Sacituzumab Drozuntecan

BioNTech on track for a catalyst-rich year with six late-stage data readouts expected across immunomodulators, antibody-drug conjugates and mRNA cancer immunotherapies Increased focus on PD-L1 1 /VEGF-A bispecific immunomodulator pumitamig with e ight global Phase 3 clinical trials planned to be ongoing for year-end in collaboration with Bristol Myers Squibb Full year 2025 revenues of €2.9 billion 2 , net loss of €1.1 billion (adjusted 3 net loss of €0.1 billion) and diluted loss per share of €4.70 ($5.31 4 ) (adjusted 3 diluted loss per share of €0.48 ($0.55 4 )) Strong financial position continues to de-risk execution with cash, cash equivalents and security investments of €17.2 billion 5 Expect 2026 total revenues of €2.0 billion to €2.3 billion, adjusted 3 R&D expenses between €2.2-2.5 billion and adjusted 3 SG&A expenses 7 between €700-800 million BioNTech co-founders Ugur Sahin and Özlem Türeci to establish an independent company  with a focus on next-generation mRNA innovations; management transition by end of 2026 Conference call and webcast scheduled for March 10, 2026, at 8:00 a.m. EDT (1:00 p.m. CET) MAINZ, Germany, March 10, 2026 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three months and full year ended December 31, 2025 and provided an update on its corporate progress. “2025 was a year of strong execution and pipeline momentum, marked by substantial progress in delivering on our strategy. We advanced our oncology pipeline by moving multiple programs into late-stage development and initiated trials assessing novel-novel combination approaches with the aim of delivering differentiated therapeutic pro ” said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech . “With our unique pipeline and strong financial position, we remain committed to leveraging our pioneering position in the immuno-oncology space with next-generation agents designed to elevate outcomes for patients with cancer. 2026 is poised to be a pivotal year with multiple readouts expected across our portfolio, representing a significant step toward our objective of becoming a multi-product company by 2030.” Financial Review for Fourth Quarter and Full Year 2025 3 in millions €, except per share data Full Year 2025 Full Year 2024 IFRS Results Adjusted Results 3 IFRS Results Adjusted Results 3 Revenues 2,869.9 2,869.9 2,751.1 2,751.1 Net profit / (loss) (1,136.1) (117.1) (665.3) 121.7 Diluted earnings / (loss) per share (4.70) (0.48) (2.77) 0.50 in millions €, except per share data Fourth Quarter 2025 Fourth Quarter 2024 IFRS Results Adjusted Results 3 IFRS Results Adjusted Results 3 Revenues 907.4 907.4 1,190.0 1,190.0 Net profit / (loss) (305.0) (79.5) 259.5 432.4 Diluted earnings / (loss) per share (1.25) (0.33) 1.08 1.79 Revenues for the three months ended December 31, 2025 were €907.4 million, compared to €1,190.0 million for the comparative prior year period. For the year ended December 31, 2025, revenues were €2,869.9 million, compared to €2,751.1 million for the comparative prior year period. The quarterly year-on-year decrease was primarily driven by lower sales of the Company’s COVID-19 vaccines due to reduced market demand. The full year revenue increase was primarily driven by revenues related to BioNTech’s collaboration with Bristol Myers Squibb Company (“BMS”) that were recognized in the third quarter of 2025. Research and development (“R&D”) expenses were €505.4 million for the three months ended December 31, 2025, compared to €611.8 million for the comparative prior year period. For the year ended December 31, 2025, R&D expenses were €2,104.9 million, compared to €2,254.2 million for the comparative prior year period. Both quarterly and full year year-on-year decreases were mainly driven by cost savings resulting from active portfolio management and positive effects resulting from our pumitamig cost sharing with BMS, partly offset by the acceleration of late-stage trials for immuno-oncology (“IO”) and antibody-drug conjugate (“ADC”) development programs. Adjusted R&D expenses were €505.4 million for the three months ended December 31, 2025, compared to €530.3 million for the comparative prior year period. For the year ended December 31, 2025, adjusted R&D expenses were €2,019.5 million, compared to €2,172.7 million for the