 21.7% of study subjects experienced some form of minor complaint within the first month of taking Lopimune as described.

The results demonstrated its potential as a self-applied therapy for HPV infection and related cervical lesions.

The proof-of-concept study is published in the Public Library of Science (PLoS) One.

DARE-HPV was also previously evaluated in 12 healthy, non-pregnant, premenopausal women without high-risk HPV or CIN, in a double-blind, placebo controlled, Phase 1 clinical study to assess PK and safety in New Zealand.

Participants inserted one tablet vaginally daily for 21 days.

The mean daily vaginal irritation score was 1.47 ± 1.29 for active product users (n=8) versus 1.40 ± 0.9 for placebo product users (n=4).

We are developing DARE-HPV under our license agreement with Douglas Pharmaceuticals, Limited.

See "Strategic Agreements for Pipeline Development" below for discussion of the terms of that agreement.

See "Strategic Agreements for Pipeline Development" below for discussion of that merger agreement and related license agreements.

DARE-PDM1 is an investigational proprietary hydrogel formulation of diclofenac for vaginal administration designed to treat primary dysmenorrhea.

DARE-PDM1 utilizes our proprietary hydrogel technology to vaginally deliver the active pharmaceutical ingredient, diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), in a novel way for the treatment of primary dysmenorrhea.

DARE-PDM1 utilizes our proprietary hydrogel technology (the same technology utilized for XACIATO) to vaginally deliver the active pharmaceutical ingredient, diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), in a novel way for the treatment of primary dysmenorrhea.

Primary dysmenorrhea is defined as painful menstruation in girls and women with normal pelvic anatomy, typically described as cramping pain in the low back or lower abdomen before or during the menstrual period.

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The study observation period encompassed approximately three menstrual cycles.

In December 2023, we announced topline data from the DARE-PDM1-001 study.

Participants received 1% diclofenac (n=14), 3% diclofenac (n=14) or placebo (n=14).

All 42 participants completed the nine study visits.

The topline data indicate that the study treatment was well-tolerated, and TEAE profiles were comparable between the DARE-PDM1 treatment groups and the placebo group.

All adverse events were mild or moderate;

most adverse events (85%) were mild.

There were no early discontinuations due to an adverse event, and no SAEs were reported.

The most common TEAEs were nausea, vomiting and abdominal discomfort, followed by vulvovaginal candidiasis and pelvic discomfort.

The data indicate that the study treatment was well-tolerated, and TEAE profiles were comparable between the DARE-PDM1 treatment groups and the placebo group.

There were no differences in the

frequency of reported TEAEs (P=0.41) or treatment related TEAEs (P=0.13) between the 1% and 3% diclofenac strengths, and placebo groups.

All TEAEs were mild or moderate in severity.

No SAEs were reported, and no TEAEs led to study drug discontinuation or study discontinuation.

There were two adverse drug reactions in the 1% diclofenac strength group which included mild vomiting and a mild burning sensation in the lower abdomen.

There was a slightly higher frequency of TEAEs reported by participants in the 1% and 3% diclofenac strength groups compared to participants in the placebo group;

these were not statistically significant.

Three participants (21.4%) and four participants (28.6%) in the 1% and 3% diclofenac strength groups, respectively, reported a total of nine treatment related TEAEs.

Gastrointestinal symptoms were the most common treatment related TEAE.

Eight of the nine total treatment related TEAEs reported during the study were considered to be mild in severity.

One participant in the 3% diclofenac strength group experienced a moderate treatment related TEAE of nausea.

The vaginal fluid PK results exhibited dose proportionality for the 1% and 3% diclofenac strengths of the DARE-PDM1 study treatment.

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There was no difference in the exploratory assessment of frequency of use of rescue medications in the treatment phase between the three groups.

We believe the topline results of the Phase 1 study support continued clinical development of DARE-PDM1 as a treatment for primary dysmenorrhea.

We believe the results of the Phase 1 study support continued clinical development of DARE-PDM1 as a treatment for primary dysmenorrhea.

At the conclusion of the development program, if successful, we intend to leverage the existing safety and efficacy data for diclofenac to utilize the FDA's 505(b)(2) pathway to obtain marketing approval of DARE-PDM1 in the U.S.

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DARE-PTB1 is being developed for the prevention of preterm birth.

DARE-FRT1 and DARE-PTB1 use the same IVR technology platform as DARE-HRT1.

DARE-FRT1 and DARE-PTB1 use the same IVR technology platform as utilized for DARE-HRT1 and DARE to RECLAIM.

We are conducting development activities to support IND submissions and Phase 1 clinical studies of these product candidates.

We have a grant award from the NIH to support a Phase 1 study of DARE-PTB1, but do not plan to conduct the Phase 1 studies until after we secure additional capital.

We have a Small Business Innovation Research (SBIR) grant award from the NIH to support a Phase 1 study of DARE-PTB1, but do

not plan to conduct the Phase 1 studies until after we secure additional capital.

At the conclusion of these development programs, if successful, we intend to leverage the existing safety and efficacy data for progesterone to utilize the FDA’s 505(b)(2) pathway to obtain marketing approval of DARE-FRT1 and DARE-PTB1 in the U.S.

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NCT05174884).

The ongoing Phase 1 study is being conducted by FHI 360, a nonprofit organization, with support from the Foundation.

The ongoing Phase 1 study is being conducted by FHI 360, a nonprofit organization, with support from a grant award.

There are no development costs to us at this time.

Casea S was recently acquired by Theramex.

In February 2025, we entered into a co-development and licensing agreement with Theramex for the development of Casea S in the U.S.

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See "Strategic Agreements for Pipeline Development" below for discussion of the terms of that agreement.

503B Compounding

Sildenafil citrate is currently listed as a nominated bulk drug substance that may be used in compounding by 503B-registered outsourcing facilities, and we are taking action to make our proprietary Sildenafil Cream formulation available via prescription under Section 503B of the FDCA.

Under Section 503B of the FDCA, outsourcing facilities, which must be registered with the FDA and are subject to current Good Manufacturing Practice, or cGMP, requirements and FDA inspections, may provide compounded drugs without an individual patient prescription.

See "Government Regulation—U.S.

Government Regulation—Regulation of Compounded Drugs” below for additional

information regarding compounding under Section 503B of the FDCA.

We are targeting to make our proprietary Sildenafil Cream formulation available in the fourth quarter of 2025.

For additional information, see ITEM 7.

“MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS–Recent Events–Sildenafil Cream as a Compounded Drug,” below.

Our Pipeline:

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DARE-LARC1’s woman-centered design seeks to offer the benefits of traditional long-acting reversible contraceptives with the added flexibility and convenience for the user to pause and resume release of levonorgestrel, depending on her desire for fertility or contraceptive protection.

Under a grant agreement we entered into in June 2021, as amended, we may receive up to approximately $49.0 million, payable over approximately five years, to advance development of the technology through nonclinical proof of principle studies to enable an IND submission.

As of the date of this report, we have received payments totaling approximately $31.8 million under the grant agreement.

Under a grant agreement we entered into in June 2021, as amended, we may receive up to approximately $49.0 million to advance development of the technology through nonclinical proof of principle studies to enable an IND submission.

As of the date of this report, we have received payments totaling approximately $41.8 million under the grant agreement, the term of which was recently extended to December 31, 2027.

Additional payments are contingent upon the DARE-LARC1 program's achievement of development and reporting milestones specified in the grant agreement.

The DARE-LBT program has been supported by a private foundation grant of approximately $585,000 under a grant agreement that we entered into in November 2022.

The grant funds supported activities related to development of a vaginal thermosetting gel formulation for the delivery of live biotherapeutics that can be reconstituted at the point of care.

We believe DARE-LBT merits further development as a delivery vehicle with potential to enhance the availability of novel therapeutics for vaginal health in the United States and worldwide, including in countries with varying climatic conditions and/or where extended storage may be required.

We refer to the technology underlying DARE-LARC1 as our intelligent drug delivery system, or DARE-IDDS, platform.

We believe DARE-IDDS has broad potential application beyond contraception in therapeutic areas that currently rely on frequent injections or daily oral dosing, and we are exploring strategic collaboration discussions to expand evaluation of DARE-IDDS for uses outside of reproductive health.

Sales and Marketing

We do not have established marketing, sales or distribution infrastructure or capabilities.

In order to commercialize any of our product candidates if approved for commercial sale, we must either establish a sales and marketing organization with technical expertise and supporting distribution capabilities or collaborate with third-parties that have sales and marketing experience.

Our approach is to develop an appropriate commercialization strategy for each of our product candidates based on the size of the market opportunity, the level of competition and the anticipated complexity of the launch.

As we move our product candidates through development toward, and in some cases, through regulatory approval, we evaluate several options for each product candidate's commercialization strategy.

In order to commercialize any of our product candidates that would be a new drug, medical device, or drug-device combination product if approved for commercial sale by the FDA or comparable foreign regulatory authorities, we must either establish a sales and marketing organization with technical expertise and supporting distribution capabilities or collaborate with third-parties that have sales and marketing experience.

Our approach is to develop an appropriate

commercialization strategy for each of our product candidates based on the size of the market opportunity, the level of competition and the anticipated complexity of the launch.

As we move our product candidates through preclinical and clinical development toward, and in some cases, through regulatory approval, we evaluate several options for each product candidate's commercialization strategy.

These options include building our own sales force and other commercial infrastructure, entering into strategic marketing partnerships with third parties, including commercial sales organizations or other pharmaceutical or biotechnology companies, out-licensing the product to other pharmaceutical or biotechnology companies, and combinations of these strategies.

Organon has global commercial rights to XACIATO under our exclusive license agreement, and we have an exclusive license agreement with Bayer to out-license U.S.

commercialization of Ovaprene.

Each of these collaborators has established marketing, sales and distribution capabilities in women's health.

Organon, which has established marketing, sales and distribution capabilities for prescription products in women's health, has global commercial rights to XACIATO under our exclusive license agreement.

We expect to continue to evaluate each product opportunity and pursue the commercialization strategy that we believe will maximize the return on our assets in and outside of the U.S.

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We have engaged third parties to assist in commercial planning and other commercial readiness activities for our product candidates and intend to continue to do so, as needed.

See “Strategic Agreements for Product Commercialization” below for a discussion of the terms of our out-license agreements.

See below for a discussion of the terms of our exclusive out-license agreement with Organon.

Manufacturing and Supply

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These arrangements require less upfront capital expenditure and allow us to maintain a smaller and more flexible infrastructure.

Under the terms of our license agreement with Organon, we were responsible for providing product supply of XACIATO on an interim basis until Organon assumed such responsibility.

In March 2022, we entered into a long-term supply and manufacturing agreement with the contract manufacturing organization, or CMO, that provided clinical supplies of XACIATO for our pivotal Phase 3 DARE-BVFREE clinical study.

Under the terms of our agreement, the CMO was responsible for obtaining supplies, at our expense, of all components necessary for the manufacture of XACIATO, including the API, clindamycin.

In December 2023, Organon assumed our obligations under the agreement with the CMO and our product supply agreement with Organon was terminated.

