Calidi Biotherapeutics Inc. (NYSE American: CLDI) Is ‘One to Watch’

• Calidi’s unique OV platforms are engineered to protect and amplify virus efficacy, enhancing tumor targeting and patient safety.
• Calidi’s lead programs, CLD-101, CLD-201, and CLD-400, are advancing through key development stages, with major milestones anticipated, including Phase 1b/2 enrollment for CLD-101 in Q1 2025 and Phase 1 trials for CLD-201 expected in 2H 2024.
• The company targets a $13-15 billion U.S. market across multiple high-need cancer types, including GBM, TNBC and lung cancer.
• Calidi’s leadership team combines business, scientific and operational expertise, with a track record of successful exits and growth.

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company pioneering proprietary technology that empowers the immune system to combat cancer. Calidi’s innovative, off-the-shelf cell-based platforms use allogeneic stem cells to deliver potent oncolytic viruses (“Ovs”) across multiple oncology indications, including high-grade glioma (brain cancers) and solid tumors. In addition, Calidi has presented a breakthrough systemic technology, RTNova, which utilizes an exteracellular enveloped virotherapy. RTNova is pre-clinical and has been extremely well-received by market analysts and large-cap biopharma – opening the door for potential collaboration.

These cell-based platforms are engineered to protect, amplify and enhance the efficacy of oncolytic viruses, resulting in improved patient safety and potentially advancing treatment outcomes for metastatic disease. By employing a dual approach that combines OV delivery with immune activation, Calidi’s therapies aim to not only treat but potentially prevent the spread of metastatic cancers.

The company’s development pipeline leverages this technology to address pressing needs in cancers such as glioblastoma (brain cancer), metastatic melanoma, triple-negative breast cancer, head & neck cancer, and lung cancer. Calidi’s approach has shown early signals of efficacy and safety, establishing it as a distinctive player in the growing OV 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 advanced cell-based platforms targeting a variety of oncology indications, each designed to harness the power of oncolytic virotherapy for improved cancer treatment outcomes.

• 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 Phase 1/1b trials for recurrent cases. FDA clearance for a Phase 1b/2 trial at Northwestern University was received in September 2024, with patient enrollment expected to begin in Q1 2025. This trial will utilize multiple-dose intracerebral administration to maximize safety and efficacy in newly diagnosed HGG patients.
• SuperNova (“CLD-201”): Built on Calidi’s foundational technology, SuperNova utilizes an engineered Vaccinia virus (“CAL1”) delivered via 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 plans to begin a Phase 1 trial with multiple dose regimens for SuperNova in the coming months.
• RTNova (“CLD-400”): Calidi’s systemic delivery platform for lung and metastatic cancers, RTNova employs an extracellular enveloped virotherapy (“envRT-01”) technology for intravenous (“IV”) administration, simplifying the treatment process and expanding its potential applications. Currently in preclinical stages, RTNova focuses on demonstrating efficacy and safety through systemic administration. A clinical trial targeting metastatic lung cancer is anticipated for Q2 2026, using a single-arm monotherapy with dose escalation. Calidi has partnered with SIGA Technologies (NASDAQ: SIGA) to support the development of this program.

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

Allan Camaisa, CEO, Chairman and co-founder, is a seasoned leader with extensive experience in scaling businesses to successful exits. Mr. Camaisa previously led High Technology Solutions, growing it from two employees to over 500 with $50 million in revenue. He also served as CEO of Parallel6 Inc. and is a U.S. Naval Academy graduate with further studies at Harvard Business School.

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 (“RTNova”) 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.

Boris Minev, M.D., President of Medical and Scientific Affairs, is a renowned physician-scientist with expertise in Immuno-Oncology, stem cell biology, and oncolytic viruses. Previously, Dr. Minev served as Director of Immunotherapy and Translational Oncology at Genelux Corporation and remains an adjunct professor at the Moores UCSD Cancer Center. His background includes research at the National Cancer Institute.

Andrew Jackson, CFO, has held executive finance roles with experience in biotech and clinical-stage companies, including Eterna Therapeutics and Ra Medical Systems. Mr. Jackson holds an MSBA in Finance from San Diego State University and a BSB in Accounting from the University of Minnesota.

For more information, visit the company’s website at https://www.calidibio.com/.

NOTE TO INVESTORS: The latest news and updates relating to CLDI are available in the company’s newsroom at https://ibn.fm/CLDI

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