Clene(US:CLNN) Globenewswire·2026-02-24 13:00Core Insights - Clene Inc. is focused on developing treatments for neurodegenerative diseases, particularly ALS, through its investigational drug CNM-Au8, with key regulatory and clinical milestones anticipated in 2026 [1][2] Financial Position - The company completed an oversubscribed registered direct offering of over $28 million in January 2026, providing sufficient cash to fund operations into the fourth quarter of 2026 [4][7] - Additional financing tranches totaling over $22 million are structured to align with NDA acceptance and FDA approval milestones, expected to support operations into 2027 [4] Regulatory Steps and Clinical Milestones - Clene has engaged with the FDA regarding CNM-Au8, with an in-person Type C meeting scheduled by the end of Q1 2026 to discuss data submitted in late 2025 [5][7] - The company plans to submit a New Drug Application (NDA) for CNM-Au8 via an accelerated regulatory pathway in Q2 2026, with potential FDA acceptance and PDUFA date issuance in the second half of 2026 [5][7] Clinical Data and Efficacy - CNM-Au8 has shown prolonged survival in ALS patients, with a median life expectancy of 2-4 years post-diagnosis, and demonstrated statistically significant reductions in mortality risk and clinical worsening [6][8] - The treatment has also shown favorable safety and tolerability, with no serious adverse events reported across over 1,000 patient years of treatment [9] Future Trials - A confirmatory Phase 3 RESTORE-ALS trial is planned to begin later in 2026 to further evaluate the survival benefit of CNM-Au8 [10] Broader Pipeline - CNM-Au8 is also being explored for potential benefits in multiple sclerosis (MS) and Parkinson's disease, with plans to finalize Phase 3 clinical trial designs for MS in 2026 [12]