Pumitamig

尽管目前的Ai热潮席卷全球，但是若论哪一个行业最先会让中国在全球的产业中披荆斩棘，统治整个世界，我不会选中国的AI，也不会选中国的风能，光能，储能以及电动汽车等等。不是中国的这些产业不够好，不够强。诸如这些能在全球占据优势的产业，中国还有很多，比如汽车配件产业，钢铁产业等等。但是若以本身具有的含金量，体量，以及未来拥有的不可撼动的竞争优势以及商业模式和永续发展的角度看。中国的创新药当成为中国在全世界最耀眼的产业。如果你不相信，那请看看中国的创新药公司已经在全球的渗透的宽度和体量。以下是我简单列举的中国的创新药公司在FDA申报的临床的管线。为什么选30家公司？因为这30家公司就代表着30只大军。代表着300万的创新药大军早就在诺曼底登陆了。代表着一直庞大的不可逆的力量发起了气势磅礴的进攻第一军：百济神州。有多款经FDA批准临床实验的产品，较为典型的有5款，分别为百悦泽®、百泽安®、索托克拉、BGB-16673、Ociperlimab。百济神州每年大概都能将20个左右的临床前分子推进到临床，不用去关心百济在FDA有多少款临床的管线，临床对百济就像每天喝水一样简单，百济神州追求的全球的重磅炸弹。第二军，恒瑞医药。有近20个创新药项目获得美国FDA批准开展临床实验。其中，有4款自主研发的ADC创新药获得美国FDA快速通道资格认定，3款创新药获得美国FDA孤儿药资格认定。恒瑞实行的是群狼战术，总有一些产品能跑出来，在仿制转创新的路上，恒瑞医药连一秒钟都没有犹豫，你大爷毕竟还是你大爷。第三军，迈威生物。有8款进入FDA临床实验的产品，分别是7MW4911、9MW2821、7MW3711和9MW3811，3011,7141,1911,3211。实际上，迈威生物已经准备了12款FDA的临床申报产品，全都是全球首发。对于一个不到200亿人民币的创新药企来说，迈威生物无异于拼命三郎。如果选一个未来的最确定的10倍创新药企业，我首先迈威生物。第四军，百利天恒。有6款FDA批准的临床实验产品，分别为BL-B01D1、BL-M07D1、SI-B001、BL-M05D1、BL-M11D1和BL-M17D1，实际上，百利天恒已经在2024年报里公布了9款FDA申报临床的产品。百利天恒就是一个灰姑娘的逆袭的故事。掌门人朱义已经明确不想多BD了，要少买，要自己在全球卖药。百利天恒的1000多亿市值是很有道理的。第五军，中国生物制药。有6款FDA获批临床实验的产品，分别为LM-350、TQB2102、LM-302、LM-305、TQB2101和TQB6411。第六军，映恩生物。有7款获得FDA批准临床实验的产品，分别为DB-1303、DB-1310、DB-1311、DB-1305、DB-1419、DB-2304和DB-1317。资本市场总是有很多的聪明的资金的，映恩生物拥有多款对国际企业BD的产品，充分证明在线管线的技术含量。我也很意外映恩生物还拥有如此之多的FDA临床的产品，这个公司野心不小。第七军，信达生物。在FDA临床的药品有8款。以12亿美元的首付款BD后，信达生物摘去了头上的研发能力不强的帽子。信达生物的管线很丰富，很厚，这家公司奉行低调发育，时不时的搞一大笔钱。走的稳，自然也就走的远，按照信达生物现在的市值，我认为属于明显的低估了。第八军，康方生物。有3款FDA批准临床相关的产品，分别是派安普利单抗、依沃西单抗和AK146D1,5，诺诚健华有3款FDA批准临床实验的产品，分别为奥布替尼、ICP-248、ICP-332。康方生物的依沃西单抗BD给SUMMIT后，在击败K药的战斗中，不十分利索，但是康方生物拥有15个左右的全球最佳分子的潜力，给一点点时间，康方生物一定会调整姿势，席卷FDA。第九军，亚盛医药。有3款FDA批准临床实验的产品，分别为奥雷巴替尼、利沙托克拉（APG-2575）、APG-244。孤儿药之王，亚盛医药拥有超过16个孤儿药之王的认证。对于研发的实力，毋庸置疑，多年受困资金的束缚的亚盛医药，总有一天，会在解决掉资金的压力后，展现孤儿药之王应有的风采。第十军，远大医药。有3款经FDA批准临床实验并获批相关适应症的产品，分别为TLX250-CDx、SIR-Spheres®钇（90Y）微球注射液和TLX591-CDx。远大在中国创新药的投资者中，名声不够显赫，但是远大医药却拥有两个FDA的突破性疗法的认证。甚至FDA让远大医药一天展开更多的适应症。由于罗列的军队太多，每一支军队都有自己的独特的优势，一以下的20只军队，就不再一一的解读了。也有一些数据不太准确，大差不差。第十一军，先声药业。有5款FDA批准的临床实验产品，分别为SIM0500、SIM0508、SIM0609、SIM0686和先必新®舌下片第十二军，君实生物。有7款创新药物获准在美国开展临床试验，分别为JS001、JS004、JS016、JS006、JS009、JS110、JS207第十三军，和誉B。有3款FDA批准的临床实验产品，分别为匹米替尼（ABSK021）、依帕戈替尼（ABSK011）和ABSK131第十四军，和铂医药。有5款FDA批准的临床实验产品，分别为HBM1020、HBM1022,，HBM1007、HBM9027和HBM9033第十五军，百奥赛图。有4款FDA批准临床实验的产品，分别是YH001、YH003、YH008和YH002第十六军，加科思。有3款FDA批准临床实验的产品，分别是JAB-23E73、JAB-30355和戈来雷塞（JAB-21822）,第十七军，乐普生物。有3款FDA批准临床实验的产品，分别是MRG003、MRG004A和Cretostimogene（CG0070第十八军，宜明昂科。有7款FDA批准临床实验的产品，分别为IMM01、IMM0306、IMM2510、IMM2520、IMM2902、IMM47和IMM40H第十九军，荣昌生物。有3款FDA批准临床实验的产品，分别是泰它西普、维迪西妥单抗和RC88第二十军，科伦博泰。有2款FDA批准临床实验的产品，分别是芦康沙妥珠单抗（sac-TMT）和第二代选择性RET抑制剂A400（EP0031）第二十一军，三生制药。有3款FDA批准临床实验的产品，分别是SSGJ-706、SSGJ-707和抗IL-4Rα单抗第二十二军，迪哲医药。有1款产品获FDA批准上市，另有1款产品获FDA“快速通道认定”，总共有不低于5款药品申请了FDA的临床实验。第二十三军，益方生物。有3款产品获得了FDA批准开展临床实验，分别是D-0120、D-0502和D-2570十四军，海创药业。公司有5个获得FDA临床批准的产品，分别为HC-1119、HP501、HP515、HP537和HP5682第二十五军，石药集团。有6款FDA批准临床试验的产品。第二十六军，复宏汉霖。有4款FDA批准临床实验的产品，分别是HLX43、HLX22、HLX13和HLX42第二十七军，翰森制药。有5个产品获得FDA临床批准，分别是HS-20110、HS-20089、HS-20093、HS-10535和HS-20094第二十八军，维立志博。有6款产品获得了FDA的临床许可，具体如下：LBL-024：LBL-034：LBL-033：。LBL-047：LBL-015：LBL-007：第二十九军，德琪医药。有3款FDA批准临床的产品，分别是ATG-031、ATG-017和ATG-022第三十军,诺诚健华。有3款FDA批准临床实验的产品，分别为奥布替尼、ICP-248、ICP-332二，BD不过沿途下了个蛋中国创新药产业正经历着从"追赶者"到"规则制定者"的历史性转变。根据最新统计数据，全球创新药管线中，中国贡献占比从2020年的8%跃升至2025年的32%，正式超越日本成为"第二梯队"领头羊。正如我在第一部分的罗列，如出一辙。这一转变在FDA临床试验批准方面表现得尤为突出。中国创新药在美国的临床研发起步相对较晚，但增长势头强劲。2007-2023年期间，共有177家中国本土药企的350款原研创新药在美国开展了针对499个适应症的691项临床试验，包括I期临床试验399项（49%）、II期临床试验269项（39%）和III期临床试验83项（12%）162。2024年成为中国创新药FDA临床试验的重要转折点。根据Insight数据库统计，2024年启动的临床试验中，申办者是中国企业、试验地点包含海外的新药临床试验共122项，其中III期（包括II/III）共有14项164。从药物类型看，包括2款PROTAC、4款ADC、1款双抗和1款三抗，其余均为化药，显示出中国创新药研发的多元化趋势。如果投资创新药的投资者稍微用一点心，你可以发现，在我罗列的30只大军中，几乎每一支大军都有对全球药企进行BD，但是，但是，你们发现了没有，每一支大军又留了许多的后手，一是全部保留了中国市场的权益，另外，在BD的管线之外，全部留有自己的王牌的在研管线。你以为的中国创新药业BD是卖身？是丧失了更多的利益？不，相对于创新药本身要求的长时间，大量的资金以及风险的偏好。整个中国对于创新药的资本支持，太少了。少到了中国的创新药企业不得不在全球猥琐发育，顺便就BD几个项目，下几个金蛋，然后拿着BD回来的钱，继续下一阶段的发育。在BD的研发管线之外，即使你不去看更多的资料，仅仅按照我在第一部分的30路大军里去寻找，我们可以清晰的看到，在BD的管线之外，我们的创新药企，仍然有太多的重磅炸弹。我们任然具备许多重磅的全球权益的产品。三，平行的世界，平行的估值2023年8月，恒瑞医药将哮喘药SHR-1905的海外权益以2500万美元首付、潜在里程碑款总计10.25亿美元授权给美国药企AiolosBio。仅半年后，跨国药企GSK即以10亿美元首付款和4亿美元里程碑款的价格整体收购AiolosBio，而从恒瑞医药买来的SHR-1905管线是AiolosBio的唯一资产。这一买一卖之间，AiolosBio凭空赚到了10亿美元首付款，恒瑞医药的这款管线被高价转手，不少从业者认为恒瑞医药吃了大亏。无独有偶。2023年11月，普米斯生物与德国药企BNT达成首笔授权协议，以5500万美元首付款，授予BNT除大中华区外的全球权益，潜在里程碑款总计超10亿美元，将其PD-L1/VEGF双抗PM8002（后被BNT命名为BNT327）授权给BNT。2024年11月13日，BNT又以8亿美元现金和1.5亿里程碑款全资收购了普米斯生物，将其变为自己的中国研发中心。2025年6月2日，BNT与美国药企BMS宣布达成战略合作，双方将共同开发双抗药物BNT327。