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- **Clinical Momentum**: Positive DDI and TIDAL results support Phase III启动 for IPF慢性咳嗽，2026年上半年启动非IPF-ILD和RCC试验。
- **财务稳健**：$195M现金，支持至2028年开发，Q3净亏损收窄至$11.8M。
- **战略亮点**：孤儿药指定请求中；Phase III设计优化剂量滴定以减少副作用；CHEST会议显示医生对治疗未满足咳嗽需求的强烈兴趣。
- **市场扩展**：非IPF-ILD患者群是IPF的两倍，计划与IPF共用临床和商业化资源。

**【CEO Opening Remarks】**
- Presented positive data from CORAL (IPF chronic cough) and RIVER (refractory chronic cough) trials at CHEST 2025, generating strong interest from pulmonologists.
- Secured $115M in June, providing cash runway into 2028 to support Phase III programs.
- Completed Phase I studies: DDI with antifibrotics (no PK issues) and TIDAL (no respiratory safety signals in IPF patients).
- Planning end-of-Phase II meeting with FDA for IPF chronic cough Phase III design.
- Expanding into non-IPF-ILD (228,000 patients) and RCC Phase IIb in H1 2026.

**【Clinical Updates】**
- **IPF Program**: DDI study showed no clinically meaningful interactions; TIDAL interim data safe, with DSMB approval to complete enrollment. Phase III expected to start H1 2026.
- **Non-IPF-ILD**: Will align with IPF trial design, targeting similar cough criteria (≥10 coughs/hour) and lung fibrosis.
- **RCC**: Planning Phase IIb dose-ranging study in H1 2026.

**【Financial Results】**
- Q3 2025: Net loss $11.8M (vs. $13.2M YoY). R&D: $10.1M (-9% YoY) due to reduced clinical activity. G&A: $3.8M (+31% YoY) for SOX compliance.
- Cash: $195M as of Sep 30, 2025, supporting 2 Phase III trials, non-IPF-ILD Phase IIb, and long-term extension studies.

**【Q&A Highlights】**
- **Regulatory Strategy**: Will request orphan drug designation post-Phase II meeting. Phase III design includes 54mg BID (titrated from 27mg) to minimize AE risk.
- **Market Feedback**: CHEST meeting showed high physician interest in addressing unmet cough need in ILD patients.
- **Safety Monitoring**: Long-term (52-week) safety data collection planned for Phase III.
- **Global Expansion**: Phase III sites to include US, Canada, and Europe, leveraging existing ILD networks.

Trevi Therapeutics, Inc. (TRVI) Q3 2025 Earnings Call Transcript

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