Core Viewpoint - Trevi Therapeutics is a biopharmaceutical firm with high expectations from analysts despite having no FDA-approved products, leading to potential significant returns if its drug Haduvio gains approval [1][2]. Company Overview - Trevi Therapeutics (NASDAQ: TRVI) currently trades at $3.10, with a price target of $9, indicating a potential return of 200% [1]. - The company has a market capitalization of $215 million [10]. Drug Development - Trevi's flagship drug, Haduvio (nalbuphine ER), is in Phase 2 FDA trials targeting chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF) and Refractory Chronic Cough (RCC) [3][4]. - Haduvio has shown efficacy in reducing cough frequency by 50.8% over placebo, and is noted as the first therapy to demonstrate robust effects on chronic cough in IPF [9]. Market Potential - IPF and RCC currently lack specific approved treatments, presenting a significant opportunity for Trevi if Haduvio receives approval [4]. - RCC affects approximately 200 to 500 per 100,000 people, while IPF affects 13 to 20 per 100,000, indicating a larger patient base for RCC [6]. Competitive Landscape - Merck's Gefapixant is an approved treatment for RCC in certain regions but was not approved by the FDA for this indication, highlighting a competitive gap that Haduvio could fill [5]. - Haduvio's ability to target both IPF and RCC markets provides a strategic advantage over Gefapixant, which is limited to RCC [7][8]. Financial Projections - Analysts project Trevi will not see significant revenue until 2028, with an estimated sales forecast of $87 million, potentially increasing to $884 million by 2031 [9]. - The success of Haduvio is critical, as only 12% of drugs entering trials achieve FDA approval, which poses a risk to projected revenues [10].

Professor Jacky Smith will present on the correlation between the change in objective cough count and improvement in patient-reported outcomes with nalbuphine ER in IPF patients NEW HAVEN, Conn., Sept. 4, 2024 /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 idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that da ...

NEW HAVEN, Conn., Aug. 28, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinicalstage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that senior management will be attending the following investor and medical conferences in September. 2024 Wells Fargo Healthcare Conference September 4-6, 2024, Boston, MA Trevi Represe ...

Financial Data and Key Metrics Changes - For Q2 2024, the company reported a net loss of $12.4 million, compared to a net loss of $7.1 million in Q2 2023 [14] - R&D expenses increased to $10 million in Q2 2024 from $5.8 million in Q2 2023, reflecting strong clinical activity across all trials [14] - G&A expenses rose to $3.3 million in Q2 2024 from $2.5 million in Q2 2023, primarily due to increases in personnel and related expenses [14] - As of June 30, 2024, cash, cash equivalents, and marketable securities totaled $69.5 million, down from $83 million as of December 31, 2023 [14] Business Line Data and Key Metrics Changes - The Phase 2a RIVER trial for refractory chronic cough (RCC) is expected to read out in Q4 2024, with approximately 80% of subjects enrolled [5][7] - The IPF chronic cough trial, CORAL, is a Phase 2b study involving approximately 160 patients, with enrollment progressing well [8][9] - The human abuse potential (HAP) study is 95% enrolled, with data expected in Q4 2024 [10] Market Data and Key Metrics Changes - The company estimates that there are approximately 2 million to 3 million treatable patients in the U.S. for RCC, with about 7 million diagnosed [55] - There is a significant unmet need for therapies in both RCC and IPF chronic cough, with no currently approved treatments for chronic cough in IPF [6][8] Company Strategy and Development Direction - The company is focused on executing clinical development plans for chronic cough and IPF, with a commitment to prioritize IPF as the lead indication [31] - The company aims to optimize the value of Haduvio by potentially positioning it as a third-line therapy behind other treatments in the RCC market [31] - The company is conducting supportive studies to inform the development path for Haduvio in chronic cough conditions [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for Haduvio to address significant unmet needs in chronic cough conditions [4][6] - The company anticipates steady news flow of data in the upcoming months and plans to participate in several investor conferences [63] Other Important Information - The company issued approximately 1.5 million shares from its ATM during the quarter, strengthening its cash runway post-data readouts [14] - The company expects cash burn to average between $9 million to $12 million per quarter in 2024, with a cash runway extending into 2026 [14] Q&A Session Summary Question: Regarding the RIVER chronic cough trial, were different powering assumptions used for different severity groups? - Management confirmed that the same assumptions were made for the effect size in subgroup analyses [17] Question: Can you confirm the scheduling status of nalbuphine and its implications? - Management indicated that nalbuphine remains unscheduled and expressed confidence that it should remain so based on existing data [18] Question: What are the expectations for enrollment in the respiratory physiology study? - Management stated that the study will start with the same population as the CORAL study and will expand to include sleep-disordered breathing subtypes [24] Question: How does the outcome of the RCC trial impact plans for IPF? - Management emphasized that IPF remains the lead indication, but the outcome of the RCC trial will be considered in future strategies [31] Question: What is the current patent coverage for nalbuphine? - Management detailed that method of treatment patents extend through 2039, with additional applications being prosecuted to extend coverage further [52] Question: How many patients are diagnosed with RCC and seeking treatment? - Management estimated that there are about 2 million to 3 million treatable patients in the U.S. for RCC [55] Question: What is the anticipated delay for the RCC readout due to enrollment imbalance? - Management does not expect any delay and reaffirmed guidance for Q4 2024 for data readout [59]

