Cidara Therapeutics, Inc. (CDTX) Q3 2025 Earnings Call Transcript

CD388 Phase III Development: CD388 has advanced into Phase III development on an accelerated timeline, with the ANCHOR trial starting six months earlier than planned. The trial evaluates safety and efficacy in high-risk populations for influenza.

Expanded Patient Population: Enrollment expanded to include healthy adults over 65, doubling the eligible patient population in the U.S. from 50 million to over 100 million.

Breakthrough Therapy Designation: CD388 received breakthrough therapy designation from the FDA, offering benefits like enhanced FDA access, rolling data review, and priority review eligibility.

BARDA Funding: Awarded up to $339 million from BARDA to support manufacturing and clinical development, with $58 million allocated for the first 24 months.

Market Expansion for CD388: The expanded patient population and potential approval for broader use positions CD388 as a significant player in the influenza prevention market, targeting over 100 million people in the U.S.

Clinical Trial Progress: The ANCHOR trial is over 50% enrolled, with 6,000 participants targeted across 150 sites, and is on track to complete Northern Hemisphere enrollment by December.

Manufacturing Onshoring: BARDA funding supports onshoring manufacturing to the U.S., enhancing the commercial supply chain.

R&D Day Announcement: Cidara plans to host a virtual R&D Day on December 15 to provide updates on CD388 and share market research insights.

Regulatory Feedback and Trial Expansion: The expansion of the patient population for the Phase III trial based on FDA feedback, while beneficial for enrollment, introduces complexities in trial management and increases the scope of regulatory compliance.

Financial Obligations: The initiation of the Phase III ANCHOR trial triggered a $45 million milestone payment to J&J, which adds financial pressure as it will be paid in Q4.

Trial Enrollment and Execution: The need to enroll 6,000 participants across 150 sites and potentially expand to the Southern Hemisphere if enrollment targets are not met in the Northern Hemisphere adds operational challenges and risks of delays.

Manufacturing and Supply Chain: The onshoring of manufacturing to the United States and the need to expand the initial commercial supply chain introduces risks related to production scalability, cost management, and potential delays.

Dependence on External Funding: While the BARDA award provides significant financial support, the reliance on multiyear agreements with option periods introduces uncertainty if future funding is not secured.

Market Competition: CD388 faces competition from existing vaccines and antivirals, and its success depends on demonstrating clear advantages in efficacy, safety, and cost-effectiveness.

Phase III Development of CD388: The lead candidate, CD388, has advanced into Phase III development on an accelerated timeline. The Phase III ANCHOR trial began six months earlier than planned and aims to evaluate the safety and efficacy of CD388 in high-risk populations for influenza complications. Enrollment has been expanded to include healthy adults over 65, doubling the potential eligible patient population in the U.S. from 50 million to over 100 million. The study is over 50% enrolled and is on track to achieve target enrollment in the Northern Hemisphere by December 2025. An interim analysis in late Q1 2026 will determine if additional enrollment in the Southern Hemisphere is necessary.

Regulatory and Designation Updates for CD388: CD388 received breakthrough therapy designation from the FDA in October 2025, which provides enhanced access to the FDA, rolling data review, and eligibility for priority review. This designation is expected to accelerate development and regulatory timelines. CD388 also holds fast track status.

BARDA Funding for CD388: Cidara received an award valued up to $339 million from BARDA to support expanded manufacturing and clinical development of CD388. The base period of $58 million over 24 months will fund onshoring of manufacturing to the U.S., expanded commercial supply chain, and additional clinical and nonclinical studies. Option periods could provide up to an additional $281 million for further studies in targeted and broader populations.

Financial Position and Funding: Cidara has approximately $476 million in cash as of September 30, 2025, ensuring that the Phase III development program for CD388 is fully funded through completion, including potential expansion to the Southern Hemisphere.

Future Updates and R&D Day: Cidara plans to host a virtual R&D Day on December 15, 2025, to provide updates on the CD388 program, including enrollment progress and commercial opportunities.

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