Calidi Biotherapeutics Raises $4.25M in Public Offering, Advancing Pipeline and Market Position

Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, has announced the closing of a $4.25 million public offering of common stock. This funding round is a testament to the company's innovative approach to cancer treatment and its potential to make a significant impact on the lives of patients.

The $4.25 million public offering will enable Calidi to continue advancing its pipeline, including CLD-101, CLD-201, and CLD-202. These programs utilize a potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications. The funding will support the company's mission to push the frontiers of stem cells and oncolytic viral therapies and make a difference in the lives of patients.

Calidi's CLD-101 program is currently in a Phase 1b clinical trial for the treatment of high-grade glioma. The study focuses on the safety and feasibility of delivering up to four weekly intracerebral doses of CRAd-S-pk7 to patients with recurrent high-grade gliomas. The initial patient began treatment in May 2023, and currently, three patients in Treatment Schedule 2 and three in Treatment Schedule 3 have been enrolled and treated safely. Calidi is currently enrolling patients in Treatment Schedule 4.

CLD-201, another key program in Calidi's pipeline, is in preclinical trial for the treatment of advanced solid tumors, such as triple-negative breast cancer, metastatic lung cancer, and metastatic melanoma. Non-clinical data presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting supports the upcoming Phase 1 clinical trial for CLD-201. Animals treated with the maximum tolerated dose of 2e6 PU/animal showed no signs of adverse toxicity and exhibited a reduction in tumor volume compared to the control group. No toxicity findings were associated with CLD-201 in the disease-free model, and additionally, virus detection in the lungs was cleared within two weeks following the last CLD-201 treatment.



CLD-202, a novel systemic enveloped oncolytic virotherapy targeting all tumor sites, has also shown promising preclinical data. This technology enables targeted delivery of oncolytic viruses to multiple tumor sites, killing tumor cells, and expressing any desired protein within the tumor, thus modifying the tumor microenvironment. In preclinical murine models, envRT-01 targeted multiple tumor types and led to tumor growth inhibition with a single systemic injection of 4.5e6 PFU env-RT-01. envRT-01 induced changes in tumor immune microenvironment, targeted lung cancer and metastatic sites, and induced dramatic changes in lung metastasis tumor microenvironments.

This investment aligns with Calidi's long-term strategy of advancing allogeneic stem cell and oncolytic virus combinations for multiple oncology indications. By focusing on this innovative technology, Calidi positions itself as a leader in the immuno-oncology space, targeting unmet needs in cancer treatment. The Series B funding led by Jackson Investment Group and participation from Calidi Cure, LLC further supports this strategy and enables Calidi to continue pushing the frontiers of stem cells and oncolytic viral therapies, ultimately making a difference in the lives of patients.

In conclusion, Calidi Biotherapeutics' $4.25 million public offering of common stock is a significant milestone in the company's mission to develop targeted immunotherapies for various cancer indications. With this funding, Calidi is well-positioned to continue advancing its pipeline and solidifying its market position in the immuno-oncology space. As the company's programs, including CLD-101, CLD-201, and CLD-202, progress through clinical development, investors can expect to see a strong return on their investment in Calidi's innovative approach to cancer treatment.