CLDI Calidi Biotherapeutics Inc

Calidi Biotherapeutics, Inc. (NYSE American: CLDI or “Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, 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.

The United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,036,278 titled, “Smallpox Vaccine for Cancer Treatment,” 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 well-positioned to fully capture the potential of our universal off-the-shelf SuperNova platform to radically transform the landscape for patients with advanced solid tumors.”

The patent covers methods and compositions related to immunotherapy of cancer, specifically compositions combining a smallpox vaccine with stem cells, selected from among 19 different stem cell types and their combinations. Importantly, this patent broadens previously allowed claims to include 21 smallpox vaccine virus strains. Extensive 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 tumors,” said Dr. Boris Minev, President, Medical and Scientific Affairs at Calidi Biotherapeutics and a patent inventor. “Building on the initial clinical success of our autologous adipose-derived stem cells loaded with vaccinia oncolytic viruses, we look forward to submitting an IND to initiate our first-in-human clinical trial of this off-the-shelf allogeneic therapy, as we continue building our understanding of the safety and effectiveness of CLD-201 in patients with advanced solid tumors.”

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 Form S-4 filed on August 2, 2023, on Form S-1 filed on October 6, 2023, on Form S-1 filed on January 29, 2024, as amended on February 7, 2024, on Form 10-K filed on March 15, 2024, and Final Prospectus filed on April 17, 2024.

For Investors and Media:

Stephen Thesing

IR@Calidibio.com