AUTL 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-11

• •We reported net product revenue of $45.7 million for three months ended June 30, 2026, compared to $20.9 million for the same period the prior year and compared to $26.2 million for three months ending March 31, 2026. Net revenues were primarily driven by increasing product demand both within exist…

• •Additional data from the FELIX trial focusing on the impact of tumor burden and bridging therapy on safety and efficacy in adult r/r ALL patients treated with obe-cel were presented at the American Society of Clinical Oncology (“ASCO”) and European Hematology Association (“EHA”) annual meetings.

• •Our Phase 2 portion of the ongoing CATULUS trial of obe-cel in pediatric relapsed or refractory (r/r) B-cell precursor ALL (“B-ALL”) patients is on track and data is expected to be reported at the end of 2027.

• •Our next data update from the Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (“SLE”) has been submitted for presentation at the American College of Rheumatology (“ACR”) Annual Meeting in the fourth quarter of 2026. LUMINA, the pivotal Phase 2 study of obe-cel…

• •The Phase 1 BOBCAT trial is expected to include up to 18 adult patients and will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS.

相对上期删除的文字 · 来源:10-Q · 2026-05-14

• •We reported net product revenue, net of $26.2 million for three months ended March 31, 2026, compared to $9.0 milion for the three months ended March 31, 2025.

• •We launched AUCATZYL in the U.K. in January 2026 and it is now available under routine commissioning.

• •Data from the Real-World Outcomes Collaborative for CAR T in Adult ALL (“ROCCA”) consortium database evaluating patient characteristics, toxicity and response after real-world administration of AUCATZYL was presented at the TANDEM meeting in February 2026. Real-world data show consistency in both s…

• •The Phase 2 portion of the ongoing CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-ALL patients is underway and we expect to report data at the end of 2027. The U.S. Food and Drug Administration (“FDA”) has granted regenerative medicine advanced therapy (“RMAT”) designa…

• •Data from the Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (“srSLE”) supported progression of obe-cel as a treatment for LN and selection of the recommended Phase 2 dose of 50 million cells. Following alignment with the FDA on a potential registrational pat…

相对上期删除的文字 · 来源:10-Q · 2026-05-14

• On May 13, 2026, Mr. John Berriman, a member of the board of directors of the Company since 2014, notified the Company of his intention not to stand for re-election at the Company’s 2026 Annual General Meeting of Shareholders. Mr. Berriman has indicated that this decision was not the result of any d…