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Tvardi Therapeutics (TVRD)
NASDAQ:TVRD

Tvardi Therapeutics (TVRD) AI Stock Analysis

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TVRD

Tvardi Therapeutics

(NASDAQ:TVRD)

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Underperform 38 (OpenAI - 4o)
Rating:38Underperform
Price Target:
$4.00
▲(0.50% Upside)
Cara Therapeutics' overall stock score is primarily impacted by its poor financial performance, characterized by declining revenues and negative profitability. The technical analysis also suggests a bearish trend, with the stock trading below major moving averages. Valuation metrics further reflect the company's financial struggles, with a negative P/E ratio and no dividend yield. While there are some positive developments in clinical trials, the recent setback in the Phase 2 trial underscores ongoing challenges.
Positive Factors
Strong Cash Position
Tvardi's strong cash position provides a solid runway to fund operations into late 2026, supporting ongoing R&D and strategic initiatives.
Pipeline Progress
Advancements in clinical trials for TTI-101 indicate potential breakthroughs in oncology and fibrosis treatments, enhancing long-term growth prospects.
Innovative Drug Development
The development of TTI-109 as a next-gen STAT3 inhibitor showcases Tvardi's innovation, potentially improving drug delivery and patient outcomes.
Negative Factors
Clinical Trial Setback
The failure of the Phase 2 IPF trial highlights challenges in clinical efficacy, potentially delaying product development and impacting market confidence.
Revenue Decline
The substantial revenue decline reflects ongoing struggles to achieve stable financial performance, affecting long-term sustainability and growth.
Negative Cash Flow
Persistent negative cash flow from operations suggests inefficiencies in cash conversion, posing risks to financial health and operational funding.

Tvardi Therapeutics (TVRD) vs. SPDR S&P 500 ETF (SPY)

Tvardi Therapeutics Business Overview & Revenue Model

Company DescriptionTvardi Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. Their lead candidate, TTI-101, is currently in Phase 2 clinical trials for idiopathic pulmonary fibrosis (IPF) and hepatocellular carcinoma (HCC).
How the Company Makes MoneyTvardi Therapeutics generates revenue primarily through the development and commercialization of its drug candidates. The company may receive funding through various mechanisms, including grants, equity financing, and strategic partnerships with larger pharmaceutical firms that provide financial support in exchange for future royalties or profit-sharing agreements. Additionally, Tvardi may generate revenue from licensing agreements for its drug candidates or technologies, as well as from milestone payments associated with the successful progression of its products through clinical trials and regulatory approvals. Ongoing research collaborations and partnerships can also contribute to the company's earnings by providing access to additional resources and expertise.

Tvardi Therapeutics Earnings Call Summary

Earnings Call Date:Mar 04, 2024
(Q4-2023)
|
% Change Since: |
Next Earnings Date:Aug 14, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted a strategic focus on a promising NP program with potential for significant clinical and commercial success. However, challenges with KORSUVA revenue and increased R&D expenses were notable concerns.
Q4-2023 Updates
Positive Updates
Focus on Notalgia Paresthetica
Cara Therapeutics has prioritized its program focusing on oral difelikefalin for notalgia paresthetica (NP), a chronic neuropathic condition with a significant unmet need. This strategic focus extends their cash runway into 2026.
Successful Phase II Study for NP
Phase II proof-of-concept study for oral difelikefalin showed statistically significant results in reducing itch in NP patients, with rapid enrollment in the Phase II/III COURAGE I study.
Strong Demand Growth for KORSUVA Injection
KORSUVA injection saw a 22% increase in demand quarter-to-quarter, reflecting its clinical benefit.
Financial Strategy Enhancements
Cara completed a financing transaction with Healthcare Royalty, bringing forward the value of ex-U.S. and Japan royalties in a nondilutive manner, strengthening their balance sheet.
Negative Updates
Challenges with KORSUVA Revenue
Despite demand growth, unfavorable reimbursement changes are expected to significantly restrict access to KORSUVA, leading to minimal revenue contributions.
Increased R&D Expenses
Research and development expenses increased to $28.4 million in Q4 2023, primarily due to clinical trial costs for late-stage development programs.
Decreased Cash Reserves
Cash, cash equivalents, and marketable securities decreased significantly from $156.7 million in 2022 to $1.8 million at the end of 2023, largely due to operating activities.
Company Guidance
In the earnings call for Cara Therapeutics, the company provided guidance focused on the development of oral difelikefalin for notalgia paresthetica (NP), prioritizing this program to extend their cash runway into 2026. They reported significant demand growth for KORSUVA injection, with a 22% increase in vial shipments in Q4 2023, although future revenue from KORSUVA is not expected to be substantial due to reimbursement changes. The company highlighted that 34 million U.S. adults suffer from chronic pruritus, with 650,000 diagnosed NP patients, noting the lack of approved therapies and the significant unmet need for effective treatment. The Phase II/III COURAGE I study for NP has completed enrollment ahead of schedule, with top-line results anticipated in Q3 2024. Financially, Cara reported $3 million in revenue for Q4 2023 and ended the year with $1.8 million in cash, cash equivalents, and marketable securities, after using $92.1 million in operating activities and securing $36.5 million from a financing transaction.

