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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 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

Development of Allogeneic Stem Cell-Based Platform for Delivery and Potentiation of Oncolytic Virotherapy

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

Calidi Biotherapeutics to Present at the 7th Annual Oncolytic Virotherapy Summit

Calidi Biotherapeutics Presents Promising Pre-Clinical Data from SuperNova-1 (SNV1), a Novel Oncolytic-Cell Based Platform, at the Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022)

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

Calidi Biotherapeutics Announces Appointment of Guy Travis Clifton, MD as Chief Medical Officer, Consultant and Advisor

Calidi Biotherapeutics Announces Closing of $3.9 Million Registered Direct Offering and Concurrent Private Placement

Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Operational Highlights

Calidi Biotherapeutics Announces Pricing of $3.9 Million Registered Direct Offering and Concurrent Private Placement

Calidi Biotherapeutics and City of Hope Provide Update on a Phase 1 Clinical Trial with CLD-101 Virotherapy in Patients with Recurrent High-Grade Glioma

Rationale for the clinical use of adipose-derived mesenchymal stem cells for COVID-19 patients

ASCO-SITC Clinical Immuno-Oncology Symposium February 6-8, 2020 Orlando, Florida.

A cell-based platform to potentiate oncolytic virus: Potential approach for cancer therapies.

First-in-human study of TK-positive oncolytic vaccinia virus delivered by adipose stromal vascular fraction cells

First-in-human study of TK-positive oncolytic vaccinia virus delivered by adipose stromal vascular fraction cells

Delivery of oncolytic vaccinia virus by matched allogeneic stem cells overcomes critical innate and adaptive immune barriers

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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