Calidi Biotherapeutics and TransferAI Announce Strategic Partnership
New partnership enables Calidi's regulatory teams to move seamlessly from scientific documentation to AI-powered analysis, drafting, and review — in support of a year-end IND filing for CLD-401.
TransferAI Team
TransferAI, the domain-specific AI platform for biopharma technical operations, and Calidi Biotherapeutics (NYSE American: CLDI), a biotechnology company pioneering the development of targeted genetic medicines, today announced a strategic partnership to deploy TransferAI's Sofie platform in support of Calidi's IND submission for CLD-401. The partnership enables Calidi's regulatory, clinical, and manufacturing teams to coordinate complex multi-step regulatory workflows using Sofie's agentic AI, without interrupting established regulatory processes.
IND submissions require coordinating large volumes of scientific, clinical, and manufacturing documentation across multiple teams and review cycles. CLD-401, the lead candidate from Calidi's RedTail platform — a systemically delivered virotherapy designed to selectively target tumors and deliver therapeutic genetic payloads directly within the tumor — is currently in IND-enabling studies with a year-end filing target. Through the partnership, Calidi will use Sofie to support the coordination of multi-step regulatory workflows, helping teams manage cross-referencing, document drafting, and review activities with the precision and traceability required for high-stakes submissions.
The partnership is designed to support the full lifecycle of regulatory preparation for CLD-401's IND submission. Sofie works alongside Calidi's existing teams, preserving human oversight at critical decision points, while coordinating the research, documentation, and review workflows that span scientific, clinical, and manufacturing functions. This builds on the regulatory depth Calidi brings, whose members have collectively advanced multiple IND submissions across biologics and advanced therapeutic programs, with TransferAI providing agentic AI orchestration to accelerate execution across the full workflow.
"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 Biotherapeutics. "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 — and that's exactly what Sofie is built for," said Ryan Hawkins, Co-Chief Executive Officer of TransferAI. "Calidi's team brings remarkable scientific and regulatory expertise, and our role is to amplify that expertise through agentic orchestration — coordinating the research, cross-referencing, drafting, and review activities that make complex regulatory workflows faster and more reliable. We're proud to support Calidi's mission of advancing transformative genetic medicines to patients."
By connecting TransferAI's agentic AI platform with Calidi's experienced regulatory teams, the partnership aims to accelerate IND preparation, streamline documentation workflows, and unlock new efficiencies for biopharma teams working on complex, multi-disciplinary regulatory submissions.
About TransferAI
TransferAI is domain-specific AI for biopharma technical operations. Its platform, Sofie, streamlines work across regulatory affairs, tech transfer, manufacturing, and quality management — from document drafting and data analysis to meeting intelligence and end-to-end workflow automation — to drive efficiency, precision, and traceability. Biotechs, CDMOs, and biopharma companies use TransferAI to move faster from development to patients. For more information, visit www.usetransfer.ai.
About Calidi Biotherapeutics
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, intended to reach tumor sites, induce tumor lysis, and deliver potent genetic medicine(s) to metastatic locations. For more information, visit www.calidibio.com.