comparative prior year period. For 2025 and 2024, the Company’s adjusted R&D expenses exclude impairments. Sales, general and administrative (“SG&A”) expenses 7 were €217.9 million for the three months ended December 31, 2025, compared to €132.1 million for the comparative prior year period. For the year ended December 31, 2025, SG&A expenses were €624.4 million, compared to €599.0 million for the comparative prior year period. Both quarterly and full year year-on-year increases were mainly driven by our ongoing commercial build-up, partly offset by lower costs for external services. Other operating result was negative €173.6 million during the three months ended December 31, 2025, compared to negative €54.0 million for the comparative prior year period. For the year ended December 31, 2025, other operating result was negative €903.7 million compared to negative €670.9 million for the prior year period. Both quarterly and full year year-on-year decreases were primarily driven by expenses from settlements of contractual disputes, expenses in connection with our pipeline prioritization and foreign exchange differences. Adjusted other operating result was €21.4 million during the three months ended December 31, 2025, compared to negative €1.6 million for the comparative prior year period. For the year ended December 31, 2025, other operating result was negative €0.6 million compared to negative €13.5 million for the prior year period. For fiscal years 2025 and 2024, our quarterly and full year adjusted other operating results exclude expenses in connection with the settlements of legal proceedings. In addition, our quarterly and full year adjusted other operating results during fiscal year 2025 exclude employee-related costs in connection with our pipeline prioritization and a bargain purchase. Net loss was €305.0 million for the three months ended December 31, 2025, compared to a net income of €259.5 million for the comparative prior year period. For the year ended December 31, 2025, net loss was €1,136.1 million, compared to a net loss of €665.3 million for the comparative prior year period. Adjusted net loss was €79.5 million for the three months ended December 31, 2025, compared to an adjusted net profit of €432.4 million for the comparative prior year period. For the year ended December 31, 2025, adjusted net loss was €117.1 million, compared to an adjusted net profit of €121.7 million for the comparative prior year period. Diluted loss per share was €1.25 for the three months ended December 31, 2025, compared to diluted earnings per share of €1.08 for the comparative prior year period. For the year ended December 31, 2025, diluted loss per share was €4.70, compared to diluted loss per share of €2.77 for the comparative prior year period. Adjusted diluted loss per share was €0.33 for the three months ended December 31, 2025, compared to adjusted diluted earnings per share of €1.79 for the comparative prior year period. For the year ended December 31, 2025, adjusted diluted loss per share was €0.48, compared to adjusted diluted earnings per share of €0.50 for the comparative prior year period. Cash, cash equivalents and security investments as of December 31, 2025 were €17,235.6 million, comprising €7,675.4 million in cash and cash equivalents, €7,158.5 million in current security investments disclosed as financial assets and €2,401.7 million in non-current security investments disclosed as financial assets. Shares outstanding as of December 31, 2025 were 251,325,340, excluding 7,702,147 shares held in treasury. “Our strong financial position fuels and de-risks our R&D activities as we prepare for multiple product launches in the coming years. Our financial discipline, active portfolio management and targeted investments will continue to drive innovation and create long-term value for BioNTech’s stakeholders,” said Ramón Zapata, Chief Financial Officer at BioNTech . 