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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 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

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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