Dare Bioscience, Inc.

Previous wording

Daré Bioscience® is a registered trademark of Daré Bioscience, Inc. and XACIATO™ is a trademark of Daré Bioscience, Inc. with registration pending. Ovaprene® is a registered trademark licensed to Daré Bioscience, Inc. All other trademarks, service marks or trade names appearing in this report are the property of their respective owners. Use or display by us of other parties’ trademarks, service marks or trade names is not intended to and does not imply a relationship with, or endorsements or sponsorship of, us by the trademark, service mark or trade name owners.

Current wording

Daré Bioscience® is a registered trademark of Daré Bioscience, Inc. and DARE TO PLAY™ is a trademark of Daré Bioscience, Inc. with registration pending. Ovaprene® is a registered trademark licensed to Daré Bioscience, Inc. XACIATO™ is a registered trademark of N.V. Organon. All other trademarks, service marks or trade names appearing in this report are the property of their respective owners. Use or display by us of other parties’ trademarks, service marks or trade names is not intended to and does not imply a relationship with, or endorsements or sponsorship of, us by the trademark, service mark or trade name owners.

Previous wording

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. We have assembled our diverse portfolio of assets through acquisitions, exclusive in-licenses, and other collaborations. 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, or Section 503B. We are also aiming to bring to market consumer health products that can be obtained without a physician’s prescription.

Current wording

With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting. However, access to real, evidence-based solutions continues to lag. 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.

Previous wording

As discussed below, we will need to raise substantial additional capital to continue to fund our operations and execute our current business strategy. Our business is subject to a number of risks common to biopharmaceutical companies (see ITEM 1A. RISK FACTORS in Part I of our 2024 10-K) and the process of developing and obtaining regulatory approvals for prescription drug and drug/device products in the United States and in foreign jurisdictions is inherently uncertain and requires the expenditure of substantial financial resources without any guarantee of success.

Current wording

Our business is subject to a number of risks common to biopharmaceutical companies (see ITEM 1A. RISK FACTORS in Part I of our 2024 10-K) and the process of developing, obtaining regulatory approvals for, and commercializing prescription drug and drug/device products in the United States and in foreign jurisdictions is inherently uncertain and requires the expenditure of substantial financial resources without any guarantee of success.

Previous wording

Our product candidates are in various stages of development, from pre-clinical through a pivotal Phase 3 clinical study, and will require review and approval from the FDA, or a comparable foreign regulatory authority, prior to being marketed and sold. The most 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 HealthCare LLC, or Bayer; Sildenafil Cream, 3.6%, or Sildenafil Cream, a novel cream formulation of sildenafil, the active ingredient in Viagra®, for the treatment of female sexual arousal disorder, or 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. See ITEM 1. "BUSINESS," in Part I of our 2024 10-K and “—Recent Events—Product Candidate Updates,” below, for additional information regarding our product candidates.

Current wording

Our product candidates are in various stages of development, from pre-clinical through a pivotal Phase 3 clinical study, and will require review and approval from the FDA, or a comparable foreign regulatory authority, prior to being marketed and sold. The most clinically advanced product candidates we are developing are: Ovaprene®, an investigational, hormone-free, monthly intravaginal contraceptive currently being evaluated in a pivotal Phase 3 clinical study, whose U.S. commercial rights are under a license agreement with Bayer HealthCare LLC, or Bayer; Sildenafil Cream, 3.6%, or Sildenafil Cream, a novel cream formulation of sildenafil, the active ingredient in Viagra®, for the treatment of female sexual arousal disorder, or FSAD; DARE-HRT1, an intravaginal ring designed to deliver combination menopausal hormone therapy, bio-identical 17β-estradiol and progesterone together, continuously over a 28-day period for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes. DARE-VVA1, investigational formulation of tamoxifen in a soft gelatin capsule for intravaginal administration as a hormone-free alternative to estrogen-based therapies for the treatment of moderate-to-severe dyspareunia, or pain during sexual intercourse; and DARE-HPV, an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment of genital human papillomavirus (HPV) infection in women as well as treatment of cervical intraepithelial neoplasia (also known as cervical dysplasia), and other HPV-related pathologies. See ITEM 1. "BUSINESS," in Part I of our 2024 10-K and “—Recent Events—Product Candidate Updates,” below, for additional information regarding our product candidates.

Previous wording

To successfully bring our proprietary formulations to market under Section 503B, among other things, we will need to successfully identify and enter into arrangements with one or more 503B-registered outsourcing facilities. We also intend to enter into arrangements with telehealth platforms and other third parties with marketing, sales or distribution capabilities in the Section 503B market. We intend to focus our resources on provider-to-provider education about disease state and our proprietary formulations, leveraging online resources, including web-based ordering platforms and collaborations with telehealth platforms and other third parties. We do not plan to establish marketing, sales or distribution capabilities in order to bring our proprietary formulations to market under Section 503B.

Current wording

To successfully execute our Section 503B compounding strategy, among other things, we will need to identify and enter into arrangements with one or more 503B-registered outsourcing facilities. We also intend to enter into arrangements with telehealth platforms and other third parties with marketing, sales or distribution capabilities in the Section 503B market. We intend to focus our resources on provider-to-provider education about disease state and our proprietary formulations, leveraging online resources, including web-based ordering platforms and collaborations with telehealth platforms and other third parties. We do not plan to establish marketing, sales or distribution capabilities in order to bring our proprietary formulations to market under Section 503B.

