CLDI News & Events

Calidi Biotherapeutics presented on its proprietary manufacturing process for CLD-401 at the BioProcessing Summit in Barcelona. RedTail is Calidi's systemically delivered virotherapy platform designed to selectively target tumor cells, remodel the tumor microenvironment, 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, a known T-cell and Natural Killer cell activator, in the TME. "The process discussed today highlights key scalability properties of the manufacturing system we have developed for the RedTail platform and CLD-401" said Antonio 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."

Calidi Biotherapeutics announced the pricing of its underwritten public offering of 10,519,631 units, with each unit consisting of one share of common stock, one 6 month warrant to purchase one share of common stock, one 12 month warrant to purchase one share of common stock and one five year warrant to purchase one share of common stock. Ladenburg Thalmann & Co. Inc. is acting as sole book-running manager for the offering. Each unit is being sold to the public at a price of $0.50 per unit and each pre-funded unit is being sold to the public at the public offering price of each unit less the $0.001 per share nominal exercise price for each pre-funded warrant. The gross proceeds to the Company from this offering are expected to be approximately $5.2M, before deducting underwriting discounts and commissions and other estimated offering expenses. The Company has granted the underwriter a 45-day option to purchase up to an additional 1,575,000 shares of common stock and/or warrants to purchase up to 1,575,000 shares of common stock for each series of warrants described above, or any combination thereof, solely to cover over-allotments, if any, at the public offering price, less underwriting discounts and commissions.This offering is expected to close on or about March 9, 2026, subject to the satisfaction of customary closing conditions.

Calidi Biotherapeutics announced that it intends to offer and sell, subject to market and other conditions, units consisting of shares of its common stock and, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock, in an underwritten public offering. Ladenburg Thalmann & Co. is acting as sole book-running manager for the offering.

Calidi Biotherapeutics presented data on its novel approach to the use of BiTEs in solid tumors by utilizing its systemically delivered RedTail platform at the AACR Immuno-Oncology, AACR-IO, conference being held in Los Angeles, California. RedTail is Calidi's systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment, and enable high-level expression of therapeutic genetic payloads directly within the tumor. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 superagonist, a known T-cell activator, in the TME. In data presented at the meeting, Calidi demonstrated RedTail viruses that could express both a functional BiTE, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous alteration of the TME and T-cell activation and introduction into the TME of a solid-tumor targeting BiTE. BiTEs have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits T-cell activity. By remodeling the TME and driving T-cell activation while expressing a tumor-localized BiTE, RedTail may overcome the historical limitations of BiTEs in solid tumors.