Financial Performance - The net loss for Q3 2024 was $34.1 million, or $0.36 per share, compared to a net loss of $31.5 million, or $0.34 per share, in the previous quarter[17]. - Research and development (R&D) expenses for Q3 2024 were $32.2 million, an increase from $30.7 million in the previous quarter, primarily due to higher manufacturing expenses[16]. - General and administrative (G&A) expenses rose to $8.2 million in Q3 2024, compared to $7.4 million in the preceding quarter, driven by increased personnel-related costs[17]. Cash and Assets - As of September 30, 2024, cash, cash equivalents, and marketable securities totaled approximately $492.5 million[15]. - Cash, cash equivalents, and marketable securities rose to $492,536 thousand, an increase of 54.6% from $318,393 thousand at the end of 2023[22]. - Total assets increased to $511,282 thousand as of September 30, 2024, up from $340,035 thousand on December 31, 2023, representing a growth of 50.4%[22]. - Stockholders' equity increased to $488,877 thousand, up 53.3% from $318,830 thousand at the end of 2023[22]. - Total liabilities increased slightly to $22,405 thousand from $21,205 thousand, reflecting a growth of 5.6%[22]. Clinical Trials - The CANYON Phase 2 trial for sevasemten in adults with Becker is set to report data in December 2024, involving 40 adults and 29 adolescents over a 12-month treatment period[4]. - The GRAND CANYON trial, an expansion of the CANYON trial, will evaluate the safety and efficacy of sevasemten in 120 adults over 18 months, with data potentially supporting a marketing application[5]. - The LYNX Phase 2 trial in boys with Duchenne is planned to report data in Q4 2024, guiding the design of a Phase 3 trial expected to start in 2025[8]. - In the Phase 1 trial of EDG-7500, no clinically meaningful changes in vital signs or LVEF were observed across a range of doses, indicating good tolerability[11]. - The CIRRUS-HCM trial reported a 67% mean reduction in resting left ventricular outflow tract pressure gradient with a single dose of EDG-7500, without significant changes in LVEF[12]. Community Engagement - The company continues to engage with the scientific and patient communities, participating in major events for Becker and muscular dystrophy awareness[14].
Edgewise Therapeutics(EWTX) - 2024 Q3 - Quarterly Results