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 ...

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, 2024 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 jurisdictio ...

Financial Position - As of December 31, 2024, Trevi Therapeutics estimates its cash, cash equivalents, and marketable securities to be $107.6 million[4]. - The company emphasizes that the cash estimate is preliminary and subject to change, pending audit and review[5]. - The company has not yet filed audited financial results for the preliminary cash estimate[5]. - The report indicates that the company is not an emerging growth company under the relevant regulations[3]. Clinical Trials - The Phase 2a RIVER trial for refractory chronic cough has completed patient visits, with topline results expected in Q1 2025[7]. - The Phase 2b CORAL trial in idiopathic pulmonary fibrosis is approximately 80% enrolled, with topline results anticipated in the first half of 2025[8]. - The original sample size for the CORAL trial remains reaffirmed at 160 patients following a positive outcome from a sample size re-estimation analysis[8]. - Forward-looking statements include expectations for clinical trials and cash runway, highlighting inherent risks and uncertainties[9]. Events and Communications - The company is participating in the 14th Annual LifeSci Partners Corporate Access Event from January 13 to 15, 2025[4]. - The press release detailing these updates was issued on January 8, 2025[10].

Announced positive topline data from the Phase 2a RIVER trial in patients with refractory chronic cough (RCC), making Haduvio the first therapy in clinical development to show benefit in patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and RCCCompleted enrollment in the Phase 2b CORAL trial in IPF patients with chronic cough in February 2025, with topline data expected in the second quarter of 2025Announced positive outcome from sample size re-estimation in the Phase 2b CORAL trial, result ...

Conference call and webcast to be held at 4:30 p.m. ETNEW HAVEN, Conn., March 11, 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) and refractory chronic cough (RCC), today announced that senior management will host a conference call and live audio webcast on Tuesday, March 18, 2025, at 4:30 p.m. E ...

On Monday, Trevi Therapeutics, Inc. TRVI reported topline results from its Phase 2a RIVER trial of Haduvio (oral nalbuphine ER) for the treatment of patients with refractory chronic cough (N=66).Haduvio met the primary endpoint with a statistically significant reduction in the objective 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted basis.Haduvio demonstrated a statistically significant reduction in 24-hour cough frequency of 66% in the severe cough (20+ coughs/hour) subgroup and ...

Haduvio met the primary endpoint with a statistically-significant reduction (p<0.0001) in 24-hour cough frequency with a 57% placebo-adjusted change from baseline Haduvio showed similar efficacy in patients with moderate or severe cough counts (p<0.0001) Haduvio is the first and only therapy to show a statistically-significant reduction in chronic cough across both RCC and IPF patientsPatient reported and other secondary outcomes were statistically significant and consistent with the primary endpointCompany ...

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][6] - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough hypersensitivity [4] Industry Context - Refractory chronic cough (RCC) affects approximately 2-3 million patients in the U.S. and has no approved therapies, defined as a cough lasting over 8 weeks despite treatment for underlying conditions [3] - Chronic cough is prevalent in IPF patients, impacting up to 85% of this population, with around 140,000 IPF patients in the U.S. [5] - The condition can lead to significant social and economic burdens, including sleep disruption and social embarrassment [3] Upcoming Events - The company will hold a conference call and live webcast on March 10, 2025, at 8:30 a.m. ET to share topline results from the Phase 2a RIVER trial of Haduvio in patients with RCC [1][2]

Core Insights - Trevi Therapeutics, Inc. is focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [5][6][7] - The company will participate in several investor conferences in March 2025 to present its corporate strategy and updates [2][3][4] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company [5] - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough hypersensitivity [5] - Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency [5] Market Context - Chronic cough affects up to 85% of the 140,000 U.S. IPF patients, with patients coughing up to 1,500 times daily, leading to significant health complications [6] - There are no approved therapies for chronic cough in IPF patients, and current off-label treatments offer minimal benefits [6] - Refractory chronic cough impacts approximately 2-3 million adults in the U.S., causing various complications and significant social and economic burdens [7]

Core Insights - Trevi Therapeutics has completed enrollment in its Phase 2b CORAL trial for Haduvio, targeting chronic cough in patients with idiopathic pulmonary fibrosis (IPF), with topline results expected in the first half of 2025 [1][2] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio (oral nalbuphine ER) for chronic cough in IPF and refractory chronic cough (RCC) [5] - Haduvio functions as a kappa agonist and mu antagonist, acting on the cough reflex arc to manage cough hypersensitivity [5] Clinical Trial Details - The CORAL trial is a double-blind, randomized, placebo-controlled study evaluating three doses of Haduvio (27mg, 54mg, and 108mg) against placebo over a 6-week period, involving approximately 160 IPF patients [3] - The primary efficacy endpoint is the relative change in 24-hour cough frequency at the end of Week 6 compared to baseline, measured with an objective cough monitor [3] Market Need - Chronic cough affects up to 85% of the IPF population, with around 140,000 IPF patients in the U.S., leading to significant health impacts and a high frequency of coughing [4] - There are currently no approved therapies for chronic cough in IPF patients, highlighting a substantial unmet medical need [4] Refractory Chronic Cough Context - Refractory chronic cough impacts approximately 2-3 million adults in the U.S., causing various complications and significant social and economic burdens [6]