Prulacabtagene Leucel

关注无癌家园 我们战癌到底 γδT细胞是一个独特的 T 细胞亚群，与传统的αβT细胞不同，能够以非MHC（主要组织相容性复合体）限制的方式识别抗原。γδT 细胞占人外周血中 T 淋巴细胞的 1%～5%，参与多种免疫反应，如肿瘤免疫、感染免疫、免疫功能调节等，兼具先天免疫和获得性免疫的双重优势，被视为连接先天免疫和获得性免疫的桥梁。 γδT细胞治疗的优势 大量杀伤因子 γδT分泌穿孔素、颗粒酶等，产生细胞毒性，激活的γδT细胞可作为抗原递呈细胞发挥作用。 非MHC限制性 γδT细胞可直接识别靶细胞表面的蛋白或肽类分子，因此肿瘤细胞不能通过下调MHC（主要组织相容性复合体）I类分子而逃逸CD8+T细胞杀伤。 低氧低糖耐受 γδT细胞能耐受低氧、低糖的肿瘤微环境。 安全有效 研究发现γδT细胞在肝癌、肺癌的治疗上表现出比未用γδT细胞治疗组更好的效果；此外因为γδT的非MHC限制性，所以几乎没有GvHD（移植物抗宿主病）反应。 目前，国内外越来越多基于γδT细胞的临床试验如雨后春笋般涌现。截至2024年11月18日，ClinicalTrails.gov上注册的与γδT细胞免疫治疗相关的临床试验共有45项，主要集中在中国、美国和欧洲，适应证包括实体瘤、血液瘤和病毒感染。同时，许多国家如美国、英国、荷兰、新加坡、中国等都有企业积极进行“现货”的同种异体天然γδT细胞产品和基因工程γδT细胞产品领域的管线布局 ，已有众多候选 γδT 细胞疗法的研发与应用取得了积极的进展，发展势头迅猛。 近年来，γδT细胞已经成为肿瘤免疫细胞治疗领域的“新黑马”，在众多癌种（肺癌、肝细胞癌、肾癌、胰腺癌等实体瘤以及急性髓系白血病、多发性骨髓瘤等血液肿瘤）中表现出优越的抗肿瘤潜力和应用前景。 100%患者肿瘤细胞完全消失并维持1年，现货型γδ T细胞疗法表现亮眼！ 2024年欧洲血液学协会（EHA）年会上，现货型γδ T细胞疗法INB-100在一项针对白血病患者的1期临床试验中展示了亮眼的治疗效果。 试验数据截止至2024年5月31日，结果显示所有参与试验的白血病患者均存活，并维持完全缓解长达一年。 INB-100是一款来自健康供体的同种异体γδ T细胞，在体外经过扩增和激活后，被输注到白血病患者体内。 值得一提的是，此次临床试验的参与者均为高风险和复发急性髓系白血病（AML）患者，且之前已经历了包括CAR-T细胞疗法在内的多种治疗方案。 这一结果对于血液癌症患者来说，无疑是巨大的福音。此次研究中，有两例接受γδ T细胞治疗的患者已经无癌生活超过3年半，而另一例患者也接近3年无癌，实在是可喜可贺！此外，γδ T细胞疗法在安全性方面也表现优异，未出现任何治疗相关的不良反应。 提高γδT细胞水平，肾癌患者的无复发生存率近2倍！ 肾细胞癌 (RCC) 是一种相对罕见的癌症，近几十年来发病率不断上升。手术是治疗局限性 RCC 最有效的策略，在癌症早期阶段预后良好。然而，即使患者接受早期 RCC 根治性切除，也会观察到复发；约 10%的此类患者在 5 年内复发，约 2% 的患者在 5 年后复发。 因此，有国外的研究学者们对肾细胞癌 (RCC) 手术前外周血中 γδT 细胞的比例进行观察，并回顾性地研究其比例是否影响无复发生存期 (RFS) 和总生存期 (OS)，这项研究结果刊登在国际知名期刊《Science Direct》上。 本研究纳入的137例患者中，40例患者外周血γδT细胞比例＜1%，低于正常范围，97例患者外周血γδT细胞比例≥1%。在γδT细胞低水平组中，13例（32.5%）患者复发，9例患者在观察期间死亡；γδT细胞正常水平组中，16例（16.5%）患者复发，8例患者死亡。γδT细胞正常组的RFS和OS预后明显较好，如下图所示。 图源《Science Direct》官网 最长生存期延长35个月！γδT细胞疗法助力肺癌/肝癌患者开启长生存之路！ γδ T 细胞，特别是 Vγ9Vδ2 亚群，是人类外周血中 γδ T 细胞中占主导地位的亚群，以不依赖人类白细胞抗原 (HLA) 的方式识别靶细胞。此外，γδ T 细胞无需树突状细胞 (DC) 的参与即可直接杀死靶细胞，并在抗肿瘤和抗感染免疫中发挥双重功能。 对于晚期恶性肝癌和肺癌患者，目前尚无可延长其生存期或改善其生活质量的治疗方法。因此，基于同种异体Vγ9Vδ2 T细胞的转移方法可能成为一种抗肿瘤免疫细胞治疗的新策略。 一项刊登在《Cell Mol Immunol》国际知名杂志上关于“新配方扩增的同种异体Vγ9Vδ2T细胞对晚期肝癌和肺癌患者的免疫治疗”的临床研究中，纳入了符合招募标准的132例晚期癌症患者，其中包括肺癌、肝癌、胰腺癌、乳腺癌或其他实体肿瘤患者，共计进行414次同种异体Vγ9Vδ2T细胞回输治疗，且大多数患者仅接受了1~4次细胞输注。 根据临床记录，仅 8 例肝癌患者和 10 例肺癌患者接受了≥5 次 NF 细胞输注；随后对这 18 例患者进行了随访，他们的临床信息和生存数据：8例肝癌患者中有 7 例和 10 例肺癌患者中有 9 例存活≥10 个月。 代表性 CT 图像也说明了 NF 细胞的治疗效果，如图所示。在2020 年 6 月的最新随访中，8例肝癌患者的平均生存时间延长到23.1个月（最长35个月），其中3例存活；10例肺癌患者的平均生存时间延长到19.1个月（最长33个月），其中2例存活。 图源《Cell Reports Medicine》官网 值得一提的是，异体γδT细胞回输没有发生一例严重副作用，仅有部分患者产生一过性的轻微临床反应，后续自行缓解，这证实了异体γδT细胞回输安全有效！ 想寻求γδT细胞疗法或NK、TILs、CAR-T等疗法及其他国内外治疗新技术帮助，且经济条件允许的情况下，患者可以先将病历提交至无癌家园医学部（400-626-9916）进行初步评估。 显著延长生存期！不可逆电穿孔联合γδT细胞疗法成胰腺癌新选择！ 由于免疫抑制微环境（ISM）的存在，免疫治疗对局部晚期胰腺癌（LAPC）的疗效有限。不可逆电穿孔（IRE）不仅可以诱导免疫原性细胞死亡，还可以减轻免疫抑制。 