Calidi gets FDA pre-IND feedback on CLD-401, still targets Q1 2027 first dose

Calidi Biotherapeutics reported second quarter 2026 results on August 13, 2026, and said the FDA gave positive pre-IND feedback for CLD-401, indicating agreement on the current development strategy toward a first-in-human study targeting first patient dosing in Q1 2027.¹

During the pre-IND meeting, the FDA and Calidi reached agreement on key elements of the chemistry, manufacturing and controls plan and the non-clinical program, and the FDA commented on the design proposed for the first-in-human study.¹ This Type B pre-IND interaction followed earlier scientific advice obtained through a Type D meeting with the agency.¹ CEO Eric Poma said the company still expects CLD-401 to enter the clinic in the first quarter of 2027.¹

At the 2026 ASCO Annual Meeting, Calidi presented preclinical data on CLD-501, a program from its in situ T-cell engager approach. CLD-501 is a systemically delivered virotherapy designed to home in on tumors while driving high-level local expression of a TROP-2-targeted T-cell engager along with an IL-15 superagonist.¹ The company also shared preclinical findings on CLD-401 itself, describing it as a systemically delivered virotherapy built to selectively reach tumors and drive high expression of IL-15 superagonist, activating NK, NK-T and gamma delta T-cells and producing strong responses in immunocompetent animal models.¹

The board added Corsee Sanders, Ph.D., a former Genentech/Roche and Celgene executive, who advised Celgene's Chief Medical Officer after the Juno acquisition and spent 23 years at Genentech/Roche in senior clinical operations roles.¹

On finances, general and administrative costs fell by $1.5 million, or 48%, versus the same quarter in 2025.¹ Cash stood at $4.1 million as of June 30, 2026, down from $5.6 million at the end of 2025, with restricted cash unchanged at $0.2 million in both periods.¹ The company said it will keep managing expenses tightly to fund its pipeline.