Nivolumab

免疫治疗（IO）深刻改变了肿瘤治疗的格局，这一切可追溯至2011和2014年：全球首个CTLA-4抑制剂伊匹木单抗（Y药）和首个PD-1抑制剂纳武利尤单抗（O药）相继获批，不仅开启了全新的治疗时代，也让背后的企业——百时美施贵宝（BMS）在全球肿瘤赛道确立了重要地位。 其后十余年间，免疫治疗赛道呈现出极高的竞争烈度，而BMS在竞争格局多次演变中始终得以保持其竞争力。如果要对BMS这一阶段的策略进行总结，其关键在于前瞻的适应症布局、差异化的临床策略，以及成熟的临床证据转化能力。也正是这些综合实力，为其在后免疫治疗时代肿瘤战略的多维布局奠定了基础。 / 01 / IO时代：路径选择与背后逻辑 BMS 在免疫治疗中的探索轨迹颇具启发性：并非单纯依靠“起跑早”而保持领先，而是通过在关键领域的差异化布局——从消化肿瘤突破，到推动治疗关口前移，再到坚持“双免联合”探索，逐渐形成区别于同行的路径。 聚焦消化肿瘤：未满需求巨大的突破口 在免疫治疗发展的早期，当肺癌、黑色素瘤等热门赛道已开始呈现拥挤格局时，BMS选择胃癌作为突破口，是其中一个经典案例。这一选择背后可能有两方面考量：一是当时胃癌长期缺乏有效创新药物，标准化疗方案十余年来未能改善患者生存，存在巨大的临床未满足需求；二是胃癌等消化肿瘤在东亚尤其高发，而当时中国免疫肿瘤治疗市场正处于快速扩张阶段，新疗法的价值和需求正在凸显。 值得注意的是，这一战略选择的落地，也体现了 BMS 在临床研发上的执行力。与此前的同类研究相比，BMS的晚期胃癌一线免疫治疗CheckMate-649 研究入组规模更大，覆盖了超过 2000 例患者，从而确保能在高度异质的胃癌患者中取更稳健的统计学结果；其中中国患者比例更高，也使得研究结果在全球范围内具有更强的外推性和中国本土临床价值。 基于其坚实的设计，CheckMate-649 取得了突破性的结果，不仅首次证实了免疫联合化疗可在晚期一线胃癌患者中显著改善OS，还在五年长随访中显示出长期获益：数据显示，中国患者的五年生存率达到24%（CPS≥5 人群）[1]，标志着胃癌治疗目标正在从单纯延长生存迈向“慢病化管理”。 与此同时，BMS同步快速推进了CheckMate-648、CheckMate-577等研究，率先在中国完成了上消化道瘤种（胃癌、食管癌）、病理类型（鳞癌、腺癌），以及食管癌中不同分期（早期、晚期）的全面覆盖，进一步巩固了在消化肿瘤领域的优势。 早期探索：推动治疗关口前移 BMS 在免疫治疗中开辟的另一个关键战场是早期可切除肿瘤。随着癌症早诊早筛的推进，这一领域同样充满机遇，但也长期面临挑战：如何在不影响患者根治机会、不增加过度治疗风险的前提下，进一步改善患者的长期生存。 相比此前多数研究集中在较为“稳妥”的术后辅助领域，BMS的布局显得更为前瞻，早在2015年就开展了首个探索将免疫治疗用于NSCLC新辅助的研究CheckMate-159。随后在NADIM等一系列研究积累基础上，CheckMate-816被业内普遍视为具有突破意义的里程碑：它首次在III 期试验中证实了新辅助免疫+化疗能够显著提高NSCLC的病理缓解和无事件生存期（EFS），证实了这一模式的价值；更基于今年公布的5年数据，成为了迄今唯一证实单纯新辅助免疫治疗可显著改善实体肿瘤OS的研究，重塑了可切除NSCLC的治疗范式，影响深远。 在此基础上，BMS进一步延展其研发思路，同步开展了 CheckMate-77T，将其证据进一步延伸至围术期（新辅助 + 辅助）模式，通过两项研究进一步丰富了不同免疫治疗策略在可切除NSCLC领域的证据，也强化了自身的循证壁垒。 值得强调的是，新辅助临床研究本身的落地难度远高于辅助或晚期研究：既要确保新辅助带来的生存获益，同时尽可能不影响手术时机和手术机会，还需实现跨学科的质量控制，包括确立病理评估标准、确保判读一致性等。而BMS能最先“跑通”这一系列复杂路径、引领后续行业探索，除了产品的优异疗效之外，也是其临床开发能力的体现。 双免联合：进一步丰富治疗策略 BMS在免疫治疗中的另一个独特标签是其“双免策略”——O+Y，其探索在最初带有一定冒险色彩：两种免疫检查点抑制剂的联合意味着通过协同效应实现更强的免疫激活，但也需要解决AE管理、剂量组合等难题。 BMS在这一方向的策略是保持长期投入，通过大量探索逐步优化治疗方案和研究设计，以期达到疗效和安全性的平衡，从而提高总生存获益。以早期的II期研究CheckMate-040为例，其在肝细胞癌人群中设立了多个剂量组合的探索队列，以比较不同 O药与 Y药剂量的安全性和疗效差异。基于这一循证积累，双免O+Y得以在III期研究CheckMate-9DW中确立最优的剂量组合，证实了双免疗法在肝细胞癌一线中的显著疗效优势：3年OS率高达38%、客观缓解率（ORR）达36%、中位缓解时间（mDOR）超30个月[2]。 此外，双免O+Y也在多个瘤种中验证了其独特的临床价值。例如在 MSI-H /dMMR不可切除或转移性结直肠癌中，CheckMate-8HW证实了双免O+Y的疗效优于单免，确立了新的标准；在非小细胞肺癌中，CheckMate-227六年随访显示双免O+Y的疗效呈现明显的“长尾效应”。 这些结果表明，尽管起步时挑战颇多，双免策略最终在多个瘤种中确立了临床价值。这一历程反映了 BMS 在复杂机制下的长期验证能力：通过早期剂量探索、跨瘤种积累与长期随访，推动了差异化免疫联合方案进入标准治疗序列。 总之，回顾以上路径，可以发现 BMS 在免疫治疗时代的成功高度源于其前瞻性与执行力：聚焦未满足需求较突出、有望给治疗实践带来突破的领域，能够推动复杂研究落地，并在长期随访中不断积累循证证据。这些经验奠定了其在肿瘤领域的行业地位，也为后续的多元化布局建立了基础。 / 02 / IO+战略： 突破免疫治疗边界的多路径探索 而随着免疫治疗成为多个瘤种的治疗标准，新的问题逐渐凸显——部分人群原发无效，部分患者继发耐药，这也使得“IO+”成为下一个时代的核心探索方向——即在既有的免疫检查点阻断理论基础上，通过新的靶点或双特异性分子设计，进一步扩大获益人群。 BMS在这一领域最受关注的布局，是于今年6月引进的目前全球研发进度领先的PD-L1xVEGF双抗pumitamig（BNT-327）。