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Item 1A. Risk Factors

2022-03-31 compared with 2021-03-30 · 918 added, 708 removed, 315 unchanged (84% of the section changed)

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This summary does not address all of the risks that we face.

We urge investors to carefully review and consider the additional discussion of the risks summarized in this risk factor summary, and other risks that we face, which can be found below under the heading “Risk Factors,” together with other information in this report and our other public filings, before making investment decisions regarding our securities.

• We will need to raise additional capital to continue our operations and remain a going concern, and our ability to do so may be limited and more expensive due to low trading volume, price or market capitalization, our lack of revenue, net losses and limited operating history, and/or applicable laws and regulations.

If we fail to obtain additional capital, we will be unable to complete development or obtain regulatory approval for commercialization of our product candidates.

We urge investors to carefully review and consider the additional discussion of the risks summarized in this risk factor summary, and other risks that we face, which can be found below under the heading “Risk Factors,” together with other information in this report, before making investment decisions regarding our securities.

• We will need to raise additional capital to continue our operations, execute our business strategy and remain a going concern, and our ability to do so may be limited.

If we fail to obtain additional capital, we may be unable to complete development or obtain regulatory approval to commercialize for our product candidates.

• 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.

• The COVID-19 pandemic and efforts to reduce the spread of COVID-19 could negatively impact our business, including by increasing the cost and timelines for our clinical development programs.

• We may not receive any additional payments under our license agreement with Bayer, and Bayer may terminate the agreement at any time without cause upon limited prior notice.

• Due in part to our limited financial resources, we may fail to effectively develop the product candidates in our portfolio and execute our current product development plans, including the commencement and completion of clinical trials and regulatory submissions, in accordance with our current timeline expectations.

• We depend heavily on the success of our lead product candidates, DARE-BV1, Ovaprene and Sildenafil Cream, 3.6%.

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

XACIATO is our first and only FDA-approved product.

Our other products are investigational, require the conduct and successful completion of clinical studies and nonclinical work, and may never complete development or be submitted for or receive regulatory approval.

• Clinical development is a lengthy and expensive process with an inherently uncertain outcome.

Failure to successfully develop and obtain regulatory approval to market and sell any of these product candidates on our anticipated timelines, or at all, could have a material adverse effect on our business, operating results and financial condition.

• We have a relatively small number of employees and if we fail to attract and retain key personnel, we may not successfully complete development of, obtain regulatory approval for or commercialize our product candidates, or otherwise implement our business plan.

• We rely on, and intend to continue to rely on, third parties for the execution of significant aspects of our product development programs, including the conduct of our clinical and non-clinical studies and the supply and manufacture of our product candidates.

Failure of these third parties, including multiple single source suppliers and manufacturers, 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.

• Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data, and others, including regulatory authorities, may not agree with our interpretation of study data.

• Our business depends on obtaining the approval of regulatory authorities, and in particular, FDA approval, for our product candidates in a timely manner, and the requirements or pathways for obtaining approval for our product candidates may change over time, requiring more financial resources and development time than we currently anticipate.

• Our business strategy is to establish and leverage strategic partnerships to achieve commercialization of our product candidates, if approved.

We have no internal sales, marketing or distribution capabilities.

Under any such collaborations, we may not have control over several key elements relating to the development and commercialization of our product candidates, and any failure by such third parties to adequately perform their obligations under our agreements could negatively impact our business, operating results and financial condition.

• The product candidates we are developing or may develop are likely to face significant competition.

If we receive marketing approval for any of our product candidates, their ability to compete and potential to generate revenue will be impacted by the efficacy and safety outcomes of our clinical trials, the label claims that the FDA or other regulatory authorities approve for the product, and the degree of acceptance among the medical community and consumers and their preference of our products over available alternative products.

• Even if we obtain regulatory approval in the United States or elsewhere to market any of our products, the reimbursement environment at the time of approval may hurt our financial prospects.

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

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

• 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.

• Lack of patent protection for the active ingredients in certain of our product candidates, including DARE-BV1 and Sildenafil Cream, 3.6%, 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.

• The price of our common stock has been and may continue to be highly volatile and such volatility could be unrelated to our performance and operating results.

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

• There is no assurance that we will continue satisfying the listing requirements of the Nasdaq Capital Market, and such failure could result in the suspension or delisting of our common stock, which could, among other things, 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.

• Future sales and issuances of our equity, including sales and issuances of our common stock in at the market, or ATM, offerings through a sales agent, under our purchase agreement with Lincoln Park and upon exercise of our stock options and warrants, or the perception that such sales may occur, could adversely affect the market price of our common stock, even if our business is doing well.

• Cyber-attacks, security breaches, loss of data and other disruptions to our information technology systems or those of our third-party service providers could compromise sensitive information related to our business, delay or prevent us from accessing critical information or expose us to liability, any of which could adversely affect our business and our reputation.

Failure to successfully complete clinical trials and nonclinical activities and obtain regulatory approval to market and sell our product candidates on our anticipated timelines at reasonable costs to us, or at all, particularly Ovaprene and Sildenafil Cream, 3.6%, could have a material adverse effect on our business, operating results and financial condition.

• The regulatory approval processes of the FDA and comparable foreign authorities are expensive, lengthy, time-consuming, and inherently unpredictable.

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.

Manufacturing and supply delays and disruptions may significantly delay our clinical studies, disrupt commercial supply of any approved product, and be expensive for us to resolve.

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

If we are unable to establish and maintain strategic collaborations, 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.

• 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.

• 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, 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.

• XACIATO and any future products will face intense competition, including from generic products, and our business, operating results and financial condition will suffer if we, or our commercial collaborators, fail to compete effectively.

• XACIATO and any future 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.

• Failure to successfully obtain coverage and reimbursement for XACIATO and any future products from government health care programs and private commercial health insurance companies, or the availability of coverage only at limited levels, would diminish our ability, or that of a commercial collaborator, to generate net product revenue.

If out-of-pocket costs for our products 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 experience significant increases in our compensation costs 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 products and product candidates, including XACIATO and Sildenafil Cream, 3.6%, 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.

• The COVID-19 pandemic, escalating geopolitical events and 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 negatively impacting our ability to raise additional capital.

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

• The price of our common stock has been and may continue to be highly volatile and such volatility may be related or unrelated to our performance and operating results.

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.

• There is no assurance that we will continue satisfying the listing requirements of the Nasdaq Capital Market, and failure to do so could result in the suspension or delisting of our common stock, 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.

• 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 our equity securities and upon the exercise of stock options and warrants, or the expectation that such sales of equity may occur, could adversely affect the market price of our common stock, even if our business is doing well.

• 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 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.

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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.

Each of these risk factors, as well as

additional risks not presently known to us or that we currently deem immaterial, could adversely affect our business, operating results, growth prospects or financial condition, as well as the trading price of our common stock, in which case you may lose all or part of your investment.

Risks Related to Our Business

We will need to raise additional capital to continue our operations and execute our current product development plans.

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 potentially acquire, license and develop additional product candidates.

Advancing our portfolio of innovative investigational products for women’s health through clinical development and pursuing regulatory approval will require substantial additional investment.

Each of these risk factors, as well as additional risks not presently known to us or that we currently deem immaterial, could adversely affect our business, operating results, growth prospects or financial condition, as well as the trading price of our common stock, in which case you may lose all or part of your investment.

Risks Related to Our Financial Position and Capital Needs

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

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 any product candidates we may add to our portfolio in the future.

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

We currently do not have the capital necessary to advance all of our product candidates through research and clinical development and regulatory approval.

Our ability to continue as a going concern depends on our ability to raise additional capital through financings, government or other grant funding, collaborations and strategic alliances or other similar types of arrangements, to successfully execute our current operating plan and to continue the development of our current product candidates.

XACIATO is our first and only product approved for marketing and sale and we do not anticipate the potential upfront, milestone and royalty payments to us under our exclusive license agreement for XACIATO will be sufficient to cover all of our operating expenses.

Accordingly, our ability to continue as a going concern and execute our business strategy depends on our ability to raise additional capital through equity, debt or structured financings, government or other grant funding, collaborations and strategic alliances or other similar types of arrangements.

This report includes disclosures and an opinion from our independent registered public accounting firm stating that our recurring losses and negative cash flows from operations raise substantial doubt about our ability to continue as a going concern.

Our financial statements as of December 31, 2021 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.

Our capital needs have been and will continue to depend highly on the product development programs we choose to pursue, the progress of these programs, including the number, size, timing, rate of patient recruitment, duration of patient treatment and follow-up and the results of our clinical trials and pre-clinical studies, the cost and timing of development and supply of material for our clinical trials and pre-clinical studies, the cost, timing and outcomes of regulatory submissions and decisions regarding a potential approval for any one or more of our current or future product candidates we may choose to develop, and the terms of our contracts with service providers and license partners.

In addition, the development of our clinical-stage candidates and the advancement of our pre-clinical product candidates will depend on results of ongoing and upcoming clinical trials and pre-clinical testing and our financial resources at the time of such results.

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, or should the duration of our planned and ongoing clinical trials be longer than anticipated due to difficulties in patient recruitment or otherwise, our cash resources will be further strained.

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

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

• the product development programs we choose to pursue;

• the cost and pace of preclinical and clinical development;

• clinical trial results;

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

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

• the costs involved in acquiring or in-licensing product candidates or technologies;

• our commercialization plans and the timing and terms of our agreements with third parties relating to commercialization of any approved product.

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.

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.

At December 31, 2021, our cash and cash equivalents were approximately $51.7 million and our accumulated deficit was approximately $110.1 million.

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We expect negative cash flows from our operations to continue for the foreseeable future.

Based on our current operating plan estimates, we do not have sufficient cash to satisfy our working capital needs and other liquidity requirements over the next 12 months from the date of issuance of the accompanying consolidated financial statements unless we raise additional capital or significantly curtail our operations.

We must raise additional capital to finance our operations and remain a going concern.

We will need to raise additional capital or significantly curtail our planned operations to remain a going concern.

Additional capital may not be available to us, or even if it is, the cost of such capital may be high.

We may be forced to obtain additional capital before reaching clinical and/or regulatory milestones, when our stock price or trading volume or both are low, or when the general market for life sciences companies is weak.

We may be forced to obtain additional capital before reaching clinical, regulatory and/or sales milestones, when our stock price or trading volume or both are low, or when the general market for life sciences companies is weak.

Raising capital under any of these or similar scenarios, if we can raise any at all, may lead to significant dilution to our existing stockholders.

See also "Our ability to raise capital may be limited by laws and regulations," and “We are heavily reliant on our ability to raise capital through capital market transactions.

A low trading volume, price and market capitalization together with our lack of revenue, net losses and limited operating history may make it difficult and expensive for us to raise additional capital” below.

If we raise capital through collaborations, strategic alliances or other similar types of arrangements, we may have to relinquish, on terms that are not favorable to us, rights to some of our technologies or product candidates we would otherwise seek to develop or commercialize.

In addition, we may enter into collaborations, such as our license agreement with Bayer, that do not provide significant near-term or guaranteed funding, thus requiring that we continue to seek to raise additional capital to fund product development through other means.

See also “We may not receive any additional payments under our license agreement with Bayer, and Bayer may terminate the agreement at any time without cause upon limited prior notice,” below.

Further, the COVID-19 pandemic may adversely affect our ability

to enter into strategic collaborations for development and/or commercialization of our product candidates.

Operational disruptions, resource constraints or shifts in business strategy of potential partners as a result of the COVID-19 pandemic may adversely affect collaboration opportunities for our product candidates.

See also “The COVID-19 pandemic and efforts to reduce the spread of COVID-19 could negatively impact our business, including by increasing the cost and timelines for our clinical development programs,” below.

A low trading volume, price and market capitalization together with our lack of revenue, net losses, limited operating history and limited amount of unissued authorized common stock may make it difficult and expensive for us to raise additional capital” below.

If we raise capital through collaborations, strategic alliances or other similar types of arrangements, we may be required to relinquish, on terms that are not favorable to us, rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize.

In addition, our current and future commercial license agreements may not provide a level of funding sufficient to satisfy our working capital needs or liquidity requirements, thus requiring that we continue to seek to raise additional capital to fund product development through other means.

See also “If a commercial counterparty terminates its exclusive license agreement with us or fails to perform as expected, our need for additional capital may significantly increase,” below.

Further, operational disruptions, resource constraints or shifts in business strategy of potential collaborators as a result of the COVID-19 pandemic, macroeconomic factors or escalating geopolitical events may adversely affect collaboration terms and opportunities for our product candidates.

See also “Risks Related to Our Business Operations and Industry- The COVID-19 pandemic has negatively impacted our business and, in the future, may materially and adversely affect our business, financial condition and results and stock price, including by increasing the cost and timelines for our clinical development programs,” and “- Our business may be adversely affected by unfavorable or unanticipated macroeconomic conditions and geopolitical events,” below.

There can be no assurance that we can raise capital when needed or on terms favorable to us and our stockholders.

With the potential to significantly affect investor sentiment and increase market volatility, the COVID-19 pandemic and measures taken by federal, state and local governments to reduce the spread of COVID-19, increase uncertainty around our ability to access the capital markets when needed and on acceptable terms.

The COVID-19 pandemic, macroeconomic conditions, and heightened global uncertainties may adversely affect general commercial activity and the U.S.

and global economies and financial markets, which increases uncertainty around our ability to access the capital markets when needed and on acceptable terms.

If we cannot raise capital when needed on acceptable terms, or at all, we will not be able to advance our product candidates as currently planned or grow our product portfolio, we will need to reevaluate our planned operations, we may relinquish rights under our license agreements with third parties relating to our product candidates, and we may need to delay, scale back or eliminate some or all of our development programs, reduce expenses or cease operations, any of which would have a significant negative impact on our prospects and financial condition, as well as the trading price of our common stock.

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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 are a clinical-stage biopharmaceutical company with a limited operating history upon which to evaluate our business and prospects.

Development of drug and drug/device combination products is a highly speculative, lengthy and expensive undertaking and involves substantial risk.

To date, 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 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.

Other than XACIATO, which received FDA approval in December 2021 and has not yet been commercially launched, 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 have devoted significant resources to acquiring our portfolio of product candidates and to research and development, or R&D, activities for our product candidates.

We have devoted significant resources to acquiring XACIATO and our product candidates and to research and development, or R&D, activities for them.

Since inception, we have incurred significant operating losses.

As discussed above, we must raise additional capital to finance our operations and remain a going concern.

The COVID-19 pandemic and efforts to reduce the spread of COVID-19 could negatively impact our business, including by increasing the cost and timelines for our clinical development programs.

The COVID-19 pandemic and efforts to reduce the spread of COVID-19 remain a rapidly evolving and uncertain risk to our business, operating results, financial condition and stock price.

In large part, the extent to which the pandemic affects us will depend on future developments that are beyond our knowledge or control, including, but not limited to, the duration and severity of the pandemic, governmental and individual organization actions and policies implemented to reduce transmission of the disease, and the speed with which and degree to which normal economic and operating conditions resume.

The longer the pandemic persists, the greater the potential for significant adverse impact to our business operations and those of the contract research organizations (CROs), contract manufacturing organizations (CMOs) and other third-party consultants and vendors on which we depend to, among other things, conduct our clinical and nonclinical studies, supply our clinical trial materials, and assist with regulatory affairs necessary to advance our programs.

Employee and family member illness, increased childcare and elder care responsibilities, and quarantines, travel restrictions, prohibitions on non-essential gatherings, shelter-in-place orders and other similar directives and policies intended to reduce the spread of the disease, may reduce our productivity and that of the third parties on which we rely and may disrupt and delay many aspects of our business, including R&D activities, production and supply of clinical trial materials and regulatory affairs activities.

As a result of resource constraints, third parties on which we rely may not meet their contractual obligations to us or may allocate constrained resources to projects other than ours, any of which could significantly increase the cost and timelines for our development programs.

In addition, the increase in personnel working remotely, both ours and those of the third parties on which we rely, could increase our cybersecurity risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which could significantly adversely impact our business operations or significantly delay necessary interactions with the FDA and other regulatory agencies, our CROs and CMOs, clinical trial sites, current and potential collaborators, and other third parties.

The COVID-19 pandemic could cause delays in current timelines for our ongoing and planned clinical studies, our regulatory submissions and potential marketing approvals and, ultimately, commercial launch of any approved product.

One or more of the clinical and regulatory milestones we anticipate will occur in 2021 or 2022 may be delayed or otherwise adversely impacted as a result of the pandemic.

For example, clinical trial site initiation and/or patient enrollment may be significantly delayed or suspended as a result of personnel and other resource constraints

of healthcare providers, as well as adherence to governmental orders and internal policies intended to reduce the spread of COVID-19.

In addition, the pandemic has resulted in disruption and volatility in the global capital markets, and while the longer-term economic impact is difficult to assess and predict at this time, it could negatively impact our ability to access additional capital when needed or on terms favorable to us and our stockholders.

If we cannot raise capital when needed on acceptable terms, or at all, we will not be able to continue development of our product candidates as currently planned or at all, will need to reevaluate our planned operations and may need to delay, scale back or eliminate some or all of our development programs, reduce expenses or cease operations, any of which could have a significant negative impact on our prospects and financial condition, as well as the trading price of our common stock.

A key aspect of our business strategy is to seek collaborations with partners, such as large pharmaceutical companies, that are willing to conduct later-stage clinical trials and further develop and commercialize our product candidates.

As a result of the pandemic, potential and current partners may experience operational disruptions and financial and other resource constraints and implement new strategic plans that delay or reduce their efforts in the women’s health in general or in our programs in particular, which could adversely affect our ability to enter into or maintain collaborations, strategic alliances or other similar types of arrangements and may result in or contribute to disruption and delays in later-stage clinical development and, if approved, commercial launch of our product candidates.

We do not have, and do not currently plan to develop, the internal sales, marketing and distribution infrastructure necessary to independently market and sell our product candidates, if approved.

To help mitigate the impact of the pandemic on our business, we developed a plan with our third-party service providers designed to address the challenges and risks presented by the pandemic on our ongoing clinical trials, and we developed a plan designed to protect the safety, health and well-being of our employees while maintaining employee productivity.

However, there can be no assurance that such plans will be effective in mitigating the potential adverse effects of the pandemic on our ongoing and planned clinical trials and nonclinical studies, on the productivity of our employees or on our business, financial condition and results of operations.

The extent to which the pandemic and efforts to reduce its spread impact our business, financial condition and results of operations is uncertain and cannot be predicted with reasonable accuracy at this time and will depend on future developments that are also uncertain and cannot be predicted with reasonable accuracy at this time, including new information that may emerge concerning the degree to which COVID-19 is contagious and virulent, the effect of actions taken in the United States and other countries to contain and treat COVID-19, the rate and efficacy of vaccinations against COVID-19, and further actions implemented to contain and treat the disease and its impact, among others.

The COVID-19 pandemic may also have the effect of heightening many of the other risks and uncertainties described in this “Risk Factors” section.

We may not receive any additional payments under our license agreement with Bayer, and Bayer may terminate the agreement at any time without cause upon limited prior notice.

In January 2020, we entered into an exclusive license agreement with Bayer for the commercialization of Ovaprene in the U.S.

Under our agreement, Bayer will have no future 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.

Should Bayer elect to do so, it must pay us an additional $20.0 million (the “Clinical Trial and Manufacturing Activities Fee”).

If we do not successfully complete clinical development 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 decide not to pay the Clinical Trial and Manufacturing Activities Fee regardless of the outcome of the pivotal clinical trial.

Further, Bayer may elect to terminate the license agreement without cause at any time upon 90 days’ prior notice.

If the license grant does not become effective or if Bayer terminates the agreement, our ability to complete development of and commercialize Ovaprene may be significantly impaired and it could have material adverse effect on our business and prospects in general and on our stock price.

If Bayer elects to make the license grant effective, it will obtain exclusive rights to commercialize Ovaprene in the U.S.

In this case, Ovaprene's value to us will be generated through royalties on net sales and achievement of commercial milestones.

If Bayer is not successful or has limited success in commercializing Ovaprene, Ovaprene’s value to us will be significantly impaired.

We may realize only a small fraction of the potential value of the license agreement.

Other than the upfront fee, the Clinical Trial and Manufacturing Activities Fee and a milestone payment in the low double-digit millions upon the first commercial sale of Ovaprene in the U.S., Bayer’s milestone and royalty payment obligations are based on annual net sales of Ovaprene.

