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6-K 1 form6-kq32025earningsprear.htm 6-K Document


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
FOR THE MONTH OF NOVEMBER 2025

COMMISSION FILE NUMBER 001-39081
BioNTech SE
(Translation of registrant’s name into English)
An der Goldgrube 12
D-55131 Mainz
Germany
+49 6131-9084-0
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7): ☐




DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K

On November 3, 2025, BioNTech SE (the “Company”) issued a press release announcing its third quarter 2025 financial results and corporate update and details of a conference call to be held at 8:00 am EST on November 3, 2025 to discuss the results. The press release and the conference call presentation are attached as Exhibits 99.1 and 99.2, respectively, and incorporated by reference herein.
The information contained in Exhibits 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, unless expressly set forth by specific reference in such a filing.



SIGNATURE
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

BioNTech SE
By: /s/ Ramón Zapata-Gomez By: /s/ Dr. Sierk Poetting
Name: Ramón Zapata-Gomez Name: Dr. Sierk Poetting
Title: Chief Financial Officer Title: Chief Operating Officer
Date: November 3, 2025



EXHIBIT INDEX




EX-99.1 2 a99120251103_bntxq32025pre.htm EX-99.1 Document
Exhibit 99.1
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BioNTech Announces Third Quarter 2025 Financial Results and Corporate Update

•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 stages
•Demonstrated 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 cancer
•Launched variant-adapted COVID-19 vaccine for the 2025/2026 vaccination season in multiple regions
•Third 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”) partnership
•Increased 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-date
2025


Year-to-date
2024
Revenues


1,518.9


1,244.8


1,962.5


1,561.1
Net 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.


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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

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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.

Endnotes
1 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 Outlook 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.
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Variant-adapted COVID-19 Vaccine


•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.
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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.

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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.
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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 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, 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 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: 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).
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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.

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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 Relations
Douglas Maffei, PhD
Investors@biontech.de

Media Relations
Jasmina Alatovic
Media@biontech.de


Target Overview
B7-H3
Also known as CD276, cluster of differentiation 276
EpCAM
Epithelial cell adhesion molecule
HER2 (or HER3)
Human epidermal growth factor receptor 2 (or 3)
HR
Hormone Receptor
PD-(L)1
Programmed cell death protein (death-ligand) 1
TROP2
Trophoblast cell-surface antigen 2
VEGF-A
Vascular endothelial growth factor A

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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


1,561.1
Cost 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


103.0
Operating profit / (loss)


(46.9)


10.5


(1,082.1)


(1,462.9)
Finance income


96.8


156.2


324.8


498.8
Finance 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)


54.1
Net 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)

10


image_0.jpg
Interim Condensed Consolidated Statements of Financial Position










September 30,


December 31,
(in millions €)


2025


2024
Assets


(unaudited)



Non-current assets






Goodwill


357.7


380.6
Other intangible assets


1,389.8


790.4
Property, plant and equipment


1,039.7


935.3
Right-of-use assets


201.0


248.1
Contract assets


3.9


9.8
Other financial assets


2,476.0


1,254.0
Other non-financial assets


24.6


26.3
Deferred tax assets


17.7


81.7
Total non-current assets


5,510.4


3,726.2
Current assets






Inventories


225.7


283.3
Trade and other receivables


690.8


1,463.9
Contract assets


8.9


10.0
Other financial assets


4,434.7


7,021.7
Other non-financial assets


292.9


212.7
Income tax assets


84.8


50.0
Cash and cash equivalents


10,092.9


9,761.9
Total current assets


15,830.7


18,803.5
Total assets


21,341.1


22,529.7







Equity and liabilities






Equity






Share capital


248.6


248.6
Capital reserve


1,453.2


1,398.6
Treasury shares


(8.1)


(8.6)
Retained earnings


18,266.9


19,098.0
Other reserves


(1,483.3)


