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]

Summary of Clene Inc. FY Conference Call (September 05, 2025) Company Overview - **Company**: Clene Inc. (Ticker: CLNN) - **Industry**: Clinical-stage biopharmaceutical company focused on developing nanotherapeutics for neurodegenerative diseases, specifically targeting ALS (Amyotrophic Lateral Sclerosis) and MS (Multiple Sclerosis) [1][2] Core Points and Arguments - **Product Development**: Clene is pioneering a catalytic nanotherapeutic called CNM-Au8 aimed at treating ALS and MS, focusing on improving mitochondrial function [3][4] - **Clinical Trials**: - Completed two Phase II proof of concept studies: HEALEY and RESCUE, both of which missed primary endpoints but provided valuable insights [4][9] - Achieved significant secondary endpoints, including a 94% risk reduction in time to death (p=0.04) and a 71% reduction in clinical worsening for RESCUE-ALS [10][11] - Neural filament levels, a biomarker for neuron damage, showed a p=0.04 reduction, indicating potential for disease progression monitoring [12][14] - **Regulatory Engagement**: Clene is in discussions with the FDA regarding the potential for accelerated approval based on neural filament data and survival benefits [16][19] Financial Position - **Cash Position**: As of the end of June, Clene reported $7.3 million in cash, with an additional $1.9 million raised subsequently, leading to a pro forma cash position of approximately $11 million [25] Additional Important Information - **Safety Profile**: Over 1,000 participant-years of exposure to CNM-Au8 with no serious adverse events reported, although some mild side effects like nausea and headache were noted [7][8] - **Market Need**: Emphasis on the importance of cognitive and functional improvements in MS, with ongoing discussions for a Phase III trial focused on cognition [23][24] - **Future Outlook**: Clene aims for commercialization of CNM-Au8 by late 2026, contingent on successful regulatory filings and clinical outcomes [24] Conclusion - Clene Inc. is positioned at a critical juncture with promising clinical data and a solid financial runway to advance its innovative therapies for ALS and MS, with significant regulatory discussions on the horizon [26][27]

Core Insights - Clene Inc. announced new preclinical data indicating that CNM-Au8® improves cellular health in a dopaminergic neuron model of Parkinson's disease, showcasing its potential therapeutic benefits [1][4][6] Group 1: Study Details - The study utilized skin cells from 8 sporadic PD patients, 14 familial PD patients, and 13 healthy individuals, converting them into dopaminergic neurons to study disease processes [2] - The innovative model retains age-related characteristics, allowing for a more accurate representation of Parkinson's disease [2] Group 2: Key Findings - CNM-Au8 treatment improved mitochondrial health, restored cellular metabolism, reduced inflammation, and normalized dysregulated gene expression in both familial and sporadic Parkinson's disease [4][5] - Specifically, CNM-Au8 increased mitochondrial health and volume while reducing harmful reactive oxygen species in familial PD neurons, with milder effects in sporadic PD neurons [5] - The treatment also lowered levels of inflammatory proteins in sporadic PD neurons, contributing to reduced neuroinflammation [5] - CNM-Au8 increased the NAD+/NADH ratio, correcting intracellular metabolite levels in both familial and sporadic PD neurons [5] - The treatment normalized gene expression profiles in PD neurons, bringing them closer to control levels [5] Group 3: Safety and Future Development - CNM-Au8 demonstrated a favorable safety profile, showing no toxicity towards dopaminergic cells at all tested doses, consistent with clinical observations from previous studies [5] - Clene is advancing CNM-Au8 through late-stage clinical studies for ALS and plans to design a Phase 2 clinical study for Parkinson's disease [6]

Core Insights - Clene Inc. and its subsidiary Clene Nanomedicine Inc. are focused on revolutionizing treatments for neurodegenerative diseases such as ALS and MS [1][2] - The company will present at the H.C. Wainwright 27th Annual Global Investment Conference and host 1x1 investor meetings [1] Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company dedicated to improving mitochondrial health and protecting neuronal function [2] - The investigational therapy CNM-Au8 targets mitochondrial function and the NAD pathway, aiming to enhance the survival and function of central nervous system cells while reducing oxidative stress [2] - Clene is headquartered in Salt Lake City, Utah, with R&D and manufacturing operations located in Maryland [2]

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]

