Management View - Trevi Therapeutics reported that 2025 was a significant inflection point for growth, driven by positive data readouts from the CORAL trial in patients with idiopathic pulmonary fibrosis (IPF) [2]

Trevi Therapeutics (NasdaqGM:TRVI) Q4 2025 Earnings call March 17, 2026 04:30 PM ET Company ParticipantsAlexa Deemer - VP of Biotechnology Equity ResearchBrandon Folkes - Managing Director of Biopharma Biotechnology Equity ResearchDavid Hastings - CFODebanjana Chatterjee - VP of Healthcare ResearchFarrell Simon - Chief Commercial OfficerJames Cassella - Chief Development OfficerJayed Momin - Biopharma Equity Research AssociateJennifer Good - President and CEORyan Deschner - Equity Research AssociateConferen ...

Financial Data and Key Metrics Changes - The company ended 2025 with approximately $188 million in cash equivalents and marketable securities, providing a runway into 2028 to fund key clinical trials [15][14] - The cash runway is expected to support top-line data in pivotal phase 3 clinical trials for IPF-related chronic cough and phase 2B trials for RCC and non-IPF ILD [15] Business Line Data and Key Metrics Changes - The company is preparing to initiate two pivotal phase 3 clinical trials for Haduvio in IPF-related chronic cough, with the first trial expected to start in Q2 2026 [6][4] - The second phase 3 trial is anticipated to begin in the second half of 2026, focusing on a 12-week primary efficacy endpoint [6][7] Market Data and Key Metrics Changes - In the US, there are approximately 150,000 IPF patients, with two-thirds experiencing uncontrolled chronic cough, indicating a significant unmet medical need [8] - The market opportunity for non-IPF ILD patients is estimated to be around 228,000, with 50%-60% suffering from uncontrolled cough, effectively doubling the market potential [10] Company Strategy and Development Direction - The company aims to become a leader in chronic cough treatment, focusing on developing therapies for patients with high unmet needs [12] - The strategy includes conducting adaptive phase 2B trials for non-IPF ILD and refractory chronic cough, with plans to file supplemental NDAs for these indications [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clarity of the path forward for registration trials following positive FDA interactions [5][4] - The company is optimistic about the enrollment demand for the IPF chronic cough pivotal study, citing increased awareness among physicians and patient advocacy groups [78][77] Other Important Information - The company plans to hold an investor and analyst day on May 7, 2026, to discuss clinical and commercial strategies in detail [12] - The company will also participate in the American Thoracic Society meeting, sharing new data from various trials [12] Q&A Session Summary Question: Can you elaborate on the remaining phase 1 studies discussed with the FDA? - The studies are label-informative, focusing on drug-drug interactions and metabolism, which are not rate-limiting and can be conducted in parallel with phase 3 trials [17][19] Question: What design features are being aligned with the FDA for the non-IPF ILD trial? - The company plans to propose an adaptive phase 2B trial design, leveraging insights from the IPF end-of-phase 2 meeting [20][22] Question: Will the label dose in RCC be the same as in IPF? - The company is exploring the dosing strategy and may require additional IP if the dosing differs significantly [58] Question: What are the expectations for recruitment pace in the phase 3 IPF cough trial? - The company anticipates a one-year enrollment period for the phase 3 trial, focusing on 80 to 100 sites primarily in the US [102] Question: Will there be any pre-specified analyses for dyspnea and exacerbations in the phase 3 trial? - The company will track various metrics related to cough, breathlessness, and other patient concerns, but the primary focus remains on cough [116][115]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO TREVI THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 45-0834299 (State or other jurisdiction of incorporation or organizatio ...

Trevi Therapeutics Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business Updates Exhibit 99.1 Following the End-of-Phase 2 meeting with the FDA, the Company gained alignment on its Phase 3 program for the treatment of patients with idiopathic pulmonary fibrosis-related chronic cough On track to initiate a Phase 2b clinical trial for the treatment of patients with refractory chronic cough in the second quarter of 2026 Company ended 2025 with $188.3 million in cash, cash equivalents ...

