Calidi Biotherapeutics presents a compelling opportunity as a clinical-stage biotech at the forefront of oncolytic virotherapy (OV), a promising multi-billion-dollar area in cancer treatment. Calidi is pioneering the development of both systemic and localized OVs, leveraging engineered viruses to target and destroy cancer cells while arming the immune system for a comprehensive attack on tumors. Calidi's cell-based technologies uniquely protect OVs from immune system elimination, ensuring higher efficacy and opening the tumor microenvironment to treatment. This approach has shown promising efficacy in initial studies, while their breakthrough IV-based technology and direct tumor administration methods differentiate them within the oncology field.

Targeting metastatic melanoma, glioblastoma, triple-negative breast cancer, head & neck cancer, and lung cancer, Calidi addresses a substantial and growing market with an estimated $13 billion to $15 billion annual total addressable market in the US alone. The need for effective treatments in these areas remains high, providing a significant opportunity for growth and impact. Calidi’s current development pipeline includes:

• NeuroNova (CLD-101): This pioneering program targets high-grade glioma (HGG), a particularly aggressive brain cancer. Utilizing neuronal stem cells combined with an engineered adenovirus (CRAD-s-Pk7), NeuroNova has moved beyond a successful and published safety study in newly diagnosed HGG, to a Phase 1/1b clinical trial currently underway in recurrent HGG.
• SuperNova (CLD-201): Built around the company's foundational technology, SuperNova employs an engineered Vaccinia virus (CAL1) and allogeneic adipose-derived mesenchymal stem cells. This program targets advanced solid tumors, demonstrating Calidi’s commitment to leveraging its platform across a range of cancer types. An early safety study using autologous (patient’s own) stem cells showed safety and strong signals of efficacy. Moving forward, SuperNova plans to expand into multiple dose regimens in a Phase 1 study expected to launch in 2H24.
• RTNova (CLD-400): RTNova represents a breakthrough in systemic delivery for treating lung cancer and metastatic cancers. Using an enveloped Vaccinia virus technology, RTNova can be administered intravenously, simplifying the delivery process and potentially broadening its applicability. This program is in the preclinical stage, focusing on demonstrating efficacy and safety in a systemic administration model.

Calidi Biotherapeutics offers a unique value proposition through its innovative technology, robust development pipeline, clear market need, competitive edge, and near-term milestone catalysts, making it a compelling investment opportunity in the rapidly evolving field of cancer treatment.