Calidi Biotherapeutics Inc.

Company Overview

Business Model: Calidi Biotherapeutics, Inc. is a publicly traded biotechnology company focused on pioneering targeted therapies that deliver genetic medicines to distal sites of disease. The Company's core value proposition revolves around its proprietary oncolytic virus platforms: RedTail, SuperNova, and NeuroNova. The RedTail platform utilizes an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites, aiming to shield the virus from immune clearance and deliver genetic medicines to tumor microenvironments. The SuperNova and NeuroNova platforms are designed to protect oncolytic viruses from neutralizing immune responses, enhance viral amplification within tumors, and modify the tumor microenvironment. Currently, Calidi Biotherapeutics, Inc. has no products approved for commercial sale and has not generated any revenue from product sales, nor does it expect to in the foreseeable future.

Market Position: Calidi Biotherapeutics, Inc. operates in a highly competitive biotechnology and pharmaceutical market, specifically within the immuno-oncology sector for cancer treatment. The Company faces competition from major pharmaceutical and biotechnology companies, including AstraZeneca, Bristol-Myers Squibb, Gilead Sciences, Inc., Merck & Co., Novartis, Pfizer, and Genentech, Inc., as well as specialized viral immunotherapy developers such as Oncorus, Inc., Replimune Group, Inc., Amgen Inc., ImmVira Co., Ltd., IconOVir Bio, Inc., Candel Therapeutics, Inc., CG Oncology, Inc., Genelux Corporation, Imugene Limited, Viromissile, Oncolytics Biotech Inc., and FerGene, Inc. Many of these competitors possess significantly greater financial resources and expertise. The only currently approved oncolytic virus therapy is T-VEC (Imlygic).

Recent Strategic Developments: Calidi Biotherapeutics, Inc. completed a business combination on September 12, 2023, which resulted in its current corporate structure. In July 2025, CLD-201, a product candidate from the SuperNova platform, was granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of soft tissue sarcoma. In November 2025, the Company presented new data on CLD-401, the first therapeutic candidate from its RedTail platform, at the Society of Immunotherapy for Cancer Annual Meeting. On October 27, 2025, Calidi Biotherapeutics, Inc. divested its 75% ownership interest in its then majority-owned subsidiary, Nova Cell, Inc., for a purchase price of $6.0 million, satisfied partly by debt cancellation and deferred consideration. The Company also engaged in several equity financing activities in 2025 and early 2026, including public offerings, registered direct offerings, and warrant inducement offers, raising significant gross proceeds.

Geographic Footprint: Calidi Biotherapeutics, Inc. primarily operates in the United States, with its corporate headquarters and laboratory facilities located in San Diego, California. Internationally, the Company has a wholly-owned subsidiary, StemVac GmbH, in Bernried, Germany, which provides research and development services. Additionally, Calidi Biotherapeutics Australia Pty Ltd, a wholly-owned subsidiary in Australia, was formed in October 2022 to conduct certain clinical trial activities for the SNV1 program.

Financial Performance

Revenue Analysis

Profitability Metrics:

• Gross Margin: Not applicable as the company has not generated revenue.
• Operating Margin: Not applicable as the company has not generated revenue.
• Net Margin: Not applicable as the company has not generated revenue.

Investment in Growth:

• R&D Expenditure: $9.7 million (2025), $8.9 million (2024)
• Capital Expenditures: $0.12 million (2025), $0.016 million (2024)
• Strategic Investments: In 2024, a $2.0 million investment was made by a related party into Nova Cell, Inc., a former subsidiary. In 2025, Calidi Biotherapeutics, Inc. divested its 75% ownership in Nova Cell, Inc. for $6.0 million.

Product Candidate Portfolio

RedTail for Metastatic Solid Tumors

Financial Performance: Not applicable; in preclinical development. Product Portfolio:

• CLD-401 (lead compound): Engineered enveloped vaccinia virus expressing IL-15 superagonist.
• Additional leads: Compounds simultaneously expressing a bispecific T-cell engager (TCE) and a T-cell activator, as well as compounds for non-oncology uses. Key Growth Drivers: Systemic administration, targeting of metastatic sites, delivery of genetic medicines to the tumor microenvironment, engineered CD55 expression to avoid immune clearance, tumor-specific replication, and demonstrated enhanced biological efficacy in animal models. Development Stage: CLD-401 is in pre-IND studies, with an Investigational New Drug application for a Phase I trial expected by the end of 2026. Market Dynamics: Addresses metastatic solid tumors, a significant unmet medical need where oncolytic viruses have historically faced challenges due to rapid immune elimination.

