Dare Bioscience, Inc.

Previous wording

•We will need to raise substantial additional capital to continue our operations, execute our business strategy and remain a going concern, and we may not be able to raise adequate capital on a timely basis, on favorable terms, or at all. Raising additional capital may cause substantial dilution to our stockholders, restrict our operations or require us to relinquish rights in our technologies or product candidates and their future revenue streams.

Current wording

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

Previous wording

•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.

Current wording

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

Previous wording

•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.

Current wording

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

Previous wording

•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.

Current wording

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

Previous wording

•We have no manufacturing, sales, marketing or distribution infrastructure. We depend heavily on, and expect to continue to rely on, the performance of third parties, including our strategic collaborators, contract manufacturers and suppliers, CROs, medical institutions, and scientific, medical, regulatory and other consultants and advisors, to develop our product candidates and commercialize any approved products.

Current wording

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

Previous wording

•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.

Current wording

•The commercial success of XACIATO is outside of our control and will depend on Organon’s efforts and capabilities, and if commercialization of XACIATO is not successful, our reputation, business and prospects may suffer.

Previous wording

•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.

Current wording

•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 Organon fail to compete effectively.

Previous wording

•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.

Current wording

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

Previous wording

•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.

Current wording

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

Previous wording

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

Current wording

•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.

Previous wording

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. 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.

Current wording

We have a history of losses from operations, we expect significant losses from operations, net losses and negative cash flows from operations for at least the next several years as we develop and seek to bring to market 503B compounded drugs and our product candidates and as we seek to potentially acquire or license and develop additional product candidates. At December 31, 2025, we had an accumulated deficit of approximately $188.7 million, cash and cash equivalents of approximately $24.7 million, and working capital of approximately $3.4 million. Our cash and cash equivalents at December 31, 2025 included funds received under grant agreements that generally may be applied solely toward direct costs for the funded project under those grant agreements other than an approximately 5% to 22% indirect cost allowance, and as of December 31, 2025, our deferred grant funding liability was approximately $19.7 million, substantially all of which consisted of funds intended to support the DARE-LARC1 program, the Ovaprene Phase 3 clinical study, and the DARE-HPV program. We will need additional capital to fund our operating needs through the fourth quarter of 2026 and to meet our current obligations as they become due. These circumstances raise substantial doubt about our ability to continue as a going concern. 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.

Previous wording

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

Current wording

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

Previous wording

•the product development programs we choose to pursue;

Current wording

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

Previous wording

•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;

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

As discussed above, we may seek to raise additional capital through a variety of means. Raising capital through the issuance of shares of our common stock, or securities convertible into or exercisable for our common stock, may depress our stock price and substantially dilute our existing stockholders. The terms of securities issued may include liquidation or other preferences that may materially adversely affect the rights of our existing stockholders. Debt and other structured financings, if available, would increase our fixed payment obligations and may involve covenants requiring us to maintain specified financial ratios or a specified cash balance, or limiting or restricting our ability to take specific actions, such as incurring additional debt, acquiring, selling or licensing intellectual property rights, and making capital expenditures, or impose other operating restrictions that could adversely impact our ability to operate our business and pursue our strategic objectives. We could also be required to meet certain milestones in connection with a debt financing and the failure to achieve such milestones by certain dates may force us to relinquish rights to some of our technologies, product candidates or products, or otherwise agree to terms unfavorable to us. In addition, we may forego part or all of potentially valuable streams of future payments (e.g., milestone and/or royalty revenue) to raise immediate capital to fund our operations and advance our development programs, such as in the case of our royalty interest financing agreement and the Royalty Purchase

