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6-K 1 form6-kq22025earningsprear.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 AUGUST 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 August 4, 2025, BioNTech SE (the “Company”) issued a press release announcing its second quarter 2025 financial results and corporate update and details of a conference call to be held at 8:00 am EDT on August 4, 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: August 4, 2025



EXHIBIT INDEX




EX-99.1 2 a991bntxq22025pressrelease.htm EX-99.1 Document
Exhibit 99.1
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BioNTech Announces Second Quarter 2025 Financial Results and Corporate Update
Continued execution of BioNTech’s oncology strategy with focus on two pan-tumor programs including two announced transactions: mRNA-based cancer immunotherapy candidates and BNT327, a bispecific antibody candidate targeting PD-L11 and VEGF-A
•Entered a global strategic co-development and co-commercialization collaboration with Bristol Myers Squibb (“BMS”) to jointly execute a broad clinical development program to evaluate and advance BNT327 across numerous solid tumor types
•Announced strategic transaction to acquire CureVac N.V. (“CureVac”) to strengthen the research, development, manufacturing and commercialization of mRNA-based cancer immunotherapy candidates
•Presented multiple clinical updates across diversified oncology pipeline at medical meetings validating the Company’s oncology combination strategy
•Approval received for new variant-adapted COVID-19 vaccine by the European Commission (“EC”); further launch preparation underway as recommended by regulators, with deliveries expected to be ready as early as August, subject to regulatory approval in respective markets
•Second quarter 2025 revenues of €0.3 billion2, net loss of €0.4 billion and basic and diluted loss per share of €1.60 ($1.823)
•Maintained strong financial position with €16.0 billion in cash, cash equivalents and security investments as of June 30, 2025; Partnership with Bristol Myers Squibb expected4 to further strengthen BioNTech’s financial position with $1.5 billion expected to be reflected in third quarter 2025 cash position
•Full year 2025 financial guidance reaffirmed5

Conference call and webcast scheduled for August 4, 2025, at 8:00 a.m. EDT (2:00 p.m. CEST)
MAINZ, Germany, August 4, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the six months ended June 30, 2025 and provided an update on its corporate progress.
“In the second quarter, we took significant steps to advance BioNTech into a multiproduct biotechnology company by strengthening the two pillars of our oncology strategy,” said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. “We entered into a collaboration with BMS to accelerate and expand the development of our PD-L1xVEGF-A bispecific antibody candidate BNT327 and announced a strategic transaction to acquire CureVac to complement our own capabilities and proprietary technologies in mRNA design, delivery formulations, and mRNA manufacturing. These transformative transactions contribute to our mission of delivering truly transformative options for patients in need.”

Financial Review for Second Quarter and First Half of 2025













in millions €,
except per share data


Second Quarter 2025


Second Quarter 2024


First Half
2025


First Half
2024
Revenues


260.8


128.7


443.6


316.3
Net loss


(386.6)


(807.8)


(802.4)


(1,122.9)
Basic and diluted loss per share


(1.60)


(3.36)


(3.33)


(4.67)
Revenues for the three months ended June 30, 2025, were €260.8 million, compared to €128.7 million for the comparative prior year period. For the six months ended June 30, 2025, revenues were €443.6 million, compared to €316.3 million for the comparative prior year period. The increases were mainly driven by higher revenues derived from BioNTech’s COVID-19 vaccine collaboration.
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Research and development (“R&D”) expenses were €509.1 million for the three months ended June 30, 2025, compared to €584.6 million for the comparative prior year period. For the six months ended June 30, 2025, R&D expenses were €1,034.7 million, compared to €1,092.1 million for the comparative prior year period. The decreases were mainly driven by the reprioritization of clinical trials towards focus programs.
Sales, general and administrative (“SG&A”) expenses, in total, amounted to €137.4 million for the three months ended June 30, 2025, compared to €183.8 million for the comparative prior year period. For the six months ended June 30, 2025, SG&A expenses were €258.0 million, compared to €316.4 million for the comparative prior year period. The decreases were primarily driven by a reduction in external services.
Net loss was €386.6 million for the three months ended June 30, 2025, compared to a net loss of €807.8 million for the comparative prior year period. For the six months ended June 30, 2025, net loss was €802.4 million, compared to a net loss of €1,122.9 million for the comparative prior year period.
Basic and diluted loss per share was €1.60 for the three months ended June 30, 2025, compared to a basic and diluted loss per share of €3.36 for the comparative prior year period. For the six months ended June 30, 2025, basic and diluted loss per share was €3.33, compared to a basic and diluted loss per share of €4.67 for the comparative prior year period.
Cash and cash equivalents plus security investments as of June 30, 2025, reached €15,989.3 million, comprising €10,269.5 million in cash and cash equivalents, €3,363.8 million in current security investments and €2,356.0 million in non-current security investments.
Shares outstanding as of June 30, 2025, were 240,398,724, excluding 8,153,476 shares held in treasury.

“Joining BioNTech is a privilege, especially during this decisive phase in which we aim to capitalize on our innovative pipeline with clear strategic focus. While we continue to significantly invest into the execution of our strategy, our commitment to operational and financial discipline is starting to show tangible results,” said Ramón Zapata, Chief Financial Officer at BioNTech. “With the strategic BMS collaboration we will further strengthen our topline and cash position. As such, we will receive an upfront cash-payment of $1.5 billion in Q3 that we anticipate to be recognized as revenue over the development phase of BNT327.”

Anticipated Financial Effect4 of the BMS Partnership
As part of the agreement with BMS, BioNTech expects to receive $1.5 billion in an upfront cash payment this year, and for this payment to be reflected in the Company’s reported cash position as of the third quarter 2025. BioNTech also expects to receive $2.0 billion in total non-contingent anniversary cash payments from 2026 through 2028. The upfront and non-contingent cash payments, amounting to $3.5 billion, are expected to be recognized as revenues over the development phase of BNT327.
In addition, BioNTech will be eligible to receive up to $7.6 billion in development, regulatory and commercial milestones, with the majority of milestone payments expected to be triggered upon approvals and during commercialization. All milestones payments are anticipated to be reflected in the Company’s cash position and to be recognized as revenues following milestone achievement.
Under the agreement, BioNTech and BMS will share joint development and manufacturing costs of BNT327 on a 50:50 basis, subject to certain exceptions. Global profits and losses will be equally shared between BioNTech and BMS.
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2025 Financial Year Guidance Reaffirmed5:
Revenues for the 2025 financial year
€1,700 million - €2,200 million
BioNTech expects its revenues for the full 2025 financial year to be in the range of €1,700 - €2,200 million and revenue phasing primarily concentrated in the last three to four months, driving the full year revenue figure. The revenue guidance assumes: relatively stable 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 vaccines sales in Pfizer Inc.’s (“Pfizer”) territory; anticipated revenues from a pandemic preparedness contract with the German government, from collaborations and from the BioNTech Group service businesses. Current and potential further developments in law, public policy, international trade, and public sentiment as they continue to evolve could further negatively impact the anticipated COVID-19 vaccine revenues and expenses.