Under the terms of our license agreement with Organon, Organon is responsible for the manufacture and distribution of XACIATO.

Under our agreement with ADVA-Tec, ADVA-Tec is responsible for providing all clinical trial and commercial supplies of Ovaprene, either directly or through a CMO, and except under limited circumstances, we may not obtain supplies of Ovaprene from any source other than ADVA-Tec or its CMO and licensor, Poly-Med, Inc.

Other than our agreement with ADVA-Tec, we have no long-term arrangements for the production or supply of our product candidates or the materials required to produce them.

Under the terms of our license agreement with SST, SST was responsible for providing clinical supplies of Sildenafil Cream for Phase 2 clinical studies in the U.S., and we are responsible for providing supplies of Sildenafil Cream for Phase 3 clinical development and, if approved, for marketing and sale.

Currently, we plan to obtain clinical supplies of Sildenafil Cream from the same CMO that manufactured Sildenafil Cream for the Phase 2b RESPOND clinical study.

For Phase 3 clinical development of Sildenafil Cream and, if approved, for marketing and sale, currently, we plan to obtain clinical supplies from a single source CMO.

We expect that our current arrangements will meet our foreseeable needs for clinical trial materials or, generally, that alternative supply sources will be readily available.

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"RISK FACTORS – Risks Related to Product Research & Development and Regulatory Approval – Delays in the manufacture of our clinical supplies as well as other supply chain disruptions could postpone the initiation of or interrupt clinical studies, extend the timeframe and cost of development of our product candidates, delay potential regulatory approvals and impact the commercialization of any approved products” below.

Strategic Agreements for Product Commercialization

Organon License Agreement

In March 2022, we entered into an agreement with Organon, which became fully effective in June 2022, whereby Organon licensed exclusive worldwide rights to develop, manufacture and commercialize XACIATO and other future intravaginal or urological products for human use formulated with clindamycin that rely on intellectual property we control.

In 2022, we received a $10.0 million non-refundable and non-creditable payment from Organon, which was recorded as license fee revenue.

In 2023, Organon paid us $1.0 million in connection with entering into an amendment to our license agreement, which was also recorded as license fee revenue, and $1.8 million in connection with the first commercial sale of a licensed product in the United States, which was recorded as milestone revenue.

Under the terms of our license agreement, as amended, Organon agreed to pay tiered double-digit royalties based on net sales and potential future milestone payments of up to $180.0 million in tiered commercial sales milestones and regulatory milestones.

Royalty payments will be subject to customary reductions and offsets.

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

As described below, in April 2024, we sold to XOMA our rights to all royalty and potential milestone payments based on net sales of XACIATO under our license 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.

Unless terminated earlier, our license agreement with Organon will expire on a product-by-product and country-by-country basis upon expiration of the applicable royalty period for each licensed product.

In addition to customary termination rights for both parties, Organon may terminate the agreement in its entirety or on a country-by-country basis at any time in Organon’s sole discretion on 120 days’ advance written notice.

Our license agreement with Organon includes customary representations and warranties, covenants and indemnification obligations of each party.

In addition, the agreement provides Organon exclusive worldwide rights of first negotiation for specified potential future products of ours.

Bayer License Agreement

In January 2020, we entered into a license agreement with Bayer regarding the further development and commercialization of Ovaprene in the U.S.

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

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

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

and co-exclusive with us with regard to development.

Royalties and Milestone Payments Payable by Bayer.

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

and escalating milestone payments based on annual net sales of Ovaprene during a calendar year, totaling up to $310.0 million if all such milestones, including the first commercial sale, are achieved, (b) tiered royalties starting in the low double digits based on annual net sales of Ovaprene during a calendar year, subject to customary royalty reductions and offsets, and (c) a percentage of sublicense revenue .

As described below, in April 2024, we sold to XOMA a portion of our rights to the potential $20.0 million payment from Bayer described above and our rights to a portion of future net sales of Ovaprene under our agreement with Bayer.

We will be responsible for the pivotal trial for Ovaprene and for its development and regulatory activities and we have product supply obligations.

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

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

years from the first commercial sale of Ovaprene in the U.S.

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

Strategic Agreements for Pipeline Development

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In February 2025, we entered into a co-development and licensing agreement with Theramex for an investigational biodegradable contraceptive implant called Casea S recently acquired by Theramex.

Under the agreement, we received a royalty-free, exclusive, fully paid up, sublicensable license to the U.S.

agreement, we received a royalty-free, exclusive, fully paid up, sublicensable license to the U.S.

patents Theramex recently acquired for Casea S.

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In August 2023, we entered into a license agreement with Douglas Pharmaceuticals Limited, or Douglas, under which we acquired the exclusive rights to develop and commercialize a lopinavir and ritonavir combination soft gel vaginal insert for the treatment of CIN and other HPV-related pathologies, and an agreement with The University of Manchester, pursuant to which The University of Manchester consented to Douglas' sublicense to us of certain rights it previously granted to Douglas and agreed to grant us a direct license to such rights if its license agreement with Douglas is terminated.

As a result of these agreements, we commenced our DARE-CIN program.

As a result of these agreements, we commenced our DARE-HPV program.

Under our agreement with Douglas, we received an exclusive, royalty-bearing license to research, develop and commercialize the licensed intellectual property in the United States for the treatment or prevention of all indications for women in female reproductive health.

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Pursuant to the terms of the CRADA, we are responsible for providing clinical supplies of Ovaprene, coordinating interactions with the FDA, preparing and submitting supportive regulatory documentation, and providing a total of $5.5 million to NICHD to be applied toward the costs of conducting the Phase 3 study, all of which had been paid as of September 30, 2024.

NICHD is responsible for the other costs related to the conduct of the Phase 3 study and for managing the payment of expenses to other parties involved with the study.

However, for recent developments relating to NICHD's performance under the CRADA, see "Our Pipeline:

Clinical Stage Programs–Ovaprene–Pivotal Phase 3 Clinical Study" above.

Unless earlier terminated, the CRADA will expire in accordance with its terms in July 2026.

Either we or NICHD may terminate the CRADA for any reason upon 30 days’ prior written notice to the other party.

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The CRADA also contains customary representations, warranties, and indemnification and confidentiality obligations.

The CRADA expires five years from its effective date.

MBI Acquisition

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(formerly, Microchips Biotech, Inc.), or MBI, to secure the rights to develop a long-acting reversible contraception method that a woman can turn on or off herself, according to her own needs.

This candidate is now known as DARE-LARC1.

This candidate is now known as DARE-LARC1 and an enhanced version of the drug delivery technology underlying DARE-LARC1 is now known as our intelligent drug delivery system platform, DARE-IDDS.

Under the terms of the merger agreement, the Company agreed to pay former MBI stockholders:

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and (c) tiered royalty payments ranging from low single-digit to low double-digit percentages based on annual net sales of such products sold by the Company (but not by sublicensee) and a percentage of sublicense revenue related to such products.

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

In July 2021, our board of directors elected to make these milestone payments in shares of our common stock, to the extent permissible under the terms of the merger agreement with MBI, and, in September 2021, we issued approximately 58,334 shares of our common stock to former stockholders of MBI and paid $75,000 in cash to the stockholders' representative in accordance with the terms of the merger agreement in satisfaction of the $1.25 million in milestone payments associated with milestones achieved in June 2021.

In June 2021, a total of $1.25 million of the contingent consideration became payable upon the achievement of certain of the funding and product development milestone events.

In accordance with the terms of the merger agreement with MBI, $75,000 of the amount payable was paid in cash and the balance was paid in shares of our common stock.

TriLogic and MilanaPharm License Agreement / Hammock Assignment Agreement

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Both agreements relate to the Exclusive License Agreement among Hammock, TriLogic and MilanaPharm dated as of January 9, 2017, or the MilanaPharm License Agreement.

Under the Assignment Agreement and the MilanaPharm License Agreement, as amended by the License Amendment, we acquired an exclusive, worldwide license under certain intellectual property to, among other things, develop and commercialize products for the diagnosis, treatment and prevention of human diseases or conditions in or through any intravaginal or urological applications.

intravaginal or urological applications.

The licensed intellectual property relates to the hydrogel drug delivery platform of TriLogic and MilanaPharm known as TRI-726.

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In September 2021, we entered into a second amendment to the License Agreement.

In March 2022, in connection with entering into our exclusive license agreement with Organon, we entered into a consent, waiver and stand-by license agreement with TriLogic, MilanaPharm and Organon, which further amended the License Agreement.

License Amendment, as amended:

In 2022, in connection with entering into our exclusive license agreement with Organon, we entered into a consent, waiver and stand-by license agreement with TriLogic, MilanaPharm and Organon, which further amended the License Agreement.

Under the terms of the License Amendment, as amended:

Milestone Payments.

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In addition to customary termination rights for all parties, MilanaPharm may terminate the license granted to us solely with respect to a licensed product or process in a country if, after having launched such product or process in such country, (1) we or our affiliates or sublicensees discontinue the sale of such product or process in such country and MilanaPharm notifies us of such termination within 60 days of having first been notified by us of such discontinuation, or (2) we or our affiliates or sublicensees (A) discontinue all commercially reasonable marketing efforts to sell, and discontinue all sales of, such product or process in such country for nine months or more, (B) fail to resume such commercially reasonable marketing efforts within 120 days of having been notified of such failure by MilanaPharm, (C) fail to reasonably demonstrate a strategic justification for the discontinuation and failure to resume to MilanaPharm, and (D) MilanaPharm gives 90 days’ notice to us.

Assignment Agreement, as amended

Under the terms of the Assignment Agreement, as amended:

Technology Transfer .

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Milestone Payments.

Catalent is eligible to receive (1) up to $12.5 million in the aggregate in payments based on the achievement of specified clinical and regulatory milestones, and (2) up to $30.3 million in the aggregate in payments based on the achievement of specified commercial sales milestones for each product or process covered by the licenses granted under the agreement.

payments based on the achievement of specified commercial sales milestones for each product or process covered by the licenses granted under the agreement.

Royalty Payments .

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If we sublicense our rights under the license agreement, in lieu of royalty payments to ADVA-Tec, ADVA-Tec is eligible to receive a double-digit percentage of sublicense revenue received by us during the royalty term;

provided, however, that for sublicense revenue we receive prior to the first commercial sale of a licensed product that represents an upfront payment or license fee due on or around the effective date of the sublicense, ADVA-Tec is eligible to receive a single-digit percentage of that sublicense revenue.

provided, however, that for sublicense revenue we receive prior to the first commercial sale

of a licensed product that represents an upfront payment or license fee due on or around the effective date of the sublicense, ADVA-Tec is eligible to receive a single-digit percentage of that sublicense revenue.

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

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(2) satisfy the annual spending obligation described above, (3) use commercially reasonable efforts to complete all necessary pre-clinical and clinical studies required to support and submit a PMA, or (4) conduct clinical trials as set forth in the development plan to which we and ADVA-Tec agree, and as may be modified by a joint research committee, unless such failure is caused by events outside of our reasonable control.

Organon Exclusive License Agreement

In 2022, we entered into an exclusive license agreement with Organon, whereby Organon licensed exclusive worldwide rights to develop, manufacture and commercialize XACIATO and other future intravaginal or urological products for human use formulated with clindamycin that rely on intellectual property controlled by us.

