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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)

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 Trials
Haduvio has demonstrated impressive placebo-adjusted reductions in cough across multiple clinical studies.
Financial Stability
TRVI has a cash position of $204mn, providing a financial runway into 2029 and supporting multiple upcoming trials.
Market Opportunities
Trevi's Haduvio is seen as a multi-billion dollar opportunity, addressing significant treatment gaps in chronic cough.
Negative Factors
Competitive Landscape
The clinical development program for Haduvio has established a differentiated profile versus competitors.
Regulatory Challenges
The company anticipates moving towards Phase 3 initiation in IPF, contingent on results from the respiratory depression study and an end-of-Phase-2 meeting with the FDA.

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:Aug 07, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 05, 2025
Earnings Call Sentiment Positive
The earnings call was largely positive, highlighting successful trial results, a strong financial position, and clear plans for future clinical development. While there were increased expenses and a reported net loss, these were balanced by significant achievements and forward-looking strategies.
Q2-2025 Updates
Positive Updates
Successful Data Readouts
Positive data readouts from both the CORAL trial for chronic cough in IPF patients and the RIVER trial for RCC patients, leading to significant progress in clinical development.
Strong Financial Position
Raised approximately $115 million, resulting in total cash and investments of approximately $204 million as of June 30, 2025, providing a solid financial runway into 2029.
CORAL Trial Success
The CORAL trial met the primary endpoint with statistically significant reduction in 24-hour cough frequency and significant improvements in quality of life assessments using the Leicester Cough Questionnaire.
Planned Phase III Trials
Plans to initiate Phase III trials for chronic cough in IPF patients and a study for non-IPF interstitial lung diseases, expanding the potential market.
Advancement in Drug-Drug Interaction Studies
Ongoing Phase I studies, including a drug-drug interaction study, are expected to provide crucial data for the end of Phase II meeting with the FDA.
Negative Updates
Net Loss Reported
Reported a net loss of $12.3 million for Q2 2025, although slightly improved from the $12.4 million loss in Q2 2024.
Increased General and Administrative Expenses
G&A expenses increased to $4.3 million during Q2 2025, primarily due to professional fees and increased headcount, with expectations of similar expenses in the second half of 2025.
Company Guidance
During the Trevi Therapeutics Second Quarter 2025 Earnings Conference Call, significant guidance was provided concerning the company's clinical and financial outlook. Trevi raised approximately $115 million in capital, resulting in a total cash and investment balance of around $204 million as of June 30, 2025, providing a financial runway into 2029. The company plans to initiate several clinical trials, including two Phase III trials for Haduvio in chronic cough associated with idiopathic pulmonary fibrosis (IPF) and a separate trial for non-IPF interstitial lung disease cough, projected to launch in the first half of 2026. The CORAL trial produced positive results, showing significant reductions in 24-hour cough frequency and improvements in quality of life as measured by the Leicester Cough Questionnaire. Additionally, discussions with the FDA for an end-of-Phase II meeting are expected in the fourth quarter of 2025 to finalize the Phase III program plans. Financially, Trevi reported a net loss of $12.3 million for Q2 2025, with R&D expenses slightly decreasing to $9.4 million and G&A expenses increasing to $4.3 million, mainly due to rising professional fees and headcount.

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 Revenue146.00K0.000.000.000.000.00
Gross Profit-38.00K-147.00K-123.00K-43.00K-50.00K-47.00K
EBITDA-49.79M-47.79M-33.80M-28.02M-32.71M-32.27M
Net Income-47.30M-47.91M-29.07M-29.15M-33.94M-32.76M
Balance Sheet
Total Assets208.34M110.90M89.40M123.02M38.48M47.13M
Cash, Cash Equivalents and Short-Term Investments203.88M107.62M82.97M120.51M36.83M45.00M
Total Debt891.00K1.03M1.34M9.18M14.63M14.21M
Total Liabilities9.85M11.26M6.86M15.56M21.40M19.85M
Stockholders Equity198.49M99.64M82.55M107.46M17.07M27.28M
Cash Flow
Free Cash Flow-42.69M-38.29M-31.85M-28.33M-28.95M-29.03M
Operating Cash Flow-42.68M-38.26M-31.71M-28.18M-28.95M-29.00M
Investing Cash Flow-28.77M-21.53M59.43M-107.37M0.00-32.00K
Financing Cash Flow175.54M61.48M-7.91M111.31M20.77M16.72M

Trevi Therapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price7.23
Price Trends
50DMA
7.00
Positive
100DMA
6.67
Positive
200DMA
5.53
Positive
Market Momentum
MACD
0.04
Positive
RSI
48.43
Neutral
STOCH
10.62
Positive
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 7.23 is below the 20-day moving average (MA) of 7.40, above the 50-day MA of 7.00, and above the 200-day MA of 5.53, indicating a neutral trend. The MACD of 0.04 indicates Positive momentum. The RSI at 48.43 is Neutral, neither overbought nor oversold. The STOCH value of 10.62 is Positive, 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
67
Neutral
$1.02B-3.40%22.68%42.45%
55
Neutral
$885.32M-35.74%-8.46%
55
Neutral
$441.94M-66.85%-95.24%-493.05%
51
Neutral
$7.92B-0.43-41.69%2.21%22.29%-1.85%
48
Neutral
$793.76M-34.71%17.87%41.27%
44
Neutral
$590.46M-343.83%304.17%29.37%
40
Underperform
$348.53M-69.65%10.36%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
TRVI
Trevi Therapeutics
7.01
4.06
137.63%
PRTA
Prothena
8.55
-11.78
-57.94%
RCKT
Rocket Pharmaceuticals
3.28
-15.23
-82.28%
ANAB
AnaptysBio
21.09
-14.81
-41.25%
DNTH
Dianthus Therapeutics
26.50
-0.12
-0.45%
PHAR
Pharming Group
15.26
8.18
115.54%
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