Clene INC 8-K filings

Clene Inc. announced Q2 2026 results, highlighting progress towards an ALS drug NDA submission and providing an operating runway through late Q4 2026, alongside financial updates.

Clene Inc. announced new biomarker analyses from its CNM-Au8 trials, showing a correlation between NfL biomarker response and improved survival and function in ALS patients, which will be included in its upcoming NDA submission for accelerated approval.

Clene Inc. has deferred debt payments and received shareholder approval to increase its 2020 Stock Plan by 1 million shares.

Clene Inc. announced a second amendment to its senior secured convertible promissory notes, extending the maturity date and deferring payments, alongside positive updates on its CNM-Au8 program for ALS, targeting a Q3 2026 NDA submission.

Clene Inc. has priced an underwritten offering of 1,000,000 shares of common stock at $7.00 per share to raise approximately $6.4 million in net proceeds.

Clene Inc. announced it will file an accelerated approval New Drug Application (NDA) for its ALS treatment, CNM-Au8, following a successful meeting with the FDA.

Clene Inc. announced its full year 2025 financial results and provided updates on its CNM-Au8 programs, including an upcoming FDA meeting for ALS accelerated approval pathway.

Clene Inc. outlines key regulatory and clinical milestones for its lead drug candidate, CNM-Au8, in 2026, alongside an extended operating capital runway.

Clene Inc. announced an oversubscribed registered direct offering of over $28 million, including common stock and warrants, to fund its CNM-Au8 neurodegenerative disease program through potential FDA approval and commercialization.

Clene Inc. announced new biomarker data for CNM-Au8 in ALS, supporting a potential New Drug Application filing ahead of an in-person FDA meeting in Q1 2026.

Clene Inc. provided an update on its CNM-Au8 program for amyotrophic lateral sclerosis (ALS) via a conference call and webcast.

Clene Inc. announced statistically significant reductions in key ALS biomarkers, NfL and GFAP, for its drug CNM-Au8, supporting an accelerated approval pathway.

Clene Inc. announced its third quarter 2025 financial results and provided updates on its CNM-Au8 programs for ALS, MS, and PD, including plans for an ALS NDA submission in Q1 2026.

Clene Inc. announced a prospectus supplement to offer an additional $18.88 million in common stock under its existing equity distribution agreement.

Clene Inc. released an updated corporate presentation containing preliminary unaudited cash and cash equivalents as of September 30, 2025, and gross proceeds from its equity distribution agreement through October 14, 2025.

Clene Inc. announced new clinical data at ECTRIMS 2025, demonstrating its drug candidate CNM-Au8 significantly improves brain energy metabolism in multiple sclerosis patients.

Clene Inc. announced the filing of a prospectus supplement to offer and sell an additional $6.28 million in common stock under an existing equity distribution agreement.

Clene Inc. extended debt maturity and secured new convertible notes and equity to fund operations into Q1 2026, despite reporting an increased net loss in Q2 2025.

Clene Inc. announced an update to its at-the-market equity distribution agreement, having sold approximately $1.7 million in common stock and filing a prospectus supplement for an additional $2.015 million.

Clene Inc. announced constructive feedback from the FDA on its neurofilament biomarker analysis plan for ALS and confirmed two additional FDA meetings in Q3 2025, keeping its ALS NDA submission on track for late 2025.

Clene Inc. announced it has regained compliance with Nasdaq's continued listing requirements after its market value of listed securities exceeded $35.0 million for 10 consecutive business days.

Clene Inc. stockholders have approved an amendment to the 2020 Stock Plan, increasing shares reserved for issuance by 800,000, and ratified adjustments to the Board of Directors Compensation Program following a reverse stock split.

Clene Inc. reports its first quarter 2025 financial results, highlighting progress with CNM-Au8 for ALS and MS treatments, and plans for upcoming FDA meetings and NDA submission.

Clene Inc. has entered into an equity distribution agreement with Canaccord Genuity LLC to offer and sell up to $25 million of its common stock from time to time.

Clene Inc. reports evidence of remyelination and neuronal repair with CNM-Au8 treatment in multiple sclerosis patients from the long-term extension of the Phase 2 VISIONARY-MS clinical trial.

Clene Inc. issues 35,311 shares of common stock to settle $125,000 in outstanding debt.

Clene Inc. reports its full year 2024 financial results, highlights progress on its CNM-Au8 program for ALS, and announces plans for an NDA submission in the second half of 2025.

Clene Inc. announces new data showing CNM-Au8 treatment delivers a significant survival advantage for people living with ALS, based on a cross-regimen analysis of the HEALEY ALS Platform Trial.

Clene Inc. has secured an additional $8 million in funding from the National Institutes of Health for the second year of its Expanded Access Program for ALS treatment.

Clene Inc. has secured a new $10 million debt facility to replace its existing loan with Avenue Capital, improving its cash position and extending its operational runway.