On March 12, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported on its proprietary manufacturing process for CLD-401, the Company’s first lead candidate from its RedTail platform, at the BioProcessing Summit in Barcelona.

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RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumor cells, remodel the tumor microenvironment (TME), and enable high-level expression of therapeutic genetics at the tumor. CLD-401 is designed to reach metastatic sites, replicate only in tumor cells, and express high levels of IL-15 superagonist (IL-15 SA), a known T-cell and Natural Killer cell activator, in the TME.

At the meeting, Calidi outlined key aspects of its manufacturing system designed to support scalable and high-yield manufacturing of CLD-401. This process, developed in-house, maintains the integrity of the CD55 over-expressing envelope unique to the Company’s RedTail virus that allows for systemic delivery by preventing immune recognition.

Calidi has interacted with the FDA around the Company’s manufacturing and analytical approaches through its Type D meeting request process. The feedback it has received from the agency supports the use of this process for the clinical development of CLD-401.

"The process discussed today highlights key scalability properties of the manufacturing system we have developed for the RedTail platform and CLD-401" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "Based on our interactions with the FDA, we believe this process can be used to support CLD-401 through clinical development with the ultimate goal of commercialization."

"The RedTail platform represents an exciting new approach for the systemic and targeted delivery of genetic payloads to distal sites of disease," said Eric Poma, PhD, Chief Executive Officer of Calidi. "Early engagement with the FDA on our manufacturing strategy has been an important step in building a scalable and robust manufacturing program, and the feedback we have received supports our approach as we advance CLD‑401 through clinical development"

Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The Company anticipates submitting an Investigational New Drug (IND) application for CLD-401 by the end of 2026. The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, MAR 12, 2026, https://www.calidibio.com/calidi-biotherapeutics-presents-its-innovative-and-scalable-manufacturing-process-for-cld-401-at-the-9th-annual-bioprocessing-summit-fda-feedback-support-companys-approach-to-manufacturing/ [SID1234663489])