Extending the Boundaries of Targeted Cancer Therapies with Radio-DARPins and Next-Gen Immune Cell Engagers Q3 Financials October 30, 2025 Nasdaq, SIX Swiss Exchange: MOLN Disclaimer This presentation contains forward looking statements. Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including without limitation: implied and express statem ...

ESMO: AlphaMedixTM phase 2 data support first-in-class potential of new targeted alpha therapy in gastroenteropancreatic neuroendocrine tumors New AlphaMedix data showed sustained and clinically meaningful responses across both RLT-naïve and RLT-exposed patients with unresectable or metastatic GEP-NETs First phase 2 study to evaluate TAT with lead-212 supporting its potential to address high unmet medical needs in difficult-to-treat, rare cancersPhase 2 study met all primary efficacy endpoints and was pre ...

AlphaMedixTM (212Pb-DOTAMTATE) achieved all primary efficacy endpoints in phase 2 study, demonstrating clinically meaningful benefits in patients with gastroenteropancreatic neuroendocrine tumors AlphaMedixTM showed prolonged and clinically meaningful benefits across PRRT-naïve and PRRT-exposed patients with unresectable or metastatic GEP-NETs, highlighting the potential of Targeted Alpha Therapy with lead-212 as a new treatment option Results will form the basis of future discussions with health authoritie ...

核心观点 - AlphaMedix (Pb-DOTAMTATE) 在治疗胃肠胰神经内分泌肿瘤的二期临床试验中达到所有主要疗效终点，在未接受过和已接受过肽受体放射性核素治疗的患者群体中均显示出临床意义的益处 [1] - 该疗法获得了美国FDA的突破性疗法认定，其基于铅-212的靶向α疗法平台展示了解决未满足临床需求的潜力 [2] - 完整研究结果将在2025年欧洲肿瘤内科学会大会上公布，并将作为与卫生当局讨论的基础 [3][6] 临床试验结果 - ALPHAMEDIX-02二期研究为开放标签、多中心试验，评估了AlphaMedix在61名不可切除或转移性GEP-NETs患者中的疗效和安全性，包括35名PRRT未接受者和26名PRRT接受者 [4] - 研究达到所有主要疗效终点，包括根据RECIST1.1标准的客观缓解率，并在关键次要终点如无进展生存期和总生存期方面观察到益处 [1] - 该疗法在两组患者中均表现出可控的安全性特征 [1] 疗法与技术平台 - AlphaMedix是一种研究性靶向α疗法，利用铅-212同位素靶向生长抑素受体 [1] - α发射体因其α粒子射程短，可能减少对周围健康组织的照射，与现有疗法相比可能具有更高的效力和靶向肿瘤活性 [2] - Orano Med公司利用其独特的铅-212获取渠道，开发将铅-212与多种靶向剂结合的治疗方法，并在法国和美国设有生产和研发设施 [8] 疾病背景 - 神经内分泌肿瘤是一组异质性癌症，起源于神经内分泌细胞，多发生于胃肠道和胰腺，全球估计患病率约为每10万人中35人 [5] - 在美国，每年约有12,000人被诊断出神经内分泌肿瘤，转移期患者的平均五年生存率为60% [5][7] - 大多数神经内分泌肿瘤高度表达生长抑素受体 [5] 合作与后续计划 - 赛诺菲作为合作方，强调了这些数据坚定了公司为难治性癌症开发创新疗法的承诺 [3] - 研究仍在进行中，完整结果将用于与监管机构的未来讨论，以尽快为GEP-NETs患者群体带来这一治疗选择 [3][6]