Organon has all manufacturing, regulatory, and compliance responsibilities for XACIATO and is also responsible for commercializing, promoting, determining pricing, and negotiating reimbursement matters related to XACIATO

Under the terms of our license agreement, as amended, Organon agreed to pay tiered double-digit royalties based on net sales and up to $180.0 million in tiered commercial sales milestones and regulatory milestones.

Royalty payments are subject to customary reductions and offsets.

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

See below under "Royalty Monetization Transactions" for additional information.

Our license agreement with Organon includes customary representations and warranties, covenants and indemnification obligations of each party.

In addition, the agreement provides Organon exclusive worldwide rights of first negotiation for specified potential future products of ours.

Royalty Monetization Transactions

Traditional and Synthetic Royalty Purchase Agreements with XOMA

On April 29, 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), and XOMA paid $22.0 million to us.

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), and XOMA paid $22.0 million to us.

In addition, if XOMA receives total payments under the Royalty Purchase Agreements (as described below) equal to an amount that exceeds $88.0 million (which we refer to as the Revenue Sharing Threshold), XOMA will pay $11.0 million to us for each successive $22.0 million XOMA receives under the Royalty Purchase Agreements (such $11.0 million payments to us we refer to as the Contingent Purchase Price Payments).

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(a) 100% 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 (i) all royalty and milestone payments due and payable and actually paid by or on behalf of us under our exclusive license agreement with third-party licensors TriLogic and MilanaPharm, and (ii) all payments due and payable and actually paid by or on behalf of us under our royalty interest financing agreement with United in Endeavour, LLC, or UiE (such net amount we refer to as the Purchased Receivables);

(b) 25% of the potential future $20.0 million payment that we would otherwise have the right to receive under our license agreement with Bayer relating to Ovaprene, if Bayer, in its sole discretion, elects to make the license granted thereunder effective following completion of the pivotal clinical trial of Ovaprene;

(b) 25% of the $20.0 million payment that we could have potentially received under our since terminated license agreement with Bayer relating to Ovaprene;

(c) a synthetic royalty of 4.0% of our, our affiliates’ and our sublicensees’ future net sales of Ovaprene, and 2.0% of our, our affiliates’ and our sublicensees’ future net sales of Sildenafil Cream;

provided, however , that, if XOMA receives total payments under the Royalty Purchase Agreements, net of any Contingent

Purchase Price Payments made to us, equal to an amount that exceeds $110.0 million, the foregoing percentages will be reduced to 2.5% and 1.25%, respectively (such amounts described in the foregoing clauses (b) and (c) we collectively refer to as the Revenue Participation Right).

provided, however , that, if XOMA receives total payments under the Royalty Purchase Agreements, net of any Contingent Purchase Price Payments made to us, equal to an amount that exceeds $110.0 million, the foregoing percentages will be reduced to 2.5% and 1.25%, respectively (we refer to the amounts described in this clause (c) as the Revenue Participation Right).

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 under the traditional royalty purchase agreement.

As of April 29, 2024, we cannot elect to receive any additional funding from UiE under our royalty interest financing agreement with UiE without XOMA’s prior written consent.

Under the traditional royalty purchase agreement, 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 contain certain representations and warranties regarding our rights and obligations with respect to our license agreement with Organon, our license agreement with Bayer and our in-license agreements relating to XACIATO, Ovaprene and Sildenafil Cream, as well as customary representations and warranties for a transaction of this nature.

The Royalty Purchase Agreements contain certain representations and warranties regarding our rights and obligations with respect to our license agreement with Organon and our in-license agreements relating to XACIATO, Ovaprene and Sildenafil Cream, as well as customary representations and warranties for a transaction of this nature.

The Royalty Purchase Agreements also contain customary covenants for a transaction of this nature, including 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).

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We refer to each such payment as a Supplemental Discretionary Investment Amount, and collectively, as the Total Supplemental Discretionary Investment Amount.

We will make payments to UiE under the agreement until such time when UiE has received aggregate payments equaling a 12% internal rate of return, or the IRR, on the Initial Investment and the Total Supplemental Discretionary Investment Amount, if any (referred to as the Hard Cap).

Until such time as the IRR has been achieved, we agreed to make payments to UiE equal to (i) from the date of the agreement through December 31, 2025, 50% of the amount of royalty payments remaining after all amounts that are due and payable and actually paid by us to any licensor or sublicensee on the royalty payments generated and received by us on net sales of XACIATO by Organon have been deducted (such payments referred to as the Net Royalty Payments), (ii) from January 1, 2026 through December 31, 2029, 75% of the Net Royalty Payments, and (iii) from the date of the agreement through December 31, 2029, 10% of the amount of milestone payments remaining after all amounts that are due and payable and actually paid by us to any licensor or sublicensee on the milestone payments generated and received by us on net sales of XACIATO by Organon have been deducted.

After December 31, 2029, we will be required to make certain additional payments to UiE to the extent UiE has not received payments equaling the Hard Cap by December 31, 2029, December 31, 2033, and December 31, 2034, respectively.

In addition, if UiE has not received payments equaling the Hard Cap by December 31, 2035 and we have other sources of assets or income besides XACIATO sufficient to complete such payments, we have agreed to pay UiE quarterly payments evenly divided over a two-year term, such that UiE will have obtained the IRR, taking into account all other payments received by UiE from us under the agreement.

UiE’s right to receive payments will terminate when UiE has received the Hard Cap.

We have the right, but not the obligation, at any time, to repurchase all of the interest from UiE at a repurchase price equal to the Hard Cap, calculated as of the date of we exercise such call option.

The agreement contains representations and warranties, covenants, indemnification obligations, and other provisions customary for transactions of this nature and will terminate on the date that is the earlier of (i) the date upon which the payment of the purchased interest in respect of XACIATO is made in full to UiE, and (ii) the payment to UiE of an aggregate amount equal to the Hard Cap.

Under the agreement, we agreed to make the following payments to UiE until such time when UiE has received aggregate payments equaling a 12% internal rate of return, or the IRR, on the Initial Investment and the Total Supplemental Discretionary Investment Amount, if any:

(i) from the date of the agreement through December 31, 2025, 50% of the amount of royalty payments remaining after all amounts that are due and payable and actually paid by us to any licensor or sublicensee on the royalty payments generated and received by us on net sales of XACIATO by Organon have been deducted (such payments referred to as the Net Royalty Payments), (ii) from January 1, 2026 through December 31, 2029, 75% of the Net Royalty Payments, and (iii) from the date of the agreement through December 31, 2029, 10% of the amount of milestone payments remaining after all amounts that are due and payable and actually paid by us to any licensor or sublicensee on the milestone payments generated and received by us on net sales of XACIATO by Organon have been deducted.

After December 31, 2029, we will be required to make certain additional payments to UiE to the extent UiE has not received payments equaling the IRR by December 31, 2029, December 31, 2033, and December 31, 2034, respectively.

In addition, if UiE has not received payments equaling the IRR by December 31, 2035 and we have other sources of assets or income (besides XACIATO) sufficient to complete such payments, we have agreed to pay UiE quarterly payments evenly divided over a two-year term (such payments referred to as Catch-up Payments), such that UiE will have obtained the IRR, taking into account all other payments received by UiE from us under the agreement.

UiE’s right to receive payments will terminate when UiE has received

payments in an amount equal to the IRR (such period of time referred to as the Financing Term).

Under the agreement, we have the right, at any time and from time to time, to make voluntary prepayments to UiE, and such payments will be credited against the IRR.

In addition, we have the right at any time to pay in full and retire all of our payment obligations to UiE by paying the full amount of the IRR, calculated as of the date of the payment.

In connection with the agreement, we issued to UiE a warrant to purchase up to 422,804 shares of our common stock.

In addition, for every $1.0 million of Supplemental Discretionary Investment Amount, we agreed to issue an additional warrant to purchase up to 84,561 shares of our common stock, for an aggregate of additional warrants to purchase up to 591,927 shares of our common stock.

The warrants are exercisable, in full or in part, at any time on or prior to the fifth anniversary of the date of issuance of the particular warrant at an exercise price of $0.410 per share, subject to customary anti-dilution adjustments.

The warrants are exercisable, in full or in part, at any time on or prior to the fifth anniversary of the date of issuance of the particular warrant at an exercise price of $4.10 per share, subject to customary adjustment for stock splits and similar transactions.

The warrants may be exercised for cash, or if at the time of exercise there is no effective registration statement registering for resale the shares underlying the warrants, then in lieu of paying the exercise price in cash, the holder may elect to exercise the warrant on a cashless basis.

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Under the terms of the Assignment Agreement with Hammock Pharmaceuticals, Inc.

and the License Amendment with TriLogic Pharma, LLC and MilanaPharm, LLC, regarding the thermosetting hydrogel platform which includes XACIATO, we are the exclusive licensee of three issued U.S.

patents, two of which are set to expire in December 2028 and one of which is set to expire in September 2036, subject to any extensions or disclaimers, and three foreign patents, including one European Patent Office, or EPO, patent validated in four countries, that expire in December 2028, subject to any extensions or disclaimers, as well as two foreign patents, including one EPO patent validated in 22 countries, that expire in July 2036, subject to any extensions or disclaimers.

One of the three issued U.S.

patents is listed in the FDA’s compendium of “Approved Drug Products with Therapeutic Equivalence Evaluation," known as the Orange Book, under the Patent Exclusivity Information for XACIATO.

In addition, we have rights to three pending foreign patent applications and one pending U.S.

and the License Amendment with TriLogic Pharma, LLC and MilanaPharm, LLC, regarding the thermosetting hydrogel platform which includes XACIATO, we are the exclusive licensee of four issued U.S.

patents, two of which are set to expire in December 2028 and two of which are set to expire in September 2036, subject to any extensions or disclaimers, and two foreign patents, including one European Patent Office, or EPO, patent validated in four countries, that expire in December 2028, subject to any extensions or disclaimers, as well as three foreign patents, including one EPO patent validated in 22 countries, that expire in July 2036, subject to any extensions or disclaimers.

Two of the four issued U.S.

patents are listed in the FDA’s compendium of “Approved Drug Products with Therapeutic Equivalence Evaluation," known as the Orange Book, under the Patent Exclusivity Information for XACIATO.

In addition, we have rights to two pending foreign patent applications and one pending U.S.

patent application.

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Organon has licensed XACIATO-specific patents and applications from us.

Under the terms of the ADVA-Tec license agreement, regarding Ovaprene, we are the exclusive licensee of five granted U.S.

Under the terms of the ADVA-Tec license agreement, regarding Ovaprene, we are the exclusive licensee of four granted U.S.

patents, one pending U.S.

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The other U.S.

and foreign patents are expected to expire in 2025 or 2026.

and foreign patents are expected to expire in 2026.

The patent terms for any patents issuing from the pending applications would be expected to expire in 2035, subject to any extensions or disclaimers.

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patents and 17 foreign patents, including three EPO patents validated in a total of 20 countries).