2026 Financial Year Guidance 6 : Revenues for the 2026 financial year €2,000 – €2,300 m In 2026, BioNTech anticipates lower COVID-19 vaccine revenues compared to 2025, driven by declines in both the European and United States markets. The United States continues to be a competitive and dynamic market, where as a result, lower revenues are expected. In Europe, we expect lower revenues as we defend our market share and begin managing the transition of multi-year contracts. In Germany, specifically, BioNTech recognizes direct sales of its COVID-19 vaccines as revenue. Hence, the anticipated declines in the Company’s sales of COVID-19 vaccines in the country will have a direct impact on its topline, whereas revenues outside of Germany only affect the Company’s topline as part of the 50% gross profit split with our partner Pfizer Inc. (“Pfizer”). Per the outlined partnership terms, revenues from the collaboration with BMS in 2026 are expected to be broadly in line with 2025. Revenues from the pandemic preparedness contract with the German government and service businesses are expected to remain stable. Planned 2026 Financial Year Adjusted Expenses 6 : Adjusted R&D expenses €2,200 – €2,500 m Adjusted SG&A expenses €700 – €800 m BioNTech will continue to 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 foster innovation and 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 audited consolidated financial statements as of and for the year ended December 31, 2025, can be found in BioNTech’s Annual Report on Form 20-F filed today with the U.S. Securities and Exchange Commission (“SEC”) and available at . Endnotes 1 An overview of abbreviations is compiled in a directory at the end of this press release. 2 All numbers in this press release have been rounded. 3 In addition to BioNTech’s results determined in accordance with International Financial Reporting Standards (“IFRS”), or IFRS Accounting Standards, or IFRS results, BioNTech reports certain adjusted, non-IFRS measures used internally as a supplemental measure of our business performance (each referred to with the prefix “Adjusted” or, as a whole, “Adjusted Results”). The calculation of these measures and the adjusted results as a whole is based on the concepts of the applicable IFRS Accounting Standards, but includes certain adjustments. Reconciliation of the adjusted results to BioNTech’s measures based on IFRS Accounting Standards and more information can be found at the end of this press release and in BioNTech’s Report on Form 20-F for the year ended December 31, 2025 filed on March 10, 2026, which is available at . While non-IFRS measures may offer additional insights, BioNTech’s non-IFRS measures are not, and should not be viewed as, a substitute for their most directly comparable IFRS Accounting Standards measures, and should always be considered alongside our financial statements prepared in accordance with IFRS Accounting Standards. 4 Calculated applying the average foreign exchange rate for the year ended December 31, 2025, as published by the German Central Bank (Deutsche Bundesbank). 5 As of December 31, 2025. 6 Excludes risks that are not yet known and/or quantifiable and related activities. It includes effects identified from licensing arrangements, collaborations and Merger & Acquisitions (“M&A”) transactions to the extent disclosed. The guidance is based on non-IFRS measures and excludes certain effects compared to measures based on IFRS Accounting Standards. More information can be found in BioNTech’s Report on Form 20-F for the year ended December 31, 2025 filed on March 10, 2026, which is available at . 7 Sales, general and administrative expenses (“SG&A”) include sales and marketing expenses as well as general and administrative expenses. Adjusted SG&A expenses include adjusted sales and marketing expenses as well as adjusted general and administrative expenses. Operational Review for the Fourth Quarter and Full Year 2025, Key Post Period-End Events and Outlook on 2026 Corporate Update for the Fourth Quarter 2025 and Post Period Events On March 10, 2026, BioNTech announced plans for an independent company to be established and led by BioNTech co-founders Prof. Ugur Sahin, M.D., and Prof. Özlem Türeci, M.D. The new company with distinct resources, operations and funding options will advance next-generation mRNA innovations. BioNTech plans to contribute related rights and mRNA technologies to the new company to enable and support the prioritized development of next-generation mRNA innovations with disruptive potential. With both companies focusing on their respective strategic priorities, BioNTech expects to maximize value for patients and shareholders alike. Ugur Sahin and