Core Insights - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [3][4]. Company Overview - Trevi Therapeutics is developing Haduvio™, which acts as a kappa agonist and mu antagonist (KAMA) targeting cough hypersensitivity through opioid receptors [3]. - The investigational therapy is not currently scheduled by the U.S. Drug Enforcement Agency [3][6]. Market Need - Chronic cough affects up to 85% of the 140,000 U.S. patients with IPF, leading to severe impacts on quality of life and potential disease progression [4]. - There are no approved therapies for chronic cough in IPF, and current off-label treatments offer minimal benefits [4]. - Refractory chronic cough impacts approximately 2-3 million adults in the U.S., causing significant social and economic burdens [5]. Upcoming Events - Trevi's senior management will attend several investor conferences in February 2025, including: - Piper Sandler Biopharma Mogul Summit (February 2-4, 2025) [2] - Oppenheimer Healthcare 2025 Winter CEO & Investor Summit (February 3-6, 2025) [2] - Oppenheimer 35th Annual Healthcare Life Sciences Virtual Conference (February 11-12, 2025) with a corporate presentation on February 11 [2].

Core Viewpoint - Trevi Therapeutics, Inc. (TRVI) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks rating system is based solely on a company's changing earnings picture, tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - For the fiscal year ending December 2024, Trevi Therapeutics is expected to earn -$0.49 per share, reflecting a 69% decrease from the previous year's reported number [9]. - Over the past three months, the Zacks Consensus Estimate for Trevi Therapeutics has increased by 0.7%, indicating a positive trend in earnings estimates [9]. Impact of Institutional Investors - Changes in a company's future earnings potential, as shown by earnings estimate revisions, are strongly correlated with near-term stock price movements, largely due to institutional investors adjusting their valuations based on these estimates [5]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, which subsequently affects stock prices [5]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of Trevi Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [11].

Core Viewpoint - Trevi Therapeutics, Inc. has announced a public offering of 12,500,000 shares of its common stock at a price of $4.00 per share, aiming to raise total proceeds of $50 million before expenses [1] Group 1: Offering Details - The offering is fully underwritten and is expected to close on December 17, 2024, subject to customary closing conditions [1] - The shares are being sold under a shelf registration statement filed with the SEC, which was declared effective on August 15, 2023 [3] - The final terms of the offering will be disclosed in a prospectus supplement to be filed with the SEC [3] Group 2: Investor Participation - The financing includes participation from both new and existing investors, such as Adage Capital Partners LP, Frazier Life Sciences, and others [2] - Leerink Partners, Stifel, and Oppenheimer & Co. are acting as joint book-running managers for the offering, with Needham & Company as the lead manager [2] Group 3: Company Overview - Trevi Therapeutics is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [5] - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough hypersensitivity [5]

Core Viewpoint - Trevi Therapeutics announced positive results from a human abuse potential study of oral nalbuphine, indicating lower "Drug Liking" compared to butorphanol, supporting its potential as a treatment for chronic cough in idiopathic pulmonary fibrosis and refractory chronic cough [1][2][5]. Study Results - The HAP study was a randomized, double-blind, placebo-controlled trial involving recreational drug users, assessing the peak effect for "Drug Liking" on a 100-point visual analog scale [2][8]. - Statistically significant lower "Drug Liking" was observed for oral nalbuphine doses of 81mg and 162mg compared to 6mg IV butorphanol, with p-values of p<0.0001 and p=0.0008 respectively [3]. - The mean Emax for "Drug Liking" was 71.2 for 81mg and 74.5 for 162mg oral nalbuphine, compared to 82.3 for butorphanol [3]. Secondary Endpoints - Secondary endpoints showed that oral nalbuphine also had higher scores for "Take Drug Again" and lower scores for "I Feel High" and "I Feel Good" compared to butorphanol, indicating a favorable profile [4]. - No serious adverse events were reported during the study, reinforcing the safety profile of oral nalbuphine [4]. Company Insights - Trevi Therapeutics is focused on developing Haduvio (oral nalbuphine ER) for chronic cough in patients with idiopathic pulmonary fibrosis and refractory chronic cough, addressing significant unmet medical needs [1][9]. - The company plans to report data from ongoing studies for chronic cough, emphasizing the potential of nalbuphine to meet health needs without the risks associated with traditional opioids [5][6]. Market Context - Chronic cough affects approximately 140,000 patients with idiopathic pulmonary fibrosis in the U.S., with a significant percentage experiencing debilitating symptoms [10]. - Refractory chronic cough impacts 2-3 million adults in the U.S., leading to various complications and a lack of approved therapies [11].

