Trevi Therapeutics(TRVI) - 2025 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION This section presents Trevi Therapeutics' unaudited condensed consolidated financial information, covering statements, management's discussion, market risk, and controls Item 1. Condensed Consolidated Financial Statements (Unaudited) This section presents Trevi Therapeutics' unaudited condensed consolidated financial statements, including balance sheets, comprehensive loss, equity, and cash flows, with detailed notes for Q1 2025 and FY 2024 Condensed Consolidated Balance Sheets This section presents the unaudited condensed consolidated balance sheets for Trevi Therapeutics, Inc. as of March 31, 2025, and December 31, 2024 | Metric (in thousands) | March 31, 2025 | December 31, 2024 | Change | % Change | | :-------------------- | :------------- | :---------------- | :----- | :------- | | Cash and cash equivalents | $19,374 | $34,097 | $(14,723) | -43.18% | | Marketable securities | $83,883 | $73,525 | $10,358 | 14.09% | | Total current assets | $105,621 | $109,428 | $(3,807) | -3.48% | | Total assets | $107,004 | $110,900 | $(3,896) | -3.51% | | Total current liabilities | $6,866 | $10,509 | $(3,643) | -34.67% | | Total liabilities | $7,547 | $11,256 | $(3,709) | -32.95% | | Total stockholders' equity | $99,457 | $99,644 | $(187) | -0.19% | Condensed Consolidated Statements of Comprehensive Loss This section presents the unaudited condensed consolidated statements of comprehensive loss for the three months ended March 31, 2025, and 2024 | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | % Change | | :-------------------- | :-------------------------------- | :-------------------------------- | :----- | :------- | | Research and development | $7,811 | $8,804 | $(993) | -11.28% | | General and administrative | $3,659 | $3,102 | $557 | 17.96% | | Total operating expenses | $11,470 | $11,906 | $(436) | -3.66% | | Loss from operations | $(11,470) | $(11,906) | $436 | -3.66% | | Interest income, net | $1,125 | $998 | $127 | 12.73% | | Net loss | $(10,340) | $(10,902) | $562 | -5.15% | | Basic and diluted net loss per common share | $(0.09) | $(0.11) | $0.02 | -18.18% | Condensed Consolidated Statements of Stockholders' Equity This section presents the unaudited condensed consolidated statements of stockholders' equity for the three months ended March 31, 2025 | Metric (in thousands) | Balance at Dec 31, 2024 | Stock-based Compensation | Stock Option Exercise | Warrant Exercise | Net Loss | Balance at Mar 31, 2025 | | :-------------------- | :---------------------- | :----------------------- | :-------------------- | :--------------- | :------- | :---------------------- | | Common Stock (Amount) | $94 | — | — | $6 | — | $100 | | Additional Paid-in Capital | $386,534 | $1,208 | $718 | $8,214 | — | $396,669 | | Accumulated Deficit | $(287,045) | — | — | — | $(10,340) | $(297,385) | | Total Stockholders' Equity | $99,644 | $1,208 | $718 | $8,220 | $(10,340) | $99,457 | Condensed Consolidated Statements of Cash Flows This section presents the unaudited condensed consolidated statements of cash flows for the three months ended March 31, 2025, and 2024 | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Net cash used in operating activities | $(13,477) | $(10,467) | $(3,010) | | Net cash used in investing activities | $(9,951) | $(8,091) | $(1,860) | | Net cash provided by (used in) financing activities | $8,705 | $(28) | $8,733 | | Net decrease in cash and cash equivalents | $(14,723) | $(18,586) | $3,863 | | Cash and cash equivalents at end of period | $19,374 | $13,811 | $5,563 | Notes to Unaudited Condensed Consolidated Financial Statements This section provides detailed notes explaining the accounting policies, financial instruments, and other relevant financial information supporting the unaudited condensed consolidated financial statements Note 1. Nature of the Business Trevi Therapeutics is a clinical-stage biopharmaceutical company developing Haduvio for chronic cough in IPF, non-IPF ILD, and RCC, utilizing a kappa agonist and mu antagonist mechanism - Trevi Therapeutics is a clinical-stage biopharmaceutical company developing Haduvio (oral nalbuphine ER) for chronic cough in IPF, non-IPF ILD, and RCC[29] - Haduvio's mechanism of action is a kappa agonist and mu antagonist (KAMA), targeting opioid receptors to control chronic cough, potentially mitigating abuse risk associated with mu-opioid agonists[30] Note 2. Summary of Significant Accounting Policies This note outlines significant accounting policies for interim financial statements, covering basis of presentation, estimates, and recently adopted pronouncements for various financial items - The financial statements are prepared in accordance with GAAP for interim financial information and SEC rules, with certain information condensed or omitted[31] - Significant estimates include R&D expenses, valuation of stock-based awards, and valuation allowance for deferred tax assets[34] - The Company adopted ASU 2023-07 (Segment Reporting) for the fiscal year beginning January 1, 2024, resulting in incremental disclosures[73] - The Company is evaluating the impact of ASU 2024-03 (Disaggregation of Income Statement Expenses) and ASU 2023-09 (Improvements to Income Tax Disclosures), effective for fiscal years beginning after December 15, 2026, and December 15, 2024, respectively[74][75] Note 3. Marketable Securities This note details the Company's available-for-sale marketable securities by type and maturity, including amortized cost, unrealized gains/losses, and fair value as of March 31, 2025 Marketable Securities by Type (March 31, 2025) | Type of security | Amortized Cost ($ thousands) | Gross Unrealized Gains ($ thousands) | Gross Unrealized Losses ($ thousands) | Estimated Fair Value ($ thousands) | | :--------------- | :--------------------------- | :----------------------------------- | :------------------------------------ | :------------------------------- | | U.S. treasury securities | 24,887 | 44 | (3) | 24,928 | | Commercial paper | 22,609 | 3 | (5) | 22,607 | | Corporate bonds | 17,434 | 26 | (1) | 17,459 | | U.S. government agency securities | 13,325 | 16 | (5) | 13,336 | | Asset backed securities | 5,555 | — | (2) | 5,553 | | Total marketable securities | 83,810 | 89 | (16) |