Core Viewpoint - BioNTech SE has received overwhelming approval from CureVac shareholders for its exchange offer, with over 99.16% voting in favor, and expects to complete the offer promptly [1][9]. Group 1: Offer Details - The exchange offer for CureVac shares is set to expire at 9:00 a.m. Eastern Time on December 3, 2025, with shareholders advised to tender their shares by 6:00 p.m. Eastern Time on December 2, 2025 [2][9]. - The exchange ratio is established at 0.05363 of a BioNTech American Depositary Share (ADS) for each CureVac share, based on a volume-weighted average price of $101.88 over the 10 trading days ending November 25, 2025 [3][9]. - BioNTech will recalculate the exchange ratio if the offer is extended and will announce the new ratio via press release [3]. Group 2: Tendering Process - CureVac shareholders holding shares through brokers should provide instructions to their brokers to tender shares, while other shareholders can follow the instructions in the Letter of Transmittal [4]. - Following the acceptance of tendered shares, BioNTech will initiate a subsequent offering period of not less than 10 business days [4]. Group 3: Conditions and Reorganization - The offer is contingent upon BioNTech acquiring at least 80% of the outstanding CureVac shares, with a potential reduction to 75% if certain conditions are met [5]. - Upon satisfaction of all conditions, non-tendering CureVac shareholders will receive BioNTech ADSs or cash in lieu of fractional ADSs, subject to a 15% Dutch dividend withholding tax [6]. Group 4: Regulatory and Market Context - The announcement of the exchange ratio serves as a pricing notice under EU regulations for the public offering of BioNTech ADSs to CureVac shareholders in several European countries [7][9]. - BioNTech is a biopharmaceutical company focused on developing innovative therapies for cancer and other serious diseases, leveraging its expertise in mRNA technology [10].