Additionally, there is one patent application pending in the US, one in Europe, and two in other international markets.

Additionally, there is one patent application pending in the US, one in Europe, and three in other international markets.

The issued U.S.

patents have a patent term that expires in June 2029, including any patent term adjustment, and may be eligible for regulatory exclusivity under the Hatch-Waxman Act, while several foreign patents have a term that is set to expire in late 2031, each of such terms being subject to any future

extensions or disclaimers.

Additionally, relative to the sildenafil program, we are the sole owner of a pending PCT application with an expected term, if granted, until 2044, subject to any extensions or disclaimers.

Under the terms of the Catalent license agreement, regarding our intravaginal ring platform which includes DARE-HRT1, we are the exclusive licensee of two issued U.S.

patents with patent terms set to expire in February 2025 and September 2027, including patent term adjustment.

Additionally, relative to the DARE-HRT1 program, we are the sole owner of one pending PCT application with an expected term, if granted, until 2044, subject to any extensions or disclaimers.

Additionally, relative to the sildenafil program, we are the sole owner one patent application pending in the U.S., one in Europe, and five in other international markets with an expected term, if granted, until 2044, subject to any extensions or disclaimers.

Under the terms of the Catalent license agreement, regarding our intravaginal ring platform which includes DARE-HRT1, we are the exclusive licensee of one issued U.S.

patent with patent terms set to expire in September 2027, including patent term adjustment.

Additionally, relative to the DARE-HRT1 program, we are the sole owner of one patent application pending in the U.S., one in Europe, and eight in other international markets with an expected term, if granted, until 2044, subject to any extensions or disclaimers.

When we acquired Pear Tree Pharmaceuticals, Inc.

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The Japanese patent has a term that is set to expire in June 2027.

Additionally, relative to the DARE-VVA1 program, we are the sole owner of one pending PCT application with an expected term, if granted, until 2044, subject to any extensions or disclaimers.

Additionally, relative to the DARE-VVA1 program, we are the sole owner of one patent application pending in the U.S., one in Europe, and one in Canada with an expected term, if granted, until 2044, subject to any extensions or disclaimers.

When we acquired MBI in 2019, we obtained the rights to over 100 patents and applications.

The key technology underlying the platform currently is supported by 10 U.S.

patents and 49 foreign patents, including six EPO patents validated in various European countries, and 12 pending patent applications.

We believe that the four most recently filed patent families are directly applicable to our DARE-LARC1 program.

patents and 35 foreign patents, including four EPO patents validated in various European countries, and 13 pending patent applications.

We believe that the five most recently filed patent families are directly applicable to our DARE-LARC1 program.

Those patent families have patent terms that are set to expire 2032, 2033, 2034, 2040, and 2046 respectively, subject to any extensions or disclaimers.

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and other key international markets.

Under the terms of the Hennepin license agreement, we are the exclusive licensee of five issued U.S.

patents and four foreign patents, as well as three pending U.S.

applications and twelve pending foreign applications.

patents are set to expire in 2025, 2026, 2028, 2033 and 2034 including any patent term adjustment, extensions or disclaimers, and the foreign patents have patent terms until 2025 or 2033.

Under the terms of the Hennepin license agreement, we are the exclusive licensee of six issued U.S.

patents and four foreign patents, as well as two pending U.S.

applications and seven pending foreign applications.

patents are set to expire in 2026, 2028, 2033 and 2034 including any patent term adjustment, extensions or disclaimers, and the foreign patents have patent terms until 2033.

and foreign applications, if granted, are expected to have patent terms that expire in 2033, 2037, 2038, and 2042, subject to any extensions or disclaimers.

Under the terms of the Douglas license agreement, we are the exclusive licensee of four granted U.S.

Under the terms of the Douglas license agreement, we are the exclusive licensee of five granted U.S.

patents and four pending U.S.

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We presently seek protection, in part, through confidentiality and proprietary information agreements.

We hold a domestic registration for the trademark Daré Bioscience and our registration for the XACIATO trademark in the U.S.

We own trademark applications and registrations in the United States Patent & Trademark Office for the DARÉ BIOSCIENCE mark, as well as marks related to various taglines, product candidate and product names, including DARE to PLAY, DARE to RESTORE, and DARE to RECLAIM.

According to our agreement with Organon, all XACIATO trademarks have been assigned.

In accordance with the terms of the ADVA-Tec license agreement, we are the exclusive licensee of the OVAPRENE registered trademark.

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The women’s health sector is very fragmented, highly competitive and subject to rapid and significant change.

We anticipate that our product candidates may compete not only with FDA-approved, prescription and over-the-counter, branded and generic drug products, but also compounded drug products, medical devices, dietary supplements, and cosmetics.

We face and will continue to face intense competition from a variety of businesses, including large, fully integrated, well-established pharmaceutical companies and specialty pharmaceutical companies that already possess a significant share of the women’s health market, as well as generics manufacturers, compounding pharmacies and other drug compounding facilities, and dietary supplements manufacturers.

We anticipate that our products and, if approved, our product candidates may compete not only with FDA-approved, prescription and over-the-counter, branded and generic drug products, but also compounded drug products, medical devices, dietary supplements, and cosmetics.

In addition, academic and other research institutions are and could be engaged in research and development efforts for products in the therapeutic areas targeted by our product candidates.

Our success is highly dependent upon our ability to acquire or in-license, develop and obtain regulatory approval for innovative products on a cost-effective basis and to market them successfully, either on our own or together with strategic partners, or to make our proprietary formulations available as compounded drugs.

Many of our potential competitors have greater clinical, regulatory, manufacturing, marketing, distribution, compliance and financial

resources and experience than we do.

Many of our potential competitors have greater clinical, regulatory, manufacturing, marketing, distribution, compliance and financial resources and experience than we do.

"RISK FACTORS—Risks Related to Commercialization of Products We Develop" and "Risks Related to 503B Compounding" below.

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In addition, some compounding entities have partnered with telemedicine providers, enabling them to expand the potential market for their compounded drugs.

The availability of other sildenafil products, could potentially make it more challenging for Sildenafil Cream to build and maintain market share.

If we are successful in bringing our proprietary Sildenafil Cream formulation to market under Section 503B of the FDCA, it would compete directly with other topical cream formulations of sildenafil citrate provided by compounding entities described above.

However, our proprietary Sildenafil Cream formulation, as of the filing date of this report, to our knowledge, would be the only compounded form of sildenafil citrate that has completed toxicology studies and Phase 1, and Phase 2 human clinical studies.

DARE-HRT1, if approved as a treatment for moderate to severe VMS due to menopause, will compete with the many products on the market targeted to or FDA-approved for the treatment of menopausal symptoms, including VMS.

Such products include hormone therapies in the form of pills, patches and creams, some of which are FDA-approved products and others which are supplied by compounding entities, as well as non-hormonal products, including an FDA-approved medication (Veozah® (fezolinetant)) and dietary supplements.

While, as of the filing date of this report, to our knowledge, DARE to PLAY will be the only compounded form of sildenafil citrate that has completed toxicology studies and Phase 1 and Phase 2 human clinical studies, the availability of other sildenafil products, could potentially make it more challenging for DARE to PLAY and, in the future, if approved by the FDA, Sildenafil Cream, to build and maintain market share.

If we are successful in bringing DARE to RECLAIM, or DARE-HRT1 to market, these products will compete with the many products on the market targeted to or FDA-approved for the treatment of menopausal symptoms, including VMS.

Such products include hormone therapies in the form of pills, patches and creams, some of which are FDA-approved products and others which are supplied by compounding entities, as well as non-hormonal products, including FDA-approved medications Veozah® (fezolinetant) marketed by Astellas Pharma and Lynkuet® (elinzanetant) marketed by Bayer, and dietary supplements.

Both the supplement and the compounded hormone therapy markets are very significant.

A considerable segment of the compounded hormone therapy market is comprised of compounded hormones in pellet form that are implanted under the skin as a non-daily alternative, which could be directly competitive with DARE-HRT.

In addition, we are aware of non-hormonal drug products in development for the treatment of VMS, including elinzanetant, a dual neurokinin-1 and 3 (NK-1 and NK-3) receptor antagonist, for which Bayer submitted an NDA in August 2024, and is anticipated to launch in the second half of 2025.

We expect the options for hormone therapy to continue to expand with time.

We intend for DARE-HRT1, if approved by the FDA, to offer advantages to compounded hormone therapy products, including by providing a product with a well characterized safety and efficacy profile that will have been vetted by the FDA.

We believe DARE-HRT1 has the potential to address a preference among some women and health care providers for bio-identical hormones delivered in a non-oral route, as well as offer convenience compared to existing FDA-approved hormone therapies in that one IVR is designed to deliver the bio-identical hormones together over 28 days without any daily intervention.

We expect the options for hormone therapy and non -hormonal therapies to continue to expand with time.

We intend for DARE-HRT1, if approved by the FDA, to offer advantages to currently available compounded hormone therapy products, including by providing a product with a well characterized safety and efficacy profile that will have been vetted by the FDA.

We believe DARE to RECLAIM and DARE-HRT1 each has the potential to address a preference among some women and health care providers for bio-identical hormones delivered in a non-oral route, as well as offer convenience compared to existing FDA-approved hormone therapies in that one IVR is designed to deliver the bio-identical hormones together over 28 days without any daily intervention.

DARE-VVA1, if approved as a treatment for moderate-to-severe dyspareunia, or pain during sexual intercourse, a symptom of GSM, will compete with other hormonal and non-hormonal products for the treatment of dyspareunia or other GSM symptoms.

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DARE-HPV has the potential to be the first FDA-approved product for the treatment of genital HPV infection in women and/or CIN (also known as cervical dysplasia).

Persistent HPV infections can progress to cervical cancer through a series of cervical

Persistent HPV infections can progress to cervical cancer through a series of cervical lesions.

Currently, there are no FDA-approved therapeutic treatments for HPV infections and no non-surgical pharmaceutical intervention to treat CIN2+.

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Preclinical studies include laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess potential safety and efficacy.

The Consolidated Appropriations Act for 2023, signed into law on December 29, 2022, (P.L.

117-328) amended the FDCA to specify that nonclinical testing for drugs may, but is not required to, include in vivo animal testing.

The Consolidated Appropriations Act for 2023 amended the FDCA to specify that nonclinical testing for drugs may, but is not required to, include in vivo animal testing.

According to the amended language, a sponsor may fulfill nonclinical testing requirements by completing various in vitro assays (e.g., cell-based assays, organ chips, or microphysiological systems), in silico studies (i.e., computer modeling), other human or non-human biology-based tests (e.g., bioprinting), or in vivo animal tests.

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Generally, pivotal trials are Phase 3 trials, but they may be Phase 2 trials if the design provides a well-controlled and reliable assessment of clinical benefit, particularly in an area of unmet medical need.

Congress also recently amended the FDCA, as part of the Consolidated Appropriations Act for 2023, in order to require sponsors of a Phase 3 clinical trial, or other “pivotal study” of a new drug to support marketing authorization, to design and submit a diversity action plan for such clinical trial.

