Trevi Therapeutics, Inc. (TRVI)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 net loss improved to $11.8M vs. $13.2M in Q3 2024, driven by lower R&D and higher interest income; G&A stepped up with SOX 404(b) readiness .
• Cash, cash equivalents and marketable securities were $194.9M with runway into 2028; management reiterated preparations to request End-of-Phase 2 meeting in Q4 and to initiate IPF chronic cough Phase 3 in H1 2026 .
• EPS was ($0.08) vs. Wall Street consensus of ($0.10)*, a modest beat; revenue remained at $0 as the company is clinical-stage and reported operating expenses with no revenue line item .
• Stock reaction catalysts: FDA End-of-Phase 2 (minutes ~30 days post-meeting), TIDAL respiratory safety data inclusion, and launch preparations for multiple trials (IPF Phase 3, non-IPF ILD, RCC Phase 2b) in H1 2026 .

What Went Well and What Went Wrong

What Went Well

• No safety signals in the sentinel cohort of the IPF respiratory function and safety (TIDAL) study; approval to complete enrollment with data to be included in the End-of-Phase 2 package .
• Phase 1 drug–drug interaction study with pirfenidone or nintedanib showed no clinically meaningful PK interactions, supporting concomitant use with antifibrotics .
• Cash balance and interest income supported Other Income rising to $2.1M, helping narrow net loss QoQ/YoY .
• “We are on track to submit our End-of-Phase 2 meeting request to the FDA in the fourth quarter… Our overall corporate strategy is built on a clear path for growth” — Jennifer Good, CEO .

What Went Wrong

• G&A increased to $3.8M vs. $2.9M YoY, reflecting higher professional fees and SOX 404(b) readiness costs, raising opex despite lower R&D .
• Cash runway updated to “into 2028,” down from “into 2029” communicated post-June financing, reflecting updated development program timing/costs .
• Continued clinical-stage status with no product revenue; operating expenses remain the key P&L driver and create ongoing net losses .

Financial Results

Notes: The company reported operating expenses and losses without presenting a revenue line item; Q3 loss from operations equaled total operating expenses, consistent with no reported revenue .

Estimates vs. Actuals

Values retrieved from S&P Global.*

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We have been executing on the studies necessary to advance our IPF chronic cough program and are on track to submit our End-of-Phase 2 meeting request to the FDA in the fourth quarter.” — Jennifer Good, CEO .
• “No clinically meaningful changes in the pharmacokinetics… when nalbuphine ER was co-administered with pirfenidone or nintedanib.” — Prepared remarks .
• “A planned review… concluded that there were no safety signals… approval to complete enrollment [for TIDAL].” — Prepared remarks .
• “As of September 30, 2025, our cash and investments totaled approximately $195 million… runway into 2028… fund two Phase 3 trials in IPF, a non-IPF ILD program, RCC trial, and supportive Phase 1 studies.” — Jennifer Good .
• “Fifty-four milligram BID will be our top dose going forward… 27 mg BID as titration… extend titration to mitigate early GI/CNS AEs.” — James Cassella, CDO .

Q&A Highlights

• Inclusion/Exclusion for non-IPF ILD: Entry criteria to focus on cough burden (e.g., ~10 coughs/hour) and lung fibrosis with broad inclusion; minimal carve-outs anticipated .
• Additional DDI work: Expect further Phase 1 DDI with CYP2C9/CYP2C19 inhibitors; concomitant opioids contraindicated due to mu antagonism .
• IPF dose selection and titration: 54 mg BID selected; titration extended to reduce early AEs; antifibrotic background therapy allowed (~80% in CORAL) .
• Orphan strategy: Plan to request orphan drug designation for IPF cough post-EoP2 to avoid distraction in the meeting; label will contraindicate concurrent opioids .
• Competitive/macro: New IPF treatments (e.g., Teton data) seen as complementary; cough therapy considered first/second-line and concomitant with antifibrotics; potential market growth from better diagnosis .

Estimates Context

• Q3 2025 EPS was ($0.08) vs. Wall Street consensus of ($0.10), a ~$0.02 beat; revenue consensus was $0.0, consistent with clinical-stage status and reported operating-only P&L .
• With higher Other Income and lower R&D YoY, results modestly outperformed expectations; estimate revisions may reflect updated opex trajectory and cash runway into 2028 .

Values retrieved from S&P Global.*

Key Takeaways for Investors

• Regulatory inflection approaching: EoP2 meeting request in Q4, with minutes ~30 days later; a constructive outcome could catalyze the stock ahead of H1 2026 Phase 3 initiation .
• Clinical de-risking: Clean TIDAL sentinel data and no DDI findings with standard antifibrotics reduce regulatory/clinical risk for IPF cough Phase 3 .
• Dose clarity improves execution: 54 mg BID selected with extended titration to mitigate early AEs; consistent with CORAL learnings and expected tolerability profile .
• Portfolio breadth: Parallel advancement in non-IPF ILD and RCC (Phase 2b) broadens TAM and supports multi-indication strategy; non-IPF ILD shares common biology/endpoints with IPF .
• Financial runway: ~$195M cash/investments support planned trials into 2028; watch G&A trajectory with SOX 404(b) readiness and the runway shift vs. Q2 communication .
• Near-term events: CHEST presentations completed; expect TIDAL completion Q4 data for EoP2 package, additional DDI Phase 1 planning, and trial site/vendor setup for 2026 starts .
• Trading lens: A positive EoP2 read-through (protocol alignment, safety database clarity) and Phase 3 start visibility are likely the primary narrative movers in the next 1–2 quarters .