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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 a proposed public offering of 5 million American Depositary Shares (ADSs), with an existing shareholder granting underwriters an option for 750,000 additional ADSs. Following this, a rights offering for existing ADS and ordinary shareholders will occur, with a subscription price yet to be determined. Notably, shareholders controlling 74.83% of ordinary shares will not transfer or exercise their rights. Indications of interest from certain investors, including Pfizer, may total $200 million, though these are not binding commitments.
BioNTech (BNTX) and Pfizer announced preliminary findings from the German Phase 1/2 trial of their BNT162b1 mRNA COVID-19 vaccine. The study involved 60 participants and showed high SARS-CoV-2 neutralizing titers and robust CD4+ and CD8+ T cell responses. Notably, T cells exhibited a Th1 phenotype, suggesting strong antiviral potential. The vaccine also demonstrated broad neutralization against multiple variants, including the D614G strain. No serious adverse events occurred, with mild to moderate reactions reported. The data support further development, with plans for a larger global Phase 2b/3 trial anticipated to begin in late July 2020.
BioNTech (BNTX) and Pfizer announce an agreement with the UK to supply 30 million doses of their BNT162 mRNA-based COVID-19 vaccine, pending regulatory approval. The companies aim to manufacture up to 100 million doses by the end of 2020 and potentially over 1.3 billion doses by the end of 2021. The vaccine candidates are undergoing clinical trials and have shown potential for neutralizing antibodies at low doses. Both companies are engaged with multiple governments and the COVAX Facility for broader vaccine distribution.
Pfizer and BioNTech announced that two investigational COVID-19 vaccine candidates, BNT162b1 and BNT162b2, received Fast Track designation from the FDA. This designation aims to expedite the development of drugs addressing serious medical needs. Preliminary data from ongoing Phase 1/2 studies in the U.S. and Germany supported this designation. If successful, a Phase 2b/3 trial could begin soon, with potential for 100 million doses by end of 2020 and over 1.2 billion by end of 2021.
BioNTech (Nasdaq: BNTX) announced a conference call on July 1, 2020, at 11:00 a.m. EDT to discuss preliminary data from its ongoing Phase 1/2 trial of an mRNA-based vaccine against SARS-CoV-2. The firm continues to leverage its expertise in mRNA vaccine development and manufacturing to advance multiple vaccine candidates for infectious diseases and an extensive oncology pipeline. The call can be accessed via phone or webcast, with a replay available for 30 days post-event.
BioNTech (BNTX) and Pfizer announced preliminary results from a Phase 1/2 clinical trial of their mRNA vaccine candidate BNT162b1 against SARS-CoV-2. In 45 subjects, those receiving 10 µg and 30 µg doses exhibited significantly elevated RBD-binding IgG antibody levels and neutralizing antibody titers, outperforming convalescent sera. No serious adverse events were reported. If successful, a global Phase 2b/3 trial could start in July 2020, with plans to manufacture up to 100 million doses by the end of 2020 and over 1.2 billion by 2021, pending regulatory approval.
BioNTech (BNTX) announced a private investment totaling USD 250 million from Temasek and other accredited investors. The investment will include approximately USD 139 million in ordinary shares and USD 112 million in mandatory convertible notes, which carry a 4.5% annual coupon. Investors will receive 2,595,996 ordinary shares subject to a 180-day lock-up. The deal is expected to close in early to mid-August 2020, pending customary conditions. BioNTech focuses on patient-specific immunotherapies for cancer and infectious diseases.
BioNTech has secured a €100 million debt financing agreement from the European Investment Bank (EIB) to advance its BNT162 COVID-19 vaccine initiative and enhance manufacturing capacity in Europe. This funding is disbursed in two tranches linked to specific milestones, supported by European Commission initiatives including Horizon 2020 and the European Fund for Strategic Investments. BioNTech leads with multiple BNT162 vaccine candidates in clinical trials, aiming to expedite global supply amidst the pandemic.
BioNTech SE (BNTX) provided an update on its COVID-19 vaccine program BNT162, now in Phase 1/2 trials in Europe and the U.S. The first cohorts have been dosed, with the trial aiming to determine the optimal dose and evaluate safety and immunogenicity. As of March 31, 2020, BioNTech reported cash equivalents of €451.6 million and a net loss of €53.4 million for Q1 2020. The company is on track to fund BNT162 development through partnerships, estimating approximately €300 million in net cash for 2020. A conference call is scheduled for May 12, 2020.
BioNTech (Nasdaq: BNTX) has completed the acquisition of Neon Therapeutics, Inc. (Nasdaq: NTGN) in an all-stock deal, announced initially on January 16, 2020. The newly formed subsidiary, BioNTech US Inc., will be based in Cambridge, Massachusetts, serving as BioNTech’s U.S. headquarters. As of May 7, 2020, Neon’s common stock will cease trading. This acquisition represents a strategic move to enhance BioNTech's immunotherapy portfolio, particularly in mRNA-based therapies, further solidifying its position in the biopharmaceutical market.