Congress also amended the FDCA in 2022 to require sponsors of a Phase 3 clinical trial, or other “pivotal study” of a new drug to support marketing authorization, to design and submit a diversity action plan for such clinical trial.

The action plan must include the sponsor’s diversity goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them.

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If the FDA objects to a sponsor’s diversity action plan or otherwise requires significant changes to be made, it could delay initiation of the relevant clinical trial.

In February 2026, via an editorial published the New England Journal of Medicine , the FDA Commissioner and the director of the FDA’s Center for Biologics Evaluation and Research announced a policy shift whereby, going forward, the FDA’s default position will be a “a one-trial requirement,” meaning that one adequate and well-controlled study, combined with confirmatory evidence, will serve as the basis of marketing authorization of novel product candidates.

Confirmatory evidence can include mechanistic science, data from a related indication, animal models, information from other drugs of the same class, real-world evidence, or a second adequate and well-controlled study.

The announcement represents a major shift from the FDA’s historical default requirement of two pivotal clinical trials.

However, as indicated by FDA representatives during informal interviews and other media appearances, if FDA shifts to only requiring a single trial, it may heighten the standard for these trials in terms of quality.

For example, the FDA indicated it will carefully examine all aspects of study design with particular focus on controls, end points, effect size, and statistical protocols.

The FDA may still require additional adequate and well-controlled studies if a product candidate has a nebulous, pluripotent, or nonspecific mechanism of action;

if it affects a labile, short-term, or surrogate outcome;

or if a trial has some underlying limitation or deficiency.

The editorial also referenced a new

postmarket initiative being rolled out synchronously to collect robust data on all drugs and devices.

The FDA has not published formal guidance regarding the new one-trial default option or postmarket surveillance initiative.

Clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with the FDA’s GCP requirements.

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Section 505(b)(2) permits the filing of an NDA in which the applicant relies, at least in part, on information from studies made to show whether a drug is safe or effective that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use.

A Section 505(b)(2) applicant may eliminate or reduce the need to conduct certain pre-clinical or clinical studies, if it can establish that reliance on studies conducted for a previously-approved product is scientifically appropriate.

A Section 505(b)(2) applicant may eliminate or reduce the need to conduct certain nonclinical or clinical studies, if it can establish that reliance on studies conducted for a previously-approved product is scientifically appropriate.

The FDA may also require companies to perform additional studies or measurements, including nonclinical and clinical studies, to support the change from the approved product.

The FDA may then approve the new product candidate for all or

some of the labeled indications for which the referenced product has been approved, as well as for any new indication for which the Section 505(b)(2) NDA applicant has submitted data.

The FDA may then approve the new product candidate for all or some of the labeled indications for which the referenced product has been approved, as well as for any new indication for which the Section 505(b)(2) NDA applicant has submitted data.

The FDA conducts a preliminary review of all NDAs it receives, whether submitted under Section 505(b)(1) or Section 505(b)(2), to ensure that they are sufficiently complete for substantive review before it accepts them for filing.

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Additionally, the CRL may include recommended actions that the applicant might take to place the application in a condition for approval.

In September 2025, the FDA began publishing CRLs soon after issuing them to the respective sponsors, breaking with long standing agency tradition of publishing CRLs with approval documentation after the product is approved.

If a CRL is issued, the applicant may either resubmit the NDA, addressing all of the deficiencies identified in the letter, or withdraw the application.

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In addition, the FDA may require post marketing clinical trials, sometimes referred to as “Phase 4” clinical trials, designed to further assess a product’s safety and effectiveness, and/or testing and surveillance programs to monitor the safety of approved products that have been commercialized.

After approval, some types of changes to the approved product, such as adding new

indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.

After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.

Special FDA Programs to Facilitate and Expedite Development and Review of Certain New Drugs

The FDA is authorized to designate certain products for expedited development or review if they are intended to address an unmet medical need in the treatment of a serious or life-threatening disease or condition.

These programs include, but are not limited to, fast track designation, QIDP designation, and priority review designation.

These programs include, but are not limited to, fast track designation, QIDP designation, priority review designation, and the Commissioner's National Priority Voucher pilot program.

The purpose of these programs is to provide important new drugs to patients earlier than could occur under standard FDA procedures for interacting with and responding to product sponsors during development and regulatory review.

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In addition, fast track designation may be withdrawn by the sponsor or rescinded by the FDA if the designation is no longer supported by data emerging in the clinical trial process.

The Food and Drug Administration Safety and Innovation Act of 2012, or FDASIA, included the Generating Antibiotics Incentives Now Act, or the GAIN Act, which directed FDA to implement the QIDP designation program.

Under the Generating Antibiotics Incentives Now Act, or the GAIN Act, Congress directed the FDA to implement the QIDP designation program.

The GAIN Act created incentives for the development of antibacterial and antifungal drug products for the treatment of serious or life-threatening infections.

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As discussed further below under “New Drug Marketing Exclusivity under the Hatch-Waxman Act Amendments & GAIN Exclusivity Extension - Qualified Infectious Disease Product Exclusivity,” the GAIN Act also provides the possibility of a five-year exclusivity extension that is added to any other marketing exclusivity for which a QIDP-designated drug qualifies upon FDA approval.

Finally, the FDA may designate a product for priority review if it is a drug that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.

Additionally, the FDA may designate a product for priority review if it is a drug that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.

The FDA determines at the time that the marketing application is submitted, on a case-by-case basis, whether the proposed drug represents a significant improvement in treatment, prevention or diagnosis of disease when compared with other available therapies.

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A priority review designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action on a marketing application from ten months to six months.

In 2025, the FDA created a new voucher program called the Commissioners National Priority Voucher, or CNPV, with the goal of radically expediting therapeutic product review and approval processes.

The agency may award a CNPV to a company or a specific product candidate that demonstrates alignment with certain national health priorities.

The FDA aims to take action on a marketing application for which a CNPV is issued within one to two months after the filing date.

Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

Furthermore, fast track designation, QIDP designation, and priority review do not change the standards for marketing approval and may not ultimately expedite the development or approval process.

Furthermore, none of these programs changes the standards for marketing approval and may not ultimately expedite the development or approval process.

From time to time, new legislation and regulations may be implemented that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products regulated by the FDA.

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Post-Approval Requirements for Prescription Drugs

reporting of adverse experiences with the product, product sampling and distribution restrictions, complying with promotion and advertising requirements, which include restrictions on promoting drugs for unapproved uses or patient populations (i.e., “off-label use”) and limitations on industry-sponsored scientific and educational activities.

Following approval of a new drug product, the manufacturer and the approved drug are subject to pervasive and continuing regulation by the FDA, including, among other things, monitoring and recordkeeping activities, reporting of adverse experiences with the product, product sampling and distribution restrictions, complying with promotion and advertising requirements, which include restrictions on promoting drugs for unapproved uses or patient populations (i.e., “off-label use”) and limitations on industry-sponsored scientific and educational activities.

Although physicians may prescribe legally available products for off-label uses, manufacturers may not market or promote such uses.

The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

As noted above, in February 2026, the FDA announced a new postmarket data ‑ collection initiative applicable to all drugs and devices, but the FDA has not yet published guidance specific to this new program.

Moreover, if there are any modifications to the product, including changes in indications, labeling or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new NDA or an NDA supplement, which may require the applicant to develop additional data or conduct additional preclinical studies and clinical trials.

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FDA regulations also require, among other things, the investigation and correction of any deviations from cGMP and the imposition of reporting and documentation requirements upon the NDA sponsor and any third-party manufacturers involved in producing the approved drug product.

Accordingly, both sponsors and manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance and other aspects of quality control and quality assurance, and to ensure ongoing compliance with other statutory requirements of the FDCA, such as the requirements for making manufacturing changes to an approved NDA.

assurance, and to ensure ongoing compliance with other statutory requirements of the FDCA, such as the requirements for making manufacturing changes to an approved NDA.

Accordingly, even after a new drug approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.

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Today, both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution.

The Drug Supply Chain Security Act, or DSCSA, was enacted in 2013 with the aim of building an electronic system to identify and trace certain prescription drugs distributed in the United States.

The DSCSA mandated resource-intensive obligations for pharmaceutical manufacturers, repackagers, wholesale distributors, and dispensers (primarily pharmacies) over a 10-year period that culminated in November 2023.

It also replaced certain provisions from the PDMA pertaining to wholesale distribution of prescription drugs with a more comprehensive statutory scheme, requiring uniform national standards for wholesale distribution and, for the

first time, for third-party logistics providers.

In February 2022, the FDA released proposed regulations to amend the existing national standards for licensing of wholesale drug distributors by the states (which had been promulgated under the PDMA);

to establish new minimum standards for state licensing third-party logistics providers;

and to create a federal system for licensure for use in the absence of a state program, each of which is mandated by the DSCSA.

Most recently, the FDA announced a one-year stabilization period to November 2024 followed by trading partner-specific exemptions through specified dates in 2025, giving entities subject to the DSCSA additional time to finalize interoperable tracking systems and to ensure supply chain continuity.

The Drug Supply Chain Security Act, or DSCSA, was enacted in 2013 to, among other things, require use of an electronic system to identify and trace certain prescription drugs distributed in the United States.

The DSCSA mandates resource-intensive obligations for pharmaceutical manufacturers, repackagers, wholesale distributors, and dispensers (primarily pharmacies).

Most recently, the FDA announced trading partner-specific exemptions through specified dates in 2025, giving entities subject to the DSCSA additional time to finalize interoperable tracking systems and to ensure supply chain continuity.

From time to time, new legislation and regulations may be implemented that could significantly change the statutory provisions governing the approval, manufacturing, and marketing of prescription drug products regulated by the FDA.

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These types of medical devices may be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device, and accordingly device manufacturers are responsible for identifying cybersecurity risks and hazards associated with their products.

In recent years, the FDA has increased its scrutiny of this issue as part of the review and marketing authorization process for new medical devices;

recent years, the FDA has increased its scrutiny of this issue as part of the review and marketing authorization process for new medical devices;

the agency also monitors reports of cybersecurity risks as part of its post-marketing device surveillance activities.

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Medical devices are classified into one of three classes on the basis of the controls deemed by the FDA to be necessary to reasonably assure their safety and effectiveness.

Class I devices are those low risk devices for which reasonable assurance of safety and effectiveness can be provided by adherence to the FDA’s general controls for medical devices, which include applicable portions of the FDA’s Quality System Regulation, or QSR;

facility registration and product listing;

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however, some Class I devices require premarket clearance by the FDA through the 510(k) process.

Notably, the agency has issued a final rule called the Quality Management System Regulation, or QMSR, to harmonize the FDA's medical device current good manufacturing practice regulations with the International Organization for Standardization, or ISO, standard for device quality management systems (ISO 13485:2016).

The effective date for the QMSR final rule is February 2, 2026.

Until then, manufacturers are required to comply with QSR.

Notably, the QMSR was developed and implemented to harmonize the FDA's previous medical device current good manufacturing practice regulations (referred to as the Quality System Regulation, or QSR) with the International Organization for Standardization, or ISO, standard for device quality management systems (ISO 13485:2016);

it became effective on February 2, 2026.