(1,325.5)
Total equity


18,477.3


19,411.1
Non-current liabilities






Lease liabilities, loans and borrowings


192.0


214.7
Other financial liabilities


96.4


46.9
Provisions


24.2


20.9
Contract liabilities


219.0


183.0
Other non-financial liabilities


85.5


87.5
Deferred tax liabilities


24.2


42.4
Total non-current liabilities


641.3


595.4
Current liabilities






Lease liabilities, loans and borrowings


53.4


39.5
Trade payables and other payables


399.8


426.7
Other financial liabilities


597.4


1,443.4
Income tax liabilities


6.3


4.5
Provisions


211.5


144.8
Contract liabilities


796.1


294.9
Other non-financial liabilities


158.0


169.4
Total current liabilities


2,222.5


2,523.2
Total liabilities


2,863.8


3,118.6
Total equity and liabilities


21,341.1


22,529.7
11


image_0.jpg
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


132.6
Share-based payment expenses


27.9


40.9


82.1


77.4
Net 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


14.8
Government 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)


0.7
Working capital adjustments:












Decrease / (Increase) in trade and other receivables, contract assets and other assets


881.7


(830.2)


1,002.7


1,267.6
Decrease 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)


590.7
Interest received and realized gains from cash and cash equivalents


83.5


73.1


275.2


353.3
Interest 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


102.7
Net cash flows from / (used in) operating activities


780.7


(638.9)


146.5


671.0
Investing 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


0.5
Purchase 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


7,974.3
Net 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)


1.2
Change in cash and cash equivalents resulting from other valuation effects


1.0


39.1


(5.6)


15.2
Cash and cash equivalents at the beginning of the period


10,269.5


10,376.7


9,761.9


11,663.7
Cash and cash equivalents as of September 30


10,092.9


9,624.6


10,092.9


9,624.6
12

EX-99.2 3 a992bntxq32025presentati.htm EX-99.2 a992bntxq32025presentati
3rd Quarter 2025 Financial Results & Corporate Update November 3rd, 2025 Exhibit 99.2


 
2 This Slide Presentation Includes Forward-Looking Statements This presentation 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, referred to as COMIRNATY where approved for use under full or conditional marketing authorization, 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 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 trials, and the registrational potential of any 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 BMS; 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 tariff policy; 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 presentation 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 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 in the United States and other countries; 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 presentation in the event of new information, future developments or otherwise. Furthermore, certain statements contained in this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and BioNTech’s own internal estimates and research. While BioNTech believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, any market data included in this presentation involves assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. While BioNTech believes its own internal research is reliable, such research has not been verified by any independent source. In addition, BioNTech is the owner of various trademarks, trade names and service marks that may appear in this presentation. Certain other trademarks, trade names and service marks appearing in this presentation are the property of third parties. Solely for convenience, the trademarks and trade names in this presentation may be referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. An abbreviation directory of defined terms can be found at the end of the presentation.


 
1 Progress Highlights Uğur Şahin, Co-founder & Chief Executive Officer 2 Oncology Execution Update Özlem Türeci, Co-founder & Chief Medical Officer 3 Financial Update Ramón Zapata, Chief Financial Officer


 
1 Progress Highlights Uğur Şahin, Co-founder & Chief Executive Officer 3rd Quarter 2025


 
Translating Science into Survival Building a Global Immunotherapy Powerhouse


 
Purpose-Built Pipeline To Enable Novel–Novel Combinations Across Solid Tumors Pumitamig2 Novel mRNA cancer immunotherapies PD-L1/VEGF-A bispecific antibodyNext generation of personalized cancer therapy targeting tumor associated antigens and cancer mutations FixVac & iNeST1 Next-Generation IO-backbone Neoadjuvant, adjuvant 1L advanced/metastatic Late stage, refractory cancers Clinical-stage candidates for novel-novel combinations Immunomodulators mRNA cancer immunotherapies ADCs 6 1. Partnered with: Genentech, a member of the Roche Group; 2. Formerly BNT327, partnered with Bristol Myers Squibb.


 
3Q 2025 Progress Towards Our Strategic Goals mRNA cancer immunotherapies Pumitamig1 • Executing broad pan-tumor development plan led by registrational Phase 3 clinical trials in lung2 and breast cancer with first potential launches before the end of the decade • Progressed clinical mono-agent profiling of potential combination partners, informing future registrational plans for novel- novel combinations • Advanced 10+ new signal-seeking trials to expand into additional indications and explore novel-novel combinations • Showcased BioNTech’s fully integrated AI capabilities, and unique position to build personalized immunotherapies and precision medicines Innovation Series: AI Day Financials • Strong balance sheet with ~€16.7 bn total cash and cash equivalents plus security investments5 • Received regulatory approvals in U.S. and other major markets, including Europe, UK, Japan, for the commercial roll-out of variant-adapted COVID-19 vaccine COMIRNATY4 • Progressing late-stage trials for FixVac and iNeST3 with two recent randomized Phase 2 updates • Recent readouts in advanced disease provide insights that further support current focus for iNeST3 in the adjuvant setting Oncology Execution Tech-bio Innovation COVID-19 Leadership Corporate Strength 7 Partnered with: 1. Formerly BNT327, partnered with Bristol Myers Squibb; 2. Includes a Phase 2/3 seamless clinical trial in NSCLC; 3.Genentech, a member of the Roche Group; 4. Pfizer; 5. 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.


