mRNA cancer immunotherapies
Search documents
BioNTech Announces Appointment of Kylie Jimenez to Management Board as Chief People Officer
Globenewswire· 2026-01-28 13:00
Mainz, Germany, January 28, 2026 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that the Supervisory Board has appointed Kylie Jimenez to the Management Board as Chief People Officer (“CPO”) effective March 1, 2026. The appointment is in line with BioNTech’s strategy to become a multi-product oncology company by 2030 and underscores the importance of its global, highly skilled workforce in achieving this objective. In the newly created Management Board role, Kylie ...
BioNTech Closes Acquisition of CureVac N.V. Including Subsequent Offering Period to Strengthen its Unique Position in the mRNA Field
Globenewswire· 2025-12-18 09:45
Core Viewpoint - BioNTech has successfully completed the acquisition of CureVac, enhancing its mRNA technology capabilities and supporting its oncology strategy [1][6]. Group 1: Acquisition Details - The acquisition of CureVac was finalized on December 18, 2025, with the subsequent offering period for CureVac shares expiring at 12:01 a.m. Eastern Time on the same day [1]. - A total of 195,341,219 CureVac shares, representing approximately 86.75% of the outstanding shares, were tendered in the exchange offer [3][6]. - BioNTech plans to complete the compulsory acquisition of the remaining CureVac shares in January 2026 as part of a post-offer reorganization [3][6]. Group 2: Strategic Implications - The acquisition aims to complement BioNTech's proprietary technologies in mRNA design, delivery formulations, and manufacturing, thereby strengthening its position in the global mRNA industry [1][6]. - BioNTech's oncology strategy focuses on mRNA-based cancer immunotherapy candidates and a bispecific antibody candidate, pumitamig (BNT327/BMS986545), developed in collaboration with Bristol Myers Squibb [1][6]. - The merger is seen as a synergy of two pioneering German mRNA firms, contributing to the country's innovation agenda [2]. Group 3: Management and Operations - Following the acquisition, the Management Board of CureVac SE will consist of BioNTech executives, while former CureVac board members have resigned [2]. - CureVac will continue its existing organizational processes to ensure business continuity, while BioNTech will conduct strategic and operational analyses for future organizational setup [2][6].
BioNTech Shares Progress on Exchange Offer for CureVac Shares and Highlights December 3, 2025, at 9:00 a.m. Eastern Time Expiration
Globenewswire· 2025-11-26 12:30
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].
BioNTech SE(BNTX) - 2025 Q3 - Earnings Call Transcript
2025-11-03 14:02
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]
BioNTech SE(BNTX) - 2025 Q3 - Earnings Call Transcript
2025-11-03 14:00
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]
BioNTech to Host Innovation Series R&D Day on November 11, 2025
Globenewswire· 2025-10-28 11:45
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]
BioNTech to Report Third Quarter 2025 Financial Results and Corporate Update on November 3, 2025
Globenewswire· 2025-10-27 11:45
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]
BioNTech to Host Second AI Day as an Edition of Its Innovation Series on October 1, 2025
Globenewswire· 2025-09-23 10:45
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]
BioNTech to Report Second Quarter 2025 Financial Results and Corporate Update on August 4, 2025
Globenewswire· 2025-07-21 10:45
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].
BioNTech Announces Ryan Richardson to Step Down from the Management Board
Globenewswire· 2025-07-17 12:30
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]