CLD-201 (SuperNova) for Solid Tumors (Breast Cancer, Sarcoma, and Head and Neck)

Financial Performance: Not applicable; in clinical development. Product Portfolio:

• CLD-201: CAL1 vaccinia virus loaded into the allogeneic AD-MSC cell line VP-001. Key Growth Drivers: Therapeutic potential for multiple solid tumors including breast cancer, sarcoma, and head and neck cancer. Received Fast Track Designation from the U.S. Food and Drug Administration in July 2025 for soft tissue sarcoma. Development Stage: Investigational New Drug application approved by the U.S. Food and Drug Administration in April 2025 for clinical development.

CLD-101 (NeuroNova) for Newly Diagnosed High Grade Glioma (HGG) and Recurrent HGG

Financial Performance: Not applicable; in clinical development. Product Portfolio:

• CLD-101: Oncolytic adenovirus (CRAd-S-pk7) delivered by allogeneic neural stem cells. Key Growth Drivers: Targets newly diagnosed and recurrent High Grade Glioma (HGG). Development Stage: Northwestern University has an open Investigational New Drug application for a Phase 1b/2 clinical trial for newly diagnosed HGG. City of Hope is conducting a Phase 1 clinical trial for recurrent HGG, with the first patient dosed in May 2023, supported by a grant from the California Institute for Regenerative Medicine.

Capital Allocation Strategy

Shareholder Returns:

• Share Repurchases: $0.0 billion (2025), $0.0 billion (2024)
• Dividend Payments: $0.0 billion (2025), $0.0 billion (2024). Calidi Biotherapeutics, Inc. has not paid any cash dividends to date and intends to retain future earnings.
• Future Capital Return Commitments: Not disclosed.

Balance Sheet Position:

• Cash and Equivalents: $0.0056 billion (as of December 31, 2025)
• Total Debt: $0.0006 billion (principal amount of promissory note as of December 31, 2025)
• Net Cash Position: $0.0050 billion (as of December 31, 2025)
• Credit Rating: Not disclosed.
• Debt Maturity Profile: $0.6 million of principal debt is due in 2027.

Cash Flow Generation:

• Operating Cash Flow: $(0.021) billion (2025), $(0.020) billion (2024)
• Free Cash Flow: $(0.021) billion (2025), $(0.020) billion (2024)
• Cash Conversion Metrics: Not explicitly disclosed.

Operational Excellence

Production & Service Model: Calidi Biotherapeutics, Inc. is developing scalable manufacturing processes for extracellular enveloped viruses and allogeneic cell product candidates. The Company possesses strong in-house process development capabilities for oncolytic viruses, cell banks, and combinatory products. It currently leverages external Contract Development and Manufacturing Organizations (CDMOs) to produce drug substance and drug product, requiring them to comply with Current Good Manufacturing Practices (CGMPs). The long-term strategy involves continued investment in building proprietary internal manufacturing expertise and evaluating the establishment of its own CGMP manufacturing facilities.

Supply Chain Architecture: Key Suppliers & Partners:

• Neural Stem Cell Bank (CLD-101): Procured from City of Hope, extended at a commercial-ready CDMO.
• NeuroNova Oncolytic Virus (CRAd-S-pk7): Master virus seed procured from Northwestern University, extended master virus bank manufactured at City of Hope.
• AAA Cell Bank (VP-001 for CLD-201): Produced by VetStem Biopharma.
• CAL1 Vaccinia Virus (for CLD-201): Manufactured at Genscript ProBio in China.
• CDMOs: Utilizes external CDMOs for drug substance and drug product manufacturing, with pilot and/or initial GMP batches for CLD-101 and CLD-201 anticipated from early-stage CDMOs on an as-needed basis. Calidi Biotherapeutics, Inc. does not have long-term supply arrangements in place with its CDMOs.

