Clene Reports Second Quarter 2024 Financial Results and Recent Operating Highlights

About this update from Clene Inc.

Survival analyses with CNM-Au8® 30 mg treatment compared to matched PRO-ACT controls demonstrated improved survival up to 3.5 years post-baseline CNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated significant clinical improvements in survival, functional status (slowed ALSFRS-R decline), and combined function and survival (CAFS scores) compared to NfL non-responders CNM-Au8 demonstrated neuroprotective effects in an in vitro model of Rett Syndrome, a rare pediatric neurodevelopmental disease Enrolled first ALS patient in NIH -funded Expanded Access Program (EAP) in June Regained compliance with Nasdaq Listing Rule 5550(a)(2) for continued listing on Nasdaq Submitted briefing book to the U.S. Food and Drug Administration (FDA) in advance of granted Type C interaction to occur in the third quarter of 2024 Cash and cash equivalents of $21.7 million as of June 30, 2024 SALT LAKE CITY , Aug. 07, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc. , a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its second quarter 2024 financial results and provided recent updates on its CNM-Au8® programs. “We are approaching our next FDA interaction focused on the regulatory path forward to potentially bring CNM-Au8 to people living with ALS,” said Rob Etherington , President and CEO of Clene . “With this imminent timing, we are optimistic about the possibility of submitting a new drug application later this year. Our utmost priority is to help patients and their families for whom time is critical.” Second Quarter 2024 and Recent Operating Highlights CNM-Au8 for the treatment of ALS In June, the Company 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 . The data highlights up to 42 months of survival follow-up and 76 weeks of long-term NfL biomarker results, including a NfL responder subset (CNM-Au8 NfL Responders) from the HEALEY ALS Platform Trial who had consistent and sustained NfL reductions, comprising nearly half of all CNM-Au8 patients. The data demonstrated improved survival compared to matched PRO-ACT controls as well as continued significant decline in plasma NfL levels in CNM-Au8 treated patients. 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 (HR): 0.431 (95% CI: 0.276-0.672), p-value = 0.0002. Reduced NfL Biomarker Levels in CNM-Au8 NfL Responders: CNM-Au8 NfL Responder Subset: The CNM-Au8 NfL Responder analysis was completed to identify NfL decreases in participants who showed consistent NfL declines (n=55). CNM-Au8 NfL 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. CNM-Au8 NfL Responders demonstrated an average NfL reduction of 28%, which is suggestive of decreased axonal loss on an ongoing basis; geometric mean ratio (GMR) at week 76 change vs. baseline: 0.72, (95% CI: 0.67 – 0.79), p The NfL results are based on earlier announced analyses of plasma NfL collected from participants (n=99) in the 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 GMR vs. placebo at week 76 was 0.841, 95% CI: 0.73 – 0.98, p = 0.023. On July 13, 2024 , the Company submitted a briefing book to FDA in advance of a granted Type C interaction expected to occur in the third quarter of 2024. The briefing book contains new post-hoc analyses from two independently conducted Phase 2 clinical trials of CNM-Au8 for the treatment for ALS. This new information supplements the original data previously discussed with the FDA in late 2023 and is intended to guide the planned FDA Type C interaction to discuss an accelerated approval regulatory pathway. The Company plans to publicly announce the topline FDA feedback following the conclusion of the Type C interaction. CNM-Au8 NfL Responders demonstrated a 28% mean reduction in NfL levels compared to baseline, while NfL levels continued to increase in CNM-Au8 NfL non-responders (all doses; GMR difference at week 76 post-baseline: 0.57, 95% CI: 0.50 – 0.64, p Late last year, Clene , in collaboration with Columbia University and Synapticure, announced the award of a four-year grant from the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), to support an EAP for the Company’s investigational drug, CNM-Au8 in ALS. The Company enrolled its first EAP patient in June. CNM-Au8 for the treatment of Rett Syndrome In June, Clene presented new, preliminary data demonstrating the potential of CNM-Au8 as a treatment for Rett Syndrome. at the International Rett Syndrome Foundation 2024 Annual Meeting. The presentation was titled, “CNM-Au8, a Candidate First-in-Class Nanotherapeutic for Treatment of Rett Syndrome.” Key findings included: Statistically significant improvement in neuronal health (p

View stock analysis, news, and events for Clene Inc.