BMS将向BNT支付15亿美元的首付款，并在2028年前支付总计20亿美元的非或有性周年付款，此外，BNT还有资格获得高达76亿美元的额外开发、监管和商业里程碑付款，潜在交易总额达到111亿美元。这两笔BD交易，极大的震撼了中国的创新药企业和投资者。我们在之前，从来没有想过中国的在线管线可以值这么钱，我们从来没有想过可以这么给一个在研的管线估值。中国创新药企业可以吃一次亏，可以吃两次亏，但是不可能永远吃亏。此后，2025年5月，三生制药首付款12.5亿美金BD了在研管线，2025年10月，信达生物的BD照样是收到了首付款12亿美金。很明显，这些巨额的首付款的背后，是对中国的创新药的在研管线的估值重构。而这些在研管线的拥有者，中国的创新药企业却依然在按照白菜价的估值水平。默沙东收购只有唯一药品Ohtuvayre（ensifentrine，恩西芬群）的维罗纳公司，花了100亿美金。诺华收购网页链接{AvidityBiosciences}花了120亿美金，后者没有商业化的产品，只拥有RNA疗法的技术平台和几款临床前的产品。强生收购Intra-Cellular花了146亿美金，以获得其重磅抗精神病药物Caplyta。、看看这些并购，通常都是为了一款药品，或者一个技术平台，代价都是上百亿美金。不出意外，也不会有意外，不需要两三年时间，就会有MNC向中国的创新药公司发起上百亿美金的并购案例。那时我们终将明白，既然都是在FDA做临床试验，既然都是在欧洲做临床试验，既然都是在中国做临床试验。无论在临床的管线是美国公司，还是中国公司的，抑或是欧洲公司的，这些管线面对的监管是一样的，要求的技术水平是一样的，面对的病人群体是一样的，开出的药品价格是一样的。当然，同样的市场，收益也应该是一样的。就不应该永远存在美国公司高高在上的估值，而中国的创新药公司白菜价的局面。平行的世界，就应该是平行的估值。而要走到这个平行的世界，中国的创新药公司，很多很多，都还具备很多倍的潜力。

Continued clinical execution of oncology strategy with focus on two pan-tumor programs, including combination approaches to address the full continuum of cancer from early to late disease stagesDemonstrated encouraging anti-tumor activity and manageable safety profile of pumitamig (BNT327/BMS986545), a bispecific antibody candidate targeting PD-L11 and VEGF-A, in first disclosed interim data from global Phase 2 trial in extensive-stage small cell lung cancer Plan to initiate additional pivotal trials for pumitamig in first-line microsatellite stable colorectal cancer and first-line gastric cancerLaunched variant-adapted COVID-19 vaccine for the 2025/2026 vaccination season in multiple regionsThird quarter 2025 revenues of €1.5 billion2, net loss of €28.7 million and basic and diluted loss per share of €0.12 ($0.143)Strengthened financial position to €16.7 billion in cash, cash equivalents and security investments4; received $1.5 billion payment from Bristol Myers Squibb (“BMS”) partnershipIncreased revenue guidance range of €2.6-2.8 billion and lowered expense guidance ranges for R&D to €2.0-2.2 billion, for SG&A to €550-650 million, and for capital expenditures for operating activities to €200-250 million5 Conference call and webcast scheduled for November 3, 2025, at 8:00 a.m. EST (2:00 p.m. CET) MAINZ, Germany, November 3, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three and nine months ended September 30, 2025 and provided an update on its corporate progress. “In the third quarter, we made substantial progress in executing against our oncology strategy. We advanced our priority pan-tumor programs, mRNA cancer immunotherapies and pumitamig. Simultaneously, we further broadened these programs to include evaluation of novel combinations with the aim to deliver differentiated or best-in-class therapeutic profiles,” said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. “Our collaboration with Bristol Myers Squibb on pumitamig is already demonstrating the strength of this partnership, with multiple additional pivotal trials in preparation with pumitamig planned to start this and next year. This illustrates our commitment to delivering truly transformative options for patients in need.” Financial Review for Third Quarter and Year-to-Date 2025 in millions €, except per share data Third Quarter 2025 Third Quarter 2024 Year-to-date2025 Year-to-date2024Revenues 1,518.9 1,244.8 1,962.5 1,561.1Net profit / (loss) (28.7) 198.1 (831.1) (924.8)Basic earnings / (loss) per share (0.12) 0.82 (3.45) (3.83)Diluted earnings / (loss) per share (0.12) 0.81 (3.45) (3.83) Revenues for the three months ended September 30, 2025, were €1,518.9 million, compared to €1,244.8 million for the comparative prior year period. For the nine months ended September 30, 2025, revenues were €1,962.5 million, compared to €1,561.1 million for the comparative prior year period. The increases in both quarterly and year-to-date revenues compared to the prior year were primarily driven by revenues related to BioNTech’s collaboration with BMS that were recognized in the third quarter of 2025. This increase was partially offset by lower sales volumes of BioNTech’s COVID-19 vaccines. Research and development (“R&D”) expenses were €564.8 million for the three months ended September 30, 2025, compared to €550.3 million for the comparative prior year period. For the nine months ended September 30, 2025, R&D expenses were €1,599.5 million, compared to €1,642.4 million for the comparative prior year period. Year-to-date R&D expenses were mainly driven by the start of late-stage trials for immuno-oncology (“IO”) and antibody-drug conjugate (“ADC”) development programs and partly offset by cost savings resulting from active portfolio management. Sales, general and administrative (“SG&A”) expenses, in total, amounted to €148.5 million for the three months ended September 30, 2025, compared to €150.5 million for the comparative prior year period. For the nine months ended September 30, 2025, SG&A expenses were €406.5 million, compared to €466.9 million for the comparative prior year period. The year-to-date and quarter-to-quarter decreases were mainly driven by lower external costs, partially compensated by an ongoing commercial build-up. Other operating result amounted to negative €704.2 million during the three months ended September 30, 2025, compared to negative €354.6 million for the comparative prior year period. For the nine months ended September 30, 2025, other operating result amounted to negative €730.1 million compared to negative €616.9 million for the prior year period. The increase in other operating expenses compared to the third quarter of 2024 was primarily influenced by the settlement of a contractual dispute. Net loss was €28.7 million for the three months ended September 30, 2025, compared to a net income of €198.1 million for the comparative prior year period. For the nine months ended September 30, 2025, net loss was €831.1 million, compared to a net loss of €924.8 million for the comparative prior year period. Basic and diluted loss per share was €0.12 for the three months ended September 30, 2025, compared to a basic earnings per share of €0.82 and diluted earnings per share of €0.81 for the comparative prior year period. For the nine months ended September 30, 2025, basic and diluted loss per share was €3.45, compared to a basic and diluted loss per share of €3.83 for the comparative prior year period. Cash and cash equivalents plus security investments as of September 30, 2025, reached €16,704.9 million, comprising €10,092.9 million in cash and cash equivalents, €4,275.6 million in current security investments and €2,336.4 million in non-current security investments. Shares outstanding as of September 30, 2025, were 240,455,450, excluding 8,096,750 shares held in treasury. “The receipt of $1.5 billion from our partnership with Bristol Myers Squibb further underscores the strategic value of our collaborations not only in the long but also in the short term,” said Ramón Zapata, Chief Financial Officer at BioNTech. “We are increasing our 2025 full year revenue guidance to €2.6-2.8 billion. At the same time, we continue to optimize our cost base to support a sustainable development trajectory and ensure operational efficiency.” 2025 Financial Year Guidance5: FY Guidance March 2025 FY Guidance November 2025 Revenues for the 2025 financial year €1,700 - €2,200 million €2,600 - €2,800 million BioNTech has increased its previous revenue guidance and now expects its revenues for the full 2025 financial year to be in the range of €2,600 - €2,800 million. With regards to COVID-19 vaccine franchise, the guidance reflects the following assumptions: relatively stable COVID-19 vaccine pricing and market share as compared to 2024; inventory write-downs and other charges estimated to be approximately 15% of BioNTech’s share of gross profit from COVID-19 vaccine sales in Pfizer Inc.’s (“Pfizer”) territory; and anticipated revenues from a pandemic preparedness contract with the German government. Current and potential further developments in law, global public policy, international trade, and public sentiment as they continue to evolve could further impact the anticipated COVID-19 vaccine revenues and expenses. The revenue guidance also includes anticipated revenues from collaborations, and from the BioNTech Group service businesses. Planned 2025 Financial Year Expenses and Capex: FY Guidance March 2025 FY Guidance November 2025 R&D expenses €2,600 - €2,800 million €2,000 - €2,200 million SG&A expenses €650 - €750 million €550 - €650 million Capital expenditures for operating activities €250 - €350 million €200 - €250 million BioNTech has lowered expense guidance ranges for R&D, SG&A and capital expenditures for operating activities for the 2025 financial year. The Company expects to continuously focus investments on R&D and scaling the business for late-stage development and commercial readiness in oncology, while remaining cost-disciplined. Strategic capital