Current wording

As discussed above, we may seek to raise additional capital through a variety of means. Raising capital through the issuance of shares of our common stock, or securities convertible into or exercisable for our common stock, may depress our stock price and substantially dilute our existing stockholders. The terms of securities issued may include liquidation or other preferences that may materially adversely affect the rights of our existing stockholders. Debt and other structured financings, if available, would increase our fixed payment obligations and may involve covenants requiring us to maintain specified financial ratios or a specified cash balance, or limiting or restricting our ability to take specific actions, such as incurring additional debt, acquiring, selling or licensing intellectual property rights, and making capital expenditures, or impose other operating restrictions that could adversely impact our ability to operate our business and pursue our strategic objectives. We could also be required to meet certain milestones in connection with a debt financing and the failure to achieve such milestones by certain dates may force us to relinquish rights to some of our technologies, product candidates or products, or otherwise agree to terms unfavorable to us. In addition, we may forego part or all of potentially valuable streams of future payments (e.g., milestone and/or royalty revenue) to raise immediate capital to fund our operations and advance our development programs, such as in the case of our royalty interest financing agreement and the Royalty Purchase Agreements. 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.

Previous wording

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.

Current wording

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 which to date has not resulted in a material amount of net sales, and the successful development and commercialization of Ovaprene and/or Sildenafil Cream, which are subject to significant risks and uncertainties, some of which are outside of our control, as discussed elsewhere in this Risk Factors section.

Previous wording

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.

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

We have entered into an exclusive license agreement with Organon for the commercialization of XACIATO and an exclusive license agreement with Bayer for the commercialization of Ovaprene, if approved for commercial sale. Each of these license agreements may be terminated by the licensee for convenience upon the completion of a specified notice period, subject to limited restrictions. Furthermore, under our agreement with Bayer, Bayer has no payment obligations to us, unless, after reviewing the results of our pivotal clinical trial of Ovaprene, it elects, in its sole discretion, to make the license grant under our agreement effective by making a $20.0 million payment to us. If we do not successfully complete a pivotal clinical trial of Ovaprene in a timely manner, the license grant may never become effective, and we may not receive any additional payments from Bayer. Bayer may elect not to make the license grant effective regardless of the outcome of the pivotal clinical trial. If an exclusive license agreement is terminated early, or in Ovaprene's case, does not become fully effective, we may realize only a small fraction of the potential value of the agreement to us, and we would need to raise significant additional capital to pursue further development and commercialization of XACIATO or Ovaprene, as applicable, or establish another commercial collaboration, which we may not be able to do on a timely basis, on favorable terms, or at all.

Current wording

We have an exclusive license agreement with Organon for the commercialization of XACIATO. That license agreement may be terminated by Organon for convenience upon the completion of a specified notice period, subject to limited restrictions. If Organon determines to terminate the exclusive license agreement with us, we may realize only a small fraction of the potential value of the agreement to us, and we would need to raise significant additional capital to pursue further development and commercialization of XACIATO, or establish another commercial collaboration, which we may not be able to do on a timely basis, on favorable terms, or at all. For example, we had an exclusive license agreement with Bayer for the commercialization of Ovaprene. As discussed elsewhere in this report, we received a notice of termination of the license agreement from Bayer in November 2025, and we agreed with Bayer to terminate the license agreement effective December 2, 2025. If Ovaprene were to receive marketing approval from the FDA, we will need to enter into an agreement with a third party to commercialize Ovaprene, for which no assurances can be given, and if we do not enter into such agreement, the commercialization of Ovaprene would be delayed. See also the risk factor titled, “Our existing product development and commercialization collaboration is important to our business, and future collaborations may also be important to us. If we are unable to maintain our existing collaboration, if it is not successful, or if we are unable to establish additional strategic collaborations, our business and prospects may be materially harmed,” below.

