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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 (NASDAQ: BNTX) will showcase data from its oncology pipeline at the AACR Annual Meeting in Chicago (April 25-30, 2025). The presentations will feature:
1. BNT327: A next-generation bispecific antibody showing superior anti-tumor activity in preclinical studies when combined with antibody-drug conjugates (ADCs)
2. BNT116: Phase 1 clinical trial data in combination with cemiplimab for non-small cell lung cancer (NSCLC), demonstrating anti-tumor activity and manageable safety profile
3. BNT314/GEN1059: Preclinical data showing enhanced anti-tumor activity when combined with PD-1 inhibition
The company's oncology portfolio includes mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, with over 20 active Phase 2 and 3 trials. Multiple data readouts are expected in 2025 and 2026.
BioNTech SE (Nasdaq: BNTX) has announced it will release its first quarter 2025 financial results on Monday, May 5, 2025. The company will host a conference call and webcast at 8:00 a.m. EDT (2:00 p.m. CEST) to discuss the financial results and provide a corporate update.
Investors, financial analysts, and the public can access the conference call via telephone by registering through a provided link, which will supply dial-in numbers and a PIN. Registration is recommended at least one day in advance. The webcast and slide presentation will be accessible through the company's Investor Relations section, with a replay available for 30 days after the call.
BioNTech (BNTX) reported Q4 2024 revenues of €1.2 billion and full-year revenues of €2.8 billion, with a net loss of €0.7 billion for 2024. The company maintains a strong financial position with €17.4 billion in cash and investments as of December 31, 2024.
Key highlights include:
- Advanced oncology pipeline with over 20 active Phase 2 and 3 clinical trials
- Completed acquisition of Biotheus, securing control of BNT327 immunomodulator candidate
- Successfully launched JN.1 and KP.2-adapted COVID-19 vaccines
- 2025 revenue guidance of €1.7-2.2 billion
The decrease in revenues was primarily attributed to lower COVID-19 vaccine sales due to reduced market demand and write-downs by collaboration partner Pfizer. R&D expenses increased to €2.25 billion in 2024, focusing on advancing clinical studies for late-stage oncology candidates. The company expects multiple data readouts in 2025 and 2026, aiming to become a diversified multi-product oncology portfolio company by 2030.
BioNTech SE (Nasdaq: BNTX) has announced it will release its fourth quarter and full year 2024 financial results on Monday, March 10, 2025. The company will host a conference call and webcast at 8:00 a.m. EDT (1:00 p.m. CET) on the same day.
Investors, financial analysts, and the public can participate in the conference call by registering through a provided link to receive dial-in numbers and a PIN. The presentation slides and webcast audio will be accessible through another link and the company's website. A replay of the webcast will be available for 30 days after the call on BioNTech's website.
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.