2020年10月23日，一项关于“不可逆电穿孔联合同种异体Vγ9Vδ2 T细胞增强局部晚期胰腺癌患者的抗肿瘤作用”的临床研究刊登在国际知名杂志《Nature》上。此研究旨在探讨IRE加同种异体γδT细胞对LAPC患者的抗肿瘤疗效。 图源截自于《Nature》杂志官网 不可逆电穿孔( IRE) 是一种新的、非热的、微创的技术，已被 FDA 和 CFDA 批准用于 LAPC。IRE可以通过短时间的高压电脉冲导致肿瘤细胞死亡。近年来，多项研究证实 IRE 是一种很有前途的治疗 LAPC 的技术，且不损伤血管和神经。人类γδT细胞可以以主要组织相容性复合体（MHC）非依赖的方式被激活，这使它具有更广泛的抗肿瘤细胞毒作用。Vγ9Vδ2 T 细胞是免疫效应细胞的重要组成部分，有助于对多种肿瘤进行肿瘤免疫监视，这表明 Vγ9Vδ2-T 细胞可作为 LAPC 新的候选治疗方法。 该试验共招募了62例符合资格标准的患者，随机分为A组（n=30）、B组（n=32）。所有患者均接受IRE治疗，A组患者接受IRE后，至少连续接受两个周期的γδ T细胞输注。A组患者的中位总生存期14.5个月明显长于B组的11个月，中位无进展生存期11个月明显长于B组的8.5个月。此外，接受多个疗程γδ T细胞输注治疗的A组患者比接受单疗程（13.5个月）的患者具有更长的OS（17个月）。 综上，本次临床试验表明IRE联合γδT细胞可以增强抗肿瘤作用，延长生存期，为LAPC患者提供了新的治疗策略。 γδT 细胞疗法迎来井喷期，多种形式的研发百花齐放！ 目前已有多家公司开发基于γδT细胞的免疫疗法，这些疗法主要是过继性细胞疗法，即将未经改造或基因改造的γδT同种异体细胞在体外扩增后回注体内治疗肿瘤患者。此外，也有基于体内γδT细胞的激活和扩增或靶向体内天然存在的γδT细胞，将其募集至肿瘤细胞，促进对肿瘤细胞的杀伤。接下来，无癌家园小编将总结基于γδ细胞的免疫治疗策略。 基因改造的耐化疗 γδT 细胞同种疗法 化疗是实体肿瘤治疗的主要手段，但同时也会破坏免疫细胞，且化疗前往往需要清除淋巴细胞，这会严重抑制抗肿瘤免疫反应，包括γδT细胞的免疫反应。经过基因改造的同种异体天然γδT细胞可免受化疗引起的损伤，使其在化疗的同时被输送，在肿瘤经历化疗引起的最大应激时识别并杀死剩余的肿瘤细胞。 IN8bio（美国阿拉巴马州伯明翰）的化疗耐药基因改造γδT细胞产品包括INB-200和INB-400。INB-200是一种基因改造的自体γδT细胞，在治疗胶质母细胞瘤的临床试验中已被证明是安全和耐受性良好的，并将很快进入2期临床试验。INB-400是一种基因改造的同种异体γδT细胞产品，将扩展到其他实体瘤类型。 嵌合抗原受体（CAR） γδ T 细胞疗法 CAR-T 细胞表达可增强 T 细胞的抗肿瘤活性，对表达靶抗原的肿瘤细胞有效。针对 CD19 的 CAR-T 细胞疗法已在B 细胞恶性肿瘤患者（尤其是急性淋巴细胞白血病和大 B 细胞淋巴瘤）中显示出良好的疗效。 ADI-001是一种针对B细胞抗原CD20的同种异体通用CAR-γδT细胞疗法。2022年12月，Adicet Bio（美国加利福尼亚州斯坦福市）公布了ADI-001在复发或难治性B细胞非霍奇金淋巴瘤患者中的1期研究的新数据。临床试验结果显示，ADI-001在接受过大量预治疗的侵袭性非霍奇金淋巴瘤患者中表现出良好的安全性和持久性。4例先前接受过自体CD19 CAR-T疗法的患者的完全缓解率为100％。 此外，该公司还在推进CAR-γδT细胞疗法在实体肿瘤领域的应用，Adicet Bio自有的GPC3-CAR-Vδ1T细胞疗法ADI-002也正在申请新药临床试验（IND）中，用于治疗GPC3阳性肝癌。 天然、未经修饰的 γδ T 细胞同种疗法 γδT 细胞对肿瘤细胞具有高度细胞毒性作用，不受 MHC 限制，这使它们在抗肿瘤免疫领域独树一帜。2022 年 3 月，TC BioPharm公司公布了其同种异体天然 γδ T 细胞产品 OmnImmune® 治疗急性髓系白血病的 1a/2b 期临床研究的中期结果。在接受高剂量治疗的四例患者中，有两例患者获得了完全缓解，且安全性良好。 目前，OmnImmune® 的 2b/3 期临床试验已经启动。这是首个进入临床试验的冷冻/解冻 γδ T 疗法，允许临床医生在短时间内将产品从储存设施带到专科药房进行解冻并向患者提供治疗。 小编有话说 γδT细胞是强大的抗癌效应细胞，它通过独特的受体结构识别多样化的抗原，具备对抗多种肿瘤的能力。 近年来，对γδT细胞不同亚群的免疫识别机制研究均取得了显著进展。多样化的识别机制使γδT细胞能够在多种肿瘤中发挥杀伤作用，并激活其他免疫反应。然而，它们的作用有时也可能受到肿瘤微环境等因素的影响而促进肿瘤的发生发展。 因此，深入了解γδT细胞的免疫效应机制并最大限度地利用其杀伤潜力已成为目前肿瘤治疗研究的重点，研究人员正积极探索运用该细胞在各类免疫治疗中的可能性。 拓展阅读 除了上述提到的γδT细胞疗法外，还有： 1. CAR-T疗法：CAR-T疗法（嵌合抗原受体T细胞免疫疗法）是一种治疗肿瘤的新型精准靶向治疗，只不过机制比PD-1更复杂。通过基因工程技术将T细胞激活，并装上定位导航装置CAR（肿瘤嵌合抗原受体），将T细胞这个普通“战士”改造成“超级战士”，即CAR-T细胞，专门识别体内肿瘤细胞，并高效杀灭肿瘤细胞，从而达到治疗恶性肿瘤的目的。 2. 树突状细胞疫苗：一群异质性的免疫细胞，抗原提呈功能最强, 是唯一能够激活初始型T细胞的专职抗原递呈细胞，因此也称为免疫系统的“哨兵”。 3. TCR-T疗法：相较于CAR-T疗法，TCR-T疗法在实体瘤治疗领域具备独特优势； 4.CAR-NK疗法：2020年,CAR-NK免疫细胞治疗曾被权威学术期刊《自然-医学》纳入度生物医学领域的十代瞩目进展之一。在实体瘤方面优势较为突出！ 5. CTL疗法：利用癌细胞特有的、正常细胞上没有或者含量很低的蛋白质做诱饵，把外周血中那“万里挑一”的真正能抗癌的淋巴细胞，挑选出来，然后在体外进一步改良和扩增，然后回输给患者。 若想了解更多关于细胞免疫疗法的相关临床试验及临床技术请持续关注无癌家园（400-626-9916）。 