• Company to also share progress with cell-based virotherapy platforms for advanced solid tumors

SAN DIEGO / Dec 13, 2023 / Business Wire / Calidi Biotherapeutics, Inc. (NYSE American: CLDI or “Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced three presentations on Calidi’s NeuroNova (NNV) and SuperNova (SNV) allogeneic stem cell-based virotherapy platforms at the upcoming 8th Oncolytic Virotherapy Summit to be held December 12-14, 2023 in Boston, Mass. During presentations at the summit, Jana Portnow, M.D., principal investigator, professor in the Department of Medical Oncology & Therapeutics Research and co-director of the Brain Tumor Program at City of Hope Comprehensive Cancer Center, will present the clinical trial design and safety of a Phase 1 study opened in June 2023, using multiple doses of Calidi’s NeuroNova administered intracerebrally, to recurrent high grade glioma patients. Antonio F. Santidrian PharmD, Ph.D., Chief Scientific Officer and Boris R. Minev, M.D., President, Medical & Scientific Affairs, will present updates on the company’s targeted immunotherapies, leveraging allogeneic stem cells to target tumors and deliver anti-cancer payloads in the form of cancer-killing viruses.

“Our cell-based virotherapeutics are designed to target tumors directly and to help the immune system recognize and attack distant tumor sites,” said Boris R. Minev. M.D, President, Medical & Scientific Affairs of Calidi Biotherapeutics. “We are testing this approach in high-grade glioma and anticipate initiating a new clinical trial in several difficult-to-treat advanced solid tumors in the second half of 2024.”

The company has four clinical and preclinical programs utilizing different viruses and different types of allogeneic stem cells to overcome the inactivation of Calidi’s virotherapies by the patients’ immune system. This unique approach utilizes specially selected viruses to kill tumor cells and modify the tumor microenvironment, thus enabling the release of tumor antigens. Subsequently, the antigen-presenting cells are able to induce potent antitumor immune responses to detect, attack, and destroy metastatic tumor sites.

Updates to be presented at the upcoming 8th Oncolytic Virotherapy Summit include:

1. Progress in Recurrent High Grade Glioma (HGG) Trial. Calidi’s collaborator: City of Hope Comprehensive Cancer Center dosed the first patient in June 2023 in a Phase 1 clinical trial of NeuroNova (NNV2) and has dosed 6 patients to-date. Dr. Portnow will present an initial update on this trial. Of note, Calidi holds an exclusive worldwide licensing agreement with City of Hope and the University of Chicago for patents covering the NSC-CRAd-S-pk7 technology (NeuroNova).
2. Plans to Commence a Dose Escalation Trial in Newly Diagnosed HGG in 1H 2024. Calidi plans to commence a Phase 1b/2 clinical trial for NeuroNova (NNV1) in collaboration with Northwestern University during the first half of 2024. The Phase 1b dose escalation lead portion of this anticipated trial will explore the final dosing regimen for NNV1, including the feasibility of repeated dosing.
3. Plans to File IND Application for Clinical Trial Initiation in Advanced Solid Tumors in 2H 2024. SuperNova (SNV1) is the company’s first internally developed preclinical product candidate utilizing the SuperNova™ Delivery Platform. The company plans to file its IND application for the clinical development of CLD-201 to enable the initiation of a Phase 1 clinical trial for SNV1 during the second half of 2024.
4. Systemic Programs for Metastatic Solid Tumors. Calidi is currently engaged in early discovery research involving its next generation cell-based virotherapies. The company’s research is focused on engineered oncolytic vaccinia virus to increase the tumor specificity and oncolytic potency with improved systemic anti-tumor immunity.

Full details for the conference presentations are below:

City of Hope Comprehensive Cancer Center Presentation:

Title: Neural Stem Cell Based-Oncolytic Virotherapy for Treatment of Glioblastoma (Calidi NNV2 Clinical Update)
Speaker: Dr. Jana Portnow
Date: December 14, 2023
Time: 4:45 p.m. EST

Calidi Presentations:

Title: The Oncolytic Virotherapy Innovation Showcase
Speaker: Dr. Antonio F. Santidrian
Date: December 13, 2023
Time: 4:15 p.m. EST

Title: Optimized Cell-Based Delivery & Potentiation of Oncolytic Virotherapies
Speaker: Dr. Boris R. Minev
Date: December 14, 2023
Time: 9:30 a.m. EST

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 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. These forward statements include, but are not limited to, statements concerning the filing of an IND application with the FDA, statements related to ongoing clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates that are in clinical trials. 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 Form S-4 filed on August 2, 2023, on Form S-1 filed on October 6, 2023 and Form 10-Q filed on November 14, 2023.