On March 27, 2026 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported its fourth quarter and full-year 2025 operating and financial results and reviewed recent business highlights.

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"We are extremely excited about the continued progress at Calidi," said Eric Poma, PhD, CEO of Calidi Biotherapeutics. "We continue to advance CLD-401, the first lead from our RedTail platform, towards the clinic and have built a world-class scientific advisory board to aid those efforts. We have also expanded what the RedTail platform can do with our new approach of in situ T-cell engagers."

Fourth Quarter 2025 and Recent Corporate Developments

Partnered with Avance Clinical, a full-service contract research organization (CRO) with a proven track record and experience in obtaining regulatory approval and clinical trial initiation in Australia. The partnership is focused on rapidly initiating a first-in-human clinical trial for CLD-401 in Australia. CLD-401, the Company’s lead asset, is a systemically delivered oncolytic virus that replicates only in tumor cells. CLD-401 induces high concentrations of IL-15 superagonist (IL15 SA) expression in the tumor microenvironment while limiting peripheral exposure.

In parallel, Calidi is pursuing an IND filing with the FDA by the end of 2026. Calidi has interacted with the FDA around the Company’s manufacturing and analytical approaches through its Type D meeting request process. The feedback it has received from the agency supports the use of this process for the clinical development of CLD-401.

Partnered with Matica Bio, a leading CDMO in the field of oncolytic virus manufacturing, for the GMP manufacturing of CLD-401. Matica has successfully executed multiple oncolytic virus programs at its state-of-the-art, purpose-built GMP facility in College Station, Texas. That facility was designed specifically to support complex viral vector modalities like CLD-401.

Presented data demonstrating the expression of an in situ T-cell engagers (TCEs) for solid tumors and the simultaneous expression of a T-cell activating agent (e.g., IL-15 SA) through its systemically delivered RedTail platform at the AACR (Free AACR Whitepaper) Immuno-Oncology (AACR-IO) conference. High expression of in situ TCE coincident with expression of a T-cell activator in the TME may overcome the traditional limitations of TCEs in solid tumor.

Raised $6.0 million in gross proceeds from an underwritten public offering with new and existing investors in Q1-2026 and $0.5 million in gross proceeds from the sale of stock under our ATM in Q4-2025, strengthening the balance sheet and extending Calidi’s cash runway.

Fourth Quarter 2025 Financial Results

The company reported a net loss attributable to common stockholders of $4.1 million, or $0.57 per share, for the three months ended December 31, 2025, compared to a net loss attributable to common stockholders of $4.1 million, or $3.23 per share, for the same period in 2024.

Research and development expenses were $2.4 million for the three months ended December 31, 2025, compared to $1.8 million for the comparable period in 2024, respectively.

General and administrative expenses were $2.1 million for the three months ended December 31, 2025, compared to $2.2 million for the comparable period in 2024, respectively.

Full Year 2025 Financial Results

The company reported a net loss attributable to common stockholders of $25.6 million, or $5.95 per share, for the year ended December 31, 2025, compared to a net loss attributable to common stockholders of $23.8 million, or $35.70 per share, for the year ended December 31, 2024.

Research and development expenses were $9.7 million for the year ended December 31, 2025, compared to $8.9 million for the year ended December 31, 2024, respectively.

General and administrative expenses were $10.5 million for the year ended December 31, 2025, compared to $12.9 million for the year ended December 31, 2024, respectively.

The company had approximately $5.6 million in cash and $0.2 million in restricted cash as of December 31, 2025, compared to $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024.

(Press release, Calidi Biotherapeutics, MAR 27, 2026, View Source [SID1234663988])