Clene to Submit ALS New Drug Application in Q4 2025

Clene plans to analyze neurofilament light data from its NIH-sponsored Early Access Protocol in Q4 2025. The company will hold a Type C meeting with the FDA in Q3 2025 to discuss the survival benefit of CNM-Au8 dosing. A New Drug Application for potential accelerated approval of CNM-Au8 in ALS is expected in Q4 2025. A Type B end-of-Phase 2 meeting with the FDA will be held in Q3 2025 to discuss the MS clinical development program. Clene has $7.3 million in cash and cash equivalents as of June 30, 2025, with additional funding raising its cash runway into Q1 2026.

Clene Inc. (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company, reported its second quarter 2025 financial results and provided updates on its ALS and MS development programs. The company announced key meetings with the FDA and plans to submit a New Drug Application (NDA) for its ALS treatment program by the end of 2025. Financial highlights include a cash position of $7.3 million as of June 30, 2025, with additional funding extending its runway into Q1 2026.

Clene reported a net loss of $7.4 million for the quarter, driven by reduced operating expenses. Research and development (R&D) expenses were $3.5 million, down from $4.2 million in Q2 2024, primarily due to cost-saving initiatives and decreased personnel expenses. General and administrative (G&A) expenses were $2.4 million, down from $3.3 million in Q2 2024, mainly due to cost-saving measures and decreased stock-based compensation expenses.

The company announced plans to analyze neurofilament light (NfL) biomarker data from its NIH-sponsored Early Access Protocol (EAP) in Q4 2025. A Type C meeting with the FDA is scheduled for Q3 2025 to discuss the survival benefit of CNM-Au8 dosing. Additionally, a Type B end-of-Phase 2 meeting with the FDA is planned for Q3 2025 to discuss the MS clinical development program. Clene expects to submit an NDA for potential accelerated approval of CNM-Au8 in ALS by the end of 2025.

Clene has $7.3 million in cash and cash equivalents as of June 30, 2025, with additional funding raising its cash runway into Q1 2026. The company's commitment to developing impactful therapeutic agents for neurodegenerative diseases remains unwavering.

[1] https://www.stocktitan.net/news/CLNN/clene-reports-second-quarter-2025-financial-results-and-recent-sho6g811e3i6.html