Summary of Edgewise Therapeutics Conference Call Company Overview - **Company**: Edgewise Therapeutics (NasdaqGS:EWTX) - **Event**: 2026 Healthcare Innovation Conference - **Key Speaker**: Behrad Derakhshan, Chief Operating Officer Key Points Industry and Product Focus - Edgewise is focused on developing treatments for hypertrophic cardiomyopathy (HCM) and Becker muscular dystrophy, with significant unmet needs in these areas [5][6] - The company is preparing for a Phase 3 readout in its Becker program with sevasemten, aiming to launch the first drug for Becker patients [5] Clinical Trials and Data - The company is excited about the upcoming Part D data related to obstructive and non-obstructive HCM, emphasizing the rigorous data quality over competitor timelines [16][17] - Changes in screening criteria for clinical trials have been implemented to reduce AFib observations, including extending the look-back period for patient history and enhancing cardiac monitoring [11][12][13] - The company reported no AFib burden during extensive screening, indicating progress in addressing previous concerns [13] Competitive Landscape - Edgewise aims to differentiate its drug by allowing physicians to dose optimize without the need for rigorous echo monitoring, which is a limitation for current treatments [26][27][36] - The company believes there is still room for improvement in the obstructive population, particularly outside of centers of excellence where community physicians manage heart failure [24][25] Future Plans and Regulatory Considerations - Edgewise plans to initiate Phase 3 trials in the fourth quarter of 2026 and is preparing to engage with the FDA regarding registration studies [46][49] - The company is considering the potential for a synergistic use of its drug with current treatments in the obstructive setting, although it may lead to a switch rather than combination therapy [47] Commercial Strategy - Edgewise is building a commercial organization in anticipation of positive data, aiming for a broad label to treat patients diagnosed during adolescence [60][62] - The company is focused on demonstrating the long-term benefits of its drug to justify orphan drug pricing and ensure patient retention [59][60] Other Programs - The company is also advancing EDG-15400, with data expected in the second quarter of 2026, targeting heart failure with preserved ejection fraction (HFpEF) [48][49] - The Grand Canyon study for sevasemten is on track, with a low dropout rate indicating strong patient retention [53][54] Market Positioning - Edgewise is positioning itself to capture a significant market share in HCM and Becker muscular dystrophy by addressing unmet needs and simplifying treatment protocols for physicians [38][60] Conclusion - Edgewise Therapeutics is poised for significant developments in the coming year, with a focus on rigorous data quality, innovative treatment approaches, and a strong commercial strategy to meet the needs of patients with HCM and Becker muscular dystrophy [5][6][60]

Core Viewpoint - Edgewise Therapeutics is experiencing a positive market response following a bullish recommendation from analyst Yasmeen Rahimi of Piper Sandler, who has set a price target of $51 per share for the company's stock [2][3]. Company Overview - Edgewise Therapeutics' stock rose by 4% in a single day, outperforming the S&P 500 index, which only increased by 0.5% [2]. - The current stock price is $30.27, with a market capitalization of $3.1 billion [7]. Clinical Development - The company is advancing its leading cardiovascular drug candidate, EDG-7500, which targets hypertrophic cardiomyopathy (HCM) and is currently in a Phase 2 clinical trial [5][6]. - A readout from the clinical trial is expected in the second quarter of the calendar year, and the drug's novel functionality is anticipated to provide a competitive edge in the market [6]. Pipeline Potential - In addition to EDG-7500, Edgewise is developing Sevasemten, a treatment for muscular dystrophy, which is also well advanced in the development cycle [9]. - The analyst believes that several other pipeline programs have solid potential, indicating a robust future for the company's product offerings [9].

Core Insights - Edgewise Therapeutics, Inc. (NASDAQ:EWTX) is recognized as one of the top 14 booming stocks to buy, with a stock price increase of over 57% in the last three months as of January 12 [1] Company Updates - On January 13, Edgewise Therapeutics closed 3% higher after providing a corporate update and outlining its priorities for 2026 [2] - Major milestones for 2026 include expected top-line findings for Sevasemten by Q4, which would be the first approved therapy for Becker disease [2] - The company anticipates Phase 2 results for its selective cardiac sarcomere modulator, EDG-7500, in the first half of the year, aimed at treating hypertrophic cardiomyopathy (HCM) [2] Analyst Ratings - The stock has a one-year average share price target of $38.14, indicating an upside potential of 58.06% as of January 12 [2] - Wall Street analysts maintain a consensus Strong Buy rating for Edgewise Therapeutics [2] - Stifel Nicolaus has a Hold rating with a $16 price target, while JPMorgan has reiterated an Overweight rating on the stock [2] Company Profile - Edgewise Therapeutics is a biopharmaceutical company focused on developing therapeutics for muscular dystrophies and cardiac diseases [2]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Company Overview - Edgewise Therapeutics is a biopharmaceutical company focused on muscle diseases, developing novel orally active drugs for conditions such as muscular dystrophy, serious cardiac issues, and metabolic diseases [2] - The company leverages its expertise in muscle physiology to create first-in-class therapeutic agents [2] Recent Developments - In 2025, Edgewise Therapeutics completed enrollment in the pivotal Becker study for its drug sevasemten, with data readout expected by the end of the year [3] - The Duchenne program has shown promising results, with a decrease in the rate of decline in patients previously treated with steroids and gene therapy, and data collection on a subset of 60 patients is anticipated later this year [4] - Positive data has also been reported for the cardiovascular asset, referred to as 7500 [4]

