Press Release

Calidi Biotherapeutics Announces FDA Approval for COVID-19 Treatment Manufactured by Partner, Personalized Stem Cells

SAN DIEGO, CA – (BUSINESS WIRE) – Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, announced today that the Investigational New Drug (IND) application submitted by its partner, Personalized Stem Cells, Inc. (PSC), has received FDA approval for the treatment of COVID-19 and pneumonia patients using stem cell therapy. Calidi has partnered with PSC for over two years—most recently contributing the stem cell lines used to manufacture treatment for the upcoming first trial, “CoronaStem 1,” which will be conducted among 20 hospitalized COVID-19 patients in California.

“We are extremely pleased to continue our partnership with PSC, securing and providing stem cells from healthy donors in strict accordance with FDA guidelines,” said Allan J. Camaisa, Chairman and CEO of Calidi Biotherapeutics. “We’ve seen the impressive capabilities of allogeneic mesenchymal stem cells [MSCs] firsthand through Calidi’s years of work, and strongly believe that they can help provide a therapeutic solution for the global pandemic. They’ve also demonstrated to be efficient vehicles for oncolytic virus delivery and potentiation upon direct injection into cancerous tumors, an approach which has revealed potent anti-tumor effects not only at the injected tumor site but also at distant metastatic tumor sites.”

At the request of the White House Coronavirus Task Force, PSC applied for expedited review of their IND filing in the PSC-Calidi product through the newly-formed FDA Coronavirus Therapeutic Accelerator Program (CTAP) in April 2020.

“We’re optimistic about the efficacy of these adipose-derived MSCs for therapeutic treatment of COVID-19 patients as well as powerful treatments for cancer. They are truly powerful cells,” said Dr. Bob Harman, Chairman and CEO of Personalized Stem Cells. We’ve also been very pleased with the results of our good manufacturing practices and interactions with the FDA.”

The CoronaStem 1 study will proceed in the coming weeks, managed and conducted by PSC, among a limited number of COVID-19 patients, as outlined in the IND submission. PSC plans to proceed onto a larger phase 2 clinical trial and potentially into FDA compassionate use programs to reach more patients pending the success of the initial trial.

About Calidi Biotherapeutics

Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the effective delivery of oncolytic viruses for targeted therapy against difficult-to-treat cancers. Calidi Biotherapeutics is advancing a potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications. Calidi’s off-the-shelf, universal cell-based delivery platform is designed to protect, amplify, and potentiate oncolytic viruses currently in development leading to enhanced efficacy and improved patient safety. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.

About Personalized Stem Cells

Personalized Stem Cells was formed in 2018 to advance and legitimize human regenerative medicine. This privately-held biopharmaceutical enterprise, based near San Diego (California), offers qualified physicians who enroll, FDA-compliant stem cell products for use in FDA approved clinical trials. PSC is driving development and adoption of stem cell and regenerative medicine within the FDA-IND process by providing quality manufactured, safety tested cells, and well-defined clinical trials. PSC has licensed a portfolio of over 70 issued patents in the field of regenerative medicine. Please visit www.personalizedstemcells.com for additional information.

Forward-Looking Statement

Some of the statements in this press release may be forward-looking statements that involve risks and uncertainties inherent in research and development. Such forward-looking statements include the expectations, plans, and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. No forward-looking statement can be guaranteed. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control. Calidi Biotherapeutics does not make any representation or warranty, express or implied, as to the completeness or updated status of such statements.