Core Insights - Trevi Therapeutics presented additional analyses from the Phase 2a RIVER trial of Haduvio, which showed a statistically significant reduction in 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted basis (p<0.0001) for patients with refractory chronic cough (RCC) [1][2] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in patients with idiopathic pulmonary fibrosis (IPF) and RCC [7] - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for both IPF and RCC patients [7] Phase 2a RIVER Trial Details - The Phase 2a RIVER trial was a randomized, double-blind, placebo-controlled study with two treatment periods, each lasting 21 days, separated by a 21-day washout period [5] - The primary endpoint was the mean change in 24-hour cough frequency, assessed by an objective cough monitor at Day 21 [5] Refractory Chronic Cough (RCC) Insights - RCC affects approximately 2-3 million patients in the U.S. and is characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions [6] - There are currently no approved therapies for RCC in the U.S., making Haduvio a potentially significant treatment option [6] Efficacy and Safety Findings - Responder analyses indicated statistically significant reductions in 24-hour cough frequency at thresholds of 30%, 50%, and 75% for patients on Haduvio across all doses [8] - Patients reported significant improvement in the Leicester Cough Questionnaire at Day 21 for the 108 mg BID dose (p<0.0001) [8] - Adverse events were more frequently observed during the initial exposure to Haduvio, particularly at the 27 mg BID dose, but diminished over time [8]

Group 1 - Trevi Therapeutics, Inc. (TRVI) shares have increased by 4.1% over the past four weeks, closing at $6.46, with a mean price target of $19.06 indicating a potential upside of 195.1% [1] - The average of eight short-term price targets ranges from a low of $11 to a high of $29, with a standard deviation of $6.01, suggesting a potential increase of 70.3% to 348.9% from the current price level [2] - Analysts show strong agreement regarding TRVI's ability to report better earnings than previously predicted, which supports the view of potential upside [4][11] Group 2 - The Zacks Consensus Estimate for TRVI's current year has increased by 21.5% over the past month, with five estimates rising and no negative revisions [12] - TRVI holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating a strong potential upside [13] - While consensus price targets may not be reliable for predicting exact gains, they can provide a directional guide for price movement [10][13]

Trevi Therapeutics Inc (TRVI) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Jennifer Good - Co-Founder, CEO, President & DirectorLisa Delfini - Chief Financial OfficerAnnabel Samimy - Managing DirectorJames Cassella - Chief Development OfficerJohn Gionco - Equity ResearchDebanjana Chatterjee - DirectorMayank Mamtani - Senior Managing DirectorFarrell Simon - Chief Commercial Officer Conference Call Participants Faisal Khurshid - Senior Research Analyst - Emerging ImmunologyLeland Gershe ...

Financial Data and Key Metrics Changes - For Q1 2025, the company reported a net loss of $10.4 million, an improvement from a net loss of $10.9 million in Q1 2024 [12] - R&D expenses decreased to $7.8 million from $8.8 million in the same quarter of 2024, primarily due to reduced costs related to a human abuse potential study [12] - G&A expenses increased to $3.7 million from $3.1 million in Q1 2024, mainly due to higher personnel-related expenses [13] - As of March 31, 2025, cash and investments totaled $103.3 million, providing a runway into Q4 2026 [13] Business Line Data and Key Metrics Changes - The Phase 2a RIVER trial in refractory chronic cough (RCC) patients showed a 57% placebo-adjusted reduction in cough frequency, achieving a p-value of less than 0.0001 [6] - The Phase 2b CORAL trial for chronic cough in idiopathic pulmonary fibrosis (IPF) patients completed enrollment with approximately 160 patients across 10 countries [7] Market Data and Key Metrics Changes - RCC affects approximately 2 to 3 million patients in the U.S. with no approved therapies currently available [4] - The company is preparing for the release of top-line data from the CORAL trial this quarter, which is expected to provide insights into treatment options for IPF patients [8] Company Strategy and Development Direction - The company aims to advance its development programs based on the data from the ongoing trials, particularly focusing on chronic cough conditions in both RCC and IPF [8] - There is an emphasis on the importance of the central mechanism underlying neurogenic chronic cough conditions, which differentiates the company's approach from others in the market [6] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's responsiveness and guidance, which is critical for the development programs [9] - The company plans to be active at the upcoming ATS conference, sharing insights from the RCC data set and engaging with key opinion leaders [10] Other Important Information - The company has received positive feedback from the FDA regarding a Type C request, which is crucial for the development of their programs [9] - The company is considering strategic partnerships for commercialization in Europe and Japan, depending on the data and timing [68] Q&A Session Summary Question: What would be considered a positive readout for the CORAL trial? - A statistically significant positive trial would be necessary for continued development, with no unusual adverse events expected [17][19] Question: What are the next catalysts for the company following the CORAL readout? - The company plans to outline future catalysts after receiving the IPF data, which will inform their path forward [21] Question: Can you clarify the discontinuation rate powered for the study? - The study was powered for a 30% discontinuation rate, but the actual rate was less than 10% [28] Question: What are the long-term patient safety monitoring protocols? - The company plans to include 52 weeks of safety data in their Phase III program, as advised by the FDA [65] Question: What are the trends observed in the RIVER study regarding patient baseline characteristics? - It is too early to determine specific trends, but the drug showed significant efficacy across a broad patient population [71][72]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 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 Commission File Number: 001-38886 (203) 304-2499 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the ...

