Summary of Clene (CLNN) Conference Call - August 20, 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][5] Core Points and Arguments Clinical Development - Clene is pioneering catalytic nanotherapeutic suspensions for potential treatments of multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) [5][6] - The company has completed five phase two proof of concept studies, including two for ALS [5][6] - Clene is currently discussing the next stage for its MS program with the FDA, aiming for phase three [6][21] Drug Mechanism and Safety - The drug CNMAU8 is orally administered and targets energy metabolism by enhancing mitochondrial function [7][8] - Over 1,000 participant years of exposure to CNMAU8 have shown no serious adverse events attributed to the drug, with only mild side effects like nausea and headaches reported [9][10][36] Clinical Study Results - Two phase two studies (RESCUE and Healy) missed their primary endpoints but showed interesting secondary outcomes, including survival benefits and clinical worsening improvements [11][12][13] - In the Healy study, a 74% improvement in clinical worsening was observed, and a 71% improvement was noted in the RESCUE study [13] - Neurofilament levels, a biomarker for neuron death, were significantly reduced in patients taking CNMAU8, correlating with survival benefits [14][15][17] Regulatory Pathway - Clene plans to file a new drug application (NDA) by the end of the year based on neurofilament biomarker data and survival benefits [19][43] - The company is also exploring the possibility of accelerated approval with the FDA [19][42] Financial Position - As of June 30, Clene reported a cash position of $7.3 million, with additional funding raised post-reporting, bringing the pro forma cash balance to nearly $11 million [25][26] - This funding is expected to support operations through the first quarter of the following year, including FDA interactions and data analysis [26] Additional Important Content - Clene is actively engaging with potential partners for its MS program and has had numerous meetings to discuss collaboration [40][41] - The company emphasizes the devastating impact of ALS and expresses gratitude for the support from patients and investors [45][46] Upcoming Milestones - An important FDA meeting is scheduled for the upcoming quarter to discuss survival benefits and neurofilament data [30][31] - The company anticipates significant developments in the next few months regarding its regulatory pathway and clinical data analysis [31][32]

Group 1 - Clene Inc. reported a quarterly loss of $0.78 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.49, and improved from a loss of $1.06 per share a year ago, indicating an earnings surprise of -59.18% [1] - The company posted revenues of $0.03 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 73%, and down from $0.09 million in the same quarter last year [2] - Clene shares have declined approximately 31.3% since the beginning of the year, contrasting with the S&P 500's gain of 10% [3] Group 2 - The current consensus EPS estimate for the upcoming quarter is -$0.43 on revenues of $0.1 million, and for the current fiscal year, it is -$1.69 on revenues of $0.44 million [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the bottom 41% of over 250 Zacks industries, suggesting that the industry outlook can significantly impact stock performance [8]

In April, Clene presented new evidence of remyelination and neuronal repair with CNM-Au8 treatment at the American Academy of Neurology (AAN) Late-Breaking Science Session at the AAN 2025 Annual Meeting. The presentation, titled "Physiologic and Anatomical Evidence of Neuronal Repair and Remyelination from the Long-Term Open-Label Extension of the Phase 2 VISIONARY-MS Trial," highlighted significant and clinically meaningful improvements in cognition and visual function, supported by corresponding objective ...

Following constructive FDA feedback on its proposed statistical analysis plan, Clene plans to analyze the neurofilament light data from its large NIH-sponsored Early Access Protocol early in the fourth quarter of 2025A second Type C meeting has been scheduled with the FDA in the third quarter of 2025 to review the survival benefit associated with CNM-Au8 dosingThe Company expects to submit a New Drug Application in the fourth quarter of 2025 for potential accelerated approval of CNM-Au8® in ALSA Type B end- ...