Previous wording

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

Current wording

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

Previous wording

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 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 Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD), part of the U.S. National Institutes of Health (NIH), and within the Contraceptive Clinical Trials Network (CCTN). Recent initiatives of the current U.S. presidential administration have negatively impacted the Phase 3 study and NICHD’s ability to carry out its responsibilities under the CRADA, and the future NICHD budget for the CRADA remains uncertain. 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 has been impacted. 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, and we do not anticipate that they will resume enrolling new participants. Currently, there are nine CCTN sites following enrolled participants in the study. However, recruitment is proceeding at the five study sites outside of the CCTN that we contracted directly with and initiated in the first quarter of 2025 with grant funding we received in November 2024, and to date, we have been pleased with the pace of enrollment at those sites. We are evaluating whether to contract directly with up to three additional study sites or aim to complete enrollment in the study with the five new study sites. At this time, due to the foregoing, we cannot reasonably predict the enrollment rate for the remainder of the study or an estimated time for completion of enrollment. However, we continue to anticipate there will be sufficient data on Ovaprene use in the study by the end of the second quarter of 2025 to reach the 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 DSMB meeting is scheduled for July 2025.

Current wording

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) across the five study sites we initiated in the first quarter of 2025 with grant funding we received in November 2024, and to date, we continue to be pleased with the pace of enrollment at those sites. We are evaluating whether to contract directly with additional study sites or aim to complete enrollment in the study with the five currently recruiting study sites. At this time, due to the foregoing, we cannot reasonably predict the enrollment rate for the remainder of the study or an estimated time for completion of enrollment. We do not expect enrollment will be completed in 2025.

Previous wording

We continue to prepare to advance Sildenafil Cream into the first of two anticipated Phase 3 clinical studies to support a new drug application to the FDA for the indication of treatment of female sexual arousal disorder (FSAD) in premenopausal women utilizing the 505(b)(2) regulatory pathway. For additional information regarding our Sildenafil Cream program, see ITEM 1. "BUSINESS," in Part I of our 2024 10-K. 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 previously submitted information to the FDA in response and we are targeting submission of additional requested information, along with the protocol and statistical analysis plan for the Phase 3 study to the FDA by the end of the second quarter of 2025. We are targeting 2025 for commencement of the Phase 3 study, pending review of any additional feedback from the FDA in response to our submissions. However, we do not plan to conduct the Phase 3 study until after we secure additional capital.

Current wording

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. 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. As a result, we do not anticipate initiating the first Phase 3 study in 2025 and cannot at this time reasonably predict when the study will commence.

Previous wording

We continue to work on the development of our other clinical and preclinical-stage programs, including conducting activities necessary to enable submission of an investigational new drug, or IND, application to the FDA for a pivotal Phase 3 clinical study of DARE-HRT1, activities in preparation for a Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1 based on our FDA-cleared IND relating to DARE-VVA1 and the anticipated study, and activities necessary to enables submission of an IND application to the FDA for a Phase 2 clinical study of DARE-HPV in the United States. We do not plan to commence the Phase 3 study of DARE-HRT1 or a Phase 2 study of DARE-VVA1 until after we secure additional capital.

Current wording

We continue to work on the development of our other clinical and preclinical-stage programs, including conducting activities necessary to enable submission of an investigational new drug, or IND, application to the FDA for a pivotal Phase 3 clinical study of DARE-HRT1, activities in preparation for a Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1 based on our FDA-cleared IND relating to DARE-VVA1 and the anticipated study, and activities necessary to enable submission of an IND application to the FDA for a Phase 2 clinical study of DARE-HPV in the United States.

Previous wording

As announced in March 2025, we are taking action to bring our proprietary Sildenafil Cream formulation to market under Section 503B. We are targeting to have our proprietary Sildenafil Cream formulation available, and we expect to begin recording revenue from sales thereof, in the fourth quarter of 2025, however, we do not expect the amount of such revenue, if any, to be material during 2025. We anticipate needing to invest no more than $1.0 million to support a 503B-registered outsourcing facility with technology-transfer activities specific to our Sildenafil Cream formulation, activate an awareness campaign, and facilitate access to our proprietary Sildenafil Cream formulation as an option for providers and women.

Current wording

As announced in March 2025, we are taking action to bring our proprietary topical cream formulation of sildenafil to market under Section 503B. The compounded drug will be branded as DARE to PLAY Sildenafil Cream. We are targeting to have DARE to PLAY Sildenafil Cream available by prescription in the U.S., and we expect to begin recording revenue from sales thereof, in the fourth quarter of 2025, however, we do not expect the amount of such revenue, if any, to be material during 2025. We anticipate needing to invest no more than $1.0 million to support a 503B-registered outsourcing facility with technology-transfer activities specific to our Sildenafil Cream formulation, activate an awareness campaign, and facilitate access to our proprietary Sildenafil Cream formulation as an option for providers and women.

Previous wording

We are also taking action to bring DARE-HRT1 to market under 503B. We are targeting to have DARE-HRT1 available, and we expect to begin recording revenue from sales thereof, by the end of 2026, however, we do not expect the amount of such revenue, if any, to be material during 2026. There are no FDA approved products that provide estradiol and progesterone together in a non-oral monthly form.

