Clene Inc. said it expects its operating capital runway to be sufficient into the fourth quarter of 2026, following an oversubscribed registered direct offering of more than $28 million completed in January. The company said the initial tranche of more than $6 million is expected to fund operations into Q4 2026, while two potential additional tranches totaling more than $22 million are structured to align with potential NDA acceptance and FDA approval milestones and are expected to extend capital into 2027. Clene said an in-person Type C FDA meeting is scheduled by the end of the first quarter of 2026 to discuss CNM-Au8 data submitted in late 2025, with FDA minutes expected early in the second quarter. The company said it anticipates submitting a New Drug Application for CNM-Au8 via an accelerated pathway in the second quarter of 2026 and said FDA acceptance and a PDUFA date could occur in the second half of 2026. Clene also said it has treated more than 800 patients with CNM-Au8 and reported more than 1,000 patient-years of treatment across trials and expanded access programs, with no CNM-Au8-related serious adverse events reported. The company said it plans to dose the first patient in its confirmatory Phase 3 RESTORE-ALS trial later in 2026.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Clene Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202602240800PRIMZONEFULLFEED9659898) on February 24, 2026, and is solely responsible for the information contained therein.
Comments