SAN DIEGO, June 02, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering the development of systemic oncolytic targeted immunotherapies with the ability to deliver genetic payloads, today announced the presentation of its lead RedTail platform candidate, CLD-401, at the American Society of Clinical Oncology (ASCO) Annual Meeting.

Calidi has previously demonstrated its pioneering efforts in developing an enveloped form of its proprietary oncolytic virus that is significantly more resistant to immune clearance than non-enveloped forms, allowing for systemic delivery and efficacy in syngeneic tumor-bearing pre-clinical models. Calidi has further advanced this technology with CLD-401, its first therapeutic candidate from the RedTail platform. New data presented at the meeting demonstrate a novel genetic modification in which a chimeric CD55 receptor is incorporated into the envelope shielding the virus. Because CD55 receptor expression acts as a robust inhibitor of complement, this modification further enhances the virus’s resistance to rapid clearance by the humoral immune system following intravenous administration.

In addition, the RedTail viral platform also allows for the delivery of potent genetic payloads directly into the tumor microenvironment. CLD-401 expresses an IL-15 superagonist, a next-generation cytokine known to activate and expand natural killer (NK) cells and CD8+ T cells—key components of the immune system with demonstrated clinical efficacy.

“The integration of CD55 into our RedTail platform marks a major advancement in systemic virotherapy,” said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. “By improving the shielding of the virus from complement-mediated destruction, we enhance its stability in circulation and enable the in situ expression of immune-activating payloads—such as the IL-15 superagonist—directly within the tumor microenvironment, where they can stimulate a robust antitumor immune response.”

“RedTail is the result of over a decade of focused innovation at Calidi,” added Eric Poma, PhD, Chief Executive Officer. “Our systemic approach overcomes the limitations of traditional intratumoral oncolytic viruses and enables the treatment of metastatic cancers through intravenous administration. The use of a chimeric CD55 enhancement is a critical enabler of this vision.”

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

A copy of the ASCO poster featuring the CD55 data is available [here].

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company pioneering the development a new generation of targeted immunotherapies. 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 gene therapies to metastatic locations.

The lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical need. Additionally, Calidi is developing protected virotherapies, in clinical-stage, for intratumoral and localized administration, focusing on a subset of injectable cancer indications.

Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.

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 upcoming key milestones (including the reporting of interim clinical results and the dosing of patients), 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 Registration Statements filed with the SEC on (i) Form S-4 filed on August 2, 2023 and the corresponding prospectus filed on August 4, 2023, and (ii) on Form S-1 filed on April 15, 2024, and the Company’s periodic reports filed with the SEC on Form 10-K filed on March 31, 2025 and on Form 10-Q filed on May 14, 2025. These reports may be amended or supplemented by other reports we file with the SEC from time to time.

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