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Trevi Therapeutics, Inc.

Trevi Therapeutics, Inc.

NASDAQ•TRVI
CEO: Ms. Jennifer L. Good
Sector: Healthcare
Industry: Biotechnology
Listing Date: 2019-05-07
Trevi Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of therapy Haduvio for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) conditions targeting the central and peripheral nervous systems. The company is developing Haduvio, an oral extended-release formulation of nalbuphine, which is in phase 2b Cough Reduction in IPF with nalbuphine ER (CORAL) clinical trial for treatment of chronic cough in patients with IPF; phase 2a Refractory Chronic Cough Improvement Via NAL ER (RIVER) clinical trial for reducing chronic cough in RCC patients; phase 2 clinical trial in patients with pruritus; phase 2b/3 clinical trial in patients with prurigo nodularis. It has a license agreement with Endo Pharmaceuticals Inc. to develop and commercialize products incorporating nalbuphine hydrochloride in any formulation. The company was incorporated in 2011 and is headquartered in New Haven, Connecticut.
Contact Information
195 Church Street, 16th Floor, New Haven, CT, 06510, United States
203-304-2499
www.trevitherapeutics.com
Market Cap
$1.82B
P/E (TTM)
-44.8
42.6
Dividend Yield
--
52W High
$14.39
52W Low
$2.36
52W Range
98%
Rank67Top 91.5%
1.8
F-Score
Modified Piotroski Analysis
Based on 9-year fundamentals
Weak • 1.8 / 9 points
Scoring Range (0-9)
8-9: Excellent Value
6-7: Strong Fundamentals
4-5: Average Quality
0-3: Weak Performance
Data Period: 2016-2024

Financial Dashboard

Q3 2025 Data

Revenue

$0.00+0.00%
4-Quarter Trend

EPS

-$0.08-38.46%
4-Quarter Trend

FCF

-$10.89M+13.98%
4-Quarter Trend

2025 Q3 Earnings Highlights

Key Highlights

Strong Financing Cash Inflow Net cash from financing activities totaled $120.7M, driven by June 2025 offering, boosting cash reserves to $56.9M.
Positive Phase 2b Trial Results CORAL trial met primary endpoint; 108 mg BID dose showed 60.2% reduction in 24-hour cough frequency versus placebo.
Net Loss Narrows Significantly Nine months net loss reduced to $34.4M from $36.5M, reflecting lower R&D spending compared to the prior year period.
Extended Cash Runway Forecast Total cash and marketable securities reached $193.9M, expected to fund operations and capital needs into fiscal year 2028.

Risk Factors

Need Substantial Future Funding Substantial expenditures expected for Phase 3 trials; failure to raise capital timely could delay or force abandonment of development.
Increased Operating Cash Burn Operating activities used $34.5M cash in nine months, up from $28.7M last year, increasing cash burn rate significantly.
Sole Product Candidate Dependency Business success relies entirely on Haduvio development, regulatory approval, and commercialization across IPF, non-IPF ILD, and RCC.
Opioid Class Label Warning Risk Active ingredient carries opioid class warning; potential for restrictive marketing or distribution regulations if applied to Haduvio.

Outlook

Key FDA Meeting Scheduled Planning End-of-Phase 2 meeting with FDA in Q4 2025; Phase 3 initiation for IPF expected in the first half of 2026.
Advance Multiple Clinical Programs Plan to initiate Phase 3 IPF trial and Phase 2b RCC trial in 2026, alongside ongoing TIDAL respiratory function study.
R&D Expenses Decreasing Nine month R&D expenses fell to $27.3M from $30.0M due to completion of several active Phase 2 clinical trials.
G&A Costs Increasing General and administrative expenses rose $2.6M for nine months, driven by personnel costs and SOX 404(b) compliance preparation.

Peer Comparison

Revenue (TTM)

Zymeworks Inc.ZYME
$134.48M
+116.2%
Syndax Pharmaceuticals, Inc.SNDX
$111.55M
+574.6%
Immatics N.V.IMTX
$93.54M
-26.7%

Gross Margin (Latest Quarter)

Nanobiotix S.A.NBTX
100.0%
+0.0pp
Immatics N.V.IMTX
100.0%
+0.0pp
Syndax Pharmaceuticals, Inc.SNDX
95.4%
-4.6pp

Key Metrics

Symbol
Market Cap
P/E (TTM)
ROE (TTM)
Debt to Assets
SYRE$2.09B-80.5-31.2%0.0%
ZYME$1.95B-0.1-24.5%4.8%
TRVI$1.82B-44.8-31.2%0.4%

Long-Term Trends

Last 4 Quarters
Revenue
Net Income
Operating Cash Flow
4Q Revenue CAGR
N/M
Revenue Volatile
4Q Net Income CAGR
N/M
Profitability Shift
Cash Flow Stability
0%
Cash Flow Needs Attention

Research & Insights

Next earnings:Mar 17, 2026
|
EPS:-$0.11
|
Revenue:-
Reports
All Years

  • Form 10-Q - Q3 2025

    Period End: Sep 30, 2025|Filed: Nov 13, 2025|
    Revenue: $0.00+0.0%
    |
    EPS: $-0.08-38.5%
    N/A

  • Form 10-Q - Q2 2025

    Period End: Jun 30, 2025|Filed: Aug 7, 2025|
    Revenue: $0.00+0.0%
    |
    EPS: $-0.09-21.3%
    N/A

  • Form 10-Q - Q1 2025

    Period End: Mar 31, 2025|Filed: May 8, 2025|
    Revenue: $0.00+0.0%
    |
    EPS: $-0.09-20.1%
    N/A

  • Form 10-K - FY 2024

    Period End: Dec 31, 2024|Filed: Mar 18, 2025|
    Revenue: $0.00+0.0%
    |
    EPS: $-0.47-62.1%
    N/A

  • Form 10-Q - Q3 2024

    Period End: Sep 30, 2024|Filed: Nov 6, 2024|
    Revenue: $0.00+0.0%
    |
    EPS: $-0.13+67.7%
    N/A

  • Form 10-Q - Q2 2024

    Period End: Jun 30, 2024|Filed: Aug 8, 2024|
    Revenue: $0.00+0.0%
    |
    EPS: $-0.12+65.7%
    N/A

  • Form 10-Q - Q1 2024

    Period End: Mar 31, 2024|Filed: May 7, 2024|
    Revenue: $0.00+0.0%
    |
    EPS: $-0.11+69.5%
    N/A

  • Form 10-K - FY 2023

    Period End: Dec 31, 2023|Filed: Mar 20, 2024|
    Revenue: $0.00+0.0%
    |
    EPS: $-0.29+35.6%
    N/A