[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) Trevi Therapeutics announced positive Phase 2b CORAL trial results for Haduvio in IPF chronic cough, completed a $115 million offering, and extended its cash runway to 2029 [Key Announcements and CEO Commentary](index=1&type=section&id=Key%20Announcements%20and%20CEO%20Commentary) Trevi Therapeutics announced positive top-line results from the Phase 2b CORAL trial of Haduvio for IPF chronic cough and completed a $115 million underwritten offering, extending cash runway to 2029 - Haduvio's Phase 2b CORAL trial for IPF chronic cough achieved **positive top-line results**[1](index=1&type=chunk)[2](index=2&type=chunk) - Completed a **$115 million** underwritten public offering[1](index=1&type=chunk)[8](index=8&type=chunk) - Projected cash runway to support operations until **2029**[1](index=1&type=chunk)[2](index=2&type=chunk)[8](index=8&type=chunk) [Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) Haduvio's Phase 2b CORAL trial met its primary endpoint with significant cough frequency reduction and LCQ improvements, with Phase 3 initiation planned for H1 2026 - Haduvio achieved its primary endpoint in the CORAL trial, demonstrating a **significant reduction in 24-hour cough frequency**[3](index=3&type=chunk) CORAL Trial 24-Hour Cough Frequency Reduction from Baseline (as of June 30, 2025) | Dose Group | Reduction from Baseline | p-value | Placebo Reduction | | :--------- | :---------------------- | :------ | :---------------- | | 108 mg BID | 60.2% | <0.0001 | 16.9% | | 54 mg BID | 53.4% | <0.0001 | 16.9% | | 27 mg BID | 47.9% | <0.01 | 16.9% | - Additional analysis showed positive results for Haduvio on the Leicester Cough Questionnaire (LCQ) total score, with **108 mg BID and 54 mg BID dose groups increasing by 3.4 and 3.7 points**, respectively (clinical meaningfulness threshold >1.3 points)[8](index=8&type=chunk) - The company plans an End-of-Phase 2 meeting with the FDA in **Q4 2025** and anticipates initiating the Phase 3 program in **H1 2026**[3](index=3&type=chunk) [Second Quarter 2025 Financial Review](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Review) Q2 2025 saw total operating expenses slightly increase, with R&D decreasing and G&A rising, while net other income grew, leading to a narrowed net loss [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Total operating expenses for Q2 2025 increased slightly to **$13.7 million** from **$13.3 million** in Q2 2024, driven by higher G&A expenses offsetting reduced R&D costs [Research and Development (R&D) Expenses](index=2&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) Q2 2025 R&D expenses decreased to **$9.4 million** from **$10.0 million** in Q2 2024, primarily due to reduced clinical development costs for Phase 2a RIVER, HAP, and Phase 2b CORAL trials, partially offset by new Phase 1 study and personnel costs Research and Development Expenses (Q2 2025 vs Q2 2024) | Period | 2025 (in thousands USD) | 2024 (in thousands USD) | Year-over-Year Change (Absolute) | Year-over-Year Change (Percentage) | | :------------------------ | :---------------------- | :---------------------- | :------------------------------- | :--------------------------------- | | Three Months Ended June 30 | $9,389 | $10,021 | -$632 | -6.3% | - The decrease in R&D expenses was primarily due to reduced clinical development costs for the Phase 2a RIVER, HAP, and Phase 2b CORAL trials, which were actively recruiting in the prior year period[4](index=4&type=chunk) - This decrease was partially offset by a newly initiated Phase 1 drug-drug interaction study and increased personnel-related expenses[4](index=4&type=chunk) [General and Administrative (G&A) Expenses](index=2&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) Q2 2025 G&A expenses increased to **$4.3 million** from **$3.3 million** in Q2 2024, primarily due to higher professional service fees and personnel-related costs General and Administrative Expenses (Q2 2025 vs Q2 2024) | Period | 2025 (in thousands USD) | 2024 (in thousands USD) | Year-over-Year Change (Absolute) | Year-over-Year Change (Percentage) | | :------------------------ | :---------------------- | :---------------------- | :------------------------------- | :--------------------------------- | | Three Months Ended June 30 | $4,333 | $3,268 | +$1,065 | +32.6% | - The increase in G&A expenses was primarily due to higher professional service fees and personnel-related expenses[5](index=5&type=chunk) [Other Income and Net Loss](index=2&type=section&id=Other%20Income%20and%20Net%20Loss) Q2 2025 net other income increased due to higher interest income from cash and marketable securities, resulting in a slight narrowing of net loss to **$12.3 million** from **$12.4 million** in Q2 2024 Net Other Income (Q2 2025 vs Q2 2024) | Period | 2025 (in thousands USD) | 2024 (in thousands USD) | Year-over-Year Change (Absolute) | Year-over-Year