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Item 1A. Risk Factors

2026-03-26 compared with 2025-03-31 · 279 added, 252 removed, 1241 unchanged (30% of the section changed)

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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 fail to regain and maintain compliance with the continued listing requirements of the Nasdaq Capital Market, our common stock could be delisted, which could, among other things, limit demand for our common stock, substantially impair our ability to raise additional capital and have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock.

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.

• There is no assurance that we will continue to satisfy the listing requirements of the Nasdaq Capital Market.

Until July 24, 2026, we are subject to a Nasdaq discretionary panel monitor.

If we fail to maintain compliance with any continued listing requirement in Nasdaq’s Listing Rules through July 24, 2026, Nasdaq will issue a delist determination letter, and we will have an opportunity to request a new hearing with Nasdaq’s hearing panel.

Based on information currently available to us, our stockholders' equity is expected to be below the $2.5 million threshold as of March 31, 2026, which, if not remedied prior to the time our quarterly report for the first quarter is filed with the SEC, is expected to result in Nasdaq issuing a delist determination letter, with no guarantee that a subsequent hearing before Nasdaq's hearings panel would result in a favorable outcome.

The delisting of our common stock or the commencement of delisting proceedings could materially impair our ability to raise capital and limit financing and business opportunities.

• We have a limited operating history, a history of significant losses from operations, and expect significant losses from operations, net losses and negative cash flows from operations to continue for the foreseeable future, which, together with our limited financial resources, make it difficult to assess our prospects.

• We plan to generate revenue from sales of our proprietary Sildenafil Cream formulation produced under Section 503B of the FDCA.

We have no experience in this line of business and may not succeed in our efforts.

We will rely on third parties for the compounding and distribution of our proprietary Sildenafil Cream formulation, 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 new regulations and potential liability.

• We plan to generate revenue from sales of DARE to PLAY and other potential compounded drugs under Section 503B of the FDCA.

We have limited experience in this line of business and may not succeed in our efforts.

We rely on, and will rely on, third parties for the compounding and distribution of DARE to PLAY and 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 additional regulations and potential liability.

• Our business depends on obtaining the approval of regulatory authorities, and in particular, FDA approval, to market products that we develop.

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If we are not able to obtain regulatory approvals for our product candidates, our ability to generate product revenue will be materially impaired.

• We rely on in-license agreements with third parties for rights to develop and commercialize XACIATO and our product candidates.

• We rely on in-license agreements with third parties for rights to develop and commercialize XACIATO, our product 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 collaborations are important to our business.

If we are unable to maintain existing strategic collaborations or establish new ones, or if they are not successful, we may require substantial additional capital to develop and commercialize our products and product candidates and our business and prospects may be materially harmed.

• Strategic collaborations are a key part of our strategy and our existing strategic collaboration related to XACIATO is important to our business.

If we are unable to maintain our existing strategic collaboration or establish new ones, or if they are not successful, we may require substantial additional capital to develop and commercialize XACIATO and our product candidates, and our business and prospects may be materially harmed.

• Delays and disruptions in the supply and manufacturing of our product candidates could postpone the initiation of or interrupt our clinical studies, extend the timeframe and cost of development of our product candidates, delay potential regulatory approvals and adversely impact the commercialization of any approved products.

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• Due in part to our limited financial and human resources, we may fail to effectively execute our product development, regulatory submission and commercialization plans in accordance with communicated timelines, or at all.

• 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, and if commercialization of XACIATO is not successful, our reputation, business and prospects may suffer.

• The commercial success of XACIATO is outside of our control and will depend on Organon’s efforts and 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, or our commercial collaborators, fail to compete effectively.

• Failure to successfully obtain 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.

Our business, operating results and financial condition will suffer if we or 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.

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• We may not be successful in our efforts to identify and acquire or in-license additional product candidates or technologies, which may limit our growth potential.

• If we and our licensors are unable to obtain and maintain sufficient intellectual property protection, competitors could develop and 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.

• If we and our licensors are unable to obtain and maintain sufficient intellectual property protection, competitors could develop, market, 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.

• Most of the products we are developing utilize active pharmaceutical ingredients that are not proprietary to us or our licensors and the patents and patent applications owned by us and our licensors intended to protect our products and product candidates relate to specific formulations, processes, methods of delivery, and/or uses, which may not afford sufficient protection against competitors.

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• Future dilution to our existing stockholders from sales and issuances of our common stock to raise additional capital, or the market's expectation that such sales may occur, could adversely affect our stock price even if our business is doing well.

• 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.

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We will need to raise substantial additional capital to continue our operations and execute our business strategy, and we may not be able to raise adequate capital on a timely basis, on favorable terms, or at all.

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 our existing product candidates and as we seek to potentially acquire or license and develop additional product candidates.

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

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

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

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

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

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 product candidates and as we seek to potentially acquire or license and develop additional product candidates.

At December 31, 2025, we had an accumulated deficit of approximately $188.7 million, cash and cash equivalents of approximately $24.7 million, and working capital of approximately $3.4 million.

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

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

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

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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 product development programs;

relinquish rights under our license agreements with third parties relating to our product candidates;

forgo opportunities to expand our product portfolio;

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;

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Our capital needs have depended on, and will continue to depend on, many factors that are highly variable and difficult to predict, including:

• the product development programs we choose to pursue;

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

• the initiation, type, number, scope, progress, expansions, results, costs, and timing of clinical trials and preclinical studies of our product candidates that we are pursuing or may choose to pursue in the future;

• the cost and timing of manufacturing for 503B compounded drugs;

• the cost and timing of manufacturing for clinical supplies of product candidates and, if applicable, commercial product at sufficient scale;

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• the cost and timing of commercialization activities we undertake or engage third parties to undertake for any product;

• 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, or the Royalty Purchase Agreements;

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

• our ability to maintain, and establish new, strategic collaborations relating to the development and/or commercialization of our product and product candidates, and the terms and timing of such arrangements;

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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 product development efforts succeed, we will need to develop and implement a commercialization plan for each product, which may also require significant resources to create and implement.

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.

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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), 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.

economic crisis or recession or recessionary concerns, inflation, rising interest rates, public health 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.

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Raising capital through the issuance of shares of our common stock, or securities convertible into or exercisable for our common stock, may depress our stock price and substantially dilute our existing stockholders.

The terms of securities issued may include liquidation or other preferences that may materially adversely affect the rights of our existing stockholders.

The terms of securities issued may include liquidation or other preferences that may materially adversely affect the rights of our existing

stockholders.

Debt and other structured financings, if available, would increase our fixed payment obligations and may involve covenants requiring us to maintain specified financial ratios or a specified cash balance, or limiting or restricting our ability to take specific actions, such as incurring additional debt, acquiring, selling or licensing intellectual property rights, and making capital expenditures, or impose other operating restrictions that could adversely impact our ability to operate our business and pursue our strategic objectives.

We could also be required to meet certain milestones in connection with a debt financing and the failure to achieve such milestones by certain dates may force us to relinquish rights to some of our technologies, product candidates or products, or otherwise agree to terms unfavorable to us.

In addition, we may forego part or all of potentially valuable streams of future payments (e.g., milestone and/or royalty revenue) to raise immediate capital to fund our operations and advance our development programs, such as in the case of our royalty interest financing agreement and the Royalty Purchase

Moreover, the lower our cash balance when we seek to raise additional capital, the more difficult, costly or dilutive to our existing stockholders it may be for us to raise additional capital.

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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, 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, 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.

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 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, we expect our revenue streams related to those products will be based primarily on net sales, which will be largely outside of our control.

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.

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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.

exclusive license agreements with Organon and Bayer, assuming the license grant to Bayer becomes effective, 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.

Due to our exclusive license agreements with Organon, our royalty interest financing agreement, and the Royalty Purchase Agreements, XACIATO’s value to us will be based primarily on net sales, as determined under those agreements.

In the future, we may rely on revenues received from third-party licensees to fund our operations, and failure to receive such revenues, or receipt of only minimal revenue, may cause us to, among other things:

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• take other measures to reduce our expenses, pursue strategic transactions, such as a merger or other business combination or sale of assets, file for bankruptcy, or cease operations.

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

We have entered into an exclusive license agreement with Organon for the commercialization of XACIATO and an exclusive license agreement with Bayer for the commercialization of Ovaprene, if approved for commercial sale.

Each of these license agreements may be terminated by the licensee for convenience upon the completion of a specified notice period, subject to limited restrictions.

Furthermore, under our agreement with Bayer, Bayer has no payment obligations to us, unless, after reviewing the results of our pivotal clinical trial of Ovaprene, it elects, in its sole discretion, to make the license grant under our agreement effective by making a $20.0 million payment to us.

If we do not successfully complete a pivotal clinical trial of Ovaprene in a timely manner, the license grant may never become effective, and we may not receive any additional payments from Bayer.

Bayer may elect not to make the license grant effective regardless of the outcome of the pivotal clinical trial.

If an exclusive license agreement is terminated early, or in Ovaprene's case, does not become fully effective, we may realize only a small fraction of the potential value of the agreement to us, and we would need to raise significant additional capital to pursue further development and commercialization of XACIATO or Ovaprene, as applicable, or establish another commercial collaboration, which we may not be able to do on a timely basis, on favorable terms, or at all.

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

We have an exclusive license agreement with Organon for the commercialization of XACIATO.

That license agreement may be terminated by Organon for convenience upon the completion of a specified notice period, subject to limited restrictions.

If Organon determines to terminate the exclusive license agreement with us, we may realize only a small fraction of the potential value of the agreement to us, and we would need to raise significant additional capital to pursue further development and commercialization of XACIATO, or establish another commercial collaboration, which we may not be able to do on a timely basis, on favorable terms, or at all.

For example, we had an exclusive license agreement with Bayer for the commercialization of Ovaprene.

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

If Ovaprene were to receive marketing approval from the FDA, we will need to enter into an agreement with a third party to commercialize Ovaprene, for which no assurances can be given, and if we do not enter into such agreement, the commercialization of Ovaprene would be delayed.

See also the risk factor titled, “Our existing product development and commercialization collaboration is important to our business, and future collaborations may also be important to us.

If we are unable to maintain our existing collaboration, if it is not successful, or if we are unable to establish additional strategic collaborations, our business and prospects may be materially harmed,” below.

We have relied heavily on sales of our common stock to fund our operations, and 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.

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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 million in gross proceeds in fiscal years 2021 and 2022 through the sale of shares of our common stock in offerings made under a Form S-3 “shelf” registration statement.

For example, we raised an aggregate of approximately $21.3 million in in gross proceeds during 2025, and approximately $93.0 million in gross proceeds since January 1, 2021, 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.

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.

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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.

If 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 or under a Form S-1 registration statement.

Based 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.

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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.

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.

Due in part to our limited financial resources, we may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable indications or therapeutic areas for our product candidates, we may be unable to pursue and complete the clinical trials we would like to pursue and complete, and we may be unable to commence or complete clinical trials and pursue regulatory approvals in accordance with our current timeline expectations.