 
2 Oncology Execution Update Özlem Türeci, Co-founder & Chief Medical Officer 3rd Quarter 2025


 
Advancing Towards Commercial Stage in Oncology Partnered with: 1. Formerly BNT327, partnered with Bristol Myers Squibb; 2. Formerly BNT323/DB-1303, partnered with DualityBio. 9 Pumitamig1 Trastuzumab pamirtecan2 mRNA Cancer Immunotherapies Aim to accelerate and expand Pumitamig1 development in strategic collaboration with BMS Generating data that support and inform our current development strategy Advancing T-Pam2 towards BLA submission in EC and BC


 
Pumitamig – Executing a Parallel Three-Wave Strategy to Build a Proprietary IO Franchise 10 Partnered with: 1. Bristol Myers Squibb. Establish Expand Elevate SCLC 1L Ph3 (Global) 2L Ph3 (China) 1L/2L Ph2 (Global) NSCLC 1L Ph2/3 (Global) 2L Ph2 (Global) 2L EGFRm Ph2 (China) IIT neoadjuvant (China) TNBC 1L Ph3 trial (Global) 1L Ph3 (China) Foundational Registrations Registrational Trials with Pumitamig1 ongoing in 3 High-Impact Tumors Broad Pan-Tumor Applicability With Standard-of-Care Chemotherapy 12+ Studies Exploring Pumitamig1 in 10+ New Indications Registrational-Intent 1L Gastric Ph2/3 (Global) 1L CRC Ph2/3 (Global) Signal-Seeking 1L CRC Ph2 (China) 1L PDAC Ph2 (China) 1L HCC Ph2 (China) 1L MPM Ph2 (China) 1L NEN Ph2 (China) HNSCC, RCC, CC, PROC, EC, Melanoma Ph1/2 (China) Q3 actions advanced registrational readiness (dose, design, geography) and combination rationale, the two prerequisites for a durable backbone. Combining with our ADCs targeting • HER2 • TROP2 • B7H3 Exploring synergies with our IO agents • EpCam x 4-1BB • TIGIT x PVRIG • mRNA cancer immunotherapy Defining Potential New Standards of Care 10+ Novel-Novel Combinations • HER3 • EGFR x HER3 • Novel targets 1. Formerly BNT327, partnered with Bristol Myers Squibb.


 
11 cORR 66.7%cORR 85.0% 20 0 -20 -40 -60 -80 -100 30 mg/kg20 mg/kg B e s t C h a n g e f ro m B a s e lin e ( % ) PD SD PR CR Patient Population 2L SCLC China IO Naïve 30mg/kg Q3W 2L SCLC China IO Treated 30mg/kg Q3W 1L ES-SCLC China 30mg/kg Q3W 1L ES-SCLC Global 20mg/kg Q3W 1L ES-SCLC Global 30mg/kg Q3W N 22 43 48 20 18 cORR (%) 50.0 37.2 85.4 85.0 66.7 DCR (%) 81.8 90.7 97.9 100 100 mPFS (months) 5.5 5.4 6.9 6.3 7.0 mOS (months) 14.7 14.3 16.8 - - Congress ELCC 2025 ELCC 2025 WCLC 2025 Broad Presence Ph3 and Ph1/2 trials across 1L and later lines; pan-tumor insights inform indication strategy; novel combinations also being evaluated Safety Profile Consistent and manageable safety profile across studies with low discontinuation rates and no new safety concerns Consistent Performance Activity and safety confirmed in China and global datasets, supporting frontline benefit Unique Positioning Designed to improve on current chemo-IO standard-of-care; combination potential being explored Heymach et al. WCLC 2025 Oral #OA13.02 Establishing Pumitamig1 in Small Cell Lung Cancer 1. Formerly BNT327, partnered with Bristol Myers Squibb,; 2. This benchmarking is not based on head-to-head trials between BioNTech’s investigational candidates and other products or product candidates. Furthermore, definitive conclusions cannot be drawn from cross-trial comparisons or anticipated data, as they may be confounded by various factors, and should be interpreted with caution; 3. L. Horn et al., New England Journal of Medicine, 2018; 4. I. Paz-Ares et al., The Lancet, 2019. Benchmark data2 1L ES-SCLC Regimen ORR (%) mPFS (months) mOS (months) Pivotal Trial Atezo + Chemo 60 5.2 12.3 IMpower1333 Durva + Chemo 68 5.1 12.9 CASPIAN4


