What changed in this filing

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Item 1A. Risk Factors

2025-03-31 compared with 2024-03-28 · 569 added, 506 removed, 924 unchanged (54% 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.

• We have a limited operating history, have incurred significant losses since our inception and expect to continue to incur losses for the foreseeable future, which, together with our limited financial resources and substantial capital requirements, make it difficult to assess our prospects.

• 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.

• 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.

• 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.

• Drug products and drug/device combination products are complex to manufacture and we face significant challenges in scaling up manufacturing of our product candidates for larger clinical trials and commercial production.

Manufacturing and supply delays and disruptions 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.

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

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.

• Unless and until one of our product candidates receives regulatory approval, payments under our license agreement with Organon based on net sales of XACIATO represent our only potential source of ongoing revenue and the amount of those net sales is largely outside of our control.

• 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.

• We have no manufacturing, sales, marketing or distribution infrastructure.

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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 loss or impairment of our rights under our license agreements for XACIATO or any of our product candidates could prevent us from developing or commercializing them, which could have a material adverse effect on our business prospects, operations and viability.

• The commercial success of XACIATO 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.

• XACIATO and any future products will face intense competition, including from generic products, 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 and fail to achieve market acceptance.

• 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.

• 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.

If out-of-pocket costs for products we develop are deemed by women to be unaffordable, a commercial market may never develop.

• We have a relatively small number of employees, and if we fail to attract and retain key personnel or effectively manage our personnel costs, our business may materially suffer.

• We have a relatively small number of employees and if we fail to attract and retain key personnel our business may materially suffer.

• 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.

• Our failure to adequately protect or enforce our intellectual property rights, and those of our licensors, could materially harm our proprietary position in the marketplace or prevent or impede the commercialization of XACIATO and any future products.

• Lack of patent protection for the active ingredients in certain of our product candidates, including Sildenafil Cream and DARE-HRT1, may limit the commercial opportunity for those products if competitors are able to develop and commercialize safe and effective alternative formulations or methods of delivery of the active ingredients.

• Volatility in the financial markets, geopolitical conflicts and events, public health emergencies such as the COVID-19 pandemic and other macroeconomic factors may negatively impact our business, financial condition and results and our stock price, including by increasing the cost and timelines for our clinical development programs or making it more difficult or costly to raise additional capital when needed.

• 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.

• 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.

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

• Product liability lawsuits against us could cause us to incur substantial liabilities and divert management attention from our business.

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Volatility in our stock price may subject us to increased risk of securities litigation, including class-action lawsuits, which could be expensive and divert management attention.

• Future dilution to our existing stockholders from sales and issuances of our common stock through at-the-market, or ATM, offerings, other types of public or private offerings of equity or equity-linked securities and upon the exercise of stock options, or the market's expectation that such sales could adversely affect our stock price, even if our business is doing well.

• 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 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.

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.

Investment in our securities involves a high degree of risk and uncertainty.

Our business, operating results, growth prospects and financial condition are subject to various risks, many of which are not exclusively within our

control, that may cause actual performance to differ materially from historical or projected future performance.

Our business, operating results, growth prospects and financial condition are subject to various risks, many of which are not exclusively within our control, that may cause actual performance to differ materially from historical or projected future performance.

We urge investors to consider carefully the risks described below, together with all of the information in this report and our other public filings, before making investment decisions regarding our securities.

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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 negative cash flows from our operations to continue for the foreseeable future, and we expect that our net losses will continue for the foreseeable future 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.

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.

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

Our financial statements as of December 31, 2023 were prepared under the assumption that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.

At December 31, 2023, our accumulated deficit was approximately $171.2 million, our cash and cash equivalents were approximately $10.5 million, our deferred grant funding liability under our grant agreements related to DARE-LARC1 and DARE-LBT was approximately $13.7 million, and our working capital deficit was approximately $2.9 million.

Our cash and cash equivalents at December 31, 2023 represented funds received under such grant agreements and such funds may be applied solely toward direct costs for the development of DARE-LARC1 and DARE-LBT, other than approximately 10% of such funds, which may be applied toward general overhead and administration expenses that support our entire operations.

We will require additional capital to fund our operating needs into the third quarter of 2024.

and to meet our current obligations as they become due.

Advancing our investigational women's health products through clinical development and pursuing regulatory approval and commercialization will require substantial additional investment.

The consolidated financial statements included in this report were prepared under the assumption that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.

Advancing our investigational products through clinical development and pursuing regulatory approval and commercialization will require substantial additional investment.

We will need to raise substantial additional capital to continue to fund our operations and execute our current business strategy.

The amount and timing of our capital needs have and will continue to depend highly on many factors, as discussed further below as well as under "ITEM 7.

MANAGEMENT'S DISCUSSION OF AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS—Liquidity and Capital Resources—Plan of Operations and Future Funding Requirements."

The amount and timing of our capital needs have and will continue to depend highly on many factors, as discussed further below.

Our management may devote significant time and we may incur substantial costs in pursuing, evaluating and negotiating potential capital-raising transactions and those efforts may not prove successful on a timely basis, or at all.

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or file for bankruptcy or cease operations.

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

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

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• the product development programs we choose to pursue;

• the cost and pace of preclinical and clinical development;

• the results of preclinical activities and clinical trials;

• the cost and timing of obtaining clinical supplies of product candidates;

• the cost and timing of regulatory submissions and decisions by the FDA and other regulatory authorities on our applications to commence and advance clinical development of and to market our product candidates;

• 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 clinical supplies of product candidates and, if applicable, commercial product at sufficient scale;

• the cost and timing of regulatory submissions to and the timing and outcome of decisions by the FDA and other regulatory authorities on our applications to commence and advance clinical development of and to market our product candidates;

• the amount and timing of payments to third parties required under acquisition, in-license and other agreements relating our rights to develop and commercialize our product and product candidates;

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

• the amount and timing of future royalty, milestone or other payments, if any, we receive under our commercial collaboration agreements for XACIATO and Ovaprene;

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

• 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;

• 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;

• the extent to which we acquire, in-license, or otherwise invest in new product candidates or technologies and the terms of any such transaction;

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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 a commercialization plan for each product, which may also require significant resources to create and implement.

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.

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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We may seek to raise additional capital through a variety of means, including equity, equity-linked or debt securities offerings, government or other grant funding, strategic collaborations or alliances, debt, royalty monetization or other structured financings, or other similar types of arrangements.

Our past success in raising capital through equity offerings, grant funding, collaboration agreements, and a royalty monetization financing should not be viewed as an indication we will be successful in raising capital through those or any other means in the future.

Our past success in raising capital through equity offerings, grant funding, collaboration agreements, and royalty monetization transactions should not be viewed as any indication we will be successful in raising capital through those or any other means in the future.

We expect that our ability to raise additional capital and the amount of capital available to us will depend not only on progress we and our collaborators make toward successfully developing, obtaining regulatory approval for and commercializing our product and product candidates, but also on factors outside of our control, such as macroeconomic and financial market conditions.

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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, 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 relations between the 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.

and a number of other countries, social and political discord and unrest in the U.S.

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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 be required to relinquish valuable rights to future revenue streams, such as in the case of the royalty interest financing agreement we entered into in December 2023.

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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If we obtain funding through grants from governmental entities or private organizations, such parties may impose restrictions on our rights to technologies, product candidates or products developed with such funding, obtain rights to license such technologies, product candidates or products to third parties (e.g., if we are unable or unwilling to commercialize a product or make it available to certain patient populations in a timely manner or at certain prices), or require future royalty or other payments if such technologies, product candidates or products are commercialized.

We have a limited operating history, have incurred significant losses since our inception and expect to continue to incur losses for the foreseeable future, which, together with our limited financial resources and substantial capital requirements, make it difficult to assess our prospects.

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 have a limited operating history upon which to evaluate our business and prospects.

The development of drug and drug/device combination products in order to obtain regulatory approval is a highly speculative, lengthy and expensive undertaking and involves substantial risk.

We cannot accurately determine the duration and completion costs of our development programs, or if, when and to what extent we will generate revenue from the commercialization of any of our product candidates.

Other than XACIATO, which was recently commercially launched by our collaborator Organon, we have not obtained any regulatory approvals for any of our product candidates, commercialized any of our product candidates or generated any product revenue.

We do not expect the potential milestone and royalty payments to us under our exclusive license agreement for XACIATO will be sufficient to cover our operating expenses.

We cannot accurately determine the duration and completion costs of our development programs, or if, when and to what extent we will generate revenue from any products we develop.

Other than XACIATO, we have not obtained any regulatory approvals for any of our product candidates, commercialized any of our product candidates or generated any product revenue.

We have not been profitable since we commenced operations and may never achieve profitability.

We devote significant resources to licensing or otherwise acquiring the rights to our product candidates and to research and development, or R&D, activities for them.

Since inception, we have incurred significant operating losses.

We have a history of significant operating losses.

As discussed above, we must raise additional capital to finance our operations and remain a going concern and adequate additional capital may not be available to us on a timely basis, or at all.

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.

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.

The royalties we may receive under our license agreements with our commercial collaborators are based on net sales, which will be largely outside of our control.

We expect XACIATO’s and Ovaprene’s value to us under our license agreements with Organon and Bayer, assuming the license grant to Bayer becomes effective, to be generated primarily through royalties and potential commercial milestone payments, in each case, based on net sales.

The amount of net sales our products may

generate, if any, is largely outside of our control because marketing and sales activities will be conducted by the licensee and the product pricing will be determined by the licensee.

Gross sales can be greatly reduced by sales discounts and allowances, which will also be determined by the licensee (or mandated by governmental entities) and outside of our control.

The Revenue Sharing Threshold may never be achieved and, as a result, we may not realize any future income based on sales of XACIATO.

We have sold our right, title and interest in 100% of the royalties and potential milestone payments we would otherwise have the right to receive under our license agreement with Organon based on net sales of XACIATO, net of payments to upstream third-party licensors and UiE.

Whether we receive any future income based on net sales of XACIATO will depend on whether the Revenue Sharing Threshold is reached, which may not occur.

Whether the Revenue Sharing Threshold is reached will depend, in part, on Organon’s future commercial success with XACIATO, which is outside of our control, 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.

To the extent we enter into such licensing agreements, the amount of net sales our products may generate, if approved for commercial sale, will be largely outside of our control because marketing and sales activities will be conducted by the licensee and product pricing and costs that impact net sales will be determined by the licensee.

Gross sales can be greatly reduced by sales discounts and allowances, which will be determined by our licensee (or mandated by governmental entities).

Sales discounts may be particularly substantial for new products compared to established products to incentivize purchases and promote customer loyalty.

These factors would serve to reduce our royalties and delay potential achievement of commercial milestones.

If a commercial collaborator has no or limited commercialization success, or net sales are otherwise minimal due to pricing and discount structures, our operating results would be negatively impacted and our need for additional capital could significantly increase or be accelerated.

These factors would serve to reduce the royalties payable to us and delay potential achievement of commercial milestones and the corresponding milestone payments to us.

If a licensee has no or limited commercialization success, or net sales are otherwise minimal due to pricing and discount structures, our financial condition and operating results could be negatively impacted and our need for additional capital could significantly increase or be accelerated.

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.

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:

• pursue raising additional funds through equity or debt financings that could be dilutive to our stockholders or involve restrictive covenants, operational restrictions and security interests in our assets;

• pursue raising additional funds through equity, debt or other structured financings that could be dilutive to our stockholders or involve restrictive covenants, operational restrictions, security interests in our assets, and/or relinquishing part or all of our rights to potentially valuable future revenue streams;

• enter into new strategic collaborations that may be less favorable than those we would have obtained under different circumstances;

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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.

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

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.

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.

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.

Our ability to raise additional capital may be limited by a low trading volume, stock price and market capitalization, as well as by laws, regulations and market conditions.

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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.

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.

As an example, as of March 27, 2024, we could not offer or sell more than approximately $19.0 million of new securities under our shelf registration statement.

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.

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While our common stock is currently listed on the Nasdaq Capital Market, there can be no assurance that we can maintain such listing.

See, “Risks Related to Our Securities—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,” below.

See, “Risks Related to Ownership of Our Common Stock—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,” below.

Our ability to raise capital on a timely basis through the issuance and sale of equity securities may also be limited by Nasdaq’s stockholder approval requirement for any transaction that is not a public offering (as defined in Nasdaq listing rules).

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Under Nasdaq rules, stockholder approval is also required prior to the issuance of securities when the issuance or potential issuance will result in a change of control of our company.

Even if a public offering under Nasdaq rules is not subject to the 20% limitation described above, it may involve publicly announcing the proposed transaction before it is completed, which often has the effect of depressing a company's stock price.

Even if a public offering under Nasdaq rules is not subject to the 20% limitation described above, it may involve publicly announcing the proposed transaction, which often has the effect of depressing the market price of a company's stock and could result in a reduced offering price.

Accordingly, our existing investors may suffer greater dilution if we seek to raise additional capital through such a public offering of our securities.

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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.

Our current financial and technical resources are limited and not sufficient to develop all of the product candidates to which we hold licenses or options to license.

Our current financial and other resources are limited and not sufficient to develop all of the product candidates to which we hold licenses or options to license.

This may affect our efforts to develop and bring to market the product candidates currently in our portfolio and any candidates we may add to our portfolio in the future.

Due to our limited resources, we have curtailed, and may be required to further curtail, our development programs and clinical and nonclinical development activities that might otherwise have led, or lead, to more rapid progress in the development of our product candidates, or product candidates that we may in the future choose to develop.

Due to our limited resources, we have curtailed, and may be required to further curtail, certain of our development programs and clinical and nonclinical development activities that might otherwise have led, or lead, to more rapid progress in the development of our product candidates, or product candidates that we may in the future choose to develop.

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.

As a result of financial and other resource constraints, we may be unable to commence or complete our planned clinical trials or prepare and submit applications for marketing approval of our product candidates in accordance with our currently anticipated timelines.

See also “Risks Related to Product Research & Development, and Regulatory Approval – Delays in the commencement or completion of clinical testing of product candidates we

are developing or may develop in the future may occur due to any of a number of factors and could result in significantly increased costs and longer timelines and could impact our ability to ever become profitable” below.

See also “Risks Related to Product Research & Development and Regulatory Approval – Delays in the commencement or completion of clinical testing of our product candidates may occur due to any of a number of factors and could result in significantly increased costs and longer timelines and could impact our ability to ever become profitable” below.

Women’s health has historically been an underfunded sector.

In recent years, a number of public companies focused in women’s health failed to achieve expected commercial success and struggled to access sufficient capital.

We are solely focused in women’s health and may be unfavorably impacted by weak investor sentiment and a lack of interest in the category.

Our ability to access capital and to advance our candidates could be adversely impacted.

We are solely focused in women’s health, and primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease and menopause.

The sector has historically been underfunded, with only about one percent of healthcare research and innovation in the U.S.

invested in female-specific conditions beyond oncology according to market research.

Non-oncologic women's health therapeutics product launches in recent years have not been perceived as successful.

Those perceived commercial failures and the failure of the women’s health sector to receive consistent and committed investment fuels investor sentiment that market opportunities for new products in women’s health are limited.

While women's health recently has received more attention, and investment in the women's health sector has seen progress with new or increased funding programs from the federal government, it remains an underinvested sector.

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

presidential administration will continue programs initiated by the prior presidential administration that led to increased funding for research and development in women’s health.

Our stock price and our ability to access additional capital on acceptable terms when needed may be adversely impacted by unfavorable investor perception of market opportunities for women’s health products, and our business, operating results, financial condition and prospects could suffer.

Uncertainty in U.S.

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.

We have received federal government grants and awards in support of several of our development programs.