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We may make determinations with regard to the indications and clinical trials on which to focus our resources that result in our realization of less than the full potential value of a product candidate.

The decisions to allocate our research,

management, personnel and financial resources toward particular indications may not lead to positive clinical milestones or to the development of viable commercial products and may divert resources from better opportunities.

The decisions to allocate our research, management, personnel and financial resources toward particular indications may not lead to positive clinical milestones or to the development of viable commercial products and may divert resources from better opportunities.

Similarly, our decisions to delay or terminate development programs may also cause us to miss valuable opportunities, including the potential for some of our product candidates to be first-in-category products.

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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 new U.S.

Further, there is a high level of uncertainty regarding whether the federal government under the current 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.

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federal government funding and contracting policies may adversely affect our business.

Changes in federal funding and contracting policies under the new 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.

Changes in federal funding and contracting policies under the current U.S.

presidential administration could materially impact the progress of certain of our development programs, including 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.

As discussed elsewhere in this report, 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.

such institutions.

These changes could adversely affect our development programs, financial condition, operating results and business plans.

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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, on 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.

While we were 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, 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 the closure of a financial institution, or that such access would be afforded in a timely fashion.

For example, in March 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 for a few days.

While we were eventually afforded full access to our accounts, there is no guarantee that in the event of a 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.

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Accordingly, while some of our product candidates have undergone clinical trials and demonstrated positive results, including Ovaprene and Sildenafil Cream, there is no guarantee of successful outcomes in current or future clinical studies of these product candidates or of obtaining marketing approval for any of them.

For example, while PCT clinical trials have been used as a surrogate marker for contraceptive effectiveness and our PCT clinical trial of Ovaprene met its primary endpoint, there is no guarantee Ovaprene will demonstrate contraceptive effectiveness in its ongoing pivotal Phase 3 clinical study or demonstrate a level of contraceptive effectiveness that will enable it to compete effectively in the contraceptive market.

As another example, while data from our exploratory Phase 2b RESPOND study of Sildenafil Cream allows us to advance Sildenafil Cream into Phase 3 development, the co-primary efficacy endpoints of the Phase 2b study were not met and there is no guarantee that our planned Phase 3 clinical studies, which will have the same co-primary efficacy endpoints used in the Phase 2b study, will be successful.

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If interim, preliminary or final results from our clinical studies are not positive, or are perceived by third parties, including the medical community, current and potential collaborators, and the investment community, as not positive, our stock price could decline significantly, our reputation may suffer, and our ability to raise additional capital to continue to operate as a going concern and execute our business strategy could be adversely impacted.

If a product candidate fails to demonstrate adequate

safety or effectiveness in a clinical study, we may determine to delay, scale back or terminate the program, and we may not realize any return on our investment in the program.

If a product candidate fails to demonstrate adequate safety or effectiveness in a clinical study, we may determine to delay, scale back or terminate the program, and we may not realize any return on our investment in the program.

Even if we conduct and complete clinical trials for our product candidates, we may not obtain regulatory approval to market and sell any of them on the timelines we anticipate, or at all, which would have a material adverse effect on our business and operations.

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Global supply chain disruptions and the subsequent effects thereof may adversely affect the ability of contract manufacturers to manufacture and supply our clinical trial material.

Our prospective or contracted clinical trial sites may experience

resource constraints, including staffing shortages, stemming from global or regional issues, such as a public health emergency, natural disaster, or worker strike, and become unable to allocate adequate resources to reach agreements necessary to commence our clinical trials at their facilities or, even if agreements are in place, to conduct our clinical trials.

Our prospective or contracted clinical trial sites may experience resource constraints, including staffing shortages, stemming from global or regional issues, such as a public health emergency, natural disaster, or worker strike, and become unable to allocate adequate resources to reach agreements necessary to commence our clinical trials at their facilities or, even if agreements are in place, to conduct our clinical trials.

For ongoing clinical trials, macroeconomic factors or events, such as a global pandemic, may result in lower than anticipated subject enrollment and completion rates, including because clinical trial sites may temporarily close or reallocate resources away from clinical research, or study participants may withdraw prior to receiving study treatment or discontinue their treatment or follow up visits to avoid medical settings or because they become sick or must care for a sick family member.

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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, the ongoing pivotal clinical study of Ovaprene will require far more clinical product supplies than were manufactured for prior clinical and nonclinical studies combined.

For example, if the ongoing pivotal clinical study of Ovaprene required 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.

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The finished products (and their APIs) used in clinical trials or approved for commercial sale must be manufactured in accordance with cGMP requirements in the U.S.

that are enforced by the FDA and must comply with applicable requirements of foreign regulatory authorities for sales outside of the U.S.

that are enforced by the FDA and must comply with applicable requirements of foreign

regulatory authorities for sales outside of the U.S.

These regulations govern manufacturing processes and procedures, including record keeping and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale.

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Government Regulation–FDA Review and Approval Process for Prescription Drugs, FDA Review and Approval of Medical Devices, and FDA Review and Approval Process for Combination Products” and “–Government Regulation Outside the U.S.” above.

development and commercialization efforts would be impaired, which could have a material adverse effect on our business, financial condition and results of operations.

If our contract manufacturers are unable to produce sufficient quantities of our product candidates (or their APIs) for clinical trials or, if approved for commercial sale, for commercialization at acceptable quality levels, our development and commercialization efforts would be impaired, which could have a material adverse effect on our business, financial condition and results of operations.

As product candidates progress through the development process, it is not uncommon that manufacturing methods are altered along the way in an effort to optimize yield, manufacturing batch size, minimize costs, achieve consistent quality and results, or to comply with regulatory authority requirements.

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While we worked with experts to select existing as well as develop novel patient reported outcome (PRO) instruments for our exploratory Phase 2b RESPOND study of Sildenafil Cream, tested the potential PRO instruments in a content validity study, reviewed the results of that study with the FDA and aligned with the FDA on the Phase 2b study design, there is no precedent program that has utilized these same endpoints in a Phase 3 study and there is no assurance they will be adequate to detect a treatment effect.

In addition, the Phase 2b RESPOND study proved more difficult to enroll than anticipated given the enrollment criteria for the study, particularly the requirement that the partner be enrolled in the study.

In addition, the Phase 2b RESPOND study proved more difficult to enroll than anticipated given the enrollment criteria for the study, particularly the requirement that the

partner be enrolled in the study.

Moreover, the Phase 2b RESPOND study did not demonstrate statistical significance for the co-primary or secondary efficacy endpoints.

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In our exploratory Phase 2b RESPOND study, we experienced a slower than anticipated pace of enrollment given the enrollment criteria for the study, which lengthened our original estimated timeline for the study.

We may experience delays in future clinical studies of Sildenafil Cream relative to our communicated expectations due to the novel nature of the studies and the

complexities of the condition it is intended to treat, which may significantly lengthen clinical study timelines, increase overall costs, and may lead to unfavorable results.

We may experience delays in future clinical studies of Sildenafil Cream relative to our communicated expectations due to the novel nature of the studies and the complexities of the condition it is intended to treat, which may significantly lengthen clinical study timelines, increase overall costs, and may lead to unfavorable results.

With respect to any clinical study of Sildenafil Cream, even if we can identify and enroll a sufficient number of women for whom inadequate blood flow to the genital tissue is the primary contributing factor to their arousal disorder, there is no guarantee that the use of Sildenafil Cream will meaningfully improve their sensations of arousal or demonstrate statistically significant improvement in the primary or secondary efficacy endpoints of the study.

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and elsewhere is expensive, may take many years and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved.

In addition, requirements for approval may change over time and our current development plans may not accurately anticipate all applicable requirements for marketing

approval by the FDA or comparable regulatory authorities for jurisdictions outside the U.S.

In addition, requirements for approval may change over time and our current development plans may not accurately anticipate all applicable requirements for marketing approval by the FDA or comparable regulatory authorities for jurisdictions outside the U.S.

See also ITEM 1.

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We expect to utilize the FDA’s Section 505(b)(2) pathway for most of our current product candidates, including all of our clinical-stage candidates other than Ovaprene, and if that pathway is not available, the development of our product candidates will likely take significantly longer, cost significantly more and entail significantly greater complexity and risk than currently anticipated, and, in any case, may not be successful.

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.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.

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.

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In regard to Ovaprene, a change in the FDA’s prior determination that CDRH would lead the review of a marketing application for Ovaprene would adversely impact Ovaprene’s development timeline and significantly raise our costs to complete clinical development and obtain regulatory approval.

Ovaprene is composed of both device and

drug components and is considered a combination product by the FDA.

Ovaprene is composed of both device and drug components and is considered a combination product by the FDA.

The process for obtaining FDA approval of Ovaprene will require compliance with complex procedures because concordance between two centers of the FDA (CDRH and CDER) is necessary.

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The cost and timeline for development of product candidates determined to be combination products may be substantially greater than product candidates that are not considered combination products.

The FDA’s shift toward “radical transparency,” including plans to release future complete response letters promptly after they are issued to drug product sponsors and increase oversight and enforcement for violations of direct-to-consumer drug advertising, could adversely impact our business and commercial prospects.

There has been recent regulatory activity and enforcement in the United States stemming from an announced shift by FDA toward “radical transparency” resulting in increased scrutiny and transparency in the pharmaceutical drug space that may impact our business.

In July 2025, the FDA announced its intent to increase transparency by publicly releasing CRLs issued to drug and biologic product sponsors and, in September 2025, announced that, going forward, it would publicly release future CRLs promptly after they are issued to product sponsors, describing it as “real-time release” of future CRLs, and, when approving new drug or biologic product applications will release all CRLs associated with that application.

The FDA also released a number of previously unpublished CRLs issued since 2024 associated with pending or withdrawn applications.

CRLs, which are issued when an application for marketing approval of a new drug or biologic product cannot be accepted in its current form, outline the reasons for non-approval and may contain confidential or proprietary information relating to the sponsor’s product, including clinical trial, chemistry, manufacturing and controls, and technical information, and specific observations about study design and clinical endpoints.

Although the FDA has stated that all CRLs will be redacted to remove confidential commercial information, trade secrets, and personal private information, it remains unclear how such redactions will be implemented.

Any public release of a CRL issued to us or a collaborator could result in the inadvertent disclosure of information that could compromise our confidential and proprietary information, including our trade secrets and know-how, or facilitate third-party efforts to design around or challenge the validity, enforceability, or scope of our patents, accelerating the development of competitive products.

Moreover, once a CRL is published, we may have limited ability to correct or contextualize the FDA’s statements.

If we were to modify or limit the information shared with the FDA to mitigate such risks, it could increase our costs, slow our regulatory interactions, or delay our product approval timelines.

Further, in September 2025, HHS and the FDA announced a series of measures to address “misleading” direct-to-consumer (DTC) prescription drug advertisements.

