DARE 10-K & 10-Q changes, risk factors and insider trading

•We will need to raise substantial additional capital to continue our operations, execute our business strategy and remain a going concern, and we may not be able to raise adequate capital on a timely basis, on favorable terms, or at all. Raising additional capital may cause substantial dilution to our stockholders, restrict our operations or require us to relinquish rights in our technologies or product candidates and their future revenue streams. Our ability to obtain additional capital through stock sales or other securities offerings may be more costly or dilutive to our stockholders than in the past, or may not be available to us at all, due to our current inability to use a Form S-3 “shelf” registration statement for primary offerings.

•We plan to generate revenue from sales of ourDARE proprietaryto SildenafilPLAY Creamand formulationother producedpotential compounded drugs under Section 503B of the FDCA. We have nolimited experience in this line of business and may not succeed in our efforts. We rely on, and will rely onon, third parties for the compounding and distribution of ourDARE proprietaryto SildenafilPLAY Creamand formulation,other potential compounded drugs, and the failure of such third parties to perform as expected could harm our reputation and negatively impact our ability to succeed. In addition, this line of business subjects us to newadditional regulations and potential liability.

•We rely on in-license agreements with third parties for rights to develop and commercialize XACIATO andXACIATO, our product candidates.candidates, and DARE to PLAY and other potential compounded drugs. The loss or impairment of our rights under these agreements could disrupt or require us to discontinue development or commercialization activities, or impair our rights to receive payments from our sublicensees, which could have a material adverse effect on our operations and business prospects and viability.

•Strategic collaborations are a key part of our strategy and our existing strategic collaborationscollaboration arerelated to XACIATO is important to our business. If we are unable to maintain our existing strategic collaborationscollaboration or establish new ones, or if they are not successful, we may require substantial additional capital to develop and commercialize our productsXACIATO and our product candidatescandidates, and our business and prospects may be materially harmed.

•We have no manufacturing, sales, marketing or distribution infrastructure. We depend heavily on, and expect to continue to rely on, the performance of third parties, including our strategic collaborators, contract manufacturers and suppliers, CROs, medical institutions, and scientific, medical, regulatory and other consultants and advisors, to develop our product candidates and commercialize any approved products. Failure of these third parties to perform as expected could result in substantial delays, increased costs or failures of our product development programs, delayed or unsuccessful commercialization of any approved products, and the need for significant additional capital.

•The commercial success of XACIATO is outside of our control and will depend on Organon’s efforts and capabilities and a variety of factors, many of which currently are unknown or uncertain,capabilities, and if commercialization of XACIATO is not successful, our reputation, business and prospects may suffer.

•Our product candidates, if approved for commercial sale, will face intense competition and may fail to achieve the degree of market acceptance necessary for commercial success. Our business, operating results and financial condition will suffer if we,we or our commercial collaborators,Organon fail to compete effectively.

•Failure to successfully obtain and maintain coverage and adequate reimbursement for XACIATO and any future products from government health care programs and other third-party payors would diminish our ability, or that of a commercial collaborator, to generate net product revenue or net sales. If out-of-pocket costs for products we develop are deemed by women to be unaffordable, a commercial market may never develop.

•If we and our licensors are unable to obtain and maintain sufficient intellectual property protection, competitors could developdevelop, andmarket, commercialize or make available products similar or identical to ours, which could significantly limit the commercial potential of our products and product candidates and materially harm our business, financial condition, results of operations, and prospects.

•Volatility in the financial markets, geopolitical conflicts and events, natural disasters, public health emergencies , international trade policies,andpolicies, and other macroeconomic factors may negatively impact our business, financial condition and results and our stock price, including by increasing the cost and timelines for our clinical development programs or making it more difficult or costly to raise additional capital when needed.

•We have been subject to a cyber-related crime and our controls and security measures may not be successful in preventing other cybersecurity incidents in the future. Cyber-attacks, security breaches, loss of data and other disruptions to our information technology systems or those of our strategic collaborators or third-party service providers could compromise sensitive or confidential information related to our business, delay or prevent us from accessing critical information, subject us to significant financial loss, or expose us to liability, any of which could adversely affect our business and our reputation.

We have a history of losses from operations, we expect significant losses from operations, net losses and negative cash flows from operations for at least the next several years as we develop and seek to bring to market 503B compounded drugs and our existing product candidates and as we seek to potentially acquire or license and develop additional product candidates. At December 31, 2024,2025, we had an accumulated deficit of approximately $175.3$188.7 million, cash and cash equivalents of approximately $15.7$24.7 million, and a working capital deficit of approximately $3.2$3.4 million. We will need additional capital to fund our operating needs into the third quarter of 2025 and to meet our current obligations as they become due. All of ourOur cash and cash equivalents at December 31, 20242025 representedincluded funds received under grant agreements that generally may be applied solely toward direct costs of carrying outfor the respectivefunded projectsproject under those grant agreements.agreements other than an approximately 5% to 22% indirect cost allowance, and as of December 31, 2025, our deferred grant funding liability was approximately $19.7 million, substantially all of which consisted of funds intended to support the DARE-LARC1 program, the Ovaprene Phase 3 clinical study, and the DARE-HPV program. We havewill a history of losses from operations and we expect significant losses from operations, net losses, and negative cash flows from operations for at least the next several years as we continue to develop and seek to bring to market our product candidates. We are dependent on securing substantialneed additional capital fromto onefund orour moreoperating third-partyneeds sourcesthrough the fourth quarter of 2026 and to satisfymeet our workingcurrent capitalobligations needsas andthey otherbecome liquidity requirements over at least the next 12 months from the date of issuance of the accompanying consolidated financial statements.due. These circumstances raise substantial doubt about our ability to continue as a going concern. The consolidated financial statements included in this report were prepared under the assumption that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. Advancing our investigational products through clinical development and pursuing regulatory approval and commercialization will require substantial additional investment. We will need to raise substantial additional capital to continue to fund our operations and execute our current business strategy. The amount and timing of our capital needs have and will continue to depend highly on many factors, as discussed further below.

