Financial Data and Key Metrics Changes - Income in Q3 2025 remained similar to Q3 2024, amounting to CHF 0.1 million, primarily related to patent license maintenance and services from Neurosterix [17] - R&D expenses were CHF 0.2 million in Q3 2025, consistent with Q3 2024, mainly for the GABA-B PAM program [17] - G&A expenses were CHF 0.5 million in Q3 2025, stable compared to Q3 2024 [17] - Cash at the end of Q3 2025 was CHF 2.2 million, providing a runway through mid-2026, with a significant reduction in cash burn following the Neurosterix spin-out [5][18] Business Line Data and Key Metrics Changes - Progress was made in the GABA-B PAM program, with IND-enabling studies ready to start, subject to financing [6][12] - The Dipraglurant program for post-stroke recovery is advancing, with preparations for clinical studies ongoing [4][10] Market Data and Key Metrics Changes - There is a significant unmet medical need in chronic cough treatment, with current standards of care ineffective in 30% of patients [11][25] - The market for post-stroke recovery is growing, with over 100 million stroke survivors worldwide, increasing at an annual rate of 12 million [8][9] Company Strategy and Development Direction - The company is focusing on advancing its GABA-B PAM program for chronic cough and repositioning Dipraglurant for brain injury recovery [19] - Collaboration with Neurosterix and Lund University is ongoing to complete preclinical profiling of Dipraglurant [4][19] - The company is evaluating potential indications for its mGluR2 PAM program, received back from J&J, to advance towards clinical studies [19] Management's Comments on Operating Environment and Future Outlook - Management highlighted the urgent need for pharmacological agents to promote recovery in post-stroke patients, emphasizing the potential of Dipraglurant [9][10] - The company is optimistic about the progress of its spin-out company, Neurosterix, and its M4 PAM program, which is set to start phase one this year [19] Other Important Information - The company has a strong patent position for Dipraglurant and believes it can become a first-in-class drug for post-stroke recovery [10] - Stalicla, a private clinical-stage company, is advancing its patient stratification study in autism and is working on a Series C financing [5][28] Q&A Session Summary Question: Commercial outlook for chronic refractory cough - Management noted that Gefapixent is not performing well in the U.S. market, and there is a significant unmet medical need in chronic cough treatment [24][25] Question: Funding catalyst for Stalicla and potential IPO - Stalicla is working on Series C financing to fund clinical programs and is considering an IPO as a potential funding mechanism [27][28] Question: Competitive clinical development in post-stroke recovery - Management acknowledged the ongoing Camaris trial with Maraviroc and expressed interest in learning from its outcomes for Dipraglurant development [22][30] Question: Indivior's next steps in collaboration - Management stated that Indivior has completed IND-enabling studies and is preparing to move the program forward, but further details could not be disclosed [32]

Core Insights - Trevi Therapeutics, Inc. has appointed David Hastings as the new Chief Financial Officer effective January 6, 2026, to lead financial strategy and support the company's growth phase [1][2][3] Company Overview - Trevi Therapeutics is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for treating chronic cough associated with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC) [1][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 RCC patients [4] Market Need - There are approximately 150,000 patients with IPF in the U.S., with two-thirds experiencing uncontrolled chronic cough, and around 228,000 patients with non-IPF ILD, with 50-60% also suffering from uncontrolled chronic cough [5] - RCC affects an estimated 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] Leadership Experience - David Hastings brings over 25 years of financial leadership in life sciences and biopharmaceuticals, having raised over $2 billion in equity and debt financing throughout his career [2] - His previous roles include CFO at Arbutus and Incyte, where he managed financial operations during significant transitions and commercialization phases [2][3] Strategic Importance - Hastings' experience is deemed critical as Trevi transitions into Phase 3 development for Haduvio, with a focus on advancing the treatment for chronic cough [3] - The company is positioned with statistically significant data across target indications, limited competition, and a strong cash position, which are expected to enhance long-term value for patients and shareholders [3]