The measures include (1) initiating rulemaking to close the “adequate provision” requirement, which permits drug manufacturers to include a general statement of risk alongside a webpage or publication and 1-800 number to access the full product labeling, (2) aggressive deployment of its available enforcement tools, including artificial intelligence and other technology-enabled tools to monitor drug ads for DTC violations, and (3) expanded oversight of prescription drug advertising on social media.

On September 9, 2025, FDA issued thousands of letters to pharmaceutical companies directing them to remove any noncompliant advertising and bring all promotional communications into compliance.

Later in September 2025, the FDA released about 80 warning letters, the majority of which targeted compounding pharmacies and telehealth companies for misleading claims about compounded drugs, including sildenafil, underscoring the FDA’s previously stated and growing concern over consumer confusion and medications that lack FDA approval and marking a clear shift in the FDA’s enforcement strategy for compounded drugs.

Although we have not received an enforcement letter from FDA relating to our specific advertising and promotional activities, there is no assurance that we will not receive one in the future.

We continue to actively monitor the evolving regulatory landscape and follow the marketing regulations required by the FDA.

Nevertheless, these new policies of radical transparency and increased enforcement could result in unforeseen reputational, operational, financial, regulatory and legal consequences for our company and have the potential to impact our business and how we market our products.

Our clinical-stage product candidates have only been tested in a small number of women over short periods of use and no data exists regarding a potential increase in fetal abnormalities in pregnant women.

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Additionally, past receipt of grant funding may not be predictive of our ability to secure additional grants to fund further development of a program.

Our portfolio includes several pre-clinical stage programs

and if they fail to be adequately valued by investors or potential strategic collaborators, our business, financial condition and stock price may be adversely affected.

Our portfolio includes several pre-clinical stage programs and if they fail to be adequately valued by investors or potential strategic collaborators, our business, financial condition and stock price may be adversely affected.

Several of our product candidates are in pre-clinical stages of development and may never advance to clinical development.

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The grants and other non-dilutive funding awards supporting several of our development programs do not guarantee that the pre-clinical or clinical development work being funded will be successful or that we will be able or will choose to fund the additional development work that will be required in the future to advance the product candidates toward regulatory approval.

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, 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.

The grants and other non-dilutive funding supporting development of several of our 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.

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Risks Related to Our Dependence on Third Parties

Our existing product development and commercialization collaborations are important to our business, and future collaborations may also be important to us.

If we are unable to maintain any of these collaborations, if these collaborations are not successful, or if we are unable to establish additional strategic collaborations, our business and prospects may be materially harmed.

Our existing product development and commercialization collaboration is important to our business, and future collaborations may also be important to us.

We have limited resources and no internal sales, marketing or distribution capabilities.

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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 out-license agreements with third parties for the commercialization of XACIATO and, if approved for commercial sale, Ovaprene.

We intend to seek additional strategic collaborations.

For example, we have entered into an out-license agreement with Organon for the commercialization of XACIATO.

We intend to seek additional strategic 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, the successful development and commercialization of our products and product candidates may become partially or entirely dependent upon the performance of third parties.

To the extent we do enter into strategic collaborations similar to our agreements for the commercialization of 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, and any future strategic collaborations we establish, involve significant risks to the success of the product, including that:

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

• collaborators may have significant discretion in determining the efforts and resources that they will apply to these collaborations;

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• 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, our out-license agreements 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.

For example, as was the case with our former out-license agreement for Ovaprene, our out-license agreement for XACIATO may be terminated by the counterparty for convenience upon the completion of a specified notice period, subject to limited restrictions.

If a collaborator terminates its agreement with us or if a collaboration does not result in the successful development of any product candidates and/or commercialization of any approved products, we may not receive any future royalty revenue, commercial milestones or other revenues under the collaboration, our development programs may not be funded as we expect, and our ability to establish another collaboration for the applicable product or product candidate may be negatively impacted.

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In such event, our ability to generate revenues from such products and achieve or sustain profitability would be significantly hindered which would materially harm our business and financial condition.

Prolonged failure to carry out its responsibilities or underperformance of NICHD under the CRADA, lack of additional federal government funding allocated to the CRADA budget, or termination of the CRADA, may significantly delay or jeopardize the conduct and completion of the ongoing Phase 3 clinical study of Ovaprene and significantly increase the overall development timeline and costs for Ovaprene.

The Phase 3 study of Ovaprene is being conducted, in part, under our CRADA with HHS, as represented by NICHD.

As a result of the CRADA, the conduct and completion of the study is dependent, in part, on performance of NICHD and the third parties it engages to assist in the conduct of the study.

Twenty clinical research sites from within the CCTN were initiated to enroll participants in the study.

Currently, there are 15 active CCTN sites following enrolled participants in the study, but none are recruiting new participants.

Enrollment is currently proceeding at five study sites outside of the CCTN that were initiated in 2025, funded by a grant we received in 2024 from the Foundation.

Under the CRADA, NICHD, together with its selected CRO, is responsible for overseeing the clinical investigators in the conduct of the study at the CCTN sites, providing clinical site monitoring and quality assurance and performing data analysis, which are key factors to the successful completion of a clinical trial.

We do not control those third parties and they may not perform as expected.

For example, in 2024 there was slower than expected participant recruitment and enrollment at a number of the CCTN sites, leading to a decision by us and NICHD to proceed with recruitment at a subset of ten of the CCTN sites that had been initiated.

In the first quarter of 2025, executive orders and other actions taken by the new U.S.

presidential administration have negatively impacted the Phase 3 study and NICHD’s ability to carry out its responsibilities under the CRADA.

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

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

Depending on its duration, this pause in recruitment at the CCTN sites could adversely impact the overall enrollment rate for the study and increase the time and cost to us to complete the study.

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

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

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

If NICHD is unable to enter into new contracts or contract modifications with CCTN sites for a prolonged period, or terminates its contracts with CCTN sites in our study before the study follow-up visits with existing participants are completed or before the study is completed, we may determine to contract directly with those sites to enable them to restart recruitment and enrollment of new participants and/or ensure they remain active sites to continue follow-up with existing participants, which could increase the time and cost to us to complete the study.

In addition, if CCTN sites are closed, some participants may drop out of the study, which could adversely affect completion or results of the study.

Though the CRADA has a five-year term ending in 2026, either party may terminate it for any reason or for no reason upon 30 days’ prior written notice to the other party.

Termination of the CRADA by NICHD or by us could significantly delay the conduct and/or completion of the Phase 3 study and significantly increase the overall timeline and costs for development of Ovaprene.

If the CRADA is terminated before completion of the Phase 3 study, NICHD will cooperate with us to transfer the data and the conduct of the study to us or our designee and will continue to conduct the study for so long as necessary to enable such transfer to be completed without interrupting the study.

If we terminate the CRADA before the completion of any active study protocol, we generally will be responsible for providing sufficient clinical supplies of Ovaprene to NICHD in order to complete the study.

NICHD may retain and use the cash payments we have made under the CRADA for up to one year after expiration or termination to cover costs associated with the conduct of activities described under the research plan in the CRADA that were initiated prior to expiration or termination.

Suspension by NICHD of activities under the CRADA or termination by NICHD or by us of the CRADA could have a material adverse effect on the Phase 3 study and on our business, results of operations and financial condition, and may cause the market price of our common stock to decline.

We do not have, and we do not have plans to establish, our own manufacturing capabilities and instead rely on third-party suppliers and manufacturers for our clinical study supplies, including multiple single source suppliers and manufacturers.

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Failure to pass inspections, or to timely remediate any compliance issues identified by the FDA, could substantially delay marketing approval.

As long as we are the product candidate sponsor or the holder of the product approval or manufacturer of record with the FDA or other regulatory authority, we are ultimately responsible for

compliance with regulatory requirements for manufacturing and distribution of our product candidates and any future approved products, regardless of our lack of control over our third-party manufacturers and suppliers.

Failure of those third parties to comply with cGMP and other applicable regulatory requirements may result in fines and civil penalties on us, suspension of production, delay or failure to obtain product approval, product seizure or recall, or withdrawal of product approval.

As long as we are the product candidate sponsor or the holder of the product approval or manufacturer of record with the FDA or other regulatory authority, we are ultimately responsible for compliance with regulatory requirements for manufacturing and distribution of our product candidates and any future approved products, regardless of our lack of control over our third-party manufacturers and suppliers.

Failure of those third parties to comply with cGMP and other applicable regulatory requirements may result in fines and civil penalties

on us, suspension of production, delay or failure to obtain product approval, product seizure or recall, or withdrawal of product approval.

Our CMOs and component suppliers may experience delays in producing and supplying, or may become unable or unwilling to produce and supply, our clinical trial material or commercial supply material due to financial or personnel constraints, their obligations to, or their decision to prioritize the production and supply of products for, other customers, partial or full loss of their facilities, or supply chain disruptions, including as a result of geopolitical conflicts, macroeconomic events or conditions, natural or manmade disasters, or public health emergencies such as the COVID-19 pandemic.

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If our CMOs encounter difficulties or otherwise fail to comply with their contractual obligations or there are delays entering commercial supply agreements, we may have insufficient quantities of material to support ongoing or planned clinical trials or to meet commercial demand for any approved product in the future.

In addition, any delay or interruption in the supply of materials necessary or useful to manufacture our product candidates could delay the completion of our clinical trials, increase the costs associated with our development programs, and depending upon the period of delay, require us to terminate the clinical trials completely and commence new clinical trials at significant

additional expense.

Delays or interruptions in the supply of commercial product could result in increased cost of goods sold and lost sales.

Manufacturing or quality control problems may arise in connection with the manufacture of our clinical trial material or future approved product and CMOs may not be able to maintain the necessary governmental licenses and approvals to continue their manufacturing services for us.

Manufacturing or quality control problems may arise in connection with the manufacture of our

clinical trial material or future approved product and CMOs may not be able to maintain the necessary governmental licenses and approvals to continue their manufacturing services for us.

In addition, with respect to any finished product or key components manufactured outside the U.S., such as the API for Sildenafil Cream, which is sourced from a supplier located in India, we may experience interruptions in supply due to shipping or customs difficulties or regional instability.

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In addition, these third parties may have relationships with companies developing competitive products and prioritize a competitor’s clinical or nonclinical studies or regulatory affairs activities over their work for us, which could harm our competitive position.

Because of our dependence on these third parties, if they fail to meet expected deadlines, adhere to our study protocols, meet regulatory and legal requirements, or otherwise perform in a substandard manner, we could suffer significant delays and additional costs in, and potentially failure of, the development of one or more of our product candidates.

Because of our dependence on these third parties, if they fail to meet expected deadlines, adhere to our study protocols, meet regulatory and legal

requirements, or otherwise perform in a substandard manner, we could suffer significant delays and additional costs in, and potentially failure of, the development of one or more of our product candidates.

Our CROs, study sites and other consultants generally have the right to terminate their agreements with us without cause upon the completion of a specified notice period, subject to limited restrictions.

