A. History and Development of the Company We are committed to improving the health of people worldwide with our fundamental research and development of immunotherapies. Scientific rigor, innovation and passion are our driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. We were founded and incorporated on June 2, 2008 as Petersberg 91, V AG, a German stock corporation (Aktiengesellschaft). We changed our name to BioNTech AG on December 11, 2008. On March 8, 2019, we converted to a European stock corporation (Societas Europaea, or SE) under the laws of Germany and the European Union called BioNTech SE. We completed our initial public offering in October 2019. ADSs representing our ordinary shares are currently listed on the Nasdaq Global Select Market under the symbol “BNTX”. Our principal executive offices are located at An der Goldgrube 12, D-55131 Mainz, Germany. Our telephone number is +49 6131-9084-0. Our website address is www.biontech.com. The information contained on, or that can be accessed through, our website is not part of this document. Our agent for service of process solely for the purpose of notices and communications from the SEC in the United States is c/o BioNTech US Inc., 40 Erie Street, Suite 110, Cambridge, Massachusetts 02139, +1 (617) 337-4701. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov. For information on our principal capital expenditures and divestitures, see Item 5 of this Annual Report. B. Business Overview I. Overview We are a global next-generation immunotherapy company aiming to pioneer novel medicines against cancer, infectious diseases and other serious diseases. Since our founding in 2008, we have focused on harnessing the power of the immune system to address human diseases with unmet medical needs and major global health burdens. Our fully integrated model combines decades of research in immunology with a multi-technology innovation engine, GMP manufacturing, translational drug discovery, clinical development, commercial capabilities, computational medicine, data science and artificial intelligence, or AI, and machine learning, or ML, capabilities to discover, develop and commercialize our marketed product and product candidates. 105 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents We have built a broad toolkit across multiple technology platforms, including a diverse range of potentially first- in-class therapeutic approaches. This includes investigational messenger ribonucleic acid, or mRNA immunotherapies and protein-based therapeutics (including targeted antibodies such as monoclonal, bispecific and antibody-drug conjugates, or ADCs). Our multi-technology combination of platforms and product candidates aims to position us as pioneers in the field of individualized, patient-centric therapeutic approaches in oncology and infectious diseases. We believe that by combining complementary treatment modalities, we can leverage the potential of each technology to provide precise and personalized treatments to patients. Such treatments, if approved, could both increase the likelihood of therapeutic success and reduce the risk of therapeutic resistance. Our primary focus is oncology, where we endeavor to address the full continuum of cancer from early to late disease stages. The root causes of cancer treatment failure are cancer heterogeneity and interindividual variability. Driven by random sequential mutations, every patient’s cancer is different and within one patient’s tumor, every cell is different. Addressing these two challenges is the core of our strategy. To augment anti-tumor activity and to counteract resistance mechanisms, we seek to combine compounds with non-overlapping, potentially synergistic mechanisms of action. In infectious diseases, our goal is to develop vaccines and therapeutics caused by respiratory viruses, latent viruses, bacteria and parasites. We believe our scientific approach and our mRNA technology have the potential to significantly contribute to the fight against global health threats caused by infectious diseases. We have pursued both strategic partnerships and corporate collaborations to partially fund our infectious disease global health programs and aim to continue to do so. Our infectious disease programs aim to contribute to equitable access to innovative vaccines for high medical need indications. Our approach has generated a robust and diversified product candidate pipeline across a range of technologies in oncology and infectious disease, and has led to the approval of our first marketed pharmaceutical product, Comirnaty. Innovation is at the core of our company, and we see potential for our technologies to expand beyond oncology and infectious diseases. II. Execution of BioNTech’s Strategy In 2025, we made important progress across key strategic areas of the company to strengthen our technology platforms, capabilities and infrastructure, through strategic investments, acquisitions and partnerships impacting patients, shareholders and other stakeholders. 1. Advanced Oncology Pipeline We continued to develop our innovative oncology pipeline. In 2025, we started multiple clinical trials and brought several assets into mid- and late-stage development, namely Phase 2 and Phase 3 clinical trials, across a range of technologies and indications. Today, our pipeline consists of 16 clinical programs in oncology, with more than 25 Phase 2 and Phase 3 clinical trials and 10 novel combination trials ongoing with our investigational bispecific antibody pumitamig. In 2025, we and our partners reported data across our portfolio at multiple medical meetings and published manuscripts in peer reviewed journals. 2. COVID-19 Vaccine Market Leadership We continued to build our COVID-19 vaccine franchise and maintained market leadership in multiple key geographies. In 2025, we and Pfizer successfully launched our SARS-CoV-2 variant-adapted vaccine for the 2025/2026 vaccination season in 69 markets globally. We maintained our leadership position in the global COVID-19 vaccine market, achieving a market share of over 50% during the fall 2025 vaccination season. 3. Strategic Transactions and Partnerships 106 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents In February 2025, we announced the completion of our acquisition of Biotheus. With the acquisition, we obtained full global rights to the late-stage clinical asset pumitamig. In June 2025, we entered into a global co- development and co-commercialization agreement with Bristol Myers Squibb Company, or Bristol Myers Squibb, to jointly develop, manufacture and commercialize pumitamig across numerous solid tumor types. The collaboration leverages both partners’ expertise, resources and global footprint to accelerate pumitamig’s path towards potential regulatory approvals and market launches In December 2025, we announced our acquisition of CureVac N.V., or CureVac. The strategic transaction complements BioNTech’s capabilities and proprietary technologies in mRNA design and delivery formulations. 4. Maintained Strong Financial Position In 2025, we maintained a strong balance sheet through disciplined financial performance, ending the year with approximately €17.2 billion in total cash, cash equivalents and security investments. With a strong financial position, leading COVID-19 vaccine franchise and innovative oncology and infectious disease pipeline, we believe we are well positioned to continue executing our vision of pioneering novel medicines against cancer, infectious diseases and other serious diseases. On March 10, 2026, we announced plans for an independent company to be established and led by BioNTech co-founders Prof. Ugur Sahin, M.D., and Prof. Özlem Türeci, M.D. The new company with distinct resources, operations and funding options, will advance next-generation mRNA innovations. We plan to contribute related rights and mRNA technologies to the new company to enable and support the prioritized development of next- generation mRNA innovations with disruptive potential. With both companies focusing on their respective strategic priorities, we expect to maximize value for patients and shareholders alike. Our CEO and CMO will transition into the management of their new company by the end of 2026 after their current service agreements end. Our Supervisory Board has initiated an executive search to identify successors for the positions to ensure a smooth transition and seamless execution of our strategy. III. Company Evolution We are committed to translating science into survival for patients by advancing BioNTech’s strategy and executing it to become a global immunotherapy powerhouse with multiple approved products and revenue streams. As part of this continued approach, we have built a unique pipeline that includes technologies and candidates with disruptive potential. In oncology, we focus on potentially synergistic therapeutic approaches, including innovative immunomodulators, targeted therapies, and mRNA cancer immunotherapies. We plan to continue to significantly invest in their broad clinical evaluation across multiple cancer indications with significant (unmet) medical needs, as well as their commercialization in key markets. We aim to further enhance the therapeutic profile of our investigational therapies through the evaluation of novel-novel combinations, including our differentiated portfolio targeted therapy candidates such as ADCs. As we continue to invest in executing our vision, we remain committed to cost-effective value generation. We actively manage our whole pipeline and assess all sites across BioNTech, including newly acquired assets, according to key criteria: strategic alignment, operational efficiency, and sustainable value creation. For 2026, we consequently plan to continue to significantly invest in essential areas while optimizing capacities in others. The consolidation and adjustment of capacities announced in 2025 are ongoing and are expected to span through 2027. We currently expect that this will involve consolidating and adjusting capacities within our manufacturing network. We will continue to drive progress with a focus on our highest potential opportunities and we believe we are well-positioned to continue advancing our strategic vision. We look forward to another year of meaningful progress building on our achievements in 2025. 107 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents IV. Marketed Products: Comirnaty, our COVID-19 Vaccine Program (BNT162) COVID-19 vaccination has played an important role in saving lives and livelihoods across the world. Our commercial product, developed in 2020, Comirnaty, was the first-ever approved mRNA-based product, and, to our knowledge, remains the fastest ever developed prophylactic vaccine from viral sampling to approval. As of March 2026, our COVID-19 vaccine products have been authorized or approved for emergency or temporary use or granted marketing authorization in more than 180 countries and regions worldwide. Our efforts have resulted in over 5 billion doses shipped globally. Under our collaboration with Pfizer, we are the Marketing Authorization Holder in the United States, the European Union, or EU, the UK, Canada and other countries. Additionally, we are the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries for the COVID-19 vaccine program. Pfizer has marketing and distribution rights worldwide apart from Greater China, Germany, and Türkiye. We have the marketing and distribution rights to Comirnaty in Germany and Türkiye. Under our collaboration with Fosun Pharmaceutical Industrial Development, Co., Ltd, or Fosun Pharma, Fosun Pharma has marketing and distribution rights in Mainland China, Hong Kong Special Administrative Region, or SAR, Macau SAR and Taiwan region. 1. Commercial, Manufacturing and Distribution Updates We expect that as SARS-CoV-2 continues to evolve, and the risk of severe COVID-19 disease and deaths persists, there will be continued demand for primary and seasonal vaccinations, especially for at-risk and immunocompromised populations. Studies have demonstrated that natural immunity acquired by SARS-CoV-2 infection is variable across individuals and wanes over time due to viral escape mutations and decreasing antibody titers. The risk of severe COVID-19 disease remains high in vulnerable populations. Vaccination not only reduces the risk of severe COVID-19 but may also mitigate the risk of health impairments related to COVID-19. Given this, and our current understanding of COVID-19’s burden on healthcare systems during the fall and winter season, along with its observed peaks at other times of the year, we anticipate the need for annual adapted vaccines to be a long-term component of COVID-19 vaccination practices. In 2025, we and Pfizer continued our global COVID-19 vaccine leadership with the commercial launch of our SARS-CoV-2 variant-adapted vaccine for the 2025/2026 vaccination season. Since the declaration of the pandemic, we have developed and commercialized multiple COVID-19 vaccine products, including our most recently developed COVID-19 vaccine targeting the LP.8.1 strain. Each is referred to as Comirnaty. In 2025, we continued transitioning from an advanced purchase agreement framework to commercial market ordering in some geographies. We and Pfizer have an ongoing COVID-19 Vaccine Purchase Agreement with the European Commission, or the EC, to deliver COVID-19 vaccines to the EU. The agreement reflects our and Pfizer’s commitment to working collaboratively to help address ongoing public health needs. The 2023 agreement rephased delivery of doses annually through 2026. In addition, the agreement includes an aggregate volume reduction, providing additional flexibility for EU Member States. The EC will maintain access to future adapted COVID-19 vaccines and the ability to donate doses. We and Pfizer have established an efficient and robust global vaccine supply chain and manufacturing network capable of meeting global demand. More details on our manufacturing operations and facilities can be found in “VII. Manufacturing.” 2. Clinical Development and Regulatory Updates 108 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents While JN.1 and KP.2 variant-adapted vaccines provided some protection against a range of outcomes from JN.1- lineage related COVID-19 disease, evidence suggests that vaccines better matched to currently circulating SARS-CoV-2 sublineages may provide improved protection against symptomatic and severe COVID-19 disease. –In May 2025, the WHO, EMA and FDA each issued recommendations to update the antigenic composition of authorized COVID-19 vaccines for the 2025-2026 vaccination season. The WHO advised manufacturers that monovalent JN.1 or KP.2 vaccines remain appropriate vaccine antigens and that monovalent LP.8.1 is a suitable alternative vaccine antigen. The EMA recommended that marketing authorization holders adapt vaccines to target the LP.8.1 variant of the JN.1 family of Omicron subvariants, and vaccines targeting JN.1 or KP.2 strains could be considered for the vaccination campaigns in 2025 until the updated LP.8.1 vaccines become available. The FDA advised manufacturers that COVID-19 vaccines for use in the United States in the fall of 2025 should be a monovalent JN.1-lineage-based composition, preferentially targeting the LP.8.1 strain. –In July 2025, the EMA’s Committee for Medicinal Products for Human Use, or CHMP, recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine. In August 2025, following authorization by the EC, the new variant-adapted COVID-19 vaccine was made available for shipment to applicable EU member states. –In August 2025, the FDA approved the supplemental Biologics License Application for our and Pfizer’s LP.8.1- adapted monovalent COVID-19 vaccine for use in adults aged 65 years and older, as well as in individuals aged five through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The new variant-adapted COVID-19 vaccine was shipped promptly following approval and was made available in pharmacies, hospitals, and clinics across the United States. Ahead of the 2025-2026 COVID-19 vaccination season, we initiated a Phase 3 (NCT07069309) study to investigate the safety, tolerability, and immunogenicity of our LP.8.1-adapted COVID-19 vaccine in adults 65 and older and adults aged 18 through 64 with at least one underlying risk condition for severe COVID-19. In September 2025, we announced positive topline results from the Phase 3 trial. The preliminary data show a robust increase in neutralizing antibodies targeting the LP.8.1 sublineage of SARS-CoV-2 following vaccination. The safety profile of the vaccine was consistent with previous studies, with no new safety concerns identified. Three post-marketing commitment clinical trials are ongoing, with a fourth planned. We and Pfizer intend to continue to monitor the evolving epidemiology of COVID-19 and remain prepared to develop modified vaccine formulas as the data support and as regulatory agencies recommend. V. Pipeline of Product Candidates Below is a summary of active clinical trials evaluating our product and clinical product candidates, organized by platform and indication. 109 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Oncology1,2 Phase 1 Phase 1/2 Phase 2 Phase 2/3 Phase 3 BNT116Adv. NSCLC BNT324/DB-13115Multiple solid tumors Pumitamig3 + BNT32131L HCC4,11 Autogene cevumeran6Adj. CRC Pumitamig32L ES-SCLC11 Pumitamig3 or BNT325/DB-13055 + BNT324/DB-13115Multiple solid tumors4 BNT1131L HPV16+ HNSCC Gotistobart7Met. NSCLC BNT211Multiple solid tumors BNT325/DB-13055Multiple solid tumors Pumitamig3 +BNT324/DB-13115Adv./met. NSCLC and SCLC4 Autogene cevumeran6Adj. PDAC Pumitamig32L+ EGFRm NSCLC11 Pumitamig31L met. CRC Pumitamig31L ES-SCLC BNT314/GEN10599Multiple solid tumors BNT329Multiple solid tumors Pumitamig3 +BNT325/DB-13055Multiple solid tumors4 BNT116101L adv. NSCLC Pumitamig32L Glioblastoma11 Pumitamig31L NSCLC Pumitamig32L SCLC11 BNT317Multiple solid tumors Gotistobart7Met. CRPC Pumitamig3 +BNT326/YL2028Multiple solid tumors BNT326/YL2028Multiple solid tumors11 Pumitamig31L HCC11 Pumitamig31L adv./met.TNBC11 BNT326/YL2028Multiple solid tumors Gotistobart7Multiple solid tumors Pumitamig3 +BNT326/YL2028Adv. NSCLC BNT326/YL2028Adv./met. BC.11 Pumitamig31L MPM11 Trastuzumab pamirtecan5Met. BC Pumitamig3Multiple solid tumors Pumitamig3 + Trastuzumab pamirtecan5Adv./met. BC4 Gotistobart7PROC Pumitamig32L NEN11 Trastuzumab pamirtecan52L EC Pumitamig31L adv./met. TNBC11 Trastuzumab pamirtecan5Multiple solid tumors Pumitamig31L met. CRC11 Pumitamig32L adv./met. NSCLC Pumitamig3 + BNT314/GEN10599Met. CRC4 Pumitamig31L ES-SCLC11 Pumitamig31L met. PDAC11 Pumitamig3 + BNT3212Multiple solid tumors Pumitamig31L/2L+ ES-SCLC Pumitamig31L/2L adv./met. TNBC Next generation immunomodulator Targeted therapy mRNA cancer immunotherapy Novel-novel combination Infectious Diseases1,2 Phase 1 Phase 1/2 Phase 2 Commercial BNT16312HSV BNT162 + BNT16113COVID-19 - Influenza combination BNT16616Mpox BNT16213,14COVID-19 BNT351HIV BNT16415Tuberculosis BNT165Malaria BNT16616Mpox Antibody mRNA 110 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents (1)For further details about BioNTech’s rights, see elsewhere in this Annual Report. (2)Abbreviations are defined in the corresponding trial descriptions. (3)Partnered with Bristol Myers Squibb. (4)Trial is currently being conducted by or on behalf of BioNTech. Bristol Myers Squibb holds co-exclusive rights to pumitamig. (5)Partnered with DualityBio. (6)Partnered with Genentech, a member of the Roche Group. (7)Partnered with OncoC4. (8)Partnered with MediLink Therapeutics. (9)Partnered with Genmab. (10)In collaboration with Regeneron. (11)Trial ongoing in China only. (12)Partnered with University of Pennsylvania. (13)Partnered with Pfizer. (14)Partnered with Fosun Pharma. (15)Funded by the Gates Foundation. (16)Funded by the Coalition for Epidemic Preparedness Innovations (CEPI). A. Oncology Programs 1. Pumitamig (BNT327/BMS986545), a Bispecific Immunomodulator Candidate Targeting PD-L1 and VEGF-A Pumitamig is a bispecific immunomodulator candidate targeting both PD-L1 and VEGF-A. Pumitamig is currently being evaluated in multiple Phase 2 and Phase 3 global and China-only clinical trials to assess its efficacy and safety as monotherapy or in combination with chemotherapy, ADCs or mRNA-based cancer immunotherapies in various indications. We and our partner, BMS, expect to have eight global registrational trials for pumitamig ongoing by the end of 2026. Pumitamig is also being evaluated in combination with next-generation ADC candidates trastuzumab pamirtecan (BNT323/DB-1303), BNT324/DB-1311, BNT325/DB-1305, BNT326/YL202 and BNT3212, and in combination with bispecific antibody candidates BNT314/GEN1059 and BNT3213. ROSETTA Lung-01 Phase 3 Clinical Trial in First-Line Extensive-Stage Small Cell Lung Cancer, or ES-SCLC A global Phase 3 clinical trial (NCT06712355) is being conducted to evaluate pumitamig in combination with chemotherapy compared to atezolizumab in combination with chemotherapy as a first-line treatment for patients with ES-SCLC. –In June 2025, pumitamig received Orphan Drug Designation from the FDA for the treatment of small cell lung cancer. Phase 3 Clinical Trial in Second-Line Small-Cell Lung Cancer, or SCLC A Phase 3 clinical trial (NCT06616532) is being conducted in China to evaluate pumitamig in combination with chemotherapy compared to investigator’s choice chemotherapy as a second-line treatment for patients with SCLC. Phase 2 Clinical Trial in ES-SCLC A global Phase 2 clinical trial (NCT06449209) is being conducted to evaluate pumitamig in combination with chemotherapy in patients with untreated ES-SCLC and in patients with SCLC that progressed after first- or second-line treatment. The trial is fully enrolled and treatment is ongoing. –In September 2025, interim data from this trial were presented at the IASLC 2025 WCLC. The data, which are consistent with data presented at European Lung Cancer Congress, or ELCC, 2025 from a Phase 2 clinical trial conducted in China (NCT05844150), showed encouraging anti-tumor responses and a positive trend in 111 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents progression free survival. Pumitamig plus chemotherapy was observed to have a manageable safety profile with no new safety signals and a low discontinuation rate. Phase 2 Clinical Trial in First-Line ES-SCLC A Phase 2 clinical trial (NCT05844150) is being conducted in China to evaluate pumitamig in combination with chemotherapy as a first-line treatment for patients with ES-SCLC. –In March 2025, data from this trial were presented at the ELCC 2025 in Paris, France. Preliminary data showed anti-tumor activity and an acceptable safety profile with no new safety signals beyond those typically described for chemotherapy agents and anti-PD-(L)1 and anti-VEGF monotherapies. These data were the first presented for pumitamig as a potential first-line treatment in ES-SCLC supporting the ongoing global randomized Phase 3 clinical trial ROSETTA Lung-01 (NCT06712355). –Updated data from this trial are expected to be presented at the ELCC 2026 taking place on March 25-28, 2026 in Copenhagen, Denmark. Phase 2 Clinical Trial in Second-Line SCLC A Phase 2 clinical trial (NCT05879068) is being conducted in China to evaluate pumitamig in combination with chemotherapy as a second-line treatment for patients with SCLC. –In March 2025, data from this trial were presented at the ELCC 2025. Preliminary data showed anti-tumor activity, which was observed regardless of prior immuno-oncology treatment, and an acceptable safety profile. ROSETTA Lung-201 Phase 3 Clinical Trial in Unresectable Stage III NSCLC A global Phase 3 clinical trial (NCT07361497) to evaluate pumitamig compared to durvalumab following concurrent chemoradiation therapy in patients with unresectable stage III NSCLC is planned to start in 2026. ROSETTA Lung-202 Phase 3 Clinical Trial in First-Line NSCLC A global Phase 3 clinical trial (NCT07361510) to evaluate pumitamig compared to pembrolizumab as a first-line treatment for patients with advanced PD-L1 ≥ 50% NSCLC is planned to start in 2026. ROSETTA Lung-02 Phase 2/3 Clinical Trial in First-Line NSCLC A global Phase 2/3 clinical trial (NCT06712316) is being conducted to evaluate pumitamig in combination with chemotherapy compared to pembrolizumab and chemotherapy as a first-line treatment for patients with NSCLC. The Phase 2 portion of the trial is fully enrolled, and the Phase 3 portion is underway. –We expect data from the Phase 2 part of this trial in 2026. ROSETTA Lung-107 Phase 2 Clinical Trial in Second-Line NSCLC A global Phase 2 clinical trial (NCT06841055) is being conducted to evaluate pumitamig in combination with docetaxel as a second-line treatment for patients with NSCLC. Phase 2 Clinical Trial in EGFR-mutant Non-Squamous NSCLC A Phase 2 clinical trial (NCT05756972) is being conducted in China to evaluate pumitamig in combination with chemotherapy in patients with EGFR-mutant non-squamous NSCLC who progressed after EGFR-tyrosine kinase inhibitor treatment. –Updated data from this trial are expected to be presented at the ELCC 2026 taking place on March 25-28, 2026 in Copenhagen, Denmark. 112 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents ROSETTA Breast-01 Phase 3 Clinical Trial in Locally Advanced or Metastatic First-Line TNBC A global Phase 3 clinical trial (NCT07173751) is being conducted to evaluate pumitamig in combination with chemotherapy compared to chemotherapy alone as a first-line treatment for patients with PD-L1 combined positive score, or CPS, ≤ 10 TNBC. Phase 3 Clinical Trial in Locally Advanced or Metastatic First-Line TNBC A Phase 3 clinical trial (NCT06419621) is being conducted in China to evaluate pumitamig in combination with chemotherapy compared to chemotherapy alone as a first-line treatment for patients with locally advanced or metastatic TNBC. –Based on current event accrual projections, we expect first interim data from this trial in 2026. Phase 2 Clinical Trial in Locally Advanced or Metastatic TNBC 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 TNBC. –In December 2025, the first data from this trial were presented at the 2025 San Antonio Breast Cancer Symposium, or SABCS. The data showed encouraging anti-tumor responses and a manageable safety profile for pumitamig plus chemotherapy in first- and second-line treatment setting. Phase 1/2 Clinical Trial in Locally Advanced/Metastatic TNBC A Phase 1/2 clinical trial (NCT05918133) is being conducted in China to evaluate pumitamig in combination with chemotherapy in patients with locally advanced or metastatic TNBC without previous systematic treatment. ROSETTA CRC-203 Phase 2/3 Clinical Trial in Metastatic First-Line CRC A global Phase 2/3 clinical trial (NCT07221357) is being conducted to evaluate pumitamig as a first-line treatment for patients with microsatellite stable, or MSS, or Microsatellite Instability-Low and Proficient Mismatch Repair, or MSI-L/pMMR, metastatic colorectal cancer. Phase 2 Clinical Trial in Metastatic First-Line CRC A Phase 2 clinical trial (NCT07133750) is being conducted in China to evaluate pumitamig in combination with chemotherapy as a first-line treatment in patients with MSS or MSI-L/pMMR metastatic colorectal cancer. –We expect data from this trial in 2026. ROSETTA Gastric-204 Phase 2/3 Clinical Trial in Metastatic First-Line Gastric Cancer A global Phase 2/3 clinical trial (NCT07221149) is being conducted to evaluate pumitamig in combination with chemotherapy compared to nivolumab in combination with chemotherapy as a first-line treatment for patients with metastatic gastric cancer. ROSETTA HNSCC-205 Pivotal Clinical Trial in First-Line HNSCC A global pivotal clinical trial evaluating pumitamig as a first-line treatment for patients with HNSCC is planned to start in 2026. Phase 2 Clinical Trial in First-Line Hepatocellular Carcinoma, or HCC A Phase 2 clinical trial (NCT05864105) is being conducted in China to evaluate pumitamig in combination with chemotherapy as a first-line treatment for patients with unresectable HCC. –We expect data from this trial in 2026. 113 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents ROSETTA HCC-206 Phase 1/2 Clinical Trial in First-Line HCC A Phase 1/2 clinical trial (NCT07291076) is being conducted to evaluate pumitamig alone or in combination with ipilimumab as a first-line treatment for patients with advanced or unresectable HCC. Phase 2 Clinical Trial in First-Line Malignant Mesothelioma A Phase 2 clinical trial (NCT05918107) is being conducted in China to evaluate pumitamig in combination with chemotherapy as a first-line treatment for patients with malignant mesothelioma. –In June 2025, the first data from this trial were presented at the 2025 ASCO Annual Meeting. The preliminary data indicated anti-tumor activity and a manageable safety profile. Phase 2 Clinical Trial in Second-Line Neuroendocrine Neoplasm, or NEN A Phase 2 clinical trial (NCT05879055) is being conducted in China to evaluate pumitamig in combination with chemotherapy as a second-line treatment for patients with NEN. Phase 2 Clinical Trial in First-Line PDAC A Phase 2 clinical trial (NCT07255404) is being conducted in China to evaluate pumitamig in combination with chemotherapy as a first-line treatment for patients with metastatic PDAC. Phase 2 Clinical Trial in Second-Line Glioblastoma A Phase 2 clinical trial (NCT07297212) is being conducted in China to evaluate pumitamig alone or in combination with temozolomide as a second-line treatment for patients with recurrent glioblastoma. ROSETTA RCC-208 Phase 1/2 Clinical Trial in RCC A Phase 1/2 clinical trial (NCT07293351) to evaluate pumitamig alone or in combination with ipilimumab or cabozantinib in patients with advanced RCC is planned to start in 2026. Phase 1/2 Clinical Trial in Advanced Solid Tumors A Phase 1/2 clinical trial (NCT05918445) is being conducted in China to evaluate pumitamig as a monotherapy in patients with advanced solid tumors. –Updated data from this trial are expected to be presented at the ELCC 2026 taking place on March 25-28, 2026 in Copenhagen, Denmark. We have initiated several signal-seeking clinical trials to evaluate pumitamig with some of our proprietary novel assets in our portfolio: Combination with Trastuzumab Pamirtecan (BNT323/DB-1303) Phase 1/2 Clinical Trial in Advanced/Metastatic Breast Cancer A Phase 1/2 clinical trial (NCT06827236) is being conducted to evaluate trastuzumab pamirtecan in combination with pumitamig in patients with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), human epidermal growth factor (HER)2-low, ultra-low, or null advanced metastatic breast cancer or TNBC. –We expect data from this trial in 2026. Combination with BNT324/DB-1311 Phase 1/2 Clinical Trial in Advanced Lung Cancers A Phase 1/2 clinical trial (NCT06892548) is being conducted to evaluate BNT324/DB-1311 in combination with pumitamig in patients with advanced lung cancers. 114 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents –We expect data from this trial in 2026. Combination with BNT324/DB-1311 Phase 2 Clinical Trial in Advanced/Metastatic Solid Tumors A Phase 2 clinical trial (NCT06953089) is being conducted to evaluate BNT324/DB-1311 in combination with pumitamig or with TROP2 ADC candidate BNT325/DB-1305 in patients with advanced solid tumors. –We expect data from this trial in 2026. Combination with BNT325/DB-1305 Phase 1/2 Clinical Trial in Advanced Solid Tumors A Phase 1/2 clinical trial (NCT05438329) is being conducted to evaluate BNT325/DB-1305 in patients with advanced solid tumors. As part of this clinical trial, pumitamig is being evaluated in combination with BNT325/ DB-1305 in various solid tumor indications. –In April 2025, at AACR 2025 Annual Meeting, we presented the first clinical data evaluating the combination of pumitamig plus BNT325/DB-1305. The interim data showed a manageable safety profile and early signs of anti-tumor activity in a cohort with patients with platinum-resistant ovarian cancer, or PROC. Across the 13 efficacy evaluable patients with PROC, seven patients achieved partial response and three stable disease. Responses were also observed in patients with NSCLC or TNBC. –We expect data from the Phase 2 part of this trial in patients with TNBC in 2026. Combination with BNT326/YL202 Phase 1/2 Clinical Trial in Advanced Solid Tumors A Phase 1/2 clinical trial (NCT07070232) is being conducted to evaluate BNT326/YL202 as monotherapy and in combination with pumitamig in advanced solid tumors. Combination with BNT326/YL202 Phase 1/2 Clinical Trial in Advanced NSCLC A Phase 1/2 clinical trial (NCT07111520) is being conducted to evaluate BNT326/YL202 in combination with pumitamig in advanced NSCLC. –We expect data from this trial in patients with NSCLC or 2L+ EGFRm NSCLC in 2026. Combination with BNT314/GEN1059 Phase 1/2 Clinical Trial in Advanced/Metastatic colorectal cancer A Phase 1/2 clinical trial (NCT07079631) is being conducted to evaluate BNT314/GEN1059 in combination with pumitamig and chemotherapy in patients with advanced colorectal cancer. Combination with BNT3212 Phase 1/2 Clinical Trial in Advanced Solid Tumors A Phase 1/2 clinical trial (NCT07147348) is being conducted to evaluate BNT3212, a novel bispecific antibody- drug conjugate candidate targeting EGFR and HER3, for use as monotherapy and in combination with pumitamig in patients with advanced solid tumors. Combination with BNT3213 Phase 1/2 Clinical Trial in First-Line HCC A Phase 1/2 clinical trial (NCT06584071) is being conducted in China to evaluate pumitamig in combination with BNT3213, a novel bispecific antibody candidate targeting TIGIT and PVRIG, as a first-line treatment for patients with locally advanced or metastatic HCC. 2. iNeST and FixVac a) Autogene Cevumeran (RO7198457/BNT122), an Individualized Neoantigen Specific Immunotherapy, or iNeST 115 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Autogene cevumeran is an investigational individualized mRNA cancer immunotherapy based on specific neoantigens that are present on a patient’s tumor. BNT122-01 Phase 2 Clinical Trial in Adjuvant Colorectal Cancer, or CRC A randomized Phase 2 clinical trial (NCT04486378) is being conducted to evaluate autogene cevumeran as an adjuvant treatment of circulating tumor DNA, or ctDNA, positive, surgically resected Stage II (high risk)/Stage III CRC. The trial is expected to enroll about 327 patients to evaluate the efficacy of autogene cevumeran compared to watchful waiting after surgery and chemotherapy, which is the current standard of care for these high-risk patients. The primary endpoint for the trial is disease-free survival, or DFS. Secondary objectives include OS and safety. –At the first pre-specified interim analysis of the ongoing BNT122-01 Phase 2 clinical trial, the futility boundary was crossed. The interim analysis was reviewed by an independent Data and Safety Monitoring Board, or DSMB, which is responsible for overseeing the safety and integrity of the trial. The DSMB considered autogene cevumeran to be generally well tolerated with no new safety signals identified, and also indicated that the data was not yet mature enough to draw reliable conclusions about efficacy, with a median follow-up time for participants at the time of the analysis of approximately nine months, which was deemed to be insufficient to evaluate the trial’s primary endpoint. This assessment is consistent with recent data from a study published in Nature (Nakamura Y, et al., 2024), which showed that a majority of patients with ctDNA- positive colorectal cancer experience disease recurrence within 24 months after surgery. However, because the futility boundary was crossed, the DSMB was bound by its charter to make a non-binding recommendation to terminate the study. Based on this assessment that the data are not yet mature enough to draw reliable conclusions about efficacy, we have continued the trial in accordance with the protocol. The sponsor remains masked, and interim data will not be disclosed at this time ensuring the integrity of the ongoing trial and allowing for a comprehensive and mature assessment of the treatment’s efficacy at the final analysis of the trial. The DSMB had no objections with the continuation of the study in the absence of safety concerns. –An update from the ongoing Phase 2 trial in Stage II (high-risk)/ Stage III ctDNA+ adjuvant CRC is expected in early 2026. Timing of the data read-out from the final analysis of this trial has been updated from 2026 to 2027, given that events have accrued more slowly than projected. IMCODE004 Phase 2 Clinical Trial in Adjuvant High-risk Muscle-invasive Urothelial Carcinoma, or MIUC A Phase 2 clinical trial (NCT06534983) is being conducted to evaluate autogene cevumeran as an adjuvant treatment in combination with nivolumab compared to nivolumab alone in patients with high-risk MIUC. The trial aims to enroll approximately 362 patients. The primary endpoint for the trial is investigator-assessed DFS. Secondary endpoints include OS and safety. We and our partner Roche have decided to discontinue the Phase 2 clinical trial (IMcode004; NCT06534983) evaluating autogene cevumeran as an adjuvant treatment in combination with nivolumab compared to nivolumab alone in patients with high-risk MIUC due to the rapidly emerging treatment landscape and shifting standard of care. IMCODE003 Phase 2 Clinical Trial in Adjuvant Pancreatic Ductal Adenocarcinoma, or PDAC A Phase 2 clinical trial (NCT05968326) is being conducted to evaluate autogene cevumeran in combination with atezolizumab followed by chemotherapy compared to chemotherapy alone as an adjuvant treatment for patients with resected PDAC who have not received prior systemic anti-cancer treatment and showed no evidence of disease after surgery. The trial aims to enroll 260 patients. The primary endpoint is DFS. Secondary endpoints include OS and safety. IMCODE001 Phase 2 Clinical Trial in First-line Advanced Melanoma 116 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents The IMCODE001 (NCT03815058) trial was the first randomized Phase 2 clinical trial with autogene cevumeran as part of the broader IMCODE study program. The trial evaluated 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. The primary endpoint was progression free survival, or PFS, and was events-based. Secondary endpoints included OS, ORR, DOR and safety. In January 2025, the IMCODE001 trial was completed. –In March 2025, topline results of the primary analysis were disclosed. While the initial data of the primary analysis support the findings across the broader autogene cevumeran study program demonstrating that autogene cevumeran can induce and expand high-magnitude and long-lived immune responses against the encoded neoantigens in this aggressive stage of melanoma, the trial did not meet its primary efficacy endpoint of statistically significant improvement of PFS in this advanced treatment setting. A numerical trend favoring the combination arm in OS was observed. 