Clene Reports First Quarter 2021 Operating and Financial Highlights

Interim Phase 2 data indicate that CNM-Au8 has a homeostatic effect on brain bioenergetics and support its potential to drive meaningful neurological functional improvements in MS patients

Awarded Michael J. Fox Foundation (MJFF) grant to accelerate development of CNM-Au8 as a treatment for Parkinson’s disease

Phase 2 RESCUE-ALS trial and Phase 2 target engagement trials in MS and PD remain on track for topline data in 2H 2021

Cash of $48.0 million as of March 31, 2021

SALT LAKE CITY, May 11, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to revolutionizing the treatment of neurodegenerative disease using bioenergetic nanocatalysis, today reported its first quarter 2021 operating and financial results.

“Clene is off to a strong start in 2021, having made great progress across its programs,” said Rob Etherington, president and chief executive officer of Clene. “During the first quarter, we announced compelling interim data in MS patients indicating that CNM-Au8 has a homeostatic effect on brain bioenergetics, which may allow it to ultimately slow or halt disease progression. We also received important external validation for our Parkinson’s Disease program in the form of a grant from the Michael J. Fox Foundation that will enable us to accelerate CNM-Au8’s development in this high unmet need indication. Looking ahead, we are on track to achieve multiple key inflection points across our pipeline over the remainder of the year, the most notable being the announcement of topline data from our placebo-controlled, Phase 2 RESCUE-ALS study in the second half of 2021. With our strong cash position, we will continue to work expeditiously on our mission to change the treatment paradigm for patients with neurodegenerative diseases.”

First Quarter 2021 and Recent Highlights

CNM-Au8 for the treatment of amyotrophic lateral sclerosis (ALS):

Phase 3 registrational trial in ALS on track for full enrollment in second half of 2021

In the first quarter of 2021, the HEALEY ALS Platform trial, a multi-center, multi-regimen, placebo-controlled, Phase 3 / registrational clinical program evaluating the safety and efficacy of multiple investigational products for the treatment of ALS, reached 50% of its target enrollment for the first three of the ongoing studies, including CNM-Au8. This first-ever ALS platform trial is designed to reduce trial time, reduce costs, and increase patient participation in developing novel therapies for ALS. It includes substantial financial support from philanthropic donors and foundations and provides access to more than 50 expert ALS clinical trial sites across the U.S. Full enrollment of 160 patients into the CNM-Au8 portion of the trial is anticipated before the end of 2021, with topline data expected in the first half of 2022.

CNM-Au8 for the treatment of multiple sclerosis (MS)

Presented blinded interim data from the Phase 2 VISIONARY-MS trial at ACTRIMS Forum 2021Updated blinded interim data from VISIONARY-MS continue to support the potential of CNM-Au8 to drive meaningful neurological improvements in people with MS. Interim blinded data from all enrolled participants (randomized 2:1, active CNM-Au8 to placebo) showed clinically relevant mean improvements in key MSFC sub-scales, as well as a composite score including all of the MSFC sub-scales. The overall study population's progress on study was compared to the mildest sub-population (EDSS ≤1.5) scores at Baseline (mixed-effects model; p