本文为无癌家园原创，转载需授权！ 参考文献 1.https://investors.in8bio.com/news-releases/news-release-details/in8bio-announces-clinical-pipeline-prioritization-focus-inb-100/ 2.https://www.cell.com/cell-reports-medicine/fulltext/S2666-3791(24)00494-4? 3.https://www.nature.com/articles/s41392-020-00260-1#MOESM1 4.https://www.science.org/doi/10.1126/science.abq7248 5.https://pmc.ncbi.nlm.nih.gov/articles/PMC8027668/#MOESM1 6.https://pmc.ncbi.nlm.nih.gov/articles/PMC6368763/ 如果您对于目前的治疗方案有疑问，或者想要咨询更合适的治疗方案，请联系无癌家园医学部（400-626-9916）申请国际会诊。 免疫治疗国际专家推荐 无癌家园提醒癌友们 国内细胞免疫治疗技术，包括CAR-T细胞（除上市的CAR-T外）、树突细胞疫苗、NK细胞、TILs细胞（除上市的TILs外）、TCR-T细胞（除上市的TCR-T外）、癌症疫苗等技术均处于临床试验阶段，未获准在医院正式使用。国内患者可以参加正规临床试验，在医生的监管下使用，无癌家园网不推荐患者冒然尝试任何医疗机构和研发机构的收费治疗。 无癌家园 抗癌资讯｜新技术｜新药研发｜权威专家 热门临床试验 相关文章 Review past  ▶▶▶ 1.【实体瘤细胞疗法招募】急招宫颈癌患者！实体瘤“杀手锏”TILS细胞治疗临床试验强势来袭！ 2.【TCR-T疗法免费招募】TC-N201注射液终于启动临床啦！现正急招滑膜肉瘤等NY-ESO-1阳性实体瘤患者！ 3.【肺癌新药招募】@EGFR 20ins非小细胞肺癌患者注意啦！新一代靶向药PLB1004终于启动临床啦！ 4.【实体瘤免费临床新药】急招宫颈癌患者！TILS细胞免疫治疗实体瘤临床试验招募！ 5.【CAR-T-19招募】RC19D2注射液终于启动临床啦！急招B细胞急性淋巴细胞白血病患者！ 分享、收藏、点赞、在看安排一下？

Announced positive preliminary safety and efficacy data from Phase 1 clinical trial of ADI-001 in patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE); data highlighted rapid and sustained reductions in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score and Physician’s Global Assessment (PGA), improved renal function, and favorable safety and tolerability profile as of the August 31, 2025 data cut-off date Company plans to request a meeting with U.S. Food and Drug Administration (FDA) in 1Q/2026 to inform potentially pivotal ADI-001 trial design; study anticipated to commence in 2Q/2026 Ongoing enrollment of patients in Phase 1 study with LN, SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) On track to share clinical update from Phase 1 study of ADI-001 in LN, SLE, and SSc in 1H/2026 Actively enrolling patients with treatment-refractory rheumatoid arthritis (RA) in Phase 1 study of ADI-001 evaluating potential to reduce the need for conditioning Plan to submit regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCPRC) in 1Q/2026 Completed underwritten registered direct offering to extend projected cash runway into 2H/2027 REDWOOD CITY, Calif. --(BUSINESS WIRE)--Nov. 5, 2025-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today reported financial results and operational highlights for the third quarter ended September 30, 2025 . “We were pleased to announce positive preliminary data last month from seven SLE and LN patients treated in our Phase 1 trial of ADI-001, underscoring its broad potential as a