Adaptimmune Reports Q1 2024 Financial and Business Updates
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
Afami-Cel在公司投资者日发布了商业和监管最新情况（在此重播）；FDA的审查和检查正在进行中，PDUFA的日期为2024年8月4日
Commercial and manufacturing infrastructure in place to support afami-cel commercial launch upon approval
商业和制造基础设施到位，可在获得批准后支持 afami-cel 的商业推出
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 at ASCO
来自使用 afami-cel 的 SPEARHEAD-1 关键试验的数据发表于 《柳叶刀》；来自计划在ASCO上公布的关键lete-cel IGNYTE-ESO试验的中期分析的数据
Cash runway into late 2025
直到 2025 年底的现金流道
Conference call today at 8 a.m. EDT webcast link HERE
美国东部时间今天上午8点的电话会议网络直播链接在这里
Philadelphia, Pennsylvania and Oxford, United Kindgom--(Newsfile Corp. - May 15, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today reports financial results and business updates for the first quarter ended March 31, 2024. The Company will host a live webcast at 8:00 a.m. EDT (1:00 p.m. BST) today.
宾夕法尼亚州费城和英国牛津--（Newsfile Corp.，2024年5月15日）——重新定义细胞疗法治疗实体瘤癌的公司Adaptimmune Therapeutics plc（纳斯达克股票代码：ADAP）今天公布了截至2024年3月31日的第一季度财务业绩和业务最新情况。该公司将于今天美国东部时间上午 8:00（英国夏令时间下午 1:00）举办网络直播。
Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "Support from the sarcoma community continues to highlight the high unmet medical need for new therapies for synovial sarcoma and we are making great progress preparing for the commercial launch of afami-cel on approval. Behind afami-cel, we plan to launch lete-cel for synovial sarcoma and MRCLS in 2026 with projected peak US sales of $400 million for our sarcoma franchise."
阿德里安·罗克利夫， Adaptimmune 首席执行官： “肉瘤界的支持继续凸显出对滑膜肉瘤新疗法的高度未得到满足的医疗需求，我们正在为afami-cel获得批准的商业上市做准备取得长足的进展。在afami-cel背后，我们计划在2026年推出用于滑膜肉瘤的lete-cel和MRCLS，预计我们的肉瘤系列在美国的峰值销售额为4亿美元。”
Sarcoma Franchise with afami-cel and lete-cel
afami-cel 和 lete-cel 的肉瘤特许经营权
- U.S. FDA accepted the BLA for afami-cel for the treatment of advanced synovial sarcoma with priority review and a PDUFA date of August 4th, 2024
- The BLA mid-cycle review meeting was held with FDA in April
- FDA GCP Bioresearch Monitoring Program (BIMO) inspections have been conducted at Adaptimmune and at selected clinical sites that participated in the pivotal
SPEARHEAD-1 trial - FDA GMP Pre-license inspections (PLI) have taken place at the Company's Navy Yard facility and at the lentiviral vector contract manufacturer's facility
- Preliminary plans for confirmatory evidence for afami-cel's full approval were previously agreed with FDA, including Cohort 2
- Adaptimmune expects to discuss post-marketing requirements and commitments at the late-cycle meeting which is scheduled for the second half of May
- To date, the FDA has not requested an Advisory Committee meeting or a REMS program
- The marketing application for the companion diagnostic for MAGE-A4 is currently under FDA review and is expected to be approved contemporaneously with the BLA
- Adaptimmune is preparing to launch afami-cel on approval in the U.S. Initially, launch will be focused on 6-10 selected treatment centers ("Authorized Treatment Centers" or "ATCs") and will expand to up to ~30 ATCs.
- 100% of the customer facing commercial and medical affairs teams is now in place
- Company launched : an unbranded website aimed at educating healthcare providers about TCR T-cell therapy in solid tumors, including synovial sarcoma, and the role of biomarkers and testing to determine future treatments
- The second product in Adaptimmune's sarcoma franchise, lete-cel, is being investigated in the pivotal IGNYTE-ESO trial (NCT03967223), which at a planned interim analysis exhibited response in 18/45 of patients (ORR 40%). The primary efficacy endpoint requires 16/60 patients have responses, so this trial has met its primary endpoint for efficacy. The full pivotal analyses are anticipated in late 2024.
