UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 17, 2024 Autolus Therapeutics plc (Exact name of registrant as specified in its Charter) England and Wales 001-38547 Not applicable (State or other jurisdiction of (Commission File (I.R.S. Employer Identification incorporation or organization) Number) No.) The Mediaworks 191 Wood Lane Londo ...

Longer follow up and subset analyses from the pivotal FELIX Phase 2 data to be presented in oral presentations at ASCO and EHA Two patients enrolled in Phase 1 Systemic Lupus Erythematosus (SLE) trial; study on track for initial data end of 2024 Market Authorization Application (MAA) for obe-cel in r/r adult ALL accepted by European Medicines Agency (EMA) Conference call to be held today at 08:30 am EDT/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press ...

Longer follow up and subset analyses from the pivotal FELIX Phase 2 data to be presented in oral presentations at ASCO and EHA Two patients enrolled in Phase 1 Systemic Lupus Erythematosus (SLE) trial; study on track for initial data end of 2024 Market Authorization Application (MAA) for obe-cel in r/r adult ALL accepted by European Medicines Agency (EMA) Conference call to be held today at 08:30 am EDT/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press ...

LONDON, April 24, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), a clinical- stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the abstract for longer-term follow-up and additional data analysis from the pivotal Phase 2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) was selected for an oral presentation at the 2024 American Society of Clinical Oncology ( ...

LONDON, April 23, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), a clinical- stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced that it will release its first quarter 2024 financial results and operational highlights before open of US markets on Tuesday, May 14, 2024. Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST to discuss the company's financial results and provide a general business update. Conference c ...

Table of contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the transition period from to Commission file number: 001-38547 Autolus Therapeutics plc (Exact name of Registrant as specified in its charter) England and Wales Not applicable (State ...

财务数据和关键指标变化 - 公司2023年12月31日的现金及现金等价物为2.396亿美元,相比2022年12月31日的3.824亿美元有所下降 [65] - 2023年全年总运营费用净额为1.797亿美元,相比2022年同期的1.434亿美元有所增加 [66] - 研发费用从2022年的1.174亿美元增加到2023年的1.305亿美元,主要是由于公司新制造设施的运营成本增加、合同里程碑付款以及人员成本增加所致 [67] - 一般管理费用从2022年的3,190万美元增加到2023年的4,670万美元,主要是由于支持业务整体增长的行政人员增加,主要与商业化准备活动有关 [69] - 2023年全年归属于普通股东的净亏损为2.084亿美元,相比2022年同期的1.488亿美元有所增加 [70] 各条业务线数据和关键指标变化 - 公司目前主要聚焦于obe-cel在成人ALL适应症的开发,没有提及其他业务线的具体数据和指标变化 [9-29] 各个市场数据和关键指标变化 - 公司正在准备在美国、欧洲和英国三大市场推出obe-cel,已完成MHRA对制造设施的检查和批准,并分别向FDA和EMA提交了上市申请 [26][52] - 公司计划在obe-cel上市时拥有30家已认证的治疗中心为患者提供服务 [28] 公司战略和发展方向及行业竞争 - 公司与BioNTech达成战略合作,BioNTech将投资2.5亿美元,双方将在制造、商业化和产品开发等方面展开合作 [12-17] - 公司计划将obe-cel拓展至其他B细胞恶性肿瘤适应症,并探索在自身免疫性疾病领域的应用 [53-60] - 公司正在评估是否启动另一个自身免疫性疾病的关键性研究,或启动一个非霍奇金淋巴瘤的关键性研究 [115-117] 管理层对经营环境和未来前景的评论 - 公司在2023年取得了重大进展,包括完成制造设施建设和验证、提交obe-cel的BLA和MAA申请,为商业化做好准备 [19-28][52] - 公司现金充足,加上BioNTech交易和增发,预计有足够资金推进obe-cel商业化和管线发展计划 [65][71] - 管理层对obe-cel在成人ALL适应症的前景表示乐观,并计划在2024年中期和年底提供更多临床数据更新 [20-23][74] - 管理层认为obe-cel在自身免疫性疾病领域也有广阔前景,正在推进首个适应症的临床研究 [30-31][121-123] 问答环节重要的提问和回答 问题1 **James Shin 提问** 询问MHRA检查是否与FDA或EMA检查有重叠 [82] **Christian Itin 回答** MHRA检查是独立于FDA的,但与欧洲申报相关,是欧洲申报的先决条件。MHRA和FDA在GMP制造标准方面的审查基础是相同的,但是两个机构进行独立的审查 [82-83] 问题2 **Gil Blum 提问** 询问桥接治疗对患者生存的影响,以及公司是否考虑进一步研究优化桥接治疗 [100-104] **Christian Itin 回答** 桥接治疗是ALL治疗不可或缺的一部分,可以显著影响患者的疾病负荷和预后。公司允许灵活使用桥接治疗是为了更好地管理患者,未来可能会进一步研究不同桥接治疗方案的影响 [100-104] 问题3 **Eric Yeung 提问** 询问公司自身免疫项目与竞争对手项目的差异和优势 [115-119] **Christian Itin 回答** 公司的产品与德国Erlangen大学的产品在结构和临床数据上有很强的相似性,这为预测公司产品在自身免疫适应症的表现提供了依据。相比竞争对手,公司产品在安全性方面具有明显优势,这得益于其独特的CAR设计 [115-119]

Full Year 2023 Financial Results and Business Updates ...

Announced strategic collaboration and equity investment from BioNTech for aggregate proceeds of $250 million upfront, plus underwritten offering of ADSs for $350 million, for gross proceeds of $600 million received in February 2024 Submitted a Biologics License Application (BLA) for obecabtagene autoleucel (obe-cel), a potentially transformational treatment for relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL), to the US Food & Drug Administration (FDA); Prescription Drug User Fee Ac ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 14, 2024 Autolus Therapeutics plc (Exact name of registrant as specified in its Charter) England and Wales 001-38547 Not applicable (State or other jurisdiction of (Commission File (I.R.S. Employer Identification No.) incorporation or organization) Number) The Mediaworks 191 Wood Lane Lon ...