Recent Updates — CLNNW

Clene Inc. reported a net loss of $13.4 million, or $1.08 per share, for the second quarter ended June 30, 2026, compared to a $7.4 million loss in the prior year period. The company announced it expects to submit a New Drug Application (NDA) for its investigational therapy CNM-Au8 for amyotrophic lateral sclerosis (ALS) under the accelerated approval pathway in early Q4 2026, following FDA confirmation that proposed data may support such submission. Recent biomarker analyses indicated that patients with declining or stabilized neurofilament light levels experienced improved survival and functional outcomes. Financially, cash and cash equivalents stood at $9.7 million as of June 30, 2026, providing an operating runway through late Q4 2026. In May, Clene closed a registered direct offering for $7.0 million in gross proceeds and amended its convertible debt facilities to extend maturities to August 2027. The company operates as a late clinical-stage biopharmaceutical firm focused on developing therapies for neurodegenerative diseases.

Clene Inc. announced on August 10, 2026, that new biomarker analyses will be included in its New Drug Application (NDA) seeking accelerated approval for CNM-Au8 in amyotrophic lateral sclerosis (ALS). The data indicates that patients whose neurofilament light chain (NfL) levels declined or stabilized experienced significantly longer survival and better functional outcomes compared to controls. Specifically, NfL responders showed a 38% lower risk of death over the full follow-up period, with an average survival gain of nearly six months at four years in the HEALEY trial. These findings address questions raised by the FDA during a March 2026 Type C meeting regarding NfL as a surrogate endpoint. Clene plans to file the NDA early in Q4 2026, supported by these post hoc analyses and a planned Phase 3 confirmatory trial called RESTORE-ALS. Clene Inc. is a late clinical-stage biopharmaceutical company focused on developing therapies for neurodegenerative diseases.