Change (Percentage) | | :------------------------ | :---------------------- | :---------------------- | :------------------------------- | :--------------------------------- | | Three Months Ended June 30 | $1,400 | $929 | +$471 | +50.7% | - The increase in net other income was primarily due to higher interest income from increased balances of cash equivalents and marketable securities[5](index=5&type=chunk) Net Loss (Q2 2025 vs Q2 2024) | Period | 2025 (in thousands USD) | 2024 (in thousands USD) | Year-over-Year Change (Absolute) | Year-over-Year Change (Percentage) | | :------------------------ | :---------------------- | :---------------------- | :------------------------------- | :--------------------------------- | | Three Months Ended June 30 | $(12,301) | $(12,352) | +$51 | +0.4% | Basic and Diluted Net Loss Per Share (Q2 2025 vs Q2 2024) | Period | 2025 (USD) | 2024 (USD) | Year-over-Year Change (USD) | | :------------------------ | :--------- | :--------- | :-------------------------- | | Three Months Ended June 30 | $(0.09) | $(0.12) | +$0.03 | [About Trevi Therapeutics and Haduvio](index=3&type=section&id=About%20Trevi%20Therapeutics%20and%20Haduvio) Trevi Therapeutics is a clinical-stage biopharmaceutical company developing Haduvio for chronic cough in IPF and RCC, addressing significant unmet medical needs with its unique KAMA mechanism [Company Profile](index=3&type=section&id=Company%20Profile) Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing Haduvio™ (oral nalfurafine extended-release) for chronic cough in patients with IPF, non-IPF ILD, and refractory chronic cough, acting as a kappa agonist and mu antagonist (KAMA) - Trevi Therapeutics is a **clinical-stage biopharmaceutical company**[1](index=1&type=chunk)[10](index=10&type=chunk) - The company is developing Haduvio™ (oral nalfurafine extended-release) for chronic cough in patients with **IPF, non-IPF ILD, and refractory chronic cough**[1](index=1&type=chunk)[10](index=10&type=chunk) - Haduvio acts as a **kappa agonist and mu antagonist (KAMA)**, targeting key opioid receptors involved in chronic cough control[10](index=10&type=chunk) [Haduvio and Target Indications](index=3&type=section&id=Haduvio%20and%20Target%20Indications) Haduvio is the first and only investigational therapy to demonstrate statistically significant cough frequency reduction in IPF and refractory chronic cough patients, though its safety and efficacy are yet to be evaluated by regulatory agencies - Haduvio is the **first and only investigational therapy** to demonstrate a statistically significant reduction in cough frequency in patients with IPF and refractory chronic cough[10](index=10&type=chunk) - The company intends to name oral nalfurafine extended-release as Haduvio, but its safety and efficacy have not been evaluated by any regulatory agency[13](index=13&type=chunk) [Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF)](index=3&type=section&id=Chronic%20Cough%20in%20Idiopathic%20Pulmonary%20Fibrosis%20(IPF)) Chronic cough affects up to **85% of approximately 150,000 IPF patients** in the US, causing frequent daily coughing, potentially worsening disease progression, and severely impacting quality of life, with no approved treatments currently available - Chronic cough affects up to **85% of approximately 150,000 IPF patients** in the U.S[11](index=11&type=chunk) - Patients may cough up to **1,500 times daily**, potentially leading to disease exacerbation, increased risk of progression, death, or lung transplant[11](index=11&type=chunk) - There are **no approved treatments** for chronic cough in IPF, and existing off-label therapies have limited efficacy[11](index=11&type=chunk) [Refractory Chronic Cough (RCC)](index=3&type=section&id=Refractory%20Chronic%20Cough%20(RCC)) Refractory chronic cough (RCC) is defined as cough persisting over **8 weeks** despite treatment for underlying conditions, affecting **2-3 million patients** in the US, caused by cough reflex hypersensitivity, and currently lacks approved treatments - Refractory chronic cough is defined as a cough persisting for more than **8 weeks** despite treatment of any underlying conditions[12](index=12&type=chunk) - It affects approximately **2-3 million patients** in the U.S. and is caused by hypersensitivity of the cough reflex in both central and peripheral nerves[12](index=12&type=chunk) - There are **no approved treatments** for refractory chronic cough in the U.S[12](index=12&type=chunk) [Selected Financial Data](index=5&type=section&id=Selected%20Financial%20Data) Selected financial data shows significant increases in balance sheet items driven by a recent offering, alongside detailed operational results indicating a narrowed net loss [Selected Balance Sheet Data](index=5&type=section&id=Selected%20Balance%20Sheet%20Data) As of June 30, 2025, Trevi Therapeutics' cash and cash equivalents, marketable securities, working capital, total