BIONTECH - BNTX STOCK NEWS

BioNTech (NASDAQ: BNTX) has completed the acquisition of Biotheus, a clinical-stage biotechnology company focused on antibody development for oncological and inflammatory diseases. The transaction, valued at $800 million plus potential milestone payments of up to $150 million, was primarily paid in cash with a small portion in BioNTech ADSs.

The acquisition strengthens BioNTech's oncology strategy by securing full global rights to BNT327, a bispecific antibody targeting PD-L1 and VEGF-A, along with Biotheus' entire pipeline and antibody generation platform. Biotheus will become BioNTech's indirect Chinese subsidiary, providing local R&D capabilities and an advanced biologics manufacturing facility.

BioNTech (BNTX) presented its 2025 strategic priorities and pipeline updates at the 43rd Annual J.P. Morgan Healthcare Conference. The company is advancing its oncology portfolio with two main focuses: mRNA-based cancer immunotherapies and the BNT327/PM8002 bispecific antibody program.

Key developments include the initiation of global clinical trials for BNT327/PM8002 in first-line small cell lung cancer and non-small cell lung cancer, with plans to start additional trials in triple-negative breast cancer. The company also launched a Phase 2 trial for autogene cevumeran in urothelial carcinoma and is preparing for a potential BLA submission for BNT323/DB-1303 in endometrial cancer.

Regarding COVID-19 vaccines, BioNTech and Pfizer expect stable vaccination rates and market share in the U.S. for 2025, with revenue primarily concentrated in the second half of the year.

BioNTech (BNTX) and DualityBio presented promising Phase 1/2a trial results for BNT324/DB-1311, a B7-H3 targeting antibody-drug conjugate, at ESMO Asia 2024. The trial included 277 patients with advanced solid tumors, showing encouraging antitumor activity and manageable safety. Key findings include:

- 70.4% unconfirmed objective response rate in SCLC patients with prior immunotherapy at 9 mg/kg dose
- 28.0% response rate in CRPC patients with 7.2 months median rPFS
- Overall response rate of 32.4% across all evaluable patients
- Common side effects included nausea and decreased blood cell counts

The companies plan to start a Phase 1/2 combination trial with BNT327/PM8002 in SCLC/NSCLC patients in 2025.

BioNTech announces the acquisition of Biotheus for $800 million upfront plus up to $150 million in milestone payments. The deal includes full global rights to BNT327/PM8002, a late-stage bispecific antibody targeting PD-L1 and VEGF-A for cancer treatment. The acquisition strengthens BioNTech's oncology portfolio and includes Biotheus' pipeline candidates, bispecific antibody capabilities, and Chinese R&D hub. Multiple registrational trials for BNT327/PM8002 are planned for 2024-2025, targeting various solid tumors. The transaction is expected to close in Q1 2025, adding over 300 employees and a biologics manufacturing facility to BioNTech's operations.

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.