Edgewise Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Highlights
Edgewise Therapeutics (NASDAQ:EWTX) reported its Q2 2025 financial results and clinical progress. The company announced positive top-line data from multiple trials of sevasemten in muscular dystrophy patients. Key highlights include 99% enrollment in the MESA open-label extension trial for Becker muscular dystrophy, showing sustained disease stabilization over 18 months.
The company completed enrollment of 175 adults in the GRAND CANYON pivotal trial, with topline data expected in Q4 2026. For Duchenne muscular dystrophy, encouraging results were reported from the LYNX and FOX Phase 2 trials. Additionally, Edgewise is advancing its CIRRUS-HCM Phase 2 trial of EDG-7500 for Hypertrophic Cardiomyopathy.
Financially, Edgewise maintains a strong position with $594.0 million in cash and equivalents. Q2 2025 R&D expenses were $33.6 million, down from $36.8 million in Q1, with a net loss of $36.1 million ($0.34 per share).
Edgewise Therapeutics (NASDAQ:EWTX) ha comunicato i risultati finanziari del secondo trimestre 2025 e i progressi clinici. L'azienda ha annunciato dati positivi preliminari da diversi studi su sevasemten in pazienti con distrofia muscolare. Tra i punti salienti, si segnala un 99% di arruolamento nello studio di estensione open-label MESA per la distrofia muscolare di Becker, che evidenzia una stabilizzazione della malattia mantenuta per 18 mesi.
La societ脿 ha completato l'arruolamento di 175 adulti nello studio pivotale GRAND CANYON, con dati preliminari attesi nel quarto trimestre 2026. Per la distrofia muscolare di Duchenne, sono stati riportati risultati incoraggianti dagli studi di Fase 2 LYNX e FOX. Inoltre, Edgewise sta portando avanti lo studio di Fase 2 CIRRUS-HCM con EDG-7500 per la Cardiomiopatia Ipertrofica.
Dal punto di vista finanziario, Edgewise mantiene una posizione solida con 594,0 milioni di dollari in liquidit脿 e equivalenti. Le spese di R&S nel secondo trimestre 2025 sono state di 33,6 milioni di dollari, in calo rispetto ai 36,8 milioni del primo trimestre, con una perdita netta di 36,1 milioni di dollari (0,34 dollari per azione).
Edgewise Therapeutics (NASDAQ:EWTX) inform贸 sus resultados financieros del segundo trimestre de 2025 y avances cl铆nicos. La compa帽铆a anunci贸 datos preliminares positivos de m煤ltiples ensayos con sevasemten en pacientes con distrofia muscular. Entre los aspectos destacados, se alcanz贸 un 99% de inscripci贸n en el ensayo de extensi贸n abierto MESA para distrofia muscular de Becker, mostrando estabilizaci贸n sostenida de la enfermedad durante 18 meses.
La empresa complet贸 la inscripci贸n de 175 adultos en el ensayo pivotal GRAND CANYON, con datos preliminares esperados para el cuarto trimestre de 2026. Para la distrofia muscular de Duchenne, se reportaron resultados alentadores en los ensayos de Fase 2 LYNX y FOX. Adem谩s, Edgewise avanza en su ensayo de Fase 2 CIRRUS-HCM con EDG-7500 para la Miocardiopat铆a Hipertr贸fica.
Financieramente, Edgewise mantiene una posici贸n s贸lida con 594,0 millones de d贸lares en efectivo y equivalentes. Los gastos de I+D en el segundo trimestre de 2025 fueron de 33,6 millones de d贸lares, una disminuci贸n respecto a los 36,8 millones del primer trimestre, con una p茅rdida neta de 36,1 millones de d贸lares (0,34 d贸lares por acci贸n).
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須岇偓電� GRAND CANYON 欷戩稊 鞛勳儊鞁滍棙鞐愳劀 175氇呾潣 靹膘澑 頇橃瀽 霌彪鞚� 鞕勲頄堨溂氅�, 欤检殧 雿办澊韯半姅 2026雲� 4攵勱赴鞐� 氚滍憸霅� 鞓堨爼鞛呺媹雼�. 霋れ叴 攴检澊鞓侅枒歃� 雽�靸� LYNX 氚� FOX 2靸� 鞁滍棙鞐愳劀霃� 瓿犽鞝侅澑 瓴瓣臣臧� 氤搓碃霅橃棃鞀惦媹雼�. 霕愴暅 Edgewise電� 牍勲寑靹� 鞁芳氤戩 旃橂鞝� EDG-7500鞚� CIRRUS-HCM 2靸� 鞁滍棙鞚� 歆勴枆 欷戩瀰雼堧嫟.
