Edgewise Therapeutics(EWTX) - 2024 Q3 - Quarterly Report

Financial Performance - Net losses for the three months ended September 30, 2024, were $34.1 million, compared to$25.7 million for the same period in 2023, representing an increase of $8.4 million[90]. - Total operating expenses for the nine months ended September 30, 2024, were$113.3 million, compared to $80.5 million for the same period in 2023, an increase of$32.8 million[96]. - Net cash used in operating activities was $82.1 million for the nine months ended September 30, 2024, compared to$65.1 million in 2023[105]. - Cash used in investing activities amounted to $205.6 million in 2024, primarily due to$413.9 million in purchases of marketable securities[108]. - Cash provided by financing activities was $246.4 million in 2024, significantly higher than$0.2 million in 2023[110]. Research and Development - Research and development expenses for the three months ended September 30, 2024, were $32.2 million, up from$23.8 million in 2023, reflecting an increase of $8.4 million driven by higher clinical trial activity[93]. - Research and development expenses increased to$90.6 million for the nine months ended September 30, 2024, up from $63.2 million in 2023, representing a$27.4 million increase[99]. - The increase in R&D expenses was primarily driven by a $14.7 million rise in sevasemten clinical program expenses and a$9.2 million increase in EDG-7500 clinical program expenses[99]. - Significant additional spending is expected to progress product candidates through clinical development phases, particularly for sevasemten and EDG-7500[84]. - The company is advancing two clinical-stage programs: Sevasemten (EDG-5506) for Becker muscular dystrophy and EDG-7500 for hypertrophic cardiomyopathy, with multiple Phase 2 trials ongoing[75]. Cash and Liquidity - The company had cash and cash equivalents of $492.5 million as of September 30, 2024, which is expected to fund operations for at least the next 12 months[79]. - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling$492.5 million[103]. - The company expects to require substantial additional capital to develop product candidates and fund operations in the foreseeable future[112]. Expenses - General and administrative expenses increased to $8.2 million for the three months ended September 30, 2024, from$5.7 million in 2023, an increase of $2.5 million primarily due to higher personnel-related costs[94]. - General and administrative expenses rose to$22.7 million in 2024 from $17.3 million in 2023, an increase of$5.4 million[100]. Interest Income - Interest income rose to $6.3 million for the three months ended September 30, 2024, compared to$3.7 million in 2023, an increase of $2.6 million attributed to higher balances of marketable securities[95]. - Interest income grew to$19.1 million for the nine months ended September 30, 2024, compared to $10.5 million in 2023, marking an increase of$8.7 million[101]. Market and Economic Conditions - The company is monitoring macroeconomic and geopolitical developments that could impact operations, including inflation and credit market conditions[80]. Company Status and Future Outlook - The accumulated deficit as of September 30, 2024, was $338.9 million, with total gross proceeds from private placements and public offerings amounting to$767.3 million since inception[79]. - The total operating lease liability balance as of September 30, 2024, was $4.4 million, with$1.0 million classified as a current liability[122]. - The company will remain an emerging growth company until December 31, 2024[127]. - As of June 30, 2024, the market value of the company's common stock held by non-affiliates exceeds $700.0 million[127]. - The company will transition to a "large accelerated filer" status effective January 1, 2025[127]. - The company has elected to take advantage of an extended transition period for adopting new or revised accounting standards[126].