A：BioNTech has developed a diversified toolkit of modalities for cancer treatment, which includes immunomodulators, ACS and mRNA-based immunotherapies.

A：BioNTech expects to have more than 17 late-stage programs by 2030, spanning various tumor types and lines of treatment. The company aims to become a diversified, multi-product commercial company by 2030.

A：The goal of BioNTech's clinical development strategy is to address the full continuum of cancer care, from early-stage to advanced and treatment-resistant diseases, with a focus on higher incidence and unmet need areas like lung cancer and breast cancer.

A：BioNTech's lung cancer strategy includes a matrix across disease stages and settings, clinical and molecular subgroups, and treatment backbones and combinations with Prometei and avelumab. This strategy encompasses a range of trials, including the phase 1B2A trial and the Rosetta Lung O2 trial.

A：The phase 1B2A trial for Mami in non-small lung cancer showed an overall confirmed objective response rate of 46%, a median progression-free survival of 13.6 months, and a median overall survival of 27 months, with a disease control rate of 96%. The activity observed across PD-L1 subgroups was noteworthy, especially a strong response rate of 71% in PD-L1 high expression tumors.

A：The collaboration with Bินg INLINE aims to combine LLL retargeted cell engagement or rexam me with pembrolizumab to explore a novel treatment regimen for extensive stage small cell lung cancer. The clinical trial is expected to present phase I data at SCo 2026.

A：The pivotal stage of the preserve Oo 3 trial is expected to provide interim data later this year based on current event accrual projections.

A：The phase 3 clinical trial in HR positive compared to low metastatic breast cancer (the DYNASTY trial) is continuing to enroll patients and an interim analysis is expected later this year based on current event accrual projections.

A：The portfolio of innovative mRNA cancer immunotherapies aims to activate and educate the immune system with pre-ionization. The personalized approach includes autogen suberin, which is partnered with Ro Genetics, and data from multiple trials support a focus on the adjuvant setting. Long-term follow-up from the PDF Phase 1 trial shows that among patients who mounted an immune response, 7 remained alive for up to six years post-surgery.

A：Future plans for the pometum C plus ADC combination trials include informing the design of the first pivotal combination trials, marking the next chapter of the company's novel strategy. Early data from these trials will be important for the design of the upcoming pivotal trials.

A：The first quarter performance was in line with expectations and reflected seasonal demand. Revenues for the first quarter of 2026 were €119 million compared to €193 million in the same period last year, primarily due to lower demand from COVID-19 vaccines. Expenses were €557 million compared to €526 million in the prior year period, driven by higher spending on immuno oncology and ADC programs and costs from BioNTech China. The company ended the first quarter with €16.8 billion in cash, cash equivalents, and security investments.

A：The reaffirmed full year 2026 financial guidance indicates total revenues between €2.6 and €2.3 billion, with lower COVID-19 vaccine revenues compared to 2025 due to competition in the U.S. market and managing the transition away from multi-year contracts in Europe. Adjusted R&D expenses are expected to be in the range of €2.2 to €2.5 billion, and adjusted S&A expenses in the range of €700 to €800 million. The company expects the BMS collaboration payment of €613 million to be recognized in the third quarter.

A：The BMS collaboration payment of €613 million is expected to be recognized in the third quarter of 2026.

A：BioNTech's share repurchase program aims to provide the company with the ability to deploy capital when the share price may be disconnected from intrinsic company value, enhance capital management discipline, and demonstrate a commitment to delivering long-term value to shareholders.

A：The key principles guiding BioNTech's capital allocation strategy are opportunistic flexibility, the continued support of a robust pipeline which remains a primary driver of value, and the optimization of operational efficiency with a commitment to sustainable value creation.

A：BioNTech plans to optimize operational efficiency by aligning and consolidating its manufacturing network, focusing on sites where capacities will be underutilized or where excess capacity exists, and by accessing operations at specific manufacturing sites, leading to the divestment of certain positions.

A：BioNTech plans to manage its manufacturing capacities and partnerships by aligning with its broader manufacturing network, ensuring the supply of COVID-19 vaccines through its partnership with Pfizer, and handling the supply of the COVID-19 vaccine via established manufacturing capacities.

A：BioNTech anticipates recurring annual savings of approximately $50 million once the cost-saving measures are fully implemented, which are intended to further support the advancement of the oncology pipeline towards commercialization.