PART I—FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss of $7.4 million for Q2 2025 and $8.2 million year-to-date, facing a $8.5 million stockholders' deficit and a going concern warning [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet highlights a decrease in cash and total assets, alongside a stockholders' deficit of $8.5 million as of June 30, 2025 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | 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 & Stockholders' Deficit** | | | | Total current liabilities | $7,574 | $10,291 | | **TOTAL LIABILITIES** | **$30,675** | **$36,194** | | **TOTAL STOCKHOLDERS' DEFICIT** | **($8,550)** | **($8,857)** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $7.4 million for Q2 2025 and $8.2 million for the six months ended June 30, 2025, with reduced operating losses year-over-year Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $27 | $91 | $108 | $164 | | Research and development | $3,514 | $4,150 | $4,995 | $10,019 | | General and administrative | $2,377 | $3,314 | $5,033 | $6,734 | | Loss from operations | ($5,864) | ($7,391) | ($9,940) | ($16,623) | | **Net loss** | **($7,419)** | **($6,785)** | **($8,170)** | **($17,865)** | | **Net loss per share** | **($0.78)** | **($1.06)** | **($0.89)** | **($2.78)** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating activities used $9.7 million in cash for the first six months of 2025, partially offset by financing activities, leading to a net decrease in cash Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Category | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($9,755) | ($13,438) | | Net cash provided by investing activities | $0 | $6,319 | | Net cash provided by financing activities | $4,806 | $9 | | **Net decrease in cash** | **($4,870)** | **($7,139)** | | **Cash at end of period** | **$7,343** | **$21,740** | - Financing activities in the first six months of 2025 were primarily driven by **$5.0 million** in net proceeds from the issuance of common stock[13](index=13&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on nanotechnology therapeutics, a reverse stock split, and subsequent financing activities post-quarter end - The company is a clinical-stage pharmaceutical firm focused on clean-surfaced nanotechnology therapeutics for neurological disorders like ALS, MS, and Parkinson's disease[15](index=15&type=chunk) - A **1-for-20 reverse stock split** was effective July 11, 2024, with all historical share and per-share data retroactively adjusted[24](index=24&type=chunk)[25](index=25&type=chunk) - Subsequent to quarter-end, the company sold an additional **$1.9 million** of common stock via its ATM agreement, amended its 2024 SSCP Notes to extend maturity, and issued **$1.5 million** in new 2025 SSCP Notes[133](index=133&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk) - The company has raised **$1.5 million** from the issuance of new senior secured convertible promissory notes (2025 SSCP Notes) on August 13, 2025[135](index=135&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Operating loss decreased to $9.9 million year-to-date 2025 due to reduced expenses, with FDA guidance for CNM-Au8® in ALS, but going concern doubts remain [Business Overview and Recent Developments](index=32&type=section&id=Business%20Overview%20and%20Recent%20Developments) The company focuses on clean-surfaced nanotechnology for neurodegenerative diseases and received FDA guidance for an accelerated approval pathway for CNM-Au8® in ALS - The company is focused on developing clean-surfaced nanotechnology (CSN®) therapeutics for neurodegenerative diseases, with lead programs in ALS, MS, and Parkinson's disease[138](index=138&type=chunk)[140](index=140&type=chunk) - Following a meeting with the FDA's Division of Neurology 1 (DN1), the company received guidance on a potential **accelerated approval pathway** for its lead drug candidate, CNM-Au8®, in ALS[145](index=145&type=chunk) - The company plans to submit a New Drug Application (NDA) for CNM-Au8® by the end of 2025, contingent on supportive data from its ongoing Expanded Access Programs (EAPs), with a confirmatory Phase 3 trial planned for the first half of 2026, subject to funding[146](index=146&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) Operating loss decreased by 40% year-to-date 2025, driven by significant reductions in research and development and general and administrative expenses Comparison of Results of Operations (in thousands) | Metric | Q2 2025 | Q2 2024 | Change | YTD 2025 | YTD 2024 | Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Total revenue | $27 | $91 | (70)% | $108 | $164 | (34)% | | Research and