Our management may devote significant time and we may incur substantial costs in pursuing, evaluating and negotiating potential capital-raising transactions and those efforts may not prove successful on a timely basis, or at all. If we cannot raise adequate additional capital when needed, we may be forced to reduce, or even terminate our operations. We may delay, scale back or eliminate one or more of our 503B compounded drug offerings and/or our product development programs; relinquish rights under our license agreements with third parties relating to our 503B compounded drug offerings and/or our product candidates; forgo opportunities to expand our 503B compounded drug offerings and/or our product portfolio; take other measures to reduce our expenses; reorganize or merge with another entity; or file for bankruptcy or cease operations. For example, in recent years, due to our limited capital resources, we have focused our resources primarily on the advancement of Ovaprene and Sildenafil Cream, unless a program has been supported by grant or other non-dilutive funding, and we have delayed R&D activities for other programs. If we become unable to continue as a going concern, we may have to liquidate our assets, and might realize significantly less than the values at which they are carried on our financial statements, and our stockholders may lose all or part of their investment in our common stock.

•the 503B compounded drug offerings and/or product development programs we choose to pursue;

•the amount and timing of future royalty, milestone or other payments, if any, we receive under our licensing agreement with Bayer, any future out-licensing agreement,agreement or the Royalty Purchase Agreements;

Should we add product candidates to our portfolio, should our existing product candidates require testing or other capital-intensive development activities that we do not anticipate, should the duration of our clinical trials be longer than anticipated, should manufacturing and supply be disrupted, or should regulatory approvals be delayed, our cash resources will be further strained. Should our 503B business strategy and/or product development efforts succeed, we will need to develop and implement a commercialization plan for each 503B compounded drug and/or product, which may also require significant resources to create and implement. In addition, the terms of any collaboration agreements for development and/or commercialization of our product and product candidates may significantly impact our need for additional capital. Because of these uncertainties and the other risks and uncertainties discussed in this Risk Factors section, we cannot reasonably estimate the amount funding necessary to successfully complete development of and seek regulatory approval for our product candidates or to commercialize any approved products. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our planned operations.

Unstable and unfavorable market and economic conditions may harm our ability to raise additional capital. The occurrence or continued occurrence of macroeconomic factors or events similar to those experienced in recent years, such as a U.S. economic crisis or recession or recessionary concerns, inflation, rising interest rates, public health emergencies (such as the COVID-19 pandemic),emergencies, geopolitical conflict (such as the wars in Ukraine and the Middle East), natural/environmental disasters, supply-chain disruptions, terrorist attacks, strained trade and other relations between the U.S. and a number of other countries, social and political discord and unrest in the U.S. and other countries, and government shutdowns, among others, increase market volatility and have long-term adverse effects on the U.S. and global economies and financial markets. Volatility and deterioration in the financial markets and liquidity constraints or other adverse developments affecting financial institutions may make equity or debt financings more difficult, more costly or more dilutive and may increase competition for, or limit the availability of, funding from other third-party sources, such as from strategic collaborations and government and other grants.

We have sold our right, title and interest in 100% 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, net of payments to upstream third-party licensors and UiE. Whether we receive any future income based on net sales of XACIATO will depend on whether the Revenue Sharing Threshold is reached, which may not occur. Whether the Revenue Sharing Threshold is reached will depend, in part, on Organon’s future commercial success with XACIATO, which is outside of our control,control and which to date has not resulted in a material amount of net sales, and the successful development and commercialization of Ovaprene and/or Sildenafil Cream, which are subject to significant risks and uncertainties, some of which are outside of our control, as discussed elsewhere in this Risk Factors section.

To the extent we enter into licensing agreements for third-party commercialization of products we develop, as is the case with XACIATO and Ovaprene,XACIATO, we expect our revenue streams related to those products will be based primarily on net sales, which will be largely outside of our control.

In a typical biopharmaceutical licensing or “partnering” deal, the biopharmaceutical company out-licenses technology and other assets to a third party in exchange for future payments, the bulk of which (e.g., royalties and milestones) are conditional on the licensee successfully developing and/or commercializing the licensed assets and determined based on net sales. To the extent we enter into such licensing agreements, the amount of net sales our products may generate, if approved for commercial sale, will be largely outside of our control because marketing and sales activities will be conducted by the licensee and product pricing and costs that impact net sales will be determined by the licensee. Gross sales can be greatly reduced by sales discounts and allowances, which will be determined by our licensee (or mandated by governmental entities). Sales discounts may be particularly substantial for new products compared to established products to incentivize purchases and promote customer loyalty. These factors would serve to reduce the royalties payable to us and delay potential achievement of commercial milestones and the corresponding milestone payments to us. If a licensee has no or limited commercialization success, or net sales are otherwise minimal due to pricing and discount structures, our financial condition and operating results could be negatively impacted and our need for additional capital could significantly increase or be accelerated. Due to our exclusive license agreements with Organon and Bayer, assuming the license grant to Bayer becomes effective,Organon, our royalty interest financing agreement, and the Royalty Purchase Agreements, XACIATO’s and Ovaprene’s value to us will be based primarily on net sales, as determined under those agreements.

If one of our commercial collaboratorscollaborator terminates its exclusive license agreement with us, our need for additional capital may significantly increase.

We have relied heavily on our ability to raise capital by selling shares of our common stock. For example, we raised an aggregate of approximately $79.1$21.3 million in in gross proceeds during 2025, and approximately $93.0 million in gross proceeds insince fiscalJanuary years1, 2021 and 20222021, through the sale of shares of our common stock in offerings made under a Form S-3 “shelf” registration statement. Our ability to raise additional capital through sales of our common stock or other securities offerings will depend on several factors, many of which may not be in our favor, including the trading volume and volatile trading price of our common stock, our relatively low public float and market capitalization, our potential inability to regain and maintain compliance with the listing requirements of the Nasdaq Capital Market, unfavorable financial market conditions, and the other risks and uncertainties described in this Risk Factors section. If we are unable to raise additional capital through the offering and sale of shares of our common stock, or securities convertible into or exercisable for our common stock, on a timely basis or acceptable terms, or at all, we may seek additional capital through other third-party sources that require us to relinquish valuable rights in our intellectual property, technologies, product candidates or future revenue streams, or that subject us to restrictive covenants, operational restrictions or security interests in our assets, or we may need to delay, scale back or eliminate some or all of our development programs, reduce other expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations.

