Clene(CLNN) - 2024 Q4 - Annual Results

Financial Performance - Clene 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[13]. - Total revenue for 2024 was $342,000, a decrease of 47.7$654,000 in 2023[20]. - Product revenue decreased to $237,000 in 2024 from$498,000 in 2023, representing a decline of 52.5%[20]. - Comprehensive loss for 2024 was $39,528,000, compared to$49,508,000 in 2023, indicating a reduction of 20.2%[20]. - Net loss for 2024 was $39,400,000, an improvement of 20.4$49,504,000 in 2023[20]. Cash and Assets - 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[9]. - Cash and cash equivalents decreased to $12,155,000 in 2024 from$28,821,000 in 2023, a decline of 57.8%[21]. - Total assets decreased to $27,337,000 in 2024 from$52,341,000 in 2023, a reduction of 47.9%[21]. - Total liabilities decreased slightly to $36,194,000 in 2024 from$38,951,000 in 2023[21]. - Additional paid-in capital increased to $273,194,000 in 2024 from$255,913,000 in 2023, reflecting a growth of 6.7%[21]. Research and Development - Research and development expenses were $20.1 million for the year ended December 31, 2024, compared to$26.7 million for the same period in 2023, reflecting a decrease primarily due to lower expenses related to ongoing clinical trials[10]. - Research and development expenses were $20,058,000 in 2024, down 24.5$26,655,000 in 2023[20]. - Clene is collecting and analyzing biomarker NfL data from its NIH-sponsored Early Access Protocol (EAP) for evaluation in the third quarter of 2025[5]. Clinical Trials and Regulatory Updates - Clene plans to submit a New Drug Application (NDA) in the second half of 2025 for potential Accelerated Approval of CNM-Au8 in ALS[5]. - Clene intends to initiate the confirmatory Phase 3 RESTORE-ALS trial in mid-2025, designed to investigate the effects of CNM-Au8 on improved survival and delayed time to ALS clinical worsening events[7]. - The FDA provided guidance on a potential path to meet the regulatory standard for substantial evidence of effectiveness supporting accelerated approval for CNM-Au8 in ALS[6]. - Overall Survival Improvement of 4.1 months was observed in participants treated with CNM-Au8 compared to a control group in the HEALEY ALS Platform Trial[6]. General and Administrative Expenses - General and administrative expenses decreased to $13.3 million for the year ended December 31, 2024, from$14.4 million for the same period in 2023[11]. Debt and Financing - Clene secured a new $10.0 million debt facility at a lower interest rate to replace the remaining outstanding$7.85 million debt balance with Avenue Capital[5]. - The weighted average common shares used to compute basic and diluted net loss per share increased to 6,954,133 in 2024 from 5,246,941 in 2023[20].