
First Quarter 2025 Financial Results and Recent Operating Highlights CEO Statement & Strategic Outlook Clene is focused on prolonging ALS patient survival and is actively preparing for a potential CNM-Au8 NDA submission in Q4 2025 under Accelerated Approval, supported by upcoming NfL biomarker data and ongoing FDA dialogue - The company's critical mission is to prolong survival for individuals living with ALS3 - Clene plans to analyze NfL biomarker data from its NIH-sponsored Expanded Access Protocol (EAP) in Q3 2025, aligning with FDA recommendations347 - The company is actively preparing to potentially submit an NDA for CNM-Au8 for ALS under the Accelerated Approval pathway in Q4 202537 - Clene maintains active dialogue with the FDA's Division of Neurology regarding the potential NDA submission3 Clinical Program Updates Clene reported significant positive developments for its lead candidate CNM-Au8 in both ALS, showing a statistically significant survival benefit, and MS, providing evidence of remyelination and neuronal repair CNM-Au8 for ALS New analysis of the HEALEY ALS Platform Trial demonstrated that CNM-Au8 30 mg significantly improved overall survival by 4.1 months, with an 11.9-month median survival improvement and 44% mortality risk reduction in severe ALS patients - A meeting is scheduled with the FDA in Q2 2025 to finalize the statistical analysis plan (SAP) for the NfL biomarker data47 - A cross-regimen analysis of the HEALEY ALS Platform Trial showed an overall survival improvement with a covariate-adjusted restricted mean survival time (RMST) gain of 4.1 months (p=0.045)5 - In a subgroup of more severe ALS patients, median survival improved by 11.9 months, and mortality risk decreased by 44% (p=0.006)5 CNM-Au8 for MS Data from the VISIONARY-MS trial's long-term extension presented at AAN 2025 showed evidence of remyelination and neuronal repair with CNM-Au8, leading to clinically meaningful improvements in cognition and vision, with an end-of-Phase 2 FDA meeting planned for Q3 2025 - New evidence of remyelination and neuronal repair with CNM-Au8 treatment was presented at the AAN 2025 Annual Meeting67 - The data highlighted significant improvements in cognition and visual function, supported by objective biomarkers including advanced MRI (DTI) and mf-VEP assessments6 - Clene plans to discuss the complete VISIONARY-MS trial data with the FDA in an end-of-Phase 2 meeting in Q3 20256 First Quarter 2025 Financial Results Clene ended Q1 2025 with $9.8 million in cash, expecting to fund operations into Q3 2025, and reported a significantly reduced net loss of $0.8 million compared to $11.1 million in Q1 2024, driven by lower operating expenses and non-cash gains Financial Highlights | Financial Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $9.8 million | N/A | | Net Loss | $0.8 million | $11.1 million | | Net Loss Per Share | $0.09 | $1.73 | | Research & Development Expenses | $1.5 million | $5.9 million | | General & Administrative Expenses | $2.7 million | $3.4 million | - Cash and cash equivalents of $9.8 million as of March 31, 2025, are expected to provide a cash runway into the third quarter of 202578 - The year-over-year decrease in R&D and G&A expenses was primarily due to NIH grant revenue recognized as an offset, lower regulatory and manufacturing costs, and reduced personnel and investor relations expenses910 - Total other income was $3.3 million, primarily due to non-cash gains on the change in fair values of derivative and common stock warrant liabilities11 Condensed Consolidated Financial Statements The financial statements detail Q1 2025 performance, showing a significant reduction in net loss, with total assets of $25.3 million, total liabilities of $30.3 million, and a stockholders' deficit of $5.0 million as of March 31, 2025 Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended March 31, 2025, Clene reported total revenue of $81 thousand and a net loss of $751 thousand, a substantial improvement from Q1 2024's $11.1 million net loss, driven by lower operating expenses and significant other income Statements of Operations | (In thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total revenue | $81 | $73 | | Loss from operations | $(4,076) | $(9,232) | | Total other income (expense), net | $3,325 | $(1,848) | | Net loss | $(751) | $(11,080) | | Net loss per share | $(0.09) | $(1.73) | Condensed Consolidated Balance Sheets As of March 31, 2025, Clene's balance sheet showed total assets of $25.3 million, total liabilities of $30.3 million, and a stockholders' deficit of $5.0 million, reflecting decreases from year-end 2024 primarily due to changes in warrant and derivative liabilities and note repayments Balance Sheets | (In thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $9,832 | $12,155 | | Total Assets | $25,314 | $27,337 | | Total Liabilities | $30,287 | $36,194 | | Total Stockholders' Deficit | $(4,973) | $(8,857) |