Trevi Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Updates Completed enrollment and last patient last visit in the Phase 2b CORAL trial in IPF patients with chronic cough; topline results continue to be expected in the second quarter of 2025 Exhibit 99.1 Announced positive topline results from the Phase 2a RIVER trial in patients with refractory chronic cough Management to host a conference call and webcast today at 4:30 p.m. ET • Enrollment was completed in February 2025 ...

Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [4][5] - Haduvio is the first therapy in clinical development to demonstrate a statistically significant reduction in chronic cough for both IPF and RCC patients [4] Market Need - Chronic cough affects up to 85% of the 140,000 U.S. IPF patients, leading to severe impacts on their quality of life, including social, physical, and psychological decline [5] - Refractory chronic cough, affecting approximately 2-3 million patients in the U.S., has no approved therapies and is characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions [6] Upcoming Events - Trevi will participate in several investor conferences in April 2025, including: - 24th Annual Needham Virtual Healthcare Conference on April 7, with a corporate presentation by Jennifer Good, President and CEO [2] - Jones Healthcare and Technology Innovation Conference on April 9, with a presentation by Jennifer Good [3] - Piper Sandler Spring Biopharma Symposium on April 16-17, featuring Jennifer Good and James Cassella [4] Product Details - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough hypersensitivity [4] - The safety and efficacy of Haduvio have not yet been evaluated by any regulatory authority [7]

Financial Data and Key Metrics Changes - For Q4 2024, the company reported a net loss of $11.4 million, compared to a net loss of $7.8 million in Q4 2023 [25] - R&D expenses increased to $9.3 million in Q4 2024 from $6.5 million in Q4 2023, primarily due to higher clinical trial costs [25][26] - G&A expenses rose to $2.9 million in Q4 2024 from $2.4 million in the same period in 2023, mainly due to increased stock-based compensation [26] - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $107.6 million, bolstered by a $50 million offering completed in December [26][27] Business Line Data and Key Metrics Changes - The company achieved three positive data readouts in 2024, including studies on Human Abuse Potential, the CORAL study in chronic cough patients with IPF, and the RIVER study in patients with refractory chronic cough [6][20] - The RIVER trial met its primary endpoint with a statistically significant reduction in 24-hour objective cough frequency, achieving a p-value of less than 0.0001% [17] Market Data and Key Metrics Changes - The RIVER study targets a patient population of approximately 2 million to 3 million in the US suffering from refractory chronic cough, which currently has no approved therapies [16] - The company plans to focus on patients who have failed prior therapies, addressing a significant unmet need in the market [18] Company Strategy and Development Direction - The company aims to develop Haduvio as a first-in-class therapy for chronic cough conditions, with a focus on both IPF and RCC [23][24] - Plans include preparing for an End-of-Phase 2 meeting with the FDA by the end of 2025 to discuss pivotal program designs and safety databases [21] - The company intends to release more data from the RIVER trial at upcoming medical conferences, indicating a proactive approach to stakeholder engagement [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical trials and the potential of Haduvio to address significant unmet needs in chronic cough conditions [6][23] - The company remains optimistic about the upcoming data readouts and the potential for Haduvio to be positioned as a best-in-class therapy [23] Other Important Information - The company expects cash burn of approximately $12 million to $14 million per quarter in Q1 and Q2 of 2025, with guidance to be updated as trial designs are finalized [28] - The current fully diluted shares outstanding are approximately 137 million, including about 10 million stock options [29] Q&A Session Summary Question: Could you speak about the patients enrolled in the CORAL study? - Management confirmed that no changes were made to the study protocol or sites after the sample size estimation, maintaining consistency in enrollment statistics [33][34] Question: What are the placebo response expectations for the IPF chronic cough Phase 2 study? - Management clarified that the study includes a two-week titration period, and previous studies indicated a placebo effect ranging from 15% to 23% [42][43] Question: How will the RCC patient population be split between P2X3 and Haduvio? - Management indicated that Haduvio would be positioned as a second or third-line therapy for patients who have failed P2X3 treatments, addressing a significant unmet need [46][48] Question: What exploratory metrics are expected at the time of the IPF chronic cough readout? - Management confirmed that key secondary endpoints will include the EXACT-2 and CS-VAS metrics, but specifics on additional secondary endpoints were not provided [82] Question: Will the next RCC trial have any changes in inclusion criteria? - Management stated that the inclusion criteria will remain similar to the previous study, focusing on patients with a minimum level of cough [60]