Planned 2025 Financial Year Expenses and Capex
R&D expenses


€2,600 million - €2,800 million

SG&A expenses
€650 million - €750 million
Capital expenditures for operating activities
€250 million - €350 million

BioNTech 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 create 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 June 30, 2025, filed today with the United States Securities and Exchange Commission (“SEC”) and is 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 June 30, 2025, as published by the German Central Bank (Deutsche Bundesbank).
4    These statements, including the anticipated timing of certain events, are based on BioNTech’s current expectations regarding the BMS collaboration and are subject to the successful co-development, approval and co-commercialization of BNT327. These statements are also based in part on assumptions and judgments that the Company has made, which may be subject to significant uncertainties. Although the Company’s approach to revenue recognition is based on facts and circumstances known to the Company and various other assumptions that the Company believes to be reasonable under the circumstances, the revenue assessment is ongoing, and its actual results may deviate from its current expectations. Revenue of initially constrained milestone payments may be recognized at the point of satisfaction or over time, including catch-up effects for prior periods as applicable. More information can be found in BioNTech’s Report on Form 6-K for the three and six months ended June 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.
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. These statements are also based in part on assumptions and judgments that the Company has made, which may be subject to significant uncertainties.
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Although the Company’s approach to revenue recognition is based on facts and circumstances known to the Company and various other assumptions that the Company believes to be reasonable under the circumstances, the revenue assessment is ongoing and its actual results may deviate from its current expectations. 
Operational Review for the Second Quarter 2025, Key Post Period-End Events and 2025 Outlook
Variant-adapted COVID-19 Vaccine
BioNTech and Pfizer have submitted regulatory applications to the European Medicines Agency (“EMA”) and to the United States Food and Drug Administration (“FDA”) for approval of their LP.8.1-adapted monovalent 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 EMA’s Committee for Medicinal Products for Human Use (“CHMP”). The new variant-adapted COVID-19 vaccine will be ready to ship to applicable EU member states in August.
Selected Oncology Pipeline Updates
Next-Generation Immunomodulators and Combinations
BNT327 is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization.
•A global Phase 3 clinical trial (ROSETTA Lung-01; NCT06712355) is being conducted to evaluate BNT327 as a first-line treatment in combination with chemotherapy compared to atezolizumab in combination with chemotherapy in patients with untreated extensive-stage small cell lung cancer (“ES-SCLC”).
•A global Phase 2 clinical trial (NCT06449209) to evaluate BNT327 in combination with chemotherapy in patients with untreated ES-SCLC and in patients with SCLC whose disease progressed after first- or second-line treatment is fully enrolled and treatment is ongoing. Data from this clinical trial is expected in 2025.
•In June, BNT327 received Orphan Drug Designation from the FDA for the treatment of SCLC.
•A global Phase 2/3 clinical trial (ROSETTA Lung-02; NCT06712316) is being conducted to evaluate BNT327 in combination with chemotherapy compared to pembrolizumab and chemotherapy in patients with first-line non-small cell lung cancer (“NSCLC”).
•A global Phase 2 clinical trial (NCT06449222) is being conducted to evaluate BNT327 in combination with chemotherapy as a first- and second-line treatment for patients with locally advanced or metastatic triple-negative breast cancer (“TNBC”). Data from this clinical trial is expected in 2025. A global Phase 3 clinical trial in patients with first-line TNBC (ROSETTA Breast-01) is planned to start in 2025.
•In June, at the 2025 American Society of Clinical Oncology (“ASCO”) Annual Meeting, preliminary data were presented from an ongoing Phase 2 clinical trial (NCT05918107) evaluating BNT327 in combination with chemotherapy in first-line mesothelioma. The preliminary data indicated anti-tumor activity and a manageable safety profile. Two trial-in-progress posters were also presented for ROSETTA Lung-01 and ROSETTA Lung-02.
In the last quarter, BioNTech initiated several signal-seeking clinical trials to evaluate BNT327 with the Company’s proprietary novel assets:
•In May, the first patient was dosed in a Phase 1/2 clinical trial (NCT06827236) evaluating BNT327 in combination with BioNTech and Duality Biologics (Suzhou) Co. Ltd.’s (“DualityBio”) HER2 antibody-drug conjugate (“ADC”) candidate BNT323/DB-1303 in patients with HR+ or HR-, HER2-low, ultra-low, or null advanced metastatic breast cancer or TNBC.
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•In May, the first patient was dosed in a Phase 1/2 clinical trial (NCT06892548) evaluating BNT327 in combination with BioNTech and DualityBio’s B7-H3 ADC candidate BNT324/DB-1311 in patients with advanced lung cancers.

•In July, the first patient was dosed in a Phase 2 clinical trial (NCT06953089) evaluating BNT324/DB-1311 in combination with BNT327 or with BioNTech and DualityBio’s TROP2 ADC candidate BNT325/DB-1305 in patients with advanced solid tumors.
•A Phase 1/2 clinical trial (NCT07070232) to evaluate BNT327 in combination with BioNTech and MediLink Therapeutics’s (“MediLink”) HER3 ADC candidate BNT326/YL202 and BNT326/YL202 as monotherapy in advanced solid tumors is expected to start in 2025.

•A Phase 1/2 clinical trial (NCT07079631) to evaluate BNT327 and/or chemotherapy in combination with BioNTech and Genmab AS’s (“Genmab”) novel EpCAM x 4-1BB bispecific antibody BNT314/GEN1059 in patients with advanced colorectal cancer is expected to start in 2025.

Antibody-Drug Conjugates
BNT323/DB-1303 (trastuzumab pamirtecan) is an ADC candidate targeting HER2 that is being developed in collaboration with DualityBio.
•A Phase 1/2 clinical trial (NCT05150691) is being conducted to evaluate BNT323/DB-1303 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 planned to be shared at a medical conference in 2026.
•A global Phase 3 clinical trial (NCT06340568) to evaluate BNT323/DB-1303 in patients with advanced endometrial cancer is expected to start in 2025.
BNT324/DB-1311 is an B7-H3-targeted ADC candidate that is being developed in collaboration with DualityBio.
•In June, preliminary data from the ongoing Phase 1/2 clinical trial (NCT05914116) evaluating BNT324/DB-1311 in patients with advanced solid tumors were presented at the 2025 ASCO Annual Meeting. In 73 patients with heavily pretreated castration-resistant prostate cancer (“CRPC”), BNT324/DB-1311 was observed to have a manageable safety profile and showed encouraging preliminary clinical activity.
mRNA Cancer Immunotherapies
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 in collaboration with Regeneron Pharmaceuticals Inc. (“Regeneron”) to evaluate BNT116 as monotherapy and in several combinations including with chemotherapy, cemiplimab, and some of BioNTech’s proprietary assets across various treatment lines and clinical settings in patients with NSCLC.
•In May, the first patient was dosed in a new cohort in the LuCa-MERIT-1 clinical trial to evaluate BNT116 in combination with BNT324/DB-1311.

