Clene posts FY2023 net loss $49.5M; FDA discussions for CNM-Au8 accelerated approval ongoing

Clene Inc.

Net loss $49.5M ($0.47/share) vs $29.9M ($0.46/share) in FY2022; cash $35.0M, expected to fund ops into Q4 2024.
R&D expenses $26.7M (down from $31.9M); G&A $14.4M (down from $16.9M).
FDA Q4 2023 meeting: initial NfL biomarker data insufficient for accelerated approval; planning supplemental data submission in 2024, potential NDA.
HEALEY ALS OLE: CNM-Au8 reduced plasma NfL at 76 wks (p=0.023) and 60% decreased risk of all-cause mortality (>18 months, p=0.0167).
EAP survival: 68% and 57% reduced mortality risk vs historical controls (p=0.0001); MS trial showed vision and cognition improvements through 35 months.

item 2.02 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.95

Clene Inc. reported financial results for the year ended December 31, 2023.

Period: the year ended December 31, 2023
Result: reported results

Exact text from the filing

On March 13, 2024, Clene Inc. (the “Company”) issued a press release announcing its full year operating and financial results for its year ended December 31, 2023.

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Source: SEC EDGAR

accession 0001437749-24-007543

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