Summary of Cidara Therapeutics FY Conference Call Company Overview - Cidara Therapeutics is an 11-year-old biotechnology company focused on developing a universal influenza preventative, CD388, based on its Cloudbreak platform [4][5][6] Core Points and Arguments - **Clinical Development**: CD388 has progressed through preclinical testing and multiple clinical phases, with a successful phase 2b study demonstrating a 76.1% efficacy rate against influenza [7][10] - **FDA Interaction**: The FDA has recommended expanding the phase 3 trial to include high-risk populations, specifically those over 65 years old, in addition to immunocompromised individuals [10][12] - **Phase 3 Study Design**: The ongoing phase 3 study involves 6,000 participants testing the 450 mg dose of CD388 versus placebo, with an interim analysis expected by March 2026 [12][13] - **Efficacy Expectations**: The study is designed to be 90% powered to detect a 60% efficacy rate, with the potential for stronger results if the flu season is severe [12][13] - **Real-World Testing**: The phase 3 study allows for vaccination among participants to assess CD388's effectiveness in both vaccinated and unvaccinated individuals [19][20] Market Opportunity - **Target Population**: Cidara estimates over 100 million patients could be eligible for CD388, including 50 million with moderate to severe comorbidities and another 100 million at increased risk according to CDC guidelines [25][26] - **Pricing and Access**: Ongoing market research is being conducted to understand pricing and access opportunities, with updates expected at the upcoming analyst day [26][27] Manufacturing and Supply Chain - **Manufacturing Plans**: Cidara is preparing to have millions of doses ready at launch, with a focus on establishing a domestic supply chain through a contract with BARDA for onshore manufacturing [29][33] Additional Insights - **Safety and Efficacy**: CD388 is characterized as a long-acting antiviral, distinct from vaccines, and is expected to maintain efficacy throughout the flu season [7][20] - **Regulatory Support**: The FDA has indicated that the phase 2b study could support the registration package, enhancing the potential for a broad label upon approval [23] This summary encapsulates the key points discussed during the Cidara Therapeutics FY Conference Call, highlighting the company's strategic direction, clinical advancements, market potential, and operational plans.