•Data from a cohort from the LuCa-MERIT-1 clinical trial evaluating BNT116 in combination with cemiplimab in patients with NSCLC who have received chemoradiotherapy will be provided in a mini-oral session at the 2025 World Conference on Lung Cancer (“WCLC”) in Barcelona, Spain, September 6-9, 2025.

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Corporate Update for the Second Quarter 2025
•In June, BioNTech and BMS entered into an agreement for the global co-development and co-commercialization of BNT327 across numerous solid tumor types. Under the agreement, BMS will pay BioNTech $1.5 billion in an upfront cash payment and $2 billion total in non-contingent anniversary payments from 2026 through 2028. In addition, BioNTech will be eligible to receive up to $7.6 billion in additional development, regulatory and commercial milestones.

•In June, BioNTech entered into a definitive Purchase Agreement pursuant to which BioNTech intends to acquire all of the shares of CureVac, a clinical-stage biotech company developing a novel class of transformative medicines in oncology and infectious diseases based on mRNA. The transaction is expected to close in 2025.
•In May, BioNTech signed a grant agreement with the United Kingdom (“UK”) Government to broaden the Company’s R&D activities for innovative medicines in the UK. As part of the agreement, BioNTech is committed to investing up to £1 billion over the next 10 years. The Company’s efforts will be supported by a grant of up to £129 million for a period of 10 years by the UK Government, which marks one of the largest grants of its kind in UK history for a pharmaceutical company.
Upcoming Investor and Analyst Events
•AI Day: October 1, 2025, in London, United Kingdom
•Innovation Series R&D Day: November 11, 2025 in New York City, United States
Conference Call and Webcast Information
BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, August 4, 2025, at 8:00 a.m. EDT (2:00 p.m. CEST) to report its financial results and provide a corporate update for the second 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.
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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). 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 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 June 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



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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
June 30,


Six months ended
June 30,
















2025


2024


2025


2024
(in millions €, except per share data)


(unaudited)


(unaudited)


(unaudited)


(unaudited)
Revenues


260.8


128.7


443.6


316.3
Cost of sales


(76.4)


(59.8)


(160.2)


(118.9)
Research and development expenses


(509.1)


(584.6)


(1,034.7)


(1,092.1)
Sales and marketing expenses


(19.7)


(12.9)


(33.4)


(28.5)
General and administrative expenses


(117.7)


(170.9)


(224.6)


(287.9)
Other operating expenses


(117.2)


(290.8)


(165.7)


(314.7)
Other operating income


78.2


24.1


139.8


52.4
Operating loss


(501.1)


(966.2)


(1,035.2)


(1,473.4)
Finance income


105.4


167.7


228.0


345.3
Finance expenses


(7.0)


(7.3)


(40.9)


(9.5)
Loss before tax


(402.7)


(805.8)


(848.1)


(1,137.6)
Income taxes


16.1


(2.0)


45.7


14.7
Net loss


(386.6)


(807.8)


(802.4)


(1,122.9)
Loss per share












Basic and diluted loss per share


(1.60)


(3.36)


(3.33)


(4.67)



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Interim Condensed Consolidated Statements of Financial Position










June 30,


December 31,
(in millions €)


2025


2024
Assets


(unaudited)



Non-current assets






Goodwill


364.1


380.6
Other intangible assets


1,487.0


790.4
Property, plant and equipment


1,017.8


935.3
Right-of-use assets


224.3


248.1
Contract assets


5.9


9.8
Other financial assets


2,504.8


1,254.0
Other non-financial assets


26.8


26.3
Deferred tax assets


77.8


81.7
Total non-current assets


5,708.5


3,726.2
Current assets






Inventories


230.7


283.3
Trade and other receivables


1,368.3


1,463.9
Contract assets


8.7


10.0
Other financial assets


3,767.2


7,021.7
Other non-financial assets


215.0


212.7
Income tax assets


69.7


50.0
Cash and cash equivalents


10,269.5


9,761.9
Total current assets


15,929.1


18,803.5
Total assets


21,637.6


22,529.7







Equity and liabilities






Equity






Share capital


248.6


248.6
Capital reserve


1,447.9


1,398.6
Treasury shares


(8.2)


(8.6)
Retained earnings


18,295.6


19,098.0
Other reserves


(1,478.8)


(1,325.5)
Total equity


18,505.1


19,411.1
Non-current liabilities






Lease liabilities, loans and borrowings


217.2


214.7
Other financial liabilities


145.0


46.9
Provisions


22.9


20.9
Contract liabilities


787.7


183.0
Other non-financial liabilities


80.4


87.5
Deferred tax liabilities


28.5


42.4
Total non-current liabilities


1,281.7


595.4
Current liabilities






Lease liabilities, loans and borrowings


52.4


39.5
Trade payables and other payables


504.2


426.7
Other financial liabilities


40.9


1,443.4
Income tax liabilities


3.7


4.5
Provisions


145.6


144.8
Contract liabilities


945.4


294.9
Other non-financial liabilities


158.6


169.4
Total current liabilities


1,850.8


2,523.2
Total liabilities


3,132.5


3,118.6
Total equity and liabilities


21,637.6


22,529.7



11


image_0a.jpg

Interim Condensed Consolidated Statements of Cash Flows
















Three months ended
June 30,


Six months ended
June 30,
















2025


2024


2025


2024
(in millions €)


(unaudited)


(unaudited)


(unaudited)


(unaudited)
Operating activities












Net loss


(386.6)


(807.8)


(802.4)


(1,122.9)
Income taxes


(16.1)


2.0


(45.7)


(14.7)
Loss before tax


(402.7)


(805.8)


(848.1)


(1,137.6)
Adjustments to reconcile loss before tax to net cash flows:












Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets


51.0


49.9


93.8


88.2
Share-based payment expenses


32.1


20.2


54.2


36.5
Net foreign exchange differences


12.2


(13.2)


60.5


(41.9)
Gain on disposal of property, plant and equipment


(0.3)


(0.2)


(0.4)


(0.2)
Finance income excluding foreign exchange differences


(105.4)


(167.7)


(228.0)


(342.6)
Finance expense excluding foreign exchange differences


6.6


4.8


14.5


9.5
Government grants


(18.5)


