Hafnium oxide nanoparticles

Financial foundation toward self-sustained long-term growth established with the closing with HealthCare Royalty (“HCRx”) of a non-dilutive royalty financing valued up to $71 million Progress in the JNJ-1900 (NBTXR3) global development program announced including first data from a Phase 1 esophageal cancer study sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”) Completed the NANORAY-312 sponsorship transfer to Johnson & Johnson in the majority of regions Advanced the Curadigm Nanoprimer program with updated plans for internal pipeline development and external collaborations Clinical updates from ongoing or completed JNJ-1900 (NBTXR3) Phase 1 studies sponsored by Nanobiotix or MD Anderson in melanoma, lung cancer amenable to re-irradiation, pancreatic cancer, and esophageal cancer expected in 2026 €20.4 million in cash and cash equivalents as of September 30, 2025 PARIS and CAMBRIDGE, Mass., Nov. 24, 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 reported an operational update and financial results for the third quarter of 2025 along with an outlook for clinical updates from studies sponsored by Nanobiotix or The University of Texas MD Anderson Cancer Center (“MD Anderson”) expected in 2026 and announced the closing of its non-dilutive royalty financing transaction with HCRx. Operational Highlights Establishing the Financial Foundation for Self-sustained Long-term Growth Closed the royalty financing transaction with Healthcare Royalty (“HCRx”) triggering an upfront payment of $50 million Nanobiotix expects to receive an additional $21 million in one year, subject to reaching certain conditions Progressing JNJ-1900 (NBTXR3) Clinical Development Presented first data from a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) for patients with esophageal cancer presented at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO), adding another potential indication that warrants further investigation Completed the sponsorship transfer of Phase 3 study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced head and neck cancer who are ineligible for cisplatin (NANORAY-312) in the majority of regions, along with the transfer of full operational control of the Phase 3 study, to Johnson & Johnson (“J&J”) Advancing the Curadigm Nanoprimer Program Four new patent applications filed to expand the Curadigm Nanoprimer intellectual property portfolio and support an initial proprietary internal pipeline of Nanoprimer-based products in addition to external collaborations New in vivo pre-clinical data evaluating the Nanoprimer in combination with therapeutic vaccines presented at the 2025 Partnership Opportunities in Drug Delivery conference (PODD) that could serve as the foundation for an initial internal proprietary pipeline of Nanoprimer-based products Momentum building for external collaborations featuring Nanoprimer platform combinations with numerous material transfer agreements already in place Chemistry, Manufacturing, and Controls (CMC) activities launched to support internal pipeline and external collaborations Closed the royalty financing transaction with Healthcare Royalty (“HCRx”) triggering an upfront payment of $50 million Nanobiotix expects to receive an additional $21 million in one year, subject to reaching certain conditions Presented first data from