As discussed elsewhere in this report, our pivotal Phase 3 study of Ovaprene is being conducted, in part, in collaboration with NICHD under our CRADA, and our DARE-HPV program is being supported in large part with funding provided by federal agencies.

There is no guarantee that such contracts and funding will not be frozen, restricted, or terminated as a result of changes in federal funding and contracting policies.

In addition, potential future funding and collaboration opportunities through HHS, NIH or other federal agencies may be delayed, reduced or made unavailable.

Further, research and development conducted in collaboration with U.S.-based colleges and universities could be delayed or discontinued due to changes in federal funding and contracting policies relating to such institutions.

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

Our cash could be adversely impacted if a financial institution with which we have deposit or other accounts fails.

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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.

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.

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.

Women’s health has historically been an underfunded sector.

Recently, a number of public companies focused in women’s health have failed to achieve expected commercial success and struggled to access sufficient capital.

We are solely focused in women’s health and may be unfavorably impacted by weak investor sentiment and a lack of interest in the category.

Our ability to access capital and to advance our candidates could be adversely impacted.

We are solely focused in women’s health, and primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility.

The sector has historically been underfunded, with only about one percent of healthcare research and innovation in the U.S.

invested in female-specific conditions beyond oncology according to market research.

The failure of the women’s health sector to receive consistent and committed investment fuels investor sentiment that market opportunities for new products in women’s health are limited.

Risks Related to Product Research & Development and Regulatory Approval

XACIATO is our first and only FDA-approved product.

The FDA’s approval of XACIATO does not provide any assurance or predict that we will be successful in developing or achieving regulatory approval of any other product candidate.

To date, XACIATO is the only FDA-approved product to emerge from our portfolio.

The FDA’s approval of XACIATO does not provide any assurance or predict that we will be successful in developing or achieving regulatory approval to market any other product candidate.

If we are unable to successfully conduct and complete development of and obtain regulatory approvals for our investigational products, which may never occur, our business may fail and you could lose all or part of your investment.

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Each of our development programs is unique and subject to substantial uncertainty of success inherent in pharmaceutical and biopharmaceutical development.

Our pipeline consists entirely of investigational products, which we also refer to as product candidates, which means that they must successfully complete one or more clinical studies to be considered for marketing approval and undergo a submission and review process with the FDA to obtain approval to be marketed in the U.S., or a similar process with comparable regulatory authorities in other jurisdictions to be marketed anywhere outside of the U.S.

Our current pipeline consists entirely of investigational products, which we also refer to as product candidates, which means that they must successfully complete one or more clinical studies to be considered for marketing approval and undergo a submission and review process with the FDA to obtain approval to be marketed in the U.S., or a similar process with comparable regulatory authorities in other jurisdictions to be marketed anywhere outside of the U.S.

FDA or other regulatory authority approval may never be obtained.

See also ITEM 1.

“BUSINESS–Government Regulation–U.S.

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.

If we are unable to successfully complete development of and obtain regulatory approvals for our product candidates, our business may fail and you could lose all or part of your investment.

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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.

As another example, while we believe the objectives of our exploratory Phase 2b RESPOND study of Sildenafil Cream were met and enabled successful completion of an end-of-Phase 2 meeting with the FDA and alignment on key elements of the Phase 3 program for Sildenafil Cream, the co-primary efficacy endpoints of the Phase 2b study were not met and there is no guarantee that Phase 3 clinical studies will be successful.

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.

The fact that the active pharmaceutical ingredients in certain of our product candidates, including Sildenafil Cream, received regulatory approval in other formulations and/or for other indications does not guarantee successful development of our product candidates for their proposed intended uses.

Clinical trials may never demonstrate sufficient safety and effectiveness to obtain the requisite regulatory approvals for our product candidates.

Outcomes of our clinical trials, particularly later-stage clinical trials, including our ongoing Phase 3 study of Ovaprene, may significantly impact our stock price and our business prospects.

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.

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.

Outcomes of our clinical trials, particularly later-stage clinical trials, may significantly impact our stock price.

If the results of our pivotal Phase 3 clinical study of Ovaprene are not positive, our stock price could decline and our business and prospects may be adversely affected.

Ovaprene is one of our lead product candidates.

If the results of our pivotal Phase 3 clinical study of Ovaprene are not positive or are perceived by third parties, including financial market participants, as not positive, our business, prospects and stock price could suffer significantly.

If Ovaprene fails to demonstrate adequate safety or contraceptive effectiveness in the Phase 3 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.

In addition, if we, the investment community, potential collaborators or the FDA view the topline or complete results of the study 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.

Delays in the commencement or completion of clinical testing of our product candidates may occur due to any of a number of factors and could result in significantly increased costs and longer timelines and could impact our ability to ever become profitable.

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The timing of initiation, conduct and completion of clinical trials and other development activities for our product candidates may vary dramatically due to factors within and outside of our control and is difficult to predict accurately.

We may make statements regarding anticipated timing for commencement, completion of enrollment, and/or availability of results from our clinical studies, but those statements are predictions based on significant assumptions and the actual timing of achievement of development milestones may differ materially from our predictions for a variety of reasons.

We may make statements regarding anticipated timing of clinical development milestones, such as commencement, completion of enrollment, and/or availability of results from our clinical studies, but those statements are predictions based on significant assumptions and the actual timing of achievement of development milestones may differ materially from our predictions for a variety of reasons.

The commencement of clinical trials of our product candidates can be delayed for many reasons, including:

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• lack of adequate capital and the need to obtain additional funding;

• failure to conduct the clinical trial in accordance with regulatory or IRB requirements;

• failure to conduct the clinical trial in accordance with its protocol or regulatory or IRB requirements;

• slower than expected rates of participant recruitment and enrollment;

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• failure to achieve certain efficacy and/or safety standards;

• participants experiencing severe undesirable side effects or other unexpected adverse events related to the investigational product;

• participants experiencing severe undesirable side effects or other unexpected adverse events;

• disruptions in or insufficient supply of clinical trial material or inadequate quality of such materials;

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• delays in quality control/quality assurance procedures necessary for study database lock and analysis of unblinded data.

Unexpected serious adverse events or other undesirable side effects could arise during clinical development and interrupt, delay, or cause the termination of clinical trials, and require us to conduct additional clinical and nonclinical studies that were not part of our development plan, which could significantly increase the development costs and timeline for a program and adversely impact its value and our ability to continue product development.

Unexpected SAEs or other undesirable side effects could arise during clinical development and interrupt, delay, or cause the termination of clinical trials, and require us to conduct additional clinical and nonclinical studies that were not part of our development plan, which could significantly increase the development costs and timeline for a program and adversely impact its value and our ability to continue product development.

These events may also cause our reputation to suffer and subject us to lawsuits.

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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 pandemic or other public health emergency, 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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Delays in the manufacture of our clinical supplies as well as other supply chain disruptions could postpone the initiation of or interrupt clinical studies, extend the timeframe and cost of development of our product candidates, delay potential regulatory approvals and impact the commercialization of any approved products.

The manufacture of our product candidates is complex and subject to compliance with extensive regulatory requirements, and in most cases we rely on single source contract manufacturers and suppliers.

The manufacture of our product candidates is subject to compliance with extensive regulatory requirements, in some cases is complex, and in most cases we rely on single source contract manufacturers and suppliers.

As a result, we face significant risks of manufacturing and supply delays and disruptions that may be difficult and expensive to resolve and may cause substantial delays in the development and regulatory approval of our product candidates or the commercialization of any approved product.

To date, our clinical-stage product candidates have been tested in a relatively small number of clinical study participants.

Significant scale-up of manufacturing will be required to provide adequate supplies of our product candidates for larger Phase 2 and Phase 3 clinical trials and may take longer and be more expensive than anticipated, potentially having a significant negative impact on our development costs and timelines.

We have, and we expect we will continue to, face multiple challenges as our contract manufacturers scale their processes to provide supplies for larger clinical trials or commercial production including, among others, potential difficulties with process scale-up, process reproducibility, stability and purity issues, compliance with cGMP, lot consistency, and timely availability of acceptable raw materials.

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.

A substantial scale up in production was necessary to meet the study’s requirements and required more time and expense than anticipated.

Additional clinical supplies must be produced to complete the study and manufacturing disruptions may occur that extend the overall timeline and cost to complete the study.

A substantial scale up in production of Ovaprene clinical supplies was necessary to support the ongoing Phase 3 clinical study of Ovaprene, which took longer and was more expensive than anticipated, impacting our development timeline.

Under our agreement with ADVA-Tec, we are dependent on ADVA-Tec and its contract manufacturer, Poly-Med, Inc., for all Ovaprene clinical and commercial product supplies, and we do not control these third parties and have limited influence the efforts and resources they expend to meet our supply requirements.

Furthermore, some of the key raw materials and components of Ovaprene have only a single source of supply.

Global supply chain disruptions may also result in delays in and increased costs for the manufacture and supply of sufficient quantities of Ovaprene to meet the pivotal clinical study’s requirements.

Disruptions and delays in scaling up manufacturing of our product candidates for later stage clinical studies may have a significant negative impact on our development costs and timelines.

The manufacture of our product candidates is subject to extensive regulation.

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Further, even minor deviations in the manufacturing process, including filling labeling, packaging, storage and shipping, and quality control and testing, may result in shipment delays, lot failures, recalls or spoilage, and delay or disrupt our clinical studies or commercial supply of any approved product.

If our contract manufacturers are unable to produce sufficient quantities of our product candidates (or their APIs) for clinical trials or, if approved, 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.

See also ITEM 1.

“BUSINESS–Government Regulation–U.S.

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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We may need to alter the materials, equipment or processes for making our product candidates in order to yield commercially viable products.

As discussed above, manufacturing changes could increase development costs and timing and may not achieve the

intended objectives.

Manufacturing costs may negatively impact the commercial viability of our product candidates, if approved.

As discussed above, manufacturing changes could increase development costs and timing, delay regulatory approval or disrupt commercial supply and may not achieve the intended objectives.

Manufacturing costs may negatively impact the commercial viability of our product candidates, if approved for commercial sale.

See also “Risks Related to Our Dependence on Third Parties- 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 clinical study materials, including multiple single source suppliers and manufacturers.

If these third parties do not perform as we expect, do not maintain their regulatory approvals or become subject to negative circumstances, it could delay, prevent or impair our product development or commercialization efforts, or those of our collaborators, and harm our business,” and “- In some cases, we may be contractually required to obtain clinical or commercial product supplies from specific third parties or there may be a limited number of third-party suppliers of raw materials and other components of our product candidates or future products, which may heighten our dependence on those third parties and the risk of manufacturing disruptions” below.

Many of our product candidates, including Ovaprene, will or may be considered combination products by the FDA and other regulatory authorities, which could increase the complexity, cost and timeline for their development and regulatory approvals.

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 for Ovaprene.

To the extent our product candidates meet the FDA’s or any other regulatory authority’s definition of a combination product, the regulatory approval requirements can be more complex and costly because in addition to the individual regulatory requirements for each component, e.g., a drug and a medical device, additional combination product regulatory requirements may apply.

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.

See also ITEM 1.

"BUSINESS–Government Regulation–U.S.

Government Regulation–FDA Review and Approval Process for Combination Products,” above.

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.

Ovaprene previously underwent a request for designation, or RFD, process with the FDA that determined that CDRH would lead the review of a PMA for potential marketing approval of this product candidate.

If the designation were to be changed to CDER, or if either center were to institute additional requirements for the approval of Ovaprene, we could be required to complete clinical studies with more patients and over longer periods of time than is currently anticipated.

This would significantly increase the anticipated cost and timeline to completion of Ovaprene’s development and require us to raise additional funds.

Based on discussions with the FDA, we believe that if our ongoing pivotal clinical study of Ovaprene is successful, the FDA will not require additional clinical studies to support the PMA for Ovaprene.

However, the FDA may determine that the results of the study are not sufficiently robust or convincing and require additional clinical and/or nonclinical studies prior to approval of Ovaprene.

Because Ovaprene is one of our lead product candidates, the impact of either a change in the lead FDA review center or the imposition of additional, currently unplanned requirements for approval could be significant to us and have a material adverse effect on the prospects for developing Ovaprene, as well as on our business and our financial condition.

See also “The commercial success of Ovaprene will depend on market acceptance of a hormone-free monthly, intravaginal product, availability and effectiveness of alternative contraceptive products and women's preferences, as well as the success of Bayer’s marketing and sales efforts” below.

If these third parties do not perform as we expect, do not maintain their regulatory approvals or become subject to negative circumstances, it could delay, prevent or impair our product development or commercialization efforts, or those of our collaborators, and harm our business,” and “- In some cases, we may be contractually required to obtain clinical or commercial product supplies from specific third parties or there may be a limited number of third-party suppliers of raw materials and other components of our product candidates or future products, which may heighten our dependence on those third parties, increase the risk of manufacturing disruptions, and result in higher development costs or costs of goods sold” below.

The factors contributing to female sexual dysfunction disorders, including FSAD, are complex and there is limited clinical trial precedent from which to draw experience, making the design and execution of a clinical trial that demonstrates effectiveness of Sildenafil Cream in treating FSAD more inherently challenging and uncertain compared with investigational products for many other conditions.

There are currently no FDA-approved pharmacologic treatments for female sexual arousal disorder, or FSAD, and there is no precedent program to reference in the design of our clinical trials for Sildenafil Cream.

There are currently no FDA-approved pharmacologic treatments for FSAD and there is no precedent program to reference in the design of our clinical trials for Sildenafil Cream.

Female sexual dysfunction disorders in women vary in nature and may be the result of a variety of physiological and psychological factors.

Given the variability of factors contributing to the underlying condition, and the product candidates' attributes, clinical studies to evaluate effectiveness in any subset of the conditions under the umbrella of Sexual Dysfunction, such as FSAD, are complex.

While we worked with experts to 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, 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, although we determined that topline data supported continued clinical development of Sildenafil Cream and further analysis of the study data identified certain subsets of participants that achieved clinically meaningful and statistically significant improvement in certain items relating to the co-primary efficacy endpoints and data from the RESPOND study enabled successful completion of an end-of-Phase 2 meeting with the FDA and ongoing feedback from the FDA to align on key elements of the Phase 3 program for Sildenafil Cream.

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.

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

While post-hoc analyses of data from the Phase 2b RESPOND study identified a subset of participants that achieved statistically significant improvement in one of the co-primary efficacy endpoints of the study and the planned Phase 3 study will be in that subset of patients, there can be no assurance that Sildenafil Cream will be successful in the planned Phase 3 study.

Sildenafil Cream is designed to work primarily by increasing blood flow to the genital tissue.

Therefore, identifying and enrolling patients in our clinical trials of Sildenafil Cream for whom inadequate blood flow to the genital tissue is the primary contributor to their arousal disorder is critical.

If we fail to screen properly, and instead enroll patients with different contributing factors, the results of our clinical trials are unlikely to demonstrate effectiveness of Sildenafil Cream.

Conversely, trying to screen out patients with different contributing factors may slow enrollment in a study, delay its completion and increase its costs.

If we fail to screen study participants properly, the results of our clinical trials are unlikely to demonstrate effectiveness of Sildenafil Cream.

Conversely, screening procedures may slow enrollment in a study, delay its completion and increase its costs.

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.

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 guaranty that the use of Sildenafil Cream will improve their general feelings of arousal or that the PRO instruments we utilize to measure the effectiveness of Sildenafil Cream in the study will adequately capture their genital arousal response.

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.

We expect to conduct two Phase 3 studies to support an NDA for Sildenafil Cream.

