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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

Transforming all Tumor Sites: The Power of Systemic Enveloped Virotherapy

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 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

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

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