 
ADC Single Agent Profiling to Inform Late-Stage Mono and Combo Development 12 Combination Partner Compound Indications + T-Pam1 HER2 ADC HR+ HER2-low, ultra-low/null BC or TNBC + BNT324/DB-13111 B7-H3 ADC NSCLC, SCLC, HCC, HNSCC, CC, PROC + BNT325/DB-13051 TROP2 ADC TNBC, NSCLC, OC, PROC + BNT326/YL2022 HER3 ADC NSCLC, EGFRm NSCLC, Melanoma, HER2-neg BC + BNT3212 EGFR x HER3 bsADC Multiple solid tumors + BNT314/GEN10593 EpCAM x 4-1BB bsAb MSS-CRC + BNT32134 TIGIT x PVRIG bsAb HCC + BNT116 NY-ESO-1,MAGE-A3- tyrosinase,TPTE mRNA NSCLC Multiple Signal-Seeking Pumitamig Combination Trials with ADCs and other Novel Modalities BNT324/DB-13111 (B7H3) Monotherapy in 2L+ SCLC and NSCLC Cheng et al. ESMO Asia 2024 57O BNT324/DB-13111 (B7H3) Monotherapy in 2L+ mCRPC Parsonson et al. ASCO 2025 5015 B e s t c h a n g e f ro m b a s e lin e in s u m o f ta rg e t le s io n d ia m e te r (% ) 9 mg/kg 6 mg/kg −80 −60 −40 −20 0 20 40 −100 Partnered with: 1. DualityBio; 2. MediLink; 3. Genmab; 4. China-only trial. Study day BNT325/DB-13111 (TROP2) Monotherapy in 2L+ mTNBC Hamilton et al. ESMO 2025 #557P 20% -30% 75 50 25 0 -25 -50 -75 -100 0 6 12 18 24 30 36 42 48 54 60 66 PDSDPR cORR: 34.6 % DCR: 80.9% mPFS: 5.55 months Overall response (RECIST 1.1) 70 nsqNSCLC (n=41) ORR 22.0% sqNSCLC (n=25) ORR 16.0% B e s t c h a n g e f ro m b a s e lin e ( % ) SCLC (n=73) ORR 56.2% EGFRm (n=14) ORR 21.4% C h a n g e f ro m b a s e lin e i n s u m o f ta rg e t le s io n d ia m e te r (% )


 
13 Individualized Immunotherapy: iNeST FixVac Autogene cevumeran (BNT122/RO7198457)1 BNT1112 BNT113 BNT116 Adjuvant 1L R/R R/R 1L Multiple settings MIUC Phase 2 CRC Phase 2 PDAC Phase 2 Melanoma Phase 2 Solid tumors Phase 1 Melanoma Phase 2 HPV16+ PD-L1 CPS ≥1 HNSCC Phase 2/3 NSCLC Phase 1 & 2 + Nivolumab Monotherapy + Atezolizumab + mFOLFIRINOX + Pembrolizumab Monotherapy and + Atezolizumab + Cemiplimab + Pembrolizumab Mono & combo with IO, ADCs and mRNA Recruitment ongoing Recruitment ongoing Data presented from epi sub-study at ASCO 2024 and from biomarker sub-study at ESMO-GI 2024 Recruitment ongoing Data from Phase 1 trial published: Rojas et al., Nature 2023; Sethna et al., Nature 2025 Trial completed (N=125) Primary endpoint (significant PFS improvement) not met. Numerical OS benefit trend observed. Data presented at ESMO 2025 Trial completed (N=272) Data ​published (Lopez et al., Nature Medicine 2025) Trial completed (N=184) Positive topline data announced in 2024 Data presented at ESMO 2025 Recruitment ongoing Trial updated to Phase 2/3 Recruitment completed in Phase 2 in 1L NSCLC2 Data presented at SITC 2023, AACR 2024 and SITC 2024. Data in frail patients presented at AACR 2025 Data in patients after CRT presented at WCLC 2025 Clinical Trial Execution Across iNeST and FixVac Portfolios Partnered with: 1. Genentech, a member of the Roche Group; 2. In collaboration with Regeneron.