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Under the license agreement with TriLogic Pharma and MilanaPharm, we must use commercially reasonable efforts and resources consistent with those we undertake in pursuing development and commercialization of other pharmaceutical products, taking into account program-specific factors, (a) to develop and commercialize at least one licensed product or process in the United States and at least one licensed product or process in at least one of Canada, the United Kingdom, France, Germany, Italy or Spain, and (b) following the first commercial sale of a licensed product or process in any jurisdiction, to continue to commercialize that product or process in that jurisdiction.

In addition to customary termination rights, MilanaPharm may terminate our license with respect to a licensed product or process in a country if, after having launched such product or process in such country, we, or our affiliates or sublicensees, as applicable, discontinue the sale of, or commercially reasonable marketing efforts to sell, such product or process in such country, and fail to resume such efforts or to reasonably demonstrate a

strategic justification for the discontinuation and failure.

"BUSINESS-Strategic Agreements for Pipeline Development-Hammock/MilanaPharm Assignment and License Agreement,” above.

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Furthermore, we cannot guarantee that any license agreement will be enforceable.

The termination of these license agreements or our inability to enforce our rights under these license agreements could result in the loss of our ability, or that of our sublicensees,

to develop, manufacture, market or sell XACIATO or the product candidate covered by the agreement, as well as our ability to grant rights to other third parties to collaborate with us in the development and commercialization of our product candidates and our ability to receive milestone and royalty payments from third-party sublicensees, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

The termination of these license agreements or our inability to enforce our rights under these license agreements could result in the loss of our ability, or that of our sublicensees, to develop, manufacture, market or sell XACIATO or the product candidate covered by the agreement, as well as our ability to grant rights to other third parties to collaborate with us in the development and commercialization of our product candidates and our ability to receive milestone and royalty payments from third-party sublicensees, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Disputes may arise regarding intellectual property subject to, and any of our rights and obligations under, any license or other strategic agreement, including:

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In addition, the agreements under which we license intellectual property or technology to or from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations.

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights

to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize, or maintain third-party collaborations to commercialize, the affected product or product candidate.

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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 agreements with Organon for XACIATO and Bayer for Ovaprene.

We may not be able to maintain our existing commercial collaborations or establish and maintain other commercial collaborations on favorable terms, on a timely basis, or at all.

We currently have no commercialization agreements with third parties other than our license agreement with Organon for XACIATO.

We may not be able to maintain our existing commercial collaboration 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.

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All of these factors could strain our cash resources and require us to raise additional capital.

Failure or delay in entering into and maintaining arrangements with third parties to market and sell, or assist us in marketing and selling, our product candidates, if approved for commercial sale, or in establishing capabilities to independently commercialize our product candidates could significantly delay commercial launch and negatively impact their potential commercial success, which could have a material adverse effect on our business, financial condition and results of operations.

impact their potential commercial success, which could have a material adverse effect on our business, financial condition and results of operations.

Our product candidates, if approved for commercial sale, will face intense competition and our business and operating results will suffer if we, or our commercial collaborators, fail to compete effectively.

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We are aware of products currently under development intended for the same indications as our product candidates.

These competitive product candidates may prove safer, more tolerable, more effective, and less expensive, and may be introduced to market earlier, or produced, marketed and sold more effectively or on a more

cost-effective basis, than our product candidates.

The success of competitive products may render our product candidates noncompetitive or obsolete, even prior to completion of their development.

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Generic competition is particularly strong in contraception and hormone therapy, which are areas in which we seek to compete.

Our product candidates for menopause symptoms will additionally have to compete with compounded hormones supplied by compounding pharmacies and other drug compounding facilities, as well as dietary supplements marketed for relief of menopause symptoms.

Our product candidates for menopause symptoms will

additionally have to compete with compounded hormones supplied by compounding pharmacies and other drug compounding facilities, as well as dietary supplements marketed for relief of menopause symptoms.

Compounded sildenafil cream medications are also currently being supplied by compounding pharmacies and other drug compounding facilities.

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See also the risks and uncertainties described under “Risks Related to Our Dependence on Third Parties,” above.

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.

Today, there is a wide range of prescription and over-the-counter contraceptive options, including hormone-free options such as condoms, diaphragms, cervical caps, sponges, copper IUDs, spermicides and vaginal gels, as well as hormonal products such as pills, patches, vaginal rings, IUDs, implantable rods and injectables.

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If Ovaprene receives regulatory approval, its commercial success, or the success of any other future contraceptive product we develop, including our current early clinical-stage and pre-clinical stage candidates, will depend upon the contraceptive market and market acceptance of an alternative method.

in the medical community necessary for commercial success, which would negatively impact our business," as well as:

Factors expected to impact broad market acceptance of a new contraceptive product include those discussed above under "Our product candidates may fail to achieve the degree of market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success, which would negatively impact our business," as well as:

• demonstration of minimum acceptable contraceptive efficacy rates;

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If one or more of these risks occur, it could reduce the market potential for Ovaprene, or any other contraceptive product we develop, and place pressure on our business, financial condition, results of operations and prospects.

Under our license agreement with Bayer, provided the license grant becomes effective, Bayer will have exclusive rights to market and sell Ovaprene in the U.S.

Accordingly, the potential value of Ovaprene to our company may be highly dependent on the efforts and activities of Bayer.

Should Ovaprene fail to generate compelling clinical safety and efficacy data, the license grant under our agreement with Bayer may never become effective.

Even if Bayer elects to make the license agreement effective, Bayer has significant discretion in determining the resources that it will allocate to commercialization of Ovaprene and Ovaprene’s commercial success may be limited, in which case our business, financial condition, results of operations and prospects could suffer significantly.

As a result of the termination of our license agreement with Bayer for Ovaprene in December 2025, we will need to enter into an agreement with a third party to commercialize Ovaprene, for which no assurances can be given, and if we do not enter into such agreement, the commercialization of Ovaprene would be delayed.

See also the risk factor titled, “Our existing product development and commercialization collaboration is important to our business, and

future collaborations may also be important to us.

The commercial success of an FDA-approved Sildenafil Cream product will depend on the availability of alternative treatments and products, the effectiveness of the sales and marketing strategy and efforts for the product, including the success of efforts to educate women and their health care providers about FSAD, and the availability and extent of third-party coverage and reimbursement for the product, among other factors.

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In addition, FSAD is a condition that impacts women of many ages, including older and elderly populations.

We have not yet thoroughly studied the topical or clinical pharmacology of Sildenafil Cream in different patient

populations, and sildenafil, the active ingredient in our drug candidate, has not been tested over long periods of time in older or elderly women.

We have not yet thoroughly studied the topical or clinical pharmacology of Sildenafil Cream in different patient populations, and sildenafil, the active ingredient in our drug candidate, has not been tested over long periods of time in older or elderly women.

Older or elderly women may react differently and adversely to Sildenafil Cream than younger populations.

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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 product (Veozah® (fezolinetant)), and dietary supplements.

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 products Veozah® (fezolinetant) marketed by Astellas Pharma and Lynkuet® (elinzanetant) marketed by Bayer, and dietary supplements.

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

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

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

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

DARE-HRT1 is designed to offer a convenient vaginal ring that continuously delivers a combination of bioidentical estradiol and progesterone over 28 days.

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.

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Depending upon the direction of the factors above, a commercial market for DARE-HRT1 may develop more slowly than expected, or not at all, and our business, financial condition, results of operation and prospects could be hurt as a result.

Potential safety concerns regarding hormone therapy could adversely affect our business.

Women have used hormone therapy products for decades to manage menopausal symptoms.

However, the use of hormone therapy has been, and continues to be, the subject of scientific debate and regulatory and public health scrutiny.

Published clinical studies have associated certain forms of hormone therapy with potential serious safety risks, including an increased likelihood of cardiovascular events, stroke, blood clots, probable dementia, and certain hormone ‑ sensitive cancers, including breast cancer and endometrial cancer.

Although the studies have indicated that the nature and magnitude of these risks may differ materially depending on the type of hormone therapy, the route of its administration, patient age, proximity of initiation of hormone therapy to menopause onset, duration of use, and individual patient characteristics, heightened attention to these issues may influence prescribing behavior, patient acceptance, and regulatory expectations.

In November 2025, HHS announced that the FDA was initiating the removal of broad “black box” warnings from hormone replacement therapy products for menopause following a comprehensive review of the scientific literature, an expert panel on the risks and benefits related to menopause hormone therapy in July 2025, and a public comment period.

Specifically, the FDA announced it will work with companies to update language in hormone replacement therapy product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia.

The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.

However, the longstanding controversy over hormone therapy may continue to shape public perception and influence prescribing behavior.

Historical precedent illustrates the potential magnitude of these impacts.

In 2002, alarming results from the Women’s Health Initiative (WHI) study, a large, long-term government ‑ funded study, were released suggesting that varying forms of systemic hormone therapy that included estrogen and progesterone could increase risks of cardiovascular problems, breast cancer, endometrial cancer, and probable dementia.

Media coverage was widespread and, shortly after, the FDA implemented a broad “black box” warning on all menopause treatments containing estrogen.

In the months and years following the 2002 WHI publication, millions of women discontinued hormone therapy and the hormone therapy market contracted substantially.

While more recent analyses of the WHI study suggested flaws in the original findings and findings from subsequent studies have led to more nuanced hormone therapy guidelines and recommendations, including those issued by the Menopause Society, there have been lasting effects on prescribing behavior, patient attitudes, and regulatory labeling.

If new data, safety signals, or adverse event reports emerge, whether or not directly related to our hormone therapy products or product candidates, we could face negative publicity, reduced demand, increased regulatory oversight, labeling changes, reclassification of product risks, additional post ‑ marketing requirements, or restrictions or contraindications on use.

The FDA or professional medical organizations may also update treatment guidelines or recommendations in ways that discourage or limit hormone therapy use, narrow the indicated patient population,

recommend alternative treatments, or otherwise reduce the commercial opportunity for hormone therapy products, as was seen following the 2002 WHI publication.

Any of these developments could adversely affect commercial introduction and sales of DARE to RECLAIM estradiol progesterone intravaginal ring, impede further clinical development and potential regulatory approval of our hormone therapy product candidates, require additional clinical studies, and materially harm our reputation, business, financial condition and results of operations.

The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses for prescription medical products.

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In particular, a product may not be promoted for uses that are not approved by the FDA (i.e., off-label uses), as reflected in the product’s approved or cleared labeling.

Promotional labeling and advertising for any of our drug product candidates that receive marketing approval, must be submitted to FDA at the time of first use and the agency actively solicits reports from health care professionals about improper promotional claims or

activities by the drug manufacturer or distributor.

Medical device promotion and advertising are subject to similar off-label restrictions, although without the same requirement to submit promotional materials to FDA at the time of first use.

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Any new legislation addressing drug safety issues could result in delays in product development or commercialization, or increased costs to assure compliance.