Class II devices are moderate risk devices and are subject to the FDA’s general controls, and any other special controls, such as performance standards, post-market surveillance, and FDA guidelines, deemed necessary by the FDA to provide reasonable assurance of the devices’ safety and effectiveness.

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The device to which the sponsor’s device is compared for the purpose of determining substantial equivalence is called a “predicate device.” The FDA’s goal is to make a substantial equivalence determination within 90 days of FDA’s receipt of the 510(k) application, but it often takes longer if the FDA requests additional information.

Most 510(k)s do not require supporting

data from clinical trials, but such data is typically required if the predicate device relied in part on clinical trial data to obtain clearance.

Most 510(k)s do not require supporting data from clinical trials, but such data is typically required if the predicate device relied in part on clinical trial data to obtain clearance.

After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, will require a new clearance or possibly a pre-market approval.

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Although the FDA is not bound by the advisory panel decision, it considers such recommendations when making final decisions on approval.

In addition, the FDA will conduct a preapproval inspection of the manufacturing facility to ensure compliance with the QSR.

In addition, the FDA will conduct a preapproval inspection of the manufacturing facility to ensure compliance with the QMSR.

New PMA applications or supplements are also required for product modifications that affect the safety and efficacy of the device.

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Novel medical device types that the FDA has not previously classified as Class I, II or III are automatically classified into Class III regardless of the level of risk they ultimately pose to patients and/or users.

The Food and Drug Administration Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the De Novo classification procedure.

The Food and Drug Administration Modernization Act of 1997 established an alternative route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the De Novo classification procedure.

This procedure allows a manufacturer whose novel device is automatically classified into Class III to request down-classification of its medical device into Class I or Class II based on a benefit-risk analysis demonstrating the device actually presents low or moderate risk, rather than requiring the submission and approval of a PMA application.

Today, as a result of certain amendments to the FDCA, manufacturers may request De Novo classification from the FDA without first submitting a 510(k) premarket notification and receiving a not substantially equivalent determination.

The FDA is required under the statute to classify the device within 120 days following receipt of the De Novo application, however, the most recent FDA premarket review goals state that in fiscal year 2024, FDA will attempt to issue a decision on 80% of all De Novo classification requests received within 150 days of receipt.

Today, as a result of certain amendments to the FDCA, manufacturers may request De Novo classification from the FDA without first submitting a

510(k) premarket notification and receiving a not substantially equivalent determination.

The FDA is required under the statute to classify the device within 120 days following receipt of the De Novo request, however, the most recent FDA premarket review goals state that in fiscal year 2026, FDA will attempt to issue a decision on 80% of all De Novo classification requests received within 150 days of receipt.

If the manufacturer seeks reclassification into Class II, the manufacturer must include a draft proposal for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device.

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Generally, clinical trials for a significant risk device may begin once the IDE is approved by the FDA and the study protocol and informed consent form are approved by a duly-appointed IRB at each clinical trial site.

A diversity action plan will be required for most clinical studies of investigational medical devices intended to support marketing authorization as a result of the December 2022 FDCA amendments.

A diversity action plan will be required for most clinical studies of investigational medical devices intended to support marketing authorization as a result of the 2022 FDCA amendments.

FDA’s IDE regulations govern investigational device labeling, prohibit promotion, and specify an array of GCP requirements, which include, among other things, recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

Clinical trials must further comply with the FDA’s regulations for IRB approval and for informed consent and other human subject protections.

Required records and reports are subject to inspection by

Required records and reports are subject to inspection by the FDA.

The results of clinical testing may be unfavorable or, even if the intended safety and efficacy success criteria are achieved, may not be considered sufficient for the FDA to grant approval or clearance of a product.

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• submitting and updating establishment registration and device listings with the FDA;

• compliance with the QSR, which requires manufacturers to follow stringent design, testing, control, documentation, record maintenance, including maintenance of complaint and related investigation files, and other quality assurance controls during the manufacturing process;

• compliance with the QMSR, which requires manufacturers to follow stringent design, testing, control, documentation, record maintenance, including maintenance of complaint and related investigation files, and other quality assurance controls during the manufacturing process;

• pre-scheduled or unannounced device facility inspections by the FDA;

• labeling regulations, which prohibit the promotion of devices for uncleared or unapproved (or “off-label”) uses and impose other restrictions relating to promotional activities;

• corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FDCA that may present a risk to health;

• correction and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FDCA that may present a risk to health;

• post-market surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and effectiveness data for the device.

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• a product comprising two or more regulated constituent parts that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

• two or more separate products packaged together in a single package or as a unit and comprised of drug and device products;

• a drug or device packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug or device where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose;

• two or more separate products packaged together in a single package or as a unit and comprised of drug and device components;

• a drug or device packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug or device where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be updated to reflect its new use as part of the combination;

• any investigational drug or device packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

The FDA’s Office of Combination Products, or OCP, was established to provide prompt determination of the FDA Center with primary jurisdiction over the review and regulation of a combination product;

ensure timely and effective premarket review by overseeing the timeliness of and coordinating reviews involving more than one center;

ensure consistent and appropriate post-market regulation;

resolve disputes regarding review timeliness;

and review/revise agreements, guidance and practices specific to the assignment of combination products.

The FDA’s Office of Combination Products, or OCP, provides sponsors with a prompt determination of the FDA Center with primary jurisdiction over a combination product;

ensures timely and effective premarket review by coordinating reviews involving more than one center;

ensures consistent and appropriate post-market regulation;

resolves disputes regarding review timeliness;

and reviews/revises agreements, guidance and practices specific to combination products.

OCP determines which Center will have primary jurisdiction for the combination product, referred to as the Lead Center, based on the combination product’s “primary mode of action,” or PMOA.

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In most instances, the Lead Center applies its usual regulatory pathway.

For example, a drug-device combination product assigned to CDER will typically be reviewed under an NDA, while a drug-device combination product assigned to CDRH is typically reviewed under through a 510(k), PMA, or De Novo classification request.

Often it is difficult for OCP to determine with reasonable certainty the most important therapeutic action of the combination product.

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For example, a combination product for which an NDA is submitted is subject to the NDA fee under PDUFA.

Likewise, a combination product for which a PMA is submitted is subject to the PMA fee under the Medical Device User Fee and Modernization Act.

Since a combination product incorporates two or more constituent parts that have different regulatory requirements, a combination product manufacturer must comply with all cGMP and QSR requirements that apply to each constituent part.

Likewise, a combination product for which a PMA is submitted is subject to the PMA user fee.

Since a combination product incorporates two or more constituent parts that have different regulatory requirements, a combination product manufacturer must comply with all cGMP and QMSR requirements that apply to each constituent part.

The FDA has issued a combination product cGMP regulation, along with final guidance, describing two approaches a combination product manufacturer may follow to demonstrate compliance.

Under these two options, the manufacturer demonstrates compliance with:

(1) All cGMP regulations applicable to each separate

regulated constituent part included in the combination product;

or (2) either the drug cGMP or the QSR, as well as with specified provisions from the other of these two sets of requirements (also called the “streamlined approach”).

(1) All cGMP regulations applicable to each separate regulated constituent part included in the combination product;

or (2) either the drug cGMP or the QMSR, as well as with specified provisions from the other of these two sets of requirements (also called the “streamlined approach”).

In addition, the 21st Century Cures Act, or the Cures Act, amended the FDCA to clarify that for drug-device combination products with a device PMOA and an FDA-approved drug constituent part, Hatch-Waxman Act requirements apply.

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As part of the NDA review and approval process, applicants are required to list with the FDA each patent that has claims that cover the applicant’s product or method of therapeutic use.

Upon approval of a new drug, each of the patents listed in the application for the drug is then published in the Orange Book.

Upon approval of a new drug, each of the

patents listed in the application for the drug is then published in the Orange Book.

Drugs listed in the Orange Book can, in turn, be cited by potential follow-on competitors in support of approval of an ANDA or a 505(b)(2) NDA that relies in full or in part on the reference product.

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If the follow-on applicant does not challenge the innovator’s listed patents, FDA will not approve the ANDA or 505(b)(2) application until all the listed patents claiming the referenced product have expired.

A certification that the

new product will not infringe the already approved product’s listed patents, or that such patents are invalid, is called a Paragraph IV certification.

A certification that the new product will not infringe the already approved product’s listed patents, or that such patents are invalid, is called a Paragraph IV certification.

If the follow-on applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once the ANDA or 505(b)(2) NDA has been accepted for filing by the FDA.

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Under the GAIN Act amendments to the FDCA, the FDA may designate a product as a QIDP for a specific use for which it is being studied, upon the written request of a sponsor at any time prior to submission of a marketing application.

In order to qualify for designation as a QIDP, the drug product candidate must qualify as an antibiotic or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by either (i) an antibiotic or antifungal resistant pathogen, including novel or emerging infectious pathogens, or (ii) a so-called “qualifying pathogen” found on a list of potentially dangerous, drug-resistant organisms established and maintained by the FDA.

In order to qualify for designation as a QIDP, the drug product candidate must qualify as an antibiotic or

antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by either (i) an antibiotic or antifungal resistant pathogen, including novel or emerging infectious pathogens, or (ii) a so-called “qualifying pathogen” found on a list of potentially dangerous, drug-resistant organisms established and maintained by the FDA.

In addition to the expedited review benefits that a QIDP-designated drug candidate may be eligible for (described above under “Special FDA Programs to Facilitate and Expedite Development and Review of Certain New Drugs”), such a drug that is approved for the use for which the QIDP designation was granted will receive a five-year extension to any non-patent marketing exclusivity period for which the drug qualified upon approval, such as a five-year NCE exclusivity or three-year new clinical data exclusivity.

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The length of the patent term extension is related to the length of time the drug or medical device is under regulatory review while the patent is in force.

The restoration period granted on a patent covering a

new FDA-regulated medical product is typically one-half the time between the date a clinical investigation on human beings is begun and the submission date of an application for premarket approval of the product, plus the time between the submission date of an application for approval of the product and the ultimate approval date.

The restoration period granted on a patent covering a new FDA-regulated medical product is typically one-half the time between the date a clinical investigation on human beings is begun and the submission date of an application for premarket approval of the product, plus the time between the submission date of an application for approval of the product and the ultimate approval date.

Patent term restoration cannot be used to extend the remaining term of a patent past a total of 14 years from the product’s approval date.

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Failure to timely register a covered clinical study or to submit study results as provided for in the law can give rise to civil monetary penalties and also prevent the non-compliant party from receiving future grant funds from the federal government.

The NIH’s Final Rule on ClinicalTrials.gov registration and reporting requirements became effective in 2017, and the government has brought enforcement actions against clinical trial sponsors that fail to comply with such requirements.

Health Care Laws and Compliance Requirements

As we plan to commercialize our product candidates, if approved, we are subject to additional health care statutory and regulatory requirements and enforcement by federal government and the states and foreign governments in the jurisdictions in which we conduct our business.

Health care providers, physicians and third-party payors play a primary role in the recommendation and prescription of any product candidates for which we may obtain marketing approval.

We are subject to additional health care statutory and regulatory requirements and enforcement by federal government and the states and foreign governments in the jurisdictions in which we conduct our business.

