Clene Reports Third Quarter 2026 Financial Results and Recent Operating Highlights
Key Highlights
- ➤NDA submitted to FDA seeking accelerated approval for CNM-Au8 in ALS
- ➤$4.0 million registered direct offering extends operating runway through mid-first quarter 2027
- ➤Phase 3 RESTORE-ALS trial planned to begin in second quarter 2027
- ➤Q3 net income $3.9 million versus $8.8 million loss year earlier
- ➤Cash and equivalents $9.9 million at September 30, 2026, versus $5.2 million year-end 2025
Expert Statements
Rob Etherington, President and CEO of Clene
“Clene’s submission of the NDA for CNM-Au8 is a pivotal achievement for the company and, more importantly, a meaningful step toward bringing new treatment options to people living with ALS”
Rob Etherington, President and CEO of Clene
“People living with ALS urgently need additional treatment options, and we appreciate the FDA’s constructive engagement throughout this process. We look forward to working closely with the Agency during its pending review.”
Rob Etherington, President and CEO of Clene
“We believe CNM-Au8 has the capacity to restore and protect neuronal health and function and improve survival.”
* Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in October 2026 seeking accelerated approval for CNM-Au8(®) in amyotrophic lateral sclerosis (ALS) * Completed a $4.0 million registered direct offering in September that is expected to fund operations through mid-first quarter 2027 * Plans to initiate the Phase 3 RESTORE-ALS confirmatory trial of CNM-Au8 in ALS in the second quarter of 2027 SALT LAKE CITY, Nov. 04, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced its third quarter 2026 financial results and provided updates on its CNM-Au8 programs.
“Clene’s submission of the NDA for CNM-Au8 is a pivotal achievement for the company and, more importantly, a meaningful step toward bringing new treatment options to people living with ALS,” said Rob Etherington, President and CEO of Clene. “People living with ALS urgently need additional treatment options, and we appreciate the FDA’s constructive engagement throughout this process. We look forward to working closely with the Agency during its pending review. We believe CNM-Au8 has the capacity to restore and protect neuronal health and function and improve survival.”
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