Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Edgewise Therapeutics and its officers or directors, following a significant stock price drop after clinical trial data was deemed insufficient for accelerated FDA approval [1][3]. Group 1: Company Overview - Edgewise Therapeutics, Inc. is publicly traded on NASDAQ under the ticker EWTX [1]. - The company is focused on developing treatments for Becker and Duchenne muscular dystrophies, with its lead asset being sevasemten [3]. Group 2: Recent Developments - On June 26, 2025, Edgewise reported clinical trial data for sevasemten, which it described as "positive," but the FDA indicated that the data was insufficient for accelerated approval [3]. - Following the announcement, Edgewise's stock price decreased by $1.27, or 8.86%, closing at $14.33 per share [3]. Group 3: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of advocating for victims of securities fraud and corporate misconduct [4].

Group 1 - Edgewise Therapeutics is under investigation for potential securities fraud or unlawful business practices involving its officers and/or directors [1] - The company reported clinical trial data for its lead asset, sevasemten, indicating "positive" results for Becker and Duchenne muscular dystrophies, but the FDA deemed the data insufficient for accelerated approval [2] - Following the announcement, Edgewise's stock price decreased by $1.27 per share, or 8.86%, closing at $14.33 per share [3] Group 2 - Pomerantz LLP is a prominent firm specializing in corporate, securities, and antitrust class litigation, with a history of recovering multimillion-dollar damages for victims of securities fraud and corporate misconduct [4]

Summary of Edgewise Therapeutics Conference Call Company Overview - **Company**: Edgewise Therapeutics (EWTX) - **Focus**: Development of treatments for Becker and Duchenne muscular dystrophy (BMD and DMD) Key Industry Insights - **Duchenne Muscular Dystrophy (DMD)**: Affects over 35,000 patients in major markets, with significant unmet medical needs despite recent approvals - **Becker Muscular Dystrophy (BMD)**: Affects over 12,000 adolescent boys and men, with no approved treatment options currently available Core Points and Arguments 1. **Sevasemtin's Efficacy**: - Positive observations in open-label extension study (MESA) and three-year data from ARCH MESA trial indicate significant promise for treating DMD and BMD [6][7][8] - Clinically meaningful decrease in functional decline observed in Duchenne patients compared to natural history [7] - Fast track designation received from the FDA for sevasemtin due to the severity of Becker muscular dystrophy [8] 2. **Regulatory Pathway**: - Positive interaction with the FDA regarding a clear path to approval for sevasemtin [6] - FDA emphasized the need for statistical significance in controlled studies for accelerated approval, indicating that the CANYON data alone was insufficient [21][70] - Plans to share ongoing data from open-label extensions and natural history modeling with the FDA to support future filings [95] 3. **Clinical Trial Updates**: - Enrollment of over 175 patients in the Grand Canyon study, which is powered at over 98% to deliver statistically significant results [10][22] - Top-line data expected in Q4 2026 for the Grand Canyon study [6][63] 4. **Safety and Efficacy Data**: - Sevasemtin demonstrated a favorable safety profile over three years, with significant biomarker responses [8][24] - In the CANYON study, CK levels decreased by 28% and TNNI2 by 77%, indicating a positive treatment effect [13] - Functional data showed stabilization in North Star assessments, contrasting with expected declines in placebo groups [15][19] 5. **Future Directions**: - Plans to initiate Phase III trials for both Becker and Duchenne muscular dystrophy in 2026 [62][64] - Exploration of potential combination therapies and the impact of glucocorticoids on treatment efficacy [58][90] Additional Important Insights - **Patient Population Considerations**: - Emphasis on enrolling a more homogeneous patient population for future studies to enhance signal detection [74][78] - Discussion on the potential for early intervention in younger patients, with ongoing considerations for dosing and pharmacokinetics [99][100] - **Financial Position**: - Company reported $624 million in cash equivalents, with a cash runway through 2028, supporting multiple upcoming clinical milestones [63][64] - **Market Context**: - The company is positioned to be a leader in the treatment of rare diseases with significant unmet needs, particularly in the muscular dystrophy space [59][60] This summary encapsulates the key points discussed during the Edgewise Therapeutics conference call, highlighting the company's advancements, regulatory strategies, and future plans in the context of muscular dystrophy treatments.

Sevasemten Update June 26, 2025 Forward Looking Statement This presentation 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 press release 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 sevasemten, statements regarding the potential marke ...