Successful commercialization of a contraceptive product is subject to many risks and uncertainties, including factors outside of our control or Bayer’s.

receive the full amount of potential milestone payments under the agreement, and royalty and sublicense payments, if any, may be far less than projected.

Failure to realize significant value under our license agreement with Bayer could have a material adverse effect on our business, results of operations and financial condition.

If a commercial counterparty terminates its exclusive license agreement with us or fails to perform as expected, 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 Organon, we will not receive any payments unless the agreement becomes fully effective, and the effective date of the agreement is subject to the satisfaction of closing conditions, including antitrust law clearance which is outside of our control.

Moreover, under our agreement with Bayer, Bayer has no future 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 does not become fully effective, we may realize none or only a small fraction of the potential value of the agreement to us, and we may need to raise significant additional capital to pursue further development and commercialization of XACIATO or Ovaprene, as applicable.

If these license agreements are not terminated and the license grants become effective, we expect XACIATO’s and Ovaprene’s value to us to be generated primarily through royalties based on net sales and achievement of commercial milestones.

The successful or timely achievement of these milestones is largely outside of our control because the relevant activities will be conducted by the licensee.

Accordingly, if the licensee is not successful or has limited commercialization success, our ability to monetize XACIATO and, if approved, Ovaprene, may be significantly impaired and our need for additional capital could significantly increase.

In the future, we may depend to a large degree on payments from third-party licensees to fund our operations, and failure to receive such payments 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;

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

• delay, reduce or terminate one or more development programs;

• reduce headcount;

• forgo opportunities to expand our product portfolio;

• consider strategic transactions with a third party.

Our ability to raise capital may be limited by laws and regulations.

In 2020 and through March 29, 2021, we raised approximately $23.5 million in gross proceeds through the sale of equity securities under a Form S-3 “shelf” registration statement.

During the year ended December 31, 2021 and through March 30, 2022, we raised approximately $70.9 million in gross proceeds through the sale of equity securities under a Form S-3 “shelf” registration statement.

Using a shelf registration statement 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.

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For example, in fiscal year 2020, we were subject to the "baby shelf rule" because the market value of our outstanding shares of common stock held by non-affiliates, or public float, was less than $75.0 million at the time we filed our shelf registration statement on Form S-3 and remained below $75.0 million during the year.

This means that we were able to 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.

As a result, that we were able to 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, any intended sale did 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 alternative to increase the cost of raising additional capital relative to using our shelf registration statement.

In the future, if our public float were to decline below $75.0 million at the time we file our next annual report on Form 10-K, which will be due in March of 2023, we could again become subject to the baby shelf rule.

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.

In addition, under SEC rules and regulations, our common stock must be listed and registered on a national securities exchange in order to use a Form S-3 registration statement (1) for a primary offering, if our public float is not at least $75.0 million as of a date within 60 days prior to the date of filing the Form S-3 or a re-evaluation date, whichever is later, and (2) to register the resale of our securities by persons other than us (i.e., a resale offering).

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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.

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.

In addition, although 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 before it is completed, which often has the effect of depressing a company's stock price.

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

Furthermore, our ability to raise capital through the issuance and sale of equity securities is limited by the number of shares of our common stock that we are authorized to issue, and increasing the number of authorized shares of our common stock requires stockholder approval.

Currently, we are authorized to issue up to 120,000,000 shares of our common stock and, as of March 30, 2022, 92,244,591 shares of our common stock were outstanding or reserved for issuance upon exercise of outstanding warrants or stock options or for future equity awards under our stock incentive plan, which leaves only 27,755,409 shares of our authorized common stock unreserved and available for issuance.

Obtaining stockholder approval is a costly and time-consuming process.

If we must obtain stockholder approval to increase the amount of common stock we are authorized to issue or for a potential transaction, we would expect to spend substantial additional money and resources.

We are heavily reliant on our ability to raise capital through capital market transactions.

We are heavily reliant on our ability to raise additional capital by selling shares of our common stock or securities linked to our common stock.

Our ability to raise capital through capital market transactions 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 continue to satisfy the listing requirements of the Nasdaq Capital Market, unfavorable market conditions or other market factors outside of our control, and the risk factors described elsewhere in this report.

In addition, our ability to raise additional capital by selling shares of our common stock or securities linked to our common stock is limited by the amount of our unissued authorized common stock.

See also “Our ability to raise capital may be limited by laws and regulations,” above, and the risk factors under “Risks Related to Ownership of Our Common Stock,” below.

Even if we are able to raise additional capital, it will likely be dilutive to existing stockholders and the cost of such capital may be substantial and may be more expensive than the cost of capital for larger public companies.

that may have negative consequences for us, including, among other things, by increasing our vulnerability to adverse economic and industry conditions, limiting our ability to obtain additional funding and enter into partnership and other strategic agreements, and requiring the dedication of a portion of our cash flow to service our indebtedness.

There can be no assurance that we can raise additional capital when needed.

Failing to raise additional capital when needed would have a material adverse effect on our business.

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.

This may affect our efforts to develop and bring to market our key portfolio candidates and any future candidates we may choose to develop.

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

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 may be required to curtail our development programs and clinical and nonclinical development activities that might otherwise have led to more rapid progress of our product candidates, or product candidates that we may in the future choose to develop, through the regulatory and development processes.

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.

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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 Clinical Development, Manufacturing and Commercialization– 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.

We are heavily reliant on our ability to raise capital through capital market transactions.

We are heavily reliant on our ability to raise additional capital by selling shares of our common stock or securities linked to our common stock.

See “Our ability to raise capital may be limited by laws and regulations,” above, and the risk factors under “-Risks Related to Our Securities,” below.

The terms of any funding we obtain may not be favorable to us and may be highly dilutive to our stockholders, and debt financing, if available, may involve restrictive covenants, operational restrictions and security interests in our assets that may have negative consequences for us, including, among other things, by increasing our vulnerability to adverse economic and industry conditions, limiting our ability to obtain additional funding and enter into partnership and other strategic agreements, and requiring the dedication of a portion of our cash flow to service our indebtedness.

There can be no assurance that we can raise additional capital when needed.

Failing to raise additional capital when needed would have a material adverse effect on our business.

We intend to seek collaborations with partners to develop and commercialize our product candidates and, if we enter into such collaborations, we may not have control over several key elements relating to the development and commercialization of our product candidates.

A key aspect of our strategy is to seek collaborations with partners, such as large 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 face significant competition in seeking these types of partners.

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

In 2020, we entered into a license agreement with Bayer for the commercialization of Ovaprene in the U.S., if it is approved, as well as agreements with contract research organizations Health Decisions, Inc.

and Avomeen to help accelerate development of key programs in a capital-efficient manner.

We may not be able to enter into other collaborations on acceptable terms, or at all.

We have no internal sales, marketing or distribution capabilities and our model is to partner with companies with existing sales and marketing capabilities to sell and distribute our products, if approved.

If we fail to secure third-party collaborators for commercialization of our product candidates on a timely basis, even if they receive regulatory approval on our anticipated timelines, the commercial launch of our products may be significantly delayed, which could have a material adverse effect on our financial condition and results of operations.

If we enter into definitive agreements with third parties to commercialize our product candidates, if approved, our revenues from the sale of such products will depend, in whole or in part, on the ability of such third parties to successfully market, sell and distribute our products and to perform their contractual obligations to us and there is no assurance these third parties will be effective or successful.

In addition, if a partnered product is viewed by other potential collaborators as underperforming after commercial launch, our ability to partner other product candidates we are developing may be negatively impacted.

By entering into a strategic collaboration with a partner, we may rely on the partner for financial resources and for development, regulatory and commercialization expertise and we may agree that the partner will control elements of product development and commercialization that are important to the product’s success.

Even if we are successful in entering into a strategic collaboration for one of our product candidates, our partner may fail to develop or effectively commercialize the product candidate because that partner:

• does not have sufficient resources or decides not to devote adequate resources to our collaboration due to internal constraints such as limited cash or human resources;

• decides to pursue a competitive potential product developed outside of the collaboration;

• cannot obtain the necessary regulatory approvals;

• changes its business strategy and areas of focus;

• determines that the market opportunity is not attractive;

• cannot obtain sufficient quantities of our products or product candidates at a reasonable cost;

• elects to terminate our strategic collaboration for any reason.

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.

Those factors may include the design and outcomes of our clinical studies, the likelihood of approval by regulatory authorities, the potential market for the product, the costs and complexities of manufacturing and delivering such product to customers, the potential of competing products, the strength of the intellectual property, other potential sources of market exclusivity for such product, and industry and market conditions generally.

The collaborator may also consider alternative products or technologies for similar indications that may be available to collaborate on and whether such collaboration could be more attractive than the one with us for our products or product candidates.

We also face competition in our search for collaborators from other biotechnology and pharmaceutical companies worldwide, many of which are larger and able to offer more attractive deals in terms of financial commitments, contribution of human resources, or development, manufacturing, regulatory or commercial expertise and support.

Inadequate capitalization of our company, or the perception thereof, could negatively affect our negotiating leverage in transactions.

Any potential collaboration agreement into which we might enter may call for licensing or cross-licensing of potentially blocking patents, know-how or other intellectual property.

Due to the potential overlap of data, know-how and intellectual property rights, there can be no assurance that a collaborator will not dispute its right to use, license or distribute such data, know-how or other intellectual property rights, and this may lead to disputes, liability or termination of the collaboration.

If we elect to fund development or commercialization activities on our own or to co-promote a product with a third party, we will need to obtain significant additional capital, which may not be available to us when needed on acceptable terms or at all.

If we elect to commercialize a product on our own or to co-promote a product with a third party, we may also need to rapidly grow and reorganize our company and develop and implement new systems and processes to support marketing, sale and distribution of the product, none of which we currently have in place as a clinical-stage biopharmaceutical company.

If we are not successful in attracting collaborators and entering into collaborations on acceptable terms for our product candidates or otherwise monetizing our product candidates, we may not complete development of or obtain regulatory approval for such product candidates, or if we obtain regulatory approval, commercial launch may be delayed and market penetration could be limited.

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.

The product candidates we are developing or may develop are likely to face significant competition and our business and operating results will suffer if we 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.

These companies include Merck & Co., Inc.

(and its intended spinoff, Organon & Co.), AMAG, Inc., TherapeuticsMD, Inc., Cooper Surgical, Inc., AbbVie, Inc., Bayer AG, Johnson & Johnson, and Pfizer Inc.

Additionally, several generic manufacturers currently market and continue to introduce new contraceptive and other products in women's health, including Sandoz International GmbH, Glenmark Pharmaceuticals Ltd., Lupin Pharmaceuticals, Inc., Mylan, Inc.,

Perrigo Company, PLC and Amneal Pharmaceuticals LLC.

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

• much greater financial, research, technical and human resources than we have at every stage of the product development and commercialization life cycle;

• more extensive experience in designing and conducting clinical trials, nonclinical studies, obtaining regulatory approvals, and in manufacturing, marketing and selling prescription products;

• approved products or product candidates in late stages of development for one or more of our target indications.

We will face intense competition from products that have already been approved and accepted by the medical community for contraception and the treatment of some of the conditions for which we are developing or may develop product candidates.

If our product candidates fail to generate compelling clinical results or if patients and physicians fail to appreciate the convenience that our product candidates may offer, our commercial opportunity could be reduced or eliminated.

We also expect to face competition from new products that enter the market.

We believe there are a significant number of products currently under development intended to prevent pregnancy or to treat the same conditions for which our product candidates are in development.

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

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

Our ability to compete effectively will be impacted by the efficacy and safety outcomes of our clinical trials, the label claims that the FDA or other regulatory authorities approve for our product candidates, the degree of acceptance of products we develop among the medical community and patients, and their preference for those products over available alternative products.

It is possible that the potential advantages of our product candidates do not materialize.

Our competitors may also obtain FDA or other regulatory approval for their competing products more rapidly than we may obtain approval for any of our product candidates, which could result in our competitors establishing a strong market position before we are able to enter the market.

See also the discussion of risks and uncertainties related to commercial success of specific product candidates we are developing under “Risks Related to Clinical Development, Manufacturing and Commercialization” below.

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

As of March 29, 2021, we had 23 employees, of which 16 were full-time and seven were part-time.

Our focus on limiting cash utilization requires us to manage and operate our business in a highly efficient manner, relying on external consultants for needed product development and operational expertise, and to limit full-time personnel resources.

With a small number of employees, our ability to supervise the external consultants and vendors we engage 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.

In response to the COVID-19 pandemic, in March 2020, we implemented work-from-home and restricted travel policies.

Since March 2020, the governors of California and Massachusetts, states in which we have operations, have issued, rescinded and reinstated statewide or regional stay-at-home orders to help combat the spread of COVID-19 that have impacted our ability to require or allow our employees to work in our facilities.

In addition, many, if not all, of our consultants, partners and vendors on which we rely heavily have implemented similar policies, are or may be subject to similar orders, and/or may re-allocate resources otherwise intended for our activities to activities intended to address the COVID-19 pandemic.

While we have modified, and we may further modify, our work-from-home and restricted travel policies to allow some of our personnel to return to working in our facilities for a portion of their working time as the pandemic and state and local stay-at-home orders evolve , the duration of these policies and the extent and duration of various state and local stay-at-home orders currently is indeterminable.

We have systems and technologies in place that enable our employees to work from home;

however, state and local stay-at-home orders, work-from-home policies and travel restrictions may adversely affect our ability to effectively manage and operate our business, materially increase our expenses and may result in delays in our anticipated development program timelines.

In addition, we and our consultants, partners and vendors may experience high rates of employee leave during the COVID-19 pandemic due to increased rates of worker or family member illness, school and childcare center closures and federal and state family and medical leave laws that may allow workers to take up to 12 weeks of job-protected leave if unable to work or telework due to their own health condition or need to care for children or other

family members.

Due to our small workforce, extended employee leaves of absence may adversely affect our ability to effectively manage and operate our business, materially increase our expenses, including by requiring us to hire new employees or engage additional consultants to perform the job responsibilities of the employees on leave, and may result in delays in our anticipated development program timelines.

If we fail to attract and retain management and other key personnel, we may not successfully complete development of, obtain regulatory approval for or commercialize our product candidates, or otherwise implement our business plan.

Our ability to compete in the highly competitive pharmaceutical, biotechnology and medical device industries depends upon our ability to attract and retain highly qualified managerial and key personnel.

We depend highly on our senior management.

Losing the services of our senior management employees could impede, delay or prevent the development and commercialization of our product candidates, hurt our ability to raise additional funds and negatively impact our ability to implement our business plan.

If we lose the services of any of our senior management employees, we might not find suitable replacements on a timely basis or at all, and our business could be materially harmed.

We do not maintain “key man” insurance policies on the lives of any of our senior management employees.

We might not attract or retain qualified management and other key personnel in the future due to the intense competition for qualified personnel among biopharmaceutical and biotechnology companies and other life sciences R&D organizations, particularly in the San Diego area where we are headquartered.

In addition, our limited personnel and financial resources may result in greater workloads for our employees compared to those at companies with which we compete for personnel, which may lead to higher levels of employee burnout and turnover.

As a result, we may have to expend significant financial resources in our employee recruitment and retention efforts.

Many of the other companies within the women’s health products industry with whom we compete for qualified personnel have greater financial and other resources, different risk profiles and longer histories in the industry than we do.

They also may provide more diverse opportunities and better opportunities for career advancement.

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.

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.

Our business development strategy has included, and will likely continue to include, strategic transactions to assemble the portfolio of product candidates we develop.

We may not successfully manage the integration of new assets or businesses, and the costs of these transactions may not be outweighed by the benefits we realize from them.

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

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

We expect to expand our portfolio from time to time through similar transactions.

These transactions could subject us to several risks, including, but not limited to:

• our inability to appropriately evaluate the potential risks and uncertainties associated with a transaction;

• our inability to effectively integrate a new technology, product and/or business, personnel, intellectual property or business relationships;

• our inability to generate milestones or revenues from a strategic transaction sufficient to meet our objectives in undertaking the transaction.

If we underestimate development costs, timelines, regulatory approval challenges and commercial market opportunity for a strategic transaction, we may fail to realize the anticipated value of the transaction.

Any strategic transaction we may pursue may not produce the outcomes and benefits we originally anticipated, may result in costs that outweigh the benefits, and may adversely impact our financial condition and be detrimental to our company in general.

Cyber-attacks, security breaches, loss of data and other disruptions to our information technology systems or those of our third-party service providers could compromise sensitive information related to our business, delay or prevent us from accessing critical information or expose us to liability, any of which could adversely affect our business and our reputation.

We utilize information technology systems and networks to process, transmit and store electronic information in connection with our business activities.

As the use of digital technologies has increased, cyber incidents, including

deliberate attacks, the deployment of harmful malware or ransomware, denial of service, and attempts to gain unauthorized access to computer systems and networks, have increased in frequency and sophistication.

These threats pose a risk to the security of our systems and networks and those of our third-party service providers, and could compromise the confidentiality, availability and integrity of our data, confidential information, or other intellectual property, all of which are vital to our operations and business strategy.

Organizations and governmental bodies with far greater resources than ours dedicated to cyber security have proven vulnerable to cyber-attacks.

There can be no assurance we will succeed in preventing cyber security breaches or successfully mitigate their effects.

Despite implementing security measures, any of the internal computer systems belonging to us or our third-party service providers are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failure.

Moreover, the prevalent use of mobile devices that access confidential information increases the risk of data security breaches.

Any system failure, accident, security breach or data breach that causes interruptions in our own or in third-party service vendors’ operations could result in a material disruption of our product development programs.

For example, losing clinical study data from future clinical studies could result in delays in our or our partners’ regulatory approval efforts and significantly increase our costs in order to recover or reproduce the lost data.

In addition, a security breach or privacy violation that leads to disclosure of personally identifiable information or protected health information could harm our reputation, compel us to comply with federal and/or state breach notification laws and foreign law equivalents, subject us to mandatory corrective action, require us to verify the correctness of database contents and subject us to litigation or other liability under laws and regulations that protect personal data.

Further, our information technology and other internal infrastructure systems, including firewalls, servers, leased lines and connection to the Internet, face the risk of systemic failure, which could disrupt our operations.

If any disruption or security breach results in a loss or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we may incur resulting liability, our product development programs and competitive position may be adversely affected, and the further development of our products may be delayed.

Furthermore, we may incur additional costs to remedy the damage caused by these disruptions or security breaches.

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

We may become exposed to the risk of employees, independent contractors, clinical investigators, consultants, suppliers, commercial partners or vendors engaging in fraud or other misconduct.

Misconduct by employees, independent contractors, clinical investigators, consultants, suppliers, commercial partners and vendors could include intentional failures, such as failures to:

(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 law, 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.

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.

Misconduct by current or future employees, independent contractors, clinical investigators, consultants, suppliers, commercial partners and vendors could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory or civil sanctions and serious harm to our reputation.

It is not always possible to identify and deter misconduct by employees, independent contractors, clinical investigators, consultants, suppliers, commercial partners and vendors, 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.

We expect to continue to incur increased costs as a result of operating as a public company, and our management will have to devote substantial time to compliance initiatives and corporate governance practices.

We incur and expect to continue to incur significant legal, accounting and other expenses as a public reporting company.

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.

Under recently adopted SEC rules, 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 requirements of being a public company.

Even while we have non-accelerated filer status, our management and other personnel will need to continue to devote

substantial time towards maintaining compliance with the requirements of being a public company.

The Sarbanes-Oxley Act of 2002 and rules and regulations subsequently implemented by the SEC and Nasdaq imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.

Our management and other personnel, of whom we have a small number, devote substantial time to these compliance initiatives.

Moreover, if and when we become an accelerated filer, our compliance costs will increase.

For example, pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, we must furnish a report annually by our management on the effectiveness of our internal control over financial reporting, and performing the system and process documentation and evaluation necessary to issue that report requires us to incur substantial expense and expend significant management time.

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.

Risks Related to Clinical Development, Manufacturing and Commercialization

We depend heavily on the success of our lead product candidates, DARE-BV1, Ovaprene and Sildenafil Cream, 3.6%.

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.

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.

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.

Historical success in clinical development of and obtaining regulatory approval for a product candidate does not guarantee or predict future successful outcomes for other investigational products.

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

Except for XACIATO, which was approved by the FDA for U.S.

marketing in December 2021 but has not yet been commercially launched, 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 by the FDA, or similar regulatory authorities for jurisdictions outside of the U.S., and will require submission of an application to and approval of that application by the FDA to be marketed in the U.S., and will need to undergo a submission, review and approval process with other regulatory authorities to be marketed outside of the U.S.

