Calidi Biotherapeutics targets CLD-401 IND submission by end-2026, plans first-in-human trial in early 2027

Calidi Biotherapeutics, Inc.

Calidi Biotherapeutics, Inc.

CLDI

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  • Calidi set an end-2026 target to submit a US IND for CLD-401, based on FDA pre-IND alignment on its development plan.
  • IND-enabling studies will continue, supporting a planned Phase 1 first-in-human trial start in early 2027.
  • Regulatory filing in Australia is being explored in parallel to broaden the program’s path to the clinic.
  • Early Phase 1 data is expected to help validate the RedTail platform, alongside efforts to expand the platform and pursue partnerships.


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