Business Context and Reporting Period
Company: Calidi Biotherapeutics, Inc. (CLDI)
Filing Type: Form 10-K (Annual Report)
Reporting Period: Fiscal year ended December 31, 2025
Business Overview: Calidi is a clinical-stage biotechnology company developing targeted therapies using its proprietary RedTail platform (enveloped oncolytic viruses) and legacy SuperNova/NeuroNova platforms (stem cell-based oncolytic viruses). The company has no approved products and has not generated any revenue from product sales. Its primary focus is advancing CLD-401 (RedTail) toward a Phase 1 IND filing expected by the end of 2026.
Key Financial Metrics
| Metric | 2025 | 2024 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(20.1) million | $(22.2) million |
| Accumulated Deficit | $(141.6) million | $(121.7) million |
| Cash and Restricted Cash | $5.8 million | $9.8 million |
| Working Capital | $2.3 million | $731 thousand |
| Operating Expenses | $(20.2) million | $(21.8) million |
| Debt Obligations | $0.7 million (Promissory Note) | $3.8 million (Term Notes, Bridge Loan, Promissory Note) |
Note: The company reported a net loss attributable to common stockholders of $(25.6) million for 2025 due to a deemed dividend on warrants.
Material Changes vs. Prior Period
- Net Loss Reduction: Net loss decreased by approximately $2.1 million (10%) compared to 2024, primarily driven by a $2.4 million decrease in General and Administrative (G&A) expenses (due to lower insurance, legal, and salary costs) partially offset by a $0.9 million increase in Research and Development (R&D) expenses.
- Debt Repayment: The company settled all related party term notes and bridge loans outstanding in 2024. As of December 31, 2025, the only outstanding debt is a $0.6 million promissory note with a third-party lender.
- Capital Structure: The company executed two reverse stock splits (1-for-10 in July 2024 and 1-for-12 in August 2025) to maintain listing standards. Outstanding common shares increased from 1.7 million to 7.2 million due to multiple equity financings.
- Subsidiary Divestiture: In October 2025, the company sold its 75% interest in Nova Cell, Inc., recognizing a gain on sale of $0.2 million. Nova Cell is no longer a consolidated subsidiary.
Guidance, Outlook, Risks, and Unusual Items
Outlook and Guidance
- Going Concern: Management has concluded there is substantial doubt about the company's ability to continue as a going concern for at least 12 months from the date of the report. Cash on hand ($5.6 million) is insufficient to fund operations for the next year without additional financing.
- Development Milestones: The company expects to file an Investigational New Drug (IND) application for CLD-401 by the end of 2026. In July 2025, CLD-201 received Fast Track Designation from the FDA for soft tissue sarcoma.
- Financing Needs: The company anticipates needing substantial additional funding through equity or debt offerings to support clinical trials and operations.
Recent Financing Activities (2025)
- Conducted multiple equity offerings including a January CMPO ($4.3M), March Registered Direct Offering ($3.5M), July Warrant Inducement Offer ($4.6M), and August Public Offering ($6.9M).
- Issued 534,265 shares under an At-The-Market (ATM) facility for $3.2 million in net proceeds.
Key Risks
- Liquidity Risk: Insufficient cash to continue operations for the next 12 months; dependent on raising capital.
- Development Risk: No products approved; clinical trials may fail to demonstrate safety or efficacy.
- Legal Proceedings: Ongoing litigation involving former executives (Kalajian/Sanchez cases) with a trial date set for November 2026; a securities fraud case (Zeng) is in discovery.
- Forward Purchase Agreements: Due to the low trading price of the stock relative to the reset price, it is unlikely the company will receive any settlement amount under existing Forward Purchase Agreements.
Important Facts for Investor Verification
- Cash Runway: Verify the company's ability to raise capital immediately, as current cash ($5.6M) is projected to be insufficient for 12 months of operations.
- Legal Exposure: Monitor the status of the consolidated litigation against former executives (Kalajian/Sanchez) and the securities fraud case (Zeng), as outcomes could result in significant damages.
- Stock Price Volatility: Note the impact of two reverse stock splits in 2024 and 2025 and the delisting of public warrants (now trading OTC) on liquidity and market perception.
- Debt Settlement: Confirm that all related-party debt has been settled and review the terms of the remaining $0.6 million third-party promissory note.
- Going Concern Opinion: Review the auditor's report (CBIZ CPAs P.C.) which includes an explanatory paragraph regarding the substantial doubt about the company's ability to continue as a going concern.