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BioNTech SE (BNTX) is a global biotechnology pioneer advancing mRNA-based therapies for cancer and infectious diseases. This page provides investors and stakeholders with timely updates on corporate developments, clinical research milestones, and strategic initiatives shaping the future of personalized medicine.
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Bookmark this page for streamlined access to BioNTech's evolving role in oncology therapeutics and next-generation vaccine development. Regularly updated to reflect the company's scientific advancements and business strategy execution.
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.
Pfizer and BioNTech have provided an update on their mRNA-based combination vaccine program against influenza and COVID-19 for individuals aged 18-64. In a Phase 3 trial, the vaccine candidate met one of its two primary immunogenicity objectives. The trial showed robust influenza A responses and comparable COVID-19 responses versus comparator vaccines. However, it did not meet the non-inferiority objective against the influenza B strain.
Additionally, Pfizer reported encouraging data from a separate Phase 2 trial of its second-generation trivalent influenza mRNA vaccine, demonstrating robust immunogenicity against all strains compared to a standard of care influenza vaccine. The companies are evaluating adjustments to the combination vaccine candidate and will discuss next steps with health authorities.
BioNTech announced its second quarter 2024 financial results, revealing a net loss of €807.8 million and revenues of €128.7 million, down from the previous year's €167.7 million. The company is investing heavily in R&D, spending €525.6 million, primarily on oncology and non-COVID-19 mRNA projects. BioNTech launched an updated COVID-19 vaccine in the EU, received UK approval, and initiated a rolling sBLA with the U.S. FDA.
Key clinical developments include positive Phase 2 results for cancer vaccine BNT111 and the commencement of trials for novel drug combinations. Despite the financial loss, BioNTech holds a strong cash position of €18.5 billion.
The company reiterates its 2024 revenue guidance of €2.5-3.1 billion. R&D expenses for the full year are projected between €2.4-2.6 billion, with SG&A expenses between €700-800 million. BioNTech continues to target long-term growth in oncology and infectious diseases.
BioNTech (BNTX) announced positive topline results from its Phase 2 trial of BNT111, an mRNA immunotherapy for advanced melanoma. The trial met its primary endpoint, showing a statistically significant improvement in overall response rate (ORR) when BNT111 was combined with cemiplimab, compared to historical control in anti-PD-(L)1 relapsed/refractory patients. Both monotherapy arms also showed clinical activity. The treatment was well-tolerated, with a safety profile consistent with previous trials.
BNT111, based on BioNTech's FixVac platform, received Fast Track and Orphan Drug designations from the FDA in 2021. The company plans to present detailed data at an upcoming medical conference and submit for peer-reviewed publication.