Özlem Türeci will transition into the management of their new company by the end of 2026 after their current service agreements end. BioNTech’s Supervisory Board has initiated an executive search to identify successors for the positions to ensure a smooth transition and seamless execution of BioNTech’s strategy. On March 1, Kylie Jimenez joined BioNTech’s Management Board as Chief People Officer (“CPO”). The appointment is in line with BioNTech’s strategy to become a multi-product biopharmaceutical company by 2030 and underscores the importance of its global, highly skilled workforce in achieving this objective. Kylie will focus on attracting, developing and retaining talent, while strengthening an inclusive culture. Select Oncology Pipeline Updates Next-Generation Immunomodulators and Combinations Pumitamig (BNT327/BMS986545) is a bispecific immunomodulator candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization that is being developed in collaboration with BMS. A global Phase 3 clinical trial in patients with first-line triple-negative breast cancer (“TNBC”) (ROSETTA Breast-01; NCT07173751 ) is enrolling. A global Phase 2/3 clinical trial to evaluate pumitamig in first-line microsatellite stable colorectal cancer (“CRC”) (ROSETTA CRC-203; NCT07221357 ) is enrolling. A global Phase 2/3 clinical trial to evaluate pumitamig in first-line gastric cancer (ROSETTA Gastric-204; NCT07221149 ) is enrolling. A global Phase 2/3 clinical trial (ROSETTA Lung-02; NCT06712316 ) is ongoing 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 currently recruiting. Data from the Phase 2 part of the trial are expected in 2026. Additional pivotal Phase 2/3 and Phase 3 trials are planned to start in 2026, in unresectable stage III NSCLC (ROSETTA Lung-201, NCT07361497 ), first-line PD-L1 ≥ 50% NSCLC (ROSETTA Lung-202, NCT07361510 ) and first-line head and neck squamous cell carcinoma (“HNSCC”) (ROSETTA HNSCC-205). Pumitamig is also being evaluated in additional solid tumor indications, including first-line hepatocellular carcinoma (“HCC”), second-line glioblastoma (“GBM”), first-line pancreatic ductal adenocarcinoma (“PDAC”) and first-line renal cell carcinoma (“RCC”) in various Phase 1/2 and Phase 2 trials, both as monotherapy and in combination with standard of care. In 2025, BioNTech initiated several signal-seeking clinical trials to evaluate pumitamig with the Company’s proprietary assets. These trials will inform the dose selection for pumitamig and explore anti-tumor activity in multiple tumors for later-stage development. Gotistobart (BNT316/ONC-392) is a tumor microenvironment-selective regulatory T cell depletion candidate that targets CTLA-4 and is being developed in collaboration with OncoC4, Inc. (“OncoC4”). A global Phase 3 clinical trial (PRESERVE-003; NCT05671510 ) is ongoing to evaluate the efficacy and safety of gotistobart as monotherapy in patients with metastatic squamous NSCLC (“sqNSCLC”) that progressed under previous platinum-based chemotherapy and PD-(L)1-inhibitor treatment. In December 2025, data from the non-pivotal dose-confirmation stage, the first of two stages of the global Phase 3 clinical trial, were presented at the International Association for the Study of Lung Cancer (“IASLC”) American Society of Clinical Oncology (“ASCO“) 2025 North America Conference on Lung Cancer (“NACLC”). Gotistobart demonstrated a clinically meaningful overall survival benefit compared to standard of care chemotherapy and a manageable safety pro patients with squamous NSCLC whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy. Based on current event accrual projections, interim data from the pivotal stage of the two-stage Phase 3 clinical trial are expected in 2026. In January 2026, gotistobart received Orphan Drug Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of squamous NSCLC. In 2022, gotistobart received Fast Track Designation from the FDA for the treatment of patients with metastatic NSCLC whose disease progressed on prior anti-PD-(L)1 therapy. 