allocation will continue to be a key driver of the Company’s trajectory. As part of BioNTech’s strategy, the Company may continue to evaluate appropriate corporate development opportunities with the aim of driving sustainable long-term growth and creating future value. The full interim unaudited condensed consolidated financial statements can be found in BioNTech’s Report on Form 6-K for the period ended September 30, 2025, filed today with the United States Securities and Exchange Commission (“SEC”) and available at www.sec.gov. Endnotes1 An overview of target abbreviations is compiled in a directory at the end of this press release.2 All numbers in this press release have been rounded.3 Calculated applying the average foreign exchange rate for the three months ended September 30, 2025, as published by the German Central Bank (Deutsche Bundesbank).4 As of September 30, 2025. 5 Financial guidance excludes external risks that are not yet known and/or quantifiable, including, but not limited to, the effects of ongoing and/or future legal disputes and related activities, as well as certain potential one-time effects and charges related to portfolio prioritization. It includes effects identified from licensing arrangements, collaborations and M&A transactions to the extent disclosed and completed and may be subject to update. It excludes the effect of the announced transaction to acquire CureVac, which is ongoing. The Company does not expect to report a positive net income figure for the 2025 financial year. The Company’s approach to revenue recognition, including the amount and timing of revenues, is based on the facts and circumstances known to the Company and various other judgments, estimates, and assumptions that the Company believes to be reasonable under the circumstances. More information can be found in BioNTech’s Report on Form 6-K for the three and nine months ended September 30, 2025, filed today, and in BioNTech’s Report on Form 20-F for the year ended December 31, 2024 filed on March 10, 2025, both of which are available at www.sec.gov. Operational Review for the Third Quarter 2025, Key Post Period-End Events and OutlookVariant-adapted COVID-19 Vaccine In the third quarter of 2025, BioNTech and Pfizer executed the commercial launch of their variant-adapted COVID-19 vaccine for the 2025/2026 vaccination season. In July, BioNTech and Pfizer’s LP.8.1-adapted monovalent COVID-19 vaccine was approved by the European Commission following recommendation for marketing authorization by the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”). The companies began shipments of the vaccine to EU member states that ordered this formulation. In August, the U.S. Food and Drug Administration (“FDA”) approved the companies’ LP.8.1-adapted COVID-19 vaccine. Shipping of the vaccine began immediately to ensure timely availability of this season’s vaccine in pharmacies, hospitals, and clinics across the United States. Select Oncology Pipeline Updates Next-Generation Immunomodulators and Combinations Pumitamig (BNT327/BMS986545) is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization that is being developed in collaboration with BMS. In September 2025, interim data from a global Phase 2 clinical trial (NCT06449209) evaluating pumitamig in combination with chemotherapy in patients with untreated extensive-stage small-cell lung cancer (“ES-SCLC”) were presented at the IASLC 2025 World Conference on Lung Cancer (“WCLC”). The data showed encouraging anti-tumor responses, with a positive trend in the secondary endpoint, progression free survival (“PFS”) and a manageable safety profile with no new safety signals and a low discontinuation rate. The clinical trial is fully enrolled and treatment is ongoing, including further cohorts evaluating pumitamig in combination with chemotherapy in patients with SCLC whose disease has progressed on first- or second-line treatment. A global Phase 3 clinical trial (ROSETTA Lung-01; NCT06712355) is being conducted to evaluate pumitamig as a first-line treatment in combination with chemotherapy compared to atezolizumab in combination with chemotherapy in patients with untreated ES-SCLC.A global Phase 2/3 clinical trial (ROSETTA Lung-02; NCT06712316) is being conducted to evaluate pumitamig in combination with chemotherapy compared to pembrolizumab and chemotherapy in patients with first-line non-small cell lung cancer (“NSCLC”). The Phase 