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Edgewise Therapeutics (EWTX)
NASDAQ:EWTX
US Market
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Edgewise Therapeutics (EWTX) AI Stock Analysis

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EWTX

Edgewise Therapeutics

(NASDAQ:EWTX)

Rating:40Underperform
Price Target:
Edgewise Therapeutics' overall score reflects significant risks due to its pre-revenue stage and increasing losses. Positive corporate events, including substantial fundraising and promising trial results, offer growth potential. However, the bearish technical indicators and valuation challenges highlight the stock's high-risk profile typical of early-stage biotech companies.
Positive Factors
Clinical Progress
Favorable readouts from all three clinical programs, including trials for sevasemten in BMD and DMD, and EDG-7500 in HCM, highlight promising progress in their clinical pipeline.
Financial Performance
Edgewise announced financial results with EPS better than both the company's and consensus estimates.
Regulatory Pathways
A successful Type C meeting with the FDA to discuss sevasemten’s potential filing strategies as the first-ever therapy for BMD indicates a positive regulatory pathway.
Negative Factors
Approval Process
EWTX plans to meet with the FDA to iron out details for the next steps in Duchenne muscular dystrophy, including patient population, aiming to progress to a Phase 3 study.
Regulatory Challenges
The FDA did not think EWTX's CANYON data alone was sufficient to support accelerated approval but provided clear and supportive feedback towards a traditional approval.
Safety Concerns
Key debates remain on the safety front, especially focused on the elimination of left ventricular ejection fraction reduction risk, which is a key potential differentiator from existing cardiac myosin inhibitors.

Edgewise Therapeutics (EWTX) vs. SPDR S&P 500 ETF (SPY)

Edgewise Therapeutics Business Overview & Revenue Model

Company DescriptionEdgewise Therapeutics (EWTX) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of therapies for rare muscle disorders. The company's primary aim is to address the unmet medical needs of patients with debilitating neuromuscular diseases by leveraging its proprietary drug discovery platform to develop novel, small molecule therapies. Edgewise's lead product candidates target specific genetic mutations and pathways involved in muscle dysfunction, offering potential therapeutic solutions for conditions such as Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD).
How the Company Makes MoneyEdgewise Therapeutics generates revenue primarily through the development and commercialization of its proprietary drug candidates. The company makes money by conducting clinical trials, gaining regulatory approvals, and ultimately marketing its therapies to healthcare providers and patients. Revenue streams include upfront payments, milestone payments, and royalties from licensing agreements with strategic partners. Edgewise may also engage in collaborations with larger pharmaceutical companies to co-develop or co-market its products, which can provide additional funding and resources to support its research and development efforts. However, as a clinical-stage company, Edgewise may primarily rely on funding from investors and strategic partnerships until its products reach the market.

Edgewise Therapeutics Financial Statement Overview

Summary
Edgewise Therapeutics is in a typical pre-revenue biotech phase with no revenue streams. The company has a strong cash position crucial for R&D, but high and increasing losses are critical risks.
Income Statement
20
Very Negative
Edgewise Therapeutics consistently reports zero revenue, indicating a pre-commercial stage typical in biotechnology. The company has a negative net income, which is expected given significant R&D expenses. However, the increasing net losses over the years raise concerns about financial sustainability without sufficient revenue generation.
Balance Sheet
35
Negative
The company has a strong cash position with substantial cash and cash equivalents, which is crucial for ongoing R&D activities. However, the negative equity in earlier periods and fluctuating debt levels suggest potential financial instability. The recent improvement in equity reflects successful financing rounds, but long-term sustainability depends on revenue growth.
Cash Flow
30
Negative
Negative operating and free cash flows indicate that Edgewise Therapeutics is reliant on external financing to fund its operations. The growth in financing cash flow shows successful capital raising, but persistent negative cash flows highlight the risk of future cash constraints without revenue generation.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue2.12M0.000.000.000.000.00
Gross Profit-2.35M-2.29M-1.73M-538.00K-272.00K-185.00K
EBITDA-167.43M-131.52M-112.81M-67.10M-42.94M-17.01M
Net Income-150.70M-133.81M-100.16M-67.64M-42.81M-17.05M
Balance Sheet
Total Assets613.33M486.82M340.04M367.10M285.23M131.14M
Cash, Cash Equivalents and Short-Term Investments593.99M470.17M318.39M351.95M280.79M129.09M
Total Debt4.37M4.74M5.41M4.41M0.00160.21M
Total Liabilities24.26M27.60M21.20M20.39M10.85M164.56M
Stockholders Equity589.07M459.22M318.83M346.72M274.38M-33.42M
Cash Flow
Free Cash Flow-125.67M-110.34M-97.69M-58.18M-34.17M-14.84M
Operating Cash Flow-124.78M-109.03M-91.95M-52.63M-33.51M-14.63M
Investing Cash Flow-71.98M-184.66M102.89M-70.58M-242.23M-24.38M
Financing Cash Flow196.68M249.25M53.17M129.64M186.38M120.28M