(3.1)


(33.0)


(12.2)
Other non-cash (income) / loss






(15.0)


Unrealized (gain) / loss on derivative instruments at fair value through profit or loss


(17.3)


5.0


(28.6)


6.7
Working capital adjustments:












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


(400.4)


1,599.6


121.0


2,097.8
Decrease in inventories


22.8


5.3


56.6


17.6
(Decrease) / Increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions


914.6


760.8


(56.4)


472.8
Interest received and realized gains from cash and cash equivalents


73.1


80.8


191.7


280.2
Interest paid and realized losses from cash and cash equivalents


(2.7)


(1.6)


(5.8)


(5.3)
Income tax received / (paid), net


(14.9)


66.4


(27.1)


(192.4)
Share-based payments


(11.5)


(6.8)


(15.1)


(9.2)
Government grants received


7.8


32.8


31.0


42.0
Net cash flows from / (used in) operating activities


146.5


1,627.2


(634.2)


1,309.9
Investing activities












Purchase of property, plant and equipment


(27.1)


(88.6)


(76.0)


(147.1)
Proceeds from sale of property, plant and equipment


0.5


0.2


1.0


0.2
Purchase of intangible assets


(3.1)


(52.7)


(572.3)


(131.1)
Acquisition of subsidiaries and businesses, net of cash acquired






(78.5)


Investment in other financial assets


(1,670.0)


(2,448.2)


(4,177.7)


(7,343.3)
Proceeds from maturity of other financial assets


1,635.3


2,347.9


6,085.9


5,075.5
Net cash flows from / (used in) investing activities


(64.4)


(241.4)


1,182.4


(2,545.8)
Financing activities












Repayment of loans and borrowings


(3.7)


(2.3)


(8.2)


(2.3)
Payments related to lease liabilities


(9.6)


(20.6)


(18.9)


(28.4)
Net cash flows used in financing activities


(13.3)


(22.9)


(27.1)


(30.7)
Net increase / (decrease) in cash and cash equivalents


68.8


1,362.9


521.1


(1,266.6)
Change in cash and cash equivalents resulting from exchange rate differences


9.2


(3.3)


(6.9)


3.5
Change in cash and cash equivalents resulting from other valuation effects


6.6


40.5


(6.6)


(23.9)
Cash and cash equivalents at the beginning of the period


10,184.9


8,976.6


9,761.9


11,663.7
Cash and cash equivalents as of June 30


10,269.5


10,376.7


10,269.5


10,376.7

12

EX-99.2 3 a992bntxq22025presentati.htm EX-99.2 a992bntxq22025presentati
2nd Quarter 2025 Financial Results & Corporate Update August 4th, 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 June 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.


 
Strategic Outlook Ryan Richardson, Chief Strategy Officer 3 Financial Update Ramón Zapata, Chief Financial Officer 4 Oncology Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer2 2nd Quarter 2025 Update Ugur Sahin, Co-founder & Chief Executive Officer1


 
1 2nd Quarter 2025 Update Ugur Sahin, Co-founder & Chief Executive Officer


 
Building a Global Immunotherapy Powerhouse Translating Science into Survival


 
6 Partnered with: 1. Genentech, a member of the Roche Group; 2. Bristol Myers Squibb. Our Priorities are Our Novel mRNA Cancer Immunotherapies and Our Next-Generation IO-Backbone PD-L1/VEGF-A antibody BNT3272 Novel mRNA cancer immunotherapies Potential to become the next-generation IO-backboneNext-generation of personalized cancer therapy targeting tumor associated antigens and cancer mutations FixVac & iNeST1 Our next-generation IO-backbone Resected cancers (adjuvant) Neoadjuvant, 1L advanced/metastatic Late stage, refractory cancers Clinical-stage candidates for combination therapy IO molecules mRNA immunotherapies ADCs


 
Q2 2025+ Progress Towards Our Strategic Goals 7 BNT3271 • Preparing for global commercial roll-out of new variant-adapted COVID-19 vaccine3 Additional corporate updates • Expanded partnership with UK Government to broaden regional R&D activities with plans to invest up to £1 bn over the next decade mRNA cancer immunotherapies Execution in oncology COVID-19 leadership • Announced planned strategic transaction to acquire CureVac in public exchange offer • Achieved FPD in cohort evaluating BNT116 in combination with B7-H3 ADC BNT324/DB-13112 • Progressing broad pan-tumor development plan spearheaded by Phase 3 trials in lung and breast cancer • Announced global strategic partnership with BMS to co-develop and co-commercialize BNT3271 • Achieved FPD in trials evaluating the combination with HER2 ADC BNT323/DB-13032 and B7-H3 ADC BNT324/DB-13112 Partnered with 1. Bristol Myers Squibb; 2. DualityBio; 3. Pfizer, pending approvals from the relevant health authorities; 4. Cash and cash equivalents plus security investments as of June 30, 2025, reached €15,989.3 million, comprising €10,269.5 million in cash and cash equivalents, €3,363.8 million in current security investments and €2,356.0 million in non-current security investments. Strategic R&D partnership Financials COMIRNATY • Strong balance sheet with ~€16.0 bn total cash and cash equivalents plus security investments4


 
8 BioNTech and BMS Enter Landmark Strategic Collaboration to Advance BNT3271 Potential to transform standard of care and establish new IO backbone treatment option for patients with high unmet medical needs Maximizing potential of next-generation immunomodulator BNT3271 with global co-development and co-commercialization partnership • Bispecific antibody targeting PD-L1 and VEGF-A • Over 1,200 patients treated in clinical trials across multiple tumor types • Broad development ongoing in 10+ indications, including initial registrational trials Anti-VEGF-A Anti-PD-L1 VHH 1. Partnered with Bristol Myers Squibb.


 
9 Harnessing Complementary Expertise to Maximize BNT3271 Potential 1. Partnered with Bristol Myers Squibb. Patient-centric scientific excellence United in oncology combination strategy Operational execution & speed to market Manufacturing scalability Commercial presence ➢ Unique pipeline enabling multiple potential BNT3271 combinations for solid tumors (e.g., ADCs, mRNA) ➢ BNT3271: Studied in 10+ indications, 20+ trials, 3 ongoing or planned global registrational trials ➢ Building global commercial capabilities including U.S. and non-U.S. key markets ➢ Global clinical development expertise in novel and combination therapies; 3 approved IO assets ➢ 30+ U.S. FDA approvals since 2015; 20+ potential NMEs in oncology pipeline ➢ Top-tier, global market leader with preeminent commercial capabilities and infrastructure


