Edgewise Therapeutics, Inc. (EWTX) closed the last trading session at $14.35, gaining 5.4% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $39.17 indicates a 173% upside potential.The average comprises 12 short-term price targets ranging from a low of $14.00 to a high of $51.00, with a standard deviation of $12.96. While the lowest estimate indicates a decline of 2.4% from the curr ...

Core Viewpoint - Edgewise Therapeutics, Inc. is under investigation for possible securities fraud following a decline in stock price after the announcement of clinical trial results for its lead asset, sevasemten [3][4]. Group 1: Company Overview - Edgewise Therapeutics, Inc. is focused on developing treatments for Becker and Duchenne muscular dystrophies [3]. - The company's lead asset is sevasemten, which recently reported clinical trial data [3]. Group 2: Recent Developments - On June 26, 2025, Edgewise Therapeutics announced clinical trial results that it characterized as "positive," but the FDA deemed the data insufficient for accelerated approval [3]. - Following this announcement, Edgewise's stock price fell by $1.27 per share, approximately 8.86%, closing at $14.33 per share [4]. Group 3: Legal Actions - The Portnoy Law Firm has initiated an investigation into Edgewise Therapeutics and may file a class action on behalf of investors who lost money [1]. - Investors are encouraged to contact the law firm for a complimentary case evaluation regarding their legal rights and options for recovering losses [2].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40236 Edgewise Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other juris ...

