Business
Clene Reports Second Quarter 2024 Financial Results and Recent Operating Highlights
Survival analyses with CNM-Au8® 30 mg treatment compared to matched PRO-ACT controls demonstrated improved survival up to 3.5 years post-baselineCNM-Au8
About this update from Clene Inc.
[{"type":"text","content":"Survival analyses with CNM-Au8® 30 mg treatment compared to matched PRO-ACT controls demonstrated improved survival up to 3.5 years post-baselineCNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated significant clinical improvements in survival, functional status (slowed ALSFRS-R decline), and combined function and survival (CAFS scores) compared to NfL non-respondersCNM-Au8 demonstrated neuroprotective effects in an in vitro model of Rett Syndrome, a rare pediatric neurodevelopmental diseaseEnrolled first ALS patient in NIH-funded Expanded Access Program (EAP) in JuneRegained compliance with Nasdaq Listing Rule 5550(a)(2) for continued listing on NasdaqSubmitted briefing book to the U.S. Food and Drug Administration (FDA) in advance of granted Type C interaction to occur in the third quarter of 2024Cash and cash equivalents of $21.7 million as of June 30, 2024 SALT LAKE CITY, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its second quarter 2024 financial results and provided recent updates on its CNM-Au8® programs. “We are approaching our next FDA interaction focused on the regulatory path forward to potentially bring CNM-Au8 to people living with ALS,” said Rob Etherington, President and CEO of Clene. “With this imminent timing, we are optimistic about the possibility of submitting a new drug application later this year. Our utmost priority is to help patients and their families for whom time is critical.” Second Quarter 2024 and Recent Operating Highlights CNM-Au8 for the treatment of ALS In June, the Company presented new long-term CNM-Au8 treatment results for survival and neurofilament light (NfL) levels from the HEALEY ALS Platform Trial open label extension (OLE) at the European Network for the Cure of ALS (ENCALS) meeting in Stockholm, Sweden. The data highlights up to 42 months of survival follow-up and 76 weeks of long-term NfL biomarker results, including a NfL responder subset (CNM-Au8 NfL Responders) fro...