Using a shelf registration statement to conduct an equity offering to raise capital generally takes less time and is less expensive than other means, such as conducting an offering under a Form S-1 registration statement. We currently have a shelf registration statement effective, however, our ability to raise capital under a shelf registration statement is, and may continue to be, limited by, among other things, current and future SEC rules and regulations impacting the eligibility of smaller companies to use Form S-3 for primary offerings of securities. For example, we currently are subject to the "baby shelf rule" because the market value of our outstanding shares of common stock held by non-affiliates, or our public float, was less than $75.0 million at the time of filing this annual report on Form 10-K, calculated in accordance with SEC rules. This means that we may use our shelf registration statement to raise additional funds only to the extent that the aggregate market value of securities sold by us or on our behalf pursuant to Instruction I.B.6. of Form S-3 during the 12 calendar months immediately prior to, and including, the intended sale does not exceed one-third of the aggregate market value of our public float, calculated in accordance with the instructions to Form S-3. IfBased on the aggregate market value of securities sold by us or on our behalf pursuant to Instruction I.B.6. of Form S-3 in 2025, we do not expect to sell any shares pursuant to Instruction I.B.6. of Form S-3, including under our ATM sales agreement, during the approximately 12-month period from July 2025, unless and until our public float exceeds approximately $54.0 million, as determined in accordance with SEC rules. While our ability to offer securities under an effective shelf registration statement is limited, including by the baby shelf rule, we may choose to conduct an offering of our securities under an exemption from registration under the Securities Act of 1933, as amended, or the Securities Act, or under a Form S-1 registration statement. We would expect either of these alternatives to take more time and be a more expensive method of raising additional capital relative to using our shelf registration statement.

Obtaining stockholder approval is a costly and time-consuming process. If we must obtain stockholder approval for a potential transaction, we would expect to spend substantial additional money and resources. In addition, seeking stockholder approval would delay our receipt of otherwise available capital, which may materially and adversely affect our ability to execute our business plan, and there is no guarantee our stockholders ultimately would approve a proposed transaction. For example, we will need to obtain stockholder approval to sell more shares of our common stock to Lincoln Park under our equity line arrangement due to the limitations described above related to sales at less than the Minimum Price.

We are solely focused in women’s health, and primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease and menopause. The sector has historically been underfunded, with only about one percent of healthcare research and innovation in the U.S. invested in female-specific conditions beyond oncology according to market research. Non-oncologic women's health therapeutics product launches in recent years have not been perceived as successful. Those perceived commercial failures and the failure of the women’s health sector to receive consistent and committed investment fuels investor sentiment that market opportunities for new products in women’s health are limited. While women's health recently has received more attention, and investment in the women's health sector has seen progress with new or increased funding programs from the federal government, it remains an underinvested sector. Further, there is a high level of uncertainty regarding whether the federal government under the newcurrent U.S. presidential administration will continue programs initiated by the prior presidential administration that led to increased funding for research and development in women’s health. Our stock price and our ability to access additional capital on acceptable terms when needed may be adversely impacted by unfavorable investor perception of market opportunities for women’s health products, and our business, operating results, financial condition and prospects could suffer.

Changes in federal funding and contracting policies under the newcurrent U.S. presidential administration could materially impact the progress of certain of our development programs, including Ovaprene and DARE-HPV, as well as our operating results and financial resources. We have received federal government grants and awards in support of several of our development programs. As discussed elsewhere in this report, our pivotal Phase 3 study of Ovaprene is being conducted, in part, in collaboration with NICHD under our CRADA, and our DARE-HPV program is being supported in large part with funding provided by federal agencies. There is no guarantee that such contracts and funding will not be frozen, restricted, or terminated as a result of changes in federal funding and contracting policies. In addition, potential future funding and collaboration opportunities through HHS, NIH or other federal agencies may be delayed, reduced or made unavailable. Further, research and development conducted in collaboration with U.S.-based colleges and universities could be delayed or discontinued due to changes in federal funding and contracting policies relating to such institutions. These changes could adversely affect our development programs, financial condition, operating results and business plans.

Our cash and cash equivalents we use to satisfy our working capital and operating expense needs are held in accounts at various financial institutions. The balance held in deposit accounts often exceeds the Federal Deposit Insurance Corporation (“FDIC”) deposit insurance limit or similar government deposit insurance schemes. Our cash and cash equivalents could be adversely impacted, including the loss of uninsured deposits and other uninsured financial assets, if one or more of the financial institutions in which we hold our cash or cash equivalents fails or is subject to other adverse conditions in the financial or credit markets. For example, onin March 10, 2023, Silicon Valley Bank was closed by the California Department of Financial Protection and Innovation and taken into receivership by the FDIC. At that time, substantially all of our cash and cash equivalents were held in accounts with Silicon Valley Bank and we could not access such accounts.accounts for a few days. While we were eventually afforded full access to our accounts on March 13, 2023 as a result of action taken by the U.S. Department of the Treasury, the Federal Reserve and the FDIC under the systemic risk exception,accounts, there is no guarantee that the systemic risk exception will be relied upon to provide access to uninsured deposits and other assets in the future in the event of thea future closure of a financial institution, we would have access to our funds or that such access would be afforded in a timely fashion. Any loss of our cash or cash equivalents or any delay in our access thereto could, among other risks, adversely impact our ability to pay our operating expenses, result in breaches of our contractual obligations, or result in violations of federal or state wage and hour laws if we are unable to pay our employees on a timely basis.

The manufacture of our product candidates is subject to compliance with extensive regulatory requirements, in some cases is complex, and in most cases we rely on single source contract manufacturers and suppliers. As a result, we face significant risks of manufacturing and supply delays and disruptions that may be difficult and expensive to resolve and may cause substantial delays in the development and regulatory approval of our product candidates or the commercialization of any approved product. To date, our clinical-stage product candidates have been tested in a relatively small number of clinical study participants. Significant scale-up of manufacturing will be required to provide adequate supplies of our product candidates for larger Phase 2 and Phase 3 clinical trials and may take longer and be more expensive than anticipated. For example, if the ongoing pivotal clinical study of Ovaprene will requirerequired far more clinical product supplies than were manufactured for prior clinical and nonclinical studies combined. A substantial scale up in production of Ovaprene clinical supplies was necessary to support the ongoing Phase 3 clinical study of Ovaprene, which took longer and was more expensive than anticipated, impacting our development timeline. Under our agreement with ADVA-Tec, we are dependent on ADVA-Tec and its contract manufacturer, Poly-Med, Inc., for all Ovaprene clinical and commercial product supplies, and we do not control these third parties and have limited influence the efforts and resources they expend to meet our supply requirements. Disruptions and delays in scaling up manufacturing of our product candidates for later stage clinical studies may have a significant negative impact on our development costs and timelines. We have, and we expect we will continue to, face multiple challenges as our contract manufacturers scale their processes to provide supplies for larger clinical trials or commercial production including, among others, potential difficulties with process scale-up, process reproducibility, stability and purity issues, compliance with cGMP, lot consistency, and timely availability of acceptable raw materials.