从战略层面来看，这一决策背后有多重考量：首先，pumitamig旨在既往免疫治疗瓶颈突出或存在空白的瘤种领域进行探索，以小细胞肺癌（SCLC）为例，目前晚期患者的5年OS率仅5%，且缺乏有效的后续治疗方案；其次，pumitamig的双特异性机制也填补了BMS旗下“免疫+抗血管”策略的空白，和既有产品可组成互补的矩阵。 就在今年WCLC大会上，pumitamig公布了其联合化疗用于ES-SCLC一线治疗II期研究队列1的43例患者中期分析结果[3]：38例可评估疗效的患者中， 客观缓解率（ORR）高达76.3%，疾病控制率（DCR）更达到100%；所有43例患者的中位无病生存期（PFS）为6.8个月，同时安全性良好，仅14%患者终止pumitamig治疗。业内普遍认为，pumitamig的早期数据结合BMS在临床落地方面的能力，使得这一管线具有较高的发展确定性。 在 pumitamig 之外，BMS 旗下还拥有多个“IO+”机制管线，例如：第三款免疫检查点抑制剂产品Opdualag（LAG-3抑制剂relatlimab与纳武利尤单抗复方制剂）已在部分海外市场上市；纳武利尤单抗联合Fucosyl-GM1抑制剂atigotatug治疗SCLC的III期研究已在全球开展，中国亦同步参与。这些管线共同构成了 BMS未来的“IO+”矩阵——在免疫治疗已成标准的格局下，通过新靶点和新机制持续扩展治疗边界。 / 03 / 靶向蛋白降解平台： 破解更多“不可成药”靶点 在免疫治疗外，BMS近年来重点布局的另一条肿瘤领域关键技术路线是靶向蛋白降解技术（Targeted Protein Degradation，TPD）。TPD并非直接“抑制”致病蛋白，而是通过“招募”泛素-蛋白酶体系统等降解机制，使目标蛋白被深度降解，被认为是当下富有潜力的新型研发路径之一。 BMS在 TPD领域建立了行业领先的CELMoD平台，其优势在于基于对CRBN（E3泛素连接酶中的底物受体）的针对性设计开发，使药物能够与靶点CRBN及其底物形成稳定的三元复合物，从而取得强大的靶蛋白降解效率。这一平台已形成多款临床研发管线，目前主要包括iberdomide、mezigdomide和golcadomide三款药物，覆盖多发性骨髓瘤（MM）与淋巴瘤等多种血液肿瘤。这三款CELMoD药物均已进入III期临床试验阶段。 其中，iberdomide的进展最快，用于治疗复发/难治性MM患者的III期研究EXCALIBER-RRMM近期已宣布在预设的中期分析中达到主要终点之一：微小残留病（MRD）阴性率相比对照组取得了具有统计学意义的显著改善，这意味着CELMoD作为一类新型药物，其价值得到了首个III期研究的初步验证。 值得一提的是，在多发性骨髓瘤中，MRD已成为一种高度敏感、具有重要临床价值的治疗反应评估工具：虽然MRD阴性并不意味着所有癌细胞都已清除，但它可能预示着更好的临床结局。目前，MRD正越来越多地被用于临床试验，作为PFS的替代终点，并因其在加速治疗方案研发中的作用而获得监管机构的认可。如果基于MRD作为主要终点的研究结果后续得到监管批准适应症，则意味着MM临床研究随访周期过长的痛点有望得到改善，也反映出BMS在研究设计上的前瞻性。 除此之外，mezigdomide同样聚焦MM，I/II期研究已于2023年登上《NEJM》，其联合地塞米松的全口服方案在多线复杂耐药的MM患者中ORR仍可达41%[4]；golcadomide则主要针对淋巴瘤赛道，也已有系统的I/II期数据积累。整体来看，BMS的CELMoD管线布局已初步成型。 除CELMoD外，BMS在TPD领域还拥有配体导向型降解剂（LDD，已进入III期临床试验阶段）、降解抗体偶联物（DAC）等多条技术路线。可以看出，BMS的研发逻辑延续了以往的模式：通过结构优化和广泛开展临床研究，逐步推动新机制药物进入标准治疗序列；如果能在TPD领域建立起类似此前免疫治疗的先发优势，或将为BMS下一阶段的血液肿瘤战略提供重要支撑。 / 04 / 新型核药：诊疗一体化的又一支柱 核药（即放射性药物）并非新鲜概念，而近年来，通过将放射性核素偶联至能与肿瘤靶点结合的分子上，形成了更精准的新型核药——放射性配体药物（RLT）。与传统核药的“非精准化杀伤”不同，RLT 的核心创新在于“靶向递送 + 核素适配”的设计，同一靶向分子可分别用于“肿瘤定位诊断”与“精准放射治疗”，契合当下热门的 “诊疗一体化（Theranostics）” 理念。 在此背景下，BMS于 2023 年并购 RayzeBio 为关键节点，快速切入 RLT 领域，并构建起差异化技术壁垒：不同于当前市场上主流 RLT 产品采用的 β 粒子核素，其旗下核心管线包括RYZ101（靶向SSTR2，用于胃肠胰神经内分泌肿瘤等实体瘤）、RYZ801（靶向GPC3，用于肝癌等实体瘤）等，均采用 α 粒子核素作为放射源：其“射程” 仅为几个细胞直径，能在精准杀伤肿瘤细胞的同时，最大限度减少对周围正常组织的辐射损伤，代表了RLT升级的方向之一。总之，BMS在RLT领域的切入不仅是赛道补全，更体现了其在“诊疗一体化”趋势下的战略前瞻性。 / 05 / 总结 回顾过去十余年，BMS 在临床开发、适应症选择和长期数据积累上的能力，已经在免疫治疗中得到了体现；进入后免疫治疗时代，其战略也并非简单复制既有路径，而是沿着“突破局限、补足空白”的思路，在多个维度展开布局：从“IO+”策略，到以 CELMoD为代表的蛋白降解平台，再到RLT等新兴赛道，逐步构建出一套多靶点、多机制的创新组合。这一趋势也预示着行业的竞争逻辑正在发生变化：从单一“爆款”驱动，逐步走向更加多元的治疗生态，以更好应对肿瘤治疗的复杂性。 参考资料： [1] Shen, L. at el. ASCO GI 2025, San Francisco, California, United States. Abstract 392. [2] Yau, T. et al. Lancet. 2025;405(10492):1851-1864. [3] Heymach, JV. et al. WCLC 2025, Barcelona, Spain. OA13.02. [4] Richardson, PG. et al. N Engl J Med. 2023;389(11):1009-1022. PS：欢迎扫描下方二维码，添加氨基君微信号交流。

