About Clene Clene Inc., (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson's disease, and multiple sclerosis. CNM-Au8 is an investigational first-in-class therapy that improves central nervous system cells' survival and function via a mec ...

Summary of Clene (CLNN) Conference Call - July 17, 2025 Company Overview - Clene Inc. (CLNN) is a late-stage clinical biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases [1] Core Industry Insights - The company is primarily involved in the development of treatments for neurodegenerative diseases, specifically Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) [1][2] - Clene's drug, CNMAU8, is being evaluated for its ability to reduce neurofilament levels in ALS patients, which serves as a biomarker for neuronal damage [3][4] Key Developments - Clene met with the FDA in June 2025 to discuss the evaluation of neurofilament as a biomarker for ALS treatment [2] - The company received $45 million in funding from the NIH to support a study involving 180 ALS patients, with data collection starting next month and continuing until September [4][5] - Clene aims to submit data to the FDA for a new drug application (NDA) by the end of 2025, with a decision expected in the first quarter of 2026 [8][6] Clinical Trial Plans - A confirmatory Phase 3 clinical trial is planned to commence later in 2025, focusing on survival as the primary endpoint [10][11] - The trial will compare the survival rates of patients taking CNMAU8 against a placebo group [10] Biomarker Insights - Neurofilament levels can indicate the onset of ALS symptoms before clinical presentation [12] - Clene is the only company in a Phase II double-blind placebo-controlled study that has shown a reduction in neurofilament levels [13] Future Directions - Clene is also exploring the potential of CNMAU8 for other neurodegenerative diseases, including MS, Parkinson's, Huntington's, and frontotemporal dementia [16][17] - The company is in discussions with the FDA regarding its MS program, which uses the same drug and dosage as in the ALS program [15][16] Additional Considerations - The company is focused on the energetic support of mitochondria, which is crucial for neuronal function [16] - Clene has presented data suggesting remyelination of damaged neurons in MS, although similar conclusions for ALS are still pending [14] This summary encapsulates the critical points discussed during the Clene conference call, highlighting the company's focus on neurodegenerative diseases, ongoing clinical trials, and future research directions.

Summary of Conference Call Records Company Overview Clean Inc. (NASDAQ: CLNN) - Clean Inc. is a late-stage clinical biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, particularly ALS [1][2]. Sono Group NV (OTCQB: SEVCF) - Sono Group NV, through its subsidiary Sono Motors GmbH, is pioneering solar technology integration into commercial vehicles, aiming to revolutionize mobility by making every commercial vehicle solar [20][22]. Key Points from Clean Inc. Conference Call Core Insights - Clean Inc. met with the FDA in June to discuss the evaluation of neurofilament as a biomarker for ALS, which is indicative of neuronal damage [2][4]. - The company is leveraging a $45 million grant from the NIH to fund a study involving 180 ALS patients, with data collection starting next month [4][5]. - Clean Inc. aims to submit a new drug application (NDA) to the FDA by the end of the year, contingent on positive data regarding neurofilament levels and survival rates [6][7]. - A confirmatory Phase 3 clinical trial is planned, focusing on survival as the primary endpoint, with the first patients expected to start treatment by the end of this year [9][10]. Additional Insights - Neurofilament levels can indicate ALS progression before clinical symptoms appear, and Clean Inc. is the only company in a Phase 2 study showing a reduction in neurofilament [12][14]. - The company is also exploring other neurodegenerative diseases, including multiple sclerosis (MS), Parkinson's, and Huntington's disease, with ongoing discussions with the FDA regarding MS [15][17]. Key Points from Sono Group NV Conference Call Core Insights - Sono Group is focused on integrating solar technology into commercial vehicles, with a patent portfolio of nine granted patents and over 30 pending patents [24][25]. - The company has received orders from six large OEMs and expects significant revenue growth in Q3 and Q4, with an average revenue per unit projected to reach €8,000 [29][30]. - Sono Group aims to uplist to a major national exchange, enhancing visibility and liquidity, which is expected to drive long-term shareholder value [32][34]. Additional Insights - The company has won a green innovation award and received national type certification for solar bus kits in Germany, simplifying the installation process across fleets [27][28]. - The solar solutions are designed to work across various vehicle types, including diesel, hybrid, and electric, providing immediate CO2 reductions and cost benefits [25][33]. - The management team emphasizes a commitment to sustainability, with employees actively participating in eco-friendly practices [31]. Conclusion Both Clean Inc. and Sono Group NV are positioned in innovative sectors with significant growth potential. Clean Inc. is advancing in the biopharmaceutical space with a focus on ALS, while Sono Group is leading in solar mobility solutions for commercial vehicles. Both companies are preparing for critical developments in the near future, including regulatory submissions and market expansions.

