Clene plans Q3 2026 NDA submission for CNM-Au8 ALS; Q1 net loss $8.1M, cash $5.9M

Clene Inc.

FDA Type C meeting confirmed data may support NDA under accelerated approval for ALS; submission planned Q3 2026.
May 2026: Amended $10M convertible debt; maturity extended to Aug 2027, monthly payments cancelled.
Q1 2026 net loss $8.1M ($0.69/share) vs $0.8M loss in Q1 2025; R&D down, other expense up from financing.
Cash $5.9M at Mar 31; with $7M May offering and $7M warrant exercises, runway expected into 2027.

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.9

Clene Inc. reported first quarter 2026 results: net income net loss of $8.1 million , or $0.69 per share, EPS $0.69 per share.

Period: first quarter 2026
Net income: net loss of $8.1 million , or $0.69 per share
EPS: $0.69 per share
Result: reported results

Exact text from the filing

Clene reported a net loss of $8.1 million , or $0.69 per share, for the quarter ended March 31, 2026 , compared to a net loss of $0.8 million , or $0.09 per share, for the same period in 2025 .

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Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.9

Clene Inc. amended Second Amendment with Kensington Clene 2024, LLC, 4Life Research, LLC, La Scala Investments, LLC (effective 2026-05-11).

Action: amendment
Agreement: notes offering
Counterparty: Kensington Clene 2024, LLC, 4Life Research, LLC, La Scala Investments, LLC
Effective: 2026-05-11

Exact text from the filing

On May 11, 2026, Clene Inc. (the “Company”) entered into the second amendment (the “Second Amendment”) to the amended and restated senior secured convertible promissory notes (the “Amended Notes”) with Kensington Clene 2024, LLC (“Kensington”), 4Life Research, LLC (“4Life”) and La Scala Investments, LLC (“La Scala,” and collectively with Kensington and 4Life, the “Holders”).

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Clene Inc. filing history →

Source: SEC EDGAR

accession 0001437749-26-016881

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