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. –In October 2025, data from this trial including exploratory endpoints and biomarker correlations were presented at the 2025 European Society For Medical Oncology, or ESMO, Congress. These data showed that autogene cevumeran can induce durable immune responses against the encoded neoantigens that persisted for up to 1.5 years after the last dose of autogene cevumeran. In the combination arm, the breadth of immune response correlated with a prolonged PFS. Further translational data showed a trend of improved OS in the combination arm compared to pembrolizumab monotherapy in patients with low tumor mutational burden, a population that usually responds poorly to checkpoint inhibitor treatment, and in tumors where immune-cell PD-L1 was high. These data support our therapeutic strategy to pursue autogene cevumeran to address the unmet medical need in the adjuvant or minimal residual disease treatment settings. These settings are characterized by lower tumor burden and heterogeneity, which aligns with the focus of our ongoing randomized Phase 2 trials in colorectal and pancreatic cancer. b) FixVac FixVac is our fully owned, systemic, off-the-shelf mRNA-based cancer immunotherapy approach. FixVac candidates are designed to target shared antigens that have been identified to be frequently expressed across patients with a specific cancer type. i. BNT111 BNT111 is designed to elicit an immune response to four antigens (NY-ESO-1, MAGE-A3, tyrosinase, TPTE) that have each been found to be associated with cutaneous melanoma. Phase 2 Clinical Trial in Anti-PD-(L)1 Refractory/Relapsed Unresectable Stage III or Stage IV Melanoma A Phase 2 clinical trial (BNT111-01; NCT04526899) in collaboration with Regeneron Pharmaceuticals Inc., or Regeneron, to evaluate BNT111 in combination with cemiplimab in patients with anti-PD-(L)1 refractory/relapsed, unresectable Stage III or IV melanoma has been completed. –In October 2025, data from this trial were presented at the 2025 ESMO Congress. As previously disclosed in August 2024, the trial met its primary efficacy outcome measure, demonstrating a statistically significant improvement in ORR in patients treated with BNT111 in combination with cemiplimab, as compared to a 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. Follow-up data showed a positive trend towards improved long-term survival for the combination of BNT111 and cemiplimab. No further development of BNT111 in advanced melanoma is currently planned. ii. BNT113 117 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents BNT113 contains two different RNAs encoding the two HPV16 oncoproteins E6 and E7, which are exclusively expressed in pre-malignant and malignant tissue. AHEAD-MERIT Phase 2/3 Clinical Trial in Unresectable Recurrent or Metastatic, PD-L1+, HPV16+ Head and Neck Squamous Cell Carcinoma, or HNSCC A Phase 2/3 clinical trial (AHEAD-MERIT; NCT04534205) is being conducted to evaluate BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment for patients with unresectable recurrent or metastatic, PD-L1+, HPV16+ HNSCC. –In December 2025, the FDA granted Fast Track designation to BNT113 for the treatment of patients with PD- L1+, HPV16+ HNSCC. –Based on current event accrual projections, we expect data from the first interim analysis from the Phase 3 part of this trial in 2026. iii. BNT116 BNT116 is comprised of six different NSCLC-associated tumor-associated antigens. BNT116 is being evaluated in two clinical trials as monotherapy and in combination with other immunotherapies, ADCs and chemotherapies in patients with advanced or metastasized NSCLC. EMPOWERVAX Lung 1 Phase 2 Clinical Trial in PD-L1 ≥ 50% Advanced NSCLC A Phase 2 clinical trial (NCT05557591) is being conducted in collaboration with Regeneron to evaluate BNT116 in combination with cemiplimab versus cemiplimab alone as a first-line treatment for patients with advanced NSCLC whose tumors express PD-L1 in ≥ 50% of their tumor cells. The primary objective of the Phase 2 trial is to assess the ORR per blinded-independent review committee. LuCa-MERIT-1 Phase 1 Clinical Trial in NSCLC A Phase 1 clinical trial (NCT05142189) is being conducted to evaluate the safety, tolerability and preliminary efficacy of BNT116 as monotherapy and in several combinations including with chemotherapy, cemiplimab, and some of our proprietary assets across various treatment lines and clinical settings in patients with NSCLC. – In April 2025, at the 2025 Annual Meeting of the American Association for Cancer Research, or AACR, data from a cohort with frail patients from the Phase 1 trial were presented. The preliminary data showed anti-tumor activity, consistent immune response induction and a manageable safety profile in patients with PD-L1 positive (TPS≥1%) unresectable Stage III or metastatic Stage IV NSCLC who are not eligible for chemotherapy as first-line treatment. –In September 2025, data were presented at the IASLC 2025 World Congress on Lung Cancer, or 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. 3. Antibody-Drug Conjugates i. Trastuzumab Pamirtecan (BNT323/DB-1303), an ADC in Development in Collaboration with DualityBio Trastuzumab pamirtecan is a topoisomerase-1 inhibitor-based ADC directed against Human Epidermal Growth Factor Receptor 2, or HER2, a target that is over-expressed in a variety of cancers and contributes to the aggressive growth and spread of cancer cells. The program received Fast Track Designation and Breakthrough Therapy designation from the FDA for advanced endometrial cancer. 118 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents DYNASTY-Breast02 Phase 3 Clinical Trial in Advanced or Metastatic HR+, HER2-low Breast Cancer A Phase 3 clinical trial (NCT06018337) is being conducted to evaluate trastuzumab pamirtecan compared to investigator’s choice of chemotherapy in advanced or metastatic HR+, HER2-low breast cancer subjects whose disease has progressed on at least two lines of prior endocrine therapy or within six months of first-line endocrine therapy and cyclin-dependent 4/6, or CDK4/6, inhibitor and no prior chemotherapy. The trial aims to enroll approximately 532 patients. The primary endpoint is PFS. Secondary endpoints include OS, ORR, DOR and safety, as well as patient-reported outcomes. –Based on current event accrual projections, we expect interim data from this trial in 2026. Phase 1/2 Clinical Trial in Advanced/Unresectable, Recurrent, or Metastatic HER2-Expressing Solid Tumors A Phase 1/2 clinical trial (NCT05150691) is being conducted to evaluate trastuzumab pamirtecan in patients with advanced/unresectable, recurrent, or metastatic HER2-expressing solid tumors. –A potentially registrational cohort with HER2-expressing (IHC3+, 2+, 1+) patients with advanced/recurrent endometrial cancer has completed enrollment. –We expect data from this cohort in 2026. –We and DualityBio are continuing discussions with the FDA and plan to file a biologics license application, or BLA, in second line endometrial cancer in 2026, subject to regulatory feedback. Phase 3 Clinical Trial in Advanced Endometrial Cancer A Phase 3 trial (NCT06340568) is being conducted to evaluate trastuzumab pamirtecan compared to investigator’s choice of chemotherapy in patients with advanced and recurrent endometrial cancer. The trial aims to enroll approximately 480 patients. The primary endpoints are PFS and ORR. Secondary endpoints include OS, DOR and safety. ii. BNT324/DB-1311, an ADC in Development in Collaboration with DualityBio BNT324/DB-1311 is a topoisomerase-1 inhibitor-based ADC directed against B7H3. It has received Fast Track Designation from the FDA for the treatment of patients with advanced/unresectable, or metastatic CRPC, who have progressed on or after standard systemic regimens. It has also received Orphan Drug Designation from the FDA for the treatment of patients with advanced or metastatic esophageal squamous cell carcinoma and SCLC. Phase 3 Clinical Trial in Metastatic CRPC A Phase 3 clinical trial (NCT07365995) to evaluate BNT324/DB-1311 compared to docetaxel in patients with metastatic CRPC, is planned to start in 2026. Phase 1/2 Clinical Trial in Advanced Solid Tumors A Phase 1/2 clinical trial (NCT05914116) is being conducted to evaluate BNT324/DB-1311 in patients with advanced solid tumors. –In June 2025 at the 2025 ASCO Annual Meeting, data from this trial were presented. In 73 patients with heavily pretreated metastatic CRPC, BNT324/DB-1311 was observed to have a manageable safety profile and showed encouraging preliminary clinical activity. –In December 2025 at the 2025 ESMO Asia Congress, data from this trial were presented. In patients with previously treated cervical cancer or platinum resistant ovarian cancer BNT324/DB-1311 showed encouraging efficacy and a manageable safety profile. 119 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents –In February 2026, updated data from this trial were presented at the ASCO GU Cancers Symposium. BNT324/DB-1311 showed durable efficacy in heavily pretreated mCRPC patients with no new safety signals reported. iii. BNT325/DB-1305, an ADC in Development in Collaboration with DualityBio BNT325/DB-1305 is a topoisomerase-1 inhibitor-based ADC directed against TROP2. Phase 1/2 Clinical Trial in Advanced Solid Tumors A Phase 1/2 clinical trial (NCT05438329) is being conducted to evaluate BNT325/DB-1305 in patients with advanced solid tumors. As part of this clinical trial, BNT325/DB-1305 is being studied in combination with pumitamig in various solid tumor indications. –In October 2025 at the 2025 ESMO Congress, data from this trial in patients with pretreated TNBC were presented. Data showed BNT325/DB-1305 to have encouraging durable antitumor activity and a manageable safety profile. iv. BNT326/YL202, an ADC in Development in Collaboration with MediLink Therapeutics BNT326/YL202 is a topoisomerase-1 inhibitor-based ADC directed against HER3. Phase 1 Clinical Trial in Advanced or Metastatic EGFR-Mutated NSCLC or HR-Positive and HER2-Negative Breast Cancer A Phase 1 clinical trial (NCT05653752) is being conducted to evaluate BNT326/YL202 as a later-line treatment in patients with locally advanced or metastatic EGFR-mutated NSCLC or HR-positive and HER2-negative breast cancer. Phase 2 Clinical Trial in Advanced Solid Tumors A Phase 2 clinical trial (NCT06107686) is being conducted in China to evaluate BNT326/YL202 in patients with advanced solid tumors. –Data from this trial are expected to be presented at the ELCC 2026 taking place on March 25-28, 2026 in Copenhagen, Denmark. Phase 2 Clinical Trial in Multiple Breast Cancers A Phase 2 clinical trial (NCT06439771) is being conducted in China to evaluate BNT326/YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low- expression. –In December 2025, data from this trial in patients with HR+ breast cancer with HER2-null (including HER2- ultralow) or HER2-low expression were presented at the 2025 SABCS. Data showed BNT326/YL202 to have encouraging antitumor activity and a manageable safety profile. v. BNT329, an ADC for the Treatment of Advanced Solid Tumors BNT329 is a fully owned carbohydrate antigen 19-9, or CA19-9, targeting ADC. CA19-9 is expressed in pancreatic cancers and other solid tumors, plays a role in tumor adhesion and metastasis formation, and is a marker of an aggressive cancer phenotype. Phase 1/2 Clinical Trial in Advanced Solid Tumors A Phase 1/2 clinical trial (NCT07186842) is being conducted to evaluate BNT329 in patients with advanced solid tumors. 120 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents 4. Other Antibody Product Candidates i. Gotistobart (BNT316/ONC-392), a Selective Treg Modulator Antibody Candidate in Development in Collaboration with OncoC4 Gotistobart (BNT316/ONC-392) is a tumor microenvironment-selective regulatory T cell-depleting antibody targeting cytotoxic T-lymphocyte associated protein 4, or CTLA-4, candidate being developed in collaboration with OncoC4. The program received Fast Track Designation from the FDA in 2022, and Orphan Drug Designation for the treatment of sqNSCLC in January 2026. PRESERVE-003 Phase 3 Clinical Trial in NSCLC A two-stage global Phase 3 trial (NCT05671510) is being conducted to evaluate the efficacy and safety of gotistobart as monotherapy in patients with metastatic NSCLC that progressed under previous platinum-based chemotherapy and PD-(L)1-inhibitor treatment. –In December 2025, at the IASLC ASCO 2025 North America Conference on Lung Cancer, data from the non- pivotal dose-confirmation stage of the two-stage global Phase 3 trial were presented. Gotistobart demonstrated a clinically meaningful OS benefit compared to standard of care chemotherapy and a manageable safety profile in sqNSCLC patients whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy. –Based on current event accrual projections, we expect interim data from the pivotal stage of the two-stage Phase 3 trial in 2026. PRESERVE-004 Phase 2 Clinical Trial in PROC A Phase 2 clinical trial (NCT05446298) is being conducted to evaluate gotistobart in combination with pembrolizumab in patients with PROC. The clinical trial is designed to evaluate multiple doses of gotistobart in combination with a fixed dose of pembrolizumab in participants with ovarian cancer who are resistant to platinum-based chemotherapy. The primary endpoints are ORR and safety. Secondary endpoints include DOR, DCR, PFS and OS. PRESERVE-006 Phase 1/2 Clinical Trial in Metastatic CRPC A Phase 1/2 clinical trial (NCT05682443) is being conducted to evaluate the safety and efficacy of gotistobart in combination with lutetium Lu-177 vipivotide tetraxetan in patients with mCRPC who have disease progressed on androgen receptor pathway inhibition. The primary endpoints are PSA50 and safety. –In June 2025, data from the Phase 1 part of this trial were presented at the ASCO Annual Meeting and in February 2026, updated data from the Phase 1 part were presented at the ASCO GU Cancers Symposium.. The data indicated a manageable safety profile and preliminary clinical activity for gotistobart in combination with Lu 177 in patients with mCRPC. –We expect data from the Phase 2 part of this trial in 2026. PRESERVE-001 Phase 1/2 Clinical Trial in Advanced or Metastatic Solid Tumors A Phase 1/2 dose escalation clinical trial (NCT04140526) is being conducted to evaluate gotistobart as a single agent and in combination with pembrolizumab in patients with advanced or metastatic solid tumors. –In June 2025, at the 2025 ASCO Annual Meeting, updated data from the melanoma cohorts of the ongoing trial were presented. The data suggested encouraging preliminary clinical activity and a manageable tolerability profile with no new safety signals observed. 121 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents ii. BNT314/GEN1059 is being developed in collaboration with Genmab. BNT314/GEN1059 is a potential first-in- class bispecific antibody product candidate designed to boost antitumor immune responses through epithelial cell adhesion molecule-, or EpCAM-, dependent 4-1BB agonistic activity. Phase 1 Clinical Trial in Advanced or Metastatic Solid Tumors A Phase 1 clinical trial (NCT06150183) is being conducted to evaluate the safety and preliminary antitumor activity of BNT314/GEN1059 in patients with advanced or metastatic solid tumors. iii. BNT317, an Antibody for the Treatment of Advanced Solid Tumors Phase 1 Clinical Trial in Advanced Solid Tumors A Phase 1 clinical trial (NCT06750185) is being conducted to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of BNT317 in participants with advanced solid tumors. 5. Oncology Cell Therapy Product Candidates i. BNT211, a chimeric antigen receptor, or CAR, T-cell therapy – CAR-T - in multiple solid tumors BNT211 is a novel approach combining an autologous tumor-specific CAR-T cell therapy candidate targeting the oncofetal antigen Claudin-6 (CLDN6) with a CLDN6-encoding CAR-T cell amplifying RNA vaccine, or CARVac, that is based on BioNTech’s FixVac platform in one regimen. Phase 1 Clinical Trial in CLDN6-Positive Relapsed or Refractory Solid Tumors A Phase 1 dose escalation clinical trial (NCT04503278) is being conducted to evaluate BNT211 as monotherapy or in combination with CARVac in patients with CLDN6-positive relapsed or refractory solid tumors, including non-small cell lung cancer, gastric cancer, ovarian cancer and testicular germ cell tumors. B. Infectious Disease Programs 1. Next-Generation COVID-19 Vaccine In collaboration with Pfizer, we are aiming to develop a vaccine candidate that enhances and broadens SARS- CoV-2 immunogenicity responses. 2. COVID-19 – Influenza Combination mRNA Vaccine Program – BNT162 + BNT161 In collaboration with Pfizer Phase 1/2 clinical trials are being conducted to evaluate the safety, tolerability and immunogenicity of the combination of the companies’ mRNA vaccine candidates against influenza and COVID-19. We expect to provide updates as the program progresses. 3. Herpes Simplex Virus Vaccine Program – BNT163 A Phase 1 clinical trial (NCT05432583) is being conducted to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of BNT163 for the prevention of genital lesions caused by HSV-2 and potentially HSV-1. –In October 2025, data from this trial were presented at the 2025 Infectious Disease Week, or IDWeek, congress. The data showed BNT163 was well-tolerated with an acceptable safety profile and induced binding antibody and neutralizing titers to HSV-2 antigens. 4. Tuberculosis Vaccine Program - BNT164 In December 2025, a Phase 1a clinical trial (NCT05537038) to evaluate the safety, reactogenicity, and immunogenicity of BNT164 was completed. A Phase 1b/2a clinical trial (NCT05547464) is being conducted to assess the safety, reactogenicity, and immunogenicity of mRNA vaccine candidates against tuberculosis disease. 122 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents 5. Malaria Vaccine Program – BNT165 A Phase 1/2 trial (NCT06069544) to evaluate the safety, tolerability, immunogenicity and efficacy of a second investigational RNA-based vaccine candidate is on clinical hold by the FDA, as announced on March 4, 2025. BioNTech has complied with the hold by the FDA and, in accordance with the clinical trial protocol, had proactively paused the study. BioNTech is assessing next steps in the development of this vaccine candidate. 6. Mpox Vaccine Program – BNT166 A Phase 1/2 clinical trial (NCT05988203) is being conducted to evaluate the safety, tolerability, reactogenicity and immunogenicity of an mRNA-based multivalent vaccine candidate (BNT166a). –In October 2025, data from the Phase 1 portion of this trial were presented at the 2025 IDWeek congress. The data showed that BNT166 was well-tolerated and induced multiantigen-directed antibodies with cross-mpox virus clade and cross-orthopoxvirus neutralization activity in vaccinia virus-naïve and experienced participants. A randomized, placebo-controlled Phase 2 clinical trial (NCT07379580) is being conducted to evaluate the safety, reactogenicity, and immunogenicity of BNT166 in healthy participants. 7. Shingles Vaccine Program – BNT167 A Phase 1/2 clinical trial (NCT05703607) to evaluate the safety, tolerability, and immunogenicity of BNT167 in up to 900 healthy volunteers 50 through 69 years of age was terminated. –Both we and Pfizer have decided to opt-out of the further development of BNT167. 8. HIV Antibody Program – BNT351 In February 2026, the first patient was dosed in a Phase 1 clinical trial (NCT07392372) to evaluate the safety, pharmacokinetics, and antiviral activity of BNT351 in adults living with and without HIV. VI. Sales, Marketing and Distribution Our commercial organization currently focuses on supporting sales of our COVID-19 vaccine in Germany and Türkiye. Our commercial organization is responsible for promoting our products to health care providers and providing information to stakeholders, including governmental organizations, in Germany and Türkiye. As a result of our partnership with Pfizer, under which our commercialization responsibilities are limited to Germany and Türkiye, we maintain a lean fixed cost base for our COVID-19 vaccine business. Our commercial organization is also responsible for preparing and obtaining reimbursement from third-party payors, including governmental organizations, for our COVID-19 vaccine. We aim to build a specialized oncology sales force in major markets, including North America and Europe, while leveraging our commercial partners for co-commercialization. We are working towards being commercial-ready in anticipation of potential commercial oncology launches as soon as 2027, if approved. VII. Manufacturing We are building a fully integrated biotechnology company, with operations spanning from research through clinical development, manufacturing and sales and marketing. To successfully bring individualized immunotherapies and vaccines to people around the world, we believe that it is crucial to have in-house manufacturing capabilities that can be efficiently scaled for global clinical and commercial distribution. We have several manufacturing sites capable of developing automated production processes for on-demand production of our investigational therapies and vaccines. These can be classified into distinct GMP manufacturing capabilities. 123 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents We operate GMP-certified manufacturing facilities in Germany, where we manufacture mRNA therapeutics and engineered cell therapies for both our own pipeline, including a state-of-the art, multi-platform, GMP-certified manufacturing facility located in Marburg, Germany. We also operate a fifth facility in Germany where we manufacture custom peptides both to support our extensive immunomonitoring activities within our development programs and for third parties. Our subsidiary BioNTech Innovative Manufacturing Services GmbH, or BioNTech IMFS, has been manufacturing GMP-certified cellular products since 1999. Outside of Germany, we operate manufacturing sites in Zhuhai and Nantong, China. The Zhuhai site serves as a local R&D and biotech hub, while the Nantong site serves as an industrial-scale antibody production (drug substance and drug product) facility for clinical programs. We are building a BioNTainer site in Kigali, Rwanda, with the intent to enable robust end-to-end manufacturing in Africa for mRNA-based medicines. Furthermore, we are advancing the development and commissioning of a state-of-the-art mRNA manufacturing facility at La Trobe University in Melbourne, Australia, and have established R&D mRNA manufacturing capabilities in leased laboratory space at the university. Our approach has been to proactively build capacity in anticipation of demand from both internal research and development from our collaborators. We have done so by continuing to make significant investments in our manufacturing infrastructure, including our capacity to manufacture mRNA, viral vectors, cellular products and peptides. We believe that the development and optimization of our manufacturing processes in parallel to drug development is crucial to our success. A. Manufacturing Operations COVID-19 Vaccine. Our manufacturing site in Marburg was approved by the EMA for manufacturing of our COVID-19 drug product in March 2021. This approval made it one of the largest mRNA manufacturing sites worldwide. In addition, we have another GMP facility that currently produces our COVID-19 vaccine candidates for clinical trials. We have a network of sub-contractors established to provide drug products, and fill and finish services to enable production. mRNA. We believe scaling up manufacturing for mRNA can best be executed as part of a proprietary manufacturing approach, rather than as part of an outsourcing strategy. We believe this approach allows us to maintain control of our proprietary processes and gives us the flexibility we need for scheduling batch production for our drug substances to match our development plans as they evolve. Our mRNA manufacturing is currently conducted at our in-house BioNTech IMFS facility, our BioNTech East Wing facility, and our Marburg facility. The East Wing facility manufactures iNeST (finished product). BioNTech IMFS produces DS, formulated Drug Product as well as precursors (Liposomes) for early clinical supply. Our manufacturing facility in Marburg is one of the largest mRNA vaccine manufacturing sites worldwide with an annual capacity of up to three billion doses of mRNA drug substance and we believe we are well positioned to supply the quantities required by global market demand. Cell Therapy Products. We have end-to-end capabilities and teams in Germany with over 20 years of experience in cell therapy manufacturing, quality control and release. Our cell therapy programs target novel and known tumor-specific antigens, including patient-specific mutant neoantigens. We also leverage our mRNA vaccine technology to further boost T-cell activation, expansion, and persistence. Our state-of-the-art manufacturing processes of cellular products involve the isolation of primary human blood cells and subpopulations, such as, e.g., CD3+ T cells. At our BioNTech IMFS facility, cell products are cultured, expanded and genetically modified (e.g., CAR-T cells) in an aseptic automated production process in specialized cleanroom facilities with a turn- around time of below 35 days. We also have the capability for in-house mRNA production for the genetic modification of such innovative cell therapy products. Peptides. Our custom peptide synthesis business has developed unique technologies to produce several million peptides over the past ten years to support our growing clinical pipeline. These include fast small-scale 124 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents manufacturing of peptides for target and epitope discovery as well as for neoepitope characterization and production of high content arrays. It is important to synthesize highly purified peptides in order to avoid false positives in immunomonitoring in our mRNA immunotherapy trials. We also use peptides as starting materials in our engineered cell therapies as well as in some drug formulations and biomarker discovery studies. We have developed proprietary technologies to produce highly complex and purified peptide pools that consist of overlapping peptides spanning entire antigens or neoepitopes. In September 2025, we moved into a new manufacturing plant in Berlin, which approximately doubled our manufacturing capacity to produce peptides and diversified our peptide activities towards new fast-growing markets. B. Manufacturing Facilities The information included herein is as of the date of this Annual Report. Manufacturing sites in Germany Marburg Marburg is one of our fully owned, state-of-the-art manufacturing facilities for just-in-time delivery and scalable production. Our Marburg manufacturing facility comprises eight large and small molecule production suites. It is one of the largest mRNA vaccine manufacturing sites globally. The facility has the capacity to produce up to three billion doses of mRNA drug substance vaccine annually. Marburg is our central hub for innovation and development of novel manufacturing solutions. It is a center of excellence, not only in terms of facilities and devices, but as a know-how hub with appropriate and forward- looking staff training. We have about 450 employees on site. To ensure production, we work in flexible/different shift models up to 24/7 if required. Idar-Oberstein BioNTech IMFS: Our manufacturing operations for cell therapy products and clinical bulk mRNA are housed in our wholly owned subsidiary. Founded in 1997, BioNTech IMFS specializes in services for innovative therapeutic approaches. In 2009, BioNTech IMFS became our wholly owned subsidiary, giving us access to synergistic platforms and complementary expertise for development, testing and manufacturing services. BioNTech IMFS and its predecessors have had GMP-certified cell and gene therapy manufacturing capabilities since 1999, and obtained GMP manufacturing authorization for mRNA production in 2011. In 2017, BioNTech IMFS began automated manufacturing of the iNeST product candidate and entered its first commercial supply contract for retroviral vectors. The BioNTech IMFS facility is located near Mainz. Around 500 staff members are employed at this facility, with collective expertise in molecular biology, cell biology and virology and a close working relationship with our R&D teams in Mainz. We consider BioNTech IMFS our powerhouse for early-stage mRNA material. Mainz BioNTech iNeST Clinical Manufacturing (East Wing): We utilize our GMP-certified manufacturing facility at our headquarters in Mainz, Germany for the production of iNeST immunotherapies. In 2015, our wholly owned subsidiary, BioNTech RNA Pharmaceuticals GmbH, or BioNTech RNA, and Siemens announced a collaboration for developing an automated, paperless and digitalized production site for individualized mRNA. We obtained our GMP manufacturing authorization for iNeST production at our East Wing facility in June 2018 and manufactured our first drug product there the following month. Over 300 staff members are employed at this facility and operate it seven days per week. In its first year of operation, the facility manufactured and released more than 250 batches of mRNA and has manufactured and released more than 1,700 batches of mRNA since inception. 125 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents To perform our target identification process to feed into the iNeST downstream GMP manufacturing process, our headquarters also hold our core facility, which operates under Good Clinical Practice, or GCP, for labs. Incoming patients’ materials (blood and tumor samples) are received and analyzed to identify characteristic mutations to generate the patient-specific target list used for individualized mRNA production. BioNTech Clinical Manufacturing: Our GMP-certified manufacturing facility in Kupferbergterrasse, Mainz is authorized to conduct secondary packing, labeling, storage and batch release of primary packed investigational medicinal products. Another GMP facility in Mainz for mRNA-based products was completed in 2025, with a target manufacturing license date of 2027. With advanced automation and streamlined processes, this new facility is designed to serve a high four-digit number of patients annually. Tübingen In January 2026, we became the sole owner of the German mRNA company CureVac’s business operations. CureVac’s Tübingen site is a GMP-compliant mRNA manufacturing hub primarily designed for clinical-stage supply. It includes multiple multi-product GMP suites and an upscaled facility planned for supporting late-stage trials and potentially commercial supply. A key asset is the automated “RNA Printer” enabling small-batch, end- to-end mRNA and LNP production suited for personalized oncology. Berlin JPT, our peptide manufacturing facility located in Berlin, was established in 2004 and became a wholly owned subsidiary of BioNTech in 2008. JPT has manufacturing capacity to produce up to 1 million peptides per year for research applications, including drug discovery and bioanalysis. Global manufacturing sites Outside of Europe, we maintain sites in China, Rwanda and Australia. Nantong and Zhuhai, China Biotheus, now a BioNTech subsidiary, operates two strategic Chinese sites linked to its biologics pipeline. Its Zhuhai location serves as a local R&D and biotech hub, with GMP production for early-phase clinical trials. The larger Nantong campus provides industrial-scale antibody production (drug substance and drug product) for clinical programs and is intended to support initial launches and ongoing commercial supply. Currently, Nantong operates a single drug substance line with three 2000-liter reactors and one filling line. A second drug substance line is under construction. The BioNTainer: a platform for localized and sustainable mRNA production The BioNTainer is an example of our innovative approach to establishing scalable vaccine production. It was developed to ensure sustainable, equitable access to our programs, particularly in low-income countries and regions with limited infrastructure. The BioNTainer allows scalable vaccine production by developing and delivering mRNA manufacturing facilities based on a containerized clean room solution with a modular design, standardized equipment, and software components. Each BioNTainer unit is a clean room, which we equip with state-of-the-art manufacturing solutions for the manufacture and formulation of mRNA-based vaccines. Each BioNTainer unit is built of six to eight ISO-sized containers. A BioNTainer unit can be equipped to manufacture a range of mRNA-based vaccines targeted to regional needs: for example, our COVID-19 vaccine and our investigational malaria, tuberculosis, or mpox vaccines, if they are successfully developed, approved, and authorized by regulatory authorities and in line with regional demand. The BioNTainer units can also support clinical-scale manufacturing of investigational mRNA-based medicines. Kigali, Rwanda Manufacturing Facility 126 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Our first international BioNTainer site was the BioNTainer manufacturing facility in Kigali, Rwanda. The Kigali facility was planned to install two sets of BioNTainer units for commercial-scale bulk production of mRNA vaccines with the intent to enable robust end-to-end manufacturing in Africa for mRNA-based medicines. The first BioNTainer unit arrived in Kigali, Rwanda in 2023. We acknowledged this important milestone in progressing mRNA vaccine manufacturing capabilities in Africa with the inauguration of our site in Kigali, Rwanda. In 2024, we announced that CEPI would be committing up to $145 million to support us to establish further mRNA clinical-scale manufacturing capabilities at the Kigali facility. The setup of clinical-scale manufacturing capabilities for mRNA-based vaccine candidates involves the installation of two additional BioNTainer units at the Kigali facility - one unit for clinical scale Drug Substance and bulk Drug Product production and one unit for vaccine filling. The clinical scale BioNTainer units are expected to be installed in 2026 and are intended to produce and fill up to 500,000 doses of clinical trial material and/or commercial vaccines per year. We plan to apply for a GMP manufacturing license in 2027. Under the terms of the agreement with CEPI, we intend to provide sustainable supply of our prophylactic vaccines manufactured at the Kigali facility if successfully developed and authorized, such as vaccines against malaria, mpox and tuberculosis, to low and lower middle- income countries, with priority supply to African countries. The facility’s manufacturing capacity will depend on the mRNA product being manufactured and various factors, such as dosage and formulation. For commercial vaccine production or in response to a pandemic, we may activate all installed BioNTainers on site and could potentially manufacture up to 50 million doses annually of a product, using an RNA process similar to that used for the COVID-19 vaccines by Pfizer and us. The European Investment Bank, or EIB, and European Commission, or EC, are supporting the development of our mRNA manufacturing site in Rwanda. In October 2025, up to €95 million in blended EC and EIB financing was awarded to support site infrastructure and facility operations and to develop contract development manufacturing organization