2 part of the seamless Phase 2/3 trial achieved full enrollment and the Phase 3 portion is recruiting. A global Phase 2 clinical trial (NCT06449222) is being conducted to evaluate pumitamig in combination with chemotherapy as a first- and second-line treatment for patients with locally advanced or metastatic triple-negative breast cancer (“TNBC”). Interim data from this clinical trial are planned to be presented at the San Antonio Breast Cancer Symposium (“SABCS”) in December. A global Phase 3 clinical trial in patients with first-line TNBC (ROSETTA Breast-01; NCT07173751) is planned to start by the end of 2025.Additional pivotal Phase 2/3 clinical trials for pumitamig in first-line microsatellite stable colorectal cancer (“CRC”) (ROSETTA CRC-203; NCT07221357) and first-line gastric cancer (ROSETTA GI-204; NCT07221149) are planned. In the last quarter, BioNTech initiated several signal-seeking clinical trials to evaluate pumitamig with the Company’s proprietary assets: In August, the first patient was dosed in a Phase 1/2 clinical trial (NCT07079631) to evaluate BioNTech and Genmab AS’s (“Genmab”) bispecific antibody candidate BNT314/GEN1059 in combination with pumitamig and chemotherapy in patients with advanced CRC.Also in August, the first patient was dosed in a Phase 1/2 clinical trial (NCT07070232) to evaluate pumitamig in combination with BioNTech and MediLink Therapeutics’ (“MediLink”) HER3 ADC candidate BNT326/YL202 and BNT326/YL202 as monotherapy in advanced solid tumors. In September, the first patient was dosed in a Phase 1/2 clinical trial (NCT07147348) to evaluate BNT3212, a novel bispecific ADC candidate targeting EGFR and HER3, as monotherapy and in combination with pumitamig in patients with advanced solid tumors.In October, the first patient was dosed in a Phase 1/2 clinical trial (NCT07111520) to evaluate BioNTech and MediLink’s BNT326/YL202 in combination with pumitamig in advanced NSCLC. Antibody-Drug Conjugates Trastuzumab pamirtecan (BNT323/DB-1303) is an ADC candidate targeting HER2 that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd.’s (“DualityBio”). A Phase 1/2 clinical trial (NCT05150691) is being conducted to evaluate trastuzumab pamirtecan in patients with advanced HER2-expressing tumors. A potentially registrational cohort with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) patients with recurrent endometrial cancer is ongoing. Data are expected to be shared at a medical conference in 2026. BioNTech and DualityBio continue discussions with the FDA and now plan to file a biologics license application (“BLA”) in 2026, subject to regulatory feedback. In September, the first patient was dosed in a global Phase 3 clinical trial (NCT06340568) to evaluate trastuzumab pamirtecan in patients with advanced endometrial cancer.Also in September, BioNTech and DualityBio announced that the pivotal Phase 3 clinical trial (NCT06265428) which DualityBio is conducting in China to evaluate trastuzumab pamirtecan versus trastuzumab emtansine (“T-DM1”) in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy met its primary endpoint of PFS at a pre-specified interim analysis. A global Phase 3 clinical trial (DYNASTY-Breast02, NCT06018337) for trastuzumab pamirtecan in HR-positive, HER2-low metastatic breast cancer is ongoing. Data are expected in 2026. BNT325/DB-1305 is a TROP2-targeted ADC candidate that is being developed in collaboration with DualityBio. A Phase 1/2 clinical trial (NCT05438329) evaluating BNT325/DB-1305 in patients with advanced solid tumors is ongoing. In October, data from this trial in patients with pretreated TNBC were presented at the European Society For Medical Oncology (“ESMO”) Congress 2025. Data showed encouraging anti-tumor activity and a manageable safety profile. mRNA Cancer Immunotherapies Autogene cevumeran (BNT122/RO7198457) is an mRNA cancer immunotherapy candidate for individualized neoantigen-specific immunotherapy (“iNeST”) that is being developed in collaboration with Genentech, Inc. (“Genentech”), a member of the Roche Group (“Roche”). In October, data from a randomized Phase 2 clinical trial (IMCODE001; NCT03815058) evaluating the efficacy and safety of autogene cevumeran in combination with pembrolizumab versus pembrolizumab alone as a potential first-line treatment for patients with previously untreated advanced melanoma were presented at the 2025 ESMO Congress. While, as previously disclosed, the