Section 505(b)(2) of the FDCA permits the filing of an NDA in which the applicant relies, at least in part, on the FDA's prior findings of safety and efficacy data for an existing product, or published literature, in support of its NDA, potentially eliminating or reducing the need to conduct certain nonclinical testing or clinical studies and expediting development timelines relative to the traditional or "full" NDA under Section 505(b)(1) of the FDCA.SeeFDCA. See ITEM 1. “BUSINESS–Government Regulation–U.S. Government Regulation–FDA Review and Approval Process for Prescription Drugs– Marketing Application Submission and FDA Review” above for more information. If the FDA changes its 505(b)(2) policies and practices, if Congress were to amend the FDCA, or if the current 505(b)(2) pathway is otherwise not available for a product candidate as anticipated, we likely would need to conduct more clinical trials and nonclinical testing than planned to generate additional safety and efficacy data and other information to support an NDA. If this were to occur, the time and financial resources required to obtain FDA approval, as well as the development complexity and risk associated with these programs, would likely substantially increase, which could have a material adverse effect on our business and financial condition. In addition, Section 505(b)(2) NDAs are subject to special requirements designed to protect the patent rights of sponsors of previously approved drugs referenced in a Section 505(b)(2) NDA, and the filing of a patent infringement lawsuit against us following our submission of a 505(b)(2) NDA could significantly delay any potential FDA approval of the NDA. Even if we are able to utilize the Section 505(b)(2) regulatory pathway for one or more of our candidates, there is no guarantee this would ultimately lead to faster product development or earlier approval or commercial launch.

Pre-clinical studies refer to a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected. Because of their early nature, pre-clinical product candidates tend to carry a higher risk of failure as compared with clinical-stage assets. Pre-clinical candidates must generate sufficient safety and efficacy data through in vitro studies, animal studies and a variety of tests before they can be considered appropriate for testing in humans. The development risks, timeline and cost of pre-clinical assets can be high because of the unknowns and absence of data. It can be difficult to identify relevant tests and animal models for pre-clinical studies. Even if the results from our pre-clinical studies are favorable, we still may not be able to advance the candidates into clinical trials. If pre-clinical studies of product candidates do not generate strong data, our pre-clinical stage programs may never progress to clinical development and may prove to be worthless.

The grants and other non-dilutive funding supporting development of several of our programs, including Ovaprene, DARE-HPV, DARE-PTB1, DARE-LARC1, DARE-LBT, and activities to aid in the identification and development a novel non-hormonal intravaginal contraceptive candidate,programs should not provide any assurance that pre-clinical or clinical development supported by that funding will be successful, or, even if we are successful with all specified development activities, that we will be able or will choose to fund the additional development work that will be required to continue to advance the product candidates toward commercialization. Further, the grant agreements or other non-dilutive funding award agreements supporting these development programs generally feature milestone-based payments or, in the case of NIH grants, payments are received in reimbursement of specified activities, and there is no assurance that we will be able to achieve or otherwise demonstrate satisfaction of the specified development and reporting milestones required to receive future payments under the agreements. Additionally, the counterparties to these agreements may modify, suspend, discontinue payment of funds or terminate the agreements in certain circumstances largely in their discretion. Accordingly, we may never receive future payments under these agreements or realize the full potential amount of the grant or other funding award.

Our existing product development and commercialization collaborationscollaboration areis important to our business, and future collaborations may also be important to us. If we are unable to maintain anyour ofexisting these collaborations,collaboration, if theseit collaborations areis not successful, or if we are unable to establish additional strategic collaborations, our business and prospects may be materially harmed.

We have limited resources and no internal sales, marketing or distribution capabilities. A key aspect of our strategy is to establish collaborations with third parties, such as large and mid-size pharmaceutical companies and other third parties with the relevant R&D and/or commercial expertise and infrastructure, to help bring our product candidates to market. We currently do not expect to directly market, sell or distribute any of our products that receive regulatory approval, and instead intend to enter into agreements with third parties to market, sell and distribute and provide related support services for those products. For example, we have entered into an out-license agreementsagreement with third partiesOrganon for the commercialization of XACIATO and, if approved for commercial sale, Ovaprene.XACIATO. We intend to seek additional strategic collaborations.collaborations, including for Ovaprene, if approved for commercial sale, as a result of the termination of our prior strategic collaboration with Bayer. However, such strategic collaboration opportunities may not be available to us for a variety of reasons. For example, certain potential pharmaceutical company collaborators have announced discontinuation or significant reduction in their research and development efforts in women's health therapeutics. To the extent we do enter into strategic collaborations similar to our agreements for the commercialization of XACIATO and Ovaprene,XACIATO, the successful development and commercialization of our products and product candidates may become partially or entirely dependent upon the performance of third parties. By entering into strategic collaborations, we may relinquish control over important elements of product development and commercialization, and the collaborator may fail to develop or effectively commercialize the applicable products or product candidates. In addition, in the case of commercial collaborations, our product revenues may be lower than if we were to sell and distribute products that we develop ourselves.

Our existing collaborations,collaboration, and any future strategic collaborations we establish, involve significant risks to the success of the product, including that:

•collaborations may be terminated for the convenience of the collaborator and, if terminated, could significantly delay product development and commercial launch and increase the cost to us to pursue further development or commercialization of the applicable product or product candidate. For example, as was the case with our former out-license agreement for Ovaprene, our out-license agreementsagreement for XACIATO and Ovaprene and the CRADA with NICHD may be terminated by the counterparty for convenience upon the completion of a specified notice period, subject to limited restrictions.