- Lete-cel will enable Adaptimmune to expand its addressable synovial sarcoma patient population by targeting the NY-ESO cancer antigen, in addition to MAGE-A4 targeted by afami-cel, as well as treating Myxoid Round Cell Liposarcoma (MRCLS) patients.
- Sarcoma franchise of afami-cel and lete-cel leverages same development and commercial footprint with US peak year sales projected to be up to $400 million
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Data presentations
- Data from pivotal SPEARHEAD-1 trial with afami-cel published in The Lancet: article entitled "Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial"
- Data from the planned interim analysis of the pivotal IGNYTE-ESO trial with lete-cel to be presented by Dr. Sandra P. D'Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, in an oral presentation at ASCO entitled "Lete-cel in patients with synovial sarcoma or myxoid/round cell liposarcoma: Planned interim analysis of the pivotal IGNYTE-ESO trial" during the Developmental Therapeutics-Immunotherapy session in Hall D2 on June 3, 2024 at 11:30 a.m. CDT
- 美国食品药品管理局接受了用于治疗晚期滑膜肉瘤的 afami-cel 的 BLA，优先审查，PDUFA 日期为 2024 年 8 月 4 日
- BLA周期中期审查会议于4月与美国食品和药物管理局举行
- FDA GCP 生物研究监测计划 (BIMO) 已在 Adaptimmune 和参与关键检查的特定临床场所进行了检查
SPEARHEAD-1 试用版 - FDA GMP 许可前检查 (PLI) 已在该公司的海军造船厂和慢病毒载体合同制造商的工厂进行
- 此前已与美国食品药品管理局商定了为afami-cel获得全面批准提供确证证据的初步计划，包括队列2
- Adaptimmune预计将在定于5月下半月举行的周期末会议上讨论上市后的要求和承诺
- 迄今为止，美国食品和药物管理局尚未要求召开咨询委员会会议或REMS计划
- MAGE-A4 伴随诊断的上市申请目前正在接受美国食品药品管理局的审查，预计将与BLA同时获得批准
- Adaptimmune正准备在美国获得批准后推出afami-cel。最初，将重点推出6-10个选定的治疗中心（“授权治疗中心” 或 “ATC”），并将扩大到最多约30个ATC。
- 面向客户的商业和医疗事务团队现已全部到位
- 公司推出：一个无品牌的网站，旨在教育医疗保健提供者了解包括滑膜肉瘤在内的实体瘤的TCR T细胞疗法，以及生物标志物和测试在确定未来治疗方法方面的作用
- 在关键的IGNYTE-ESO试验（NCT03967223）中，Adaptimmune肉瘤系列中的第二款产品lete-cel正在研究中，该试验（计划中的中期分析）显示18/45名患者（ORR 40％）出现反应。主要疗效终点要求16/60名患者有反应，因此该试验已达到其主要疗效终点。完整的关键分析预计将在2024年底完成。
- Lete-Cel 将使 Adaptimmune 能够通过靶向 NY-ESO 癌症抗原以及 afami-cel 靶向的 MAGE-A4 以及治疗粘液圆形细胞脂肪肉瘤（MRCLS）患者来扩大其可寻址的滑膜肉瘤患者群体。
- afami-cel和lete-cel的肉瘤特许经营权利用了相同的开发和商业足迹，预计美国旺季销售额将高达4亿美元
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数据演示
- 来自 afami-cel 的关键 SPEARHEAD-1 试验的数据发表在《柳叶刀》上：文章标题为”用于晚期滑膜肉瘤和粘液样圆细胞脂肪肉瘤（SPEARHEAD-1）的Afamitresgene autoleucel：一项国际开放标签的2期试验”
- 计划对使用lete-cel的关键IGNYTE-ESO试验进行中期分析的数据，将由纪念斯隆·凯特琳癌症中心肉瘤内科肿瘤医学博士桑德拉·德安杰洛博士在ASCO的口头发言中公布，题目是”滑膜肉瘤或粘液样/圆细胞脂肪肉瘤患者中的Lete-cel：计划对关键的IGNYTE-ESO试验进行中期分析” 中部夏令时间 2024 年 6 月 3 日上午 11:30 在 D2 大厅举行的发育疗法-免疫疗法会议上
Clinical pipeline
临床管道
- Uzatresgene autoleucel ("uza-cel", formerly ADP-A2M4CD8) is being investigated in the SURPASS-3 Phase 2 clinical trial (NCT05601752) for the treatment of platinum-resistant ovarian cancer. Uza-cel received FDA RMAT designation in 2022 for the treatment of patients with platinum resistant ovarian cancer. The SURPASS-3 trial is currently enrolling patients.
