Financial Position and Cash Flow - Total cash, cash equivalents, and investments as of June 30, 2024, amounted to 334.4million[86]−TheJanuary2024publicofferingresultedinnetproceedsof161.4 million after deducting underwriting discounts and offering costs[88] - As of June 30, 2024, the company had 334.4millionincash,cashequivalents,andinvestments,whichisexpectedtofundoperatingexpensesandcapitalexpendituresinto2027[125]−NetcashusedinoperatingactivitiesforthesixmonthsendedJune30,2024was32.9 million, a 19.6millionincreasecomparedtothesameperiodin2023[133]−NetcashusedininvestingactivitiesforthesixmonthsendedJune30,2024was199.0 million, primarily due to purchases of investments using proceeds from the January 2024 Offering[134] - Net cash provided by financing activities for the six months ended June 30, 2024 was 161.4million,primarilyfromtheJanuary2024Offering[135]−Thecompanyhasraisedaggregategrossproceedsofapproximately359.7 million from outside capital, including Series A convertible preferred stock, Pre-Merger Financing Transaction, and the January 2024 Offering[125] Net Losses and Accumulated Deficit - Net losses for the six months ended June 30, 2024, were 30.8million,comparedto23.6 million for the same period in 2023[87] - Accumulated deficit as of June 30, 2024, was 92.8million[87]−Netlossincreasedby1.4 million to 17.5millionforQ22024comparedtoQ22023[115]−Netlossincreasedby7.2 million to 30.8millionforthefirstsixmonthsof2024comparedtothesameperiodin2023[119]−Thecompanyincurrednetlossesof30.8 million and 23.6millionforthesixmonthsendedJune30,2024and2023,respectively,withanaccumulateddeficitof92.8 million as of June 30, 2024[125] Research and Development Expenses - Research and development expenses increased by 1.3millionto15.7 million for Q2 2024 compared to Q2 2023[116] - Research and development expenses increased by 6.5millionto27.1 million for the first six months of 2024 compared to the same period in 2023[120] - The company expects significant increases in research and development and general and administrative costs in the future[124] General and Administrative Expenses - General and administrative expenses increased by 4.3millionto6.2 million for Q2 2024 compared to Q2 2023[118] - General and administrative expenses increased by 9.1millionto12.4 million for the first six months of 2024 compared to the same period in 2023[122] - The company expects significant increases in research and development and general and administrative costs in the future[124] Clinical Trials and Product Development - The company initiated a Phase 2 trial of pacibekitug in patients with chronic kidney disease (CKD) and elevated high-sensitivity CRP (hs-CRP) in April 2024, with topline data expected in the first half of 2025[85] - The company expects to report topline data from the pivotal Phase 2b spiriTED trial in 2025 and commence a pivotal Phase 3 trial in the second half of 2024[83] - The company has identified thyroid eye disease (TED) as the beachhead indication for its FcRn+ strategy, with ongoing clinical trials[82] - Future funding requirements will depend on factors such as clinical trial costs, regulatory review costs, and commercialization expenses for pacibekitug and other product candidates[129] Revenue and Sales Milestones - No revenue generated since inception, with no expectation of near-term product sales[103] - The global sales of four anti-IL-6 or anti-IL-6R antibodies exceeded 3.5billionin2023[80]−Thecompanyhasnotgeneratedanyrevenuefromproductsalesandexpectstorequiresubstantialadditionalcapitalforproductdevelopmentandcommercialization[126]ObligationsandRoyalties−ThecompanyisobligatedtopayPfizerupto128.0 million for development and regulatory milestones and up to 525.0millionforsalesmilestones[94]−ThecompanyisobligatedtopayLonzaaroyaltyinthelow−singledigitsontheNetSalesofproductscontainingpacibekitug[99]−ThecompanymayberequiredtopayPfizerupto128.0 million for development and regulatory milestones and up to 525.0millionforsalesmilestonesrelatedtopacibekitug[131]OtherIncomeandFutureFunding−Otherincome,netincreasedby8.4 million to $8.7 million for the first six months of 2024 compared to the same period in 2023[123] - The company will need additional capital to fund operations, potentially from equity or debt financings, collaborations, or licensing arrangements[124] Regulatory and Reporting Status - The company remains an emerging growth company and a smaller reporting company, with reduced disclosure obligations[143][144]