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- **Phase III Trial Milestones**: Initiation of two pivotal trials in Q2 2026, targeting 300+ and 130 patients for IPF-related chronic cough.
- **Market Expansion**: Addressing ~378,000 chronic cough patients across IPF and non-IPF ILD, with adaptive trial design for non-IPF ILD.
- **Financial Strength**: $188M cash runway into 2028, supporting clinical execution without immediate capital needs.
- **FDA Alignment**: Clear path for NDA submission with Phase III data, including safety and efficacy endpoints.

**【CEO Summary Section】**
- **FDA Alignment and Trial Initiation**: Trevi secured FDA agreement for a Phase III program in IPF-related chronic cough, with two trials (52-week and 12-week) set to begin in Q2 2026. The 52-week trial will enroll ~300 patients, while the 12-week trial will include ~130 patients.
- **Market Opportunity**: ~150,000 IPF patients in the U.S., with 2/3 suffering from uncontrolled cough. Non-IPF ILD patients (~228,000) represent a larger market for chronic cough.
- **Upcoming Events**: Investor & Analyst Day on May 7, 2026, and an ATS investor event on May 18, 2026, to discuss clinical and commercial strategies.

**【CFO Financial Commentary】**
- **Cash Position**: $188 million as of Q4 2025, providing runway into 2028 to fund key trials, including Phase IIb in RCC and pivotal Phase III in IPF-related chronic cough.
- **Capital Efficiency**: Trevi is well-positioned to execute clinical milestones without immediate capital needs, though ongoing capital management is a priority.

**【Q&A Key Highlights】**
- **Phase I Studies**: FDA requested standard label-enabling studies (e.g., drug-drug interactions, hepatic/renal impairment), which can be conducted in parallel with Phase III trials.
- **Adaptive Design for Non-IPF ILD**: Trevi plans an adaptive Phase IIb/III trial to confirm dose and efficacy, with potential NDA submission post-readout.
- **Orphan Drug Designation**: Application to be filed in 2026, though success is uncertain due to broader potential utility of ADUVIO.
- **Enrollment Expectations**: ~80-100 sites for the 52-week Phase III trial, targeting 1-year enrollment completion. Placebo response (~17%) is consistent with prior trials.
- **Regulatory Considerations**: No immediate need for additional Phase I DDI studies, though timing of new IPF therapies may influence future decisions.

Trevi Therapeutics, Inc.(TRVI)-20260318-2025 Q4 Earnings call transcript

- **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

- **CORAL trial success**: 54mg/108mg BID doses achieved 3.7/3.4-point LCQ improvements (p=0.01), with strong patient-reported quality of life gains.
- **$204M cash runway**: Supports 2 Phase III trials, non-IPF ILD expansion, and pre-commercial activities through 2029.
- **Phase III planning**: 54mg BID dose prioritized; FDA end-of-Phase II meeting Q4 2025 to align on trial design.
- **Market expansion**: Non-IPF ILD cough market doubles IPF opportunity (228K patients), with same pulmonologist network.

**【CEO Summary Section】**
- Trevi achieved a major inflection point in Q2 2025 with positive CORAL trial results for Haduvio in chronic cough (IPF), raising $115M in capital for a $204M cash runway into 2029.
- CORAL trial showed statistically significant 3.7/3.4-point LCQ improvements (p=0.01) at 54mg/108mg BID doses, with 24-hour cough frequency reduction. Patient feedback highlighted life-changing impact on daily activities.
- Phase III planning underway for IPF cough, with FDA end-of-Phase II meeting expected Q4 2025. Expansion into non-IPF ILD (228K patients) and RCC Phase IIb trials planned for H1 2026.

**【CFO Financial Commentary】**
- Q2 2025 net loss of $12.3M (flat vs. Q2 2024). R&D expenses decreased 6% to $9.4M due to completed trials, offset by G&A growth (+30%) to $4.3M (SOX compliance costs).
- $204M cash balance (including $115M June equity raise) funds 2 Phase III trials, non-IPF ILD study, and pre-commercial activities.

