Tvardi Therapeutics (TVRD) AI Stock Analysis

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Tvardi Therapeutics

(NASDAQ:TVRD)

Rating:57Neutral

Price Target:―

Cara Therapeutics' stock is currently buoyed by strong technical momentum, with prices significantly above key moving averages and positive market indicators. However, significant financial challenges, including negative profitability and cash flow issues, weigh heavily on the stock's long-term outlook. The lack of profitability is reflected in a negative P/E ratio, making valuation difficult and risky. Investors should be cautious of the high financial risks despite the current positive technical trends.

Positive Factors

Efficacy in Clinical Trials

The TTI-101 trial's interim analysis shows a positive trend on lung function with no safety concerns, suggesting a potentially successful outcome.

Financial Position

The recent merger and financings provide a financial runway into the second half of 2026, ensuring stability beyond upcoming trial readouts.

Market Potential

STAT3 inhibition can curb a range of inflammatory and fibrotic pathways, potentially driving a superior FVC response versus standard of care, making TTI-101 a potential cornerstone therapy in the multi-billion IPF market.

Negative Factors

Competition and Scarcity

There is scarcity value in TTI-101 as the only STAT3 inhibitor in development for IPF in the US, with expected increased strength in the stock as appreciation for its potential grows.

Development Challenges

TVRD is the presumptive first mover in the development of STAT3 inhibitors for fibrotic diseases.

Valuation Concerns

The stock is seen as undervalued ahead of Phase 2 IPF data, supported by the compelling and novel mechanism of action, encouraging interim efficacy results, and significant scarcity value in TVRD’s approach.

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

Market Cap

$243.85M

Dividend YieldN/A

Average Volume (3M)48.36K

Price to Earnings (P/E)―

Beta (1Y)1.07

Revenue Growth-65.96%

EPS Growth40.80%

CountryUS

Employees17

SectorHealthcare

Sector Strength55

IndustryBiotechnology

Share Statistics

EPS (TTM)-46.64

Shares Outstanding9,360,904

10 Day Avg. Volume56,708

30 Day Avg. Volume48,356

Financial Highlights & Ratios

PEG RatioN/A

Price to Book (P/B)N/A

Price to Sales (P/S)0.00

P/FCF RatioN/A

Enterprise Value/Market CapN/A

Enterprise Value/RevenueN/A

Enterprise Value/Gross ProfitN/A

Enterprise Value/EbitdaN/A

Forecast

1Y Price Target

$56.20

Price Target Upside114.34% Upside

Rating ConsensusStrong Buy

Number of Analyst Covering5

Tvardi Therapeutics Business Overview & Revenue Model

Company DescriptionCara Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus (itching) and pain by selectively targeting kappa opioid receptors. The company operates within the healthcare sector, specifically in the biotechnology and pharmaceuticals industries. Cara Therapeutics' core product is KORSUVA (difelikefalin) injection, which is developed for the treatment of pruritus associated with chronic kidney disease in patients undergoing hemodialysis.

How the Company Makes MoneyCara Therapeutics generates revenue primarily through the commercialization of its lead product, KORSUVA injection. The company earns money by selling this product to healthcare providers and institutions treating patients with chronic kidney disease on dialysis who experience pruritus. Additionally, Cara Therapeutics has entered into strategic partnerships and licensing agreements with other pharmaceutical companies to expand the distribution and commercialization of KORSUVA in various markets outside the United States, which contributes to its revenue through milestone payments and royalties. The company's financial performance is significantly influenced by regulatory approvals, market acceptance of its product, and the ability to successfully expand its distribution network.

Tvardi Therapeutics Earnings Call Summary

Earnings Call Date:Feb 26, 2025

(Q4-2023)

% Change Since: 2.38%|

Next Earnings Date:May 12, 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

Income Statement

Balance Sheet

Cash Flow

Breakdown
Income Statement		Total Revenue
	Gross Profit
	EBIT
	EBITDA
	Net Income Common Stockholders
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
	Total Assets
	Total Debt
	Net Debt
	Total Liabilities
	Stockholders Equity
Cash Flow		Free Cash Flow
	Operating Cash Flow
	Investing Cash Flow
	Financing Cash Flow

Tvardi Therapeutics Technical Analysis

Technical Analysis Sentiment

Neutral

Last Price26.22

Price Trends

50DMA

23.42

Positive

100DMA

19.32

Positive

200DMA

15.33

Positive

Market Momentum

MACD

0.50

Positive

RSI

49.20

Neutral

STOCH

28.35

Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For TVRD, the sentiment is Neutral. The current price of 26.22 is below the 20-day moving average (MA) of 28.10, above the 50-day MA of 23.42, and above the 200-day MA of 15.33, indicating a neutral trend. The MACD of 0.50 indicates Positive momentum. The RSI at 49.20 is Neutral, neither overbought nor oversold. The STOCH value of 28.35 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for TVRD.

Tvardi Therapeutics Peers Comparison

Overall Rating

UnderperformOutperform

Sector (54)

Financial Indicators

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
TVRD	57 Neutral	$243.85M	―	-414.88%	―	-65.96%	40.80%
Sector *	54 Neutral	$5.38B	3.31	-45.11%	3.29%	16.82%	0.04%
SLRX	30 Underperform	$1.57M	―	-300.16%	―	―	79.57%
PCSA	29 Underperform	$4.08M	―	-192.72%	―	―	56.26%
WINT	28 Underperform	$2.93M	―	-120.01%	―	―	97.84%
QNRX	25 Underperform	$4.89M	―	-138.80%	―	―	42.26%

* Healthcare Sector Average

Performance Comparison

TVRD

Tvardi Therapeutics

26.11

10.14

63.49%

SLRX

Salarius Pharmaceuticals

0.71

-2.97

-80.71%

WINT

Windtree Therapeutics

0.60

-148.90

-99.60%

QNRX

Quoin Pharmaceuticals

8.47

-16.73

-66.39%

PCSA

Processa Pharmaceuticals

0.34

-1.31

-79.39%

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.