Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Operational Highlights

March 28, 2026 - 04:19

Calidi Biotherapeutics has announced significant strides across its clinical pipeline and operational strategy, highlighted by a new partnership and key regulatory feedback. The company has entered into a collaboration with an Australian clinical research organization (CRO) designed to accelerate the initiation of the clinical trial for its lead candidate, CLD-401.

On the regulatory front, Calidi has engaged in productive Type D interactions with the U.S. Food and Drug Administration (FDA). Following this feedback, the company reports that its proposed manufacturing and analytical methods for CLD-401 are aligned with the agency's guidance. This alignment supports Calidi's plan to submit an Investigational New Drug (IND) application for CLD-401 by the end of 2026. To bolster this effort, Calidi has also partnered with Matica Bio for the Good Manufacturing Practice (GMP) production of the therapy.

Beyond its lead program, Calidi showcased new preclinical data at a major oncology conference, presenting findings on its platform of in situ T-cell engagers (TCEs). This research underscores the broader potential of its technology platform. To fund these ongoing initiatives, the company recently secured $6.5 million in a public offering, providing capital to advance its novel immuno-oncology therapeutics toward the clinic.