Given the multiple factors contributing to arousal disorders and the novelty of the clinical endpoints that may be utilized to measure effectiveness of Sildenafil Cream in treating FSAD, we may be required to conduct multiple clinical trials in large patient populations, extending the timeline and increasing the cost of development for Sildenafil Cream, without any guarantee of positive results.

Given the multiple factors contributing to arousal disorders and the novelty of the clinical endpoints that will be utilized to measure effectiveness of Sildenafil Cream in treating FSAD, we may be required to conduct multiple clinical trials in large patient populations, extending the timeline and increasing the cost of development for Sildenafil Cream, without any guarantee of positive results.

If we are unable to efficiently and successfully advance Sildenafil Cream through clinical development, our business, operating results and financial conditional, as well as our stock price, could suffer.

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Information we determine not to publicly disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate, product or our business.

If the topline data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and

commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

If the topline data that we report differ from complete results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

Our business depends on obtaining regulatory approval to market our product candidates in a timely manner, in particular, FDA approval.

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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.

“BUSINESS–Government Regulation–U.S.

Our success depends on our ability to obtain regulatory approvals for our product candidates in a timely and cost-efficient manner.

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Changing testing or manufacturing requirements for our product candidates or for product candidates deemed to be comparable to ours may adversely impact our financial resources, our development timelines and may harm the perception held by others of our business.

We expect to utilize the FDA’s Section 505(b)(2) pathway for most of our current product candidates 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.

We intend to develop and seek approval for many of our product candidates, including Sildenafil Cream, pursuant to the FDA’s 505(b)(2) pathway.

If the FDA determines that we may not use this regulatory pathway, then we would need to seek regulatory approval via a “full” or “stand-alone” NDA under Section 505(b)(1) of the FDCA.

This would require us to conduct additional clinical trials and nonclinical testing, provide additional safety and efficacy data and other information, and meet additional standards for regulatory approval.

A change in the regulatory approval pathway we anticipate for a product candidate could significantly increase development cost and timeline and heighten the risk of failure.

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.

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.

The Drug Price Competition and Patent Term Restoration Act of 1984, informally known as the Hatch-Waxman Act, added Section 505(b)(2) to the FDCA.

Section 505(b)(2) permits the filing of an NDA where at least

some of the information required for approval comes from studies and information that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference.

Section 505(b)(2), if applicable to us under the FDCA, would allow an NDA we submit to the FDA to rely in part on data in the public domain or the FDA’s prior conclusions regarding the safety and effectiveness of approved compounds, which could expedite our development programs relative to seeking approval under the 505(b)(1) regulatory pathway.

If the FDA changes its 505(b)(2) policies and practices or if Congress were to amend the statute to alter the currently available regulatory pathway, it could delay or even prevent the FDA from approving any NDA we submit under Section 505(b)(2).

In addition, the pharmaceutical industry is highly competitive, and Section 505(b)(2) NDAs are subject to special requirements designed to protect the patent rights of sponsors of previously approved drugs referenced in a Section 505(b)(2) NDA.

Even if we are able to utilize the Section 505(b)(2) regulatory pathway for one or more of our candidates, there is no guarantee this would ultimately lead to faster product development or earlier approval.

Moreover, any delay resulting from our inability to pursue the FDA's 505(b)(2) pathway could result in new competitive products reaching the market more quickly than our product candidates, which may have a material adverse impact on our competitive position and prospects.

Even if we are allowed to pursue the FDA's 505(b)(2) pathway, we cannot assure you that our product candidates will receive the requisite approvals for commercialization.

In addition, Section 505(b)(2) NDAs are subject to special requirements designed to protect the patent rights of sponsors of previously approved drugs referenced in a Section 505(b)(2) NDA, and the filing of a patent infringement lawsuit against us following our submission of a 505(b)(2) NDA could significantly delay any potential FDA approval of the NDA.

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.

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.

"BUSINESS–Government Regulation–U.S.

Government Regulation–FDA Review and Approval Process for Combination Products,” above for more information about the FDA review and approval process for combination products.

This would significantly increase the anticipated cost and timeline to completion of Ovaprene’s development and require us to raise additional funds.

However, the FDA may determine that the results of the study are not sufficiently robust or convincing and require additional clinical and/or nonclinical studies prior to approval of Ovaprene.

If we are unable to pursue FDA approval via the FDA's 505(b)(2) pathway or, in the case of Ovaprene, through review of a PMA by CDRH, new competitive products may reach the market more quickly than our product candidates, which may have a material adverse impact on our competitive position and prospects.

Even if we are allowed to pursue the FDA's 505(b)(2) pathway, and in the case of Ovaprene, review of a PMA by CDRH, we cannot assure you that our product candidates will receive the requisite approvals for commercialization.

Some of our product candidates may be considered combination products by the FDA and other regulatory authorities, which could increase the complexity, cost and timeline for their development and regulatory approval.

To the extent our product candidates meet the FDA’s or any other regulatory authority’s definition of a combination product, the regulatory approval requirements can be more complex and costly because, in addition to the individual regulatory requirements for each component, e.g., a drug and a medical device, additional combination product regulatory requirements may apply.

"BUSINESS–Government Regulation–U.S.

Government Regulation–FDA Review and Approval Process for Combination Products,” above.

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.

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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Thus, the risk of adverse fetal development from any one or more of these product candidates may be greater than expected.

Should any of these product candidates be shown to increase the risk of adverse fetal development, our ability to develop those or other product candidates would be substantially impaired, our business prospects and operations would be materially harmed, and we could also be subject to potential claims and lawsuits.

Pre-clinical product candidates may not be valued by investors and may be difficult to fund.

Should any of these product candidates be shown to increase the risk of adverse fetal development, our ability to develop those or other product candidates would be substantially impaired, our business prospects and operations could be materially harmed, and we could also be subject to potential claims and lawsuits.

Pre-clinical product candidates may be undervalued by investors and may be difficult to fund.

Given their early stage of development and the lack of data, many pre-clinical assets are often perceived as having low valuations by investors and potential strategic collaborators, such as pharmaceutical companies.

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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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If pre-clinical studies of product candidates do not generate strong data, our pre-clinical stage programs may never progress to clinical development and may prove to be worthless.

The grants supporting the DARE-LARC1 and DARE-LBT programs do not guarantee that pre-clinical development will be successful or that we will be able to fund their clinical development in the future.

The grants supporting pre-clinical development of DARE-LARC1 and DARE-LBT, including the grant agreement under which we were awarded up to $48.95 million in non-dilutive funding for pre-clinical development of DARE-LARC1, do not guarantee that pre-clinical development will be successful, or, even if we are successful with all

specified pre-clinical activities, that we will be able to fund their future clinical development.

Further, while we received aggregate payments of approximately $28.4 million under the 2021 DARE-LARC1 grant agreement as of December 31, 2023, additional payments are contingent upon the DARE-LARC1 program’s achievement of specified development and reporting milestones during the grant period and our compliance with other obligations under the agreement, and there is no assurance those milestones will be achieved or that we will receive additional payments or the full potential amount of the grant.

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.

Further, the grant agreements or other non-dilutive funding award agreements supporting these development programs generally feature milestone-based payments or, in the case of NIH grants, payments are received in reimbursement of specified activities, and there is no assurance that we will be able to achieve or otherwise demonstrate satisfaction of the specified development and reporting milestones required to receive future payments under the agreements.

Additionally, the counterparties to these agreements may modify, suspend, discontinue payment of funds or terminate the agreements in certain circumstances largely in their discretion.

Accordingly, we may never receive future payments under these agreements or realize the full potential amount of the grant or other funding award.

Risks Related to Our Dependence on Third Parties

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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, Ovaprene.

We also have a CRADA for the conduct of a pivotal clinical study of Ovaprene with NICHD.

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.

However, these collaborations make the successful development and commercialization of our products and product candidates dependent upon the performance of third parties.

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.

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.

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Moreover, the risks relating to product development, regulatory approval and commercialization and compliance with health care related laws and regulations described in this report also apply to the activities of our collaborators.

Except to the extent of any license fees or milestone payments under our current and any future collaboration agreements, because we currently have only one FDA-approved product, our ability to generate revenue over the next several years will largely be dependent on royalties and net sales-based milestones under our exclusive license agreement with Organon.

Accordingly, our revenues may be dependent on Organon's ability to successfully market, sell and distribute XACIATO and to perform its contractual obligations.

Organon has global commercial rights to XACIATO under our exclusive license agreement.

There is no assurance that commercialization of XACIATO in the U.S.

will be successful, or that Organon will pursue development and commercialization of XACIATO outside of the U.S.

The amount of royalty and milestone payments we will receive under the license agreement is uncertain.

As discussed elsewhere in this Risk Factors section, as a result of the traditional royalty purchase agreement we entered into with XOMA, whether we receive any future income based on net sales of XACIATO will depend on whether the Revenue Sharing Threshold is reached, which will depend, in part, on Organon's future commercial success with XACIATO, which is outside of our control.

Apart from Organon's diligence obligation under our license agreement, we have no control over the efforts and resources Organon devotes to the marketing and sale of XACIATO.

The occurrence of any of the risks described above could negatively impact the commercial success of XACIATO and have a material adverse effect on our business, financial condition and results of operations.

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

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

If the CRADA is terminated before completion of the Phase 3 study of Ovaprene, 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.

If we fail to make any scheduled payment to NICHD under the CRADA, NICHD is not obligated to carry out R&D activities until it receives the funds.

We have paid NICHD $5.0 million under the CRADA to date.

Under the terms of the CRADA, a final payment of $0.5 million was due in the second quarter of 2023.

Pursuant to our discussions with NICHD, we expect to make the final payment in the third quarter of 2024.

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 of Ovaprene and on our business, results of operations and financial condition, and may cause the market price of our common stock to decline.

We face significant competition in seeking strategic collaborations.

Collaborations can also be complex and time-consuming arrangements to negotiate and document.

If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product or

product candidate, reduce or delay one or more of our other development programs, delay or reduce the scope of any commercial readiness activities, delay commercialization, or increase our expenditures and undertake development or commercialization activities at our own expense.

If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product or product candidate, reduce or delay one or more of our other development programs, delay or reduce the scope of any commercial readiness activities, delay commercialization, or increase our expenditures and undertake development or commercialization activities at our own expense.

Our success in entering into a definitive agreement for any collaboration will depend upon, among other things, our assessment of the prospective collaborator’s resources and expertise, the terms of the proposed collaboration and the proposed collaborator’s evaluation of several factors.

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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.

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.

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 man-made disasters, or public health emergencies such as the COVID-19 pandemic.

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.

For example, our single source CMO for Ovaprene is located in an area of the U.S.

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We may not have adequate or any recourse against a CMO or supplier who does not perform or terminates its agreement with us if such non-performance or termination is excused under the applicable agreement.

We do not have long-term supply agreements with any of our CMOs.

We do not have long-term supply agreements with any of our CMOs or raw materials suppliers.

We generally enter into manufacturing agreements on a project-by-project basis based on our development needs, which may heighten the risk of timely availability of sufficient quantities of our product candidates at acceptable costs for clinical trials.

For example, we do not have any long-term manufacturing or supply agreements with the CMO from which we plan to obtain clinical supplies for our first Phase 3 clinical study of Sildenafil Cream or with the current supplier of the API for Sildenafil Cream.

Future supplies of Sildenafil Cream or the raw materials required to produce it may be more difficult and costly to obtain because we do not have long-term supply contracts, which could make us more vulnerable to significant price increases.

As we advance development of our product candidates, we will need to negotiate agreements for commercial supply and we may not be able to reach agreement on a timely basis or acceptable terms, or at all.

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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.

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.

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

Furthermore, changes in currency fluctuations, shipping costs, or import tariffs could adversely affect cost of goods sold.

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.

Furthermore, future currency fluctuations, increased shipping costs, or new or increased U.S.

tariffs and trade disputes with other countries could increase our clinical development costs, and ultimately, our cost of goods sold, which could adversely impact our operating results and financial condition.

Any of the above factors could cause us to delay or suspend anticipated or ongoing clinical trials, regulatory submissions or commercialization of a product candidate, entail higher costs, or result in being unable to effectively commercialize an approved product.

Our dependence on third parties for the manufacture of our product candidates or future approved products may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis.

Similarly, while Organon now holds the FDA marketing approval and we have transferred XACIATO manufacturing responsibilities to Organon, commercial production and supply of XACIATO remains subject to comparable manufacturing risks as described herein, and any interruption in the commercial supply of XACIATO that directly or indirectly results in significant loss of product sales could have a material adverse effect on the payments we receive under our license agreement.

In some cases, we may be contractually required to obtain clinical or commercial product supplies from specific third parties or there may be a limited number of third-party suppliers of raw materials and other components of our product candidates or future products, which may heighten our dependence on those third parties and the risk of manufacturing disruptions.

Similarly, while Organon assumed manufacturing responsibility for XACIATO from us in December 2023, commercial production and supply of XACIATO remains subject to comparable manufacturing risks as described herein, and any interruption in the commercial supply of XACIATO that directly or indirectly results in significant loss of product sales could have a material adverse effect on future payments we may receive under the traditional royalty purchase agreement we entered into with XOMA.

Our agreement with ADVA-Tec restricts our ability to engage a manufacturing source for Ovaprene other than ADVA-Tec during Ovaprene's development period as well as following regulatory approval, subject to limited exceptions.

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Furthermore, for some key raw materials and components of Ovaprene, there currently is only a single source of supply, and alternate sources of supply may not be readily available.

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

We do not have any long-term manufacturing or supply agreements with the CMO from which we plan to obtain Sildenafil Cream for our first Phase 3 clinical study of Sildenafil Cream or with any supplier of the raw materials required to produce Sildenafil Cream.

Future supplies of Sildenafil Cream or the raw materials required to produce Sildenafil Cream may be more difficult and costly to obtain.

For example, the current supplier of sildenafil is located in India.

Should this supplier slow production, shut down its factory or increase its prices for any reason, including due to factors outside of its control such as a public health emergency or geopolitical conflicts or events, we may not be able to obtain adequate supplies of sildenafil to satisfy our clinical supply requirements.

We rely on, and intend to continue to rely on, third parties for the execution of significant aspects of our product development programs.

Failure of these third parties to successfully carry out their contractual duties, comply with regulatory requirements and applicable law, or meet expected deadlines may cause significant delays in our development timelines and/or failure of our programs.

Our business model relies on the outsourcing of important product development functions, tests and services to CROs, medical institutions and other specialist providers, vendors and consultants.

We rely on these third parties to conduct our clinical trials and perform related activities, including quality assurance, clinical monitoring and clinical data management, as well as to assist us in preparing, submitting and supporting the applications necessary to gain marketing approvals for our product candidates.

For example, we engaged CROs to run all aspects of the pivotal Phase 3 clinical trial of XACIATO, the exploratory Phase 2b RESPOND clinical trial of Sildenafil Cream, the PCT clinical trial for Ovaprene, and our respective Phase 1/2 clinical studies of DARE-HRT1 and DARE-VVA1.

In addition, our ongoing pivotal Phase 3 clinical trial of Ovaprene is being conducted by third parties under our CRADA with NICHD.

We similarly expect to rely on CROs and other third parties to perform all clinical and nonclinical testing and many other important development and regulatory affairs activities needed to support applications for regulatory approvals of all product candidates we develop.

We do not control these third parties and they may not devote sufficient time and resources to our projects, or their performance may be substandard, resulting in clinical trial delays or suspensions, delays in submission of our marketing applications or failure of a regulatory authority to accept our applications for filing.

There is no assurance that the third parties we or our strategic collaborators engage will be able to provide the functions, tests, activities or services as agreed upon, or provide them at the agreed upon price and timeline or to our requisite quality standards, including due to macroeconomic factors, geopolitical conflicts or events, natural or manmade disasters, public health emergencies or pandemics or poor workforce relations or human capital management.

