USFDAJul 21, 2026, 08:02 AM
Calidi Biotherapeutics Receives Positive FDA Feedback for CLD-401
AI Summary
Calidi Biotherapeutics received positive pre-IND feedback from the US FDA for its lead candidate CLD-401, agreeing on its development strategy and targeting first patient dosing in Q1 2027. The company also highlighted advancements in its RedTail platform, including new data for CLD-501 and EpCam-targeted In Situ TCEs. Additionally, Calidi strengthened its Board of Directors with the appointment of Corsee Sanders, Ph.D., and reduced general and administrative expenses by $1 million from Q1 2025 to Q1 2026.
Key Highlights
- Received positive pre-IND feedback from US FDA for CLD-401.
- Targeting first patient dosing for CLD-401 Phase I trial in Q1 2027.
- Anticipating first patient data for CLD-401 trial in Q2 2027.
- Demonstrated $1 million reduction in G&A expenses from Q1 2025 to Q1 2026.
- Strengthened Board of Directors with addition of Corsee Sanders, Ph.D.
- New data on RedTail platform and in situ TCEs to be presented at AACR D3, ESMO, and SITC conferences.
Price Impact
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