Cidara Therapeutics (CDTX) investor relations material

Program overview and clinical progress

• CD388, a universal influenza preventative, was developed from the Cloudbreak platform and showed strong preclinical efficacy and safety, leading to a partnership with J&J in 2021.

• After J&J exited infectious diseases, the asset was reacquired with $240 million in funding, enabling a 5,000-participant phase II-B study in fall 2024.

• The NAVIGATE phase II-B study demonstrated 76.1% efficacy and a P value <0.0001, with results exceeding expectations.

• CD388 is a long-acting antiviral, not a vaccine, and is effective across all influenza strains and populations.

• Financing was secured to support the entire phase III program.

Phase III trial design and regulatory feedback

• The FDA recommended expanding the phase III trial to include high-risk, immunocompromised, and over-65 populations.

• The phase III study involves 6,000 participants, testing a 450 mg dose versus placebo, with enrollment expected to complete soon.

• The study is 90% powered to detect 60% efficacy, with an interim analysis planned for March next year.

• Depending on the flu season's severity, the interim analysis may lead to additional enrollment in the Southern Hemisphere.

• The phase II-B study will support the registration package and label, with the FDA indicating a broad label is possible.

Study populations and endpoints

• Phase II-B focused on healthy, unvaccinated adults 18-65, while phase III targets high-risk, immunocompromised, and elderly populations.

• Nonclinical and clinical evidence suggests similar efficacy in both immune-competent and immune-compromised groups.

• Vaccination is allowed but not mandated in phase III; about 65% of participants are expected to be vaccinated.

• CD388 targets neuraminidase, offering additive protection with vaccines, potentially achieving up to 90% protection.

• The study is not powered for subpopulation efficacy but will include diverse high-risk groups.