CLDI News & Events

Calidi announced that it has received pre-IND regulatory feedback from the FDA providing alignment and clarity on Calidi's IND-enabling preclinical plans and clinical strategy for CLD-401 prior to advancing the drug candidate into Phase 1 clinical studies. In the pre-IND meeting, the FDA and Calidi agreed on key aspects of the CMC and non-clinical programs as well as feedback on the overall design for the proposed first-in-human clinical study. This pre-IND interaction builds on the engagement and alignment achieved through early scientific advice as part of a Type D interaction with the FDA. Calidi is committed to rapidly advancing CLD-401 into the clinic, believing that early Phase I data for CLD-401 will validate the company's proprietary RedTail platform. The company continues to expand the functionality of the RedTail platform while actively pursuing strategic partnerships to accelerate clinical development and broaden its impact.

Calidi Biotherapeutics advised that its Financial Statements included in its Annual Report on Form 10-K for the year ended December 31, 2025, contained an audit report from its Independent Registered Public Accounting Firm with an explanatory paragraph emphasizing that the Consolidated Financial Statements were prepared assuming that the company will continue as a going concern.

Calidi Biotherapeutics will present new data at the American Association of Cancer Research, AACR, annual meeting in San Diego, California on April 21 2026. The Company showcased new data on CLD-401, a systemically delivered oncolytic virus that is designed to express high levels of IL-15 superagonist only in the tumor microenvironment, currently in IND-enabling studies. The Company expects to file an IND for CLD-401 by the end of 2026. Data at AACR detailed the immune changes in the TME induced by CLD-401 including the recruitment and activation of NK, NK-T, and gamma delta (gammadelta) T-cells that lead to a therapeutic response in the immunocompetent animal models. In addition to IL-15 SA delivery with CLD-401, the RedTail platform has also been shown to enable in situ expression of tumor-targeted T cell engagers, as demonstrated in a separate AACR presentation focused on the CLD-501 program