- Cohorts in the Phase 1 SURPASS trial are ongoing for people with head & neck and urothelial (bladder) cancers with uza-cel in combination with standard of care checkpoint inhibitor therapy.
- 用于治疗耐铂卵巢癌的 SURPASS-3 二期临床试验（NCT05601752）正在研究Uzatresgene autoleucel（“uza-cel”，前身为 ADP-A2M4CD8）。Uza-Cel于2022年获得美国食品药品管理局RMAT认证，用于治疗耐铂卵巢癌患者。SURPASS-3 试验目前正在招收患者。
- 使用uza-cel与标准护理检查点抑制剂疗法联合治疗的头颈癌和尿路上皮（膀胱）癌患者的1期SURPASS试验的队列正在进行中。
Preclinical pipeline
临床前产品线
- IND-enabling studies are underway for ADP-600 (PRAME) and ADP-520 (CD70) programs.
- Wholly owned allogeneic pipeline advancing; process development in progress at Adaptimmune's allogeneic manufacturing facility in Milton Park, UK.
- ADP-600（PRAME）和 ADP-520（CD70）项目正在进行支持IND的研究。
- 全资异体管道正在推进；Adaptimmune位于英国米尔顿公园的异体制造工厂正在进行工艺开发。
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Data presentation
- Poster presented by George Pope, Ph.D., Associate Director Preclinical Safety at Adaptimmune, entitled "Development and Preclinical Characterization of an Engineered T-Cell Therapy Targeting PRAME-Expressing Solid Tumors" at the American Society of Gene & Cell Therapy (ASGCT) Annual meeting
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数据演示
- 由Adaptimmune临床前安全副总监乔治·波普博士主办的海报，标题为”针对表达 PRAME 的实体瘤的工程化 T 细胞疗法的开发和临床前表征“在美国基因与细胞疗法学会（ASGCT）年会上
Corporate news
企业新闻
- As announced earlier today, Adaptimmune has secured up to $125 million in debt financing with Hercules Capital with the first tranche of $25 million available upon closing; and an additional $25 million available upon afami-cel approval
- Cash runway into late 2025 which includes current cash on hand, anticipated revenues from the launch of afami-cel, expected future income from partners and other non-dilutive capital sources including the Company's new debt facility with Hercules Capital
- Company announced that its strategic collaboration with Genentech was terminated
- 正如今天早些时候宣布的那样，Adaptimmune已向Hercules Capital获得了高达1.25亿美元的债务融资，第一笔2500万美元在收盘时可用；另有2500万美元将在afami-cel批准后可用
- 到2025年底的现金流，其中包括当前的手头现金、启动afami-cel的预期收入、来自合作伙伴的预期未来收入以及其他非稀释性资本来源，包括公司与Hercules Capital的新债务额度
- 公司宣布终止与基因泰克的战略合作
Financial Results for the three months ended March 31, 2024
截至2024年3月31日的三个月的财务业绩
- Cash / liquidity position: As of March 31, 2024, Adaptimmune had cash and cash equivalents of $140.7 million and Total Liquidity[1] of $143.7 million, compared to $144.0 million and $146.9 million respectively, as of December 31, 2023.
