Calidi Biotherapeutics Inc. (NYSE American: CLDI) is advancing its targeted antitumor virotherapy programs, NeuroNova (CLD-101) and RTNova (CLD-400), despite reporting a net loss of $5.1 million for the third quarter of 2024. The company's efforts to combat high-grade glioma and solid tumors are underpinned by recent FDA clearance for NeuroNova and promising data presentations for RTNova. However, financial constraints necessitate careful management as clinical trials approach.
FDA Clearance and Clinical Trial Plans for NeuroNova
The FDA has cleared Northwestern University's Investigational New Drug (IND) application for NeuroNova (CLD-101), a stem cell-based platform designed to deliver oncolytic viruses to tumors. This clearance paves the way for a Phase 1b/2 clinical trial in newly diagnosed high-grade glioma, anticipated to commence in early 2025 at Northwestern University. High-grade gliomas are aggressive brain cancers with limited treatment options, making innovative approaches like NeuroNova particularly significant.
Allan Camaisa, CEO and Chairman of Calidi Biotherapeutics, stated, "We are pleased that Northwestern University has received U.S. FDA clearance to advance our CLD-101 program in the clinic for newly diagnosed high-grade glioma."
RTNova Data Presentations
Calidi presented data on RTNova (CLD-400), its systemic antitumor virotherapy platform, at the International Oncolytic Virotherapy Conference (IOVC), Immuno US 2024, and the Society for Immunotherapy of Cancer (SITC) annual meeting. RTNova is engineered to evade elimination by the humoral immune system, targeting multiple tumor sites and altering the tumor immune microenvironment. This systemic approach aims to broaden the patient population that can benefit from virotherapy.
Financial Results and Funding
For the third quarter ended September 30, 2024, Calidi reported a net loss of $5.1 million, or $0.65 per share, compared to a net loss of $2.0 million, or $1.41 per share, for the same period in 2023. Research and development expenses decreased from $3.3 million to $2.2 million, and general and administrative expenses decreased from $4.0 million to $3.1 million. The company had approximately $1.9 million in cash as of September 30, 2024. In October, Calidi raised $2 million through a registered direct offering and concurrent private placement.
Financial Outlook and Challenges
Despite reducing operating expenses, Calidi's financial position remains precarious. The company's limited cash reserves and increased net loss highlight the need for additional funding to support ongoing and planned clinical trials. The initiation of Phase 1b/2 trials for NeuroNova in early 2025 will require significant capital investment. Investors should closely monitor Calidi's ability to secure additional financing and manage its resources effectively to advance its virotherapy platforms.
