Press Release

Calidi Biotherapeutics Announces Dr. Maciej S. Lesniak Presentation at 13th International Oncolytic Virotherapy Conference

Calidi Biotherapeutics

LA JOLLA, Calif.--(BUSINESS WIRE)--Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, announced today that its physician advisor, Maciej S. Lesniak, MD, Department Chair of Neurological Surgery, Feinberg School of Medicine, Northwestern University, will present at the upcoming International Oncolytic Virotherapy Conference (IOVC), which will be held in hybrid format November 5 through November 7, 2021, as both a virtual event and an in-person meeting in Sedona, AZ.

Dr. Lesniak’s presentation: “Neural Stem Cell Delivery of Oncolytic Virotherapy for Glioma,” will focus on the use of stem cells for virotherapy of cancer, featuring clinical findings from a first-in-human, open-label, Phase 1, dose-escalation trial demonstrating strong safety and efficacy signals for the NSC-CRAd-S-pk7 product, which Calidi refers to as NeuroNova (NNV), in patients with newly diagnosed high-grade glioma. Results from the clinical trial are published in The Lancet Oncology (June 29, 2021).

“Malignant glioma has been historically associated with dismal survival rates due to a lack of effective treatment,” said Maciej S. Lesniak, MD, Department Chair of Neurological Surgery, Feinberg School of Medicine, Northwestern University. “I’m eager to share the promising results of our recently completed Phase 1 trial examining the safety and activity of NeuroNova in patients with advanced glioma.”

In June 2021, Calidi reached an exclusive license agreement with Dr. Lesniak’s team at Feinberg School of Medicine, Northwestern University—designating exclusive commercialization rights to Northwestern’s investigational new drug (IND) application and data generated from the clinical trial, as well as commercial development rights for stem-cell based products loaded with adenovirus. NNV is composed of an immortalized neural stem cell (NSC) line loaded with an engineered oncolytic adenovirus.

“Calidi’s continued collaboration with Dr. Lesniak has been critical to the development and clinical success of our NeuroNova platform,” said Allan J. Camaisa, Chairman and CEO of Calidi Biotherapeutics.

Scheduled for Sunday, November 7, Dr. Lesniak’s presentation will occur during Scientific Session 9: Clinical Trials 3 of the IOVC. Hosted by the American Society of Gene & Cell Therapy (ASGCT), the conference spans three days, with presentations from credentialed professionals in the following categories: Novel Payloads and Mechanisms of Action, Novel Combinations and Mechanisms of Action, Novel Platforms, and Clinical Trials. A full program schedule and complete list of invited speakers are available at asgct.org/events/iovc.

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 La Jolla, California. For more information, please visit calidibio.com.

About Feinberg School of Medicine, Northwestern University

Northwestern Medicine is the shared strategic vision of Northwestern Memorial HealthCare (NMHC) and Northwestern University Feinberg School of Medicine to transform the future of healthcare and become a premier integrated academic health system. Feinberg is a research-intensive medical school that fosters powerful collaborations on a thriving academic medical campus. We are driven by our mission to transform the practice of medicine and profoundly impact human health beyond the individual patient. Northwestern University is a comprehensive research university, established in 1851, that is deeply interdisciplinary across multiple schools and units. Additional information is available at feinberg.northwestern.edu.

About the American Society of Gene & Cell Therapy

The American Society of Gene & Cell Therapy (ASGCT) is the primary professional membership organization for gene and cell therapy. The ASGCT’s members are scientists, physicians, patient advocates, and other professionals who work in a wide range of settings, including universities, hospitals, government agencies, foundations, and biotechnology and pharmaceutical companies. The mission of ASGCT is to advance knowledge, awareness, and education leading to the discovery and clinical application of genetic and cellular therapies to alleviate human disease. ASGCT's strategic vision is to be a catalyst for bringing together scientists, physicians, patient advocates, and other stakeholders to transform the practice of medicine by incorporating the use of genetic and cellular therapies to control and cure human disease. Visit asgct.org 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.

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