If a regulatory agency discovers previously unknown problems with a product, such as problems with the facility where the product is manufactured, or it disagrees with the promotion, marketing or labeling of a product, the regulatory agency may impose restrictions on that product or on us or our commercial collaborator, including requiring withdrawal of the product from the market.

withdrawal of the product from the market.

If we or our commercial collaborators are unable to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:

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A payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved.

Managed care organizations and other private insurers frequently adopt their own payment or reimbursement reductions.

Managed care organizations and other private

insurers frequently adopt their own payment or reimbursement reductions.

Consolidation among managed care organizations has increased the negotiating power of these entities.

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Net prices for products may be reduced by mandatory discounts or rebates required by third-party payors and by any future relaxation of laws that presently restrict imports of products from countries where they may be sold at lower prices than in the U.S.

payor separately, with no assurance that coverage and adequate payment will be applied consistently or obtained.

Accordingly, the coverage determination process is often a time-consuming and costly process that will require us or our commercial collaborator to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate payment will be applied consistently or obtained.

The process for determining whether a payor will cover and how much it will reimburse a product may be separate from the process of seeking approval of the product or for setting the price of the product.

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remains uncertain, in part because multiple large pharmaceutical companies and other stakeholders (e.g., the U.S.

Chamber of Commerce) have initiated federal lawsuits against CMS arguing the program is unconstitutional for a variety of reasons, among other complaints.

Chamber of Commerce) have initiated federal lawsuits against CMS arguing the program

is unconstitutional for a variety of reasons, among other complaints.

Those lawsuits are currently ongoing.

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The commercial success of any products we develop will significantly depend upon our ability, or that of our commercial collaborator, to obtain approval from the FDA and other regulatory authorities of prescribing information for the product that adequately describes expected features or benefits.

Failure to achieve such approval will prevent or substantially limit our or our collaborators’ ability to advertise and promote such features and benefits in order to differentiate our products from competing products.

Failure to achieve such approval will prevent or substantially limit our or our collaborators’ ability to advertise and promote such features and benefits in order to

differentiate our products from competing products.

This failure could have a material adverse effect on our business, financial condition, results of operations and prospects.

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If we adopt alternative names, we would lose any goodwill or brand recognition developed for previously used names and marks, such as Ovaprene, as well as the benefit of any existing trademark applications for such product candidate and may be required to expend significant additional resources in an effort to identify a suitable product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties, and be acceptable to the FDA.

We or a commercial collaborator may be unable to build a successful brand identity for a new trademark in a timely manner or at all, which would limit our or our collaborator’s ability to commercialize our product candidates.

We or a commercial collaborator may be unable to build a successful brand

identity for a new trademark in a timely manner or at all, which would limit our or our collaborator’s ability to commercialize our product candidates.

Even if we receive marketing approval from the FDA, we may fail to receive similar approvals outside the U.S., which could substantially limit the value of our products.

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The marketing approval process in other countries may include all of the risks associated with obtaining FDA approval in the U.S., as well as other risks.

Further, for approval in foreign jurisdictions, we may not have rights to reference the necessary clinical and nonclinical data that we do not own or have licensed rights to use, as we anticipate doing under the 505(b)(2) regulatory pathway in the U.S., and we, or our commercial collaborator, may have to conduct further

nonclinical studies or clinical trials or develop other additional data to seek approvals in other jurisdictions.

In addition, in many countries outside the U.S., a new product must receive pricing and reimbursement approval prior to commercialization.

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Risks Related to Section 503B Compounding

We plan to generate revenue from sales of our proprietary Sildenafil Cream formulation produced by Section 503B-registered outsourcing facilities, but we have no experience in this line of business and may not be successful in our efforts.

One aspect of our business strategy is to enter into licensing arrangements with outsourcing facilities through which we can generate revenue from sales of our proprietary Sildenafil Cream formulation produced by those outsourcing facilities under Section 503B.

We have no experience in the compounded drugs market and we have never entered into arrangements with outsourcing facilities.

We will be required to successfully identify and enter into satisfactory arrangements with one or more outsourcing facilities, and no assurances can be given that we will be successful in doing so on commercially reasonable terms or at all.

We plan to generate revenue from sales of DARE to PLAY and other potential 503B compounded drugs, but we have limited experience in this line of business and may not be successful in our efforts.

One aspect of our 503B business strategy is to enter into arrangements with outsourcing facilities through which we can generate revenue from sales of DARE to PLAY and other potential 503B compounded drugs produced by those outsourcing facilities under Section 503B.

Other than entering an arrangement with Bravado, the 503B outsourcing facility for DARE to PLAY, in 2025, we have never entered into arrangements with outsourcing facilities.

Although we have entered into the arrangement with Bravado, we may need to identify and enter into additional satisfactory arrangements with one or more other outsourcing facilities in order to successfully execute our commercialization strategy, and no assurances can be given that we will be successful in doing so on commercially reasonable terms or at all.

Even if we are successful in this regard, we may not generate sufficient revenue to recover our costs.

Establishing such arrangements could be expensive and time consuming, disrupt our other operations, require significant capital expenditures and distract management and our other employees from other aspects of our business.

We will be reliant on Section 503B-registered outsourcing facilities to produce our proprietary Sildenafil Cream formulation, and their failure to adequately perform their obligations could harm our reputation, business and financial condition.

If we are able to enter into arrangements with one or more outsourcing facilities, we will be reliant on them to compound and distribute our proprietary Sildenafil Cream formulation and to comply with applicable statutory and regulatory requirements, including FDA's cGMP regulations and related FDA guidance for drugs compounded at outsourcing facilities.

We will also be reliant on suppliers that supply sildenafil citrate to the outsourcing facilities.

We will not control or direct the compounding or distribution process used by these parties, and we will have no control over their ability to maintain adequate quality control, quality assurance and qualified personnel.

Establishing such additional arrangements could be expensive and time consuming, disrupt our other operations, require significant capital expenditures and distract management and our other employees from other aspects of our business.

We are and will remain reliant on Section 503B-registered outsourcing facilities to produce DARE to PLAY and potentially other 503B compounded drugs, and their failure to adequately perform their obligations could harm our reputation, business and financial condition.

We have entered into an arrangement with one outsourcing facility for the compounding and distribution of DARE to PLAY, and we may enter into additional arrangements with one or more outsourcing facilities for DARE to PLAY or other potential 503B compounded drugs.

We are reliant on our current outsourcing facility, and will be reliant on any future outsourcing facilities, to compound and distribute DARE to PLAY and any other 503B compounded drugs, and to comply with applicable statutory and regulatory requirements, including FDA's cGMP regulations and related FDA guidance for drugs compounded at outsourcing facilities.

Outsourcing facilities have been subject to increased scrutiny of their compounding activities by the FDA and state governmental agencies.

Governmental inquiries or actions or litigation brought against us or any of our outsourcing facilities, whether or not such inquiry, action or litigation ultimately results in penalties, changes to our business practices or other consequences, could have an adverse effect on our reputation, business and financial condition.

We are also reliant on suppliers that supply sildenafil citrate and potentially other active pharmaceutical ingredients to the outsourcing facilities.

control or direct the compounding or distribution process used by these parties, and we have no control over their ability to maintain adequate quality control, quality assurance and qualified personnel.

These arrangements also involve other risks, including:

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• breach, termination or non-renewal of agreements in a manner or at a time that is costly or damaging to us;

• inability to procure or maintain state licenses in those states into which our proprietary Sildenafil Cream formulations are shipped;

• inability to procure or maintain state licenses in those states into which DARE to PLAY or any other 503B compounded drugs are shipped;

• third parties may not devote sufficient resources to our needs;

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• logistics carrier disruptions or increased costs that are beyond our control.

Adverse developments affecting the supply of sildenafil citrate or the compounding or distribution operations of parties involved in the compounding and distribution of our proprietary Sildenafil Cream formulation may result in lot

failures, inventory shortages, shipment delays, product withdrawals or recalls or other interruptions in the availability of our proprietary Sildenafil Cream formulation.

In addition to the risks enumerated above, our ability to commence and sustain commercial distribution of potential 503B compounded drugs is subject to the completion of process validation at outsourcing facilities we engage.

Under FDA's cGMP regulations applicable to Section 503B outsourcing facilities, commercial distribution of a compounded drug formulation from a Section 503B outsourcing facility generally requires the satisfactory completion of process validation protocols demonstrating that the manufacturing process consistently produces a product meeting its predetermined specifications and quality attributes.

As of the date of this report, process validation for DARE to PLAY has not been completed.

Until process validation is successfully completed, commercial distribution of DARE to PLAY may be delayed.

Process validation may take longer than anticipated, may reveal deficiencies requiring remediation, or may ultimately not be achievable with the current outsourcing facility, any of which could materially delay or prevent the commercial launch of a potential 503B compounded drug.

Adverse developments affecting the supply of sildenafil citrate or other active pharmaceutical ingredients, or the compounding or distribution operations of parties involved in the compounding and distribution of DARE to PLAY or any other 503B compounded drugs, may result in lot failures, inventory shortages, shipment delays, product withdrawals or recalls or other interruptions in the availability of DARE to PLAY or such other 503B compounded drugs.

We may also have to undertake costly remediation efforts, or seek more costly supply, compounding and distribution alternatives.

Some of these events could be the basis for FDA action, including injunction, request for recall, seizure, total or partial suspension of production, or issuance of a Form 483 or Warning Letter.

Our plan to bring our proprietary Sildenafil Cream formulation to market under Section 503B will subject us to a variety of new regulations and related potential liability.

We plan to enter into arrangements with one or more outsourcing facility(ies) to produce and distribute our proprietary Sildenafil Cream formulation under Section 503B.

An outsourcing facility must meet certain conditions under Section 503B, including registering with the FDA, operating in compliance with the FDA’s cGMP regulations and guidance, and is subject to FDA inspection.

Outsourcing facilities have been subject to increased scrutiny of their compounding activities by the FDA and state governmental agencies.

Governmental inquiries or actions or litigation brought against us or any of our suppliers or outsourcing facilities relating to our proprietary Sildenafil Cream formulation, whether or not such inquiry, action or litigation ultimately results in penalties, changes to our business practices or other consequences, could have an adverse effect on our reputation, business and financial condition.

We or any outsourcing facility with which we have a business relationship may also face allegations, litigation, and regulatory investigations under federal or state laws related to the promotion, advertising, fulfillment, distribution, and/or sale of our proprietary Sildenafil Cream formulation under Section 503B.

Litigation and regulatory proceedings, and particularly the healthcare, pharmaceutical-related, consumer protection, data privacy and/or class action matters we could face, may be protracted and expensive, and the results are difficult to predict.

Such litigation or regulatory proceedings and investigations, unexpected side effects or safety or efficacy concerns with our proprietary Sildenafil Cream formulation or related negative publicity could have an adverse effect on our reputation, business and financial condition.

Achieving and maintaining market acceptance of our proprietary Sildenafil Cream formulation produced and distributed under Section 503B could be negatively impacted by perceived risks associated with compounded drugs.

