Clene Reports Full Year 2024 Financial Results and Recent Operating Highlights

Core Insights - Clene Inc. reported its full year 2024 financial results and highlighted its ongoing clinical programs for neurodegenerative diseases, particularly ALS and MS [1][2][3] Financial Performance - Clene's cash, cash equivalents, and marketable securities totaled $12.2 million as of December 31, 2024, down from$35.0 million as of December 31, 2023 [8] - The company reported a net loss of $39.4 million, or$5.67 per share, for the year ended December 31, 2024, compared to a net loss of $49.5 million, or$9.43 per share, for the same period in 2023 [12] - Research and development expenses were $20.1 million for 2024, a decrease from$26.7 million in 2023, primarily due to lower expenses related to ongoing clinical trials [9] Clinical Development - Clene plans to submit a New Drug Application (NDA) in the second half of 2025 for potential Accelerated Approval of CNM-Au8 for ALS [4][5] - The company is set to initiate the confirmatory Phase 3 RESTORE-ALS trial in mid-2025, which aims to evaluate the effects of CNM-Au8 on survival and clinical worsening events in ALS patients [6][17] - Clene is collecting and analyzing neurofilament light chain (NfL) biomarker data from its NIH-sponsored Early Access Protocol (EAP) to support its NDA submission [4][5] Regulatory Engagement - Clene received written guidance from the FDA regarding a potential accelerated approval pathway for CNM-Au8 in ALS [3] - The company plans to meet with the FDA in the second quarter of 2025 to align on its statistical analysis plan for the NfL biomarker data [2][5] Debt and Financing - Clene secured a new $10.0 million debt facility to replace its outstanding$7.85 million debt balance, with a fixed interest rate of 12% [7] - The new debt facility is partially convertible into shares of Clene's common stock at a fixed conversion price of $5.67, representing a 30% premium to the stock price at signing [7] Market Position - Clene is focused on revolutionizing the treatment of neurodegenerative diseases, including ALS and MS, through its investigational therapy CNM-Au8, which targets mitochondrial function and reduces oxidative stress [13][15]