- Revenue: Revenue for the three months ended March 31, 2024, was $5.7 million compared to $47.6 million for the same period in 2023. Revenue has decreased in 2024, compared to the same period in 2023 primarily due to the termination of the Astellas collaboration in the first quarter of 2023, resulting in the remaining deferred income for the collaboration being recognized as revenue in March 2023.
- Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2024, were $35.2 million compared to $25.5 million for the same period in 2023. R&D expenses in the three months ended March 31, 2024 increased in employee-related costs and additional costs associated with lease properties following the acquisition of TCR2 in June 2023 and a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits.
- General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2024, were $19.7 million compared to $20.4 million for the same period in 2023. G&A expenses in the three months ended March 31, 2024 decreased due to restructuring and charges recognised in the first quarter of 2023 and a decrease in other corporate costs due to an increase in accounting, legal and professional fees incurred in relation to the TCR2 Therapeutics, Inc merger agreement that were not repeated in 2024, offset by an increase in depreciation due to leasehold improvements capitalised in 2023.
- Net loss/profit: Net loss attributable to holders of the Company's ordinary shares for the three months March 31, 2024, was $48.5 million ($(0.03) per ordinary share), compared to a profit of $1.0 million ($0.00 per ordinary share), for the same periods in 2023.
- 现金/流动性状况： 截至2024年3月31日，Adaptimmune的现金及现金等价物为1.407亿美元，总流动性[1] 为1.437亿美元，而截至2023年12月31日，分别为1.44亿美元和1.469亿美元。
- 收入：截至2024年3月31日的三个月，收入为570万美元，而2023年同期为4,760万美元。与2023年同期相比，2024年的收入有所下降，这主要是由于安斯泰来在2023年第一季度终止了合作，导致该合作的剩余递延收入在2023年3月被确认为收入。
- 研发（R&D）费用： 截至2024年3月31日的三个月，研发费用为3520万美元，而2023年同期为2550万美元。在截至2024年3月31日的三个月中，研发费用增加了与员工相关的成本以及收购TCR后与租赁物业相关的额外成本2 2023年6月，研发税收和支出抵免的抵消应收报销额有所减少。
- 一般和行政（G&A）费用： 截至2024年3月31日的三个月，并购支出为1,970万美元，而2023年同期为2,040万美元。在截至2024年3月31日的三个月中，由于重组和2023年第一季度确认的费用，以及与TCR相关的会计、法律和专业费用增加导致其他公司成本的减少，G&A支出有所减少2 Therapeutics, Inc的合并协议在2024年没有重复，但被2023年资本化租赁权改善导致的折旧增加所抵消。
- 净亏损/利润： 2024年3月31日这三个月，归属于公司普通股持有人的净亏损为4,850万美元（每股普通股0.03美元），而2023年同期的利润为100万美元（每股普通股0.00美元）。
Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities, together with anticipated revenues from the launch of afami-cel, expected future income from partners and other non-dilutive capital sources including the Company's new debt facility with Hercules Capital announced earlier today, will fund the Company's current operations into late 2025, as further detailed in the Company's Quarterly Report on Form 10-Q for the three months ended March 31, 2024, to be filed with the Securities and Exchange Commission following this earnings release.
财务指导
该公司认为，其现有现金、现金等价物和有价证券，加上推出afami-cel的预期收入、合作伙伴和其他非稀释性资本来源的预期未来收入，包括公司今天早些时候宣布的与Hercules Capital的新债务额度，将为公司当前的业务提供到2025年底的资金，该公司将提交的截至2024年3月31日的三个月的10-Q表季度报告中进一步详述美国证券交易委员会将关注这笔收益发布。
Today's Webcast Details
A live webcast and replay can be accessed at . Call in information is as follows: 1-800-806-5484 (US or Canada) or +416-340-2217 (International and additional options available HERE) and the passcode is 3025919#. Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.
