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Press Release

Calidi Biotherapeutics Announces FDA Clearance of IND Application for CLD-201 in Solid Tumors

SAN DIEGO, April 17, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering targeted antitumor virotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLD-201. This investigational, allogeneic stem cell-based immunotherapy is set to advance into clinical development for the treatment of solid tumors in adults, focusing on breast cancer, head & neck cancer and soft tissue sarcoma.

The Newsroom

Calidi Biotherapeutics Announces FDA Clearance of IND Application for CLD-201 in Solid Tumors

Calidi Biotherapeutics Announces Issuance of New U.S. Patent Covering Novel SuperNova Technology Platform and Updates Anticipated Clinical Milestones

Calidi Biotherapeutics Reports Third Quarter 2023 Operating and Financial Result

Annual Meeting – SITC 2023 – Nov 1st to 5th 2023 in San Diego, CA, USA.

Calidi Biotherapeutics (NYSEAM: CLDI) Presents Data on CLD-201 Demonstrating Inhibition of Tumor Growth and Induction of Robust Anti-Tumor Immunity at the Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC 2023)

Calidi Biotherapeutics Announces Key Leadership Promotions and New Board Appointment

Calidi Biotherapeutics Announces Appointment of Andrew Jackson as Chief Financial Officer

Calidi Biotherapeutics Presents CLD-101 Phase 1 Trial Update and Preclinical Data Highlighting RTNova and CLD-201 at 2024 ASCO Annual Meeting

Calidi Biotherapeutics Announces Exercise of Warrants for $2.1 Million Gross Proceeds

Calidi Biotherapeutics Reports First Quarter 2024 Operating and Financial Results

Calidi Biotherapeutics Announces Upcoming Presentations at the 2024 ASCO Annual Meeting

Calidi Biotherapeutics, Inc. Announces Closing of $6.1 Million Public Offering

Calidi Biotherapeutics, Inc. Announces Pricing of $6.1 Million Public Offering

Transforming all Tumor Sites: The Power of Systemic Enveloped Virotherapy

Phase 1 Study of Multiple Intracerebral Doses of a Neural Stem Cell-based Oncolytic Virotherapy for Treatment of Recurrent High-grade Gliomas

Non-Clinical Evidence Supporting the Upcoming CLD-201 Clinical Trial: Cell-Based Oncolytic Virotherapy for Multiple Solid Tumors

Transforming Tumor Immune Microenvironments with a Novel Systemic Enveloped Oncolytic Virotherapy Targeting All Tumor Sites

Stem Cell Platforms for Enhanced Oncolytic Virotherapy

Deciphering Anticancer Mechanisms of Oncolytic Virus-loaded Stem Cells

Good Morning San Diego, Calidi Bio Treatments Discussed

KUSI San Diego News - Calidi Bio CEO, Allan Camaisa Interviewed

Analyst Bullish On Calidi Biotherapeutics, Newly Listed Cancer Treatment Player

Calidi Biotherapeutics: A Promising Player in the Cancer Treatment Market

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