capabilities with the goal of enabling the manufacture of clinical trial materials for local partners. Our partnership with CEPI and the EC/EIB strengthens Africa’s vaccine ecosystem. By the end of 2025, BioNTech Rwanda employed approximately 40 people from eight different African countries and is expected to continue to grow in 2026. Melbourne, Australia Manufacturing Facility In 2023, we signed a multi-year strategic partnership with the State of Victoria, Australia, for an initiative to strengthen the local mRNA ecosystem with our BioNTainer technology. This partnership aims to provide high- tech manufacturing capabilities and our expertise to develop projects for further research and development. We are advancing the development and commissioning of our state-of-the-art mRNA manufacturing facility on the Bundoora campus of La Trobe University in Melbourne. Having broken ground on the site in 2024, construction activities on the building structure have gained momentum. In November 2025, we celebrated the “topping-out” of the building, with the successful completion of the concrete superstructure. Once operationally ready, the facility is intended to support Australia’s growing mRNA ecosystem by producing R&D and cGMP clinical-scale investigational mRNA-based medicines. In advance of the completion of our R&D and clinical-scale mRNA manufacturing facility, in mid-2025, we established R&D mRNA manufacturing capabilities in leased laboratory space at La Trobe University. In October 2025, we celebrated the successful manufacture of mRNA on Australian soil. Our R&D mRNA manufacturing services are now available to the growing mRNA ecosystem, and we expect our capabilities to expand through 2026. Upon completion of construction, we expect to transfer our R&D processes and equipment trains into our own facility. Following the opening of our Innovation Center in Melbourne’s central business district in mid-2024, our local scientific and strategic leadership team made a concerted effort to engage with and integrate into the mRNA 127 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents ecosystem in Australia and the broader region. We expect to continue to leverage our local and global expertise to assess and identify mRNA-focused research projects from academia and industry and facilitate their transition to clinical-stage development as potential future product candidates. C. Other Certifications BioNTech Diagnostics has a quality management system that is certified according to ISO 13485:2016 and JPT maintains an ISO 9001:2015 certified Quality Management System. D. Quality Assurance We have implemented and maintain several Quality Assurance systems. BioNTech IMFS, BioNTech Clinical Manufacturing and BioNTech iNeST Clinical Manufacturing have implemented GMP-certified quality assurance systems. BioNTech Diagnostics has a quality management system that is certified according to ISO 13485:2016 and JPT maintains an ISO 9001:2015 certified Quality Management System. VIII. Third-Party Collaborations We have forged productive collaborations with pharmaceutical companies and academic research institutions with area expertise and resources in an effort to advance and accelerate our discovery and development programs in oncology, and also to leverage our drug classes into additional disease indications while minimizing our incremental costs. Our collaborations include, without limitation: –Bristol Myers Squibb to jointly develop, manufacture and commercialize pumitamig; –DualityBio for the research and development of certain antibody drug conjugates; –Genentech for our iNeST platform in our mRNA drug class; –Genmab for our next-generation checkpoint immunomodulator platform in our protein-based therapeutics drug class; –OncoC4 for the research and development of certain monoclonal anti-CTLA4 antibodies; and –Pfizer for our COVID-19 vaccine program, which leverages technology from our infectious disease mRNA- based platform. We either wholly own or retain significant rights to all of our clinical stage programs, either in the form of a global share of profit and co-commercialization rights with our collaborators in certain markets or significant royalties and milestones. We plan to continue to identify potential collaborators who can contribute meaningful resources and insights to our programs and allow us to more rapidly expand our impact to broader patient populations. A. BMS Collaboration On June 2, 2025, we entered into a Global Co-Development and Co-Commercialization Agreement, which we refer to as the Original Agreement, with Bristol Myers Squibb Company, or BMS, to jointly develop, manufacture and commercialize our investigational bispecific antibody pumitamig across numerous solid tumor types. Other than the right to receive upfront payment, non-contingent anniversary payments and development and regulatory approval milestones (which stay with BioNTech SE), we assigned our rights and obligations under the Original Agreement to our subsidiary BioNTech US Inc. pursuant to an Assignment and Assumption Agreement dated June 2, 2025 which was amended on August 15, 2025. In connection with the assignment, the parties also entered into a Parent Guarantee in favor of BMS dated June 2, 2025. The Original Agreement was amended and 128 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents restated on August 15, 2025 to further define the performance-related rights and obligations of the collaboration, which, as so amended and restated, we refer to as the BMS Agreement. Under the BMS Agreement, BMS paid us $1.5 billion in an upfront payment and agreed to pay $2 billion total in non-contingent anniversary payments through 2028. Furthermore, we will be eligible to receive up to $7.6 billion in additional development, regulatory and commercial milestones. The parties will equally share global profits and losses. The parties have agreed to use commercially reasonable efforts to jointly develop pumitamig, as a monotherapy or in combination with other products, pursuant to a Joint Development Plan, or JDP. Development costs will generally be shared equally; provided, if a particular joint clinical trial involves pumitamig in combination with a proprietary or in-licensed asset of either party, cost sharing will be on an adjusted basis, subject to certain exceptions. Each party may propose new clinical trials for additional indications or combinations to be added to the JDP. If the other party declines co-funding of a proposed new trial in the JDP, the proposing party may proceed independently at its own cost, under the oversight of the Joint Development Committee, subject to certain reimbursement rights against the other party. The parties have also agreed to use commercially reasonable efforts to jointly commercialize pumitamig pursuant to a jointly-developed global commercialization strategy and certain co-commercialization and market access plans. The parties will equally share any profits and losses from the commercialization of pumitamig. A Joint Commercialization Committee will coordinate and allocate commercial responsibilities, including the “lead” role with respect to specific activities, in an equitable manner to maximize the success of pumitamig and to maximize the efficiencies of the collaboration and avoid duplication of efforts as much as possible. Each party has the right to contribute equally (on a market-by-market basis) to all strategic commercial planning and execution, subject to certain exceptions. We will be solely responsible and will use commercially reasonable efforts for the global clinical supply of pumitamig initially before the completion of a manufacturing technology transfer from us to BMS. Following the completion of the manufacturing transfer, we will continue to be responsible and will use commercially reasonable efforts for the global clinical supply of pumitamig, but the parties may agree for BMS to manufacture certain quantities of the clinical supply. Following the completion of the manufacturing transfer and BMS being otherwise ready to manufacture and supply at scale, BMS will be responsible for the commercial supply of pumitamig, provided that we retain the right to contribute a certain percentage of global commercial supply, subject to certain conditions. Each party has granted to the other party certain co-exclusive licenses under its intellectual property, or IP, including patents and know-how (including to each party’s share of any future jointly owned IP under the BMS Agreement), to perform development and medical affairs activities with respect to seek and obtain regulatory approvals of, and manufacture, commercialize and otherwise exploit pumitamig. The parties have also agreed to a mutual right of first negotiation, effective from the date of the BMS Agreement through the fifth anniversary thereof, with respect to certain events related to next generation antibodies, where either party (a) receives a transaction proposal from a third party, (b) intends to enter into such a transaction with a third party, or (c) determines to initiate a registrational trial for such next generation antibody. The term of the BMS Agreement commenced on June 2, 2025 and will remain in effect until and unless the parties mutually agree to permanently terminate and cease all exploitation of pumitamig, or the BMS Agreement is otherwise earlier terminated by the parties in accordance with its terms. BMS has the right to terminate for convenience by giving a specified period of prior notice. BMS may also terminate if BMS determines in good faith that there is unacceptable risk for harm in humans relating to pumitamig that is not resolved, or a Safety 129 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Issue. Each party may also terminate for uncured material breach or insolvency of the other party. In the event that the termination is by BMS for convenience or by us for uncured material breach, the parties will continue to co-fund certain ongoing clinical trials until the earlier of the completion or wind-down of such clinical trials or the conclusion of a specified period from the date of notice of termination. Upon termination, all licenses granted under the BMS Agreement will terminate, except that BMS will grant us a reversion license (other than where termination is by BMS for a Safety Issue) to BMS’s interest in specified reversion IP to allow us to continue developing and commercializing licensed products in the form such licensed products existed as of the date of termination, subject to the parties agreeing on the financial payments for such reversion license. The grant of the reversion license is contingent on (i) the parties’ agreement upon commercially reasonable financial payments and (ii) the parties entering into a reasonable license agreement for the reversion license. In the event that the parties cannot agree on commercially reasonable financial payments during a specified period, the parties will refer such matter for resolution by baseball arbitration. During the period between termination and entry into the reversion license (or a specified period following the termination date, if earlier), BMS may not bring any claim against us for infringement of any reversion IP in the conduct of any development activities ongoing as of the termination date. B. DualityBio Global Strategic Partnership In 2023, we entered into three License and Collaboration Agreements with DualityBio, which we refer to as the DualityBio Agreements. Each of the DualityBio Agreements relates to specific ADC assets. The first agreement, the HER2 Agreement, relates to the ADC asset targeting HER2 and was entered into on March 16, 2023. The second agreement, the B7H3 Agreement, relates to the ADC asset targeting B7H3 and was entered into on March 31, 2023. The third agreement, the TROP2 Agreement, relates to the ADC asset targeting TROP2 and was entered into on August 4, 2023. Each of the three DualityBio Agreements relates to a license granted to us with respect to certain patents and know-how owned or otherwise controlled by DualityBio and our collaboration with DualityBio in the research and development of ADC therapeutics. In each of the DualityBio Agreements, DualityBio granted us the exclusive, royalty-bearing and sublicensable right to exploit certain patents and know-how, which we refer to as the DualityBio IP, for the research, development, manufacture and commercialization of the respective ADC compound and pharmaceutical products comprising such compound, which we refer to as the DualityBio Products, in any field in the territory, which is all countries of the world except for mainland China, Hong Kong and Macau, which we refer to as the DualityBio Retained Territory. We were also granted the sole right to exploit the DualityBio IP to develop and manufacture the DualityBio Products in the DualityBio Retained Territory solely for the purpose of developing, manufacturing and commercializing the DualityBio Products in the territory. Each party has final decision-making authority and is generally responsible for clinical trial supply costs and regulatory activities and costs with respect to their respective territory. We are responsible for the commercialization of any DualityBio Products in the territory. The B7H3 Agreement also grants DualityBio the option to share the development and commercialization costs and the profits and losses from the exploitation of the first original DualityBio Product in the United States. Under the B7H3 Agreement, we have further granted to DualityBio the option to assume a percentage of the total sales force of the first original DualityBio Product in the United States. In partial consideration of DualityBio’s granting of the licenses and rights to us under the DualityBio Agreements, we have made upfront payments to DualityBio in an aggregate amount of $220 million. In addition, we agreed to make potential payments upon the achievement of specified development, regulatory and commercial milestones. Such milestone payments could amount up to $2.6 billion in the aggregate (the TROP2 Agreement also provides for additional sales milestone payments in the event DualityBio works on, and we exercise, the 130 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents option regarding the next-generation product). We further agreed to between single-digit to double-digit tiered royalties on net sales of all DualityBio Products, which also differ between the DualityBio Agreements. Royalties are subject to stacking provisions and will be reduced in case of respective biosimilar products entering the market. Furthermore, we agreed to reimburse DualityBio for certain development costs. The DualityBio Agreements end on a country-by-country and DualityBio Product-by-DualityBio Product basis upon expiration of the respective last DualityBio royalty term for a DualityBio Product in that country. Thereafter, the licenses granted to us with respect to such product in such country will convert into a perpetual, exclusive, fully paid-up and royalty-free license. In addition to termination rights granted to each party in the case of the other party’s uncured material breach or insolvency, we may terminate each DualityBio Agreement, in whole or in part, for convenience upon prior written notice. On November 12, 2024, we and DualityBio entered into a side letter to the DualityBio Agreements to undertake certain development activities in the territory and DualityBio Retained Territory with DualityBio Products in combination with other product(s) that are proprietary to or owned or controlled by us or our affiliates. C. Genentech iNeST Collaboration Collaboration Agreement On September 20, 2016, we entered into a Collaboration Agreement with Genentech and F. Hoffman-La Roche Ltd, together with all amendments thereto, collectively referred to as the Genentech Collaboration Agreement, to jointly research, develop, manufacture and commercialize certain pharmaceutical products that comprise neoepitope RNAs, or the Genentech Collaboration Products, which include our iNeST development candidates, for any use worldwide. Under the Genentech Collaboration Agreement, we and Genentech agreed to perform joint research under a research plan to further improve our technology platform for the manufacturing of Genentech Collaboration Products. Under the terms of the Genentech Collaboration Agreement, Genentech paid us $310 million in upfront and near-term milestone payments. We and Genentech must use commercially reasonable efforts to jointly develop one or more Genentech Collaboration Products in accordance with an agreed global development plan, with the costs of such development to be shared equally. We continued certain clinical studies that were initiated prior to the execution of the Genentech Collaboration Agreement at our sole expense. Genentech may access and use any data generated in these clinical studies. In addition to the clinical studies included in the global development plan, we may propose certain additional clinical studies for indications not included in the global development plan, and if the joint development committee formed by the parties does not elect to include the proposed studies in the global development plan, then we may conduct the study at our sole expense under certain conditions, and subject to certain restrictions. Genentech has the option to select any candidate in such studies for potential further joint development and/or commercialization by Genentech as a Genentech Collaboration Product. In the case that Genentech wishes to pursue the clinical development of a Genentech Collaboration Product in an indication that we are not interested in pursuing, then under certain conditions, we may opt out of the co-funding of such development and Genentech may continue do so at its own costs, except that we are obligated to repay Genentech’s development costs in the event that such product subsequently receives regulatory approval. Genentech has the sole right to commercialize the Genentech Collaboration Products on a worldwide basis, with all profits and losses from such commercialization to be split equally with us. If we exercise our right to opt out of sharing equally in future development costs for any Genentech Collaboration Products, then we will no longer split all such profits and losses for such Genentech Collaboration Products equally with Genentech and will instead receive a royalty on annual worldwide net sales of such Genentech Collaboration Products that are covered by a valid claim included in certain of our patents and certain joint patents that arise out of the 131 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents collaboration. Furthermore, for certain Genentech Collaboration Products for which we share co-promotion rights with Genentech, we have the option to assume a percentage to be determined of the total sales force in the United States and certain other countries, including Germany and other major European markets. In addition, under certain regulatory and other circumstances, we have the right to independently commercialize Genentech Collaboration Products in indications that the joint development committee declines to pursue and that Genentech does not subsequently elect to commercialize, provided that we market such Genentech Collaboration Products under a separate brand and trademark that is approved by the joint commercialization committee established by the parties as not confusingly similar to the Genentech Collaboration Products being commercialized by Genentech. Our ability to research, develop, co-promote and/or independently commercialize Genentech Collaboration Products may be terminated or limited in the event we undergo a change of control. We granted to Genentech an exclusive license under certain of our intellectual property, and our interest in any jointly-owned intellectual property developed under this agreement, to research, develop, make, sell and import any pharmaceutical products that comprise neoepitope RNA. Genentech granted to us an exclusive, non- transferable, sublicensable licenses under certain Genentech intellectual property, our intellectual property exclusively licensed to Genentech, and their interest in any jointly-owned intellectual property developed under this agreement for the performance of our ongoing clinical studies and the exercise of our rights and obligations under the Genentech Collaboration Agreement. Until the first marketing approval for a Genentech Collaboration Product, we have granted Genentech the first right to negotiate an exclusive license to develop, manufacture and commercialize combination therapies involving pharmaceutical products based on neoepitope RNA and pharmaceutical products based on non- neoepitope RNA for the treatment of cancer in humans. The Genentech Collaboration Agreement will remain in effect so as long as Genentech Collaboration Products are in development or commercialization, or until the date of the expiration of the last royalty term if BioNTech has exercised its option to opt-out of joint development of Genentech Collaboration Products. If the agreement expires, the licenses granted to Genentech become fully-paid up, royalty-free and irrevocable. Genentech may terminate the Collaboration Agreement if we fail to achieve certain milestone targets or at any time for convenience with or without reason upon 60 days’ prior written notice. In the event of any such termination, all rights to the development and commercialization of Genentech Collaboration Products developed under the collaboration would revert to us and Genentech would grant us licenses under its intellectual property to further develop and commercialize Genentech Collaboration Products. We would be required to pay certain royalties to Genentech for such license(s). In addition, either party may terminate the agreement upon the other party’s uncured material breach or insolvency. Manufacturing Development and Supply Agreement Concurrent with the Genentech Collaboration Agreement, we entered into a Manufacturing Development and Supply Agreement with Genentech and F. Hoffman-La Roche Ltd, or the Genentech Manufacturing Agreement, which governs the manufacturing, related manufacturing development activities and supply of Genentech Collaboration Products. Pursuant to the Genentech Manufacturing Agreement, we are responsible for clinical manufacturing and supply, for developing and implementing manufacturing processes (including pursuant to specified target turnaround times), and for constructing, commissioning, qualifying and obtaining permits for the clinical facilities. We are permitted to subcontract certain steps in the clinical manufacturing process to our affiliate, BioNTech IMFS. In addition, we are responsible for developing the commercial manufacturing process, which requires more stringent turnaround times than the clinical manufacturing process. Genentech will generally be responsible for conducting commercial manufacturing. We are obligated to use commercially reasonable efforts to achieve certain predetermined clinical manufacturing capacity commitments. 132 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Under the Genentech Manufacturing Agreement, we and Genentech will jointly develop a manufacturing network plan detailing the location, capacity, scale-out, associated timing and other appropriate details of the commercial manufacturing facilities. We may participate in commercial manufacturing through our right to include as part of the commercial manufacturing network one of our own facilities in the European Union or the United States and one of our own facilities in another region to be agreed upon with Genentech (provided that in each region our facility is not the first facility to be included in the commercial manufacturing network). D. Genmab Next-generation Immunomodulator Collaboration On May 19, 2015, we entered into a License and Collaboration Agreement with Genmab, which was subsequently amended and supplemented by side letters, to jointly research, develop and commercialize polypeptide-based bispecific antibodies against certain target combinations for the treatment of cancer worldwide, or the Genmab Agreement Field, using certain Genmab technology. In connection with our entry into that License and Collaboration Agreement, Genmab paid us an upfront fee of $10 million. On July 18, 2022, this agreement was amended and restated by an Amended and Restated License and Collaboration Agreement (which, as amended, is referred to as the Genmab Agreement). Under the Genmab Agreement, we and Genmab must use commercially reasonable efforts to research and develop clinical candidates, including our next-generation checkpoint immunomodulators, with costs split equally during the research and evaluation phase. Our joint activities in this phase were governed by a research plan, which was subject to annual review and updates, and which specifies the clinical candidates to be developed. This research and evaluation phase expired on September 18, 2022. We and Genmab must use commercially reasonable efforts to develop candidates selected by the joint research committee, or the LCA Products, through preclinical and clinical development. The preclinical and clinical development of the LCA Products would be performed pursuant to a development plan to be agreed upon by us and Genmab, with costs to be split equally. The joint steering committee may designate a third party as a manufacturer of an LCA Product or of any of its components. We and Genmab must use commercially reasonable efforts to jointly commercialize all LCA Products and share equally all expenses and profits arising from such commercialization. We and Genmab, on a product-by-product basis and at least 12 months prior to the anticipated start of a pivotal clinical trial for an LCA Product, will jointly designate between the two of us a lead party responsible for establishing the distribution and marketing operations in each geographical region. Each party would be entitled to equally co-commercialize the products pursuant to a separately negotiated global commercialization agreement that the parties agree to negotiate. Unless otherwise agreed by the joint steering committee established under the agreement, Genmab is responsible for all regulatory actions and shall own all regulatory approvals obtained for the LCA Products. Genmab is obligated to provide regular updates to us on regulatory activities. Each party grants to the other party a worldwide, co-exclusive, sublicensable, royalty-free license under certain of such first party’s intellectual property, including certain patents and know-how, to perform the research under this agreement and to research, develop, make, import, use and sell LCA Products in the Genmab Agreement Field pursuant to the terms of the Genmab Agreement. These licenses shall continue on a country-by-country and product-by-product basis for as long as development or commercialization activities are contemplated under the Genmab Agreement. During the preclinical and clinical development phase for any LCA Product, engagement in research and development activities in the Genmab Agreement Field unilaterally by a party relating to an LCA Product or its Back-up Candidate or any bispecific antibody which targets the same target combination for which such LCA Product or Back-up Candidate has been developed would require the other party’s prior written consent. 133 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Each party has the right to discontinue its participation in the further development and commercialization of an LCA Product at two points: (i) when an IND submission package has been agreed upon by the parties and (ii) when the draft clinical trial report from the first Phase 1/2 clinical trial becomes available. The other party may elect to continue the development and commercialization of the LCA Product or divest its interest in such LCA Product. If the other party elects to pursue development and commercialization of such LCA Product alone as a Unilateral Product, at its sole cost and subject to pre-defined milestone and royalty payments and certain additional pre-defined terms. If the other party wishes to not pursue such continued development and commercialization on such pre-defined payment and additional terms, then the parties will jointly divest their interest in such LCA Product to a third party, and if such divestiture fails, the parties will cease all development and commercialization of such LCA Product. The Genmab Agreement will remain in effect until the later of (i) the expiration of the last-to-expire royalty term for any Unilateral Product or (ii) the time when no LCA Products, Joint Combination Products or Proprietary Combination Products are being developed or commercialized under this agreement. Either party may terminate the agreement in its entirety or on a product-by-product basis with immediate effect upon the other party’s uncured material breach or insolvency. On August 5, 2022, we and Genmab expanded our global strategic collaboration to develop and commercialize novel immunotherapies for the treatment of cancer patients. Under this expansion, we and Genmab will jointly work to research, develop and commercialize novel monospecific antibody candidates for various cancer indications. E. OncoC4 Collaboration On March 17, 2023, we and OncoC4 entered into a License and Collaboration Agreement, or the OncoC4 Agreement, for the license, development and commercialization of ONC-392 and all other monoclonal anti- CTLA4 antibodies owned or controlled by OncoC4 (referred to as OncoC4 Licensed Compounds) as of the execution date, including development of combinations of such antibody with other products, for use in humans or animals, or the OncoC4 Field. OncoC4 granted us an exclusive license under ONC-392 and OncoC4’s interest in joint intellectual property to exploit OncoC4 Licensed Compounds and any pharmaceutical or biologic product containing OncoC4 Licensed Compound (referred to as OncoC4 Licensed Products) in the OncoC4 Field in the entire world, which we refer to as the OncoC4 Territory. Furthermore, OncoC4 granted us an exclusive option that ended June 30, 2024 to license AI-061, which is a biopharmaceutical composition containing as its sole active ingredients both ONC-392 and an anti-PD-1 antibody. OncoC4 retains all rights to the anti-PD-1 antibody outside of the combination with ONC-392. We agreed to collaborate on research, development, and commercialization of ONC-392 in the OncoC4 Territory and to use commercially reasonable efforts to conduct development activities of OncoC4 Licensed Compounds and OncoC4 Licensed Products either as a monotherapy or in combination with an anti-PD-(L)1 antibody and/or standard of care product (which we refer to collectively as the Mono/PD-1/SOC Combinations) in accordance with a joint clinical development plan which is governed by a joint steering committee. All costs associated with the joint development responsibilities are shared equally between us and OncoC4. We are solely responsible for all development activities for the OncoC4 Licensed Compounds and OncoC4 Licensed Products in any other form or combination other than the Mono/PD-1/SOC Combinations (we refer to such other combinations as OncoC4 Other Combinations) at our own expense and in accordance with a research and development plan prepared by us and shared with OncoC4 through the joint steering committee. We agreed to use commercially reasonable efforts to develop an OncoC4 Licensed Product in at least one indication for an OncoC4 Other Combination. We agreed to first offer OncoC4 the opportunity to co-fund any development of a PD-1 Combination prior to pursing such development independently or with a third party. 134 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents We agreed to be solely responsible, at our expense, for commercialization of OncoC4 Licensed Products worldwide and to use commercially reasonable efforts to commercialize OncoC4 Licensed Products for each approved indication in certain major markets. In consideration for the rights granted to us by OncoC4, we made an upfront payment of $200 million, with a portion of the upfront payment to be used to fund OncoC4’s share of the joint research and development costs related to ONC-392, and agreed to make potential payments upon the achievement of specified development and regulatory milestones and upon the achievement of specified sales milestones. We have further agreed to pay OncoC4 double digit, tiered royalties on annual net sales of OncoC4 Licensed Products during a certain royalty term starting from launch of product. The OncoC4 Agreement shall continue until the last-to-expire royalty term in all countries in the OncoC4 Territory for all OncoC4 Licensed Products. Upon the expiration of the royalty term for an OncoC4 Licensed Product in a given country in the OncoC4 Territory, the exclusive license granted to us will become a perpetual, irrevocable, non-exclusive, fully paid-up, and royalty-free license with respect to such OncoC4 Licensed Product in such country. In addition to termination rights granted to each party in the case of the other party’s uncured material breach or insolvency, we have the right to terminate the OncoC4 Agreement in its entirety for convenience with prior written notice to OncoC4. F. Pfizer COVID-19 Vaccine Collaboration On April 9, 2020, effective as of March 17, 2020, we entered into a Collaboration Agreement with Pfizer for the research and development of immunogenic compositions comprising RNA encoding a SARS-CoV-2 polypeptide or fragment thereof for prophylaxis against SARS-CoV-2 in humans, which we refer to as the Pfizer Corona Field. On January 29, 2021, effective as of March 17, 2020, we entered into an amended and restated Collaboration Agreement with Pfizer for the research, development and commercialization of immunogenic compositions comprising RNA in the Pfizer Corona Field, which we refer to as the Pfizer Agreement. We and Pfizer agreed to collaborate on research, development and commercialization in the Pfizer Corona Field worldwide (excluding the Fosun collaboration territory), which we refer to as the Pfizer Collaboration Territory. The details of such activities are set forth in a research and development plan that is governed by a joint steering committee. Each party bears its own personnel and capital expenditures costs, but the parties will share the costs of all other agreed development activities (including the costs of manufacturing material for use in clinical trials) evenly. Each party will, in good faith, seek funding from government funds, non-governmental organizations and other third-party organizations to support their research and development activities. Under the Pfizer Agreement, Pfizer is leading clinical development of and is seeking regulatory approval for any candidates or products in the United States and we are leading clinical development of and are seeking regulatory approval for any candidates or products in the European Union, and we will agree on a strategy for all other countries in the Pfizer Collaboration Territory on an ongoing basis through the joint steering committees. BioNTech can solely commercialize the vaccine in Germany and Türkiye (collectively referred to as the BioNTech Commercialization Territory, which is a subset of the Pfizer-Collaboration Territory). We have the option to opt-out of commercializing the vaccine in Germany and/or Türkiye, whereupon such countries will become part of the Pfizer Commercialization Territory of the Pfizer Collaboration Territory. Pfizer has the right to commercialize any approved COVID-19 vaccine in the rest of the Pfizer Collaboration Territory. On a country-by-country basis in relation to the United Arab Emirates, Southeast Asia, and certain developing countries, if we obtain funding from a third-party organization that obligates us to commercialize an approved vaccine in such country, we are obligated to request from Pfizer in writing a decision as to whether Pfizer wishes to commercialize or distribute such vaccine in such country in accordance with the requirements agreed with the third-party funder. If Pfizer elects not to commercialize the vaccine in such country, then such country shall become a part of the BioNTech Commercialization Territory. 