Financial Data and Key Metrics Changes - For Q4 2024, the company reported a net loss of $11.4 million, compared to a net loss of $7.8 million in Q4 2023, indicating a deterioration in financial performance [17] - R&D expenses increased to $9.3 million in Q4 2024 from $6.5 million in Q4 2023, primarily due to higher clinical trial costs [17] - G&A expenses rose to $2.9 million in Q4 2024 from $2.4 million in Q4 2023, mainly due to increased stock-based compensation and personnel-related expenses [17] - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $107.6 million, bolstered by a $50 million offering completed in December [18] Business Line Data and Key Metrics Changes - The company achieved three positive data readouts in 2024, including studies related to chronic cough patients with IPF and refractory chronic cough [3][4] - The Human Abuse Potential Study showed statistically significant lower drug liking compared to butorphanol, supporting the drug's profile [6] - The Sample Size Re Estimation analysis confirmed the original sample size of 160 patients for the Phase 2b study in IPF chronic cough, allowing the company to stay on track for enrollment [8] Market Data and Key Metrics Changes - The RIVER trial in patients with refractory chronic cough showed a 57% placebo-adjusted change from baseline with a p-value of less than 0.0001, indicating strong efficacy [11] - The company is targeting a subsegment of the refractory chronic cough population, focusing on patients who have failed prior therapies, which represents a significant unmet need [12] Company Strategy and Development Direction - The company plans to develop HEDUVO in serious chronic cough conditions, positioning it as a first-in-class therapy in IPF and potentially best-in-class across chronic cough indications [15] - The next steps include preparing for an end-of-Phase 2 meeting with the FDA for the IPF program and developing a protocol for the next RCC study [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical trials and the positive data readouts, which are expected to drive future growth [3][4] - The company anticipates cash burn of approximately $12 million to $14 million per quarter in Q1 and Q2 of 2025, with guidance remaining unchanged for cash runway into the second half of 2026 [18][19] Other Important Information - The company plans to present more data at upcoming conferences, including the American Thoracic Society meeting in May and the European Respiratory Society Congress in September [14][15] - The company is actively planning for the next steps in the development of HEDUVO, with a focus on both IPF and RCC [12] Q&A Session Summary Question: Could you speak about the patients enrolled in the CORAL study? - Management confirmed that no changes were made to the study protocol or sites after the sample size estimation, maintaining consistency in the patient population [22][23] Question: Can you comment on the discontinuation rate in the CORAL study? - The discontinuation rate remained in single digits throughout the study, indicating stability in patient retention [24] Question: What are the placebo response expectations for the IPF chronic cough Phase 2 study? - Management indicated that the placebo effect has been well-behaved in prior studies, with conservative assumptions around the expected effect size [29] Question: How will the RCC patient population be split between P2X3 and HEDUVO? - The company plans to target treatment failure patients, suggesting that HEDUVO will be considered after P2X3 therapy fails [33] Question: What secondary endpoints will matter most for driving HEDUVO prescriptions? - Management highlighted the importance of linking secondary endpoints to the primary endpoint of objective cough severity, with quality of life metrics also being considered [80]

Trevi Therapeutics Inc (TRVI) Q4 2024 Earnings Call March 18, 2025 04:30 PM ET Company Participants Jennifer Good - Co-Founder, CEO, President & DirectorLisa Delfini - Chief Financial OfficerMayank Mamtani - Senior Managing DirectorAnnabel Samimy - Managing DirectorRyan Deschner - Vice President - Equity ResearchBrandon Folkes - Managing Director - Equity Research Conference Call Participants None - AnalystLeland Gershell - MD & Senior Biotechnology AnalystSerge Belanger - Senior Analyst Operator Good after ...