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) [1][4] - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough hypersensitivity [1][4] Market Need - Chronic cough is prevalent among approximately 140,000 IPF patients in the U.S., with up to 85% experiencing this symptom, leading to significant health impacts [2] - Patients with chronic cough may cough up to 1,500 times per day, which can worsen their disease and increase the risk of progression, death, or the need for lung transplants [2] - There are currently no approved therapies for chronic cough in IPF, and existing off-label treatments offer minimal benefits [2] Refractory Chronic Cough - Refractory chronic cough affects around 2-3 million adults in the U.S., caused by cough reflex hypersensitivity [3] - This condition is disruptive and can lead to complications such as urinary incontinence, sleep disruption, and social embarrassment, imposing significant social and economic burdens [3] - Similar to chronic cough in IPF, there are no approved therapies for RCC in the U.S. [3] Upcoming Events - Trevi Therapeutics will present at the Piper Sandler 36th Annual Healthcare Conference on December 4, 2024, at 1:00 p.m. ET, with additional investor meetings scheduled [1]

Financial Data and Key Metrics Changes - For Q3 2024, the company reported a net loss of $13.2 million, compared to a net loss of $7.7 million in Q3 2023, indicating a significant increase in losses [27] - R&D expenses rose to $11.2 million in Q3 2024 from $6.3 million in the same quarter of 2023, reflecting increased clinical development activities [27] - G&A expenses were $2.9 million in Q3 2024, slightly up from $2.7 million in Q3 2023, primarily due to increased stock-based compensation [28] - As of September 30, 2024, cash, cash equivalents, and marketable securities totaled $65.5 million, down from $83 million at the end of 2023 [28] - The company expects a cash burn of $41 million to $43 million for 2024, projecting a cash runway into the second half of 2026 [28] Business Line Data and Key Metrics Changes - The company is advancing clinical development for chronic cough and idiopathic pulmonary fibrosis (IPF), with significant upcoming data readouts expected [9][25] - The CORAL trial for IPF chronic cough is a Phase 2b study with 160 patients, and a sample size re-estimation is expected in December 2024 [17][19] - The RIVER trial for refractory chronic cough (RCC) is fully enrolled, with top-line data expected in Q1 2025 [21][24] Market Data and Key Metrics Changes - The RCC affects approximately 2 to 3 million U.S. adults, with a significant unmet need for approved therapies [21][22] - The company believes its unique mechanism of action could address the failures seen in previous RCC drug developments [22] Company Strategy and Development Direction - The company is focused on advancing late-stage development and preparing for NDA submissions, with a strong emphasis on addressing unmet medical needs in chronic cough and IPF [8][25] - The recent hiring of a Chief Development Officer with extensive experience in CNS therapies is expected to enhance the company's development capabilities [6][8] Management's Comments on Operating Environment and Future Outlook - Management highlighted the ongoing failures of competitors in both IPF and RCC, underscoring the need for new therapies [10] - The company anticipates a strong news flow in the upcoming months, representing important value inflection points [25] Other Important Information - The Human Abuse Potential (HAP) study is being conducted to meet FDA guidance, with results expected in December 2024 [11][15] - The company is preparing for an end-of-Phase 2 meeting with the FDA, which will include discussions on the HAP study results [44] Q&A Session Summary Question: Clarification on butorphanol drug liking and nalbuphine's HAP study - Management explained the complexity of the studies and the criteria for patient qualification, emphasizing the importance of differentiating nalbuphine from butorphanol in terms of abuse potential [31][34] Question: Sample size increase for SSRE - Management confirmed that the sample size for the SSRE could range from 160 to 400, depending on the actual data observed [38] Question: Balancing of RCC trial arms - Management assured that while the RCC trial arms may not be perfectly balanced, sufficient numbers exist for statistical analysis [40][42] Question: Timing of TIDAL respiratory physiology study - Management indicated that the TIDAL study is ongoing and aims to provide data by the end of the Phase 2 meeting in the second half of next year [48] Question: DEA decision timeline post-HAP results - Management clarified that the DEA's decision would follow the NDA submission and is not guaranteed to occur [52]

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 September 30, 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 ju ...

Exhibit 99.1 Trevi Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Updates Completed enrollment of the Phase 2a RIVER trial in refractory chronic cough (RCC) with topline results expected in the first quarter of 2025 Reached 50% enrollment for the Phase 2b CORAL trial in chronic cough in idiopathic pulmonary fibrosis (IPF), with sample size re-estimation outcome expected in December 2024 Ended the third quarter of 2024 with $65.5 million in cash, cash equivalents and marketab ...

Completed enrollment of the Phase 2a RIVER trial in refractory chronic cough (RCC) with topline results expected in the first quarter of 2025Reached 50% enrollment for the Phase 2b CORAL trial in chronic cough in idiopathic pulmonary fibrosis (IPF), with sample size re-estimation outcome expected in December 2024Ended the third quarter of 2024 with $65.5 million in cash, cash equivalents and marketable securities, with expected cash runway into the second half of 2026Management to host a conference call and ...

Conference call and webcast to be held at 4:30 p.m. ET NEW HAVEN, Conn., Oct. 30, 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 senior management will host a conference call and live audio webcast on Wednesday, November 6, 2024, at 4:30 p.m. ET, to prov ...