135 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents If our Collaboration Agreement with Fosun expires or is otherwise terminated for any reason, as between us and any international pharmaceutical group headquartered outside of China, we have granted Pfizer a right of first negotiation to expand the Pfizer Commercialization Territory to include the Fosun Territory. We and Pfizer share responsibilities for manufacturing and supplying our approved COVID-19 vaccines. If there is insufficient supply to satisfy the entire demand for vaccines in the Pfizer Collaboration Territory, we and Pfizer have agreed to determine by mutual consent the allocation of supplies on a fair and equitable basis, subject also to any applicable law, export controls, and taking into account any government supply obligations, or supply obligations included in any agreement reached with a third-party funding organization. Under the Pfizer Agreement, we have granted Pfizer an exclusive, sublicensable license in the Pfizer Collaboration Territory under certain of our intellectual property, including our patents and know-how, relating to uridine RNA, modified RNA and replicons in the Pfizer Corona Field as well as certain intellectual property in- licensed by us from third parties, to use, research, develop, manufacture, commercialize and otherwise exploit candidates and products selected under the Pfizer Agreement. We undertake to maintain in full effect all intellectual property licenses held by us at the time we entered into the Pfizer Agreement and not to modify or amend any such license in a manner that would adversely affect any of the rights granted to Pfizer under the Pfizer Agreement. We are obligated to notify Pfizer of any breach of our current licenses and may be obligated to take steps to maintain Pfizer’s access to any intellectual property licensed under such licenses. Under the Pfizer Agreement, we are obligated to indemnify Pfizer with respect to certain product liability and patent infringement claims. During the term of the Pfizer Agreement and a certain period thereafter, we and Pfizer have committed not to research, develop, manufacture, commercialize or otherwise exploit immunogenic compositions comprising RNA in the Pfizer Corona Field, or exploit vaccine candidates or products developed under the agreement for any use, other than pursuant to the Pfizer Agreement, provided, however, that Pfizer shall have the right to work as a contract manufacturer for a third party and Pfizer shall not be precluded from acquiring a third party, or being acquired by a third party, that at the time of acquisition is active in the development or commercialization of an immunogenic composition comprising mRNA in the Pfizer Corona Field. On April 9, 2020, Pfizer also subscribed for $113 million of our ordinary shares under a separate investment agreement. In addition, under the Pfizer Agreement, Pfizer made an upfront payment of $72 million and agreed to make potential payments of up to $563 million upon the achievement of specified regulatory and commercial milestones. We and Pfizer agreed to share development costs equally. We and Pfizer will share the gross profits from commercializing a vaccine evenly, as well as the costs for shipping. The Pfizer Agreement continues for so long as either at least a vaccine is being developed for use in the Pfizer Collaboration Territory or a vaccine is being commercialized anywhere in the Pfizer Collaboration Territory. In addition to termination rights granted to each party in the case of the other party’s uncured material breach, Pfizer may terminate the agreement (i) upon our insolvency or (ii) on a country-by-country basis or in its entirety for convenience upon one (1) year’s prior written notice provided that any such termination shall not become effective less than two (2) years from the first commercial sale of an approved vaccine. IX. Government Regulation Government authorities in the United States at the federal, state and local levels, and in the European Union and other countries and jurisdictions, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, packaging, storage, record-keeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting and import and export of pharmaceutical products, including biological products. In addition, some jurisdictions regulate the pricing of pharmaceutical products. The processes for obtaining marketing approvals in the United States and in other jurisdictions, along with subsequent compliance with applicable statutes and regulations and other requirements of regulatory authorities, require the expenditure of substantial time and financial resources. 136 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents A. Regulation and Procedures Governing Approval of Drug and Biological Products in the United States In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and its implementing regulations and biologics under the FDCA, the Public Health Service Act, or the PHSA, and their implementing regulations. Both drugs and biologics are subject to other federal, state and local statutes and regulations. The process of obtaining regulatory approvals and subsequent compliance with applicable federal, state and local statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or following approval may subject a sponsor or marketing authorization (BLA/NDA) holder to administrative or judicial sanctions. These sanctions could include, among other actions, the FDA’s refusal to approve pending applications, withdrawal of an approval, license revocation, clinical hold, untitled or warning letters, voluntary or mandatory product recalls, market withdrawals, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement and civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us. A sponsor seeking approval to market and distribute a new drug or biological product in the United States generally must satisfactorily complete each of the following steps: –preclinical laboratory tests, animal studies and formulation studies all performed in accordance with applicable regulations, including the FDA’s good laboratory practices, or GLP, regulations; –submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin; –approval by the IRB representing each clinical site before each clinical trial may be initiated; –performance of adequate and well-controlled human clinical trials to establish the safety, potency and purity of the product candidate for each proposed indication, in accordance applicable regulations, including GCP; –preparation and submission to the FDA of a NDA for a drug product, or a BLA for a biological product requesting marketing approval for one or more proposed indications, including submission of detailed information on the manufacture and composition of the product in clinical development, evidence of safety, purity and potency from preclinical testing and clinical trials, and proposed labeling; –review of the product by an FDA advisory committee, if applicable; –satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities, including those of third parties, at which the product, or components thereof, are produced to assess compliance with current GMP requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; –satisfactory completion of any FDA audits of the clinical study sites to assure compliance with applicable regulations and GCP, and the integrity of clinical data in support of the NDA or BLA; –payment of user fees and securing FDA approval of the NDA or BLA; and –compliance with applicable regulations post approval, including any post-approval requirements, such as the potential requirement to implement a REMS and to conduct any post-approval studies required by the FDA. The preclinical and clinical testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product candidates and any future product candidates will be granted on a timely basis, or at all. 137 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Preclinical Studies and Investigational New Drug Application Before testing any drug or biological product candidate in humans, the product candidate must undergo preclinical testing. Preclinical tests include laboratory evaluations of product chemistry, formulation and stability, as well as animal studies to evaluate the potential for activity and toxicity. The conduct of the preclinical tests and formulation of the compounds for testing must comply with federal regulations and requirements. The results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, are submitted to the FDA as part of an IND application. The IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions about the product or conduct of the proposed clinical trial, including concerns that patients will be exposed to unreasonable health risks, and places the trial on a clinical hold. In that case, the IND sponsor and the FDA must resolve any outstanding FDA concerns before the clinical trial can begin. As a result, submission of the IND may result in the FDA not allowing the trial to commence or not be conducted on the terms originally specified by the sponsor in the IND. If the FDA raises concerns or questions either during this initial 30-day period, or at any time during the IND process, it may choose to impose a partial or complete clinical hold. If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under terms authorized by the FDA. A clinical hold issued by the FDA may therefore delay either a proposed clinical study or cause suspension of an ongoing study, until all outstanding concerns have been adequately addressed and the FDA has notified the company that investigation may proceed. This could cause significant difficulties in completing planned clinical trials in a timely manner. The FDA may impose clinical holds on a product candidate at any time before or during clinical trials due to safety concerns or non-compliance. Human Clinical Trials in Support of an NDA or a BLA Clinical trials involve the administration of the investigational product candidate to healthy volunteers or patients with the disease to be treated under the supervision of qualified principal investigators, generally physicians not employed by or under the trial sponsor’s control, in accordance with GCP requirements, which include the requirement that all patients provide their informed consent for their participation. Clinical trials are conducted under study protocols detailing, among other things, the objectives of the study, inclusion and exclusion criteria, the parameters to be used in monitoring safety, dosing procedures and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. A sponsor who wishes to conduct a clinical trial outside the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, the sponsor may submit data from the clinical trial to the FDA in support of the NDA or BLA so long as the clinical trial is well-designed and well-conducted in accordance with GCP, including review and approval by an independent ethics committee, and the FDA is able to validate the study data through an onsite inspection, if necessary. Further, each clinical trial must be reviewed and approved by an IRB either centrally or individually at each institution at which the clinical trial will be conducted. The IRB will consider, among other things, clinical trial design, patient informed consent, ethical factors and the safety of patients. An IRB must operate in compliance with FDA regulations. The FDA, IRB, or the clinical trial sponsor may suspend or discontinue a clinical trial at any time for various reasons, including a finding that the clinical trial is not being conducted in accordance with FDA requirements or that the patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive GCP rules and the requirements for informed consent. The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject or his or her legal representative and receive periodic reports regarding the investigation from the investigators. Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, 138 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents known as a data safety monitoring board or committee, or DSMB. This group may recommend continuation of the study as planned, changes in study conduct, or cessation of the study at designated check points based on access to certain data from the study. Clinical trials typically are conducted in three sequential phases, but the phases may overlap or be combined. Additional studies may be required after approval. –Phase 1 clinical trials (or Phase 1) are initially conducted in a limited population to test the product candidate for safety, including adverse effects, dose tolerance, absorption, metabolism, distribution, excretion and pharmacodynamics in healthy humans or, on occasion, in patients, such as in the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers. –Phase 2 clinical trials (or Phase 2) are generally conducted in a limited patient population to identify possible adverse effects and safety risks, preliminarily evaluate the efficacy of the product candidate for specific targeted indications and determine dose tolerance and optimal dosage. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning larger Phase 3 clinical trials. When a drug is intended to treat life-threatening or severely debilitating illnesses, and particularly for rare diseases, the FDA may accept well-controlled Phase 2 clinical trials as adequate to provide sufficient data on the drug’s safety and effectiveness to support a decision on its approvability for marketing, in which case Phase 3 clinical trials would not be required. –Phase 3 clinical trials (or Phase 3) proceed if the Phase 2 clinical trials demonstrate that a certain dose or dose range of the product candidate is potentially effective and has an acceptable safety profile. Phase 3 clinical trials are undertaken within an expanded patient population, often at geographically dispersed clinical trial sites, to gather additional information about safety and effectiveness necessary to evaluate the overall benefit-risk relationship of the product and to provide the basis for product labeling. In some cases, the FDA may approve an NDA or a BLA for a product candidate but require the sponsor to conduct additional clinical trials to further assess the product candidate’s safety and/or effectiveness after approval. Such post-approval trials are typically referred to as Phase 4 clinical trials (or Phase 4). These studies may be used to gain additional experience from the treatment of patients in the intended therapeutic indication and to document a clinical benefit in the case of biologics approved under accelerated approval regulations. If the FDA approves a product while a company has ongoing clinical trials that were not necessary for approval, a company may be able to use the data from these clinical trials to meet all or part of any Phase 4 clinical trial requirement or to request a change in the product labeling. Failure to exhibit due diligence with regard to conducting required Phase 4 clinical trials or to comply with post approval commitments could result in withdrawal of approval for products. During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical trial investigators. Annual progress reports detailing the results of the clinical trials must be submitted to the FDA. Written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected adverse events, any findings from other trials, tests in laboratory animals or in vitro testing that suggest a significant risk for patients, or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life- threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information. The FDA or the sponsor or its DSMB may suspend a clinical trial at any time on various grounds, including a finding that the patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in 139 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents accordance with the IRB’s requirements or if the new drug candidate or biological product candidate has been associated with unexpected serious harm to patients. There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries. Sponsors of clinical trials of FDA-regulated products, including biologics, are required to register and disclose certain clinical trial information, which is publicly available at www.clinicaltrials.gov. Information related to the product, patient population, phase of investigation, trial sites and investigators, and other aspects of the clinical trial is then made public as part of the registration. Sponsors are also obligated to discuss the results of their clinical trials after completion. Disclosure of the results of these trials can be delayed until the new product or new indication being studied has been approved. Compliance with GMP Requirements Before approving an NDA or a BLA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in full compliance with GMP requirements and adequate to assure consistent production of the product within required specifications. Among other things, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final drug or biological product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the drug or biological product does not undergo unacceptable deterioration over its shelf life. In particular, the PHSA emphasizes the importance of manufacturing control for products like biologics whose attributes cannot be precisely defined. Manufacturers and others involved in the manufacture and distribution of drugs and biological products must also register their establishments with the FDA and certain state agencies. Both domestic and foreign manufacturing establishments must register and provide additional information to the FDA upon their initial participation in the manufacturing process. The manufacturing facilities may be subject to periodic announced and unannounced inspections by government authorities to ensure compliance with GMPs and other laws. Manufacturers may have to provide, on request, electronic or physical records regarding their establishments. Delaying, denying, limiting or refusing inspection by the FDA may lead to a product being deemed to be adulterated. Review and Approval of an NDA or a BLA The results of product candidate development, preclinical testing and clinical trials, including negative or ambiguous results as well as positive findings, are submitted to the FDA as part of an NDA or a BLA requesting a license to market the product. These applications must contain extensive manufacturing information and detailed information on the composition of the product and proposed labeling. The FDA adjusts the Prescription Drug User Fee Act, or PDUFA, user fees on an annual basis. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on NDAs or BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication. The FDA has 60 days after submission of the application to conduct an initial review to determine whether the NDA or BLA is sufficient to accept for filing based on the agency’s threshold determination that it is substantially complete so as to permit substantive review. Once the submission has been accepted for filing, the FDA begins an in-depth review of the application. Under the goals and policies agreed to by the FDA under PDUFA, the FDA aims to complete its initial review of a standard application and respond to the sponsor within ten months of the 60-day filing date, and for a priority review application within six months. The FDA does not always meet its PDUFA goal dates for standard and priority NDA or BLA applications, and its review goals are subject to change from time to time. The review process may often be significantly extended by FDA requests for additional information or clarification. The review process and the PDUFA goal date may also be extended by three months 140 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents if the FDA requests or if the sponsor otherwise provides additional information or clarification regarding information already provided in the submission within the last three months before the PDUFA goal date. The FDA reviews NDA and BLA applications to determine, among other things, whether the proposed product is safe and potent, and/or effective, for its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with GMP requirements to assure and preserve the product’s identity, safety, strength, quality, potency and purity. On the basis of the FDA’s evaluation of the application and accompanying information, including the results of the inspection of the manufacturing facilities and any FDA audits of clinical trial sites to assure compliance with GCPs, the FDA may issue either an approval letter or a complete response letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. Under the FDCA, the FDA may approve an NDA if it determines that the product is safe and effective for its intended use, the benefits of the drug outweigh any risks, and the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality and purity. Under the PHSA, the FDA may approve a BLA if it determines that the product is safe, pure and potent and the facility where the product will be manufactured meets standards designed to ensure that it continues to be safe, pure and potent. If the application is not approved, the FDA may issue a complete response letter, which will contain the conditions that must be met in order to secure final approval of the application, and when possible will outline recommended actions the sponsor might take to obtain approval of the application. If a complete response letter is issued, the sponsor may either resubmit the NDA or BLA, addressing all of the deficiencies identified in the letter, or withdraw the application. Sponsors that receive a complete response letter who elect to address the deficiencies may submit to the FDA information that represents a complete response to the issues identified by the FDA in the response letter. Such resubmissions are classified under PDUFA as either Class 1 or Class 2, based on the information submitted by a sponsor in response to an action letter. Under the goals and policies agreed to by the FDA under PDUFA, the FDA aims to review and act on a Class 1 resubmission with two months of receipt and, with respect to a Class 2 resubmission, within six months of receipt. The FDA will not approve an application until issues identified in the complete response letter have been addressed. The FDA may also refer the application to an Advisory Committee for review, evaluation and recommendation as to whether the application should be approved and under what conditions. In particular, the FDA may refer applications for novel drug or biological products or drug or biological products that present difficult questions of safety or efficacy to an advisory committee. Typically, an Advisory Committee is a panel of independent experts, including clinicians and other scientific experts. The FDA is not bound by the recommendations of an Advisory Committee, but it considers such recommendations carefully when making decisions. If the FDA approves a new product, it may limit the approved indications for use of the product or limit the approval to specific dosages. It may also require that certain contraindications, warnings or precautions be included in the product labeling. In addition, the FDA may call for post-approval studies, including Phase 4 clinical trials, to further assess the product’s safety after approval. The agency may also require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms, including risk evaluation and mitigation strategies, or REMS, to help ensure that the benefits of the product outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals, and elements to assure safe use, or ETASU. ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring and the use of patent registries. If the FDA concludes a REMS is needed, the sponsor of the NDA or BLA must submit a proposed REMS; the FDA will not approve the NDA or BLA without a REMS, if required. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval, many types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval. 141 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Fast Track, Breakthrough Therapy and Priority Review Designations The FDA may designate certain products for expedited review if they are intended to address an unmet medical need in the treatment of a serious or life-threatening disease or condition. These programs include fast track designation, breakthrough therapy designation and priority review designation. The FDA may designate a product for fast track review if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such disease or condition. Fast track designation applies to the combination of the product and the specific indication for which it is being studied. The sponsor of a new drug or biologic may request that the FDA designate the drug or biologic as a fast track product at any time during the clinical development of the product. For fast track products, sponsors may have greater interactions with the FDA and the FDA may initiate review of sections of a fast track product’s application before the application is complete. This rolling review may be available if the FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a fast track product may be effective. The sponsor must also provide, and the FDA must approve, a schedule for the submission of the remaining information and the sponsor must pay applicable user fees. However, the FDA’s time period goal for reviewing a fast track application does not begin until the last section of the application is submitted, and designation as a fast track product does not guarantee a decision by that goal date. Fast track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process. A product may be designated as a breakthrough therapy if it is intended, either alone or in combination with one or more other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The FDA may take certain actions with respect to breakthrough therapies, including holding additional meetings with the sponsor throughout the development process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff in the review process; assigning a cross-disciplinary project lead for the review team; and taking other steps to facilitate the design of clinical trials in an efficient manner. The FDA may designate a product for priority review if it is a product that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. The FDA determines, on a case- by-case basis, whether the proposed product represents a significant improvement when compared with other available therapies. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting product reaction, documented enhancement of patient compliance that may lead to improvement in serious outcomes and evidence of safety and effectiveness in a new subpopulation. A priority designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action on a marketing application to six months (compared to 10 months under standard review). A designation of priority review does not guarantee a decision by the priority review date. Fast track designation, priority review and breakthrough therapy designation may expedite the development or approval process, but do not change the standards for approval. Accelerated Approval Pathway The FDA may grant accelerated approval to a product for a serious or life-threatening condition that provides meaningful therapeutic advantage to patients over existing treatments based upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. The FDA may also grant accelerated approval for such a condition when the product has an effect on an intermediate clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, or IMM, and that is reasonably likely to predict an effect on IMM or other clinical benefit, taking into account the severity, rarity or 142 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents prevalence of the condition and the availability or lack of alternative treatments. Products granted accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. An intermediate clinical endpoint is a measurement of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a product, such as an effect on IMM. The FDA has stated that although it has limited experience with accelerated approvals based on intermediate clinical endpoints, such endpoints generally may support accelerated approval where the therapeutic effect measured by the endpoint is not itself a clinical benefit and basis for traditional approval, if there is a basis for concluding that the therapeutic effect is reasonably likely to predict the ultimate clinical benefit of a product. The accelerated approval pathway is most often used in settings in which the course of a disease is long and an extended period of time is required to measure the intended clinical benefit of a product. Thus, accelerated approval has been used extensively in the development and approval of products for treatment of a variety of cancers in which the goal of therapy is generally to improve survival or decrease morbidity and the duration of the typical disease course requires lengthy and sometimes large trials to demonstrate a clinical or survival benefit. The accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the product’s clinical benefit. As a result, a product candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies, or to confirm a clinical benefit during post- marketing studies, may lead the FDA to withdraw the product from the market under expedited withdrawal procedures applicable to products approved under accelerated approval. All promotional materials for product candidates approved under accelerated regulations are subject to prior review by the FDA. Accelerated approval pathways are available for regenerative medicine therapies that meet certain conditions. Regenerative medicine therapies include cell therapies (both allogeneic and autologous), therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except those regulated under section 361 of the PHSA. Human gene therapies, including genetically modified cells, that lead to a sustained effect on cells or tissues, may also meet the definition of a regenerative medicine therapy, as may xenogeneic cell products. Regenerative medicine therapies designed to treat, modify, reverse or cure serious conditions are eligible for FDA’s expedited programs, including fast track designation, breakthrough therapy designation, priority review and accelerated approval, if they meet the criteria for such programs. They may also be eligible for Regenerative Medicine Advanced Therapy Designation, or RMAT designation. An investigational drug is eligible for RMAT designation if it meets the definition of regenerative medicine therapy, it is intended to treat, modify, reverse or cure a serious condition, and preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such condition. An unmet medical need is a condition whose treatment or diagnosis is not addressed adequately by available therapy. RMAT designation confers all the benefits of the fast track and breakthrough therapy designation programs, including early interactions with the FDA. The FDA reviews each application on a case-by-case basis to determine whether the clinical evidence is sufficient to support RMAT designation, considering factors such as the rigor of data collection, the consistency and persuasiveness of the outcomes, the number of patients, and the 143 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents severity, rarity or prevalence of the condition, among other factors. The FDA may decline to grant RMAT designation if it finds the clinical evidence insufficient. RMAT designation may expedite the development or approval process, but it does not change the standards for approval. Emergency Use Authorizations The Secretary of Health and Human Services has the authority to authorize unapproved medical products, including vaccines, to be marketed in the context of an actual or potential emergency that has been designated by government officials. The COVID-19 pandemic has been designated such a national emergency. After an emergency has been announced, the Secretary of Health and Human Services may authorize the issuance of, and the FDA Commissioner may issue, Emergency Use Authorizations, or EUAs, for the use of specific products based on criteria established by statute, including that the product at issue may be effective in diagnosing, treating, or preventing serious or life-threatening diseases when there are no adequate, approved, and available alternatives. An EUA is subject to additional conditions and restrictions and is product-specific. An EUA terminates when the emergency determination underlying the EUA terminates or full approval is obtained. An EUA is not a long-term alternative to obtaining FDA approval, licensure, or clearance for a product. FDA may revoke an EUA where it is determined that the underlying health emergency no longer exists or warrants such authorization, so it is not possible to predict how long an EUA may remain in place. Post-Approval Regulation If regulatory approval for marketing of a product or for a new indication for an existing product is obtained, the sponsor will be required to comply with rigorous and extensive post-approval regulatory requirements as well as any post-approval requirements that the FDA has imposed on the particular product as part of the approval process. The sponsor will be required, among other things, to report certain adverse reactions and manufacturing problems, or certain other events to the FDA, provide updated safety and efficacy information and comply with requirements concerning advertising and promotional labeling. Manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including GMP regulations, which impose certain procedural and documentation requirements upon manufacturers. Accordingly, the BLA holder and its third-party manufacturers must continue to expend time, money and effort in the areas of production and quality control to maintain compliance with GMP regulations and other regulatory requirements. In addition, changes to the manufacturing process or facility generally require prior FDA approval before being implemented, and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval. Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market study requirements or clinical trial requirements to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things: –restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; –fines, untitled letters or warning letters or holds on post-approval clinical trials; –adverse publicity, including FDA statements regarding the safety of products; 144 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents –refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals; –product seizure or detention, or refusal to permit the import or export of products; or –injunctions, fines, debarment, disgorgement of profits or the imposition of civil or criminal penalties. The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Pharmaceutical products may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. Orphan Drug Designation Orphan drug designation in the United States is designed to encourage sponsors to develop products intended for rare diseases or conditions. In the United States, a rare disease or condition is statutorily defined as a disease or condition that affects fewer than 200,000 individuals in the United States or that affects more than 200,000 individuals in the United States but for which there is no reasonable expectation that the cost of developing and making available the product for the disease or condition will be recovered from sales of the product in the United States. Orphan drug designation qualifies a company for certain financial incentives, including tax advantages and, if the product receives the first FDA approval for the indication for which it has orphan designation, market exclusivity for seven years following the date of the product’s marketing approval. An application for designation as an orphan product can be made any time prior to the filing of an application for approval to market the product. Once a product receives orphan drug designation from the Office of Orphan Products Development at the FDA, the product must then go through the review and approval process like any other product. In addition, a sponsor of a product that is otherwise the same product as an already approved orphan drug may seek and obtain orphan drug designation for the subsequent product for the same rare disease or condition if it can present a plausible hypothesis that its product may be clinically superior to the first product. More than one sponsor may receive orphan drug designation for the same product for the same rare disease or condition, but each sponsor seeking orphan drug designation must file a complete request for designation. The period of exclusivity begins on the date that the marketing application is approved by the FDA and applies only to the indication for which the product has been designated. The FDA may approve a second application for the same product for a different use or a second application for a clinically superior version of the product for the same use. The FDA cannot, however, approve the same product made by another manufacturer for the same indication during the market exclusivity period unless it has the consent of the sponsor, the manufacturer makes a showing of clinical superiority over the product with orphan exclusivity, or the sponsor is unable to provide sufficient quantities. Orphan product designation does not convey any advantage in or shorten the duration of the regulatory review and approval process. Pediatric Studies and Exclusivity Under the Pediatric Research Equity Act of 2003, an NDA or a BLA or supplement thereto must contain data that are adequate to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. Sponsors who are planning to submit a marketing application for a drug or biological product that includes a new active ingredient, new indication, new dosage form, new dosing regimen 145 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents or new route of administration must also submit pediatric study plans prior to the assessment data, and no later than 60 calendar days following an end-of-Phase 2 meeting with the FDA or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 study. Pediatric study plans must contain an outline of the proposed pediatric study or studies the sponsor plans to conduct, including study objectives and design, any deferral or waiver requests and other information required by regulation. The sponsor, the FDA, and the FDA’s internal review committee must then review the information submitted, consult with each other and agree upon a final plan. The FDA or the sponsor may request an amendment to the plan at any time. The FDA may, on its own initiative or at the request of the sponsor, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. Additional requirements and procedures relating to deferral requests and requests for extension of deferrals are contained in the Food and Drug Administration Safety and Innovation Act. Unless otherwise required by regulation, the pediatric data requirements do not apply to products with orphan designation. Pediatric exclusivity is another type of non-patent marketing exclusivity in the United States and, if granted, provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity, including the non-patent and orphan exclusivity. This six-month exclusivity may be granted if an NDA or a BLA sponsor submits pediatric data that fairly respond to a written request from the FDA for such data. The data do not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond to the FDA’s request, the additional protection is granted. If reports of requested pediatric studies are submitted to and accepted by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection cover the product are extended by six months. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve another application. Biosimilars and Reference Product Exclusivity The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, signed into law in 2010, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009, or the BPCIA, which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-approved reference biological product. To date, a number of biosimilars have been licensed under the BPCIA, and numerous biosimilars have been approved in Europe. Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture, it is unclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which are governed by state pharmacy law. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars. Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency, can be shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. 146 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Complexities associated with the larger, and often more complex, structures of biological products, as well as the processes by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval pathway that are still being worked out by the FDA. The BPCIA is complex and continues to be interpreted and implemented by the FDA. In addition, recent government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate implementation and impact of the BPCIA is subject to significant uncertainty. B. Regulation and Procedures Governing Approval of Medicinal Products in the European Union The process governing approval of medicinal products, including biological medicinal products and advanced therapy medicinal products, or ATMPs, which comprise gene therapy products, somatic cell therapy products and tissue-engineered products, in the European Union generally follows the same lines as in the United States. It entails satisfactory completion of pharmaceutical development, nonclinical and clinical studies to establish the safety and efficacy of the medicinal product for each proposed indication. Moreover, an applicant must also demonstrate the ability to manufacture the product to a suitable quality. Clinical Trial Approval Until recently, pursuant to the Clinical Trials Directive 2001/20/EC and the Directive 2005/28/EC on GCP, a system for the approval of clinical trials in the European Union had been implemented through national legislation of the member states. Under this system, a sponsor had to obtain approval from the competent national authority of a European Union member state in which the clinical trial is to be conducted or in multiple member states if the clinical trial is to be conducted in a number of member states. Furthermore, the sponsor could only start a clinical trial at a specific study site after an independent ethics committee had issued a favorable opinion. In April 2014, the European Union adopted a new Clinical Trials Regulation (EU) No 536/2014, which took effect on January 31, 2022 and replaced the Clinical Trials Directive 2001/20/EC. Commission Implementing Regulation (EU) 2017/556 replaced the GCP Directive 2005/28/EC. The Clinical Trials Regulation has overhauled the former system of approvals. Specifically, the Regulation, which is directly applicable in all member states, aims to simplify and streamline the approval of clinical trials in the European Union. For instance, Regulation (EU) No 536/2014 enables sponsors to submit one online application via a single online platform known as the Clinical Trials Information System (CTIS) for approval to run a clinical trial in several European countries, making it more efficient to carry out such multinational trials. It provides for strictly defined deadlines for the assessment of clinical trial applications. This means that one national authority takes the lead in reviewing the application and the other national authorities have only limited involvement, although the clinical trial approval is still granted by each national competent authority. Any substantial changes to the trial protocol or other information submitted with the clinical trial applications must be notified to or approved by the relevant competent authorities and ethics committees. As of January 31, 2025, all new or ongoing clinical trials in the European Union are subject to the requirements of the Clinical Trials Regulation (and the Clinical Trial Directive no longer applies). Clinical trials must be conducted in accordance with European Union and national regulations and the International Conference on Harmonization, or ICH, guidelines on GCP. Additional GCP guidelines from the European Commission, with a focus on traceability, apply to clinical trials of ATMPs. If the sponsor of the clinical trial is not established within the European Union, it must appoint an entity within the European Union to act as its legal representative. The clinical trial application must be accompanied by a copy of the trial protocol and an investigational medicinal product dossier with supporting information prescribed by applicable legislation as further detailed in applicable 147 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents guidance documents. Moreover, the sponsor must take out a clinical trial insurance policy, and in most European Union countries the sponsor is liable to provide ‘no fault’ compensation to any study subject injured in the clinical trial. The sponsor of a clinical trial must register the clinical trial in advance, and information related to the product, patient population, phase of investigation, study sites and investigators, and other aspects of the clinical trial will be made public as part of the registration. The results of the clinical trial must be submitted to the competent authorities and, with the exception of non-pediatric Phase 1 trials, will be made public at the latest within 12 months after the end of the trial. During the development of a medicinal product, the European Medicines Agency, or EMA, and national medicines regulators within the European Union provide the opportunity for dialogue and guidance on the development program. At the EMA level, this is usually done in the form of scientific advice, which is given by the Scientific Advice Working Party of the Committee for Medicinal Products for Human Use, or CHMP. A fee is incurred with each scientific advice procedure. Advice from the EMA is typically provided based on questions concerning, for example, quality (chemistry, manufacturing and controls testing), nonclinical testing and clinical studies, and pharmacovigilance plans and risk-management programs. Advice is not legally binding with regard to any future marketing authorization application of the product concerned. Marketing Authorization To obtain a marketing authorization for a product under the European Union regulatory system, a sponsor must submit a marketing authorization application, or MAA, either under the centralized procedure administered by the EMA or one of the procedures administered by competent authorities in European Union member states (decentralized procedure, mutual recognition procedure, or if the product is to be approved in only one member state, the national procedure). All application procedures require an application in the common technical document, or CTD, format, which includes the submission of detailed information about the manufacturing and quality of the product, and nonclinical and clinical trial information. There is an increasing trend in the European Union toward greater transparency and, while certain of the manufacturing or quality information is currently generally protected as commercially confidential information, the EMA and national regulatory authorities are now liable to disclose much of the nonclinical and clinical information in marketing authorization dossiers, including the full clinical study reports, in response to freedom of information requests after the marketing authorization has been granted. In October 2014, the EMA adopted a policy under which clinical study reports would be posted on the agency’s website following the grant, denial or withdrawal of a MAA, subject to procedures for limited redactions and protection against unfair commercial use. The full operation of this policy has been suspended in recent years due to priorities. However, it continues to apply the policy to COVID-19 vaccines and therapeutics and any medicines with new active substances that received a CHMP opinion from September 2023 onwards or were withdrawn before the opinion stage. A similar transparency requirement is contained in the Clinical Trials Regulation (EU) No 536/2014. A marketing authorization may be granted only to a sponsor established in the European Union. Regulation (EC) No. 1901/2006 on medicinal products for pediatric use provides that prior to obtaining a marketing authorization in the European Union in the centralized procedure, a sponsor must demonstrate compliance with all measures included in an EMA-approved Pediatric Investigation Plan covering all subsets of the pediatric population, unless the EMA has granted a product-specific waiver, class waiver or deferral for one or more of the measures included in the Pediatric Investigation Plan. The centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid for all European Union and European Economic Area member states. Pursuant to Regulation (EC) No. 726/2004, the centralized procedure is compulsory for specific products, including for 148 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents medicines (including vaccines) produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy medicinal products and products with a new active substance indicated for the treatment of certain diseases, including products for the treatment of cancer. For products with a new active substance indicated for the treatment of other diseases and products that are highly innovative or for which a centralized process is in the interest of patients, the centralized procedure is optional. Under the centralized procedure, the CHMP established at the EMA is responsible for conducting the assessment of a product to define its risk/benefit profile. Under the centralized procedure, the maximum timeframe for the evaluation of an MAA is 210 days, excluding clock stops when additional information or written or oral explanation is to be provided by the applicant in response to questions from the CHMP. Accelerated evaluation may be granted by the CHMP in exceptional cases, when a medicinal product is of major interest from the point of view of public health determined by three cumulative criteria: (i) the seriousness of the disease (e.g., heavy disabling or life-threatening diseases) to be treated, (ii) the absence or insufficiency of an appropriate alternative therapeutic approach, and (iii) anticipation of high therapeutic benefit. If the CHMP accepts such a request, the time limit of 210 days will be reduced to 150 days, but it is possible that the CHMP may revert to the standard time limit for the centralized procedure if it determines that it is no longer appropriate to conduct an accelerated assessment. The Committee for Advanced Therapies, or CAT, is responsible in conjunction with the CHMP for the evaluation of ATMPs. The CAT is primarily responsible for the scientific evaluation of ATMPs and prepares a draft opinion on the quality, safety and efficacy of each ATMP for which a MAA is submitted. The CAT’s opinion is then taken into account by the CHMP when giving its final recommendation regarding the authorization of a product in view of the balance of benefits and risks identified. Although the CAT’s draft opinion is submitted to the CHMP for final approval, the CHMP may depart from the draft opinion if it provides detailed scientific justification. The CHMP and CAT are also responsible for providing guidelines on ATMPs and have published numerous guidelines, including specific guidelines on gene therapies and cell therapies. These guidelines, which are not legally binding, provide additional guidance on the factors that the EMA will consider in relation to the development and evaluation of ATMPs and include, inter alia, the preclinical studies required to characterize ATMPs, the manufacturing and control information that should be submitted in a MAA; and post-approval measures required to monitor patients and evaluate the long term efficacy and potential adverse reactions of ATMPs. The European Commission may grant a so-called “marketing authorization under exceptional circumstances.” Such authorization is intended for products for which the applicant can demonstrate that it is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, or in the present state of scientific knowledge, comprehensive information cannot be provided, or it would be contrary to generally accepted principles of medical ethics to collect such information. Consequently, marketing authorization under exceptional circumstances may be granted subject to certain specific obligations, which may include the following: –the applicant must complete an identified program of studies within a time period specified by the competent authority, the results of which form the basis of a reassessment of the benefit/risk profile; –the medicinal product in question may be supplied on medical prescription only and may in certain cases be administered only under strict medical supervision, possibly in a hospital, and in the case of a radio- pharmaceutical, by an authorized person; and –the package leaflet and any medical information must draw the attention of the medical practitioner to the fact that the particulars available concerning the medicinal product in question are as yet inadequate in certain specified respects. 149 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents A marketing authorization under exceptional circumstances is subject to annual review to reassess the risk- benefit balance in an annual re-assessment procedure. Continuation of the authorization is linked to the annual reassessment and a negative assessment could potentially result in the marketing authorization being suspended or revoked. The renewal of the marketing authorization of a medicinal product under exceptional circumstances follows the same rules as a “normal” marketing authorization. After five years, the marketing authorization will then be renewed under exceptional circumstances for an unlimited period, unless the EMA decides, on justified grounds, to proceed with one additional five-year renewal. The European Commission may also grant a so-called “conditional marketing authorization” prior to obtaining the comprehensive clinical data required for an application for a full marketing authorization. Such conditional marketing authorizations may be granted for product candidates (including medicines designated as orphan medicinal products and vaccines) if the CHMP finds that all the following requirements are met: –the benefit-risk balance of the product is positive; –it is likely that the applicant will be able to provide comprehensive data; –unmet medical needs will be fulfilled; and –the benefit to public health of the medicinal product’s immediate availability on the market outweighs the risks due to need for further data. A conditional marketing authorization will contain specific obligations to be fulfilled by the marketing authorization holder, including obligations with respect to the completion of ongoing or new studies, manufacturing information and with respect to the collection of pharmacovigilance data. Conditional marketing authorizations are valid for one year, and may be renewed annually, if the risk-benefit balance remains positive, and after an assessment of the need for additional or modified conditions and/or specific obligations. The timelines for the centralized procedure described above also apply with respect to the review by the CHMP of applications for a conditional marketing authorization. Once comprehensive data on the medicinal product have been obtained, the marketing authorization may be converted into a standard marketing authorization which is no longer subject to specific obligations. Initially, this is valid for five years, but can be renewed for unlimited validity. During the COVID-19 pandemic, the EMA followed a “rolling review” process for COVID-19 vaccines, which is an ad hoc procedure by which data is assessed as it becomes available with the aim of granting a conditional marketing authorization. The European Union medicines rules expressly permit the member states to adopt national legislation prohibiting or restricting the sale, supply or use of any medicinal products containing, consisting of or derived from a specific type of human or animal cell, such as embryonic stem cells. Periods of Authorization and Renewals A marketing authorization is valid for five years, in principle, and it may be renewed after five years on the basis of a reevaluation of the risk benefit balance by the EMA or by the competent authority of the authorizing member states. To that end, the marketing authorization holder must provide the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorization was granted, at least six months before the marketing authorization ceases to be valid. Once renewed, the marketing authorization is valid for an unlimited period, unless the European Commission or the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period. Any authorization that is not followed by the placement of the product on the European Union market (in the case of the centralized procedure) or on the market of the authorizing member state within three years after authorization ceases to be valid (referred to as the “sunset” clause). 150 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Emergency Use Distribution The European Union medicines rules, as implemented into the national laws of the EU member states, permit national authorities to authorize temporarily the distribution of an unapproved medicinal product in certain emergency situations, including suspected or confirmed spread of pathogenic agents. Such an emergency use distribution, or EUD (sometimes referred to as a “temporary exemption,” i.e., a temporary exemption from the requirement to obtain a marketing authorization), would apply for the duration of the emergency only and would be limited to the member state in which it has been issued. When considering whether to grant an EUD, the relevant member state decides, which data it requires for the grant of the EUD. COVID-19 vaccines to date have followed the centralized procedure, which was previously combined with a rolling review of data with a view to granting conditional marketing authorizations. Regulatory Requirements after Marketing Authorization Following approval, the holder of the marketing authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of the medicinal product. These include compliance with the European Union’s stringent pharmacovigilance or safety reporting rules, pursuant to which post-authorization studies and additional monitoring obligations can be imposed. The holder of a marketing authorization must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance who is responsible for oversight of that system. Key obligations include expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports, or PSURs. All new MAAs must include a risk management plan, or RMP, describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the marketing authorization. Such risk-minimization measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization safety or efficacy studies. RMPs and PSURs are routinely available to third parties requesting access, subject to limited redactions. In addition, the manufacturing of authorized products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with the EMA’s GMP requirements and comparable requirements of other regulatory bodies in the European Union, which mandate the methods, facilities and controls used in the manufacturing, processing and packing of products to assure their safety and identity. Specifically, medicinal products may only be manufactured in the European Union, or imported into the European Union from another country, by the holder of a manufacturing/import authorization from the competent national authority. The manufacturer or importer must have a qualified person who is responsible for certifying that each batch of product has been manufactured in accordance with European Union standards of good manufacturing practice, or GMP, before releasing the product for commercial distribution in the European Union or for use in a clinical trial. Manufacturing facilities are subject to periodic inspections by the competent authorities for compliance with GMP. Finally, the marketing and promotion of authorized products, including industry-sponsored continuing medical education and advertising directed toward the prescribers of products and/or the general public, are strictly regulated in the European Union. In principle, all advertising and promotional activities for the product must be consistent with the approved summary of product characteristics, and therefore all off-label promotion is prohibited. Direct-to-consumer advertising of prescription medicines (including vaccines) is also prohibited in the European Union. Although general requirements for advertising and promotion of medicinal products are established under Directive 2001/83/EC, as amended, the details and the enforcement of these rules are governed by regulations in each member state and can differ from one country to another. The enforcement actions and consequences for non-compliance with the EU legislation are similar to those listed above for the United States. For centrally approved products in the EU, there is the possibility of fines for 151 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents regulatory non-compliance with certain of the legal requirements, including in relation to obligations regarding placing the product on the market, safety monitoring and pediatric compliance. Human Cells and Tissues Human cells and tissues that are intended for human applications but that do not fall within the scope of rules governing medicinal products or medical devices are not subject to premarket review and approval, nor do they require extensive preclinical and clinical testing. However, there are European Union rules governing the donation, procurement, testing and storage of human cells and tissues intended for human application, whether or not they are ATMPs. These rules also cover the processing, preservation and distribution of human cell and tissues that are not ATMPs. Establishments that conduct such activities must be licensed and are subject to inspection by regulatory authorities. Such establishments must implement appropriate quality systems and maintain appropriate records to ensure that cells and tissues can be traced from the donor to the recipient and vice versa. There are also requirements to report serious adverse events and reactions linked to the quality and safety of cells and tissues. More detailed rules may exist at the national level. Named Patient Supplies and Compassionate Use Programs The European Union medicines rules allow individual member states to permit the supply of a medicinal product without a marketing authorization to fulfill special needs, where the product is supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of a healthcare professional and for use by an individual patient under his direct personal responsibility. This may in certain countries also apply to products manufactured in a country outside the European Union and imported to treat specific patients or small groups of patients. Some member state laws also provide for compassionate use on a “cohort” basis, subject to review and approval of the cohort program based on the local laws in the member state. Orphan Drug Designation and Exclusivity Regulation (EC) No. 141/2000 and Regulation (EC) No. 847/2000 provide that a product can be designated as an orphan drug by the European Commission if its sponsor can establish: that the product is intended for the diagnosis, prevention or treatment of (i) a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the European Union when the application is made, or (ii) a life-threatening, seriously debilitating or serious and chronic condition in the European Union and that without incentives it is unlikely that the marketing of the product in the European Union would generate sufficient return to justify the necessary investment. For either of these conditions, the sponsor must demonstrate that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the European Union or, if such method exists, the product has to be of significant benefit compared to products available for the condition. An orphan drug designation provides a number of benefits, including fee reductions, regulatory assistance and the possibility to apply for a centralized European Union marketing authorization. Marketing authorization for an orphan drug leads to a 10-year period of orphan market exclusivity. During this orphan market exclusivity period, neither the EMA nor the European Commission or the member states can accept an application or grant a marketing authorization for a “similar medicinal product.” A “similar medicinal product” is defined as a medicinal product containing a similar active substance or substances as contained in a currently authorized orphan medicinal product, and which is intended for the same therapeutic indication. The market exclusivity period for the authorized therapeutic indication may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan drug designation. European Data Collection and Data Protection Laws 152 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents We are required to comply with strict data protection and privacy legislation in the jurisdictions in which we operate, including the General Data Protection Regulation (EU) 2016/679, or GDPR. The GDPR governs our collection and use of personal data in the European Union relating to individuals (e.g., patients). The GDPR imposes several requirements on organizations that process such data, including: to observe core data processing principles; to comply with various accountability measures; to provide more detailed information to individuals about data processing activities; to establish a legal basis to process personal data (including enhanced consent requirements); to maintain the integrity, security and confidentiality of personal data; and to report personal data breaches. The GDPR also restricts the transfer of personal data outside of the European Economic Area (e.g., to the United States and other countries that are not deemed to provide adequate protection under their domestic laws). The GDPR may impose additional responsibility and liability in relation to personal data that we process, and require us to put in place additional mechanisms ensuring compliance with the new data protection rules. This may be onerous and adversely affect our business, financial condition, results of operations and prospects. Failure to comply with the requirements of the GDPR and related national data protection laws of European Union member states may result in a variety of enforcement measures, including significant fines and other administrative measures. The GDPR has introduced substantial fines for breaches of the data protection rules, increased powers for regulators, enhanced rights for individuals, and new rules on judicial remedies and collective redress. We may be subject to claims by third parties, such as patients or regulatory bodies, that we or our employees or independent contractors inadvertently or otherwise breached GDPR and related data protection rules. Litigation may be necessary to defend against these claims. There is no guarantee of success in defending these claims, and if we do not prevail, we could be required to pay substantial fines and/or damages and could suffer significant reputational harm. Even if we are successful, litigation could result in substantial cost and be a distraction to management and other employees. C. Coverage, Pricing and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we may obtain regulatory approval. Even if our product candidates are approved for marketing, sales of such product candidates will depend, in part, on the extent to which third-party payors, including government health programs in the United States (such as Medicare and Medicaid), commercial health insurers and managed care organizations, provide coverage and establish adequate reimbursement levels for such product candidates. In the United States, the member states of the European Union and markets in other countries, patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Reimbursement rules and levels are not harmonized in the European Union and therefore differ from member state to member state. Patients are unlikely to use any product candidates we may develop unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of such product candidates. The process for determining whether a payor will provide coverage for a product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the product once coverage is approved. Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services and imposing controls to manage costs. In order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost- effectiveness of the product, and the cost of these studies would be in addition to the costs required to obtain FDA or other comparable marketing approvals. Even after pharmacoeconomic studies are conducted, product candidates may not be considered medically necessary or cost effective. A decision by a third-party payor not to cover any product candidates we may develop could reduce physician utilization of such product candidates once approved and have a material adverse effect on our sales, results of operations and financial condition. Additionally, a payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. For example, the payor may require co-payments that patients find unacceptably high. Further, one payor’s determination to provide coverage for a product does not assure that such coverage will continue or that other payors will also provide coverage and reimbursement for the product, 153 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents and the level of coverage and reimbursement can differ significantly from payor to payor. Third-party reimbursement and coverage may not be adequate to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. The insurance coverage and reimbursement status of newly approved products for orphan diseases is particularly uncertain, and failure to obtain or maintain adequate coverage and reimbursement for any such product candidates could limit a company’s ability to generate revenue. The containment of healthcare costs also has become a priority of U.S. federal and state and other non-U.S. governments as well as other third-party payors such as statutory health insurance funds, and the prices of pharmaceuticals have been a focus in this effort. Governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit a company’s revenue from the sale of any approved products. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which a company or its collaborators receive marketing approval, less favorable coverage policies and reimbursement rates may be implemented or coverage may be ended in the future. Outside the United States, we will face challenges in ensuring and obtaining adequate coverage and payment for any product candidates we may develop. Pricing of prescription pharmaceuticals is subject to governmental control in many countries, including in particular the member states of the European Union. Pricing negotiations with governmental authorities or other third-party payors such as statutory health insurance funds can extend well beyond the receipt of regulatory marketing approval for a product and may require us to conduct a clinical trial or non-interventional study that compares the cost effectiveness of any product candidates we may develop to other available therapies. The conduct of such a clinical trial or study could be expensive and result in delays in our commercialization efforts. In the European Union, pricing and reimbursement schemes vary widely from country to country. Some countries provide that products may be marketed only after a reimbursement price has been agreed. Some countries may require the completion of additional studies that compare the cost effectiveness of a particular product candidate to currently available therapies (so called health technology assessments) in order to obtain reimbursement or pricing approval. The European Union recently adopted Regulation (EU) 2021/2282 on health technology assessment, which provides a framework for member states to cooperate on health technology assessments at the EU level. The Regulation is directly applicable in all EU member states which is in a phased period of applicability since January 12, 2025, although pricing will still be determined nationally. Moreover, at the national level, European Union member states may restrict the range of products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. Member states may approve a specific price for a product or may instead adopt a system of direct or indirect controls on the profitability of the company placing the product on the market. Other member states allow companies to fix their own prices for products, but monitor and control prescription volumes and issue guidance to physicians to limit prescriptions. Recently, many countries in the European Union have increased the amount of discounts required on pharmaceuticals and these efforts could continue as countries attempt to manage healthcare expenditures, especially in light of the severe fiscal and debt crises experienced by many countries in the European Union. The downward pressure on health care costs in general, particularly prescription products, has become intense. As a result, increasingly high barriers are being erected to the entry of new products in the marketplace. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various European Union member states and parallel trade (arbitrage between low-priced and high-priced member states) can further reduce prices. Special pricing and reimbursement rules may apply to orphan drugs. Inclusion of orphan drugs in reimbursement systems tend to focus on the medical usefulness, need, quality and economic benefits to patients and the healthcare system as for any product. Acceptance of any medicinal product for reimbursement may come with cost, use and often volume restrictions, which again can vary by country. In addition, results-based 154 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents rules of reimbursement may apply. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products, if approved in those countries. For COVID-19 vaccine candidates in the European Union, no pricing and reimbursement or health technology assessments discussions have taken place with the respective health insurances and competent bodies at a national member state level. Currently, COVID-19 vaccine candidates are supplied in the European Union based on vaccine supply agreements with the European Commission that is acting on behalf and in the name of the member states of the European Union. D. United Kingdom Following the UK’s withdrawal from the European Union on January 31, 2020, the Trade and Cooperation Agreement, or the TCA, which formally entered into force on May 1, 2021, serves as the primary treaty defining the political and economic relationship between the UK and the European Union after such withdrawal. While the TCA governs tariff and quota free trade between the United Kingdom and the European Union markets, it does not provide for regulatory alignment. The regulatory framework for medicinal products in the United Kingdom is predominantly derived from European Union law. The UK currently offers different routes to obtain a marketing authorization: (a) a national application route with a 150-day assessment timeline, excluding clock stops or (b) an international recognition route by which a company relies on a positive CHMP opinion or an approval granted by another reference regulator, including the FDA and the Japanese PDMA. The international recognition procedure takes 60 days with no clock stops for simpler applications that were approved by the reference regulator within the past two years and 110 days with the possibility of a clock stop for all other eligible applications. Clinical trial rules in the UK are based on the wording of the previous European Union Clinical Trials Directive 2001/20/EC, although the UK recently updated its legislation governing clinical trials pursuant to the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. The reforms retain the core requirements of clinical trial regulation, including the need for both regulatory and ethics committee approval, but introduce procedural changes such as a combined regulatory and ethics committee review process, streamlined and accelerated assessments for low intervention clinical trials, and enhanced transparency obligations. Domestic United Kingdom law provided that all existing European Union law in force on December 31, 2020 was retained in UK national law, subject to certain revisions that became necessary as a result of Brexit. However, the Retained EU Law (Revocation and Reform) Act 2023 came into force on January 1, 2024. This revoked some retained EU laws (although not any relating to medicines regulation). All other retained EU laws have been renamed as “assimilated laws” and are no longer subject to the EU principles of interpretation. Thus, while at least initially the United Kingdom and the European Union laws relating to medicines are largely aligned, there is the potential for further divergence in the future. Under the terms of the Northern Ireland Protocol to the Withdrawal Agreement, European Union law governing medicinal products continued to apply to and in Northern Ireland resulting in the potential for separate marketing authorizations in Great Britain and Northern Ireland. In March 2023, the Northern Ireland Protocol was adjusted by the Windsor Framework, which is another post-Brexit agreement between the EU and the UK. The Windsor Framework aims to make it easier to move certain goods, including medicines, from Great Britain to Northern Ireland. Beginning January 1, 2025, medicines for supply in the UK are now authorized UK-wide by the Medicines and Healthcare products Regulatory Agency (MHRA) only and companies can no longer apply for, or maintain, separate licenses for Great Britain and Northern Ireland to market new medicines. Other key changes introduced by the Windsor Framework include removing the requirements of the EU Falsified Medicines Directive (FMD) from products intended for Northern Ireland and a requirement that all medicines placed on the UK market be labeled “UK Only.” 155 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents E. Greater China Mainland China Similar to the United States and the European Union, Mainland China has rules governing the approval for development and commercialization of drugs, including specialized rules for vaccines. China’s drug law and regulations require that NMPA’s Center for Drug Evaluation, or CDE, approve a clinical trial application prior to initiating a study to support the safety and effectiveness of a drug, including a therapeutic or preventive biologic (i.e., a vaccine). This clinical trial application generally takes approximately 60 business days but may be expedited to 30 business days in the case of innovative drugs that meet certain conditions. Once approved, vaccine clinical trials must be conducted at sites that are qualified disease prevention and control, or CDC, institutions and grade III hospitals, and the implementation of the trial must be in accordance with China’s general drug and specialized vaccine good clinical practice regulations and related guidelines. Other drug trials must be conducted at designated hospital sites in accordance with China’s general drug good clinical practice rules. Furthermore, prior to the commencement of the clinical trial in China each site’s ethics committee must approve the trial, and the National Health Commission must approve the collection and use of certain human samples containing genetic material and related genetic data. The human genetic resources, or HGR, approval requires a joint approval or record-filing application by the Chinese and foreign parties, setting forth the parties that will handle data and samples, the type and amount of samples that will be utilized during the study, the tests/analysis run, and the plans for storage or destruction, and potentially the intellectual property sharing arrangement among the parties, among other items. If the research is exploratory (i.e., not tied to a program designed to obtain registration in China), patentable IP arising from the use of the HGR samples and data must be jointly owned by the Chinese and foreign parties. Once approved, the HGR approval/filing may require updates and amendments and additional procedures to transfer data to foreign parties that are not on the approval. A final report is due at the end of the study. Once a clinical trial in China is complete and/or foreign data is assembled, a company may submit an application for a marketing authorization, or MA, of the drug. This procedure will include submission of pre-clinical and clinical data, manufacturing information and test results, among other items, and may include an onsite pre- market verification by the Center for Food and Drug Inspections of NMPA. This application may be considered more quickly if the applicant qualifies for admission to various expedited programs, including breakthrough designation for drugs that are new to the world in some respect, treat life threatening or quality of life altering diseases and either have no comparator on the market or represent a significant clinical advantage over existing approved therapies. Conditional approval procedures permit approval of a drug based on earlier stage data, but subject continued marketing to the fulfillment of post-market conditions with a designation period of time, such as the completion of additional studies. Therapeutic biologics and small molecule drugs follow similar steps to approval for development and marketing. These steps are similar for drugs that are imported and those that are produced domestically in China. However, domestically produced drugs must be produced at a facility that also obtains a drug manufacturing license based, in part, on a pre-marketing good manufacturing practice inspection. At both the clinical trial and MA stages, applicants for imported drugs must list a regulatory agent on the application. The agent must be an entity in China. An imported drug MA holder must also make a filing to a provincial level government appointing a domestic responsible entity, which is an entity that assists the marketing authorization holder, or MAH, with fulfilling its post-market drug regulatory obligations in China. The domestic responsible entity of the MAH is jointly liable with the MAH for these drug regulatory obligations. Once approved, vaccines may be procured by the CDC through platforms organized by the provincial governments. Vaccines in China must be sold and directly distributed by domestic manufacturers or general distributors appointed to represent overseas makers to municipal level CDCs, which handle allocation and distribution to points of vaccination in China. Distribution of other drugs occurs through procurement processes for sales at public hospitals or sales to private hospitals or pharmacies. Distributors of all drugs must possess a MA for the drug they are distributing for wholesale or a drug distribution license for wholesale or retail activities. 156 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents As is the case with all drugs, once on the market, MAHs will also have post-market obligations, including fulfillment of post-marketing commitments that were part of the grant of their MA. In the case of vaccines, MAHs must pay compensation for injuries caused adverse events following inoculation, or AEFIs, if the vaccine is not one required as part of the National Inoculation Program. The government bears the cost of NIP vaccines and related AEFIs. All drug MAHs are subject to other post-market obligations for drug marketing authorization holders, including recalls, adverse reaction reporting, annual reporting, and inspections. All drug MAs must be renewed every five years, and supplemental applications, notifications, or reports may need to be submitted for major, moderate and minor changes, respectively, to the original registration (e.g., significant manufacturing changes). Advertisements of prescription drugs, including vaccines, must be pre-approved and may only be placed in approved medical journals. Other forms of “academic promotion” may be performed by medical representatives who are authorized in writing by MAHs (or their agents) and their information filed on government designated websites. Currently, medical representatives are permitted to provide information about the drug to health care professionals (in accordance with certain procedural rules) and collect feedback as to drug safety, although a proposed revision to this rule may further restrict the activities of the medical representatives. Hong Kong and Macao Mainland China’s drug regulatory system does not apply in Hong Kong or Macao. These administrative regions are governed by separate laws on the development, approval, manufacturing, distribution and advertising and promotion of drugs, including vaccines. Similar rules restricting advertising and promotional content and, in the case of Macao, government approved advertisements, also apply. F. Türkiye Other countries such as Türkiye and those in the Middle East have regulatory review processes and data requirements for medicinal products, including vaccines, similar to those described for the European Union. The regulatory licensing process in these countries may include local marketing authorization requirements, manufacturing/testing facility inspections, testing of drug product upon importation and other domestic requirements. Some countries, such as Türkiye, have introduced specific emergency authorization regimes for COVID-19 vaccines. G. Rest of the World Regulation The requirements governing the conduct of clinical trials, product (including vaccine) licensing, pricing, and reimbursement vary from country to country in markets outside the European Union and the United States. In many markets, clinical trials must be conducted in accordance with Good Clinical Practice and applicable regulatory requirements. Ethical standards typically follow the Declaration of Helsinki principles. In response to the COVID-19 pandemic, some markets have granted or are considering the grant of emergency use authorizations for vaccine candidates instead of the otherwise available regulatory approval pathways. Supply of the COVID-19 vaccine to a number of countries outside of the United States and the European Union is similarly governed by vaccine supply agreements with local governments. In Africa, there is limited harmonization of the regulation of drug and biological products across the continent, and the functionality and regulatory capacity of national medicines regulatory authorities varies between jurisdictions. For example, many regulators lack the technical expertise to independently assess marketing authorization applications and instead have adopted “reliance” procedures, whereby authorization by a foreign stringent regulatory authority or registration as a WHO pre-qualified product may be a condition for approval. The African Union (“AU”) has issued several harmonization initiatives for medicines, including adopting the AU Model Law on Medical Products Regulation in 2016 and establishing the African Medicines Agency, or AMA, in 2019. The AMA’s responsibilities will include evaluating medicines for the treatment of priority diseases, among other harmonization-related responsibilities, but has yet to issue any regulatory guidelines or procedures to date. 157 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Failure to adhere to regulatory requirements may lead to, among others, fines, suspension or withdrawal of regulatory authorizations or approvals, product recalls, seizure of products, restrictions or suspensions of operations, or criminal prosecution. H. Healthcare Law and Regulation Healthcare providers and third-party payors play a primary role in the recommendation and prescription of pharmaceutical products that are granted marketing approval. Our current and future arrangements with providers, researchers, consultants, third-party payors and customers are subject to broadly applicable federal and state fraud and abuse, anti-kickback, false claims, transparency and patient privacy laws and regulations and other healthcare laws and regulations that may constrain our business and/or financial arrangements. Restrictions under applicable federal and state healthcare laws and regulations in the United States and elsewhere include, without limitation, the following: –the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in-cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or a specific intent to violate it in order to have committed a violation. Moreover, the government may assert that a claim that includes items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act; –the U.S. federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false, fictitious, or fraudulent or knowingly making, using, or causing to be made or used a false record or statement to avoid, decrease, or conceal an obligation to pay money to the federal government; –HIPAA, which created additional U.S. federal criminal laws that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or a specific intent to violate it in order to have committed a violation; –HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without the appropriate authorization by entities subject to the law, such as healthcare providers, health plans and healthcare clearinghouses and their respective business associates; –the U.S. federal transparency requirements, known as the federal Physician Payments Sunshine Act, under the ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services, or CMS, within the U.S. Department of Health and Human Services, information related to payments and other transfers of value made by that entity to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; –U.S. federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; 158 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents –U.S. federal government price reporting laws, which require us to calculate and report complex pricing metrics to government programs and which may be used in the calculation of reimbursement and/or discounts on marketed products; –the Foreign Corrupt Practices Act, a U.S. law which regulates certain financial relationships with foreign government officials (which could include, for example, certain medical professionals); –the national anti-bribery laws and laws governing interactions with healthcare professionals of European Union member states; –the U.K. Bribery Act 2010; and –analogous laws and regulations in U.S. states and other jurisdictions, such as U.S. state anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party payors, including private insurers. Some U.S. state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring pharmaceutical manufacturers to report information related to payments to physicians and other health care providers or marketing expenditures and pricing information. Laws in U.S. states and other jurisdictions also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. U.S. federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Violations of these laws can subject us to criminal, civil and administrative sanctions including monetary penalties, damages, fines, disgorgement, individual imprisonment and exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, reputational harm, and we may be required to curtail or restructure our operations. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to similar actions, penalties, and sanctions. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from the business. Moreover, we expect that there will continue to be federal and state laws and regulations, proposed and implemented, that could impact our future operations and business. I. Current and Future Healthcare Reform Legislation In the United States and other jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval. We expect that current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we, or any collaborators, may receive for any approved products. The incoming new United States presidential administration may seek to pursue different or additional approaches to drug pricing and reimbursement or could seek additional legislation affecting drug pricing, either of which could affect future profitability. 159 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Additionally, other federal health reform measures have been proposed and adopted in the United States in recent years: –The American Taxpayer Relief Act of 2012, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. –The Middle Class Tax Relief and Job Creation Act of 2012 required that CMS reduce the Medicare clinical laboratory fee schedule by 2% in 2013, which served as a base for 2014 and subsequent years. In addition, effective January 1, 2014, CMS also began bundling the Medicare payments for certain laboratory tests ordered while a patient received services in a hospital outpatient setting. Further, there has been heightened governmental scrutiny in the United States and elsewhere over the manner in which manufacturers set prices for their marketed products, which have resulted in several recent Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. In addition, the U.S. federal government, state legislatures, and other governments have shown significant interest in implementing cost containment programs, including price-controls, restrictions on reimbursement, and requirements for substitution of generic products for branded prescription drugs to limit the growth of government-paid health care costs. For example, the U.S. federal government has passed legislation requiring pharmaceutical manufacturers to provide rebates and discounts to certain entities and governmental payors to participate in federal healthcare programs. Individual states in the United States have also become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation, from other countries and bulk purchasing. J. Packaging and Distribution in the United States and Other Jurisdictions If our products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply in the United States (and similar laws may apply in other jurisdictions). Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act. Manufacturing, sales, promotion and other activities also are potentially subject to federal and state consumer protection and unfair competition laws. The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products. The failure to comply with any of these laws or regulatory requirements subjects firms to possible legal or regulatory action. Depending on the circumstances, failure to meet applicable regulatory requirements can result in criminal prosecution, fines or other penalties, injunctions, exclusion from federal healthcare programs, requests for recall, seizure of products, total or partial suspension of production, denial or withdrawal of product approvals, or refusal to allow a firm to enter into supply contracts, including government contracts. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. Prohibitions or restrictions on sales or withdrawal of future products marketed by us could materially affect our business in an adverse way. Changes in regulations, statutes, or the interpretation of existing regulations could impact our business in the future by requiring, for example, (i) changes to our manufacturing arrangements, (ii) additions or modifications to product labeling, (iii) the recall or discontinuation of our products or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. 160 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents K. Other Environmental, Health and Safety Laws and Regulations In the United States, the European Union and other jurisdictions, we may be subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. From time to time and in the future, our operations may involve the use of hazardous and flammable materials, including chemicals and biological materials, and may also produce hazardous waste products. Even if we contract with third parties for the disposal of these materials and waste products, we cannot completely eliminate the risk of contamination or injury resulting from these materials. In the event of contamination or injury resulting from the use or disposal of our hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations. We maintain workers’ compensation employers’ liability insurance to cover us for costs and expenses we may incur due to injuries to our employees, but this insurance may not provide adequate coverage against potential liabilities. In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. Current or future environmental laws and regulations may impair our research, development or production efforts. In addition, failure to comply with these laws and regulations may result in substantial fines, penalties or other sanctions. L. Regulation of Artificial Intelligence Systems and Models Government authorities in the United States at the federal, state and local levels have been actively engaged in advancing policy frameworks, guidance documents, discussion papers, standards, and proposed legislation regarding the development and use of AI by life sciences companies and, where applicable, applying existing regulatory frameworks (e.g., FDA regulations) to particular uses of AI. Likewise, the EU and other countries and jurisdictions extensively regulate (or intend to extensively regulate) the development and use of AI systems and models. The processes for monitoring emerging regulatory frameworks, evaluating how current and emerging requirements for AI apply to our business, along with subsequent compliance with applicable requirements and best practices, require the expenditure of substantial time and financial resources. A biotech company could use AI in a number of different contexts. For example, it may use AI in the medicines lifecycle for drug discovery, for non-clinical research and development, for data analysis in clinical trials and analysis of real world data, for precision medicine (e.g., clinical decision support), for supporting clinical trial design or assessing patient eligibility for clinical trials, for drafting medicinal product information documents, in the manufacturing of medicinal products and in machinery, or to assist with post-authorization safety monitoring, among other potential uses. If the AI is intended to perform a regulated activity (such as related to drug manufacturing, release testing, or producing clinical/diagnostic outputs) or otherwise be used in operations that are the subject of scrutiny by health authorities, the use of AI could trigger health authority oversight and, in some cases, application of existing laws and regulations relevant to healthcare, pharmaceuticals, and/or medical devices or sector-agnostic AI laws and regulations. Outside the drug development and commercialization context, a biotech company may use AI for other operational reasons. For example, a company may have plans to use automated personnel recruitment tools, deploy facial recognition technology to ensure security of its services, use customer service chatbots, or allow its employees to use generative AI or general-purpose AI tools to increase the efficiencies of administrative tasks. A company will need to identify how it uses AI in its business operations, and identify the relevant applicable regulatory regime that applies to ensure compliance. Failure to adhere to (or remain up to date with evolving) regulatory requirements may lead to compliance actions, penalties and other risks. 161 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents United States In the United States, Congress, the White House, various federal agencies, and states have advanced proposed AI legislation, policy frameworks, guidance documents, whitepapers, and governing principles to address the use of AI, including when used in healthcare and life sciences. Of particular relevance to biotech companies, the FDA has been adapting and applying existing regulatory frameworks to account for AI and has issued guidance, discussion papers, and frameworks outlining FDA’s approach to regulation and oversight of health-related uses of AI. To date, FDA has not issued a new regulatory framework specific to AI; rather, it has been applying its existing regulations for drug and biologic discovery, development, clinical testing and manufacturing to companies utilizing AI in these processes, such that companies seeking to incorporate AI into processes that are subject to FDA oversight need to demonstrate compliance with the existing regulations for drug and biologic sponsors. In this context, FDA issued two discussion papers on the use of AI in drug manufacturing (March 2023) and the development of drug and biological products (May 2023), and hosted a related public workshop in August 2024. Following feedback on the discussion papers and the workshop, in January 2025, FDA issued its first draft guidance document regarding uses of AI in drug development and other parts of the drug lifecycle, entitled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products.” AI to support regulatory decision-making, within the scope of the draft guidance, includes AI intended to support regulatory determinations made by FDA (e.g., with respect to safety or effectiveness of a drug in a New Drug Application) and to support actions taken by sponsors in conformance with FDA’s regulatory authority (e.g., current good manufacturing practices, post-marketing requirements, and INDs). The draft guidance proposes a seven-step risk-based framework for assessing the risk and credibility of AI models intended to support regulatory decision-making to determine whether the AI model is adequate for a specific use, and describes the associated documentation FDA may expect to review in an application or during an inspection. FDA also actively regulates some health-related AI as “software as a medical device,” or SaMD, under FDA’s existing medical device frameworks and has issued guidance describing specific regulatory considerations that may apply to AI-based SaMD. Most recently, FDA issued draft guidance in January 2025 on lifecycle management and marketing submission recommendations for AI-enabled device software functions, and hosted its inaugural Digital Health Advisory Committee meeting in November 2024 to discuss total product lifecycle considerations for generative AI-enabled devices. Additionally, at the executive level, the Trump Administration revoked a Biden Administration Executive Order on the Safe, Secure, and Trustworthy Development of Artificial Intelligence that Order contained a number of directives that would have impacted the life sciences sector, including directives to HHS to establish an AI “Task Force” responsible for issuing guidance on a number of AI topics (such as long-term safety and real-world performance monitoring, predictive and generative AI, equity principles, and privacy and security standards), develop a strategy for regulating the use of AI in drug development processes, develop an “AI assurance policy” to evaluate the performance of AI-enabled healthcare tools, and establish a common framework for capturing clinical errors resulting from AI deployed in healthcare settings. The Trump Administration issued a new Executive Order in January 2025 on Removing Barriers to American Leadership in Artificial Intelligence that established a policy of “global AI dominance” and directed entities to suspend, revise, or rescind any actions taken under the Biden Administration Executive Order that are inconsistent with this policy. Members of Congress also have introduced a number of bills on AI regulation and frameworks for regulating AI. For example, the Bipartisan House AI Task Force released an AI report in December 2024 and the Bipartisan Senate AI Working Group released a roadmap for AI policy in May 2024, both of which included sections on policy recommendations for AI in health care. Senator Bill Cassidy (R-LA), who now chairs the Senate Health, Education, Labor, and Pensions Committee, also released a whitepaper on the “Framework for the Future of AI” in September 2023 that disfavored a “one-size-fits-all” approach to AI regulation and instead called for a flexible approach that takes into account the context of use and leverages existing frameworks. 162 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents U.S. state legislatures also have actively pursued AI legislation. For example, the Colorado AI Act imposes requirements for developers and deployers of certain high-risk AI systems, and other laws will require notice or disclosures for certain uses of generative AI or other AI systems. In addition to proposed and passed legislation, regulators have sought to apply existing legal authorities to AI systems, including in the life sciences sector. For example, the California Attorney General issued a legal advisory providing guidance to healthcare providers, vendors, investors, and other healthcare entities that develop, sell, and use AI systems and similar technologies. The advisory advised entities on their obligations under existing California law and described certain health- related uses of AI or marketing practices that might be unlawful. We continue to monitor developments in the regulation of AI in drug and biologic development and commercialization, or for more general business practices, and to assess the applicability of these evolving frameworks and policies as well as existing legal frameworks that apply to our uses of AI. If we fail to meet regulator expectations or comply with applicable requirements, that could impact our ability to utilize AI-related processes or information in our development of product candidates or could subject us to delays, penalties or other risks. European Union The EU Artificial Intelligence Act, or the EU AI Act, entered into force on August 1, 2024. It establishes rules governing certain AI systems and general-purpose AI models that apply across the EU. It applies to various actors along the AI value chain, including “providers” and “deployers” of AI systems classified as “high-risk,” “providers” of general-purpose AI models, and “providers” of general-purpose AI models with “systemic risk.” It also prohibits certain AI practices and imposes transparency requirements in relation to certain AI systems and general-purpose AI models. The EU AI Act sets out a transition period of two years (by August 2026) for most provisions, with the following exceptions: (i) the provisions relating to prohibited AI practices and AI literacy apply after six months (by February 2025); (ii) the provisions relating to general-purpose AI models and the AI Act’s governance framework apply after one year (by August 2025); and (iii) the provisions relating to high-risk AI systems that are used as safety components of products or are themselves products regulated by certain EU harmonization legislation (e.g., machinery, medical devices) requiring third-party conformity assessments apply after three years (by August 2027). The EU AI Act applies to providers, located in or outside the EU, that place on the market or put into service AI systems in the EU, or that place on the market general-purpose AI models in the EU. It also applies to deployers of AI systems located or established in the EU, and to providers or deployers located or established outside the EU where the output of the system is used in the EU. Whether a biotech company incurs obligations under the EU AI Act depends on whether it develops, offers, or uses any AI systems or general-purpose AI models; whether it qualifies as a “provider,” “deployer,” or other regulated actor; and the jurisdiction where the system is put into service, where the system or model is placed on the market, or where the output of a system is used. Providers and deployers of “high-risk AI systems” will need to comply with numerous obligations that apply to such systems. The obligations for providers and deployers differ, with the majority of obligations falling to providers. The EU AI Act also contemplates circumstances where a deployer or other third-party must assume the obligations of the provider, e.g., where the third-party makes a substantial modification to a high-risk AI system that has already been placed on the market or put into service, but where the modified system remains high risk. The EU AI Act sets out an exhaustive list of “high-risk AI systems” in Annexes I and III. The categories of such systems that might be relevant to offerings of biotech companies include products that require a notified body conformity assessment under the EU Medical Devices Regulation 2017/745 or EU In Vitro Diagnostic Medical Devices Regulation 2017/746. 163 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents The EU AI Act imposes a separate set of obligations on providers of “general-purpose AI models” and an additional set of obligations on providers of “general-purpose AI models with systemic risk.” The European Commission will designate general-purpose AI models that have “high-impact capabilities” as models with “systemic risk.” Providers of general-purpose AI models—with or without “systemic risk”— must comply with certain obligations, including to draw up technical documentation about the general-purpose AI model, implement a copyright policy to comply with EU copyright laws, and make available a summary of the content used to train the model. Additional obligations apply to providers of general-purpose AI models with systemic risk, including, for example, to perform model evaluation (such as adversarial testing) and to report serious incidents to the European Commission’s AI Office. Whether these obligations apply to a biotech company will depend on whether it develops any general-purpose AI models (or have them developed on its behalf) and places them on the market in the EU. If so, it will need to comply with the obligations that apply to all general- purpose AI models and assess whether any of these models could qualify as general-purpose AI models with systemic risk, which would require it to comply with additional obligations. Of particular relevance to the biotech industry, the EMA has published a reflection paper on the use of AI (September 2024), which is aimed at biopharmaceutical companies intending to use AI in the lifecycle of their medicines, including for drug discovery, design, and development. It also covers the use of medical devices with AI/machine-learning (ML) technology that are used to generate data or other evidence to support an EU marketing authorization for a medicine (i.e., used within the context of clinical trials or combined with the use of a medicine). The EMA’s view of “high patient risk” or “high regulatory impact” that AI can have differs from the classifications used in the EU AI Act. This requires biotech companies to assess whether the use of AI could affect patient safety (“high patient risk”) or impact regulatory decision-making (“high regulatory impact”) for the purpose of the EU medicines rules. This means that potentially, non-high-risk AI under the EU AI Act could still be relevant to the EMA if it impacts patient safety or evidence generation for a medicine subject to regulatory approval. The EMA guidance puts the onus on marketing authorization applicants/marketing authorization holders to ensure AI used during the medicines lifecycle is compliant with the medicines rules. If a biotech company intends to use AI in the context of its medicines it will need to carry out a regulatory impact and risk analysis and potentially discuss use cases with the EMA, including when there is no clearly written guidance available. Failure to adhere to (or remain up to date with evolving) EU regulatory requirements may lead to delays, compliance risks, and penalties. Rest of World Outside the United States and EU, the requirements governing the use and deployment of AI may vary from country to country, though health regulators have taken some steps toward international harmonization on AI best practices. For example, FDA, UK MHRA, and Health Canada have issued joint guiding principles on topics such as good machine learning practices and transparency for ML-enabled devices. A company will need to identify how it uses AI in its business operations, and identify the relevant applicable regulatory regime that applies to ensure compliance. Failure to adhere to (or remain up to date with evolving) regulatory requirements may lead to delays, compliance risks, and penalties. X. Intellectual Property A. Introduction We pursue a layered intellectual property strategy to protect our various technology platforms and their application to the treatment of serious diseases, such as cancer and infectious diseases including COVID-19. One focus of our intellectual property strategy is to provide protection for our platforms and products as they are developed. We also pursue intellectual property protection for assets that may be used in future development programs, may be of interest to our collaborators, and/or otherwise may prove valuable in the field. 