[Operating Highlights](index=1&type=section&id=Operating%20Highlights) 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](index=1&type=section&id=CNM-Au8%20for%20the%20treatment%20of%20ALS) 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](index=4&type=chunk) - Analysis of the NfL biomarker data is expected to be conducted early in the **fourth quarter of 2025**[4](index=4&type=chunk)[8](index=8&type=chunk) - A second Type C meeting with the FDA is planned for **Q3 2025** to review long-term survival benefit data from CNM-Au8 treatment[5](index=5&type=chunk)[8](index=8&type=chunk) - The company plans to submit a New Drug Application (NDA) under the accelerated approval pathway for ALS by the **end of 2025**[3](index=3&type=chunk)[5](index=5&type=chunk)[8](index=8&type=chunk) [CNM-Au8 for the treatment of MS](index=1&type=section&id=CNM-Au8%20for%20the%20treatment%20of%20MS) 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 Meeting[6](index=6&type=chunk) - Data from the VISIONARY-MS trial showed significant improvements in cognition and visual function, supported by objective biomarkers (MRI DTI and mf-VEP)[6](index=6&type=chunk) - 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 improvement[7](index=7&type=chunk)[8](index=8&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) 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, 2024[9](index=9&type=chunk) - 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 2026**[2](index=2&type=chunk)[8](index=8&type=chunk)[9](index=9&type=chunk) - 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 expense[10](index=10&type=chunk) - The decrease in G&A expenses was mainly driven by lower personnel costs, stock-based compensation, and legal fees[11](index=11&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) 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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=2&type=section&id=Company%20Overview) 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](index=2&type=section&id=About%20Clene) 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 MS[14](index=14&type=chunk) - The company's therapeutic strategy is to improve mitochondrial health and protect neuronal function[14](index=14&type=chunk) [About CNM-Au8®](index=2&type=section&id=About%20CNM-Au8%C2%AE) 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 function[15](index=15&type=chunk) - It works by driving critical cellular energy-producing reactions, which enables neuroprotection and remyelination[15](index=15&type=chunk)

Core Insights - Clene Inc. reported its second quarter 2025 financial results, highlighting progress in its CNM-Au8 programs for treating neurodegenerative diseases, particularly ALS and MS, and confirmed sufficient cash runway into Q1 2026 [1][6]. Financial Performance - Cash and cash equivalents as of June 30, 2025, totaled $7.3 million, down from $12.2 million as of December 31, 2024 [8]. - Research and development expenses for Q2 2025 were $3.5 million, a decrease from $4.2 million in Q2 2024, attributed to cost-saving initiatives and reduced personnel expenses [9]. - General and administrative expenses were $2.4 million for Q2 2025, down from $3.3 million in Q2 2024, primarily due to decreased personnel and legal fees [10]. - Clene reported a net loss of $7.4 million, or $0.78 per share, for Q2 2025, compared to a net loss of $6.8 million, or $1.06 per share, for the same period in 2024 [12]. Clinical Development Updates - Clene is preparing for a Type C meeting with the FDA to discuss survival data from CNM-Au8 in ALS patients, with a New Drug Application (NDA) submission planned by the end of 2025 [2][4]. - The company plans to analyze neurofilament light biomarker data from its NIH-sponsored expanded access program in Q4 2025, which is crucial for supporting its NDA submission [3][6]. - Clene presented evidence of remyelination and neuronal repair in MS patients treated with CNM-Au8 at the AAN 2025 Annual Meeting, indicating significant improvements in cognition and visual function [5]. Future Plans - A second Type C meeting with the FDA is scheduled for Q3 2025 to review long-term survival benefits associated with CNM-Au8 treatment [4][6]. - Clene plans to hold an end-of-Phase 2 Type B meeting with the FDA in Q3 2025 to discuss the MS clinical development program [7].

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)

Summary of Clean Nanomedicine Conference Call Company Overview - Clean Nanomedicine is focused on developing a nanotherapeutic suspension, primarily targeting Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) [3][6] Key Points on ALS Program - The company is in discussions with the US FDA regarding accelerated approval for its ALS asset, utilizing neurofilament as a biomarker [3][4] - A $45 million NIH program is assessing neurofilament in 180 subjects, which is intended to support the Healy program's data [3][4] - The FDA has proposed leveraging the ongoing NIH program to enhance the Healy data's persuasiveness [3][4] - The company aims to apply for accelerated approval based on neurofilament and survival data, with a meeting scheduled with the FDA at the end of the current quarter [5][6] - The survival data from the Healy study has been submitted to the FDA, and discussions are ongoing about using survival as a secondary endpoint for accelerated approval [5][19] - The company has shown a 28% survival benefit with a p-value of less than 0.04, which could improve to 44% when accounting for certain covariates [19] Key Points on MS Program - The MS program is also active, with cognition as a primary endpoint in the upcoming phase three study [6][7] - The Symbol Digit Modality Test (SDMT) is being considered as a cognition endpoint, which has been used in MS studies for two decades [7][8] - The company is exploring strategic partnerships for the MS program, which has garnered more interest compared to ALS due to its larger market potential [11][12] Regulatory Environment - The FDA's approach has evolved, showing more regulatory flexibility and a willingness to consider neurofilament as a surrogate endpoint [20][30] - The company plans to file a New Drug Application (NDA) by the end of the year, which could lead to a decision in the first quarter of the following year [22][23] - The FDA's leadership changes have not negatively impacted the discussions, and there is a sense of alignment with the agency's current stance on ALS therapies [28][30] Financial Considerations - As of the last quarter, the company reported $10 million in cash, which is expected to last into the third quarter [43] - The company is optimistic about its financial runway, especially with upcoming catalysts related to the ALS and MS programs [43] Other Important Insights - The company has a clean safety profile with no serious adverse events reported across its clinical programs [35][36] - The geopolitical risks associated with gold prices, a key material in their product, are not expected to significantly impact operations [39][40] - The company is considering international opportunities for approval once the NDA is filed in the US [32][34] This summary encapsulates the critical aspects of Clean Nanomedicine's conference call, highlighting the company's strategic focus, regulatory interactions, and financial outlook.