Treatment remained well-tolerated with consistent injection feasibility in 103 heavily pre-treated patients with R/M-HNSCC naïve or resistant to anti-PD-1 63% (26/41) disease control rate (“DCR”) and 37% (15/41) objective response rate (“ORR”) in evaluable anti-PD-1 naïve patients per RECIST 1.1 74% (37/50) DCR and 32% (16/50) ORR in evaluable anti-PD-1 resistant patients per RECIST 1.1 15.5 months median Overall Survival (“mOS”) in evaluable anti-PD-1 naïve patients 11.4 months mOS in evaluable anti-PD-1 resistant patients Investigators concluded that these promising results warrant further exploration in randomized controlled trials Data presented as a “Top-rated Abstract in Head and Neck Cancer” at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO) on September 29th PARIS and CAMBRIDGE, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced updated data from cohorts 1 and 2 of Study 1100, a multicenter Phase 1 dose escalation and expansion trial evaluating JNJ-1900 (NBTXR3) activated by radiation therapy (“RT”) followed by anti-PD-1 immune checkpoint inhibitors (pembrolizumab or nivolumab; “ICIs”) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (“R/M-HNSCC”) that is naïve (cohort 1) or resistant (cohort 2) to prior anti-PD-1 therapy. Study results were presented as a “Top-rated Abstract in Head and Neck Cancer” by Study 1100 Coordinating Investigator Colette Shen, MD, PhD, Assistant Professor of Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center, at the 2025 Annual Meeting of the American Society of Radiation Oncology (ASTRO). ABSTRACT #245: PHASE 1 DOSE ESCALATION/DOSE EXPANSION TRIAL OF NBTXR3/SBRT IN COMBINATION WITH NIVOLUMAB OR PEMBROLIZUMAB FOR TREATMENT OF ANTI-PD-1 NAÏVE OR RESISTANT PATIENTS WITH RECURRENT/METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMAColette Shen1, Ammar Sukari2, William A. Stokes3, George Yang4, Nabil F. Saba3, Jared Weiss1, Jessica Frakes4, Jimmy Caudell4, Paul Chang5, Septimiu Murgu5, Michele Lohr6, Jason Chan7, Kedar Kirtane4, David Rolando8, Omar I. Vivar8, Zhen Gooi5, Aditya Juloori5, Trevor Hackman1, Ari Rosenberg51University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA; 2Karmanos Cancer Institute, Detroit, MI, USA; 3Emory Winship Cancer Institute, Atlanta, Georgia, USA; 4Moffitt Cancer Center, Tampa, Florida, USA; 5The University of Chicago, Chicago, Illinois, USA; 6Sanford Cancer Center, Sioux Falls, South Dakota, USA; 7UCSF, San Francisco, CA, USA; 8Nanobiotix, SA, Paris, France