Topline results expected in the fourth quarter of 2024 in the Phase 2a RIVER trial in refractory chronic cough (RCC) Sample size re-estimation milestone is expected in the fourth quarter of 2024 in the Phase 2b CORAL trial in chronic cough in idiopathic pulmonary fibrosis (IPF) Ended the second quarter of 2024 with $69.5 million in cash, cash equivalents and marketable securities with expected cash runway into 2026 Management to host a conference call and webcast today at 4:30 p.m. ET NEW HAVEN, Conn., Aug. ...

Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for treating chronic cough associated with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [3] - Haduvio acts as a dual κ-opioid receptor agonist and µ-opioid receptor antagonist, potentially providing a synergistic antitussive effect [3] Market Opportunity - Chronic cough significantly impacts patients' social, physical, and psychological quality of life, particularly in IPF, where it may worsen the disease and increase risks of progression, death, or lung transplant [4] - Current treatment options for chronic cough in IPF offer minimal benefits, and there are no approved therapies for RCC in the US, indicating a substantial unmet medical need [4] Upcoming Events - The company will host a conference call and live audio webcast on August 8, 2024, at 4:30 p.m. ET to provide a corporate update and review financial results for the quarter ended June 30, 2024 [1][2]

Investor Contact Katie McManus Trevi Therapeutics, Inc. 203-304-2499 [email protected] Two abstracts accepted for oral presentation at the 13th London International Cough Symposium Leerink Partners Therapeutics Forum: I&I and Metabolism July 9-10, 2024, Boston, MA Trevi Representatives: Jennifer Good, President and CEO, and Lisa Delfini, CFO Oppenheimer's Biotech in the Berkshires August 5-7, 2024, Lenox, MA Trevi Representative: Jennifer Good, President and CEO About Trevi Therapeutics, Inc. Trevi Therapeu ...

Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q1 2024 Earnings Conference Call May 7, 2024 4:30 PM ET Company Participants Jennifer Good - President and Chief Executive Officer Lisa Delfini - Chief Financial Officer David Clark - Chief Medical Officer Conference Call Participants Leland Gershell - Oppenheimer Jack Padovano - Stifel Nathanael Charoensook - Leerink Partners Mayank Mamtani - B. Riley Securities Operator Good afternoon, and welcome to the Trevi Therapeutics First Quarter 2024 Earnings Conference Call. ...

FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (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, 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 jurisd ...

Exhibit 99.1 Trevi Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates Reaffirms guidance for the Phase 2a RIVER trial in refractory chronic cough and Human Abuse Potential (HAP) Study with topline data for each expected in the second half of 2024 Topline results continue to be expected in the first half of 2025 for the Phase 2b CORAL trial in chronic cough in IPF IND cleared with the FDA for planned Phase 1b trial to evaluate respiratory physiology in IPF patients with v ...