 
Key Inclusion Criteria BNT111 FixVac Phase 2 Data in PD-(L)1 Melanoma Yield Insights That Guide Further Development 14 BNT111 is active in difficult to treat, post-IO setting Signal-seeking trials evaluating other FixVac candidates in combination with ADCs and IO are ongoing 1. In collaboration with Regeneron. Key Findings • A statistically significant improvement (ORR: 18.1%) of BNT111 + cemiplimab versus an assumed historical control ORR of 10% in heavily pretreated, PD-(L)1–r/r advanced/metastatic melanoma • 11.7% complete responses, and responses were deep and durable • BNT111 also indicated clinical activity as monotherapy • BNT111 showed a manageable safety profile as single agent and in combination Calibrator arms n=180 Optional upon disease progression BNT111 + Cemiplimab U.S. FDA Fast Track Designation and Orphan Drug Designation Ascierto et al. ESMO 2025 #1605MO Trial Design • IIIc/IV melanoma, measurable disease • ≥12 weeks of aPD-(L)1 treatment • ≤ 6 months after confirmed disease progression on/after aPD- (L)1 • ≤ 5 prior lines of treatment (including ipilimumab) • Prior B-RAF ± MEKi for patients with positive B-RAF tumor(s) • Serum LDH ≤ ULN Cemiplimab n=45 BNT111 + Cemiplimab n=94 BNT111 n=45 R 2:1:1 -60 -20 20 60 100 140 180 −100 220 0 12 24 36 48 60 72 84 96 108 120 132 144 156 BNT111 + Cemiplimab P e rc e n t c h a n g e i n S L D f ro m b a s e lin e Time, Weeks Best overall response CR PR SD PD NE BNT111 + cemiplimab (n=94) CR, n (%) 11 (11.7) PR, n (%) 6 (6.4) SD, n (%) 35 (37.2) ORR, n (%) 17 (18.1) DCR, n (%) 52 (55.3)


 
Trial Design Key Findings iNest1 Phase 2 Data in 1L Melanoma Yield Insights That Support Current Development Focus 15 1. Partnered with Genentech, a member of the Roche Group Improved PFS in patients who had a higher breadth of immune response as stratified by the number of neoantigen-specific T-cell responses A trend of improved OS in patients with PD-L1 High vs. PD-L1-Low in the autogene cevumeran combination arm vs. the pembrolizumab arm A trend of improved OS in patients with tumors with low mutation burden treated with autogene cevumeran combination vs pembrolizumab arm P a ti e n ts ( % ) Progression Free Survival 0 20 40 60 80 100 0 6 12 2418 30 36 42 48 54 Arm A (Pembrolizumab) Arm B (Pembrolizumab + autogene cevumeran) Time (Months) Arm A Arm B >3 neoantigen-specific T-cell responses Arm B  3 neoantigen-specific T-cell responses Time (Months) 0 10 20 30 40 50 60 0 25 50 75 100 Overall Survival P a ti e n ts ( % ) Arm A (Pembrolizumab) Arm B (Pembrolizumab + autogene cevumeran) Arm A: PD-L1 IC-High Arm A: PD-L1 IC-Low Arm B: PD-L1 IC-High Arm B: PD-L1 IC-Low 100 75 0 25 50 Time (Months) P a ti e n ts ( % ) Arm A (Pembrolizumab) Arm B (Pembrolizumab + autogene cevumeran) Arm A: TMB-High Arm A: TMB-Low Arm B: TMB-High Arm B: TMB-Low Overall Survival • Primary endpoint of progression free survival was not met. A numerical trend favoring the combination in overall survival at 12 and 24 months was observed • Robust neoantigen-specific T-cell responses, with multi-epitope breadth and persistence of T-cell clones well beyond induction • The combination of mRNA immunotherapy with a PD1 was well tolerated with mostly Grade 1 or 2 TRAEs with no new safety signals Sullivan et al. ESMO 2025 #954P 0 10 20 30 40 50 60 1L advanced melanoma Autogene Cevumeran + Pembrolizumab Pembrolizumab (1 cycle) R 1:2 Crossover allowed after confirmed PD n=125 Pembrolizumab


