Risk Factors Update Summary

• Added dependence on third-party collaborators for the development and commercialization of palazestrant.
• Lead product candidate, palazestrant (OP-1250), now includes conducting a Phase 3 clinical trial. This change signifies a significant advancement in the development process.
• Transition to public company requires additional managerial responsibilities and controls.
• Potential market acceptance challenges for palazestrant (OP-3136) due to factors like efficacy, pricing, and competition. This change highlights key factors that may impact commercial success.
• Addition of "the European Commission" to regulatory authorities may impact approval processes and prospects.
• Risks related to intellectual property, patent protection, and potential infringement could impact commercial success.
• Introduction of "accelerated approval pathways" may affect the speed and cost of product development.
• Anticipated significant costs associated with the development of palazestrant (OP-3136) and any future product candidates. This change highlights the financial implications of product development.
• Cybersecurity threats pose risks of data breaches, regulatory investigations, and financial harm.
• Initiated Phase 1/2 clinical studies of palazestrant (OP-1250) in combination with other inhibitors. This change signifies progress in exploring combination therapies.
• Failure to educate physicians on benefits of prescribing palazestrant could delay launch.
• Entered into a sales agreement allowing the sale of common stock up to $150.0 million.
• Inclusion of "additional" side effects associated with palazestrant increases potential risks and uncertainties.
• The need for "additional" international clinical trials may impact approval timelines and market entry.
• Reliance on third-party service providers for critical business systems poses security and operational risks.
• Increased the number of outstanding shares from 40 million to 54 million.
• Increase in employees from 74 to 86, including those in research and development.
• Inclusion of "lowering drug costs" initiatives may impact revenue and profitability of future products.
• Mention of "variation" in regulatory approvals introduces uncertainty and potential delays in marketing.
• Changes in data privacy laws, such as the EU GDPR, may lead to increased compliance costs and regulatory challenges.
• Accumulated deficit increased to $305 million as of December 31, 2023, from $209 million in 2022. This change indicates a significant increase in accumulated deficit.
• Entered into a loan agreement providing up to $50.0 million, with $25.0 million available as of December 31, 2023. This change indicates a new financial arrangement to support operations.
• Added provisions in the certificate of incorporation affecting stockholder rights and governance.
• Net losses of $96.7 million for the year ended December 31, 2023, compared to $104.8 million in 2022. This change shows a decrease in net losses year over year.
• Multiple clinical trials for palazestrant and OP-3136 concurrently could impact development goals.
• Expanded potential risks related to collaborations, including delays in clinical trials and competition.
• Disclosed potential impacts from geopolitical and macroeconomic events on the company's operations.
• Mentioned the potential limitations on returns to stockholders due to restrictions on dividends.