鞛鞝侅溂搿� Edgewise電� 5鞏� 9,400毵� 雼煬 鞚挫儊鞚� 順勱笀 氚� 順勱笀靹� 鞛愳偘鞚� 氤挫湢頃橂┌ 瓴碃頃� 鞛 靸來儨毳� 鞙犾頃橁碃 鞛堨姷雼堧嫟. 2025雲� 2攵勱赴 鞐瓣惮臧滊皽牍勲姅 3,360毵� 雼煬搿� 1攵勱赴 3,680毵� 雼煬 雽�牍� 臧愳唽頄堨溂氅�, 靾滌啇鞁れ潃 3,610毵� 雼煬(欤茧嫻 0.34雼煬)鞓�鞀惦媹雼�.
Edgewise Therapeutics (NASDAQ:EWTX) a publi茅 ses r茅sultats financiers du deuxi猫me trimestre 2025 ainsi que ses avanc茅es cliniques. La soci茅t茅 a annonc茅 des donn茅es pr茅liminaires positives issues de plusieurs essais portant sur le sevasemten chez des patients atteints de dystrophie musculaire. Parmi les points cl茅s, on note un taux de recrutement de 99% dans l'essai d'extension en ouvert MESA pour la dystrophie musculaire de Becker, montrant une stabilisation durable de la maladie sur 18 mois.
L'entreprise a termin茅 le recrutement de 175 adultes dans l'essai pivot GRAND CANYON, avec des donn茅es pr茅liminaires attendues au quatri猫me trimestre 2026. Pour la dystrophie musculaire de Duchenne, des r茅sultats encourageants ont 茅t茅 rapport茅s lors des essais de phase 2 LYNX et FOX. Par ailleurs, Edgewise fait progresser son essai de phase 2 CIRRUS-HCM avec EDG-7500 pour la cardiomyopathie hypertrophique.
Sur le plan financier, Edgewise conserve une position solide avec 594,0 millions de dollars en liquidit茅s et 茅quivalents. Les d茅penses en R&D du deuxi猫me trimestre 2025 se sont 茅lev茅es 脿 33,6 millions de dollars, en baisse par rapport 脿 36,8 millions au premier trimestre, avec une perte nette de 36,1 millions de dollars (0,34 dollar par action).
Edgewise Therapeutics (NASDAQ:EWTX) ver枚ffentlichte seine Finanzergebnisse f眉r das zweite Quartal 2025 sowie den klinischen Fortschritt. Das Unternehmen meldete positive vorl盲ufige Daten aus mehreren Studien mit Sevasemten bei Patienten mit Muskeldystrophie. Zu den wichtigsten Highlights z盲hlt eine 99%ige Einschreibung in die offene Verl盲ngerungsstudie MESA bei Becker-Muskeldystrophie, die eine anhaltende Stabilisierung der Erkrankung 眉ber 18 Monate zeigt.
Das Unternehmen schloss die Einschreibung von 175 Erwachsenen in der entscheidenden GRAND CANYON-Studie ab, mit vorl盲ufigen Ergebnissen, die im vierten Quartal 2026 erwartet werden. F眉r die Duchenne-Muskeldystrophie wurden vielversprechende Ergebnisse aus den Phase-2-Studien LYNX und FOX berichtet. Zudem treibt Edgewise die Phase-2-Studie CIRRUS-HCM mit EDG-7500 bei hypertropher Kardiomyopathie voran.
Finanziell steht Edgewise mit 594,0 Millionen US-Dollar an liquiden Mitteln und 脛quivalenten solide da. Die F&E-Ausgaben im zweiten Quartal 2025 betrugen 33,6 Millionen US-Dollar und sanken damit gegen眉ber 36,8 Millionen im ersten Quartal, bei einem Nettoverlust von 36,1 Millionen US-Dollar (0,34 US-Dollar pro Aktie).
- Strong cash position of $594.0 million as of June 30, 2025
- 99% enrollment rate in MESA trial with sustained disease stabilization in Becker patients
- Successful completion of enrollment in GRAND CANYON pivotal trial with 175 adults
- Encouraging results from LYNX and FOX Phase 2 trials in Duchenne muscular dystrophy
- Reduced R&D expenses by $3.2 million compared to previous quarter
- Net loss of $36.1 million in Q2 2025
- GRAND CANYON topline data not expected until Q4 2026
- Phase 3 trial designs for Duchenne still pending FDA discussion
Insights
Edgewise's pipeline is advancing with positive results for sevasemten in muscular dystrophies and continued development of cardiac programs.
Edgewise's Q2 update highlights important progress across its muscular dystrophy portfolio. The MESA open-label extension trial demonstrated sustained disease stabilization in Becker muscular dystrophy patients after up to three years of sevasemten treatment. This is clinically meaningful as the North Star Ambulatory Assessment (NSAA) scores continued to diverge from the expected functional declines seen in natural history studies, suggesting a durable treatment effect.
