Risk Factors Update Summary

• FDA approval of XACIATO does not predict outcomes for product candidates, particularly Ovaprene and Sildenafil Cream.
• The company entered agreements with pharmaceutical manufacturers for price negotiations starting in October 2023.
• Failure to efficiently advance Sildenafil Cream through development could impact business operations.
• Substantial potential dilution risk with the issuance of up to 7.0 million additional shares.
• Loss or impairment of in-license agreements could adversely affect the company's competitive position.
• Weighted average remaining contractual exercise period for outstanding options is approximately 7.5 years.
• Failure of the exploratory Phase 2b RESPOND study could significantly impact business results.
• Uncertainty surrounds the impact of the IRA program on the pharmaceutical industry in the U.S.
• Potential delays in clinical studies of Sildenafil Cream may lengthen timelines and increase costs.
• Commercial success of Sildenafil Cream depends on its effectiveness and market perception.
• Uncertainty exists regarding the continuation of march-in rights under the Bayh-Dole Act.
• Delay in the manufacture of clinical supplies may extend pivotal clinical study timelines.
• Potential issuance of approximately 9.5 million registered shares could lead to substantial dilution.
• The company may face challenges in obtaining insurance coverage for Sildenafil Cream, 3.6%.
• The company relies on third-party suppliers for product manufacturing, which may lead to immediate shortages.
• The company may face delisting from the Nasdaq Capital Market due to non-compliance with the Minimum Bid Price Requirement.
• The company has outstanding options to purchase up to approximately 15 million shares of common stock.