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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 Issuance of New U.S. Patent Covering Novel SuperNova Technology Platform and Updates Anticipated Clinical Milestones

Calidi Biotherapeutics Reports Third Quarter 2023 Operating and Financial Result

Annual Meeting – SITC 2023 – Nov 1st to 5th 2023 in San Diego, CA, USA.

Calidi Biotherapeutics (NYSEAM: CLDI) Presents Data on CLD-201 Demonstrating Inhibition of Tumor Growth and Induction of Robust Anti-Tumor Immunity at the Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC 2023)

Calidi Biotherapeutics Announces Key Leadership Promotions and New Board Appointment

Calidi Biotherapeutics Announces Appointment of Andrew Jackson as Chief Financial Officer

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

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

Calidi Biotherapeutics Reports First Quarter 2024 Operating and Financial Results

Calidi Biotherapeutics Announces Upcoming Presentations at the 2024 ASCO Annual Meeting

Calidi Biotherapeutics, Inc. Announces Closing of $6.1 Million Public Offering

Calidi Biotherapeutics, Inc. Announces Pricing of $6.1 Million Public Offering

Annual Meeting – SITC 2023 – Nov 1st to 5th 2023 in San Diego, CA, USA.

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

Neural stem cell delivery of an oncolytic adenovirus in newly diagnosed malignant glioma: a first-in-human, phase 1, dose-escalation trial

Abstract 6542: CAL1 vaccinia virus as oncolytic agent and potential use of cell-based platform to enhance its therapeutic effects

Abstract 4473: Evaluation of the potential of oncolytic vaccinia virus delivered by autologous SVF to modulate innate and adaptive immunity in patients with diverse solid and hematological malignancies

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

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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