Calidi Biotherapeutics, Inc. (NYSE American: CLDI or “Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced the issuance of a new patent for the company’s SuperNova technology, strengthening its intellectual property portfolio and positioning Calidi to advance its CLD-201 program into the clinic. In addition, the company also provided an update on the timing of its anticipated clinical milestones.

The United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,655,455 titled, “Enhanced systems for cell-mediated oncolytic viral therapy,” directed to Calidi’s SuperNova platform composed of adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus.

“This latest patent granted to Calidi covering meaningful features of our SuperNova platform represents an important milestone as we prepare to advance CLD-201 into the clinic,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “We are pleased to continue strengthening an already robust intellectual property portfolio, and feel we are well-positioned to capture the potential of our efforts to develop a universal and off-the-shelf SuperNova platform to radically transform the landscape for patients with advanced solid tumors.”

The patent covers a composition where cells are incubated with an oncolytic virus for a defined period allowing the expression of at least one immunomodulatory protein or recombinant therapeutic protein encoded by the virus, by virtue of association of the virus, with the carrier cell. Early Calidi research has shown the potential ability of the SuperNova platform to shield the viral payload from the immune system, supporting efficient delivery to tumor sites and effectively potentiating oncolytic viruses’ therapeutic efficacy.

"We see great potential in our SuperNova technology to address the vast unmet need for effective treatments of solid tumor cancers," said Dr. Antonio F. Santidrian, Chief Scientific Officer at Calidi Biotherapeutics. "We look forward to initiating our first-in-human clinical trial of our off-the-shelf and allogeneic therapy in 2024."

In addition, Calidi also provided updates on the timing for certain anticipated clinical milestones for its NeuroNova and SuperNova platforms.

Anticipated Clinical Milestones

• 1H 2024: First patient dosed in CLD-101 (NeuroNova) Phase 1b/2 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients
• 2H 2024: First patient dosed in CLD-201 (SuperNova) Phase 1 trial

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. Any forward-looking statements contained in this discussion, including but not limited to statements listed in “Anticipated Clinical Milestones,” and statements concerning the safety and efficacy of our product candidate CLD-201 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 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.

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