Calidi Biotherapeutics, Inc. (CLDI) reported a net loss of $22.2 million for the year ended December 31, 2024, compared to a net loss of $29.2 million in 2023. The company's research and development expenses decreased by $4.1 million to $8.9 million in 2024, primarily due to lower drug manufacturing and preclinical study costs. General and administrative expenses also decreased by $3.1 million to $12.9 million, mainly due to lower compensation and legal expenses. Other income (expense), net, increased by $0.2 million to a net expense of $0.4 million in 2024, primarily due to decreased grant income and changes in the fair value of certain financial instruments.
Significant changes compared to the previous fiscal year include the completion of the business combination with First Light Acquisition Group, Inc. on September 12, 2023, resulting in the issuance of 2,737,560 shares of Calidi common stock as merger consideration. The company also completed several equity financings during 2024, including a public offering, confidentially marketed public offerings, and a private placement, raising approximately $22.7 million in gross proceeds. A 1-for-10 reverse stock split was also implemented on July 15, 2024. A Standby Equity Purchase Agreement with YA II PN, Ltd. was terminated on January 23, 2025.
Key operational developments include the advancement of several product candidates. CLD-101 (NeuroNova™ platform) for newly diagnosed high-grade glioma is in a Phase 1b/2 clinical trial, while CLD-101 for recurrent HGG is in a Phase 1 clinical trial. The company filed an Investigational New Drug application for CLD-201 (SuperNova™ platform) in March 2025, anticipating a Phase 1 clinical trial in the first half of 2025. Preclinical research continues on CLD-301 (AAA platform) and CLD-400 (RTNova platform). As of December 31, 2024, Calidi had 28 employees, 17 of whom were involved in research and development.
The company's 10-K filing highlights several risk factors, including the significant operating losses incurred since inception, the need for substantial additional funding, the inherent uncertainties in biopharmaceutical product development, and the intense competition in the immuno-oncology market. The filing also details the complexities of regulatory approvals, potential product liability, and the challenges associated with intellectual property protection and commercialization. Calidi acknowledges substantial doubt about its ability to continue as a going concern due to its recurring operating losses and the need for additional funding. The company's outlook is contingent upon successful clinical trials, regulatory approvals, and securing sufficient funding to support its operations.
About Calidi Biotherapeutics, Inc.
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