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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.

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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.

April 17, 2025

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

SAN DIEGO, April 10, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced the appointment of Guy Travis Clifton, MD as Chief Medical Officer, Consultant and Advisor.

April 10, 2025

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

SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) (“Calidi” or the “Company”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced the closing of its previously announced registered direct offering, with a single institutional investor, for the issuance and sale of 3,325,000 shares of the Company’s common stock, and pre-funded warrants to purchase up to 2,728,000 shares of Common Stock. In a concurrent private placement, the Company issued and sold to the investor Series G common warrants to purchase up to an aggregate of 6,053,000 shares common stock.

March 31, 2025

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

SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today reported its fourth quarter and full-year 2024 operating and financial results and reviewed recent business highlights.

March 31, 2025

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

SAN DIEGO, March 28, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) (“Calidi” or the “Company”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced that it has entered into a definitive securities purchase agreement with a single institutional investor for the purchase and sale of 3,325,000 shares of the Company’s common stock at a per share purchase price of $0.65, and at the election of the investor, in lieu of the common stock, pre-funded warrants to purchase up to 2,728,000 shares of Common Stock at a price of $0.649 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant, in a registered direct offering.

March 28, 2025

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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

SAN DIEGO and LOS ANGELES, March 26, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, and City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, are pleased to jointly announce progress from a phase 1 clinical trial utilizing Calidi’s CLD-101 investigational agent (neural stem cell-based oncolytic virotherapy) that is administered intracerebrally. This trial is the first to evaluate the safety and therapeutic potential of a multiple-dose regimen of this novel virotherapy for recurrent high-grade glioma - among the most aggressive and deadly forms of brain cancer.

March 26, 2025

Press Release

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

Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced the presentation of three abstracts in a poster session during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

June 3, 2024

Press Release

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

Calidi Biotherapeutics, Inc. (NYSE American: CLDI), a clinical-stage biotechnology company, has entered a definitive agreement for the immediate exercise of Series B and C warrants, expected to generate approximately $2.1 million. The new unregistered warrants issued will have a five-and-a-half-year term and an exercise price of $0.30 per share, pending shareholder approval. The proceeds will support Calidi's clinical and pre-clinical programs, operational expenses, and working capital.

May 31, 2024

Press Release

Calidi Biotherapeutics Reports First Quarter 2024 Operating and Financial Results

May 14, 2024

Press Release

Calidi Biotherapeutics Announces Upcoming Presentations at the 2024 ASCO Annual Meeting

Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced the acceptance of three abstracts that will be presented in a poster session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31-June 4, 2024, in Chicago, Illinois.

May 1, 2024

Press Release

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

Calidi Biotherapeutics, Inc. (NYSE American: CLDI or “Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced the closing of its previously announced public offering of 15,197,500 shares of common stock (or pre-funded warrants in lieu thereof) and accompanying Series A Common Warrants, Series B Unit Warrants, with each unit consisting of one share of common stock and a Series B-1 Common Warrant and Series C Unit Warrants, with each unit consisting of one share of common stock and a Series C-1 Common Warrant at an effective combined price of $0.40 per share and common warrants for aggregate gross proceeds of approximately $6.1 million, before deducting placement agent fees and other offering expenses. The common warrants will have an exercise price of $0.60 per share, and the Series A Common Warrants, Series B Unit Warrant and Series C Unit Warrant will be exercisable immediately. The common warrants will expire in five years (with respect to the Series A Common Warrant, the Series B-1, Warrant and the Series C-1 Common Warrant), twelve months (with respect to the Series B common warrants) and four months (with respect to the Series C common warrants) from the issuance date.

April 19, 2024

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

Calidi Biotherapeutics announces a public offering to raise $6.1 million closing by April 18, 2024.

April 16, 2024

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33rd Annual Meeting & Pre-Conference Programs of the Society for Immunotherapy of Cancer | November 7-11, 2018 Washington, D.C.

November 7, 2018

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The Society for Immunotherapy of Cancer’s (SITC) 33rd Annual Meeting | November 7-11, 2018 Washington, D.C.

Abstract P617: A cell-based platform to protect and enhance oncolytic virus therapies

November 7, 2018

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The Society for Immunotherapy of Cancer’s (SITC) 33rd Annual Meeting | November 7-11, 2018 Washington, D.C.

Abstract P609: First in man study of TK positive oncolytic vaccinia virus delivered by adipose stromal vascular fraction cells

November 7, 2018

Media

Good Morning San Diego, Calidi Bio Treatments Discussed

April 13, 2019

Media

KUSI San Diego News - Calidi Bio CEO, Allan Camaisa Interviewed

April 12, 2019

In The News

Analyst Bullish On Calidi Biotherapeutics, Newly Listed Cancer Treatment Player

Baird initiates coverage on Calidi Biotherapeutics Inc CLDI, which uses allogeneic stem cells to deliver oncolytic viruses to tumors for cancer treatment. Just a month back, Calidi Biotherapeutics became the latest biotech to take the special purpose acquisition company route to the public market

October 9, 2023

In The News

Calidi Biotherapeutics: A Promising Player in the Cancer Treatment Market

Calidi Biotherapeutics Inc (NYSE: CLDI) is making waves in the biotech industry with its innovative approach to cancer treatment. The company utilizes allogeneic stem cells to deliver oncolytic viruses directly to tumors, offering new hope for patients.

October 9, 2023

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