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. (“DualityBio”). A Phase 1/2 clinical trial ( NCT05150691 ) is ongoing 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 plan to biologics license application (“BLA”) in 2026, subject to regulatory feedback from the FDA. A global Phase 3 clinical trial (DYNASTY-Breast02, NCT06018337 ) to evaluate trastuzumab pamirtecan in patients with HR-positive, HER2-low metastatic breast cancer is ongoing. Based on current event accrual projections, data are expected in 2026. BNT324 /DB-1311 is an ADC candidate targeting B7H3 that is being developed in collaboration with DualityBio. In February 2026, updated data from a Phase 1/2 clinical trial ( NCT05914116 ) were presented at the ASCO Genitourinary Cancers Symposium. BNT324/DB-1311 demonstrated durable efficacy in heavily pretreated metastatic castration-resistant prostate cancer (“mCRPC”) patients with no new safety signals reported. A Phase 3 clinical trial ( NCT07365995 ) to evaluate BNT324/DB-1311 compared to docetaxel in patients with mCRPC is expected to initiate in 2026. mRNA Cancer Immunotherapies BNT113 is an mRNA cancer immunotherapy candidate and based on BioNTech’s fully owned, off-the-shelf FixVac platform, encoding the two oncoproteins E6 and E7 that are frequently found in human papillomavirus type 16 positive (“HPV16+”) solid tumors. In December 2025, the FDA granted Fast Track designation to BNT113 for the treatment of patients with PD-L1+, HPV16+ HNSCC. Based on current event accrual projections, data are expected in 2026 from the first interim analysis of the Phase 3 part of the ongoing Phase 2/3 clinical trial (AHEAD-MERIT; NCT04534205 ) evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment for patients with unresectable recurrent or metastatic, PD-L1+, HPV16+ HNSCC. 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”). An update from the ongoing Phase 2 clinical trial in Stage II (high-risk)/Stage III circulating tumor DNA positive (“ctDNA+”) adjuvant colorectal cancer (“CRC”) is expected in early 2026. Data read-out from the final analysis of this trial has been updated from 2026 to 2027, given that events have accrued more slowly than projected. BioNTech and Roche, the sponsor of the trial, have decided to discontinue the Phase 2 clinical trial (IMcode004; NCT06534983 ) evaluating autogene cevumeran as an adjuvant treatment in combination with nivolumab compared to nivolumab alone in patients with high-risk muscle-invasive urothelial carcinoma due to the rapidly emerging treatment landscape and shifting standard of care. The companies will focus on advancing autogene cevumeran in the currently ongoing randomized Phase 2 clinical trials in adjuvant pancreatic ductal adenocarcinoma (“PDAC”) and adjuvant CRC. Expected 2026 Milestones Program Modality Trial Readout Phase Indication Late-Stage Trial Readouts Trastuzumab pamirtecan 3 ADC Single-arm Phase 2 2L+ HER2-expressing endometrial cancer Phase 3 interim analysis Chemo naïve HR+ HER2-low breast cancer Gotistobart 2 Immunomodulator Phase 3 interim analysis 2L+ sqNSCLC Phase 2 2L+ mCRPC BNT113 mRNA cancer immunotherapy Phase 3 interim analysis 1L HPV16+ PD-L1+ HNSCC Pumitamig 1 Immunomodulator Phase 3 in China interim analysis 1L TNBC Early-Stage Pumitamig & ADC Trial Readouts Pumitamig 1 Immunomodulator Phase 2 1L NSCLC Phase 2 1L extensive-stage small-cell lung cancer (“ES-SCLC”) Phase 2 in China 1L HCC Phase 2 in China 1L microsatellite stable colorectal cancer (“MSS-CRC”) Pumitamig 1 + Trastuzumab pamirtecan (HER2-ADC) 3 Immunomodulator + ADC Phase 1/2 Breast cancer Pumitamig 1 + BNT324/DB-1311 (B7H3-ADC) 3 Phase 1/2 Advanced solid tumors Phase 2 NSCLC/SCLC Pumitamig 1 + BNT325/DB-1305 (TROP2-ADC) 3 Phase 2 TNBC Pumitamig 1 + BNT326/YL202 (HER3-ADC) 4 Phase 1/2 NSCLC BNT324/DB-1311 (B7H3-ADC) 3 ADC Phase 1/2 2L+ mCRPC Phase 3 Trial Initiations Pumitamig 1 Immunomodulator Phase 3 1L MSS-CRC Phase 3 1L HER2- PD-L1+ gastric cancer Phase 3 1L HNSCC Phase 3 NSCLC stage 3 unresectable Phase 3 1L NSCLC PD-L1 high BNT324 /DB-1311 (B7H3-ADC) 3 ADC Phase 3 1L mCRPC BLA Submission Trastuzumab pamirtecan (HER2-ADC) 3 ADC - 2L+ HER2-expressing endometrial cancer Partnered with: 1. BMS; 2. OncoC4; 3. DualityBio; 4. MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink"). Upcoming Investor and Analyst Events BioNTech First Quarter 2026 Financial Results and Corporate Update: May 5, 2026 BioNTech Annual General Meeting: May 15, 2026 Conference Call and Webcast Information BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, March 10, 2026, at 8:00 a.m. EDT (1:00 p.m. CET) to