[Executive Summary & Q2 2025 Highlights](index=1&type=section&id=News%20Release) [Q2 2025 Highlights and CEO Commentary](index=1&type=section&id=Q2%202025%20Highlights%20and%20CEO%20Commentary) Edgewise Therapeutics reported Q2 2025 results, highlighting positive sevasemten data and EDG-7500 progress - Announced positive top-line data from the open-label extension MESA trial of sevasemten in participants with Becker muscular dystrophy[1](index=1&type=chunk) - Announced encouraging top-line data from the Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular dystrophy[1](index=1&type=chunk) - Advanced the Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM)[1](index=1&type=chunk) - Company is advancing skeletal and cardiac muscle programs and building commercial infrastructure for a potential U.S. launch of sevasemten in Becker, while exploring Phase 3 trial designs in HCM and Duchenne[2](index=2&type=chunk) [Recent Business Highlights](index=1&type=section&id=Recent%20Highlights) [Muscular Dystrophy Program](index=1&type=section&id=Muscular%20Dystrophy%20Program) Edgewise advanced its muscular dystrophy program with positive sevasemten trial results for Becker and Duchenne [Sevasemten and Becker Muscular Dystrophy](index=1&type=section&id=Sevasemten%20and%20Becker) Sevasemten showed sustained disease stabilization in Becker muscular dystrophy, with GRAND CANYON data expected Q4 2026 - Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect against contraction-induced muscle damage in muscular dystrophies[3](index=3&type=chunk) - Becker muscular dystrophy is a rare, genetic, life-shortening, debilitating, and degenerative neuromuscular disorder with no currently approved therapies[4](index=4&type=chunk) - Positive data from the MESA open-label extension trial showed sustained disease stabilization in NSAA scores for Becker participants, with a favorable safety profile after up to **three years of treatment**[5](index=5&type=chunk)[6](index=6&type=chunk) - The global pivotal placebo-controlled GRAND CANYON trial completed enrollment of **175 adults** in February 2025 and is on track for top-line data in **Q4 2026**[7](index=7&type=chunk)[8](index=8&type=chunk) - The Company completed a successful Type C meeting with the FDA, providing a clear path to registration of sevasemten as the first therapy for Becker[8](index=8&type=chunk) [Sevasemten and Duchenne Muscular Dystrophy](index=2&type=section&id=Duchenne) Sevasemten Phase 2 trials in Duchenne showed encouraging results, identifying a **10 mg** dose for Phase 3 - Duchenne is the most common type of muscular dystrophy, a severe degenerative muscle disorder with high unmet medical need despite existing therapies[9](index=9&type=chunk) - LYNX Phase 2 trial showed encouraging observations across functional measures (SV95C, NSAA, 4 stair-climb) and identified a **10 mg dose** for Phase 3[10](index=10&type=chunk) - FOX Phase 2 trial in Duchenne boys previously treated with gene therapy supports the potential of sevasemten **10 mg** to reduce the rate of functional decline[11](index=11&type=chunk) - The Company plans to meet with the FDA in **Q4 2025** to discuss Phase 3 design and initiate a pivotal study in **2026**[12](index=12&type=chunk) [Cardiovascular and Cardiometabolic Programs](index=3&type=section&id=Cardiovascular%20and%20Cardiometabolic%20Programs) Edgewise advances cardiovascular programs with EDG-7500 in Phase 2 for HCM and EDG-15400 entering Phase 1 [EDG-7500 and Hypertrophic Cardiomyopathy (HCM)](index=3&type=section&id=EDG-7500%20and%20HCM) The CIRRUS-HCM Phase 2 trial for EDG-7500 is recruiting for Part D, with an update expected in Q4 2025 - EDG-7500 is a novel oral, selective, cardiac sarcomere modulator designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM[14](index=14&type=chunk) - HCM is the most common form of genetic heart disease, affecting approximately **one in 500 people**, with significant unmet needs for additional therapeutic approaches, particularly for nonobstructive HCM (nHCM)[14](index=14&type=chunk) - The multi-part, open-label CIRRUS-HCM Phase 2 trial is actively recruiting participants for Part D (**12-week study** in oHCM and nHCM), with an update expected in **Q4 2025**[15](index=15&type=chunk) [Heart Failure and Preclinical Programs](index=3&type=section&id=Heart%20failure%20and%20preclinical%20programs) Edgewise plans to initiate a Phase 1 trial for EDG-15400 in heart failure in Q3 2025 - The Company expects to begin dosing in a first-in-human Phase 1 trial of EDG-15400 for heart failure during **Q3 2025**[16](index=16&type=chunk) - Edgewise continues to advance its preclinical cardiometabolic programs[16](index=16&type=chunk) [Strengthened Engagement with the Scientific and Patient Communities](index=3&type=section&id=Strengthened%20Engagement%20with%20the%20Scientific%20and%20Patient%20Communities) Edgewise continued engagement with muscular dystrophy and HCM communities through educational outreach and conferences - The Company participated in the Parent Project Muscular Dystrophy annual conference, CureDuchenne Futures conference, and the Annual Congress of the Heart Failure Association of the ESC[17](index=17&type=chunk) - Edgewise continues to sponsor and participate in numerous other clinician and patient-focused events[17](index=17&type=chunk) [Second Quarter Financial Results](index=3&type=section&id=Second%20Quarter%20Financial%20Results) [Financial Position (Cash, Cash Equivalents, Marketable Securities)](index=3&type=section&id=Financial%20Position%20(Cash%2C%20Cash%20Equivalents%2C%20Marketable%20Securities)) Edgewise Therapeutics maintained a strong liquidity position with **$594.0 million** in cash, cash equivalents, and marketable securities Cash, Cash Equivalents and Marketable Securities | Metric | June 30, 2025 | | :----- | :------------ | | Cash, cash equivalents and marketable securities | **$594.0 million** | [Operating Expenses](index=3&type=section&id=Operating%20expenses) Total operating expenses for Q2 2025 decreased to **$42.6 million**, primarily due to reduced R&D activities Total Operating Expenses (QoQ) | Metric | Q2 2025 | Q1 2025 | Change | | :----- | :------ | :------ | :----- | | Total operating expenses | **$42.610 million** | **$45.959 million** | **-$3.349 million** | [Research and Development (R&D) Expenses](index=3&type=section&id=Research%20and%20development) R&D expenses decreased by **$3.2 million** to **$33.6 million** in Q2 2025, driven by reduced clinical development and personnel costs Research and Development Expenses (QoQ) | Metric | Q2 2025 | Q1 2025 | Change | | :----- | :------ | :------ | :----- | | R&D expenses | **$33.6 million** | **$36.8 million** | **-$3.2 million** | - Decrease primarily driven by a **$2.6 million** decrease in sevasemten clinical development, a **$0.9 million** decrease in EDG-7500 clinical development, and a **$1.1 million** decrease in personnel-related costs, offset by a **$1.7 million** increase in manufacturing expenses[19](index=19&type=chunk) [General and Administrative (G&A) Expenses](index=4&type=section&id=General%20and%20administrative) G&A expenses remained stable at **$9.1 million** for Q2 2025 General and Administrative Expenses (QoQ) | Metric | Q2 2025 | Q1 2025 | Change | | :----- | :------ | :------ | :----- | | G&A expenses | **$9.1 million** | **$9.2 million** | **-$0.1 million** | [Net Loss and Net Loss Per Share](index=4&type=section&id=Net%20loss) Edgewise reported a net loss of **$36.1 million** (or **$0.34 per share**) for Q2 2025, an improvement Net Loss and Net Loss Per Share (QoQ) | Metric | Q2 2025 | Q1 2025 | Change | | :----- | :------ | :------ | :----- | | Net loss | **$(36.1) million** | **$(40.8) million** | **+$4.7 million** | | Net loss per share | **$(0.34)** | **$(0.43)** | **+$0.09** | [Company Overview](index=4&type=section&id=About%20Edgewise%20Therapeutics) [Company Mission and Product Pipeline](index=4&type=section&id=Company%20Mission%20and%20Product%20Pipeline) Edgewise Therapeutics develops novel therapeutics for muscular dystrophies and cardiac conditions, with sevasemten and EDG-7500 as key candidates - Edgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions[21](index=21&type=chunk) - Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor in late-stage clinical trials for Becker and Duchenne muscular dystrophies[21](index=21&type=chunk) - EDG-7500 is a novel cardiac sarcomere modulator for hypertrophic cardiomyopathy and other diseases of diastolic dysfunction, currently in Phase 2 clinical development[21](index=21&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) [Condensed Statement of Operations](index=6&type=section&id=Condensed%20Statement%20of%20Operations) The condensed statement of operations shows a net loss of **$36.1 million** for Q2 2025, an improvement driven by reduced R&D expenses Condensed Statement of Operations (Three months ended, in thousands) | Operating expenses: | June 30, 2025 | March 31, 2025 | | :------------------ | :------------ | :------------- | | Research and development | **$33,558** | **$36,757** | | General and administrative | **$9,052** | **$9,202** | | Total operating expenses | **$42,610** | **$45,959** | | Loss from operations | **$(42,610)** | **$(45,959)** | | Interest income | **$6,495** | **$5,161** | | Net loss | **$(36,115)** | **$(40,798)** | | Net loss per share - basic and diluted | **$(0.34)** | **$(0.43)** | | Weighted-average shares outstanding, basic and diluted | **104,940,493** | **95,130,053** | [Condensed Balance Sheet Data](index=6&type=section&id=Condensed%20Balance%20Sheet%20Data) Total assets increased to **$613.3 million** as of June 30, 2025, driven by increased cash and marketable securities Condensed Balance Sheet Data (in thousands) | Assets | June 30, 2025 | December 31, 2024 | | :----- | :------------ | :---------------- | | Cash, cash equivalents and marketable securities | **$593,992** | **$470,170** | | Other assets | **$19,342** | **$16,647** | | Total assets | **$613,334** | **$486,817** | | Liabilities | **$24,263** | **$27,601** | | Stockholders' equity | **$589,071** | **$459,216** | | Total liabilities and stockholders' equity | **$613,334** | **$486,817** | [Additional Information](index=4&type=section&id=Additional%20Information) [Cautionary Note Regarding Forward-Looking Statements](index=4&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section outlines forward-looking statements, emphasizing inherent risks and uncertainties that could cause actual results to differ - The press release contains forward-looking statements regarding product candidates, clinical trials, potential launches, market opportunities, and financial expectations[22](index=22&type=chunk) - Actual results could differ materially due to numerous risks and uncertainties, including those related to early development, lack of approved products, need for capital, dependence on product candidates, clinical trial outcomes, regulatory approvals, and intellectual property[22](index=22&type=chunk) [Company Contacts](index=6&type=section&id=Edgewise%20Contacts) Contact information is provided for investor relations and media inquiries - Investors can contact Michael Carruthers, Chief Financial Officer, at ir@edgewisetx.com[28](index=28&type=chunk) - Media inquiries can be directed to Maureen Franco, VP Corporate Communications, at media@edgewisetx.com[28](index=28&type=chunk)

