Question-and-Answer SessionMaybe we could just start with an overview of the company for those who might be less familiar, or newer to the story? That would be great.Jennifer GoodCo-Founder, CEO, President, Interim Principal Financial Officer & Director Yes, happy to do that. And thank you to everyone that came. I see some old friends in the audience. And Judah, thank you to you and Morgan Stanley, our newest relationship, newest analyst. That's great. So Trevi has had a strong year. We are a single-asset c ...

Question-and-Answer SessionMaybe we could just start with an overview of the company for those who might be less familiar, or newer to the story? That would be great.Jennifer GoodCo-Founder, CEO, President, Interim Principal Financial Officer & Director Yes, happy to do that. And thank you to everyone that came. I see some old friends in the audience. And Judah, thank you to you and Morgan Stanley, our newest relationship, newest analyst. That's great. So Trevi has had a strong year. We are a single-asset c ...

Summary of Trevi Therapeutics FY Conference Call Company Overview - **Company**: Trevi Therapeutics (NasdaqGM:TRVI) - **Focus**: Development of a single asset drug in the opioid category, specifically a mixed agonist-antagonist that provides efficacy and safety without addiction potential [2][30] Core Points and Arguments Drug Mechanism and Indications - The drug targets three indications related to cough: 1. Chronic cough in idiopathic pulmonary fibrosis (IPF) 2. Other interstitial lung diseases (ILDs) 3. Refractory chronic cough (RCC) [3][4] - IPF is a severe condition with a poor prognosis, where 85% of patients experience chronic cough [3] - The drug has shown strong data in IPF, and the company aims to position itself as best in class against competitors [4] Competitive Landscape - There are currently no approved therapies for chronic cough associated with IPF and ILDs, creating a significant market opportunity [8] - Existing antifibrotics do not alleviate cough symptoms, leaving a gap in treatment options [8] - The company believes its drug's broad mechanism of action provides a competitive advantage over other peripheral-only mechanisms that have failed in trials [8][9] Clinical Development Plans - The company is preparing for a phase 3 trial in IPF, with a focus on maintaining a rigorous study design to manage placebo responses [12][10] - The upcoming phase 2 study for non-IPF ILDs is expected to enroll quickly due to overlapping patient populations [24][18] - The company plans to conduct a responder analysis to ensure robust data for safety and efficacy [14] Market Opportunity - Approximately 150,000 patients in the U.S. have IPF, with about two-thirds experiencing uncontrolled chronic cough [18] - Non-IPF ILDs could double the patient population, with 225,000 patients and a similar prevalence of chronic cough [18] Financial Position and Strategy - Trevi has over $200 million in cash, sufficient to fund multiple trials through late 2028 or early 2029 [43] - The company aims to leverage its capital efficiency by focusing on one drug across three indications [43] Regulatory Considerations - The company is preparing for an end of phase 2 meeting with the FDA, which will be critical for advancing its IPF program [27] - There are ongoing discussions about merging the ILD indication into the IPF program if positive results are obtained [24] Pricing Strategy - Specialty pricing is anticipated to be between $60,000 to $85,000, with expectations of inelastic demand [39] - The company plans to maintain pricing strategies across indications, including RCC, while exploring potential lower dosing options [40] Intellectual Property - Trevi has secured patents for its drug's method of treatment, with coverage extending to both IPF and RCC [41][42] External Factors - The company does not perceive significant competitive threats from rising biotech innovation in China, as respiratory therapies are not a primary focus there [46] - Trevi is exploring the use of AI to enhance operational efficiency and decision-making as it approaches commercialization [48] Important but Overlooked Content - The company has a strong focus on maintaining a tight study design to control variability in clinical trials, particularly for refractory chronic cough [11][20] - Trevi's drug has been unscheduled by the DEA, indicating a lower risk of abuse compared to traditional opioids [30] - The company is actively monitoring regulatory changes and their potential impacts, particularly concerning the FDA's evolving landscape [51][52]

Trevi Therapeutics (TRVI) 2025 Conference September 04, 2025 02:10 PM ET Speaker0Okay, great. All right, good afternoon, everyone, and thanks for everyone in the room and on the webcast for joining us for our next session. I'm Steve Sedos on the Cantor Biotech team, and really a privilege to welcome the next participating company at our conference, Trevari Therapeutics, a company we recently picked up coverage of and are very excited about. I'm joined on stage by CEO Imran Alibhai. Apologies if my mic got o ...

