Calidi Biotherapeutics Inc. (NYSE American: CLDI)

Calidi Biotherapeutics Inc. (NYSE American: CLDI) is a clinical-stage biotechnology company pioneering the development of systemic oncolytic targeted immunotherapies with the ability to deliver genetic payloads. Calidi has recently presented data on its breakthrough systemic technology, RedTail, at prestigious biotechnology conferences like American Association for Cancer Research (AACR) and American Society of Clinical Oncology (ASCO). RedTail utilizes an extracellular enveloped virotherapy and delivers genetic medicine in the form of IL-15 superagonist. RedTail is currently in IND enabling studies and has been extremely well-received by market analysts and large-cap biopharma – opening the door for potential collaboration.

These platforms are engineered to protect, amplify, and enhance the efficacy of oncolytic viruses, resulting in improved patient safety and advancing treatment outcomes for metastatic disease. By employing a dual approach that combines OV delivery with immune activation at the disease site, Calidi’s therapies are designed to not only attack the tumor but train the immune system to respond and prevent recurrence.

The company’s development pipeline leverages this technology to address pressing needs in cancers such as lung cancer and metastatic cancers, triple-negative breast cancer, head & neck cancer, soft tissue sarcoma, lung cancer, and glioblastoma. Calidi’s approach has shown early signals of efficacy and safety, establishing it as a distinctive player in the growing OV and genetic medicine market, which is projected to increase significantly in value over the next decade.

Calidi is headquartered in San Diego, California.

Products

Calidi’s product pipeline includes genetic medicine delivery and advanced oncolytic targeted immunotherapy platforms targeting a variety of oncology indications, each offering protection to the virus from the body’s immune system.

• RedTail (CLD-400): Calidi’s systemic delivery platform targeting lung and metastatic cancers, RedTail employs an extracellular enveloped virotherapy (envRT-01) technology for intravenous (IV) administration while delivering a genetic medicine payload, simplifying the treatment process and expanding its potential applications. Currently in IND-enabling stages, RedTail focuses on demonstrating efficacy and safety through systemic administration. Calidi is also exploring RedTail’s application outside of oncology, including autoimmune.
• SuperNova (CLD-201): Built on Calidi’s foundational technology, SuperNova utilizes an engineered vaccinia virus (CAL1) loaded in allogeneic adipose-derived mesenchymal stem cells to target advanced solid tumors, including head & neck, triple-negative breast cancer, and soft tissue sarcomas. Early studies with autologous stem cells demonstrated both safety and promising efficacy, and Calidi has an approved IND to begin a Phase 1 trial with multiple dose regimens for SuperNova.
• NeuroNova (CLD-101): A platform designed for treating high-grade gliomas (HGG), NeuroNova employs neuronal stem cells combined with an engineered adenovirus (CRAD-s-Pk7) to selectively target glioma cells. After a successful Phase 1 safety study in newly diagnosed HGG, NeuroNova has now progressed into a Phase 1trial at City of Hope for recurrent cases. FDA clearance for a Phase 1b/2 trial at Northwestern University has received FDA clearance for a Phase 1b/2 trial for newly diagnosed HGG patients.

Market Opportunity

The global oncology drugs market was valued at $201.75 billion in 2023 and is projected to grow to $518.25 billion by 2032, with a CAGR of 11.3%. The oncolytic virotherapy market in particular is growing rapidly, driven by increasing approval rates and significant unmet needs.

The market for OV treatments is expected to expand from one approved product generating $150 million in the U.S. in 2021 to 6-8 approved therapies generating $2.4 billion by 2030. As a leader in OV technology, Calidi is well-positioned to address these high-demand areas in oncology.

Alongside global trends, the American Cancer Society projects nearly two million new cancer diagnoses in the U.S. in 2024, reflecting a 28% increase since 2010. This underscores the urgent need for novel therapies that not only treat disease progression but also enhance patient quality of life, reinforcing the demand for Calidi’s innovative approaches.

Management Team

Eric Poma, Ph.D., CEO, has more than 30 years of experience in the biopharmaceutical industry, with a strong record of capital fundraising, big pharma collaboration agreements, and clinical program development. Prior to joining Calidi, Dr. Poma served as CEO of Molecular Templates (NASDAQ: MTEM), a clinical-stage biotech focused on the development of a novel class of therapeutic agents with unique biology in oncology. At Molecular Templates he raised over $250 million in equity financing and secured over $150 million in strategic capital through agreements with Takeda, Vertex and BMS. Dr. Poma received a Ph.D. in Microbiology and Immunology from the University of North Carolina at Chapel Hill, an M.B.A. from the Leonard N. Stern School of Business and a Bachelor of Science in Biology from the University of North Carolina at Chapel Hill.

Andrew Jackson, CFO, has held chief executive finance roles with experience in biotech and clinical-stage companies, including Eterna Therapeutics, Ra Medical Systems, and Celladon Corporation before Calidi. Mr. Jackson holds an MSBA in Finance from San Diego State University and a BSB in Accounting from the University of Minnesota. He is a certified public accountant (inactive).

Antonio Santidrian, Ph.D., Chief Scientific Officer, leads all research and development initiatives at Calidi and is the coinventor of the company’s CLD-201 (Supernova) and CLD-400 (RedTail) platforms. Since joining Calidi in 2015, he has applied his 20+ years of expertise in academia and biotech, focusing on anti-cancer translational research, to drive the company’s innovative drug pipeline. Before Calidi, Dr. Santidrian led translational studies at The Scripps Research Institute, advancing treatments for breast cancer metastasis, and contributed to the development of ACADRA for chronic lymphocytic leukemia (CLL) at the University of Barcelona, Spain.

Guy Travis Clifton, M.D., Chief Medical Officer, Consultant and Advisor, is a practicing surgical oncologist with over 17 years of experience in drug development, early phase and translational clinical trials, and cancer immunotherapy. He has previously served as the Chief Medical Officer and co-founder of Parthenon Therapeutics/Incendia Therapeutics for over three years and has worked with over 20 companies in an advisory role. Dr. Clifton has over 80 peer-reviewed publications on cancer and related topics. Dr. Clifton received his Bachelor of Science in Chemistry from the United States Military Academy, West Point, and Doctor of Medicine from Vanderbilt University; completed his residency in General Surgery from the Brooke Army Medical Center; and held a fellowship in General Surgical Oncology at the University of Texas MD Anderson Cancer Center.