BIONTECH - BNTX STOCK NEWS

BioNTech (BNTX) will announce its Q2 2020 financial results on August 11, 2020, followed by a conference call at 08:00 a.m. EDT. Investors can access a webcast of the event and see a slide presentation. The company focuses on immunotherapy, developing innovative treatments for cancer and infectious diseases using mRNA technology. BioNTech collaborates with several major pharmaceutical companies, including Pfizer and Sanofi, to advance its diverse pipeline of therapies and vaccines.

BioNTech (BNTX) and Fosun Pharma announce the initiation of a Phase 1 clinical trial for the COVID-19 vaccine candidate BNT162b1 in China, enrolling 144 participants aged 18-55 and over 55. The trial, approved by the NMPA, aims to evaluate safety and immunogenicity, with participants receiving two doses of either 10µg or 30µg of the vaccine or placebo. The study builds on prior trials in Germany and the U.S. and could support regulatory approval in China. If successful, Fosun Pharma will exclusively commercialize the vaccine in mainland China.

Pfizer and BioNTech have signed an agreement with Japan's Ministry of Health to supply 120 million doses of their BNT162 mRNA vaccine, pending regulatory approval, starting in 2021. The companies are advancing their clinical trials for BNT162, aiming for regulatory review by October 2020. They plan to manufacture up to 100 million doses by the end of 2020 and 1.3 billion doses by the end of 2021. Recent trials for the BNT162b1 and BNT162b2 candidates received Fast Track designation from the FDA, indicating promising data from initial studies.

BioNTech has announced a collaboration with Regeneron to conduct a Phase 2 clinical trial combining BNT111 FixVac and Libtayo for treating melanoma, specifically in patients with anti-PD-1 refractory melanoma. This partnership aims to explore the potential of these two immunotherapies to enhance treatment outcomes. The study will share development costs equally, with both companies retaining commercial rights to their respective therapies. The trial is expected to begin in Q4 2020, following further details to be disclosed in Q3 2020.

BioNTech (BNTX) announced preliminary Phase 1 results from the Lipo-MERIT trial for its cancer vaccine BNT111, showing a favorable tolerability profile in 89 advanced melanoma patients. Efficacy analysis indicated durable responses in a subset of 42 patients previously treated with checkpoint inhibitors, with BNT111 leading to significant T-cell activation. The company plans to commence a Phase 2 trial with potential registrational implications.

Pfizer and BioNTech have initiated a global Phase 2/3 clinical trial for their BNT162b2 vaccine candidate, targeting COVID-19 with a 30 µg dose in a two-dose regimen. The study will enroll up to 30,000 participants aged 18 to 85, with expected sites across 120 locations globally, including areas with high SARS-CoV-2 transmission. If successful, the companies aim to seek regulatory review in October 2020 and supply 100 million doses by year-end, with a total of 1.3 billion doses by the end of 2021.

BioNTech (Nasdaq: BNTX) announced the closing of its underwritten offering of 5,500,000 American Depositary Shares (ADSs) at $93.00 each, raising approximately $512 million. The underwriters have a 30-day option to purchase an additional 825,000 ADSs. BioNTech plans to utilize these funds to enhance its pipeline of immunotherapies targeting oncology and infectious diseases. J.P. Morgan, BofA Securities, and Berenberg led the offering. A registration statement regarding these securities was effective as of July 22, 2020.

BioNTech SE (BNTX) announced a firm commitment underwritten offering of 5,500,000 American Depositary Shares (ADSs) at a public price of $93.00 per ADS, generating gross proceeds of $511.5 million, increased from a previous offering of 5,000,000 ADSs. The offering closes on July 27, 2020. Simultaneously, a rights offering of up to 7,505,596 ordinary shares has been announced, with certain shareholders agreeing not to exercise their rights. The exercise period for ADS rights is from July 28 to August 14, 2020. Proceeds from the offering will not benefit the company.

The U.S. government has ordered 100 million doses of the BNT162 COVID-19 vaccine from Pfizer and BioNTech for $1.95 billion, with an option for an additional 500 million doses. This agreement supports the Operation Warp Speed initiative, aiming to deliver 300 million vaccine doses by 2021. The vaccine will be provided free to Americans. Pfizer and BioNTech plan to manufacture up to 100 million doses by year-end 2020 and potentially over 1.3 billion by the end of 2021. Clinical trials are underway, with the companies seeking regulatory review soon.