SAN DIEGO, April 29, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, announced today that it has entered into a collaboration with TransferAI to drive efficiencies in its IND submission for CLD-401 by using TransferAI’s proprietary agentic artificial intelligence platform, SofieTM, including pre-built and customizable orchestrations for biopharma.
CLD-401 is the lead candidate from the Company’s RedTail platform, a systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment, and enable high-level expression of therapeutic genetic payloads directly within the tumor. CLD-401 is engineered to express high levels of IL-15 superagonist (“IL-15 SA”), a known activator of CD8 T-cells, gamma delta T-cells, and NK cells. IND-enabling studies are underway for CLD-401, and the IND filing is expected byyear end. Calidi will utilize TransferAI’s industry-leading expertise in using AI-powered regulatory workflows to support and streamline regulatory efforts. This initiative builds on Calidi’s experienced clinical, regulatory, and manufacturing teams, whose members have collectively supported and advanced multiple IND submissions across biologics and advanced therapeutic programs, with TransferAI providing agentic AI orchestration to support complex, multi-step regulatory workflows within established regulatory processes.
“We believe that TransferAI is the best partner to bring the power of agentic AI to support our regulatory efforts around CLD-401,” said Eric Poma, PhD, Chief Executive Officer of Calidi. “TransferAI’s Sofie platform works alongside our teams, helping orchestrate complex regulatory workflows while preserving the rigor required for IND submissions, and we believe it will meaningfully support our goal of submitting the CLD-401 IND by year end.”
“IND submissions demand precision, traceability, and deep regulatory context,” said Ryan Hawkins, Co-Chief Executive Officer of TransferAI. “Sofie, our platform for agentic AI orchestration, is designed to help coordinate research, cross-referencing, drafting, and review activities across regulatory workflows, allowing biopharma teams like Calidi’s to focus on scientific, manufacturing and clinical execution.”
Calidi believes it can rapidly demonstrate the promise of its systemic virotherapy early in phase I. The Company continues to expand the functionality of the RedTail platform, with data presented at AACR across multiple programs including CLD-401 and CLD-501, and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.
About Calidi
Calidi Biotherapeutics (NYSE American: CLDI) is a biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The company’s proprietary RedTail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent genetic medicine(s) to metastatic locations.
CLD-401, the lead candidate from the RedTail platform, currently in IND-enabling studies, targets non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need. Calidi continues to advance its pipeline utilizing the RedTail platform including its novel approach to incorporate in situ T-cell engagers in solid tumors.
Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or view Calidi’s Corporate Presentation here.
About TransferAI
TransferAI is a force multiplier for biopharma operations. The company's agentic AI platform, purpose-built for the industry, amplifies what teams can accomplish across development, manufacturing, supply chain, quality, and regulatory by removing the friction and turbulence from technical workflows that move medicines to patients. TransferAI is headquartered in Austin, Texas. For more information, please visit www.usetransfer.ai.
Forward-Looking Statements
This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning key milestones, including certain pre-clinical data, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s annual report filed with the SEC on Form 10-K on March 27, 2026, as may be amended or supplemented by other reports we file with the SEC from time to time. We disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
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