We rely on the efforts of these third parties and if they fail to perform as expected, we could suffer significant delays and additional costs in, and potentially failure of, the development of one or more of our product candidates.

There is also no assurance these third parties will not make errors in the design, management or retention of our data or data systems.

Any failures by such third parties could lead to a loss of data, which in turn could lead to

delays in clinical development and obtaining regulatory approval.

Third parties may not pass FDA or other regulatory audits, which could delay or prohibit regulatory approval.

In addition, the cost of such services could significantly increase over time.

If these third parties do not successfully carry out their contractual duties or meet expected deadlines, regulatory approval of current and future product candidates may be delayed, prevented or cost significantly more than expected, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

In particular, as a result of the CRADA, we are highly dependent on NICHD and the third parties it engages for the conduct and completion of our ongoing pivotal Phase 3 clinical trial of Ovaprene.

Pursuant to the terms of the CRADA, the study is being conducted within NICHD’s Contraceptive Clinical Trial Network, or the CCTN, with NICHD's selected CRO providing clinical coordination and data collection and management services for the study.

NICHD is responsible for selecting participating clinical sites from the pool of CCTN sites and, together with its selected CRO, overseeing the clinical investigators in the conduct of the study, providing clinical site monitoring and quality assurance along with establishing the electronic data capture database for the study and performing data analysis, which are key factors to the successful completion of a clinical trial.

We do not control these third parties and, accordingly, our control over the conduct and completion of the study is limited.

If NICHD or the third parties it engages for the study prioritize other projects over the study or otherwise do not devote adequate time and resources to the study, or their performance is substandard, completion of the study may be delayed or suspended or the study may be unsuccessful, which could significantly harm our business, operating results and financial condition, as well as our relationship with Bayer, and cause the price of our common stock to decline.

We rely on, and intend to continue to rely on, third parties to conduct our clinical and nonclinical studies and execute other significant aspects of our product development programs.

Failure of these third parties to successfully carry out their contractual duties, comply with our clinical protocols or regulatory requirements and applicable law, or meet expected deadlines may cause significant delays in our development timelines and/or failure of our programs.

Our business model relies on the outsourcing of important product development functions, tests and services to third parties.

We rely on CROs, medical institutions, clinical investigators, laboratories, vendors and consultants to conduct all of our clinical trials and perform nonclinical testing.

These third parties play a significant role in the conduct and timing of our clinical and nonclinical studies and the collection, management and analysis of study data, which are critical to our business.

In addition, we have relied, and expect in the future to rely, on third parties to assist us in preparing, submitting and supporting the applications necessary to gain marketing approvals for our product candidates.

We enter into agreements with these third parties governing their work for us, but we do not control them and have limited influence over their actual performance.

They may not devote sufficient time and resources to our projects, or their performance may be substandard, resulting in clinical trial delays, suspensions or terminations, delays in submission of our marketing applications, failure of a regulatory authority to accept our applications for filing or receipt of a CRL.

The performance of these third parties may also be negatively impacted by macroeconomic factors, geopolitical conflicts or events, natural or manmade disasters, public health emergencies, information system and cybersecurity incidents, and workforce challenges.

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.

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.

If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties on commercially reasonable terms, in a timely manner, or at all.

Switching or adding additional CROs, study sites, and other third party service providers due to substandard or inadequate performance or termination of a relationship involves additional cost and requires our management’s time and focus.

In addition, there is a natural transition period when a new CRO commences work.

As a result, delays occur, which can materially impact our ability to meet our communicated clinical development timelines.

Though we work to carefully manage our relationships with our CROs, study sites, and other third parties, we have encountered challenges and delays in our clinical and nonclinical studies as a result of performance issues in the past, and there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition, and prospects.

Our ability to develop and commercialize our product candidates depends upon maintaining rights granted to us under license agreements with third parties.

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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.

strategic justification for the discontinuation and failure.

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

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In February 2018, we entered into a world-wide license and collaboration agreement with SST for the exclusive worldwide rights to develop and commercialize Sildenafil Cream for all indications for women related to female sexual dysfunction and/or female reproductive health, including treatment of FSAD.

The SST license agreement provides that each party will have customary rights to terminate the agreement in the event of material

uncured breach by the other party and under certain other circumstances.

The SST license agreement provides that each party will have customary rights to terminate the agreement in the event of material uncured breach by the other party and under certain other circumstances.

The SST license agreement provides SST with the right to terminate it with respect to the applicable SST licensed products in specified countries upon 30 days’ notice if we fail to use commercially reasonable efforts to perform development activities in substantial accordance with the development plan contained in the SST license agreement, or any updated development plan approved by the joint development committee, and do not cure such failure within 60 days of receipt of SST’s notice thereof.

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In April 2018, we entered into the Catalent license agreement under which we acquired exclusive global rights to Catalent's IVR technology platform, including the product candidates we now call DARE-HRT1, DARE-FRT1, and DARE-PTB1.

Under this agreement, we must use commercially reasonable efforts to develop and make at least one product or process available to the public, which efforts include achieving specific diligence requirements by specific dates specified in the agreement, and Catalent may terminate the agreement upon 60 days’ notice for any uncured material breach by us of any of our other obligations under the agreement.

Under this agreement, we must use commercially reasonable efforts to develop and make at least one product or process available to the public, which efforts include achieving specific diligence requirements by dates specified in the agreement, and Catalent may terminate the agreement upon 60 days’ notice for any uncured material breach by us of any of our other obligations under the agreement.

"BUSINESS-Strategic Agreements for Pipeline Development-Catalent JNP License Agreement,” above.

In May 2018, we completed our acquisition of Pear Tree and obtained exclusive global rights to certain patents and know-how to develop and commercialize a proprietary formulation of tamoxifen for vaginal administration, which led to our DARE-VVA1 program.

Under the applicable license agreements, as amended, we are required to use commercially reasonable efforts or reasonable best efforts to bring licensed products and processes to market, which include achieving specified milestones.

The licensors may terminate the agreements for failure to make certain payments due to the licensors and any uncured material breach or default, including breach of our diligence obligations.

"BUSINESS-Strategic Agreements for Pipeline Development—Pear Tree Acquisition and License Agreements,” above.

In August 2023, we entered into a license agreement with Douglas for exclusive rights to develop and commercialize a lopinavir and ritonavir combination soft gel vaginal insert for the treatment of CIN and other HPV-related pathologies, and commenced our DARE-HPV program.

Under this agreement, we must use commercially reasonable efforts to develop and introduce to market at least one product or process, which efforts include achieving specific diligence requirements by dates specified in the agreement.

Douglas may terminate the agreement for any uncured failure to make certain payments, any uncured material failure to fulfill our diligence obligations, or any other uncured material breach of our other obligations under the agreement.

"BUSINESS-Strategic Agreements for Pipeline Development—Douglas License Agreement / The University of Manchester Stand-by Direct License Arrangement,” above.

If we do not meet our obligations under our license agreements in a timely manner, some of which require the expenditure or payment to the licensor of significant amounts of cash, or if we are unable to obtain an extension of deadlines for satisfying our obligations, we could lose our rights under these agreements.

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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, which could have a material adverse effect on our business prospects and operations.

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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• our diligence obligations under the license agreement and what activities satisfy those diligence obligations;

• the timing and amount of milestone or royalty payments due to the licensor;

• the sublicensing of patent and other rights to third parties under any such agreement or collaborative relationships;

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Even if we obtained the rights to additional product candidates, there can be no assurance those candidates would ever be advanced successfully through clinical development.

Risks Related to Commercialization of XACIATO and Our Product Candidates

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

If commercialization of XACIATO is not successful, or is perceived to be unsuccessful, our business, financial condition, results of operations and prospects may suffer, particularly because XACIATO is the first and only product for which we have received regulatory approval.

XACIATO’s commercial success will depend on many factors, including:

• the capabilities of Organon and its commitment of sufficient resources to market, distribute and sell the product;

• timely and adequate commercial supply of the finished product and its components;

• perceived superiority of its cure rates compared to other available treatments;

• the extent to which the approved product labeling contains features or expected benefits that differentiate it from other available treatments;

• preferences by health care providers and women for a vaginally administered therapy;

• the prevalence and severity of any adverse side effects;

• patient satisfaction and willingness to use it again and refer it to others;

• price pressure given the high level of generic treatments and changes in health care laws and regulations, including the Inflation Reduction Act of 2022;

• adequate coverage, pricing and reimbursement from third-party payors;

• the willingness of patients, without third-party insurance coverage or adequate reimbursement, to pay for the product;

• the success or failure of other branded therapies;

• market exclusivity provided by our intellectual property rights or conferred by regulatory authorities;

• approval of new entrants, including alternative, non-antibiotic treatment options.

There is no assurance that Organon’s efforts with respect to XACIATO will be successful or that product sales will be able to generate revenue to us at the levels or within the timing we expect or at the levels or within the timing necessary to support our goals.

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

We have no internal sales, marketing or distribution capabilities.

If we are unable to establish those capabilities on our own or through third parties, we will be unable to successfully commercialize our product candidates, if approved, or generate product sales revenue.

We do not have a product marketing, sales or distribution infrastructure.

Risks Related to Commercialization of Products We Develop

We have no internal sales, marketing or distribution capabilities, and we may need to invest significant resources to establish those capabilities.

If we are unable to timely establish those capabilities on our own or through arrangements with third parties, product launch may be delayed, commercialization may be adversely impacted, and we may not be able to generate product sales revenue.

We currently do not have, and have never had, product marketing, sales or distribution infrastructure.

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

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

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

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.

To generate revenue from our product candidates, if approved, we may need to establish a commercial infrastructure.

There are significant risks involved with establishing our own commercial infrastructure.

For example, recruiting and training a sales force is expensive and time-consuming and could delay product launch.

If we recruit and train a sales force and the commercial launch of the product is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred significant commercialization expenses.

This may be costly, and our investment would be lost if we could not retain or reposition our sales and marketing personnel.

Both the launch and ongoing commercial support of our products would require significant capital, which may not be available to us

when needed or on acceptable terms 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.

To generate revenue from our product candidates, if approved for commercial sale, we may need to establish our own sales forces and commercial infrastructure.

There are significant challenges and risks involved with building and managing a sales organization and other commercial infrastructure, even if we collaborate with third parties that have established sales forces and distribution systems to augment our own capabilities, including:

• difficulties in recruiting and retaining adequate numbers of qualified individuals;

• providing adequate training for sales and marketing and support personnel;

• effectively managing a geographically dispersed sales force;

• difficulties generating sales leads;

• potential lack of complementary products our sales personnel may be able to offer compared with sales personnel for competitive products;

• unforeseen costs and expenses associated with establishing a new corporate function and the rapid growth of our company.

Recruiting, incentivizing and training a sales force is expensive and requires substantial management time and focus.

On the other hand, if we do not timely establish a sales force and other commercial infrastructure, a product launch may be significantly delayed, adversely impacting the potential commercial success of the product, as well as our operating results and financial condition.

Both the launch and ongoing commercial support of our products would require significant capital, which may not be available to us when needed or on acceptable terms or at all.

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

In addition, there is no guarantee that our efforts to generate product revenue would be successful.

Factors that may hinder efforts to commercialize our products on our own include:

• our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

• the inability of sales personnel to obtain access to physicians or educate an adequate number of physicians as to the benefits of our products;

• the lack of complementary products our sales personnel could offer, which may put us at a competitive disadvantage compared to companies with more extensive product lines;

• unforeseen costs and expenses associated with creating an independent sales and marketing organization.

The risks described above may also apply if our commercial collaborations do not involve an exclusive license of substantially all commercialization rights to a third party and we instead enter into co-promotion arrangements with a third party.

Failure to timely enter into or maintain a commercialization arrangement with a third party or establish our own commercialization capabilities could significantly delay commercial launch of our products or require us to reduce the scope of any sales and marketing activities, which could have a material adverse effect on our business, financial condition and results of operations.

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

The biopharmaceutical industry is intensely competitive and characterized by rapid technological developments.

Our competitors and potential competitors include large, well-established pharmaceutical and biotechnology companies, many of which have robust product portfolios and strong franchises in women’s health.

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.

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.

The pharmaceutical industry is intensely competitive and characterized by rapid technological developments.

Moreover, the women’s health sector is very fragmented and highly competitive.

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

We face and will continue to face intense competition from a variety of businesses, including large, fully integrated, well-established pharmaceutical companies and specialty pharmaceutical companies that already possess robust product portfolios and strong franchises in women’s health in areas in which we plan to compete, as well as generics manufacturers, compounding pharmacies and other drug compounding facilities, and dietary supplements manufacturers.

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

Many of our competitors or potential competitors, either alone or with strategic collaborators, have:

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Alternatively, competitive products may be safer or more effective, more convenient to use, have better insurance coverage or reimbursement levels or be more effectively marketed and sold than our products.

Our product candidates, if approved, will compete with products that have already been accepted by the medical community and patients.

Many of our product candidates, if approved for commercial sale, will compete with products that have already been accepted by the medical community and patients.

If our product candidates fail to generate compelling clinical results or if patients and health care providers fail to adopt our products for their respective indications, their commercial potential could be adversely impacted or severely diminished.

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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.

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.

With respect to XACIATO, there are many FDA-approved products for treating bacterial vaginosis, and many are generic.

XACIATO will compete with those products.

Current therapies for the treatment of bacterial vaginosis primarily consist of oral and vaginal formulations of antibiotics delivered as a single dose or through multiple doses over consecutive days.

If health care providers do not view the prescribing information for XACIATO as compelling compared with other products available for the treatment of bacterial vaginosis, or if competitive products have better insurance coverage or reimbursement levels than XACIATO, health care providers may opt to continue to prescribe existing treatments rather than recommend or prescribe XACIATO to their patients.

In addition, women may prefer orally delivered options to vaginally administered XACIATO unless they view XACIATO as providing significantly

superior efficacy, safety and/or convenience.

Failure of our commercial collaborator to generate significant net sales of XACIATO would negatively effect the payments we receive under our license agreement.

The women's health market includes many generic products and growth in generics is expected to continue, which could make the successful introduction of our branded products difficult and expensive.

With respect to XACIATO, there are multiple generic and branded prescription drug products currently approved in the U.S.

for the treatment of bacterial vaginosis, including oral and vaginal gel formulations of metronidazole and vaginal cream formulations of clindamycin.

If health care providers do not view the prescribing information for XACIATO as compelling compared with other products available for the treatment of bacterial vaginosis, or if competitive products have better insurance coverage or reimbursement levels than XACIATO, health care providers may opt to prescribe a competitive product rather than recommend or prescribe XACIATO to their patients.

In addition, women may prefer orally delivered options to vaginally administered XACIATO unless they view XACIATO as providing significantly superior efficacy, safety and/or convenience.

If our commercial collaborator fails to generate significant net sales of XACIATO which exceed the Revenue Sharing Threshold, we will not have any future revenue stream relating to XACIATO.

The women's health market includes many generic FDA-approved drug products, compounded drugs, as well as dietary supplements and consumer health products, and growth in these categories is expected to continue, which could make the successful introduction of our products difficult and expensive.

The proportion of the U.S.

market made up of generic products has been increasing.

If this trend continues, it may be more difficult for us or a commercial collaborator to introduce a new branded medical product, if approved, at a price that will allow us to achieve acceptable levels of revenue and net income from product sales.

Generic competition is particularly strong in contraception and hormone therapy, which are areas in which our product candidates, if approved, will compete.

In order for our branded products to develop commercial markets and for third-party payors to cover these higher cost products, our products must demonstrate better patient compliance and clinical benefit in their clinical trials compared to other available products.

