Calidi Biotherapeutics Announces New Data to be Presented on its Therapeutic Lead, CLD-401, at the 2025 SITC Annual Meeting

Rhea-AI Summary

Calidi Biotherapeutics (NYSE: CLDI) will present new preclinical data for its lead candidate CLD-401 at the SITC Annual Meeting (Nov 7–9, 2025).

CLD-401 is a systemically delivered, tumor-tropic oncolytic virus from the RedTail platform that reportedly homes to metastatic sites, replicates in tumor cells, induces tumor lysis and immune priming, and expresses high levels of IL-15 superagonist in the tumor microenvironment.

Calidi is conducting IND-enabling studies and anticipates submitting an IND by end of 2026 while pursuing strategic partnerships to accelerate development.

Positive

• Durable tumor clearance reported in preclinical syngeneic models
• Systemic tumor tropism: CLD-401 reaches metastatic sites after IV administration
• High IL-15 superagonist expression in the tumor microenvironment

Negative

• Preclinical-only data: no human clinical results reported yet
• IND not yet submitted; planned submission by end of 2026

SAN DIEGO, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, today announced the presentation of new data on its first therapeutic candidate from its RedTail platform, CLD-401, at the Society of Immunotherapy for Cancer (SITC) Annual Meeting.

CLD-401 is a tumor-tropic oncolytic virus designed to 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).

“The RedTail platform represents a major advance in virotherapy and genetic medicines,” said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. “RedTail allows for systemically administered genetic medicines that avoid immune clearance, are tropic for tumor cells, induce tumor lysis and immunologically prime the TME, and can deliver a genetic payload.”

“In our syngeneic models, CLD-401 can reach metastatic sites when administered systemically where it can destroy tumor cells through a novel mechanism that also induces an immune priming effect,” added Eric Poma, PhD, Chief Executive Officer. “CLD-401 builds on these mechanisms by also delivering high levels of IL-15 superagonist to the TME to activate a potent T-cell and NK cell response to the tumor.”

Calidi is currently conducting IND-enabling studies for CLD-401 and anticipates submitting an Investigational New Drug (IND) application by the end of 2026. The company is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

CLD-401 Presentation

Meeting: SITC 40th Anniversary Annual Meeting, November 7–9, 2025, National Harbor, MD
Title: In Situ Tumor Delivery of IL-15 Superagonist via RedTail Gene Therapy Achieves Durable Tumor Clearance
Abstract Number: 1175
Presentation Time: Friday, November 7, 2025, 12:15–1:45 PM and 5:35–7:00 PM

About Calidi 

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The company’s proprietary Redtail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent genetic medicine(s) to metastatic locations.

CLD-401, the lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need.

Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or view Calidi’s Corporate Presentation here.

Forward-Looking Statements

This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning key milestones, including certain pre-clinical data, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s annual report filed with the SEC on Form 10-K on March 31, 2025, as may be amended or supplemented by other reports we file with the SEC from time to time. We disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

For Investors:

Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com

FAQ

What data will Calidi (CLDI) present for CLD-401 at SITC on November 7, 2025?

Preclinical results showing in situ tumor delivery of an IL-15 superagonist via RedTail gene therapy with reported durable tumor clearance in syngeneic models.

How does CLD-401 (CLDI) work to target metastatic tumors?

CLD-401 is a tumor-tropic oncolytic virus designed to home to metastatic sites, replicate in tumor cells, induce lysis and immune priming, and deliver IL-15 superagonist to the TME.

When does Calidi expect to file an IND for CLD-401 (CLDI)?

Calidi anticipates submitting an IND by the end of 2026 as it completes IND-enabling studies.

Will the CLD-401 SITC presentation include human clinical data for CLDI?

No; the announcement describes preclinical syngeneic model data, not human clinical results.

Where and when is Calidi presenting CLD-401 at SITC 2025?

Presentation is at the SITC 40th Annual Meeting, National Harbor, MD on Friday, November 7, 2025 with sessions at 12:15–1:45 PM and 5:35–7:00 PM (Abstract #1175).

What are the near-term development priorities for CLD-401 mentioned by Calidi (CLDI)?

Completing IND-enabling studies, filing an IND by end of 2026, and pursuing strategic partnerships to accelerate clinical development.