FDA or other regulatory authority approval may never be obtained.

XACIATO has not been approved for marketing anywhere outside of the U.S., and cannot be marketed outside of the U.S.

unless and until marketing applications for other jurisdictions are submitted and approved by the applicable regulatory authorities, which may require additional clinical and nonclinical development, and may never occur.

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.

We depend heavily on the successful development of our lead product candidates, Ovaprene and Sildenafil Cream, 3.6%.

Clinical development is a lengthy and expensive process with an inherently uncertain outcome.

Failure to successfully develop and obtain regulatory approval to market and sell any of these product candidates would likely adversely affect our business.

Failure to successfully develop and obtain regulatory approval to market and sell either of these product candidates would likely adversely affect our business.

Our business depends on the successful clinical development and regulatory approval of our lead product candidates, which may never occur.

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The outcome of preclinical testing and early clinical trials may not be predictive of success of later clinical trials, and interim results of a particular clinical trial do not necessarily predict final results of that trial.

Accordingly, while some of our product candidates have undergone clinical trials and demonstrated positive results, including DARE-BV1, Ovaprene and Sildenafil Cream, 3.6%, there is no guarantee of successful outcomes in future clinical studies of these product candidates or of obtaining marketing approval for any of them.

The fact that the active pharmaceutical ingredients in certain of our product candidates, including DARE-BV1 and Sildenafil Cream, 3.6%, have received regulatory approval in other formulations and/or for other indications does not guarantee successful development of our product candidates.

Accordingly, while some of our product candidates have undergone clinical trials and demonstrated positive results, including Ovaprene and Sildenafil Cream, 3.6%, there is no guarantee of successful outcomes in future clinical studies of these product candidates or of obtaining marketing approval for any of them.

The fact that the active pharmaceutical ingredients in certain of our product candidates, including Sildenafil Cream, 3.6%, have 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.

We have never received a regulatory approval for any product.

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

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

Our rights to some of our product candidates, including our lead product candidates, arise from license agreements with third parties.

The loss or impairment of our licensed rights to develop and commercialize these product candidates, including as a result of our inability or other failure to meet our obligations under any one of such license agreements, including, without limitation, our payment obligations, could have a substantial negative effect on our company’s prospects.

We entered into a license agreement with ADVA-Tec for the exclusive worldwide rights to develop and commercialize Ovaprene that became effective in July 2017.

In addition to standard termination rights, ADVA-Tec may terminate the license agreement if we (1) fail to make significant scheduled investments in product development activities over the course of the agreement, (2) fail to commercialize Ovaprene within six months of obtaining a pre-market approval from the FDA, (3) with respect to the license in any particular country, fail to commercialize Ovaprene in that particular country within three years of the first commercial sale, (4) develop or commercialize a non-hormonal ring-based vaginal contraceptive device other than Ovaprene, (5) fail to conduct certain clinical trials, or (6) fail to make certain milestone, sublicense and/or royalty payments to ADVA-Tec, including a milestone payment due upon the FDA's approval to commence a pivotal human clinical trial of Ovaprene.

"BUSINESS-Overview-License Agreements-ADVA-Tec License Agreement," above.

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, 3.6% for all indications for women related to female sexual dysfunction and/or female reproductive health, including treatment of the female sexual arousal disorder 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.

"BUSINESS-Overview-License Agreements-SST License and Collaboration Agreement,” above.

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-OAB1.

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.

"BUSINESS-Overview-License Agreements-Catalent JNP License Agreement,” above.

In December 2018, we entered into definitive agreements with Hammock Pharmaceuticals, Inc., TriLogic Pharma LLC and MilanaPharm LLC under which we acquired exclusive global rights to DARE-BV1 for the treatment of bacterial vaginosis, as well as the rights to utilize the underlying proprietary hydrogel drug delivery technology for any vaginal or urological application in humans.

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.

MilanaPharm may terminate our license if, after having launched such product or process in such country, we, or our affiliates or sublicensees, as applicable, discontinue the sale of, or commercially reasonable marketing efforts to sell, such product or process in such country, and fail to resume such efforts or to reasonably demonstrate a strategic justification for the discontinuation and failure.

"BUSINESS-Overview-License Agreements-Hammock/MilanaPharm Assignment and License Agreement,” above.

If any of our agreements with ADVA-Tec, SST, Catalent, or Hammock Pharmaceuticals/MilanaPharm are terminated, impaired, or limited, we could lose the ability to develop and commercialize Ovaprene, Sildenafil Cream, 3.6%, DARE-BV1, or any of our IVR product candidates, including DARE-HRT1, as applicable.

The termination of our rights under these agreements to develop and commercialize any of our lead product candidates could have a material adverse effect on our business prospects and operations.

We may seek to license the product and technology rights to additional product candidates in accordance with our business strategy, but there can be no assurance we will be able to do so on favorable terms or at all.

There are risks, uncertainties and costs associated with identifying, licensing and advancing product candidates through successful clinical development.

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

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.

The tests and clinical trials of product candidates we develop may not commence, progress or be completed as expected, and delays could significantly impact our product development costs and timelines, as well as a product candidate’s market potential, if ultimately approved.

The timing of initiation, conduct and completion of clinical trials and other testing of 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 a number of significant assumptions and the actual timing of achievement of development milestones may differ materially from our predictions for a variety of reasons.

We currently do not have adequate capital to conduct all of the clinical studies that we plan to conduct in 2021 and 2022.

Commencement of planned clinical studies may be delayed if we do not secure adequate capital.

In addition to lack of adequate capital, commencement and/or completion of these studies may be delayed, terminated or suspended as a result of the occurrence of any of a number of other factors, including the need to obtain authorizations from the FDA and the institutional review boards, or IRBs, of prospective clinical study sites, delayed or inadequate supply of our product candidates or other clinical trial material, slower than expected rates of patient recruitment or enrollment, other factors described below, and unforeseen events.

In addition, among other factors, our

ability to commence our planned pivotal clinical study of Ovaprene is subject to the FDA’s review and clearance of an IDE.

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

• obtaining required funding;

• obtaining guidance or authorizations from the FDA or foreign regulatory authorities;

• finalizing the trial design as a result of discussions with the FDA, other regulatory authorities or prospective clinical trial investigators or sites;

• reaching agreement on acceptable terms with prospective CROs and clinical trial sites;

• obtaining sufficient quantities of our product candidates and other clinical trial material;

• obtaining IRB approval to conduct a clinical trial at a prospective site.

In addition, once a clinical trial has begun, it may experience unanticipated delays or be suspended or terminated by us, an IRB, the FDA or other regulatory authorities due to several factors, all of which could impact our ability to complete our clinical trials in a timely and cost-efficient manner, including:

• lack of adequate funding;

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.

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.

Clinical trials of our product candidates may not commence, progress or be completed as expected.

Delays could significantly impact our product development costs and timelines, as well as a product candidate’s market potential, if ultimately approved.

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.

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

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

• delays in obtaining guidance or authorizations from the FDA or foreign regulatory authorities;

• delays in obtaining approval from the institutional review boards, or IRBs, of prospective clinical study sites;

• delays in finalizing the trial design as a result of discussions with the FDA, foreign regulatory authorities, prospective clinical trial investigators or IRBs;

• delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;

• inability to obtain sufficient quantities of clinical product supplies from our contract manufacturers and suppliers.

Once a clinical trial has begun, it may be delayed, suspended or terminated by us, an IRB, the FDA or other regulatory authorities as a result of the occurrence of any of a number of events or circumstances, including the following:

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

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

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• higher than anticipated participant drop-out rates;

• failure of clinical trial participants to use the product as directed or to report data as per trial protocols;

• failure of participants to use the investigational product as directed or to report data as per trial protocols;

• inspection of the clinical trial operations or clinical trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;

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

• participants experiencing severe side effects or other adverse events related to the investigational treatment;

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

• failure of our CROs or other third-party contractors to meet their contractual obligations to us in a timely manner, or at all;

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

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

• failure of our CROs or other third-party service providers to meet their contractual obligations to us in a timely manner, or at all;

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

The COVID-19 pandemic remains a rapidly evolving and uncertain additional risk to our timelines for commencement and completion of our clinical trials.

Our prospective or contracted clinical trial sites may temporarily suspend activities at their sites to help secure the safety of their employees or to adhere to government recommendations or orders related to social distancing and limiting public gatherings, or they may experience resource constraints stemming from the pandemic 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 clinical trials that we are able to initiate, we may experience lower than anticipated subject enrollment and completion rates, including because individuals may avoid medical settings due to concerns related to the pandemic or they may become subject to governmental orders or recommendations that impose curfews or that ask individuals to leave their homes only if essential.

In addition, increased rates of worker illness and implementation of work-from-home and restricted travel policies due to the COVID-19 pandemic may delay any regulatory authority and/or IRB approvals necessary for our clinical trials and/or prevent our CROs and other third-party contractors who are necessary for the conduct of our clinical trials from meeting their contractual obligations to us in a timely manner, any of which could delay commencement and completion of our clinical trials.

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.

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

The COVID-19 pandemic and recent geopolitical events are evolving and uncertain additional risks to our development timelines, having the potential to cause or contribute to significant delays in commencement and completion of our clinical trials.

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

Our prospective or contracted clinical trial sites may temporarily suspend activities at their sites for the safety of their employees or to adhere to government recommendations or orders related to social distancing and limiting public gatherings, or they may experience resource constraints, including staffing shortages, stemming from the pandemic 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 clinical trials that we are able to initiate, we may experience lower than anticipated subject enrollment and completion rates, including because individuals may avoid medical settings due to concerns of contracting COVID-19 or may become subject to governmental orders or adhere to governmental guidelines intended to reduce the spread of COVID-19, or, during periods when COVID-19 case rates are low, prospective participants may be less inclined to participate in or complete clinical studies that require multiple clinic visits when they have more freedom to travel and participate in other activities that were not available or considered too risky during other stages of the pandemic.

In addition, increased rates of employee absences due to worker or family member illness and work-from-home and restricted travel policies implemented in response to the COVID-19 pandemic may delay any regulatory authority and/or IRB approvals necessary for our clinical trials and/or prevent our CROs and other third-party contractors who are necessary for the conduct of our clinical trials from meeting their contractual obligations to us in a timely manner, any of which could delay commencement and completion of our clinical trials.

Significant clinical trial delays could adversely impact on financial condition and results of operations by substantially increasing the costs of our development programs.

Significant clinical trial delays also could jeopardize our ability to meet obligations under agreements under which we license our rights to our product candidates, allow other companies to bring competitive products to market before we do, shorten any period of market exclusivity we may otherwise have under our patent rights, and weaken our negotiating position in discussions with potential collaborators, any of which could impair our ability to successfully commercialize our product candidates, if ultimately approved.

Any significant delays in commencement or completion of clinical trials of our product candidates, or the suspension or termination of a clinical trial, could materially harm our business, financial condition and results of operations.

We plan to submit an NDA to the FDA for approval of DARE-BV1 based largely on data from our recently completed Phase 3 DARE-BVFREE clinical trial;

however, there can be no assurance that the FDA will grant

marketing approval of DARE-BV1 for the treatment of bacterial vaginosis without additional clinical or nonclinical studies.

DARE-BV1 is a novel thermosetting bioadhesive hydrogel formulation of clindamycin, an antibiotic with FDA approval in other formulations to treat bacterial infections, including bacterial vaginosis.

Bacterial vaginosis effects over 20 million women and is known for being a difficult vaginal infection to cure.

Our formulation is designed to provide extended release of the drug at the site of infection over multiple days and require no intervention by the patient beyond the initial application, which we believe will improve outcomes.

Other pharmaceutical companies have employed a similar approach, with clindamycin and other antibiotics, and have generated only marginally improved outcomes.

DARE-BV1 has been studied in 30 women diagnosed with bacterial vaginosis in an investigator-sponsored study and in a randomized, multicenter, double-blind, placebo controlled Phase 3 clinical study that randomized 307 women diagnosed with bacterial vaginosis in 32 study sites across the U.S.

In December 2020, we announced positive topline results from the Phase 3 DARE-BVFREE study.

DARE-BV1 met the primary endpoint of the study and all of the pre-specified secondary efficacy endpoints, demonstrating significantly greater clinical cure rates compared to placebo.

Drug product candidates must demonstrate substantial evidence of effectiveness, as well as safety, to be approved in the U.S.

The FDA has interpreted that statutory standard as generally requiring at least two adequate and well-controlled clinical trials, each convincing on its own, to establish effectiveness.

Under certain circumstances the FDA will determine that data from one adequate and well-controlled clinical trial together with confirmatory evidence obtained prior to or after such clinical trial are sufficient to constitute substantial evidence of effectiveness.

Based on discussions with the FDA regarding the DARE-BV1 program and, specifically, the DARE-BVFREE study design, we believe that data from the DARE-BVFREE study, together with other existing safety and efficacy data on DARE-BV1 and clindamycin, will be sufficient to demonstrate substantial evidence of effectiveness, as well as safety, of DARE-BV1;

provided that, after a comprehensive review of data from the DARE-BVFREE study, complete results are at least as positive as the topline results.

However, regardless of our analyses of and conclusions about the DARE-BVFREE study data, the FDA may determine that the data are not sufficiently robust or convincing and may require additional clinical and/or nonclinical studies prior to approval of DARE-BV1 to treat bacterial vaginosis.

If additional unplanned development studies or other activities are required for regulatory approval, our R&D expenses and DARE-BV1’s development timeline could increase significantly, DARE-BV1’s value could decrease significantly, and our financial condition and results of operations could be materially adversely affected.

If DARE-BV1 receives FDA approval, it will face significant competition from existing and potentially new therapies.

See “The commercial success of DARE-BV1 will depend on its effectiveness in treating bacterial vaginosis compared to available competitive products and on women’s preferences” below.

Ovaprene is a drug/device combination and the process for obtaining regulatory approval in the United States will require compliance with more complex requirements of the FDA applicable to combination products.

A change in the FDA’s prior determination that Ovaprene has a device-primary mode of action and re-assignment of primary oversight responsibility to CDER would adversely impact Ovaprene’s development timeline and significantly raise our costs to complete clinical development and obtain regulatory approval for Ovaprene.

Manufacturing and supply delays and disruptions may significantly delay our clinical studies and be expensive for us to resolve.

Our product and product candidates are complex to manufacture and we rely on single source contract manufacturers and suppliers.

Manufacturing disruptions may occur that may be difficult and expensive to resolve and may cause substantial delays in development of our product candidates.

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

A significant scale-up of manufacturing by our contract manufacturers and suppliers may be necessary to meet our supply requirements for Phase 2 or Phase 3 clinical studies, which may take longer and be more expensive than anticipated, potentially resulting in a significant negative impact our development timelines and costs.

For example, the pivotal clinical study of Ovaprene will require far more clinical product supplies than were manufactured for prior clinical and nonclinical studies combined, and the quantity of Ovaprene clinical supplies needed to support the pivotal clinical study has not yet been produced.

A substantial scale up in production is necessary to meet the study’s requirements, which may not occur on projected timelines and may be more expensive for us than anticipated.

Manufacturing disruptions may delay commencement of the pivotal clinical study or disrupt the conduct of the study after commencement.

Under our agreement with ADVA-Tec, we are dependent on ADVA-Tec and its contract manufacturers for all Ovaprene clinical and commercial product supplies and we have limited ability to influence or control 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 related to the COVID-19 pandemic or recent geopolitical events may contribute to delays in and increased costs for the manufacture and supply of sufficient quantities of Ovaprene to meet the pivotal clinical study’s requirements.

See also “Risks Related to Our Dependence on Third Parties- We rely on third-party suppliers and manufacturers for clinical and commercial supplies of XACIATO and our product candidates, including multiple single source suppliers and manufacturers, and we currently have no plans to build or acquire our own manufacturing capabilities.

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 “- 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 and product candidates, which may heighten our dependence on those third parties and the risk of manufacturing disruptions” below.

Ovaprene is a drug/device combination and the process for obtaining regulatory approval in the United States will require compliance with complex procedures because concordance between two centers of the FDA (CDRH and CDER) is necessary for approval of this combination product.

A change in the FDA’s prior determination that CDER 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.

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

It is an intravaginal contraceptive product that releases a locally acting spermiostatic agent and has a permeable knitted polymer in its center designed to create a partial barrier to sperm.

The barrier seeks to block the progression of sperm into the cervical mucus while the agents seek to create an environment inhospitable to sperm.

Ovaprene previously underwent a request for designation, or RFD, process with the FDA that determined that the product had a device-primary mode of action and CDRH would lead the review of a PMA for the product.

If the designation were to be changed to drug-primary mode of action and assigned to CDER, or if either division 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.

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 planned contraceptive effectiveness and safety study of Ovaprene is successful, the FDA will not require additional clinical studies to support the PMA for Ovaprene.

Based on discussions with the FDA, we believe that if our planned 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.

In addition, our ability to commence the pivotal clinical study of Ovaprene is subject to the FDA’s review and approval of an IDE, the timing of which will be later than we anticipated when we initiated the process based feedback from the FDA, and could delay or contribute to a delay in the commencement of the pivotal clinical study.

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 monthly, hormone-free 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.

The factors contributing to female sexual dysfunction disorders, including genital arousal disorders, are complex making the design and implementation of a successful clinical trial of Sildenafil Cream, 3.6% challenging.

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.

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, 3.6% in treating FSAD more inherently challenging and uncertain compared with investigational products for many other conditions.

There are currently no FDA-approved 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, 3.6%.

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, clinical studies to evaluate effectiveness in any subset of the condition under the umbrella of Sexual Dysfunction, such as female sexual arousal disorder, or FSAD, are complex.

Sildenafil Cream, 3.6% is designed to work primarily by increasing blood flow to the genital tissue.

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 condition under the umbrella of Sexual Dysfunction, such as FSAD, are complex.

While we worked with experts to develop novel patient reported outcome, or PRO, instruments for our ongoing Phase 2b study of Sildenafil Cream, 3.6%, tested the proposed 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 study may nevertheless prove difficult to enroll on the anticipated timeline or fail to demonstrate effectiveness of Sildenafil Cream, 3.6% in treating FSAD.

For example, Sildenafil Cream, 3.6% is designed to work primarily by increasing blood flow to the genital tissue.

Therefore, it will be critical for us to identify and enroll patients in our clinical trials of Sildenafil Cream, 3.6% for whom inadequate blood flow to the genital tissue is the primary contributor to their arousal disorder.

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, 3.6%.

Even if we can identify women for whom inadequate blood flow to the genital tissue is the primary contributing factor to their sexual arousal difficulties, there is no guaranty that the use of Sildenafil Cream, 3.6% will improve their general feelings of arousal or that we can utilize a patient reported outcome measure that adequately captures their genital arousal response.

Given the factors contributing to arousal disorders, we may be required to run clinical trials in large patient populations, extending the timeline and increasing the cost of development for Sildenafil Cream, 3.6%.

Today, there are no FDA-approved treatments for FSAD, and we lack a precedent program to assist in the design of our clinical trials.

These factors increase our development risk and the chance of failure.

While we have worked with experts to develop novel patient reported outcome, or PRO, instruments for our planned Phase 2b study of Sildenafil Cream, 3.6%, tested the proposed 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 study may nevertheless fail to demonstrate effectiveness of Sildenafil Cream, 3.6% in treating FSAD.

Our failure to design and implement a successful clinical trial for Sildenafil Cream, 3.6% could have materially adverse effect on our business and our financial condition.

DARE-HRT1 and DARE-FRT1 utilize a vaginal ring technology that has not completed any human clinical trials.

DARE-HRT1 represents the earliest of our clinical-stage assets and the Phase 1 study in Australia represents the first human testing of this novel intravaginal ring technology.

DARE-FRT1 utilizes the same IVR technology as DARE-HRT1.

Other than the Phase 1 study of DARE-HRT, to date, all studies of DARE-HRT1 and DARE-FRT1 have been in vitro studies or animal studies.

The risks associated with earlier stage technologies tend to be higher and the rate of failure tends to be greater.

While the IVR technology has generated promising results in pre-clinical studies, there can be no assurance these results will be replicated when tested in human subjects.

Even if successful, many approved therapies exist for treating symptoms of menopause, including vasomotor symptoms, and for pregnancy maintenance.

There is no guaranty that women will prefer the convenience of a monthly vaginal ring over pills, patches and creams.

