SAN DIEGO, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, is pleased to invite investors to a webinar on November 19, 2025, at 1:15 p.m. PT. The exclusive event, hosted by RedChip Companies, will feature Calidi’s CEO, Eric Poma, Ph.D. Attendees will gain insights into Calidi’s pio ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact name of registrant as specified in its charter) Delaware 86-2967193 (State or other jurisdiction of incorporation or organization) WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-40789 Calidi Biotherapeutics, I ...

Exhibit 99.1 SAN DIEGO, November 13, 2025 — (Business Wire) — Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical- stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today reported its third quarter 2025 operating and financial results and reviewed recent business highlights. The company reported a net loss $5.2 million for the three months ended September 30, 2025, compared to a net lo ...

Core Insights - Calidi Biotherapeutics is making significant progress in developing targeted therapies for delivering genetic medicines to metastatic tumor sites, with its lead candidate CLD-401 advancing to clinical trials [2][4][5] Financial Results - For Q3 2025, Calidi reported a net loss of $5.2 million, slightly higher than the $5.1 million loss in Q3 2024. The total net loss attributable to shareholders increased to $10.8 million due to a non-cash charge for deemed dividends on warrants [6][15] - The net loss per share for Q3 2025 was $2.21, compared to $7.75 in the same period of 2024 [6][15] - Research and development expenses were $2.4 million in Q3 2025, up from $2.2 million in Q3 2024, while general and administrative expenses decreased to $2.7 million from $3.1 million [7][15] - As of September 30, 2025, the company had approximately $10.4 million in cash, an increase from $9.6 million at the end of 2024 [8][14] Corporate Developments - Calidi established a new Scientific Advisory Board (SAB) to support the development of CLD-401 and the RedTail platform, featuring esteemed members with extensive experience in drug development and cancer treatment [4][5] - The company presented new preclinical data at the Society of Immunotherapy for Cancer (SITC) annual meeting, demonstrating the effectiveness of the RedTail platform in delivering genetic medicines specifically to tumor sites while avoiding systemic exposure [4][5] - Calidi raised $6.9 million in gross proceeds through a public offering, increasing total gross proceeds raised in 2025 to $23.0 million, which strengthens the company's financial position [4][5]

Core Insights - Calidi Biotherapeutics, Inc. presented new data on its first therapeutic candidate, CLD-401, at the Society of Immunotherapy for Cancer Annual Meeting, highlighting its innovative approach in targeted genetic medicines [1][4]. Group 1: Product Development - CLD-401 is designed as a tumor-tropic oncolytic virus that targets metastatic sites, replicates only in tumor cells, and induces immune responses through the expression of IL-15 superagonist in the tumor microenvironment [2][3]. - The data from syngeneic murine models indicate that the RedTail platform can evade immune clearance and effectively deliver genetic medicines at tumor sites, achieving concentrations similar to localized dosing while minimizing systemic exposure [3]. Group 2: Clinical Trials and Future Plans - Calidi is currently conducting IND-enabling studies for CLD-401 and plans to submit an Investigational New Drug application by the end of 2026 [4][7]. - The company is actively seeking strategic partnerships to enhance clinical development and expand the impact of its RedTail platform [4]. Group 3: Expert Insights - During an investor day, experts including Dr. Dimitri Zamarin and Dr. John Wrangle discussed the potential and differentiation of CLD-401 and the RedTail platform, emphasizing its promise in the field of virotherapy [5].

Core Insights - Calidi Biotherapeutics, Inc. is hosting an investor event at the Society of Immunotherapy for Cancer (SITC) Annual Meeting to discuss its RedTail platform and lead candidate CLD-401 [1][2] - The company is conducting IND-enabling studies for CLD-401, targeting non-small cell lung cancer, head and neck cancer, and other high unmet medical need tumor types, with an IND application expected by the end of 2026 [2][4] Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted genetic medicines using its proprietary RedTail platform, which utilizes an engineered enveloped oncolytic virus for systemic delivery to metastatic sites [3][4] - The RedTail platform aims to shield the virus from immune clearance, allowing effective virotherapy to reach tumor sites and deliver potent genetic medicines [3] Event Details - The investor presentation will take place on November 7 from 8:30 AM to 9:30 AM at the Gaylord National Hotel and Convention Center in National Harbor, Maryland, and will be live-streamed [2] - Key speakers at the event include Eric Poma, PhD, CEO of Calidi, and other experts from the Scientific Advisory Board [2][6]

