On March 31, 2025 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, reported its fourth quarter and full-year 2024 operating and financial results and reviewed recent business highlights (Press release, Calidi Biotherapeutics, MAR 31, 2025, View Source [SID1234653217]).

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"Calidi continues to make great progress on all three of our platforms; our systemic asset CLD-400 proved it can deliver a gene therapy payload to targeted tumors, we filed an IND for our solid tumor asset CLD-201, and our CLD-101 program treating high-grade glioma is advancing in two Phase 1 trials," said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. "We think our multi-modal mechanism of action is a game changer in treating multiple deadly cancers, including metastatic cancer and lung cancer, solid tumors and high-grade glioma."

Fourth Quarter 2024 and Recent Corporate Developments

New data showed that a single dose of a tumor-selective triple knockout ("3KO") RT virus genetically engineered to encode a specific immune-boosting payload (undisclosed) increased the antitumor immune response. These increased shifts in immune composition, driven by virotherapy encoding a payload, ultimately led to complete eradication of certain tested tumors in the preclinical model.
In March 2025, Calidi filed an IND for a company sponsored, open label dose escalation trial of CLD-201 in adult patients with solid tumors, specifically with the indications of breast cancer, head & neck squamous cell carcinoma, and soft tissue sarcoma.
In February 2025, Northwestern University hospital started recruiting for the CLD-101 Phase 1 clinical trial in patients with newly diagnosed high-grade glioma, an aggressive and often fatal form of brain cancer. This physician-led and NCI sponsored clinical trial, led by prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp, builds on the promising results from a prior Phase 1 trial involving 12 patients treated with a single dose of CLD-101 published in the prestigious journal The Lancet Oncology.
City of Hope and Calidi announced the 14th patient treated in a physician-sponsored Phase 1 trial assessing the safety and feasibility of a multi-dosing regimen to treat recurrent high-grade glioma. This program has secured $12 million award from the California Institute for Regenerative Medicine (CIRM) to support this groundbreaking study.
Upcoming Anticipated Milestones

Q2 2025: Payload and lead candidate information revealed on CLD-400 systemic platform
Q2 2025: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients
Q3 2025: First patient dosed in CLD-201 Phase 1 trial
Fourth Quarter 2024 Financial Results

The company reported a net loss attributable to common stockholders of $4.1 million, or $0.27 per share, for the three months ended December 31, 2024, compared to a net loss attributable to common stockholders of $8.2 million, or $0.23 per share, for the same period in 2023.

Research and development expenses were $1.8 million for the three months ended December 31, 2024, compared to $4.0 million for the comparable period in 2023, respectively.

General and administrative expenses were $2.2 million for the three months ended December 31, 2024, compared to $5.9 million for the comparable period in 2023, respectively.

Full Year 2024 Financial Results

The company reported a net loss attributable to common stockholders of $23.8 million, or $2.97 per share, for the year ended December 31, 2024, compared to a net loss attributable to common stockholders of $29.2 million, or $17.33 per share, for the year ended December 31, 2023.

Research and development expenses were $8.9 million for the year ended December 31, 2024, compared to $13.0 million for the year ended December 31, 2023, respectively.

General and administrative expenses were $12.9 million for the year ended December 31, 2024, compared to $16.0 million for the year ended December 31, 2023, respectively.

The company had approximately $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024, compared to $1.9 million in cash and $0.2 million in restricted cash as of December 31, 2023.