产品获批 - 公司于8月1日获得美国FDA批准,Tecelra成为首个获批用于治疗实体瘤的基因改造细胞疗法,也是10多年来治疗滑膜肉瘤的首个新疗法[5] - Tecelra为单次输注治疗,无需风险评估和缓解策略(REMS)计划[6] 产品商业化 - 公司计划于2025年开始递交lete-cel的生物制品许可申请(BLA),并于2026年商业化上市,预计美国峰值销售额达4亿美元[5] 研发管线 - 公司与Galapagos达成临床合作,共同评估uza-cel(新一代改造TCR T细胞疗法)在头颈癌和其他实体瘤适应症的安全性和有效性[8] 财务状况 - 公司获得Hercules Capital提供的最高1.25亿美元的贷款额度,在获得Tecelra批准后可提取2500万美元[10] - 公司第二季度总流动性为2.148亿美元,较2023年末增加4.785亿美元[3][11] - 第二季度收入为1.282亿美元,同比增长25倍,主要由于Genentech合作的终止[11] - 第二季度净利润为6950万美元,上年同期亏损2130万美元[11] - 公司现金及现金等价物为2.148亿美元，较上年同期增加1.346亿美元[38] - 公司营业收入为2.218亿美元，较上年同期增加4.067亿美元[31] - 公司净利润为2.102亿美元，较上年同期增加4.137亿美元[31] - 公司研发费用为6.16亿美元，较上年同期增加0.647亿美元[32] - 公司经营活动产生的现金流量净额为1.545亿美元，较上年同期增加9.65亿美元[33] - 公司发行新股筹集资金2.917亿美元[36] - 公司发行新债筹集资金2.45亿美元[36] - 公司应收账款净额为2.335亿美元，较上年同期增加1.514亿美元[23] - 公司存货为3.665亿美元，较上年同期减少2.315亿美元[23] - 公司固定资产净值为4.587亿美元，较上年同期减少5.079亿美元[24]

Adaptimmune received U.S. FDA accelerated approval of Tecelra® (afami-cel), the first approved engineered cell therapy for a solid tumorPatients can begin treatment journey; biomarker testing available; Adaptimmune systems ready to receive ordersAt the end of Q2, Adaptimmune had Total Liquidity[1] of $214.8 millionPhiladelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - August 12, 2024) - Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers ...

Adaptimmune to Report Q2 2024 Financial and Business Updates on Monday, August 12, 2024August 05, 2024 8:00 AM EDT | Source: Adaptimmune Therapeutics PLCPhiladelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - August 5, 2024) - Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, will report financial results and provide business updates for the second quarter ended June 30, 2024, before the US markets open on ...

Loading...Loading...By Michael KimREAD THE FULL ADAP RESEARCH REPORTWe are initiating coverage of Adaptimmune Therapeutics plc ADAP with a 12-month price target of $3.00, translating into sizeable upside from the stock's current price. Adaptimmune designs, develops, manufactures, and delivers innovative cell therapies via the company's unique T-cell receptor (TCR) platform to treat cancers across multiple solid tumor types.Our investment thesis revolves around:1. Unique T-cell therapy: Adaptimmune's mission ...

Adaptimmune and Galapagos to conduct clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel (next generation MAGE-A4 TCR T-cell therapy) produced on Galapagos' decentralized manufacturing platform in patients with head & neck cancerUza-cel has shown encouraging results in head & neck cancer with partial responses in four out of five patients to date in a Phase 1 trial using Adaptimmune's centralized manufacturing platform Initial in vitro testing of uza-cel produced on Galapagos' dec ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ 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 001-37368 ADAPTIMMUNE THERAPEUTICS PLC (Exact name of Registrant as specified in its charter) England and Wales Not Applicabl ...