 
2 Oncology Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer


 
Advancing Towards Commercial Stage in Oncology Partnered with: 1. Bristol Myers Squibb; 2. DualityBio 11 BNT3271 BNT323/DB-13032 mRNA Cancer Immunotherapies Aim to accelerate and expand BNT3271 development with strategic BMS collaboration mRNA cancer immunotherapy data expected in late 2025 or early 2026 Advance BNT323/DB-13032 towards BLA submission in EC and BC


 
BNT3271 Synergistic Targeting of PD-L1 and VEGF Local neutralization of angiogenic and immunosuppressive VEGF-A effects NSCLC IHC2 Bispecific MOA 1. Partnered with Bristol Myers Squibb; 2. IHC data: Human Protein Atlas VEGF-A PD-L1 Targeting the TME and blockade of PD-1/PD-L1 signaling Anti-VEGF-A (Fab) Anti-PD-L1 (VHH) VEGF-A dimer in the TME PD-L1 ligand on tumor cells Tumor microenvironment (TME) BNT327 VEGF-A dimer in the TME Anti-VEGF-A (Fab) Anti-PD-L1 (VHH) PD-L1 ligand on tumor cells 12


 
13 Partnered with: 1. Bristol Myers Squibb Accelerating and Broadening BNT3271 Global Clinical Development Exploring the potential of BNT3271 in three waves of focused development 3 Broaden2 Combine1 Establish BNT3271 + ADC: Explore expansion to novel combinations with ADCs in high unmet need indications BNT3271 + novel assets: Broaden to further indications • Two Phase 2 dose optimization trials ongoing in TNBC and SCLC with data in 2025 • Phase 3 trial ongoing in SCLC (ROSETTA Lung-01) • Phase 2/3 trial ongoing in NSCLC (ROSETTA Lung-02) • Phase 3 trial planned in TNBC (ROSETTA Breast-01) • Three Phase 1/2 and one Phase 2 combination trials with three novel ADCs ongoing • Phase 1/2 combination trial with a fourth novel ADC planned BNT3271 + chemo: Establish in combination with chemo in key indications with fast-to-market potential


 
Establish: BNT3271 Combined With Chemotherapy Indicated Encouraging Efficacy in 1L ES-SCLC in Phase 2 Study 1. Partnered with: 1. Bristol Myers Squibb; 2. Incidence from: SEER data for diagnosed SCLC incidence in U.S.; Cancer Research UK; Zentrum für Krebsregisterdaten; Sante Publique; AIOM; EPDATA. 3. Benchmark study: IMpower133 as reported in L. Horn et al., New England Journal of Medicine, 2018 4. The above information 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. Unmet medical need remains high for patients with ES-SCLC Patients with ES-SCLC2 have a 5-year survival rate of 3% We believe BNT327 has the potential to become a new first-line treatment option for patients with ES-SCLC3 Benchmark3 comparator data (IMpower133) L. Horn et al., New England Journal of Medicine, 2018 1L ES-SCLC Benchmark regimen Atezo + Chemo ORR 60% Median PFS 5.2 months Median OS 12.3 months The above data are not based on a head-to-head study comparing BioNTech’s investigational products with other products/candidates - no conclusions can be drawn.4 Phase 2 Study (NCT05844150)​: Emerging efficacy profile Ying Cheng et al. presented at ELCC 2025 ITT population (n=48)​ Confirmed ORR (95% CI) 85.4 % (72.2, 93.9) Median PFS (95% CI) 6.9 months (4.34, 8.21) Median OS (95% CI) OS events, n (%) 16.8 months (14.3, --)​ 17 (35.4) 12-month OS rate (95% CI) 72.7 % (57.6, 83.1)​ A manageable safety profile was observed, with no new safety signals beyond those typically described for chemotherapy agents and anti-PD-(L)1 and anti-VEGF monotherapies. 14 Global Phase 3 study ongoing (ROSETTA Lung-01)


 
Establish: BNT3271 Monotherapy Efficacy in 1L NSCLC 15 1. Partnered with Bristol Myers Squibb; 2. Reck, M. et al., New England Journal of Medicine, 2016. Phase 1b/2a (NCT05918445): cohort 1, 1L NSCLC (EGFR & ALK WT) Wu, C. et al. presented at ASCO 2024. Poster #8533. 1L NSCLC mono treatment (cohort 1, n=17): ORR 47%, DCR 100%, mPFS 13.6 months Comparable ORR in PD-L1 1–49% (n=9) and PD-L1 ≥50% (n=8) Waterfall/spider plots and Kaplan-Meier curves (PFS) PD-L1 ≥50% PD-L1 1–49% SD PR 60 40 20 0 −20 −40 −60 −80 B e s t c h a n g e f ro m b a s e lin e ( % ) 0 50 SD PD PR On Treatment 30 10 −10 −30 −50 −70 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 C h a n g e f ro m b a s e lin e ( % ) Months Data Cut of Date: 2024-03-15 Indication Benchmark regimen ORR mPFS mOS Benchmark study 1L NSCLC (PD-L1 > 50%) Pembro monotherapy 45% 7.7 mo 26.3 mo KEYNOTE-0242 Global Phase 2/3 study ongoing (ROSETTA Lung-02)


 
Establish: BNT3271 Combined With Chemotherapy Indicated Encouraging Efficacy in 1L TNBC Irrespective of PD-L1 Status in Phase 1/2 Study 1. Partnered with Bristol Myers Squibb; 2. Incidence from SEER (U.S.); Zentrum für Krebsregisterdaten (DE); Globocan (ES); Sante Publique (FR); AIOM (IT); Cancer Research UK . 3 Benchmark study: KEYNOTE-355 as reported in Cortes, J, et al. New England Journal of Medicine, 2022. 4. The above information 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. 5. Obtained from subgroup analysis. 6. mPFS for CPS < 10 subgroup from Cortes, J. et al. Lancet, 2020. Unmet medical need remains high for patients with TNBC Patients with Stage IV TNBC2 have a 5-year survival rate of 10% We believe BNT327 has the potential to become a first-line treatment option for patients with TNBC3, including those currently not addressed by existing IO therapies Benchmark3 comparator data by PD-L1 expression level (Keynote-355) Cortes, J, et al., New England Journal of Medicine, 2022 1L TNBC (CPS <10)5,6 1L TNBC (CPS ≥ 10) Benchmark regimen Chemo Pembro + Chemo ORR 35 % 53 % Median PFS 5.7 months 9.7 months Median OS 15.2 months 23.0 months The above data are not based on a head-to-head study comparing BioNTech’s investigational products with other products/candidates - no conclusions can be drawn.4 Phase 1/2 Study (NCT05918133)​: Interim overall survival Jiong Wu et al. presented at SABCS 2024 ITT population (n=42)​ Confirmed ORR (95% CI) 73.8 % (58.0, 86.1) Median PFS (95% CI) 13.5 months (9.4, 19.3) 12-month OS rate (95% CI) 80.8 % (65.3, 89.9)​ 18-month OS rate (95% CI) 69.7 % (52.7, 81.6)​ A manageable safety profile was observed, with no new safety signals beyond those typically described for nab-paclitaxel and anti-PD-1/PD-L1 and anti-VEGF monotherapies.​ 16 Global Phase 3 planned for 2025 (ROSETTA Breast-01)