**【Q&A Key Highlights】**
- **Respiratory safety study**: 2 active sites, on track for FDA end-of-Phase II meeting. No expected impact on DEA scheduling.
- **Drug-drug interaction (DDI) study**: Evaluating nalbuphine with pirfenidone/nintedanib. No anticipated PK interactions but required for Phase III.
- **Phase III dose selection**: 54mg BID is "sweet spot" with strong efficacy/safety profile. FDA alignment sought on dose rationale and safety database requirements.
- **Commercial strategy**: U.S. pulmonologists will drive prescribing. No plans to partner U.S. rights; focused on Europe/Japan for potential partnerships.
- **Medical presentations**: IPF data to be presented at CHEST 2025 (October), RCC data at ERS 2025.

Trevi Therapeutics, Inc. (TRVI) Q2 2025 Earnings Call Transcript

- **Breakthrough Cough Data**: RIVER trial shows 57% cough reduction in RCC, first mechanism to work across RCC and IPF.
- **CORAL Trial Milestone**: Enrollment complete for IPF chronic cough, data expected Q2 2025 with potential ILD expansion.
- **FDA Supportive**: Timely guidance on Type C request, aligning on trial endpoints for chronic cough.
- **Strong Cash Position**: $103.3M runway to Q4 2026, supporting Phase 2b completion and strategic decisions.
- **Upcoming Catalysts**: ATS 2025 presentations and potential Phase 3 discussions post-CORAL readout.

**【CEO Business Update】**
- **RIVER Trial Success**: Phase 2a trial for RCC showed a 57% placebo-adjusted reduction in cough frequency (p < 0.0001), with all secondary endpoints statistically significant. This is the first mechanism to demonstrate efficacy across both RCC and IPF chronic cough.
- **CORAL Trial Progress**: Phase 2b trial for IPF chronic cough completed enrollment of 160 patients across 60 sites. Topline data expected this quarter, with plans for a basket trial in ILD if successful.
- **FDA Interaction**: Received timely guidance on a Type C request, highlighting FDA's ability to provide clarity despite regulatory challenges.
- **Upcoming Events**: Active presence at ATS 2025, including a KOL panel and investor dinner, with plans to share full RIVER data insights.

**【CFO Financial Highlights】**
- **Q1 2025 Financials**: Net loss of $10.4M (vs. $10.9M in Q1 2024), with R&D expenses down 12% to $7.8M due to reduced HAP study costs. G&A increased 19% to $3.7M due to headcount growth.
- **Cash Position**: $103.3M as of March 31, 2025, providing runway into Q4 2026. Funds allocated to CORAL trial completion and future development decisions.

**【Q&A Key Takeaways】**
- **CORAL Success Criteria**: Statistically significant efficacy and no new safety signals (AE discontinuation rate <10%).
- **FDA Pathway**: Positive Type C feedback suggests alignment on endpoints, with plans for Phase 3 discussions post-CORAL.
- **ILD Strategy**: Exploring crossover trial design, leveraging ILD patient overlap with chronic cough. Long-term safety plans include 52-week monitoring for NDA submission.
- **Partnership Outlook**: Open to ex-US collaborations, with US commercialization capabilities under evaluation.


Trevi Therapeutics, Inc. (TRVI) Q1 2025 Earnings Call Transcript

- **Clinical Success**: Trevi achieved three key clinical wins in 2024, including 57% cough reduction in RCC patients and successful trial power confirmation for IPF program.
- **Development Momentum**: Phase 2b IPF data expected Q2 2025, with potential FDA meeting by year-end; RCC expansion targeting treatment-failure patients.
- **Financial Strength**: $107.6M cash runway into 2026, supported by $50M equity raise in Dec 2024.
- **Market Differentiation**: Haduvio positioned to capture ~70% of RCC market (unmet need segment) if P2X3 antagonist approved.