Our commercialization strategy for DARE to PLAY and other potential 503B compounded drugs relies on, and will rely on, third-party telehealth platforms, dispensing pharmacies, and other commercial partners, which subjects us to a variety of regulations and related potential liability.

We have entered into arrangements with third-party telehealth platforms, dispensing pharmacies, and other commercial partners in connection with bringing DARE to PLAY to market, and we may enter into additional arrangements for DARE to PLAY or other 503B compounded drugs we seek to bring to market.

The FDA has intensified its enforcement posture with respect to the promotion and advertising of compounded drugs, and particularly compounded products marketed through telehealth channels.

In September 2025, the FDA announced measures to address misleading direct-to-consumer prescription drug advertisements and issued enforcement correspondence directed at compounding pharmacies and telehealth companies for misleading claims about compounded drugs, including compounded sildenafil specifically.

The FTC also actively monitors advertising and marketing claims for consumer health and pharmaceutical products and may take enforcement action against claims it deems to be unfair or deceptive.

Allegations, litigation, or regulatory investigations brought against us or any of our commercial partners relating to the promotion, advertising, fulfillment, distribution, and/or sale of any of the 503B compounded drugs we bring to market, whether or not such litigation or investigation ultimately results in penalties, changes to our business practices or other consequences, could have an adverse effect on our reputation, business and financial condition.

The litigation and regulatory proceedings we could face may be protracted and expensive, and the results are difficult to predict.

Such litigation or regulatory proceedings and investigations, unexpected side effects or safety or efficacy concerns with DARE to PLAY or any other 503B compounded drug we bring to market or related negative publicity could have an adverse effect on our reputation, business and financial condition.

In addition, the practice of telemedicine, and the prescribing of compounded prescription drugs through telehealth platforms, is subject to a patchwork of state laws governing the practice of medicine, prescribing, and pharmacy licensure.

The ability of our dispensing pharmacy partners to ship compounded drug products to patients may be limited by state pharmacy laws and licensure requirements, and any inability of our commercial partners to procure or maintain required state licenses could restrict or prevent distribution of DARE to PLAY or any other 503B compounded drug in certain states, which could materially limit our addressable market.

State legislatures and regulators continue to develop and revise rules governing telehealth prescribing, including with respect to the establishment of valid prescriber-patient relationships, mandatory in-person examination requirements, and permissible modalities for telehealth consultations.

Changes in state law or enforcement of existing requirements could restrict or eliminate our commercial partners' ability to prescribe, dispense, and ship DARE to PLAY or any other 503B compounded drug in particular states.

We cannot guarantee that all promotional materials, digital marketing, social media content, or other patient-facing communications generated or used by us or our commercial partners will fully comply with FDA, FTC, and applicable state requirements at all times.

Any finding of non-compliance — whether directed at us or at a commercial partner — could result in warning letters, required corrective advertising, civil penalties, injunctive relief, or other enforcement action, and could require material changes to our marketing practices.

Even if any such enforcement action is ultimately resolved in our favor, it could negatively affect demand for the 503B compounded drugs we bring to market, harm our reputation, and adversely affect our business.

Achieving and maintaining market acceptance of DARE to PLAY produced and distributed under Section 503B could be negatively impacted by perceived risks associated with compounded drugs.

Compounded drugs are not FDA-approved products;

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In addition, certain outsourcing facilities have experienced both facility and product quality issues and been the subject of negative media coverage and litigation, and the actions of these facilities have resulted in increased scrutiny of compounding activities.

Our ability to generate revenue from sales of our proprietary Sildenafil Cream formulation produced and distributed under Section 503B will be adversely impacted if we are unable to achieve and maintain market acceptance for it.

Sildenafil citrate must remain on the list of bulk substances that may be used in compounding under Section 503B, and if it were to be removed, we would be unable to offer our proprietary Sildenafil Cream formulation under Section 503B.

Our ability to generate revenue from sales of DARE to PLAY produced and distributed under Section 503B will be adversely impacted if we are unable to achieve and maintain market acceptance for it.

Sildenafil citrate must remain on the list of bulk substances that may be used in compounding under Section 503B, and if it were to be removed, we would be unable to offer DARE to PLAY under Section 503B.

Sildenafil citrate is currently listed among those nominated substances for which bulk drug substance may be used in compounding by Section 503B-registered outsourcing facilities;

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However, we have no control over whether sildenafil citrate will remain on the list of bulk drug substance that may be used in compounding by outsourcing facilities or for how long.

If sildenafil citrate is removed from the list, we would be unable to offer our proprietary Sildenafil Cream formulation via a Section 503B-registered outsourcing facility, and it could harm our reputation, business and financial condition.

If sildenafil citrate is removed from the list, we would be unable to offer DARE to PLAY via a Section 503B-registered outsourcing facility, and it could harm our reputation, business and financial condition.

In addition, a third party could request that the FDA remove sildenafil citrate from the list of bulk substances that may be used in compounding by Section 503B-registered outsourcing facilities.

If removed from such list, outsourcing facilities would be prohibited from producing any compounded drug that includes sildenafil citrate, including our proprietary Sildenafil Cream formulation.

If removed from such list, outsourcing facilities would be prohibited from producing any compounded drug that includes sildenafil citrate, including DARE to PLAY.

For information regarding how the FDA intends to evaluate whether there exists a clinical need for compounding with a bulk drug substance, see "Regulation of Compounded Drugs," below.

If a compounded drug formulation provided by an outsourcing facility leads to patient injury or death, or results in a product recall, we may be exposed to significant liability and reputational harm.

The success of our proprietary Sildenafil Cream formulation produced and distributed under Section 503B will depend to a significant extent upon perceptions of product quality.

We could be adversely affected if the formulation is

subject to negative publicity.

We could also be adversely affected if it or similar products sold by other companies, or any products sold by outsourcing facilities that produce our proprietary Sildenafil Cream formulation, prove to be, or are alleged or asserted to be, harmful to patients.

The success of DARE to PLAY produced and distributed under Section 503B will depend to a significant extent upon perceptions of product quality.

We could be adversely affected if DARE to PLAY is subject to negative publicity.

We could also be adversely affected if it or similar products sold by other companies, or any products sold by outsourcing facilities that produce DARE to PLAY, prove to be, or are alleged or asserted to be, harmful to patients.

There are a number of factors that could result in the injury or death of a patient who takes a compounded drug, including quality issues, manufacturing or labeling flaws, improper packaging or unanticipated or improper distribution or other uses of the compounded drug, any of which could result from human or other error.

Any of these situations could lead to a recall of, or safety alert relating to, the compounded drug.

Any of these situations

could lead to a recall of, or safety alert relating to, the compounded drug.

Similarly, to the extent any of the ingredients used to produce a compounded drug have quality or other problems that adversely affect the finished compounded drug, its sales could be adversely affected.

Because of our dependence upon perceptions of prescribing physicians and their patients, any adverse publicity associated with illness or other adverse effects resulting from the use or misuse of our proprietary Sildenafil Cream formulation produced and distributed under Section 503B, any similar product sold by other companies, or related to compounded formulations generally, could have a material adverse impact on our reputation, business, and financial condition.

Because of our dependence upon perceptions of prescribing physicians and their patients, any adverse publicity associated with illness or other adverse effects resulting from the use or misuse of DARE to PLAY produced and distributed under Section 503B, any similar product sold by other companies, or related to compounded formulations generally, could have a material adverse impact on our reputation, business, and financial condition.

Risks Related to Employee Matters and Managing Our Growth

We have a relatively small number of employees to manage and operate our business.

As of March 28, 2025, we had 23 employees, of which 21 were full-time and two were part-time.

As of March 25, 2026, we had 24 employees.

Our focus on controlling our cash utilization requires us to manage and operate our business in a highly efficient manner, relying on consultants and other third-party service providers for product development and operational expertise we require, and to limit full-time personnel resources.

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Our business development strategy involves identifying and acquiring or in-licensing potential product candidates or technologies.

We assembled our current portfolio of product candidates through the acquisition of companies and assets and in-licensing transactions beginning in 2017.

We assembled our current portfolio of product candidates through the acquisition of

companies and assets and in-licensing transactions beginning in 2017.

We may engage in strategic transactions that could cause us to incur additional liabilities, commitments or significant expense.

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Risks Related to Our Intellectual Property

If we and our licensors are unable to obtain and maintain sufficient intellectual property protection, competitors could develop and 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.

If we and our licensors are unable to obtain and maintain sufficient intellectual property protection, competitors could develop, market, 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.

Our success depends in part on our ability, and the ability of our licensors, to obtain, maintain, enforce, and defend patent rights, proprietary know-how, and trademarks of sufficient scope in the U.S.

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While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

Non-compliance events that could result in abandonment or lapse of a patent or patent

application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.

Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.

In such an event, our competitors might be able to enter the market, which would have a material adverse effect on our business.

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Such organizations may currently have, or may obtain in the future, legally blocking proprietary rights, including patent rights, in one or more products or methods we are developing or considering for development.

These rights may prevent us from commercializing technology, or they may require us to obtain a

license from the organizations to use the technology.

These rights may prevent us from commercializing technology, or they may require us to obtain a license from the organizations to use the technology.

We may not obtain any such licenses that may be required on reasonable financial terms, if at all, and there can be no assurance that the patents underlying any such licenses will be valid or enforceable.

As with other companies in the pharmaceutical industry, we are subject to the risks that persons located in other countries will engage in development, marketing or sales activities of products that would infringe our intellectual property rights if such activities were conducted in the U.S.

As with other companies in the pharmaceutical industry, we are subject to the risks that

persons located in other countries will engage in development, marketing or sales activities of products that would infringe our intellectual property rights if such activities were conducted in the U.S.

and enforcing our intellectual property rights against such persons may be difficult or not possible.

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We also have indemnification obligations under our out-license agreements for XACIATO and Ovaprene, which could subject us to significant liabilities that may have a material adverse effect on our business, results of operations and financial condition.

Our rights to indemnification by our licensors and licensees may not be adequate to compensate us for losses or the

potential loss of our ability to manufacture and sell products.

Our rights to indemnification by our licensors and licensees may not be adequate to compensate us for losses or the potential loss of our ability to manufacture and sell products.

If we were unsuccessful in enforcing and protecting our intellectual property rights and protecting our products, it could materially harm our business.

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During the term of the subaward agreement and for three years thereafter, we are subject to certain restrictions on foreign access to the intellectual property and other technology developed by or for us in or for the provision of such services, including restrictions on our sale or other transfer of such technology to a foreign firm or institution (which would include a sale of our company and a sale or licensing of such technology, but not sales of products or components) without the prior approval of the federal agency providing funding for the subaward agreement.

Under our notice of award from NICHD to support the development of DARE-PTB1, the federal government has a royalty-free license to use the patent rights to any invention developed with federal funds support and requires that anyone exclusively licensed to sell any such invention in the U.S.

to manufacture it substantially within the country, and the federal government reserves the right to require us to license any such invention to others in certain circumstances.

federal government retains certain rights in inventions produced with its financial assistance.