transformative, off-the-shelf, one-time therapy for autoimmune diseases. We are now preparing to discuss the trial design for a potentially pivotal study of ADI-001 with the FDA in the first quarter of 2026, with initiation targeted for the second quarter of 2026,” said Chen Schor , President and Chief Executive Officer of Adicet Bio . “As part of our broader clinical strategy, we are also exploring the potential to reduce or eliminate the need for conditioning with a separate Phase 1 trial of ADI-001 in treatment-refractory RA patients. We are actively enrolling patients in our Phase 1 trial across LN, SLE, SSc, IIM, SPS and AAV patients, with a clinical update for LN, SLE and SSc expected in the first half of 2026.” Mr. Schor continued: “In addition, we are continuing to advance ADI-212, an optimized next-generation gene-edited and armored clinical candidate designed to target prostate specific membrane antigen, and expect to submit a regulatory filing for the mCRPC program in the first quarter of 2026 and share initial clinical data in the second half of 2026, subject to regulatory clearance. ADI-212 is designed to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. Supported by our recent capital raise in October, which extended our cash runway into the second half of 2027, we are well-positioned to continue clinical execution across our pipeline of differentiated gamma delta 1 CAR T therapies.” Third Quarter 2025 and Recent Operational Highlights: Autoimmune diseases Announced positive preliminary data in LN and SLE patients from Phase 1 study of ADI-001 in autoimmune diseases. In October 2025 , Adicet announced positive initial safety and efficacy data from seven patients (five LN and two SLE patients) dosed with ADI-001 in the ongoing Phase 1 trial, with follow-up ranging from two to nine months as of the August 31, 2025 data cut-off date. All patients demonstrated rapid and sustained reductions in the SLEDAI-2K score and PGA. All patients in the LN cohort achieved improved renal function, including three complete renal responses and Definition of Remission In Systemic lupus erythematosus (DORIS) remissions, and two partial responses. ADI-001 also demonstrated multiple hallmarks of immune reset with subsequent emergence of naïve and previously undetected B cell repertoire following single dose treatment. ADI-001 was generally well tolerated and demonstrated a favorable safety profile, with no Grade 2 or higher Cytokine Release Syndrome (CRS), and no cases of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) observed. Based on these results, the Company