Calidi Biotherapeutics Inc. announced a corporate update outlining key milestones achieved in 2025 and plans for 2026. The company reported successful execution of its 2025 priorities, including demonstrating in clinically relevant immunocompetent murine models and ex vivo human immune assays that its RedTail platform can prevent immune clearance after systemic administration and selectively replicate in tumor cells. Calidi plans to file an Investigational New Drug $(IND)$ application in the fourth quarter of 2026 for its first RedTail lead candidate, CLD-401, which is designed to deliver high concentrations of IL-15 superagonist to the tumor microenvironment in patients with metastatic disease. Additionally, Calidi expects to present proof-of-concept data in 2026 demonstrating the versatility of the RedTail platform, including the simultaneous delivery of tumor-localized Bi-specific T cell engagers (BiTEs) alongside T-cell amplifiers. The company also aims to expand the platform’s applicability to non-oncology indications, exploring new payloads for inflammatory and immune diseases and targeting other cell types through envelope engineering. Calidi anticipates that initial dose cohorts for its lead candidate may be in the therapeutic range, allowing for early proof-of-concept data in phase I studies.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Calidi Biotherapeutics Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001493152-26-004089), on January 29, 2026, and is solely responsible for the information contained therein.