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were EUR 1,519 million, an increase from EUR 1,245 million in Q3 2024, primarily driven by a $700 million recognition from the BMS collaboration [34] - The net loss for Q3 2025 was EUR 29 million, compared to a net income of EUR 198 million in the same period last year, mainly due to settlement disputes [36] - Cash, cash equivalents, and security investments totaled EUR 16.7 billion at the end of Q3 2025, including a $1.5 billion upfront payment from BMS [36] Business Line Data and Key Metrics Changes - The company is focusing on two priority pan-tumor programs: pumitamig and mRNA cancer immunotherapies, with multiple ongoing phase II and III trials [39] - Significant progress was made in advancing pumitamig, with global registration trials in lung cancer and plans to initiate a TNDC phase III trial [8][9] Market Data and Key Metrics Changes - The company continues to see stable market share and pricing for its COVID-19 vaccine, COMIRNATY, with U.S. vaccination rates around 20% [81] - The updated revenue guidance for 2025 was increased to EUR 2.6 billion - EUR 2.8 billion, mainly due to the BMS collaboration [37] Company Strategy and Development Direction - The company aims to build a global immunotherapy powerhouse, focusing on a diversified clinical pipeline that includes mRNA immunotherapies and next-generation immunomodulators [5][6] - The strategy includes a three-wave plan for pumitamig, focusing on establishing foundational indications, expanding opportunities, and elevating clinical impact through novel combinations [14][15] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of generating meaningful data across oncology programs to steer late-stage decisions and maintain financial discipline [39] - The company is committed to transforming scientific advances into late-stage progress in priority oncology programs while preparing for commercialization [11] Other Important Information - The company hosted its second AI day, showcasing AI-based approaches for personalized therapy development [10] - The company plans to present additional clinical data at the upcoming annual Innovation Series R&D Day event on November 11 [39] Q&A Session Summary Question: Market opportunity for MSS-CRC and first-line gastric cancer - Management highlighted that both indications are high medical need areas, and the combination of VEGF-A and PD-L1 blocking has potential for improved clinical benefit [44][45] Question: Delay in BLA filing for BNT323 - The delay is due to ongoing discussions with the FDA regarding additional data needs, with plans to submit in 2026 [52][71] Question: Strategy for pumitamig's establishment and elevation - The three-wave strategy is designed to focus on speed to market while generating data in combination studies [56][57] Question: Phase II details for BNT327 in triple-negative breast cancer - Management confirmed that efficacy, safety, and dose data will be presented at SABCS [62] Question: Collaboration with Bristol Myers Squibb - The collaboration involves a Joint Steering Committee for decision-making on clinical development, allowing flexibility for both partners [88][89]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were EUR 1,519 million, an increase from EUR 1,245 million in Q3 2024, primarily driven by a $700 million recognition from the BMS collaboration [32] - Cost of sales decreased to approximately EUR 148 million from EUR 179 million year-over-year, attributed to lower inventory write-downs [32] - Research and development expenses rose to approximately EUR 565 million from EUR 550 million, driven by late-stage trials for immunomodulators and ADC programs [33] - The company reported a net loss of EUR 29 million for Q3 2025, compared to a net income of EUR 198 million in the same period last year, mainly due to settlement disputes [34] - Cash, cash equivalents, and security investments totaled EUR 16.7 billion at the end of Q3 2025, including a $1.5 billion upfront payment from BMS [34] Business Line Data and Key Metrics Changes - The PD-L1 VEGF-A bispecific antibody pomitamic is undergoing a broad registration program in partnership with Bristol-Myers Squibb, with significant progress made in Q3 [11][12] - The mRNA cancer immunotherapy platform has advanced with updates on BNT111 and autogene cevumeran, reinforcing the focus on adjuvant settings [8][24] - The HER2-targeted ADC TPEM is progressing towards its first BLA submission planned for 2026, with ongoing trials in metastatic endometrial cancer and breast cancer [11] Market Data and Key Metrics Changes - The company is focusing on high medical need indications such as MSS-CRC and first-line gastric cancer, with a rationale for development based on the combination of VEGF-A and PD-L1 blocking [39][55] - The COVID-19 vaccine franchise remains stable, with a strong market share and stable pricing, despite lower vaccination rates compared to previous years [52] Company Strategy and Development Direction - The company aims to build a global immunotherapy powerhouse, focusing on a diversified clinical pipeline that includes mRNA immunotherapies and next-generation immunomodulators [4][5] - The strategy emphasizes capital concentration on two priority pan-tumor programs, pomitamic and mRNA cancer immunotherapies, to establish new standards of care [5][37] - The company is committed to rigorous financial discipline while pursuing long-term sustainable growth through evidence-led prioritization of clinical programs [36][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of pomitamic to establish new standards of care across diverse tumor types, with ongoing global registration trials [6][18] - The company anticipates generating additional meaningful data for its oncology programs in the coming months, which will inform late-stage decisions [31][37] - The management highlighted the importance of maintaining flexibility in resource allocation to maximize long-term value [41] Other Important Information - The company updated its financial guidance for 2025, increasing revenue expectations to EUR 2.6 billion - EUR 2.8 billion, driven by the BMS collaboration [35] - R&D expense guidance was lowered to EUR 2 billion - EUR 2.2 billion, reflecting active portfolio management and prioritization of key programs [35] Q&A Session Summary Question: Market opportunity for MSS-CRC and first-line gastric cancer - Management highlighted that both indications are high medical need areas, with the combination of VEGF-A and PD-L1 blocking having potential for improved clinical benefit [39] Question: Delay in BLA filing for BNT323 - The delay is due to ongoing discussions with the FDA regarding additional data needs, with the submission now planned for 2026 [42][48] Question: Strategy with pomitamic - The three-wave strategy of establish, expand, and elevate is ongoing in parallel, focusing on speed to market while generating data for combination studies [43] Question: Confidence in pomitamic's phase 3 trial design - Management is continuously re-evaluating statistical analysis plans for ongoing trials, including the Rosetta 02 trial [46] Question: Collaboration with Bristol-Myers Squibb - The governance structure allows for collaborative decision-making, with both partners having opportunities to conduct combination trials independently [56]

Core Insights - BioNTech will host an Innovation Series R&D Day on November 11, 2025, to discuss its strategy and clinical progress [1] - The event will be accessible online, with a replay available for one year [2] Company Overview - BioNTech is a global next-generation immunotherapy company focused on developing novel therapies for cancer and serious diseases [3] - The company utilizes a variety of computational discovery and therapeutic modalities for rapid biopharmaceutical development [3] - BioNTech's oncology portfolio includes mRNA cancer immunotherapies, immunomodulators, targeted therapies like antibody-drug conjugates (ADCs), and CAR T cell therapies [3] - The company is also developing multiple mRNA vaccine candidates for infectious diseases alongside its oncology pipeline [3] - BioNTech collaborates with several global pharmaceutical companies, including Bristol Myers Squibb, Pfizer, and Roche [3]