Current wording

We are also taking action to bring DARE-HRT1 to market under 503B. We are targeting to have DARE-HRT1 available, and to begin recording revenue from sales thereof, in late 2026, however, we do not expect the amount of such revenue, if any, to be material during 2026. There are no FDA approved products that provide estradiol and progesterone together in a non-oral monthly form.

Previous wording

We are also working to bring to market consumer health products. We have sourced vaginal probiotics from Europe that we aim to make available initially via a strategic partnership, and we expect to begin recording revenue from sales thereof, in the fourth quarter of 2025, however we do not expect the amount of such revenue, if any, to be material during 2025.

Current wording

We are also working to bring to market consumer health products. We have sourced vaginal probiotics from Europe that we are targeting to make available as consumer health products in the U.S. after DARE to PLAY Sildenafil Cream is available by prescription in the U.S.

Previous wording

Similar to our plans with respect to our Section 503B business strategy, we do not plan to establish marketing, sales or distribution capabilities in order to bring our proprietary formulations to market as consumer health products, but rather we plan to identify and enter into strategic agreements and collaborations with telehealth platforms and other third parties with marketing, sales or distribution capabilities in the consumer health products market.

Current wording

Similar to our plans with respect to our Section 503B business strategy, we do not plan to establish marketing, sales or distribution capabilities in order to bring our proprietary formulations to market as consumer health products, but rather we plan to identify and enter into strategic agreements and collaborations with third parties with marketing, sales or distribution capabilities in the consumer health products market.

Previous wording

There may be significant future effects on the women's health sector and the pharmaceutical and biopharmaceutical industries as a result of federal policy and regulatory changes under the current U.S. presidential administration, including in areas relating to regulatory framework and oversight, research and development funding, drug pricing reform, global trade policy and tariffs, and others. Recent initiatives have resulted in significant reductions in staffing levels at the FDA and NIH and could impact the agencies’ ability to retain remaining key personnel and hire additional personnel, which may disrupt their ability to perform routine activities or function in the normal course. With respect to the FDA, this may result in delays or limitations on our ability to obtain guidance from agency staff, slow review times for applications we submit to commence clinical studies and obtain requisite regulatory approvals in the future, and consequently, negatively impact the cost and timelines for developing and obtaining regulatory approval of our product candidates. Moreover, our business strategy has included seeking non-dilutive sources of funding and collaborations to support product development, and we have benefited significantly from federal government funding through grants and other agreements in support of several of our development programs, including Ovaprene and DARE-HPV. See above under “Recent Events,” Note 10 “Grant Awards” to the accompanying condensed consolidated financial statements, and our 2024 10-K for additional information. The U.S. presidential administration has recently taken actions to freeze or terminate more than $1.0 billion in NIH grants and the future of the NIH’s budget and research funding is highly uncertain. Our business, financial condition and operating results may be significantly adversely affected if existing grants or other arrangements supporting our development programs are frozen or terminated or we are unable to secure additional grants or other federal government funding in the future. Given the high level of uncertainty regarding federal policy and enforcement and regulatory changes and that circumstances are rapidly evolving, including as a result of legal challenges to recent federal government actions, we are not able to reasonably predict the potential impact on our business at this time. We continue to monitor these evolving developments and conditions and their potential impacts of our business, financial condition, and results of operations, and will attempt to adjust our plans, as appropriate, to mitigate risks. For additional information, see the risk factors described in Part II, Item 1A, Risk Factors in this report and Part I, Item 1A. Risk Factors in our 2024 10-K.

Current wording

There may be significant future effects on the women's health sector and the pharmaceutical and biopharmaceutical industries as a result of federal policy and regulatory changes under the current U.S. presidential administration, including in areas relating to regulatory framework and oversight, research and development funding, drug pricing reform, global trade policy and tariffs, and others. Recent initiatives have resulted in significant reductions in staffing levels at the FDA and NIH and could impact the agencies’ ability to retain remaining key personnel and hire additional personnel, which may disrupt their ability to perform routine activities or function in the normal course. With respect to the FDA, this may result in delays or limitations on our ability to obtain guidance from agency staff, slow review times for applications we submit to commence clinical studies and obtain requisite regulatory approvals in the future, and consequently, negatively impact the cost and timelines for developing and obtaining regulatory approval of our product candidates. Moreover, our business strategy has included seeking non-dilutive sources of funding and collaborations to support product development, and we have benefited significantly from federal government funding through grants and other agreements in support of several of our development programs, including Ovaprene and DARE-HPV. See Note 10 “Grant Awards” to the accompanying condensed consolidated financial statements and our 2024 10-K for additional information. In early 2025, the U.S. presidential administration took actions to freeze or terminate more than $1.0 billion in NIH grants and the future of the NIH’s budget and research funding remains highly uncertain. Our business, financial condition and operating results may be significantly adversely affected if existing grants or other arrangements supporting our development programs are frozen or terminated or we are unable to secure additional grants or other federal government funding in the future. Given the high level of uncertainty regarding federal policy and enforcement and regulatory changes and that circumstances are rapidly evolving, including as a result of legal challenges to recent federal government actions, we are not able to reasonably predict the potential impact on our business at this time. We continue to monitor these evolving developments and conditions and their potential impacts of our business, financial condition, and results of operations, and will attempt to adjust our plans, as appropriate, to mitigate risks. For additional information, see the risk factors described in Part II, Item 1A, Risk Factors in this report and Part I, Item 1A. Risk Factors in our 2024 10-K.