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Any exercise by the government of march-in rights could harm our competitive position, business, financial condition, results of operations and prospects.

projects funded by the respective grants (referred to as Funded Developments), available and accessible at an affordable price to people most in need within developing countries, and to promptly and broadly disseminate the knowledge and information gained from the project funded by the grant (referred to as the Global Access Commitment).

Under our grant agreements with the Foundation, we agreed to make products, services, processes, technologies, materials, software, data, other innovations, and intellectual property resulting from the respective projects funded by the respective grants (referred to as Funded Developments), available and accessible at an affordable price to people most in need within developing countries, and to promptly and broadly disseminate the knowledge and information gained from the project funded by the grant (referred to as the Global Access Commitment).

In connection with the Global Access Commitment, under the agreement, we also granted the foundation that awarded the grant a nonexclusive, perpetual, irrevocable, worldwide, royalty-free, fully paid up, sublicensable license to make, use, sell, offer to sell, import, distribute, copy, create derivative works, publicly perform, and display Funded Developments and essential background technology (referred to as the Humanitarian License).

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Risks Related to Our Business Operations and Industry

Disruptions at the FDA, NIH, SEC and other government agencies, including due to lack of funding, changes in leadership, significant personnel turnover, or diminished staffing, could delay or disrupt clinical and preclinical development and potential marketing approval of our product candidates and hinder our ability to raise additional capital.

Twice in the past decade, the previous appropriations legislation deadline was reached and Congress failed to pass a new appropriations bill or continuing resolution to temporarily extend funding, resulting in U.S.

government shutdowns that caused federal agencies to halt non-essential operations.

The federal government came close to another shutdown several times in recent years.

Disruptions at government agencies, including due to government shutdowns, other funding shortages, policy changes, leadership changes, layoffs or significant personnel turnover, or public health concerns, could impede development and potential marketing approval of our product candidates and our ability to raise additional capital.

Over the last several years, the U.S.

government has shut down several times and certain federal regulatory agencies, such as the FDA and SEC, furloughed or laid off employees and halted non-essential operations due to the failure of Congress to pass a new appropriations bill or continuing resolution to temporarily extend funding.

Political polarization among lawmakers may lead to a higher frequency and longer duration of government shutdowns in the future.

A federal government shutdown could prevent or delay staff at federal agencies from performing key functions that may adversely affect our business.

In addition, considerable uncertainty exists regarding how federal government policy changes and budget decisions will unfold, including the regulatory and spending priorities of the new U.S.

presidential administration and Congress, and what challenges potential policy changes and budget reductions will present for us and our industry generally.

Measures being implemented by the new U.S.

presidential administration are expected to significantly impact federal regulatory agencies, such as by reducing funding to or restructuring such agencies.

For example, in the first quarter of 2025, the new U.S.

presidential administration began terminating federal government employees and federal agencies were directed to develop plans for large-scale reductions in force and reorganization.

As a result, agencies throughout the federal government may experience mass layoffs, as well as a significant number of voluntary departures.

The impact of these changes at federal government agencies with which we interact is uncertain at this time, however, mass layoffs and large-scale voluntary departures, in particular at the FDA, NIH, ARPA-H and SEC, could adversely impact our company.

For example, if it experiences significant workforce reduction or turnover, the FDA in the future may be unlikely to meet its application review goals or be available for timely interactions regarding our product development plans, which could delay our ability to advance clinical development of our product candidates or obtain marketing approvals.

A federal government shutdown or other disruption to ordinary course operations could prevent or delay staff at federal agencies from performing key functions that may adversely affect our business, and the more prolonged the disruption, the greater risks it may pose to our business.

In addition, considerable uncertainty exists regarding the current U.S.

presidential administration’s initiatives and how these might impact federal government agencies, including the FDA, NIH, and ARPA-H, their implementation of laws, regulations, policies, and guidance, and their personnel.

Alternatively, state governments may attempt to address or react to changes at the federal level with changes to their own regulatory frameworks in a manner that is adverse to our business or operations.

The ability of the FDA to review and approve new product applications or take action with respect to other regulatory matters can be affected by a variety of factors, including funding levels, ability to accept the payment of user fees, ability to hire and retain key personnel, and statutory, regulatory, and policy changes.

Government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

For example, the current U.S.

presidential administration has issued certain policies and executive orders directed towards reducing, and subsequent reductions have occurred to, the employee headcount and costs associated with U.S.

administrative agencies, including the FDA, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA’s ability to conduct routine activities.

Disruptions at the FDA may delay meetings and other communications with or on-site inspections by agency staff necessary to progress development of our product candidates and may slow the time necessary for acceptance, review, and approval of applications to commence clinical studies or to market a new product in the U.S.

By way of further example, disruptions at the NIH, including its various institutes and centers, such as NICHD, could delay or prevent providing or processing new grant awards to fund research and development activities and disrupt staff’s work and other activities or funding under active grant/cooperative agreements.

As discussed elsewhere in this report, including in this Risk Factors section, changes and disruptions at HHS agencies could result in delays or disruptions to our Phase 3 clinical study of Ovaprene and advancement of our DARE-HPV program.

Moreover, reduced funding levels or leadership and policy changes at HHS agencies could negatively impact our ability to obtain additional grant awards or other non-dilutive federal funding opportunities.

Disruptions at the SEC could prevent or delay SEC staff from performing key functions, including, for example, granting acceleration requests for registration statements, declaring registration statements or amendments thereto effective and providing interpretive guidance or no-action letters.

For example, if a federal government shutdown halts non-essential SEC operations for an extended period during which we do not have an effective shelf registration statement, it may negatively impact our ability to raise additional capital through registered offerings of our securities.

If a federal government shutdown halts non-essential SEC operations for an extended period during which we do not have an effective shelf registration statement, it may negatively impact our ability to raise additional capital through registered offerings of our securities.

If a prolonged U.S.

workforce reduction or employee turnover, it could significantly impact the ability of these agencies to timely review and process our regulatory submissions and may impede our access to additional capital needed to maintain or expand our operations or to complete important acquisitions or other transactions, which could have a material adverse effect on our business.

government shutdown or other event or condition occurs that prevents or significantly delays the FDA, NIH, SEC or other regulatory agencies from hiring and retaining personnel and conducting their regular activities, or if an agency is restructured or experiences significant reduction in funding, leadership changes, workforce reduction or employee turnover, it could significantly impact the ability of these agencies to timely review and process our regulatory submissions and may impede our access to additional capital needed to maintain or

expand our operations or to complete important acquisitions or other transactions, which could have a material adverse effect on our business.

Business interruptions resulting from public health crises, natural disasters or telecommunication and electrical failures may materially and adversely affect our business, operating results and financial condition.

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• disruption and volatility in the financial markets which negatively impacts our access to additional capital or stock price.

For example, in March 2020, the COVID-19 pandemic began to impact the global economy.

The COVID-19 pandemic disrupted our product development activities and the business activities of third parties on which we rely.

The COVID-19 pandemic contributed to a slower than anticipated pace of enrollment of participants in our exploratory Phase 2b RESPOND clinical study of Sildenafil Cream as a result of operational restrictions or closure of certain study sites due to their adherence to governmental guidelines intended to reduce the spread of COVID-19.

The COVID-19 pandemic also caused us to prioritize advancement of certain of our development programs over others, or certain development activities within a program over others, due to anticipated or actual difficulties and delays in recruiting clinical study sites and participants and obtaining clinical trial materials and supplies.

The strategies we implement designed to mitigate the effects or potential effects on our business of a public health emergency such as the COVID-19 pandemic, a natural or manmade disaster, act of terrorism, war or telecommunications or electrical failure that impacts our facilities or employees or those of third parties on which we rely may not be effective.

The strategies we implement designed to mitigate the effects or potential effects on our business of a public health emergency, a natural or manmade disaster, act of terrorism, war or telecommunications or electrical failure that impacts our facilities or employees or those of third parties on which we rely may not be effective.

The occurrence of such an event or condition could cause significant delays in the timelines for our clinical studies, our regulatory submissions or potential marketing approvals of our product candidates, substantially increase our development costs, and delay or contribute to delays in the commercial launch of any approved product or market acceptance of the product.

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• a decline in our stock price.

We carry product liability insurance that we believe to be adequate for our clinical testing and product development programs and in connection with XACIATO.

We carry product liability insurance that we believe to be adequate for our clinical testing and product development programs and in connection with XACIATO and for our potential 503B products.

However, insurance coverage is increasingly expensive, and it may be difficult to obtain adequate product liability insurance in the future.

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(1) comply with FDA or other regulators’ requirements, (2) provide accurate information to such regulators, (3) comply with clinical and nonclinical research standards and manufacturing standards established by us and/or required by the FDA or other laws and regulations, or (4) comply with SEC rules and regulations.

Sales, marketing and business arrangements in the health care industry are subject to extensive

laws, regulations and industry guidance intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.

Sales, marketing and business arrangements in the health care industry are subject to extensive laws, regulations and industry guidance intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.

These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

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Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

• the Physician Payments Sunshine Act, enacted as part of the ACA, which, among other things, imposes reporting requirements on manufacturers of FDA-approved drugs, devices, biologics and medical supplies covered by Medicare or Medicaid to report to CMS, on an annual basis, information related to payments and other transfers of value to physicians (defined broadly to include doctors, dentists, optometrists, podiatrists, and chiropractors), certain advanced non-physician health care practitioners, and teaching

hospitals, as well as ownership and investment interests held by physicians and their immediate family members in such manufacturers;

• HIPAA, as amended by HITECH, and their respective implementing regulations, which impose specified requirements relating to the privacy, security and electronic exchange of individually identifiable health information, or "protected health information" when subject to HIPAA.

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"Covered entity" or entities that must comply with HIPAA, include certain health care providers, health plans, and health care clearinghouses.

HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and third parties unlawfully in possession of protected health information, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorney’s fees and costs associated with pursuing federal civil actions;

actions for damages or injunctions in federal courts to enforce HIPAA and seek attorney’s fees and costs associated with pursuing federal civil actions;

Foreign Corrupt Practices Act, which prohibits U.S.

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As the use of digital technologies has increased, cyber incidents, including deliberate attacks (such as the deployment of harmful malware and other malicious code, ransomware, denial of service, social engineering, and other attempts to gain unauthorized access to computer systems and networks), have increased in frequency and sophistication, and have become increasingly difficult to detect.

These threats pose a risk to the security of our systems and networks and those of our collaborators and third-party service providers, including our CMOs and CROs for our clinical studies, which store sensitive or confidential data of ours, and could compromise the confidentiality, availability and integrity of such information which may be vital

to our operations and business strategy.

A successful cyber-attack could cause serious negative consequences for us, including, without limitation, the disruption of our operations, the misappropriation or destruction of our confidential information and sensitive data, including clinical trial data, corporate strategic plans and financial information, and the misappropriation of other assets, including our cash.