 
Upcoming Data Guide Late-Stage Development Strategies 16 Partnered with: 1. Formerly BNT327, partnered with Bristol Myers Squibb; 2. DualityBio; 3. Medilink; 4. Genentech, a member of the Roche Group; 5 OncoC4. Establishing Pumitamig’s Foundation Pumitamig1 1L/2L TNBC Global Phase 2 Helps inform Phase 3 dose Validating our Broader ADC Platform BNT324/DB-13112 CC and PROC Phase 1/2 Informs contribution of components for combination strategy and late-stage development BNT325/DB-13052 mTNBC Phase 1/2 BNT326/YL2023 HR+ HER2-null or low BC Phase 1/2 Informing Optimal Setting for mRNA Cancer Immunotherapy Development Autogene Cevumeran4 Adjuvant CRC Phase 2 First randomized trial data in the adjuvant setting Advancing our Next-Wave Immuno-Oncology Assets Gotistobart5 2L sq NSCLC Global Phase 3 (Stage 1) Helps de-risk pivotal stage of ongoing Phase 3


 
3 Financial Update Ramón Zapata, Chief Financial Officer 3rd Quarter 2025


 
Q3 and YTD Financial Results 18 Balance Sheet as of September 30, 2025 – Cash and cash equivalents plus security investments2 €16.7 bn (in millions €, except per share data)1 Three months ended September 30, Nine months ended September 30, 2025 2024 2025 2024 Revenues 1,519 1,245 1,963 1,561 Cost of sales (148) (179) (309) (298) Research and development expenses (565) (550) (1,600) (1,642) Sales and marketing expenses (27) (18) (61) (47) General and administrative expenses (121) (132) (346) (420) Other operating result (705) (355) (729) (617) Operating income / (loss) (47) 11 (1,082) (1,463) Finance result 72 148 259 484 Income taxes (54) 39 (8) 54 Net profit / (loss) (29) 198 (831) (925) 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) 1. Numbers have been rounded and may have been adjusted in the table to add up to the totals. Presentation of the consolidated statements of profit or loss has been condensed. 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 with the U.S. SEC and available at https://www.sec.gov/; 2. 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.


 
19 1. 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. FY Guidance March 2025 FY Guidance November 2025 Planned FY 2025 Revenues Revenues €1,700 – €2,200 m €2,600 – €2,800 m Planned FY 2025 Expenses and Capex R&D expenses €2,600 – €2,800 m €2,000 – €2,200 m SG&A expenses €650 – €750 m €550 – €650 m Capital expenditure for operating activities €250 – €350 m €200 – €250 m Guidance Considerations 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 are estimated to be ~15% of BioNTech’s share of gross profit from COVID-19 vaccines sales in Pfizer’s territory • Anticipated revenues from a pandemic preparedness contract with the German government However, 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. BioNTech Increases Revenues Guidance and Reduces Expenditures Guidance for the Full Year 20251


 
Save the date Innovation Series R&D Day November 11, 2025 New York, NY U.S. Thank you!


 
Appendix


 
22 Selected Pipeline Milestones in 2025 and Beyond Program Indication 2025+ Milestone Next-Generation Immunomodulator Pumitamig1 1L/2L SCLC Global Phase 2 dose optimization data 1L/2L TNBC Global Phase 2 dose optimization data mRNA Cancer Immunotherapy Autogene cevumeran2 ctDNA+ adj. CRC Phase 2 update BNT1113 2L+ melanoma Phase 2 data Targeted Therapy Trastuzumab pamirtecan4 2L+ HER2 EC Phase 2 data5 Regulatory submission6 Partnered with: 1. Formerly BNT327, partnered with Bristol Myers Squibb; 2. Genentech, a member of the Roche Group; 3. In collaboration with Regeneron; 4. Formerly BNT323/DB-1303, partnered with DualityBio; 5. We plan to share these data at a medical conference in 2026; 6. We plan to file a BLA in second-line endometrial cancer in 2026, subject to regulatory feedback.


