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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 Demonstrated Ability To Deliver Transient Gene Therapy (Payload) To Tumors Using Systemic Platform

Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital

Join Calidi Biotherapeutics’ Exclusive Live Investor Webinar and Q&A Session on February 5

Calidi Biotherapeutics Announces Bolstered Cash Balance and Termination of its Standby Equity Purchase Agreement

Calidi Biotherapeutics Announces Presentation of New Data of Systemic Virotherapy RTNova Platform at the AACR Annual Meeting in April 2025

Calidi Biotherapeutics Announces Closing of $4.25 Million Public Offering of Common Stock

Calidi Biotherapeutics Reports Third Quarter 2024 Operating and Financial Results

Calidi Biotherapeutics to Present Data Supporting RTNova at Upcoming Scientific Conferences

Calidi Biotherapeutics Announces Pricing of $2 Million Registered Direct Offering and Concurrent Private Placement

Calidi Biotherapeutics Announces FDA Clearance of the Northwestern University IND Application for CLD-101 Clinical Trial in High-Grade Glioma

Calidi Biotherapeutics Reports Second Quarter 2024 Operating and Financial Results

Calidi Biotherapeutics Announces Launch of Nova Cell Subsidiary and $3 Million Aggregate Investment from Dr. Ronald Rigor

33rd Annual Meeting & Pre-Conference Programs of the Society for Immunotherapy of Cancer | November 7-11, 2018 Washington, D.C.

The Society for Immunotherapy of Cancer’s (SITC) 33rd Annual Meeting | November 7-11, 2018 Washington, D.C.

The Society for Immunotherapy of Cancer’s (SITC) 33rd Annual Meeting | November 7-11, 2018 Washington, D.C.

Scientific Advisory Board Member Interview - Santosh Kesari, M.D./Ph.D.

Scientific Advisory Board Member Interview - Bernard Fox, Ph.D.

Scientific Advisory Board Member Interview - W.K. Alfred Yung, M.D.

Scientific Advisory Board Member Interview - Ashok Srivastava, M.D./Ph.D.

Big Biz TV - Stephen Thesing

Big Biz TV - Allan Camaisa

Analyst Bullish On Calidi Biotherapeutics, Newly Listed Cancer Treatment Player

Calidi Biotherapeutics: A Promising Player in the Cancer Treatment Market

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