Additional marketing and educational efforts may be required to introduce a new branded prescription medical product in order to overcome the trend towards generics and gain access to reimbursement by payors.

If we or a commercial collaborator cannot introduce a product at the desired price or gain reimbursement from payors for the product, or if patients opt for a lower cost generic product rather than pay out-of-pocket or a higher co-pay for our product, our revenues or royalties and other license fees, as applicable, will be limited.

XACIATO and any of our future approved products 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.

XACIATO and any future products may fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community.

If XACIATO and any future products do not achieve an adequate level of market acceptance, they may not generate significant net product revenue or net sales or result in significant payments to us from our commercial collaborators, we may suffer reputational harm and we may never become profitable.

The degree of market acceptance of XACIATO and any future products will depend on several factors, including:

• the timing of our receipt of any marketing approvals and the jurisdictions in which marketing approvals are obtained;

• the terms of any approvals, such as any restrictions on the use of our product together with other medications;

• the indications for which the product is approved;

• demonstrated evidence of efficacy and safety;

• the approval and availability of alternative treatments and products for the same indications as our product;

• the prevalence and severity of any adverse side effects associated with our product;

• convenience and ease of administration for patients compared to alternative treatments and products, or other potential advantages and disadvantages compared to the alternatives;

• adverse publicity about our product or favorable publicity about competing products;

• our ability to offer our product for sale at competitive prices;

• the willingness of the target patient population to try a new product and of physicians to prescribe a new product;

• the success of any physician education programs for our product;

• the availability and extent of third-party coverage and reimbursement for our product and amount of out-of-pocket cost to patients;

• the willingness of uninsured patients to pay for the product;

• the willingness of pharmacy chains to stock the product;

• effectiveness of our or our collaborators’ sales and marketing strategy and efforts.

If XACIATO or any future product does not achieve an adequate level of market acceptance, it could have a material and adverse effect on our business, financial condition, results of operation and prospects.

The commercial success of Ovaprene, if approved, will depend on market acceptance of a hormone-free, monthly intravaginal product, availability and effectiveness of alternative contraceptive products and women's preferences, as well as the success of Bayer’s marketing and sales efforts.

Today, there are a variety of hormonal and non-hormonal contraceptive options available to women, including oral contraceptive pills and intrauterine devices, newer hormonal contraceptive products including implants, injectables, vaginal rings, patches, and hormonal intrauterine systems, and non-hormonal methods such as female condoms, novel diaphragms, and new methods of female sterilization.

drug market made up of generic products has been increasing.

In addition, compounded drugs and dietary supplements in women’s health are multi-billion dollar markets.

As a result, even if our product candidates are approved, it may be more difficult for us or a commercial collaborator to introduce a new product, particularly a branded prescription product, at a price that will allow us to achieve acceptable levels of revenue and net income from product sales.

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.

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

In order for our branded products to develop commercial markets and for third-party payors to cover these higher cost products, our products must demonstrate better patient compliance and clinical benefit as compared to what other available products have demonstrated.

Additional marketing and educational efforts may be required to introduce a new branded prescription medical product in order to overcome use of generic products, compounded drugs and dietary supplements and gain access to reimbursement by payors.

If we or a commercial collaborator cannot introduce a product at the desired price or gain reimbursement from payors for the product, or if patients opt for a lower cost generic product, compounded drug, or dietary supplement rather than pay out-of-pocket or a higher co-pay for our product, our sales revenues or royalties and other license fees, as applicable, will be limited and we may never become profitable.

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.

The commercial success of any product we develop and bring to market, or is marketed by a licensee, will depend significantly on the broad acceptance of the product by physicians, patients, and others in the medical community, as well as, in many cases, third-party payors.

The degree of market acceptance of our products will depend on several factors, including:

• the indication for which the product is approved;

• the timing of market introduction of the product and availability of alternative treatments and products for the same indication;

• the demonstrated clinical efficacy and safety of the product, including as compared to alternative products;

• the terms of regulatory approval, such as any restrictions on the use of the product together with other medications, or required warnings in the product labeling;

• the prevalence and severity of any adverse side effects associated with the product, including as compared to alternative treatments and products;

• the convenience and ease of administration for patients, including as compared to alternative treatments and products;

• the willingness of the target patient population and prescribing physicians to try a new product ;

• the effectiveness of the sales and marketing strategy and efforts for the product, including the success of efforts to educate the medical community and third-party payors regarding the benefits of the product;

• the pricing and cost-effectiveness of the product, including as compared to alternative treatments and products;

• the availability and extent of third-party coverage and reimbursement for the product;

• the willingness of patients to pay all, or a portion of, the out-of-pocket cost for the product in the absence or insufficiency of third-party payor coverage and reimbursement;

• unfavorable publicity relating to the product or products with the same or similar APIs, or favorable publicity about competing therapies or products ;

• the existence and extent of pending or potential product liability claims.

If XACIATO or any future product does not achieve an adequate level of market acceptance, the product may not generate significant revenue or may generate substantially less revenue than anticipated, which could have a material and adverse effect on our business, financial condition, results of operation and prospects.

We may suffer reputational harm and we may never become profitable.

XACIATO’s commercial success will depend on many factors, including those discussed elsewhere in these “Risks Related to Commercialization of Products We Develop” and “Risks Related to Our Intellectual Property” below, as well as the capabilities of Organon and its commitment of sufficient resources to market, distribute and sell the product, preferences by health care providers and women for a vaginally administered therapy, and regulatory approval and market introduction of alternative therapies, including non-antibiotic treatment options.

We have limited control over Organon’s efforts with respect to XACIATO and there is no assurance they will be successful or that the Revenue Sharing Threshold will be reached.

As discussed elsewhere in this Risk Factors section, we will not receive any payments based on product sales until after the Revenue Sharing Threshold is reached.

We may suffer reputational harm if XACIATO is not commercially successful and our ability to raise additional capital or enter into other commercial collaborations could be impaired.

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.

In addition, multiple new methods of pregnancy prevention are in development, including hormone-free options, and some may be marketed in the U.S.

before Ovaprene, potentially adding to the level of market competition Ovaprene will face, if approved.

In surveys, women have said that the features they consider most important when selecting a contraceptive method are efficacy, ease-of-use and side effects.

To have significant revenue potential as a new contraceptive product option, Ovaprene may need to have a typical use efficacy outcome (which is the expected rate of pregnancy protection once the product is used widely under everyday circumstances) comparable to current non-implanted hormonal contraceptive methods (pills, patches and vaginal rings), which is approximately 86%-91% typical use efficacy.

To have significant revenue potential as a new contraceptive product option, Ovaprene may need to demonstrate typical use efficacy (or the expected rate of pregnancy protection once the product is used widely under everyday circumstances) that approaches the approximately 93% typical use efficacy at 12 months of current FDA-approved non-implanted, non-injected hormonal contraceptive methods (pills, patches and vaginal rings).

Clinical testing will also need to demonstrate that the product can be safely worn for multiple weeks.

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

Risks related to market acceptance include:

• minimum acceptable contraceptive efficacy rates;

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.

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;

• perceived safety differences of hormonal and/or non-hormonal contraceptive options;

• competition from new lower dose hormonal contraceptives with more favorable side effect profiles;

• new generic contraceptive options including a generic version of the hormone-containing intravaginal product NuvaRing®;

• competition from new lower dose hormonal contraceptives with more favorable side effect profiles compared with higher dose hormonal contraceptives;

• preference for a monthly format product over contraceptive products to be taken daily or used in the moment;

• preference for an intravaginal product over other formats such as pills, patches, injectables and condoms;

• generic contraceptive options, including generic versions of the hormone-containing intravaginal product NuvaRing®;

• the effects of changes in health care laws and regulations on third-party payor coverage (including the birth control coverage mandate) and reimbursement and out-of-pocket costs to patients.

• the availability and extent of third-party coverage and reimbursement for our product, the amount of out-of-pocket cost to patients and the effects of any changes in health care laws and regulations, including the birth control mandate, on product pricing and coverage and out-of-pocket costs to patients.

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

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 is highly dependent on the efforts and activities of Bayer.

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.

The commercial success of Sildenafil Cream, if approved, will depend on the availability of alternative products for female sexual dysfunction disorders, the age group for which our product is indicated and women's preferences, in addition to the market's acceptance of our topical cream.

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.

Today, there are no FDA-approved products to treat FSAD.

While our goal is for Sildenafil Cream to be the first product to receive such approval, one or more competitive products may be approved before our product.

Even if we achieve our goal of being first-to-market for FSAD, the costs associated with introducing a new product into the sexual dysfunctions market would likely be significant, and regardless of the amount spent, there is no guarantee that our new product will be broadly adopted.

Women may be hesitant to use Sildenafil Cream for many reasons, including the lack of experience with any product designed to treat FSAD, the lack or perceived lack of clinical evidence supporting its benefits, and the out-of-pocket cost of Sildenafil Cream, particularly if it is not covered by insurance.

In addition, an FDA-approved Sildenafil Cream product may also have to compete with compounded drugs.

Some compounding entities currently supply topical cream formulations of sildenafil.

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

The availability of cream formulations of sildenafil through compounding entities, could make it more challenging for Sildenafil Cream to build and maintain market share.

Even if we achieve our goal of being first-to-market for FSAD, the costs associated with introducing a new branded prescription product into the female sexual dysfunction market would likely be significant, and regardless of the amount spent, there is no guarantee that our new product will be broadly adopted.

Broad market adoption of Sildenafil Cream will depend not only on Sildenafil Cream’s ability to demonstrate safety and effectiveness in treating FSAD in Phase 3 clinical trials, but a variety of factors, as 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.” If we or a commercial collaborator are not successful in increasing awareness and understanding about FSAD and Sildenafil Cream, the market potential of Sildenafil Cream will not be realized.

Women who experience low or no genital arousal may be hesitant to seek treatment due to stigma and embarrassment associated with sexual health issues, lack of understanding of normal versus abnormal sexual functioning, or lack of awareness that FSAD may be treated with medication.

Health care providers may be hesitant to prescribe Sildenafil Cream for many reasons, including lack of understanding or experience with female sexual dysfunction in general and FSAD in particular, lack of experience with any product approved to treat FSAD, or perceived lack of clinical evidence of the safety and efficacy of Sildenafil Cream.

Women may also be hesitant to use Sildenafil Cream for many reasons, including the lack of experience with any product designed to treat FSAD, concern over potential side effects, and the out-of-pocket cost of Sildenafil Cream, particularly if it is not covered by insurance.

Currently, third-party payors such as government health care programs and private insurance companies often do not cover products prescribed to treat female sexual dysfunction disorders.

If Sildenafil Cream is not an affordable option for a significant segment of potential users, the ability to build a commercial market for Sildenafil Cream will be significantly impaired.

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.

Based on our end-of-Phase 2 meeting with the FDA, we expect our pivotal Phase 3 clinical trials of Sildenafil Cream will be conducted in a premenopausal population.

Therefore, we expect initial FDA approval of Sildenafil Cream, if received, would be limited to premenopausal women.

We expect our pivotal Phase 3 clinical trials of Sildenafil Cream will be conducted in a premenopausal population.

Therefore, we expect initial FDA approval of Sildenafil Cream, if received, to be limited to premenopausal women.

Should Sildenafil Cream not be studied in older or elderly women, or, if studied in those populations, should it show increased risk of adverse reactions, or signs thereof, in older or elderly women during clinical development, the potential market for Sildenafil Cream could be significantly limited, which could have a material adverse impact on the value of this program.

If we receive marketing approval in the future, our commercial success with Sildenafil Cream will depend, in large part, on the ability of the product candidate to demonstrate safety and effectiveness in treating FSAD in clinical trials, as well as our ability, or that of a commercial collaborator, to educate doctors and women about the need to diagnose and treat FSAD and the potential benefits of using of Sildenafil Cream, which may not prove successful.

Sexual arousal can be influenced by many emotional and physiological factors.

To be successful, our clinical trials of Sildenafil Cream must anticipate such factors.

Sildenafil Cream is designed to increase local blood flow to the genital tissue.

Even if Sildenafil Cream demonstrates success in increasing blood flow, the product candidate may not demonstrate a significant, or any, increase in arousal or improvement in the overall sexual experience in some women in our clinical trials.

If we fail to generate compelling clinical results, we may not receive regulatory approval to market Sildenafil Cream, or, if approved, many physicians may not prescribe and/or many women diagnosed with sexual arousal disorder may opt not to try Sildenafil Cream.

If we fail to produce strong clinical outcomes, our ability to build a commercial market for Sildenafil Cream will be materially adversely impacted.

The commercial success of DARE-HRT1, if approved, will depend on the availability of alternative products for managing the vasomotor and vaginal symptoms of menopause and women's preferences, in addition to the market's acceptance of our IVR.

Treatments to address the symptoms associated with menopause, including the vasomotor symptoms, also known as hot flashes, include combinations of prescription hormones, some of which are FDA-approved and others which are prepared in compounding pharmacies.

Numerous products already exist, and this number is likely to expand with time.

In addition, there has been an emerging preference among some women and providers for bio-identical hormones that are chemically identical to those the body produces.

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

Until relatively recently, no FDA-approved bio-identical hormone treatments existed.

In 2018, Bijuva® estradiol and progesterone capsules, which are to be taken daily, received the first such approval.

Studies have failed to demonstrate that bio-identical hormones are safer than other hormones, so DARE-HRT1 will need to compete with many types of hormone therapy options in terms of convenience, safety and efficacy in managing symptoms of menopause.

Risks related to market acceptance of DARE-HRT1, if approved for hormone therapy, include:

• preference for a vaginal ring delivery of hormone therapy over pills, patches and creams by menopausal women;

• data regarding symptom relief of DARE-HRT1 over other hormonal treatments for vasomotor symptoms associated with menopause;

• preference for bio-identical hormones by women and health care providers;

• positive or negative news and research regarding bio-identicals;

• preference for an FDA-approved product by women and health care providers over treatments prepared in compounding pharmacies;

• the success or failure of Bijuva®, the first FDA-approved bio-identical product;

The commercial success of DARE-HRT1, if approved for commercial sale, will depend on the availability of alternative products for managing menopause symptoms, concerns about the safety of hormone therapy, and women's preferences, among other factors.

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.

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.

Bioidentical hormones refer to compounds that are chemically identical to those produced naturally in the human body.

Studies have not demonstrated that bioidentical hormones are safer than synthetic hormones, so DARE-HRT1 will need to compete with many types of hormone therapy options in terms of convenience, safety and efficacy in managing symptoms of menopause.

Risks related to market acceptance of DARE-HRT1 include:

• women's preference for vaginal ring delivery of hormone therapy over pills, patches and creams;

• women's preference for a monthly product format over products to be taken or applied daily;

• data regarding symptom relief of DARE-HRT1 compared with other treatments and products for VMS;

• preference for bioidentical hormones by women and health care providers;

• positive or negative news and research regarding hormone therapy in general and bioidentical hormone therapy in particular;

• preference for an FDA-approved product by women and health care providers over treatments prepared in compounding entities;

• the success or failure of other FDA-approved bioidentical hormone products and FDA-approved non-hormonal products for VMS;

• new information supportive or against the use of hormones in menopause;

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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

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.

Both prescription drug and medical device promotional materials must present a fair balance between the product’s effectiveness and the risks associated with its use, and must be truthful and not misleading.

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Should increased risk of miscarriage or other adverse effects on maternal or fetal outcomes or breastfed infants be observed in future data from market surveillance or clinical trials of XACIATO or other clindamycin products, XACIATO’s commercial potential may be limited and we could become subject to product liability claims and lawsuits.