On this news, Edgewise's stock price fell $1.27 per share, or 8.86%, to close at $14.33 per share on June 26, 2025. The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, London, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomer ...

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.

Becker Muscular Dystrophy (BMD) - Sevasemten shows positive observations in Becker patients with continued dosing[12] - A positive Type C FDA meeting offers a clear path to potential approval for Sevasemten[12] - The GRAND CANYON trial is on track for topline data in Q4 2026[12], with >98% power to deliver a statistically significant difference in NSAA vs placebo[20] - In the CANYON study, the NSAA score between the Sevasemten group and the placebo group showed a difference of +1.12 at month 12[27] - In the MESA open-label study, 99% of eligible participants are currently enrolled[30] - Natural history modeling reveals that 92% of CANYON participants improved vs their predicted scores[39], and 89% of ARCH participants achieved higher NSAA scores vs predicted[42] Duchenne Muscular Dystrophy (DMD) - In the LYNX & FOX trials, Sevasemten treatment reduced the functional decline in Duchenne patients[15] - A path to Phase 3 is open with the selection of 10 mg as the target dose[16] - In Duchenne patients, a -82% change in TNNI2 was observed in the 30mg cohort at Month 3[72] - In the FOX study, participants are an average of 11 years old and 4 years out from receiving gene therapy[99] Financial Status - Edgewise has approximately $624 million in cash, cash equivalents, and marketable securities as of March 31, 2025, providing a cash runway through 2028[112][113]

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].