Clene(US:CLNN)2025-08-14 12:02PART I—FINANCIAL INFORMATION Item 1. Financial Statements 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 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 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 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 stock13 Notes to Condensed Consolidated Financial Statements 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 disease15 - A 1-for-20 reverse stock split was effective July 11, 2024, with all historical share and per-share data retroactively adjusted2425 - 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 Notes133134135 - The company has raised $1.5 million from the issuance of new senior secured convertible promissory notes (2025 SSCP Notes) on August 13, 2025135 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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 disease138140 - 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 ALS145 - 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 funding146 Results of Operations 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 ALS165166 - 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 costs167 Liquidity and Capital Resources 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 date172177178 - 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 positions178 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 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 risk203 Item 4. Controls and Procedures 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, 2025204 - 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 controls206209 - Remediation efforts are ongoing in 2025, including strengthening the internal accounting team, refining processes, and engaging external consultants for complex accounting matters207 PART II—OTHER INFORMATION Item 1. Legal Proceedings 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 proceedings211 Item 1A. Risk Factors 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-Q212 Other Items (Items 2, 3, 4, 5, 6) 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 quarter213215217