Financial Performance - Net losses for Edgewise Therapeutics were $133.8 million in 2024, up from $100.2 million in 2023, reflecting an increase of $33.6 million [655]. - The net loss for 2024 was $133.8 million, compared to a net loss of $100.2 million in 2023, indicating a 33% increase in losses [734]. - The total comprehensive loss for 2024 was $133.5 million, compared to $98.7 million in 2023, representing a 35% increase [734]. - The Company reported a net loss of $133.8 million for the year ended December 31, 2024, compared to a net loss of $100.2 million for 2023, representing a 33.5% increase in net loss year-over-year [816]. Research and Development Expenses - Research and development expenses rose to $127.0 million in 2024 from $90.9 million in 2023, an increase of $36.1 million [672]. - Research and development expenses for the year ended December 31, 2024, were $127.0 million, up 40% from $90.9 million in 2023 [734]. - The sevasemten clinical program incurred $51.7 million in expenses in 2024, up from $34.8 million in 2023, a rise of $16.8 million [673]. - EDG-7500 clinical program expenses increased by $8.9 million to $17.9 million in 2024, primarily due to the activation of the Phase 2 CIRRUS-HCM trial [673]. - Research and development expenses increased to $80.2 million in 2024 from $57.5 million in 2023, reflecting a 39.4% increase [824]. - Accrued research and development costs were $6.5 million as of December 31, 2024, compared to $5.7 million in 2023, indicating an increase of 14.4% [820]. Cash Flow and Liquidity - As of December 31, 2024, Edgewise Therapeutics had cash, cash equivalents, and marketable securities totaling $470.2 million [679]. - Cash used in investing activities in 2024 amounted to $184.7 million, primarily due to $477.1 million in purchases of marketable securities, offset by $277.9 million in maturities of marketable securities [685]. - Cash provided by financing activities in 2024 was $249.3 million, significantly higher than $53.2 million in 2023, driven by $239.1 million in net proceeds from the issuance of common stock [687][688]. - Cash flows from operating activities resulted in a net cash used of $109.0 million in 2024, up from $91.9 million in 2023, indicating an 18.5% increase in cash outflow [739]. - Cash and cash equivalents decreased to $41.7 million in 2024 from $86.1 million in 2023, a decline of 52% [733]. - The company believes its cash and marketable securities will be sufficient to fund operations for at least the next 12 months [749]. Capital and Financing - The company expects significant additional spending to progress its product candidates through clinical trials and regulatory approval [660]. - The company expects to require substantial additional capital to develop product candidates and fund operations, with a shelf registration statement filed for equity and debt offerings of up to $175 million [689]. - The company raised $240.0 million in gross proceeds from an underwritten registered direct offering of 21,818,182 shares at $11.00 per share in January 2024 [745]. - The company has entered into a sales agreement allowing for the potential sale of up to $175.0 million in common stock through an at-the-market offering program [746]. Operational Expenses - General and administrative expenses increased to $31.9 million in 2024 from $23.5 million in 2023, an increase of $8.4 million [677]. - The company reported total operating expenses of $158.8 million for 2024, a 39% increase from $114.4 million in 2023 [734]. - Non-cash charges in operating activities for 2024 included stock-based compensation expense of $24.7 million and depreciation of $2.1 million [683]. Shareholder Equity and Stock Options - The weighted-average shares outstanding increased to 92.4 million in 2024 from 63.7 million in 2023, reflecting a 45% increase [734]. - Additional paid-in capital rose to $837.4 million in 2024 from $563.5 million in 2023, marking a 48% increase [733]. - The company has 15,416,761 stock options outstanding with a weighted average exercise price of $9.40 and total intrinsic value of $267.4 million [787]. - The total stock-based compensation expense for the year ended December 31, 2024 was $24.7 million, an increase from $17.6 million in 2023 [800]. - The company granted 2,817,497 stock options in 2024 at a weighted average exercise price of $17.67 [787]. Compliance and Regulatory - The company ceased to be an "emerging growth company" and "smaller reporting company" as of December 31, 2024, which is expected to increase public company compliance costs [711][712]. - The company maintained effective internal control over financial reporting as of December 31, 2024, according to the auditor's opinion [719]. Marketable Securities - As of December 31, 2024, the total fair value of marketable securities was $469,978,000, with unrealized gains of $530,000 and unrealized losses of $110,000 [768]. - The remaining contractual maturities of $394.4 million of marketable securities were less than one year, and $33.7 million were between 1 and 2 years as of December 31, 2024 [769]. - The company has not recognized any impairment charges for long-lived assets during the years ended December 31, 2024, and 2023 [762].
Edgewise Therapeutics(EWTX) - 2024 Q4 - Annual Report