We currently do not have, and have never had, product marketing, sales or distribution infrastructure. 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. 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. These options include building our own sales force and other commercial infrastructure, or collaborating with third parties that have established sales forces and distribution systems, either to augment our own sales force and commercial infrastructure or in lieu of establishing our own sales force and commercial infrastructure. We currently have no commercialization agreements with third parties other than our license agreementsagreement with Organon for XACIATO and Bayer for Ovaprene.XACIATO. We may not be able to maintain our existing commercial collaborationscollaboration or establish and maintain other commercial collaborations on favorable terms, on a timely basis, or at all. In addition, our product revenue and our profitability, if any, may be lower if we rely on third parties to commercialize products we develop than if we were to do it ourselves.

The commercial success of Ovaprene, if approved for commercial sale, will depend on the degree of market acceptance of a hormone-free, monthly intravaginal product, clinical efficacy and safety of the product, including as compared to alternative contraceptive methods, pricing of the product, and the availability and extent of third-party coverage and reimbursement for the product, as well as other factors including Bayer’s marketing and sales efforts.product.

DARE-HRT1, if approved as a treatment for moderate to severe VMS due to menopause, will compete with the many options on the market targeted to or FDA-approved for the treatment of menopausal symptoms, including VMS. Such options 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 options, including an FDA-approved productproducts (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 and non-hormonal therapies to continue to expand with time. DARE-HRT1 is designed to offer a convenient vaginal ring that continuously delivers a combination of bioidentical estradiol and progesterone over 28 days. Bioidentical hormones refer to compounds that are chemically identical to those produced naturally in the human body. Studies have not demonstrated that bioidentical hormones are safer than synthetic hormones, so DARE-HRT1 will need to compete with many types of hormone therapy options in terms of convenience, safety and efficacy in managing symptoms of menopause.

InOur addition,Pipeline: ourClinical portfolioStage includesand thePre-Clinical followingStage preclinical stage programs:Programs

Our primary operations consist of research and development activities to advance our portfolio of product candidates through late-stage clinical development and/or regulatory approval.approval, Duringand 2025,commercialization activities for the 503B and consumer health products we are also taking actionseek to bring our proprietary Sildenafil Cream formulation to market under Section 503B of the FDCA.market. Until we secure additional capital to fund our operating needs, we will focus our research and development resources primarily on advancement of Ovaprene. In addition, we expect to incur significant research and development expenses for the DARE-LARC1 and DARE-HPV programs, but we also expect such expenses will be supported by non-dilutive funding, with respect to DARE-LARC1, through atDecember least 2026,2027, and with respect to DARE-HPV, through October 2026. See Note 15, "Grant Awards" to the accompanying consolidated financial statements for additional information.

TheramexTermination Co-Developmentof andBayer LicensingLicense Agreement

An investment in shares of our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described in our 2025 10-K, in addition to other information in this report, before investing in our common stock. The occurrence of any of these risks could have a material adverse effect on our business, financial condition, results of operations and growth prospects. In these circumstances, the market price of our common stock could decline, and you may lose all or part of your investment. ThereExcept as discussed below, there have been no material changes from the risk factors disclosed in Part I, Item 1A. Risk Factors in our 2025 10-K.

Daré Bioscience® is a registered trademark of Daré Bioscience, Inc. and DARE to PLAY™, DARE to RESTORE™, Flora Sync LF5™, and DARE to RECLAIM™ are trademarks 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.

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, sexual health to fertility, vaginal health to infectious disease, we’re working to close critical gaps in care using science that serves her needs. In March 2025, we announced an expansion of our business model to include a dual-path approach to bringing new products to market. For select proprietary formulations, we are pursuing both traditional FDA approval and earlier market access via Section 503B compounding. We believe this strategy allows us to respond to clinician and patient demand for timely access while continuing to generate the data necessary to seek FDA approval and support long-term value creation. In addition to prescription-based offerings — both FDA-approved products and compounded drugs— we intend to bring to market select consumer health products that do not require a physician’s prescription, where appropriate based on product profile and market opportunity.

Our proprietary topical cream formulation of sildenafil is our first product to market under Section 503B. The compounded drug is branded as DARE to PLAY Sildenafil Cream and became available for pre-order fulfillment by prescription in the U.S. in December 2025. We expect product to begin shipping product and recordingto record revenue from sales thereof in the third quarter of 2026, however, we do not expect the amount of such revenue, if any, to be material during 2026. BecauseThe amount of potential revenue we may generate remains uncertain because we are in the early stages of executing against our Section 503B compounding strategystrategy, we rely on a third-party Section 503B-registered outsourcing facility to manufacture DARE to PLAY and to obtain and maintain all state-level pharmacy and outsourcing facility licenses required to fulfill DARE to PLAY prescriptions, and, as an organization, we have no experience in and limited infrastructure for commercializing products, the amount of potential revenue we may generate during 2026 remains uncertain.products.

Our primary operations consist of research and development activities to advance our portfolio of product candidates through late-stage clinical development and/or regulatory approval, and commercialization activities for the 503B and consumer health products we seek to bring to market. Until we secure additional capital to fund our operating needs, we will focus our research and development resources primarily on advancement of Ovaprene. In addition, we expect to incur significant research and development expenses for the DARE-LARC1 and DARE-HPV programs, but we also expect such expenses will be supported by non-dilutive funding, with respect to DARE-LARC1, through DecemberIND-enabling 2027,preclinical work, and with respect to DARE-HPV, through Octoberour 2026.ongoing Phase 2 clinical study. See Note 10, "Grant Awards" to the accompanying condensed consolidated financial statements for additional information.

