财务状况 - 公司第二季度现金、现金等价物和可流通证券为6950万美元，预计现金可持续到2026年[4] - 第二季度净亏损为1236万美元，较上年同期增加73%[10] 临床试验进展 - 公司正在进行的重要临床试验包括RCC的2a期RIVER试验和IPF慢性咳嗽的2b期CORAL试验[2][3][6][7] - RIVER试验目前已完成约80%的患者入组，预计在2024年第四季度公布顶线数据[6][7] - CORAL试验预计在2024年第四季度完成样本量重估，如无需调整样本量，预计在2025年上半年公布顶线结果[7] - 公司还在进行HAP研究和TIDAL生理学研究等支持性试验[7] 研发投入 - 第二季度研发费用为1000万美元，较上年同期增加72%，主要由于临床试验开支增加[8]

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. ...

Conference call and webcast to be held at 4:30 p.m. ET NEW HAVEN, Conn., Aug. 1, 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 Thursday, August 8, 2024, at 4:30 p.m. ET, to provide ...

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 ...

财务数据和关键指标变化 - 公司在2024年第一季度报告净亏损1090万美元,相比2023年同期的640万美元有所增加 [24] - 研发费用从2023年同期的500万美元增加到880万美元,主要是由于CORAL、RIVER和HAP试验的临床开发费用增加 [24] - 一般及管理费用从2023年同期的260万美元增加到310万美元,主要是由于信息技术、财务人员和活动以及专业费用的增加 [25] - 截至2024年3月31日,公司的现金、现金等价物和可流通证券总额为7280万美元,相比2023年12月31日的8300万美元有所下降 [26] 各条业务线数据和关键指标变化 - 公司正在推进治疗难治性慢性咳嗽(RCC)和特发性肺纤维化(IPF)慢性咳嗽的临床开发计划 [8] - RCC的RIVER II期a期试验预计今年下半年完成,该试验将评估Haduvio对咳嗽频率的影响 [10][11][12] - IPF慢性咳嗽的CORAL II期b期剂量范围研究试验预计今年下半年完成样本量重估分析,全面结果预计2025年上半年公布 [15] 各个市场数据和关键指标变化 - 目前美国没有批准的RCC治疗药物,存在巨大的未满足和紧迫的需求 [9] - IPF患者约85%会出现慢性咳嗽,对患者的身心和社会生活造成严重影响,也可能加重IPF的病情进展 [13][14] 公司战略和发展方向及行业竞争 - 公司认为Haduvio的作用机制可以在更多患者中发挥作用,并可能在基线咳嗽计数较高的患者中产生更强的疗效 [9] - 公司正在推进Haduvio在RCC和IPF慢性咳嗽适应症的临床开发,希望通过这些试验为Haduvio在慢性咳嗽领域的发展道路提供重要信息 [20] - 公司正在与FDA就Haduvio的滥用潜力研究进行沟通,希望能够保持口服Haduvio不被列管 [17][18] 管理层对经营环境和未来前景的评论 - 公司认为Haduvio的作用机制可以在更多患者中发挥作用,并可能在基线咳嗽计数较高的患者中产生更强的疗效 [9] - 公司对即将完成的临床试验结果感到兴奋,认为这些数据将有助于指导Haduvio在慢性咳嗽适应症的未来发展 [20] - 公司正在与FDA就Haduvio的滥用潜力研究进行沟通,希望能够保持口服Haduvio不被列管 [17][18] 问答环节重要的提问和回答 问题1 **Leland Gershell 提问** 关于即将在ATS会议上发表的CANAL研究中关于咳嗽发作的分析,公司如何定义咳嗽发作,以及这对IPF患者有何影响 [29] **Jennifer Good 和 David Clark 回答** - 目前业界还没有统一的咳嗽发作定义,不同专家使用不同的标准 [30][31][34][35] - 公司将在会议上听取两位专家使用不同方法进行的分析结果 [31][33] - 咳嗽发作可能对患者造成更大的伤害,因此研究这一指标很重要 [30] 问题2 **Jack Padovano 提问** 如果CORAL试验的样本量重估分析时已经达到统计学显著性,公司是否会提前终止试验 [43] 此外,如果Haduvio在IPF慢性咳嗽中显示出强大的疗效,公司是否可以直接进入III期试验 [46] **David Clark 和 Jennifer Good 回答** - 样本量重估分析的目的是确认假设是否合理,而不是评估疗效是否达标 [46][47] - 即使疗效很强,公司也需要进行II期剂量探索试验,再进入III期关键试验 [48][49] 问题3 **Nathanael Charoensook 提问** RIVER试验为何选择21天的疗程,而其他晚期试验通常为12-24周 [53] 此外,公司是否会评估不同基线咳嗽严重程度患者的疗效差异 [54] **Jennifer Good 和 David Clark 回答** - II期a期试验通常采用交叉设计的短期试验,为验证药物概念提供依据 [54] - 公司之前的CANAL研究数据显示,基线咳嗽严重程度并未影响Haduvio的疗效 [57] - 公司将分析不同基线咳嗽严重程度患者的疗效变化,并评估其他指标如咳嗽发作 [58][61]

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 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 re fractory 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 ...

Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q4 2023 Earnings Conference Call March 20, 2024 4:30 PM ET Company Participants Jennifer Good - President & CEO Lisa Delfini - CFO David Clark - Chief Medical Officer Conference Call Participants Leland Gershell - Oppenheimer Serge Belanger - Needham & Company Operator Good afternoon, and welcome to the Trevi Therapeutics Fourth Quarter and Year-End 2023 Earnings Conference Call. At this time, all participants will be in listen-only mode. [Operator Instructions] 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, 2023 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 ...

Exhibit 99.1 Trevi Therapeutics Reports Fourth Quarter and Year End 2023 Financial Results and Provides Business Updates Reaffirms guidance for the Phase 2a RIVER trial of Haduvio in RCC patients with topline data expected in the second half of 2024 Enrollment progressing in the Phase 2b CORAL dose-ranging trial of Haduvio for the treatment of chronic cough in IPF patients Human Abuse Potential Study more than 50% enrolled Management to host a conference call and webcast today at 4:30 p.m. ET New Haven, Con ...