CNM-Au8 Therapeutic Potential - Clene is pioneering catalytic nanotherapeutics to treat neurodegenerative diseases like ALS, Parkinson's, and MS[13] - CNM-Au8 is a nanocrystal suspension administered orally, targeting energy metabolism and oxidative stress, and can penetrate the blood-brain barrier[27] - CNM-Au8 contains >100 trillion nanocrystals per 60 mL dose (at 30 mg)[24] - Over 800 participant-years of exposure to CNM-Au8 with predominantly mild-to-moderate TEAEs and no related SAEs across all clinical programs[36] ALS Clinical Trial Outcomes - In the HEALEY ALS Platform Trial, CNM-Au8 30 mg showed a 94% risk reduction in time to death or PAV during the double-blind period[41] - During the OLE to Month 12 of the HEALEY ALS Platform Trial, CNM-Au8 30 mg showed a 78% risk reduction in time to death or PAV[46] and a 62% risk reduction in time to death[48] - A 71% risk reduction in delayed time to clinical worsening was observed in two independent Phase 2 trials[50] - Participants with NfL decline at Week 24 in the HEALEY ALS Platform Trial showed a 91% risk reduction in time to death or PAV[92] MS Clinical Trial Outcomes - In MS patients on DMTs, CNM-Au8 demonstrated significantly improved vision as measured by Change in Low Contrast Letter Acuity (LCLA)[124] - CNM-Au8 demonstrated global neurological improvement in stable MS patients on DMTs[123] Financial Status - As of March 31, 2025, Clene Inc had $9.8 million in cash and equivalents on hand (unaudited)[178]

Core Insights - Clene, Inc. and its subsidiary Clene Nanomedicine are focused on developing therapies for neurodegenerative diseases, including ALS and MS, and have provided a regulatory update following a Type C meeting with the FDA [1][4] Regulatory Update - Clene discussed its proposed statistical analysis plan (SAP) for neurofilament light (NfL) biomarker data from its NIH-sponsored Expanded Access Protocol (EAP) involving nearly 200 ALS patients treated with CNM-Au8 [2][6] - The FDA provided constructive feedback on the proposed analysis methodology for assessing NfL change, which will be analyzed after 9 months (primary analysis) and 6 months (supportive analysis) of treatment [2][3] - The acceptance of the SAP by the FDA is expected this summer, establishing a framework for NfL change analyses in EAP participants [3][6] Future Meetings and Plans - Two additional meetings with the FDA are scheduled for the 3rd quarter of 2025 to discuss long-term ALS survival results and the End-of-Phase 2 MS results [4][6] - If the NfL analyses demonstrate a clinically meaningful decline, it may support a new drug application (NDA) submission under the accelerated approval pathway, planned for the end of 2025 [3][6] Product Information - CNM-Au8 is an investigational therapy designed to improve mitochondrial health and protect neuronal function, targeting neurodegenerative diseases [5][8] - The therapy aims to enhance energy production and utilization in central nervous system cells, potentially leading to neuroprotection and remyelination [8]

Summary of Clene (CLNN) Conference Call - June 10, 2025 Company Overview - Clene (CLNN) is focused on improving mitochondrial health and protecting neuron function, targeting neurodegenerative diseases such as ALS, MS, and Parkinson's through catalytic nanotherapeutics [10][11][34] Core Points and Arguments - **Therapeutic Focus**: Clene is pioneering treatments for neurodegenerative diseases, emphasizing the need for breakthroughs in this area [10] - **Clinical Programs**: The company has completed several Phase II programs, including studies named Visionary (MS), Healy (ALS), and Rescue (ALS), with ongoing regulatory discussions [11][16] - **Safety Profile**: Clene reports a clean safety profile with no serious adverse events related to their drug AU8, despite some mild side effects like headache and nausea [14][34] - **Regulatory Interactions**: Clene has had multiple interactions with the FDA and plans to submit a New Drug Application (NDA) by the end of the year, contingent on positive data from ongoing studies [15][32][36] - **Clinical Efficacy**: Although primary endpoints were missed in some studies, significant secondary endpoints were achieved, including survival benefits and clinical worsening improvements [16][18][24] - **Neurofilament as a Biomarker**: The company is utilizing neurofilament light levels as a predictive biomarker for disease progression and treatment efficacy, showing significant risk reduction in patients with high