Trevi Therapeutics(TRVI) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights Trevi Therapeutics announced positive Phase 2b CORAL trial results for Haduvio in IPF chronic cough, completed a $115 million offering, and extended its cash runway to 2029 Key Announcements and CEO Commentary Trevi Therapeutics announced positive top-line results from the Phase 2b CORAL trial of Haduvio for IPF chronic cough and completed a $115 million underwritten offering, extending cash runway to 2029 - Haduvio's Phase 2b CORAL trial for IPF chronic cough achieved positive top-line results[1][2] - Completed a $115 million underwritten public offering[1][8] - Projected cash runway to support operations until 2029[1][2][8] Recent Business Highlights Haduvio's Phase 2b CORAL trial met its primary endpoint with significant cough frequency reduction and LCQ improvements, with Phase 3 initiation planned for H1 2026 - Haduvio achieved its primary endpoint in the CORAL trial, demonstrating a significant reduction in 24-hour cough frequency[3] CORAL Trial 24-Hour Cough Frequency Reduction from Baseline (as of June 30, 2025) | Dose Group | Reduction from Baseline | p-value | Placebo Reduction | | :--------- | :---------------------- | :------ | :---------------- | | 108 mg BID | 60.2% | <0.0001 | 16.9% | | 54 mg BID | 53.4% | <0.0001 | 16.9% | | 27 mg BID | 47.9% | <0.01 | 16.9% | - Additional analysis showed positive results for Haduvio on the Leicester Cough Questionnaire (LCQ) total score, with 108 mg BID and 54 mg BID dose groups increasing by 3.4 and 3.7 points, respectively (clinical meaningfulness threshold >1.3 points)[8] - The company plans an End-of-Phase 2 meeting with the FDA in Q4 2025 and anticipates initiating the Phase 3 program in H1 2026[3] Second Quarter 2025 Financial Review Q2 2025 saw total operating expenses slightly increase, with R&D decreasing and G&A rising, while net other income grew, leading to a narrowed net loss Operating Expenses Total operating expenses for Q2 2025 increased slightly to $13.7 million from $13.3 million in Q2 2024, driven by higher G&A expenses offsetting reduced R&D costs Research and Development (R&D) Expenses Q2 2025 R&D expenses decreased to $9.4 million from $10.0 million in Q2 2024, primarily due to reduced clinical development costs for Phase 2a RIVER, HAP, and Phase 2b CORAL trials, partially offset by new Phase 1 study and personnel costs Research and Development Expenses (Q2 2025 vs Q2 2024) | Period | 2025 (in thousands USD) | 2024 (in thousands USD) | Year-over-Year Change (Absolute) | Year-over-Year Change (Percentage) | | :------------------------ | :---------------------- | :---------------------- | :------------------------------- | :--------------------------------- | | Three Months Ended June 30 | $9,389 | $10,021 | -$632 | -6.3% | - The decrease in R&D expenses was primarily due to reduced clinical development costs for the Phase 2a RIVER, HAP, and Phase 2b CORAL trials, which were actively recruiting in the prior year period[4] - This decrease was partially offset by a newly initiated Phase 1 drug-drug interaction study and increased personnel-related expenses[4] General and Administrative (G&A) Expenses Q2 2025 G&A expenses increased to $4.3 million from $3.3 million in Q2 2024, primarily due to higher professional service fees and personnel-related costs General and Administrative Expenses (Q2 2025 vs Q2 2024) | Period | 2025 (in thousands USD) | 2024 (in thousands USD) | Year-over-Year Change (Absolute) | Year-over-Year Change (Percentage) | | :------------------------ | :---------------------- | :---------------------- | :------------------------------- | :--------------------------------- | | Three Months Ended June 30 | $4,333 | $3,268 | +$1,065 | +32.6% | - The increase in G&A expenses was primarily due to higher professional service fees and personnel-related expenses[5] Other Income and Net Loss Q2 2025 net other income increased due to higher interest income from cash and marketable securities, resulting in a slight narrowing of net loss to $12.3 million from $12.4 million in Q2 2024 Net Other Income (Q2 2025 vs Q2 2024) | Period | 2025 (in thousands USD) | 2024 (in thousands USD) | Year-over-Year Change (Absolute) | Year-over-Year Change (Percentage) | | :------------------------ | :---------------------- | :---------------------- | :------------------------------- | :--------------------------------- | | Three Months Ended June 30 | $1,400 | $929 | +$471 | +50.7% | - The increase in net other income was primarily due to higher interest income from increased balances of cash equivalents and marketable securities[5] Net Loss (Q2 2025 vs Q2 2024) | Period | 2025 (in thousands USD) | 2024 (in thousands USD) | Year-over-Year Change (Absolute) | Year-over-Year Change (Percentage) | | :------------------------ | :---------------------- | :---------------------- | :------------------------------- | :--------------------------------- | | Three Months Ended June 30 | $(12,301) | $(12,352) | +$51 | +0.4% | Basic and Diluted Net Loss Per Share (Q2 2025 vs Q2 2024) | Period | 2025 (USD) | 2024 (USD) | Year-over-Year Change (USD) | | :------------------------ | :--------- | :--------- | :-------------------------- | | Three Months Ended June 30 | $(0.09) | $(0.12) | +$0.03 | About Trevi Therapeutics and Haduvio Trevi Therapeutics is a clinical-stage biopharmaceutical company developing Haduvio for chronic cough in IPF and RCC, addressing significant unmet medical needs with its unique KAMA mechanism Company Profile Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing Haduvio™ (oral nalfurafine extended-release) for chronic cough in patients with IPF, non-IPF ILD, and refractory chronic cough, acting as a kappa agonist and mu antagonist (KAMA) - Trevi Therapeutics is a clinical-stage biopharmaceutical company[1][10] - The company is developing Haduvio™ (oral nalfurafine extended-release) for chronic cough in patients with IPF, non-IPF ILD, and refractory chronic cough[1][10] - Haduvio acts as a kappa agonist and mu antagonist (KAMA), targeting key opioid receptors involved in chronic cough control[10] Haduvio and Target Indications Haduvio is the first and only investigational therapy to demonstrate statistically significant cough frequency reduction in IPF and refractory chronic cough patients, though its safety and efficacy are yet to be evaluated by regulatory agencies - Haduvio is the first and only investigational therapy to demonstrate a statistically significant reduction in cough frequency in patients with IPF and refractory chronic cough[10] - The company intends to name oral nalfurafine extended-release as Haduvio, but its safety and efficacy have not been evaluated by any regulatory agency[13] Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF) Chronic cough affects up to 85% of approximately 150,000 IPF patients in the US, causing frequent daily coughing, potentially worsening disease progression, and severely impacting quality of life, with no approved treatments currently available - Chronic cough affects up to 85% of approximately 150,000 IPF patients in the U.S[11] - Patients may cough up to 1,500 times daily, potentially leading to disease exacerbation, increased risk of progression, death, or lung transplant[11] - There are no approved treatments for chronic cough in IPF, and existing off-label therapies have limited efficacy[11] Refractory Chronic Cough (RCC) Refractory chronic cough (RCC) is defined as cough persisting over 8 weeks despite treatment for underlying conditions, affecting 2-3 million patients in the US, caused by cough reflex hypersensitivity, and currently lacks approved treatments - Refractory chronic cough is defined as a cough persisting for more than 8 weeks despite treatment of any underlying conditions[12] - It affects approximately 2-3 million patients in the U.S. and is caused by hypersensitivity of the cough reflex in both central and peripheral nerves[12] - There are no approved treatments for refractory chronic cough in the U.S[12] Selected Financial Data Selected financial data shows significant increases in balance sheet items driven by a recent offering, alongside detailed operational results indicating a narrowed net loss Selected Balance Sheet Data As of June 30, 2025, Trevi Therapeutics' cash and cash equivalents, marketable securities, working capital, total assets, and stockholders' equity significantly increased from December 31, 2024, primarily due to a recent $115 million underwritten offering Selected Balance Sheet Data (as of June 30, 2025 vs December 31, 