Clene Inc (NASDAQ: CLNN) is a clinical-stage biopharmaceutical company developing drug candidates targeting central nervous system disorders. The company generates no product revenue, funding operations through NIH grants recognized as reductions in research and development costs. Its lead asset, CNM-Au8, is a catalytically-active gold nanocrystal suspension targeting mitochondrial dysfunction via NAD+ production, in development for amyotrophic lateral sclerosis, multiple sclerosis, and Parkinson's disease. Clene has incurred a net loss of $26.2 million for the year ended December 31, 2025, and $39.4 million for the year ended December 31, 2024, with an accumulated deficit of $308.3 million as of December 31, 2025. The company has received NIH subawards totaling up to $30.9 million in aggregate under a four-year grant awarded in October 2023, with the third annual subaward of $8.0 million granted in March 2026. Clene holds 10,849,974 shares outstanding as of December 31, 2025 and carries a stockholders' deficit on its balance sheet.

Revenue model

No commercial product revenue. Operations are funded through NIH grant subawards, which are recognized as reductions in research and development costs. The company is pre-revenue and relies on equity issuances, notes payable, and grant funding to finance clinical development.

Products and services

CNM-Au8, a concentrated aqueous suspension of catalytically-active gold nanocrystals, is the lead drug candidate. It targets mitochondrial dysfunction by catalyzing NAD+ production and is in clinical development for ALS, MS, and Parkinson's disease. An NDA submission under the FDA accelerated approval pathway is planned by end of June 2026 for ALS, contingent on funding. A planned Phase 3 RESTORE-ALS trial is contingent on funding. The company is also conducting the ACT-EAP expanded access program for ALS in collaboration with NYU and Synapticure, with 183 participants enrolled as of February 25, 2026.

Customers and end markets

Target patient populations are adults with ALS, multiple sclerosis, and Parkinson's disease. The ACT-EAP program serves ALS patients through a public-private partnership funded by the NIH under the Accelerating Access to Critical Therapies for ALS Act. No commercial customers exist as of the filing date.

Value-chain role

Clinical-stage drug developer. Contracts with third-party contract research organizations, principal investigators, and clinical trial sites for trial execution. Uses third-party manufacturers for drug supply. Handles internal research, regulatory strategy, and clinical program management.

Geographic exposure

Incorporated and headquartered in the United States. Regulatory interactions are primarily with the FDA. The NIH grant is a U.S. federal funding source. No international commercial operations are disclosed in the excerpts.

Source: SEC 10-K, filed 2026-03-17

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