Edgewise Therapeutics Conference Call Summary Company Overview - **Company**: Edgewise Therapeutics (NasdaqGS:EWTX) - **Focus**: Biopharmaceutical company specializing in muscle diseases, particularly muscular dystrophy and cardiac conditions [2][4] Key Programs and Developments Muscular Dystrophy - **Sevasamtan**: Drug for muscular dystrophy, pivotal study enrollment completed in February 2025, data readout expected by the end of 2026 [2][4] - **Duchenne Program**: Positive data from studies showing decreased decline rates in patients previously treated with steroids and gene therapy [2][3] - **Becker Program**: Focus on a rare genetic disease with a unique mechanism of action targeting muscle damage, showing promising results in clinical trials [5][6][8] Cardiovascular Assets - **EDG-7500**: Cardiac sarcomere modulator with a strong safety profile, showing no changes in left ventricular ejection fraction (LVEF) [3][4][18] - **EDG-15400**: Second-generation molecule filed for IND, expected to enter HFpEF studies in the second half of 2026 [4][25] Financial Position - **Funding**: Successfully raised $200 million, with a total of $563 million in cash and no debt, providing a runway through 2028 [4][24] Market Potential - **Becker Disease Market**: Estimated at $5 billion, with 6,000 patients in the U.S. and 12,000 in major markets [14] - **Hypertrophic Cardiomyopathy (HCM) Market**: Potentially a $10 billion opportunity, targeting 165,000 symptomatic patients [23][24] Clinical Data and Efficacy - **Becker Program**: - 99% of patients in open-label extension remain on study, indicating durable response [8] - Statistically significant decreases in biomarkers of muscle damage [7][10] - NorthStar endpoint measures functional capacity, with a target of a 1-2 point change [8][11] - **EDG-7500**: - 89% of patients showed significant improvement in KCCQ scores [20] - No relationship between drug concentration and changes in ejection fraction, indicating a unique safety profile [22][23] Regulatory and Development Strategy - **FDA Engagement**: Plans to discuss trial designs for phase three studies in obstructive and non-obstructive HCM with the FDA [25][44] - **Commercial Strategy**: Building a commercial backbone for Sevasamtan while executing on HCM opportunities [49][50] Upcoming Milestones - **Data Readouts**: - Becker pivotal study results expected in December 2026 [25] - 12-week study data for EDG-7500 anticipated in the second quarter of 2026 [25] - **NDA Submissions**: Planned for 2027 following successful trial outcomes [24][25] Conclusion - Edgewise Therapeutics is positioned for significant growth with two differentiated assets in the muscular dystrophy and cardiovascular spaces, backed by strong financials and promising clinical data. The company is focused on executing its development and commercial strategies effectively to capitalize on the substantial market opportunities ahead [24][26]

Forward Looking Statement This presentation contains contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this presentation that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, Edgewise's product candidates and programs, including sevasemten, EDG-7500, ...

Core Insights - Edgewise Therapeutics, Inc. is a leading biopharmaceutical company focused on developing novel therapeutics for muscle diseases and serious cardiac conditions [3] Group 1: Company Overview - Edgewise Therapeutics specializes in therapeutics for muscular dystrophies and cardiac conditions, leveraging deep expertise in muscle physiology [3] - The company is developing Sevasemten, a first-in-class fast skeletal myosin inhibitor, which is in late-stage clinical trials for Becker and Duchenne muscular dystrophies [3] - EDG-7500 is a novel cardiac sarcomere modulator for hypertrophic cardiomyopathy, currently in Phase 2 clinical development [3] - EDG-15400 is another cardiac sarcomere modulator aimed at treating heart failure, which is in Phase 1 clinical development [3] - The mission of Edgewise is to change the lives of patients and families affected by serious muscle diseases [3] Group 2: Event Details - Kevin Koch, Ph.D., President and CEO of Edgewise Therapeutics, will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, at 8:15 am PT [1][2] - The presentation will be available via a live webcast, with a link accessible on the Edgewise Events & Presentations page [2]

Company Overview - Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on precision medicines for rare muscle disorders, particularly dystrophinopathies [5][8] - The company’s lead product candidate, EDG-5506, targets Duchenne and Becker muscular dystrophy [8] - As of the latest period, Edgewise has not generated commercial revenue, relying on a research-driven business model [8] Financial Performance - As of September 30, Edgewise Therapeutics had a market capitalization of $2.61 billion and reported a net income loss of $157.24 million over the trailing twelve months [4] - The stock price was $24.62, reflecting a 14% decline over the past year, underperforming the S&P 500, which increased by approximately 15.5% during the same period [3][4] - The company reported a third-quarter net loss of about $40.7 million, attributed to increased R&D spending as it advanced multiple late-stage and mid-stage programs [10] Investment Activity - Foresite Capital Management VI fully exited its position in Edgewise Therapeutics during the third quarter, selling 585,000 shares valued at approximately $7.67 million [1][2] - Prior to the exit, Edgewise represented about 4.3% of Foresite's assets under management [3] - The exit reflects a recalibration of risk-reward dynamics for Foresite, as the remaining portfolio is heavily concentrated in early-stage biotech [11] Market Context - Edgewise's stock experienced significant volatility, with shares dropping as much as 40% from earlier highs following a $200 million underwritten offering announced in April [9] - By the end of the third quarter, the stock remained down year-over-year despite a strong balance sheet with approximately $563 million in cash and marketable securities [10]

Group 1 - The article discusses Edgewise Therapeutics, Inc. (EWTX) and its ongoing development of EDG-7500 despite safety concerns related to atrial fibrillation (AF) [2] - The author, Terry Chrisomalis, has extensive experience in the biotech sector and provides in-depth analysis of pharmaceutical companies through the Biotech Analysis Central service [2] - The Biotech Analysis Central service includes a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2] Group 2 - The article does not provide any specific financial data or performance metrics related to Edgewise Therapeutics or its products [1][3][4]