CLDI Calidi Biotherapeutics Inc

Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that its abstract, titled "Development of a Systemic Enveloped Virotherapy for Targeting All Metastatic Sites", has been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting April 25-30, 2025 in Chicago, IL.

This significant milestone reflects Calidi’s ongoing commitment to advancing systemic enveloped virotherapy as a transformative approach to target and kill metastatic cancers, which are the leading cause of cancer-related mortality. The data presented will focus on the development of Calidi's proprietary RTNova systemic platform, showcasing its potential to overcome current barriers in metastatic cancer treatment by enabling targeted systemic delivery to multiple tumor sites without rapid elimination by the body’s immune system.

This systemic platform addresses the challenges of treating advanced-stage metastatic cancers, including lung cancer, when intratumoral administration is not feasible. Calidi designed a novel vaccinia virus strain that is enveloped with a human cell membrane (extracellular enveloped virus or EEV) that offers protection while targeting distant tumors and upon reaching the tumor, induces a robust response from the patient’s immune cells which produces a more durable therapeutic effect.

“Our acceptance to present at AACR underscores the transformative potential of our systemic virotherapy platform,” said Allan Camaisa, CEO and Chairman of Calidi Biotherapeutics. “We are proud to share our pioneering research on the RTNova systemic virotherapy platform, which has the potential to redefine how metastatic cancers are treated and significantly improve outcomes for patients facing advanced-stage disease.”

In addition to the AACR presentation, Calidi plans to submit an abstract to unveil further key data at the ASCO Annual Meeting in June 2025, highlighting its progress toward selecting a lead clinical candidate for RTNova. This work complements Calidi’s ongoing clinical and preclinical efforts in localized and intratumoral cell-based virotherapies with SNV (SuperNova) and NNV (NeuroNova), collectively demonstrating Calidi's approach to revolutionizing cancer treatment.

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies, are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. 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 (i) Form 10-K filed on March 15, 2024, (ii) Form 10-Q filed on May 14, 2024, (iii) Form 10-Q filed on August 13, 2024, and (iv) Form 10-Q filed on November 12, 2024. These reports may be amended or supplemented by other reports we file with the SEC from time to time.

Corporate Communications:

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

Source: Calidi Biotherapeutics, Inc.