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Trevi Therapeutics Inc (TRVI)
NASDAQ:TRVI
US Market
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Trevi Therapeutics (TRVI) AI Stock Analysis

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TRVI

Trevi Therapeutics

(NASDAQ:TRVI)

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Neutral 55 (OpenAI - 4o)
Rating:55Neutral
Price Target:
Trevi Therapeutics shows promise with significant clinical progress and a strong cash position, essential for sustaining operations in a pre-revenue phase. However, ongoing financial losses and valuation risks temper the outlook. The stock's technical indicators suggest strong momentum, but investors should be cautious due to potential volatility and financial risks inherent in early-stage biotechnology companies.
Positive Factors
Clinical Progress
Significant clinical progress with positive data readouts enhances the potential for regulatory approval and future commercialization of Haduvio.
Financial Stability
A strong cash position provides a runway into 2026, ensuring the company can fund its operations and clinical trials without immediate financial stress.
Regulatory Pathway
Engagement with the FDA for an End-of-Phase 2 meeting indicates progress towards regulatory approval, a critical step for market entry.
Negative Factors
Increased Net Loss
Rising net losses due to increased R&D expenses highlight financial strain, which could impact long-term sustainability if not managed.
Higher R&D Expenses
Escalating R&D costs, while necessary for development, increase financial pressure and require continued capital access to maintain operations.
Negative Cash Flow
Negative cash flow from operations necessitates reliance on external financing, posing a risk if future funding becomes challenging.

Trevi Therapeutics (TRVI) vs. SPDR S&P 500 ETF (SPY)

Trevi Therapeutics Business Overview & Revenue Model

Company DescriptionTrevi Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. The company is developing Haduvio, an oral extended-release formulation of nalbuphine, which is in phase IIb/III clinical trial for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis. 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.
How the Company Makes MoneyTrevi Therapeutics primarily makes money through the development and potential commercialization of its lead product candidate, Haduvio. Revenue is anticipated to be generated from product sales once Haduvio receives regulatory approval and is launched in the market. The company may also explore partnerships and licensing agreements with larger pharmaceutical companies to enhance its distribution capabilities and reach. Additionally, Trevi might earn revenue from milestone payments or royalties associated with such partnerships. However, as a clinical-stage company, Trevi Therapeutics currently does not have any products on the market and relies on funding from investors to support its research and development activities.

Trevi Therapeutics Earnings Call Summary

Earnings Call Date:Nov 13, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 25, 2026
Earnings Call Sentiment Positive
The earnings call was largely positive, with Trevi Therapeutics reporting successful trial data, financial stability, and strategic plans to expand their market opportunities. Although there were some financial losses and regulatory challenges, the company's advancements and cash reserves suggest a promising outlook.
Q3-2025 Updates
Positive Updates
Successful Data Readouts and Funding
Trevi Therapeutics reported positive data readouts from the CORAL trial for chronic cough in IPF patients and the RIVER trial for refractory chronic cough. They raised approximately $100 million in June, providing cash runway into 2028.
Progress in Clinical Trials
Trevi has completed important Phase I studies for their IPF cough program and received no clinically meaningful changes in drug interactions. They also reported no safety signals in a sentinel cohort of their TITLE study.
Financial Stability
As of September 30, 2025, Trevi's cash and investments totaled approximately $195 million, sufficient to fund multiple Phase III trials and ongoing studies.
Market Expansion Opportunities
Trevi plans to initiate studies in non-IPF ILD, potentially doubling the market opportunity for their chronic cough treatments.
Negative Updates
Net Loss Reported
Trevi reported a net loss of $11.8 million for Q3 2025, though this was an improvement over the $13.2 million loss in Q3 2024.
Ongoing Challenges with Regulatory Compliance
Increased professional fees were incurred due to preparation for SOC 404 compliance, indicating ongoing regulatory challenges.
Company Guidance
During Trevi Therapeutics' third quarter 2025 earnings call, CEO Jennifer Good highlighted several key developments and financial metrics. The company successfully raised approximately $100 million in June, providing a cash runway into 2028 to support its robust pipeline, including the advancement of clinical studies for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Trevi reported a net loss of $11.8 million for the quarter, an improvement from the $13.2 million loss in the same period last year, primarily due to decreased R&D expenses, which fell to $10.1 million. With cash and investments totaling around $195 million as of September 30, 2025, Trevi is positioned to fund two Phase III trials of Hiduveo for IPF chronic cough, alongside other clinical initiatives. The company is actively preparing for several trials in the first half of next year, with plans to initiate a Phase 2b/3 trial for non-IPF interstitial lung diseases (ILD) and a study for RCC. This strategic progression underscores Trevi's commitment to advancing its therapies and creating shareholder value.

