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Edgewise Therapeutics(EWTX) - 2024 Q4 - Annual Report

Financial Performance - Net losses for Edgewise Therapeutics were 133.8millionin2024,upfrom133.8 million in 2024, up from 100.2 million in 2023, reflecting an increase of 33.6million[655].Thenetlossfor2024was33.6 million [655]. - The net loss for 2024 was 133.8 million, compared to a net loss of 100.2millionin2023,indicatinga33100.2 million in 2023, indicating a 33% increase in losses [734]. - The total comprehensive loss for 2024 was 133.5 million, compared to 98.7millionin2023,representinga3598.7 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 100.2millionfor2023,representinga33.5100.2 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 90.9millionin2023,anincreaseof90.9 million in 2023, an increase of 36.1 million [672]. - Research and development expenses for the year ended December 31, 2024, were 127.0million,up40127.0 million, up 40% from 90.9 million in 2023 [734]. - The sevasemten clinical program incurred 51.7millioninexpensesin2024,upfrom51.7 million in expenses in 2024, up from 34.8 million in 2023, a rise of 16.8million[673].EDG7500clinicalprogramexpensesincreasedby16.8 million [673]. - EDG-7500 clinical program expenses increased by 8.9 million to 17.9millionin2024,primarilyduetotheactivationofthePhase2CIRRUSHCMtrial[673].Researchanddevelopmentexpensesincreasedto17.9 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 57.5millionin2023,reflectinga39.457.5 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 5.7millionin2023,indicatinganincreaseof14.45.7 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 184.7million,primarilydueto184.7 million, primarily due to 477.1 million in purchases of marketable securities, offset by 277.9millioninmaturitiesofmarketablesecurities[685].Cashprovidedbyfinancingactivitiesin2024was277.9 million in maturities of marketable securities [685]. - Cash provided by financing activities in 2024 was 249.3 million, significantly higher than 53.2millionin2023,drivenby53.2 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 109.0millionin2024,upfrom109.0 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 41.7millionin2024from41.7 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 175million[689].Thecompanyraised175 million [689]. - The company raised 240.0 million in gross proceeds from an underwritten registered direct offering of 21,818,182 shares at 11.00pershareinJanuary2024[745].Thecompanyhasenteredintoasalesagreementallowingforthepotentialsaleofupto11.00 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 31.9millionin2024from31.9 million in 2024 from 23.5 million in 2023, an increase of 8.4million[677].Thecompanyreportedtotaloperatingexpensesof8.4 million [677]. - The company reported total operating expenses of 158.8 million for 2024, a 39% increase from 114.4millionin2023[734].Noncashchargesinoperatingactivitiesfor2024includedstockbasedcompensationexpenseof114.4 million in 2023 [734]. - Non-cash charges in operating activities for 2024 included stock-based compensation expense of 24.7 million and depreciation of 2.1million[683].ShareholderEquityandStockOptionsTheweightedaveragesharesoutstandingincreasedto92.4millionin2024from63.7millionin2023,reflectinga452.1 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 563.5millionin2023,markinga48563.5 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 267.4million[787].ThetotalstockbasedcompensationexpensefortheyearendedDecember31,2024was267.4 million [787]. - The total stock-based compensation expense for the year ended December 31, 2024 was 24.7 million, an increase from 17.6millionin2023[800].Thecompanygranted2,817,497stockoptionsin2024ataweightedaverageexercisepriceof17.6 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,withunrealizedgainsof469,978,000, with unrealized gains of 530,000 and unrealized losses of 110,000[768].Theremainingcontractualmaturitiesof110,000 [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].