Previous wording

Our revenue reflects payments earned under our license agreement with Organon to commercialize XACIATO. Pursuant to our traditional royalty purchase agreement with XOMA, from and after April 1, 2024, all of the royalties and potential milestone payments we would otherwise have the right to receive under our license agreement with Organon based on net sales of XACIATO will be paid to XOMA, net of payments made under our exclusive license agreement with third-party licensors TriLogic Pharma, LLC and MilanaPharm LLC and under our royalty interest financing agreement with United in Endeavour, LLC, or UiE. Accordingly, from and after April 1, 2024, any revenue we recognize under our license agreement with Organon based on net sales of XACIATO will be payable to UiE and recognized as non-cash royalty revenue. For information regarding potential payments to upstream licensors, see Note 3 “Strategic Agreements” to the accompanying condensed consolidated financial statements. For information regarding our contractual obligations to XOMA and UiE, see Note 8 “Royalty Purchase Agreements” and Note 7 “Royalty Interest Financing,” respectively, to the accompanying condensed consolidated financial statements.

Current wording

Our revenue reflects payments earned under our license agreement with Organon to commercialize XACIATO. Pursuant to our traditional royalty purchase agreement with XOMA, from and after April 1, 2024, all of the royalties and potential milestone payments we would otherwise have the right to receive under our license agreement with Organon based on net sales of XACIATO will be paid to XOMA, net of payments made under our exclusive license agreement with third-party licensors TriLogic Pharma, LLC and MilanaPharm LLC and under our royalty interest financing agreement with United in Endeavour, LLC, or UiE. Accordingly, from and after April 1, 2024, any revenue we recognize under our license agreement with Organon based on net sales of XACIATO will be payable to UiE and recognized as non-cash royalty revenue. Generally, because the royalties are required to be paid more than 45 days after the end of each quarter other than with respect to the fourth quarter, we estimate the non-cash royalty revenue we will recognize for a particular quarter based on our analysis of historical experience and interim data provided by Organon including its publicly announced sales. Differences between actual and estimated royalty revenue will be adjusted for in the quarter in which the actual amount becomes known, which is generally expected to be the following quarter. For information regarding potential payments to upstream licensors, see Note 3 “Strategic Agreements” to the accompanying condensed consolidated financial statements. For information regarding our contractual obligations to XOMA and UiE, see Note 8 “Royalty Purchase Agreements” and Note 7 “Royalty Interest Financing,” respectively, to the accompanying condensed consolidated financial statements.

Previous wording

The majority of our operating expenses during a fiscal year are research and development, or R&D, expenses, a significant portion of which, excluding those funded by non-dilutive grants, are associated with the clinical development for our product candidates that have reached the human clinical study development phase. We expect our R&D expenses will continue to represent the majority of our operating expenses for at least the next twelve months. R&D expenses consist primarily of:

Current wording

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

Previous wording

We have received, and may in the future receive, funding through grants and other financial awards from governmental entities, private foundations and other organizations that support activities related to the development of certain of our product candidates. As we incur eligible expenses under those grants or awards, we recognize grant funding in the statements of operations as a reduction to R&D expenses (contra-R&D expense). For more information, see Note 2 "Basis of Presentation and Summary of Significant Accounting Policies–Grant Funding" to our consolidated financial statements contained in our 2024 10-K and Note 10 "Grant Awards" to the accompanying condensed consolidated financial statements. For the three months ended March 31, 2025 and 2024, we recognized contra-research and development expense of approximately $3.1 million and $2.9 million, respectively.

Current wording

We have received, and may in the future receive, funding through grants and other financial awards from governmental entities, private foundations and other organizations that support activities related to the development of certain of our product candidates. As we incur eligible expenses under those grants or awards, we recognize grant funding in the statements of operations as a reduction to R&D expenses (contra R&D expense). For more information, see Note 2 "Basis of Presentation and Summary of Significant Accounting Policies–Grant Funding" to our consolidated financial statements contained in our 2024 10-K and Note 10 "Grant Awards" to the accompanying condensed consolidated financial statements. We recognized contra R&D expense of approximately $4.5 million and $7.6 million for the three and six months ended June 30, 2025, respectively, and $2.2 million and $5.1 million for the three and six months ended June 30, 2024, respectively.

Previous wording

At any one time, we are working on multiple programs at various stages of development. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each development program on an ongoing basis based on our cash resources and in response to the results of ongoing and future clinical trials and preclinical studies, regulatory developments, and our ongoing assessments as to the commercial potential of each product candidate. Until we secure additional capital to fund our operating needs, we expect our research and development spend will be primarily on advancement of Ovaprene. In addition, we expect to incur significant research and development expenses for the DARE-LARC1 and DARE-HPV programs, but we also expect such expenses will be supported by non-dilutive funding, with respect to DARE-LARC1, through at least 2026, and with respect to DARE-HPV, through October 2026. See Note 10 "Grant Awards" to the accompanying condensed consolidated financial statements for additional information.