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Approximately $0.2 million of the fraud loss was covered by insurance.

We do not believe this incident had or will have a material impact on our business, financial condition or results of operations.

We do not believe this incident had or will have a material impact

on our business, financial condition or results of operations.

However, cyber-related criminal activities continue to evolve and increase in frequency and sophistication, including as a result of advancements in generative artificial intelligence technology, and our security measures and controls may not be successful in preventing further cyber-related crimes.

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Further, our insurance may not cover all claims made against us and could have high deductibles in any event, and defending a suit, regardless of its merit, could be costly and divert management attention.

Moreover, if the information technology systems of our third-party

collaborators, service providers or vendors become subject to disruptions or security breaches, we may have insufficient recourse against such third parties and we may have to expend significant resources to mitigate the impact of such an event.

Moreover, if the information technology systems of our third-party collaborators, service providers or vendors become subject to disruptions or security breaches, we may have insufficient recourse against such third parties and we may have to expend significant resources to mitigate the impact of such an event.

Our business may be adversely affected by general conditions in the global economy and financial markets and geopolitical tensions and events.

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government shutdown, delay or failure of the U.S.

government to raise the federal debt ceiling, an increased rate of inflation, rising interest rates, adverse developments affecting financial institutions or the financial services industry, recessionary concerns and overall unfavorable economic conditions and uncertainties, including those resulting from geopolitical events, including the wars in Ukraine and the Middle East and strained relations between the U.S.

relations between the U.S.

and a number of foreign countries;

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climate change concerns;

or public health emergencies, including the COVID-19 pandemic.

or public health emergencies.

government actions to reduce the federal deficit, or its delay or failure to raise the federal debt ceiling, may result in reduced funding for government-funded or subsidized health programs or require the federal government to stop or delay making payments on its obligations under such programs, which could impact sales of our products covered under such programs, if any, and negatively affect our operating results.

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• significant developments with third-party products or product development programs perceived as competitive to ours, such as results of clinical trials, unanticipated serious safety concerns, suspension or discontinuation of a program, significant communications or decisions from the FDA or other regulatory authorities, introduction of new product candidates or new uses for existing products, commercial launch and product sales;

• significant business disruptions, including as a result of cybersecurity incidents, geopolitical events, including military conflicts, war, terrorism or economic conflicts, or natural disasters such as earthquakes, typhoons, floods and fires or public health emergencies such as the COVID-19 pandemic;

• events or conditions that affect the financial markets or U.S.

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Such litigation, if instituted against us, could result in substantial costs and diversion of management’s attention and resources, which could materially and adversely affect our business and financial condition.

If we fail to regain and maintain compliance with the continued listing requirements of The Nasdaq Capital Market, our common stock could be suspended and delisted, which could, among other things, limit demand for our common stock, substantially impair our ability to raise additional capital and have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock.

There is no assurance that we will continue satisfying the listing requirements of the Nasdaq Capital Market.

Our common stock is listed on the Nasdaq Capital Market.

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

Nasdaq Listing Rule 5550(b)(2) requires a company listed on Nasdaq to maintain a minimum market value of listed securities of $35.0 million, which we refer to as the “Minimum MVLS Rule.” We were provided an initial period of 180 calendar days, or until February 10, 2025, to regain compliance with the Minimum MVLS Rule.

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

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

The hearing was held on March 25, 2025.

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

There can be no assurance that the Panel will grant us any extension period within which to regain compliance with the Minimum MVLS Rule, or if any extension period is granted, that we will regain compliance with the Minimum MVLS Rule within such extension period, or that we will be able to satisfy all other continued listing requirements of The Nasdaq Capital Market and maintain the listing of our common stock on The Nasdaq Capital Market even if we regain compliance with the Minimum MVLS Rule.

For example, until we regained compliance on

July 18, 2024, we were not in compliance with the continued listing standard commonly referred to as the minimum bid price rule since July 19, 2023.

The suspension or delisting of our common stock, for whatever reason, could, among other things, substantially impair our ability to raise additional capital;

To maintain our listing we are required to satisfy continued listing requirements, including the requirements commonly referred to as the minimum bid price rule and with either the stockholders’ equity rule or the market value of listed securities rule.

The minimum bid price rule requires that the closing bid price of our common stock be at least $1.00 per share, and the stockholders’ equity rule requires that our stockholders' equity be at least $2.5 million, or, alternatively, that the market value of our listed securities be at least $35 million or that we have net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the three most recently completed fiscal years.

We were not in compliance with the stockholders’ equity rule or the market value of listed securities rule from August 2024 until July 24, 2025, and we were not in compliance with the minimum bid price rule from July 2023 until July 2024 and from December 2022 until January 2023.

Although we regained compliance with the applicable rule in each instance, there can be no assurance that we will continue to satisfy those or other continued listing requirements and maintain the listing of our common stock on the Nasdaq Capital Market.

When Nasdaq confirmed on July 24, 2025, that we regained compliance with the stockholders’ equity rule, it also informed us that, pursuant to Nasdaq Listing Rule 5815(d)(4)(B), we would be subject to a mandatory panel monitor for a period of one year from that date, and that if, within that one-year period, the Nasdaq Listing Qualifications Staff, or the Staff, determines that we are out of compliance with the stockholders’ equity rule, the Staff will issue a delist determination letter, and we will have an opportunity to request a new hearing with Nasdaq’s Hearings Panel.

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

The foregoing would limit our ability to remedy any future non-compliance with the stockholders’ equity rule, and would increase the likelihood that our common stock could be delisted, if we were to fall out of compliance with the stockholders’ equity rule during the one-year monitoring period.

We were in compliance with the stockholders’ equity rule as of December 31, 2025.

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

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

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

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

The suspension or delisting of our common stock, or the commencement of delisting proceedings, for whatever reason, could, among other things, substantially impair our ability to raise additional capital;

result in the loss of interest from institutional investors, the loss of confidence in our company by investors and employees, and in fewer financing, strategic and business development opportunities;

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Claims related to any such breaches, with or without merit, could result in costly litigation, significant liabilities and diversion of our management’s time and attention and could have a material adverse effect on our financial condition, business and results of operations.

In addition, the suspension or delisting of our common stock, for whatever reason, may materially impair our stockholders’ ability to buy and sell shares of our common stock and could have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock.

In addition, the suspension or delisting of our common stock, or the commencement of delisting proceedings, for whatever reason, may materially impair our stockholders’ ability to buy and sell shares of our common stock and could have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock.

The sale of our common stock in ATM offerings or under our equity line arrangement may cause substantial dilution to our existing stockholders, and such sales, or the anticipation of such sales, may cause the price of our common stock to decline.

We have used at-the-market, or ATM, offerings to fund a significant portion of our operations in prior years, and we may continue to use ATM offerings to raise additional capital in the future.

For example, in 2021, we sold an aggregate of approximately 3.0 million shares of our common stock in ATM offerings.

We sold substantially fewer shares in ATM offerings in 2022 and 2023 and to date in 2024, however, we may sell significant amounts of shares in ATM offerings again in the future.

In addition, we may sell up to approximately $14.5 million in shares of our common stock under our equity line arrangement.

We have used at-the-market, or ATM, offerings and sales of shares of our common stock under our equity line arrangement to fund a significant portion of our operations in prior years, and we may continue to do so to raise additional capital in the future.

For example, in 2025, we sold an aggregate of approximately 4.3 million shares of our common stock in ATM offerings and under our equity line arrangement.

If we seek and obtain stockholder approval for the sale of additional shares of our common stock under our equity line arrangement, we may sell up to approximately an additional $11.7 million in shares of our common stock under our equity line arrangement.

The purchase price for the shares we may sell under our equity line arrangement will vary based on the market price of our common stock at the time we initiate a sale.

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If, in the future, we issue additional shares of common stock, warrants or other equity or equity-linked securities in one or more transactions, at prices and in a manner we determine from time to time, in connection with a financing, acquisition, litigation settlement, employee arrangements or otherwise, any such issuance could result in substantial dilution to our existing stockholders and could cause the price of our common stock to decline.

We may issue preferred stock with terms that could dilute the voting power or reduce the value of our common stock.

Our Restated Certificate of Incorporation, as amended, authorizes us to issue, without stockholder approval, one or more series of preferred stock having such designation, powers, privileges, preferences, including preferences over our common stock respecting dividends and distributions, terms of redemption and relative participation, optional, or other rights, if any, of the shares of each such series of preferred stock and any qualifications, limitations or restrictions thereof, as our board of directors may determine.

The terms of one or more series of preferred stock could dilute the voting power or reduce the value of our common stock.

For example, the repurchase or redemption rights or liquidation preferences we could assign to holders of preferred stock could affect the residual value of our common stock.

We have designated preferred stock with terms that could reduce the value of our common stock.

Our Restated Certificate of Incorporation, as amended, authorizes us to issue, without stockholder approval, up to 5,000,000 shares of preferred stock, in one or more series, having such designation, powers, privileges, preferences, including preferences over our common stock respecting dividends and distributions, terms of redemption and relative participation, optional, or other rights, if any, of the shares of each such series of preferred stock and any qualifications, limitations or restrictions thereof, as our board of directors may determine.

In anticipation of the initial closing of our Regulation A Offering, in January 2026, we filed a Certificate of Designation of Series A Convertible Preferred Stock with the Secretary of State of the State of Delaware that designates 4,999,620 shares of our authorized preferred stock as Series A Convertible Preferred Stock.

Our Series A Convertible Preferred Stock ranks, as to rights upon our liquidation, dissolution, or winding up, senior to our common stock.

The liquidation preference for each share of our Series A Convertible Preferred Stock is $5.00 per share, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events affecting our Series A Convertible Preferred Stock.

As of the filing date of this report, we have issued 65,640 shares of our Series A Convertible Preferred Stock.

For additional information regarding the powers, preferences and rights, and qualifications, limitations and restrictions of our Series A Convertible Preferred Stock, see Note 17, “Subsequent Events," to our consolidated financial statements included in this report.

Assuming no change in the authorized number of shares of Series A Convertible Preferred Stock, our board of directors has the authority, without further action by our stockholders, to issue up to 380 shares of preferred stock in one or more series and to fix the rights, preferences, privileges and restrictions thereof, including dividend rights, conversion rights, voting rights, terms of redemption and liquidation preferences, any or all of which may be greater than the rights of the holders of our common stock.

In addition, to the extent that any shares of Series A Preferred Convertible Stock previously designated under the Certificate of Designation referenced in the paragraph above are not issued, our board of directors may, subject to applicable law, redesignate such shares as a new or different series of preferred stock and establish the rights, preferences, privileges and restrictions of such series, any or all of which may be greater than the rights of the holders of our common stock.

We do not anticipate paying any cash dividends on our common stock in the foreseeable future;

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

What changed 10-K

Item 1A. Risk Factors