Core Insights - Trevi Therapeutics is advancing its investigational therapy Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), with plans to initiate a comprehensive Phase 3 program in the first half of 2026 [1][5]. Financial Performance - The company reported a net loss of $11.8 million for Q3 2025, an improvement from a net loss of $13.2 million in Q3 2024 [7][13]. - Research and development (R&D) expenses decreased to $10.1 million in Q3 2025 from $11.2 million in Q3 2024, primarily due to reduced clinical development costs [4][13]. - General and administrative (G&A) expenses increased to $3.8 million in Q3 2025 from $2.9 million in Q3 2024, attributed to higher professional fees and personnel-related expenses [6][13]. - The company ended Q3 2025 with $194.9 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2028 [1][4]. Clinical Development - Trevi Therapeutics is preparing to submit an End-of-Phase 2 meeting request to the FDA in Q4 2025 and plans to initiate its Phase 3 program in the first half of 2026 [2][5]. - The safety review committee for the Phase 1 TIDAL study concluded there were no safety signals, allowing for the completion of patient enrollment [5]. - Positive results from the Phase 2a RIVER trial were presented at major medical meetings, and a Phase 2b RCC study is planned for the first half of 2026 [5][9]. Market Opportunity - There are approximately 150,000 patients with IPF in the U.S., with two-thirds experiencing uncontrolled chronic cough, and around 228,000 patients with non-IPF interstitial lung disease, with 50-60% also suffering from uncontrolled chronic cough [9]. - RCC affects an estimated 2-3 million patients in the U.S., representing a significant unmet medical need as there are currently no FDA-approved therapies for these conditions [9].

Core Insights - Trevi Therapeutics, Inc. announced the acceptance of two abstracts for presentation at the CHEST 2025 Annual Meeting, focusing on the efficacy and safety results of nalbuphine ER for chronic cough treatment in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [1][5] Group 1: Clinical Trials - The Phase 2b CORAL trial evaluated nalbuphine ER in three doses (27 mg, 54 mg, and 108 mg twice daily) against placebo for chronic cough in IPF patients over a 6-week period, with 165 patients randomized [3] - The primary efficacy endpoint was the relative change in 24-hour cough frequency, measured by an objective cough monitor, comparing nalbuphine ER to placebo at the end of Week 6 [3] - The Phase 2a RIVER trial assessed nalbuphine ER's efficacy, safety, and tolerability in RCC patients through a crossover study design, with each treatment period lasting 21 days [4] Group 2: Patient Population and Unmet Need - There are approximately 150,000 patients with IPF in the U.S., with two-thirds experiencing uncontrolled chronic cough, and around 228,000 patients with non-IPF ILD, with 50-60% also facing uncontrolled chronic cough [6] - Chronic cough can lead to significant morbidity and mortality, including increased respiratory hospitalizations and a decline in quality of life [6] - RCC affects an estimated 2-3 million patients in the U.S., characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions, indicating a high unmet medical need [6] Group 3: Product Information - Trevi Therapeutics is developing Haduvio™ (oral nalbuphine ER) as a potential treatment for chronic cough in IPF, non-IPF ILD, and RCC, which has shown statistically significant reductions in cough frequency in clinical trials [5] - Nalbuphine acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough control [5]

Financial Data and Key Metrics Changes - The company completed H1 2025 with cash of CHF 2.3 million, providing a runway through mid-2026 [6] - Income decreased by $100,000 in Q2 2025 compared to Q2 2024, amounting to $100,000, primarily due to the completion of the funded research phase with Indivior [18] - R&D expenses of $200,000 in Q2 2025 decreased by $100,000 compared to Q2 2024, mainly due to the completion of the research phase with Indivior [19] - G&A expenses of $500,000 decreased by $100,000 in Q2 2025 compared to Q2 2024, primarily due to decreased legal fees [19] - Current liabilities increased by $300,000 compared to December 2024, primarily due to increased payables [20] Business Line Data and Key Metrics Changes - The GABA B PAM program has made significant progress, with IND enabling studies completed by the partner Indivior for substance use disorders [21] - The company has advanced its independent GABA B PAM program for chronic cough and is ready to start IND enabling studies, subject to securing financing [21] - The repositioning of diproglurant for brain injury recovery has been initiated, with an exclusive license agreement for mGluR5 inhibitors [5] Market Data and Key Metrics Changes - The chronic cough market presents a large unmet medical need, with current treatments ineffective in 30% of patients and only moderately effective in up to 60% [12] - The company believes that GABA B PAMs could offer superior efficacy in chronic cough patients compared to current standards of care [12] Company Strategy and Development Direction - The company is focused on advancing its GABA B PAM program and has regained rights to its mGluR2 positive allosteric modulator program [4] - The strategic objective includes validating partnerships with industry and supportive investors while maintaining a strong balance sheet [21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the renewed interest in the neuropsychiatry space, highlighting recent transactions and the potential for Neurosterics and Stellicla [25] - The company is actively pursuing financing strategies for Stellicla, which is focused on patient stratification technology [26] Other Important Information - The company has invested in Stellicla, which has developed a precision medicine platform for neurodevelopmental disorders [5] - The IND enabling studies for the GABA B PAM program are planned to start this year, with promising preclinical data [16] Q&A Session Summary Question: Recent developments in the neuropsychiatry space and implications for Neurosterics and Stellicla - Management noted renewed excitement in the neuropsychiatry space and highlighted the successful financing of Neurosterics [25][26] Question: Insights into long-acting injectable formulations for Neurosterics - Management indicated that while they cannot speculate, there is potential for longer-acting formulations in the m4 PAM space due to compliance issues [30][31] Question: Ideal target patient population for the chronic cough program - Management stated that the GABA B PAMs were selected to maximize the range of chronic cough patients, focusing on centrally acting compounds [33]

