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Kyverna Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results
KYTXKyverna Therapeutics(KYTX) Prnewswire·2025-03-27 20:02

Core Insights - Kyverna Therapeutics is advancing its clinical programs for KYV-101, targeting stiff person syndrome, myasthenia gravis, and lupus nephritis, with a clear path to commercialization [2][7][17] - The company has aligned with the FDA on a registrational Phase 2 trial design for KYSA-8 in stiff person syndrome, with 70% enrollment completed and topline data expected in the first half of 2026 [7][11] - Financially, Kyverna reported 286millionincashandequivalentsasofDecember31,2024,providingacashrunwayinto2027[11][21]ClinicalDevelopment−KYV−101isanautologous,fullyhumanCD19CART−cellproductcandidate,currentlyinpivotalPhase2trialsforstiffpersonsyndromeandmyastheniagravis,andPhase1/2trialsforlupusnephritis[3][15]−ThecompanyexpectstoreportinterimdatafromthePhase2trialinmyastheniagravisinthesecondhalfof2025,andPhase1datafromlupusnephritistrialsinthesametimeframe[6][7]−KyvernaisalsoexploringadditionalindicationsforKYV−101throughinvestigator−initiatedtrialsacrossvariousautoimmunediseases[9][17]FinancialPerformance−FortheyearendedDecember31,2024,Kyvernareportedanetlossof286 million in cash and equivalents as of December 31, 2024, providing a cash runway into 2027 [11][21] Clinical Development - KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate, currently in pivotal Phase 2 trials for stiff person syndrome and myasthenia gravis, and Phase 1/2 trials for lupus nephritis [3][15] - The company expects to report interim data from the Phase 2 trial in myasthenia gravis in the second half of 2025, and Phase 1 data from lupus nephritis trials in the same timeframe [6][7] - Kyverna is also exploring additional indications for KYV-101 through investigator-initiated trials across various autoimmune diseases [9][17] Financial Performance - For the year ended December 31, 2024, Kyverna reported a net loss of 127.5 million, or 3.33pershare,comparedtoanetlossof3.33 per share, compared to a net loss of 60.4 million, or 89.61pershare,in2023[12][20]−Operatingexpensesincreasedsignificantly,withresearchanddevelopmentcostsrisingto89.61 per share, in 2023 [12][20] - Operating expenses increased significantly, with research and development costs rising to 112.5 million from 49.9millioninthepreviousyear[20]−Thecompany’stotalassetsasofDecember31,2024,were49.9 million in the previous year [20] - The company’s total assets as of December 31, 2024, were 304.6 million, a substantial increase from $75.2 million in 2023 [21] Strategic Initiatives - Kyverna has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for its programs [7][8] - The company is strengthening its management team to support its growth strategy, with key appointments in executive roles [13] - Future plans include filing an investigational new drug application for KYV-102 in the second half of 2025, which aims to improve patient access to CAR T therapies [9][16]