Calidi Biotherapeutics Receives Pre-IND Regulatory Feedback From FDA Providing Alignment, Clarity On IND-Enabling Preclinical Plans And Clinical Strategy For CLD-401 Prior To Advancing Drug Candidate Into Phase 1 Clinical Studies

Calidi Biotherapeutics, Inc. (NYSE:CLDI) ("Calidi" or "the Company"), a biotechnology company pioneering the development of targeted genetic medicines, today announces that it has received pre-IND regulatory feedback from the U.S. Food and Drug Administration (FDA) providing alignment and clarity on Calidi's IND-enabling preclinical plans and clinical strategy for CLD-401 prior to advancing the drug candidate into Phase 1 clinical studies.

In the pre-IND meeting, the FDA and Calidi agreed on key aspects of the CMC and non-clinical programs as well as feedback on the overall design for the proposed first-in-human clinical study. This pre-IND (Type B) interaction builds on the engagement and alignment achieved through early scientific advice as part of a Type D interaction with the FDA.

Calidi is committed to rapidly advancing CLD-401 into the clinic, believing that early Phase I data for CLD-401 will validate the Company's proprietary RedTail platform. The Company continues to expand the functionality of the RedTail platform while actively pursuing strategic partnerships to accelerate clinical development and broaden its impact.