Clene INC 8-K filings

Clene Inc. announced that the FDA has provided a potential path for accelerated approval of its drug CNM-Au8 for ALS, based on additional biomarker data.

Clene Inc. reported its third quarter 2024 financial results, highlighted by a $7.3 million capital raise and progress in discussions with the FDA regarding an accelerated approval pathway for its ALS treatment.

Clene Inc. presented the preliminary design for its international Phase 3 clinical trial, RESTORE-ALS, of CNM-Au8 30 mg for Amyotrophic Lateral Sclerosis (ALS) at the 2024 NEALS Meeting.

Clene Inc. has amended its loan agreement with Avenue Venture Opportunities Fund, reducing a principal payment and potentially securing an interest-only period, contingent on equity milestones and FDA progress.

Clene Inc. has announced a $7.3 million capital raise through a registered direct offering and concurrent private placements, priced at market under Nasdaq rules.

Clene Inc. has been granted an in-person meeting with the FDA to discuss its CNM-Au8 drug for ALS, following initial concerns about its briefing package.

Clene Inc. reported its second quarter 2024 financial results, highlighting positive clinical data for its CNM-Au8 drug in ALS and Rett Syndrome, and regained Nasdaq compliance.

Clene Inc. has submitted new biomarker and clinical efficacy data to the FDA for its CNM-Au8 treatment for ALS, demonstrating significant improvements in survival and functional status for a subset of patients.

Clene Inc. has received notification from Nasdaq that it has regained compliance with listing rules after its stock price closed above $1.00 for ten consecutive business days.

Clene Inc. plans to submit a briefing book to the FDA to seek feedback on the potential for accelerated approval of its drug CNM-Au8 for treating amyotrophic lateral sclerosis (ALS).

Clene Inc. has announced a 1-for-20 reverse stock split effective July 11, 2024, to regain compliance with Nasdaq's minimum bid price requirement.

Clene Inc. presented new data showing improved survival and reduced neurofilament light levels in ALS patients treated with CNM-Au8 in an open label extension of the HEALEY ALS Platform Trial.

Clene Inc. stockholders approved an increase in authorized shares of common stock and an amendment to the company's 2020 stock plan at the 2024 Annual Meeting.

Clene Inc. announced its first quarter 2024 financial results, highlighting positive clinical data from its CNM-Au8 program and a $7.3 million NIH sub-award.

Clene Inc. has amended and restated its exclusive supply and license agreements with 4Life Research, LLC, an international health supplement supplier and related party, extending the partnership through 2033.

Clene Inc. released data from its VISIONARY-MS trial long-term extension, showing significant evidence of repair and remyelination in multiple sclerosis patients treated with CNM-Au8.

Clene Inc. has entered into a subaward agreement with Columbia University for $7.3 million to support an Expanded Access Program for its CNM-Au8 treatment for ALS.

Clene Inc. announced its full year 2023 financial results and highlighted positive clinical data for its lead drug candidate, CNM-Au8, including significant survival benefits in ALS patients and vision improvements in MS patients, while also initiating discussions with the FDA for accelerated approval of its ALS treatment.

Clene Inc. reported significant and sustained improvements in vision and cognition in multiple sclerosis patients treated with CNM-Au8 over a 35-month period.

Clene Inc. reported a significant survival benefit for ALS patients treated with CNM-Au8 in compassionate use programs compared to historical controls.

Clene Inc. has received a second extension from Nasdaq to regain compliance with the minimum bid price requirement, now until July 29, 2024.