Core Insights - Edgewise Therapeutics has reported positive results from its sevasemten program for Becker and Duchenne muscular dystrophies, demonstrating sustained disease stabilization and a clear path to potential registration as the first therapy for Becker [1][3]. Group 1: Becker Muscular Dystrophy - The MESA trial data showed that 99% of eligible participants (n=85) are enrolled, with significant improvements in North Star Ambulatory Assessment (NSAA) scores, indicating sustained disease stabilization over 18 months [2]. - Participants from the CANYON trial who transitioned to MESA exhibited an average NSAA score improvement of 0.8 points from baseline, while those on placebo showed a 0.2 point improvement after starting sevasemten [2]. - The FDA has provided a clear path for sevasemten registration, emphasizing the importance of NSAA as a clinically meaningful endpoint for traditional approval [3]. Group 2: Duchenne Muscular Dystrophy - Encouraging topline data from Phase 2 trials (LYNX and FOX) indicate that sevasemten is well-tolerated and shows potential for reducing functional decline at a target dose of 10 mg [4][6]. - The LYNX trial focuses on four- to nine-year-old participants, while the FOX trial involves six- to fourteen-year-old participants previously treated with gene therapy, both assessing safety and biomarkers of muscle damage [5][6]. - The company plans to meet with the FDA in Q4 2025 to discuss Phase 3 design, aiming to initiate the pivotal study in 2026 [7]. Group 3: Company Overview - Edgewise Therapeutics is a biopharmaceutical company focused on developing novel therapeutics for muscular dystrophies and cardiac conditions, with sevasemten being a first-in-class fast skeletal myosin inhibitor [9][12]. - The company has achieved significant regulatory milestones, including FDA Orphan Drug Designation and Fast Track designations for both Becker and Duchenne [9]. - Edgewise is dedicated to changing the lives of patients affected by serious muscle diseases, with a strong emphasis on innovative therapeutic solutions [12].

Edgewise Therapeutics (EWTX) FY 2025 Conference June 09, 2025 03:20 PM ET Speaker0 Okay. We'll continue with the next session, which is Edgewise Therapeutics. Good afternoon, everyone. I'm Paul Choi, and I cover biotechnology here at the firm. It's my pleasure to welcome to my immediate left Kevin, CEO and Mehrot, COO. What we'll do is kick it off with let Kevin kick it off with some maybe high level overview of the company, sort of where the lead programs are and then we'll get into Q and A. Speaker1 Yes. ...

Edgewise Therapeutics (EWTX) 2025 Conference May 20, 2025 09:00 AM ET Speaker0 Thanks everyone for being here. Our next presenting company is Edgewise Therapeutics represented by Kevin, their c CEO, and Broad, their chief operating officer. So thanks for being here. Speaker1 Thank you, Kymena. Great. Yeah. Speaker0 So maybe we'll just jump right in. I mean, recently, you guys reported four week data for EDG seven thousand five hundred in HCM, and it's got a fairly unique efficacy profile. So maybe can you c ...

Core Viewpoint - Edgewise Therapeutics, Inc. (EWTX) has received a Zacks Rank 2 (Buy) upgrade due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is primarily based on a company's changing earnings picture, specifically tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - The Zacks rating upgrade for Edgewise Therapeutics reflects a positive outlook on its earnings, which could positively affect its stock price [4][6]. Impact of Earnings Estimates on Stock Prices - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements [5]. - Institutional investors utilize earnings estimates to determine the fair value of a company's shares, influencing their buying or selling actions, which subsequently affects stock prices [5]. Recent Performance of Edgewise Therapeutics - Edgewise Therapeutics is projected to earn -$1.82 per share for the fiscal year ending December 2025, indicating a year-over-year decline of 25.5% [9]. - Over the past three months, the Zacks Consensus Estimate for Edgewise Therapeutics has increased by 2.1%, suggesting a positive trend in earnings estimates [9]. Zacks Rank System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of Edgewise Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [11].

Group 1 - Edgewise Therapeutics, Inc. (EWTX) shares have increased by 14.4% over the past four weeks, closing at $14.89, with a mean price target of $40.90 indicating a potential upside of 174.7% [1] - The average of 10 short-term price targets ranges from a low of $14 to a high of $52, with a standard deviation of $14.28, suggesting variability in analyst estimates [2] - Analysts show strong agreement on EWTX's ability to report better earnings than previously predicted, which supports the potential for stock upside [4][11] Group 2 - The Zacks Consensus Estimate for EWTX's current year earnings has increased by 6.8% over the past month, with four estimates rising and one falling [12] - EWTX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating strong potential for near-term upside [13] - While consensus price targets may not be reliable for predicting exact stock gains, they can provide a directional guide for price movement [13]

