On January 28, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, reported 2025 successes and provided an update on the Company’s upcoming 2026 milestones.

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"I am incredibly proud of the Calidi team for their successful execution of our 2025 priorities," said Eric Poma, PhD, Chief Executive Officer of Calidi. "We demonstrated that in clinically relevant immunocompetent murine models and ex vivo human immune assays, our RedTail platform has been engineered to prevent immune clearance after systemic administration and to only replicate in tumor cells with high specificity. Our data also demonstrate that the platform can effectively express genetic medicines at the tumor site at levels comparable to those achieved with localized dosing while avoiding systemic exposure. This reflects a scalable therapeutic approach that overcomes the limitations of tumor accessibility. I anticipate that we will complete our IND-enabling studies for CLD-401, the lead candidate from the RedTail platform, and submit an IND application by the end of this year."

2025 Accomplishments

First data presented on Calidi’s RedTail platform and selection of first lead candidate, CLD-401. CLD-401 is a tumor-tropic oncolytic virus designed to avoid immune clearance, home to metastatic sites after systemic administration, replicate only in tumors cells, induce an immune priming event at the tumor site, and express high levels of IL-15 superagonist, a potent cytokine that induces NK and T-cell responses to the tumor, in the tumor microenvironment (TME).
Presented new preclinical data surrounding CLD-401 at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) on May 30, 2025, in Chicago, IL., demonstrating enhanced biological efficacy in clinically relevant immunocompetent tumor models through the delivery of IL-15 superagonist to metastatic tumors sites after systemic administration. Calidi also demonstrated the engineered expression of CD55 on the enveloped virus, allowing the virus to avoid immune clearance and enabling systemic administration. The systemic administration of the CD55-expressing enveloped virus allows Calidi to target metastatic disease patients with high unmet need.
CLD-401 data presented at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) on November 7, 2025, in National Harbor, MD., demonstrating that in syngeneic murine models, the RedTail platform is protected from immune clearance after systemic administration and can find and specifically replicate in tumor cells at metastatic sites. The data also demonstrate that the platform can effectively express genetic medicines at the tumor site in concentrations that are similar to what is achievable with localized dosing while avoiding systemic exposure.
Bolstered management team with hiring of new Chief Executive Officer and Chief Medical Officer with deep biopharmaceutical experience
CEO transition to Eric Poma, PhD, bringing more than 25 years of experience in the biopharmaceutical industry, with a strong record of capital fundraising, big pharma collaboration agreements, and clinical program development.
Appointed Guy Travis Clifton, MD, as CMO. Dr. Clifton is a practicing surgical oncologist with over 17 years experience in drug development, early phase and transitional translational trials, and cancer immunotherapy.
Reconstituted Scientific Advisory Board with internationally esteemed advisors to support development of CLD-401 and advance the RedTail platform for the systemic delivery of targeted genetic medicine.
New members added in October 2025:

Mace L. Rothenberg, MD, FACP, former Chief Medical Officer of Pfizer, a physician executive with more than 30 years of experience in drug development, translational research, and risk benefit assessment; and
John Wrangle, MD, MPH, a thoracic oncologist and scientist and expert in translational immunotherapy with extensive experience around IL-15-based treatment in metastatic cancer.
Reduced debt and G&A expenses
Calidi reduced term debt and notes payable (including accrued interest) by $3.1 million in 2025, from $3.8 million at December 31, 2024 to $0.7 million at December 31, 2025 (unaudited).
Calidi reduced G&A expenses by $2.3 million in the first nine months of 2025 compared to the first nine months of 2024, as disclosed in the Company’s Form 10-Q filed with the SEC on November 13, 2025.
2026 Anticipated Milestones

Company intends to file an IND in Q4 2026 for its first RedTail lead candidate, CLD-401, a systemic delivered, targeted genetic medicine engineered to convert tumors into IL-15 superagonist producers.
Phase I study expected to be conducted in a basket of solid tumors, including non-small cell lung cancer, triple-negative breast cancer, and head and neck cancer.
Anticipate streamlined dose escalation study with limited number of doses to be tested.
Initial dose cohort is expected to be in the therapeutic range with the potential for proof-of-concept data early in phase I
Calidi expects to present proof of concept data demonstrating the versatility of RedTail platform to deliver tumor-localized Bi-specific T cell engager (BiTE) alongside T-cell amplifiers.
BiTEs have struggled to drive efficacy in solid tumors because of a lack of activated T-cells in the TME
The RedTail platform allows for the simultaneous delivery of high expression of multiple payloads into TME
BiTE delivery with T-cell amplifiers may overcome the previous limitations of BiTEs in solid tumors
Calidi expects to present proof of concept data for use of RedTail platform into non-oncology indications.
Calidi is exploring new payloads for inflammatory and immune disease
The Company anticipates targeting other cell types via envelope engineering (e.g. CD38, BCMA, etc.)
Calidi expects to leverage selective viral replication in proliferative cells (e.g. activated B cells)

(Press release, Calidi Biotherapeutics, JAN 28, 2026, View Source [SID1234662320])