trial did not meet its primary efficacy endpoint of statically significant improvement of PFS in this advanced and aggressive tumor type, a numerical trend favoring the combination arm in overall survival (“OS”) and PFS was observed, with the breadth of immune response correlating with a prolonged PFS in the combination arm. Autogene cevumeran induced and expanded high-magnitude and durable immune responses against the encoded neoantigens that persisted for up to 1.5 years after treatment completion. The combination of autogene cevumeran with PD-L1 checkpoint blockade was well tolerated and adverse events were consistent with the known safety profiles of the individual trial treatments, with no new safety signals observed. BNT111 is based on BioNTech’s fully owned, off-the-shelf FixVac platform, and encodes four melanoma-associated antigens. In October, data from a randomized Phase 2 clinical trial (BNT111-01; NCT04526899) conducted in collaboration with Regeneron Pharmaceuticals Inc. (“Regeneron”) to evaluate BNT111 in combination with cemiplimab in patients with anti-PD-(L)1 refractory/relapsed, unresectable Stage III or IV melanoma were presented at the 2025 ESMO Congress. As previously disclosed, the trial met its primary endpoint demonstrating statistically significant improvement in objective response rate (“ORR”) in patients treated with BNT111 in combination with cemiplimab, as compared to an historical control. The data showed that the combination of BNT111 and cemiplimab induced anti-tumor responses that were deep and durable and a manageable safety profile for BNT111 as a single agent and in combination. BNT116 is based on BioNTech’s fully owned, off-the-shelf FixVac platform, and is designed to elicit an immune response to six tumor-associated antigens that were identified to be frequently expressed in NSCLC. A Phase 1 clinical trial (LuCa-MERIT-1; NCT05142189) is being conducted to evaluate BNT116 as monotherapy and in several treatment combinations, including with chemotherapy, cemiplimab, and BioNTech’s proprietary assets across various treatment lines and clinical settings in patients with NSCLC. In September, data were presented at the IASLC 2025 WCLC from a cohort evaluating BNT116 in combination with cemiplimab as consolidation treatment in patients with NSCLC after receiving concurrent chemoradiotherapy. BNT116 in combination with cemiplimab demonstrated encouraging event-free and overall survival rates and a manageable safety profile. Corporate Update for the Third Quarter 2025 In October, BioNTech and InstaDeep Ltd. (“InstaDeep”), its artificial intelligence (“AI”) subsidiary, hosted their second AI Day live event in London, United Kingdom, as part of their Innovation Series. BioNTech showcased its AI strategy, capabilities as well as scaling and deployment across its pipeline with a focus on personalized cancer immunotherapies and precision medicines Upcoming Investor and Analyst Events Innovation Series R&D Day: November 11, 2025, in New York City, United States, with the option to join via webcast.Fourth Quarter and Full Year 2025 Financial Results and Corporate Update: March 10, 2026 Conference Call and Webcast Information BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, November 3, 2025, at 8:00 a.m. EST (2:00 p.m. CET) to report its financial results and provide a corporate update for the third quarter of 2025. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN number will be provided. The slide presentation and audio of the webcast will be available via this link. Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page of the Investor section of the Company’s website at www.BioNTech.com. A replay of the webcast will be made available shortly after the closing of the call and archived on the Company’s website for 30 days following the call. About BioNTechBiopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Bristol Myers Squibb, Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. For more information, please visit www.BioNTech.