Previous wording

We have relied heavily on our ability to raise capital by selling shares of our common stock. For example, we raised an aggregate of approximately $79.1 million in gross proceeds in fiscal years 2021 and 2022 through the sale of shares of our common stock in offerings made under a Form S-3 “shelf” registration statement. Our ability to raise additional capital through sales of our common stock or other securities offerings will depend on several factors, many of which may not be in our favor, including the trading volume and volatile trading price of our common stock, our relatively low public float and market capitalization, our potential inability to regain and maintain compliance with the listing requirements of the Nasdaq Capital Market, unfavorable financial market conditions, and the other risks and uncertainties described in this Risk Factors section. If we are unable to raise additional capital through the offering and sale of shares of our common stock, or securities convertible into or exercisable for our common stock, on a timely basis or acceptable terms, or at all, we may seek additional capital through other third-party sources that require us to relinquish valuable rights in our intellectual property, technologies, product candidates or future revenue streams, or that subject us to restrictive covenants, operational restrictions or security interests in our assets, or we may need to delay, scale back or eliminate some or all of our development programs, reduce other expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations.

Current wording

We have relied heavily on our ability to raise capital by selling shares of our common stock. For example, we raised an aggregate of approximately $21.3 million in in gross proceeds during 2025, and approximately $93.0 million in gross proceeds since January 1, 2021, through the sale of shares of our common stock in offerings made under a Form S-3 “shelf” registration statement. Our ability to raise additional capital through sales of our common stock or other securities offerings will depend on several factors, many of which may not be in our favor, including the trading volume and volatile trading price of our common stock, our relatively low public float and market capitalization, our potential inability to regain and maintain compliance with the listing requirements of the Nasdaq Capital Market, unfavorable financial market conditions, and the other risks and uncertainties described in this Risk Factors section. If we are unable to raise additional capital through the offering and sale of shares of our common stock, or securities convertible into or exercisable for our common stock, on a timely basis or acceptable terms, or at all, we may seek additional capital through other third-party sources that require us to relinquish valuable rights in our intellectual property, technologies, product candidates or future revenue streams, or that subject us to restrictive covenants, operational restrictions or security interests in our assets, or we may need to delay, scale back or eliminate some or all of our development programs, reduce other expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations.

Previous wording

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

Current wording

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

Previous wording

Obtaining stockholder approval is a costly and time-consuming process. If we must obtain stockholder approval for a potential transaction, we would expect to spend substantial additional money and resources. In addition, seeking stockholder approval would delay our receipt of otherwise available capital, which may materially and adversely affect our ability to execute our business plan, and there is no guarantee our stockholders ultimately would approve a proposed transaction.

Current wording

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

Previous wording

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.

Current wording

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

Previous wording

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.

Current wording

Changes in federal funding and contracting policies under the current U.S. presidential administration could materially impact the progress of certain of our development programs, including DARE-HPV, as well as our operating results and financial resources. We have received federal government grants and awards in support of several of our development programs. As discussed elsewhere in this report, our 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.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

Pre-clinical candidates must generate sufficient safety and efficacy data through in vitro studies, animal studies and a variety of tests before they can be considered appropriate for testing in humans. The development risks, timeline and cost of pre-clinical assets can be high because of the unknowns and absence of data. It can be difficult to identify relevant tests and animal models for pre-clinical studies. Even if the results from our pre-clinical studies are favorable, we still may not be able to advance the candidates into clinical trials. If pre-clinical studies of product candidates do not generate strong data, our pre-clinical stage programs may never progress to clinical development and may prove to be worthless.

Previous wording

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.

Current wording

The grants and other non-dilutive funding supporting development of several of our programs should not provide any assurance that pre-clinical or clinical development supported by that funding will be successful, or, even if we are successful with all specified development activities, that we will be able or will choose to fund the additional development work that will be required to continue to advance the product candidates toward commercialization. Further, the grant agreements or other non-dilutive funding award agreements supporting these development programs generally feature milestone-based payments or, in the case of NIH grants, payments are received in reimbursement of specified activities, and there is no assurance that we will be able to achieve or otherwise demonstrate satisfaction of the specified development and reporting milestones required to receive future payments under the agreements. 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.

