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.