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech’s expected revenues and net profit/(loss) related to sales of BioNTech’s COVID-19 vaccine in territories controlled by BioNTech’s collaboration partners, particularly for those figures that are derived from preliminary estimates provided by BioNTech’s partners; the rate and degree of market acceptance of BioNTech’s COVID-19 vaccine and, if approved, BioNTech’s investigational medicines; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment and expected regulatory recommendations to adapt vaccines to address new variants or sublineages; the initiation, timing, progress, results, and cost of BioNTech’s research and development programs, including BioNTech’s current and future preclinical studies and clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of studies or clinical trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations; BioNTech’s expectations regarding potential future commercialization in oncology, including goals regarding timing and indications; the targeted timing and number of additional potentially registrational clinical trials, and the registrational potential of any clinical trial BioNTech may initiate; discussions with regulatory agencies; BioNTech’s expectations with respect to intellectual property; the impact of BioNTech’s collaboration and licensing agreements, including BioNTech’s partnership with Bristol Myers Squibb; BioNTech’s planned acquisition of CureVac; the development, nature and feasibility of sustainable vaccine production and supply solutions; the deployment of AI across BioNTech’s preclinical and clinical operations; BioNTech’s expectations with respect to developments in law, public policy, and international trade; BioNTech’s estimates of revenues, research and development expenses, selling, general and administrative expenses and capital expenditures for operating activities; BioNTech’s expectations regarding upcoming payments relating to litigation settlements; BioNTech’s expectations for upcoming scientific and investor presentations; and BioNTech’s expectations of net profit/(loss). In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech’s pricing and coverage negotiations regarding its COVID-19 vaccine with governmental authorities, private health insurers and other third-party payors; the future commercial demand and medical need for initial or annual booster doses of a COVID-19 vaccine; the impact of tariffs and escalations in trade policy; competition from other COVID-19 vaccines or related to BioNTech’s other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech’s and its counterparties’ ability to manage and source necessary energy resources; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; the impact of COVID-19 on BioNTech’s development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market BioNTech’s COVID-19 vaccine and, if approved, its product candidates; BioNTech’s ability to manage its development and related expenses; regulatory and political developments; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended September 30, 2025 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. CONTACTS Investor RelationsDouglas Maffei, PhDInvestors@biontech.de Media RelationsJasmina AlatovicMedia@biontech.de Target Overview B7-H3Also known as CD276, cluster of differentiation 276EpCAMEpithelial cell adhesion moleculeHER2 (or HER3)Human epidermal growth factor receptor 2 (or 3)HRHormone ReceptorPD-(L)1Programmed cell death protein (death-ligand) 1TROP2Trophoblast cell-surface antigen 2VEGF-AVascular endothelial growth factor A Interim Condensed Consolidated Statements of Profit or Loss Three months ended September 30, Nine months ended September 30, 2025 2024 2025 2024(in millions €, except per share data) (unaudited) (unaudited) (unaudited) (unaudited)Revenues 1,518.9 1,244.8 1,962.5 1,561.1Cost of sales (148.3) (178.9) (308.5) (297.8)Research and development expenses (564.8) (550.3) (1,599.5) (1,642.4)Sales and marketing expenses (27.3) (18.1) (60.7) (46.6)General and administrative expenses (121.2) (132.4) (345.8) (420.3)Other operating expenses (729.5) (410.9) (884.7) (719.9)Other operating income 25.3 56.3 154.6 103.0Operating profit / (loss) (46.9) 10.5 (1,082.1) (1,462.9)Finance income 96.8 156.2 324.8 498.8Finance expenses (25.2) (8.0) (66.1) (14.8)Profit / (Loss) before tax 24.7 158.7 (823.4) (978.9)Income taxes (53.4) 39.4 (7.7) 54.1Net profit / (loss) (28.7) 198.1 (831.1) (924.8)Earnings / (Loss) per share Basic earnings / (loss) per share (0.12) 0.82 (3.45) (3.83)Diluted earnings / (loss) per share (0.12) 0.81 (3.45) (3.83) Interim Condensed Consolidated Statements of Financial Position September 30, December 31, (in millions €) 2025 2024Assets (unaudited) Non-current assets Goodwill 357.7 380.6Other intangible assets 