The company's GRAND CANYON pivotal trial has completed enrollment with 175 adults, positioning it well for a potential regulatory submission following topline data expected in Q4 2026. A successful Type C meeting with the FDA provides a clear registration pathway for what could become the first-ever approved therapy for Becker muscular dystrophy.
For Duchenne muscular dystrophy, where competition is more established, the LYNX and FOX trials showed encouraging functional improvements, with the company identifying the 10mg dose for Phase 3 evaluation. The upcoming FDA meeting in Q4 2025 will be critical for defining the pivotal trial design.
In the cardiovascular space, EDG-7500 continues advancement in HCM, with results expected in Q4 2025. Additionally, EDG-15400 for heart failure is progressing to first-in-human trials, diversifying the company's pipeline.
Financially, Edgewise maintains a strong position with
Sevasemten shows impressive three-year disease stabilization in Becker patients with promising early data in Duchenne muscular dystrophy.
The MESA extension trial results for sevasemten represent a potential breakthrough for Becker muscular dystrophy patients. The 99% enrollment retention rate (85 participants) demonstrates extraordinary patient commitment, suggesting meaningful perceived benefit from treatment. Most significantly, the sustained stabilization of NSAA scores over three years of treatment for ARCH participants challenges the natural disease progression, where we would typically expect continued functional decline.
Mechanistically, sevasemten's approach as a fast skeletal myosin inhibitor addresses the fundamental pathophysiology of Becker - protecting against contraction-induced muscle damage that drives the irreversible muscle loss. This represents a novel therapeutic strategy compared to existing approaches in muscular dystrophies.
The LYNX and FOX trials in Duchenne provide complementary evidence of sevasemten's potential across the dystrophinopathy spectrum. The observed improvements in Stride Velocity 95th Centile (SV95C), NSAA, and 4-stair climb suggest functional benefits beyond biomarker changes. Particularly interesting is the FOX trial data showing potential benefit in post-gene therapy patients, suggesting sevasemten might serve as a complementary therapy to address ongoing disease progression even after gene therapy intervention.
The cardiovascular program targeting HCM with EDG-7500 addresses another significant unmet need, particularly for nonobstructive HCM patients who currently have no approved treatment options. The drug's mechanism of slowing early contraction velocity could improve diastolic function, potentially addressing symptoms and disease progression in this patient population.
The breadth of clinical development across multiple rare muscle diseases positions Edgewise to potentially transform care paradigms for these devastating conditions where therapeutic options remain limited.
鈥撎� Announced positive top-line data from the open-label extension听
鈥撎� Announced encouraging top-line data from the Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular dystrophy 鈥�
鈥撎� Advanced the Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM) 鈥�
"In the first half of 2025, we reached key milestones that bring us closer to delivering on our mission," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "With strong funding in place, we're advancing our skeletal and cardiac muscle programs and building the commercial infrastructure with precision and purpose to support a potential
Recent Highlights
Muscular Dystrophy Program
Sevasemten and Becker
Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect against contraction-induced muscle damage in muscular dystrophies including Becker and Duchenne.
Becker is a rare, genetic, life-shortening, debilitating and degenerative neuromuscular disorder. Genetic mutations in the听dystrophin gene result in contraction-induced muscle damage, which is the primary driver of irreversible muscle loss and impaired motor function. The disease predominantly affects males, with functional decline beginning at any age. Once that muscle loss occurs, the decline in function is irreversible and continues throughout the individual's life. Currently, there are no approved therapies on the market to treat Becker.
The
GRAND CANYON, a global pivotal placebo-controlled cohort in Becker: In February 2025, the Company completed enrollment in GRAND CANYON, an expansion of the CANYON placebo-controlled trial. The 18-month GRAND CANYON cohort is active in 12 countries, GRAND CANYON enrolled 175 adults, reflective of the Becker community's enthusiasm to have access to a therapy with the potential to stabilize their debilitating decline in function and ability to perform everyday activities.听
GRAND CANYON is highly powered to be able to show a statistically significant difference in NSAA versus placebo over 18 months and is on track for topline data in the fourth quarter of 2026. In the second quarter of 2025, the Company completed a successful Type C meeting with the FDA, which provided a clear path to registration of sevasemten as the first ever therapy for Becker. To learn more, go to clinicaltrials.gov (NCT05291091).
Duchenne
Duchenne, a severe degenerative muscle disorder, is the most common type of muscular dystrophy with a median life expectancy of around 30 years. Genetic mutations in the dystrophin gene result in contraction-induced muscle damage, which is the primary driver of irreversible muscle loss and impaired motor function. While there are approved therapies on the market aimed at treating the disease, there remains a high unmet need for additional therapies.