A：BioNTech's strategic plans for the future include becoming a multi-product biopharmaceutical company by 2030, progressing key programs into pivotal stages, leveraging partnerships, and funding its pipeline from 2026 to 2029, executing combination therapy studies, accelerating patient control trial execution, building indication-specific portfolios, and conducting first on commercial launches by 2030.

A：BioNTech's goal is to become a diversified, multi-product global biopharmaceutical company that addresses high medical needs for cancer patients worldwide, powered by a robust financial position.

A：The data from the trial will show the efficacy profile and the safety profile of two different doses of smeta when combined with chemo in the patient population, which may inform expectations from the ongoing pivotal trial part.

A：The interim overall survival hazard ratio was around 0.6, which is considered an optimal approach for chemo combination therapy. However, it is crucial to wait for the next analysis later in the year to understand the statistical significance, as the current one is uninformative on the hazard ratio.

A：The company's strategy includes multiple development phases with more than 10 ongoing clinical trials to assess the combination of A3 3 4 5 3 6 compounds. The first phase started a year ago with the AC combination, and the differentiation strategy will continue with the second phase combining chromotherapy and selected AS in various types of indications.

A：The change in the primary endpoint to PFS can potentially lead to accelerated approval based on PFS with the possibility of full approval on OS later. This change allows for a more focused approach on PFS, which is seen as the earliest and most significant endpoint related to the mechanism of action of next-generation IO. Overall survival remains a key secondary endpoint.

A：The company's capital allocation strategy remains unchanged, focusing on building a commercial-stage multi-proto-oncology company by 2030 while investing in the pipeline, building commercial capabilities, and preserving flexibility for M&A or B. The company is also returning capital to shareholders. The current revenue guidance has assumed lower Covid-19 revenues compared to last year, and the company is monitoring the developments closely, reaffirming the 2026 guidance based on available information.

A：The CEO search is being led by the supervisory board, and specific timing or process details cannot be disclosed. However, the company ensures that the overall organization will remain focused on delivering 2026 priorities and that there is no change in the operating focus. Updates will be provided as appropriate. With respect to FDA discussions, the company will add color and detail to the standard information as soon as more information becomes available.

A：The end of phase 2 cohorts for the end of world study have been presented, and the confirmatory phase three study (EC 1) is continuing to enroll participants. Discussions with the FDA are ongoing, and there are no changes to the plan to submit the data. The speaker highlights the importance of commercialization as an asset and the strategic opportunity to build a commercial infrastructure for future launches, especially in the United States, considering the nine-month timeline to peak for oncology assets.

A：The new executive team should possess skills and capabilities in late-stage development, as well as commercialization and production of pharmaceutical products, based on the characteristics shared by the chairman during the change in the management board.

A：Competitive data, specifically from PD-1 inhibitors in digest phase, shows a clear benefit and raises the bar for the company's studies. The speaker acknowledges the potential impact on the company's studies and the value of further validation, such as the data expected at ESC, but notes that this is a Chinese study and the results may not directly apply to global trials.

A：Regional reproducibility of data is generally positive, with data sets like per meter small cell lung cancer and EGF arm mutations in non-small cell lung cancer showing similarities between China and global studies. However, data may not be entirely reproducible due to differences in populations or indications like small cell lung cancer or nonsensical lung cancer, where major differences exist between global and regional populations, particularly regarding smoking rates. The company continues to monitor and follow data to assess the impact of setting-specific factors on data reproducibility.

A：The timing and approach for key late-stage readouts are to be determined together with BMS based on data and strategic considerations for the portfolio. Upcoming data results from various studies, including ESC and Toth file later in the year, and multiple readouts from his 1 two studies of combinations with Adcs with PTA, will inform the decision process. The potential for a broad Pembro label is being considered, especially given the large data set for all HER2 IHC levels, including low expression.

A：There are no outstanding data questions around Team Pump, and the focus is on confirmatory trial enrollment and the timing of data from the study. A broad HER2 label is the goal, given the comprehensive data available across all HER2 IHC levels. From a commercial perspective, having secondary options ready is important as the company moves forward with combination strategies.

A：Specific information regarding catalyst timings and stage 3 trials is limited to the fact that the company had previously guided to the second half of 2026 for the two studies. They confirm that they are on track with the events and data within the studies and that positive interim data would be communicated to the market if the studies continue without any interruptions.