Clene Inc.
For the period ended Mar 12, 2026. Filed Mar 12, 2026.
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Mar 12, 2026 · Filed Mar 12, 2026
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EX-99.1 · AND RECENT OPERATING HIGHLIGHTS
AND RECENT OPERATING HIGHLIGHTS
| ● | In-person Type C FDA meeting scheduled by end of the first quarter of 2026 to discuss the latest CNM-Au8® data submitted; Clene expects formal written meeting minutes early in the second quarter 2026 |
| ● | Oversubscribed registered direct offering of over $28 million priced above market |
| ○ | Initial financing tranche of over $6 million, which will provide cash runway to the end of the third quarter enabling funding through potential NDA acceptance decision by the FDA |
| ○ | Completion of this financing through its three tranches is expected to provide the Company with sufficient capital into 2027 |
SALT LAKE CITY, Mar. 12, 2026 -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its full year 2025 financial results and provided recent updates on its CNM-Au8 programs.
“Our next key milestone is the upcoming Type C face-to-face meeting with the U.S. Food and Drug Administration (FDA) on Clene’s biomarker and survival data, which if positive, will facilitate filing of an new drug application (NDA) under an accelerated approval pathway for ALS by the end of the second quarter of 2026,” said Rob Etherington, President and CEO of Clene. “In parallel, we continue to advance plans to initiate our confirmatory Phase 3 trial in ALS, which is required to be “underway” by CNM-Au8 approval in ALS, as well as to continue working with the FDA on the initiation of a Phase 3 clinical trial using cognition as an endpoint in MS. Based on our combined findings to date, we continue to believe that patients across multiple neurodegenerative conditions may benefit from the improved mitochondrial function plus energy metabolism associated with CNM-Au8 treatment.”
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