Calidi Biotherapeutics Receives Positive Pre-IND Feedback from US FDA for CLD-401 Indicating Agreement on its Current Development Strategy as it Advances Towards a First-in-Human Study

On June 16, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or "the Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We thank the FDA for its regulatory feedback, and we believe we are in agreement with the agency on our overall IND strategy for CLD-401," said Calidi Biotherapeutics Chief Executive Officer Eric Poma, Ph.D. "We look forward to our regulatory submission for CLD-401, a potentially ground-breaking oncolytic virus with in situ delivery of an IL-15 superagonist, which we are targeting by year-end. This positions us to initiate our first-in-human clinical trial in early 2027."

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.

(Press release, Calidi Biotherapeutics, JUN 16, 2026, View Source [SID1234668770])