neurofilament levels [19][21][22] Important but Overlooked Content - **Expanded Access Protocols**: Clene has several expanded access protocols in place, which have shown significant survival benefits compared to natural history controls [22][23] - **Financial Position**: Clene ended the first quarter with nearly $10 million in cash, sufficient to support operations through October, while exploring additional funding options [35] - **Future Plans**: The company is planning further discussions with the FDA regarding both ALS and MS, with a focus on cognitive improvements in MS patients as a significant market opportunity [32][33] This summary encapsulates the key points from the Clene conference call, highlighting the company's focus on neurodegenerative diseases, clinical progress, regulatory strategies, and financial outlook.

Summary of Clene (CLNN) Conference Call - May 21, 2025 Company Overview - Clene Inc. (CLNN) is a late clinical stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases [1] Core Drug and Therapeutic Areas - The primary drug discussed is CMA-eight, targeting neurodegenerative diseases, specifically amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS) [3][4] - CMA-eight has shown potential in remyelination and neuron protection in MS, with data presented at the American Academy of Neurology [4] Regulatory Pathway and FDA Meetings - Clene has a meeting scheduled with the FDA in June to discuss the statistical analysis plan for neurofilament data, a biomarker indicative of neuron damage [6][10] - The company is preparing to file a New Drug Application (NDA) under the accelerated approval pathway, potentially by Q4 2025 [12][13] - The FDA's evaluation will include data from a $45 million NIH-funded compassionate use program involving 170 participants with ALS [8][9] Clinical Trial Insights - The ALS study duration was shorter (6-9 months) due to the urgent needs of patients, while the MS study is planned for 12 months [19][20] - The ALS study focuses on global functional scales and survival, whereas the MS study looks at visual and cognitive changes [20] Current Market Landscape - The main approved drug for ALS is riluzole, which has been available since 1995, providing limited clinical benefit [21][22] - Clene's drug aims to improve neuronal energy and function, potentially offering significant advantages over existing treatments [23] Market Potential and Comparables - Clene believes it could achieve sales of up to $400 million in the first year post-approval, which would significantly increase its market capitalization [24][25] - A comparable ALS company previously achieved a market cap of over $2 billion after FDA approval, highlighting the potential for Clene [24] Additional Insights - The company is also exploring strategic partnerships related to its MS program, although commercialization for MS is still years away [16] - The focus remains primarily on ALS due to a quicker regulatory path [16] Conclusion - Clene is positioned to make significant advancements in the treatment of neurodegenerative diseases, with ongoing discussions with the FDA and promising clinical data supporting its drug candidates [26]

[PART I—FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for Q1 2025, including balance sheets, operations, and cash flows, highlight a "Going Concern" issue due to significant losses and financing needs [Condensed Consolidated Financial Statements](index=3&type=section&id=Condensed%20Consolidated%20Financial%20Statements) For Q1 2025, the company reported a net loss of $0.75 million, a significant improvement from the prior year, despite decreased cash and total assets, with $5.0 million cash used in operations Condensed Consolidated Balance Sheet Data (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $9,832 | $12,155 | | Total current assets | $14,671 | $16,157 | | **Total Assets** | **$25,314** | **$27,337** | | Total current liabilities | $10,764 | $10,291 | | **Total Liabilities** | **$30,287** | **$36,194** | | **Total Stockholders' Deficit** | **($4,973)** | **($8,857)** | Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total revenue | $81 | $73 | | Research and development | $1,481 | $5,869 | | General and administrative | $2,656 | $3,420 | | Loss from operations | ($4,076) | ($9,232) | | **Net loss** | **($751)** | **($11,080)** | | **Net loss per share** | **($0.09)** | **($1.73)** | Condensed Consolidated Statements of Cash Flows (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,011) | ($7,082) | | Net