Clene Inc. and its wholly owned subsidiary Clene Nanomedicine Inc. presented new long-term CNM-Au8 treatment results for survival and neurofilament light (NfL) levels from the HEALEY ALS Platform Trial open label extension (OLE) at the European Network for the Cure of ALS (ENCALS) meeting in Stockholm, Sweden. Improved Survival Compared to Matched PRO-ACT Controls: Survival analyses of participants originally randomized to CNM-Au8 30 mg treatment (n=59) and ex-placebo to CNM-Au8 (n=11) compared to matched PRO-ACT controls up to 3.5 years post-baseline. Approximately 60% decreased risk of death in CNM-Au8 30 mg treated patients compared to matched PRO-ACT controls up to 3.5 years of follow-up; covariate-adjusted hazard ratio: 0.431 (95% CI: 0.276-0.672), p-value = 0.0002.

Reduced Neurofilament Light Biomarker Levels (NfL) in NfL Responders: NfL Responder Subset: The NfL responder analysis was completed to identify NfL decreases in participants who showed consistent NfL declines (n=55). Responders were defined as participants who had all post-baseline measures with an NfL decrease or repeated declines of at least 10 pg/mL following the start of CNM-Au8 treatment: Responders demonstrated an average NfL reduction of 28%, which is suggestive of decreased axonal loss on an ongoing basis; GMR at Week 76 change vs. baseline: 0.72, (95% CI: 0.67 ?

0.79), p<0.0001. The NfL results are based on earlier announced analyses of plasma NfL collected from participants (n=99) in the HEALEY OLE who were treated with CNM-Au8 30 mg through week 76 compared to participants treated with placebo for 24 weeks prior to crossing over to active treatment for up to 52 weeks. Long-term treatment with CNM-Au8 30 mg resulted in continued significant decline of plasma NfL levels.

The geometric mean ratio (GMR) vs. placebo at week 76 was 0.841, 95% CI: 0.73 ? 0.98, p=0.023.

CNM-Au8 was safe and well-tolerated during the OLE.