Core Viewpoint - BioNTech SE will announce its financial results for Q3 2025 on November 3, 2025, and will host a conference call and webcast for discussion [1] Group 1: Financial Results Announcement - The financial results for the third quarter of 2025 will be disclosed on November 3, 2025 [1] - A conference call and webcast will take place at 8:00 a.m. EST (2:00 p.m. CET) on the same day for investors and analysts [1] Group 2: Accessing the Conference Call - Participants can register for the live conference call via a provided link, with dial-in numbers and a PIN sent post-registration [2] - It is recommended to register at least one day in advance [2] - The slide presentation and audio of the webcast will be accessible through a specified link [2] Group 3: Company Overview - BioNTech is a global next-generation immunotherapy company focused on developing novel therapies for cancer and serious diseases [4] - The company utilizes a variety of computational discovery and therapeutic modalities for rapid biopharmaceutical development [4] - BioNTech's oncology product candidates include mRNA cancer immunotherapies, immunomodulators, and targeted therapies like antibody-drug conjugates and CAR T cell therapies [4] - The company is also developing multiple mRNA vaccine candidates for infectious diseases alongside its oncology pipeline [4] - BioNTech has established collaborations with various global pharmaceutical companies, including Pfizer and Bristol Myers Squibb [4]

Core Insights - BioNTech SE, in collaboration with InstaDeep Ltd., will host its second AI Day on October 1, 2025, in London, focusing on BioNTech's AI strategy and its applications in the company's pipeline and internal processes [1] Company Overview - BioNTech is a global biopharmaceutical company specializing in next-generation immunotherapy, developing innovative therapies for cancer and serious diseases [3] - The company utilizes a variety of computational discovery and therapeutic modalities to rapidly develop novel biopharmaceuticals [3] - BioNTech's oncology product candidates include mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies such as antibody-drug conjugates (ADCs) and CAR T cell therapies [3] - The company is also researching multiple mRNA vaccine candidates for infectious diseases, leveraging its expertise in mRNA development and in-house manufacturing capabilities [3] - BioNTech has established partnerships with several global pharmaceutical companies, including Bristol Myers Squibb, Pfizer, and Roche Group [3]

Core Viewpoint - BioNTech SE will announce its financial results for the second quarter of 2025 on August 4, 2025, and will host a conference call and webcast for stakeholders to discuss these results and provide a corporate update [1]. Group 1: Financial Results Announcement - The financial results for Q2 2025 will be disclosed on August 4, 2025 [1]. - A conference call and webcast will take place at 8:00 a.m. EDT (2:00 p.m. CEST) on the same day [1]. Group 2: Accessing the Conference Call - Participants can register for the live conference call via a provided link, with dial-in numbers and a PIN sent post-registration [2]. - It is recommended to register at least one day in advance for the call [2]. - The slide presentation and audio of the webcast will be accessible through a specified link [2]. Group 3: Company Overview - BioNTech is a global next-generation immunotherapy company focused on developing novel therapies for cancer and serious diseases [4]. - The company utilizes a variety of computational discovery and therapeutic modalities for rapid biopharmaceutical development [4]. - BioNTech's oncology product candidates include mRNA cancer immunotherapies, immunomodulators, and targeted therapies such as antibody-drug conjugates and CAR T cell therapies [4]. - The company is also developing multiple mRNA vaccine candidates for infectious diseases alongside its oncology pipeline [4]. - BioNTech has established collaborations with various global pharmaceutical companies, including Bristol Myers Squibb, Pfizer, and Genentech [4].

Core Points - BioNTech SE announced the resignation of Ryan Richardson as Chief Strategy Officer effective September 30, 2025, to pursue new professional opportunities [1] - Richardson joined BioNTech in 2018 and has been instrumental in raising over USD 1 billion through various financing activities, including the Initial Public Offering on Nasdaq [2] - His contributions include building Global Strategy and Corporate Development functions, enhancing Capital Markets and Investor Relations, and serving on the Board of Directors of InstaDeep Ltd. since its acquisition in 2023 [2] Company Overview - BioNTech is a global next-generation immunotherapy company focused on developing novel therapies for cancer and other serious diseases [4] - The company has a diversified oncology product portfolio, including mRNA cancer immunotherapies, immunomodulators, and targeted therapies such as antibody-drug conjugates and CAR T cell therapies [4] - BioNTech collaborates with various global pharmaceutical companies, including Bristol Myers Squibb, Pfizer, and Genentech, to advance its research and development efforts [4]