Health care providers, physicians and third-party payors play a primary role in the recommendation and prescription of any product candidates for which we may obtain marketing approval as well as prescription drug products that are being manufactured and distributed by 503B outsourcing facilities.

Arrangements we may enter into with third-party payors or other customers expose us to broadly applicable fraud and abuse and other health care laws and regulations that constrain the business or financial arrangements and relationships through which we market, sell, and distribute any products for which we obtain marketing approval.

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Given the penalties that may be imposed on companies and individuals if convicted, allegations of such violations often result in settlements even if the company or individual being investigated admits no wrongdoing.

Settlements often include significant civil sanctions, including fines and civil monetary penalties, and corporate integrity agreements.

Settlements often include significant civil sanctions, including fines and civil

monetary penalties, and corporate integrity agreements.

If the government were to allege or convict us or our executive officers, employees or consultants of violating these laws, our business could be harmed.

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The federal Anti-Kickback Statute is subject to evolving interpretations.

In the past, the government has enforced the federal Anti-Kickback Statute to reach large settlements with

health care companies based on sham consulting and other financial arrangements with physicians.

In the past, the government has enforced the federal Anti-Kickback Statute to reach large settlements with health care companies based on sham consulting and other financial arrangements with physicians.

A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

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Business associates create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity.

HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and created penalties for third parties that unlawfully acquire protected health information.

HITECH also increased the civil and criminal penalties that may be imposed against

covered entities, business associates and created penalties for third parties that unlawfully acquire protected health information.

HITECH also gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorney’s fees and costs associated with pursuing federal civil actions;

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In the United States, third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies, but they also have their own methods and approval process apart from Medicare coverage and reimbursement determinations.

One third-party payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the product.

party payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the product.

Accordingly, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate payment will be applied consistently or granted at all.

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Additionally, the containment of health care costs has become a priority of federal and state governments and the prices of drug products have been a focus in this effort.

For example, there have been several recent U.S.

Congressional inquiries and proposed bills designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

In August 2022, President Biden signed into the law the Inflation Reduction

Act of 2022, or the IRA, which includes (among other things) multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States.

federal actions include initiatives incorporating "most favored nation" (international reference pricing) concepts for certain prescription drugs, as well as agency testing of new payment models that could tie Medicare reimbursement or manufacturer rebates to prices in specified reference countries.

For example, in August 2022, President Biden signed into the law the Inflation Reduction Act of 2022, or the IRA, which includes (among other things) multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States.

Starting in 2023, a manufacturer of drug products covered by Medicare Parts B or D must pay a rebate to the federal government if their drug product’s price increases faster than the rate of inflation.

This calculation is made on a drug product by drug product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D.

Additionally, starting for payment year 2026, CMS is negotiating drug prices annually for a select number of single source Part D drugs without generic competition.

CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028.

Additionally, CMS is negotiating drug prices annually for a select number of single source Part D drugs without generic competition.

CMS is also negotiating drug prices for a select number of Part B drugs starting for payment year 2028.

If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease.

CMS has begun to implement these new authorities, entering into the first set of agreements with pharmaceutical manufacturers to conduct price negotiations in October 2023 and ultimately announcing the first round of negotiated prices for the first 10 drugs in August 2024;

those negotiated "maximum fair prices" will be effective as of January 1, 2026 (payment year 2026).

CMS is currently engaged in its second round of negotiations and published the next 15 drugs selected for negotiation in January 2025.

CMS has begun to implement these new authorities, announcing the first round of negotiated "maximum fair prices" for the first 10 drugs in August 2024, which became effective as of January 1, 2026 (payment year 2026).

The second round of negotiated prices for 15 drug products was announced in November 2025, and CMS published the next group of drugs selected for negotiation in January 2026.

However, the IRA's impact on the pharmaceutical industry in the United States remains uncertain, in part because multiple large pharmaceutical companies and other stakeholders (e.g., the U.S.

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The outcome of such ongoing lawsuits, as well as potential legislative changes enacted by Congress or programmatic changes implemented at CMS by the Trump Administration, may impact the IRA drug price negotiation program in the future.

Separately, the Trump Administration announced the creation of a government website called TrumpRx, which will allow consumers to purchase certain drugs at reduced prices as negotiated between the drug manufacturers and the administration.

As of January 2026, the Trump Administration had secured deals with 16 major drug manufacturers to offer certain drugs at most-favored-nation prices.

We expect that federal, state and local governments in the U.S.

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Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmacy benefit managers, or PBMs, and other members of the health care and pharmaceutical supply chain, an important decision that has led to further and more aggressive efforts by states in this area.

The Federal Trade Commission in mid-2022 also launched sweeping investigations into the practices of the PBM industry, and published interim reports with its findings in mid-2024 and January 2025, that could lead to additional federal and state legislative or regulatory proposals targeting such entities’ operations, pharmacy networks, or financial arrangements, including in the current 2025-2026 congressional session.

The Federal Trade Commission in mid-2022 also launched sweeping investigations into the practices of the PBM industry, and published interim reports with its findings in mid-2024 and January 2025, that also appear to be contributing to additional federal and state legislative and regulatory proposals, as well as enforcement action and private litigation, targeting such entities’ operations, pharmacy networks, and financial arrangements.

In February 2026, President Trump signed into law several PBM regulatory reforms as part of a federal budget package.

The Department of Labor (DOL) also issued a proposed rule in January 2026 that would mandate specific PBM fee disclosures to self-insured plan fiduciaries under the Employment Retirement Income Act (ERISA).

If finalized as proposed, the DOL rule would also allow plan fiduciaries to audit those PBM disclosures to confirm accuracy.

Additional proposals and legislative changes aimed at PBMs and their business practices are likely to continue to be introduced and considered in Congress and by executive agencies.

Significant efforts to change the PBM industry as it currently exists in the U.S.

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The ACA also expanded the 340B drug discount program (excluding orphan drugs), including a 50% discount on brand name drugs for Medicare Part D participants in the coverage gap, and revised the definition of “average manufacturer price” for reporting purposes, which could increase the amount of the Medicaid drug rebates paid to states.

It also contains substantial provisions intended to broaden access to health insurance, reduce or constrain the growth of health care spending, enhance remedies against health care fraud and abuse, add new transparency requirements for the health care industry, impose new taxes and fees on pharmaceutical manufacturers, and impose additional health policy reforms.

It also contained substantial provisions intended to broaden access to health insurance, reduce or constrain the growth of health care spending, enhance remedies against health care fraud and abuse, add new transparency requirements for the health care industry, impose new taxes and fees on pharmaceutical manufacturers, and impose additional health policy reforms.

Further legislative and regulatory changes under the ACA remain possible, although it is unknown what form any such changes or any law would take, and how or whether it may affect the biopharmaceutical industry as a whole or our business in the future.

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Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures reforms may prevent or limit our ability to generate revenue, attain profitability or commercialize our product candidates.

Regulation of Compounded Drugs

Federal Regulation of Compounded Drugs

Drug compounding is a practice in which a licensed pharmacist, a licensed physician, or in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a customized medication.

Compounded drugs are regulated at the federal level primarily under Sections 503A and Section 503B of the Federal Food, Drug, and Cosmetic Act, or the FDCA, which we refer to as Section 503A and Section 503B, respectively.

As discussed above, we are seeking to make our proprietary Sildenafil Cream formulation available by prescription as a compounded drug via Section 503B.

Compounded drugs are regulated at the federal level primarily under Section 503A and Section 503B of the FDCA.

The FDA does not evaluate compounded drug products for safety, effectiveness, or quality, although it does have oversight over the compounding pharmacies and outsourcing facilities producing such drugs in compliance with the conditions of Section 503A and 503B, respectively.

As discussed above, we are making our proprietary sildenafil cream formulation available to patients by prescription as a compounded drug under the brand name DARE to PLAY Sildenafil Cream via an outsourcing facility operating under Section 503B, and we plan to make our proprietary estradiol progesterone intravaginal ring available to patients by prescription as a compounded drug under the brand name DARE to RECLAIM™ estradiol progesterone intravaginal ring via another outsourcing facility operating under Section 503B.

The term “outsourcing facility” refers to a facility that produces compounded drugs in accordance with Section 503B and distributes them either pursuant to a patient-specific prescription or in response to an order from a health care provider, such as a hospital, that is not for an identified individual patient (e.g., for office stock).

Outsourcing facilities must be registered with the FDA and are subject to cGMP requirements and FDA inspections.

In addition, an outsourcing facility must meet other conditions described in Section 503B, including reporting adverse events, labeling compounded products with certain information, reporting specific information about the drugs that it compounds, including a list of all of drugs it compounded during the previous six months, and the FDA-registered source of the active ingredients used to compound pursuant to Section 503B(b)(2).

In addition, an outsourcing facility must meet other conditions described in Section 503B, including reporting adverse events, labeling compounded products with certain information, reporting specific information about the drugs that it compounds, including a list of all of drugs it compounded during the previous six months and the FDA-registered source of the active ingredients used to compound.

Under Section 503B, outsourcing facilities are prohibited from selling compounded drugs through a wholesale distributor, subject to certain exceptions set forth in FDA guidance.

Outsourcing facilities may only compound using bulk drug substances that either appear on a list established by the FDA of bulk drug substances for which there is a clinical need or are for drug products on FDA's Drug Shortage List.

Although the FDA has not yet finalized its list of bulk drug substances for which there is a clinical need, the FDA has announced an interim policy pursuant to which bulk drug substances may be nominated for inclusion on such list and, provided certain conditions are met, outsourcing facilities may compound with such bulk drug substances pending evaluation of the substances for inclusion on the FDA’s list of bulk drug substances for which there is a clinical need.

Each of sildenafil citrate, estradiol, and progesterone as a bulk drug substance that is a component of FDA-approved drugs, is currently listed in FDA's interim Category 1 List of bulk substances that have been nominated, reviewed by FDA, and may be compounded by outsourcing facilities pending FDA’s final evaluation.

FDA does not intend to take action against an outsourcing facility for compounding drugs using bulk drug substances

classified as Category 1 substances provided that the conditions described in the agency's January 2025 interim enforcement policy are met.

Under Section 503B, outsourcing facilities are prohibited from compounding a drug that is “essentially a copy” of an FDA-approved drug, unless the drug is on the FDA’s Drug Shortage List at the time of compounding, distribution, and dispensing.

A drug is essentially a copy of an FDA-approved drug if it is identical or nearly identical to the FDA-approved drug, which the FDA has interpreted to mean that it has the same active ingredient(s), route of administration, dosage form, dosage strength and excipients as the approved drug, or if it has the same active ingredient as an approved drug and there is not a change from the approved drug that produces a clinical difference for an individual patient, as determined by the prescribing practitioner.

Sildenafil citrate is currently listed in FDA's interim Category 1 List of bulk substances that have been nominated, reviewed by FDA, and may be compounded by outsourcing facilities pending FDA’s final evaluation.

