BioNTech SE American Depositary Share - BNTX STOCK NEWS

BioNTech (BNTX) reported Q3 2024 financial results with revenues of €1.2 billion, net profit of €198.1 million, and diluted EPS of €0.81. The company expects to be at the low end of full-year 2024 revenue guidance range (€2.5-3.1 billion) and maintains R&D expense guidance of €2.4-2.6 billion. Key highlights include successful launch of variant-adapted COVID-19 vaccines and progress in oncology pipeline, particularly with BNT327/PM8002 bispecific antibody trials in lung and breast cancer. The company ended Q3 with €17.8 billion in cash and investments.

BioNTech SE (Nasdaq: BNTX) has announced its upcoming Innovation Series R&D Day, scheduled for November 14, 2024, at 10:30 a.m. EST (16:30 CET) in New York City. The event will feature presentations from the company's leadership team, who will outline corporate strategy and provide updates on clinical pipeline progress.

The event will be accessible to investors, analysts, and the public through an online webcast. Presentation materials will be available on BioNTech's website, with the webcast replay remaining accessible for one year after the event.

BioNTech SE (Nasdaq: BNTX) has announced that it will release its financial results for the third quarter of 2024 on Monday, November 4, 2024. The company will also host a conference call and webcast on the same day at 8:00 a.m. ET (2:00 p.m. CET) to discuss the financial results and provide a corporate update.

Investors, financial analysts, and the general public can access the live conference call by registering through a provided link. The slide presentation and audio of the webcast will be available via another link. Participants can also access the materials through the 'Events & Presentations' page in the Investor Relations section of BioNTech's website. A replay of the webcast will be archived on the company's website for 30 days following the call.

BioNTech and its AI subsidiary InstaDeep presented their AI strategy at the Company's Innovation Series AI Day. The event highlighted BioNTech's efforts to scale and deploy AI capabilities across its immunotherapy pipeline. Key updates include:

1. Introduction of InstaDeep's new near exascale supercomputer, Kyber, aimed at enabling large-scale computing.
2. Unveiling of novel AI Bayesian Flow Network (BFN) models for protein sequence generation.
3. Progress in deploying AI across BioNTech's pipeline, including in immunohistochemistry, DNA/RNA sequencing, proteomics, protein design, and lab functional validation.

The company also showcased its DeepChain™ multiomics design platform, now open for external partnerships. BioNTech aims to leverage AI to develop personalized vaccines and targeted therapies, positioning itself at the intersection of biotechnology and AI.

Pfizer and BioNTech have received a positive opinion from the CHMP for their Omicron KP.2-adapted COVID-19 vaccine in the European Union. The vaccine is recommended for individuals 6 months of age and older. Data shows it generates a substantially improved response against multiple circulating Omicron JN.1 sublineages, similar to the previously authorized Omicron JN.1-adapted vaccine. Upon European Commission authorization, doses will be ready to ship to EU member states. The vaccine's efficacy is based on non-clinical and manufacturing data, as well as clinical and real-world evidence from prior formulations. In the US, the vaccine was approved for ages 12 and up, with emergency use authorization for ages 6 months to 11 years on August 22, 2024.

BioNTech SE (Nasdaq: BNTX) and its AI company InstaDeep are set to host an AI Day as part of BioNTech's Innovation Series on October 1, 2024, in London. The event, starting at 09:00 a.m. EDT (3:00 p.m. CEST), will showcase the companies' AI strategy, capabilities, and its application in BioNTech's pipeline and internal processes.

A live webcast will be available for viewers, with a replay accessible on BioNTech's website for one year following the event. This presentation aims to provide insights into how BioNTech is leveraging AI technologies to advance its biopharmaceutical research and development efforts.

BioNTech SE (Nasdaq: BNTX) will present clinical trial data for selected oncology assets at the ESMO Congress 2024 in Barcelona. The presentations will cover mRNA-based cancer vaccines, next-generation immunomodulators, and targeted therapies. Key highlights include:

1. Updates on BNT327/PM8002, a bispecific antibody, in various cancer indications.
2. Preliminary data on BNT113, an mRNA immunotherapy for HPV16-driven cancers.
3. Data from a Phase 2 trial of BNT316/ONC-392 in ovarian cancer.
4. Follow-up data on BNT211, a CAR-T cell therapy for CLDN6+ solid tumors.

BioNTech aims to have ten or more potentially registrational trials in its oncology pipeline by the end of 2024.

Tempus AI (NASDAQ: TEM) has announced a multi-year collaboration with BioNTech SE (Nasdaq: BNTX) to enhance BioNTech's next-generation oncology pipeline. The partnership leverages Tempus' large multimodal datasets and computational biology expertise to support BioNTech's research and development efforts in oncology.

Tempus will provide analytical support and access to its real-world multimodal database to help BioNTech generate novel insights into biological mechanisms. This collaboration aims to advance the discovery of new therapies and enhance the development of BioNTech's clinical oncology pipeline. The partnership combines Tempus' real-world data and computational technology with BioNTech's AI capabilities and multi-platform discovery engine to potentially bring innovative therapies to cancer patients.

Pfizer and BioNTech have received FDA approval and authorization for their Omicron KP.2-adapted COVID-19 vaccine for the 2024-2025 season. The vaccine is approved for individuals 12 years and older and authorized for emergency use in children 6 months to 11 years. It's designed to target the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage, as recommended by the FDA for the upcoming fall and winter season. The vaccine will be available as a single dose for most individuals 5 years and older, with additional doses for certain immunocompromised individuals or young children. Immediate shipping has begun to ensure widespread availability across the U.S. in the coming days.