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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 FDA Approval for COVID-19 Treatment Manufactured by Partner, Personalized Stem Cells

Calidi Biotherapeutics Announces Appointment of Jim Schoeneck, Accomplished Biotech Executive, to Board of Directors

Calidi Biotherapeutics Announces Two Abstracts Accepted for Presentation at AACR 2020 Virtual Annual Meeting II

Enhancement of the therapeutic effects of oncolytic vaccinia virus by using autologous and allogeneic cell-based delivery platforms.

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

Calidi’s Contribution To The Treatment Of COVID-19

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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