Clene Inc., a clinical-stage pharmaceutical company specializing in clean-surfaced nanotechnology (CSN) therapeutics for neurodegenerative diseases, reported a net loss of $26.2 million for the year ended December 31, 2025, compared to a net loss of $39.4 million for the previous year. The company's revenue, primarily from dietary supplement sales, decreased by 42% to $200,000 in 2025 from $342,000 in 2024. Research and development expenses also decreased by 30% to $14.0 million in 2025, compared to $20.1 million in 2024, due to the conclusion of certain clinical programs and cost-saving initiatives, partially offset by increased expenses for ongoing expanded access programs (EAPs). General and administrative expenses decreased by 31% to $9.2 million in 2025 from $13.3 million in 2024, driven by reduced personnel expenses and stock-based compensation.
The company's lead drug asset, CNM-Au8, a gold nanocrystal suspension, continues to be the focus of clinical development for ALS, MS, and PD. Clene has engaged with the FDA regarding a potential accelerated approval pathway for CNM-Au8 in ALS, with a Type C meeting scheduled for the first quarter of 2026 to discuss biomarker data and the possibility of submitting an NDA by the end of June 2026. A Phase 3 RESTORE-ALS trial is planned for the second half of 2026, contingent on funding. The company is also actively supporting ongoing EAPs for ALS patients and commenced enrollment in an MS EAP in September 2024.
Operationally, Clene is focused on advancing its clinical pipeline and expanding its manufacturing capabilities. The company manufactures its CSN therapeutics at its North East, Maryland facility and plans to develop its Elkton, Maryland facility to increase manufacturing capacity, contingent on future commercialization and funding. As of December 31, 2025, Clene had 79 employees, with a significant portion dedicated to manufacturing and research and development. The company also relies on collaborations with academic institutions and contract research organizations (CROs) to support its research and development efforts.
Clene faces significant financial challenges, as indicated by its accumulated deficit of $308.3 million as of December 31, 2025, and its limited cash resources. The company acknowledges substantial doubt about its ability to continue as a going concern within the next twelve months without obtaining additional financing. To address this, Clene intends to explore various funding options, including equity and debt financing, licensing agreements, and leveraging its existing at-the-market facility. The company's future success hinges on the successful commercialization of its drug candidates, particularly CNM-Au8, and its ability to secure the necessary funding to support its operations and clinical development programs.
About Clene Inc.
Clene Inc. is a clinical-stage pharmaceutical company developing innovative nanotechnology-based therapeutics targeting neurodegenerative and infectious diseases. Its proprietary clean-surfaced nanocrystals support cellular energy, reduce oxidative stress, and address protein aggregation. Focused on CNS disorders like ALS, MS, and Parkinson’s, the company aims to revolutionize treatment through catalytically active nanocrystals with broad applicability and multi-modal mechanisms of action.
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