Failure of DARE-HRT1 in the ongoing Phase 1 clinical study could have a meaningful adverse effect, not only on the DARE-HRT1 program, but also on the DARE-FRT1 program and the likelihood of the IVR technology being investigated for use in another indication.

These developments would materially impact the value of this technology platform to our stockholders.

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 PCT clinical trial for Ovaprene and the Phase 3 clinical trial of DARE-BV1.

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 or 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 engage will be able to provide the functions, tests or services as agreed upon, including the agreed upon price and timeline, or to our requisite quality standards, including due to geopolitical actions, natural disasters, or public health emergencies or pandemics, such as the COVID-19 pandemic.

We rely on the efforts of these third

parties and if they fail to perform as expected, we could suffer significant delays 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 would have a material adverse effect on our business, financial condition, results of operations and prospects.

We rely on third-party suppliers and manufacturers of our product candidates, including multiple single source suppliers and manufacturers and, if approved, we expect to continue to rely on third parties for the manufacture of our products and supply of their component substances and materials.

Our product candidates and, if approved, our products (including their respective components) must be manufactured, packaged, tested, and labeled in conformity with cGMP and other applicable regulatory requirements.

We have a small number of employees and no personnel dedicated to marketing, manufacturing or sales and distribution.

We rely on third parties to supply and manufacture our product candidates and other materials necessary to commence and complete pre-clinical testing, clinical trials and other activities required for regulatory approval of our product candidates.

If we receive the requisite regulatory approvals for one or more products, we expect to rely on third parties for commercial manufacture such products, and as such we will be subject to inherent uncertainties related to product safety, availability and security.

In some cases, we may be contractually required to obtain supplies of our product candidates and approved products, if any, from specific third parties.

For example, our agreement with ADVA-Tec limits our ability to engage a manufacturing source for Ovaprene other than ADVA-Tec during its development period as well as following regulatory approval.

If ADVA-Tec fails to produce sufficient clinical supply of Ovaprene on anticipated timelines, our ability to complete clinical development and seek regulatory approval of Ovaprene could be significantly delayed.

If Ovaprene receives marketing approval, failure by ADVA-Tec to produce sufficient quantities of the product to meet commercial demand could have a significant adverse effect on our income and ability to become profitable.

To date, ADVA-Tec has only produced a small number of devices for clinical testing.

Furthermore, for some of the key raw materials and components of Ovaprene, we have 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 will be responsible for obtaining supplies of Sildenafil Cream, 3.6% for the Phase 2 clinical trials expected to be conducted in the United States.

Thereafter, we will be responsible for obtaining pre-clinical, clinical and commercial supplies of Sildenafil Cream, 3.6%.

Under the terms of the license arrangements for our other clinical-stage candidates, DARE-BV1 and DARE-HRT1, we will be responsible for sourcing the supply of the active ingredients and arranging for the manufacture of the products.

We do not yet have any agreements in place for commercial production of DARE-BV1.

We currently plan to obtain commercial supply of DARE-BV1 from the CMO that manufactured DARE-BV1 clinical trial material for the DARE-BVFREE Phase 3 study.

However, there can be no assurance that we will enter into any such agreement with that CMO in a timely manner, or at all.

If we are unable to do so, we would be forced to seek to engage a new CMO to manufacture commercial supply of DARE-BV1, which could lead to delays in regulatory approval and commercial launch in the U.S., as well as higher manufacturing costs.

In addition, future supplies of raw materials required to produce DARE-BV1 and Sildenafil Cream, 3.6% may be more difficult and costly to obtain.

For example, our current supplier of clindamycin is located in China, and our current supplier of sildenafil is located in India.

Should these suppliers slow production or shut down their factories due to the COVID-19 pandemic, or for any reason, we may not be able to obtain adequate supplies of clindamycin or sildenafil to satisfy our commercial or clinical development supply requirements.

In addition, political relations between the U.S.

and China could affect our ability to obtain adequate supply of clindamycin from our current supplier at reasonable costs.

If these circumstances were to occur, we could be forced to source clindamycin or sildenafil from different suppliers, which could lead to higher costs and delays in clinical development, regulatory approval and commercial launch of DARE-BV1 and Sildenafil Cream, 3.6%.

Because we currently rely, and expect to continue to rely, on third parties to supply and manufacture our product candidates and their respective components (including the active pharmaceutical ingredients) and, if approved, our commercial products, we do not expect to control the manufacturing processes for their production, all of which must be made in accordance with relevant regulations, which include, among other things, quality control, quality assurance, compliance with cGMP and the maintenance of records and documentation.

Continuous compliance with cGMP and other applicable requirements, requires significant expenditure of time, money and effort to meet requirements relating to personnel, facilities, equipment, production and process, labeling and packaging,

quality control, recordkeeping and other requirements.

In the future, it is possible that we or our third-party suppliers or manufacturers may fail to comply with cGMP requirements, other applicable FDA regulations, the requirements of other regulatory bodies or our own requirements, any of which could result in suspension or prevention of commercialization and/or manufacturing of our products or product candidates, delay or suspension of ongoing research, including clinical trials, disqualification of data or other enforcement actions such as product recall, injunctions, civil penalties or criminal prosecutions against us.

Furthermore, we may be unable to replace any third-party supplier or manufacturer with an alternate supplier or manufacturer on a commercially reasonable or timely basis, or at all.

If we are unable to obtain the product quantities needed for our clinical trials, and if approved, to meet commercial demand, our business will be materially adversely affected.

If we were to experience an unexpected loss of supply, or if any supplier or manufacturer were unable to meet its demand for our product candidates, including due to geopolitical actions, natural disasters or public health emergencies or pandemics, such as the COVID-19 pandemic, we could experience delays in research, planned or ongoing clinical trials or commercialization.

We might not find alternative suppliers or manufacturers with FDA approval, of acceptable quality, or able to provide the appropriate volumes and at an acceptable cost.

The long transition periods that may be necessary to switch manufacturers and suppliers would significantly delay our timelines, which would materially adversely affect our business, financial conditions, results of operations and prospects.

Third-party suppliers, manufacturers, distributors or regulatory service providers may not perform as agreed or may terminate their agreements with us, including due to the effects related to geopolitical actions, natural disasters, public health emergencies or pandemics, such as the COVID-19 pandemic, or force majeure events that affect their facilities or ability to perform.

Any significant problem that our suppliers, manufacturers, distributors or regulatory service providers experience could delay or interrupt our supply of materials or product candidates until the supplier, manufacturer, distributor or regulatory service provider cures the problem, until the event that resulted in the delay or interruption is adequately addressed, or until we locate, negotiate for, validate and receive FDA approval for an alternative provider (when necessary), if one is available, and we may not have recourse against the party who did not perform or terminated their agreement with us if such non-performance or termination is excused under our agreements with such party.

Failure to obtain the needed quantities of our products would have a material and adverse effect on our business, financial condition, results from operations and prospects.

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

The pace of enrollment of participants in the study during 2021 was slower than expected.

We identified a number of contributing factors and implemented mitigation strategies to increase study subject recruitment, however, the initial slower pace of enrollment lengthened our original estimated timeline for the study.

We may experience additional delays in enrollment relative to what we currently anticipate, which may further lengthen the study timeline and increase its overall cost.

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, 3.6% will improve their general feelings of arousal or that the PRO instruments we utilize to measure the effectiveness of Sildenafil Cream, 3.6% in the study will adequately capture their genital arousal response.

Given the factors contributing to arousal disorders, we may be required to conduct clinical trials in large patient populations, extending the timeline and increasing the cost of development for Sildenafil Cream, 3.6%.

For example, the total number of participants that the Phase 2b study will seek to randomize has not yet been determined and the high end of the range is almost 200 more participants than the low end.

The final size of the study will be determined by a single interim analysis for unblinded sample size re-estimation, which analysis has not yet occurred.

If the study requires a number of randomized participants on the high end of the range, then the study could take significantly longer and be significantly more expensive to complete than if the final size of the study need only be on the low end of the range.

If we are unable to efficiently and successfully complete our Phase 2b clinical trial of Sildenafil Cream, 3.6%, product development costs for the program would increase significantly, and such failure could negatively impact the perception of the program’s potential for future clinical and regulatory success, either of which could have a material adverse effect on our business, results of operations and financial condition, as well as our stock price.

Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data, and others, including regulatory authorities, may not agree with our interpretation of study data.

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Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.

There can be no guarantee that a favorable futility analysis will result in a favorable final result at the completion of the clinical trial.

There can be no guarantee that a favorable interim analysis will result in a favorable final result at the completion of the clinical trial.

Further, others, including regulatory authorities, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of study data differently than we do, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general.

In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to 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.

In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically an extensive set of data and analyses, and investors and others may disagree with the information we determine is the material or otherwise appropriate information to include in our public disclosure.

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.

For example, while we reported

positive topline data for the Phase 3 DARE-BVFREE study of DARE-BV1, the FDA may nevertheless require additional efficacy or safety trials before it will accept a DARE-BV1 NDA for filing or approve the NDA.

Our business depends on obtaining the approval of regulatory authorities, and in particular, FDA approval, for our product candidates in a timely manner, and the requirements for obtaining approval may change over time, requiring more financial resources and development time than we currently anticipate.

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

The regulatory approval processes of the FDA and comparable foreign authorities are expensive, lengthy, time-consuming, and inherently unpredictable.

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

Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, release, safety, efficacy, regulatory filings, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA, other regulatory authorities in the U.S., and comparable authorities in other countries or jurisdictions where we seek to test or market our product candidates.

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

We have not submitted a marketing application or received approval to market any of our product candidates from any regulatory authority.

Even if we successfully complete clinical studies, we may experience delays in our efforts to obtain marketing approvals for any of our product candidates.

We cannot assure you that we will ever obtain any marketing approvals in any jurisdiction.

We may change the development plan for a product candidate as a result of changes during the development period in the FDA’s marketing approval policies or the amendment or enactment of additional statutes or regulations, or following our review of outcomes of other similar product candidates under development.

Even if we successfully complete nonclinical studies, clinical studies, manufacturing and other required activities, we may still experience delays in our efforts to obtain marketing approvals for any of our product candidates.

Marketing approval applications require the submission of extensive clinical and nonclinical data and supporting information to establish the safety and efficacy of our product candidates for the specified indication.

The process of responding to the FDA or other regulatory authorities’ information requests in the review process, potentially preparing for and appearing at a public advisory committee or oral hearing, and preparing our third-party manufacturers and clinical investigators to successfully complete inspections by the FDA or other regulatory authorities during the approval process requires significant human and financial resources.

We may change the development plan for a product candidate as a result of changes during the development period in the FDA’s marketing approval policies or the amendment or enactment of additional statutes or regulations, updated interpretations of applicable policies, statutes or regulations, or upon review of outcomes of other similar product candidates under development.

This could significantly lengthen our development timelines and cost.

Further, the FDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional clinical or nonclinical studies or changes in the manufacturing process or facilities, even if we had previously aligned with the FDA on such data and other requirements.

In addition, the announcement of new requirements by the FDA, the failure of a competitive product to receive regulatory approval, or the receipt of a CRL from the FDA by another company pursuing the FDA's 505(b)(2) pathway that may have implications for our proposed regulatory approval pathway could impact how investors and potential strategic parties view the development risks associated with our product candidates.

Changing testing or manufacturing requirements for product candidates we develop 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.

If the FDA’s Section 505(b)(2) pathway is not an available regulatory pathway for DARE-BV1, Sildenafil Cream, 3.6%, DARE-HRT1, DARE-FRT1, DARE-VVA1 and DARE-LARC1, as we currently expect, or for other product candidates we may develop in the future, the development of these product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks 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 DARE-BV1, Sildenafil Cream, 3.6%, DARE-HRT1, DARE-FRT1, DARE-VVA1, DARE-LARC1 and other candidates we may license or acquire, including ORB-204 and ORB-214, pursuant to the FDA’s 505(b)(2) pathway.

If the FDA determines that we may not use that pathway for the development of any of these candidates, then we would have 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, provide additional data and information, and meet additional standards for regulatory approval including possibly pre-clinical data.

If this were to occur, the time and financial resources required to obtain FDA approval for these candidates, and the complications and risks associated with the respective product candidate or candidates, would likely substantially increase and would have a material adverse effect on our business and financial condition.

The FDA and comparable regulatory authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that the data are insufficient for approval and require additional clinical or nonclinical studies or changes in the manufacturing process or facilities, even if we had previously aligned with the FDA on such data and other requirements.

We cannot assure you that we will obtain any additional marketing approvals for our product or product candidates in any jurisdiction.

The announcement of new requirements by the FDA, the failure of a competitive product to receive regulatory approval, or the receipt of a complete response letter from the FDA by another company pursuing the FDA's 505(b)(2) pathway that may have implications for our proposed regulatory approval pathway could impact how investors and potential strategic collaborators view the development risks associated with our product candidates.

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, 3.6%, DARE-HRT1, DARE-VVA1, DARE-FRT1, DARE-PTB1, DARE-LARC1 and other candidates we may develop, including ADARE-204 and ADARE-214, 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, provide additional safety and efficacy data and other information, and meet additional standards for regulatory approval including possibly nonclinical data.

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.

As described above, 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 the development programs for DARE-BV1, Sildenafil Cream, 3.6%, our IVR product candidates, including DARE-HRT1 and DARE-FRT1, DARE-VVA1, DARE-LARC1 ORB-204 and ORB-214.

Although the FDA’s longstanding position has been that it may rely upon prior findings of safety or effectiveness to support approval of a 505(b)(2) application, this policy has been controversial and subject to challenge.

In addition, notwithstanding the approval of an increasing number of products by the FDA under Section 505(b)(2) over the last few years, certain brand-name pharmaceutical companies and others have objected to the FDA’s interpretation of Section 505(b)(2).

If the FDA’s interpretation of Section 505(b)(2) is successfully challenged, the FDA may change its 505(b)(2) policies and practices, which could delay or even prevent the FDA from approving any NDA we submit under Section 505(b)(2).

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.

development programs for Sildenafil Cream, 3.6%, our current IVR product candidates, DARE-VVA1, DARE-LARC1, ADARE-204 and ADARE-214.

Notwithstanding the approval of an increasing number of products by the FDA under Section 505(b)(2) over the last few years, certain brand-name pharmaceutical companies and others have objected to the FDA’s interpretation of Section 505(b)(2).

If the FDA’s interpretation of Section 505(b)(2) is successfully challenged, or Congress were to amend the statute to alter the currently available regulatory pathway, the FDA may change its 505(b)(2) policies and practices, which 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 would likely materially adversely impact our competitive position and prospects.

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 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.

Even if we receive regulatory approvals for our product candidates, they may not gain acceptance among physicians, consumers or the medical community, thereby limiting our potential to generate revenue, which will undermine our growth prospects.

Even if our product candidates are approved for commercial sale by the FDA or other regulatory authorities, the degree of market acceptance of any new product by consumers, physicians, other health care professionals and third-party payors will depend on several factors, including:

• demonstrated evidence of efficacy and safety;

• sufficient third-party insurance coverage or reimbursement;

• effectiveness of our or our collaborators’ sales and marketing strategy;

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

• the willingness of pharmacy chains to stock the 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.

If our clinical-stage product candidates, including Ovaprene and Sildenafil Cream, 3.6%, are successful in their clinical development, we expect that women of child-bearing age will use them, and potentially for many months or years.

To date, human clinical studies of these product candidates have been for relatively short periods of time and these product candidates lack safety data over longer periods of use.

For example, while we believe the risk of adverse fetal development from using these product candidates is low, the impact of these product candidates on fetal development has not been studied and there are no adequate or well-controlled studies of these product candidates in pregnant women.

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.

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.

Our investment of time and resources in such assets may not be appreciated or valued.

As a result, it may be difficult for us to fund such programs.

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

If DARE-VVA1, DARE-LARC1, DARE-FRT1, DARE-PTB1, DARE-RH1 or the injectable etonogestrel product candidates we may license from Adare fail to be valued, our 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.

Pre-clinical studies refer to a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected.

Because of their early nature, pre-clinical product candidates tend to carry a higher risk of failure as compared with clinical-stage assets.

Pre-clinical candidates must generate sufficient safety and efficacy data through in vitro studies, animal studies and a variety of tests before they can be considered appropriate for testing in humans.

The development risks, timeline and cost of pre-clinical assets can be high because of the unknowns and absence of data.

It can be difficult to identify relevant tests and animal models for pre-clinical studies.

Even if the results from our pre-clinical studies are favorable, we still may not be able to advance the candidates into clinical trials.

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

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

The grants supporting pre-clinical development of DARE-LARC1, 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 its 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 its future clinical development.

Further, while we received an initial

payment of $11.45 million under the grant agreement in 2021, 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.

Risks Related to Our Dependence on Third Parties

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

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

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, Ovaprene.

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

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.

By entering into strategic collaborations, we may relinquish control over important elements of product development and commercialization, and the collaborator may fail to develop or effectively commercialize the applicable products or product candidates.

In addition, in the case of commercial collaborations, our product revenues, may be lower than if we were to sell and distribute products that we develop ourselves.

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

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

• collaborators may not perform their obligations as expected;

• collaborators may not pursue development or commercialization of a product or product candidate or elect not to continue or renew a collaboration based on clinical or nonclinical study results, changes in the collaborators' strategic focus or available funding, or external factors, such as an acquisition or a pandemic, that divert its resources or create competing priorities;

• collaborators may refuse to perform clinical studies or other development work required for approval in a particular jurisdiction outside the United States;

• collaborators may delay or stop clinical studies, provide insufficient funding for or abandon a clinical program, repeat or conduct new clinical studies or require a new formulation of a product or product candidate for clinical testing;

• collaborators could independently, or together with third parties, develop and commercialize products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

• collaborators with marketing and distribution rights to one or more of our products may not commit sufficient resources to the marketing and distribution of such product or products;

• disagreements with collaborators, including disagreements over proprietary rights, contract interpretation, or product development or commercialization strategy, might cause delays or termination of the research, development or commercialization of our products or product candidates, might lead to additional responsibilities for us with respect to products or product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;

• collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

• collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;

• collaborators may violate, or be investigated for potentially violating, health care compliance and related laws and regulations, which may expose us to litigation, enforcement actions or inquiries, or other potential liability;

• 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.

If one of our collaborators terminates its agreement with us or our strategic collaborations otherwise do not result in the successful development of our product candidates and/or commercialization of any approved products, we may not receive any future payments under the collaboration, our development programs may not be funded as we expect, and our ability to establish another collaboration for the applicable product or product candidate may be negatively impacted.

We may be unable to replace any commercial collaborator with an alternate third party on a timely or commercially reasonable basis, or at all.

See also, “Risks Related to Our Financial Position and Capital Needs- If a commercial counterparty terminates its exclusive license agreement with us or fails to perform as expected, our need for additional capital may significantly increase,” above and “We rely on, and intend to continue to rely on, third parties for the execution of significant aspects of our product development programs.

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 other net sales-based payments 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.

There is no assurance that the commercial launch of XACIATO will occur when expected or be successful and the timing and amount of potential payments to us under the license agreement is uncertain.

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.

In addition, the effective date of the license agreement is subject to the satisfaction of closing conditions, including antitrust law clearance which is outside of our control.

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 commencement, 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 payments we make 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, the final one of which is due in the second quarter of 2023, NICHD is not obligated to carry out research and development activities until it receives the funds.

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.

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.

Those factors may include the design and outcomes of our clinical studies, the likelihood of approval by regulatory authorities, the potential market for the product, the costs and complexities of manufacturing and delivering such product to customers, the potential of competing products, the strength of the intellectual property and other potential sources of market exclusivity for such product, the market performance of other products we developed, and industry and market conditions generally.

The prospective collaborator may also have opportunities to collaborate with third parties on products or technologies that would compete with our products or product candidates and will evaluate whether those opportunities are more attractive than a collaboration with us.

Inadequate capitalization of our company, or the perception thereof, could negatively affect our negotiating leverage in transactions.

We may also be restricted under existing collaboration agreements from entering into other collaborations on certain terms with other potential collaborators.

For example, the terms of our exclusive license agreement also provide Organon exclusive worldwide rights of first negotiation for specified potential future products of ours, which may increase the complexity and time required, or otherwise inhibit our ability to transfer, license, sublicense, assign, grant or otherwise dispose of any rights in those potential future products to a third party, and lead to delays in their development and commercialization.

If we are not successful in attracting collaborators, entering into collaborations on acceptable terms and maintaining our collaborations for the products we develop, we may not complete development of or obtain regulatory approval for such products and product candidates, or if we obtain regulatory approval, commercial launch may be delayed and market penetration could be limited.