Tvardi Therapeutics Financial Statement Overview

Summary
Cara Therapeutics faces significant financial challenges, characterized by declining revenues, negative profitability, and weakening balance sheet strength. The persistent negative cash flows further exacerbate the risk profile, indicating a need for strategic adjustments to improve financial stability and investor confidence.
Income Statement
15
Very Negative
Cara Therapeutics has experienced significant revenue volatility over recent years, with a sharp decline from $135 million in 2020 to $7.1 million in 2024. The company has consistently reported negative net income, indicating ongoing challenges in achieving profitability. Gross profit margins have been positive when revenue is present, but operating margins such as EBIT and EBITDA margins are deeply negative, reflecting substantial operational losses.
Balance Sheet
35
Negative
The balance sheet of Cara Therapeutics shows a concerning trend with the stockholders' equity turning negative in 2024, a sign of financial distress. The company has managed its debt levels well, with no debt in 2024, but the negative equity ratio and substantial liabilities are risks. Previously, the company had a stronger equity position, but recent losses have eroded this significantly.
Cash Flow
20
Very Negative
Cash flows from operations have been consistently negative, indicating challenges in generating cash from core activities. The free cash flow position has also worsened, and despite occasional influxes from financing activities, the company's ability to sustain its cash burn rate is concerning. The operating cash flow to net income ratio remains poor, highlighting inefficiencies in cash conversion.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue6.58M7.14M20.97M41.87M23.03M135.08M
Gross Profit6.42M6.33M14.54M34.35M21.47M0.00
EBITDA-26.76M-62.60M-117.65M-83.80M-86.89M8.73M
Net Income-20.89M-70.87M-118.51M-85.47M-88.44M8.41M
Balance Sheet
Total Assets43.75M43.83M27.00M45.10M247.06M271.16M
Cash, Cash Equivalents and Short-Term Investments40.99M37.90M22.92M43.74M167.03M180.93M
Total Debt254.00K44.45M368.00K2.37M3.67M5.28M
Total Liabilities10.82M48.42M89.06M90.15M19.53M22.16M
Stockholders Equity32.93M-4.59M-62.06M-45.05M227.52M249.00M
Cash Flow
Free Cash Flow-31.58M-61.96M-21.04M-17.92M-60.13M-5.84M
Operating Cash Flow-31.58M-60.92M-21.04M-17.87M-60.09M-5.49M
Investing Cash Flow-12.93M48.74M22.47M-22.00M-4.75M-20.27M
Financing Cash Flow20.71M-3.60M2.00K4.00K46.61M39.14M

Tvardi Therapeutics Technical Analysis

Technical Analysis Sentiment
Negative
Last Price3.98
Price Trends
50DMA
6.10
Negative
100DMA
18.69
Negative
200DMA
20.55
Negative
Market Momentum
MACD
-0.86
Negative
RSI
28.50
Positive
STOCH
11.87
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For TVRD, the sentiment is Negative. The current price of 3.98 is below the 20-day moving average (MA) of 4.10, below the 50-day MA of 6.10, and below the 200-day MA of 20.55, indicating a bearish trend. The MACD of -0.86 indicates Negative momentum. The RSI at 28.50 is Positive, neither overbought nor oversold. The STOCH value of 11.87 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for TVRD.

Tvardi Therapeutics Risk Analysis

Tvardi Therapeutics disclosed 88 risk factors in its most recent earnings report. Tvardi 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

Tvardi 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
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
44
Neutral
$79.71M-0.29-8.16%22.44%
40
Underperform
$65.41M-0.52-141.82%-55.88%6.14%
38
Underperform
$37.06M-0.39-97.61%-53.67%86.75%
37
Underperform
$31.50M-0.75-195.19%-25.51%49.72%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
TVRD
Tvardi Therapeutics
3.98
-12.49
-75.83%
PSTV
Plus Therapeutics
0.57
-0.50
-46.73%
CUE
Cue Biopharma
0.27
-0.77
-74.04%
ALGS
Aligos Therapeutics
10.68
-28.17
-72.51%
GNTA
Genenta Science SpA Sponsored ADR
1.45
-3.45
-70.41%
ANL
Adlai Nortye Ltd. Sponsored ADR
1.52
-0.70
-31.53%

Tvardi Therapeutics Corporate Events

Product-Related AnnouncementsBusiness Operations and Strategy
Tvardi Therapeutics Advances STAT3 Inhibitor Clinical Trials
Positive
Nov 19, 2025

Tvardi Therapeutics announced significant progress in its clinical trials, particularly with its STAT3 inhibitor, TTI-101, which has shown promising results in reducing inflammation, fibrosis, and tumor growth in hepatocellular carcinoma (HCC) models. The company is also conducting ongoing Phase 1 and Phase 2 trials, with anticipated data releases in the first half of 2026, potentially impacting the treatment landscape for fibrosis-driven diseases and HCC.

Business Operations and Strategy
Tvardi Therapeutics Faces Setback in Phase 2 Trial
Negative
Oct 14, 2025

On October 13, 2025, Tvardi Therapeutics provided an update on preliminary data from its Phase 2 REVERT trial for idiopathic pulmonary fibrosis (IPF), revealing that the study did not meet its goals. Despite the trial’s randomized, double-blind, placebo-controlled design, no significant differences in lung function improvement were observed between the treatment and placebo groups, with high discontinuation rates due to gastrointestinal adverse events. Tvardi plans further analysis to understand these results and continues to develop its next-generation STAT3 inhibitor, TTI-109, with preliminary data expected in 2026.

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: Dec 09, 2025