Current wording

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

Previous wording

Conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may not obtain regulatory approval for any product candidate on a timely or cost-effective basis, or at all. Our future R&D expenses and the probability of success of our product candidates may be affected by numerous factors, including the number, scope, rate of progress, expense, and results of our clinical trials and nonclinical R&D activities, the countries in which our clinical trials are conducted, the phase of clinical development of our product candidates, the cost and timing of manufacturing our product candidates, our ability to scale up manufacturing as needed to support later-stage clinical trials and, if approved, commercialization of our product candidates, the extent of changes in government regulation and regulatory guidance relating to development and approval of our product candidates, the timing, receipt, and terms of any clearances to conduct clinical trials and any marketing approvals from applicable regulatory authorities, competition and commercial viability of our product candidates, the extent to which we establish and maintain intellectual property rights, the extent to which we establish and maintain license, collaboration, or other arrangements. As a result, we cannot accurately determine the duration and completion costs of development projects or if, when and to what extent we will generate revenue from any products we develop.

Current wording

Investment in the development of and seeking regulatory approval for our clinical-stage and Phase 1-ready product candidates and the development of any other potential product candidates we may advance into and through clinical trials in the pursuit of regulatory approvals, will increase our R&D expenses. Activities associated with the foregoing will require a significant increase in investment in regulatory support, clinical supplies, inventory build-up related costs, and the payment of success-based milestones to licensors. In addition, we continue to evaluate opportunities to acquire or in-license other product candidates and technologies, which may result in higher R&D expenses due to, among other factors, milestone payments. Conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may not obtain regulatory approval for any product candidate on a timely or cost-effective basis, or at all. Our future R&D expenses and the probability of success of our product candidates may be affected by numerous factors, including the number, scope, rate of progress, expense, and results of our clinical trials and nonclinical R&D activities, the countries in which our clinical trials are conducted, the phase of clinical development of our product candidates, the cost and timing of manufacturing our product candidates, our ability to scale up manufacturing as needed to support later-stage clinical trials and, if approved, commercialization of our product candidates, the extent of changes in government regulation and regulatory guidance relating to development and approval of our product candidates, the timing, receipt, and terms of any clearances to conduct clinical trials and any marketing approvals from applicable regulatory authorities, competition and commercial viability of our product candidates, the extent to which we establish and maintain intellectual property rights, the extent to which we establish and maintain license, collaboration, or other arrangements. As a result, we cannot accurately determine the duration and completion costs of development projects or if, when and to what extent we will generate revenue from any products we develop.

Previous wording

Revenues for the three months ended March 31, 2025 and March 31, 2024 are related to our license agreement with Organon to commercialize XACIATO. From and after April 1, 2024, any revenue we recognize under such license agreement will be recognized as non-cash royalty revenue. See "—Financial Overview—Revenue," above for information.

Current wording

Revenues for the three months ended June 30, 2025 and June 30, 2024 are related to our license agreement with Organon to commercialize XACIATO. From and after April 1, 2024, any revenue we recognize under such license agreement will be recognized as non-cash royalty revenue. See "—Financial Overview—Revenue," above for information. An adjustment for lower actual royalty revenue than we previously estimated for the three months ended March 31, 2025 resulted in the negative non-cash royalty revenue reported for the three months ended June 30, 2025. See “—Financial Overview—Revenue,” above.

Previous wording

The decrease of approximately $0.4 million in general and administrative expenses for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily attributable to decreases in (i) stock-based compensation expense of approximately $0.2 million, (ii) professional services expense of approximately $0.1 million, and (iii) personnel costs of approximately $0.1 million.

Current wording

The decrease of approximately $0.1 million in general and administrative expenses for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 was primarily attributable to decreases in (i) personnel costs of approximately $0.2 million, (ii) stock-based compensation expense of approximately $0.1 million, and (iii) general corporate overhead of approximately $0.1 million. Such decreases were partially offset by an increase in professional services expense of approximately $0.3 million.

Previous wording

The decrease of approximately $1.1 million in R&D expenses for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily attributable to decreases in (i) manufacturing costs related to Ovaprene, (ii) costs related to development activities for Sildenafil Cream, and (iii) costs related to development activities for our preclinical stage programs. These decreases were partially offset by increases in costs related to our Phase 1 and Phase 1-ready clinical stage programs. Contra-R&D expenses for the three months ended March 31, 2025 and 2024 primarily offset direct program costs for DARE-LARC1, one of our preclinical stage programs.

Current wording

The decrease of approximately $4.6 million in R&D expenses for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024 was primarily attributable to (i) an increase in contra R&D expenses, (ii) a decrease in manufacturing costs related to Ovaprene, and (iii) a decrease in costs related to development activities for Sildenafil Cream, partially offset by increases in costs related to development activities for (A) our Phase 1 and Phase 1-ready clinical stage programs—primarily attributable to our DARE-PTB1 program, and (B) our other advanced clinical stage programs—primarily attributable to our DARE-HPV program. Contra R&D expenses for the six months ended June 30, 2025 and 2024 primarily offset direct program costs for DARE-LARC1.

Previous wording

Royalty expenses for the three months ended March 31, 2024 related to our license agreement with MilanaPharm and our royalty interest financing agreement with UiE.

Current wording

Royalty expenses for the six months ended June 30, 2024 related to our license agreement with MilanaPharm and our royalty interest financing agreement with UiE.

Previous wording

The increase of $0.9 million in other income for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily due to a loss on the disposal of a fixed asset of $0.6 million recorded in the prior year period and the receipt in the current year of approximately $0.2 million of employee retention credits for applications filed during 2023.

Current wording

The increase of $0.9 million in other income for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024 was primarily due to a loss on the disposal of a fixed asset of $0.6 million recorded in the prior year period and the receipt in the current year of approximately $0.2 million of employee retention credits for applications filed during 2023.