We rely on third-party suppliers and manufacturers for clinical and commercial supplies of XACIATO and our product candidates, including multiple single source suppliers and manufacturers, and we currently have no plans to build or acquire our own manufacturing capabilities.

XACIATO and our product candidates (including their respective components) must be manufactured, packaged, tested, and labeled in conformity with cGMP and other applicable regulatory requirements.

We do not own or operate, nor do we expect to own or operate, facilities for manufacturing, storage and distribution, or testing of our product or product candidates.

In addition, we expect to rely on third parties to manufacture the commercial supplies of XACIATO and any future products.

This reliance on contract manufacturers and suppliers subjects us to inherent uncertainties related to product safety, availability, security and cost.

Holders of NDAs, or other forms of FDA approvals, or those distributing a regulated product under their own name, are ultimately responsible for compliance with manufacturing obligations even if the manufacturing is conducted by a third party.

Because we currently rely, and expect to continue to rely, on third parties to supply and manufacture our product and product candidates and their respective components (including the active pharmaceutical ingredients), we do not expect to control the manufacturing processes for their production, all of which must be made in accordance with relevant regulations, which include, among other things, quality control, quality assurance, compliance with cGMP and the maintenance of records and documentation.

In the future, it is possible that we or our third-party suppliers or manufacturers, or those of our commercial partners, may fail to comply with cGMP requirements, other applicable FDA regulations, the requirements of other regulatory bodies or our own requirements, any of which could result in suspension or prevention of commercialization and/or manufacturing of our products or product candidates, delay or suspension of ongoing research, including clinical trials, disqualification of data or other enforcement actions such as product recall, injunctions, civil penalties or criminal prosecutions against us.

Furthermore, we or a commercial collaborator, as applicable, may be unable to replace any third-party supplier or manufacturer with an alternate supplier or manufacturer on a commercially reasonable or timely basis, or at all.

Inability to obtain product quantities needed for

our clinical trials and to meet commercial demand, as applicable, could have a material adverse effect on our business, financial condition and results of operations.

If we were to experience an unexpected loss of supply, or if any supplier or manufacturer were unable to meet our demand for our products or product candidates, including due to geopolitical events, natural disasters or public health emergencies or pandemics, such as the COVID-19 pandemic, we could experience delays in research, planned or ongoing clinical trials or commercialization.

We might not find alternative suppliers or manufacturers with FDA approval, of acceptable quality, or able to provide the appropriate volumes and at an acceptable cost.

The long transition periods that may be necessary to switch manufacturers and suppliers could significantly increase our development costs and result in delays in clinical trials, regulatory submissions and approvals, and, if approved, commercial launch, and, for commercial products, could result in significant loss of sales and associated revenue.

Third-party suppliers, manufacturers, distributors or regulatory service providers may not perform as agreed or may terminate their agreements with us, including due to the effects related to geopolitical events, natural disasters, public health emergencies or pandemics, such as the COVID-19 pandemic, or force majeure events that affect their facilities or ability to perform.

Any significant problem that our suppliers, manufacturers, distributors or regulatory service providers experience could delay or interrupt supply of materials necessary to produce our products and product candidates or the finished product, as applicable, until the supplier, manufacturer, distributor or regulatory service provider cures the problem, until the event that resulted in the delay or interruption is adequately addressed, or until we locate, negotiate for, validate and receive FDA approval for an alternative provider (when necessary), if one is available, and we may not have recourse against the party who did not perform or terminated their agreement with us if such non-performance or termination is excused under our agreements with such party.

Failure to obtain the needed quantities of products and product candidates could have a material and adverse effect on our business, financial condition, results of operations and prospects.

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 and product candidates, which may heighten our dependence on those third parties and the risk of manufacturing disruptions.

Under our license agreement with Organon, we will be responsible for providing product supply of XACIATO on an interim basis.

We have entered into a long-term supply and manufacturing agreement for commercial supply of XACIATO with the same CMO that provided clinical supplies for our Phase 3 DARE-BVFREE clinical study.

Under our supply and manufacturing agreement, we agreed to purchase at least 80% of our XACIATO requirements from the CMO, subject to limited exceptions.

Currently, this CMO is our sole supplier of XACIATO.

As a result, XACIATO’s commercial success will depend in part on the CMO's ability to manufacture and deliver adequate commercial quantities of the product on agreed upon timelines in accordance with our specifications and in compliance with cGMP and other applicable requirements.

In addition, the CMO relies on other third parties, for supply of raw materials required to produce XACIATO and those supplies may become more difficult and costly to obtain.

For example, the current single source supplier of clindamycin is located in China.

Should this supplier slow production, shut down its factory or increase its prices for any reason, including due to factors related to the COVID-19 pandemic, recent geopolitical events, poor political relations between the U.S.

and China and increased taxes or imposition of sanctions, our CMO may not be able to obtain adequate supplies of clindamycin to manufacture sufficient commercial quantities of XACIATO, which could impede XACIATO’s commercial success.

If these circumstances were to occur, the CMO could be forced to source clindamycin from a different supplier, which could lead to higher costs to us and disruption in commercial supply of XACIATO.

After Organon assumes the manufacturing and supply responsibilities for XACIATO, we will have no control over the production and supply of the product.

Our failure, or after the transfer of manufacturing responsibilities, Organon’s failure, to produce, or cause to be produced, sufficient quantities of XACIATO for commercial sale could have a significant negative effect on commercialization efforts and the payments we receive under our license agreement.

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.

If ADVA-Tec fails to provide sufficient clinical supply of Ovaprene on anticipated timelines, our ability to complete clinical development and seek regulatory approval of Ovaprene could be significantly delayed.

A substantial scale up in production of Ovaprene clinical supplies is necessary to support the planned pivotal Phase 3 clinical study of Ovaprene, which may not occur on projected timelines and may be more expensive for us than anticipated.

If Ovaprene receives marketing approval, failure by ADVA-Tec to provide sufficient commercial product quantities at reasonable costs could have a significant adverse effect on our revenue and ability to become profitable.

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 will be responsible for obtaining supplies of Sildenafil Cream, 3.6% for Phase 2 clinical trials expected to be conducted in the United States, which includes the ongoing Phase 2b clinical study.

Thereafter, we will be responsible for obtaining pre-clinical, clinical and commercial supplies of Sildenafil Cream, 3.6%.

Future supplies of raw materials required to produce Sildenafil Cream, 3.6% 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 related to the COVID-19 pandemic and recent geopolitical 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.

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.

For example, we engaged CROs to run all aspects of the pivotal Phase 3 clinical trial of XACIATO and the PCT clinical trial for Ovaprene.

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 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 geopolitical events, natural disasters, public health emergencies or pandemics, such as the COVID-19 pandemic, 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 commencement, conduct and completion of our pivotal Phase 3 clinical trial of Ovaprene.

Pursuant to the terms of the CRADA, the study will be conducted within NICHD’s Contraceptive Clinical Trial Network, or the CCTN, with NICHD contractor Health Decisions Inc.

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 Health Decisions Inc., 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 commencement, 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, commencement and completion of the study may be delayed or suspended or the study may be unsuccessful, any of 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.

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

The loss or impairment of our rights under any of these agreements could have a material adverse effect on our business prospects, operations and viability.

Our rights to XACIATO and our product candidates arise from license agreements between us and third-party licensors.

The loss or impairment of our licensed rights to develop and commercialize XACIATO or our product candidates, including as a result of our inability or other failure (or that of our licensors, in the case of sublicenses) to meet our obligations under any one of such license agreements, including, without limitation, our payment obligations, could have a substantial negative effect on our company’s prospects.

In December 2018, we entered into definitive agreements with Hammock Pharmaceuticals, Inc., TriLogic Pharma LLC and MilanaPharm LLC under which we acquired exclusive global rights to XACIATO for the treatment of bacterial vaginosis, as well as the rights to utilize the underlying proprietary hydrogel drug delivery technology for any vaginal or urological application in humans.

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

We entered into a license agreement with ADVA-Tec for the exclusive worldwide rights to develop and commercialize Ovaprene that became effective in July 2017.

"BUSINESS-Strategic Agreements for Pipeline Development-ADVA-Tec License Agreement," above.

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.

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

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

Moreover, because some of our rights to XACIATO and our product candidates are sublicensed to us, our license agreements may be terminated or we may otherwise lose rights to intellectual property underlying our product or product candidates in the event of termination or loss of rights by our licensors, which may be outside of our control.

There is no assurance that we would be able to renew or renegotiate license agreements on acceptable terms, or at all, if our existing license agreements (or the underlying agreements in the case of sublicenses) are terminated.

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

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

• the scope of rights granted under the license agreement and other interpretation-related issues;

• the extent to which our technology and processes infringe, misappropriate or violate the intellectual property of the licensor that is not subject to the license agreement;

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

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

• the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our collaborators;

• the priority of invention of patented technology.

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

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

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

There are risks, uncertainties and costs associated with identifying, licensing and advancing product candidates through successful clinical development.

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 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;

• availability of alternative products;

• the convenience and comfort level to consumers provided by our product compared to alternative products.

If our products fail to provide a benefit over then currently available options, we are unlikely to generate sufficient revenues to achieve profitability.

The commercial success of DARE-BV1 will depend on its effectiveness in treating bacterial vaginosis compared to available competitive products and on women’s preferences.

Today, there are many FDA-approved products for treating bacterial vaginosis, and many are generic.

If approved, DARE-BV1 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.

Two of the most common antibiotics used today are generic clindamycin and metronidazole.

In particular, DARE-BV1 will likely be compared with Clindesse® (clindamycin phosphate) Vaginal Cream, 2% as this treatment is a vaginally administered, single dose cream formulation of clindamycin.

If physicians do not view the cure rates or continued clinical response rates that DARE-BV1 demonstrates in its clinical studies as significantly superior compared to other products available for the treatment of bacterial vaginosis, physicians may opt to continue to prescribe existing treatments rather than recommend or prescribe our product to their patients.

In addition, women may prefer orally delivered options to our vaginally delivered product unless our product is viewed by them as providing significantly superior efficacy, safety and/or convenience.

Should DARE-BV1 receive marketing approval, its commercial success will depend on many factors:

• strength of the efficacy data supporting the cure and clinical cure rates;

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

• price pressure given the high level of generic treatments;

• 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;

• preference by women for a vaginally administered therapy;

• price pressure given today’s high level of generic treatments;

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

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

Additionally, if we are not successful in attracting an acceptable commercialization partner or entering into an agreement with acceptable terms on a timely basis or at all, commercial launch of DARE-BV1 could be significantly delayed.

Further, any future commercialization collaboration may not be successful, in which case our ability to realize the full market potential of our product could be harmed.

Any of these factors could reduce the commercial potential for DARE-BV1 and place pressure on our business, financial condition, results of operation and prospects, particularly if DARE-BV1 is the first product candidate for which we receive regulatory approval.

The commercial success of Ovaprene will depend on market acceptance of a monthly, hormone-free 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.

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

will occur when expected.

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 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.

If we are unable to establish or maintain commercial collaborations on favorable terms, on a timely basis, or at all, we may need to establish a commercial infrastructure, which would be costly, could delay product launch, and may not be successful.

We have no internal sales, marketing or distribution capabilities.

We currently do not intend to directly sell or distribute our products into the market and instead intend to enter into agreements with third parties to market, sell and distribute and provide related support services for our product candidates that receive regulatory approval.

If we are unable to establish and maintain commercial collaborations on favorable terms, on a timely basis, or at all, to generate revenue from our products, we would need to establish a sales organization.

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.

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.

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

• much greater financial, research, technical and human resources than we have at every stage of the product development and commercialization life cycle;

• more extensive experience in designing and conducting clinical trials, nonclinical studies, obtaining regulatory approvals, and in manufacturing, marketing and selling prescription medical products;

• approved products or product candidates in late stages of development for one or more of our target indications.

Competitive products may be equally safe and as effective as our products, but sold at a substantially lower price.

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 products 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.

It is possible that the potential advantages of our product candidates do not materialize or that the approved prescribing information for our products does not describe expected features or benefits.

We also expect to face competition from new products that enter the market over time.

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

The success of competitive products may render potential application of 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.

Two of the most common antibiotics used today are generic clindamycin and metronidazole.

In particular, XACIATO will likely be compared with Clindesse® (clindamycin phosphate) Vaginal Cream, 2% as this treatment is a vaginally administered, single dose cream formulation of clindamycin.

If health care providers do not view the prescribing information for XACIATO, including the cure rates that XACIATO demonstrated in the Phase 3 DARE-BVFREE clinical study, 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.

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.

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, hormone therapy and the treatment of bacterial vaginosis, which are areas in which our product candidates, if approved, and XACIATO 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 future 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 our products do not achieve an adequate level of market acceptance, they may not generate significant net product revenues, we may not become profitable and we may suffer reputational harm.

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;

• the terms of any approvals and the countries in which marketing approvals are obtained, such as any restrictions on the use of our products together with other medications;

• the indications for which the products are approved;

• demonstrated evidence of efficacy and safety;

• availability of alternative treatments and products;

• the approval of other products for the same indications as our products;

• 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 products or favorable publicity about competing products;

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

• the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

• the success of any physician education programs that we or our commercial collaborators may create for the products;

• the availability of third-party coverage and adequate reimbursement, including patient cost-sharing programs such as co-pays and deductibles;

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

• the willingness of pharmacy chains to stock the products;

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

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

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.

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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.

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

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 candidates, will depend upon the contraceptive market and market acceptance of an alternative method.

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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, 3.6% will depend on the availability of alternative products for female sexual dysfunction disorders and women's preferences, in addition to the market's acceptance of our topical cream.

The commercial success of Sildenafil Cream, 3.6%, 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.

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

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Women may be hesitant to use Sildenafil Cream, 3.6% 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, 3.6%, particularly if it is not covered by insurance.

Our commercial success with Sildenafil Cream, 3.6% 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 to educate doctors and women about the need to diagnose and treat FSAD and the potential benefits of using of Sildenafil Cream, 3.6%, at which we or any third party with which we may collaborate to commercialize Sildenafil Cream, 3.6% may not prove successful.

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, 3.6% 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, 3.6% than younger populations.

Should Sildenafil Cream, 3.6% show increased risk of adverse reactions, or signs thereof, in older or elderly women during clinical development, the potential market for Sildenafil Cream, 3.6% 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, 3.6% 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 to educate doctors and women about the need to diagnose and treat FSAD and the potential benefits of using of Sildenafil Cream, 3.6%, at which we or any third party with which we may collaborate to commercialize Sildenafil Cream, 3.6% may not prove successful.

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

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If we fail to produce strong clinical outcomes, our ability to build a commercial market for Sildenafil Cream, 3.6% will be materially adversely impacted.

The commercial success of DARE-HRT1 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.

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.

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

If we suffer negative publicity concerning the safety or efficacy of the product candidates we develop, our reputation could be harmed, and we may be forced to cease development of such products.

If concerns should arise about the actual or anticipated clinical outcomes regarding the safety of 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 our product candidates, which could lead to a decline in potential opportunities with strategic partners or collaborators as well as investors’ expectations for the product candidate’s or our company’s prospects and a decline in the price of our common stock.

If DARE-BV1, Ovaprene, or Sildenafil Cream, 3.6% are successful in their clinical development, we expect that women of child-bearing age will use them, and potentially for many months or years.

To date, human clinical studies of these product candidates have been for relatively short periods of time and these product candidates lack safety data over longer periods of use.

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

Our Sildenafil Cream, 3.6% product candidate may pose a greater risk to older or elderly women.

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

Sildenafil, the active ingredient in Sildenafil Cream, 3.6%, 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, 3.6% and we have not yet thoroughly studied the topical or clinical pharmacology of this drug candidate in different patient populations.

Should Sildenafil Cream, 3.6% show increased risk of adverse reactions, or signs thereof, in older or elderly women, the potential market for Sildenafil Cream, 3.6% could be significantly limited and our business prospects could be harmed.

If the product candidates we develop are associated with or cause serious adverse events or other undesirable side effects during clinical testing, we may be required to conduct clinical and nonclinical studies that currently are not part of our development plans, which may delay or prevent marketing approval, or, if approval is received, may require a product to be taken off the market, require product labeling to include safety warnings or result in implementation of other restrictions that could significantly decrease our product sales.

Serious adverse events or other undesirable side effects associated with or caused by any product candidate we develop, could arise during clinical development or, if approved, after product launch.

Data from future clinical trials may show that a product candidate causes or may cause serious adverse events or other undesirable side effects, which could interrupt, delay, or cause the termination of clinical trials, resulting in delay of, or failure to obtain, marketing approval from the FDA and other regulatory authorities.

If such serious adverse events or other undesirable side effects occur:

• during the clinical development phase, regulatory authorities may impose a clinical hold which could result in substantial delays and adversely impact our ability to continue development of the product;

• during the commercial or post-marketing phase, regulatory authorities may require the addition of specific warnings or contraindications to product labeling or field alerts to physicians and pharmacies;

• we may have to change the way the product is administered or the labeling of the product;

• we may have to conduct additional clinical trials with more patients or over longer periods of time than anticipated;

• we may have to implement a risk minimization action plan, which could result in substantial cost increases and have a negative impact on our ability to commercialize the product;

• we may have to limit the patients who can receive the product;

• we may be subject to promotional and marketing limitations on the product;

• sales of the product may decrease significantly;

• regulatory authorities may require us to take an approved product off the market;

• we may be subject to litigation or product liability claims;

• our reputation may suffer.

Any of these events could prevent us or a commercial partner from achieving or maintaining market acceptance of product candidates we develop, or could substantially increase development and/or commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from product sales or receiving royalties and other payments based on sales by commercial partners.

The women's health market includes many generic products and the growth in generics is expected to continue, making the successful introduction of branded products for contraception, bacterial vaginosis and hormone therapy 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 partner to introduce a new branded 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 the areas in which two of our lead product candidates will compete, contraception and the treatment of bacterial vaginosis.

In order for Ovaprene and DARE-BV-1 to develop commercial markets and for insurers to cover these higher cost products, they 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 product in order to overcome the trend towards generics and gain access to reimbursement by payors.

If we or a commercial partner cannot introduce a product, if approved, at our desired price or gain reimbursement from payors for an approved 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.

Changes in health care laws and regulations may eliminate current requirements that health insurance plans cover and reimburse FDA-cleared or approved contraceptive products without cost sharing, which could reduce demand for branded products and lead to a preference for generic options.

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

If approved, we cannot be certain that third-party reimbursement will be available for Ovaprene, and even if reimbursement is available, the amount of any such reimbursement.

The ACA and subsequent regulations enacted by the Department of Health and Human Services, or 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.

These regulations ensure that women who wish to use an approved form of contraception may request it from their doctors and their health insurance plan must cover all costs associated with such products.

These regulations have been, and may be further, modified, repealed, or otherwise invalidated, in whole or in part.

For example, a challenge to the constitutionality of the ACA is currently pending at the Supreme Court, with a decision expected in spring 2021.

If the ACA is declared invalid in its entirety, the requirement for health plans to cover women’s preventive care without cost sharing would likely be eliminated.

Even if the ACA is not repealed, the DHHS regulations to specifically enforce the preventive health coverage mandate were modified under the Trump Administration, which altered the mandate to allow certain employers and insurers to opt out of birth control coverage for religious or moral reasons, which was partially upheld by the Supreme Court in July 2020 but continues to be the subject of litigation and other challenges.

We cannot predict the timing or impact of any future rulemaking, court decisions or other changes in the law, although the Biden Administration has signalled its intent to protect women’s access to contraception and to ensure reproductive rights for women both domestically and abroad, such as with a Presidential Memorandum issued on January 28, 2021 that rescinded several policies that had been implemented during the Trump Administration.

Any repeal or elimination of the 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, such as Ovaprene, at all.

As a result, we expect that our success will depend on the willingness of patients to pay out-of-pocket for Ovaprene in the event that either they do not have insurance or their insurance requires payment of a portion of Ovaprene by the patient, thus increasing the patient’s overall cost to use Ovaprene.

This could reduce market demand for Ovaprene or any other contraceptive candidates we may seek to develop, such as DARE-LARC1, ORB 204, ORB 214 and DARE-RH1, if and when they receive FDA approval, which would have a material adverse effect on our business, financial condition, and prospects.

As no FDA-approved treatments for FSAD currently exist, there is little precedent to help assess whether health insurance plans will cover Sildenafil Cream, 3.6% if approved.

