Afamitresgene Autoleucel

TECELRA® launch 2025 YTD metrics: 28 ATCs available; 21 patients aphresed; and 14 doses invoiced $4.0 million Tecelra net sales in Q1 2025 Instituting 2025 Tecelra full year sales guidance of $35-$45 million Lete-cel on track to initiate rolling BLA submission late 2025; approval anticipated in 2026 Adaptimmune had Total Liquidity1 of $60 million as of March 31, 2025; call at 8 a.m. EDT today Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - May 13, 2025) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today reported financial results and provided a business update for the first quarter ended March 31, 2025. Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "The launch of Tecelra continues to rapidly accelerate, as evidenced by all launch metrics. In Q4 2024 we invoiced 2 patients, in Q1 2025 we invoiced 6 patients, and in Q2 to-date we have invoiced 8 patients. The shape of the pipeline of patients being tested and apheresed continues to support a robust acceleration of sales in Q2 and the second half of the year, and we continue to experience 100% manufacturing success rates and no payer denials. As a result, we are now providing guidance for 2025 Tecelra sales in the range of $35-$45 million. I'm confident in the team's ability to identify eligible patients, manufacture a personalized engineered T cell treatment and ultimately deliver product, demonstrating that we have built a successful business platform for cell therapies in solid tumors, paving the way for an equally successful lete-cel launch in 2026." Tecelra launch momentum increasing - first commercial product in Adaptimmune's sarcoma franchise 28 Authorized Treatment Centers (ATCs) now accepting referrals On track to have the full network of approximately 30 ATCs open by the end of the year Invoiced 2 patients in Q4 2024, 6 in Q1 2025, and 8 in Q2 to-date (as of May 9, 2025) Apheresed 3 patients in Q4 2024, 13 in Q1 2025, and 8 in Q2 to-date (as of May 9, 2025) 100% success rate in manufacturing to date, with no capacity constraints and an average turnaround of 27 days Successful patient access to Tecelra with no payer denials to date Lete-cel - next product in Adaptimmune's sarcoma franchise Pivotal trial met primary endpoint with 42% ORR including 6 complete responses (CTOS 2024) On track to initiate rolling BLA submission in late 2025; approval anticipated in 2026 Lete-cel will more than double the addressable patient population in the sarcoma franchise Launch readiness activities are on track Corporate updates Review of strategic options with TD Cowen in progress Debt principal paydown of $25 million made in Q1 2025 Upcoming milestones Updates on Tecelra launch momentum Initiate rolling BLA for lete-cel to treat synovial sarcoma and MRCLS in Q4 2025 Financial Results for the three months ended March 31, 2025 Cash / liquidity position: As of March 31, 2025, Adaptimmune had cash and cash equivalents of $41.1 million and Total Liquidity2 of $59.6 million, compared to $91.1 million and $151.6 million respectively, as of December 31, 2024. Revenue: Revenue for the three months ended March 31, 2025, was $7.3 million, compared to $5.7 million for the same period in 2024. Revenue has increased primarily due to $4.0 million in product sales following the FDA approval of TECELRA on August 1, 2024. This was offset by a $2.4 million decrease in development revenue due to revenue from Galapagos replacing Genentech revenue and Galapagos generating comparatively lower revenue due to the collaboration being at an earlier stage of progress than the Genentech collaboration was in the first quarter of 2024. Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2025, were $28.9 million, compared to $35.2 million for the same period in 2024. R&D expenses decreased due to a decrease in the average number of employees engaged in R&D following the restructuring and reprioritization of activities that was announced in November 2024 and a decrease in subcontracted expenditure, offset by a decrease in offsetting reimbursements receivable for R&D tax and expenditure credits. Selling, general and administrative (SG&A) expenses: SG&A expenses for the three months ended March 31, 2025, were $23.3 million, compared to $19.7 million for the equivalent period in 2024. SG&A expenses increased due to restructuring charges for the restructuring program initiated in the fourth quarter of 2024 for which there was no equivalent in the first quarter of 2024 and an increase in accounting, legal and professional fees due to fees relating to business development work, offset by a decrease in share-based compensation expense due to forfeitures arising as a result of the restructuring program. Net loss: Net loss attributable to holders of the Company's ordinary shares for the three months ended March 31, 2025, was a loss of $47.6 million ($0.03 per ordinary share), compared to $48.5 million ($0.03 per ordinary share), for the equivalent period in 2024. Going Concern Our 2024 Annual Report on Form 10-K, which the Company filed on March 24, 2025, disclosed that there is substantial doubt about our ability to continue as a going concern. We are continuing to implement cost reduction measures and explore the strategic options outlined above. Today's Webcast Details A live webcast and replay can be accessed at https://www.gowebcasting.com/14032. Call in information is as follows: 1-833-821-0158 (US or Canada) or 1-647-846-2266 (International). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call. About Adaptimmune Adaptimmune is a fully integrated cell therapy company working to redefine how cancer is treated. With its unique engineered T cell receptor (TCR) platform, the Company is developing personalized medicines designed to target and destroy difficult-to-treat solid tumor cancers and to radically improve the patient's cancer treatment experience. Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the safe harbor provisions of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements address our expected future business, financial performance, financial condition, as well as the results of operations and often contain words such as "anticipate" "believe," "expect," "may," "plan," "potential," "will," and similar expressions. Such statements are based only upon current expectations of Adaptimmune. Reliance should not be placed on these forward-looking statements because they 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 December 31, 2024, 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. 