 
17 Partnered with: 1. Bristol Myers Squibb; 2. DualityBio; 3. MediLink. Accelerating and Broadening BNT3271 Global Clinical Development Exploring the potential of BNT3271 in three waves of focused development Ongoing • Phase 2 in TNBC • Phase 2 in SCLC • Phase 3 in SCLC (ROSETTA Lung-01) • Phase 2/3 in NSCLC (ROSETTA Lung-02) Planned • Phase 3 in TNBC (ROSETTA Breast-01) for 2025 3 Broaden2 Combine1 Establish BNT3271 + chemo: Establish in combination with chemo in key indications with fast-to-market potential BNT3271 + novel assets: Broaden to further indications Planned • Phase 1/2 with BNT326/YL2023(HER3) Ongoing • Phase 1/2 with BNT325/DB-13052 (TROP2) in solid tumors • Phase 1/2 with BNT323/DB-13032 (HER2) in advanced breast cancer • Phase 1/2 with BNT324/DB-13112(B7-H3) in advanced lung cancer • Phase 2 with BNT324/DB-13112 (B7-H3) in advanced solid tumors Diverse portfolio of clinical oncology assets in-house • Combine with novel IO bispecifics • Combine with novel ADCs • Evaluate additional indications in partnership with BMS BNT3271 + ADC: Explore expansion to novel/novel combinations with ADCs in high unmet need indications


 
Preliminary data combining BNT3271 with BNT325/DB-13052 showed a manageable safety profile with few overlapping toxicities​ and signs of clinical activity 18 1. Partnered with: 1. Bristol Myers Squibb; 2.Duality. Combine: BNT3271 with Novel ADCs in High Unmet Need Indications 20% 0 –20 –40 –60 –80 –100B e s t c h a n g e f ro m b a s e li n e i n s u m o f ta rg e t le s io n d ia m e te rs ( % ) –30% 20 40 Three Phase 1/2 and one Phase 2 combination trials with three novel ADCs ongoing Combination with an additional novel ADC planned to start in 2025 Phase 1/2 (NCT05438329): BNT3271 combined with TROP2 ADC BNT325/DB-13052 in 2L–4L PROC Erika Hamilton et al. Presented at AACR 2025. Poster: 648 / 14 Waterfall plot for PROC from dose expansion cohort in 2-4L PROC (N=13)TRAEs occurring in ≥10% of patients receiving BNT325 + BNT3271 Q3W (N=67)


 
19 Partnered with: 1. Bristol Myers Squibb; 2. DualityBio; 3. MediLink; 4. In collaboration with Regeneron; 5. Genmab Accelerating and Broadening BNT3271 Global Clinical Development Exploring the potential of BNT3271 in three waves of focused development Ongoing • Phase 2 in TNBC • Phase 2 in SCLC • Phase 3 in SCLC (ROSETTA Lung-01) • Phase 2/3 in NSCLC (ROSETTA Lung-02) Planned • Phase 3 in TNBC (ROSETTA Breast-01) for 2025 3 Broaden2 Combine1 Establish BNT3271 + novel assets: Broaden to further indications Ongoing • Phase 1/2 with BNT325/DB- 13052 (TROP2) in solid tumors • Phase 1/2 with BNT323/DB- 13032 (HER2) in advanced breast cancer • Phase 1/2 with BNT324/DB- 13112 (B7-H3) in advanced lung cancer • Phase 2 with BNT324/DB- 13112 (B7-H3) in advanced solid tumors Planned • Phase 1/2 with BNT326/YL2023 (HER3) Diverse portfolio of clinical oncology assets in-house • Combine with novel IO bispecifics • Combine with novel ADCs • Evaluate additional indications in partnership with BMS Ongoing • Phase 1/2 trial ongoing in China to evaluate BNT3271 combination with TIGIT x PVRIG bsAb BNT3214 in HCC Planned • Phase 1/2 trial to evaluate BNT3271 combination with IO bispecific BNT314/GEN10595 and/or chemotherapy in CRC is expected to start in 2025


 
Leveraging Our Leadership in mRNA to Fully Exploit Cancer Immunotherapy Target Space with Two Approaches 20 1 Partnered with Genentech, a member of the Roche Group. 2 Antigens vary across programs; 3. T-cell responses analyzed by ex vivo multimer staining analysis in blood. Individual patient samples (blood and tissue) Artificial intelligence-driven neoantigen prediction On-demand tailored RNA manufacturing Individualized immuno- therapy Mapping of mutations Fixed combination of shared tumor antigens2 Multi-antigen approach tailored to each indication Neoantigens Individualized therapy Multiple shared antigens Off-the-shelf therapy iNeST1 FixVac individualized Neoantigen- Specific immunotherapy Fixed Antigen Vaccine ANTIGEN 1 ANTIGEN 2 ANTIGEN 3 ANTIGEN 4 Strong vaccine- induced, poly- epitope ex vivo CD8+ T-cell responses across different cancer types3 10.3% 10.1% HPV16-E7 Head & Neck Cancer BNT113, HARE40 trial Mutant Neoantigen TNBC, BNT114 TNBC-MERIT trial 5% MAGE-A3 Melanoma, BNT111, Lipo-MERIT trial 2.1% NY-ESO-1 Melanoma , BNT111, Lipo-MERIT trial mRNA- lipoplex platform Described in Castle et al., Cancer Res 2011 Described in Sahin et al., Nature 2017


 
Clinical Trial Execution Across iNeST and FixVac Portfolios 21 1. Partnered with Genentech, a member of the Roche Group; 2. In collaboration with Regeneron. 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+ HNSCC Phase 2/3 NSCLC Phase 1 & 2 + Nivolumab Monotherapy + Atezolizumab + mFOLFIRINOX + Pembrolizumab + Atezolizumab + Cemiplimab + Pembrolizumab Monotherapy, + Cemiplimab or CTx or aCTLA4 Voluntary temporary hold 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 in 2023 (Rojas et al., Nature) Follow up data published in February 2025 (Sethna et al., Nature) Trial completed (N=125) Primary endpoint (significant PFS improvement) not met. Numerical OS benefit trend observed. Data to be presented at ESMO 2025 Trial completed Data ​published (Lopez et al., Nature Medicine 2025) Enrollment completed (N=184) Positive topline data announced in 2024 Data to be presented at ESMO 2025 Recruitment ongoing Trial updated to Phase 2/3 Recruitment ongoing in Ph 2 in 1L NSCLC2 Data presented at AACR 2025 Data to be presented at WCLC 2025


