BioNTech SE American Depositary Share - BNTX STOCK NEWS

BioNTech SE (BNTX) reported strong financial results for 2022, with total revenues of €17.3 billion and a net profit of €9.4 billion, translating to fully diluted earnings per share of €37.77. Approximately 2 billion doses of COMIRNATY® were invoiced in 2022, bolstered by the release of Omicron-adapted vaccines. The company initiated multiple clinical trials, expanding its oncology pipeline to 20 programs and 24 ongoing trials. For 2023, BioNTech estimates COVID-19 vaccine revenues around €5 billion, despite anticipated seasonal demand fluctuations. A share repurchase program of up to $0.5 billion is expected to be authorized in 2023.

BioNTech has entered an exclusive worldwide license with OncoC4 to develop and commercialize the anti-CTLA-4 antibody candidate ONC-392. This collaboration involves co-developing ONC-392 either as monotherapy or in combination with anti-PD1 therapies in various cancer types, with a randomized Phase 3 trial set for 2023. OncoC4 will receive a $200 million upfront payment and potential milestone payments, along with tiered royalties. ONC-392, currently in ongoing trials, has shown promising clinical results and received Fast Track designation from the FDA for treating immunotherapy-resistant non-small cell lung cancer (NSCLC).

BioNTech SE (Nasdaq: BNTX) will announce its financial results for the full year and fourth quarter of 2022 on March 27, 2023. This announcement will be followed by a conference call and webcast at 8:00 a.m. EDT (2:00 p.m. CEST) to discuss the results and provide a corporate update. Interested participants can register for the conference call via a provided link and access the presentation materials on the Company's website. BioNTech is focused on developing novel therapies for cancer and infectious diseases, leveraging its expertise in mRNA technology.

BioNTech SE (Nasdaq: BNTX) and the Weizmann Institute of Science have entered a Memorandum of Understanding to collaborate on research aimed at understanding diseases such as cancer and neurodegenerative conditions. This partnership will facilitate research at BioNTech’s newly established mRNA Excellence Center in Israel, set to operate by the end of 2023, hosting around 60 researchers across various disciplines. Additionally, BioNTech plans to establish an mRNA manufacturing facility in Israel to advance cancer therapies and enhance health threat responses.

BioNTech SE (Nasdaq: BNTX) has completed construction of its first proprietary plasmid DNA manufacturing facility in Marburg, Germany, with an investment of approximately €40 million. This facility aims to enhance the company's autonomy in producing essential components for its mRNA and cell-based therapies, notably for oncology and COVID-19 vaccines. The clinical-scale plant is already operational, while the commercial-scale plant is expected to begin by the end of 2023, pending regulatory approval. The site supports BioNTech's plan to manufacture plasmids for hundreds of millions of vaccine doses annually, contributing to local production and pandemic preparedness.

BioNTech has announced its acquisition of InstaDeep for approximately £362 million in cash and shares, aiming to enhance its AI-driven capabilities in drug discovery and development. This acquisition will add around 240 skilled professionals and strengthen BioNTech's research network across key global technology hubs. InstaDeep will operate as a subsidiary, further integrating AI and ML technologies into BioNTech's operations. The deal is expected to close in the first half of 2023, subject to regulatory approval, and involves potential future milestone payments of up to £200 million.

BioNTech signed a Memorandum of Understanding with the UK Government to enhance clinical trials for personalized cancer immunotherapies. The collaboration aims to provide treatments for up to 10,000 patients by 2030. This multi-year effort will focus on cancer immunotherapies, infectious disease vaccines, and expanding BioNTech's presence in the UK. A new R&D hub in Cambridge will employ over 70 scientists. The first patient is expected to enroll in clinical trials by H2 2023.

BioNTech (Nasdaq: BNTX) announced that CEO Prof. Ugur Sahin will present an overview at the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 9:45 am PST / 12:45 pm ET. A live webcast will be available on the Company's website and will be archived for 30 days. BioNTech is a leader in immunotherapy, focused on innovative therapies for cancer and infectious diseases, leveraging cutting-edge mRNA technology. The Company collaborates with various global pharmaceutical partners to advance its diverse oncology and vaccine pipeline.

BioNTech SE has launched a Phase 1 clinical trial for its mRNA-based malaria vaccine candidate, BNT165b1. This innovative vaccine aims to combat malaria caused by Plasmodium falciparum, with a goal to select an optimal multi-antigen candidate for further development. The study will evaluate the safety and immunogenicity of BNT165b1 and will enroll around 60 healthy volunteers in the U.S. The company’s initiative aligns with the urgent need for effective malaria prevention in sub-Saharan Africa, where malaria remains a significant health threat.