Announced partnership with Australian CRO to accelerate initiation of CLD-401 clinical trialThe Company has received feedback from the FDA through Type D interactions, and the Company believes its manufacturing and analytical approaches for CLD-401 are in alignment with FDA guidance; Calidi expects to file an IND by end of 2026Partnered with Matica Bio around the GMP manufacturing of CLD-401Presented new data on in situ T-cell engagers (TCEs) at 2026 AACR-IO conferenceRaised $6.5 million in public offering ...

SAN DIEGO, March 24, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today announced a partnership with Avance Clinical, a full-service contract research organization (CRO) with a proven track record and experience in obtaining regulatory approval and clinical trial initiation in Australia. The partnership is focused on rapidly initiating a first-in-human clinical trial ...

Core Viewpoint - Calidi Biotherapeutics is advancing its proprietary RedTail platform and its lead candidate CLD-401, which targets metastatic tumors and aims to enhance the delivery of genetic medicines [1][6]. Group 1: Company Overview - Calidi Biotherapeutics is a biotechnology company focused on developing targeted therapies for delivering genetic medicines to distal sites of disease [6]. - The RedTail platform utilizes an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites, shielding the virus from immune clearance [6]. Group 2: Product Development - CLD-401 is the first lead candidate from the RedTail platform, currently in IND-enabling studies, targeting non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need [7]. - The company anticipates submitting an Investigational New Drug (IND) application for CLD-401 by the end of 2026 [5]. Group 3: Manufacturing and FDA Interaction - Calidi presented its proprietary manufacturing process for CLD-401 at the BioProcessing Summit, emphasizing its scalability and high-yield capabilities [3]. - The manufacturing process maintains the integrity of the CD55 over-expressing envelope, which is crucial for systemic delivery and preventing immune recognition [3]. - Feedback from the FDA supports the company's manufacturing and analytical approaches, indicating a positive outlook for clinical development [4][5]. Group 4: Strategic Partnerships and Future Plans - The company is actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform [5]. - Calidi continues to expand the functionality of the RedTail platform, including incorporating T-cell engagers in solid tumors [7].

Core Insights - Calidi Biotherapeutics is presenting data on its innovative RedTail platform for targeted genetic medicines at the AACR Immuno-Oncology conference, focusing on its application in solid tumors [1][3] Group 1: RedTail Platform - The RedTail platform is designed for systemic delivery of virotherapy, targeting tumors and remodeling the tumor microenvironment (TME) to enhance therapeutic efficacy [2][5] - CLD-401, the lead candidate from the RedTail platform, is engineered to express high levels of IL-15 superagonist (IL-15 SA), which activates T-cells within the TME [2][6] Group 2: Clinical Development - Data presented indicates that RedTail can express both a functional BiTE and IL-15 SA, facilitating T-cell activation and TME alteration simultaneously, potentially overcoming previous limitations of BiTEs in solid tumors [3][4] - Calidi 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 plans to submit an Investigational New Drug (IND) application by the end of 2026 [4][6] Group 3: Company Overview - Calidi Biotherapeutics is focused on developing targeted therapies that deliver genetic medicines to metastatic disease sites, utilizing an engineered enveloped oncolytic virus to shield from immune clearance [5][6] - The company is actively pursuing strategic partnerships to enhance clinical development and expand the impact of its RedTail platform [4]

Core Insights - Calidi Biotherapeutics is set to present data on its innovative use of BiTEs in solid tumors through its RedTail platform at the AACR Immuno-Oncology conference from February 18-21, 2026 [1] Company Overview - Calidi Biotherapeutics is a biotechnology company focused on developing targeted genetic medicines, utilizing its proprietary RedTail platform for systemic delivery to metastatic sites [5] - The RedTail platform employs an engineered enveloped oncolytic virus designed to evade immune clearance, allowing effective delivery of genetic medicines to tumor sites [5] Product Development - The lead candidate from the RedTail platform, CLD-401, is engineered to express high levels of IL-15 superagonist, which activates T-cells within the tumor microenvironment [2][3] - CLD-401 is currently in IND-enabling studies and targets non-small cell lung cancer, head and neck cancer, and other tumor types with significant unmet medical needs [6] - The company plans to submit an Investigational New Drug (IND) application for CLD-401 by the end of 2026 [4] Technological Advancements - The RedTail platform has shown the ability to remodel the tumor microenvironment and induce T-cell activation, which is crucial for overcoming the limitations of BiTEs in solid tumors [3] - The platform allows for the simultaneous expression of multiple tumor-localized payloads, enhancing the potential for effective treatment [3] Strategic Initiatives - Calidi is actively pursuing strategic partnerships to accelerate the clinical development of its RedTail platform and broaden its impact in the biotechnology sector [4]

Core Insights - Calidi Biotherapeutics, Inc. has successfully executed its 2025 priorities and is set to file an IND application for its lead candidate CLD-401 by the end of 2026 [2][4][9] 2025 Accomplishments - The company demonstrated the effectiveness of its RedTail platform in preventing immune clearance and specifically targeting tumor cells, achieving comparable genetic medicine expression levels to localized dosing while avoiding systemic exposure [2][5] - CLD-401, the first lead candidate, is designed to deliver high concentrations of IL-15 superagonist to the tumor microenvironment in patients with metastatic disease [4][9] - New preclinical data presented at ASCO and SITC showed enhanced biological efficacy of CLD-401 in immunocompetent tumor models, confirming its ability to replicate in tumor cells and avoid immune clearance [5][6] - The management team was strengthened with the appointment of Eric Poma, PhD, as CEO and Guy Travis Clifton, MD, as CMO, both bringing extensive biopharmaceutical experience [5][8] Financial Performance - Calidi reduced its term debt and notes payable by $3.1 million in 2025, decreasing from $3.8 million at the end of 2024 to $0.7 million at the end of 2025 [8] - General and administrative expenses were reduced by $2.3 million in the first nine months of 2025 compared to the same period in 2024 [8] 2026 Anticipated Milestones - The company plans to conduct a Phase I study for CLD-401 targeting non-small cell lung cancer, triple-negative breast cancer, and head and neck cancer, with proof-of-concept data expected early in the trial [4][9] - Calidi aims to present data demonstrating the versatility of the RedTail platform for delivering tumor-localized BiTEs alongside T-cell amplifiers, addressing previous efficacy challenges in solid tumors [4][9] - The company is exploring new payloads for inflammatory and immune diseases, targeting other cell types through envelope engineering [4][9]

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]

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]