LYNX Phase 2 placebo-controlled, dose-finding trial in boys with Duchenne: LYNX is designed to evaluate the effect of sevasemten on safety, biomarkers of muscle damage and function in four- to nine-year-old participants with Duchenne treated with sevasemten in a three-month placebo-controlled dose ranging study, followed by an open-label extension period. In June 2025, the Company announced encouraging observations across functional measures, including Stride Velocity 95th Centile (SV95C), NSAA and 4 stair-climb, while identifying a dose of 10 mg to evaluate in Phase 3.听
FOX Phase 2 placebo-controlled trial in boys with Duchenne: FOX is designed to evaluate the effect of sevasemten on safety, biomarkers of muscle damage and function in six- to 14-year-old participants with Duchenne who have been previously treated with gene therapy. FOX participants are on average over 10 years old and four years out from receiving gene therapy. Despite the lack of extensive natural history in听Duchenne gene therapy treated boys, initial results from the FOX study support that sevasemten 10 mg has the potential to reduce the rate of functional decline.
The Company plans to meet with the FDA in the fourth quarter of 2025 to discuss a Phase 3 design including input on the patient population and endpoints, with plans to initiate a pivotal study in 2026. In addition, the Company plans to continue to collect longer-term open label extension data, which will provide further access to the drug to trial participants.听
For more information, go to clinicaltrials.gov to learn more about LYNX () and FOX (NCT06100887).听
Cardiovascular and Cardiometabolic Programs
EDG-7500 and HCM
EDG-7500 is a novel oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and other diseases of diastolic dysfunction. HCM is the most common form of genetic heart disease, affecting approximately one in 500 people, and is associated with reduced quality of life and an elevated risk of heart failure, abnormal heart rhythms, and sudden cardiac death. There are two major forms of HCM: obstructive and nonobstructive. Despite advancements in treatment options for some HCM patients, there remains a significant unmet need for additional therapeutic approaches for patients, including nonobstructive HCM (nHCM) patients, for which there are no approved treatment options.
CIRRUS-HCM Phase 2 trial in adults with HCM: The Company is advancing CIRRUS-HCM, a multi-part, open-label trial, in participants with HCM at over 20 clinical sites in the
Heart failure and preclinical programs: During the third quarter of 2025, the Company expects to begin dosing in a first-in-human Phase 1 trial of EDG-15400, a novel drug candidate intended for the treatment of heart failure. The Company continues to advance its preclinical cardiometabolic programs.
Strengthened Engagement with the Scientific and Patient Communities
The Company continued its education and outreach with the muscular dystrophy and HCM medical and patient communities. The team participated in the Parent Project Muscular Dystrophy annual conference, CureDuchenne Futures conference and the Annual Congress of the Heart Failure Association of the ESC. The Company continues to sponsor and participate in numerous other clinician and patient-focused events.
Second Quarter Financial Results
Cash, cash equivalents and marketable securities听were approximately
Research and development (R&D) expenses听were
General and Administrative (G&A) expenses听were听
Net loss and net loss per share听for the second quarter of 2025 was
About Edgewise Therapeutics
Edgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The Company's deep expertise in muscle physiology is driving a new generation of novel therapeutics. Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor in late-stage clinical trials in Becker and Duchenne muscular dystrophies. EDG-7500 is a novel cardiac sarcomere modulator for the treatment of hypertrophic cardiomyopathy and other diseases of diastolic dysfunction, currently in Phase 2 clinical development. The entire team at Edgewise is dedicated to our mission: changing the lives of patients and families affected by serious muscle diseases. To learn more, go to:听听or follow us on听,听听,听听and听.
Cautionary Note Regarding Forward-Looking Statements
This press release 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, Edgewise's product candidates and programs, including听sevasemten, EDG-7500, EDG-15400 and its cardiovascular and cardiometabolic programs; statements regarding a potential
This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.
Edgewise Therapeutics, Inc. | ||||
Condensed Statement of Operations | ||||
(in thousands except share and per share amounts, unaudited) | ||||
Three months ended | ||||
June 30, 2025 | March 31, 2025 | |||
Operating expenses: | ||||
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 | ||
Edgewise Therapeutics, Inc. | ||||
Condensed Balance Sheet Data | ||||
(in thousands, unaudited) | ||||
June 30 | December 31, | |||
2025 | 2024 | |||
Assets | ||||
Cash, cash equivalents and marketable securities | $ | 593,992 | $ | 470,170 |
Other assets | 19,342 | 16,647 | ||
Total assets | $ | 613,334 | $ | 486,817 |
Liabilities and stockholders' equity | ||||
Liabilities听听 | 24,263 | 27,601 | ||
Stockholders' equity | 589,071 | 459,216 | ||
Total liabilities and stockholders' equity | $ | 613,334 | $ | 486,817 |
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FAQ
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