Kyverna Therapeutics(US:KYTX)2025-11-12 21:11Financial Performance - Kyverna reported net losses of $36.8 million and $123.5 million for the three and nine months ended September 30, 2025, respectively, compared to $34.5 million and $90.0 million for the same periods in 2024[116]. - Kyverna has not generated any revenue from product sales since its inception in June 2018[115]. Clinical Development - The company has completed patient enrollment for the Phase 2 trial in Stiff Person Syndrome (SPS) during Q2 2025, with top line data expected in early 2026[109]. - The KYSA-6 Phase 2 trial in Myasthenia Gravis (MG) was amended to a registrational Phase 2/3 trial, with patient enrollment for the Phase 3 portion expected to begin by the end of 2025[110]. - Kyverna's lead product candidate, KYV-101, is designed for potency and tolerability, with a focus on treating autoimmune diseases through deep B cell depletion[107]. - The company is advancing a rapid whole blood manufacturing process for KYV-102, with an investigational new drug (IND) application expected to be filed in Q4 2025[112]. - The clinical development pipeline includes registrational trials for SPS and MG, as well as multi-center Phase 1/2 trials for Lupus Nephritis[108]. - Kyverna has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designations from the FDA for both SPS and MG[110]. - The total number of patients expected to be enrolled in the Phase 3 trial for MG is 60[110]. Regulatory and Reporting Status - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards until they apply to private companies[170]. - The company is also identified as a smaller reporting company, which permits it to present only the two most recent fiscal years of audited financial statements in its Form 10-K[171]. - As a smaller reporting company, the company has reduced disclosure obligations regarding executive compensation[171]. - There have been no material changes to significant accounting policies or critical accounting estimates during the nine months ended September 30, 2025[169]. - The company may choose to early adopt new or revised accounting standards whenever permitted for private companies[170]. - The condensed financial statements may not be comparable to those of companies that comply with new or revised accounting pronouncements as of public company effective dates[170]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its smaller reporting company status[172].