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Calidi Biotherapeutics Announces Exclusive Live Investor Webinar and Q&A Session on November 19, 2025
Globenewswire· 2025-11-17 13:00
Core Insights - Calidi Biotherapeutics is hosting a webinar on November 19, 2025, to discuss its innovative approach to precision genetic medicine using the RedTail platform [1][2] - The RedTail platform is designed to deliver genetic medicines to metastatic tumor sites while avoiding immune detection, showcasing promising preclinical data [2][3] - The oncology market is projected to exceed $560 billion by 2033, presenting significant growth opportunities for Calidi [3] Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted therapies for delivering genetic medicines to distal disease sites [1][6] - The proprietary RedTail platform utilizes an engineered enveloped oncolytic virus for systemic delivery, aiming to effectively reach tumor sites and induce tumor lysis [6][7] - The lead candidate from the RedTail platform targets non-small cell lung cancer, ovarian cancer, and other high unmet medical need tumor types [7] Financial Position - The third quarter 2025 earnings report indicated a strengthened balance sheet with reduced debt and an increased cash balance, alongside a decrease in general and administrative spending [3]
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 to Present at the H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-09-02 12:00
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]
Calidi Biotherapeutics Reports Second Quarter 2025 Financial Results and Recent Operational Highlights
Globenewswire· 2025-08-08 20:15
Core Viewpoint - Calidi Biotherapeutics is making significant progress in developing targeted therapies for cancer treatment, particularly through its RedTail platform, which aims to deliver genetic medicines to metastatic sites and enhance the efficacy of oncolytic viruses [2][6]. Financial Results - For Q2 2025, Calidi reported a net loss of $5.7 million, or $1.99 per share, an improvement from a net loss of $7.4 million, or $16.75 per share, in Q2 2024 [4][16]. - Research and development expenses increased to $2.6 million in Q2 2025 from $2.2 million in the same period in 2024 [4]. - General and administrative expenses decreased to $3.1 million in Q2 2025 from $3.6 million in Q2 2024 [5]. Cash Position - As of June 30, 2025, the company had approximately $5.3 million in cash and $0.1 million in restricted cash, down from $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024 [5]. Recent Corporate Developments - Calidi presented preclinical data at ASCO demonstrating the efficacy of its lead compound CLD-401, which targets metastatic tumor sites and reduces immune clearance [6][7]. - The company received FDA Fast Track Designation for CLD-201, a first-in-class stem-cell loaded intratumoral viral therapy for soft tissue sarcoma [6][7]. - Calidi raised $4.6 million in gross proceeds through a warrant inducement offering, increasing total gross proceeds in 2025 to $15.7 million [6][7]. Product Development - The RedTail platform features an engineered enveloped oncolytic virus designed for systemic delivery, targeting metastatic sites while avoiding immune clearance [8]. - The lead candidate from the RedTail platform is currently in IND-enabling studies and targets non-small cell lung cancer, ovarian cancer, and other high unmet medical need tumor types [9].
Calidi Biotherapeutics Presents systemic oncolytic platform with CD55-Enhanced expression and IL-15 Superagonist Payload at ASCO Annual Meeting
Globenewswire· 2025-06-02 12:00
Core Insights - Calidi Biotherapeutics Inc. is a clinical-stage biotechnology company focused on developing systemic oncolytic targeted immunotherapies, with its lead candidate CLD-401 presented at the ASCO Annual Meeting [1][2] Group 1: Technology and Innovation - Calidi has developed an enveloped form of its proprietary oncolytic virus that shows greater resistance to immune clearance, enhancing systemic delivery and efficacy in pre-clinical models [2] - The novel genetic modification in CLD-401 incorporates a chimeric CD55 receptor into the virus envelope, which inhibits complement-mediated clearance, improving the virus's stability in circulation [2][4] - The RedTail platform allows for the delivery of genetic payloads directly into the tumor microenvironment, with CLD-401 expressing an IL-15 superagonist to activate and expand natural killer (NK) cells and CD8+ T cells [3][4] Group 2: Strategic Development - Calidi is conducting IND-enabling studies for CLD-401 and plans to submit an Investigational New Drug (IND) application in the second half of 2026 [4] - The company is actively seeking strategic partnerships to accelerate clinical development and enhance the impact of its RedTail platform [4][6] - The lead candidate targets non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical needs [7]