The efficacy of ICI monotherapy remains limited in R/M-HNSCC, with objective response rates between approximately 13% and 18%, and median Overall Survival (“mOS”) between approximately 8 months and 12 months. As approximately 66% of patients with R/M-HNSCC experience disease recurrence locally or loco-regionally, addition of RT to the treatment regimen is often recommended to improve local control and as a potential option for stimulating immune responses. However, to date, the addition of RT has not significantly improved ICI efficacy in R/M-HNSCC. As such, patients with R/M-HNSCC have an unmet need for novel treatment strategies that can improve local tumor control and potentiate systemic immune response. Safety and Feasibility JNJ-1900 (NBTXR3) activated by RT followed by anti-PD-1 was consistently well-tolerated and remained feasible in this heavily pre-treated patient population (n=103): Injection remained consistently feasible at the recommended Phase 2 dose (33% GTV) Favorable safety profile including no additional toxicities in lesions that were injected after re-irradiation 27 patients experienced treatment-emergent adverse events (TEAEs) of any grade (1, 2, or 3+) related to JNJ-1900 (NBTXR3) and 32 patients experienced TEAEs of any grade related to the injection procedure Of these patients, 5 experienced grade 3+ TEAEs related to JNJ-1900 (NBTXR3) and 4 experienced grade 3+ TEAEs related to the injection procedure In total, 71 patients experienced TEAEs of any grade related to the overall therapeutic regimen Patients were deemed non-evaluable for efficacy (n=12) if more than one RT session was missed and/or a post-treatment tumor response assessment was unavailable Of these patients, 5 experienced grade 3+ TEAEs related to JNJ-1900 (NBTXR3) and 4 experienced grade 3+ TEAEs related to the injection procedure Signals of Efficacy Potential enhancement of local responses: Evaluable Anti-PD-1 Naïve Patients (n=41) Injected-lesion Disease Control Rate (“DCR”): 95% (39/41) Injected-lesion Overall Response Rate (“ORR”): 66% (27/41) Local Progression-free Survival (“LPFS”): 34.4 months [95% CI: 12.8; Not Reached] Evaluable Anti-PD-1 Resistant Patients (n=50) Injected-lesion DCR: 94% (47/50) Injected-lesion ORR: 50% (25/50) LPFS: 7.3 months [95% CI: 5.7; Not Reached] Injected-lesion Disease Control Rate (“DCR”): 95% (39/41) Injected-lesion Overall Response Rate (“ORR”): 66% (27/41) Local Progression-free Survival (“LPFS”): 34.4 months [95% CI: 12.8; Not Reached] Injected-lesion DCR: 94% (47/50) Injected-lesion ORR: 50% (25/50) LPFS: 7.3 months [95% CI: 5.7; Not