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Calidi Biotherapeutics Reports Third Quarter 2025 Financial Results and Recent Operational Highlights
Globenewswire· 2025-11-13 21:15
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]
Calidi Biotherapeutics Presents New Data on its Therapeutic Lead, CLD-401, at the 2025 SITC Annual Meeting and Holds Its First Investor Day at SITC
Globenewswire· 2025-11-10 13:00
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].
Calidi Biotherapeutics Announces Investor Event to be Held on Friday, November 7th at the 2025 SITC Annual Meeting
Globenewswire· 2025-11-04 13:00
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]
Calidi Biotherapeutics Announces New Data to be Presented on its Therapeutic Lead, CLD-401, at the 2025 SITC Annual Meeting
Globenewswire· 2025-10-30 12:00
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]
Calidi Biotherapeutics Announces Pricing of $6 Million Underwritten Public Offering
Globenewswire· 2025-08-20 13:15
Core Viewpoint - Calidi Biotherapeutics, Inc. has successfully priced a public offering to raise $6 million, indicating strong interest from both existing and new investors despite challenging market conditions [1][2]. Group 1: Offering Details - The offering consists of 1,472,764 common stock units priced at $2.00 each, and 1,528,000 pre-funded warrant units priced at $1.999 each [2]. - Each common stock unit includes one share of common stock and one Series I warrant, while each pre-funded unit includes one pre-funded warrant and one Series I warrant [2]. - The Series I warrants have an exercise price of $2.00 per share and are exercisable upon issuance, expiring five years from issuance [2]. Group 2: Underwriting and Closing - Ladenburg Thalmann & Co. Inc. is the sole book-running manager for the offering, with Laidlaw & Company (U.K.) Ltd. acting as a co-manager [3]. - The underwriters have a 45-day option to purchase an additional 450,000 shares of common stock and/or warrants at the public offering price [3]. - The offering is expected to close on or about August 21, 2025, pending customary closing conditions [3]. Group 3: Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted therapies for delivering genetic medicines to disease sites [6]. - The company's proprietary Redtail platform utilizes an engineered enveloped oncolytic virus for systemic delivery to metastatic sites, aiming to enhance the effectiveness of virotherapy [6]. - 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 [7].