Previous wording

We have limited resources and no internal sales, marketing or distribution capabilities. A key aspect of our strategy is to establish collaborations with third parties, such as large and mid-size pharmaceutical companies and other third parties with the relevant R&D and/or commercial expertise and infrastructure, to help bring our product candidates to market. We currently do not expect to directly market, sell or distribute any of our products that receive regulatory approval, and instead intend to enter into agreements with third parties to market, sell and distribute and provide related support services for those products. For example, we have entered into 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, 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. In addition, in the case of commercial collaborations, our product revenues may be lower than if we were to sell and distribute products that we develop ourselves.

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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 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. See ITEM 1. "BUSINESS-Strategic Agreements for Pipeline Development-SST License and Collaboration Agreement,” above.

Current wording

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 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. See

Previous wording

We currently do not have, and have never had, product marketing, sales or distribution infrastructure. In order to commercialize any of our product candidates, if approved for commercial sale, we must either establish a sales and marketing organization with technical expertise and supporting distribution capabilities or collaborate with third-parties that have sales and marketing experience. As we move our product candidates through development toward, and in some cases, through regulatory approval, we evaluate several options for each product candidate's commercialization strategy. These options include building our own sales force and other commercial infrastructure, or collaborating with third parties that have established sales forces and distribution systems, either to augment our own sales force and commercial infrastructure or in lieu of establishing our own sales force and commercial infrastructure. We currently have no commercialization agreements with third parties other than our license 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. 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.

Current wording

We currently do not have, and have never had, product marketing, sales or distribution infrastructure. In order to commercialize any of our product candidates, if approved for commercial sale, we must either establish a sales and marketing organization with technical expertise and supporting distribution capabilities or collaborate with third-parties that have sales and marketing experience. As we move our product candidates through development toward, and in some cases, through regulatory approval, we evaluate several options for each product candidate's commercialization strategy. These options include building our own sales force and other commercial infrastructure, or collaborating with third parties that have established sales forces and distribution systems, either to augment our own sales force and commercial infrastructure or in lieu of establishing our own sales force and commercial infrastructure. We currently have no commercialization agreements with third parties other than our license agreement with Organon for XACIATO. We may not be able to maintain our existing commercial collaboration or establish and maintain other commercial collaborations on favorable terms, on a timely basis, or at all. In addition, our product revenue and our profitability, if any, may be lower if we rely on third parties to commercialize products we develop than if we were to do it ourselves.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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 products Veozah® (fezolinetant) marketed by Astellas Pharma and Lynkuet® (elinzanetant) marketed by Bayer, and dietary supplements. Both the supplement and the compounded hormone therapy markets are very significant. A considerable segment of the compounded hormone therapy market is comprised of compounded hormones in pellet form that are implanted under the skin as a non-daily alternative, which could be directly competitive with DARE-HRT. We expect the options for hormone therapy and non-hormonal therapies to continue to expand with time. DARE-HRT1 is designed to offer a convenient vaginal ring that continuously delivers a combination of bioidentical estradiol and progesterone over 28 days. Bioidentical hormones refer to compounds that are chemically identical to those produced naturally in the human body. Studies have not demonstrated that bioidentical hormones are safer than synthetic hormones, so DARE-HRT1 will need to compete with many types of hormone therapy options in terms of convenience, safety and efficacy in managing symptoms of menopause.

Previous wording

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.

Current wording

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

Previous wording

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.

Current wording

One aspect of our 503B business strategy is to enter into arrangements with outsourcing facilities through which we can generate revenue from sales of DARE to PLAY and other potential 503B compounded drugs produced by those outsourcing facilities under Section 503B. Other than entering an arrangement with Bravado, the 503B outsourcing facility for DARE to PLAY, in 2025, we have never entered into arrangements with outsourcing facilities. Although we have entered into the arrangement with Bravado, we may need to identify and enter into additional satisfactory arrangements with one or more other outsourcing facilities in order to successfully execute our commercialization strategy, and no assurances can be given that we will be successful in doing so on commercially reasonable terms or at all. Even if we are successful in this regard, we may not generate sufficient revenue to recover our costs. Establishing such additional arrangements could be expensive and time consuming, disrupt our other operations, require significant capital expenditures and distract management and our other employees from other aspects of our business.