- Clene Inc. plans to submit a New Drug Application (“NDA”) for lead candidate CNM-Au8® in ALS by year-end 2025.
- FDA meetings scheduled in Q3 2025 will address ALS survival benefit data and MS development plans.
- Neurofilament light biomarker data analysis from the NIH-sponsored EAP program is expected in early Q4 2025.
- The company reported $7.3 million in cash and cash equivalents as of June 30, 2025, together with recent financing extending the company’s cash runway into Q1 2026.
Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), released its second quarter 2025 financial results and provided an update on its clinical programs. The company emphasized progress toward an NDA submission for its lead asset CNM-Au8 in ALS, expected in the fourth quarter of 2025 (https://ibn.fm/PiKqu).
CNM-Au8 is an oral suspension of gold nanocrystals designed to restore neuronal health by improving energy metabolism. Clene recently held a Type C meeting with the U.S. Food and Drug Administration (“FDA”) to align on statistical methodology for analyzing neurofilament light (“NfL”) biomarker changes in ALS patients treated with the lead drug candidate under the NIH-sponsored Expanded Access Program (“EAP”). The company expects to present data from this analysis in Q4 2025.
A second Type C meeting with the FDA is scheduled for Q3 2025 to review survival benefit data in ALS, including results from the HEALEY ALS Platform Trial. This outcome of this meeting may further support the evidentiary basis for an NDA filing under the accelerated approval pathway, which Clene intends to submit by year-end.
“We look forward to engaging with the FDA in our upcoming meeting this quarter focused on the extensive survival data that CNM-Au8 has generated in ALS patients,” said CEO Rob Etherington. “These meetings and biomarker analyses represent the final steps to our potential submission of an NDA under the accelerated approval pathway for ALS by the end of 2025. Our commitment to the ALS community remains unwavering as we endeavor to develop an impactful therapeutic agent for this devastating disease.”
Clene is also progressing its MS program. At the American Academy of Neurology meeting in April 2025, the company presented data from the long-term extension of its Phase 2 VISIONARY-MS trial, showing physiological and anatomical evidence of neuronal repair and remyelination.
The company plans to meet with the FDA in Q3 2025 for an end-of-Phase 2 Type B meeting to discuss a potential Phase 3 study. That trial would focus on cognition improvement as an adjunct to standard-of-care therapies.
As of June 30, 2025, Clene reported $7.3 million in cash and cash equivalents. Subsequent financing ($1.9 million raised in equity and a $1.5 million expansion of its convertible debt facility) extends the company’s operating runway into the first quarter of 2026.
R&D expenses decreased to $3.5 million from $4.2 million in Q2 2024, reflecting cost-saving measures, reduced personnel, and higher grant revenue tied to NIH-sponsored programs. General and administrative costs also fell to $2.4 million from $3.3 million, due to lower personnel and legal expenses, partially offset by higher finance and audit fees.
For more information, visit the company’s website at www.Clene.com.
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN
