Clene submits ALS NDA for CNM-Au8, sets Phase 3 confirmatory trial for Q2 2027

Clene Inc. announced third quarter 2026 results on November 4, 2026, reporting that in October it submitted a New Drug Application to the FDA seeking accelerated approval of CNM-Au8 for ALS.¹ The company said the filing draws on neurofilament light biomarker and clinical data from the Phase 2 HEALEY ALS Platform Trial and its open-label extension, the Phase 2 RESCUE-ALS Trial, and an NIH-sponsored Expanded Access Protocol for CNM-Au8.¹

Clene also said it plans to randomize the first participants in the Phase 3 RESTORE-ALS trial in the second quarter of 2027, a study designed to evaluate CNM-Au8's effect on survival as its primary endpoint and time to ALS clinical worsening events as a secondary efficacy endpoint.¹

On financing, the company closed a $4.0 million registered direct offering of common stock in September, priced at $3.28 per share and sold to existing stockholders including insiders, led by Chairman David Matlin along with founding investor Kensington Capital Holdings and the CEO.¹ Clene said it expects proceeds from that offering to fund operations through mid-first quarter 2027.¹ The company added that, contingent on FDA acceptance of the NDA for review, it could receive between $6.7 million and $7.8 million from common stock warrants tied to a financing completed in January 2026.¹

On the balance sheet, Clene reported cash and cash equivalents of $9.9 million as of September 30, 2026, up from $5.2 million at the end of 2025¹, while net cash used in operating activities over the first nine months of 2026 was $11.7 million, versus $13.7 million in the same period of 2025.¹ The company reiterated that its resources as of September 30, 2026 are expected to provide operating runway through mid-first quarter 2027.¹