 
BioNTech’s Oncology Pipeline – Phase 2 and Phase 3 Clinical Trials Gotistobart4 (CTLA-4) PROC, + pembrolizumab BNT1115 aPD-(L)1-R/R melanoma, + cemiplimab Autogene cevumeran2 Adj. ctDNA+ stage II or III CRC BNT1165 1L adv. PD-L1  50% NSCLC, + cemiplimab Autogene cevumeran2 Adj. PDAC, + atezolizumab + mFOLFIRINOX Autogene cevumeran2 Adj. MIUC, + nivolumab Phase 3Phase 2 mRNA immunotherapyNext generation IO Targeted therapy Trastuzumab-Pamirtecan3 (HER2) multiple solid tumors 23 Pumitamig1 (PD-L1 x VEGF-A) 2L NSCLC, + CTx Pumitamig1 or BNT325/DB-1305 + BNT324/DB-13113 combination Multiple solid tumors Gotistobart4 (CTLA-4) aPD-1/PD-L1 experienced squamous NSCLC Trastuzumab-Pamirtecan3 (HER2) HR+/HER2-low met. breast cancer Pumitamig1 (PD-L1 x VEGF-A) 2L SCLC, + CTx6 Pumitamig1 (PD-L1 x VEGF-A) 1L TNBC, + CTx6 Pumitamig1 (PD-L1 x VEGF-A) 1L SCLC, + CTx Pumitamig1 (PD-L1 x VEGF-A) 1L NSCLC, + CTx Pumitamig1 (PD-L1 x VEGF-A) 1L TNBC, + CTx PLANNED Trastuzumab-Pamirtecan3(HER2) 2L HER2+ endometrial cancer NEW BNT113 1L r./met. HPV16+ PD-L-1+ HNC, + pembrolizumab Pumitamig1 (PD-L1 x VEGF-A) 1L HCC + CTx6 Pumitamig1 (PD-L1 x VEGF-A) 1L/2L met. TNBC, + CTx Pumitamig1 (PD-L1 x VEGF-A) 1L/2L+ (ES-)SCLC, + CTx Pumitamig1 (PD-L1 x VEGF-A) 2L ES-SCLC, + CTx6 Pumitamig1 (PD-L1 x VEGF-A) 1L ES-SCLC + CTx6 Pumitamig1 (PD-L1 x VEGF-A) EGFR TKI experienced, EGFRm NSCLC, + CTx6 Pumitamig1 (PD-L1 x VEGF-A) 1L MPM, + CTx6 Pumitamig1 (PD-L1 x VEGF-A) 2L NEN, + CTx6 Pumitamig1 (PD-L1 x VEGF-A) 1L CRC6 NEW Partnered with: 1. Bristol Myers Squibb; 2. Genentech, member of Roche Group; 3. DualityBio; 4. OncoC4; 5. In collaboration with Regeneron; 6. Trial ongoing in China only.


 
BioNTech’s Oncology Pipeline – Phase 1 and Phase 1/2 Clinical Trials 24 Phase 1/2Phase 1 BNT312/GEN10422 (CD40x4-1BB) Multiple solid tumors Gotistobart4 (CTLA-4) Multiple solid tumors BNT116 Adv. NSCLC BNT211 (CLDN6) Multiple solid tumors BNT314/GEN10592 (EpCAMx4-1BB) Multiple solid tumors BNT326/YL2025 (HER3) Multiple solid tumors BNT317 Multiple solid tumors Gotistobart4 (CTLA-4) mCRPC, + radiotherapy BNT325/DB-13053 (TROP2) Multiple solid tumors BNT324/DB-13113 (B7-H3) Multiple solid tumors BNT329 Multiple solid tumors Pumitamig1 (PD-L1 x VEGF-A) 1L TNBC6 Pumitamig1 (PD-L1 x VEGF-A) Multiple solid tumors6 Pumitamig1 + BNT325/DB-13053 combination Multiple solid tumors, PROC, OC, TNBC, NSCLC Pumitamig1 + BNT324/DB-13113 combination Adv. or metastatic HNSCC, HCC, CC, PROC, NSCLC Pumitamig1 + BNT324/DB-13113 combination Adv. or metastatic NSCLC or SCLC Pumitamig1 + BNT326/YL2025 combination Multiple solid tumors Pumitamig1 + BNT314/GEN10592 combination Advanced CRC Pumitamig1 + BNT326/YL2025 combination Advanced NSCLC Pumitamig1 + Trastuzumab-Pamirtecan3 combination Adv. or metastatic HR+/- HER2-low,ultra-low or null breast cancer Pumitamig1 + BNT3213 combination 1L HCC6 NEWNEW NEW NEW Pumitamig1 + BNT3212 combination Multiple solid tumors NEW Partnered with: 1. Bristol Myers Squibb; 2. Genmab; 3. DualityBio; 4. Onco C4; 5. MediLink; 6. Trial ongoing in China only. mRNA immunotherapyNext generation IO Targeted therapy