164 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Various aspects of our technology platforms and our product candidates are claimed in patent filings. We also pursue other modalities of intellectual property protection, including trademark and trade secret protection, as appropriate. Many of our intellectual property assets were developed and are owned solely by us, some have been developed via collaboration and are jointly owned, and some have been acquired by acquisition and/or licensed from third parties. We expect that we will continue to make additional patent application filings, and will continue to pursue opportunities to acquire and license additional intellectual property assets, technologies, platforms and/or product candidates, as developments arise or are identified. Regardless, we cannot be certain that any of the patent filings or other intellectual property rights that we have pursued or obtained will provide protection for any products as commercialized. As further variants of SARS- CoV-2 arise, and its impact and characteristics evolve, the composition, manufacture, and use (including, e.g., dosage regimen) of our COVID-19 vaccine products may be adjusted or modified and our filings may not protect them. Our future commercial success depends, in part, on our ability to obtain and maintain patent and other proprietary protection for commercially important technology, inventions and know-how related to our business; defend and enforce our patents and other intellectual property; preserve the confidentiality of our trade secrets; and operate without infringing, misappropriating or violating the valid and enforceable patents and other intellectual property rights of third parties. Our ability to stop third parties from making, using, selling, offering to sell or importing our products may depend on the extent to which we have rights under valid and enforceable patents, trade secrets or other intellectual property rights that cover these activities. With respect to both our owned and licensed intellectual property, we cannot be sure that patents will issue with respect to any of the owned or licensed pending patent applications or with respect to any patent applications that we, our co-owners or our licensors may file in the future, nor can we be sure that any of our owned or licensed patents or any patents that may be issued in the future to us or our licensors will be commercially useful in protecting any products that we ultimately attempt to commercialize or any method of making or using such products. Moreover, we may be unable to obtain patent protection for certain of our product candidates generally as well as with respect to certain indications. See “Risk Factors—Risks Related to Intellectual Property” in this Annual Report. As of January 1, 2026, our overall owned and in-licensed patent portfolio included more than 600 patent families, each of which includes, or can in the future include, at least one filing in the United States or Europe, and several of which are pending or granted in multiple jurisdictions. The patent families include at least 560 patent families that are solely or jointly owned by BioNTech, including certain families acquired through our acquisitions and others that we have licensed from a third party. An issued patent provides its owner (or possibly its licensee) with a right to exclude others from making, using or selling that which is claimed in the patent, for a specified period of time (the “term” of the patent), in the jurisdiction in which the patent is issued. In the United States, and in many other countries, patents have a presumptive term of 20 years from their effective filing date (which is the earliest non-provisional filing date to which the patent claims priority). However, many jurisdictions, including the United States, require the payment of periodic maintenance fees in order for patents to remain in force for the full 20-year term. The United States also has provisions that require a patent term to be shortened if its claims are too similar to another patent owned by the same party that has a shorter term. The United States and certain other jurisdictions also have provisions that permit extension of patent term for patents that claim a drug or drug product, or its approved use, if the patent was issued before clinical trials were completed and certain other requirements were satisfied. In the United States, such extension is called a Patent Term Extension, or PTE, and it is limited to a period of not more than five years, or the total patent term including the PTE cannot exceed 14 years after the date of regulatory approval; only one patent can be extended per product approval. We did not extend any patent for our COVID-19 vaccine (Comirnaty) when it was approved by the FDA in the United States in 2021. The United States also offers a different form of patent term extension, known as Patent Term Adjustment, or PTA, whereby a particular patent’s term is automatically extended beyond the 20-year date if the U.S. Patent and Trademark 165 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Office, or the USPTO, caused delay during its examination; however, potentially available PTA is reduced by any amount of any delay caused by the patent applicant. Below, we provide a summary of the contours of our current patent portfolio as it relates to different aspects of relevant technology, including noting ownership and patent terms for filings included in the portfolio that are directed to such aspects. Particularly given our pre-commercial state of development for many product candidates, we cannot be certain that any of the patent filings in our portfolio will provide meaningful protection for products that we do or attempt to commercialize. B. Patent Portfolio The patent portfolios for our most advanced programs are summarized below. Patent prosecution is a lengthy process, during which the scope of the claims initially submitted to the USPTO and similar authorities for examination can be significantly narrowed by the time they issue, if they issue at all. We expect this could be the case with respect to some of our pending patent applications referred to below. 1. mRNA The patent portfolio for our mRNA therapeutic platforms and product candidates includes patent filings directed to features of therapeutic mRNA structures, some of which are included in our COVID-19 vaccine and in current development candidates. Our patent portfolio also includes patent filings directed to mRNA formulations (including their production and use), including the lipoplex formulations currently utilized with our FixVac and iNeST platforms, and the lipid nanoparticles currently utilized with our mRNA, RiboMab and RiboCytokine platforms, as well as patent filings directed to mRNA manufacturing, and to uses of mRNA therapeutics. We provide more detail below regarding the patent filings directed to these features. mRNA Structure Our patent portfolio includes patent filings directed to various features of mRNA structure, which may, for example, contribute to increased immunogenicity (e.g., antigen presentation), translation efficiency, and/or stability of mRNA constructs that include them. Such features include, for example, antigen-MHC fusions, 5’ cap structures and related features, 3’ UTR structures, polyA tails, reduced-uracil content mRNAs, and modified nucleoside RNAs. Filings directed to each of these features, and/or to RNA constructs that include them (singly or in combination), or collectively, the mRNA Structure Filings, have been made in the United States and various other jurisdictions. Some such mRNA Structure Filings are owned solely by BioNTech SE, which are referred to collectively in this section as BioNTech, some jointly by BioNTech and one or more third parties, and some by BioNTech licensors. We have non-exclusive rights to use certain U.S. and European patent filings owned by University of Pennsylvania and relating to RNA containing modified nucleosides through our sublicense agreements with mRNA RiboTherapeutics, Inc. (MRT) and CellScript, collectively, the MRT-CellScript Sublicenses, and summarized below in “C. In-Licensing”. Issued existing mRNA Structure Filings have, and pending existing mRNA Structure Filings, if issued, would have, 20-year terms that extend into the mid-2020s to the early-2040s. mRNA Formulations Our patent portfolio includes patent filings directed to various formulations for mRNA delivery, some of which are utilized with current development candidates. For example, our portfolio includes patent filings directed to lipoplex formulations and preparations thereof or collectively, the mRNA Lipoplex Filings. Issued mRNA Lipoplex Filing(s) has/have, and pending existing mRNA Lipoplex Filings, if issued, would have, 20-year terms that extend into the mid to late-2030s or early 2040s. Such mRNA Lipoplex Filings are solely owned by BioNTech or jointly owned by BioNTech and TRON. In addition, our portfolio includes U.S. and other patent filings directed to lipid nanoparticles and polyplex technologies, which are solely owned by BioNTech or jointly owned by BioNTech and TRON, or collectively, the 166 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents mRNA Lipid Nanoparticle/Polyplex Filings. Issued mRNA Lipid Nanoparticle/Polyplex Filings have, and pending mRNA Lipid Nanoparticle/Polyplex Filings, if issued, would have, 20 year terms that extend into the mid- to late 2030s or early 2040s. Some of such mRNA Lipid Nanoparticle/Polyplex Filings were granted in certain foreign jurisdictions, and currently include U.S. issued patents. The terms of the co-ownership of such patent filings with TRON are summarized below in “C. In-Licensing.” mRNA Manufacturing As discussed below, we utilize trade secret protection for many aspects of our mRNA manufacturing technologies, including as currently utilized for production of certain of our development candidates. In addition, our patent portfolio includes certain patent filings relevant to mRNA manufacturing, or collectively, the mRNA Manufacturing Filings, which we believe may provide commercial value to protect product candidates and/or support collaborations or other licensing arrangements. For example, our mRNA Manufacturing Filings include U.S. and other patent filings relating to certain aspects of mRNA purification and production. These mRNA Manufacturing Filings are either solely owned by BioNTech, or jointly owned by BioNTech and TRON and, if issued, would have 20-year terms that would extend into the mid- 2030s to early 2040s; there are patents granted in certain foreign jurisdictions including EP and U.S.. mRNA Commercial Products and Product Candidates Our COVID-19 vaccine (BNT162b2), marketed as Comirnaty, is our most advanced mRNA product. Additional COVID-19 vaccine candidates, as well as various dosing regimens and use in patient populations with certain medical conditions are being tested in clinical trials. Comirnaty and Other COVID-19 Vaccine mRNA Product Candidates Both our current and previously-marketed monovalent and bivalent COVID-19 vaccines utilize modified- nucleoside mRNA formulated in lipid nanoparticles. Our platform patent filings relevant to our COVID-19 vaccines, collectively, the “BNT162b2 Platform Filings”, include certain mRNA Structure Filings relating to features for increasing translation efficiency and/or stability of mRNA constructs (e.g., certain 3’ UTR structures containing a specific sequence element, interrupted polyA tails, and certain 5’ cap/cap proximal sequence combinations), including filings that are jointly owned by BioNTech and TRON; also relevant are certain mRNA Manufacturing Filings. Issued BNT162b2 Platform Filings have, and pending BNT162b2 Platform Filings, if issued, would have 20-year terms extending into the late-2020s to the early-2040s. We also have undertaken various patent filings specifically related to the BNT162b2 structure (including as may be tailored based on particular SARS-CoV-2 variants), composition, formulation, packaging, use and/or manufacture, collectively the BNT162b2 Filings, including filings that have arisen through collaboration with third parties such as Pfizer. Such filings relevant to our COVID-19 vaccines, if issued, would have 20-year terms that would extend into the early 2040s. As noted above, our MRT-CellScript Sublicenses grant us rights to use certain U.S. and European patents and applications relating to mRNA containing modified nucleosides, including as used in BNT162b2. We also have a non-exclusive license from the National Institutes of Health granting us a right to use certain technology described in U.S. and European patent filings that may relate to SARS-CoV-2 spike (S) protein mutations that lock the S protein in an antigenically preferred prefusion conformation; such a variant is utilized in BNT162b2. Additionally, we have obtained third-party licenses to technologies relating to certain lipids and/or lipid nanoparticles and formulations used in BNT162b2, including a non-exclusive license from Acuitas granting use rights relevant to proprietary lipid nanoparticles and formulations used in BNT162b2. Additional COVID-19 vaccine mRNA product candidates are being developed and tested in clinical trials, which share with BNT162b2 certain structural elements, and/or features of the composition, formulation, packaging, use and/or method of manufacture. Thus, some or all of the BNT162b2 Platform Filings and/or BNT162b2 167 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Filings, as well as the in-licensed rights discussed above with respect to BNT162b2, may be relevant to certain of these candidates. Moreover, we are currently studying safety and efficacy of our COVID-19 vaccines and vaccine candidates in various dosing regimens (including booster doses) and/or in different age groups and/or individuals with various medical conditions, and also in combination with other vaccines or therapies. Certain of our patent filings, including certain BNT162b2 Filings, cover such uses being tested in clinical trials. Oncology mRNA Product Candidates Certain mRNA oncology product candidates are also in clinical development and involve various platforms.. Some of our most advanced clinical oncology programs involve our iNeST immunotherapy product candidates being developed with our collaborator, Genentech. We also have FixVac product candidates in clinical trials. FixVac Our FixVac product candidates share many of the structural elements involved in our iNeST product candidates. Thus, some or all of the mRNA Structure Filings and mRNA Lipoplex Filings relevant to our iNeST product candidates and discussed below are also relevant to our FixVac product candidates. These patent filings, or the FixVac Platform Filings, include mRNA Structure Filings relating to antigen-MHC fusions, certain 5’ cap structures, 3’ UTR structures containing a specific sequence element, and interrupted polyA tails, which are solely or jointly owned by BioNTech or BioNTech’s licensors. Issued FixVac Platform Filings have, and pending FixVac Platform Filings, if issued, would have, 20-year terms extending into the mid-2020s to the mid-2030s. While we have pursued or obtained patent protection covering components of FixVac product candidates, manufacturing-related methods and/or formulations, we do not currently have any claims in our owned or in- licensed issued patents that cover the overall construct used in our FixVac product candidates. Our patent portfolio further includes U.S. and other patent filings relating to combined uses of our FixVac and iNeST product candidates. Such issued patent filings have, and such pending patent filings, if issued, would have, 20-year terms that extend into 2033, and are jointly owned by BioNTech and TRON. Our current clinical trials for FixVac product candidates are studying such product candidates in treatment of various cancers. While we do not currently have any claims in our owned or in-licensed issued patents that are directed to use of our FixVac product candidates in the indications of these clinical trials, certain FixVac Platform Filings include specific reference to treatment of these indications, and if issued, would have 20-year terms extending into the mid-2030s. iNeST Our patent filings relevant to our iNeST product candidates include mRNA Structure Filings relating to features for increasing antigen presentation (e.g., antigen-MHC fusions) and features for increasing translation efficiency and/or stability of mRNA constructs (e.g., certain 5’ cap structures, 3’ UTR structures containing a specific sequence element, and polyA tails of a particular length or interrupted polyA tails); mRNA Lipoplex Filings relating to negatively charged lipoplexes (e.g., for spleen targeting); and mRNA Manufacturing Filings, or collectively, the iNeST mRNA Platform Filings. While we have pursued or obtained patent protection covering components of iNeST product candidates, manufacturing-related methods and/or formulations, we do not currently have any claims in our owned or in-licensed issued patents that cover the overall construct used in our iNeST product candidates. Our patent portfolio further includes U.S. and other filings directed to the process of identifying neoantigens in patient samples and/or predicting those that will be immunoreactive in an iNeST immunotherapy product, or collectively, the Neoantigen Filings. Certain issued Neoantigen Filings have, and certain pending Neoantigen Filings, if issued, would have 20-year terms that extend into the 2030s. Many of the Neoantigen Filings are solely owned by BioNTech, or jointly owned by BioNTech and TRON; our acquisition of Neon Therapeutics, Inc., or 168 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Neon, added various Neoantigen Filings, including both BioNTech U.S.-owned and in-licensed filings. BioNTech and TRON jointly own issued EP patent number 2714071, whose claims recite steps relating to neoantigen selection, that were unsuccessfully opposed by multiple third parties. Said third parties have unsuccessfully appealed the decision to reject such opposition and the patent was maintained as granted. In addition, related EP patent number 3473267 with claims reciting steps relating to neoantigen selection for an RNA vaccine encoding a recombinant polyepitopic polypeptide was unsuccessfully opposed by a single third party. Said third party has unsuccessfully appealed the decision to reject such opposition and the patent was maintained as granted. Related EP patent number 3892295 from the same patent family with claims reciting steps relating to neoantigen selection for an RNA vaccine encoding a recombinant polyepitopic polypeptide was opposed by a third party; the opposition was rejected, no appeal was filed and the patent is maintained as granted; claims in related U.S. cases are granted. If we are unsuccessful in any future opposition/appeal proceedings, the patent claims for our iNeST product candidates may be narrowed, or a patent may not issue at all. See “Risk Factors— Risks Related to Intellectual Property” in this Annual Report. We are currently studying our iNeST product candidates in several clinical trials. Certain iNeST mRNA Platform Filings and Neoantigen Filings cover treatment of each of these indications. However, we do not currently have any claims in our owned or in-licensed issued patents that are directed to use of iNeST product candidates in the indications of these clinical trials. RiboMab and RiboCytokine We own or license a number of patent filings directed to our RiboMab and RiboCytokine programs. Many are owned solely by us, some are jointly owned, and some have been acquired or licensed. Patent filings relevant to our RiboMab and RiboCytokine programs include certain mRNA Structure Filings that are also relevant to our iNeST and/or FixVac product candidates, including certain patent filings relating to 3’ UTR structures containing a specific sequence element, and interrupted polyA tail structures; and patent filings under the MRT-CellScript Sublicenses relating to nucleoside-modified mRNAs as well as certain patent filings we have licensed from Acuitas and Genevant relating to lipid or non-liposomal formulations. Infectious Diseases beyond COVID-19 Certain patent filings that might be useful to our infectious disease mRNA vaccines beyond our COVID-19 vaccine program include certain of the mRNA Structure Filings and the mRNA Lipid Nanoparticle/Polyplex Filings as well as certain patent filings under the MRT-CellScript Sublicenses, which include patent filings directed to nucleotide-modified mRNAs. Certain patent filings relating to certain features of self-amplifying RNAs and/or trans-amplifying RNAs may also be relevant, including filings jointly owned by BioNTech SE and TRON; such filings are collectively referred herein as Amplifying RNA Filings. Such Amplifying RNA Filings, if issued, would have 20-year terms that extend into the late-2030s to early-2040s. These Amplifying RNA Filings currently include granted patents in Europe and the United States. We have also undertaken and continue to undertake filings specific to particular product candidates. We have also licensed technologies relating to certain lipids and/or lipid nanoparticles and formulations that may be useful for certain infectious disease mRNA vaccines. 2. Cell Therapy Engineered Cell Therapy Our engineered cell therapy product class features the use of chimeric antigen receptor, or CAR-, T cell or individualized T-cell receptors (TCRs) for oncology therapy. Our patent filings relevant to these platforms and product candidates, or the CAR-T/TCR Filings, are generally solely owned by BioNTech SE or co-owned by BioNTech SE and TRON. For example, the CAR-T/TCR Filings include patent filings directed to various CAR-T formats and methods of enhancing CAR-T cells by nucleic acid vaccination, as well as patent filings directed to 169 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents compositions of matter comprising individualized T-cell receptors. The CAR-T/TCR Filings, if issued, would have patent terms that would extend into the mid-2030s to mid-2040s. Certain CAR-T programs involve CAR-T-cell product candidates that target different members of the claudin family. Our patent portfolio includes certain patent filings specifically relevant to our claudin-specific CAR-T-cell product candidates and are jointly owned by BioNTech SE and TRON, or the Claudin-Specific CAR-T Cell Filings. The issued Claudin-Specific CAR-T-cell filings have, and the pending Claudin-Specific CAR-T-cell filings, if issued, would have, 20-year terms extending into the mid-2030s. The terms of our co-ownership of such patent filings with TRON are summarized below in “—C. In-Licensing.” 3. Antibodies Our antibodies product class features bispecific checkpoint immunomodulators for oncology therapy, which are developed through collaboration with Genmab. Our development candidates include bispecific antibodies that are designed to activate 4-1BB upon simultaneous binding to CD-40 or EpCAM. Our patent portfolio includes certain patent filings relevant to such bispecific antibodies, or the Bispecific Checkpoint Modulator Filings, co- owned by us and Genmab. Such Bispecific Checkpoint Modulator Filings, if issued, would have 20-year terms that would extend into the late 2030s. Our collaboration with Genmab also includes development of monospecific antibody candidates to address malignant solid tumors. For example, BNT313 is a CD27 antibody based on Genmab’s proprietary HexaBody technology platform, specifically engineered to form an antibody hexamer (a formation of six antibodies) upon binding its target on the cell membrane of the T cells. We have also undertaken and continue to undertake filings specific to particular product candidates. Our patent portfolio also includes certain patent filings relevant to the structure of pumitamig, a bispecific antibody targeting PD-L1 and VEGF-A, collectively the Pumitamig Filings. Such Pumitamig Filings, if issued, would have 20-year terms into the early 2040s. 4. Small Molecule Immunomodulators Our small molecule therapeutics product class features oncology treatment using small molecule product candidates that activate the immune system via TLR7 agonism. Our patent portfolio includes patent filings relevant to these TLR7 agonists. Certain of these filings are directed to substituted imidazoquinolines, and, if issued, would have 20-year terms that would extend into the late 2030s. C. In-Licensing Some of our intellectual property assets have been acquired by acquisition and/or in-licensing. We have pursued a strategy of identifying and in-licensing third-party patents that we believe are complementary to or otherwise interact synergistically with our own intellectual property portfolio. In addition to the agreements described in the section “—B.VIII. Third-Party Collaborations” above, we have entered into material intellectual property licensing or option arrangements with Acuitas, MRT-CellScript, the NIH, and TRON. The key terms of these arrangements are summarized below. Acuitas License Agreement In April 2020, we entered into a Non-Exclusive License Agreement with Acuitas, or the Acuitas License Agreement. Under the Acuitas License Agreement, Acuitas grants us a non-exclusive worldwide license, with the right to sublicense (subject to certain conditions) under Acuitas’ LNP technology to develop, manufacture and commercialize licensed products directed to the SARS-CoV-2 surface glycoprotein. We have the option to convert the non-exclusive licenses to exclusive licenses subject to certain additional financial obligations. 170 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Under the Acuitas License Agreement, we must pay Acuitas up to between approximately $1.6 million and $2.45 million in development milestone payments, $2.5 million and $3.75 million in regulatory milestone payments and $2.5 million and $3.75 million in commercial milestone payments upon the occurrence of certain milestone events. We are further required to pay Acuitas a low single-digit tiered percentage royalty on net sales of licensed products, subject to certain potential customary reductions. Our royalty obligations continue under the Acuitas License Agreement on a country-by-country and product-by-product basis until the later of (i) the expiration of the last-to-expire licensed valid patent claim covering such licensed product in such country, (ii) expiration of any data exclusivity, market exclusivity or supplemental protection certificates period for such product in such country, and (iii) certain years following the first commercial sale of such product in such country. The Acuitas License Agreement will continue on a product-by-product and a country-by-country basis until there are no more payments owed to Acuitas for such product in such country. Upon expiration of the Acuitas License Agreement, the license will become fully paid up and will remain in effect. We have the right to terminate the Acuitas License Agreement for convenience following a certain notice period. Either party may terminate the Acuitas License Agreement in the event of a material breach by the other party following a cure period. Alternatively, instead of exercising our right to terminate in the event of Acuitas’ material breach, we may elect to instead continue the license but reduce our milestone and royalty payment obligations to Acuitas by a certain percentage. In the event of termination of the Acuitas License Agreement by us for convenience or by Acuitas for our material breach, the licenses granted under such agreement will terminate, except that we will have the right to sell off any remaining inventories of licensed products for a certain period of time. CellScript and mRNA Ribotherapeutics License Agreement BioNTech RNA (now merged into BioNTech SE) entered into the two MRT-CellScript Sublicenses discussed above. Together, the MRT-CellScript Sublicenses grant BioNTech RNA worldwide, non-exclusive sublicenses under the Penn Modified mRNA Patent Rights (as defined in the MRT-CellScript Sublicenses) to research, develop, make, import, use and commercialize products for in vivo uses in humans and non-human animals, including therapeutic and prophylactic applications, and for certain uses in the diagnostic and prognostic field of use and certain laboratory research or screening uses. Under these sublicenses, BioNTech RNA has the right to grant sublicenses to affiliates and third parties. BioNTech RNA must use reasonable efforts to develop and commercialize products under the sublicenses. Furthermore, BioNTech RNA is obliged to pay MRT and CellScript development milestone payments of up to approximately $26 million as well as royalties in the low to mid-single digits on net sales of licensed products, depending on the field of use. The agreements continue until the expiration or abandonment of the last licensed patent to expire or be abandoned. BioNTech RNA may terminate the agreement for convenience with respect to all or certain patent rights with 60 days’ prior written notice. MRT or CellScript may terminate the respective sublicense agreement for payment default, uncured material breach or the bankruptcy of BioNTech RNA. NIH License Agreement On May 27, 2020, we and the HHS, as represented by the National Institute of Allergy and Infectious Diseases, or NIAID, of the NIH, entered into a patent license agreement to facilitate the development of a vaccine against COVID-19, or, as amended and restated on December 20, 2024, the NIH License Agreement. Pursuant to the NIH License Agreement, our royalty obligation on Net Sales (as defined in the NIH License Agreement) of Licensed Products (as defined in the NIH License Agreement, and which includes our and Pfizer’s COVID-19 vaccine) is an amount of up to a low single-digit percentage of Net Sales of Licensed Products. The NIH License Agreement also provides a framework for a license for use in Combination Products (as defined in the NIH License Agreement, and which would include the COVID-19 vaccine used in combination with other active pharmaceutical ingredients). 171 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents The NIH License Agreement remains in effect until expiration of the licensed patents. We have the right to terminate the NIH License Agreement for convenience with 60 days’ prior notice, and NIAID may terminate for our uncured material breach. TRON Agreements In 2015, we and our subsidiaries BioNTech RNA (now merged into BioNTech SE), BioNTech Diagnostics GmbH, BioNTech Protein Therapeutics GmbH, BioNTech Cell & Gene Therapies GmbH, Eufets GmbH and JPT Peptide Technologies GmbH entered into a Master Agreement for Research Services with TRON. Concurrently with this Master Agreement for Research Services, or the TRON Research Agreement, we entered into a License Agreement with Ganymed Pharmaceuticals AG, or Ganymed, TRON, Johannes Gutenberg-Universität Mainz and Universitätsmedizin der Johannes Gutenberg-Universität Mainz, or the TRON License Agreement. The TRON Research Agreement and TRON License Agreement together replaced and superseded our 2008 Cooperation, Purchase and Licensing Agreement with the University Mainz, or the 2008 Cooperation Agreement. In 2015, we and our subsidiaries BioNTech RNA (now merged into BioNTech SE), BioNTech Diagnostics GmbH, BioNTech Protein Therapeutics GmbH, BioNTech Cell & Gene Therapies GmbH, BioNTech Innovative Manufacturing Services GmbH and JPT Peptide Technologies GmbH, entered into a Framework Collaboration Agreement with TRON, or the TRON Collaboration Agreement. TRON Research Agreement Under the TRON Research Agreement, TRON from time to time performs certain services for us under work orders, which may comprise innovative applied research projects, pre-defined research and development or clinical research services. We and TRON meet at regular intervals, but no less than annually, to prepare an overall non-binding project plan, which sets the scope, period and costs for the relevant projects contemplated for that period. Individual work orders set the specific binding terms of each project or service. TRON is obligated to render services in accordance with the scientific standards, all applicable laboratory and legal provisions and with the care customary in the industry. We are entitled to the exclusive rights to all inventions, methods, specifications, materials, documents, data, know-how and other results (together, the Results) developed or discovered by TRON or by us and TRON jointly under the TRON Research Agreement, except to the extent they constitute improvements of the technologies applied by TRON in the relevant projects. Under the TRON Research Agreement, TRON granted us a non- exclusive, royalty-free license to use TRON Improvements if such TRON Improvements are necessary for the continued development and exploitation of the Results or the manufacture or marketing of products which contain any of the Results and are covered by a patent claiming any of the Results. Under the TRON Research Agreement, TRON’s services rendered in the field of applied research are invoiced at cost. For other services, fixed prices are to be set forth in the individual work orders. TRON invoices us monthly and our payments are due no later than 10 days thereafter. Additionally, we are obligated to pay to TRON low single-digit tiered royalties on net sales of any product developed under the TRON Research Agreement that is covered by a patent claiming any of the Results. The TRON Research Agreement limits each party’s liability to the other to intentional and grossly negligent actions and, in the case of gross negligence, liability for indirect and consequential damages and lost profits is excluded. We are obligated to indemnify TRON for all product liability claims in connection with the products and for third-party claims asserting that the Results violate third-party intellectual property rights. The TRON Research Agreement has an indefinite term, but may be terminated by either party on six months’ notice. If one of our subsidiaries terminates its role in the TRON Research Agreement, the agreement will survive and continue without that subsidiary. TRON License Agreement 172 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents The TRON License Agreement governs the ownership of and licenses under certain patents, inventions, know- how, technologies and other knowledge (together, the Development Results) filed and created before January 1, 2015 in the course of our collaboration with TRON, Johannes Gutenberg-Universität Mainz and Universitätsmedizin der Johannes Gutenberg-Universität Mainz (collectively, the University Parties) and Ganymed pursuant to the 2008 Cooperation Agreement. The TRON License Agreement sets forth the parties’ rights with respect to the Development Results, mainly depending on which parties have contributed to such Development Results. Ownership of the Development Results and any patents and other intellectual property in certain shares to TRON, on the one hand, and BioNTech and/or Ganymed, on the other hand included therein is allocated. Each party may assign its share in the co-owned Development Results to its affiliates provided that such party provide notice of the transfer and the identity of the new co-owner to the other co-owners. However, in case of an assignment of such share to a third party (except in case of a material asset sale), the assigning party must obligate the assignee to comply with the terms of the TRON License Agreement and the assigning party will remain bound by the obligations of the TRON License Agreement unless the other co-owners have consented to discharge the assigning party from such obligations. The parties to the TRON License Agreement grant licenses to each other under their shares in the Development Results substantially as follows. Ganymed is exclusively entitled to use the