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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 Launch of Nova Cell Subsidiary and $3 Million Aggregate Investment from Dr. Ronald Rigor

Calidi Biotherapeutics Announces Issuance of New U.S. Patent Covering Novel SuperNova Technology Platform

Calidi Biotherapeutics Announces Appointment of Dr. Mark Gilbert to Medical Advisory Board

Calidi to Effect Reverse Stock Split

Calidi Biotherapeutics Announces Appointment of Cancer Immunotherapy Pioneer Dr. George Peoples to Board of Directors

Calidi Biotherapeutics to Host Exclusive Live Investor Webinar and Q&A Session on June 13

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

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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