There is no assurance that third-party reimbursement will be available for Sildenafil Cream, 3.6%, if it receives regulatory approval.

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

Insurers may deem Sildenafil Cream, 3.6% to be a life-style drug and decide not to provide reimbursement.

Today, many health insurance plans provide reimbursement for male sexual arousal medications.

However, we cannot predict whether they will continue to do so or whether they will do so for FSAD treatments as well.

The safety and efficacy data from our clinical trials may impact whether Sildenafil Cream,

3.6% will become eligible for insurance coverage, and if it does, the level of such reimbursement.

In an environment of rapidly rising health care costs, insurers have been looking for ways to reduce costs, which could make it difficult for new therapies to gain coverage if they are not deemed medically critical or essential.

If Sildenafil Cream, 3.6% 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, 3.6%, which would have a material adverse effect on our financial condition and prospects.

Even if we obtain regulatory approval in the United States or elsewhere to market any of our products, the commercial success of our products and our financial prospects will depend in part on the extent to which the costs of our products will be covered by third-party payors for prescription medical products.

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

If we or any commercial collaborator is found or alleged to have improperly promoted any of our products for off-label uses, we may become subject to significant liability, including fines, penalties or injunctions, and reputational harm.

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription medical products such as XACIATO.

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 XACIATO, and for any other of our drug products that receive marketing approval, must be submitted to FDA at the time of first use and the agency actively solicits reports from health care professionals about improper promotional claims or activities by the drug manufacturer or distributor.

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

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.

If we or a commercial collaborator is alleged or found to have promoted XACIATO or any other future commercial product for any off-label use, we may become subject to significant liability and reputational harm.

The federal government has levied large civil and criminal fines against companies for alleged improper medical product promotion and has enjoined several companies from engaging in off-label promotion.

The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.

Other enforcement authorities may also take action against a company for promoting an off-label use of a prescription medical product, which could result in penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.

See also “Risks Related to Our Business Operations and Industry- The pharmaceutical and medical device industries are highly regulated and subject to various fraud and abuse laws, including, without limitation, the U.S.

federal Anti-Kickback Statute, the U.S.

federal False Claims Act and the U.S.

Foreign Corrupt Practices Act” below.

If we or our commercial collaborators, as applicable, cannot successfully manage the promotion of XACIATO or our product candidates, if approved in the future, to ensure compliance with these legal and regulatory requirements, we could become subject to significant liability, our reputation could be damaged, and adoption of our products could be considerably impaired.

Unexpected safety, efficacy or quality concerns relating to XACIATO could develop, which could have significant negative consequences for us.

XACIATO was approved by the FDA based on prior findings of safety or effectiveness of previously approved clindamycin products and on clinical data from the Phase 3 DARE-BVFREE clinical trial, in which 307 patients were randomized.

Following its commercial launch, XACIATO will be used by larger numbers of patients, potentially for longer periods of time.

New data may emerge from market surveillance or clinical trials of XACIATO that we or a third party may conduct in the future that give rise to safety, efficacy or quality concerns and result in negative consequences, including:

• modification to the product’s prescribing information, such as the addition of boxed or other warnings, contraindications, or limitations of use;

• restrictions on the promotion or marketing of the product;

• issuance of “Dear Doctor Letters” or similar communications to health care professionals or the public regarding safety or efficacy concerns;

• imposition of post-marketing clinical trial requirements or other post-marketing studies;

• product distribution restrictions or other risk management measures, such as a risk evaluation and mitigation strategy, or REMS, which could include elements to assure safe use;

• warning or untitled letters;

• suspension or withdrawal of marketing approvals;

• withdrawal of the product from the market;

• suspension or termination of ongoing clinical trials, if any;

• refusal by regulators to approve pending marketing applications or supplements to approved applications that we submit;

• suspension of, or imposition of restrictions on, our operations or those of our commercial collaborator or CMO, including costly new manufacturing requirements;

• costly and time-consuming corrective actions;

• voluntary or mandatory product recalls or withdrawals from the market;

• significant reputational harm;

• product liability claims and lawsuits.

Furthermore, the discovery of significant problems with another intravaginally administered or clindamycin-containing product that implicates XACIATO, or is perceived to implicate XACIATO, could have an adverse impact on commercialization of XACIATO and our business, including as a result of occurrence of the events described above.

For example, XACIATO has not been studied in pregnant or breastfeeding women.

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 products that implicate or are perceived to implicate XACIATO, 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 have a material adverse impact on our financial condition, operating results and 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 our product and 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.

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

Even though XACIATO has been approved by the FDA for the treatment of bacterial vaginosis and even if any other product candidates we develop are approved, we are and will be subject to ongoing regulatory requirements with respect to manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing clinical trials and submission of safety, efficacy and other post-approval information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities.

In addition, manufacturers and manufacturers’ facilities are required to continuously comply with FDA and comparable foreign regulatory authority requirements, including ensuring quality control and manufacturing procedures conform to cGMP regulations and corresponding foreign regulatory manufacturing requirements.

Accordingly, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in our NDA or PMA submissions to the FDA.

Any marketing approvals we receive for our other product candidates in the future may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product.

In addition, we will be required to report adverse reactions and production problems, if any, to the FDA and comparable foreign regulatory authorities (when products are approved in foreign markets).

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

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

including requiring withdrawal of the product from the market.

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

• issue warning letters;

• impose civil or criminal penalties;

• suspend or withdraw regulatory approval;

• suspend any of our ongoing clinical trials;

• refuse to approve pending applications or supplements to approved applications submitted by us;

• impose restrictions on our operations, including closing our contract manufacturers’ facilities;

• require a product recall.

Any government investigation of alleged violations of law would require us to expend significant time and resources in response and could generate adverse publicity.

Any inability to comply with ongoing regulatory requirements may significantly and adversely affect our ability to develop and commercialize our products and the value of our business, and our operating results would be adversely affected.

Failure to successfully obtain coverage and reimbursement for XACIATO and any future products in the United States, or the availability of coverage only at limited levels, would diminish our ability, or that of a commercial collaborator, to generate net product revenue.

Coverage from government health care programs and private commercial health insurance companies is critical to the commercial success of XACIATO and any future products.

Market acceptance and sales of XACIATO and any future products that we or a commercial collaborator may seek to commercialize will depend in part on the extent to which reimbursement for these products will be available from third-party payors.

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 our products to be cost-effective compared to other therapies, they may not cover our products after approval 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 partner, to sell our products on a profitable basis.

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 our products 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 our products 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.

Third-party payor coverage may not be available to patients for XACIATO or any future product.

If third-party payors do not provide adequate coverage and reimbursement, health care providers may not prescribe our products or patients may ask their health care providers to prescribe competing products with more favorable reimbursement.

Significant uncertainty exists as to the reimbursement status for newly approved prescription products, including coding, coverage and payment.

There is no uniform policy requirement for coverage and reimbursement for prescription products among third-party payors in the United States;

Significant uncertainty exists as to the reimbursement status for newly approved prescription medical products, including coverage and payment.

There is no uniform policy requirement for coverage and reimbursement for prescription medical products among third-party payors in the United States;

therefore, coverage and reimbursement for our products could differ significantly from payor to payor.

In the U.S., third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies, but they also have their own methods and approval process apart from Medicare coverage and reimbursement determinations.

Accordingly, one third-party payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the product.

To secure coverage and reimbursement for any product that might be approved for sale, we may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of the product to third-party payors, which costs would be in addition to those required to obtain FDA or other comparable regulatory approvals.

In the U.S., the principal decisions about reimbursement for new medical products are typically made by the Centers for Medicare and Medicaid Services, or CMS, as CMS decides whether and to what extent a new medical product will be covered and reimbursed under Medicare.

Third-party payors often rely upon Medicare coverage policy and payment limitations to a substantial degree in setting their own reimbursement policies, but they also have their own methods and approval process apart from Medicare coverage and reimbursement determinations.

It is difficult to predict what CMS will decide with respect to reimbursement.

Decisions regarding the extent of coverage and amount of reimbursement to be provided for XACIATO and any future products will be made on a payor-by-payor basis.

Accordingly, one third-party payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage and adequate reimbursement for the product.

Moreover, reimbursement agencies in Europe may be more conservative than CMS, should XACIATO or any of our product candidates be approved for marketing in Europe.

In addition to CMS and private payors, professional organizations can influence decisions about reimbursement for new medical products by determining standards of care.

In addition, many private payors contract with commercial vendors who sell software that provides guidelines that attempt to limit utilization of, and therefore reimbursement for, certain products deemed to provide limited benefit as compared to existing alternatives.

Such organizations may set guidelines that limit reimbursement or utilization of any of our commercialized products.

To secure coverage and reimbursement for XACIATO and any future product, we or a commercial collaborator may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of the product to third-party payors, which costs would be in addition to those required to obtain FDA or other comparable regulatory approvals.

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

Moreover, eligibility for reimbursement does not imply that any product will be paid for in all cases or at a rate that covers our costs.

Interim payments for new products, if applicable, may also not be sufficient to cover our costs and may not be made permanent.

Managed care organizations and other private

insurers frequently adopt their own payment or reimbursement reductions.

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

Third-party payors increasingly employ formularies to control costs by negotiating discounted prices in exchange for formulary inclusion.

Failure to obtain timely or adequate pricing or formulary placement for XACIATO or any future product, or obtaining such pricing or placement at unfavorable pricing levels, could materially adversely affect our business, financial conditions, results of operations and prospects.

Moreover, eligibility for reimbursement does not imply that any product will be paid for in all cases or at a rate that covers our costs, or those of a commercial collaborator.

Interim payments for new products, if applicable, also may not be sufficient to cover our costs, or those of a commercial collaborator, and may not be made permanent.

Payment rates may vary according to the use of the product and the clinical setting in which it is used, may be based on payments allowed for lower cost products that are already reimbursed and may be incorporated into existing payments for other services.

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

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

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

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

Even if reimbursement is provided, market acceptance of our products may be adversely affected if the amount of payment for our products proves to be unprofitable for health care providers or less profitable than alternative treatments or if administrative burdens make our products less desirable to use.

Additionally, the containment of health care costs has become a priority of federal and state governments and the prices of drug products have been a focus in this effort.

Even if reimbursement is provided, market acceptance of our products may be adversely affected if the amount of payment for our products proves to be cost prohibitive for health care providers or their patients, or less profitable than alternative treatments or products, or if administrative burdens make our products less desirable to use.

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.

Additionally, the containment of health care costs has become a priority of federal and state governments and the prices of drug products have been a focus of this effort.

For example, there have been several recent U.S.

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We expect that federal, state and local governments in the U.S.

will continue to consider legislation directed at lowering the total cost of health care.

will continue to consider legislation directed at lowering the total cost of health care and prescription drugs.

Individual states in the United States have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

In December 2020, the U.S.

Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical benefit managers and other members of the health care and

pharmaceutical supply chain, an important decision that may lead to further and more aggressive efforts by states in this area.

The Biden Administration has indicated that lowering prescription drug prices is a priority, but we do not yet know what steps the administration will take or whether such steps will be successful.

It is uncertain whether and how future legislation or regulatory changes, to the ACA and otherwise, could affect prospects for our product candidates or what actions third-party payors may take in response to any such health care reform proposals or legislation.

Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures reforms may prevent or limit our ability to generate revenue, attain profitability or commercialize our product candidates.

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

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

federal Anti-Kickback Statute, the U.S.

federal False Claims Act and the U.S.

Foreign Corrupt Practices Act.

Health care fraud and abuse regulations are complex, and even minor irregularities can give rise to claims that a statute or prohibition has been violated.

The laws that may affect our operations include:

• the federal Anti-Kickback Statute (and comparable state laws), which prohibits, among other things, any person from knowingly and willfully offering, providing, soliciting or receiving remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs.

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 healthcare 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.

In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act;

• federal and state civil and criminal false claims laws, including the civil False Claims Act which prohibit, among other things, any person or entity from knowingly presenting, or causing to be presented, a false, fictitious or fraudulent claim for payment to the U.S.

government, knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent claim to the U.S.

government, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S.

Actions under these laws may be brought by the U.S.

Attorney General or as a qui tam action by a private individual in the name of the government.

The federal government uses these laws, and the accompanying threat of significant liability, in its investigation and prosecution of pharmaceutical and biotechnology companies throughout the U.S., for example, in connection with the promotion of products for unapproved uses and other allegedly unlawful sales and marketing practices;

• federal, civil and criminal statues created under HIPAA (and similar state laws), which prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

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;

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 transmission of individually identifiable health information.

Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates,” defined as independent contractors or agents of covered entities, which include certain healthcare providers, health plans, and healthcare clearinghouses, that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity.

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

Foreign Corrupt Practices Act, which prohibits U.S.

organizations and their representatives from offering, promising, authorizing or making corrupt payments, gifts or transfers of value to non-U.S.

officials, which in many countries, could include interactions with certain healthcare professionals.

The scope and enforcement of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations.

Although our compliance programs and those of commercial partners, and adherence thereto, may mitigate the risk of violation of and subsequent investigation and prosecution for violations of the laws described above, the risks cannot be eliminated entirely.

Ensuring that our current and future business operations and arrangements with third parties comply with applicable healthcare 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 healthcare laws and regulations.

If we or our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, 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, healthcare 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.

If any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

If regulatory authorities challenge our activities, or those of a commercial partner, under these laws,.

any such challenge could have a material adverse effect on our reputation, business, results of operations and financial condition.

Any investigation of us or the third parties with whom we contract, including a commercial partner, regardless of the outcome, would be costly and time consuming, and may negatively affect our results of operations and financial condition.

We have no internal sales, marketing or distribution capabilities and our model is to partner with companies with existing sales, marketing and distribution capabilities to commercialize our product candidates, if approved.

Any failure by such third parties could negatively impact our business and our ability to develop and market any approved products.

We currently do not intend to directly sell or distribute our products into the market and instead intend to enter into agreements with third parties to market, sell and distribute and provide related support services for any of our product candidates that receive regulatory approval.

Failure to timely enter into such agreements could delay commercial launch of any such product.

In addition, the terms of such agreements will impact the current and future value of such products to us, including the timing of any potential cash payments, including royalty and milestone payments.

This reliance on third parties will also subject us to uncertainties related to these services, including the quality of such services.

These third parties may not effectively market, sell or distribute our products.

Further, we would depend on these third parties to ensure that the distribution process accords with applicable law and regulations, which include, among other things, compliance with current good documentation practices, the maintenance of records and documentation, and compliance with applicable state laws that govern the licensure of distributors of prescription medical products.

Failure to comply with these requirements could result in significant remedial action, including improvement of facilities, suspension of distribution or recall of product.

Furthermore, we

may be unable to replace any commercial partner or distributor with an alternate third party on a commercially reasonable or timely basis, or at all.

Additionally, any failure by us to forecast demand for a finished product, and failure by us to ensure our distributors and marketing partners have appropriate capacity to distribute and sell such quantities of finished product, could result in an interruption in the supply of certain products and a decline in sales of that product.

Should we decide to take a more active role in the commercial distribution of our products, such efforts would require the investment of significant capital, an expansion of our team and additional risk.

The commercial success of product candidates we develop will significantly depend on the label claims that the FDA and comparable regulatory authorities outside the United States approve for the product.

The commercial success of any of our product candidates will significantly depend upon our ability to obtain approval from the FDA and other regulatory authorities of product labeling containing adequate information regarding the product’s expected features or benefits.

Failure to achieve such approval will prevent or substantially limit our ability to advertise and promote such features and benefits in order to differentiate DARE-BV1, Ovaprene, Sildenafil Cream, 3.6%, DARE-HRT1, the other product candidates currently in our portfolio or any future product candidate from competing products.

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

Even if we receive marketing approval from the FDA for our product candidates, we may fail to receive similar approval outside the United States, which could substantially limit the value of such products.

To market any of the product candidates we are developing outside the United States, we 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.

Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical benefit managers and other members of the health care and pharmaceutical supply chain, an important decision that may lead to further and more aggressive efforts by states in this area.

The Biden Administration has also indicated that lowering prescription drug prices is a priority, and the Department of Health and Human Services, or DHHS, released a drug pricing plan in September 2021 that indicates the Administration supports aggressive actions such as allowing DHHS to negotiate the cost of Medicare Part B and D drugs.

Such significant changes will require either new legislation to be passed by Congress or time-consuming administrative actions.

It is uncertain whether and how future legislation or regulatory changes could affect prospects for XACIATO or our product candidates or what actions third-party payors may take in response to any such health care reform proposals or legislation.

Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures reforms, may prevent or limit our ability, or the ability of a commercial collaborator, to commercialize XACIATO or any future products as well as our ability to generate revenue and attain profitability.

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.

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, 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.

These regulations ensure that women in the U.S.

who wish to use an approved form of contraception may request it from their doctors and their health insurance plan must cover all costs associated with such contraceptive products.

In January 2022, the DHHS, Department of Labor, and Treasury Department jointly issued guidance on implementation of this ACA mandate, among other things.

The recently issued federal guidance makes clear that all FDA-approved or cleared contraceptive products that are determined by an individual’s medical provider to be medically appropriate for such individual must be covered without-cost sharing, regardless of whether the product is specifically identified in a Birth Control Guide published by the FDA.

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, 3.6% if approved.

Sildenafil Cream, 3.6%, 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, 3.6%, if approved.

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

Insurers may deem Sildenafil Cream, 3.6% to be a life-style drug and decide not to provide reimbursement.

Today, many health insurance plans provide reimbursement for male sexual arousal medications.

However, we cannot predict whether they will continue to do so or whether they will do so for FSAD treatments as well.

The safety and efficacy data from our clinical trials may impact whether Sildenafil Cream, 3.6% will become eligible for insurance coverage, and if it does, the level of such reimbursement.

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 United States.

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

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

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 supply of XACIATO and any future product.

Our product and product candidates are complex to manufacture 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.

Such problems may prevent the production of lots that meet the specifications required for sale of our product and may be difficult and expensive to resolve.

In particular because we rely on single source contract manufacturers and suppliers, if disruptions occur in the operations of one those third parties, we may experience immediate shortages of our products.

If any such issues were to arise with respect to XACIATO or future products, we could lose sales and associated revenue, incur additional costs, delay commercial launch of new products or suffer harm to our reputation.

See also ““Risks Related to Our Dependence on Third Parties- We rely on third-party suppliers and manufacturers for clinical and commercial supplies of XACIATO and our product candidates, including multiple single source suppliers and manufacturers, and we currently have no plans to build or acquire our own manufacturing capabilities.

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 and product candidates, which may heighten our dependence on those third parties and the risk of manufacturing disruptions” above.

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

Although XACIATO is FDA-approved for commercialization in the United States, it and any future product may face direct competition from generic products earlier or more aggressively than anticipated, depending upon how well such approved products perform in the United States prescription drug 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.

An ANDA relies on the nonclinical and clinical testing conducted for a previously approved reference listed drug, or RLD, and must demonstrate to the FDA that the generic drug product is identical to the RLD with respect to the active ingredients, the route of administration, the dosage form, and the strength of the drug and also that it is “bioequivalent” to the RLD.

The FDA is prohibited by statute from approving an ANDA when certain marketing or data exclusivity protections apply to the RLD.

If a third party is able to demonstrate bioequivalence without infringing our patents, that third party may then be able to introduce a competing generic product onto the market.

The FDA granted XACIATO for the treatment of bacterial vaginosis in female patients 12 years of age and older three years of data exclusivity, which was extended by five years under the GAIN Act, such that the period is set to expire on December 7, 2029.

XACIATO has also been designated as an RLD by the FDA for purposes of future generic drug development.

Accordingly, the data exclusivity period should block the FDA from approving either a subsequent ANDA or 505(b)(2) NDA that relies in whole or in part on our protected clinical data.

We cannot predict the interest of potential follow-on competitors in the future XACIATO market, whether a third party will attempt to invalidate our period of exclusivity or otherwise force the FDA to take other actions, or how quickly others may seek to come to market with competing products after the FDA-granted data exclusivity period ends.

Other products candidates we develop, if approved, may also receive marketing exclusivity under the FDCA that may similarly be subject to challenge or uncertainty.

We will need to obtain FDA approval of any proposed prescription medical product name, and any failure or delay associated with such approval may adversely affect our business.

Any name we intend to use for our current or future product candidates will require approval from the FDA regardless of whether we have secured a formal trademark registration from the United States Patent and Trademark Office, or USPTO.

The FDA typically conducts a review of proposed new prescription medical product names, including an evaluation of the potential for confusion with other product names.

