Clene Inc.
For the period ended Aug 10, 2026. Filed Aug 10, 2026.
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Aug 10, 2026 · Filed Aug 10, 2026
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EX-99.2 · NDA SUBMISSION SUPPORTING ALS ACCELERATED APPROVAL
NDA SUBMISSION SUPPORTING ALS ACCELERATED APPROVAL
| ● | Survival benefit is concentrated in participants with NfL biomarker response: CNM-Au8®-treated patients whose NfL declined or stabilized lived significantly longer than concurrently randomized controls |
| ● | Functional benefit concentrated in participants with NfL biomarker response: CNM-Au8-treated patients whose NfL declined or stabilized had significantly better outcomes on combined measures of survival and function, including daily function (ALSFRS-R) and breathing capacity (Slow Vital Capacity), than concurrently randomized controls |
SALT LAKE CITY, August 10, 2026 — Clene Inc. (Nasdaq: CLNN) today announced results from new analyses examining clinical outcomes among CNM-Au8®-treated patients whose neurofilament light chain (NfL) biomarker levels declined or stabilized. These findings will be included in Clene’s planned New Drug Application (NDA) seeking accelerated approval and are intended to address the questions raised by the U.S. Food and Drug Administration (FDA) during a March 2026 Type C meeting. At that meeting, the FDA acknowledged that NfL, a recognized blood marker of nerve-cell injury, has established prognostic value in amyotrophic lateral sclerosis (ALS) and could potentially serve as a reasonably likely surrogate endpoint to support accelerated approval.
New biomarker analyses of Clene’s two completed Phase 2 ALS trials revealed additional evidence that CNM-Au8-treated patients whose NfL declined or stabilized lived significantly longer than concurrently randomized controls and performed significantly better on combined measures of survival and function, including ALS Functional Rating Scale-Revised (ALSFRS-R) and breathing capacity (Slow Vital Capacity; SVC).
These findings were derived from multiple lines of analysis: clinical benefit versus concurrently randomized controls; the relationship between the size of the NfL reduction and clinical outcome; a causal analysis that identified likely NfL responders from pre-treatment characteristics alone, preserving the randomized comparison; and replication of the association between NfL change and survival across independent datasets.
Among patients treated with CNM-Au8:
| ● | Participants randomized to CNM-Au8 30 mg had a 74% lower risk of death after 12 months of follow-up than concurrently randomized controls from another regimen in the HEALEY ALS Platform Trial (HEALEY) (p=0.0124) |
| ● | Analyses in more than 2,000 ALS patients who never received CNM-Au8 showed that a 10% NfL decline was associated with a 6% to 10% lower risk of death (APST, p < 0.0001; ANSWER ALS, p = 0.001) |
| ● | Survival improved in participants whose NfL declined or stabilized, a 38% lower risk of death than concurrently randomized controls over the full follow-up period (HR 0.621, 95% CI 0.397–0.972; p = 0.037) in HEALEY; the average survival gain reached nearly six months at four years of follow-up (p = 0.012) |
| ● | Participants whose NfL declined or stabilized scored significantly better on the Combined Assessment of Function and Survival (CAFS), whether measured by daily function (ALSFRS-R, p = 0.032) or breathing capacity (SVC, p = 0.003), compared with concurrently randomized controls from HEALEY |
| ● | An FDA-requested causal analysis identifying likely NfL responders from pre-treatment characteristics alone found a 41% lower risk of death on CNM-Au8 30 mg versus controls in the predicted NfL responder group (HR 0.593; p = 0.026), with no significant difference among those predicted not to respond |
These biomarker analyses arepost hoc and exploratory. We believe the totality of this evidence addresses the accelerated approval standard, which the FDA will evaluate during its review of the NDA.
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