Calidi Biotherapeutics to Present New CLD-401 Data and In Situ TCE Platform Advances at the ESMO Congress 2026

Calidi is pursuing partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

Rhea-AI Summary

Calidi Biotherapeutics (CLDI) will present preclinical data on CLD-401 and its in situ T-cell engager platform at ESMO on October 24, 2026. Calidi says CLD-401 data will show high rates of complete tumor eradication in EMT6 breast cancer-bearing mice. In an MB49 bladder cancer model, CLD-401 retained antitumor activity after intravenous or direct intratumoral administration.

The presentations will also show antigen-dependent, dose-responsive T-cell killing for TROP-2- and EpCAM-targeted T-cell engagers, which redirect T cells toward tumor targets. In the EpCAM-targeted construct, adding a T-cell engager payload did not reduce expression of the accompanying IL-15 superagonist, an immune-cell activator, in the reported laboratory or animal studies.

Positive

• Minor point. Forward-looking: it has not happened yet and may not happen.CLD-401 preclinical data will show high rates of complete tumor eradication in EMT6 breast cancer-bearing mice.
• Minor pointCLD-401 retained antitumor activity following intravenous or intratumoral administration in an MB49 bladder cancer model.
• Minor point. Forward-looking: it has not happened yet and may not happen.TROP-2- and EpCAM-targeted T-cell engagers will show antigen-dependent, dose-responsive T-cell killing in preclinical presentations.
• Minor pointEpCAM-targeted construct maintained IL-15 superagonist expression with an additional T-cell engager payload in reported laboratory and animal studies.
• Minor point. Forward-looking: it has not happened yet and may not happen.Strategic partnerships are being pursued to accelerate clinical development and broaden the RedTail platform’s impact.

Negative

• None.

Key Terms

virotherapy, il-15 superagonist, t-cell engager, intratumoral administration, +1 more

5 terms

virotherapy medical

"a systemically delivered virotherapy platform engineered to selectively target tumors"

Virotherapy is a medical approach that uses live viruses, often modified, to target and destroy diseased cells or deliver therapeutic genes, most commonly in cancer treatment. For investors, virotherapy matters because results from clinical trials, regulatory approvals, manufacturing scale-up and safety profiles determine whether a therapy can become a viable product; think of it as a precision tool whose clinical success and production challenges drive potential market value and risk.

il-15 superagonist medical

"enable high-level expression of IL-15 superagonist (“IL-15 SA”)"

An IL-15 superagonist is a lab-engineered therapy that boosts the activity of IL-15, a natural immune signaling protein, effectively stepping on the accelerator for disease-fighting immune cells like natural killer and T cells. Investors pay attention because these agents can change clinical trial results, safety profiles, and regulatory outcomes; success or failure can significantly affect a biotech’s valuation and the commercial potential of immune-based treatments, like upgrading an engine can alter a car’s market value.

t-cell engager medical

"the lead compound from its in situ T-cell engager (“TCE”) platform"

A T-cell engager is a type of medicine designed to help the body's immune system attack cancer cells more effectively. It works by acting like a bridge that brings immune cells (T-cells) close to cancer cells, prompting a targeted attack. For investors, T-cell engagers are significant because they represent innovative treatments that could lead to new growth opportunities in the healthcare and biotech sectors.

intratumoral administration medical

"either systemic intravenous or localized intratumoral administration"

Injection or delivery of a drug, biologic, cell therapy, or other treatment directly into a tumor mass rather than into the bloodstream or other body compartments. This approach concentrates the therapy at the tumor site, can limit systemic exposure, often requires imaging or direct access to the lesion, and is used when a localized effect, higher local dose, or reduced whole‑body distribution is desired.

cytotoxicity medical

"antigen-dependent, dose-responsive T cell-mediated cytotoxicity"

Cytotoxicity is the ability of a substance to kill or damage living cells. Investors watch cytotoxicity results because they indicate whether a drug or chemical is likely to be effective against targeted cells (for example, cancer cells) and whether it poses safety risks to healthy tissue, which affects clinical success, regulatory approval, and commercial potential—similar to knowing if a powerful weed killer also harms the lawn around the weeds.

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SAN DIEGO, Oct. 19, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or “the Company”), a biotechnology company pioneering the development of targeted genetic medicines, announced that it will be presenting two posters at the European Society for Medical Oncology (ESMO) Congress 2026 taking place in Madrid, Spain from October 23-27, 2026. The presentations will showcase the Company’s RedTail platform, a systemically delivered virotherapy platform engineered to selectively target tumors, remodel the tumor microenvironment, and enable high-level expression of therapeutic genetic payloads directly within tumors.

On October 24, 2026, the Company will present preclinical data on its lead program, CLD-401. CLD-401 is a systemically delivered virotherapy designed to selectively target tumors and enable high-level expression of IL-15 superagonist (“IL-15 SA”), a known T- and NK-cell activator, driving profound immune changes in the tumor microenvironment (“TME”), including the recruitment and activation of NK, NK-T, and gamma delta (γδ) T-cells that lead to a robust therapeutic response in immunocompetent animal models. Data will show high rates of complete tumor eradication in EMT6 breast cancer tumor-bearing mice. CLD-401 was engineered for systemic delivery, and new data from an MB49 bladder cancer model show that it also retains antitumor activity following either systemic intravenous or localized intratumoral administration, supporting flexible delivery approaches across tumor accessibility and disease settings.

Also on October 24, 2026, the Company will present preclinical data on CLD-501, the lead compound from its in situ T-cell engager (“TCE”) platform, including CLD-501, its TROP-2-targeted candidate, and CLD-502, its EpCAM-targeted candidate. Both candidates are systemically delivered RedTail virotherapies designed to selectively target tumors and enable localized co-expression of a tumor-targeted TCE and IL-15 SA. The presentations will show antigen-dependent, dose-responsive T cell-mediated cytotoxicity for TROP-2- and EpCAM-targeted TCEs. Data from the EpCAM-targeted construct also show that incorporation of an additional TCE payload did not reduce expression of the co-encoded IL-15 SA payload in the reported in vitro or in vivo studies. By converting tumors into localized biofactories expressing TCEs and T cell-activating payloads, the In Situ TCE platform is designed to address the toxicity, tumor-exposure, and immunosuppressive TME barriers associated with systemically administered TCEs in solid tumors.

Together, the two ESMO presentations demonstrate the expanding flexibility of the RedTail platform, from CLD-401-mediated tumor immune priming to dual-payload candidates designed for localized T-cell redirection. 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.

About Calidi 

Calidi Biotherapeutics (NYSE American: CLDI) is a biotechnology 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, is being developed for metastatic non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need. Calidi continues to advance its pipeline utilizing the RedTail platform with its novel In Situ T-cell engager approach for solid tumors, including CLD-501, its TROP-2-targeted candidate, and CLD-502, its EpCAM-targeted candidate.

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 27, 2026, 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.

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FAQ

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When will Calidi present its CLD-401 and T-cell engager data at ESMO 2026?

Calidi will present both preclinical posters on October 24, 2026. The ESMO Congress takes place in Madrid, Spain, from October 23–27, 2026.

What stage of development is Calidi’s CLD-401 in?

CLD-401 is in IND-enabling studies, studies supporting an application to begin human testing. It is being developed for metastatic non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need.