Previous wording

We have received substantial funding under grant agreements with the Foundation, and we generally receive funds under those agreements before we incur the eligible expenses. Under the terms of such grant agreements, the funds we receive may be applied solely toward direct costs of carrying out the respective projects under those grant agreements, other than approximately 10% of such funds, which may be applied toward general overhead and administration expenses that support our entire operations. Funds received that have not been spent are recorded both as cash and cash equivalents and as a deferred grant funding liability in our consolidated balance sheets. Funds received that have been spent but not yet expensed in accordance with GAAP are also recorded as part deferred grant funding liability in our consolidated balance sheets. As of March 31, 2025, our deferred grant funding liability was approximately $15.1 million, substantially all of which consisted of unspent funds for the DARE-LARC1 program and the Ovaprene Phase 3 clinical study. For more information about these grant agreements, see "—Contractual Obligations and Other Commitments—Grant Agreements" below, Note 2 "Basis of Presentation and Summary of Significant Accounting Policies—Grant Funding" to our consolidated financial statements in our 2024 10-K, and Note 10 "Grant Awards—Other Non-Dilutive Grant Funding" to the accompanying condensed consolidated financial statements.

Current wording

At June 30, 2025, our cash and cash equivalents were approximately $5.0 million, and our working capital deficit was approximately $12.6 million. All of our cash and cash equivalents at June 30, 2025 represented funds received under grant agreements that may be applied solely toward direct costs for the funded project under those grant agreements, other than an approximately 5% to 22% indirect cost allowance, and as of June 30, 2025, our deferred grant funding liability was approximately $12.3 million, substantially all of which consisted of funds intended to support the DARE-LARC1 program, the Ovaprene Phase 3 clinical study, and the DARE-HPV program. For more information about these grant agreements, see "—Contractual Obligations and Other Commitments—Grant Agreements" below, Note 2 "Basis of Presentation and Summary of Significant Accounting Policies—Grant Funding" to our consolidated financial statements in our 2024 10-K, and Note 10 "Grant Awards—Other Non-Dilutive Grant Funding" to the accompanying condensed consolidated financial statements.

Previous wording

We prepared the accompanying condensed consolidated financial statements on a going concern basis, which assumes that we will realize our assets and satisfy our liabilities in the normal course of business. We have a history of losses from operations and expect significant losses from operations, net losses, and negative cash flows from operations until such time that we generate revenue to cover our operating expenses that results in net income. Because we are in the early stages of executing against our expanded business strategy announced in March 2025, it is not possible to predict when this will occur and there could be significant losses from operations and negative cash flows from operations for the next several years. Until such time that we generate revenue to cover our operating expenses that results in net income, we are dependent on securing substantial additional capital from one or more third-party sources to satisfy our working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying condensed consolidated financial statements. These circumstances raise substantial doubt about our ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of our ability to remain a going concern.

Current wording

At June 30, 2025, our accumulated deficit was approximately $183.7 million, and we had a net loss of approximately $8.4 million and negative cash flows from operations of approximately $10.9 million for the six months ended June 30, 2025. Because we are in the early stages of executing against our Section 503B compounding and consumer health products business strategies and, as an organization, we have no experience in or infrastructure for commercializing products, both the timing and amount of potential revenue we may generate remain uncertain. As a result, we may continue to incur significant losses from operations and negative cash flows from operations for the next several years, and may never generate sufficient revenues to finance our operations or achieve profitability. Based on our current analysis of the conditions described above, there is substantial doubt about our ability to continue as a going concern within the 12-month period from the issuance date of the accompanying condensed consolidated financial statements. The accompanying condensed consolidated financial statements were prepared on a going concern basis, which assumes that we will realize our assets and satisfy our liabilities in the normal course of business. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of our ability to remain a going concern.

Previous wording

We expect our operating expenses for the foreseeable future to continue to be R&D expenses and general and administrative expenses consistent with the nature of such expenses described above under “Financial Overview.” Our future expenses could also include significant costs related to commercialization of our product candidates, if approved, depending on the type, nature and terms of commercial collaborations we establish, and in particular, if we determine to engage in commercialization activities directly as opposed to through a third-party collaborator. Our future capital requirements are difficult to predict because they will depend on many factors that are highly variable and difficult to predict, including, but not limited to, those discussed in the risk factor in Part I, Item 1A of our 2024 10-K titled, “Risks Related to Our Financial Position and Capital Needs.” We cannot accurately determine the duration and completion costs of our development programs, or if, when and to what extent we will generate revenue from any products we develop.

Current wording

We expect our operating expenses will increase substantially in the future as we continue to develop and seek FDA approval for our product candidates and expand our capabilities to support our 503B compounding and consumer health business strategies. Our future capital requirements are difficult to predict because they will depend on many factors that are highly variable and difficult to predict, including, but not limited to, those discussed in the risk factor in Part I, Item 1A of our 2024 10-K titled, “Risks Related to Our Financial Position and Capital Needs.”

Previous wording

We have a sales agreement with Stifel, Nicolaus & Company, Incorporated, or Stifel, to sell shares of our common stock from time to time through an ATM offering under which Stifel acts as our agent. We have not sold any shares of our common stock under this agreement in 2025. Shares of our common stock sold under the sales agreement will be offered and sold under our shelf registration statement on Form S-3 (File No. 333-278380), declared effective by the SEC on May 10, 2024, the base prospectus included therein and the prospectus supplement thereto dated May 10, 2024 relating to the offering of up to $18.1 million of shares of our common stock, and any subsequent prospectus supplement related to the offering of shares of our common stock under the sales agreement.