 
3 Financial Update Ramón Zapata, Chief Financial Officer


 
Q2 and H1 Financial Results 23 1. Numbers have been rounded; numbers presented may not add up precisely to the totals and may have been adjusted in the table. 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 six months ended June 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 June 30, 2025, reached €15,989.3 million, comprising €10,269.5 million in cash and cash equivalents, €3,363.8 million in current security investments and €2,356.0 million in non-current security investments. (in millions €, except per share data)1 Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Revenues 261 129 444 316 Cost of Sales (76) (60) (160) (119) Research and Development Expenses (509) (585) (1,035) (1,092) Sales and Marketing Expenses (19.7) (12.9) (33.4) (28.5) General and Administrative Expenses (117.7) (170.9) (224.6) (287.9) Other Operating Result (39) (267) (26) (261) Operating Loss (501) (966) (1,035) (1,473) Finance Result 98 (160) 187 335 Income Taxes 16 (2) 46 15 Net Loss (387) (808) (802) (1,123) Basic and Diluted Loss per Share (1.60) (3.36) (3.33) (4.67) Balance Sheet as of June 30, 2025 – Cash and cash equivalents plus security investments2 €16.0 bn


 
BMS Partnership Aims to Strengthen Cash Position and P&L for Multiple Years1 24 1. These statements, including the anticipated timing of certain events, are based on BioNTech’s current expectations regarding the BMS collaboration and are subject to the successful co-development, approval and co-commercialization of BNT327. These statements are also based in part on assumptions and judgments that the Company has made, which may be subject to significant uncertainties. Although the Company’s approach to revenue recognition is based on facts and circumstances known to the Company and various other assumptions that the Company believes to be reasonable under the circumstances, the revenue assessment is ongoing, and its actual results may deviate from its current expectations. 2. Majority of milestone payments expected to be triggered upon approvals and during commercialization. 3. Revenue of initially constrained milestone payments may be recognized at the point of satisfaction or over time, including catch-up effects for prior periods as applicable. More information can be found in BioNTech’s Report on Form 6-K for the three and six months ended June 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. Payment Anticipated Cash Effect Anticipated Revenue Effect Upfront Cash Payment $1.5 bn Q3 2025 Revenue recognition over the development phase Non-Contingent Anniversary Cash Payments $2.0 bn 2026 - 2028 Revenue recognition over the development phase Development, Regulatory & Commercial Milestone Cash Payments2 up to $7.6 bn Cash payments would align to milestone timing Revenue recognition following milestone achievement3 Global profits and losses will be equally shared between BioNTech and BMS BioNTech and BMS will share joint development and manufacturing costs of BNT327 on a 50:50 basis subject to certain exceptions


 
2025 Financial Year Guidance Reaffirmed1 25 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. These statements are also based in part on assumptions and judgments that the Company has made, which may be subject to significant uncertainties. Although the Company’s approach to revenue recognition is based on facts and circumstances known to the Company and various other assumptions that the Company believes to be reasonable under the circumstances, the revenue assessment is ongoing, and its actual results may deviate from its current expectations. FY 2025 Guidance Planned FY 2025 revenues Revenues €1,700 – €2,200 m Planned FY 2025 expenses and capex R&D expenses €2,600 – €2,800 m SG&A expenses €650 – €750 m Capital expenditure for operating activities €250 – €350 m Guidance considerations Relatively stable pricing and market share as compared to 2024. Revenue phasing expected to be primarily concentrated in the last 3-4 months, driving the full year revenue figure. However, current and potential further developments in law, public policy, international trade, and public sentiment as they continue to evolve could further negatively impact our anticipated COVID-19 vaccine revenues and expenses. 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, from collaborations and from the BioNTech Group service businesses.


 
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer


 
27 Partnered with: 1. DualityBio; 2. Bristol Myers Squibb; 3. Pfizer. Strategic Priority Areas in 2025 mRNA cancer immunotherapy BNT327 PD-L1xVEGF bispecific2 Oncology commercial readiness COVID-19 vaccine3 » Expect first randomized data in the adjuvant setting (CRC) in late 2025 or early 2026 » Continue to execute 6 ongoing Phase 2 trials and first novel combination trials » Maximizing potential with global co-development and co- commercialization partnership with BMS » Generate first BNT3272+ ADC combination datasets » Advance BNT323/DB-13031 towards BLA submission » Continue to build targeted AI-enabled commercialization team in key markets » Maintain global COVID-19 vaccine market leadership » Advance next-gen and combination vaccine programs 2025


 
Save the date Innovation Series: AI Day October 1, 2025 London, UK Innovation Series R&D Day November 11, 2025 New York, NY U.S.


 
Thank you


 
Appendix


 
31 Partnered with: 1. Bristol Myers Squibb; 2. Genentech, a member of the Roche Group; 3. In collaboration with Regeneron. 4. DualityBio; 5. We plan to share these data at a medical conference in 2026. Selected Pipeline Milestones in 2025 and Beyond Demonstrate Continued Progress Across Priority Programs Program Indication 2025+ Milestone Next-generation immunomodulator BNT3271 1L/2L SCLC Global Phase 2 dose optimization data 1L/2L TNBC Global Phase 2 dose optimization data mRNA cancer immunotherapy Autogene cevumeran (BNT122 / RO7198457)2 ctDNA+ adj. CRC Phase 2 data BNT1113 2L+ melanoma Phase 2 data Targeted therapy BNT323/DB-13034 2L+ HER2 EC Phase 2 data5 Regulatory submission


