News & Events zu Calidi Biotherapeutics Inc (CLDI)CLDICalidi Biotherapeutics Inc

Calidi Biotherapeutics Issues 1,025,640 Shares at $1.17 Each

Calidi Biotherapeutics announced that it has entered into a definitive stock purchase agreement with certain accredited investors and/or qualified institutional buyers for the purchase and sale of 1,025,640 shares of the company's common stock, in a registered direct offering, at a per share purchase price of $1.17. The closing of the registered direct offering is expected to occur on or about September 18, subject to the satisfaction of customary closing conditions. The gross proceeds to Calidi from the registered direct offering, before deducting offering expenses payable by the company, are expected to be approximately $1.2M. Calidi intends to use the net proceeds from the offering for working capital and for general corporate purposes.

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.