Financial Data and Key Metrics Changes - In Q1 2025, total revenues were approximately €183 million, a slight decrease from €188 million in Q1 2024, reflecting expected seasonality in the COVID-19 vaccine market [26] - Research and development expenses increased to €526 million from €508 million in the prior year, driven by late-stage clinical studies [26] - The net loss for Q1 2025 was €416 million, compared to a net loss of €350 million in the same period last year, with a basic and diluted loss per share of €1.73 versus €1.31 [27][28] Business Line Data and Key Metrics Changes - The oncology segment is advancing with multiple clinical trials, including BNT327, which is being developed for various cancer types, including triple-negative breast cancer and small cell lung cancer [14][15] - The COVID-19 vaccine franchise remains a significant revenue driver, with preparations for a variant-adapted vaccine for the upcoming season [8] Market Data and Key Metrics Changes - The addressable market for the second-line endometrial cancer treatment is estimated at around 10,000 patients in the US and Europe, indicating a sizable opportunity [41] - The company anticipates stable vaccination rates and market shares for its COVID-19 vaccine, with revenue guidance for 2025 expected to be between €1.7 billion and €2.2 billion [30][31] Company Strategy and Development Direction - The company aims to become a fully integrated biopharmaceutical company with a focus on oncology, particularly through the development of BNT327 and mRNA cancer immunotherapies [28][36] - There is a strong emphasis on combination therapies to improve treatment outcomes across various cancer types, with ongoing investments in clinical development and commercialization capabilities [12][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their oncology pipeline to establish new standards of care and improve patient outcomes [12][25] - The company is closely monitoring regulatory changes and public sentiment regarding COVID-19 vaccines, which could impact future revenues [31][56] Other Important Information - The company announced a new Chief Financial Officer, Ramon Sapater, who will take over in July 2025, as current CFO Jens Holstein prepares for retirement [10][34] - The company is diversifying its manufacturing supply base for BNT323, currently reliant on a China-based CDMO, to mitigate risks associated with tariffs [41][44] Q&A Session Summary Question: What is the addressable population for endometrial cancer? - The estimated second-line market in endometrial cancer is about 10,000 patients in the US and Europe [41] Question: How do you see the NSCLC market evolving in five years? - Both bispecifics and ADCs will play a role in the NSCLC market, with the expectation that clinical benefit thresholds will evolve over time [50][72] Question: What impact do you anticipate from the CDC's upcoming vote on COVID boosters? - The company expects the market is already oriented towards a risk-based vaccination approach, with a base scenario of around 20% vaccination rates continuing [55] Question: Can you elaborate on the Phase II and Phase III trial timelines for BNT327? - The Phase II portion of the Rosetta trial will be completed later this year, with data to inform the Phase III portion [87] Question: How do you plan to manage toxicity observed in initial data for BNT327? - The stomatitis rate in combination with TROP-two ADC was comparable to that observed with BNT325 alone, indicating no additional additive toxicity [94]

Core Insights - BioNTech will present data from its oncology pipeline at the AACR Annual Meeting, highlighting advancements in mRNA cancer immunotherapies, immunomodulators, and targeted therapies [1][4] - The company aims to establish a future standard of care for advanced cancers through combination therapies that enhance anti-tumor activity [2] Oncology Pipeline Overview - BioNTech has a diversified oncology portfolio that includes over 20 active Phase 2 and Phase 3 clinical trials, focusing on mRNA cancer immunotherapies and the next-generation immunomodulator BNT327 [4] - The company is progressing towards becoming a multi-product oncology company with multiple data readouts expected in 2025 and 2026 [4] Key Presentations at AACR 2025 - Preclinical data for BNT327, a bispecific antibody targeting PD-L1 and VEGF-A, will be presented, showing superior anti-tumor activity compared to single treatments [7] - Early clinical data from the Phase 1/2 trial of BNT327 in combination with TROP2-targeting ADC BNT325/DB-1305 will be shared, including safety and efficacy results [7] - Data from the Phase 1 trial of mRNA cancer immunotherapy candidate BNT116 in combination with anti-PD1 cemiplimab will be presented, focusing on frail patients with advanced non-small cell lung cancer [7] Collaboration and Development - BioNTech collaborates with Duality Biologics for the development of ADCs and has established partnerships with various pharmaceutical companies to enhance its oncology pipeline [9][15]