Core Insights - Trevi Therapeutics has gained alignment with the FDA on its Phase 3 program for treating idiopathic pulmonary fibrosis-related chronic cough, with plans to initiate pivotal trials in 2026 [1][5][2] Financial Highlights - The company ended 2025 with $188.3 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2028 [1][8] - Research and development (R&D) expenses for Q4 2025 decreased to $6.2 million from $9.3 million in Q4 2024, primarily due to reduced clinical development expenses [9] - General and administrative (G&A) expenses for Q4 2025 increased to $4.0 million from $2.9 million in Q4 2024, mainly due to higher professional fees and personnel-related expenses [10] - The net loss for Q4 2025 was $8.3 million, an improvement from a net loss of $11.4 million in Q4 2024 [11] Clinical Development Updates - The company plans to initiate a Phase 2b trial for refractory chronic cough (RCC) in Q2 2026, with the primary efficacy endpoint being the mean change in 24-hour cough frequency [4][6] - Two pivotal Phase 3 trials for IPF-related chronic cough are set to begin in 2026, with the first trial enrolling approximately 300 patients and the second enrolling around 130 patients [5] - Key Phase 2b CORAL trial results for IPF-related chronic cough were published in JAMA in January 2026, supporting the company's clinical strategy [5] Market Opportunity - Chronic cough in patients with IPF and non-IPF ILD represents a significant unmet medical need, with approximately 150,000 U.S. patients with IPF and two-thirds experiencing uncontrolled chronic cough [18] - There are around 2-3 million U.S. patients with RCC, which is highly debilitating and lacks FDA-approved therapies [19]

Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. This article is intended to provide informational content and should not be viewed as an exhaustive a ...

Conference call and webcast to be held at 4:30 p.m. ETNEW HAVEN, Conn., March 10, 2026 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced that senior management will host a conference call and live au ...

Core Insights - Investors are encouraged to adopt a more active stock selection strategy by monitoring potential breakout opportunities within defined price ranges [1] Group 1: Breakout Stocks - Trevi Therapeutics, Inc. (TRVI), Metalla Royalty & Streaming Ltd. (MTA), and Vermilion Energy Inc. (VET) are identified as potential breakout stocks for March, having posted significant gains over the past year: TRVI up 119.1%, MTA up 222.2%, and VET up 54.5% [2] - The expected earnings growth rates for these companies for the current year are 23.4% for TRVI, 100% for MTA, and 268.4% for VET, indicating strong momentum [9][10][11][12] Group 2: Screening Criteria - The screening criteria for identifying breakout stocks include a percentage price change over four weeks between 10% and 20%, current price within 90% of their 52-week highs, and a Zacks Rank of 1 (Strong Buy) or 2 (Buy) [7] - Additional criteria include a beta for 60 months less than or equal to 2 and a current price less than or equal to $20, ensuring stocks are reasonably priced and exhibit controlled volatility [8]

Core Viewpoint - Trevi Therapeutics is advancing its investigational therapy Haduvio™ for chronic cough related to idiopathic pulmonary fibrosis (IPF) and plans to initiate two pivotal Phase 3 clinical trials in 2026, following a successful End-of-Phase 2 meeting with the FDA [1][2]. Group 1: Clinical Trials - The first Phase 3 trial is set to begin in Q2 2026, while the second trial is expected to start in the second half of 2026 [1]. - Both trials will be randomized, double-blind, placebo-controlled, and multicenter, evaluating the safety and efficacy of nalbuphine ER tablets at a dosing of 54 mg twice daily [2]. - The first trial aims to enroll approximately 300 patients with a 52-week fixed dosing period, with a primary endpoint at 24 weeks [2]. - The second trial plans to enroll around 130 patients with a 12-week fixed dosing period, with the same primary efficacy endpoint of relative change in 24-hour cough frequency [2]. Group 2: Unmet Medical Need - Chronic cough in IPF patients represents a significant unmet medical need, with around 150,000 patients in the U.S., two-thirds of whom experience uncontrolled chronic cough [3]. - Patients may cough up to 1,500 times per day, leading to increased morbidity and mortality risks, including disease progression and reduced quality of life [3]. Group 3: Company Overview - Trevi Therapeutics is a clinical-stage biopharmaceutical company focused on developing Haduvio™ for chronic cough in patients with IPF, non-IPF interstitial lung disease, and refractory chronic cough [4]. - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for both IPF chronic cough and refractory chronic cough [4]. - The drug acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough control [4].