 
BioNTech’s Oncology Pipeline – Phase 2 and Phase 3 Clinical Trials Partnered with: 1. Genentech, member of Roche Group; 2. Genmab; 3. MediLink Therapeutics; 4. OncoC4; 5. DualityBio. 6. In collaboration with Regeneron; 7. Trial ongoing in China only. BNT327 (PD-L1 x VEGF-A) 1L/2L met. TNBC, + CTx BNT316/ONC-392 (gotistobart)4 (CTLA-4) aPD-1/PD-L1 experienced squamous NSCLC BNT323/DB-13035 (trastuzumab pamirtecan) (HER2) HR+/HER2-low met. breast cancer BNT1116 aPD-(L)1-R/R melanoma, + cemiplimab Autogene cevumeran (BNT122/RO7198457)1 Adj. ctDNA+ stage II or III CRC BNT1166 1L adv. PD-L1  50% NSCLC, + cemiplimab Autogene cevumeran (BNT122/RO7198457)1 Adj. PDAC, + atezolizumab + mFOLFIRINOX BNT316/ONC-392 (gotistobart)4 PROC, + pembrolizumab BNT327 (PD-L1 x VEGF-A) 1L/2L+ (ES-)SCLC, + CTx Autogene cevumeran (BNT122/RO7198457)1 Adj. MIUC, + nivolumab BNT327 (PD-L1 x VEGF-A) 2L SCLC, + CTx7 BNT327 (PD-L1 x VEGF-A) 2L ES-SCLC, + CTx7 BNT327 (PD-L1 x VEGF-A) 1L ES-SCLC + CTx7 BNT327 (PD-L1 x VEGF-A) EGFR TKI experienced, EGFRm NSCLC, + CTx7 BNT327 (PD-L1 x VEGF-A) 1L MPM, + CTx7 BNT327 (PD-L1 x VEGF-A) 1L HCC + CTx7 BNT327 (PD-L1 x VEGF-A) 1L TNBC, + CTx7 Phase 3Phase 2 mRNA immunotherapy Next generation IO Targeted therapy BNT327 (PD-L1 x VEGF-A) 1L SCLC, + CTx BNT327 (PD-L1 x VEGF-A) 1L NSCLC, + CTx BNT327 (PD-L1 x VEGF-A) 1L TNBC, + CTx PLANNED BNT323/DB-13035 (trastuzumab pamirtecan) (HER2) HER2+ endometrial cancer PLANNEDBNT327 (PD-L1 x VEGF-A) 2L NEN, + CTx7 BNT323/DB-13035 (trastuzumab pamirtecan) (HER2), multiple solid tumors 32 BNT327 (PD-L1 x VEGF-A) 2L NSCLC, + CTx BNT327 or BNT325/DB-1305 + BNT324/DB-13116 combination Multiple solid tumors BNT113 1L rel./met. HPV16+ PD-L-1+ HNC, + pembrolizumab


 
BioNTech’s Oncology Pipeline – Phase 1 and Phase 1/2 Clinical Trials Partnered with: 1. Genentech, member of Roche Group; 2. Genmab; 3. In collaboration with Regeneron; 4. MediLink Therapeutics; 5. OncoC4; 6. DualityBio. 7. Trial ongoing in China only. Phase 1/2Phase 1 BNT211 (CLDN6) Multiple solid tumors BNT312/GEN10422 (CD40x4-1BB) Multiple solid tumors BNT316/ONC-392 (gotistobart)5 (CTLA-4) Multiple solid tumors BNT325/DB-13056 (TROP2) Multiple solid tumors BNT324/DB-13116 (B7-H3) Multiple solid tumors BNT116 Adv. NSCLC BNT314/GEN10592 (EpCAMx4-1BB) Multiple solid tumors BNT326/YL2024 (HER3) Multiple solid tumors BNT327 + BNT325/DB-13056 combination Multiple solid tumors BNT327 (PD-L1 x VEGF-A) 1L TNBC7 BNT327 (PD-L1 x VEGF-A) Multiple solid tumors7 BNT152 + BNT153 (IL-7, IL-2) Multiple solid tumors BNT327 + BNT3213 combination 1L HCC7 BNT317 Multiple solid tumors BNT327 + BNT323/DB-13036 (trastuzumab pamirtecan) combination Adv. or metastatic breast cancer BNT327 + BNT324/DB-13116 combination Adv. or metastatic NSCLC or SCLC BNT327 + BNT326/YL2024 combination Multiple solid tumors PLANNED Autogene cevumeran (BNT122/RO7198457)1 Multiple solid tumors 33 mRNA immunotherapy Next generation IO Targeted therapy BNT316/ONC-392 (gotistobart)5 (CTLA-4) mCRPC, + radiotherapy BNT327 + BNT314/GEN10592 combination Advanced CRC PLANNED


 
Abbreviation Directory n L nth line FixVac Fixed Antigen Vaccine PDAC Pancreatic ductal adenocarcinoma AACR American Association for Cancer Research FPD First patient dosed PD-(L)1 Programmed cell death protein (ligand) 1 ADC Antibody-drug conjugate HCC Hepatocellular carcinoma PFS Progression-free survival adj. Adjuvant HER2 (or 3) Human epidermal growth factor receptor 2 (or 3) PFS Prefilled Syringes AI Artificial intelligence HNSCC Head and neck squamous cell carcinoma PR Partial response AIOM Associazione Italiana di Oncologia Medica HPV Human papilloma virus PROC Platinum-resistant ovarian cancer ALK Anaplastic large-cell lymphoma kinase HR Hormone receptor PVRIG Poliovirus receptor-related immunoglobulin AST Aspartate aminotransferase IHC Immunohistochemistry QxW Every x week(s) ASCO American Society of Clinical Oncology IL-x Interleukin x R&D Research and development B7-H3 Also known as CD276 iNeST Individualized NeoAntigen-Specific Therapy R/R Relapsed/refractory BC Breast cancer IO Immuno-oncology SABCS San Antonio Breast Cancer Symposium BLA Biologics License Applications ITT Intention to treat (ES)SCLC (Extensive stage) small cell lung cancer bsAb Bispecific antibody M&A Merger and acquisitions SD Stable disease CD-x Cluster of differentiation MAGE-A3 Melanoma antigen A3 SDV Single dose vial CI Confidence interval MDV Multi dose vial SEC U.S. Securities and Exchange Commission CLDN6 Claudin 6 met Metastatic SEER Surveillance, epidemiology, and end results CPS Combined positive score MIUC Muscle-invasive urothelial carcinoma SG&A Selling, general and administrative expenses CRC Colorectal cancer MOA Mechanism of Action TIGIT T cell immunoreceptor with Ig and ITIM domains CRPC Castration resistant prostate cancer MPM Malignant pleural mesothelioma TKI Tyrosine kinase inhibitor ctDNA Circulating tumor DNA mRNA Messenger ribonucleic acid TME Tumor microenvironment CTLA4 Cytotoxic T-lymphocyte-associated protein 4 NCT National clinical trial TNBC Triple-negative breast cancer CTx Chemotherapy NEN Neuroendocrine neoplasm TRAE Treatment-related adverse event DCR Disease control rate NME New molecular entity TROP2 Trophoblast cell-surface antigen 2 EC Endometrial cancer NSCLC Non-small cell lung cancer UTI Urinary tract infection EGFR Epidermal growth factor receptor NY-ESO-1 New York esophageal squamous cell carcinoma-1 VEGF-A Vascular endothelial growth factor A ELCC European Lung Cancer Congress ORR Objective response rate VHH Heavy chain variable EpCAM Epithelial cell adhesion molecule OS Overall survival WBC White blood cell ESMO European Society for Medical Oncology OX40 CD134 WCLC World Conference of Lung Cancer Fab Fragment antigen binding P&L Profit and loss statement WT Wild type FDA U.S. Food and Drug Administration PD Progressive disease 34