Webcast set for 8:30 a.m. ET on December 3rdSALT LAKE CITY, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced it plans provide an update on its CNM-Au8 program in ALS, and to host an investor cal ...

Core Viewpoint - Clene Inc. is actively engaging with investors at the Benchmark 14 Annual Discovery One-on-One Investor Conference, highlighting its focus on neurodegenerative disease treatments through innovative biopharmaceutical solutions [1][2]. Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company dedicated to enhancing mitochondrial health and neuronal function to address neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), Parkinson's disease, and multiple sclerosis (MS) [2]. - The company's investigational therapy, CNM-Au8, is designed to improve the survival and function of central nervous system cells by targeting mitochondrial function and the NAD pathway while mitigating oxidative stress [2]. Conference Details - The Benchmark 14 Annual Discovery One-on-One Investor Conference is scheduled for December 4, 2025, in New York, New York, featuring 1x1 investor meetings [2].

Core Viewpoint - Clene Inc. reported a quarterly loss of $0.85 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.60, indicating a significant earnings surprise of -41.67% [1] Financial Performance - The company posted revenues of $0.02 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 81.25%, and a decline from $0.09 million in the same quarter last year [2] - Over the last four quarters, Clene has only surpassed consensus EPS estimates once [2] Stock Performance - Clene shares have increased by approximately 77.2% since the beginning of the year, outperforming the S&P 500's gain of 16.5% [3] Future Outlook - The company's earnings outlook will be crucial for investors, particularly in terms of consensus earnings expectations for upcoming quarters [4] - The current consensus EPS estimate for the next quarter is -$0.48 on revenues of $0.09 million, and for the current fiscal year, it is -$2.10 on revenues of $0.31 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Clene belongs, is currently ranked in the top 35% of over 250 Zacks industries, suggesting a favorable industry outlook [8]

Core Insights - Clene Inc. reported its third quarter 2025 financial results and updates on its CNM-Au8 programs, focusing on treatments for neurodegenerative diseases such as ALS and MS [1] Financial Performance - Cash and cash equivalents as of September 30, 2025, totaled $7.9 million, down from $12.2 million as of December 31, 2024 [11] - Research and development expenses for the quarter were $3.5 million, a decrease from $4.5 million in the same period in 2024, attributed to cost-saving initiatives and reduced manufacturing expenses [12] - General and administrative expenses were $2.2 million for the quarter, down from $3.4 million in the same period in 2024, primarily due to lower legal fees and personnel expenses [13] - The company reported a net loss of $8.8 million, or $0.85 per share, compared to a net loss of $8.0 million, or $1.22 per share, for the same period in 2024 [15] CNM-Au8 Development for ALS - Clene held a second Type C meeting with the FDA to discuss the long-term survival benefit of CNM-Au8 treatment for ALS, with a focus on ALS disease-specific biomarkers [3] - The FDA recommended three potential biomarker paths to enhance the persuasiveness of the company's ALS data, including NfL analysis from ongoing studies [4][5] - Clene plans to submit a New Drug Application (NDA) under an accelerated approval pathway in the first quarter of 2026, pending favorable data analyses [5][8] CNM-Au8 Development for MS - In September 2025, Clene held a Type B end-of-Phase 2 meeting with the FDA to review results from the Phase 2 VISIONARY-MS trial, focusing on cognition improvement as a potential primary endpoint for the planned Phase 3 study [7] - The FDA acknowledged the limitations of the Expanded Disability Status Scale and expressed openness to considering cognition as a primary endpoint [7] CNM-Au8 Development for Parkinson's Disease - New preclinical data showed that CNM-Au8 improved key measures of cellular health in a novel dopaminergic neuron model of Parkinson's disease, supporting its continued development as a treatment for PD [10] Upcoming Milestones - Clene anticipates the first patient will be dosed in its confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 2026 [6][8]

Financial 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].