report its financial results and provide a corporate update for the fourth quarter and full year 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 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 BioNTech Biopharmaceutical 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, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, Pfizer and Regeneron. For more information, please visit Forward-Looking Statements This 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: expected changes to BioNTech’s leadership and the transition of responsibilities at the Management Board, including identification and recruitment of successors; the terms of the preliminary discussions between BioNTech and the co-founders regarding the potential contribution of certain BioNTech assets to an independent company; 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; 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 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 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 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; 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 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; 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 its product candidates, if approved; 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 Annual Report on Form 20-F for the period ended December 31, 2025 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at . 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 Relations Douglas Maffei, PhD Investors@biontech.de Media Relations Jasmina Alatovic Media@biontech.de Abbreviation Overview 1L First line 2L Second line adj. Adjuvant B7H3 B7 homologue B3 (MSS-)CRC (Microsatellite stable-) colorectal cancer ctDNA Circulating tumor DNA CTLA-4 Cytotoxic T-lymphocyte-associated protein ES-SCLC Extensive-stage small cell lung cancer GBM Glioblastoma HCC Hepatocellular carcinoma HER2 (or HER3) Human epidermal growth factor receptor 2 (or 3) HNSCC Head and neck squamous cell carcinoma HPV16 Human papilloma virus 16 HR Hormone receptor IHC3+, 2+, 1+ Immunohistochemistry score 1+ (or 2+ or 3+) ISH-positive In-situ hybridization positive mCRPC Metastatic castration resistant prostate cancer RCC Renal cell carcinoma (sq) NSCLC (Squamous) non-small cell lung cancer PDAC Pancreatic ductal adenocarcinoma PD-(L)1 Programmed cell death protein (death-ligand) 1 TNBC Triple-negative breast cancer TROP2 Trophoblast cell-surface antigen 2 VEGF-A Vascular endothelial growth factor A Consolidated Statements of Profit or Loss (IFRS Results) Three months ended December 31, Years ended December 31, 2025 2024 2025 2024 (in millions €, except per share data) (unaudited) (unaudited) Revenues 907.4 1,190.0 2,869.9 2,751.1 Cost of sales (333.3) (243.5) (641.8) (541.3) Research and development expenses (505.4) (611.8) (2,104.9) (2,254.2) Sales and marketing expenses (49.3) (21.3) (110.0) (67.9) General and administrative expenses (168.6) (110.8) (514.4) (531.1) Other operating expenses (208.0) (91.6) (1,088.3) (811.5) Other operating income 34.4 37.6 184.6 140.6 Operating profit / (loss) (322.8) 148.6 (1,404.9) (1,314.3) Finance income 99.6 165.2 423.9 664.0 Finance expenses (4.2) (12.6) (69.8) (27.4) Profit / (Loss) before tax (227.4) 301.2 (1,050.8) (677.7) Income taxes (77.6) (41.7) (85.3) 12.4 Net profit / (loss) (305.0) 259.5 (1,136.1) (665.3) Earnings / (Loss) per share Basic earnings / (loss) per share (1.25) 1.08 (4.70) (2.77) Diluted earnings / (loss) per share (1.25) 1.08 (4.70) (2.77) Condensed Consolidated Statements of Profit or Loss (Adjusted Results) Adjusted Results (non-IFRS measures) 1 Three months ended December 31, Years ended December 31, 2025 2024 2025 2024 (in millions €, except per share data) (unaudited) (unaudited) Adjusted cost of sales (302.8) (204.5) (611.3) (493.2) Adjusted research and development expenses (505.4) (530.3) (2,019.5) (2,172.7) Adjusted other operating expenses (13.0) (39.2) (170.2) (154.1) Adjusted other operating income 34.4 37.6 169.6 140.6 Adjusted operating profit / (loss) (97.3) 321.5 (385.9) (527.3) Adjusted profit / (loss) before tax (1.9) 474.1 (31.8) 109.3 Adjusted net profit / (loss) 2 (79.5) 432.4 (117.1) 121.7 Adjusted earnings / (loss) per share Adjusted basic earnings / (loss) per share (0.33) 1.80 (0.48) 0.51 Adjusted diluted earnings / (loss) per share (0.33) 1.79 (0.48) 0.50 1 Certain adjusted results presented in this table are identical to our results under IFRS Accounting Standards. Reconciliation of all other adjusted results to our IFRS results can be found at the end of this press release and in BioNTech’s Report on Form 20-F for the year ended December 31, 2025, filed on March 10, 2026, which is available at 2 Tax effects are not considered as part of our non-IFRS adjustments Consolidated Statements of Financial Position December 31, December 31, (in millions €) 2025 2024 Assets Non-current assets Goodwill 367.9 380.6 Other intangible assets 1,606.0 790.4 Property, plant and equipment 1,080.9 935.3 Right-of-use assets 210.2 248.1 Contract assets 2.0 9.8 Other financial assets 2,554.2 1,254.0 Other non-financial assets 7.3 26.3 Deferred tax assets 13.5 81.7 Total non-current assets 5,842.0 3,726.2 Current assets Inventories 110.7 283.3 Trade and other receivables 924.2 1,463.9 Contract assets 8.1 10.0 Other financial assets 7,201.8 7,021.7 Other non-financial assets 173.8 212.7 Income tax assets 52.6 50.0 Cash and cash equivalents 7,675.4 9,761.9 Total current assets 16,146.6 18,803.5 Total assets 21,988.6 22,529.7 Equity and liabilities Equity Share capital 259.0 248.6 Capital reserve 2,473.3 1,398.6 Treasury shares (7.7) (8.6) Retained earnings 17,961.9 19,098.0 Other reserves (1,462.3) (1,325.5) Total equity 19,224.2 19,411.1 Non-current liabilities Lease liabilities, loans and borrowings 215.2 214.7 Other financial liabilities 94.9 46.9 Provisions 35.5 20.9 Contract liabilities 88.0 183.0 Other non-financial liabilities 104.2 87.5 Deferred tax liabilities 84.3 42.4 Total non-current liabilities 622.1 595.4 Current liabilities Lease liabilities, loans and borrowings 52.2 39.5 Trade payables and other payables 534.9 426.7 Other financial liabilities 351.7 1,443.4 Income tax liabilities 65.6 4.5 Provisions 145.3 144.8 Contract liabilities 754.9 294.9 Other non-financial liabilities 237.7 169.4 Total current liabilities 2,142.3 2,523.2 Total liabilities 2,764.4 3,118.6 Total equity and liabilities 21,988.6 22,529.7 Consolidated Statements of Cash Flows Three months ended December 31, Years ended December 31, 2025 2024 2025 2024 (in millions €) (unaudited) (unaudited) Operating activities Net profit / (loss) (305.0) 259.5 (1,136.1) (665.3) Income taxes 77.6 41.7 85.3 (12.4) Profit / (Loss) before tax (227.4) 301.2 (1,050.8) (677.7) 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 164.8 165.4 382.8 298.0 Share-based payment expenses 24.1 23.5 106.2 100.9 Net foreign exchange differences (43.0) (32.1) (6.6) (109.5) (Gain) / Loss on disposal of property, plant and equipment (0.8) (0.1) (2.5) (0.3) Finance income excluding foreign exchange differences (99.1) (149.7) (423.9) (648.5) Finance expense excluding foreign exchange differences 4.3 12.6 21.4 27.4 Government grants (19.5) (4.7) (63.0) (31.5) Other non-cash (income) / loss 600.4 — 585.4 — Unrealized (gain) / loss on derivative instruments at fair value through profit or loss 2.5 3.9 (10.4) 4.6 Working capital adjustments: (Increase) / Decrease in trade and other receivables, contract assets and other assets 81.0 (879.9) 1,083.7 387.7 Decrease in inventories 116.2 19.9 177.9 74.5 (Decrease) / Increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions (424.6) 167.7 (723.8) 758.4 Interest received and realized gains from cash and cash equivalents 61.8 121.6 337.0 474.9 Interest paid and realized losses from cash and cash equivalents (2.8) (6.6) (11.0) (13.5) Income tax received / (paid), net 40.5 (198.4) 3.8 (389.2) Share-based payments (6.0) (10.9) (25.3) (154.5) Government grants received 37.1 3.3 75.1 106.0 Net cash flows from operating activities 309.5 (463.3) 456.0 207.7 Investing activities Purchase of property, plant and equipment (63.2) (66.6) (175.1) (286.5) Proceeds from sale of property, plant and equipment 0.6 0.7 4.5 1.2 Purchase of intangible assets 1.1 (24.5) (573.9) (165.8) Acquisition of subsidiaries and businesses, net of cash acquired 264.8 — 186.3 — Investment in other financial assets (4,375.8) (2,068.8) (11,422.5) (12,370.3) Proceeds from maturity of other financial assets 1,446.9 2,765.9 9,512.2 10,740.2 Net cash flows used in investing activities (2,725.6) 606.7 (2,468.5) (2,081.2) Financing activities Proceeds from loans and borrowings 6.7 — 6.7 — Repayment of loans and borrowings (8.6) — (18.0) (2.3) Payments related to lease liabilities (10.4) (7.3) (39.6) (43.6) Transaction costs related to issuance of share capital (2.0) — (2.0) — Net cash flows used in financing activities (14.3) (7.3) (52.9) (45.9) Net decrease in cash and cash equivalents (2,430.4) 136.1 (2,065.4) (1,919.4) Change in cash and cash equivalents resulting from exchange rate differences 1.4 13.6 (27.0) 14.8 Change in cash and cash equivalents resulting from other valuation effects 11.5 (12.4) 5.9 2.8 Cash and cash equivalents at the beginning of the period 10,092.9 9,624.6 9,761.9 11,663.7 Cash and cash equivalents as of December 31 7,675.4 9,761.9 7,675.4 9,761.9 Non-IFRS Reconciliation Non-IFRS Reconciliation for the year ended December 31, 2025 non-IFRS adjustments (in millions €, except per share data) IFRS Results Expenses and income from legal proceedings Impairment and reversal Employee-related expenses from restructuring Income from bargain purchase and income and expenses from divestiture related items Adjusted Results Cost of sales (641.8) — 30.5 — — (611.3) Research and development expenses (2,104.9) — 85.4 — — (2,019.5) Other operating expenses (1,088.3) 789.5 71.6 57.0 — (170.2) Other operating income 184.6 — — — (15.0) 169.6 Operating loss (1,404.9) 789.5 187.5 57.0 (15.0) (385.9) Loss before tax (1,050.8) 789.5 187.5 57.0 (15.0) (31.8) Net loss 1 (1,136.1) 789.5 187.5 57.0 (15.0) (117.1) Loss per share Basic loss per share (4.70) (0.48) Diluted loss per share (4.70) (0.48) 1 Tax effects are not considered as part of our non-IFRS adjustments. Non-IFRS Reconciliation for the three months ended December 31, 2025 non-IFRS adjustments (in millions €, except per share data) IFRS Results Expenses and income from legal proceedings Impairment and reversal Employee-related expenses from restructuring Income from bargain purchase and income and expenses from divestiture related items Adjusted Results (unaudited) Cost of sales (333.3) — 30.5 — — (302.8) Other operating expenses (208.0) 111.4 71.6 12.0 — (13.0) Operating loss (322.8) 111.4 102.1 12.0 — (97.3) Loss before tax (227.4) 111.4 102.1 12.0 — (1.9) Net loss 1 (305.0) 111.4 102.1 12.0 — (79.5) Loss per share Basic loss per share (1.25) (0.33) Diluted loss per share (1.25) (0.33) 1 Tax effects are not considered as part of our non-IFRS adjustments. Non-IFRS Reconciliation for the year ended December 31, 2024 non-IFRS adjustments (in millions €, except per share data) IFRS Results Expenses and income from legal proceedings Impairment and reversal Employee-related expenses from restructuring Income from bargain purchase and income and expenses from divestiture related items Adjusted Results Cost of sales (541.3) — 48.1 — — (493.2) Research and development expenses (2,254.2) — 81.5 — — (2,172.7) Other operating expenses (811.5) 657.4 — — — (154.1) Operating loss (1,314.3) 657.4 129.6 — — (527.3) Profit / (Loss) before tax (677.7) 657.4 129.6 — — 109.3 Net profit / (loss) 1 (665.3) 657.4 129.6 — — 121.7 Earnings / (Loss) per share Basic earnings / (loss) per share (2.77) 0.51 Diluted earnings / (loss) per share (2.77) 0.50 1 Tax effects are not considered as part of our non-IFRS adjustments. Non-IFRS Reconciliation for the three months ended December 31, 2024 non-IFRS adjustments (in millions €, except per share data) IFRS Results Expenses and income from legal proceedings Impairment and reversal Employee-related expenses from restructuring Income from bargain purchase and income and expenses from divestiture related items Adjusted Results (unaudited) Cost of sales (243.5) — 39.0 — — (204.5) Research and development expenses (611.8) — 81.5 — — (530.3) Other operating expenses (91.6) 52.4 — — — (39.2) Operating profit 148.6 52.4 120.5 — — 321.5 Profit before tax 301.2 52.4 120.5 — — 474.1 Net profit 1 259.5 52.4 120.5 — — 432.4 Earnings per share Basic earnings per share 1.08 1.80 Diluted earnings per share 1.08 1.79 1 Tax effects are not considered as part of our non-IFRS adjustments. For the three months ended and the year ended December 31, 2023, our adjusted results were identical to our results under IFRS Accounting Standards.

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