BIONTECH - BNTX STOCK NEWS

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.

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.