plans to request a meeting with the FDA in the first quarter of 2026 to inform potential Phase 2 pivotal trial design, with the initiation of the study in LN or LN and SLE patients anticipated to commence in the second quarter of 2026. Enrollment ongoing in ADI-001 Phase 1 program. Adicet is actively enrolling patients in its Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases which include: LN, SLE, SSc, IIM, SPS and AAV. Adicet expects to provide an LN and SLE clinical update as well as an SSc clinical update in the first half of 2026. Actively enrolling patients with treatment-refractory RA in Phase 1 study of ADI-001 evaluating potential to reduce the need for conditioning. The Company is enrolling patients with treatment-refractory RA in a Phase 1 study of ADI-001 evaluating two lymphodepletion regimens: cyclophosphamide alone and cyclophosphamide with fludarabine. Adicet expects to provide a clinical update on the Phase 1 trial in the second half of 2026. Solid tumor indications Presented ADI-212 preclinical data at the 32nd annual Prostate Cancer Foundation Scientific Retreat. Adicet is continuing to advance preclinical development of ADI-212, an optimized next-generation gene-edited and armored clinical candidate designed to target PSMA. ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor-specific recognition. It integrates membrane-tethered IL-12 (mbIL-12) armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment. In October, Adicet presented preclinical data at the 32nd Annual Prostate Cancer Foundation Scientific Retreat supporting these design elements and functional enhancements in multiple models of disease. Regulatory filing on track for ADI-212 in mCRPC. Adicet plans to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the first quarter of 2026. The Company expects to share initial clinical data from the ADI-212 program in the second half of 2026, subject to regulatory clearance to proceed with a clinical trial. Corporate updates Raised $74.8 million in net proceeds in registered direct offering. In October 2025 , Adicet successfully raised $74.8 million in net proceeds through an underwritten registered direct offering of equity securities, extending its cash runway into the second half of 2027. Financial Results for Third Quarter 2025: Research and Development (R&D) Expenses: R&D expenses were $22.9 million for the three months ended September 30, 2025 , compared to $26.3 million during the same period in 2024. The decrease in R&D expenses was due to a $1.8 million decrease in payroll and personnel expenses, and a $1.0 