In December 2023, the FDA issued Guidance for Industry addressing the criteria by which the FDA intends to evaluate whether there exists a clinical need for compounding with a bulk drug substance.Under such guidance, the FDA intends to use a two-part analysis if the bulk drug substance is a component of an FDA-approved product, and if the bulk drug substance is not a component of an FDA-approved product, then the FDA intends to use only part 2 of such analysis.

Under part 1 of the analysis, the FDA intends to evaluate whether there is a basis for the FDA to conclude that (a) an attribute of the FDA-approved drug that makes it medically unsuitable to treat certain patients;

and the drug proposed to be compounded is intended to address that attribute;

and (b) the drug proposed to be compounded must be produced from a bulk drug substance rather than from the FDA-approved drug product.

If the answer to either of such questions is "no," then the FDA could determine that there is no clinical need for compounding with the bulk drug substance.

If the answer to both such questions is "yes," then the FDA intends to proceed to part 2 of the analysis.

Under part 2 of the analysis, the FDA intends to conduct a balancing test under which FDA would consider each of the following factors:

(i) the physical and chemical characterization of the bulk drug substance;

(ii) any safety issues raised by the use of the bulk drug substance in compounding;

(iii) the available evidence of effectiveness or lack of effectiveness of a drug product compounded with the bulk drug substance, if any such evidence exists;

and (iv) current and historical use of the bulk drug substance in compounded drug products, including information about medical condition(s) that the substance has been used to treat and any references in peer-reviewed medical literature.

FDA has not announced when it will complete its analysis of nominated bulk substances and make a determination of substances that will be placed, after notice and a comment period, on FDA's final list of bulk substances that may be used in compounding by outsourcing facilities.

The source of any bulk substance active ingredient used in compounding must be a Section 510 registered manufacturer, and the bulk substance must be accompanied by a Certificate of Analysis.

Section 503A of the FDCA exempts licensed pharmacists or licensed physicians who compound drugs for identified, individual patients, based on the receipt of a valid prescription order, from the FDCA’s new drug approval requirements, cGMP requirements, and the requirement to label products with adequate directions for use, provided

certain conditions are met.

These conditions include that the pharmacist or physician does not compound regularly or inordinate amounts any drug that is essentially a copy of an FDA-approved drug.

The framework for assessing if a drug is essentially a copy of an FDA-approved drug under Section 503A is different than the framework under Section 503B described above.

For instance, a Section 503A pharmacy may compound a formulation that is greater than 10% in dosage strength than the commercially available drug product, if that formulation is accompanied by a statement of significant difference.

In addition, the substances that may be used in compounding under Section 503A are much broader than under Section 503B, because Section 503A pharmacies may compound from bulk substances that are components of FDA-approved drug products and substances that are the subject of a USP/NF monograph.

Sections 503A and 503B also prohibit compounding of drugs that present “demonstrable difficulties for compounding.” The FDA must publish a list of such drugs, through notice and comment rulemaking, before implementing the prohibition, and FDA has not yet finalized any such lists for publication.

Data Privacy and the Protection of Personal Information

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While there is currently an exception for protected health information that is subject to HIPAA and clinical trial regulations, as currently written, the CCPA may impact our business activities.

More recently, a new privacy law, the California Privacy Rights Act, or CPRA, was approved by California voters in the election on November 3, 2020.

More recently, the California Privacy Rights Act, or CPRA, was approved by California voters in the election on November 3, 2020.

The CPRA went into effect in January of 2023, modifying and strengthening the CCPA significantly, potentially resulting in further uncertainty, additional costs and expenses in an effort to comply and additional potential for harm and liability for failure to comply.

Among other things, the CPRA established a new regulatory authority, the California Privacy Protection Agency, which will be enacting new regulations and will have expanded enforcement authority.

Various states such as Colorado,

Connecticut, Delaware, Florida, Indiana, Iowa, Kentucky, Maryland, Montana, Nebraska, New Hampshire, New Jersey, Oregon, Rhode Island, Tennessee, Texas, Utah and Virginia have enacted their own privacy laws similar to the CCPA, and other states are considering proposals for such.

Numerous other states have either enacted or are considering enacting their own privacy laws similar to the CCPA.

Health Care Reform and Potential Changes to Laws and Regulations

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We face the risk that the resulting prices would be insufficient to generate an acceptable return to us or any future partner of ours.

If we fail to comply with applicable

foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions, and criminal prosecution.

If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions, and criminal prosecution.

International marketing and distribution of medical devices are also subject to foreign government regulations, which may vary substantially from country to country.

There is a trend towards harmonization of quality system standards for medical device products among the European Union, United States, Canada and various other industrialized countries.

There is a trend towards harmonization of quality system

standards for medical device products among the European Union, United States, Canada and various other industrialized countries.

As of January 31, 2020, the United Kingdom is no longer a member state of the EU, and therefore a separate marketing authorization application and approval will be required to market a medicinal product in the U.K.

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In April 2014, the new Clinical Trials Regulation, (EU) No 536/2014 (Clinical Trials Regulation) was adopted and became effective on January 31, 2022.

The Clinical Trials Regulation is directly applicable in all the EU Member States, repealing the current Clinical Trials Directive 2001/20/EC.

The extent to which ongoing clinical trials will be governed by the Clinical Trials Regulation depends on when the Clinical Trials Regulation becomes applicable and on the duration of the individual clinical trial.

If a clinical trial continues for more than three years from the day on which the Clinical Trials Regulation becomes applicable the Clinical Trials Regulation will at that time begin to apply to the clinical trial.

The new Clinical Trials Regulation aims to simplify and streamline the approval of clinical trials in the European Union.

The Clinical Trials Regulation is directly applicable in all the EU Member States.

The main characteristics of the regulation include:

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The decentralized procedure provides for an applicant to apply to one-member state to assess the application (the reference member state) and specifically list other member states in which it wishes to obtain approval (concerned member states).

Under this procedure, an applicant submits an application based on identical dossiers and related materials, including

a draft summary of product characteristics, and draft labelling and package leaflet, to the reference member state and each concerned member state.

Under this procedure, an applicant submits an application based on identical dossiers and related materials, including a draft summary of product characteristics, and draft labelling and package leaflet, to the reference member state and each concerned member state.

The reference member state prepares a draft assessment report and drafts of the related materials within 210 days after receipt of a valid application which is then reviewed and approved commented on by the concerned member states.

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In the EU, only products for which marketing authorizations have been granted may be promoted.

A marketing authorization is valid for five years in principle and the marketing authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the authorizing member state.

member state.

To this end, the marketing authorization holder must provide the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorization was granted, at least six months before the marketing authorization ceases to be valid.

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The penalties could include warnings, orders to discontinue the promotion of the drug product, seizure of promotional materials, fines and possible imprisonment.

Notably, the European Commission issued a proposal in 2023 to revise and replace the existing general pharmaceutical legislation for the EU.

As of January 2026, the three EU institutions, the European Commission, the European Parliament and the Council of the EU, are in the process of negotiating the final content of the new Directive and Regulation.

Once negotiations are complete, the European Parliament and the Council of the EU will vote on whether to approve the Directive and Regulation.

If adopted and implemented, these revisions will significantly change several aspects of drug development and approval in the European Union.

Prior to May 26, 2021, the date on which the new Medical Device Regulation ("MDR") became effective, medical devices marketed in Europe were required to comply with the Essential Requirements defined in Annex I to the EU Medical Devices Directive, or MDD, a coordinated system for the authorization of medical devices.

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In 2017, European Union regulatory bodies finalized the MDR, which provided three years for transition and compliance, for a final effective date of May 26, 2020.

As a result of the COVID-19 pandemic, however, the implementation date was postponed by one year to May 26, 2021, and a further transition period until May 26, 2024 gives the medical device industry and Notified Bodies additional time to come into compliance.

A further transition period was provided until May 26, 2024 to give the medical device industry and Notified Bodies additional time to come into compliance.

The MDR changed several aspects of the existing regulatory framework for medical device marketing in Europe and increased regulatory oversight of all medical devices marketed in the EU, which may, in turn, increase the costs, time and requirements that need to be met in order to place an innovative or high-risk medical device on the European market.

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A CE certificate issued under the MDD before May 26, 2021 may remain valid until May 25, 2024 under certain conditions.

Longer transition periods for various medical devices covered by certificates or declarations of conformity issued before May 26, 2021 were implemented by the European Commission in March 2023 in order to mitigate the risk of device shortages in the EU.

The new transition periods permit devices certified in accordance with the MDD to remain on the market under such certifications until May 26, 2026 for class III implantable custom-made devices, December 31, 2027 for Class III and implantable class IIb devices, and December 31, 2028 for all other class IIb and lower risk devices.

As a new market entrant, however, the transition provisions do not apply to our business and we must acquire approvals under the MDR for new products, which could be challenging and costly.

As a new market entrant, we must acquire any necessary device approvals under the MDR for new products, which could be challenging and costly.

Review and Approval of Medicinal Products in Canada

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The approval process varies from country to country and the time may be longer or shorter than that required for the FDA, EMA, or Health Canada approval.

The requirements governing the conduct of

clinical studies, product licensing, pricing and reimbursement vary greatly from country to country.

The requirements governing the conduct of clinical studies, product licensing, pricing and reimbursement vary greatly from country to country.

In some international markets, additional clinical trials may be required prior to the filing or approval of marketing applications within the country.

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The GDPR only permits exports of data outside the EU to countries deemed by the European Commission to have adequate data privacy laws or where there is a suitable data transfer solution in place to safeguard personal data (e.g., the European Union Commission approved Standard Contractual Clauses).

On July 16, 2020, the Court of Justice of the European Union or the CJEU, issued a landmark opinion in the case Maximilian Schrems vs.

Facebook (Case C-311/18), called Schrems II .

This decision a) calls into question certain data transfer mechanisms as between the EU member states and the U.S.

and b) invalidates the EU-U.S.

Privacy Shield on which many companies had relied as an acceptable mechanism for transferring such data from the EU to the U.S.

On July 10, 2023, the European Commission adopted an adequacy decision for a new mechanism for transferring data from the EU to the United States – the EU-US Data Privacy Framework, which provides EU individuals with several new rights, including the right to obtain access to their data, or obtain correction or deletion of incorrect or unlawfully handled data.

The adequacy decision followed the signing of an executive order introducing new binding safeguards to address the points raised in the Schrems II decision.

The adequacy decision followed the signing of an executive order introducing new binding safeguards to address the points previously raised by the Court of Justice of the European Union, or the CJEU, in a decision that invalidated the former EU-U.S.

Privacy Shield.

Notably, the new obligations were geared to ensure that data can be accessed by U.S.

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As of March 25, 2026, we had 24 employees.

Twenty one of our employees are full-time and two are part-time, 17 are in research and development and six are in general and administrative.

Given the differing characteristics of our product candidates, our approach is to engage consultants with experience in varying specialties to help us develop such candidates.

Of those 24 employees, 21 were full-time and three were part-time, and 17 were in research and development and seven were in selling, general and administrative.

Our approach is to engage consultants with experience in varying specialties to help us develop our diverse portfolio of product candidates and bring to market 503B compounded products and consumer health products.

Our numerous consultants serve as an extension to our employee base.

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

What changed 10-K

Item 1. Business