Core Insights - Calidi Biotherapeutics, Inc. is advancing its first therapeutic candidate, CLD-401, from its RedTail platform, which focuses on targeted genetic medicines for cancer treatment [1][5] - CLD-401 is designed to target metastatic sites, replicate in tumor cells, and induce immune responses through the expression of IL-15 superagonist [2][3] - The company plans to submit an Investigational New Drug (IND) application for CLD-401 by the end of 2026 and is seeking strategic partnerships to enhance clinical development [3][5] Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company based in San Diego, California, specializing in the development of targeted therapies for cancer [5] - The RedTail platform utilizes an engineered enveloped oncolytic virus for systemic delivery to metastatic sites, aiming to evade immune clearance and effectively deliver genetic medicines [4][5] Product Details - CLD-401 targets non-small cell lung cancer, head and neck cancer, and other tumor types with significant unmet medical needs [5] - The therapeutic candidate is currently undergoing IND-enabling studies, with a focus on achieving durable tumor clearance through innovative mechanisms [4][5] Upcoming Events - CLD-401 will be presented at the SITC 40th Anniversary Annual Meeting scheduled for November 7-9, 2025, with a specific presentation on its efficacy in tumor delivery and immune response activation [4]

Core Insights - Calidi Biotherapeutics, Inc. has formed a Scientific Advisory Board (SAB) to enhance the development of its RedTail platform and advance its lead candidate CLD-401 into clinical trials [1][2][4] Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted genetic medicines using its proprietary RedTail platform, which employs an engineered enveloped oncolytic virus for systemic delivery to metastatic sites [18][19] Scientific Advisory Board Formation - The SAB consists of leading industry and academic researchers with extensive experience in drug development, aimed at guiding the efficient development of CLD-401 [1][4] - Founding members include: - Mace L. Rothenberg, MD, with over 30 years in drug development and a history of leading clinical development at Pfizer [4][6] - Dmitriy Zamarin, MD, PhD, a leader in virotherapy for cancer and a member of the Icahn Genomics Institute [7][9] - John Wrangle, MD, MPH, an expert in IL-15-based treatment for metastatic cancer [10][12] - David T. Curiel, MD, PhD, recognized for his work in cancer immunotherapy and virotherapy [14][16] RedTail Platform and CLD-401 - The RedTail platform utilizes a genetically engineered vaccinia virus designed to overexpress CD55, allowing for targeted delivery of genetic medicine to disease sites while avoiding immune clearance [2][3] - CLD-401 is designed to target metastatic sites, replicate in tumor cells, and induce immune responses through the expression of IL-15 superagonist in the tumor microenvironment [3][19]

Core Insights - Calidi Biotherapeutics, Inc. is participating in the second annual Oncology Venture, Innovation, and Partnering Summit on September 29-30, 2025, in Boston, MA [1] - CEO Eric Poma will discuss the intersection of science and capital in cancer treatment development during a fireside chat on September 30, 2025 [2] - The company's proprietary RedTail platform is designed to deliver genetic medicines to metastatic sites while protecting the virus from immune clearance [4] Company Overview - Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on targeted therapies for delivering genetic medicines to distal disease sites [4] - The RedTail platform features an engineered enveloped oncolytic virus aimed at systemic delivery and targeting metastatic sites [4] - The lead candidate from the RedTail platform is currently in IND-enabling studies, targeting non-small cell lung cancer, ovarian cancer, and other high unmet medical need tumor types [5]

Core Insights - Calidi Biotherapeutics, Inc. is participating in the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025, in New York [1] - CEO Eric Poma will present on the RedTail platform, which aims to deliver genetic medicines to metastatic sites while evading immune clearance [2] - The RedTail platform is designed to target non-small cell lung cancer, ovarian cancer, and other high unmet medical need tumor types [5] Company Overview - Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on developing targeted therapies for delivering genetic medicines to distal disease sites [4] - The proprietary RedTail platform utilizes an engineered enveloped oncolytic virus for systemic delivery and targeting of metastatic sites [4] - The company is headquartered in San Diego, California [6]