assets, and stockholders' equity significantly increased from December 31, 2024, primarily due to a recent **$115 million** underwritten offering Selected Balance Sheet Data (as of June 30, 2025 vs December 31, 2024) | Item | June 30, 2025 (in thousands USD) | December 31, 2024 (in thousands USD) | Change (Absolute) | Change (Percentage) | | :----------------------- | :------------------------------- | :----------------------------------- | :---------------- | :------------------ | | Cash and cash equivalents | $117,058 | $34,097 | +$82,961 | +243.3% | | Marketable securities | $86,827 | $73,525 | +$13,302 | +18.1% | | Working capital | $197,987 | $98,919 | +$99,068 | +100.1% | | Total assets | $208,339 | $110,900 | +$97,439 | +87.9% | | Stockholders’ equity | $198,493 | $99,644 | +$98,849 | +99.2% | [Selected Statement of Operations Data](index=5&type=section&id=Selected%20Statement%20of%20Operations%20Data) For the three months ended June 30, 2025, Trevi reported a net loss of **$12.3 million**, a slight improvement year-over-year, and a **$22.6 million** net loss for the six months, driven by decreased R&D and increased other income, partially offset by higher G&A Selected Statement of Operations Data (Three Months Ended June 30) | Item | 2025 (in thousands USD) | 2024 (in thousands USD) | Year-over-Year Change (Absolute) | | :---------------------------- | :---------------------- | :---------------------- | :------------------------------- | | Research and development expenses | $9,389 | $10,021 | -$632 | | General and administrative expenses | $4,333 | $3,268 | +$1,065 | | Total operating expenses | $13,722 | $13,289 | +$433 | | Operating loss | $(13,722) | $(13,289) | -$433 | | Net other income | $1,400 | $929 | +$471 | | Net loss | $(12,301) | $(12,352) | +$51 | | Basic and diluted net loss per share | $(0.09) | $(0.12) | +$0.03 | Selected Statement of Operations Data (Six Months Ended June 30) | Item | 2025 (in thousands USD) | 2024 (in thousands USD) | Year-over-Year Change (Absolute) | | :---------------------------- | :---------------------- | :---------------------- | :------------------------------- | | Research and development expenses | $17,200 | $18,825 | -$1,625 | | General and administrative expenses | $7,992 | $6,370 | +$1,622 | | Total operating expenses | $25,192 | $25,195 | -$3 | | Operating loss | $(25,192) | $(25,195) | +$3 | | Net other income | $2,519 | $1,925 | +$594 | | Net loss | $(22,641) | $(23,254) | +$613 | | Basic and diluted net loss per share | $(0.18) | $(0.23) | +$0.05 | [Additional Information](index=2&type=section&id=Additional%20Information) This section provides details on upcoming investor events, outlines forward-looking statement disclaimers, and lists investor and media contact information [Conference Call and Investor Events](index=2&type=section&id=Conference%20Call%20and%20Investor%20Events) Trevi Therapeutics held a conference call and webcast on August 7, 2025, to discuss Q2 2025 financial results and business updates, and plans to participate in several investor and healthcare conferences in August and September 2025 - The company held a conference call and webcast on **August 7, 2025, at 4:30 PM ET**[1](index=1&type=chunk)[7](index=7&type=chunk) - The company plans to participate in the **Stifel 2025 Biotech Summer Summit (August 11-13)**, **Wells Fargo 2025 Healthcare Conference (September 3-5)**, **Cantor Global Healthcare Conference 2025 (September 3-5)**, **H.C. Wainwright & Co. 27th Annual Global Investment Conference (September 8-10)**, **Morgan Stanley 23rd Annual Global Healthcare Conference (September 8-10)**, **2025 Leerink Partners Biopharma Summit (September 17-19)**, and the **European Respiratory Society (ERS) Congress (September 27-October 1)**[9](index=9&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding Trevi's business plans, clinical trials, financial expectations, and capital adequacy, which are subject to risks and uncertainties, and actual results may differ materially - Statements regarding Trevi's business plans, clinical trials, financial expectations, and capital adequacy are considered forward-looking statements[14](index=14&type=chunk) - These statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in forward-looking statements[14](index=14&type=chunk) - Trevi undertakes no obligation to update these statements to reflect events or circumstances occurring after the date of their publication[15](index=15&type=chunk) [Investor and Media Contacts](index=5&type=section&id=Investor%20and%20Media%20Contacts) Contact information for investor relations (Jonathan Carlson) and media relations (Rosalia Scampoli) is provided for inquiries - Investor Contact: Jonathan Carlson, Phone: **(203) 654 3286**, Email: **carlsonj@trevitherapeutics.com**[20](index=20&type=chunk) - Media Contact: Rosalia Scampoli, Phone: **914-815-1465**, Email: **rscampoli@marketcompr.com**[20](index=20&type=chunk)