Part I [Item 1. Financial Statements (Unaudited)](index=8&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported a net loss of $40.8 million for Q1 2025, an increase from $28.5 million in Q1 2024, driven by higher R&D expenses, and saw total assets decrease to $454.4 million [Condensed Balance Sheets](index=8&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $454.4 million from $486.8 million, primarily due to reduced marketable securities, while stockholders' equity fell to $429.7 million Condensed Balance Sheet Data (in thousands) | Account | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $49,921 | $41,666 | | Marketable securities, available for sale | $386,466 | $428,504 | | Total current assets | $443,178 | $475,483 | | Total assets | $454,391 | $486,817 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $21,115 | $23,860 | | Total liabilities | $24,672 | $27,601 | | Total stockholders' equity | $429,719 | $459,216 | | Total liabilities and stockholders' equity | $454,391 | $486,817 | [Condensed Statements of Operations and Comprehensive Loss](index=10&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for Q1 2025 increased to $40.8 million ($0.43 per share) from $28.5 million ($0.33 per share) in Q1 2024, driven by higher operating expenses, particularly R&D Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $36,757 | $27,694 | | General and administrative | $9,202 | $7,059 | | Total operating expenses | $45,959 | $34,753 | | Loss from operations | ($45,959) | ($34,753) | | Interest income | $5,161 | $6,228 | | Net loss | ($40,798) | ($28,525) | | Net loss per share, basic and diluted | ($0.43) | ($0.33) | [Condensed Statements of Stockholders' Equity](index=11&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) Total stockholders' equity decreased to $429.7 million from $459.2 million, primarily due to a $40.8 million net loss, partially offset by stock-based compensation and option exercises - Key changes in stockholders' equity for Q1 2025 include a **$40.8 million net loss**, a **$9.1 million increase** from stock-based compensation, and a **$2.3 million increase** from the exercise of stock options[20](index=20&type=chunk) [Condensed Statements of Cash Flows](index=12&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $37.9 million, while investing activities provided $43.9 million and financing activities provided $2.2 million, resulting in a net $8.3 million increase in cash Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($37,866) | ($28,598) | | Net cash provided by (used in) investing activities | $43,898 | ($268,308) | | Net cash provided by financing activities | $2,223 | $241,073 | | Net change in cash and cash equivalents | $8,255 | ($55,833) | | Cash and cash equivalents at end of period | $49,921 | $30,264 | [Notes to Condensed Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail the company's clinical-stage biopharmaceutical focus, significant accumulated deficit, reliance on equity financing, and sufficient cash reserves of $436.4 million to fund operations for at least 12 months - The company is a clinical-stage biopharmaceutical company focused on treatments for severe muscle diseases, with lead candidates **sevasemten** (for Duchenne and Becker muscular dystrophy) and **EDG-7500** (for hypertrophic cardiomyopathy)[24](index=24&type=chunk) - As of March 31, 2025, the company had an accumulated deficit of **$419.4 million** and cash, cash equivalents, and marketable securities of **$436.4 million**, which management believes is sufficient to fund operations for at least the next 12 months[26](index=26&type=chunk)[33](index=33&type=chunk) - The company raised net proceeds of **$231.9 million** from a direct offering in January 2024 and an additional **$188.0 million** (before expenses) from a direct offering in April 2025[28](index=28&type=chunk)[31](index=31&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $5,867 | $2,700 | | General and administrative | $3,192 | $2,171 | | **Total** | **$9,059** | **$4,871** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical program advancements, increased net loss to $40.8 million in Q1 2025 due to higher R&D expenses, and its belief that current cash, supplemented by a recent offering, will fund operations for at least 12 months [Overview](index=26&type=section&id=Overview) Edgewise is a clinical-stage biopharmaceutical company advancing sevasemten and EDG-7500, incurring a $40.8 million net loss in Q1 2025, but expects its $436.4 million cash reserves to fund operations for at least 12 months - The company is advancing two clinical-stage programs: **sevasemten** for muscular dystrophies and **EDG-7500** for hypertrophic cardiomyopathy (HCM)[64](index=64&type=chunk) - Net loss for Q1 2025 was **$40.8 million**, and the company expects to continue incurring significant losses as it advances its product candidates[66](index=66&type=chunk) - The company believes its cash, cash equivalents, and marketable securities of **$436.4 million** as of March 31, 2025, will fund operations for at least the next 12 months[67](index=67&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Operating expenses increased by $11.2 million to $46.0 million in Q1 2025, primarily due to a $9.1 million rise in R&D expenses driven by clinical trial advancements and personnel costs Comparison of Results of Operations (in thousands) | Account | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $36,757 | $27,694 | $9,063 | | General and administrative | $9,202 | $7,059 | $2,143 | | **Total operating expenses** | **$45,959** | **$34,753** | **$11,206** | | Net loss | ($40,798) | ($28,525) | ($12,273) | - The **$9.1 million increase** in R&D expenses was due to: **$1.9 million** for the sevasemten program due to increased trial activity, **$0.2 million** for the EDG-7500 program related to the Phase 2 CIRRUS-HCM trial, **$1.3 million** for discovery and preclinical expenses for the EDG-003 program, and **$5.7 million** in internal costs, mainly from increased employee headcount and stock-based compensation[83](index=83&type=chunk)[86](index=86&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) The company funds operations through equity offerings, holding $436.4 million in cash and marketable securities as of March 31, 2025, and expects these funds to cover operating expenses for at least the next 12 months - As of March 31, 2025, the company had **$436.4 million** in cash, cash equivalents, and marketable securities, with an additional **$188.0 million** raised in April 2025[85](index=85&type=chunk) Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($37,866) | ($28,598) | | Net cash provided by (used in) investing activities | $43,898 | ($268,308) | | Net cash provided by financing activities | $2,223 | $241,073 | - The company expects its existing cash and marketable securities to be sufficient to fund planned operating expenses and capital expenditure requirements for at least the next 12 months[105](index=105&type=chunk) - Long-term cash requirements include total operating lease liabilities of **$4.6 million** as of March 31, 2025[110](index=110&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate risk on its $436.4 million portfolio of short-term, low-risk investments, but a 10% interest rate change is not expected to materially affect its fair value - The company's primary market risk is interest rate sensitivity on its **$436.4 million** portfolio of cash and marketable securities[116](index=116&type=chunk) - Due to the short-term duration and low-risk profile of investments, a **10% change** in interest rates is not expected to have a material effect on the portfolio's fair market value[116](index=116&type=chunk) [Item 4. Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective[117](index=117&type=chunk) - No material changes occurred in the company's internal control over financial reporting during the first quarter of 2025[118](index=118&type=chunk) Part II [Item 1. Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though it may be involved in ordinary course claims not deemed material - The company is not currently a party to any material legal proceedings[121](index=121&type=chunk) [Item 1A. Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) This section outlines numerous risks, including the company's limited operating history, net losses, dependence on lead product candidates, clinical development uncertainties, regulatory hurdles, competition, reliance on third parties, intellectual property protection, and stock market volatility - The company has a limited operating history, has incurred significant net losses since inception (**$419.4 million** accumulated deficit as of March 31, 2025), and expects to continue incurring losses[127](index=127&type=chunk)[130](index=130&type=chunk) - The business is substantially dependent on the success of its two lead product candidates, **sevasemten** and **EDG-7500**[123](index=123&type=chunk)[166](index=166&type=chunk) - Clinical drug development is a lengthy, expensive, and uncertain process; positive results from early trials may not be predictive of future results, and product candidates may cause serious adverse events[123](index=123&type=chunk)[175](index=175&type=chunk)[186](index=186&type=chunk) - The company relies on third parties to conduct clinical trials and manufacture its product candidates, which increases risks related to quality, quantity, and cost[125](index=125&type=chunk)[428](index=428&type=chunk)[433](index=433&type=chunk) - The company faces significant competition from major pharmaceutical and biotechnology companies with greater resources, particularly in the development of treatments for Duchenne and HCM[203](index=203&type=chunk)[205](index=205&type=chunk)[210](index=210&type=chunk) - The company's success depends on its ability to obtain and maintain patent protection and trade secret protection for its product candidates and technologies[125](index=125&type=chunk)[351](index=351&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=183&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details net proceeds from multiple public offerings, including a March 2021 IPO ($186.1 million) and an April 2025 direct offering ($188.0 million), with no material change in the planned use of proceeds - There were no unregistered sales of equity securities during the period[488](index=488&type=chunk) Summary of Net Proceeds from Public Offerings | Offering | Date | Net Proceeds (approx.) | | :--- | :--- | :--- | | Initial Public Offering (IPO) | Mar 2021 | $186.1 million | | Follow-On Offering | Sep 2022 | $129.2 million | | ATM Program | Jun 2023 - Jan 2024 | $59.4 million | | Underwritten Direct Offering | Jan 2024 | $231.9 million | | Underwritten Direct Offering | Apr 2025 | $188.0 million | - There has been no material change in the use of proceeds from these offerings; funds were invested in interest-bearing, investment-grade securities[493](index=493&type=chunk)[495](index=495&type=chunk)[497](index=497&type=chunk)[499](index=499&type=chunk)[501](index=501&type=chunk) [Item 3. Defaults Upon Senior Securities](index=187&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[501](index=501&type=chunk) [Item 4. Mine Safety Disclosures](index=187&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[502](index=502&type=chunk) [Item 5. Other Information](index=187&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the last fiscal quarter - No directors or officers adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the last fiscal quarter[503](index=503&type=chunk) [Item 6. Exhibits](index=187&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including director compensation policy, officer certifications, and XBRL data files - The report includes several exhibits, such as officer certifications (31.1, 31.2, 32.1, 32.2) and Inline XBRL documents[507](index=507&type=chunk)