BioNTech SE’s Amendment No. 2 to its 2025 annual report is described as being filed solely to re-present the complete Item 17 financial statements with Ernst & Young’s audit opinions bearing a corrected date, update EY’s consent, and refresh the most recent practicable share count; it does not modify previously reported financial data or reflect events after March 10, 2026.
For 2025, BioNTech reports revenues of €2,869.9 million and a net loss of €1,136.1 million, compared with a loss of €665.3 million in 2024 and profit of €930.3 million in 2023. Cash and cash equivalents were €7,675.4 million, with total assets of €21,988.6 million and equity of €19,224.2 million as of December 31, 2025. The year includes business combinations such as the Biotheus acquisition for €280.1 million and the CureVac acquisition for €400.1 million, adding significant intangible assets.
EY issues unqualified opinions on both the consolidated IFRS financial statements and internal control over financial reporting as of December 31, 2025, noting critical audit matters around revenue recognition for COVID‑19 collaboration sales and the Bristol Myers Squibb collaboration, legal contingencies, and valuation of acquired intangibles. Internal control work excludes Biotheus Inc. and CureVac B.V., which together represent about 6% of total assets and no 2025 revenue.
BioNTech SE, together with Pfizer, reports that the European Commission has granted marketing authorization for their 2026-2027 COVID-19 vaccine formula targeting the XFG variant, for active immunization of individuals 6 months of age and older.
The authorization, based on EMA Emergency Task Force and CHMP assessments, applies across all 27 EU Member States plus Iceland, Liechtenstein and Norway. Data cited indicate the monovalent XFG-adapted vaccine elicits strong immune responses against multiple contemporary SARS-CoV-2 lineages and maintains a favorable safety and efficacy profile. Pfizer and BioNTech have already begun manufacturing at risk and expect shipments to start soon to support seasonal vaccination campaigns. The partners note that more than five billion doses of their COVID-19 vaccines have been distributed globally and that they have submitted data for the updated vaccine to regulators worldwide.
BioNTech SE filed a Form 3 identifying Iris Katharina Low-Friedrich as a director of the company. The filing reports no insider transactions or holdings, with all transaction counts and share amounts shown as zero.
BioNTech SE director Susanne Schaffert has filed a Form 3, which is an initial statement of beneficial ownership for company insiders. This filing lists her as a director and does not report any stock purchases, sales, or other share transactions.
BioNTech SE has launched a share buyback program for its American Depositary Shares (ADSs) with a total value of up to USD 1.0 billion. The program covers ADSs listed on the U.S. Nasdaq Global Select Market and runs from June 8, 2026 through May 6, 2027.
The company expects to use repurchased ADSs to satisfy obligations in the ordinary course of business, enhance capital efficiency and maintain financial flexibility. The program is carried out under an AGM authorization that permits acquiring up to 10% of share capital, capped at 24.9 million shares, and is structured to comply with EU regulations and U.S. Rules 10b-18 and 10b5-1.
BioNTech and Bristol Myers Squibb reported interim Phase 2 data from the global ROSETTA Lung-02 trial of the investigational bispecific immunomodulator pumitamig plus chemotherapy in previously untreated advanced non-small cell lung cancer.
Among 40 response-evaluable patients with a median follow-up of 9.0 months, pumitamig plus chemotherapy achieved confirmed objective response rates of 57.1% in non-squamous and 68.4% in squamous disease, with a disease control rate of 100%. At the lower evaluated dose, response rates rose to 63.6% and 72.7% respectively, and response rates were high across PD-L1 expression levels, including 100% in patients with PD-L1 TPS ≥ 50%. Safety was described as manageable, with grade ≥ 3 treatment-related adverse events in 48.8% of patients, pumitamig-related in 23.3%, leading to discontinuation in 9.3%. Pumitamig is moving into an extensive Phase 3 program in NSCLC and other tumor types.
BioNTech SE is using the 2026 ASCO Annual Meeting to showcase progress in its late-stage oncology pipeline. The company will present new clinical data and trial updates for key assets, including the bispecific immunomodulator pumitamig and the CTLA-4 antibody gotistobart, plus several antibody-drug conjugate programs.
Interim Phase 2 data from the global Phase 2/3 ROSETTA Lung-02 trial in first-line non-small cell lung cancer showed encouraging anti-tumor activity for pumitamig plus chemotherapy and are informing the ongoing pivotal Phase 3 part. Phase 2 data for gotistobart in heavily pre-treated, platinum-resistant ovarian cancer showed durable anti-tumor activity and clinically meaningful overall survival with a manageable safety profile.
Overall, BioNTech highlights more than 25 Phase 2 and Phase 3 trials, including 13 pivotal studies and multiple novel-novel combination trials across major tumor types, underscoring a broad late-stage oncology strategy spanning immunomodulators, ADCs, and mRNA cancer immunotherapies.
BioNTech SE reported that shareholders approved all agenda items at the 2026 Annual General Meeting, with around 92% of share capital represented. The Supervisory Board was expanded from six to eight members and two new oncology-focused experts, Prof. Iris Löw‑Friedrich and Dr. Susanne Schaffert, were elected alongside extensions for three existing members.
Management emphasized a strategy pivot toward the growing late‑stage oncology pipeline while maintaining infectious disease programs. For 2025, BioNTech posted IFRS revenues of €2,870 million, above its €2,600–2,800 million guidance range. In Q1 2026, revenues were €118 million and cash, cash equivalents and security investments totaled €16.8 billion, supporting continued R&D investment.
The company reaffirmed 2026 non‑IFRS revenue guidance of €2,000–2,300 million, with adjusted R&D expenses of €2,200–2,500 million and adjusted SG&A expenses of €700–800 million. BioNTech highlighted a $3.5 billion up‑front and non‑contingent payment and up to $7.6 billion in milestones from its BMS partnership around pumitamig, plans for up to $1.0 billion in share repurchases over twelve months, and manufacturing consolidation measures expected to reach about €500 million in recurring annual savings by 2029.
BioNTech SE reports beneficial ownership disclosures by Medine GmbH and Prof. Ugur Sahin, M.D. The statement shows Medine GmbH holds 39,218,111 ordinary shares (reported shared voting power) representing 15.5% of the class and Prof. Ugur Sahin, M.D. is reported as beneficial owner of 40,076,320 ordinary shares representing 15.8%.
The percentages are calculated on 252,884,261 ordinary shares outstanding as of March 31, 2026. The filing explains a written arrangement where Prof. Sahin retains voting power over certain shares held by Medine GmbH but not dispositive power; holdings are jointly filed by the two Reporting Persons.
ATHOS KG, AT Impf GmbH and Thomas Maier report beneficial ownership of 101,702,378 Ordinary Shares of BioNTech. This stake represents 40.2% of the class based on 252,884,261 ordinary shares outstanding as of March 31, 2026, per the issuer's disclosure. The holdings are reported on Amendment No. 6 to a Schedule 13G/A and reflect shared voting and dispositive power through ATHOS-related entities.