
Registrant Information This section provides basic identification details for Trevi Therapeutics, Inc Registrant Details This section provides the basic identification details of Trevi Therapeutics, Inc., including its filing type, stock exchange listing, and filer status for the quarterly period ended June 30, 2025 - Filing: Quarterly Report on Form 10-Q for the period ended June 30, 20252 - Registrant: TREVI THERAPEUTICS, INC. (Delaware)2 Securities Registered | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, $0.001 par value per share | TRVI | The Nasdaq Stock Market LLC | Filer Status | Filer Type | | :----------- | | Non-accelerated filer ☒ | | Smaller reporting company ☒ | - As of July 31, 2025, the registrant had 121,776,855 shares of common stock outstanding4 Cautionary Note Regarding Forward-Looking Statements and Industry Data This section warns that the report contains forward-looking statements and industry data with inherent risks and limitations Forward-Looking Statements and Data Limitations This section warns readers that the report contains forward-looking statements subject to substantial risks and uncertainties, meaning actual results could differ materially. It also highlights that industry and market data, including estimates for Haduvio, are based on assumptions and have limitations, and are not independently verified - All statements, other than statements of historical fact, are forward-looking and involve substantial risks and uncertainties5 - Actual results or events could differ materially from the plans, intentions, and expectations disclosed in forward-looking statements6 - Important factors that could cause actual results to differ materially are included in the 'Risk Factors' section6 - The report includes statistical and other industry and market data obtained from third-party publications and internal estimates, which involve a number of assumptions and limitations8 - Forward-looking statements include plans for clinical trials (Phase 3 IPF, Phase 1 TIDAL, non-IPF ILD, RCC), commercialization, regulatory approvals, funding, expenses, competitive position, and collaborations10 Risk Factor Summary This section summarizes principal investment risks, including financial losses, funding needs, and product development challenges Principal Investment Risks This section summarizes the key speculative and risky factors for investors, including the company's history of significant losses and expected future losses, the critical need for additional funding, and the sole dependence on the successful development and commercialization of Haduvio. It also highlights risks related to clinical trials, regulatory approvals, competition, and intellectual property - The company has incurred significant losses since inception and expects to continue incurring increasing losses, with no assurance of achieving or maintaining profitability12 - Substantial additional funding is required; failure to raise capital could force delays, reductions, or abandonment of product development or commercialization efforts12 - The business is substantially harmed if Haduvio, the sole product candidate, fails to complete clinical development, obtain marketing approval, or be successfully commercialized, or if significant delays occur12 - Clinical trials involve lengthy, expensive, and uncertain processes, with outcomes not always predictive of later success, and potential for delays in patient enrollment12 - Haduvio's active ingredient, nalbuphine, carries an opioid class label warning for serious respiratory depression, which will likely apply to Haduvio if approved12 - The company faces competition from others developing or commercializing products, and relies on third parties for clinical trials and manufacturing, including a single supplier for the active ingredient12 - Failure to comply with intellectual property licenses or obtain sufficient patent protection could lead to loss of critical rights or allow competitors to develop similar products13 - The significant number of shares underlying outstanding warrants could negatively affect the market price of common stock and make future equity financings more difficult13 PART I. FINANCIAL INFORMATION This part presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis Item 1. Condensed Consolidated Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements for Trevi Therapeutics, Inc. for the three and six months ended June 30, 2025 and 2024, including balance sheets, statements of comprehensive loss, statements of stockholders' equity, statements of cash flows, and detailed notes explaining accounting policies and specific financial line items Condensed Consolidated Balance Sheets This section presents the company's financial position at specific dates, detailing assets, liabilities, and stockholders' equity Key Balance Sheet Data (Amounts in thousands) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :--------------------------------- | :-------------------------- | :------------------ | | Total assets | $208,339 | $110,900 | | Cash and cash equivalents | $117,058 | $34,097 | | Marketable securities | $86,827 | $73,525 | | Total current assets | $207,228 | $109,428 | | Total liabilities | $9,846 | $11,256 | | Total stockholders' equity | $198,493 | $99,644 | | Accumulated deficit | $(309,686) | $(287,045) | - Total assets increased by $97.4 million from December 31, 2024, to June 30, 2025, primarily driven by increases in cash and cash equivalents and marketable securities18 Condensed Consolidated Statements of Comprehensive Loss This section details the company's financial performance over periods, including revenues, expenses, and net loss Key Comprehensive Loss Data (Amounts in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development expenses | $9,389 | $10,021 | $17,200 | $18,825 | | General and administrative expenses | $4,333 | $3,268 | $7,992 | $6,370 | | Total operating expenses | $13,722 | $13,289 | $25,192 | $25,195 | | Net loss | $(12,301) | $(12,352) | $(22,641) | $(23,254) | | Basic and diluted net loss per common share | $(0.09) | $(0.12) | $(0.18) | $(0.23) | | Comprehensive loss | $(12,350) | $(12,369) | $(22,678) | $(23,309) | - Net loss for the six months ended June 30, 2025, decreased by $613 thousand compared to the same period in 202421 - Interest income, net, increased to $2.5 million for the six months ended June 30, 2025, from $1.9 million in the prior year period21 Condensed Consolidated Statements of Stockholders' Equity This section outlines changes in the company's equity accounts over periods, including common stock, additional paid-in capital, and accumulated deficit Stockholders' Equity Changes (Amounts in thousands) | Metric | Balance at March 31, 2025 | Issuance of common stock under offering, less issuance costs | Net loss | Balance at June 30, 2025 | | :--------------------------------------- | :------------------------ | :----------------------------------------- | :--------- | :----------------------- | | Common Stock (Amount) | $100 | $20 | — | $122 | | Additional Paid-in Capital | $396,669 | $107,373 | — | $508,033 | | Accumulated Deficit | $(297,385) | — | $(12,301) | $(309,686) | | Total Stockholders' Equity | $99,457 | $107,39