Edgewise Therapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price14.85
Price Trends
50DMA
13.85
Positive
100DMA
14.15
Positive
200DMA
21.28
Negative
Market Momentum
MACD
0.12
Negative
RSI
62.15
Neutral
STOCH
83.46
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For EWTX, the sentiment is Positive. The current price of 14.85 is above the 20-day moving average (MA) of 13.84, above the 50-day MA of 13.85, and below the 200-day MA of 21.28, indicating a neutral trend. The MACD of 0.12 indicates Negative momentum. The RSI at 62.15 is Neutral, neither overbought nor oversold. The STOCH value of 83.46 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for EWTX.

Edgewise Therapeutics Risk Analysis

Edgewise Therapeutics disclosed 87 risk factors in its most recent earnings report. Edgewise 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

Edgewise 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
63
Neutral
$1.66B-5.38%26.90%62.72%
59
Neutral
$1.47B-39.36%83.88%15.24%
57
Neutral
$1.60B-705.73%87.94%57.84%
52
Neutral
$2.31B-363.16%30.20%-7.22%
52
Neutral
$1.33B174.05-23.56%22367.80%-5.15%
51
Neutral
$7.89B-0.12-39.89%2.16%21.38%-1.56%
40
Underperform
$1.56B-27.41%-1.46%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
EWTX
Edgewise Therapeutics
14.85
-5.34
-26.45%
TVTX
Travere Therapeutics
17.92
8.87
98.01%
ARDX
Ardelyx
6.11
-0.20
-3.17%
LQDA
Liquidia Technologies
26.84
17.01
173.04%
SPRY
ARS Pharmaceuticals
13.50
0.30
2.27%
IMCR
Immunocore Holdings
32.93
-3.97
-10.76%

Edgewise Therapeutics Corporate Events

Private Placements and FinancingBusiness Operations and Strategy
Edgewise Therapeutics Announces $200M Stock Offering
Positive
Apr 2, 2025

On April 2, 2025, Edgewise Therapeutics announced the pricing of an underwritten registered direct offering of 9,935,419 shares of its common stock at $20.13 per share, expecting to raise approximately $200 million. The proceeds will support the potential U.S. commercial launch of sevasemten for Becker muscular dystrophy, advance Phase 3 trials for Duchenne muscular dystrophy and other cardiac conditions, and fund ongoing research and development programs, positioning the company for significant growth and operational sustainability through 2028.

Product-Related Announcements
Edgewise Therapeutics Announces Positive Phase 2 Trial Results
Positive
Apr 2, 2025

On April 2, 2025, Edgewise Therapeutics announced positive top-line results from its Phase 2 CIRRUS-HCM trial of EDG-7500 in patients with both obstructive and nonobstructive hypertrophic cardiomyopathy. The trial demonstrated that EDG-7500 significantly reduced left ventricular outflow tract gradients and improved cardiac biomarkers without affecting systolic function, indicating its potential as a significant advancement for HCM treatment. The findings suggest a promising future for EDG-7500, with plans for further optimization and a Phase 3 trial in 2026, potentially impacting patients and clinicians by providing a new therapeutic option.

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: Apr 22, 2025