Facility Network:

• Manufacturing: Calidi Biotherapeutics, Inc. currently does not own or operate any manufacturing facilities, relying on third-party CDMOs.
• Research & Development: Leases approximately 6,221 square feet of lab space and 8,977 square feet of office space at its corporate headquarters in San Diego, California. Its wholly-owned German subsidiary, StemVac GmbH, leases approximately 4,047 square feet of office and laboratory space in Bernried, Germany.
• Distribution: Not disclosed.

Market Access & Customer Relationships

Go-to-Market Strategy: Calidi Biotherapeutics, Inc. intends to retain significant development and commercial rights for its product candidates. Upon obtaining marketing approval, the Company plans to commercialize its products independently or potentially with a partner in the United States and other regions. It currently has limited sales, marketing, and commercial product distribution capabilities and aims to build the necessary infrastructure over time as its product candidates advance.

Competitive Intelligence

Market Structure & Dynamics

Industry Characteristics: Calidi Biotherapeutics, Inc. operates in a highly competitive pharmaceutical, biotechnology, and immuno-oncology market, specifically focused on viral immunotherapies for cancer. The market includes large pharmaceutical and biotechnology companies, as well as smaller, early-stage companies. The only currently approved oncolytic virus therapy is T-VEC (Imlygic).

Competitive Positioning Matrix:

Direct Competitors

Primary Competitors:

• Large Pharmaceutical/Biotechnology Companies: AstraZeneca, Bristol-Myers Squibb, Gilead Sciences, Inc., Merck & Co., Novartis, Pfizer, Genentech, Inc. (developing immuno-oncology treatments for cancer).
• Viral Immunotherapy Developers: Oncorus, Inc., Replimune Group, Inc., Amgen Inc., ImmVira Co., Ltd., IconOVir Bio, Inc., Candel Therapeutics, Inc., CG Oncology, Inc., Genelux Corporation, Imugene Limited, Viromissile, Oncolytics Biotech Inc., FerGene, Inc. (developing viral immunotherapies for targeted indications).

Competitive Response Strategy: Calidi Biotherapeutics, Inc.'s strategy involves pioneering next-generation targeted therapies, advancing its RedTail platform for systemic administration, collaborating with industry partners for new indications and geographies, advancing clinical programs, pursuing cost-efficient manufacturing processes, and opportunistically out-licensing product candidates.

Risk Assessment Framework

Strategic & Market Risks

Market Dynamics: The Company faces risks related to the difficulty in estimating the market size for its novel product candidates, potential adverse effects from healthcare reform measures, and serious adverse consequences from unstable global economic and geopolitical conditions. Technology Disruption: Challenges are inherent in developing novel enveloped vaccinia virus and engineered allogeneic stem cell product candidates, leading to unpredictable development timelines and regulatory approval processes. Negative developments or adverse public perception in the field of immuno-oncology or oncolytic viral immunotherapy could harm the business. Customer Concentration: Not explicitly disclosed as a material risk.

Operational & Execution Risks

Supply Chain Vulnerabilities: Calidi Biotherapeutics, Inc. has significant reliance on third-party Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) for clinical trials and manufacturing. This reliance carries risks of delays, non-compliance, or failure to meet demand. The Company lacks long-term supply arrangements with its CDMOs. There is also potential scrutiny regarding the use of Chinese contract manufacturers. Geographic Concentration: Operations and third-party dependencies are susceptible to natural disasters, pandemics, or other catastrophic events. Capacity Constraints: Potential delays or termination of clinical trials due to difficulties in identifying, recruiting, and enrolling a sufficient number of eligible patients, particularly for rare indications like brain cancer.

Financial & Regulatory Risks

Demand Volatility: Revenue prospects are limited by the absence of commercialized products and dependence on future regulatory approvals. Market acceptance, pricing, and reimbursement by third-party payors are uncertain. Foreign Exchange: Exposure to foreign currency exchange rate fluctuations due to operations in Germany (StemVac GmbH) and Australia (Calidi Biotherapeutics Australia Pty Ltd). Credit & Liquidity: Calidi Biotherapeutics, Inc. has insufficient cash to continue operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern. The Company relies on additional funding through equity or debt financings, which may be dilutive or unavailable on acceptable terms. Risks are also associated with bank failures and access to uninsured deposits. Regulatory & Compliance: Subject to lengthy and unpredictable regulatory approval processes by the U.S. Food and Drug Administration and other authorities. Ongoing post-approval obligations and review may result in significant additional expenses and limitations on manufacturing and marketing. Risks include penalties for off-label promotion and potential competition from biosimilars. Compliance with anti-kickback, fraud and abuse, and other healthcare laws, as well as environmental, health, and safety regulations, is critical. Adverse impacts from changes in U.S. and international trade policies are also a risk.