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): 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. Condensed Consolidated Statement of Operations (unaudited, in thousands, except per share data) Condensed Consolidated Balance Sheets (unaudited, in thousands, except share data) Condensed Consolidated Cash Flow Statement (unaudited, in thousands) Adaptimmune Contact Investor Relations Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations T : +1 215 825 9310 M : +1 215 460 8920 Juli.Miller@adaptimmune.com Media Relations Dana Lynch, Senior Director of Corporate Communications M: +1 267 990 1217 Dana.Lynch@adaptimmune.com 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 2 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 To view the source version of this press release, please visit https://www.newsfilecorp.com/release/251851 SOURCE Adaptimmune Therapeutics PLC Released May 13, 2025

2025年3月30日，由香雪生命科学技术（广东）有限公司（简称“香雪生命科学”）作为申办方，北京大学肿瘤医院、中山大学肿瘤防治中心作为组长单位的TAEST16001治疗晚期软组织肉瘤的确证性临床试验方案专家研讨会在广州顺利召开。参与该产品I、II期临床试验的PI、投资机构负责人及研究合作伙伴等出席了本次会议。      TAEST16001作为中国首个获批开展确证性临床试验的TCR-T细胞治疗产品，标志着我国在实体瘤细胞治疗领域迈出重要的一步，可加快推进该药成为中国第一款上市的TCR-T细胞治疗药物，对中国免疫细胞治疗创新药的发展具有重要意义。【TCR-T细胞治疗实体瘤取得突破，引起行业内外高度关注】      广州市香雪制药股份有限公司董事长王永辉在致辞中指出：近日国际知名商业媒体Fast Company 公布了“全球最具创新力的10家医药公司”，其中Adaptimune Therapeutics的TECELRA作为全球首款获批用于治疗实体瘤的工程化TCR-T细胞治疗药物上榜并名列前茅。TECELRA以对实体瘤的突出疗效和良好的安全性在完成一项单臂II期临床试验后获得FDA的加速批准。中国香雪生命科学自主研发的TAEST16001作为中国首个被CDE纳入突破性治疗名单TCR-T细胞治疗药物，其在探索性II期临床试验中显示了良好的临床疗效，为治疗晚期实体瘤带来了新的希望。王董事长强调“相信在不久的将来，不止是AI，中国的细胞治疗新药也能让世界惊叹。” 对TAEST16001成为中国首个获批上市的TCR-T产品充满信心。【TAEST16001早期临床试验数据显示显著临床意义】      TAEST16001由香雪生命科学自主研发，是国内首个获得IND批件的TCR-T细胞治疗产品，开创了国内TCR-T细胞治疗实体瘤的先河。该疗法通过基因工程技术精准改造患者T细胞，赋予其高亲和力TCR靶向识别肿瘤抗原的能力，形成“细胞导弹”级杀伤效应。其核心技术突破依托香雪生命科学构建的抗原肽发现、TCR亲和力优化、TCRT产品开发及自动化生产的全链条创新体系和平台。      中山大学肿瘤防治中心张星教授在会上介绍了TAEST16001注射液I期临床试验的结果，共12例晚期软组织肉瘤受试者接受TAEST16001回输，探索了4个剂量组，临床试验显示耐受性良好，未观察到DLT，研究者评估的ORR达到41.7%。张教授充分肯定了TAEST16001注射液的临床治疗效果，为软组织肉瘤患者带来治愈新希望。      北京大学肿瘤医院樊征夫教授在会上介绍了TAEST16001探索性II期临床试验的结果，共8例晚期软组织肉瘤受试者接受了细胞剂量1.2×1010 ±30%TAEST16001回输，安全性结果与 I 期试验结果基本相似， 未发现新的安全性风险，研究者评估的客观缓解率（ORR）达62.5%，由独立影像评估委员会（IRC）评估的最佳缓解率为50%，由独立影像评估委员会和研究者评估的中位无进展生存期（mPFS）均为5.9个月，TAEST16001观察到显著临床意义疗效的数据再次得到国际顶级学术会议ASCO年会的认可。樊教授非常满意TAEST16001的II期临床试验结果，期待产品能早日上市，为患者的治疗带来新希望。【TAEST16001注射液纳入CDE突破性治疗药物名单，加快产品上市进程】      香雪生命科学的CEO曾仑在会议中回顾了TAEST16001作为基于香雪生命科学TCR-T细胞产品技术开发平台和生产制备体系，中国首个获得IND批件和唯一进入关键性II期临床试验产品的研发历程。TAEST16001在I期和II期临床试验中均表现出良好的安全性和耐受性，在针对NY-ESO-1阳性及HLA-A02:01阳性无治疗选择的晚期软组织肉瘤临床试验的数据显示了显著临床意义的治疗效果。TAEST16001作为具有突破性和颠覆性的创新药品被国家药品审评中心（CDE）纳入突破性治疗药物名单，是中国TCR-T细胞治疗领域的里程碑事件，标志着其疗效获得CDE的官方认可。”TAEST16001注射液纳入突破性治疗药物名单后，CDE将通过优化临床研发的资源配置、有效缩短临床研发周期、加快产品获批上市的进程，使罹患严重危及生命或严重影响生存质量疾病的患者早日获得更好的治疗。TAEST16001有望成为中国首个上市的TCR-T细胞治疗产品，不仅填补了软组织肉瘤这一高致死率难治性肿瘤的临床治疗空白，更推动了中国细胞治疗产业与国际前沿接轨，成为生物医药新质生产力的标杆。TAEST16001作为全球第二款冲击实体瘤的TCR-T疗法，其适应症已拓展至食管癌、非小细胞肺癌等恶性肿瘤，如开发成功，后期市场空间巨大，将以低毒性和好疗效重塑癌症治疗的新格局。【TAEST16001确证性临床试验方案已获CDE认可】      香雪生命科学的CEO曾仑介绍了TAEST16001用于治疗软组织肉瘤的确证性临床方案，该方案已获得CDE的书面认可。在会上专家们围绕该方案如何在实际操作过程中得到更好的执行及如何更好控制试验质量等方面进行了全面而细致的讨论并达成一致，为该方案的正式启动奠定了坚实基础。      本次TAEST16001项目确证性临床试验方案专家研讨会的顺利召开，将有力保障TAEST16001确证性临床试验的顺利开展，加快推进TAEST16001产品的上市进程，冲击成为全球第二款治疗实体瘤的TCR-T细胞治疗产品，为晚期软组织肉瘤患者提供新的治疗选择，成为中国自主研发细胞治疗创新产品研发的标杆。关于香雪生命科学      香雪生命科学技术（广东）有限公司（简称“香雪生命科学”）是一家聚焦TCR领域的细胞免疫治疗产品和技术的研发企业，是TCR-T细胞免疫治疗头部企业。公司以“解决人类健康难点，树立肿瘤治疗标杆”为愿景，以“聚焦TCR，赋能T细胞，攻克实体瘤”为使命。      香雪生命科学具有自主知识产权的TCR核心技术，拥有完整的TCR-T产品研发技术体系和生产制备体系，其中TCR-T产品研发技术体系包含：①抗原肽发现平台，②TCR高亲和力平台，③TCR-T开发平台；TCR-T生产制备体系包含：①自动化细胞生产平台，②质控平台；已形成了TCR-T细胞产品全链条创新产业链。      香雪生命科学研发技术体系产生丰富的在研及储备管线，涵盖实体肿瘤相关专有靶点和覆盖中国人群的HLA分型的产品，处于国际领先水平。      目前，香雪生命科学有两个产品已在中国获得IND批件，其中第一个产品是TAEST16001注射液，适应症为软组织肉瘤，目前在中国已完成I期临床试验和II期临床试验第一阶段的研究工作，纳入突破性治疗品种名单，并获得晚期食管癌及晚期非小细胞肺癌的IND批件；第二个产品是TAEST1901注射液，适应症为原发性肝癌，正在进行I期临床研究。