Development Results for certain antibodies and antibody fragments that bind to certain defined targets, or the Ganymed Field of Use. We are exclusively entitled to use the Development Results in any other field of use (including immunological therapeutics, small molecule compounds, small interfering RNA (siRNA)-based therapeutics, micro-proteins, antibody based in vitro (except for those in the Ganymed Field of Use), diagnostics and therapeutics based on long-chain RNA as well as other cell therapy applications, immune cells transgenized with recombinant directed against certain defined targets or chimeric antigen receptors and RNA-based pharmaceuticals). The University Parties may use the Development Results for internal research purposes only. We have an obligation to use reasonable efforts to develop and commercialize products in our field of use worldwide. Under the TRON License Agreement, we and Ganymed must agree on which party will have the primary role in filing, prosecuting, maintaining and defending jointly owned patents. We and Ganymed each have the exclusive right to enforce the Development Results in our respective fields of use, subject to certain step-in rights of the other parties. We are obligated to pay to the University Parties low single-digit tiered royalties on net sales on any product that is covered by certain of the patents including in the Development Results. If licenses are granted to third parties, we are obligated to pay to the University Parties a mid-single-digit share of all upfront payments, milestone payments and other remuneration we receive from such third parties in consideration for the license. Regarding upfront payments only, the University Parties’ share will be offset against subsequent license fees on net sales. In addition, we are obligated to pay certain development and regulatory milestones up to a low seven-figure amount to Johannes Gutenberg-Universität Mainz. The TRON License Agreement contains a limitation on liability as between the parties, wherein the parties will only be liable to each other for intentional and grossly negligent actions, and, in the case of gross negligence, liability for indirect and consequential damages and lost profits is excluded. We are obligated to indemnify the University Parties and Ganymed for third-party claims of product liability or violation of applicable law based on our distribution of our products or if we breach the TRON License Agreement or if we or one of our agents acts culpably. The TRON License Agreement will remain in effect as long as there are any obligations on us or Ganymed to pay license fees. After expiry of the TRON License Agreement, each party will have a perpetual, non-exclusive, royalty-free license to use the Developments Results. The TRON License Agreement may be terminated by any party on six months’ notice. The licenses granted between the parties will survive such termination. The TRON 173 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents License Agreement also grants all parties termination rights for uncured material breaches. If only one party terminates its role in the Agreement, the Agreement will survive and continue between the other parties. TRON Collaboration Agreement Under the TRON Collaboration Agreement, TRON from time to time undertakes certain projects in collaboration with us under separate project specific agreements, comprising innovative non-clinical research and development projects. We and TRON meet regularly to review and update project plans, and no less than annually to agree the budget for the on-going projects for the coming calendar year. Individual project agreements set the specific binding terms of each project. TRON is obligated to perform its obligations in accordance with the scientific standards, all applicable technical laboratory and legal provisions and with the care customary in the non-clinical biotechnology research industry. Except for the results of a particular research project which has been funded exclusively by TRON, all of the inventions, methods, specifications, materials, documents, data, know-how and other results (together, the Results) developed or discovered by TRON or by us and TRON jointly under the TRON Collaboration Agreement are jointly owned. Under the TRON Collaboration Agreement, TRON grants us an exclusive, worldwide, sublicensable license under its interest in the Results to research and have researched, develop and have developed, make and have made, use, and otherwise commercialize or have commercialized, and otherwise commercially exploit, products in a field that is specified in the corresponding project agreement. The field of use is either (a) the prophylaxis, diagnosis and treatment of all indications in humans and animals; or (b) the prophylaxis, diagnosis and treatment of oncological diseases, infectious diseases and rare genetic diseases. We are required to use our reasonable efforts to develop and commercialize products that exploit the Results. Under the TRON Collaboration Agreement, TRON’s activities are invoiced at cost. TRON invoices us monthly and our payments are due no later than 10 days thereafter. Additionally, we are obligated to pay to TRON low single-digit tiered royalties on net sales of any product developed under the TRON Collaboration Agreement that is covered by a patent claiming any of the Results or, in certain circumstances, by a patentable invention forming part of the Results which we elect to maintain as a trade secret. If licenses under Results are granted to third parties, we are obligated to pay to TRON a mid-single-digit share of all upfront payments, milestone payments and other remuneration we receive from such third parties in consideration for the license. In addition, we are obligated to pay a one-time only milestone of a low seven-figure amount to TRON the first time annual sales of a product developed under the TRON Collaboration Agreement reach a low nine-figure number. The TRON Collaboration Agreement limits each party’s liability to the other to cases of willful misconduct and gross negligence and, in the case of gross negligence, liability for indirect and consequential damages and lost profits is excluded. We are obligated to indemnify TRON for all product liability claims in connection with the products and for third-party claims asserting that the Results violate third-party intellectual property rights. The TRON Collaboration Agreement came into force with retroactive effect from January 2015 and has an indefinite term, but may be terminated by either party on nine months’ notice. If one of our subsidiaries terminates its role in the TRON Collaboration Agreement, the agreement will survive and continue without that subsidiary. D. Trademark Portfolio Certain features of our business and our product candidates are protected by trademarks. Our trademark portfolio includes, but is not limited to, BioNTech, Comirnaty, BioNTainer, FixVac, RiboCytokine, and RiboMab, including logo versions of some of these trademarks. Brand names appearing in italics throughout this report are trademarks owned by BioNTech. All other trademarks are the property of their respective owners. 174 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents E. Trade Secret Protection Certain of our technologies, including in particular certain proprietary manufacturing processes or technologies and/or neoantigen prediction technologies, are protected as trade secrets. In addition to patent protection, we rely upon unpatented trade secrets and confidential know-how and continuing technological innovation to develop and maintain our competitive position. We protect certain of our technologies, including, in particular, certain proprietary manufacturing processes and technologies and/or neoantigen prediction technologies, as trade secrets. However, trade secrets and confidential know-how are difficult to protect. We seek to protect our proprietary information, in part, by using confidentiality agreements with any future collaborators, scientific advisors, employees and consultants, and invention assignment agreements with our employees. We also have agreements requiring assignment of inventions with selected consultants, scientific advisors and collaborators. These agreements may not provide meaningful protection. These agreements may also be breached, and we may not have an adequate remedy for any such breach. In addition, our trade secrets and/or confidential know-how may become known or be independently developed by a third party, or misused by any collaborator to whom we disclose such information. Despite any measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects of our products or to obtain or use information that we regard as proprietary. Although we take steps to protect our proprietary information, third parties may independently develop the same or similar proprietary information or may otherwise gain access to our proprietary information. As a result, we may be unable to meaningfully protect our trade secrets and proprietary information. XI. Competition We compete in an industry characterized by rapidly advancing technologies, intense competition and a complex intellectual property landscape. We face substantial competition from many different sources, including large and specialty pharmaceutical and biotechnology companies, academic research institutions and governmental agencies and public and private research institutions. Many of our competitors and potential competitors, either alone or with their collaborators, have greater scientific, research and product development capabilities as well as greater financial, marketing, sales and human resources and experience than we do. In addition, smaller or early-stage companies, including immunotherapy-focused therapeutics companies, may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Some of our collaborators, such as Genmab and Pfizer, may also be competitors within the same market or other markets. Accordingly, our competitors may be more successful than us in developing and potentially commercializing technologies and achieving widespread market acceptance. In addition, our competitors may design technologies that are more efficacious, safer or more effectively marketed than ours or have fewer side effects, or may obtain regulatory approvals more quickly than we are able, which could eliminate or reduce our commercial potential. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. We anticipate that the key competitive factors affecting our technologies will be efficacy, safety, cost and convenience, ease of distribution, storage and administration, as well as our ability to build a fully-integrated biotechnology company. The availability of reimbursement from government and other third-party payors will also significantly affect the pricing and competitiveness of our products. The timing of market introduction of our products and competitive products will also affect competition among products. We expect the relative speed with which we can develop our products, complete the clinical trials and approval processes, and supply commercial quantities of the products to the market to be important competitive factors. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. 175 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Specifically, our marketed monovalent and bivalent COVID-19 vaccines and any other COVID-19 vaccines we and Pfizer develop compete with other COVID-19 vaccines that have been approved or authorized for temporary or emergency use and a number of vaccine manufacturers, academic institutions and other organizations currently have programs to develop COVID-19 vaccine candidates. XII. Legal Proceedings We are and may be involved in various legal proceedings, including patent litigation, product liability and other product-related litigation, as well as other legal proceedings that arise from time to time in the ordinary course of business, including, but not limited to, personal injury, consumer, off-label promotion, securities, antitrust, employment law, tax, environmental, and/or other claims or investigations. We currently do not believe that any of these matters will have a material adverse effect on our financial position, and will continue to monitor the status of these and other claims that may arise. However, we could incur judgments, enter into settlements or revise our expectations regarding the outcome of matters, which could have a material adverse effect on our results of operations and/or our cash flows in the period in which the amounts are accrued or paid. Our assessments, which result from a complex series of judgments about future events and uncertainties, are based on estimates and assumptions that have been deemed reasonable by management, but that may prove to be incomplete or inaccurate, and unanticipated events and circumstances may occur that might cause us to change those estimates and assumptions. Certain pending matters to which we are a party are discussed below. For a description of the risks relating to these and other legal proceedings we face and may in the future face and our assessments thereof, see “Risk Factors” in this Annual Report. Moderna Proceedings Germany Infringement Proceedings – EP’949 and EP’565 In August 2022, Moderna filed a lawsuit against us and Pfizer and our wholly owned subsidiaries, BioNTech Manufacturing GmbH, BioNTech Europe GmbH and BioNTech Manufacturing Marburg GmbH, Pfizer Manufacturing Belgium NV, Pfizer Ireland Pharmaceuticals and Pfizer Inc. in the Düsseldorf Regional Court alleging Comirnaty’s infringement of two European patents, 3590949B1, or EP’949, and 3718565B1, or EP’565. With respect to EP’565, on November 7, 2023, the Opposition Division of the EPO revoked EP’565 after a one- day oral hearing held in the co-pending opposition proceeding, and on December 7, 2023, it issued the written decision revoking EP’565. On February 7, 2024, Moderna appealed the Opposition Division’s revocation decision on EP’565. An oral hearing on Moderna’s appeal was held on January 27, 2026, and at the conclusion of this hearing, the Technical Boards of Appeal affirmed the revocation of EP’565. With respect to EP’949, on December 8, 2023, the Opposition Division issued a preliminary opinion noting that it believes EP’949 is likely invalid. As a result of those developments in the EPO proceedings, the Düsseldorf Regional Court postponed its hearing on infringement with respect to EP’949, originally scheduled for December 12, 2023, to January 21, 2025. On May 16, 2024, the EPO Opposition Division decided that EP’949 is valid, in amended form, and issued its written decision regarding the same on July 8, 2024. We appealed this decision, and the appeal is currently pending, with an oral hearing scheduled for September 2026. The Düsseldorf Regional Court held an infringement hearing on January 21, 2025, and on March 5, 2025, the Düsseldorf Regional Court issued a first- instance decision declining to stay the infringement proceedings and finding infringement of EP’949 by us and Pfizer. We and Pfizer have appealed the Düsseldorf Regional Court’s infringement decision, and the appeal is currently pending. The court has not ruled on the invalidity of EP’949, which will be decided in a next step by the EPO in the opposition appeal proceedings. Moderna has not yet taken steps to enforce the Düsseldorf Regional Court’s first-instance decision on infringement. 176 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents United Kingdom In August 2022, Moderna filed a lawsuit asserting Comirnaty’s infringement of EP’949 and EP’565 against us and our wholly owned subsidiaries, BioNTech Manufacturing GmbH, BioNTech Europe GmbH and BioNTech Manufacturing Marburg GmbH, and Pfizer Limited, Pfizer Manufacturing Belgium NV and Pfizer Inc. in the Business and Property Courts of England and Wales, in the UK High Court. In September 2022, we and Pfizer filed a revocation action in the Business and Property Courts of England and Wales requesting revocation of EP’949 and EP’565. The UK High Court held a trial between April 22, 2024, and May 21, 2024. On July 2, 2024, the UK High Court released two judgments. The first judgment concerns the validity of EP’949 and EP’565. In this first judgment, the UK High Court found that EP’565 is invalid and therefore not infringed, while EP’949 is valid and infringed. The second judgment concerns whether Moderna’s October 2020 commitment not to “enforce [its] COVID-19 related patents against those making vaccines intended to combat the pandemic,” or the Patent Pledge, amounted to a consent under UK law to carry out any acts that would otherwise amount to patent infringement. With respect to this judgment, the UK High Court found that Moderna’s Patent Pledge amounted to consent to carry out activities that might otherwise infringe its patents prior to March 2022, but not after March 2022. The UK High Court held a hearing on September 25, 2024, during which the Court granted Pfizer and BioNTech permission to appeal its judgment regarding the validity of EP’949, and declined Moderna’s permission to appeal its judgment regarding validity of EP’565. On October 16, 2024, Moderna sought permission from the UK Appeals Court to appeal the EP’565 judgment. On November 11, 2024, the UK Appeals Court denied Moderna’s application to appeal; accordingly, the UK designation of EP’565 is finally revoked with no further opportunity to appeal in UK. No party sought permission to appeal the UK High Court’s judgment on the patent pledge. The UK Court of Appeal held an oral hearing on the appeal of EP’949 on July 10-11, 2025. On August 1, 2025, the UK Court of Appeal issued a judgment agreeing with the UK High Court that EP ‘949 is valid, and dismissed our appeal. We applied for permission to appeal this decision to the UK Supreme Court, and on December 8, 2025, the UK Supreme Court denied permission to appeal. Accordingly, the UK designation of EP ‘949 is valid and infringed. However, Moderna has not yet taken steps to enforce this final judgment on infringement. Additionally, EP ‘949 is currently subject to opposition proceedings at the EPO. The Opposition Division initially issued a preliminary opinion noting that EP ‘949 is invalid, but in May 2024, issued a first-instance decision finding EP ‘949 valid. BioNTech and Pfizer appealed this first-instance decision, which is currently pending. The oral hearing in this appeal is scheduled for September 2026. United States U.S. District Court Litigation In August 2022, Moderna filed a lawsuit in the U.S. District Court for the District of Massachusetts against us and our wholly owned subsidiaries BioNTech Manufacturing GmbH and BioNTech US Inc. and Pfizer Inc. alleging Comirnaty’s infringement of U.S. Patent Nos. 10,898,574; 10,702,600 and 10,933,127 and seeking monetary relief. On April 12, 2024, the U.S. District Court for the District of Massachusetts stayed the litigation pending resolution of the inter partes review of U.S. Patent Nos. 10,702,600 and 10,933,127. Inter Partes Review In August 2023, Pfizer and we filed petitions seeking inter partes review of U.S. Patent Nos. 10,702,600 and 10,933,127 before the United States Patent Trial and Appeal Board, or the PTAB. On March 6, 2024, the PTAB issued decisions instituting inter partes review proceedings on all challenged claims of U.S. Patent Nos. 10,702,600 and 10,933,127. An oral hearing on the merits occurred on December 10, 2024. On March 5, 2025, the PTAB found all challenged claims of Moderna’s U.S. Patent Nos. 10,933,127 and 10,702,600 to be unpatentable and thus invalid. Moderna appealed this decision on May 6, 2025. 177 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents Netherlands In September 2022, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech Manufacturing GmbH and Pfizer B.V., Pfizer Export B.V., C.P. Pharmaceuticals International C.V. and Pfizer Inc. in the District Court of The Hague alleging Comirnaty’s infringement of EP’949 and EP’565. The District Court of the Hague held a hearing on October 6, 2023, on infringement and validity with respect to EP’949. On December 6, 2023, the Court found EP’949 to be invalid. On March 5, 2024, Moderna appealed this decision, and the appeal is pending. A hearing on the EP’949 appeal has been set for September 22, 2025, with a decision expected on or around March 31, 2026. The EP’565 case has been stayed pending the outcome of Moderna’s appeal of the Opposition Division’s revocation of EP’565. Ireland In May 2023, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech Manufacturing GmbH, Pfizer Inc., Pfizer Healthcare Ireland, Pfizer Ireland Pharmaceuticals, and C.P. Pharmaceuticals International C.V. alleging Comirnaty’s infringement of EP’949 and EP’565 in the High Court of Ireland. On February 26, 2024, the High Court of Ireland stayed the lawsuit pending the final determination of the EPO opposition proceedings for EP’949 and EP’565 (in each case including any appeals). Belgium In May 2023, Moderna filed a lawsuit against us, our wholly owned subsidiary BioNTech Manufacturing GmbH, Pfizer Inc. and Pfizer Manufacturing Belgium alleging Comirnaty’s infringement of EP’949 and EP’565 in the Brussels Dutch-speaking Enterprise Court. On May 29, 2024, the parties filed a joint request to stay the proceedings, which was entered by the Enterprise Court. All of the above proceedings are currently pending. We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of Moderna’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities. Arbutus and Genevant Proceedings In April 2023, Arbutus Biopharma Corp., or Arbutus, and Genevant Sciences GmbH, or Genevant, filed a lawsuit against Pfizer and us in the U.S. District Court for the District of New Jersey alleging that Pfizer and we have infringed the following patents owned by Arbutus: U.S. Patent Nos. 9,504,651; 8,492,359; 11,141,378; 11,298,320; and 11,318,098, through the use of Genevant’s lipid nanoparticle technology and methods for producing such lipids in Comirnaty, and seeking monetary relief. This proceeding is currently pending. We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the lawsuit mentioned above. However, our analysis of Arbutus and Genevant’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities. GlaxoSmithKline Proceedings 178 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents In April 2024, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC, or GSK, filed a lawsuit against Pfizer and us and our wholly owned subsidiaries BioNTech Manufacturing GmbH and BioNTech US Inc. in the U.S. District Court for the District of Delaware alleging that the cationic lipid used in Comirnaty infringes U.S. Patent Nos. 11,638,693; 11,638,694; 11,666,534; 11,766,401; and 11,786,467; and seeking monetary relief. On August 14, 2024, GSK filed an amended complaint to assert infringement of three additional patents, U.S. Patent Nos. 11,759,422; 11,655,475; and 11,851,660. A trial is scheduled to occur in June 2027. This proceeding is currently pending. Ireland In July 2025, GlaxoSmithKline Biologicals SA filed a lawsuit against our wholly owned subsidiary BioNTech Manufacturing GmbH, Pfizer Ireland Pharmaceuticals Unlimited Company, and Pfizer Healthcare Ireland Unlimited Company, alleging Comirnaty’s infringement of European Patent Nos. 2,590,626, 4,066,856, and 4,226,941 in the High Court of Ireland. This proceeding is currently pending. Unified Patent Court In July 2025, GlaxoSmithKline Biologicals SA filed two lawsuits against BioNTech SE, BioNTech Europe GmbH, BioNTech Manufacturing GmbH, and BioNTech Manufacturing Marburg GmbH, as well as 26 Pfizer entities, in the Unified Patent Court (Hague Division). In the first lawsuit, GSK alleges Comirnaty’s infringement of European Patent No. 2,590,626 (“EP 626”), and in the second lawsuit, GSK alleges Comirnaty’s infringement of European Patent Nos. 4,066,856 (“EP 856”) and 4,226,941 (“EP 941”). Oral hearings wherein the UPC will hear the parties’ arguments regarding infringement and invalidity of EP 626, EP 856, and EP 941 have been scheduled for September/October 2026. This proceeding is currently pending. United Kingdom In September 2025, we and Pfizer filed a revocation action against GlaxoSmithKline Biologics S.A. in the Business and Property Courts of England and Wales, in the U.K. High Court, requesting revocation of European Patent Nos. 2,590,626, 4,066,856, and 4,226,941. On October 7, 2025, GSK filed a defense and counterclaim for infringement against BioNTech SE and BioNTech Manufacturing GmbH, alleging Comirnaty’s infringement of European Patent Nos. 2,590,626, 4,066,856, and 4,226,941. A trial has been scheduled for February 2027. This proceeding is currently pending. We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to vigorously defend ourselves in the lawsuit mentioned above. However, our analysis of GlaxoSmithKline’s claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liabilities. Promosome Proceedings In January 2025, Promosome LLC, or Promosome, filed a lawsuit against us and Pfizer in the Unified Patent Court, or UPC, Munich Division, alleging that Comirnaty infringes EP 2 401 365 and seeking monetary relief. An oral hearing wherein the UPC will hear the parties’ arguments regarding infringement and invalidity has been scheduled for May 12-13, 2026. This proceeding is currently pending. We believe we have strong defenses against the allegations claimed relative to the patent and intend to vigorously defend ourselves in the lawsuit mentioned above. However, our analysis of Promosome’s claim is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain. Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, this matter constitute a contingent 179 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient reliability the respective contingent liability. CureVac Proceedings Although the CureVac proceedings no longer qualify as contingent liabilities in accordance with IAS 37 as of December 31, 2025, we summarize below the current status of the CureVac proceedings to enhance comparability with our prior-year disclosure. Infringement Proceedings – EP’122, DE’961, DE’974, DE’575, and EP’668 In July 2022, CureVac AG, or CureVac, filed a lawsuit against us and our wholly owned subsidiaries, BioNTech Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH, in the Düsseldorf Regional Court, alleging Comirnaty’s infringement of one European patent, EP1857122B1, or EP’122, and three Utility Models DE202015009961U1, DE202015009974U1, and DE202021003575U1. In August 2022, CureVac added European Patent EP3708668B1, or EP’668, to its German lawsuit. On August 15, 2023, the Düsseldorf Regional Court held a hearing on infringement with respect to all five IP rights. At the hearing, the Court stated it would render its infringement ruling with respect to EP’122 on December 28, 2023. On September 28, 2023, the Court issued orders suspending its infringement rulings with respect to the remaining four IP rights (DE’961, DE’974, DE’575, and EP’668) pending validity decisions in the DE’961, DE’974, and DE’575 cancellation proceedings before the German Patent and Trademark Office and in the EP’668 opposition proceedings before the Opposition Division of the European Patent Office, or the EPO. In the September 28th orders, the Court explained that it was suspending its infringement rulings until validity decisions are reached, while contemporaneously noting concerns regarding the validity of DE’961, DE’974, DE’575, and EP’668. After EP’122 was declared invalid in the first-instance nullity proceedings by the Federal Patent Court on December 19, 2023 (see below), on December 27, 2023, the Düsseldorf Regional Court canceled the December 28, 2023 decision date and stayed the infringement proceedings as to EP’122 until a final appellate decision is rendered as to the validity of EP’122 by the Federal Court of Justice. On June 7, 2024, CureVac waived DE’575 and withdrew this utility model from the infringement proceedings. On July 1, 2024, the EPO Opposition Division issued a preliminary opinion noting that it believes EP’668 is likely invalid. The EPO Opposition Division held an oral hearing regarding the validity of EP’668 between March 25-27, 2025. At the conclusion of this hearing, the Opposition Division upheld EP’668 in amended form, but only after finding that the alleged technical effect – increased protein expression – was not achieved across the broad scope of the amended claim. The written decision by the Opposition Division to uphold EP’668 in amended form was issued on July 11, 2025, and we and Pfizer appealed this written decision. An oral hearing with respect to infringement of EP’668 was scheduled by the Düsseldorf Regional Court for July 1, 2025, but it was rescheduled for January 27, 2026. On July 3, 2025, GlaxoSmithKline Biologicals SA filed a request seeking to intervene in the EP’668 infringement proceedings. This request to intervene was to be heard at the January 27, 2026 hearing. On December 15, 2025, we completed our acquisition of CureVac. On December 19, 2025, CureVac withdrew its claims of infringement with respect to EP ‘122, DE ‘961, DE ‘974, and EP ‘668. As a result of CureVac’s withdrawal of its claims of infringement, the January 27, 2026 hearing is cancelled and these infringement cases have been dismissed. Infringement Proceedings – EP’755, DE’123, and DE’130 In July 2023, CureVac SE filed a second lawsuit against us and our wholly owned subsidiaries, BioNTech Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH, in the Düsseldorf Regional Court, alleging Comirnaty’s infringement of one European patent, EP4023755B1, or EP’755, and two Utility Models DE202021004123U1, and DE202021004130U1. On June 7, 2024, CureVac waived DE’123 and withdrew this utility model from the infringement proceedings. The Court has stayed the infringement proceedings with respect to DE’130 pending a validity decision in the co-pending cancellation proceeding before the German Patent and Trademark Office. On July 24, 2024, the EPO Opposition Division issued a preliminary opinion noting that it 180 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents believes EP’755 is likely invalid, and held a three-day oral hearing beginning on May 13, 2025. At the conclusion of the hearing, the EPO Opposition Division upheld EP’755 in amended form. We appealed the Opposition Division’s written decision upon its issuance. A hearing on infringement with respect to EP’755 was to occur in the Düsseldorf Regional Court on July 1, 2025, but this was rescheduled to January 27, 2026. On July 3, 2025, GlaxoSmithKline Biologicals SA filed a request to intervene in the EP’755 infringement proceedings. This request to intervene was to be heard at the January 27, 2026 hearing. On December 15, 2025, we completed our acquisition of CureVac. On December 19, 2025, CureVac withdrew its claims of infringement with respect to EP ‘755 and DE ‘130. As a result of CureVac’s withdrawal of its claims of infringement, the January 27, 2026 hearing has been cancelled and these infringement cases have been dismissed. Nullity Proceedings – EP’122 In September 2022, we filed a nullity action in the Federal Patent Court of Germany seeking a declaration that EP’122 is invalid. In April 2023, the Federal Patent Court of Germany issued a preliminary opinion in the EP’122 nullity action in support of the validity of EP’122. The preliminary opinion does not address any infringement of EP’122. The preliminary opinion is a preliminary assessment by the court of the merits of a claim, and is non- binding. On December 19, 2023, the Federal Patent Court held an oral hearing, after which it nullified EP’122. On April 25, 2024, the Federal Patent Court issued a judgment containing its written reasons for nullifying EP’122. On May 6, 2024, CureVac appealed the judgment, which is currently pending. On December 15, 2025, we completed our acquisition of CureVac. As of this date, CureVac became a wholly-owned subsidiary of BioNTech. As a result, the parties to these proceedings are no longer adverse. An oral hearing on this appeal is scheduled for July 2026. Cancellation Proceedings – DE’961, DE’974, and DE’575 In November 2022, we filed cancellation actions seeking the cancellation of the three German Utility Models in the German Patent and Trademark Office. On December 20, 2023, the German Patent and Trademark Office issued a preliminary opinion that DE’974 is likely to be cancelled. On January 23, 2024, the German Patent and Trademark Office issued a preliminary opinion that DE’961 is likely to be cancelled. Both preliminary opinions are based on invalidity pursuant to para. 1 (2) no. 5 Utility Model Act. On March 7, 2024, the German Patent and Trademark Office issued a preliminary opinion that DE’575 is likely to be cancelled. On June 6, 2024, CureVac submitted a written statement to the German Patent and Trademark Office waiving DE’575. On June 12, 2024, we withdrew our request for cancellation of DE’575. On June 25 and 26, 2024, the German Patent and Trademark Office heard oral arguments regarding DE’961 and DE’974, and at the conclusion of the hearing on June 26, 2024, confirmed that both DE’961 and DE’974 were cancelled. In November 2024, the German Patent and Trademark Office issued its written decisions cancelling DE’961 and DE’974. CureVac has filed an appeal in both cancellation proceedings, which are currently pending. Cancellation Proceedings– DE’123 and DE’130 In November 2023, we filed cancellation actions seeking the cancellation of German Utility Models DE’123 and DE’130 in the German Patent and Trademark Office. On June 6, 2024, CureVac submitted a written statement to the German Patent and Trademark Office waiving DE’123. On June 12, 2024, we withdrew our request for cancellation of DE’123. On December 5, 2024, the German Patent and Trademark Office issued a preliminary opinion that DE’130 is likely to be cancelled. An oral hearing regarding the validity of DE’130 before the German Patent and Trademark Office was scheduled for March 10, 2026, but a postponement has been requested. As a result, the March 10, 2026 hearing will not go forward. For additional information about events and developments since the end of the calendar year ended December 31, 2025, please see Note 18 to our consolidated financial statements included elsewhere in this Annual Report. C. Organizational Structure See Item 18. 181 Annual Report on Form 20-F for the year ended December 31, 2025 Table of Contents D. Property, Plant and Equipment The following is a summary of our principal owned and leased real estate. We also lease other properties in the ordinary course of business as part of our global operations. Germany –Our headquarters are located in Mainz, where we own and lease over 105,000 square meters of office, laboratory, GMP manufacturing, and research and development space, including our wholly-owned laboratory, GMP manufacturing, storage, and office space at An der Goldgrube 12, 55131 and a GMP-compliant production facility for which we expect a manufacturing license in 2027. –We also have manufacturing facilities in Marburg, where we lease over 23,000 square meters of GMP, technical, warehouse, laboratory, and office space, Idar-Oberstein, where we own a facility of over 13,000 square meters consisting of storage, development, laboratory, clean room, and office space and also lease additional office and warehouse space, and Tübingen, where we occupy 37,000 square meters of laboratory and office space, most of which is leased. –Elsewhere in Germany, we occupy over 25,000 square meters of laboratory, office, freezer farm, and handling space, including a wholly-owned laboratory and office space in Berlin and other leased properties in Munich, Fussgoenheim, Mutterstadt and Wiesbaden. Global locations –In China, we occupy a freehold manufacturing facility in Nantong of approximately 62,000 square meters, and also lease additional office, laboratory, and pilot manufacturing space in Zhuhai. While most of the Nantong site is currently in a shell and core condition, it is intended to be developed further to support additional capacity. –In the United States, we principally occupy over 9,000 square meters of leased laboratory and office space in Cambridge, Massachusetts and Gaithersburg, Maryland. –In the United Kingdom, we lease over 7,000 square meters of shell and core laboratory and office space in Cambridge. –We are also developing modular mRNA vaccine manufacturing facilities on leased sites in Kigali, Rwanda and Melbourne, Australia, with construction expected to be complete in 2026. The Kigali site is expected to have over 9,900 square meters of manufacturing, laboratory, office, warehouse, canteen, guardhouse, and supporting utility spaces. The Melbourne site is expected to have over 8,000 square meters of manufacturing, laboratory, office, and warehouse space. –We also lease office and laboratory space in Vienna, Austria and office space in London, England, Paris, France, and Amsterdam, the Netherlands, and own a production site in Singapore. For additional information regarding plans to construct, expand or improve facilities, including expenditures and financing, see Item 4.B.VII and Item 5 to this Annual Report.