cash provided by investing activities | $0 | $71 | | Net cash provided by (used in) financing activities | $2,673 | ($19) | | **Net decrease in cash** | **($2,323)** | **($7,089)** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes reveal a "Going Concern" issue due to insufficient cash, detail significant debt obligations and outstanding warrants, and confirm nearly all revenue originates from a related party - The company is a clinical-stage pharmaceutical firm focused on nanotechnology therapeutics for central nervous system disorders like ALS, MS, and PD[15](index=15&type=chunk) - **Going Concern:** Management has substantial doubt about the company's ability to continue as a going concern[17](index=17&type=chunk) - As of March 31, 2025, cash was **$9.8 million**, while net cash used in operations for the quarter was **$5.0 million**[17](index=17&type=chunk)[18](index=18&type=chunk) - The company does not expect to have sufficient cash to sustain operations for the next twelve months without additional financing[18](index=18&type=chunk) - To mitigate funding needs, the company is raising capital, including generating **$2.7 million** from its at-the-market facility in Q1 2025[19](index=19&type=chunk) - These plans do not alleviate the substantial doubt about its ability to continue as a going concern[19](index=19&type=chunk) - The company has **$10.0 million** in Senior Secured Convertible Promissory Notes (2024 SSCP Notes) with a **12% interest rate**, maturing in June 2026[77](index=77&type=chunk) - These notes require maintaining a minimum of **$2.0 million** in unrestricted cash[78](index=78&type=chunk) - As of March 31, 2025, the company had **7.24 million shares** issuable upon the exercise of various outstanding warrants, with a mix of equity and liability classifications[107](index=107&type=chunk) - Nearly all revenue (**$80k in Q1 2025**) is generated from supply and license agreements with 4Life Research LLC, a stockholder and related party[124](index=124&type=chunk)[129](index=129&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, emphasizing the "going concern" issue, reduced Q1 2025 net loss due to lower R&D and non-cash gains, and positive clinical program developments for CNM-Au8 [Recent Developments of Our Clinical Programs](index=33&type=section&id=Recent%20Developments%20of%20Our%20Clinical%20Programs) The company received FDA guidance for accelerated approval of CNM-Au8® in ALS, planning a Q4 2025 NDA submission and H2 2025 Phase 3 trial, while VISIONARY-MS data showed remyelination and clinical improvements - The FDA provided guidance on a potential path for accelerated approval for CNM-Au8® in ALS, recommending the company leverage additional data from its Expanded Access Programs (EAPs) to substantiate the drug's effect on neurofilament light (NfL) decline[141](index=141&type=chunk) - The company plans to meet with the FDA in Q2 2025, provide additional data in Q3 2025, and potentially submit an NDA in Q4 2025[141](index=141&type=chunk) - A confirmatory Phase 3 trial, RESTORE-ALS, is planned to start in the second half of 2025[141](index=141&type=chunk) - In April 2025, the company announced new evidence of remyelination and neuronal repair from its VISIONARY-MS trial, with participants showing significant improvements in cognition and vision, supported by objective MRI and mf-VEP biomarkers[144](index=144&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Q1 2025 saw minimal revenue, a 56% decrease in operating loss, and a 93% reduction in net loss to $0.75 million, driven by lower R&D expenses and non-cash gains on liabilities Comparison of Operations (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Total revenue | $81 | $73 | 11% | | Research and development | $1,481 | $5,869 | (75)% | | General and administrative | $2,656 | $3,420 | (22)% | | **Loss from operations** | **($4,076)** | **($9,232)** | **(56)%** | | Total other income (expense), net | $3,325 | ($1,848) | * | | **Net loss** | **($751)** | **($11,080)** | **(93)%** | - Research and development expenses decreased by **75%** primarily due to a **$4.2 million** increase in grant revenue recognized as a reduction of R&D expense, related to the NIH-funded ACT-EAP for ALS[160](index=160&type=chunk)[161](index=161&type=chunk) - General and administrative expenses decreased by **22%**, mainly due to lower personnel costs, stock-based compensation, and public relations fees[162](index=162&type=chunk) - Total