Here are 1-3 brief analogies to describe Calidi Biotherapeutics:

• Calidi is like a **Moderna or BioNTech**, but for cancer treatment, using stem cells as a unique delivery vehicle for oncolytic viruses instead of lipid nanoparticles for mRNA.
• Calidi is like an **Amgen**, but instead of a bare oncolytic virus (like Imlygic), they deliver it via stem cells that act as a 'Trojan horse' to boost efficacy against solid tumors.
• Calidi is like an **Allogene Therapeutics**, but instead of off-the-shelf CAR-T cells, they develop off-the-shelf stem cells as carriers for cancer-killing oncolytic viruses.

• NeuroNova: Allogeneic neural stem cells loaded with an oncolytic adenovirus designed for the treatment of high-grade gliomas.
• SuperNova: Allogeneic adipose-derived mesenchymal stem cells loaded with tumor-selective CAL1 oncolytic vaccinia virus for the treatment of advanced metastatic solid tumors.

Calidi Biotherapeutics (CLDI) is a clinical-stage immuno-oncology company focused on the research and development of immunotherapies for cancer. The company's pipeline consists of product candidates that are currently in clinical trials, such as NeuroNova for high-grade gliomas and SuperNova for advanced metastatic solid tumors.

As a clinical-stage biotechnology company, Calidi Biotherapeutics does not currently have commercialized products available for sale to end-users or other companies. Therefore, it does not have "major customers" in the traditional sense of entities purchasing its products or services.

Eric Poma, Ph.D. Chief Executive Officer and Director

Dr. Eric Poma was appointed CEO of Calidi Biotherapeutics in April 2025. Before joining Calidi, Dr. Poma served as CEO of Molecular Templates (NASDAQ: MTEM), where he successfully raised over $250 million in equity financing and secured more than $150 million in strategic capital through agreements with Takeda, Vertex, and BMS. He holds 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 Chief Financial Officer

Andrew Jackson serves as the Chief Financial Officer of Calidi Biotherapeutics. He is also listed as a key executive at First Light Acquisition Group Inc.

Antonio F. Santidrian, PharmD, Ph.D. Chief Scientific Officer and Head of Technical Operations

Antonio F. Santidrian is the Chief Scientific Officer and Head of Technical Operations at Calidi Biotherapeutics.

Guy Travis Clifton, M.D. Chief Medical Officer

Dr. Guy Travis Clifton was appointed Chief Medical Officer and Consultant and Advisor in May 2025. He is a practicing surgical oncologist with over 17 years of experience in drug development, early-phase and translational clinical trials, and cancer immunotherapy. Dr. Clifton has served as a practicing surgical oncologist in the U.S. Army since 2013 and was also the Chief Medical Officer and co-founder of Parthenon Therapeutics / Incendia Therapeutics from October 2020 to August 2024.

Boris Minev, M.D. President, Medical & Scientific Affairs

Dr. Boris Minev is the President, Medical & Scientific Affairs at Calidi Biotherapeutics. He is an accomplished physician-scientist with extensive industrial and academic experience in immuno-oncology, oncolytic viruses, and stem cell biology. Dr. Minev has a strong background in tumor immunology and cancer vaccine development, having contributed to Melacine, the first cancer vaccine to receive regulatory approval. Previously, he was the Director of Immunotherapy and Translational Oncology at Genelux Corporation, where he led preclinical and translational projects in oncolytic virotherapy, immunotherapy, and nanotechnology. He also served as Principal Investigator and Director, Laboratory of Tumor Immunology and Immunotherapy at Moores UCSD Cancer Center for more than 15 years, and worked at the National Cancer Institute. Dr. Minev advises several biotechnology companies and has consulted for Amgen, Johnson & Johnson, Geron Corporation, McKinsey Consulting, and Thomson Current Drugs.

Here are the key risks to Calidi Biotherapeutics (CLDI):

1. Clinical Trial Failure and Regulatory Approval Uncertainty: As a clinical-stage immuno-oncology company, Calidi Biotherapeutics faces substantial risk regarding the successful completion of its clinical trials and subsequent regulatory approvals. There is an inherent uncertainty that early trial results will predict final outcomes, and clinical results could materially change as more patient data becomes available. Furthermore, there is no guarantee that Calidi will receive FDA approval for any of its therapeutic candidates, which include NeuroNova for high-grade gliomas and SuperNova for advanced metastatic solid tumors. For oncology drugs generally, the likelihood of approval from Phase I trials is historically very low, particularly for solid tumors.
2. Significant Financial Challenges and Dependence on Future Funding: Calidi Biotherapeutics consistently reports zero revenue growth and ongoing substantial losses, with negative earnings per share and highly negative returns on equity and assets. The company's financial health indicators, such as a Piotroski F-Score of 2 and an Altman Z-Score of 0, suggest potential financial distress and operational challenges. Calidi frequently undertakes public offerings to bolster its financial position, highlighting a critical dependence on external capital. The risk that the company may not be able to raise sufficient capital to fund its ongoing and anticipated clinical trials is a significant threat to its operations and ability to bring products to market.
3. Inherent Challenges and Safety Profile of Oncolytic Virus Therapies: Calidi Biotherapeutics' core technology involves developing cell-based delivery platforms for oncolytic viruses. While promising, oncolytic virus therapies carry inherent risks, including potential side effects that can range from flu-like symptoms to more severe adverse events such as cellulitis, shortness of breath, and increased heart rate. Moreover, combination therapies, which are often explored to enhance efficacy, may present increased toxicity risks compared to conventional treatments. Additionally, challenges exist in effectively delivering oncolytic viruses to tumor cells, as some approaches require direct intratumoral injection, which can be associated with risks like bleeding or metastasis at the injection site.

