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BioNTech Announces Fourth Quarter and Full Year 2023 Financial Results and Corporate Update. MAINZ, Germany, March 20, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three months and full year ended December 31, 2023, and provided an update on its corporate progress. “2023 was another year of good performance for BioNTech. We have maintained our leading position in the COVID-19 vaccine market which lays the foundation for establishing a sustainable respiratory vaccines business. In oncology, we have strengthened our core competencies by entering into several partnerships and have made numerous clinical advances. Today, our oncology pipeline encompasses multiple candidates in mid- and late-stage clinical development, including investigational ADCs, mRNA vaccines and innovative immunotherapies,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “Our goal is to achieve product approvals in ten oncological indications by 2030 and with this improve the treatment options for patients around the globe.”
BioNTech to Present Clinical Data Updates for Personalized mRNA-based and Targeted Oncology Candidates at AACR 2024 BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected candidates from its oncology pipeline at the American Association for Cancer Research (“AACR”) Annual Meeting 2024 in San Diego, California, from April 5-10, 2024. The oral and poster presentations will feature BioNTech’s investigational mRNA-based cancer vaccine and novel investigational antibody-drug conjugate (“ADC”) approaches. “This year’s AACR presentations feature candidates from our individualized and off-the-shelf mRNA cancer vaccine platforms, including a late-breaking presentation of longer-term follow-up data with our individualized mRNA-based candidate autogene cevumeran in patients with pancreatic cancer,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “Our investigational mRNA cancer vaccine approaches are an important pillar in our oncology portfolio, aimed at eliminating residual tumor foci and reducing the tumor burden by targeting multiple antigens at once. The data we will be sharing at AACR show how we’re delivering on our commitment to patients through investigating novel treatment approaches.”
BioNTech Announces Planned Retirement of Sean Marett BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that Sean Marett, Chief Business and Commercial Officer, will retire as planned from the Management Board of BioNTech. As of July 1, 2024, Sean Marett will continue as a specialist advisor to the Company at least until the end of the year. A new Chief Commercial Officer will be announced by the end of March 2024. Sean Marett’s responsibilities as Chief Business Officer are being gradually transferred to James Ryan, Ph.D., Chief Legal Officer, who will also take on the role of Chief Business Officer of BioNTech at the end of the transition phase and upon Sean Marett’s retirement.
BioNTech to Report Fourth Quarter and Full Year 2023 Financial Results and Provide Corporate Update on March 20, 2024 BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the full year and fourth quarter 2023 on Wednesday, March 20, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. ET (1:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast will be available via this link. Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page in the Investor Relations section of the Company’s website at https://biontech.com/. A replay of the webcast will be made available shortly after the call and archived on the Company’s website for 30 days following the call.
BioNTech and DualityBio Receive FDA Fast Track Designation for Next-Generation Antibody-Drug Conjugate Candidate BNT325/DB-1305 - Designation is based on preliminary safety and efficacy data from an ongoing Phase 1/2 trial in patients with platinum-resistant ovarian epithelial cancer, fallopian tube, or primary peritoneal cancer. - Fast Track designation can facilitate the development and expedite the regulatory review of BNT325/DB-1305. - Ovarian cancer is the fourth most common gynecological tumor type with over 300,000 cases diagnosed globally each year; over 90% of ovarian tumors arise from epithelial cells, including the epithelial tissue of the ovary, the lining of a fallopian tube or the peritoneum.
BioNTech and DualityBio Initiate Pivotal Phase 3 Trial Of Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Metastatic Breast Cancer - The pivotal Phase 3 trial with BNT323/DB-1303 follows positive Phase 1/2 safety and efficacy data in patients with Human Epidermal Growth Factor Receptor 2 (“HER2”)-expressing advanced solid tumors with early signs of anti-tumor activity in heavily pretreated patients with HER2-low and HER2-positive breast cancer - The trial is expected to enroll 532 patients with Hormone Receptor-positive (“HR+”) and HER2-low metastatic breast cancer progressing on hormone therapy at clinical trial sites worldwide, initially in China, followed by sites in the United States, Europe, and additional regions - The clinical milestone is in furtherance of BioNTech’s and DualityBio’s strategic objective to advance BNT323/DB-1303 into late-stage development in multiple high unmet medical need cancer indications
BioNTech Outlines 2024 Strategic Priorities at the 42nd Annual J.P. Morgan Healthcare Conference Plans to have ten or more potentially registrational trials by the end of 2024. Preparing to be commercial-ready by the end of 2025. Ended 2023 with approximately €17.5 billion (unaudited) in cash, cash equivalents and security investments. Expects full year 2024 revenues of approximately €3 billion. Presentation and webcast at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 6:00 p.m. CET/ 12:00 p.m. ET.
BioNTech and DualityBio Receive FDA Breakthrough Therapy Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Endometrial Cancer!
BioNTech Achieves Milestone at mRNA-based Vaccine Manufacturing Site in Rwanda Set-up of first BioNTainer as high-tech manufacturing solution for mRNA medicines is a critical step in establishing a resilient vaccine ecosystem in Africa and future pandemic preparedness. BioNTech plans to complete all buildings at the Kigali site and start local training of specialized personnel in the facility in 2024, with test mRNA production for process validation to be initiated in 2025. Upon successful validation, the Kigali facility will serve as a lighthouse project for subsequent mRNA-based vaccine manufacturing facilities of smaller or larger scale to support clinical development or commercial-scale production in line with local or regional demand. In addition, BioNTech is progressing the development of mRNA vaccine candidates for infectious diseases with high medical need, including vaccine candidates against tuberculosis, malaria, and HIV, as well as against infectious diseases with pandemic potential, such as mpox. Upon successful development and approval, these vaccines are intended for production at the newly established site. On invitation by H.E. President Paul Kagame of Rwanda, Heads of State and Government from Africa and around the world, leadership of the African Union and European Union, as well as from WHO, Africa CDC and CEPI attended the official inauguration of the BioNTech site in Kigali.
BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will inaugurate its first African site in Kigali, Rwanda, on Monday, December 18th, 2023. The inauguration takes place on the occasion of the set-up of the containers for the first manufacturing unit called BioNTainer. BioNTech invites media and the general public to join a live stream of the event on the same day at 2:00 pm CET. The statements of high-level dignitaries including official government representatives as well as members of BioNTech’s board will be broadcasted in addition to the ceremonial ribbon cutting. The live stream will be available via link in the full article on our website. A replay of the stream will be available via the “Events & Presentations” page of the Investor Relations section of the Company’s website at www.BioNTech.com. This will be available shortly after the conclusion of the event on the Company’s website for seven days following the event.