Geopolitical & External Risks

Geopolitical Exposure: The Company is exposed to risks from unstable global economic and geopolitical conditions, including military conflicts and terrorism. Trade Relations: Potential adverse impacts from changes in U.S. and international trade policies, such as tariffs and export controls, particularly concerning the use of Chinese contract manufacturers. Sanctions & Export Controls: Risks from sanctions imposed by the United States and other countries, which could affect financial markets and the global economy.

Innovation & Technology Leadership

Research & Development Focus: Core Technology Areas: Calidi Biotherapeutics, Inc. focuses on oncolytic viral immunotherapy platforms. The RedTail platform involves engineered enveloped vaccinia viruses for systemic delivery to metastatic sites, designed to avoid immune clearance and deliver genetic medicines (e.g., IL-15 superagonist). The SuperNova platform utilizes oncolytic viruses embedded in stem cells for initial viral amplification, while the NeuroNova platform employs oncolytic viruses delivered by neural stem cells. Innovation Pipeline: CLD-401 (RedTail platform) is expected to have a Phase I Investigational New Drug application filing by the end of 2026. Additional RedTail leads are under development, including compounds expressing bispecific T-cell engagers and T-cell activators, and applications outside oncology.

Intellectual Property Portfolio: Patent Strategy: The Company aims to obtain and maintain patent protection in key markets (U.S., Europe, Japan) for its technology platforms and product candidates, with current coverage extending to approximately 2045. Its portfolio includes five main patent families, with a strategic focus on the RedTail program (modified vaccinia viruses for systemic administration, protection until 2045 and possibly beyond). Other families cover Smallpox Vaccine for Cancer Treatment (until at least 2038) and Enhanced Systems for Cell-Mediated Oncolytic Viral Therapy (SuperNova, until at least 2039, with patents issued in the US, Japan, Eurasia, and Canada). Some older patent families are being allowed to lapse to prioritize the RedTail program. Licensing Programs: Calidi Biotherapeutics, Inc. holds exclusive commercialization rights and non-exclusive data licenses from Northwestern University for NSC-CRAd-S-pk7 (CLD-101). It also has an exclusive license from the University of Chicago (jointly owned with City of Hope and University of Alabama at Birmingham) for patents covering oncolytic adenovirus loaded into allogeneic neural stem cells for High Grade Glioma. IP Litigation: The Company acknowledges the risk of expensive, time-consuming, and potentially unsuccessful lawsuits to protect or enforce its patents, as well as third-party claims of infringement.

Technology Partnerships: Calidi Biotherapeutics, Inc. engages in strategic alliances and research collaborations with academic institutions and industry partners. Key partners include City of Hope (for NeuroNova CLD-101 clinical trials and manufacturing of CRAd-S-pk7), Northwestern University (for NeuroNova CLD-101 clinical trials and licensing of NSC-CRAd-S-pk7), University of Chicago (for exclusive license to patents covering oncolytic adenovirus with neural stem cells), and Personalized Stem Cells, Inc. (for a collaboration and license agreement related to SVF cell line banks).

Leadership & Governance

Executive Leadership Team

Leadership Continuity: Eric Poma, Ph.D. was appointed Chief Executive Officer in April 2025, bringing prior CEO experience. Andrew Jackson has over 35 years of corporate finance experience. Antonio F. Santidrian, Ph.D. has been with the Company since 2015. Allan J. Camaisa resigned as Chief Executive Officer in April 2025 but remains a director and "CEO Emeritus."

Board Composition: The Board of Directors consists of six members, divided into three classes. James A. Schoeneck serves as Chairman of the Board (appointed April 22, 2025). All directors, with the exception of Allan J. Camaisa, are considered independent under NYSE listing standards.