Current wording

We have a sales agreement with Stifel, Nicolaus & Company, Incorporated, or Stifel, to sell shares of our common stock from time to time through an ATM offering under which Stifel acts as our agent. We sold no shares of our common stock under this agreement during the six months ended June 30, 2025. We sold 4,329,116 shares of our common stock under this agreement subsequent to June 30, 2025 and received net proceeds of approximately $17.6 million. Shares of our common stock sold under the sales agreement are offered and sold under our shelf registration statement on Form S-3 (File No. 333-278380), declared effective by the SEC on May 10, 2024, the base prospectus included therein and the prospectus supplement thereto dated May 10, 2024 relating to the offering of up to $18.1 million of shares of our common stock, and any subsequent prospectus supplement related to the offering of shares of our common stock under the sales agreement. Because the market value of our outstanding shares of common stock held by non-affiliates, or our public float, is less than $75.0 million, our use of our shelf registration statement is currently limited by what is known as the SEC’s “baby shelf rule” to one-third of our public float in any 12-month period. Because of the "baby shelf rule" and based on sales of shares of our common stock under our ATM sales agreement after June 30, 2025, for approximately the next 12 months, we do not expect to sell any additional shares under our ATM sales agreement unless and until our public float exceeds approximately $54.0 million, as determined in accordance with SEC rules.

Previous wording

We have a purchase agreement with Lincoln Park under which, subject to the conditions thereof, we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $15.0 million in shares of our common stock. Such sales of our common stock to Lincoln Park, if any, will be subject to certain limitations, and may occur from time to time, at our sole discretion, over the 24-month period commencing on November 27, 2024. See Note 5 "Stockholders' Equity—Equity Line" to the accompanying condensed consolidated financial statements for additional information. We sold 150,000 shares of our common stock under this purchase agreement during the three months ended March 31, 2025 and received net proceeds of approximately $0.4 million.

Current wording

We have a purchase agreement with Lincoln Park under which, subject to the conditions thereof, we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $15.0 million in shares of our common stock. Such sales of our common stock to Lincoln Park, if any, will be subject to certain limitations, and may occur from time to time, at our sole discretion, over the 24-month period commencing on November 27, 2024. See Note 5 "Stockholders' Equity—Equity Line" to the accompanying condensed consolidated financial statements for additional information. We sold 330,000 shares of our common stock under this purchase agreement during the six months ended June 30, 2025 and received net proceeds of approximately $0.9 million. We sold 120,000 shares of our common stock under this agreement subsequent to June 30, 2025 and received net proceeds of approximately $0.3 million.

Previous wording

Net cash used in operating activities

Current wording

Net cash (used in) provided by operating activities

Previous wording

Net cash used in investing activities for the three months ended March 31, 2025 and 2024 was related to purchases of property and equipment of approximately $0.2 million and $7,300, respectively.

Current wording

Net cash used in investing activities for the six months ended June 30, 2025 and 2024 related to purchases of property and equipment.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2025 consisted primarily of net proceeds from the sales of our common stock under our purchase agreement with Lincoln Park of approximately $0.4 million partially offset by payments on the insurance financing note payable of approximately $0.2 million. Net cash provided by financing activities for the three months ended March 31, 2024 consisted primarily of proceeds from the sales of our common stock under our ATM sales agreement of approximately $0.2 million partially offset by payments on the insurance financing note payable of approximately $0.2 million.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2025 consisted primarily of net proceeds from the sales of our common stock under our purchase agreement with Lincoln Park of approximately $0.9 million partially offset by payments on (i) our facility finance lease of approximately $0.5 million and (ii) insurance premium financing of approximately $0.3 million.

Previous wording

We have assembled our pipeline primarily through acquisitions, in-license agreements, and other collaborations. We agreed to make royalty and milestone payments, and in some cases annual license fee payments, under the license and development agreements related to XACIATO, Ovaprene, and Sildenafil Cream and under other agreements related to our other clinical and preclinical candidates. The amount and timing of most of these payments are difficult to predict because the timing of milestone payments for pre-commercial programs generally depends on the progress of and success in development of a particular program, which is subject to many risks and uncertainties as discussed elsewhere in this report and difficult to predict, and the timing and amount of royalty and milestone payments related to commercial products generally depends on their commercial success, which may, as it is with XACIATO, be out of our control

Current wording

We have assembled our pipeline primarily through acquisitions, in-license agreements, and other collaborations. We agreed to make royalty and milestone payments, and in some cases annual license fee payments, under the license and development agreements related to XACIATO, Ovaprene, and Sildenafil Cream and under other agreements related to our other clinical and preclinical candidates. For information about these obligations see Note 3 "Strategic Agreements—Strategic Agreements for Pipeline Development" to the accompanying condensed consolidated financial statements. The amount and timing of most of these payments are difficult to predict because the timing of milestone payments for pre-commercial programs generally depends on the progress of and success in development of a particular program, which is subject to many risks and uncertainties as discussed elsewhere in this report and difficult to predict, and the timing and amount of royalty and milestone payments related to commercial products generally depends on their commercial success, which may, as it is with XACIATO, be out of our control.