Core Viewpoint - Trevi Therapeutics, Inc. is advancing its investigational therapy Haduvio™ for chronic cough associated with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC) [1][4]. Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment [4]. - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for patients with IPF chronic cough and RCC [4]. Market Context - Chronic cough affects up to 85% of patients with IPF, with approximately 150,000 patients in the U.S. suffering from this condition [5]. - Patients with chronic cough may cough up to 1,500 times per day, leading to severe impacts on their quality of life and potential disease progression [5]. - There are currently no approved therapies for chronic cough in IPF patients, and existing off-label treatments offer minimal benefits [5]. Refractory Chronic Cough - RCC, affecting around 2-3 million patients in the U.S., is characterized by a persistent cough lasting more than 8 weeks despite treatment for underlying conditions [6]. - The condition is associated with significant social and economic burdens, including complications like urinary incontinence and sleep disruption [6]. Upcoming Conferences - Trevi Therapeutics will participate in several healthcare conferences in September 2025, including the Wells Fargo Healthcare Conference and the Morgan Stanley Global Healthcare Conference [2][3].

Core Viewpoint - Trevi Therapeutics, Inc. is advancing its investigational therapy Haduvio™ for chronic cough associated with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), with upcoming participation in key biotech conferences [1][2]. Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment [2][5]. - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for patients with IPF chronic cough and RCC [2][5]. Industry Context - Chronic cough affects up to 85% of patients with IPF, with approximately 150,000 patients in the U.S. suffering from this condition [3]. - Patients with chronic cough may cough up to 1,500 times per day, leading to severe health impacts, including disease progression and reduced quality of life [3]. - There are currently no approved therapies for chronic cough in IPF patients, and existing off-label treatments offer minimal benefits [3]. - Refractory chronic cough, affecting around 2-3 million patients in the U.S., is characterized by a persistent cough lasting over 8 weeks without approved therapies [4].

Controlling cough where it countsTM Positive Topline Results from Phase 2b Trial of Haduvio in Patients with IPF Chronic Cough (CORAL) June 2, 2025 Nasdaq: TRVI Forward Looking Statement Disclaimer Statements contained in this presentation and oral statements made regarding the subject of this presentation regarding matters that are not historical facts are "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncer ...

Core Insights - Trevi Therapeutics, Inc. is set to announce topline results from the Phase 2b CORAL trial of its investigational therapy Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) during a conference call on June 2, 2025 [1][2] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio (oral nalbuphine extended-release) for chronic cough treatment in patients with IPF and refractory chronic cough (RCC) [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 RCC [4] - The mechanism of Haduvio involves acting on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors crucial for cough control [4] Industry Context - Chronic cough affects up to 85% of the IPF population, with approximately 140,000 patients in the U.S. suffering from IPF [3] - Patients with chronic cough may experience up to 1,500 coughs per day, leading to significant declines in their quality of life and increased risks of disease progression, death, or lung transplant [3] - Currently, there are no approved therapies for chronic cough in IPF patients, and existing off-label treatments offer minimal benefits [3]

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) [3][4] - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials involving IPF and RCC patients [3][4] Industry Context - Chronic cough affects up to 85% of the IPF population, with approximately 150,000 IPF patients in the U.S. experiencing severe coughing, up to 1,500 times per day [4] - There are currently no approved therapies for chronic cough in IPF patients, and existing off-label treatments offer minimal benefits [4] - Refractory chronic cough, affecting around 2-3 million patients in the U.S., is characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions, and it has no approved therapies [5] Upcoming Conferences - Trevi management will participate in several conferences in June 2025, including: - American Cough Conference on June 6-7, with an oral presentation on the RIVER trial [2] - CPDD 87th Annual Scientific Meeting on June 14-18, featuring a poster on the human abuse potential of nalbuphine [2] - BIO International Convention on June 16-19, with a corporate presentation scheduled for June 17 [3]