Cidara Therapeutics (CDTX) RBC Capital Markets Global Healthcare Conference 2025 summary

Platform and lead asset overview

• CD388 is a Drug-Fc Conjugate combining a potent small molecule inhibitor with an Fc antibody fragment, designed for once-per-season administration to provide universal protection against all flu strains.

• Unlike vaccines, CD388 is a long-acting drug that does not require annual reformulation and targets a universally conserved enzyme on all flu strains.

• The molecule offers improved tissue penetration due to its smaller molecular weight compared to traditional antibodies.

Clinical data and differentiation

• CD388 demonstrated strong safety in clinical studies, with no dose-limiting toxicity up to 900 mg and no concerning adverse events.

• Phase IIA human challenge study showed a 57% placebo-adjusted efficacy, outperforming historical data for Tamiflu and typical flu vaccines.

• The drug’s mechanism inhibits viral proliferation and severe symptoms, with efficacy expected to be higher in phase III, especially in high-risk populations.

Navigate phase IIB study and trial design

• The ongoing Navigate phase IIB study includes 5,000 subjects across four arms, with dose selection as the primary objective.

• The recent severe flu season increased the attack rate, prompting a revised statistical analysis plan aligned with FDA guidance.

• Primary endpoint confirmation includes PCR positivity and fever ≥38°C, focusing on severe infection signs.

• All tested doses are expected to provide protective exposure for the entire flu season, with differentiation likely at the season’s end.