Trevi Therapeutics Financial Statement Overview

Summary
Trevi Therapeutics is in a typical growth stage for a biotech company, with no revenue and reliance on external financing for operations. While the strong cash position and low debt levels are positives, the ongoing operating losses and negative cash flow highlight the financial risks associated with pre-revenue biotech firms. Continued access to capital will be crucial for its long-term viability.
Income Statement
10
Very Negative
The company has consistently reported zero revenue over the past years, which is typical for early-stage biotechnology firms focusing on R&D. However, this leads to negative net income and operating losses, reflected in the negative EBIT and EBITDA. The lack of revenue growth and persistent losses are significant weaknesses.
Balance Sheet
50
Neutral
Trevi Therapeutics maintains a strong cash position relative to its debt, indicating good liquidity. The debt-to-equity ratio is low, suggesting limited reliance on debt financing. However, the equity ratio has been declining, indicating increasing liabilities relative to assets, which could be a risk if unaddressed.
Cash Flow
30
Negative
The company has negative free cash flow, primarily due to its operating losses, which is common in the biotechnology industry during the development phase. Despite this, cash flow from financing remains positive, suggesting reliance on external funding to sustain operations. This presents a risk if future financing becomes less accessible.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit-38.00K-147.00K0.000.00-50.00K-47.00K
EBITDA-45.74M-47.79M-28.58M-27.98M-32.71M-32.27M
Net Income-45.86M-47.91M-29.07M-29.15M-33.94M-32.76M
Balance Sheet
Total Assets199.36M110.90M89.40M123.02M38.48M47.13M
Cash, Cash Equivalents and Short-Term Investments194.93M107.62M82.97M120.51M36.83M45.00M
Total Debt823.00K1.03M1.34M9.18M14.63M14.21M
Total Liabilities9.57M11.26M6.86M15.56M21.40M19.85M
Stockholders Equity189.79M99.64M82.55M107.46M17.07M27.28M
Cash Flow
Free Cash Flow-44.03M-38.29M-31.85M-28.33M-28.95M-29.03M
Operating Cash Flow-44.01M-38.26M-31.71M-28.18M-28.95M-29.00M
Investing Cash Flow-87.37M-21.53M59.43M-107.37M0.00-32.00K
Financing Cash Flow172.20M61.48M-7.91M111.31M20.77M16.72M

Trevi Therapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price13.35
Price Trends
50DMA
10.78
Positive
100DMA
9.19
Positive
200DMA
7.61
Positive
Market Momentum
MACD
0.72
Negative
RSI
73.75
Negative
STOCH
87.56
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For TRVI, the sentiment is Positive. The current price of 13.35 is above the 20-day moving average (MA) of 11.80, above the 50-day MA of 10.78, and above the 200-day MA of 7.61, indicating a bullish trend. The MACD of 0.72 indicates Negative momentum. The RSI at 73.75 is Negative, neither overbought nor oversold. The STOCH value of 87.56 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for TRVI.

Trevi Therapeutics Risk Analysis

Trevi Therapeutics disclosed 74 risk factors in its most recent earnings report. Trevi Therapeutics reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Trevi Therapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
55
Neutral
$1.32B-25.81-36.87%15.84%
54
Neutral
$4.48B-14.43-75.20%364.98%-25.33%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
48
Neutral
$1.24B-180.24%-32.79%36.87%
47
Neutral
$1.17B-86.51%103.75%33.84%
45
Neutral
$2.71B-52.49%1137.19%70.51%
43
Neutral
$1.04B-39.73%4.29%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
TRVI
Trevi Therapeutics
13.70
11.10
426.92%
NKTR
Nektar Therapeutics
57.13
41.83
273.40%
WVE
Wave Life Sciences
7.14
-7.30
-50.55%
ORIC
Oric Pharmaceuticals
10.98
1.42
14.85%
NUVB
Nuvation Bio
8.37
5.60
202.17%
PRAX
Praxis Precision Medicines
186.15
118.02
173.23%
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Mar 22, 2025