For the interim analysis, the DSMB reviewed data from 339 study subjects, contributing 1,789 menstrual cycles of safety data. The study protocol calls for at least 2,500 cycles of exposure and expects that at least 250 subjects completingwould complete 13 menstrual cycles of use.use, whom we refer to as completers. Based on current enrollment trends, we expect to achieve 2,500 menstrual cycles of exposure before 250 subjects complete 13 menstrual cycles of use.completers. Interim data reviewed by the DSMB indicate that prolonged product use was not associated with the emergence of new types of adverse events or an increase in the frequency of adverse events, which we believe may support the sufficiency of fewer than 250 subjects completing 13 menstrual cycles of usecompleters to evaluate Ovaprene's safety profile. We intend to engageengaged with the FDA regarding these findings.findings and proposed amending the study protocol to remove the specific expectation of at least 250 completers. In August 2026, the FDA approved our proposed protocol amendment, but also cautioned that it believes implementing the proposed modification would result in a study that is not able to generate sufficient evidence of Ovaprene’s safety profile to support a favorable premarket approval decision. We intend to continue engagement with FDA on this point as well as the additional study design and future premarket approval submission considerations it provided. Based on the interim safety data reviewed by the DSMB, including the absence of new types of adverse events or increased frequency of adverse events with prolonged use, and the study's expected achievement of at least 2,500 menstrual cycles of exposure, we believe the amended protocol will generate sufficient safety data to support a premarket approval submission, although there can be no assurance that the FDA will agree. We currently expect to completeproceed enrollmentto amend the protocol to eliminate the 250 completer expectation and to enroll sufficient women in 2026 to achieve at least 2,500 menstrual cycles of exposure in 2026.2027, supporting a top line data announcement in 2027.

In FebruaryMay 2026, we announced FDAthe clearanceinitiation of oura investigationalrandomized, newplacebo-controlled, drug, or IND, application for adouble-blinded Phase 2 clinical study of DARE-HPV to evaluate the safety and antiviral activity of a lower and higher dose of DARE-HPV in approximately 100 women with persistent high-risk HPV infection.infection (ClinicalTrials.gov ID: NCT07601074). The plannedprimary endpoint is HPV clearance rate at three months post end of treatment. Secondary endpoints include safety, tolerability, and reduction in viral load. The ongoing Phase 2 study is expected to be supported by ARPA-H award funding. We arecurrently preparingexpect to advancereport DARE-HPVtopline intodata from the Phase 2 study in May 2026.2027.

Receipt of PaymentsPayment Under October 2024 Grant Award

In May and February 2026, we received paymentsa payment of $1.5 million and $2.0 million, respectively, under the subaward agreement we entered into with National Collegiate Inventors and Innovators Alliance, Inc. d/b/a VentureWell in October 2024 to support the development of DARE-HPV, which was the result of our selection for an initiative award by the Advanced Research Projects Agency for Health (ARPA-H), part of the U.S. Department of Health and Human Services. For a discussion of this agreement, see Note 10, "Grant Awards" to the accompanying condensed consolidated financial statements. Taking into account thesethis payments,payment, we have received a cumulative total of approximately $9.0 million of the up to $10.0 million in potential funding under the subaward agreement.

Our business, financial condition, operating results, and our ability to raise additional capital may be adversely affected by the uncertainty in the U.S. and global macroeconomic, political, and regulatory environments, such as inflation, trade disruptions and restrictive measures, including tariffs, high interest rates,rate uncertainty, slowed economic growth or recession, uncertainty with respect to the federal budget and debt ceiling, potential or prolonged U.S. government shutdowns, volatility in financial markets, changes in the regulatory landscape in the U.S., including due to significant reductions in funding and staffing of federal agencies and changes in leadership, and geopolitical factors. Unstable and unfavorable market and economic conditions may make it more difficult, more costly, and more dilutive to our stockholders to raise additional capital to fund our operations and execute against our business strategy, as well as adversely impact market demand for the women’s health solutions we bring to market. Further, the service providers, manufacturers, vendors, and collaborators on which we rely may be adversely affected by the foregoing risks, which could directly impact our ability to achieve our operating goals within planned timelines and budgets.

There may be significant future effects on the women's health sector and the pharmaceutical and biopharmaceutical industries as a result of federal policy and regulatory changes under the current U.S. presidential administration, including in areas relating to regulatory framework and oversight, research and development funding, drug pricing reform, global trade policy and tariffs, and others. Recent initiatives have resulted in material reductions in staffing levels at the FDA and NIH, including through workforce reductions and reorganizations, and have impacted the agencies’ ability to retain remaining key personnel and hire additional personnel, disrupting their ability to perform routine activities or function in the normal course. A prolonged federal government shutdown with additional agency staff furloughed or laid off could exacerbate these risks. With respect to the FDA, this may result in delays or limitations on our ability to obtain guidance from agency staff, slow review times for applications we submit to commence clinical studies and obtain requisite regulatory approvals in the future, and consequently, negatively impact the cost and timelines for developing and obtaining regulatory approval of our product candidates. Moreover, our business strategy has included seeking non-dilutive sources of funding and collaborations to support product development, and we have benefited significantly from federal government funding through grants and other agreements in support of several of our development programs, including Ovaprene and DARE-HPV. Beginning inIn early 2025, the U.S. presidential administration took actions to freeze or terminate billions of dollars in NIH grants.grants, In addition, althoughand the Smallstatus Businessof InnovationNIH grant funding has continued to evolve since that time as a result of additional executive actions, legal challenges, and Economiccourt Securityorders, Act (S. 3971), signed into law in April 2026, reauthorizedand the SBIRlong-term andstatus STTRof programsmany throughgrants Septemberremains 30, 2031 following a lapse in legislative authority in October 2025, NIH continues to work through resulting administrative backlogs, and we have been informed that drawdowns on our existing awards are not yet available. See Note 10 “Grant Awards” to the accompanying condensed consolidated financial statements.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 challengescontinue to recent federal government actions,evolve, we are not able to reasonably predict the full extent of the potential impact on our business at this time. 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 2025 10-K.

ToFor date,the six months ended June 30, 2026, substantially all of our revenue for 2026 relates to two agreements we entered into with the Gates Foundation, or the Foundation, under which we provide research and development services related to preeclampsia and the contraceptive market. We commenced work under both agreements in November 2025. We may receive up to approximately $499,000 under the agreement related to preeclampsia, and up to approximately $300,000 under the agreement related to the contraceptive market. We began recording revenue from sales of Flora Sync LF5 in July 2026.