NEW HAVEN, Conn., Aug. 28, 2025 /PRNewswire/ -- 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 be participating in the following conferences in September.2025 Wells Fargo Healthcare Confe ...

Financial Data and Key Metrics Changes - For Q2 2025, the company reported a net loss of $12.3 million, slightly improved from a net loss of $12.4 million in Q2 2024 [13] - Research and Development (R&D) expenses decreased to $9.4 million from $10 million in the same quarter of 2024, primarily due to reduced costs in several trials [13] - General and Administrative (G&A) expenses increased to $4.3 million from $3.3 million in Q2 2024, mainly due to higher professional fees and personnel costs [14] - As of June 30, 2025, cash and investments totaled approximately $204 million, providing a cash runway into 2029 [15] Business Line Data and Key Metrics Changes - The CORAL trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) showed a statistically significant reduction in cough frequency across all dose groups [5] - The quality of life assessment using the Lester Cough Questionnaire (LCQ) indicated significant improvements, with increases of 3.7 and 3.4 points for the 54 mg and 108 mg BID doses, respectively [6] Market Data and Key Metrics Changes - The company estimates approximately 228,000 patients with non-IPF interstitial lung diseases, with 50% to 60% experiencing uncontrolled cough, effectively doubling the market opportunity for cough treatment [10] Company Strategy and Development Direction - The company plans to initiate Phase III trials for Haduvio in the first half of next year, focusing on chronic cough in both IPF and non-IPF patients [9][11] - There is an emphasis on patient-centric development and commercialization strategies, as indicated by feedback from patient advisory boards [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to execute its strategy and create value following positive data from recent trials [5] - The end of Phase II meeting with the FDA is anticipated in Q4 2025, where alignment on the Phase III program will be discussed [9][30] Other Important Information - The company is preparing for a study in refractory chronic cough, with plans to initiate a Phase IIb parallel arm study in the first half of next year [11] - The company has received positive feedback from pulmonologists regarding the potential for Haduvio in treating non-IPF interstitial lung diseases [34] Q&A Session Summary Question: Progress on the respiratory depression study - Management confirmed that the respiratory safety study is ongoing with two active sites and expects to have data for the end of Phase II meeting [20][22] Question: Key questions for the upcoming FDA meeting - The focus will be on data from the CORAL trial, adequacy of the program, and specifics of the Phase III protocol [30][31] Question: Parallel design for the non-IPF ILD study - Management indicated that the study will have minimum criteria for enrollment, allowing for a broader patient base while focusing on fibrosis and cough [46][50] Question: Tolerability and adverse events from the CORAL trial - Management expressed satisfaction with the CORAL data and indicated no changes are anticipated going forward [52] Question: Dose selection for the Phase III study - The 54 mg BID dose is expected to be a key dose moving forward based on its performance in the CORAL trial [57] Question: Additional data from the CORAL trial - Management confirmed that the LCQ data complements objective cough data and will be discussed in future meetings [63][64] Question: Commercialization plans and partnering - The company is focused on its Phase III program in the U.S. and may consider partnerships in Europe or Japan [104]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38886 TREVI THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 45-0834299 ( State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 195 Church St ...

Exhibit 99.1 Trevi Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Updates Announced positive topline results from its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF Closed $115 million underwritten offering with expected cash runway into 2029 Management to host a conference call and webcast today at 4:30 p.m. ET New Haven, Conn., August 7, 2025 – Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company deve ...

NEW HAVEN, Conn., July 29, 2025 /PRNewswire/ -- 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 be participating in the following conferences in August.Oppenheimer's 2025 Biotech in the Be ...

Trevi Therapeutics, Inc. (TRVI) closed the last trading session at $6.41, gaining 3.9% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $21.22 indicates a 231.1% upside potential.The average comprises nine short-term price targets ranging from a low of $13.00 to a high of $29.00, with a standard deviation of $4.92. While the lowest estimate indicates an increase of 102.8% from the c ...