other income (expense), net, shifted to a **$3.3 million income** from a **$1.8 million expense** in the prior year, primarily due to a **$2.5 million gain** on the change in fair value of common stock warrant liabilities and a **$1.1 million gain** on derivative liabilities[164](index=164&type=chunk)[165](index=165&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) Substantial doubt exists regarding the company's "going concern" status due to significant losses and negative cash flows, with $9.8 million cash at quarter-end and ongoing capital raising efforts insufficient for the next year - **Going Concern:** The company has incurred significant losses and negative cash flows since inception and expects this to continue[173](index=173&type=chunk)[174](index=174&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern beyond one year[175](index=175&type=chunk) - Net cash used in operating activities was **$5.0 million** in Q1 2025, compared to **$7.1 million** in Q1 2024[180](index=180&type=chunk)[181](index=181&type=chunk) - Net cash provided by financing activities was **$2.7 million** in Q1 2025, entirely from the issuance of common stock under its ATM agreement[180](index=180&type=chunk)[185](index=185&type=chunk) - Short-term material cash requirements for the next 12 months include **$4.9 million** for principal and interest on debt, **$1.4 million** for operating leases, and **$0.2 million** for capital expenditures[177](index=177&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company - The company is exempt from this disclosure requirement due to its status as a smaller reporting company[198](index=198&type=chunk) [Controls and Procedures](index=47&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of March 31, 2025, due to material weaknesses in the control environment, financial reconciliations, and IT general controls, with remediation efforts underway - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were not effective[199](index=199&type=chunk) - Material weaknesses were identified in the control environment, controls over reconciliations and manual journal entries, and IT general controls (including user access and change management)[201](index=201&type=chunk)[202](index=202&type=chunk) - Remediation efforts are underway, including strengthening the internal accounting team and engaging external consultants to assist with complex accounting applications[203](index=203&type=chunk)[205](index=205&type=chunk) [PART II—OTHER INFORMATION](index=49&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Legal Proceedings](index=49&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material pending legal proceedings - As of the filing date, Clene Inc. is not involved in any material legal proceedings[207](index=207&type=chunk) [Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) A new material risk factor highlights the company's failure to meet Nasdaq's $35 million MVLS requirement, with a November 3, 2025 deadline to regain compliance or face potential delisting - On May 6, 2025, the company received a notice from Nasdaq for failing to meet the minimum **$35.0 million** Market Value of Listed Securities (MVLS) requirement[209](index=209&type=chunk) - The company has a 180-day period, until November 3, 2025, to regain compliance with the Minimum MVLS Requirement[209](index=209&type=chunk) - If compliance is not regained, the company's stock is subject to delisting, which could lead to reduced liquidity, a 'penny stock' designation, and a decreased ability to obtain future financing[209](index=209&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=49&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity securities were sold during the reported period - There were no sales of unregistered securities in the reported period[210](index=210&type=chunk) [Defaults Upon Senior Securities](index=49&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults on its senior securities - There were no defaults upon senior securities[211](index=211&type=chunk) [Mine Safety Disclosures](index=49&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This disclosure item is not applicable to the company's operations - Not Applicable[212](index=212&type=chunk) [Other Information](index=49&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q1 2025 - No officers or directors adopted or terminated a Rule 10b5-1 trading plan during the three months ended March 31, 2025[213](index=213&type=chunk) [Exhibits](index=50&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the quarterly report, including corporate governance documents, material contracts, and required CEO and CFO certifications - The exhibits filed with the report include required certifications by the CEO and CFO under Sarbanes-Oxley Sections 302 and 906[214](index=214&type=chunk)