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].

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 ...

Core Viewpoint - Kaskela Law LLC is investigating Trevi Therapeutics, Inc. on behalf of the company's long-term investors to determine potential violations of securities laws or breaches of fiduciary duties by the company and its officers and directors [1][2]. Group 1 - The investigation is focused on recent corporate actions taken by Trevi Therapeutics [2]. - Shareholders of Trevi are encouraged to reach out to Kaskela Law LLC for more information regarding their legal rights and options [3]. - Kaskela Law LLC specializes in representing investors in securities fraud, corporate governance, and merger & acquisition litigation on a contingent basis [3].

Core Viewpoint - Trevi Therapeutics, Inc. has successfully closed a public offering of 20,010,000 shares at a price of $5.75 per share, raising approximately $115.1 million in total proceeds before expenses [1]. Group 1: Offering Details - The public offering included 2,610,000 additional shares due to the underwriters' full exercise of their option to purchase more shares [1]. - The offering was managed by Morgan Stanley, Leerink Partners, Stifel, and Cantor as joint book-running managers [2]. - The shares were offered under a shelf registration statement filed with the SEC, which was declared effective on August 15, 2023 [3]. Group 2: Company Overview - Trevi Therapeutics is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [5]. - Haduvio functions as a kappa agonist and mu antagonist (KAMA), targeting opioid receptors involved in controlling chronic cough [5].

Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [5] Offering Details - Trevi announced a public offering of 17,400,000 shares of common stock at a price of $5.75 per share, aiming for total proceeds of $100 million before deductions [1] - The offering includes a 30-day option for underwriters to purchase up to 2,610,000 additional shares at the public offering price [1] - The offering is expected to close on or about June 5, 2025, subject to customary closing conditions [1] Underwriters - Morgan Stanley, Leerink Partners, Stifel, and Cantor are acting as joint book-running managers for the offering [2] Regulatory Information - The shares are being offered under a shelf registration statement filed with the SEC, which was declared effective on August 15, 2023 [3]

Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [5] - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist (KAMA), targeting opioid receptors involved in controlling chronic cough [5] Public Offering Details - Trevi Therapeutics has initiated an underwritten public offering of $100,000,000 of its common stock, with an additional option for underwriters to purchase up to $15,000,000 more [1] - The offering is being managed by Morgan Stanley, Leerink Partners, Stifel, and Cantor as joint book-running managers [2] - The shares are offered under a shelf registration statement filed with the SEC, which was declared effective on August 15, 2023 [3] Offering Conditions - The completion of the offering is subject to market and other conditions, with no assurance on the timing or terms of the offering [2] - A preliminary prospectus supplement detailing the terms of the offering is expected to be filed with the SEC [3]