The occurrence of any of the circumstances described above could reduce XACIATO’s market acceptance, inhibit or delay its commercialization within or outside of the U.S.

and adversely affect sales of XACIATO, which could, in turn, have a significant negative impact on the payments we receive under our license agreement with our commercial collaborator for XACIATO, as well as our stock price.

The occurrence of any of the circumstances described above could reduce XACIATO’s market acceptance and adversely affect sales of XACIATO in the U.S.

and inhibit or delay its development, approval or commercialization outside of the U.S., which could, in turn, have a significant negative impact on potential payments to us under the traditional royalty purchase agreement we entered into with XOMA, as well as our stock price.

If we suffer negative publicity concerning the safety or efficacy of XACIATO or the product candidates we develop, our reputation could be harmed, product sales could be adversely affected or we may be forced to cease or curtail product development efforts.

If concerns should arise about the actual or anticipated clinical outcomes regarding the safety of XACIATO or any of our product candidates, including as a result of safety concerns related to third-party products containing the same or similar active or excipient substances, such concerns could adversely affect the market’s perception of XACIATO and our product candidates.

Negative publicity could be time consuming and expensive to address and could adversely affect potential opportunities with strategic partners or collaborators, lead to a decline in product sales, and negatively impact investor sentiment toward a product or product candidate or our company as a whole, which could lead to a decline in the price of our common stock.

If concerns should arise about the actual or anticipated clinical outcomes regarding the safety of any of our product candidates, or about adverse event reports on XACIATO, including as a result of safety concerns related to third-party products containing the same or similar active or excipient substances, such concerns could adversely affect the market’s perception of XACIATO and our product candidates.

We are and will remain subject to ongoing regulatory requirements even after obtaining regulatory approval for a product candidate.

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Third-party payors, such as government health care programs, private health insurers, managed health care providers, and other organizations, are increasingly challenging medical product prices and examining the medical necessity and cost-effectiveness of medical products, in addition to their safety and efficacy.

If these third-party payors do not consider XACIATO or any future product to be cost-effective compared to other available therapies and medical products, they may not cover the product as a benefit under their plans or, even if they do, the level of payment may not be sufficient to allow us, or a commercial collaborator, to sell the product on a profitable basis.

If these third-party payors do not consider XACIATO or any future product to be medically necessary or cost-effective compared to other available therapies and medical products, they may not cover the product as a benefit under their plans or, even if they do, the level of payment may not be sufficient to allow us, or a commercial collaborator, to sell the product on a profitable basis.

Coverage decisions can depend upon clinical and economic standards that disfavor new prescription medical products when more established or lower cost alternatives are already available or subsequently become available.

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Our inability, or that of our commercial collaborator, to obtain coverage and profitable payment rates from both government-funded and private payors for XACIATO or any future product could have a material adverse effect on our operating results, our ability to raise capital needed to execute our business strategy and our overall financial condition.

Failure by us or a commercial collaborator to obtain timely and adequate coverage and pricing for XACIATO and any future products, or obtaining such coverage and pricing at unfavorable levels, could materially adversely affect our business, financial condition, results of operations and prospects.

Failure by us or a commercial collaborator to obtain timely and adequate coverage and pricing for a product, or obtaining such coverage and pricing at unfavorable levels, could materially adversely affect our business, financial condition, results of operations and prospects.

Legislation and legislative and regulatory proposals intended to contain health care costs may adversely affect our business.

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Even seemingly small copayments or other cost-sharing requirements could dramatically reduce the market potential for XACIATO and our product candidates.

If the out-of-pocket costs for XACIATO or any of our product candidates, if approved, are deemed by women to be unaffordable, or if less expensive alternatives exist, a commercial market may never develop or the market potential for that product may be significantly reduced, which could have a material adverse effect on our business, financial condition, and prospects.

If the out-of-pocket costs for XACIATO or any of our product candidates, if approved for commercial sale, are deemed by women to be unaffordable, or if less expensive alternatives exist, a commercial market may never develop or the market potential for that product may be significantly reduced, which could have a material adverse effect on our business, financial condition, and prospects.

With regard to contraceptive products, the ACA and subsequent regulations enacted by DHHS, require health plans to provide coverage for women’s preventive care, including all forms of FDA-cleared or approved contraception, without imposing any cost sharing on the plan beneficiary.

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Any future repeal or elimination of the ACA’s preventive care coverage rules would mean that women seeking to use prescribed forms of contraceptives may have to pay some portion of the cost for such products out-of-pocket, which could deter some women from using prescription contraceptive products or branded prescription contraceptive products, including Ovaprene and our other investigational contraceptive products, if and when approved by the FDA.

As no FDA-approved treatments for FSAD currently exist, there is little precedent to help assess whether health insurance plans will cover Sildenafil Cream, if approved.

As no FDA-approved treatments for FSAD currently exist, there is little precedent to help assess whether health insurance plans will cover Sildenafil Cream, if approved for commercial sale.

Sildenafil Cream is being developed for female sexual arousal disorder, a life altering, but not a life threatening, condition.

Hence, there is no assurance that third-party reimbursement will be available for Sildenafil Cream, if approved.

Hence, there is no assurance that third-party reimbursement will be available for Sildenafil Cream, if approved for commercial sale.

Even if reimbursement becomes available, the amount of such reimbursement may not make our product affordable to women and profitable to us.

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If Sildenafil Cream fails to obtain insurance coverage, or if the patient’s share of the cost is deemed to be expensive, a market may never develop for Sildenafil Cream, which would have a material adverse effect on our financial condition and prospects.

The commercial success of products we develop, if approved, will be impacted by the prescribing information approved by the FDA and comparable regulatory authorities outside the U.S.

The commercial success of products we develop, if approved for commercial sale, will be impacted by the prescribing information approved by the FDA and comparable regulatory authorities outside the U.S.

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.

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

Drug products and drug/device combination products are complex to manufacture, and manufacturing disruptions may occur that could cause significant delays and disruption in the commercial supply of any product we develop, if approved.

The manufacture of our product candidates is complex, subject to compliance with extensive regulatory requirements and we are dependent on, and expect to continue to rely on, contract manufacturers and other third parties to supply our products and their components.

Manufacturing disruptions could cause significant delays and disruption in the commercial launch and/or supply shortages of any product we develop.

The manufacture of drug products and drug/device combination products can be complex and is subject to compliance with extensive regulatory requirements and we are dependent on, and expect to continue to rely on, contract manufacturers and other third parties to supply our products and their components.

Manufacturing disruptions may occur, including as a result of scaling up production to meet commercial requirements or due to global supply chain disruptions.

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“Risks Related to Our Dependence on Third Parties- 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 clinical study materials, including multiple single source suppliers and manufacturers.

If these third parties do not perform as we expect, do not maintain their regulatory approvals or become subject to negative circumstances, it could delay, prevent or impair our product development or commercialization efforts, or those of our collaborators, and harm our business;” and “Risks Related to Our Dependence on Third Parties- In some cases, we may be contractually required to obtain clinical or commercial product supplies from specific third parties or there may be a limited number of third-party suppliers of raw materials and other components of our product candidates or future products, which may heighten our dependence on those third parties and the risk of manufacturing disruptions.”

If competitors obtain approval for generic versions of XACIATO or any future products, our business may suffer.

XACIATO and any future product may face direct competition from generic products earlier or more aggressively than anticipated, depending upon the product's success in the market.

If these third parties do not perform as we expect, do not maintain their regulatory approvals or become subject to negative circumstances, it could delay, prevent or impair our product development or commercialization efforts, or those of our collaborators, and harm our business;” and “Risks Related to Our Dependence on Third Parties- In some cases, we may be contractually required to obtain clinical or commercial product supplies from specific third parties or there may be a limited number of third-party suppliers of raw materials and other components of our product candidates or future products, which may heighten our dependence on those third parties, increase the risk of manufacturing disruptions, and result in higher development costs or costs of goods sold.”

If competitors obtain approval for generic versions of our products, our business may suffer.

XACIATO and any future product we develop may face direct competition from generic products earlier or more aggressively than anticipated, depending upon the product's success in the market.

In addition to creating the 505(b)(2) NDA pathway, the Hatch-Waxman Act amendments to the FDCA authorized the FDA to approve generic drugs that are the same as drugs previously approved for marketing under the NDA provisions of the statute pursuant to abbreviated new drug applications, or ANDAs.

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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.

To market any future product outside the U.S., we, or our commercial collaborators, must obtain separate marketing approvals from comparable regulatory authorities for each jurisdiction and comply with numerous and varying regulatory requirements of other countries, including clinical trials, commercial sales, pricing, manufacturing, distribution and safety requirements.

To market any product outside the U.S., we, or our commercial collaborators, must obtain separate marketing approvals from comparable regulatory authorities for each jurisdiction and comply with numerous and varying regulatory requirements of other countries, including clinical trials, commercial sales, pricing, manufacturing, distribution and safety requirements.

The time required to obtain approval in other countries might differ from, and be longer than, that required to obtain FDA approval.

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In such an event, our ability, or our commercial collaborator’s ability, to market to the full target market for our products will be reduced and the full market potential of our products may not be realized, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

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.

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.

These arrangements also involve other risks, including:

• the inability of third parties to consistently meet product specifications and quality requirements;

• delay or inability to procure or expand sufficient manufacturing capacity;

• issues related to scale-up of manufacturing;

• costs and validation of new equipment and facilities required for scale-up;

• third parties may not be able to appropriately execute necessary manufacturing procedures and other logistical support requirements;

• third parties may fail to comply with cGMP requirements and other FDA or other comparable regulatory requirements;

• 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;

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

• the operations of third parties could be disrupted by conditions unrelated to our business or operations;

• 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.

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.

Compounded drugs are not FDA-approved products;

lawfully compounded drugs are specifically exempt from FDA approval pursuant to Section 503B(a).

Some physicians may be hesitant to prescribe, and some patients may be hesitant to purchase and use, a compounded drug for a variety of reasons, including because it is not required to be, and has not been, approved for marketing and sale by the FDA.

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.

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;

the so-called "Category 1" list pending FDA’s evaluation.

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.

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.

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.

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.

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.

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 27, 2024, we had 26 employees, of which 24 were full-time and five were part-time.

Our focus on limiting 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.

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

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.

With a small number of employees, our ability to supervise the service providers we engage, including our CMOs and CROs, may be constrained, which may impact the timing and quality of services we receive.

No assurance can be given that we will be able to run our operations or accomplish all of the objectives we otherwise would seek to accomplish with the limited personnel resources we currently have.

We generally allow for a hybrid work model.

We instituted remote work policies in March 2020 in response to the COVID-19 pandemic and resulting government stay-at-home orders, which have evolved into our current policies generally permitting a hybrid work schedule.

In addition, many consultants, collaborators and other third-party service providers on which we rely currently have a remote or hybrid workforce model.

The long-term impact of less frequent in-person meetings on our productivity and creativity is difficult to assess.

Remote working arrangements for our personnel and that of third parties on which we rely may weaken our ability to effectively manage and operate our business and lead to delays in our anticipated development program timelines.

In addition, due to our small workforce, if multiple employees were to become unable to work for a protracted period for any reason, or if they were to resign at roughly the same time, our business could suffer.

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If we cannot attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints that will harm our ability to implement our business strategy and achieve our business objectives.

New legal precedent, laws and regulations could make it costlier or more difficult for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the coverage that is the same or similar to our current coverage.

New legal precedent, laws and regulations and increased levels of lawsuits by public company stockholders could make it costlier or more difficult for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the coverage that is the same or similar to our current coverage.

The impact of these events could also make it more difficult for us to attract or retain qualified persons to serve as our senior management or on our board of directors.

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Risks Related to Our Intellectual Property

Our failure to adequately protect or enforce our and our licensors’ intellectual property rights could materially harm our proprietary position in the marketplace or prevent or impede the commercialization of our current and potential future products.

Our success depends in part on our ability, and the ability of our licensors, to obtain and maintain protection in the U.S.

and other countries for the intellectual property covering or incorporated into our technologies and products.

Many of the patents and patent applications relied upon by us are licensed to us by third parties.

Our ability, or the ability of our licensors, to protect our product candidates from unauthorized use or infringement by third parties depends substantially on our abilities and the abilities of such licensors to obtain and maintain, or license, valid and enforceable patents.

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.

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.

and other countries with respect to our products, product candidates and proprietary technologies.

If we are unable to obtain, maintain, enforce and defend sufficient intellectual property protection, our business, financial condition, results of operations and prospects could be materially harmed.

We depend heavily on patent rights and other intellectual property in-licensed to us from third parties to protect most of the products and technologies we develop.

For some such rights, our third-party licensors control patent strategy and prosecution and we have little, if any, influence or control over such patent strategy and prosecution, and our licensors may not always act in our best interest.

Due to evolving legal standards relating to the patentability, validity and enforceability of patents covering pharmaceutical inventions and the scope of claims made under these patents, our ability, and that of our licensors, to obtain or enforce patents is uncertain and involves complex legal and factual questions for which important legal principles are unresolved.

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We cannot predict with certainty the long-term effects of any potential changes.

Our patent strategy for protecting Ovaprene includes in-licensing several patent families from ADVA-Tec.

Patent prosecution for the intellectual property incorporated into Ovaprene is entirely controlled by ADVA-Tec and we have little, if any, influence or control over such patent prosecution.

Our patent strategy for protecting Sildenafil Cream includes in-licensing a patent family from SST, whose last U.S.

claim expires in June 2029, but which could be eligible for three-year market exclusivity under the Hatch-Waxman Act in the U.S.

However, if granted 3-year exclusivity, generic applicants can still submit an abbreviated application during the 3-year period and the FDA is required to review the application, but will defer any approval until the end of the 3-year period.

Three-year exclusivity differs from 5-year exclusivity under the Hatch-Waxman Act, which bars the submission of a generic application during the 5-year period, with the exception that a generic application can be filed after 4 years if it contains a Paragraph IV certification challenging an Orange Book-listed patent for the brand drug.

With respect to patents related to Sildenafil Cream, SST has the sole right, but not the obligation, to prepare, file, prosecute and maintain such patents.

We will be responsible for the costs incurred to maintain and prosecute all such patents and we will be kept informed of all strategies.

However, we will have little if any, influence or control over implementing the patent strategy.

With respect to patent rights related to our IVR product candidates, including DARE-HRT1 and DARE-FRT1, The General Hospital Corporation (also known as Massachusetts General Hospital or MGH) has the sole right to prosecute and maintain its patent rights, and we have the right to prosecute and maintain Catalent's patent rights.

will be responsible for the costs incurred by MGH to maintain and prosecute such patents and we will be kept informed of all strategies.

However, we will have little, if any, influence or control over MGH’s implementation of the patent strategy.

With respect to patents related to DARE-VVA1, we have the right and obligation, at our expense, to prosecute and maintain the in-licensed patent rights in certain major markets, if possible.

With respect to patents rights related to our DARE-GML program, the University of Minnesota (UMN) has the sole right to prosecute and maintain its patent rights, and we have the right to prosecute and maintain patents licensed from Hennepin Life Sciences.

We will be responsible for the costs incurred by UMN to maintain and prosecute such patents and we will be kept informed of all strategies.

However, we will have little, if any, influence or control over UMN's implementation of the patent strategy.

With respect to patent rights licensed from Douglas and underlying patent rights from University of Manchester, Douglas has the sole right to prosecute and maintain those patent rights.

We will be responsible for the costs incurred by Douglas to maintain and prosecute such patents and we will be kept informed of all strategies.

However, we will have little, if any, influence or control over Douglas's implementation of the patent strategy.

There is a substantial backlog of patent applications at the USPTO that may lead to delays in having patent applications examined by the USPTO.