[First Quarter 2025 Financial Results and Recent Operating Highlights](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results%20and%20Recent%20Operating%20Highlights) [CEO Statement & Strategic Outlook](index=1&type=section&id=CEO%20Statement%20%26%20Strategic%20Outlook) 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 ALS[3](index=3&type=chunk) - Clene plans to analyze NfL biomarker data from its NIH-sponsored Expanded Access Protocol (EAP) in Q3 2025, aligning with FDA recommendations[3](index=3&type=chunk)[4](index=4&type=chunk)[7](index=7&type=chunk) - The company is actively preparing to potentially submit an NDA for CNM-Au8 for ALS under the Accelerated Approval pathway in Q4 2025[3](index=3&type=chunk)[7](index=7&type=chunk) - Clene maintains active dialogue with the FDA's Division of Neurology regarding the potential NDA submission[3](index=3&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) 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](index=1&type=section&id=CNM-Au8%20for%20ALS) 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 data[4](index=4&type=chunk)[7](index=7&type=chunk) - 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](index=5&type=chunk) - 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](index=5&type=chunk) [CNM-Au8 for MS](index=1&type=section&id=CNM-Au8%20for%20MS) 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 Meeting[6](index=6&type=chunk)[7](index=7&type=chunk) - The data highlighted significant improvements in cognition and visual function, supported by objective biomarkers including advanced MRI (DTI) and mf-VEP assessments[6](index=6&type=chunk) - Clene plans to discuss the complete VISIONARY-MS trial data with the FDA in an end-of-Phase 2 meeting in Q3 2025[6](index=6&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) 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 2025[7](index=7&type=chunk)[8](index=8&type=chunk) - 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 expenses[9](index=9&type=chunk)[10](index=10&type=chunk) - 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 liabilities[11](index=11&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) 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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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) |

Core Viewpoint - Clene Inc. is focused on advancing its CNM-Au8 programs for treating neurodegenerative diseases, particularly ALS and MS, with plans for potential NDA submissions and ongoing clinical evaluations [2][3][6]. Financial Results - As of March 31, 2025, Clene reported cash and cash equivalents of $9.8 million, down from $12.2 million as of December 31, 2024, indicating a cash runway into the third quarter of 2025 [8]. - Research and development expenses for Q1 2025 were $1.5 million, significantly lower than $5.9 million for the same period in 2024, primarily due to grant revenue from the NIH-funded ALS EAP [9]. - General and administrative expenses decreased to $2.7 million in Q1 2025 from $3.4 million in Q1 2024, attributed to lower public relations and personnel costs [10]. - Clene reported a net loss of $0.8 million, or $0.09 per share, for Q1 2025, a substantial improvement from a net loss of $11.1 million, or $1.73 per share, in Q1 2024 [12]. CNM-Au8 Program Updates - Clene is preparing for a meeting with the FDA in Q2 2025 to finalize its statistical analysis plan for NfL biomarker data, with analysis scheduled for Q3 2025 to support the NDA submission for ALS [3][6]. - New analyses from the HEALEY ALS Platform Trial indicated a survival improvement of 4.1 months for patients receiving CNM-Au8 compared to a control group, with significant benefits observed in patients with severe ALS [4]. - Clene presented evidence of remyelination and neuronal repair associated with CNM-Au8 treatment at the AAN 2025 Annual Meeting, highlighting improvements in cognition and visual function [5][7]. Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company focused on treating neurodegenerative diseases through its investigational therapy CNM-Au8, which targets mitochondrial function and reduces oxidative stress [13][14].