The FDA may also object to a proposed product name if it believes the name inappropriately implies medical claims or contributes to an overstatement of efficacy.

If the FDA objects to any of our proposed product names, we may be required to adopt alternative names for our product candidates.

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

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

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

To market XACIATO or any future product outside the United States, 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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The marketing approval process in other countries may include all of the risks associated with obtaining FDA approval in the United States, as well as other risks.

Further, for approval in foreign jurisdictions, we may not have rights to reference the necessary clinical and nonclinical data that we do not own or have licensed rights to use, as we anticipate doing under the 505(b)(2) regulatory pathway in the United States, and we may have to develop our own additional data to seek approvals in other jurisdictions.

may have to develop our own additional data to seek approvals in other jurisdictions.

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

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Additionally, the product labeling requirements outside the United States may be different and inconsistent with the United States labeling requirements, negatively affecting our ability to market our products in countries outside the United States.

In addition, we may be subject to fines, suspension or withdrawal of marketing approvals, product recalls, seizure of products, operating restrictions and criminal prosecution if we fail to comply with applicable foreign regulatory requirements.

In such an event, our ability to market to our full target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

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

Because of their early nature, pre-clinical product candidates tend to carry a higher risk of failure as compared with clinical-stage assets.

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.

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

Various macroeconomic factors could adversely affect our business, our results of operations and financial condition, including changes in inflation, interest rates and overall economic conditions and uncertainties, including those resulting from political instability (including workforce uncertainty) or a global health emergency, and the current and future conditions in the global financial markets.

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

Similarly, these macroeconomic factors could affect the ability of our current or potential future third-party manufacturers, sole source or single source 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.

Failure by any of them to remain in business could have a material adverse effect on our ability to develop and obtain regulatory approvals for our current and any future product candidates, and, if approved, market and sell our products or provide sufficient quantities of our products to meet market demand.

In addition, we may be subject to fines, suspension or withdrawal of marketing approvals, product recalls, seizure of products, operating restrictions and criminal prosecution if we, or our commercial collaborator, fail to comply with applicable foreign regulatory requirements.

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 our ability to realize the full market potential of our products will be harmed, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

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 30, 2022, we had 28 employees, of which 20 were full-time and eight 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.

With a small number of employees, our ability to supervise the service providers we engage 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.

In response to the COVID-19 pandemic, in March 2020, we implemented work-from-home and restricted travel policies.

Since March 2020, the governors of California and Massachusetts, states in which we have operations, have issued, rescinded and reinstated statewide or regional stay-at-home orders and individual isolation and quarantine requirements to help combat the spread of COVID-19 that have impacted our ability to require or allow our employees to work in our facilities.

In addition, many, if not all, of our consultants, collaborators and vendors on which we rely heavily have implemented similar policies, are or may be subject to similar orders, and/or may re-allocate resources otherwise intended for our activities to activities intended to address the COVID-19 pandemic.

We have modified, and we may further modify, our work-from-home and restricted travel policies during the course of the pandemic.

When and if we and our collaborators and service providers revert to pre-pandemic policies is indeterminable currently.

Prolonged and indefinite remote working arrangements and travel restrictions may adversely affect our ability to effectively manage and operate our business, materially increase our expenses and may result in delays in our anticipated development program timelines.

In addition, we and our collaborators and service providers may be adversely affected by worker shortages directly or indirectly related to the COVID-19 pandemic that are difficult to predict, plan for or mitigate.

For example, in late 2021, companies across many industries began experiencing severe staffing shortages reportedly caused by work absences due to a surge in COVID-19 cases and an economic trend known as the Great Resignation in which employees are voluntarily quitting their jobs in large numbers.

Due to our small workforce, if multiple employees become unable to work or were to resign at roughly the same time, our ability to effectively manage and operate our business could become significantly impaired and our expenses could increase materially, including as a result of expenditures related to recruiting, hiring and training qualified new employees and engaging additional consultants and service providers to perform the job responsibilities of the employees on leave or who resign.

If we or our collaborators or service providers experience staffing shortages, it may result in significant delays in our anticipated development program timelines.

We depend highly on our senior management.

Losing the services of our senior management could impede, delay or prevent the development and commercialization of our product candidates, hurt our ability to raise additional funds and negatively impact our ability to implement our business plan.

If we lose the services of any of our senior management team, we might not find suitable replacements on a timely basis or at all, and our business could be materially harmed.

We do not maintain “key man” insurance policies on the lives of any of our senior management employees.

As a result, we may have to expend significant financial resources in our employee recruitment and retention efforts.

They also may provide more diverse opportunities and better opportunities for career advancement.

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.

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

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

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

These efforts may not be successful, including for reasons discussed in elsewhere in these risk factors and also:

• we may fail to appropriately evaluate the potential risks and uncertainties associated with a transaction;

• there may be intense competition to acquire or in-license promising product candidates and technologies and many of our competitors have considerably more financial, development and commercialization resources than we have;

• we may not effectively integrate the acquired or in-licensed assets, businesses, personnel, intellectual property or business relationships;

• we may underestimate the development costs, timelines, regulatory approval challenges and overestimate the market opportunity for the potential product candidates and technologies;

• the acquired or in-licensed product candidates may prove during development to be unsafe or not effective in their targeted indications.

We may fail to realize the anticipated value of any strategic transaction and the costs of a transaction may outweigh the benefits we realize from it.

Any strategic transaction we pursue may not produce the outcomes and benefits we originally anticipated and may adversely impact our financial condition and be detrimental to our company in general.

Risks Related to Our Intellectual Property

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Our success depends in part on our ability, and the ability of our licensors, to obtain and maintain protection in the United States and other countries for the intellectual property covering or incorporated into our technologies and products.

The patents and patent applications relied upon by us are licensed to us by third parties.

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.

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As a result, the validity and enforceability of patents cannot be predicted with certainty.

In addition, we do not know whether we or our licensors were the first to make the inventions covered by each of our issued patents and pending patent applications.

In addition, we do not know whether we or our licensors were the first to make the inventions covered

by each of our issued patents and pending patent applications.

We or our licensors may not have been the first to file patent applications for these inventions.

Periodic maintenance fees on any issued patent are due to be paid to the United States Patent and Trademark Office, or USPTO, and foreign patent agencies in several stages over the lifetime of the patent.

Periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.

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

We cannot be certain if any of the patents that cover our product candidates will be eligible to be listed in the FDA’s compendium of “Approved Drug Products with Therapeutic Equivalence Evaluation" (the “Orange Book").

We cannot be certain if any of the patents that cover our product candidates will be eligible to be listed in the Orange Book following a drug product marketing approval.

The advantage of being listed in the Orange Book is that, under the Hatch-Waxman Act, any future generic applicant for any of our approved products needs to include a patent certification in their generic application with respect to each patent listed in the Orange Book for an approved product (referred to as the “listed drug”) for which they are seeking approval.

If the generic applicant believes that any of the patents in the Orange Book on the listed drug is invalid, unenforceable, or not infringed by their product, the generic applicant usually will file a “Paragraph IV” certification on that patent if they plan to challenge the patent.

When a generic applicant files a Paragraph IV certification, they must provide the listed drug application (and the patent owner if different) a notice that they filed a generic application with the Paragraph IV certification.

When a generic applicant files a Paragraph IV certification, they must provide the listed drug applicant (and the patent owner if different) a notice that they filed a generic application with the Paragraph IV certification.

If, in reply to that notice, the listed drug holder files a patent lawsuit against the generic applicant within 45 days of the Paragraph IV notice, a 30-month automatic stay is imposed by the Hatch-Waxman Act on FDA during which FDA may not approve the generic application (unless the patent litigation is resolved in the generic applicant’s favor).

These 30-month stays are major protection available in the Hatch-Waxman Act for innovative drug makers.

However, if our products are approved, but one or more of our patents are not listed in the Orange Book, generic firms that might seek approval of a generic version of our product would not have to “certify” in

their generic drug applications as to any such unlisted patent.

This could result in the absence of a 30-month stay and thus faster approval of some generic applications for our products.

Other companies or individuals may independently develop similar or alternative technologies or duplicate our technologies.

This could enable our competitors to develop a competing product that avoids infringing our patents.

In such an event, our competitors might be able to enter the market, which could significantly harm the commercial opportunity for our product candidates.

The laws of some foreign countries do not protect our proprietary rights to the same extent or in the same manner as U.S.

laws, and we may encounter significant problems in protecting and defending our proprietary rights in these countries.

We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary technologies, product candidates and any future products are covered by valid and enforceable patents or are effectively maintained as trade secrets.

Our patent strategy for protecting DARE-BV1 includes in-licensing a patent family from TriLogic Pharma and MilanaPharm whose last claim expires in the fourth quarter of 2028 in the United States and Europe, with additional patent applications pending that could have terms into 2036.

MilanaPharm has the first right to prepare, file, prosecute and maintain all such patents, at MilanaPharm’s sole cost and expense.

MilanaPharm and TriLogic must keep us informed regarding the preparation, filing, prosecution, and maintenance of the licensed patents, provide us with reasonable opportunity to review and comment on material communications to and from the applicable patent authorities and take all reasonable comments made by, and otherwise act in accordance with instructions provided by, us on matters related to prosecution, maintenance and enforcement related to the licensed patents.

If MilanaPharm decides not to prepare, file, prosecute, or maintain any licensed patent, we have the option, in our sole discretion, to assume the control and direction of the preparation, filing, prosecution, and maintenance of such patent at our expense, and we may deduct some or all of such patent expenses from amounts payable to MilanaPharm under our license agreement.

We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary technologies, products and product candidates are covered by valid and enforceable patents or are effectively maintained as trade secrets.

Our patent strategy for protecting Ovaprene includes in-licensing a patent family from ADVA-Tec, whose last claim expires in August 2028, but which could be extended to August 2033 in the United States and Europe.

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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, The General Hospital Corporation (known as 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.

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

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.

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Others may challenge, seek to invalidate, infringe or circumvent any patents we own or license, including the patents we have licensed to date and any other patents we may license in the future.

Conversely, in the future we may have to

initiate litigation against third parties to enforce our intellectual property rights.

The defense and prosecution of patent and intellectual property claims are both costly and time consuming, even if the outcome is favorable to us.

Conversely, in the future we may have to initiate litigation against third parties to enforce our intellectual property rights.

The defense and enforcement of patent and intellectual property claims are both costly and time consuming, even if the outcome is favorable to us.

Any adverse outcome could subject us to significant liabilities, require us to license disputed rights from others or require us to cease selling our future products.

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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, 3.6% and DARE-BV1 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, 3.6%, is sildenafil and the active ingredient in our product candidate for the treatment of bacterial vaginosis, DARE-BV1, is clindamycin.

The patents and the patent applications covering Sildenafil Cream, 3.6% 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, 3.6%, 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 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, 3.6% and DARE-BV1 could be significantly harmed if competitors are able to develop and commercialize alternative formulations using these ingredients.

The commercial opportunity for Sildenafil Cream, 3.6% 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.

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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.

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.

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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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 DARE-BV1, 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 with in any such suit, including, if necessary, by being joined as a party to any such suit.

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 with 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 DARE-BV1.

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.

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.

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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, 3.6%.

With respect to our IVR product candidates, including DARE-HRT1, 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 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.

Our exclusive, in-license agreements covering the critical patents and related intellectual property related to our product candidates impose significant monetary obligations and other requirements that may adversely affect our ability to execute our business plan.

The termination of any of these in-license agreements could prevent us from developing and commercializing our product candidates and may harm our business.

Our license agreements with Hammock/MilanaPharm, ADVA-Tec, SST and Catalent include intellectual property rights to DARE-BV1, Ovaprene, Sildenafil Cream, 3.6%, and our IVR product candidates, including DARE-HRT1, respectively.

These agreements, as well as our merger agreements with Pear Tree and Microchips, require us, as a condition to the maintenance of our license and other rights, and as merger consideration in the case of the agreement with Pear Tree, to make milestone and royalty payments and satisfy certain performance obligations.

Our obligations under these in-license and merger agreements impose significant financial and logistical burdens upon our ability to carry out our business plan.

Furthermore, if we do not meet such obligations in a timely manner, and, in the case of milestone payment requirements, if we were unable to obtain an extension of the deadlines for meeting such payment requirements, we could lose the rights to these proprietary technologies, which would have a material adverse effect on our business, financial condition and results of operations.

Further, there is no assurance that the existing license agreements covering the rights related to DARE-BV1, Ovaprene, Sildenafil Cream, 3.6%, and the IVR product candidates, or license agreements we enter into or acquire the rights to in the future, will not be terminated due to a material breach of the underlying agreements.

With regard to the agreement covering Ovaprene, this would include a failure on our part to make milestone and royalty payments, our failure to obtain applicable approvals from governmental authorities, or the loss of rights to the underlying intellectual property by any such licensors.

With regard to the agreement covering Sildenafil Cream, 3.6%, this would include a failure to assume responsibility for suspended development activities within the requisite period, our failure to use commercially reasonable efforts in performing development activities, or the failure on our part to make milestone and royalty payments.

With regards to the agreement covering DARE-BV1, this would include failure to use commercially reasonable efforts and resources 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, our failure to make milestone and royalty payments, or our failure to continue, or to resume, using commercially reasonable marketing efforts to sell a licensed product or process in a country after having launched such product or process in that country.

With regard to the agreement covering our IVR product candidates, this would include a failure on our part to make milestone and royalty payments, our failure to obtain applicable approvals from governmental authorities or the loss of rights to the underlying intellectual property by any such licensors.

With regard to the merger agreement with Pear Tree, this would include our failure to use commercially reasonable efforts to bring a product to market.

Moreover, because some of our rights to DARE-BV1, Ovaprene, Sildenafil Cream, 3.6% and the IVR product candidates are sublicensed pursuant to underlying agreements, there is no assurance that the existing license agreements covering the rights related to DARE-BV1, Ovaprene, Sildenafil Cream, 3.6%, and DARE-HRT1 will not be terminated due to termination of the underlying agreements, or due to the loss of rights to the underlying intellectual property by Hammock's, ADVA-Tec’s, SST’s or Catalent's licensors.

There is no assurance that we will be able to renew or renegotiate license agreements on acceptable terms if our license agreements with Hammock, ADVA-Tec, SST, TriLogic/MilanaPharm or Catalent, or the underlying agreements are terminated.

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 would materially and adversely affect our ability to develop and commercialize DARE-BV1, Ovaprene, Sildenafil Cream, 3.6% and our IVR product candidates, including DARE-HRT1.

We may also rely on trade secrets to protect some of our technology, especially where we do not believe patent protection is appropriate or obtainable.

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 United States, Europe and elsewhere that is relevant to or necessary for the commercialization of our product candidates in any jurisdiction.

For example, in the United States, applications filed before November 29, 2000 and certain applications filed after that date that will not be filed outside the United States remain confidential until patents issue.

Patent applications in the United States, EU and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date.

Therefore, patent applications covering our future product candidates, or their manufacture or use may currently be unpublished.

Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our product candidates or the use of our product candidates.

The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history.

Our or our licensors’ interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact our ability to market our product candidates.

We our licensors may incorrectly determine that our product candidates are not covered by a third-party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope.

Our or our licensors’ determination of the expiration date of any patent in the United States, the EU or elsewhere that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our product candidates.

Our licensors’ failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our product candidates.

From time to time, we or our licensors may identify patents or applications in the same general area as our products and product candidates.

We or our licensors may determine these third-party patents are irrelevant to our business based on various factors including our or our licensors’ interpretation of the scope of the patent claims and our or our licensors’ interpretation of when the patent expires.

If the patents are asserted against us, however, a court may disagree with our or our licensors’ determinations.

Further, while we or our licensors’ may determine that the scope of claims that will issue from a patent application does not present a risk, it is difficult to accurately predict the scope of claims that will issue from a patent application, our determination may be incorrect, and the issuing patent may be asserted against us or our licensors.

We cannot guarantee that we or our licensors will be able to successfully settle or otherwise resolve such infringement claims.

If we or our licensors fail in any such dispute, in addition to being forced to pay monetary damages, we may be temporarily or permanently prohibited from commercializing our product candidates.

We or our licensors’ might, if possible, also be forced to redesign our product candidates so that we or our licensors’ no longer infringe on the third-party intellectual property rights.

Any of these events, even if we or our licensors’ were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.

We also rely upon trade secrets to protect our technology, product and product candidates, and trade secrets can be difficult to maintain and enforce.

In addition to patent and trademark protection, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to derive a competitive advantage for products we develop, especially

where we believe patent protection is not appropriate or obtainable.

However, trade secrets are difficult to maintain.

While we use reasonable efforts to protect our trade secrets, we or any of our collaborators’ employees, consultants, contractors or scientific and other advisors may unintentionally or willfully disclose our proprietary information to competitors and we may not have adequate remedies in respect of that disclosure.

Enforcement of claims that a third party has illegally obtained and is using trade secrets is expensive, time consuming and uncertain.

While we use reasonable efforts to protect our trade secrets, monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be effective.

Moreover, we or any of our collaborators’ employees, consultants, contractors or scientific and other advisors may unintentionally or willfully disclose our proprietary information to competitors and we may not have adequate remedies in respect of that disclosure.

Enforcement of claims that a party illegally disclosed or obtained and is using trade secrets is difficult, expensive and time consuming and the outcome is unpredictable.

In addition, foreign courts are sometimes less willing than U.S.

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If our competitors independently develop equivalent knowledge, methods and know-how, we would not be able to assert our trade secrets against them and our business could be harmed.

Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete.

We enter into confidentiality, nondisclosure, and intellectual property assignment agreements with our corporate partners, employees, consultants, outside scientific collaborators, sponsored researchers, and other advisors.

These agreements generally require that the other party keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party by us during the course of the party’s relationship with us.

Our competitors may independently develop knowledge, methods and know-how equivalent to our trade secrets.

Competitors may be able to legally obtain products of ours and replicate some or all of the competitive advantages we derive from our development efforts for technologies on which we do not have patent protection.

If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us.

If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position could be harmed.

Confidentiality agreements with employees and others may not adequately prevent disclosure of our know-how, trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete.

We enter into confidentiality, nondisclosure, and intellectual property assignment agreements with our employees, consultants, collaborators, sponsored researchers, and scientific and other advisors.

These agreements generally require that the other party keep confidential and not disclose to third parties all confidential information developed by the party on our behalf or made known to the party by us during the course of the party’s relationship with us.

These agreements also generally provide that inventions conceived by the party in the course of rendering services to us will be our exclusive property.

However, these agreements may not be honored and may not effectively assign intellectual property rights to us.

Enforcing a claim that a party illegally obtained and is using our trade secrets is difficult, expensive and time consuming and the outcome is unpredictable.

We also have not entered into any non-compete agreements with any of our employees.

Although each of our employees is required to sign a confidentiality agreement with us at the time of hire, we cannot guarantee that the confidential nature of our proprietary information will be maintained in the course of future employment with any of our competitors.

If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results and financial condition.

Risks Related to Our Securities

The price of our common stock has been and may continue to be volatile and could subject us to securities litigation, including class-action lawsuits.

We cannot guarantee that the confidential nature of our proprietary information will be maintained by our employees and others in the course of their future employment with or provision of services to a competitor.

Enforcing a claim that a party illegally disclosed or obtained and is using our know-how, trade secrets or other proprietary information is difficult, expensive and time consuming and the outcome is unpredictable.

If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, we will not be able to establish or maintain a competitive advantage for the products we develop, which could materially adversely affect our business, operating results and financial condition.

Provisions in our agreements with governmental agencies and non-profit organizations may affect our intellectual property rights and the value of our development programs to our company.

Certain of our product development activities have been funded, are being funded and may in the future be funded, by the U.S.

government and 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.

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

government has a nonexclusive, nontransferable, irrevocable, paid-up right to practice for research or other government purposes any invention of either party conceived or first actually reduced to practice in the party’s performance of the CRADA and both parties will jointly own inventions jointly invented by their employees in performing the research plan.

Under the CRADA, we were granted an exclusive option to negotiate an exclusive or nonexclusive development and commercialization license with a field of use that does not exceed the scope of the research plan to rights that the U.S.

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

Under the grant agreement supporting development of DARE-LARC1, we agreed to make DARE-LARC1, and any other products, services, processes, technologies, materials, software, data, other innovations, and intellectual property resulting from the project funded by the grant (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 of our rights in DARE-LARC1 and other Funded Developments.

