Poster also details clinical readiness for CLDI-201 and plans to initiate Phase 1 study in 2024

Calidi Biotherapeutics, Inc. (NYSE American: CLDI or “Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced the presentation of new preclinical data from the company’s CLD-201 (SuperNova) allogeneic stem cell-based platform and announces readiness for clinical trial launch in 2024 at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting. The meeting is taking place in San Diego from November 1-5, 2023.

CLD-201 builds on decades of stem cell and oncolytic virus research and is a novel allogeneic solution with potential advantages over an autologous approach including enhanced potency, improved manufacturing reproducibility, lower cost, and the ability to treat multiple cancer types. CLD-201 consists of allogeneic mesenchymal stem cells loaded with the oncolytic vaccinia virus CAL1, which has the potential to target a variety of solid tumors.

The poster presentation details the evaluation of CLD-201 in in vitro and animal models in the presence of complement and neutralizing antibodies, and the assessment of immune cell infiltration in treated and untreated tumors. Tumor growth inhibition and induction of anti-tumor immunity were compared in mice treated with unprotected CAL1 virus and CLD-201. Additionally, the poster presents the readiness of the product and plans to launch clinical trial in 2024.

“This new CLD-201 data further supports the potential of our stem-cell based platform to effectively target a variety of solid tumors while exhibiting promising anti-tumor effects in multiple animal models,” said Antonio F. Santidrian, PharmD, Ph.D., Chief Scientific Officer of Calidi Biotherapeutics. “We believe that CLD-201 is a very promising immunotherapy platform, based on its observed inhibition of tumor growth in multiple tumor types and its powerful anti-tumor immune effects, as well as its superiority to existing autologous therapies as an allogeneic alternative. We look forward to initiating a Phase 1 clinical trial in 2024 and generating additional data on the potential of CLD-201 to treat advanced solid tumors.”

Key highlights from the poster presentation are below:

  • Multiple allogeneic adipose tissue-derived mesenchymal stem cell banks were generated, and one was selected for GMP manufacturing and loaded with the oncolytic vaccinia virus CAL1, creating CLD-201.
  • CLD-201 demonstrated greater resistance to inactivation by the humoral immune system compared to the unprotected CAL1 virus.
  • CLD-201 significantly inhibited the growth of the tumors even at the very low dose of 1.5x103 cells containing 1.6x104 viral plaque forming units (PFU).
  • CLD-201 has been successfully GMP manufactured, and its safety profile has been analyzed in both immunocompetent and immunocompromised pre-clinical models.

Full details for the poster presentation are below:

Title: A Novel Stem Cell-based Platform for Delivery and Potentiation of Oncolytic Virotherapies Presenting Authors: Antonio F. Santidrian, PharmD, Ph.D., Chief Scientific Officer, Calidi Biotherapeutics Boris R. Minev, MD. President, Medical & Scientific Affairs, Calidi Biotherapeutics Abstract Number: 1419 Date: Friday, November 3, 2023 Time: 9:00 AM – 7:00 PM PDT

Following the meeting, a copy of the poster will be available on the Scientific Publications page of Calidi’s website at: https://www.calidibio.com/science.

About Calidi Biotherapeutics:

Calidi Biotherapeutics (NYSE: 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 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. 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. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Calidi will be those that it has anticipated. Any forward-looking statements involve a number of risks, uncertainties (some of which are beyond Calidi’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Form S-1 registration statement filed with the SEC and dated October 6, 2023

For Investors: Stephen Jasper Gilmartin Group stephen@gilmartinir.com

For Media: Gwen Gordon gwen@gwengordonPR.com

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