In the future, we may generate revenue from license fees, milestone payments, and research and development payments in connection with strategic collaborations, and from product sales, including sales of 503B compounded products, consumer health products, and FDA-approved products, if any. We expect to begin recording revenue from sales of DARE to PLAY in the third quarter of 2026 and of Flora Sync LF5 in June 2026. Our ability to generate such revenue will depend on the extent to which we are successful in executing against our Section 503B and consumer health product business models,strategy, the extent to which the clinical development of our product candidates is successful, and whether we or a strategic collaborator receive the regulatory approvals necessary to market such product candidates, as well as the eventual commercial success of any FDA-approved products. If we fail to successfully achieve any of the foregoing, our ability to generate future revenue and our results of operations would be materially adversely affected. 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.

Cost of revenues primarily represent expenses associated with medical education and consumer awareness related to the commercialization of DARE to PLAY through our 503B business model and the costs of providing research and development services to the Foundation. Beginning in the third quarter of 2026, cost of revenues will also include costs related to sales of Flora Sync LF5.

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 2025 10-K and Note 10 "Grant Awards" to the accompanying condensed consolidated financial statements. We recognized contra-R&D expense of approximately $3.5$4.7 million and $3.1$8.2 million for the three and six months ended MarchJune 31,30, 20262026, respectively, and $4.5 million and $7.6 million for the three and six months ended June 30, 2025, respectively.

Comparison of Three Months Ended MarchJune 31,30, 2026 and 2025 (Unaudited)

The increase of approximately $0.1$0.2 million in revenue for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 was attributable to R&D services revenues from the agreements we entered into with the Foundation in September and October 2025, partially offset by a decrease in non-cash royalty revenues related to XACIATO. See "—Financial Overview—Revenue," above for information.

Cost of revenues increased by approximately $0.2$0.3 million compared to the prior period, which had no comparable activity. Cost of revenues relates primarilyrelated to the cost of performing research and development services under our R&D services agreements we entered into with the Foundation in September and October 2025, and to expenses associated with medical education and awareness related to the commercialization of DARE to PLAY.

The decreaseincrease of approximately $0.1$0.2 million in SG&A expenses for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 was primarily attributable to decreasesan approximately $0.3 million non-cash write down of previously deferred offering costs, an increase of approximately $0.1 million in personnel costs, offsetand byan increasesincrease of approximately $0.1 million in professional services and commercial-readiness expenses driven by execution against our expanded business strategystrategy, partially offset by decreases of approximately $0.2 million in professional services and approximately $0.1 million in stock-based compensation expense. See Note 4 "Stockholders' Equity" to the accompanying condensed consolidated financial statements for additional information regarding the non-cash write down of previously deferred offering costs.

The decrease of approximately $1.6$1.2 million in R&D expenses for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 was primarily attributablerelated to an increase in contra R&D expenses in direct program costs, and decreases in expenses related to (i) the ongoing Phase 3 clinical trial of Ovaprene, (ii) our Phase 1 and Phase 1-ready clinical stage programs - primarily attributable to our DARE-PTB1 program, (ii) personnel costs, (iii) theour ongoingpre-clinical Phaseand 3other clinicaldevelopment trialprograms of—primarily Ovaprene,attributable to our DARE-LARC1 program, and (iv) Sildenafilpersonnel-related Creamcosts. andSuch DAREdecreases were partially offset by increases in expenses related to PLAY Sildenafil Cream, and (vA) our other advanced clinical stage programs - primarily attributable to our DARE-HPV program.program, and (B) Sildenafil Cream and DARE to PLAY Sildenafil Cream. Contra R&D expenses for the three months ended MarchJune 31,30, 2026 and 2025 primarily offset direct program costs for DARE-LARC1, Ovaprene and DARE-HPV.

The decrease of approximately $0.2 million$30,000 in other (expense) income for the threesix months ended MarchJune 31,30, 2026 as compared to the same period in 2025 was primarilydue drivento by(i) the absence of employee retention credits recognized in the prior year period.period— Inin the first quarter of 2025, we recognized approximately $0.2 million of employee retention credits related to applications filed in 2023 with no comparable benefit in the current period, and (ii) decreased interest expense in the current period. Such decreases were partially offset by increased interest income due to an increase on interest earned on cash balances in the current period.

At MarchJune 31,30, 2026, our cash and cash equivalents were approximately $18.5$12.6 million, and our working capital deficit was approximately $0.5$0.2 million. As of MarchJune 31,30, 2026, our deferred grant funding liability was approximately $18.2$15.0 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 our cash and cash equivalents and our deferred grant funding liability, see Note 2 "Basis of Presentation and Summary of Significant Accounting Policies—Going Concern" to the accompanying condensed consolidated financial statements, and Note 2 "Basis of Presentation and Summary of Significant Accounting Policies—Grant Funding" to our consolidated financial statements in our 2025 10-K.

We believe that our existing cash and cash equivalents will be sufficient to fund our operating needs, including planned commercial launch activities for DARE to PLAY, into the fourth quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. In addition to our ongoing Regulation A offering, weWe will continue to evaluate and may pursue various other capital raising options, including sales of equity, debt financings, government or other grant funding, collaborations, structured financings, and commercial collaborations or other strategic transactions. Our ability to obtain additional capital, including through our ongoing Regulation A offering,capital and the timing and terms thereof, depend on various factors, many aspects of which are not entirely within our control, and there can be no assurance that capital will be available when needed or, if available, on terms favorable to us and our stockholders. Raising additional capital may cause substantial dilution to our stockholders, restrict our operations or require us to relinquish rights in our technologies or product candidates and their future revenue streams. If we cannot raise capital when needed, on favorable terms or at all, we will need to reevaluate our planned operations and may need to delay, scale back or eliminate some or all of our product candidate programs and/or reduce expenses.

At MarchJune 31,30, 2026, our accumulated deficit was approximately $191.7$194.7 million, and we had a net loss of approximately $3.0$6.0 million and negative cash flows from operations of approximately $5.5$12.3 million for the threesix months ended MarchJune 31,30, 2026. 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 and limited infrastructure for commercializing products, both the timing and amount of potential revenue we may generate remain uncertain. As a result, weWe may continue to incur significant losses from operations and negative cash flows from operations for the next several years,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.