今天的网络直播详情
网络直播和重播可在以下网址观看 。 来电信息如下： 1-800-806-5484 （美国或加拿大）或 +416-340-2217 （此处提供国际和其他选项），密码是 3025919 #。 来电者应在预定开始时间前 5-10 分钟拨号，只需要求加入 Adaptimmune 通话即可。
About Adaptimmune
Adaptimmune is a clinical-stage biopharmaceutical company focused on designing, developing, and delivering cell therapies to transform the lives of people with cancer. The Company's unique engineered T-cell receptor (TCR) platform enables the engineering of T-cells to target and destroy cancers across multiple solid tumor types.
关于 Adaptimmune
Adaptimmune 是一家处于临床阶段的生物制药公司，专注于设计、开发和提供细胞疗法，以改变癌症患者的生活。该公司独特的工程化T细胞受体（TCR）平台使T细胞能够靶向和消灭多种实体瘤类型的癌症。
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended 31 December, 2023, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.
前瞻性陈述
本新闻稿包含1995年《私人证券诉讼改革法》（PSLRA）所指的 “前瞻性陈述”。这些前瞻性陈述涉及某些风险和不确定性。此类风险和不确定性可能导致我们的实际结果与此类前瞻性陈述所示结果存在重大差异，包括但不限于：我们的产品开发活动和临床试验的成功、成本和时机，以及我们通过监管和商业化程序成功推进TCR候选疗法的能力。要进一步描述可能导致我们的实际业绩与这些前瞻性陈述中表达的业绩存在重大差异的风险和不确定性以及与我们的总体业务相关的风险，请参阅我们向美国证券交易委员会提交的截至2023年12月31日止年度的10-K表年度报告、10-Q表季度报告、8-K表最新报告以及向美国证券交易委员会提交的其他文件。本新闻稿中包含的前瞻性陈述仅代表截至声明发表之日，我们没有义务更新此类前瞻性陈述以反映随后的事件或情况。
Total Liquidity (a non-GAAP financial measure)
Total Liquidity (a non-GAAP financial measure) is the total of cash and cash equivalents and marketable securities (available-for-sale debt securities). Each of these components appears separately in the condensed consolidated balance sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the condensed consolidated financial statements, which reconciles to Total Liquidity as follows (in thousands):
总流动性（非公认会计准则财务指标）
总流动性（非公认会计准则财务指标）是现金和现金等价物以及有价证券（可供出售的债务证券）的总和。这些组成部分分别出现在简明的合并资产负债表中。与总流动性最直接可比的美国公认会计准则财务指标是简明合并财务报表中报告的现金和现金等价物，该财务报表与总流动性对账如下（以千计）：
| March 31, | December 31, | ||||||||
| 2024 | 2023 | ||||||||
| Cash and cash equivalents | $ | 140,670 | $ | 143,991 | |||||
| Marketable securities - available-for-sale debt securities | 2,982 | 2,947 | |||||||
| Total Liquidity | $ | 143,652 | $ | 146,938 | |||||
| 3月31日 | 十二月 31, | ||||||||
| 2024 | 2023 | ||||||||
| 现金和现金等价物 | $ | 140,670 | $ | 143,991 | |||||
| 有价证券——可供出售的债务证券 | 2,982 | 2,947 | |||||||
| 总流动性 | $ | 143,652 | $ | 146,938 | |||||
The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its assessment of overall solvency and liquidity, financial flexibility, capital position and leverage.