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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.

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In addition, because of funding limitations and our limited cash resources, we may not be able to devote the resources that we might otherwise desire to prepare or pursue patent applications, either at all or in all jurisdictions in which we might desire to obtain patents, or to maintain already-issued patents.

The patents and the patent applications covering Sildenafil Cream and XACIATO are limited to specific formulations, processes and uses of sildenafil and clindamycin, and our market opportunity may be limited

by the lack of patent protection for the active ingredient itself and other formulations and delivery technology and systems that may be developed by competitors.

The active ingredient in our product candidate for FSAD, Sildenafil Cream, is sildenafil and the active ingredient in our FDA-approved product for the treatment of bacterial vaginosis, XACIATO, is clindamycin.

Patent protection for these ingredients has expired and generic products are available.

As a result, a competitor that obtains the requisite regulatory approvals could offer products with the same active ingredient in a different formulation so long as the competitor does not infringe any process, use or formulation patents that we have developed, or that may not be barred by any three-year Waxman-Hatch Act exclusivity, or any GAIN Act extension thereof, we might enjoy upon approval of our products.

Competitors may seek to develop and market competing formulations that may not be covered by our patents and patent applications.

The commercial opportunity for Sildenafil Cream and XACIATO could be significantly harmed if competitors are able to develop and commercialize alternative formulations using these ingredients.

The patents and the patent applications covering our IVR product candidates cover the method of delivery and the device and our market opportunity may be limited by the lack of patent protection for the active ingredients themselves and other formulations, delivery technology and systems that may be developed by competitors.

The active ingredients in our IVR product candidates include bio-identical progesterone, estrogen and oxybutynin, and none of those ingredients are proprietary to us.

As a result, we must compete with currently available products and any future products developed by competitors using same active ingredients in a different formulation or via a different delivery system.

The commercial opportunity for our IVR product candidates, including DARE-HRT1 for hormone therapy, could be significantly harmed if competitors develop and commercialize alternative formulations or better delivery approaches.

The patents and the patent applications covering the use and delivery of DARE-VVA1 and our market opportunity may be limited by the lack of patent protection for the active ingredient itself and other formulations, delivery technology and systems that may be developed by competitors.

The active ingredient in DARE-VVA1, tamoxifen, is not proprietary to us.

As a result, we must compete with currently available products and any future products developed by competitors using the same active ingredient in a different formulation or via a different delivery system.

The commercial opportunity for our product candidate for the treatment of vulvar and vaginal atrophy could be significantly harmed if competitors develop and commercialize alternative formulations or better delivery approaches.

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.

The APIs in XACIATO, Sildenafil Cream, DARE-HRT1, DARE-VVA1, DARE-HPV, and other products we are developing are not proprietary to us or our licensors.

There are generic drugs available with the same APIs.

The patent protection we and our licensors may obtain and maintain for such product candidates are limited to specific formulations, processes, methods of delivery, and/or uses, which may not afford us sufficient protection against competitors.

For example, competitors could offer products with the same API as our products in a different formulation or delivery system or for an indication that is outside the scope of our patented formulation, system or use.

The commercial opportunity for our products could be significantly harmed if competitors are able to develop or make available alternative formulations with the same APIs or better delivery approaches compared with the products we develop.

We may become involved in patent litigation or other intellectual property proceedings relating to our future product approvals, which could result in liability for damages or delay or stop our development and commercialization efforts.

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We may not have sufficient resources to enforce our intellectual property rights or to defend our patent or other intellectual property rights against a challenge.

Our rights to enforce and defend patents we in-license depend upon the terms of our agreements with our third-party licensors, and in some cases, our licensors have the right to control patent enforcement litigation and defense against patent infringement litigation, and we have indemnification obligations for certain losses arising from third-party claims.

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.

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

With respect to XACIATO, we have the initial right to enforce patents we license from TriLogic and MilanaPharm against third parties whose activities infringe such patents in a manner that could affect our exercise of the licenses granted to us, and TriLogic and MilanaPharm must reasonably cooperate in any such suit, including, if

necessary, by being joined as a party to any such suit.

In some cases, MilanaPharm may assume the defense of a claim initiated by a third-party alleging infringement of a third party’s intellectual property rights as a result of the manufacture or sale of a product we develop under our license agreement with TriLogic/MilanaPharm.

While our license agreement would require MilanaPharm to indemnify us for certain losses arising from these third-party claims, this indemnification may not be sufficient to adequately compensate us for any related losses or the potential loss of our ability to manufacture and sell XACIATO.

Additionally, our license agreement with Organon requires that we indemnify Organon from and against all liabilities, damages, expenses, fines, penalties and losses as a result of any third-party claim arising out of or relating to the development, manufacture, commercialization or other exploitation of XACIATO or any licensed product by or on behalf of us or any affiliate or licensee of ours, except for in limited circumstances.

As a result of our indemnification obligations to Organon and limitations on TriLogic's and MilanaPharm's obligations to indemnify us, any patent infringement litigation relating to XACIATO could subject us to significant liabilities that may have a material adverse effect on our business, results of operations and financial condition.

With respect to Ovaprene, ADVA-Tec has the right, in certain instances, to control the defense against any infringement litigation arising from the manufacture or development (but not the sale) of Ovaprene.

While our license agreement with ADVA-Tec requires ADVA-Tec to indemnify us for certain losses arising from these claims, this indemnification may not be sufficient to adequately compensate us for any related losses or the potential loss of our ability to manufacture and develop Ovaprene.

Additionally, our license agreement with Bayer requires that we indemnify Bayer from and against all liabilities, damages, losses and expenses arising from or occurring as a result of development, manufacture, use or commercialization of Ovaprene by us or any licensee of ours, including without limitation, product liability claims, except in limited circumstances.

As a result of our indemnification obligations to Bayer and limitations on ADVA-Tec’s obligations to indemnify us, any patent infringement litigation relating to Ovaprene could subject us to significant liabilities that may have a material adverse effect on our business, results of operations and financial condition.

With respect to Sildenafil Cream, we have the initial right to enforce the applicable licensed patents against infringers in the field of use where a third party is exploiting a topically applied pharmaceutical product that contains at least one of the same active pharmaceutical ingredients as a licensed product, and SST will provide us with reasonable assistance (excluding financial assistance), at our expense.

We also have the initial right to defend any claim initiated by any third-party alleging that a licensed product developed or commercialized under the SST license agreement has infringed any third-party intellectual property rights.

While the SST license agreement requires SST to indemnify us for certain losses arising from these claims, this indemnification may not be sufficient to adequately compensate us for any related losses or the potential loss of our ability to manufacture and develop Sildenafil Cream.

With respect to our IVR product candidates, including DARE-HRT1, DARE-FRT1, and DARE-PTB1 we have the first right to enforce the applicable licensed patents against third party infringers in the fields of pharmaceutical, therapeutic, preventative, diagnostic and palliative uses.

With respect to DARE-VVA1, we have the first right to enforce the applicable licensed patents against third-party infringers in all fields.

We cannot guarantee that we or any of our licensors’ patent searches or analyses, including but not limited to the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the U.S., Europe and elsewhere that is relevant to or necessary for the commercialization of our product candidates in any jurisdiction.

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government and/or not-for-profit organizations.

Our agreements for these sources of funding

include, and may in the future include, terms and conditions that affect our intellectual property rights.

Our agreements for these sources of funding include, and may in the future include, terms and conditions that affect our intellectual property rights.

For example, under our CRADA with NICHD for the Phase 3 clinical study of Ovaprene, the U.S.

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government may have in inventions jointly or independently invented by NICHD employees for which a patent application is filed.

Under our subaward agreement with VentureWell, the federal government has a nonexclusive license to obtain access to and to share research results and data, as well as certain rights, including “march-in” rights, in intellectual property conceived, made, created, developed or reduced to practice in our performance of the research activities and objectives relating to advancement of our DARE-HPV program specified in the subaward agreement, pursuant to and in accordance with the Bayh-Dole Act of 1980.

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.

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

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To date, no federal agency has ever exercised march-in rights;

however, the Biden administration has announced that it views march-in rights as a legitimate means for the government to address rising pharmaceutical costs and future use of march-in rights by the government is uncertain.

however, the Biden administration announced that it viewed march-in rights as a legitimate means for the government to address rising pharmaceutical costs and future use of march-in rights by the government is uncertain.

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

Under the grant agreements supporting development of DARE-LARC1 and DARE-LBT, we agreed to make DARE-LARC1, DARE-LBT and any other 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).

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).

We are required to ensure that the Humanitarian License survives the assignment or transfer of Funded Developments and essential background technology.

Our obligations under the Global Access Commitment and the Humanitarian License may limit the value to us of DARE-LARC1 and other Funded Developments.

Our obligations under the Global Access Commitment and the Humanitarian License may limit the value to us of the Funded Developments.

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.

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.

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.

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 prolonged U.S.

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 a 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.

We may experience significant business disruptions as a result of a public health emergency, natural or man made disaster, act of terrorism, war, or telecommunications or electrical failure that impacts our facilities or employees, or those of the third parties on which we rely for key business activities.

We may experience significant business disruptions as a result of a public health emergency, natural or manmade disaster, act of terrorism, war, or telecommunications or electrical failure that impacts our facilities or employees, or those of the third parties on which we rely for key business activities.

The effects of such events or conditions may materially and adversely affect our product development activities in the future, including as a result of:

• difficulties and delays in clinical study site initiation, including due to diversion of healthcare resources away from conducting clinical studies;

• difficulties and delays in clinical study site initiation, including due to diversion of healthcare resources away from conducting clinical studies or delays in IRB review and approval of clinical study protocols;

• difficulties and delays in recruiting and enrolling clinical study participants and conducting follow-up visits;

• interruption of key clinical study activities, such as study site and data monitoring, due to limitations on travel or in-person gatherings;

• staff disruptions and turnover internally or at our CMOs, CROs, clinical study sites, collaborators or other third parties on which we rely, either directly or indirectly as a result of reallocation of resources, illness, vaccine mandates or other changes in terms of employment;

• delays in receiving approval from regulatory authorities or IRBs to initiate our clinical studies;

• interruption of key clinical study activities, such as study site and data monitoring, due to operational closures or disruptions at our CROs or study sites or limitations on travel or in-person gatherings;

• staff disruptions and turnover internally or at our CMOs, CROs, clinical study sites, collaborators or other third parties on which we rely, either directly or indirectly as a result of reallocation of resources, illness, government mandates or other changes in terms of employment;

• difficulties and delays in production of clinical trial materials and commercial product, including due to supply chain disruptions or resource constraints or reallocation on the part of our CMOs and raw materials suppliers;

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or global shipping that may affect the transport and delivery of raw materials, clinical study materials and commercial product;

• imposition of new or increased tariffs, sanctions, import/export controls or other trade policies that significantly increase the costs of the components and raw materials used in the production of XACIATO or our product candidates;

• changes in local regulations in response to a public health emergency or other emergency situation that may require changes in the ways our clinical studies are conducted, require us to discontinue a clinical study, or make it more difficult for commercial and medical affairs field teams to call on or otherwise access healthcare providers;

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

Because of its size and breadth and the continued emergence of new variants, all of the direct and indirect consequences of the COVID-19 pandemic are not yet known and may not emerge for some time.

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

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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.

The longer such an event or condition persists, the greater the potential for significant adverse impacts to our business operations and those of the CROs, CMOs, commercial collaborators, and other third-party service providers and vendors on which we depend to, among other things, conduct our clinical and nonclinical studies, supply our clinical trial materials, assist with regulatory affairs necessary to advance and seek regulatory approval for our programs, and market, sell and distribute our products, if approved.

Public health emergencies, natural or man made disasters, acts of terrorism, war or telecommunications or electrical failures may also have the effect of heightening many of the other risks and uncertainties described in this “Risk Factors” section.

Public health emergencies, natural or manmade disasters, acts of terrorism, war or telecommunications or electrical failures may also have the effect of heightening many of the other risks and uncertainties described in this Risk Factors section.

Product liability lawsuits against us could cause us to incur substantial liabilities.

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

Our inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of any of our product candidates, if approved.

We also have indemnification obligations to our commercial and other collaborators.

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We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.

Our current or future employees, clinical investigators, commercial collaborators or service providers may engage in misconduct or other improper activities, including non-compliance with regulatory standards.

We may become exposed to the risk of employees, clinical investigators, commercial collaborators, CMOs, CROs, consultants or other vendors engaging in fraud or other misconduct.

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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.

In particular, 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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It is not always possible to identify and deter misconduct by these parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses, or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations.

If any such actions are instituted against us, and we are not successful in defending or asserting our rights, those actions could have a significant adverse effect on our business, including the imposition of significant fines or other sanctions, and our reputation.

The pharmaceutical and medical device industries are highly regulated and subject to various fraud and abuse laws, including, without limitation, the U.S.

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

In the past, the government has enforced the federal Anti-Kickback

Statute to reach large settlements with health care companies based on sham consulting and other financial arrangements with physicians.

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

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

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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;

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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Ensuring that our current and future business operations and arrangements with third parties comply with applicable health care laws and regulations could involve substantial costs.

It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving

applicable fraud and abuse or other health care laws and regulations.

It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other health care laws and regulations.

If we or our operations, or those of a commercial collaborator or other third party on which we rely for development or commercialization of our products and product candidates, are found to be in violation of any of the laws described above or any other governmental regulations that apply to us or that third party, we may be subject to significant civil, criminal and administrative penalties, including monetary damages, fines, individual imprisonment, disgorgement, loss of eligibility to obtain approvals from the FDA, exclusion from participation in government contracting, health care reimbursement or other government programs, including Medicare and Medicaid, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings, additional reporting requirements if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with any of these laws, and/or the curtailment or restructuring of our operations.

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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, which store sensitive data of ours, and could compromise the confidentiality, availability and integrity of information stored there which is vital to our operations and business strategy.

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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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.

Despite implementing security measures, any of the information technology systems belonging to us or our collaborators and third-party service providers and the sensitive and confidential information contained within them are vulnerable to damage or interruption from computer viruses and other malware, unauthorized access, including as a result of employee error (e.g., phishing or spoofing scams) or malfeasance, service interruptions, system malfunctions, natural disasters, terrorism, war, and telecommunication and electrical failure.

Despite implementing security measures, any of the information technology systems belonging to us or our collaborators and third-party service providers, including our CMOs and CROs for our clinical studies, and the sensitive and confidential information contained within them are vulnerable to damage or interruption from computer viruses and other malware, unauthorized access, including as a result of employee error (e.g., phishing or spoofing scams) or malfeasance, service interruptions, system malfunctions, natural disasters, terrorism, war, and telecommunication and electrical failure.

We rely on third-party service providers and technologies for our data processing-related activities, including without limitation third-party providers of cloud-based infrastructure, encryption and authentication technology, employee email, and other functions.

Our ability to monitor these third parties' cybersecurity practices is limited, and these third parties may not have adequate information security measures in place.

In addition, we do not have our own information technology department or personnel and rely on third-party consultants and other service providers to establish and maintain our information technology infrastructure and systems, and they may fail to perform as expected.

Moreover, the shift to remote working arrangements and the prevalent use of mobile devices that access sensitive or confidential

information increases the risk of data security breaches.

We rely on these third parties to implement effective security measures and identify and correct for any such failures, deficiencies or breaches.

However, our ability to monitor these third parties' cybersecurity practices is limited, and these third parties may not have adequate security measures in place.

In addition, we do not have our own information technology department or personnel and rely on third-party information technology consultants to assist our management in assessing, identifying and managing our cybersecurity risks.

We do not control these third parties and they may fail to perform as expected.

