CEL-SCI Corporation (CVM) - 10-Q Summary
Business Context and Reporting Period
Company: CEL-SCI Corporation
Filing Type: Form 10-Q (Unaudited)
Reporting Period: Three months ended December 31, 2025
Business Overview: CEL-SCI is a late clinical-stage biotechnology company focused on developing Multikine, an investigational immunotherapy for head and neck cancer, and L.E.A.P.S. technology for rheumatoid arthritis. The company has not generated any revenue to date and relies on capital raises to fund operations.
Key Financial Metrics
| Metric | Q1 2026 (Ended Dec 31, 2025) | Q1 2025 (Ended Dec 31, 2024) |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(5,469,446) | $(7,073,062) |
| Net Loss Per Share (Basic & Diluted) | $(0.68) | $(3.25) |
| Cash and Cash Equivalents (Ending) | $6,277,582 | $4,614,115 |
| Net Cash Used in Operating Activities | $(4,022,105) | $(4,139,973) |
| Total Assets | $22,894,675 | $28,155,748 |
| Total Liabilities | $11,756,021 | $12,198,663 |
| Stockholders' Equity | $11,138,654 | $15,957,085 |
Material Changes vs. Prior Period
- Net Loss Reduction: Net loss decreased by approximately $1.6 million (23%) compared to the prior year quarter, primarily due to reduced operating expenses.
- Operating Expenses: Total operating expenses declined from $6.89 million to $5.37 million.
- R&D Expenses: Decreased by $0.75 million (17%) to $3.68 million, driven by lower clinical trial costs ($0.4M reduction) and supplies ($0.28M reduction).
- G&A Expenses: Decreased by $0.77 million (31%) to $1.69 million, largely due to reduced public relations costs ($0.55M) and lower stock-based compensation.
- Cash Position: Cash decreased by $4.68 million during the quarter, primarily due to operating cash burn of $4.02 million and finance lease payments of $0.55 million. This contrasts with the prior year quarter where cash burn was offset by $5.0 million in financing proceeds.
- Share Count: Weighted average shares outstanding increased significantly to 8.02 million from 2.18 million in the prior year, reflecting a 30-for-1 reverse stock split effective May 2025 and subsequent issuances.
Outlook, Risks, and Management Commentary
- Going Concern Warning: The filing explicitly states there is "substantial doubt" about the company's ability to continue as a going concern due to recurring losses and the need for additional capital.
- Capital Requirements: Management estimates the upcoming confirmatory registration study for Multikine will cost $30-$35 million. The company must raise additional capital via equity, debt, or partnerships to proceed.
- Clinical Progress: The company is preparing for a 212-patient confirmatory Phase 3 study for Multikine in head and neck cancer patients with low PD-L1 expression. Previous Phase 3 data showed a 73% 5-year survival rate for treated patients vs. 45% for controls.
- Internal Controls: Management concluded that disclosure controls and procedures were not effective as of December 31, 2025, due to material weaknesses previously disclosed in the 10-K.
- Subsequent Events: On January 22, 2026, the CEO purchased 38,023 shares of restricted common stock for approximately $200,000.
Investor Verification Checklist
- Liquidity Runway: Verify the timeline for the next capital raise given the $6.3M cash balance and ~$4M quarterly operating burn rate.
- Confirmatory Study Funding: Assess the feasibility of raising the estimated $30-$35M required for the confirmatory registration study.
- Internal Control Remediation: Review the plan to address the material weaknesses in disclosure controls and procedures.
- Lease Obligations: Note the significant finance lease obligations (~$7.4M total, ~$2.3M current) tied to the manufacturing facility.
- Regulatory Pathway: Monitor FDA communications regarding the design and approval of the confirmatory study protocol.