CNS Pharmaceuticals Inc (NASDAQ: CNSP) is a clinical-stage biopharmaceutical company developing drug candidates for cancers of the central nervous system. The company generates no product revenue, funding operations entirely through debt and equity issuances, including an at-the-market facility established July 26, 2024 with A.G.P./Alliance Global Partners. Its two lead candidates are Berubicin, an anthracycline designed to penetrate the blood-brain barrier for treatment of glioblastoma, and TPI 287, a separate compound in preparation for clinical trials as of FY2025. The company reported a net loss of approximately $15,851,000 for the year ended December 31, 2025, compared to a net loss of approximately $14,858,000 for 2024, with research and development expense of approximately $9,772,000 in FY2025. As of December 31, 2025, CNSP held cash of approximately $7,201,000 and working capital of approximately $4,002,000. The company holds a worldwide exclusive license to Berubicin (WP744) from Houston Pharmaceuticals Inc (HPI), subject to a 2% royalty on net sales and milestone payments upon FDA approval.
- Revenue model
- Pre-revenue clinical-stage company. Operations funded through equity and debt sales, including an ATM agreement with AGP established July 26, 2024. No product revenue reported for FY2025 or FY2024. The HPI license agreement carries a 2% royalty obligation on future net sales of WP744-based products and milestone payments, but no royalty revenue has been recognized.
- Products and services
- Berubicin (WP744): an anthracycline chemotherapy agent licensed exclusively from HPI, designed to penetrate the blood-brain barrier, granted FDA Orphan Drug Designation on June 10, 2020 for malignant gliomas. Phase 2 trial CNS-201 comparing Berubicin to lomustine in recurrent glioblastoma reported topline results in March 2025. TPI 287: a second drug candidate for which the company was preparing a clinical trial and manufacturing as of FY2025.
- Customers and end markets
- End market is oncology, specifically recurrent glioblastoma and malignant gliomas. No commercial customers as of the filing date. Patients enrolled in clinical trials are research subjects. Commercial success depends on FDA approval, coverage, and reimbursement by government and third-party payers.
- Value-chain role
- Drug developer and intellectual property licensor. Holds worldwide exclusive license to Berubicin from HPI. Purchases pharmaceutical products from HPI for manufacturing of Berubicin. Relies on contract research organizations and trial sites for clinical execution. No internal manufacturing or commercial sales infrastructure disclosed.
- Geographic exposure
- Company headquartered in the United States. Regulatory focus on FDA approval pathway. Filing references international regulation as applicable but does not specify active ex-US clinical operations.
- Competitors
- Lomustine (comparator drug in CNS-201 Phase 2 trial)
Source: SEC 10-K, filed 2026-03-31
Industry:
Pharmaceutical Preparations
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