1,389.8 790.4Property, plant and equipment 1,039.7 935.3Right-of-use assets 201.0 248.1Contract assets 3.9 9.8Other financial assets 2,476.0 1,254.0Other non-financial assets 24.6 26.3Deferred tax assets 17.7 81.7Total non-current assets 5,510.4 3,726.2Current assets Inventories 225.7 283.3Trade and other receivables 690.8 1,463.9Contract assets 8.9 10.0Other financial assets 4,434.7 7,021.7Other non-financial assets 292.9 212.7Income tax assets 84.8 50.0Cash and cash equivalents 10,092.9 9,761.9Total current assets 15,830.7 18,803.5Total assets 21,341.1 22,529.7 Equity and liabilities Equity Share capital 248.6 248.6Capital reserve 1,453.2 1,398.6Treasury shares (8.1) (8.6)Retained earnings 18,266.9 19,098.0Other reserves (1,483.3) (1,325.5)Total equity 18,477.3 19,411.1Non-current liabilities Lease liabilities, loans and borrowings 192.0 214.7Other financial liabilities 96.4 46.9Provisions 24.2 20.9Contract liabilities 219.0 183.0Other non-financial liabilities 85.5 87.5Deferred tax liabilities 24.2 42.4Total non-current liabilities 641.3 595.4Current liabilities Lease liabilities, loans and borrowings 53.4 39.5Trade payables and other payables 399.8 426.7Other financial liabilities 597.4 1,443.4Income tax liabilities 6.3 4.5Provisions 211.5 144.8Contract liabilities 796.1 294.9Other non-financial liabilities 158.0 169.4Total current liabilities 2,222.5 2,523.2Total liabilities 2,863.8 3,118.6Total equity and liabilities 21,341.1 22,529.7 Interim Condensed Consolidated Statements of Cash Flows Three months ended September 30, Nine months ended September 30, 2025 2024 2025 2024(in millions €) (unaudited) (unaudited) (unaudited) (unaudited)Operating activities Net profit / (loss) (28.7) 198.1 (831.1) (924.8)Income taxes 53.4 (39.4) 7.7 (54.1)Profit / (Loss) before tax 24.7 158.7 (823.4) (978.9)Adjustments to reconcile loss before tax to net cash flows: Depreciation, amortization and impairment of property, plant, equipment, intangible assets and right-of-use assets 124.2 44.4 218.0 132.6Share-based payment expenses 27.9 40.9 82.1 77.4Net foreign exchange differences (24.1) (35.5) 36.4 (77.4)(Gain) / Loss on disposal of property, plant and equipment (1.3) — (1.7) (0.2)Finance income excluding foreign exchange differences (96.8) (156.2) (324.8) (498.8)Finance expense excluding foreign exchange differences 2.6 5.3 17.1 14.8Government grants (10.5) (14.6) (43.5) (26.8)Other non-cash (income) / loss — — (15.0) —Unrealized (gain) / loss on derivative instruments at fair value through profit or loss 15.7 (6.0) (12.9) 0.7Working capital adjustments: Decrease / (Increase) in trade and other receivables, contract assets and other assets 881.7 (830.2) 1,002.7 1,267.6Decrease in inventories 5.1 37.0 61.7 54.6(Decrease) / Increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions (242.8) 117.9 (299.2) 590.7Interest received and realized gains from cash and cash equivalents 83.5 73.1 275.2 353.3Interest paid and realized losses from cash and cash equivalents (2.4) (1.6) (8.2) (6.9)Income tax received / (paid), net (9.6) 1.6 (36.7) (190.8)Share-based payments (4.2) (134.4) (19.3) (143.6)Government grants received 7.0 60.7 38.0 102.7Net cash flows from / (used in) operating activities 780.7 (638.9) 146.5 671.0Investing activities Purchase of property, plant and equipment (35.9) (72.8) (111.9) (219.9)Proceeds from sale of property, plant and equipment 2.9 0.3 3.9 0.5Purchase of intangible assets (2.7) (10.2) (575.0) (141.3)Acquisition of subsidiaries and businesses, net of cash acquired — — (78.5) —Investment in other financial assets (2,869.0) (2,958.2) (7,046.7) (10,301.5)Proceeds from maturity of other financial assets 1,979.4 2,898.8 8,065.3 7,974.3Net cash flows from / (used in) investing activities (925.3) (142.1) 257.1 (2,687.9)Financing activities Repayment of loans and borrowings (1.2) — (9.4) (2.3)Payments related to lease liabilities (10.3) (7.9) (29.2) (36.3)Net cash flows used in financing activities (11.5) (7.9) (38.6) (38.6)Net increase / (decrease) in cash and cash equivalents (156.1) (788.9) 365.0 (2,055.5)Change in cash and cash equivalents resulting from exchange rate differences (21.5) (2.3) (28.4) 1.2Change in cash and cash equivalents resulting from other valuation effects 1.0 39.1 (5.6) 15.2Cash and cash equivalents at the beginning of the period 10,269.5 10,376.7 9,761.9 11,663.7Cash and cash equivalents as of September 30 10,092.9 9,624.6 10,092.9 9,624.6