Risks Related to Our Business Operations and Industry

The COVID-19 pandemic has negatively impacted our business and, in the future, may materially and adversely affect our business, financial condition and results and stock price, including by increasing the cost and timelines for our clinical development programs.

The ultimate impact of the COVID-19 pandemic on our operations and, financial condition is unknown and will depend on future developments that are highly uncertain, beyond our control and cannot be predicted with confidence, including, but not limited to, the duration and severity of the pandemic, governmental and individual organization actions and policies implemented to reduce transmission of the disease, governmental actions and programs implemented to mitigate and alleviate the economic impact of the pandemic, and the speed with which and degree to which normal economic and operating conditions resume.

The longer the pandemic persists, the greater the potential for significant adverse impact 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.

In addition, the significant amount of personnel continuing to work remotely, both ours and those of the third parties on which we rely, could increase our cybersecurity risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which could significantly adversely impact our business operations or significantly delay necessary interactions with the FDA and other regulatory agencies, our CROs and CMOs, clinical trial sites, current and potential collaborators, and other third parties.

Conversely, as more personnel return to work, travel and non-essential gatherings, there is increased risk of transmission of the disease and other communicable illnesses, potentially leading to resource constraints while personnel are unable to work due to illness and caring for family members who become ill.

In addition, vaccination mandates may lead to human resource constraints at our strategic collaborators, CROs, CMOs and other third parties on which we rely if substantial proportions of their workforce quit or are terminated for refusing to comply with vaccine mandates.

The COVID-19 pandemic could cause delays in the current timelines for our ongoing and planned clinical studies, our regulatory submissions, potential marketing approvals and, ultimately, commercial launch of any approved product, including XACIATO.

The clinical and regulatory milestones we are targeting to occur in 2022 and 2023 may be delayed or otherwise adversely impacted as a result of the pandemic.

For example, clinical trial site initiation and/or patient enrollment may be significantly delayed or suspended as a result of personnel and other resource constraints of health care providers, as well as adherence to governmental orders and internal policies intended to reduce the spread of COVID-19.

In addition, we may experience lower than anticipated subject enrollment and completion rates, including because individuals may avoid medical settings, particularly for non-critical conditions, due to concerns of contracting COVID-19 or due to shelter-in-place and social distancing orders, or conversely, as pandemic-related restrictions ease and there are increased opportunities to travel and participate in other activities again, individuals may be less inclined to participate in or complete clinical trials such as ours that require multiple clinic visits.

Commencement and completion of our clinical trials may also be significantly delayed by disruptions to production by our contract manufacturers of clinical supplies needed for those studies.

The COVID-19 pandemic contributed to a slower than anticipated pace of enrollment of participants in our Phase 2b clinical study of Sildenafil Cream, 3.6% as a result of operational restrictions or closure of certain study sites due to their adherence to governmental guidelines intended to reduce the spread of COVID-19.

The commencement of clinical trials and nonclinical testing for our programs may be delayed due to the failure to obtain clinical and other supplies on a timely basis as a result of supply chain disruptions and human resources constraints.

If we cannot raise capital when needed on acceptable terms, or at all, we may not be able to continue development of our product candidates

as currently planned or at all, will need to reevaluate our planned operations and may need to delay, scale back or eliminate some or all of our development programs, reduce expenses or cease operations, any of which could have a significant negative impact on our prospects and financial condition, as well as the trading price of our common stock.

A key aspect of our business strategy is to seek collaborations with third parties, such as large pharmaceutical companies, that are willing to conduct later-stage clinical trials and further develop and commercialize our product candidates.

As a result of the pandemic, potential and current collaborators may experience operational disruptions and financial and other resource constraints and implement new strategic plans that delay or reduce their efforts in the women’s health in general or in our programs in particular, which could adversely affect our ability to enter into or maintain collaborations, strategic alliances or other similar types of arrangements and may result in or contribute to disruption and delays in later-stage clinical development and, if approved, commercial launch of our product candidates.

The plans we implement to help mitigate negative impacts on our business from the COVID-19 pandemic, including those designed to protect the safety, health and well-being of our employees while maintaining employee productivity, may not be effective.

The extent to which the pandemic, efforts to reduce the spread of COVID-19 and efforts to return to pre-pandemic economic conditions impact our business, financial condition and results of operations is uncertain and cannot be predicted with reasonable accuracy at this time and will depend on future developments that are also uncertain and cannot be predicted with reasonable accuracy at this time including emergence of new and more contagious or deadly variants of the virus that causes COVID-19, new information regarding the long-term health impacts of COVID-19, the rate and efficacy of vaccinations against COVID-19, the effect of actions taken in the United States and other countries to contain and treat COVID-19 and to address the pandemic's impact on economic health, and further actions implemented to contain and treat the disease and its impact, among others.

The COVID-19 pandemic 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.

We face an inherent risk of product liability exposure as a result of testing of our product candidates in human clinical trials and will face an even greater risk following commercial launch of XACIATO and any future product we develop.

If we cannot successfully defend ourselves against claims that our products or product candidates caused injuries, we will incur substantial liabilities or be required to limit commercialization of our products.

Regardless of merit or eventual outcome, liability claims may result in:

• decreased demand for any marketed product;

• product recalls, withdrawals or labeling, marketing or promotional restrictions;

• termination of product development or commercial collaborations;

• loss of revenue;

• withdrawal of clinical study participants and delays in commencement or completion of clinical studies;

• injury to our reputation and significant negative media attention;

• significant costs to defend the related litigation;

• substantial monetary awards to patients or clinical study participants;

• diversion of our management’s time and other resources from pursuing our business strategy;

• a decline in our stock price.

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

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 XACIATO or any of our product candidates, if approved.

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

Although we will endeavor to obtain and maintain such insurance in coverage amounts we deem adequate, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage.

Our insurance policies also have various exclusions, and we may be subject to a product liability claim for which we have no coverage.

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, consultants and commercial collaborators may engage in misconduct or other improper activities, including non-compliance with regulatory standards.

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

Misconduct by employees, independent contractors, clinical investigators, consultants, suppliers, commercial collaborators and vendors could include intentional failures, such as failures to:

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.

Misconduct by current or future employees, independent contractors, clinical investigators, consultants, suppliers, commercial collaborators and vendors could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory or civil sanctions and serious harm to our reputation.

It is not always possible to identify and deter misconduct by employees, independent contractors, clinical investigators, consultants, suppliers, commercial collaborators and vendors, 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.

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

federal Anti-Kickback Statute, the U.S.

federal False Claims Act and the U.S.

Foreign Corrupt Practices Act.

Health care providers and third-party payors play a primary role in the recommendation and prescription of drug products and medical devices that are granted marketing approval.

Our arrangements with health care providers, commercial collaborators, principal investigators, consultants, third-party payors, customers and other organizations may expose us to broadly applicable fraud and abuse and other health care laws and regulations in the United States.

Health care fraud and abuse regulations are complex, and even minor irregularities can give rise to claims that a statute or prohibition has been violated.

The laws that may affect our operations include:

• the federal Anti-Kickback Statute (and comparable state laws), which prohibits, among other things, any person from knowingly and willfully offering, providing, soliciting or receiving remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal health care programs such as the Medicare and Medicaid programs.

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.

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.

government, knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent claim to the U.S.

government, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S.

Actions under these laws may be brought by the U.S.

Attorney General or as a qui tam action by a private individual in the name of the government.

• federal, civil and criminal statues created under HIPAA (and similar state laws), which prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any health care benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially

false, fictitious or fraudulent statement in connection with the delivery of or payment for health care benefits, items or services.

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, chiropractors, and 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;

Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates,” defined as independent contractors or agents of covered entities, which include certain health care providers, health plans, and health care clearinghouses, that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity.

Foreign Corrupt Practices Act, which prohibits U.S.

organizations and their representatives from offering, promising, authorizing or making corrupt payments, gifts or transfers of value to non-U.S.

officials, which in many countries, could include interactions with certain health care professionals.

The scope and enforcement of these laws is uncertain and subject to rapid change in the current environment of health care reform, especially in light of the lack of applicable precedent and regulations.

The risk of violation of, and subsequent investigation and prosecution for violations of, the laws described above may be mitigated through the implementation and maintenance of compliance programs by us and our commercial collaborators and other third parties on which we rely for important aspects of development or commercialization of our products and product candidates, but these risks cannot be eliminated entirely.

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.

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.

If any of the physicians or other health care providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded health care programs.

If regulatory authorities challenge our activities, or those of a commercial collaborator or other third party on which we rely, under these laws, any such challenge could have a material adverse effect on our reputation, business, results of operations and financial condition.

Any investigation of us or the third parties with whom we contract, including a commercial collaborator, regardless of the outcome, would be costly and time consuming, and may negatively affect our results of operations and financial condition.

Cyber-attacks, security breaches, loss of data and other disruptions to our information technology systems or those of our collaborators and third-party service providers could compromise sensitive information related to our business, delay or prevent us from accessing critical information or expose us to liability, any of which could adversely affect our business and our reputation.

We utilize information technology systems and networks to process, transmit and store electronic information in connection with our business activities.

As the use of digital technologies has increased, cyber incidents, including deliberate attacks, the deployment of harmful malware or ransomware, denial of service, and attempts to gain unauthorized access to computer systems and networks, have increased in frequency and sophistication.

These threats pose a risk to the security of our systems and networks and those of our collaborators and third-party service providers, and could compromise the confidentiality, availability and integrity of our data, confidential information, or other intellectual property, all of which are vital to our operations and business strategy.

Organizations and governmental bodies with far greater resources than ours dedicated to cyber security have proven vulnerable to cyber-attacks.

There can be no assurance we will succeed in preventing cyber security breaches or successfully mitigate their effects.

Despite implementing security measures, any of the computer systems belonging to us or our collaborators and third-party service providers are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failure.

Moreover, the prevalent use of mobile devices that access confidential information increases the risk of data security breaches.

For example, losing clinical study data from future clinical studies could result in delays in our or our collaborators’ regulatory approval efforts and significantly increase our costs in order to recover or reproduce the lost data.

If any disruption or security breach results in a loss or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we may incur resulting liability, our product development programs and competitive position may be adversely affected, the further development of our product candidates may be delayed, and the manufacture and sale of any approved products may be impaired.

Furthermore, we may incur additional costs to remedy the damage caused by these disruptions or security breaches.

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

Various macroeconomic factors could adversely affect our business, our results of operations and financial condition, including changes in inflation, interest rates and overall economic conditions and uncertainties, including those resulting from geopolitical events, international economic sanctions or a global health emergency.

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

Failure by any of them to remain in business could have a material adverse effect on our ability to develop and obtain regulatory approvals for our product candidates, and, if approved, market and sell our products or provide sufficient quantities of our products to meet market demand.

We incur and expect to continue to incur significant legal, accounting and other expenses as a public reporting company.

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.

Even while we have non-accelerated filer status, our management and other personnel will need to continue to devote substantial time towards maintaining compliance with the requirements of being a public company.

Our management and other personnel, of whom we have a small number, devote substantial time to these compliance initiatives.

Moreover, if and when we become an accelerated filer, our compliance costs will increase.

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.

The SEC established the smaller reporting company, or SRC, category of companies in 2008, and expanded it in 2018, in an effort to provide general regulatory relief for smaller companies.

SRCs may choose to comply with scaled financial and non-financial disclosure requirements in their annual and quarterly reports and registration statements relative to non-SRCs.

In addition, companies that are not “accelerated filers” can take advantage of additional regulatory relief.

Whether a company is an accelerated filer or a SRC is determined on an annual basis.

For so long as we qualify as a non-accelerated filer and/or a SRC, we will be permitted to and we intend to rely on some or all of the accommodations available to such companies.

These accommodations include:

• not being required to provide an auditor’s attestation of management’s assessment of internal control over financial reporting required by Section 404(b) of the Sarbanes-Oxley Act of 2002;

• reduced financial disclosure obligations, including that SRCs need only provide two years of financial statements rather than three years;

a maximum of two years of acquiree financial statements are required rather than three years;

fewer circumstances under which pro forma financial statements are required;

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;

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

We will continue to qualify as a SRC and non-accelerated filer for so long as (a) our public float is less than $75 million as of the last day of our most recently completed second fiscal quarter or (b) our public float is $75 million or more but less than $700 million and we reported annual revenues of less than $100 million for our most recently completed fiscal year.

We may choose to take advantage of some, but not all, of the available accommodations.

We cannot predict whether investors will find our common stock less attractive if we rely on these accommodations.

If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and the price of our common stock may be more volatile.

Risks Related to Ownership of Our Common Stock

The price of our common stock may rise and fall rapidly, substantial price fluctuations may occur regardless of developments in our business or our operating performance, and you could lose all or part of your investment as a result.

The stock market in general, and the market for biopharmaceutical companies in particular, have experienced volatility that has often been unrelated to the operating performance of particular companies.

The stocks of small cap and microcap companies in the life sciences sector like ours tend to be highly volatile.

We expect that the price of our common stock will be highly volatile for the next several years as we continue R&D and regulatory affairs activities necessary to obtain marketing approval for our product candidates, including pivotal clinical trials.

The market price for our common stock may be influenced by many factors, including:

• failure or discontinuation of any of our research programs;

Our common stock has experienced extreme trading price and volume fluctuations in the past, including fluctuations that have been unrelated or disproportionate to developments in our business and our operating performance, and we expect that our stock price will continue to experience high volatility.

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:

• failure or discontinuation of any of our product development programs;

• actual or anticipated changes to our product development and approval timelines, results from any clinical trial, and communications or decisions from regulatory authorities relating to a review of or decisions on applications we submit for our product candidates, in each case particularly those related to our clinical-stage product candidates;

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• 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 partnerships, joint ventures and capital commitments;

• additions or departures of key scientific or management personnel;

• 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;

• variations in our financial results or those of companies perceived to be similar to us;

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• results of clinical trials of product candidates of our competitors;

• general economic and market conditions and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies and effects from geopolitical actions, including war and terrorism, or natural disasters such as earthquakes, typhoons, floods and fires or public health emergencies or pandemics, such as the COVID-19 pandemic;

• general economic and market conditions and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies and effects from geopolitical events, including military conflicts, war, terrorism and economic conflicts, or natural disasters such as earthquakes, typhoons, floods and fires or public health emergencies or pandemics, such as the COVID-19 pandemic;

• regulatory or legal developments in the United States and other countries;

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

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

Pre-clinical product candidates may not be valued 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 partners, such as pharmaceutical companies.

Our investment of time and resources in such assets may not be appreciated or valued.

As a result, it may be difficult for us to fund such programs.

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

If DARE-LARC1, DARE-FRT1, DARE-VVA1, DARE-RH1 or the injectable etonogestrel product candidates we may license from Adare fail to be valued, our stock price may be adversely affected.

In addition, the suspension or delisting of our common stock, or the

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

A significant portion of our total outstanding shares of common stock may be sold into the public market at any point, which could cause the market price of our common stock to drop significantly, even if our business is doing well.

Sales of a substantial number of shares of our common stock in the public market could occur at any time, either by us or our stockholders.

For example, since January 1, 2020 and through March 29, 2021, we sold an aggregate of 15.8 million shares of our common stock in at-the-market offerings.

These sales, or the perception in the market that we or holders of a large number of shares intend to sell shares, could reduce the market price of our common stock.

For example, in 2021, we sold an aggregate of 41.1 million shares of our common stock in at-the-market, or ATM offerings and under our equity line arrangement.

Actual sales of our common stock, or the perception in the market that we or holders of a large number of shares intend to sell shares, could reduce the market price of our common stock.

Our outstanding shares of common stock may be freely sold in the public market at any time to the extent permitted by Rules 144 and 701 under the Securities Act or to the extent such shares have already been registered under the Securities Act and are held by non-affiliates.

As of December 31, 2021, there were 4.7 million shares of our common stock subject to outstanding options, almost all of which have been registered under the Securities Act on Form S-8.

The shares so registered can be freely sold in the public market after being issued to the option holder upon exercise, 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.

Furthermore, as of March 30, 2022, there were approximately 1.4 million shares of our common stock subject to outstanding warrants to purchase common stock, virtually all of which currently have an exercise price of $0.96 per share.

To the extent these warrants are exercised, the shares underlying these warrants may be immediately sold in the public market.

The sale of our common stock in ATM offerings or under our Purchase Agreement 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.

During 2020, we relied on at the market, or ATM, offerings and sales of our common stock under our Purchase Agreement to fund a significant portion of our operations, and we may continue to use these facilities to fund our operations in the future.

In March 2021, we gave notice to terminate the sales agreement pursuant to which we previously conducted ATM offerings, however, we are exploring entering into another sales agreement for ATM offerings.

In April 2020, we entered into a purchase agreement with Lincoln Park Capital Fund, LLC, pursuant to which Lincoln Park is obligated to purchase up to $15.0 million in shares of our common stock, at our sole discretion, subject to the terms and conditions set forth in the agreement and, as of March 29, 2021 approximately $3.0 million in shares remained available for us to sell under such agreement.

We refer to this agreement as our “Purchase Agreement.” The purchase price for the shares we may sell under our Purchase Agreement will vary based the market price of our common stock at the time we initiate a sale.

Although we have the right to control whether we sell any shares, if at all, under these agreements, and we generally have the right to control the timing and amount of any such sales, we are, or may become, subject to certain restrictions, including those that limit the number of shares we may sell.

For example, with respect to the Purchase Agreement, we may not sell more than 4,941,089 shares to Lincoln Park, which we refer to as the Exchange Cap, unless we obtain stockholder approval to issue shares in excess of the Exchange Cap or the average price per share of all sales to Lincoln Park equals or exceeds $1.0117, and we may not sell shares to Lincoln Park if it would result in Lincoln Park beneficially owning more than 9.99% of our then outstanding shares of common stock.

Accordingly, we may not be able to utilize the Purchase Agreement to raise additional capital when, or in the amounts, we desire.

In addition, if our public float is below $75 million when we file our next annual report on Form 10-K, which will be due in March of 2022, we could become subject to the baby shelf rule and our ability to conduct primary offerings under a Form S-3 registration statement could become limited by the restriction that, during any 12-month period, we may not sell securities pursuant to General Instruction I.B.6 to Form S-3 having an aggregate market value of more than one-third of our public float, calculated in accordance with the instructions to Form S-3.

To the extent we do sell shares of our common stock, 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.

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.

Since 2020, we have used ATM offerings to fund a significant portion of our operations, and we may continue to use ATM offerings to fund our operations 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;

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.

The exercise of our outstanding options and warrants may result in significant dilution to our stockholders.

As of December 31, 2021, we had outstanding options to purchase up to 4.7 million shares of our common stock and, and as of March 30, 2022, we had outstanding warrants to purchase up to approximately 1.4 million shares of our common stock.

The exercise of a significant portion of our outstanding options and/or warrants may result in significant dilution to our stockholders.

The warrants issued in February 2018 contain price protection in the form of anti-dilution provisions that could harm trading in our shares and make it difficult for us to obtain additional financing.

The warrants we issued and sold in the underwritten public offering that closed in February 2018 (the “February 2018 Warrants”) include price-based anti-dilution provisions.

As of March 29, 2021, February 2018 Warrants to purchase up to approximately 1.9 million shares of our common stock were outstanding and the exercise price of those warrants was $0.96 per share.

Under the terms of the February 2018 warrants, subject to certain limited exceptions, their exercise price will be reduced each time we issue or sell (or are deemed to issue or sell) any securities, including under the Purchase Agreement, for a consideration per share less than a price equal to the exercise price of the February 2018 Warrants in effect immediately prior to such issuance or sale (or deemed issuance or sale).

If we issue shares of our common stock for cash, the consideration received therefor will be deemed to be the net amount of consideration we received therefor.

In addition, if we issue, sell or enter into any agreement to issue or sell securities at a price which varies or may vary with the market price of the shares of our common stock, the holders of the February 2018 Warrants will have the right to substitute such variable price for the exercise price of the February 2018 Warrants then in effect.

The overhang represented by the February 2018 warrants, coupled with the anti-dilution provisions of such warrants, may make it more difficult for us to raise additional capital, because of the possible substantial dilution to any new purchaser of our securities and the ability of holders of the warrants to enter into short sales of our stock.

Any potential new purchaser of our securities may choose to value our common stock in such a manner that takes into

account the number of shares of our common stock that would be outstanding immediately following the exercise of all the outstanding February 2018 Warrants.

The exercise of a significant portion of our outstanding options and warrants may result in significant dilution to our stockholders.

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

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

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