Industry Overview - Nanotechnology stocks represent companies focused on developing, manufacturing, or commercializing technologies and materials at the nanoscale, which ranges from approximately 1 to 100 nanometers. These include advanced materials, nanoelectronics, targeted drug-delivery systems, and nanosensors [2] - These stocks offer thematic exposure to high-growth, often early-stage and technically specialized fields, making them potentially more volatile and speculative [2] Company Summaries Onto Innovation (ONTO) - Onto Innovation Inc. specializes in designing, developing, manufacturing, and supporting process control tools for optical metrology. The company provides lithography systems and process control analytical software, along with process and yield management solutions [3] Nano Dimension (NNDM) - Nano Dimension Ltd. engages in additive manufacturing solutions, offering 3D printers that produce high-performance electronic devices (Hi-PEDs) using proprietary conductive and dielectric substances. The company also provides micro additive manufacturing systems and industrial additive manufacturing systems for fabricating ceramic and metal parts [4] NVE Corporation (NVEC) - NVE Corporation develops and sells devices utilizing spintronics, a nanotechnology that leverages electron spin for data acquisition, storage, and transmission. The company manufactures spintronic products, including sensors and couplers [5] Clene Inc. (CLNN) - Clene Inc. is a clinical-stage pharmaceutical company focused on discovering, developing, and commercializing novel clean-surfaced nanotechnology therapeutics. Its lead drug candidate, CNM-Au8, is undergoing various clinical trials for conditions such as amyotrophic lateral sclerosis (ALS), chronic optic neuropathy, and Parkinson's Disease [6][7]

Summary of Conference Call Records Clene Inc. (NasdaqCM:CLNN) Industry: Biotechnology / Pharmaceuticals Key Points: - Clene Inc. has been actively engaging with the FDA regarding their clinical data and expanded access protocol for their ALS treatment, CNM-Au8, which is an oral nanocrystal suspension [1][2] - The company reported that their Phase II studies, Healy and Rescue, missed primary endpoints but showed nominally significant results in survival and clinical worsening [2][4] - Clene has provided compassionate use of their drug to over 500 ALS patients, with some individuals receiving treatment for over six years, which is significant given the typical prognosis for ALS patients [3][4] - The Healy study demonstrated a statistically significant benefit in neural filament light levels, which are linked to survival rates, showing an 83% to 84% risk reduction for high neural filament individuals on the drug [5][6] - Clene is preparing to analyze additional data from their expanded access protocol, which could support a new drug application (NDA) filing by the end of the year [9][10] - The company has sufficient cash to navigate upcoming inflection points, including the expected neural filament data and a meeting with the FDA [10][11] Lahontan Gold Corp. (TSXV:LG, OTCQB:LGCXF) Industry: Mining / Gold and Silver Exploration Key Points: - Lahontan Gold Corp. has seen a share price increase of over 1,000% and has experienced significant liquidity in their stock [13] - The company holds four gold and silver exploration properties in Nevada, with their flagship asset, the Santa Fe mine, having 2 million ounces of gold on record [14][15] - Lahontan is currently working on drilling programs to expand their resource estimates and is optimistic about the high-grade gold and silver prices [15][18] - The company is in the process of obtaining permits to drill their entire project, with expectations for full approval by the end of the year [16][17] - Future plans include a new resource estimate and possibly a revised feasibility study, with current gold prices making the project financially attractive [22][23] - Lahontan is focused on low-risk contract mining assumptions and plans to hire key positions as the project progresses [25] Other Important Information: - Clene Inc. is in a critical period with potential for commercialization in 2026 if the NDA is filed successfully [9][10] - Lahontan Gold Corp. is looking to consolidate assets in Nevada and is actively seeking new opportunities while managing operational costs effectively [20][21]

Core Insights - Clene Inc. and its subsidiary Clene Nanomedicine Inc. are participating in a panel discussion focused on neurodegenerative diseases at the Maxim Growth Summit, highlighting their commitment to addressing challenging therapeutic areas [1][2] - The company is advancing its investigational therapy CNM-Au8, which targets mitochondrial function and the NAD pathway to improve neuronal health and combat diseases like ALS and MS [2] Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland [2] - The company specializes in therapies aimed at improving mitochondrial health and protecting neuronal function, specifically for neurodegenerative diseases such as ALS, Parkinson's disease, and MS [2] Product Information - CNM-Au8 is a first-in-class investigational therapy designed to enhance the survival and function of central nervous system cells by reducing oxidative stress and targeting mitochondrial function [2]