a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) for patients with esophageal cancer presented at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO), adding another potential indication that warrants further investigation Completed the sponsorship transfer of Phase 3 study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced head and neck cancer who are ineligible for cisplatin (NANORAY-312) in the majority of regions, along with the transfer of full operational control of the Phase 3 study, to Johnson & Johnson (“J&J”) Four new patent applications filed to expand the Curadigm Nanoprimer intellectual property portfolio and support an initial proprietary internal pipeline of Nanoprimer-based products in addition to external collaborations New in vivo pre-clinical data evaluating the Nanoprimer in combination with therapeutic vaccines presented at the 2025 Partnership Opportunities in Drug Delivery conference (PODD) that could serve as the foundation for an initial internal proprietary pipeline of Nanoprimer-based products Momentum building for external collaborations featuring Nanoprimer platform combinations with numerous material transfer agreements already in place Chemistry, Manufacturing, and Controls (CMC) activities launched to support internal pipeline and external collaborations “2025 has been a year of strong execution against our strategic priorities, further accelerated by the momentum we built in the third quarter and to date,” said Laurent Levy, Chief Executive Officer and Chairman of the Executive Board at Nanobiotix. “We took another disciplined financing step toward self-sustained, long-term growth through the closing of a non-dilutive strategic royalty monetization with HCRx. Clinically, we saw continued advancement of the JNJ-1900 (NBTXR3) program with completion of the Phase 3 head and neck cancer study sponsorship transfer to J&J in the majority of regions and first data from a Phase 1 esophageal cancer study supporting evaluation in yet another indication. In parallel, our Curadigm Nanoprimer program is rapidly emerging as a long-term growth driver for Nanobiotix. We are well positioned to accelerate our trajectory in 2026 and beyond.” Closing of the Royalty Financing Transaction The closing of this royalty financing transaction with HCRx marks a significant milestone for the Company with an upfront payment of $50 million. The Company expects an additional $21 million in one year, subject to reaching certain conditions. HCRx will be compensated and repaid out of a capped portion of milestones and royalties on sales of JNJ-1900 (NBTXR3) payable to Nanobiotix under the Janssen license agreement. This repayment and compensation will be implemented through a trust established between (i) Nanobiotix as settlor and beneficiary, (ii) HCRx funds as beneficiaries, and (iii) European Investment Bank (“EIB”) as beneficiary. Furthermore, contractual covenants granted by Nanobiotix to HCRx regarding the proper implementation by Nanobiotix of the Janssen license agreement shall also benefit to EIB. 2026 JNJ-1900 (NBTXR3) Clinical Data Outlook for Studies Sponsored by Nanobiotix or MD Anderson Final data from Nanobiotix Study 1100 evaluating JNJ-1900 (NBTXR3) followed by pembrolizumab or nivolumab anti-PD-1 checkpoint inhibitors for patients with primary cutaneous melanoma resistant to anti-PD-1 Updated data from