公司认为，总流动性的列报为投资者提供了有用的信息，因为管理层对总流动性的审查是其评估整体偿付能力和流动性、财务灵活性、资本状况和杠杆率的一部分。
Condensed Consolidated Statement of Operations
(unaudited, in thousands, except per share data)
简明合并运营报表
（未经审计，以千计，每股数据除外）
| Three months ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenue | $ | 5,678 | $ | 47,601 | ||||
| Operating expenses | ||||||||
| Research and development | (35,207) | (25,548) | ||||||
| General and administrative | (19,732) | (20,397) | ||||||
| Total operating expenses | (54,939) | (45,945) | ||||||
| Operating (loss)/profit | (49,261) | 1,656 | ||||||
| Interest income | 1,345 | 676 | ||||||
| Other income (expense), net | (61) | (671) | ||||||
| (Loss)/profit before income tax expense | (47,977) | 1,661 | ||||||
| Income tax expense | (526) | (625) | ||||||
| Net (loss)/profit attributable to ordinary shareholders | $ | (48,503) | $ | 1,036 | ||||
| Net (loss)/profit per ordinary share | ||||||||
| Basic | $ | (0.03) | $ | 0.00 | ||||
| Diluted | $ | (0.03) | $ | 0.00 | ||||
| Weighted average shares outstanding: | ||||||||
| Basic | 1,451,241,661 | 991,330,402 | ||||||
| Diluted | 1,451,241,661 | 1,000,276,615 | ||||||
| 三个月已结束 | ||||||||
| 3月31日 | ||||||||
| 2024 | 2023 | |||||||
| 收入 | $ | 5,678 | $ | 47,601 | ||||
| 运营费用 | ||||||||
| 研究和开发 | (35,207) | (25,548) | ||||||
| 一般和行政 | (19,732) | (20,397) | ||||||
| 运营费用总额 | (54,939) | (45,945) | ||||||
| 营业（亏损）/利润 | (49,261) | 1,656 | ||||||
| 利息收入 | 1,345 | 676 | ||||||
| 其他收入（支出），净额 | (61) | (671) | ||||||
| 所得税支出前（亏损）/利润 | (47,977) | 1,661 | ||||||
| 所得税支出 | (526) | (625) | ||||||
| 归属于普通股股东的净（亏损）/利润 | $ | (48,503) | $ | 1,036 | ||||
| 每股普通股净（亏损）/利润 | ||||||||
| 基本 | $ | (0.03) | $ | 0.00 | ||||
| 稀释 | $ | (0.03) | $ | 0.00 | ||||
| 已发行股票的加权平均值： | ||||||||
| 基本 | 1,451,241,661 | 991,330,402 | ||||||
| 稀释 | 1,451,241,661 | 1,000,276,615 | ||||||
Condensed Consolidated Balance Sheets
(unaudited, in thousands, except share data)
简明合并资产负债表
（未经审计，以千计，股票数据除外）
| March 31, | December 31, | |||||||||
| 2024 | 2023 | |||||||||
| Assets | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | $ | 140,670 | $ | 143,991 | ||||||
| Marketable securities - available-for-sale debt securities (amortized cost of $2,981 and $2,940) net of allowance for expected credit losses of $0 and $0 | 2,982 | 2,947 | ||||||||
| Accounts receivable, net of allowance for expected credit losses of $0 and $0 | 8,404 | 821 | ||||||||
| Other current assets and prepaid expenses | 34,847 | 59,793 | ||||||||
| Total current assets | 186,903 | 207,552 | ||||||||
| Restricted cash | 2,858 | 3,026 | ||||||||
| Operating lease right-of-use assets, net of accumulated amortization of $14,381 and $13,220 | 19,434 | 20,762 | ||||||||
| Property, plant and equipment, net of accumulated depreciation of $48,445 and $46,020 | 48,291 | 50,946 | ||||||||
| Intangible assets, net of accumulated amortization of $5,198 and $5,155 | 524 | 330 | ||||||||
| Total assets | $ | 258,010 | $ | 282,616 | ||||||
