Calidi Biotherapeutics reports Q4 and full-year 2023 results

Calidi Biotherapeutics Inc. reported its fourth quarter and full-year 2023 operating and financial results and reviewed recent business highlights.

“Calidi continues to make great progress across our development programs while continuing to innovate and expand our industry-leading position in cell-based immunotherapies,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “We anticipate reporting an interim clinical update from our Phase 1 trial evaluating CLD-101 in high-grade glioma patients in collaboration with City of Hope in the second quarter of this year assuming we are successful in raising additional capital, and we were thrilled to recently strengthen our collaboration with City of Hope to evaluate CLD-101 for the treatment of ovarian cancer with the support of CIRM. In addition, we were proud to recently unveil our potentially paradigm-shifting advance in the treatment of advanced solid tumors, including lung cancer and metastatic disease, that required a systemic application, through our RTNova systemic delivery approach.”

Fourth quarter 2023 and recent corporate developments

• City of Hope, a leader in cancer research and treatment, was awarded $5.3 million to further support preclinical translational studies, product manufacturing (using Calidi’s next generation manufacturing process) and clinical trial design for ovarian cancer using Calidi’s licensed oncolytic virotherapy product, CLD-101. CLD-101 is a cutting-edge therapeutic candidate in Calidi’s NeuroNova program, comprising tumor-tropic neural stem cells (NSCs) that deliver an oncolytic adenovirus – CRAd-S-pk7 – selectively to tumor sites.
• Publicly announced novel systemic enveloped oncolytic virotherapy program, RTNova (CLD-400), targeting advanced solid tumors, including advanced metastatic disease. The new program builds upon Calidi’s experience using stem cells to protect oncolytic viruses from inactivation by the patient’s immune system allowing for easier administration, increased cost-effectiveness, and the ability to reach a broad patient population.
• Appointed Antonio Chiocca, M.D., Ph.D., David T. Curiel, M.D., Ph.D., and Burt L. Nabors, M.D., to the company’s Scientific and Medical Advisory Board. These physician scientists bring a deep expertise in oncology, hailing from top cancer research institutions and facilities.
• Announced the appointment of David LaPré to the company’s Board of Directors. Mr. LaPré brings significant experience in technical operations strategy and execution in the pharmaceutical industry.
• Received patent covering novel SuperNova technology platform (CLD-201) composed of adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus. This patent strengthens the company’s robust intellectual property portfolio as Calidi plans to initiate a clinical trial in the second half of 2024. Calidi has shown preclinically the potential of SuperNova to shield the viral payload from the immune system allowing for its delivery to tumor sites.

Fourth Qquarter 2023 financial results
The company reported a net loss of $8.2 million, or $0.23 per share, for the three months ended December 31, 2023, compared to a net loss of $7.8 million, or $0.90 per share, for the same period in 2022.

Research and development expenses were $4.0 million for the three months ended December 31, 2023, compared to $2.3 million for the comparable period in 2022, respectively.

General and administrative expenses were $5.9 million for the three months ended December 31, 2023, compared to $2.4 million for the comparable period in 2022, respectively.

Full year 2023 financial results
The company reported a net loss of $29.2 million, or $1.73 per share, for the year ended December 31, 2023, compared to a net loss of $25.4 million, or $2.99 per share, for the year ended December 31, 2022.

Research and development expenses were $13.0 million for the year ended December 31, 2023, compared to $7.3 million for the year ended December 31, 2022, respectively.

General and administrative expenses were $16.0 million for the year ended December 31, 2023, compared to $15.9 million for the year ended December 31, 2022, respectively.

The company had approximately $1.9 million in cash and $0.2 million in restricted cash as of December 31, 2023, compared to $0.4 million in cash and $0.2 million in restricted cash as of December 31, 2022.
MB Bureau