Calidi Biotherapeutics, Inc. (CLDI) reported a net loss of $20.1 million for the year ended December 31, 2025, compared to a net loss of $22.2 million for the previous year, representing a 10% decrease in net loss. The company, a biotechnology firm focused on developing targeted therapies, has not generated any revenue from product sales to date. Research and development expenses increased to $9.7 million from $8.9 million in the prior year, driven by higher consulting, rent, drug manufacturing, preclinical, and office expenses, partially offset by a decrease in salaries and benefits.

General and administrative expenses decreased to $10.5 million from $12.9 million, primarily due to lower insurance, legal, accounting, public company, investor relations, and rent expenses. Other income, net, was $0.2 million, compared to an expense of $0.4 million in the prior year, mainly due to decreased interest expense and a gain on the sale of an investment in Nova Cell, partially offset by a change in fair value of other liabilities and derivatives. As of December 31, 2025, Calidi had $5.6 million in cash and restricted cash of $0.2 million.

Strategic developments during the year included the presentation of new data on CLD-401 at the Society of Immunotherapy for Cancer Annual Meeting. The company also executed a Stock Repurchase Agreement and Material Purchase Agreement with Nova Cell, resulting in the sale of its 75% ownership interest in Nova Cell for $6.0 million. In January 2025, Calidi conducted a Confidentially Marketed Public Offering (CMPO), raising approximately $4.3 million in gross proceeds. In March 2025, the company entered into a Securities Purchase Agreement for a registered direct offering and concurrent private placement, and in July 2025, it executed a warrant inducement offer agreement, generating approximately $4.6 million in gross proceeds.

Key operational developments included the advancement of the RedTail platform and the receipt of Fast Track Designation from the FDA for CLD-201. As of December 31, 2025, Calidi had 29 employees. The company's financial statements include a going concern disclosure, as it believes its existing cash will not be sufficient to fund operating expenses and capital expenditure requirements for the next twelve months. Calidi anticipates submitting to the FDA for its lead RedTail product candidate, CLD-401, for a first-in-human Phase 1 clinical trial in patients with metastatic solid tumors by the end of 2026.

About Calidi Biotherapeutics, Inc.

Calidi Biotherapeutics is a clinical-stage immuno-oncology company developing proprietary allogeneic stem cell and enveloped virus platforms to deliver oncolytic viruses for cancer treatment. Its product candidates aim to enhance viral delivery, protect against immune neutralization, and modify tumor microenvironments. Focused on solid tumors and brain cancers, Calidi leverages off-the-shelf cell therapies to improve efficacy and safety in cancer immunotherapy.

This description was generated via AI from an annual report. Updated 8 months ago.

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