Previous wording

During 2025, based on our current expectations regarding the progress of development of our product candidates and sales of XACIATO, we expect approximately $0.3 million of such payments to upstream licensors to become payable. With respect to our license agreement relating to XACIATO, royalties payable by us to upstream licensors will be funded by royalty payments made by our licensee, Organon. For further discussion of these potential payments, see Note 3 "Strategic Agreements—Strategic Agreements for Pipeline Development" to the accompanying condensed consolidated financial statements.

Current wording

During the remainder of 2025, based on our current expectations regarding the progress of development of our product candidates and sales of XACIATO and DARE to PLAY Sildenafil Cream, we expect such payments to upstream licensors to be immaterial. With respect to our license agreement relating to XACIATO, royalties payable by us to upstream licensors will be funded by royalty payments made by our licensee, Organon. For further discussion of these potential payments, see Note 3 "Strategic Agreements—Strategic Agreements for Pipeline Development" to the accompanying condensed consolidated financial statements. With respect to DARE to PLAY Sildenafil Cream, for at least the first twelve months following its market introduction, we anticipate a mid single-digit royalty payment obligation to our upstream licensor on annual net sales.

Previous wording

In April 2024, we entered into a traditional royalty purchase agreement and a synthetic royalty purchase agreement with XOMA (which, together, we refer to as the Royalty Purchase Agreements) pursuant to which we sold our right, title and interest in the following to XOMA: (a) all of the royalties and potential milestone payments we would otherwise have the right to receive from and after April 1, 2024 under our exclusive license agreement with Organon based on net sales of XACIATO, net of our obligations to upstream licensors and UiE (such net amount we refer to as the Purchased Receivables); (b) a portion of a potential future $20.0 million payment from Bayer under our license agreement relating to Ovaprene and a portion of future net sales of Ovaprene; and (c) a portion of future net sales of Sildenafil Cream (such amounts described in the foregoing clauses (b) and (c) we collectively refer to as the Revenue Participation Right). We received $22.0 million from XOMA in connection with entering into the Royalty Purchase Agreements. If XOMA receives total payments equal to an amount that exceeds $88.0 million, XOMA will pay $11.0 million to us for each successive $22.0 million XOMA receives under the Royalty Purchase Agreements.

Current wording

In April 2024, we entered into a traditional royalty purchase agreement and a synthetic royalty purchase agreement with XOMA (which, together, we refer to as the Royalty Purchase Agreements) pursuant to which we sold our right, title and interest in the following to XOMA: (a) all of the royalties and potential milestone payments we would otherwise have the right to receive from and after April 1, 2024 under our exclusive license agreement with Organon based on net sales of XACIATO, net of our obligations to upstream licensors and UiE (such net amount we refer to as the Purchased Receivables); (b) a portion of a potential future $20.0 million payment from Bayer under our license agreement relating to Ovaprene and a portion of future net sales of Ovaprene; and (c) a portion of future net sales of Sildenafil Cream and DARE to PLAY Sildenafil Cream (such amounts described in the foregoing clauses (b) and (c) we collectively refer to as the Revenue Participation Right). We received $22.0 million from XOMA in connection with entering into the Royalty Purchase Agreements. If XOMA receives total payments equal to an amount that exceeds $88.0 million, XOMA will pay $11.0 million to us for each successive $22.0 million XOMA receives under the Royalty Purchase Agreements.

Previous wording

In connection with the synthetic royalty purchase agreement, we granted to XOMA a security interest in certain product assets related to Ovaprene and Sildenafil Cream. The Royalty Purchase Agreements include covenants that limit or restrict our ability to incur indebtedness or liens related to the Purchased Receivables, the Revenue Participation Right, and certain product assets related to Ovaprene and Sildenafil Cream (except pursuant to a suitable intercreditor agreement).

Current wording

In connection with the synthetic royalty purchase agreement, we granted to XOMA a security interest in certain product assets related to Ovaprene, Sildenafil Cream and DARE to PLAY Sildenafil Cream. The Royalty Purchase Agreements include covenants that limit or restrict our ability to incur indebtedness or liens related to the Purchased Receivables, the Revenue Participation Right, and certain product assets related to Ovaprene and Sildenafil Cream (except pursuant to a suitable intercreditor agreement).

Previous wording

We have two operating leases for our laboratory and office spaces that expire in 2026 and 2027, respectively. As of March 31, 2025, we had future minimum lease payments under these leases of $1.3 million, $0.6 million of which is classified as current and $0.6 million of which is classified as long-term, the remainder of which represents future interest payments. We have one finance lease for our clean room space that expires in 2026. As of March 31, 2025, we had future minimum lease payments under this lease of $2.6 million, $1.8 million of which is classified as current and $0.6 million of which is classified as long-term, the remainder of which represents future interest payments. For additional information on our lease obligations, See Note 6 "Leases" to the accompanying condensed consolidated financial statements.

Current wording

We have two operating leases for our laboratory and office spaces that expire in 2026 and 2027, respectively. As of June 30, 2025, we had future minimum lease payments under these leases of $1.1 million, $0.6 million of which is classified as current and $0.4 million of which is classified as long-term, the remainder of which represents future interest payments. We have one finance lease for our clean room space that expires in 2026. As of June 30, 2025, we had future minimum lease payments under this lease of $2.1 million, $1.8 million of which is classified as current and $0.2 million of which is classified as long-term, the remainder of which represents future interest payments. For additional information on our lease obligations, See Note 6 "Leases" to the accompanying condensed consolidated financial statements.