WeIn have an ongoingour Regulation A offering in which we are offering up to 4,854,000 units, each consisting of one share of our Series A convertible preferred stock, which is convertible into two shares of our common stock, and two warrants, each exercisable for one share of our common stock at an exercise price of $4.00 per share. The offering price of each unit is $5.00. As of the date of this report, we have issued an aggregate of 285,320338,000 units to investors in the offering, consisting of 285,320]338,000 shares of Series A convertible preferred stock and warrants to purchase up to 570,640676,000 shares of our common stock, for gross proceeds of approximately $1.4$1.7 million.

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"at-the-market," or ATM, equity offering program under which Stifel acts as our agent. During 2025, we sold 4,329,116 shares of our common stock under the sales agreement for net proceeds of approximately $17.6 million. Shares of our common stock sold under the sales agreement wereare 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. During 2025, we sold 4,329,116 shares of our common stock under the sales agreement for net proceeds of approximately $17.6 million. Because the market value of ourthe outstanding shares of our common stock held by non-affiliates, or our public float, is less than $75.0 million, ourwe useare subject to the SEC's "baby shelf rule," which limits the amount of securities we may offer and sell under a shelf registration statement is currently limited by what is known as the SEC’s “baby shelf rule” to one-third of our public float in any 12-month period. BecauseAs of August 1, 2026, all prior offers and sales under our shelf registration statement fell outside the "trailing 12-month period, and we became eligible to offer and sell our securities under the shelf registration statement, subject to the baby shelf rule" and based on sales of shares of our common stock under our ATM sales agreement, we do not expect to sell any additional shares under our ATM sales agreement during the approximately 12-month period from July 2025, unless and until our public float exceeds approximately $54.0 million, as determined in accordance with SEC rules.limitation.

We have a purchase agreement with Lincoln Park Capital Fund, LLC, or Lincoln Park, under which, subject to the conditions thereof, we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $15.0 million in shares of our common stock. Such sales of our common stock to Lincoln Park, if any, will be subject to certain limitations, and may occur from time to time, at our sole discretion through December 1, 2026. See Note 4 "Stockholders' Equity—Equity Line" to the accompanying condensed consolidated financial statements for additional information. During 2025, we sold 1,470,000 shares of our common stock under this purchase agreement and received net proceeds of approximately $3.1 million. AsWe sold 150,000 shares of theour filingcommon datestock ofunder this report, due to the limitations in the purchase agreement onduring the numbersix months ended June 30, 2026 and received net proceeds of approximately $0.3 million. We sold 120,000 shares we can sell at an average price of lessour thancommon $3.59,stock unlessunder wethis obtainagreement stockholder approvalsubsequent to doJune so, we have effectively exhausted our ability to sell shares to Lincoln Park under the purchase agreement. We are seeking stockholder approval at our30, 2026 annualand meetingreceived net proceeds of stockholders,approximately but$0.2 there can be no assurance that approval will be obtained.million.

We began recording revenue from sales of Flora Sync LF5 in July 2026, and we expect to begin recording revenue from sales of ourDARE 503Bto productsPLAY andin consumerthe healththird productsquarter whenof such2026. productsThe areamount commerciallyof availablepotential forrevenue purchasewe andmay aregenerate shipped.remains Becauseuncertain because we are in the early stages of executing against our Section 503B compounding and consumer health products strategybusiness strategies, we rely on a third-party Section 503B-registered outsourcing facility to manufacture DARE to PLAY and to obtain and maintain all state-level pharmacy and outsourcing facility licenses required to fulfill DARE to PLAY prescriptions and, as an organization, we have no experience in and limited infrastructure for commercializing products, the amount of potential revenue we may generate during 2026 remains uncertain.products.

Net cash used in operating activities of $5.5$12.3 million for the threesix months ended MarchJune 31,30, 2026 was primarily due to our net loss of $3.0$6.0 million and changes in operating assets and liabilities, offset by non-cash items such as depreciation and amortization expense, stock-based compensation expense, and our operating lease right-of-use asset. Net cash used by changes in operating assets and liabilities resulted primarily from a decrease of $1.5$4.7 million in our deferred grant funding liability, an increase of $1.4$1.8 million in other non-current assets, an increase of $0.4$1.4 million in prepaid expenses, an increase of $0.2$0.5 million in other current assets, a decrease of $0.1$0.4 million in accounts payable, a decrease of $0.3 million in operating lease liability, an increase of $0.1 million in accounts receivable, and a decrease of $45,000 in accounts payable, partially offset by an increase of $0.2$0.3 million in interest payable. The $1.4$1.8 million increase in other non-current assets relates primarily to a payment made to the third-party Section 503B-registered outsourcing facility for DARE to RECLAIM during the three months ended March 31, 2026, which will be credited against amounts otherwise owed to such third-party for future purchases of DARE to RECLAIM.

No cash was used in investing activities for the three months ended March 31, 2026. Net cash used in investing activities for the threesix months ended MarchJune 31,30, 2026 and June 30, 2025 related to purchases of property and equipment.

Net cash used in or provided by financing activities

Net cash usedprovided inby financing activities for the threesix months ended MarchJune 31,30, 2026 resulted primarily from approximately $1.5 million of net proceeds from sales of units in our Regulation A offering and approximately $0.3 million of net proceeds from sales of our common stock under our purchase agreement with Lincoln Park, partially offset by (i) approximately $0.9$1.3 million in payments on our facility financing lease and (ii) approximately $0.2 million in payments on a note payable related to an insurance premium financing obtained in July 2025 related to certain director and officer and other insurance premiums, partially offset by (A) approximately $0.3 million of net proceeds from sales of units under our Regulation A offering and (B) approximately $0.1 million of net proceeds from sales of our common stock under our purchase agreement with Lincoln Park.premiums.

Net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2025 consisted primarily of approximately $0.9 million 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(i) insuranceour financingfacility notefinance payablelease of approximately $0.2$0.5 million and (ii) insurance premium financing of approximately $0.3 million.

We have two operating leases for our laboratory and office spaces that each expire in 2027. As of MarchJune 31,30, 2026, we had future minimum lease payments under these leases of $1.1$0.9 million, $0.6 million of which is classified as current and $0.4$0.3 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 December 2026. As of MarchJune 31,30, 2026, we had future minimum lease payments under this lease of $0.6$0.2 million, all of which is classified as current. For additional information on our lease obligations, See Note 6 "Leases" to the accompanying condensed consolidated financial statements.