Clene(US:CLNN)2025-11-13 12:51Financial Performance - Clene Inc. has not generated any revenue from drug sales and has incurred operating losses since inception, with revenue from dietary supplements being minimal compared to operating expenses [142]. - Total revenue for the three months ended September 30, 2025, was $15,000, a decrease of 83% from $87,000 in 2024 [165]. - General and administrative expenses for the three months ended September 30, 2025, were $2,150,000, a decrease of 37% from $3,413,000 in 2024 [162]. - Net loss for the three months ended September 30, 2025, was $8,777,000, an increase of 10% from $7,986,000 in 2024 [165]. - Total operating expenses for the three months ended September 30, 2025, were $5,663,000, a decrease of 28% from $7,902,000 in 2024 [165]. - The company recorded a total other income (expense), net of $(3,129,000) for the three months ended September 30, 2025, an increase of 1,730% from $(171,000) in 2024 [165]. - The company incurred a loss from operations of $5.6 million for the three months ended September 30, 2025, down from $7.8 million in 2024 [180]. - The company recorded an accumulated deficit of $299.1 million as of September 30, 2025, up from $282.1 million as of December 31, 2024 [180]. - The net loss for the nine months ended September 30, 2025, was $16.9 million, adjusted for non-cash items totaling $7.4 million, while the net loss for the same period in 2024 was $25.9 million, adjusted for non-cash items totaling $7.8 million [189][190]. Research and Development - The company is focused on developing CNM-Au8 for treating neurodegenerative diseases, with a potential NDA submission for ALS planned for Q1 2026 under an accelerated approval pathway [146]. - In the REPAIR-MS trial, CNM-Au8 demonstrated a significant increase in the NAD+/NADH ratio by +0.449 units (8.65% change) after 12 weeks of treatment [153]. - The FDA has provided guidance on using neurofilament light (NfL) as a potential surrogate endpoint for ALS treatment efficacy, with plans to analyze NfL changes in ongoing studies [147]. - Clene Inc. plans to commence a confirmatory Phase 3 trial, RESTORE-ALS, in the first half of 2026, contingent on funding, to investigate CNM-Au8's effects on survival [147]. - The company reported significant associations between baseline cognitive measures and brain ATP levels, indicating a link between energy metabolism and cognitive function in MS patients [153]. - CNM-Au8 improved mitochondrial health in familial Parkinson's disease neurons, increasing membrane potential and reducing harmful reactive oxygen species [154]. - Research and development expenses for the three months ended September 30, 2025, were $3,513,000, a decrease of 21% from $4,471,000 in 2024 [169]. - Research and development expenses related to amyotrophic lateral sclerosis (ALS) increased by 156% to $1,775,000 in the three months ended September 30, 2025 [169]. - The company anticipates an increase in research and development expenses as it advances assets into Phase 3 clinical trials [159]. Cash Flow and Financing - Cash and cash equivalents totaled $7.9 million as of September 30, 2025, a decrease from $12.2 million as of December 31, 2024 [180]. - Net cash used in operating activities was $(13,747,000) for the nine months ended September 30, 2025, compared to $(16,461,000) in 2024 [188]. - The company plans to raise additional funding through equity financing, debt financing, and other capital sources to meet short-term liquidity requirements [182]. - The company generated $3.3 million in gross proceeds from its equity distribution agreement during the three months ended September 30, 2025 [182]. - Net cash used in operating activities was $13.7 million for the nine months ended September 30, 2025, compared to $16.5 million for the same period in 2024, reflecting a decrease in cash outflow [189][190]. - Net cash provided by financing activities was $9.5 million for the nine months ended September 30, 2025, compared to a net cash outflow of $4.1 million for the same period in 2024 [193]. - In October 2024, the company raised approximately $3.5 million from the sale of 725,000 shares of Common Stock and pre-funded warrants [194]. - The company sold 757,875 shares of Common Stock during the three months ended September 30, 2025, generating gross proceeds of $3.3 million [195]. Stock and Derivative Liabilities - Clene Inc. completed a reverse stock split of 1-for-20 effective July 11, 2024, adjusting all outstanding stock options and warrants accordingly [144]. - The carrying value of the 2022 DHCD Loan as of September 30, 2025, was $5.3 million, unchanged from December 31, 2024 [199]. - The change in fair value of the SSCPN Derivative Liabilities resulted in a loss of $0.8 million for the three months ended September 30, 2025 [200]. - The fair value change of the 2023 Avenue Warrant resulted in a loss of $0.1 million for Q3 2025 and a gain of $0.1 million for Q3 2024 [203]. - The fair value change of the Tranche A Warrants resulted in a loss of $0.1 million for Q3 2025 and a gain of $0.6 million for Q3 2024 [203]. - The fair value change of the 2024 Common Warrants resulted in a loss of $1.5 million for Q3 2025 and a loss of $0.2 million for the nine months ended September 30, 2025 [203]. - The expected stock price volatility was 100.70% as of September 30, 2025, with a discount rate of 15.00% [200]. - The expected stock price volatility for the 2023 Avenue Warrant was 96.10% – 110.10% as of September 30, 2025 [203]. - The risk-free interest rate for the Tranche A Warrants was 3.80% – 4.10% as of September 30, 2025 [203]. - The expected term for the 2024 Common Warrants was 4.00 years as of September 30, 2025 [203]. - The probability of change of control for the 2023 Avenue Warrant increased from 10.00% in December 2024 to 20.00% in September 2025 [203]. Tax and Regulatory Matters - The company has not recorded income tax benefits for net operating losses or research and development tax credits due to uncertainty in realizing benefits [204]. - Research and development tax credits decreased to $216,000 for the nine months ended September 30, 2025, down from $339,000 in 2024 [172]. - Significant non-cash items for 2025 included stock-based compensation expense of $5.0 million and depreciation expense of $1.1 million, while for 2024, stock-based compensation was $6.2 million and depreciation was $1.2 million [189][190]. - The expected stock price volatility for stock options was 96.77% – 110.25% for the nine months ended September 30, 2025 [206]. - The expected term of options was between 5.00 and 6.25 years for the nine months ended September 30, 2025 [206].