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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 Collaborates with SIGA Technologies to Advance Calidi’s Revolutionary RTNova Virotherapy for Lung Cancer and Metastatic Solid Tumors

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

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

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

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

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

Calidi Biotherapeutics Debuts as a Publicly Traded Company Focused on Arming the Immune System to Fight Cancer with a New Generation of Targeted Immunotherapies

Calidi Biotherapeutics to Present at Baird’s Global Healthcare Conference

Calidi Biotherapeutics and City of Hope announce first patient dosed in a Phase 1 clinical trial evaluating neural stem cells engineered to carry an oncolytic virus, CLD-101, in recurrent high-grade glioma patients

Calidi Biotherapeutics Announces Commitment of $25 Million in Series B Funding to Advance Stem Cell-Based Platforms for the Delivery and Potentiation of Oncolytic Viruses to Treat Cancer

Calidi Biotherapeutics and First Light Acquisition Group (FLAG) Announce Merger Agreement to Create a Publicly Listed, Clinical-Stage Biotechnology Company Utilizing Stem Cell-Based Platforms to Revolutionize Oncolytic Virotherapies

Calidi Biotherapeutics Receives Funding from the California Institute for Regenerative Medicine (CIRM) to Advance SuperNova-1 and NeuroNova-2 Development Programs

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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