Cidara Therapeutics (CDTX) Guggenheim SMID Cap Biotech Conference summary

Company transformation and product focus

• Transitioned to focus solely on CD388, a drug-Fc conjugate for universal influenza prevention.

• CD388 combines zanamivir with an Fc fragment to improve drug properties and extend half-life.

• Early partnership with J&J ended after J&J exited infectious diseases, prompting new financing and independent development.

• Raised $240 million PIPE financing to advance CD388 into a large phase IIb study.

Clinical development and study design

• Phase IIb NAVIGATE study enrolled 5,000 healthy unvaccinated individuals, testing three single-dose regimens.

• Study aims to select optimal dose for phase III, with all doses providing exposure above efficacy targets.

• Severe flu season increased breakthrough infection rates, allowing for earlier efficacy readout in Q2 2024.

• FDA and BARDA are expected to be supportive due to high unmet need and recent failures of other flu drugs.

Scientific rationale and competitive landscape

• CD388 targets neuraminidase, a less mutable viral protein, offering potential efficacy regardless of immune status.

• Zanamivir is highly potent but previously limited by poor drug properties, now improved via conjugation.

• Preclinical and clinical data show strong safety, no cell penetration, and no major drug interactions.

• Expected to be additive to vaccines, not a replacement, and effective in both healthy and immunocompromised populations.