| Liabilities and stockholders' equity | ||||||||||
| Current liabilities | ||||||||||
| Accounts payable | $ | 6,587 | $ | 8,128 | ||||||
| Operating lease liabilities, current | 5,250 | 5,384 | ||||||||
| Accrued expenses and other current liabilities | 23,050 | 30,303 | ||||||||
| Deferred revenue, current | 31,524 | 28,973 | ||||||||
| Total current liabilities | 66,411 | 72,788 | ||||||||
| Operating lease liabilities, non-current | 18,442 | 19,851 | ||||||||
| Deferred revenue, non-current | 147,365 | 149,060 | ||||||||
| Other liabilities, non-current | 1,417 | 1,404 | ||||||||
| Total liabilities | 233,635 | 243,103 | ||||||||
| Stockholders' equity | ||||||||||
| Common stock - Ordinary shares par value £0.001, 1,702,760,280 authorized and 1,532,974,878 issued and outstanding (2023: 1,702,760,280 authorized and 1,363,008,102 issued and outstanding) | 2,081 | 1,865 | ||||||||
| Additional paid in capital | 1,096,690 | 1,064,569 | ||||||||
| Accumulated other comprehensive loss | (2,720) | (3,748) | ||||||||
| Accumulated deficit | (1,071,676) | (1,023,173) | ||||||||
| Total stockholders' equity | 24,375 | 39,513 | ||||||||
| Total liabilities and stockholders' equity | $ | 258,010 | $ | 282,616 | ||||||
| 3月31日 | 十二月 31, | |||||||||
| 2024 | 2023 | |||||||||
| 资产 | ||||||||||
| 流动资产 | ||||||||||
| 现金和现金等价物 | $ | 140,670 | $ | 143,991 | ||||||
| 有价证券——扣除0美元和0美元的预期信贷损失备抵后的可供出售债务证券（摊销成本为2,981美元和2,940美元） | 2,982 | 2,947 | ||||||||
| 应收账款，扣除0美元和0美元的预期信贷损失备抵金 | 8,404 | 821 | ||||||||
| 其他流动资产和预付费用 | 34,847 | 59,793 | ||||||||
| 流动资产总额 | 186,903 | 207,552 | ||||||||
| 受限制的现金 | 2,858 | 3,026 | ||||||||
| 经营租赁使用权资产，扣除14,381美元和13,220美元的累计摊销额 | 19,434 | 20,762 | ||||||||
| 不动产、厂房和设备，扣除48,445美元和46,020美元的累计折旧 | 48,291 | 50,946 | ||||||||
| 无形资产，扣除5,198美元和5,155美元的累计摊销额 | 524 | 330 | ||||||||
| 总资产 | $ | 258,010 | $ | 282,616 | ||||||
| 负债和股东权益 | ||||||||||
| 流动负债 | ||||||||||
| 应付账款 | $ | 6,587 | $ | 8,128 | ||||||
| 经营租赁负债，当前 | 5,250 | 5,384 | ||||||||
| 应计费用和其他流动负债 | 23,050 | 30,303 | ||||||||
| 递延收入，当前 | 31,524 | 28,973 | ||||||||
| 流动负债总额 | 66,411 | 72,788 | ||||||||
| 经营租赁负债，非流动 | 18,442 | 19,851 | ||||||||
| 递延收入，非当期 | 147,365 | 149,060 | ||||||||
| 其他非流动负债 | 1,417 | 1,404 | ||||||||
| 负债总额 | 233,635 | 243,103 | ||||||||
| 股东权益 | ||||||||||
| 普通股——普通股面值0.001英镑，已授权1,702,760,280股，已发行和流通1,532,974,878股（2023年：授权1,702,760,280股，已发行和流通1,363,008,102股） | 2,081 | 1,865 | ||||||||
| 额外已缴资本 | 1,096,690 | 1,064,569 | ||||||||
| 累计其他综合亏损 | (2,720) | (3,748) | ||||||||
| 累计赤字 | (1,071,676) | (1,023,173) | ||||||||
| 股东权益总额 | 24,375 | 39,513 | ||||||||
| 负债和股东权益总额 | $ | 258,010 | $ | 282,616 | ||||||
Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)
简明合并现金流量表
（未经审计，以千计）
| Three months ended | |||||||||
| March 31, | |||||||||
| 2024 | 2023 | ||||||||
| Cash flows from operating activities | |||||||||
| Net (loss)/profit | $ | (48,503) | $ | 1,036 | |||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||
| Depreciation | 2,771 | 1,659 | |||||||
