Clene Nanomedicine

Want the latest on Clene’s CNM-Au8® Expanded Access Program for ALS? Join us March 12 at 5 PM ET for a live webinar with Dr. Jinsy Andrews and the Clene Inc. team. Hosted by the Sean M. Healey & AMG Center for ALS. Register: massgeneral.org/neurology/als/…

Could biomarkers help reveal treatment response in ALS? On Monday, March 9th at the @MDAorg Clinical & Scientific Conference, Marjan Sepassi of Clene will present a poster on IGFBP7 as a nexus biomarker using data from CNM-Au8® during and after the HEALEY ALS Platform Trial.

🧬 New ALS biomarker insights. Marjan Sepassi, VP of Medical Affairs at Clene, will present a poster on Monday, Mar 9th at the @MDAorg Clinical & Scientific Conference “IGFBP7 as a Nexus Biomarker Identifying a Coordinated Treatment Response Phenotype in ALS” #ALS #Biomarkers

Happening today (5–6 PM ET) Join the NEALS webinar: CNM-Au8® in ALS: NIH Expanded Access Program (EAP) Clinical & Biomarker Update Q&A with Michael Hotchkin (Clene) and Benjamin Greenberg, MD (UT Southwestern/Clene). Register Here: neals.org/educational-we… #ALS #NEALS #Webinar

Join us for an upcoming NEALS webinar on Wednesday, February 25, 2026, from 5–6 PM ET: CNM-Au8® in ALS: NIH Expanded Access Program (EAP) Clinical & Biomarker Update Don’t miss this important clinical and biomarker update Register here: neals.org/educational-we… #ALS #NEALS

Exploratory HEALEY analyses showed that responders with IGFBP7 decline on CNM-Au8 had a 78% lower mortality risk (HR 0.22, p=0.01), supporting IGFBP7 as a potential biomarker of response. PR: invest.clene.com/news-releases/…

Clene’s data align with the FDA’s accelerated approval framework in ALS, linking reproducible NfL reductions with CNM-Au8 to improved survival across independent datasets.

Independent ALS cohort analyses show that ~10% NfL reductions are linked to lower mortality risk, supporting NfL as a potential surrogate endpoint for accelerated approval. PR: invest.clene.com/news-releases/…

As we prepare for our FDA Type C meeting, follow Clene for updates on CNM-Au8® and our ongoing regulatory discussions in ALS.

Clene has been granted an in-person FDA Type C meeting in Q1 2026 to discuss CNM-Au8® and emerging biomarker data in ALS, including NfL as a potential surrogate endpoint. PR: invest.clene.com/news-releases/…

Happy Holidays from all of us at Clene! We’re grateful for 2025 progress on CNM-Au8® in ALS and excited to gear up for our FDA Type C meeting in Q1 2026 as we advance toward an accelerated approval pathway. #ALS #Biotech #Neurodegeneration #Innovation

ICYMI: FDA-recommended analyses show CNM-Au8® produced statistically significant reductions in NfL & GFAP Participants with the largest declines in both biomarkers saw the greatest long-term survival benefit, an ~80% reduced risk of death vs. controls PR:invest.clene.com/news-releases/…

Thank you @iamalsorg for highlighting new CNM-Au8® biomarker data from the ACT for ALS Expanded Access Program. These findings offer meaningful insight into survival and the importance of real-world data in ALS research. Read More: prnewswire.com/news-releases/…

Update: CNM-Au8® shows statistically significant NfL & GFAP reductions in FDA-recommended analyses. These biomarkers are linked to longer survival, supporting CNM-Au8’s potential disease-modifying effect. PR: invest.clene.com/news-releases/…

🚨Big news: We reported statistically significant ALS biomarker results, advancing CNM-Au8® toward a potential accelerated approval pathway. Tune in to our webcast today, Dec 3 at 8:30am ET for full details. ▶️ viavid.webcasts.com/starthere.jsp?… #BiotechNews #Neuroscience

Today, we reported financial results for Q3 2025 and recent operating highlights. Here’s what’s ahead: • Completion of ALS biomarker analyses expected soon, following FDA guidance • Planned NDA for CNM-Au8® in ALS Q1 2026 Full press release: invest.clene.com/news-releases/…

ALS remains a devastating disease with urgent unmet needs. At Clene Nanomedicine, our mission is to advance innovative therapies like CNM-Au8® that support cellular energy and neuronal survival. Together, we push for hope and progress. #EndALS #Neurodegeneration #ALSResearch

Great meeting with all our EAP sites at #NEALS! Launched in 2024, the EAP has provided access to investigational treatment CNM-Au8® for people living with ALS. Our partners have worked tirelessly to enroll participants. Thank you to all the teams for your incredible support.