Financial Performance - The company incurred net losses of 71.3millionand64.5 million for the years ended December 31, 2024 and 2023, respectively [426]. - The company generated negative operating cash flows of 62.6millionand52.1 million for the years ended December 31, 2024 and 2023, respectively [426]. - As of December 31, 2024, the company had an accumulated deficit of 240.9million[426].−Netlossincreasedby6.8 million, from 64.5millionin2023to71.3 million in 2024, an 11% increase [446]. - Total other income, net increased by 0.6million,from4.4 million in 2023 to 5.0millionin2024[453].−CashprovidedbyfinancingactivitiesfortheyearendedDecember31,2024,was47.9 million, primarily from the issuance and sale of common stock [477]. - The company anticipates substantial additional funding will be required to support ongoing operations and product development initiatives [464]. - The company has significant uncertainties regarding its ability to continue as a going concern within one year from the date of filing the Annual Report due to recurring losses and negative cash flows [464]. Research and Development - The company commenced the Phase 1b/2a BEACON study in Chronic Spontaneous Urticaria (CSU) in late 2023, with 100% complete responses observed at the 240mg dose level [421]. - In the Phase 1b/2a SPOTLIGHT study for Chronic Inducible Urticaria (CIndU), 93% of participants achieved a clinical response across the 40mg and 120mg dosing cohorts [429]. - The company is developing briquilimab as a one-time conditioning therapy for severe combined immunodeficiency (SCID) patients undergoing a second stem cell transplant [422]. - The company has an exclusive license agreement with Amgen for the development and commercialization of briquilimab in all indications and territories worldwide [424]. Expenses and Costs - Research and development expenses increased by 4.0million,from51.8 million in 2023 to 55.8millionin2024,representingan84.9 million, from 10.0millionin2023to14.9 million in 2024, a 49% increase [448]. - General and administrative expenses increased by 3.3million,from17.1 million in 2023 to 20.4millionin2024,a207.4 million, from 68.9millionin2023to76.2 million in 2024, an 11% increase [446]. - Program costs decreased by 2.5million,from36.8 million in 2023 to 34.3millionin2024,primarilyduetoasignificantreductioninCMOexpenses[450].CashandLiquidity−Thecompanyhadcashandcashequivalentsof71.6 million as of December 31, 2024 [427]. - Cash used in investing activities was 0.5millionfortheyearendedDecember31,2024,primarilyforpurchasesofpropertyandequipment[476].−Thecompanyfiledauniversalshelfregistrationstatementallowingfortheofferingofupto250.0 million in securities, effective until May 5, 2026 [459]. - An underwritten offering in February 2024 raised net proceeds of 47.2millionfromtheissuanceof3,900,000sharesofcommonstock[461].−AsofDecember31,2024,thecompanyhadcashandcashequivalentstotaling71.6 million, with no outstanding debt [491]. - The company intends to maintain its portfolio of cash equivalents in institutional market funds composed of U.S. Treasury and U.S. Treasury-backed securities to minimize future interest rate risk [491]. Other Considerations - The company has lease commitments of 1.2millionwithinthenext12monthsand0.7 million for the remainder of the lease term as of December 31, 2024 [468]. - The company is obligated to pay up to 9.0millioninmilestonepaymentsunderthe2021StanfordLicenseAgreement,withnoroyaltiesdueasofDecember31,2024[469].−Thecompanyhasnotexperiencedmaterialforeigncurrencytransactiongainsorlosses,andahypothetical10250 million [490].