Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced the acceptance of three abstracts that will be presented in a poster session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31-June 4, 2024, in Chicago, Illinois.

The posters will include an update from a City of Hope-led Phase 1 study of Calidi's CLD-101 program, focusing on the treatment of recurrent high-grade glioma, now advancing into its fourth cohort of participants. CLD-101 is a cutting-edge therapeutic candidate in Calidi’s NeuroNova program, comprising tumor-tropic neural stem cells (NSCs) that deliver an oncolytic adenovirus – CRAd-S-pk7 – selectively to tumor sites.

Calidi will also present preclinical data highlighting its RTNova delivery platform, a novel systemic enveloped oncolytic virotherapy program designed to target all tumor sites, and its CLD-201 program, which is expected to dose its first patient in a Phase 1 trial in the second half of 2024 subject to Calidi’s ability to raise additional capital.

Details on the posters and corresponding abstracts are shown below.

Poster Title: Phase 1 study of multiple intracerebral doses of a neural stem cell-based oncolytic virotherapy for treatment of recurrent high-grade gliomas

Abstract Number: TPS2102

Session Title: Central Nervous System Tumors

Session Date and Time: June 1, 2024, from 9:00 AM to 12:00 PM CDT

Poster Title: Transforming tumor immune microenvironments with a novel systemic enveloped oncolytic virotherapy targeting all tumor sites

Abstract Number: 2559

Session Title: Developmental Therapeutics – Immunotherapy

Session Date and Time: June 1, 2024, from 9:00 AM to 12:00 PM CDT

Poster Title: Non-clinical evidence supporting the upcoming CLD-201 clinical trial: Cell-based oncolytic virotherapy for multiple solid tumors

Abstract Number: 2553

Session Title: Developmental Therapeutics - Immunotherapy

Session Date and Time: June 1, 2024, from 9:00 AM to 12:00 PM CDT

Copies of the posters will be available on the Publications section of Calidi’s website following presentation at the meeting.

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.

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