Human Capital Strategy

Workforce Composition:

• Total Employees: 29 (as of December 31, 2025).
• Geographic Distribution: Employees are located in the U.S. and Germany (StemVac GmbH).
• Skill Mix: 24 employees (approximately 83%) are dedicated to research and development functions.

Talent Management: Acquisition & Retention: Calidi Biotherapeutics, Inc.'s objectives include identifying, recruiting, retaining, incentivizing, and integrating employees, advisors, and consultants. Equity and cash incentive plans are utilized to attract, retain, and reward personnel, aiming to align incentives with shareholder value creation. Employee Value Proposition: Compensation is designed to motivate and reward achievements, with annual performance bonuses (up to 50% for the CEO, up to 35% for other executive officers) and equity-based compensation (stock options, restricted stock units). The Company offers a 401(k) plan with safe harbor contributions (100% of elective deferral up to 4% of compensation).

Culture & Engagement: Calidi Biotherapeutics, Inc. maintains good relations with its employees, none of whom are represented by a labor union.

Regulatory Environment & Compliance

Regulatory Framework: Industry-Specific Regulations: Calidi Biotherapeutics, Inc. is subject to extensive regulation in the U.S. under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, covering all aspects of biological product development, approval, manufacturing, and commercialization. This includes preclinical studies, Investigational New Drug applications, multi-phase clinical trials (Phase 1, 2, 3), Biologics License Applications, post-approval requirements, orphan product designation, and expedited development programs (Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review). Companion diagnostics are regulated as medical devices. International Compliance: The Company is subject to similar regulatory processes in other jurisdictions, including Clinical Trial Applications in the European Union, European Medicines Agency marketing authorization, data and market exclusivity provisions, orphan drug designation, and pediatric development plans. The United Kingdom has its own regulatory body (Medicines and Healthcare Products Regulatory Agency) and pathways like the Innovative Licensing and Access Pathway and International Recognition Procedure. The Company is also subject to strict data privacy laws, such as the EU General Data Protection Regulation.

Trade & Export Controls: Calidi Biotherapeutics, Inc. is subject to anti-corruption laws (e.g., U.S. Foreign Corrupt Practices Act), import and export control laws, customs laws, and sanctions laws. Changes in U.S. and international trade policies can adversely impact operations.

Legal Proceedings: Calidi Biotherapeutics, Inc. is involved in several legal disputes. These include a consolidated case (trial set for November 6, 2026) involving its former Chief Accounting Officer and interim Chief Financial Officer, Tony Kalajian, and former Controller, Hazel Sanchez, alleging defamation, constructive discharge, and other claims, with the Company filing cross-complaints for breach of fiduciary duty. Additionally, a lawsuit was filed in July 2025 against a former executive assistant for breach of fiduciary duty and misappropriation of confidential information. A securities fraud complaint was filed against the Company by Mr. Yian Zeng in October 2024, with a pre-trial conference set for October 19, 2026; the Company is currently unable to evaluate the outcome or estimate the amount or range of potential loss for this case.

Tax Strategy & Considerations

Tax Profile:

• Effective Tax Rate: The U.S. federal statutory tax rate is 21%. Calidi Biotherapeutics, Inc. has incurred net operating losses for U.S. federal and state income tax purposes and has a full valuation allowance against its deferred tax assets. The income tax provision is primarily attributable to its German subsidiary, StemVac GmbH.
• Geographic Tax Planning: The Company files tax returns in the U.S. (federal and California), Germany, and Australia.
• Tax Reform Impact: The One Big Beautiful Bill Act (OBBBA), enacted July 4, 2025, allowing immediate expensing of domestic R&D and machinery/equipment purchases, did not materially impact the Company's results of operations. The Company's ability to utilize net operating loss carryforwards and other tax attributes may be limited by Section 382 ownership changes; an ownership change was identified in March 2018, but no study has been undertaken through December 31, 2025.

Insurance & Risk Transfer

Risk Management Framework:

• Insurance Coverage: Calidi Biotherapeutics, Inc. maintains business interruption insurance and believes it has sufficient general insurance coverage, though it acknowledges that coverage might not be adequate for all potential losses. The Company does not maintain insurance for environmental liability or toxic tort claims. Customary directors' and officers' liability insurance is maintained.
• Risk Transfer Mechanisms: Not explicitly detailed beyond insurance.