Core Insights - Autolus Therapeutics plc reported preliminary unaudited net product revenue from AUCATZYL® sales, with fourth quarter 2025 revenue expected to be approximately $24 million and full year 2025 revenue around $75 million, significantly exceeding expectations [3][6] - The company anticipates 2026 net product revenue for AUCATZYL to be between $120 million and $135 million, driven by a successful launch and positive real-world data [4][6] Commercial Updates - AUCATZYL was successfully launched in the US, with over 60 treatment centers established, and received regulatory approvals in the UK and EU [2][3] - The ROCCA consortium's real-world data confirmed AUCATZYL's high clinical activity and favorable safety profile, which is expected to enhance future growth [2][6] Pipeline Updates - Autolus reported strong initial clinical data from the Phase 1 CATULUS trial in pediatric r/r B-ALL patients, showing a 95.5% overall response rate, and plans to advance to Phase 2 [5][12] - The company is also progressing studies in lupus nephritis and multiple sclerosis, with initial data from the BOBCAT trial expected by the end of 2026 [7][12] Operational Focus - The company aims to optimize manufacturing operations to improve gross margins and drive top-line growth for AUCATZYL in 2026 [8][9] - Autolus has initiated a manufacturing life cycle plan to reduce costs and enhance capacity, with updates expected in mid-2026 [9][10] Financial Outlook - Based on current projections, Autolus expects its cash and marketable securities to fund operations into Q4 2027, supporting ongoing development and commercialization efforts [10]

Core Insights - Autolus Therapeutics plc has presented preliminary data from the Phase 1 CARLYSLE trial for its CD19-targeting CAR T-cell therapy, obe-cel, in patients with severe refractory systemic lupus erythematosus (srSLE) at the American Society of Hematology Annual Meeting [1][2] Group 1: Trial Data and Efficacy - The CARLYSLE trial shows a high rate of DORIS responses and a significant reset in the B cell compartment, indicating potential for immune reset in srSLE patients [2][5] - In the 50 million cell dose cohort, 50% of patients achieved complete response rates (CRR) and 83% achieved DORIS, with a median onset of 5.1 months and no new disease activity observed at a median follow-up of 12 months [5][6] - The 100 million cell cohort data is consistent with the 50 million cohort, supporting the progression of obe-cel as a treatment for srSLE, with the 50 million dose selected for the Phase 2 trial [6][7] Group 2: Safety Profile - Obe-cel was well tolerated, with no dose-limiting toxicities or cases of immune effector cell-associated neurotoxicity syndrome (ICANS) observed at the 50 million dose [4][7] - Grade one cytokine release syndrome (CRS) occurred in three patients at both the 50 million and 100 million doses, while transient Grade three liver toxicity was noted in one patient from the 100 million cohort [4][5] - The safety profile of obe-cel is supported by a robust database from previous clinical trials in other indications, indicating deep and durable responses [7][8] Group 3: Future Developments - Autolus has initiated the LUMINA trial, a Phase 2 trial in lupus nephritis with registrational intent, based on the positive initial experience from the CARLYSLE trial [2][6] - The company has aligned with the U.S. Food and Drug Administration (FDA) on the Phase 2 trial design and potential path to approval [6][8] - Autolus is positioned for a successful entry into the autoimmune disease market, leveraging its existing clinical data and manufacturing capabilities [8]