development | $3,514 | $4,150 | (15)% | $4,995 | $10,019 | (50)% | | General and administrative | $2,377 | $3,314 | (28)% | $5,033 | $6,734 | (25)% | | **Loss from operations** | **($5,864)** | **($7,391)** | **(21)%** | **($9,940)** | **($16,623)** | **(40)%** | | **Net loss** | **($7,419)** | **($6,785)** | **9%** | **($8,170)** | **($17,865)** | **(54)%** | - The **50% decrease in YTD R&D expense** was driven by lower manufacturing and research costs, reduced personnel expenses, and a significant increase in grant revenue recognition (**$6.2 million in 2025 vs $2.0 million in 2024**), partially offset by increased clinical program costs for ALS[165](index=165&type=chunk)[166](index=166&type=chunk) - The **25% decrease in YTD G&A expense** was primarily due to cost-saving initiatives leading to lower personnel, stock-based compensation, legal, and public relations costs[167](index=167&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces substantial doubt about its going concern ability due to recurring losses, necessitating additional capital raises and cost-saving measures - The company has incurred significant losses since inception and expects future losses, leading management to conclude there is **substantial doubt about its ability to continue as a going concern** beyond one year from the financial statement issuance date[172](index=172&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk) - To mitigate funding needs, the company plans to raise additional capital through equity/debt financing, licensing, and utilizing its at-the-market (ATM) facility, while also implementing cost-saving measures like reducing R&D programs, cutting employee compensation, and eliminating staff positions[178](index=178&type=chunk) Sources of Capital Since Inception (Gross Proceeds) | Source | Amount | | :--- | :--- | | Equity Financing | $192.1 million | | Borrowings (Debt) | $69.6 million | | Grants | $11.6 million | | R&D Tax Credits | $10.1 million | | Reverse Recapitalization | $9.4 million | | Option/Warrant Exercises | $1.1 million | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company, Clene Inc. is not required to provide quantitative and qualitative disclosures about market risk[203](index=203&type=chunk) [Item 4. Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were ineffective as of June 30, 2025, due to material weaknesses in internal control over financial reporting, with remediation ongoing - Management's evaluation concluded that disclosure controls and procedures were **not effective** as of June 30, 2025[204](index=204&type=chunk) - The ineffectiveness is due to material weaknesses in internal control over financial reporting identified in the 2024 audit, relating to the control environment, review processes, and IT general controls[206](index=206&type=chunk)[209](index=209&type=chunk) - Remediation efforts are ongoing in 2025, including strengthening the internal accounting team, refining processes, and engaging external consultants for complex accounting matters[207](index=207&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material pending legal proceedings - As of the report date, the company is not involved in any material legal proceedings[211](index=211&type=chunk) [Item 1A. Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors disclosed in the company's 2024 Annual Report on Form 10-K, except for a risk factor that was disclosed in the Q1 2025 Form 10-Q - No material changes to risk factors have occurred since the 2024 Annual Report on Form 10-K, other than one previously disclosed in the Q1 2025 10-Q[212](index=212&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=48&type=section&id=Other%20Items) The company reports no unregistered sales of equity securities, no defaults upon senior securities, and no other material information required to be disclosed under Item 5 during the quarter - There were no unregistered sales of equity securities, defaults on senior securities, or other material information to report for the quarter[213](index=213&type=chunk)[215](index=215&type=chunk)[217](index=217&type=chunk)

Clene (CLNN) FY Conference August 12, 2025 03:30 PM ET Speaker0Good afternoon, I'm Sumant Kukarny, a senior biotechnology analyst at Canaccord Genuity. It is my pleasure to have clean nanomedicine here with us today. We have a really interesting approach. It is mostly biophysical I guess. It is not your classical chemical trying to modify things.We have CEO Rob Etherington here and in the audience we have CFO Morgan Brown. So with that, I'll hand hand it over to Rob. Thanks for making the trip here and plea ...

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]