**【CEO Key Highlights】**
- **2024 Clinical Milestones**: Trevi achieved three pivotal clinical readouts: positive HAP study results (showing lower drug liking vs. butorphanol), successful SSRE analysis confirming Phase 2b CORAL trial power, and RIVER trial demonstrating 57% placebo-adjusted cough reduction in RCC patients.
- **Haduvio Development Path**: 
  - IPF Lead Indication: Phase 2b CORAL data expected Q2 2025, with potential End-of-Phase 2 FDA meeting by year-end.
  - RCC Expansion: Planning next RCC trial post-FDA consultation, targeting treatment-failure patients (unmet need segment).
- **Regulatory Strategy**: NDA filing for IPF planned with safety database; RCC as SNDA leveraging existing IPF data.

**【CFO Financial Update】**
- **Q4 2024 Results**: Net loss of $11.4M (vs. $7.8M in 2023), driven by increased R&D spend ($9.3M vs. $6.5M) on CORAL, RIVER, and HAP trials.
- **Cash Position**: $107.6M as of Dec 2024, including $50M equity raise in Dec 2024. Cash runway extends into H2 2026, supporting CORAL and initial RCC trial.
- **2025 Cash Burn**: ~$12-14M/Q1-Q2, with flexibility for future trials based on data readouts.

**【Q&A Key Takeaways】**
1. **CORAL Enrollment Dynamics**: ~90% of patients enrolled in last two months, with consistent discontinuation rate (<10%) across study.
2. **RCC Market Positioning**: Targeting ~2M-3M RCC patients who fail prior therapies; P2X3 antagonist (e.g., Glaxo's drug) likely captures <30% of market, leaving high unmet need for Haduvio.
3. **Dose Optimization**: RIVER data suggests efficacy at 54mg BID, with potential for lower doses in IPF (e.g., 27mg BID) to minimize AE risk.
4. **Safety Database**: 6-12 month safety data from prior trials will inform NDA requirements, reducing need for large Phase 3 trials.
5. **2025 Events**: CORAL data (Q2), FDA meetings (IPF Q4, RCC TBD), and RIVER data presentations at ATS (May) and ERS (Sep).

Actual				-0.48	-0.41	-0.4	-0.52	-0.44	-0.49	-0.34	-0.28	-0.24	-0.14	-0.12	-0.06	-0.06	-0.07	-0.08	-0.08	-0.11	-0.12	-0.13	-0.11	-0.09	-0.09	-0.08	-0.06
Forecast				-0.44	-0.4825	-0.5125	-0.4433	-0.51	-0.475	-0.395	-0.295	-0.2633	-0.1725	-0.13	-0.106	-0.0739	-0.085	-0.0917	-0.0917	-0.0873	-0.1086	-0.1195	-0.1282	-0.123	-0.1042	-0.0983	-0.0966
Surprise	0.00%	0.00%	0.00%	-9.09%	+15.03%	+21.95%	-17.30%	+13.73%	-3.16%	+13.92%	+5.08%	+8.85%	+18.84%	+7.69%	+43.40%	+18.81%	+17.65%	+12.76%	+12.76%	-26.00%	-10.50%	-8.79%	+14.20%	+26.83%	+13.63%	+18.62%	+37.89%

Actual	--	--	--	0	0	0	0	--	--	--	--	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Forecast	--	--	--	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%

TRVI

TRVI fundamentals

TRVI Q4 2025 Earnings

Earnings Call

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TRVI

TRVI fundamentals

TRVI Q4 2025 Earnings

Earnings Call

TRVI Earnings Call Summary for Q4/20254:30 PM on Mar 17, 2026

TRVI Earnings Call Summary for Q3/20254:30 PM on Nov 13, 2025

TRVI Earnings Call Summary for Q2/20254:30 PM on Aug 7, 2025

TRVI Earnings Call Summary for Q1/20254:30 PM on May 8, 2025

TRVI Earnings Call Summary for Q4/20244:30 PM on Mar 18, 2025

You can ask Aime