Moreover, the shift to remote working arrangements and the prevalent use of mobile devices that access sensitive or confidential information increases the risk of data security breaches.

Technology security systems and other security measures in employees’ homes or other places they may work may not be as robust and more vulnerable to cybersecurity attacks.

Any system failure, accident, security breach or data breach that causes interruptions in our own or in third-party collaborators’ or service providers’ operations could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to our sensitive or confidential information.

A security incident or other interruption could disrupt our ability (or that of third parties upon which we rely) to conduct our business operations and could divert significant resources to remedy or mitigate the damage caused.

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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.

Our business may be adversely affected by unfavorable or unanticipated macroeconomic conditions and geopolitical events.

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.

Various macroeconomic factors could adversely affect our business, our results of operations and financial condition, including a U.S.

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international economic sanctions, including those imposed on Russia;

new or increased tariffs and other barriers to trade;

climate change concerns;

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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.

Interest rates and the ability to access credit markets could adversely affect the ability of patients, payors and distributors to purchase, pay for and effectively distribute our products, if and when approved.

Similarly, unfavorable or uncertain macroeconomic factors could affect the ability of our current or potential future collaborators, third-party service providers or suppliers, including sole source or single source manufacturers or suppliers, licensors or licensees to remain in business, or otherwise manufacture or supply our clinical trial material and products or commercialize our products, if and when approved.

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We expect that these expenses will increase if and when we become an “accelerated filer,” as defined in rules adopted by the SEC under the Securities Exchange Act of 1934.

Generally, we will become an

accelerated filer if our public float as of the last business day of June is $75 million or more and we reported annual revenues of $100 million or more for our most recently completed fiscal year.

Generally, we will become an accelerated filer if our public float as of the last business day of June is $75 million or more and we reported annual revenues of $100 million or more for our most recently completed fiscal year.

Regardless of whether we become an accelerated filer, we may need to hire additional accounting, finance and other personnel in connection with our continuing efforts to comply with the corporate governance, disclosure and other reporting requirements of being a public company, and our management and other personnel, of whom we have a small number, will need to continue to devote substantial time towards compliance matters and initiatives.

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If and when we are an accelerated filer, we will also have to obtain an attestation report on our internal control over financial reporting by our independent registered public accounting firm, which may substantially increase compliance costs.

Recent SEC rules and rulemaking initiatives, such as the new pay versus performance, cybersecurity, and climate-related disclosure requirements, may result in significant additional time and expense devoted to compliance initiatives.

Recent SEC rules and rulemaking initiatives, such as those regarding pay versus performance, compensation clawback, and cybersecurity disclosure requirements, may result in significant additional time and expense devoted to compliance initiatives.

We are a smaller reporting company and a non-accelerated filer and the reduced disclosure requirements available to us may make our common stock less attractive to investors.

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and less stringent age of financial statements requirements;

• reduced non-financial disclosure obligations, including regarding the description of their business, management’s discussion and analysis of financial condition and results of operations, market risk, executive compensation, transactions with related persons, and corporate governance;

• reduced non-financial disclosure obligations, including regarding the description of their business, management’s discussion and analysis of financial condition and results of operations, market risk, executive compensation, policies governing transactions with related persons, and corporate governance;

• later deadlines for the filing of annual and quarterly reports compared to accelerated filers.

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However, our federal NOL carryforwards and other tax attributes may not be available to offset future taxable income because of restrictions under U.S.

tax law, and similar limitations may apply under state tax laws.

tax law, including limitations due to ownership changes that occurred previously or that could occur in the future, and similar limitations may apply under state tax laws.

In addition, under legislation enacted by California in 2024, generally, there is a suspension of the NOL deduction for tax years 2024 through 2026 for taxpayers with net business income or modified adjusted gross income of $1 million or more, and a limit of $5 million of business credits on the aggregate use of otherwise allowable business tax credits that any taxpayer could claim for tax years beginning 2024 through 2026.

For these reasons, we may not be able to realize a tax benefit from the use of our NOL carryforwards and other tax attributes, even if we attain profitability.

We have recorded a full valuation allowance related to our NOL carryforwards and other deferred tax assets due to the uncertainty of the ultimate realization of the future benefits of those assets.

See Note 7 “Income Taxes” to the accompanying consolidated financial statements for more information

about limitations on our ability to use our NOL carryforwards and other tax attributes.

Such limitations could result in increased future income tax liability to us and our future cash flows could be adversely affected.

An extended curtailment or halt of operations at the FDA, NIH, SEC and other government agencies, including due to a U.S.

federal government shutdown, could delay or disrupt clinical and preclinical development and potential marketing approval of our product candidates and our ability to raise additional capital.

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

The federal government came very close to another shutdown in late 2023.

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 staff at federal agencies from performing key functions that may adversely affect our business.

For example, disruptions at the FDA may delay meetings and other communications with 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 processing of new grant awards to fund research and development of potential new therapies or the disrupt staff’s work and other activities or funding under active grant/cooperative agreements.

If a prolonged government shutdown were to occur while our Phase 3 clinical study of Ovaprene is ongoing, depending on the amount of funds allocated and made available to the study before the shutdown begins, a federal government shutdown could adversely impact the ability of NICHD to carry out its responsibilities under our CRADA, including funding its share of the costs of the study, which could have a material adverse impact on our business and prospects.

In addition, a government shutdown could prevent 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.

While we currently have an effective shelf registration statement on Form S-3, a shelf registration statement on Form S-3 typically can only be used for three years, subject to a limited extension, and that three-year period for our current shelf S-3 registration statement ends on April 7, 2024.

If a federal government shutdown halts non-essential SEC operations for an extended period, it may negatively impact our ability to raise additional capital through registered offerings of our securities in the future.

If a prolonged U.S.

government shutdown or other event or condition occurs that prevents the FDA, NIH, SEC or other regulatory agencies from hiring and retaining personnel and conducting their regular activities, 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.

See Note 8 “Income Taxes” to the accompanying consolidated financial statements for more information about limitations on our ability to use our NOL carryforwards and other tax attributes.

Risks Related to Ownership of Our Common Stock

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The market price for our common stock may be influenced by a variety of factors, some of which are beyond our control or are related in complex ways, including:

• significant developments with our product development programs, such as actual or anticipated changes to development and approval timelines, results from any clinical trial, unanticipated serious safety concerns, suspension or discontinuation of a program, initiation of new programs and communications or decisions from the FDA or other regulatory authorities relating to applications we submit for clinical trials or marketing approval of our product candidates, in each case particularly those related to our clinical-stage product candidates;

• significant developments with our product development programs, such as actual or anticipated changes to development and approval timelines, results from any clinical trial, unanticipated serious safety concerns, suspension or discontinuation of a program, initiation of a new program and communications or decisions from the FDA or other regulatory authorities relating to applications we submit for clinical trials or marketing approval of our product candidates;

• announcements of capital raising transactions, including sales of our common stock or securities convertible into or exercisable for shares of our common stock by us, or expectation of additional financing efforts;

• the amount of our unrestricted cash;

• the amount of our cash;

• the level of actual or anticipated expenses related to development of our product candidates, and in particular our clinical-stage development programs;

• announcements relating to strategic collaborations or alliances or significant licenses, acquisitions or dispositions of assets by us or companies perceived to be comparable to us;

• announcements relating to strategic collaborations or alliances or significant licenses, acquisitions or dispositions of assets or capital commitments by us or our competitors or companies perceived to be economically linked to us;

• disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

• announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures and capital commitments;

• additions or departures of key management or scientific personnel;

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Our common stock is listed on The Nasdaq Capital Market.

As previously reported, on July 19, 2023, we received a letter from the Listing Qualifications Department (the “Nasdaq Staff”) of the Nasdaq Stock Market (“Nasdaq”) notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the minimum $1.00 per share requirement for continued listing on The Nasdaq Capital Market as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).

We were provided an initial period of 180 calendar days, or until January 16, 2024, to regain compliance with the Minimum Bid Price Requirement.

On January 17, 2024, the Nasdaq Staff notified us that because we had not timely regained compliance with the Minimum Bid Price Requirement, our common stock was subject to delisting from The Nasdaq Capital Market unless we timely requested a hearing before Nasdaq’s Hearings Panel (the “Panel”) to appeal the Nasdaq Staff’s delisting determination.

We submitted a timely request for a hearing before the Panel, which stayed the suspension and delisting of our common stock pending the decision of the Panel and the expiration of any extension period granted by the Panel.

On February 27, 2024, the Panel notified us that, based on its review of the written record, which included our commitment to effect a reverse stock split if necessary to regain compliance with the Minimum Bid Price Requirement, it determined to grant us a temporary exception until July 15, 2024 (the “Exception Period”) to regain compliance with the Minimum Bid Price Requirement.

The Panel granted the temporary exception subject to us obtaining board of directors and stockholder approval for and effecting the reverse stock split on or before specified dates that would enable us to demonstrate compliance with the Minimum Bid Price Requirement by evidencing a closing bid price of $1.00 or more per share for a minimum of ten consecutive trading sessions on or before July 15, 2024.

advised us that, during the Exception Period, we must provide Nasdaq with prompt notification of any significant events that may affect our compliance with Nasdaq listing requirements, including any event that may call into question our ability to meet the terms of the temporary exception.

The Panel also advised us that should we fail to meet any of the terms of the temporary exception, our common stock will immediately be delisted.

As of the date of this report, we have not regained compliance with the Minimum Bid Price Requirement.

If we seek stockholder approval of a reverse stock split, there can be no assurance that our stockholders will approve it or, if approved and implemented, that we would be able to regain compliance with the Minimum Bid Price Requirement.

There are many factors that affect the trading price of our common stock, including those described in this “Risk Factors” section, and many of those factors are outside of our control.

Even if we demonstrate compliance with the Minimum Bid Price Requirement within the Exception Period, a reverse stock split may not result in any sustained increase in the trading price of our common stock and, as a result, we may not be able to maintain compliance with the Minimum Bid Price Requirement longer term.

There can be no assurance 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 Bid Price Requirement.

Other continued listing requirements include that we satisfy the requirements of at least one of the continued listing standards commonly referred to as the stockholders’ equity rule, the market value of listed securities rule and the net income rule.

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

Based on our stockholders’ equity as of December 31, 2023 and our results of operations for our three most recently completed fiscal years, we do not satisfy the stockholders’ equity rule or the net income rule.

As of March 27, 2024, we did satisfy the market value of listed securities rule.

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;

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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.

A reverse stock split could lead to a decrease in the overall market value of our common stock and adversely affect the liquidity of our common stock.

A reverse stock split, if implemented, would reduce the number of outstanding shares of our common stock in proportion to the reverse split ratio and would have the immediate effect of proportionately increasing the per share price of our common stock.

A reverse stock split is often viewed negatively by the market and, consequently, could lead to a decrease in our overall market value.

If the per share trading price of our common stock does not increase in proportion to the reverse stock split ratio after the reverse stock split is implemented, then our overall market value (measured as the product of our outstanding shares of common stock and the per share trading price) will be less than before the reverse stock split.

In some cases, the per share stock price of companies that have effected reverse stock splits subsequently declined back to pre-reverse stock split levels.

Accordingly, if we implement a reverse stock split, there can be no assurance that our overall market value will remain the same after the reverse stock split, or that the reverse stock split would not have an adverse effect on the trading price of our common stock due to the reduced number of shares that would be outstanding after the reverse stock split.

Liquidity for our stockholders could be adversely affected by the reduced number of shares outstanding after a reverse stock split.

A reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for our common stock.

In addition, a reverse stock split may result in some stockholders owning “odd lots” of less than 100 shares.

Odd lot shares may be more difficult to sell, and brokerage commissions and other costs of transactions in odd lots are generally somewhat higher than the costs of transactions in “round lots” of even multiples of 100 shares.

The sale of our common stock in ATM offerings 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 recent years, and we may continue to use ATM offerings to raise additional capital in the future.

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, however, we may sell significant amounts of shares in ATM offerings again in the future.

While sales of shares of our common stock in ATM offerings may enable us to raise capital at a lower cost compared with other types of equity financing transactions;

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.

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.

While sales of shares of our common stock in ATM offerings and under our equity line arrangement may enable us to raise capital at a lower cost compared with other types of equity financing transactions;

such sales may result in substantial dilution to our existing stockholders, and such sales, or the anticipation of such sales, may cause the trading price of our common stock to decline.

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Shares underlying outstanding warrants represent approximately 14% of the outstanding shares of our common stock as of March 28, 2025, and the underlying shares generally may be freely sold into the public market following exercise of the warrants by the warrant holders.

In addition, pursuant to the terms of the royalty interest financing agreement we entered into in December 2023, we may issue additional warrants to purchase up to an additional 7.0 million shares of our common stock with an exercise price of $0.3467 per share.

Further, the issuance of all of the approximately 9.5 million shares of our common stock underlying outstanding options and the approximately 6.7 million shares of our common stock that remained available for future issuance under our stock incentive plan as of December 31, 2023 have been registered under the Securities Act and such shares if, and when issued, can be freely sold in the public market, except to the extent they are held by an affiliate of ours, in which case such shares will become eligible for sale in the public market as permitted by Rule 144 under the Securities Act.

In addition, the issuance of all of the approximately 0.9 million shares of our common stock underlying outstanding options and the approximately 0.5 million shares of our common stock that remained available for future issuance under our stock incentive plan as of December 31, 2024 have been registered under the Securities Act and such shares if, and when issued, can be freely sold in the public market, except to the extent they are held by an affiliate of ours, in which case such shares will become eligible for sale in the public market as permitted by Rule 144 under the Securities Act.

Almost all of our outstanding warrants have exercise periods that extend into December 2028 or March 2029 and, as of December 31, 2024, our outstanding options had a weighted average remaining contractual exercise period of approximately 6.7 years.

Accordingly, the potential adverse market and price pressures resulting from these sales, or the perception that such sales could occur, may continue for an extended period of time and continued negative pressure on the trading price of our common stock could have a material adverse effect on our ability to raise additional capital through equity or equity-linked financings.

Accordingly, the potential adverse market and price pressures resulting from these

sales, or the perception that such sales could occur, may continue for an extended period of time and continued negative pressure on the trading price of our common stock could have a material adverse effect on our ability to raise additional capital through equity or equity-linked financings.

In addition, our Restated Certificate of Incorporation, as amended, authorizes us to issue up to 240.0 million shares of our common stock.

Subject to limitations imposed by Nasdaq or such other securities exchange on which our securities may be listed, authorized shares of our common stock that are not issued and outstanding or reserved for issuance may be issued without stockholder approval at any time, in the sole discretion of our board of directors, and as of December 31, 2024, only approximately 8.7 million shares were issued and outstanding or reserved for issuance.

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 certificate of incorporation 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.

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.

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Our Third Amended and Restated By-Laws provide that, unless we consent in writing to the selection of an alternative forum, to the fullest extent permitted by law, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for most legal actions involving actions brought against us by stockholders;

provided that, the exclusive forum provision will not apply to actions or suits brought to enforce any liability or duty created by the

Securities Act, the Exchange Act, or any other claim for which the federal courts have exclusive jurisdiction.

provided that, the exclusive forum provision will not apply to actions or suits brought to enforce any liability or duty created by the Securities Act, the Exchange Act, or any other claim for which the federal courts have exclusive jurisdiction.

If any action that is required under our by-laws to be brought against us in Delaware is filed by a stockholder in a court other than a court located within Delaware, the stockholder shall be deemed to have consented to (i) the personal jurisdiction of the state and federal courts located within Delaware in connection with any action brought in any such court to enforce our Delaware forum selection provision and (ii) having service of process made upon the stockholder in any such enforcement action by service upon that stockholder's counsel, as agent for the stockholder.

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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