a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced non-small cell lung cancer (NSCLC) who are amenable to re-irradiation New data from expansion cohort of a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) in combination with standard-of-care chemotherapy (capecitabine) for patients with locally advanced or borderline resectable pancreatic cancer Updated results and establishment of the recommended Phase 2 dose (RP2D) from the proton therapy cohort of a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) activated by photon or proton therapy for patients with locally advanced esophageal cancer Third Quarter Financial Updates Cash, Cash Equivalents and Operating Runway: €20.4 million in cash and cash equivalents as of September 30, 2025 $50 million upfront payment to be received by Nanobiotix given the closing of the HCRx agreement, plus the additional $21 million expected one year post-closing upon reaching certain conditions, would extend cash visibility into early 2028 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 Janssen Pharmaceutica NV, a Johnson & Johnson company. 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 2, 2025 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2024 universal registration document filed with the AMF on April 2, 2025 under “chapter 1.5 Risk Factors”, and subsequent filings Nanobiotix makes with the SEC and AMF from time to time, including the Half-Year Report at June 30, 2025 which are available on the SEC’s website at www.sec.gov and on the AMF's website at www.amf.org, 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 Attachments http://ml.globenewswire.com/Resource/Download/7d5eefc8-b905-4ba5-8476-f80f10c972e1

编者按：胰腺癌是一种侵袭性极强的癌症，因极低的5年生存率素有“癌症之王”的称号。尽管近几十年来胰腺癌治疗领域取得显著进展，患者可选方案日益丰富，但临床上仍面临诸多挑战。目前，全球有数百个新药管线项目正处于临床研究阶段，持续探索胰腺癌治疗的更多可能性。作为医药创新的赋能者，药明康德凭借独特的CRDMO模式，持续助力全球合作伙伴加速创新药物研发进程，致力于将更多突破性治疗方案带给包括胰腺癌在内的各类癌症患者，为战胜这一疾病贡献力量。胰腺癌是一类具有高度侵袭性且致死率极高的恶性肿瘤，近年来全球范围内发病率持续上升。由于胰腺癌起病隐匿，早期缺乏特异性症状，多数患者确诊时已处于中晚期，预后极差。CA: A Cancer Journal for Clinicians于2024年发布的研究显示，胰腺癌患者的五年生存率仅为13%，这类疾病目前已跃升为全球第六大癌症致死原因。图片来源：123RF面对严峻的临床需求，全球正加速推进胰腺癌新药研发，目前临床在研管线项目达数百个。从药物类型来看，小分子、抗体共同构成研发管线的主力军。此外，抗体偶联药物（ADC）、治疗性疫苗、细胞疗法等相关探索也在持续加速，为胰腺癌治疗突破带来更多可能。2025年以来，胰腺癌新药研发领域取得了多项进展。KRAS抑制剂治疗胰腺癌展现治疗潜力近年来，针对KRAS的靶向药物在胰腺癌领域展现出越来越多的潜力。最常见的胰腺癌类型是胰腺导管腺癌（PDAC）及其变异型，占所有胰腺癌病例约92%。PDAC是最依赖RAS基因突变驱动的癌症之一，超过90%的患者携带该突变。这使得KRAS成为胰腺癌治疗中一个有吸引力的治疗靶点。今年10月，恒瑞医药在2025年欧洲肿瘤内科学会（ESMO）大会上公布了KRAS G12D抑制剂HRS-4642联合吉西他滨与白蛋白紫杉醇治疗KRAS G12D突变型晚期胰腺癌的1b/2期临床数据。数据显示：中位随访7.5个月后，确认客观缓解率（ORR）达63.3%，超半数患者肿瘤显著缩小，较标准化疗大幅提升；疾病控制率（DCR）高达93.3%，表明绝大多数患者的肿瘤生长得到有效控制，而既往化疗DCR通常不超70%；中位无进展生存期（PFS）尚未成熟，但6个月PFS达89.3%，疾病进展风险显著降低。劲方医药同月公布的KRAS G12D（ON/OFF）选择性抑制剂GFH375的1/2期临床结果同样亮眼。在59例完成至少一次治疗的KRAS G12D突变型PDAC患者中，ORR达40.7%，DCR高达96.7%，其中91.5%的患者肿瘤出现缩小。中位PFS为5.52个月，4个月无进展生存率达78.2%；中位总生存期尚未达到，4个月总生存率高达92.2%。同样在今年的ESMO大会上，Incyte报告了其KRAS G12D抑制剂INCB161734治疗KRAS G12D突变型PDAC患者的1期试验结果：接受每日600mg与1200mg治疗的患者，ORR分别为20%和34%，DCR分别达到64%与86%。Incyte预计将在2026年上半年公布疗效持久性数据。通过公开渠道梳理，目前全球范围内有数十款靶向KRAS的创新药物正处于治疗胰腺癌的临床研究阶段，涵盖小分子、RNA疗法、细胞疗法、治疗性疫苗等等。面对KRAS这一曾被认为难以成药的靶点，科研人员始终在坚持探索不同的药物研发策略。其中，共价抑制策略最终带来了突破的曙光，被证实切实有效。与传统非共价抑制剂不同，共价药物通过与靶点形成稳定的化学键，实现持久的抑制效果。凭借这一独特机制，共价药物不仅能够以更低的剂量给药，还可显著提升靶点占有率，展现出极具潜力的广阔临床应用前景。针对KRAS靶点，研究人员突破性地采用直接筛选策略，寻找能够与KRAS突变体半胱氨酸快速形成共价键的小分子化合物。这一方法不同于以往依赖修饰现有非共价分子的模式，而是开创性地针对全新靶点的突变位点进行共价结合与优化，最终推动了首批KRAS靶向疗法的问世。为帮助全球合作伙伴加速下一代共价药物的研发进程——从早期发现到IND申报，药明康德建立了一体化发现平台。