 
Abbreviation Directory 25 n L nth line ESMO European Society for Medical Oncology PDAC Pancreatic ductal adenocarcinoma AACR American Association for Cancer Research FDA Food and Drug Administration PD-(L)1 Programmed cell death protein (ligand) 1 (bs)AB (bispecific) Antibody FixVac Fixed Antigen Vaccine PD-(L)1 IC PD-L1 Immune Cell Score (bs)ADC (bispecific) Antibody-drug conjugate FY Fiscal year (m)PFS (median) Progression-free survival adj. Adjuvant HCC Hepatocellular carcinoma PR Partial response adv. Advanced HER2 (or 3) Human epidermal growth factor receptor 2 (or 3) PROC Platinum-resistant ovarian cancer AI Artificial intelligence HNC Head and neck cancer PVRIG Poliovirus receptor-related immunoglobulin ASCO American Society of Clinical Oncology HNSCC Head and neck squamous cell carcinoma QxW Every x week(s) B7-H3 B7 Homolog 3 HPV Human papilloma virus RCC Renal cell carcinoma BC Breast cancer HR Hormone receptor R&D Research and development BLA Biologics License Applications iNeST Individualized NeoAntigen-Specific Therapy RECIST Response Evaluation Criteria in Solid Tumors B-RAF Serin/Threonin-Kinase IO Immuno-oncology R/R Relapsed/refractory bsAB Bispecific antibody LDH Lactate dehydrogenase (ES/LS)SCLC (Extensive/low stage) small cell lung cancer CAPEX Capital expenditures M&A Merger and acquisitions SD Stable disease CC Cervical cancer MAGE-A3 Melanoma antigen A3 SEC U.S. Securities and Exchange Commission CD-x Cluster of differentiation MEKi Mitogen-activated protein kinase kinase inhibitor SG&A Selling, general and administrative expenses CLDN6 Claudin 6 met. Metastatic SITC Society of Immunotherapy of Cancer CPS Combined positive score MIUC Muscle-invasive urothelial carcinoma TIGIT T cell immunoreceptor with Ig and ITIM domains CR Complete response MPM Malignant pleural mesothelioma TKI Tyrosine kinase inhibitor CRC Colorectal cancer mRNA Messenger ribonucleic acid TMB-H (or L) Tumor mutational burden-high (or low) CRPC Castration resistant prostate cancer MSS Microsatellite stability (m)TNBC (metastatic) Triple-negative breast cancer CRT Chemoradiation therapy NE Not evaluable for response TPTE Transmembrane phosphatase w.tensin homology ctDNA Circulating tumor DNA NEN Neuroendocrine neoplasm TRAE Treatment-related adverse event CTLA Cytotoxic T-lymphocyte-associated protein NSCLC Non-small cell lung cancer TROP2 Trophoblast cell-surface antigen 2 CTx Chemotherapy (n)sq (non-)squamous UK United Kingdom DCR Disease control rate NY-ESO-1 NY esophageal squamous cell carcinoma-1 ULN Upper limit of normal EC Endometrial cancer OC Ovarian cancer U.S. United States EGFR(m) Epidermal growth factor receptor (mutated) (c)ORR (Confirmed) objective response rate VEGF(R) - A Vascular endothelial growth factor A ELCC European Lung Cancer Congress (m)OS (median) Overall survival WCLC World Conference of Lung Cancer EpCAM Epithelial cell adhesion molecule PD Progressive disease YTD Year-to-date