2024) | Item | June 30, 2025 (in thousands USD) | December 31, 2024 (in thousands USD) | Change (Absolute) | Change (Percentage) | | :----------------------- | :------------------------------- | :----------------------------------- | :---------------- | :------------------ | | Cash and cash equivalents | $117,058 | $34,097 | +$82,961 | +243.3% | | Marketable securities | $86,827 | $73,525 | +$13,302 | +18.1% | | Working capital | $197,987 | $98,919 | +$99,068 | +100.1% | | Total assets | $208,339 | $110,900 | +$97,439 | +87.9% | | Stockholders’ equity | $198,493 | $99,644 | +$98,849 | +99.2% | Selected Statement of Operations Data For the three months ended June 30, 2025, Trevi reported a net loss of $12.3 million, a slight improvement year-over-year, and a $22.6 million net loss for the six months, driven by decreased R&D and increased other income, partially offset by higher G&A Selected Statement of Operations Data (Three Months Ended June 30) | Item | 2025 (in thousands USD) | 2024 (in thousands USD) | Year-over-Year Change (Absolute) | | :---------------------------- | :---------------------- | :---------------------- | :------------------------------- | | Research and development expenses | $9,389 | $10,021 | -$632 | | General and administrative expenses | $4,333 | $3,268 | +$1,065 | | Total operating expenses | $13,722 | $13,289 | +$433 | | Operating loss | $(13,722) | $(13,289) | -$433 | | Net other income | $1,400 | $929 | +$471 | | Net loss | $(12,301) | $(12,352) | +$51 | | Basic and diluted net loss per share | $(0.09) | $(0.12) | +$0.03 | Selected Statement of Operations Data (Six Months Ended June 30) | Item | 2025 (in thousands USD) | 2024 (in thousands USD) | Year-over-Year Change (Absolute) | | :---------------------------- | :---------------------- | :---------------------- | :------------------------------- | | Research and development expenses | $17,200 | $18,825 | -$1,625 | | General and administrative expenses | $7,992 | $6,370 | +$1,622 | | Total operating expenses | $25,192 | $25,195 | -$3 | | Operating loss | $(25,192) | $(25,195) | +$3 | | Net other income | $2,519 | $1,925 | +$594 | | Net loss | $(22,641) | $(23,254) | +$613 | | Basic and diluted net loss per share | $(0.18) | $(0.23) | +$0.05 | Additional Information This section provides details on upcoming investor events, outlines forward-looking statement disclaimers, and lists investor and media contact information Conference Call and Investor Events Trevi Therapeutics held a conference call and webcast on August 7, 2025, to discuss Q2 2025 financial results and business updates, and plans to participate in several investor and healthcare conferences in August and September 2025 - The company held a conference call and webcast on August 7, 2025, at 4:30 PM ET[1][7] - The company plans to participate in the Stifel 2025 Biotech Summer Summit (August 11-13), Wells Fargo 2025 Healthcare Conference (September 3-5), Cantor Global Healthcare Conference 2025 (September 3-5), H.C. Wainwright & Co. 27th Annual Global Investment Conference (September 8-10), Morgan Stanley 23rd Annual Global Healthcare Conference (September 8-10), 2025 Leerink Partners Biopharma Summit (September 17-19), and the European Respiratory Society (ERS) Congress (September 27-October 1)[9] Forward-Looking Statements This press release contains forward-looking statements regarding Trevi's business plans, clinical trials, financial expectations, and capital adequacy, which are subject to risks and uncertainties, and actual results may differ materially - Statements regarding Trevi's business plans, clinical trials, financial expectations, and capital adequacy are considered forward-looking statements[14] - These statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in forward-looking statements[14] - Trevi undertakes no obligation to update these statements to reflect events or circumstances occurring after the date of their publication[15] Investor and Media Contacts Contact information for investor relations (Jonathan Carlson) and media relations (Rosalia Scampoli) is provided for inquiries - Investor Contact: Jonathan Carlson, Phone: (203) 654 3286, Email: carlsonj@trevitherapeutics.com[20] - Media Contact: Rosalia Scampoli, Phone: 914-815-1465, Email: rscampoli@marketcompr.com[20]