CNM-Au8 - (HEALEY ALS)

May 14, 2026: Clene Inc. (NASDAQ: CLNN) reported Q1 2026 results and provided a regulatory update for CNM-Au8 in amyotrophic lateral sclerosis (ALS). The company said it successfully completed an in-person FDA Type C meeting in Q1 2026 focused on statistically significant reductions in neurofilament light (NfL) and the relationship between NfL reduction magnitude and clinical benefits including longer survival. In final meeting minutes, FDA stated the “proposed data may be capable of supporting” an NDA submission and review under the accelerated approval pathway for ALS, and reminded Clene the NDA should demonstrate an effect on NfL and that the magnitude of NfL change is reasonably likely to predict clinical benefit.

Clene expects to submit an NDA for CNM-Au8 in Q3 2026 and plans to start the confirmatory Phase 3 RESTORE-ALS trial in Q1 2027, with overall survival as the primary endpoint and time to ALS clinical worsening events as a secondary endpoint.

Financing/cash runway updates included a January 2026 oversubscribed registered direct offering (> $28M) with additional tranches tied to NDA acceptance and FDA approval milestones, a May 2026 $7M registered direct offering, and a May 2026 amendment extending a $10M convertible debt facility maturity to August 2027 with no required payments before maturity.