million decrease in lab supplies and materials related to lower headcount, a $0.7 million decrease in expenses related to contract development and manufacturing organizations (CDMOs) and contracted R&D services due to lower utilization at external CDMOs, a $0.7 million decrease in expenses related to R&D consultants, partially offset by a $0.8 million of expenses related to contract research organizations; and a $0.1 million decrease in facility-related expenses. General and Administrative (G&A) Expenses: G&A expenses were $5.1 million for the three months ended September 30, 2025 , compared to $6.9 million during the same period in 2024. The decrease in G&A expenses was primarily due to a $1.6 million decrease in payroll and personnel expenses primarily related to a decrease in stock-based compensation expense, and a $0.1 million decrease in facility-related expenses. Net Loss: Net loss for the three months ended September 30, 2025 was $26.9 million , or a net loss of $0.29 per basic and diluted share, including non-cash stock-based compensation expense of $2.5 million , as compared to a net loss of $30.5 million , or a net loss of $0.34 per basic and diluted share, including non-cash stock-based compensation expense of $6.8 million during the same period in 2024. Cash Position: Cash, cash equivalents and short-term investments were $103.1 million as of September 30, 2025 , compared to $176.3 million as of December 31, 2024 . Subsequent to September 30 , the Company received approximately $74.8 million of net proceeds from a registered direct offering. The Company expects that its cash and cash equivalents and short-term investments as of September 30, 2025 , together with the proceeds raised after quarter end, will be sufficient to fund its operating expenses into the second half of 2027. About Adicet Bio, Inc. Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com. Forward-Looking Statements This press release contains “forward-looking statements” of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: clinical development of Adicet’s product candidates, including future plans or expectations for ADI-001 in autoimmune diseases and the potential safety, tolerability and efficacy for the treatment of autoimmune diseases and cancer; timing and success of the Phase 1 clinical trial of ADI-001 in LN, SLE, SSc, IIM, SPS and AAV, including timing and expectations for enrollment and future data releases; expectations regarding communications with the FDA and a potential pivotal trial for ADI-001; expectations regarding the timing and success of the Phase 1 clinical trial of ADI-001 in treatment-refractory RA; expectations regarding the preclinical and clinical development of ADI-212, including the timing of regulatory filings and future data releases; and expectations regarding Adicet’s uses of capital, expenses and financial results, including the extension of the cash runway into the second half of 2027. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet’s business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet’s product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet’s ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Adicet’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s other filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10- Q. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law. ADICET BIO, INC. Consolidated Statements of Operations and Comprehensive Income (in thousands, except share and per share amounts) (Unaudited) Three Months Ended September 30 , Nine Months Ended September 30 , 2025 2024 2025 2024 Operating expenses: Research and development $ 22,853 $ 26,253 $ 74,091 $ 76,050 General and administrative 5,099 6,900 16,137 20,822 Total operating expenses 27,952 33,153 90,228 96,872 Loss from operations (27,952 ) (33,153 ) (90,228 ) (96,872 ) Interest income 1,172 2,730 4,253 8,647 Interest expense (12 ) (1 ) (12 ) (3 ) Other expense, net (64 ) (54 ) (300 ) (167 ) Loss before income tax provision (26,856 ) (30,478 ) (86,287 ) (88,395 ) Income tax provision — — — — Net loss $ (26,856 ) $ (30,478 ) $ (86,287 ) $ (88,395 ) Net loss per share, basic and diluted $ (0.29 ) $ (0.34 ) $ (0.94 ) $ (1.02 ) Weighted-average common shares used in computing net loss per share, basic and diluted 91,086,464 90,846,293 91,315,390 86,865,285 Other comprehensive income Unrealized gain on treasury securities, net of tax 97 121 40 121 Total other comprehensive income 97 121 40 121 Comprehensive loss $ (26,759 ) $ (30,357 ) $ (86,247 ) $ (88,274 ) ADICET BIO, INC. Consolidated Balance Sheets Information (in thousands) (Unaudited) September 30 , 2025 December 31 , 2024 Cash and cash equivalents, and short-term investments in treasury securities $ 103,098 $ 176,303 Working capital 87,553 160,744 Total assets 140,479 220,219 Accumulated deficit (584,181 ) (497,894 ) Total stockholders’ equity 109,142 186,609 View source version on businesswire.com: https://www.businesswire.com/news/home/20251105901973/en/ Adicet Bio, Inc. Investor and Media Contacts Anne Bowdidge abowdidge@adicetbio.com Penelope Belnap Precision AQ 212-362-1200 Penelope.belnap@precisionaq.com Source: Adicet Bio, Inc.