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Edgewise Therapeutics (EWTX) investor relations material
Edgewise Therapeutics Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Executive summary
Advanced two clinical-stage programs: sevasemten for muscular dystrophies and EDG-7500 for cardiac diseases, both in Phase 2 trials as of June 30, 2025.
Achieved key milestones in muscle and cardiac programs, including positive top-line data for sevasemten in Becker and Duchenne muscular dystrophy and advancement of EDG-7500 in HCM.
Building commercial infrastructure for a potential U.S. launch of sevasemten in Becker and planning Phase 3 trials in HCM and Duchenne.
Net loss of $36.1 million for Q2 2025 and $76.9 million for the six months ended June 30, 2025; accumulated deficit reached $455.5 million.
No revenue generated to date; operations funded primarily through equity offerings and private placements.
Financial highlights
Cash, cash equivalents, and marketable securities totaled $594.0 million at quarter-end, expected to fund operations for at least the next 12 months.
Q2 2025 research and development expenses were $33.6 million, up $2.9 million year-over-year, but down $3.2 million from the previous quarter.
General and administrative expenses for Q2 2025 were $9.1 million, up $1.6 million year-over-year, nearly flat compared to $9.2 million in the prior quarter.
Net loss for Q2 2025 was $36.1 million ($0.34 per share), compared to $40.8 million ($0.43 per share) in Q1 2025.
Net cash used in operating activities for the first half of 2025 was $70.4 million, compared to $54.7 million in the prior year period.
Outlook and guidance
Existing cash and securities expected to fund planned operating and capital expenditures through at least the next 12 months.
GRAND CANYON trial in Becker is on track for topline data in Q4 2026, with a clear FDA path to registration.
Plans to meet with FDA in Q4 2025 to discuss Phase 3 design for Duchenne and initiate pivotal study in 2026.
CIRRUS-HCM trial update expected in Q4 2025; first-in-human Phase 1 trial of EDG-15400 for heart failure to begin dosing in Q3 2025.
Substantial additional capital will be required to fund operations and development beyond the current cash runway.
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