
Operating Highlights Clene provided significant updates on its lead drug candidate, CNM-Au8, for both ALS and MS, advancing towards potential NDA submission for ALS and planning a Phase 3 trial for MS CNM-Au8 for the treatment of ALS Clene is progressing with its CNM-Au8 program for ALS, with key regulatory interactions and data analyses planned for the second half of 2025, in preparation for a potential NDA submission - Held a productive Type C meeting with the FDA to discuss the statistical analysis methodology for neurofilament light (NfL) biomarker changes from its NIH-sponsored expanded access program (EAP)4 - Analysis of the NfL biomarker data is expected to be conducted early in the fourth quarter of 202548 - A second Type C meeting with the FDA is planned for Q3 2025 to review long-term survival benefit data from CNM-Au8 treatment58 - The company plans to submit a New Drug Application (NDA) under the accelerated approval pathway for ALS by the end of 2025358 CNM-Au8 for the treatment of MS Clene presented positive new data for CNM-Au8 in treating Multiple Sclerosis (MS) at the AAN 2025 Annual Meeting, demonstrating evidence of remyelination and neuronal repair, leading to a scheduled end-of-Phase 2 meeting with the FDA - Presented new evidence of remyelination and neuronal repair with CNM-Au8 treatment at the American Academy of Neurology (AAN) 2025 Annual Meeting6 - Data from the VISIONARY-MS trial showed significant improvements in cognition and visual function, supported by objective biomarkers (MRI DTI and mf-VEP)6 - An end-of-Phase 2 Type B meeting with the FDA is scheduled for Q3 2025 to discuss the planned Phase 3 study focusing on cognition improvement78 Second Quarter 2025 Financial Results In Q2 2025, Clene reported a net loss of $7.4 million, demonstrating fiscal discipline with year-over-year reductions in both R&D and G&A expenses, and extending its cash runway into Q1 2026 with subsequent financing Key Financial Metrics | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Research & Development Expenses | $3.5 million | $4.2 million | | General & Administrative Expenses | $2.4 million | $3.3 million | | Net Loss | $7.4 million | $6.8 million | | Net Loss Per Share | $0.78 | $1.06 | - Cash and cash equivalents were $7.3 million as of June 30, 2025, compared to $12.2 million as of December 31, 20249 - Subsequent to quarter-end, the company raised $1.9 million in equity and increased its convertible debt facility by $1.5 million, extending its cash runway into Q1 2026289 - The decrease in R&D expenses was primarily due to lower personnel costs from cost-saving initiatives and an increase in grant revenue recorded as a reduction to R&D expense10 - The decrease in G&A expenses was mainly driven by lower personnel costs, stock-based compensation, and legal fees11 Financial Statements The condensed consolidated financial statements detail Clene's financial performance and position, showing a net loss of $7.4 million for Q2 2025 and a total stockholders' deficit of $8.6 million as of June 30, 2025 Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended June 30, 2025, Clene reported total revenues of $27 thousand and a net loss of $7.4 million, or $0.78 per share, primarily driven by changes in the fair value of derivative and warrant liabilities Statements of Operations and Comprehensive Loss (in thousands, except per share amounts) | (In thousands, except per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenue | $27 | $91 | | Total operating expenses | $5,891 | $7,482 | | Loss from operations | $(5,864) | $(7,391) | | Total other income (expense), net | $(1,555) | $606 | | Net loss | $(7,419) | $(6,785) | | Net loss per share – basic and diluted | $(0.78) | $(1.06) | Condensed Consolidated Balance Sheets As of June 30, 2025, Clene's balance sheet showed total assets of $22.1 million and total liabilities of $30.7 million, resulting in a total stockholders' deficit of $8.6 million Consolidated Balance Sheets (in thousands) | (In thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | ASSETS | | | | Cash and cash equivalents | $7,285 | $12,155 | | Total current assets | $11,985 | $16,157 | | TOTAL ASSETS | $22,125 | $27,337 | | LIABILITIES AND STOCKHOLDERS' DEFICIT | | | | Total current liabilities | $7,574 | $10,291 | | TOTAL LIABILITIES | $30,675 | $36,194 | | TOTAL STOCKHOLDERS' DEFICIT | $(8,550) | $(8,857) | | TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | $22,125 | $27,337 | Company Overview Clene is a late-stage clinical biopharmaceutical company focused on treating neurodegenerative diseases by improving mitochondrial health, with its lead investigational therapy, CNM-Au8®, an oral suspension of gold nanocrystals About Clene Clene Inc. is a late clinical-stage biopharmaceutical company dedicated to developing treatments for neurodegenerative diseases such as ALS, Parkinson's disease, and MS, by enhancing mitochondrial health and protecting neuronal function - Clene is a late clinical-stage biopharmaceutical company focused on treating neurodegenerative diseases, including ALS, Parkinson's disease, and MS14 - The company's therapeutic strategy is to improve mitochondrial health and protect neuronal function14 About CNM-Au8® CNM-Au8® is Clene's lead drug candidate, an oral suspension of gold nanocrystals designed to restore neuronal health and function by increasing cellular energy production and utilization, providing neuroprotection and supporting remyelination - CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function15 - It works by driving critical cellular energy-producing reactions, which enables neuroprotection and remyelination15