Reached] Systemic responses beyond potential enhanced local control: Evaluable Anti-PD-1 Naïve Patients DCR per RECIST 1.1: 63% (26/41) ORR per RECIST 1.1: 37% (15/41) Evaluable Anti-PD-1 Resistant Patients DCR per RECIST 1.1: 74% (37/50) ORR per RECIST 1.1: 32% (16/50) DCR per RECIST 1.1: 63% (26/41) ORR per RECIST 1.1: 37% (15/41) DCR per RECIST 1.1: 74% (37/50) ORR per RECIST 1.1: 32% (16/50) Early signals of Overall Survival that is expected to mature with additional follow up: Evaluable Anti-PD-1 Naïve Patients Median Overall Survival: 15.5 months [95% CI: 11.0; Not Reached] Evaluable Anti-PD-1 Resistant Patients Median Overall Survival: 11.4 months [95% CI: 7.8; 16.7] Median Overall Survival: 15.5 months [95% CI: 11.0; Not Reached] Median Overall Survival: 11.4 months [95% CI: 7.8; 16.7] Notably, survival data in anti-PD-1 resistant patients suggests JNJ-1900 (NBTXR3) activated by RT followed by anti-PD-1 may overcome prior resistance to immune checkpoint inhibitors. Overall, these results show strong local control, with an aggregate DCR of 95% (86/91) in JNJ-1900 (NBTXR3)-injected lesions in evaluable patients, representing a critical potential outcome for patients with R/M-HNSCC. Moreover, the results suggest that the antitumoral activity of JNJ-1900 (NBTXR3) activated by RT may occur beyond the injected lesion. Investigators concluded that these promising results warrant further exploration in randomized controlled trials. “Through the evaluation of JNJ-1900 (NBTXR3) cohorts 1 and 2 of Study 1100, we are ensuring that we prioritize the clinical development of innovation that acts both locally and systemically to address the unmet needs of patients with R/M-HNSCC,” said Study 1100 Coordinating Investigator Colette Shen, MD, PhD. “Our findings from Study 1100 have consistently supported a well-tolerated safety profile with early efficacy signals, and I look forward to further investigation of JNJ-1900 (NBTXR3) as a potentially new and complementary therapeutic option for patients." About JNJ-1900 (NBTXR3) JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Johnson & Johnson. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations. Nanobiotix is the owner of more than 25 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter Disclaimer This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 02, 2025 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2024 universal registration document filed with the AMF on April 02, 2025,, and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly. Contacts Attachment 2025-09-29 -- NBTX -- Updated Ph1 Results for NBTXR3 -- FINAL