[Form 8-K Filing Details](index=1&type=section&id=Form%208-K%20Filing%20Details) [Registrant and General Information](index=1&type=section&id=Registrant%20and%20General%20Information) This section identifies **CLENE INC.** as the registrant, a Delaware corporation, and details the Form 8-K filing date of October 14, 2025, confirming its non-emerging growth company status - Registrant: **CLENE INC.**, a Delaware corporation[1](index=1&type=chunk) - Date of Report: **October 14, 2025**[1](index=1&type=chunk) - The registrant is not an emerging growth company[5](index=5&type=chunk) [Securities Registered](index=1&type=section&id=Securities%20Registered) This section details the classes of securities, Common Stock and Warrants, registered under Section 12(b) of the Act and traded on The Nasdaq Capital Market | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, $0.0001 par value | CLNN | The Nasdaq Capital Market | | Warrants, to acquire one-fortieth of one share | CLNNW | The Nasdaq Capital Market | | of Common Stock for $230.00 per share | | | [Current Report Items](index=2&type=section&id=Current%20Report%20Items) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Clene Inc. released preliminary unaudited financial information on October 14, 2025, including cash and equity proceeds, emphasizing its provisional and unaudited nature - **Clene Inc.** released preliminary unaudited financial information on **October 14, 2025**, via an updated corporate presentation[6](index=6&type=chunk) - Financial information includes **cash and cash equivalents** as of **September 30, 2025**, and **gross proceeds** from the equity distribution agreement through **October 14, 2025**[6](index=6&type=chunk) - The preliminary financial information is **unaudited**, subject to change, and should not be unduly relied upon due to potential material variations in actual results[7](index=7&type=chunk) [Item 7.01 Regulation FD Disclosure](index=2&type=section&id=Item%207.01%20Regulation%20FD%20Disclosure) This item incorporates Item 2.02 information by reference, clarifying that the furnished data, including Exhibit 99.1, is not "filed" under Section 18 of the Exchange Act - Information from **Item 2.02** of this Current Report on Form 8-K is incorporated by reference into this item[9](index=9&type=chunk) - The furnished information, including **Exhibit 99.1**, is not considered 'filed' under Section 18 of the Exchange Act and is exempt from its liabilities[10](index=10&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section enumerates the Form 8-K exhibits, specifically the Corporate Presentation (Exhibit 99.1) and the Cover Page Interactive Data File (Exhibit 104) | Exhibit Number | Exhibit Description | | :------------- | :------------------ | | 99.1 | Corporate Presentation | | 104 | Cover Page Interactive Data File (formatted as Inline XBRL) | [Signatures](index=3&type=section&id=SIGNATURES) [Report Authorization](index=3&type=section&id=Report%20Authorization) The report was duly authorized and signed by Robert Etherington, President and CEO of **CLENE INC.**, on **October 14, 2025** - The report was signed on behalf of **CLENE INC.** by **Robert Etherington**, President and Chief Executive Officer[16](index=16&type=chunk) - Date of signature: **October 14, 2025**[16](index=16&type=chunk)

Core Insights - Clene Inc. and its subsidiary Clene Nanomedicine presented combined results from the REPAIR-MS studies at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis, focusing on the treatment of neurological diseases like ALS and MS [1][5] Group 1: Study Overview - The REPAIR studies, including REPAIR-MS and REPAIR-PD, were Phase 2, open-label studies assessing the effects of CNM-Au8 on neuronal redox state and brain energy metabolism [2] - Participants received 12 weeks of CNM-Au8 treatment followed by a 6-week safety follow-up, with the primary endpoint being the change in brain NAD+/NADH ratio [2] Group 2: Key Findings - The mean NAD+/NADH ratio in the brain increased significantly by +0.449 units (8.65% change) after 12 weeks of treatment across the full REPAIR population [6] - In REPAIR-MS participants, the NAD+/NADH ratio increased by +0.480 units (9.49% change), indicating improved brain energy efficiency [6] - Significant associations were found between baseline measures of cognitive function and brain ATP levels, suggesting a link between energy metabolism and disability in MS [6] Group 3: Safety and Tolerability - CNM-Au8 treatment was reported to be safe and well-tolerated, with adverse events being transient and predominantly mild-to-moderate in severity [7] Group 4: Regulatory Insights - The FDA expressed openness to considering alternative primary endpoints beyond the Expanded Disability Status Scale, including cognitive measures, for evaluating treatment effects in MS [5][8] Group 5: Company Background - Clene Inc. is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health to treat neurodegenerative diseases, with CNM-Au8 being a first-in-class investigational therapy [9][10]