- NeuroNova (CLD-101) Phase 1 update highlights enrollment progress, safety and feasibility in delivering up to four weekly doses of CLD-101

- Showcased preclinical data on RTNova (CLD-400) platform’s ability to survive bloodstream and reach all tumors systemically

- Non-clinical data supporting the upcoming SuperNova (CLD-201) clinical trial

Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced the presentation of three abstracts in a poster session during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These posters, presented on June 1, 2024, include an update from the City of Hope-led Phase 1 study of Calidi's CLD-101 program, and preclinical data surrounding Calidi’s RTNova (CLD-400) and CLD-201 platforms.

“We are thrilled by the opportunity to present at ASCO and showcase the progress we have made across our various programs. Calidi’s cutting edge approach to antitumor virotherapy is evident through the entirety of our pipeline, and these data updates are reflective of the tireless work from our scientific team and collaborators” said Allan Camaisa, CEO and Chairman of the Board at Calidi Biotherapeutics. “In our CLD-101 program, NeuroNova’s safety and tolerability observed in the patients dosed thus far, reaffirms our belief in the combination of neural stem cells and antitumor viruses as a potentially transformative therapy for high-grade glioma patients. We are encouraged by the initial safety profile of cohorts 2 and 3, enabling the ongoing recruitment and dosing of the fourth cohort. Along with our clinical progress, we continue to be excited by our novel preclinical programs, RTNova (CLD-400), and look forward to filing our IND application with the FDA on Supernova (CLD-201) for a future phase 1 clinical trial, with their potential ability to treat a diverse set of solid tumors.”

Key highlights from the company’s three presentations at ASCO are 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

• 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.
• The study focuses on the safety and feasibility of delivering up to four weekly intracerebral doses of CRAd-S-pk7 to patients with recurrent high-grade gliomas.
• All participants receive a uniform dose of 1.50 x 10⁸ NSCs and 1.875 x 10¹¹ viral particles, the maximum feasible dose from the initial human study.
• Secondary objectives for the study include assessing the biological activity, biodistribution, immunogenicity, safety, and preliminary clinical efficacy of CRAd-S-pk7.
• The initial patient began treatment in May 2023. Currently, three patients in Treatment Schedule 2 and three in Treatment Schedule 3 have been enrolled and treated safely.
• Calidi is currently enrolling patients in Treatment Schedule 4.

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

• Calidi’s RTNova (CLD-400) systemic antitumor virotherapy platform is a novel tumor-selective vaccinia virus strain, a program designed to target all tumor sites and capable of producing a high amount of enveloped vaccinia viruses (envRTs) resistant to humoral immunity.
• The technology allows the therapy to reach every tumor systemically, killing tumor cells, and expressing any desired protein within the tumor, thus modifying the tumor microenvironment.
• In preclinical murine models, envRT-01 targeted multiple tumor types and led to tumor growth inhibition with a single systemic injection of 4.5e⁶ PFU env-RT-01
• envRT-01 induced changes in tumor immune microenvironment, targeted lung cancer and metastatic sites, and induced dramatic changes in lung metastasis tumor microenvironments.

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

Abstract Number: 2553

Session Title: Developmental Therapeutics – Immunotherapy

• Animals treated with the maximum tolerated dose of 2e⁶ PU/animal showed no signs of adverse toxicity and exhibited a reduction in tumor volume compared to the control group.
• No toxicity findings were associated with CLD-201 in the disease-free model, and additionally, virus detection in the lungs was cleared within two weeks following the last CLD-201 treatment.
• CLD-201 induced potent cytolysis across multiple cancer types in in-vitro models.
• Local administration of CLD-201 induced both robust local and systemic immune cell infiltration.
• Calidi is expecting to initiate a Phase 1 non-randomized trial to assess the safety and initial anti-tumor effects of CLD-201 administered intratumorally.

Copies of the posters are available on the Publications section of Calidi’s website.

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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