CVMHIGH SIGNALREGULATORY10-K

CEL-SCI completed a bias analysis for its Phase III Multikine study in preparation for regulatory submissions while facing increased competitive pressure from FDA's June 2025 approval of Keytruda for perioperative head and neck cancer treatment.

The completion of bias analysis indicates CEL-SCI is moving toward potential regulatory submission for Multikine, representing a critical inflection point for this clinical-stage company. However, Keytruda's new FDA approval as perioperative treatment for the same indication creates meaningful competitive headwinds, though CEL-SCI maintains its focus on the 70% of patients with low PD-L1 expressing tumors where Keytruda showed limited efficacy.

Comparing 2025-12-29 vs 2025-01-13View on EDGAR →
FINANCIAL ANALYSIS

The company's financial position shows mixed signals with current assets nearly doubling to $11.6M while cash declined to $22.7M from $36.1M, indicating continued cash burn despite reduced R&D spending of $15.9M versus $18.2M in the prior period. Revenue grew modestly but remains minimal at $264K, reflecting the pre-commercial nature of this biotech. The dramatic reduction in outstanding shares from 74.1M to 8.4M suggests a significant reverse stock split occurred during the period.

FINANCIAL STATEMENT CHANGES
Current Assets
Balance Sheet
+91.5%
$6.1M→$11.6M

Current assets grew 91.5% — improving short-term liquidity or inventory/receivables build.

Revenue
P&L
+65.5%
$160K→$264K

Strong top-line growth of 65.5% — accelerating demand or successful expansion into new markets.

Capital Expenditure
Cash Flow
-59.8%
$95K→$38K

Capex reduced 59.8% — investment cycle winding down or capital discipline; may improve near-term free cash flow.

Inventory
Balance Sheet
-54.6%
$2.2M→$1.0M

Inventory drawn down 54.6% — strong sell-through or deliberate destocking; watch for supply constraints.

Cash & Equivalents
Balance Sheet
-37.1%
$36.1M→$22.7M

Cash declined 37.1% — significant cash burn or deployment; verify adequacy of remaining liquidity runway.

Stockholders Equity
Balance Sheet
+24%
$12.9M→$16.0M

Equity base grew 24% — retained earnings accumulation or equity issuance strengthening the balance sheet.

Total Liabilities
Balance Sheet
-13.6%
$14.1M→$12.2M

Liabilities reduced 13.6% — deleveraging improves balance sheet strength and financial flexibility.

R&D Expense
P&L
-12.5%
$18.2M→$15.9M

R&D spending cut 12.5% — could signal cost discipline or concerning reduction in innovation investment.

Current Liabilities
Balance Sheet
+11.2%
$4.6M→$5.1M

Current liabilities rose 11.2% — increased short-term obligations, watch current ratio.

LANGUAGE CHANGES
NEW — 2025-12-29
PRIOR — 2025-01-13
ADDED
As of December 19, 2025, the Registrant had 8,408,746 issued and outstanding shares of common stock.
CEL-SCI is currently focused on the development of the following product candidates and technologies with an emphasis on Multikine: 1) Multikine, an investigational Phase 3 immunotherapy under development for the potential treatment of certain head and neck cancers; and 2) L.E.A.P.S.
3 CEL-SCI completed a bias analysis for the target population in the Phase III study in preparation for submission of data to regulatory agencies, including the FDA, for a confirmatory registration study.
CEL-SCI estimates that patients with tumors having low PD-L1 represent about 70% of locally advanced primary patients with squamous cell carcinoma of the head and neck, or SCCHN (hereafter also referred to as advanced primary head and neck cancer).
Keytruda was approved by FDA in June 2025 as a perioperative (before and after surgery) treatment for resectable locally advanced head and neck cancer patients whose tumors express PD-L1 at a positive level.
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REMOVED
As of January 6, 2025, the Registrant had 74,107,041 issued and outstanding shares of common stock.
CEL-SCI is currently focused on the development of the following product candidates and technologies: 1) Multikine, an investigational immunotherapy under development for the potential treatment of certain head and neck cancers; and 2) L.E.A.P.S.
CEL-SCI estimates that patients with tumors having low PD-L1 represent about 70% of locally advanced primary SCCHN patients.
While none of these drugs are currently approved as a first-line treatment before surgery, even if such approvals were to come in the future, we believe the large majority of patients having low PD-L1 would still be expected to need Multikine.
CEL-SCI published its data as abstracts and posters at the annual conferences for the 2022 American Society of Clinical Oncology (ASCO), 2022, 2023 European Society for Medical Oncology (ESMO), the 2023 European Head and Neck Society s (EHNS s) annual European Conference On Head And Neck Oncology (ECHNO), the 2023 European Society for Therapeutic Radiology and Oncology (ESTRO) and the 2023 American Head and Neck society (AHNS).
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