Clene reports Q2 2026 results, plans ALS drug filing for early Q4

Clene Inc. (Nasdaq: CLNN) reported second quarter 2026 results on August 14, 2026, and said it expects to submit a New Drug Application for CNM-Au8 in ALS under the accelerated approval pathway in early fourth quarter of 2026.¹

The company said it received formal minutes from the FDA in May confirming its ability to file under that pathway, after the agency indicated in those minutes that Clene's proposed data may be capable of supporting the submission and review of an NDA under the accelerated approval pathway for the treatment of ALS.¹ The FDA also said the filing needs to show that the magnitude of change in NfL is reasonably likely to predict clinical benefits in patients with ALS.¹

Clene said new analyses of its two completed Phase 2 ALS trials found that patients whose neurofilament light levels declined or stabilized lived significantly longer than concurrently randomized controls and performed significantly better on combined measures of survival and function, including the ALS Functional Rating Scale-Revised (ALSFRS-R) and breathing capacity (Slow Vital Capacity; SVC).¹ The planned filing is expected to draw on data from the Phase 2 "HEALEY ALS Platform Trial" and its open-label extension, the Phase 2 "RESCUE-ALS Trial," along with the NIH-sponsored Expanded Access Protocol for CNM-Au8.¹

On financing, Clene said cash and cash equivalents totaled $9.7 million as of June 30, 2026, compared to $5.2 million as of December 31, 2025.¹ The company said its resources as of June 30, 2026, will provide operating runway through late fourth quarter 2026.¹ In May, Clene said it closed an underwritten registered direct common stock offering to a single investor totaling $7.0 million in gross proceeds,¹ and separately amended two senior secured convertible debt facilities to extend their maturity dates to August 2027 and eliminate required principal and interest payments before that date.¹