Calidi Biotherapeutics (CLDI) operates in significant addressable markets for its main product candidates, NeuroNova and SuperNova.

NeuroNova (High-Grade Gliomas)

The addressable market for high-grade gliomas, the target indication for NeuroNova, was approximately USD 830 million in 2023 across the seven major markets (7MM), which include the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Specifically, the market size for high-grade glioma in the U.S. was approximately USD 580 million in 2023. This market is anticipated to experience significant growth through 2034.

SuperNova (Advanced Metastatic Solid Tumors)

For advanced metastatic solid tumors, the target for SuperNova, the global solid tumors market size was valued at US$ 170.3 billion in 2023. This market is projected to reach US$ 375.4 billion by 2034, demonstrating a compound annual growth rate (CAGR) of 7.45% during this period. Additionally, the global metastatic cancer treatment market was estimated at USD 89.97 billion in 2024 and is projected to reach approximately USD 158.08 billion by 2032, with a CAGR of 7.3%. Another estimate for the global metastatic cancer drugs market size was $67.7 billion in 2022, with a projection to reach $136.9 billion by 2032.

Calidi Biotherapeutics (CLDI), a clinical-stage immuno-oncology company, is currently pre-revenue, with analyst forecasts indicating no revenue generation in the immediate 2-3 year timeframe. Therefore, expected drivers of future revenue growth are tied to key developmental and strategic milestones that will enable commercialization or generate non-product revenue streams.

1. Advancement and Positive Data from Clinical Trials for NeuroNova (CLD-101): Calidi Biotherapeutics is developing NeuroNova for high-grade gliomas. The company commenced a Phase 1b/2 clinical trial for NeuroNova (NNV1) in newly diagnosed high-grade glioma (HGG) patients in the first half of 2024, in collaboration with Northwestern University. Additionally, a Phase 1 study for recurrent HGG (NNV2) began in June 2023 and has dosed six patients. Successful progression through these clinical stages and positive data readouts are critical for attracting further investment, securing potential licensing agreements, or paving the way for eventual market entry, which would contribute to future revenue growth.

2. Advancement and Positive Data from Clinical Trials for SuperNova (CLD-201): The SuperNova program, targeting advanced metastatic solid tumors, has received FDA Fast Track Designation for glioblastoma and soft tissue sarcoma, a status that can accelerate its development and review process. The first patient was dosed in a Phase 1 trial for SuperNova (CLD-201) in the second half of 2024. Positive clinical data from this program would significantly de-risk the asset, making it a strong driver for future revenue growth through potential partnerships or subsequent commercialization.

3. Progression of the RedTail Platform (CLD-401) to IND Filing and Clinical Trials: Calidi Biotherapeutics expects to file an Investigational New Drug (IND) application in the fourth quarter of 2026 for its lead RedTail candidate, CLD-401. This platform is designed as a systemically delivered and targeted genetic medicine for metastatic disease. Successful preclinical development and the initiation of clinical trials for this platform within or shortly after the 2-3 year timeframe will establish its therapeutic potential and could lead to future revenue through collaborations or eventual product sales.

4. Establishment of Strategic Partnerships and Licensing Agreements: For a clinical-stage biotechnology company, securing new strategic collaborations and licensing agreements is a significant driver of future revenue. These partnerships, similar to existing collaborations with institutions like Northwestern University, can provide crucial non-dilutive funding, upfront payments, and milestone payments. Such agreements are essential for financing ongoing research and development, expediting the clinical pathway, and enabling the eventual commercialization of Calidi's therapeutic candidates, thereby generating revenue within the 2-3 year timeframe or laying the groundwork for substantial future product revenue.

Share Issuance

• Calidi Biotherapeutics closed an underwritten public offering in March 2026, issuing 12,094,631 shares (or pre-funded warrants) with accompanying warrants, generating approximately $6.0 million in gross proceeds.
• In January 2025, the company completed a public offering of 5,000,000 shares of common stock at $0.85 per share, raising approximately $4.25 million in gross proceeds.
• Calidi Biotherapeutics secured approximately $4.6 million in gross proceeds in July 2025 through the exercise of various series of warrants for 6,595,000 shares at $0.70 per share, which also involved the issuance of new unregistered warrants.

Inbound Investments

• Calidi Biotherapeutics completed its business combination with First Light Acquisition Group (a SPAC) in September 2023, making approximately $28 million in gross proceeds available to the company.
• In conjunction with the SPAC merger in 2023, Calidi entered into a forward purchase agreement for up to $10 million and intended to enter another for up to $50 million, both aimed at extending its cash runway.
• The company was awarded $3.1 million from the California Institute for Regenerative Medicine (CIRM) in December 2022 to support the clinical development of its CLD-201 product.

Capital Expenditures

• In the last 12 months (prior to March 2026), Calidi Biotherapeutics reported capital expenditures of -$96,000.
• The capital expenditures for the most recent quarter (prior to March 2026) totaled -$0.0270 million USD.