Every material Form 8-K Clene Inc. has filed with the SEC since October 19, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Clene reported third quarter 2026 net income of $3.9 million, or $0.05 per diluted share, compared with a net loss of $8.8 million, or $0.85 per share, a year earlier. The company said the swing came mainly from non-operating fair value gains on warrant and derivative liabilities, while its operating loss widened to $6.3 million from $5.6 million. The company also submitted a New Drug Application for CNM-Au8 in ALS in October and said its cash runway extends to mid-first quarter 2027.
Net income of $3.9 million for the quarter ended September 30, 2026, versus a net loss of $8.8 million a year earlier; total other income was $10.3 million, mainly from fair value changes in warrant and derivative liabilities
Loss from operations was $6.3 million, up from $5.6 million; research and development expenses rose to $4.4 million from $3.5 million
Cash and cash equivalents totaled $9.9 million at September 30, 2026; a $4.0 million registered direct offering in September is expected to fund operations through mid-first quarter 2027
NDA for CNM-Au8 submitted to the FDA in October 2026 seeking accelerated approval for ALS; Phase 3 RESTORE-ALS trial planned to start in the second quarter of 2027
Clene Inc. entered into a subaward amendment on October 15, 2026, for the fourth year of a four-year $45.1 million NIH grant, with New York University receiving up to $7.2 million for the period September 1, 2026 to August 31, 2027. The grant supports an Expanded Access Program for CNM-Au8 treatment of amyotrophic lateral sclerosis, and the other terms of the subaward remain unchanged. The filing is an administrative funding update under an existing grant rather than a change in the company's financial results or guidance.
Subaward amendment dated October 15, 2026, for up to $7.2 million with New York University
Covers the period September 1, 2026 to August 31, 2027
Part of a four-year, $45.1 million NIH grant announced October 5, 2023
Other subaward terms from the March 16, 2026 filing remain in effect
Clene Inc. announced that it submitted a New Drug Application to the FDA earlier in October 2026 seeking accelerated approval of CNM-Au8 for amyotrophic lateral sclerosis (ALS). The filing contains no financial figures and does not state a review timeline. For shareholders, the submission advances the company's lead program toward a possible FDA decision, but approval is not assured.
NDA submitted earlier in October 2026 seeking accelerated approval of CNM-Au8 for ALS
Application is based on neurofilament light chain biomarker data and clinical outcomes
Company says it continues preparing for the confirmatory Phase 3 RESTORE-ALS study
Press release dated October 19, 2026, furnished as Exhibit 99.1
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