该平台融合了三大互补技术：共价DNA编码化合物库（cDEL）、共价片段药物发现（cFBDD）以及共价高通量筛选（cHTS），为共价药物发现提供了高效的解决方案。除共价药物筛选平台之外，药明康德还建立了一整套早期药物发现技术平台，涵盖生物物理学、生物化学及细胞学检测，为全球合作伙伴共价药物的开发提供坚实的支持。依托端到端的一体化CRDMO赋能平台，药明康德致力于加速突破性疗法的开发，帮助合作伙伴将创新成果高效转化为造福全球患者的解决方案。更多创新靶点涌现，展现积极疗效除KRAS外，针对其他靶点的小分子胰腺癌新药也持续取得进展。今年以来，Immuneering公司开发的口服MEK抑制剂atebimetinib（IMM-1-104）联合吉西他滨/白蛋白紫杉醇治疗胰腺癌的2a期研究取得积极结果。初步数据显示，该联合治疗方案在患者中实现了43%的ORR和86%的DCR。后续随访数据显示，6个月时患者总生存率达94%，无进展生存率为72%，DCR达到81%；至9个月时，总生存率仍保持在86%，提示该方案具有持久的抗肿瘤活性。基于这些积极结果，该公司计划于2026年启动关键性注册研究。1月，ImmunoMet Therapeutics公布了lixumistat联合吉西他滨/白蛋白结合型紫杉醇一线治疗晚期胰腺癌的1期研究结果：在推荐的2期剂量下，患者疾病控制率达100%，且耐受性良好。Lixumistat是一种蛋白质复合物1（PC1）抑制剂，通过抑制PC1可以有效阻断线粒体电子传递链，从而抑制氧化磷酸化（OXPHOS）——该通路在肿瘤的生长和增殖中至关重要。10月，Tango Therapeutics公布了其在研PRMT5抑制剂vopimetostat用于MTAP缺失型肿瘤患者的1/2期研究最新数据，结果显示积极疗效。在MTAP缺失型胰腺癌的二线治疗亚组中，患者中位无进展生存期达到7.2个月，客观缓解率为25%。既往研究已证实，PRMT5是携带MTAP纯合缺失突变肿瘤的合成致死靶点。多重创新策略，拓展胰腺癌治疗的更多可能性在肿瘤免疫治疗领域，胰腺癌长期被视为“冷肿瘤”。这不仅源于其肿瘤细胞免疫原性低，还与其致密的基质屏障、高度免疫抑制性的肿瘤微环境密切相关——大量免疫抑制细胞和信号分子的存在阻碍了抗肿瘤T细胞的浸润与激活，导致免疫疗法难以发挥应有的作用。面对这一困境，研究者正通过多重策略，持续探索改善免疫应答、提升疗效的全新策略。今年以来，多项免疫疗法的研究结果为这一领域带来了新的希望。2月，Candel Therapeutics公布了其在研免疫疗法CAN-2409的2期临床试验最终总生存期数据。该疗法联合抗病毒药物valacyclovir及标准放化疗用于治疗难以完全切除的PDAC患者，中位总生存期达31.4个月，为对照组（12.5个月）的两倍以上。CAN-2409是一种复制缺陷的现货型腺病毒载体，可将表达单纯疱疹病毒胸苷激酶（HSV-tk）的转基因递送入肿瘤，从而诱导个体化抗肿瘤免疫反应，显著改善患者生存预后。同月，BioNTech与罗氏（Roche）联合开发的个体化新抗原疫苗autogene cevumeran（BNT122）针对接受手术切除肿瘤的PDAC患者的1期临床结果发表于《自然》杂志。结果显示，对autogene cevumeran产生应答的PDAC患者的疾病复发风险与未产生应答的患者相比，降低86%。BNT122是基于BioNTech的iNeST癌症疫苗技术平台生成的个体化新抗原疫苗。新抗原是基于肿瘤特异性突变而产生的突变蛋白，这些突变蛋白被人体的免疫系统识别为外来物，从而对它们产生免疫反应。抗体偶联药物（ADC）和放射治疗领域也取得重要进展。6月，信达生物在ASCO年会上报告了IBI343（抗CLDN18.2 ADC）治疗晚期胰腺癌的1期临床数据更新：在6 mg/kg剂量组中，CLDN18.2阳性患者的中位OS达9.1个月，中位无进展生存期为 5.4个月，且整体安全性良好。5月，Nanobiotix公司公布了其新型放射增敏剂JNJ-1900（NBTXR3）用于局部晚期或临界可切除胰腺癌的1期临床试验数据。该产品通过一次性瘤内注射后经放疗激活，结果显示患者中位总生存期达到23个月，中位局部无进展生存期为13.3个月，59%的患者肿瘤标志物CA19-9恢复正常水平。探索性生物标志物分析还发现，循环肿瘤突变负荷与生存获益相关，提示其作为生物标志物的潜在价值。2025年以来，还有其他许多胰腺癌新药管线取得临床进展，此处不再一一列举。破解“癌症之王”困局当前，胰腺癌的治疗仍面临诸多核心挑战。根据Nature Reviews Gastroenterology & Hepatology于2024年发表的综述论文，该领域亟待突破的难点表现在早期诊断困难、治疗精准度有限以及现有方案疗效不足等。比如，胰腺癌领域高效、可靠的预测及预后生物标志物仍十分匮乏，同时临床前研究与临床试验结果间的差异，使许多具有坚实科学基础的发现难以转化为有效疗法。未来，胰腺癌的治疗策略将持续聚焦于方案优化与创新：化疗仍为基石，而直接靶向KRAS等癌症驱动基因的策略有望成为综合治疗的重要组成部分；与此同时，行业需加大研究投入，加速新药落地。随着创新疗法不断涌现，我们坚信胰腺癌患者将迎来更多治疗选择和新的希望。在科学探索的前行之路上，药明康德将继续助力全球合作伙伴推动创新药研发，为全球病患带来更多突破性疗法。参考资料：[1] Bray, Freddie et al. “Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.” CA: a cancer journal for clinicians vol. 74,3 (2024): 229-263. doi:10.3322/caac.21834[2] Siegel, Rebecca L et al. “Cancer statistics, 2024.” CA: a cancer journal for clinicians vol. 74,1 (2024): 12-49. doi:10.3322/caac.21820[3] Halbrook, Christopher J et al. “Pancreatic cancer: Advances and challenges.” Cell vol. 186,8 (2023): 1729-1754. doi:10.1016/j.cell.2023.02.014[4] Hu, Z Ian, and Eileen M O'Reilly. “Therapeutic developments in pancreatic cancer.” Nature reviews. Gastroenterology & hepatology vol. 21,1 (2024): 7-24. doi:10.1038/s41575-023-00840-w[5] Stoop, Thomas F et al. “Pancreatic cancer.” Lancet (London, England) vol. 405,10485 (2025): 1182-1202. doi:10.1016/S0140-6736(25)00261-2[6] Kung, HC., Zheng, K.W., Zimmerman, J.W. et al. The tumour microenvironment in pancreatic cancer — new clinical challenges, but more opportunities. Nat Rev Clin Oncol (2025). https://doi.org/10.1038/s41571-025-01077-z[7] 各公司官网及官方新闻稿免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号回复“转载”，获取转载须知。