Summary of Cidara Therapeutics (CDTX) Conference Call Company Overview - Cidara Therapeutics is focused on developing CD388, a long-acting antiviral drug targeting influenza, utilizing its Cloudbreak platform technology [2][3] - CD388 is currently in a 5,000 subject Phase 2B study [3] Core Technology and Product - CD388 is a drug Fc conjugate (DFC), combining a potent small molecule inhibitor (zanamivir) with an Fc fragment of a human antibody, designed for extended half-life and high exposure [3][4] - The drug targets neuraminidase, an enzyme essential for influenza viral exit from cells, aiming to provide universal protection against all flu strains [5][6] - Unlike traditional vaccines, CD388 does not require annual manufacturing adjustments based on circulating strains, making it a potentially more stable option [6] Clinical Development and Efficacy - CD388 has shown a 57% placebo-adjusted efficacy in Phase 2A human challenge studies, indicating its effectiveness in preventing influenza proliferation [17][21] - The drug is designed to be administered once at the beginning of the flu season, providing long-term protection [5][15] - The Phase 2B study is expected to yield results that could be compared favorably against traditional vaccines, which have an average efficacy of about 40% [22] Regulatory and Market Considerations - The company is in alignment with the FDA regarding the statistical analysis plan for the Phase 2B study, which is crucial for evaluating the results [27][40] - Cidara is targeting high-risk and immunocompromised populations for Phase 3 trials, where traditional vaccines have low efficacy (0-20%) [40] Market Opportunity - The total addressable market (TAM) for CD388 is estimated to include approximately 50 million patients in the U.S. alone, with potential pricing similar to Bifortis at around 175 million in cash, which is expected to last until the end of 2027, absent the initiation of a Phase 3 study [46] - The company is exploring various financing options, including capital markets and structured financing, to support Phase 3 preparations [46] - Drug supply for Phase 3 is ready, with plans to assume the highest dose for the study [47] Additional Insights - The Phase 2B study is designed to assess the drug's ability to prevent severe influenza symptoms, which is a critical outcome for its success [18][19] - The company is preparing for potential challenges in the upcoming flu season, which could impact trial outcomes and timelines [24][38]
Cidara Therapeutics (CDTX) 2025 Conference Transcript