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CLDI News
CLDI Events
Calidi Receives FDA Pre-IND Feedback to Advance CLD-401 Clinical Study
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 Financial Report Emphasizes Going Concern Assumption
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 to Present New Data on CLD-401 at AACR Meeting in 2026
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
Calidi Biotherapeutics Presents New Data on CLD-401 at AACR Meeting
Calidi Biotherapeutics presented new data at the American Association of Cancer Research, AACR, annual meeting in San Diego, California on April 19, 2026. The Company demonstrated new data on its approach of simultaneously activating T-cells while inducing the expression of T-cell engagers specifically in situ in the tumor microenvironment, TME. RedTail is Calidi's systemically delivered virotherapy platform designed to selectively target tumors, remodel the TME, and enable high-level expression of therapeutic genetic payloads directly at the tumor site while limiting peripheral exposure. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 superagonist, a known CD8 T-cell, NK cell, and gamma delta T-cell activator, in the TME. The Company expects to file an IND for CLD-401 by the end of 2026.
Calidi Biotherapeutics Presents CLD-401 Manufacturing Process at BioProcessing Summit
Calidi Biotherapeutics presented on its proprietary manufacturing process for CLD-401 at the BioProcessing Summit in Barcelona. RedTail is Calidi's systemically delivered virotherapy platform designed to selectively target tumor cells, remodel the tumor microenvironment, and enable high-level expression of therapeutic genetics at the tumor. CLD-401 is designed to reach metastatic sites, replicate only in tumor cells, and express high levels of IL-15 superagonist, a known T-cell and Natural Killer cell activator, in the TME. "The process discussed today highlights key scalability properties of the manufacturing system we have developed for the RedTail platform and CLD-401" said Antonio Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "Based on our interactions with the FDA, we believe this process can be used to support CLD-401 through clinical development with the ultimate goal of commercialization."
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