| Amortization | 59 | 186 | |||||||
| Share-based compensation expense | 3,102 | 1,676 | |||||||
| Unrealized foreign exchange losses | 305 | 563 | |||||||
| (Accretion)/amortization on available-for-sale debt securities | (23) | 112 | |||||||
| Other | (19) | 134 | |||||||
| Changes in operating assets and liabilities: | |||||||||
| Increase in receivables and other operating assets | 15,620 | 3,683 | |||||||
| (Decrease)/increase in payables and other current liabilities | (7,650) | 21 | |||||||
| Decrease/(increase) in deferred revenue | 2,388 | (46,353) | |||||||
| Net cash used in operating activities | (31,950) | (37,283) | |||||||
| Cash flows from investing activities | |||||||||
| Acquisition of property, plant and equipment | (102) | (2,349) | |||||||
| Acquisition of intangible assets | (256) | (173) | |||||||
| Maturity or redemption of marketable securities | — | 50,863 | |||||||
| Net cash (used in)/provided by investing activities | (358) | 48,341 | |||||||
| Cash flows from financing activities | |||||||||
| Proceeds from issuance of common stock from offerings, net of commissions and issuance costs | 29,161 | 188 | |||||||
| Proceeds from exercise of stock options | 74 | 8 | |||||||
| Net cash provided by financing activities | 29,235 | 196 | |||||||
| Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | (416) | 588 | |||||||
| Net (decrease)/increase in cash, cash equivalents and restricted cash | (3,489) | 11,842 | |||||||
| Cash, cash equivalents and restricted cash at start of period | 147,017 | 109,602 | |||||||
| Cash, cash equivalents and restricted cash at end of period | $ | 143,528 | $ | 121,444 | |||||
| 三个月已结束 | |||||||||
| 3月31日 | |||||||||
| 2024 | 2023 | ||||||||
| 来自经营活动的现金流 | |||||||||
| 净（亏损）/利润 | $ | (48,503) | $ | 1,036 | |||||
| 为使净亏损与经营活动中使用的净现金相一致而进行的调整： | |||||||||
| 折旧 | 2,771 | 1,659 | |||||||
| 摊销 | 59 | 186 | |||||||
| 基于股份的薪酬支出 | 3,102 | 1,676 | |||||||
| 未实现的外汇损失 | 305 | 563 | |||||||
| 可供出售债务证券的（增值）/摊销 | (23) | 112 | |||||||
| 其他 | (19) | 134 | |||||||
| 运营资产和负债的变化： | |||||||||
| 应收账款和其他运营资产的增加 | 15,620 | 3,683 | |||||||
| 应付账款和其他流动负债 (减少) /增加 | (7,650) | 21 | |||||||
| 递延收入减少/（增加） | 2,388 | (46,353) | |||||||
| 用于经营活动的净现金 | (31,950) | (37,283) | |||||||
| 来自投资活动的现金流 | |||||||||
| 购置不动产、厂房和设备 | (102) | (2,349) | |||||||
| 收购无形资产 | (256) | (173) | |||||||
| 有价证券的到期或赎回 | — | 50,863 | |||||||
| 净现金（用于）/由投资活动提供 | (358) | 48,341 | |||||||
| 来自融资活动的现金流 | |||||||||
| 发行普通股的收益，扣除佣金和发行成本 | 29,161 | 188 | |||||||
| 行使股票期权的收益 | 74 | 8 | |||||||
| 融资活动提供的净现金 | 29,235 | 196 | |||||||
| 货币汇率变动对现金、现金等价物和限制性现金的影响 | (416) | 588 | |||||||
| 现金、现金等价物和限制性现金净额（减少）/增加 | (3,489) | 11,842 | |||||||
| 期初的现金、现金等价物和限制性现金 | 147,017 | 109,602 | |||||||
| 期末现金、现金等价物和限制性现金 | $ | 143,528 | $ | 121,444 | |||||
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[1] Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below
[1] 总流动性是一种非公认会计准则财务指标，以下是根据公认会计原则编制的最直接可比的财务指标进行解释和核对