财务数据和关键指标变化 - 公司在Q1筹集了约3000万美元的资金,并与Hercules Capital签署了最高1.25亿美元的债务融资协议,其中第一笔2500万美元已经到账,另外2500万美元将在afami-cel获批后到账,这些资金将支持公司的优先事项,包括afami-cel的商业化发布和lete-cel的开发等 [16] 各条业务线数据和关键指标变化 - 公司正在推进lete-cel的开发,计划在ASCO会议上发布IGNYTE-ESO试验的中期数据分析结果,这将是对这一细胞疗法的重要里程碑,有助于进一步推进lete-cel在2025年提交BLA申请,预计2026年获批 [15] - 公司正在推进uza-cel在铂耐药性卵巢癌、头颈癌和膀胱癌等适应症的开发,计划在今年年底提供这些适应症的临床前期数据更新,为后续的开发方向提供指引 [39][40] 各个市场数据和关键指标变化 - 公司正在为afami-cel的商业化做准备,计划在获批后的第一个季度从6-10家治疗中心开始,并在18个月内扩展到约30家治疗中心,其中16家中心有afami-cel的临床试验经验 [53][55] - 公司预计afami-cel获批后,首批患者将在第四季度开始接受治疗,首次确认收入也将在第四季度实现,这是由于作为自体疗法,需要经过筛选、制备和运输等一系列流程 [49][70] 公司战略和发展方向及行业竞争 - 公司将afami-cel作为开启肉瘤治疗商业化的开端,未来还将推进lete-cel和uza-cel等其他管线的开发,逐步扩大细胞疗法在肿瘤治疗领域的应用 [63][64][65] - 公司认为细胞疗法有望成为肿瘤治疗的主流方式,未来还可能拓展到自身免疫性疾病等其他适应症 [61][62][65] 管理层对经营环境和未来前景的评论 - 公司对afami-cel获批后的商业化前景充满信心,认为肉瘤患者群体对这一新疗法有很高的期待和需求 [13] - 公司表示与FDA的审评进展顺利,目前未要求召开AdComm会议或制定REMS计划,正在就标签内容进行讨论 [11][32][46][47] - 公司正在扩大制造能力,以满足afami-cel上市后的预期需求 [14] 问答环节重要的提问和回答 问题1 **Jonathan Chang 提问** 询问债务融资对公司现金流预测的影响 [19] **Gavin Wood 回答** 公司已经考虑了多方面因素,包括Genentech合作终止、afami-cel进展、融资活动等,预计现金流可维持至2025年底 [21][22] 问题2 **Marc Frahm 提问** 询问公司对afami-cel标签内容的预期 [31] **Dennis Williams 回答** 公司正在与FDA就标签措辞细节进行讨论,比如如何管理细胞因子释放综合征等,但对适应症表述没有任何争议 [33][34] 问题3 **Graig Suvannavejh 提问** 询问制造设施FDA检查的最新进展 [44] **Dennis Williams 回答** 公司的制造设施和临床试验点检查已全部完成,结果良好,不预计还有其他检查 [45][46][47]

Exhibit 99.1 Adaptimmune Reports Q1 2024 Financial and Business Updates Afami-cel commercial and regulatory update presented at Company’s Investor Day (replay HERE); FDA review and inspections progressing with PDUFA date of August 4th, 2024 Commercial and manufacturing infrastructure in place to support afami-cel commercial launch upon approval Data from SPEARHEAD-1 pivotal trial with afami-cel published in The Lancet; data from a planned interim analysis of pivotal lete-cel IGNYTE-ESO trial to be presented ...

Garry Menzel joins GHO Capital as Operating Partner Former CEO of TCR² Therapeutics with significant investment and operating experience to support deal origination and provide best in class services to pioneering healthcare companies London, UK – 23 April 2024: Global Healthcare Opportunities, or GHO Capital Partners LLP ("GHO"), the European specialist investor in global healthcare, is pleased to announce the appointment of Dr. Garry Menzel as Operating Partner. Garry brings a unique blend of scientific, ...

Adaptimmune Therapeutics plc (ADAP) announced that its strategic collaboration with Roche’s (RHHBY) Genentech has been terminated. Shares of ADAP were down 10% on the news.Both companies collaborated in 2021 to develop and commercialize allogeneic cell therapies to treat multiple oncology indications.The collaboration had two components — the development of allogeneic T-cell therapies for up to five shared cancer targets and the development of personalized allogeneic T-cell therapies.ADAP was responsible fo ...