Core Insights - Trevi Therapeutics, Inc. reported positive topline results from its Phase 2b CORAL trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), achieving the primary endpoint with statistically significant reductions in 24-hour cough frequency across all dose groups at week six [1][2]. Group 1: Trial Results - The 108 mg BID, 54 mg BID, and 27 mg BID dose groups achieved reductions from baseline of 60.2%, 53.4%, and 47.9%, respectively, compared to a placebo reduction of 16.9% [2]. - A rapid reduction in 24-hour cough frequency was observed at week two, with 65% of patients on 108 mg BID, 63% on 54 mg BID, and 60% on 27 mg BID experiencing a 50% reduction at week six, compared to 19% of placebo patients [5]. - Statistically significant improvements were noted in secondary endpoints for the 108 mg BID and 54 mg BID dose groups, including a mean reduction of 3.0 points for 108 mg BID and 3.2 points for 54 mg BID on the cough-severity numerical rating scale, compared to a 1.5-point reduction for placebo [5]. Group 2: Safety and Discontinuation - Discontinuation rates due to adverse events were similar between the Haduvio (5.6%) and placebo groups (5%) [4]. Group 3: Stock Performance - Following the announcement, Trevi Therapeutics' stock declined by 10.45%, trading at $5.83 [4].

Summary of Trevi Therapeutics Inc (TRVI) Update - June 02, 2025 Company Overview - **Company**: Trevi Therapeutics Inc (TRVI) - **Focus**: Development of Haduvio for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) Key Industry Insights - **Chronic Cough in IPF**: - Approximately 140,000 patients with IPF in the U.S. - Up to 85% of IPF patients report chronic cough, significantly impacting their quality of life [8][9] - No FDA-approved therapies for chronic cough in IPF patients [9][34] Core Findings from the CORAL Phase IIb Trial - **Trial Results**: - First positive results in a Phase IIb trial for chronic cough in IPF patients [10] - Dose-related response observed: - 60% reduction in cough frequency at the highest dose (108 mg BID) - 48% reduction at the lowest dose (27 mg BID) - Placebo-adjusted difference of 43% at the highest dose [11][21] - Majority of patients (approximately 60-65%) achieved a 50% or greater reduction in cough frequency [23] - Rapid onset of effect observed as early as week two [12][22] - **Patient Reported Outcomes**: - Significant improvements in cough frequency and severity reported by patients [24][26] - At week six, the 54 mg and 108 mg BID groups showed significant differences from placebo [25] - **Safety Profile**: - Low discontinuation rates: 5% for placebo and 5.6% for Haduvio [12][27] - Common adverse events included nausea, vomiting, and headache, consistent with previous studies [28] Future Development Plans - **Phase III Program**: - Plans to request an end of Phase II meeting with the FDA to align on the Phase III program for IPF chronic cough [35] - Anticipated initiation of a trial for chronic cough in non-IPF interstitial lung disease (ILD) by the end of 2025 [33] - **Market Opportunity**: - High unmet need in both IPF and non-IPF ILD chronic cough, with potential to double the market size [33][34] - Expected rapid uptake in physician prescribing due to lack of effective therapies [30] Competitive Landscape - **Positioning**: - Trevi aims to be best-in-class and first-in-class for chronic cough treatment in IPF [30] - Current off-label treatments are ineffective, highlighting the commercial opportunity for Haduvio [32] Additional Considerations - **Patient Impact**: - Chronic cough significantly affects patients' quality of life, leading to social isolation and reduced activity levels [42][43] - Immediate benefits of Haduvio could lead to high patient adherence [46][70] - **Regulatory and Research Considerations**: - Ongoing discussions with the FDA regarding study design and duration for Phase III trials [52][53] - Future data on patient-reported outcomes and safety will inform dosing strategies [97][108] This summary encapsulates the key points from the Trevi Therapeutics conference call, focusing on the company's advancements in treating chronic cough associated with IPF and the implications for future research and market positioning.

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 ...