BIONTECH - BNTX STOCK NEWS

The U.S. FDA has expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include a booster dose for children aged 5 to 11. This booster, a 10-µg dose, can be administered at least five months after the second dose. Over 8 million children in this age group have completed the primary series. Data from clinical trials showed a strong immune response against both the Omicron variant and the wild-type virus, with no new safety issues reported.

BioNTech SE (Nasdaq: BNTX) reported first quarter 2022 revenues of €6.4 billion, net income of €3.7 billion, and diluted EPS of €14.24. The company reiterated its COVID-19 vaccine revenue guidance for 2022 at €13 billion to €17 billion. Progress in its CAR-T program targeting CLDN-6 (BNT211) showed promising preliminary Phase 1/2 data. BioNTech continues to expand its oncology pipeline, with 16 clinical-stage programs and 20 ongoing trials. Upcoming events include a conference call on May 9, 2022, for further corporate updates.

BioNTech (Nasdaq: BNTX) will announce its financial results for Q1 2022 on May 9, 2022. A conference call and webcast for investors and analysts will occur at 8:00 AM EDT (2:00 PM CEST) to report these results and provide a company update. The presentation slides and audio will be accessible via BioNTech's website. They are recognized for their pioneering work in immunotherapy and have multiple collaborations with major pharmaceutical companies, focusing on innovative therapies for cancer and infectious diseases.

Pfizer and BioNTech announced positive results from their Phase 2/3 clinical trial, showing a 36-fold increase in SARS-CoV-2 Omicron neutralizing titers after a booster dose for children aged 5-11. The booster also resulted in a 6-fold increase against the wild-type strain. In total, the trial involved 140 children, with no new safety signals reported. The companies plan to submit data for Emergency Use Authorization (EUA) in the U.S. soon, along with submissions to other global regulatory agencies.

Pfizer and BioNTech announced significant findings from a Phase 2/3 clinical trial of the COVID-19 vaccine in children aged 5-11. Following a booster dose, the vaccine showed a 36-fold increase in neutralizing antibodies against the Omicron variant, alongside a 6-fold increase against the wild-type virus. The booster was well tolerated with no new safety concerns. The companies intend to submit these results for Emergency Use Authorization to the FDA and other global regulatory agencies soon, reinforcing their commitment to providing effective vaccinations for younger populations.

BioNTech (BNTX) has entered an exclusive collaboration with Matinas BioPharma to combine their expertise in mRNA vaccine development and Lipid Nanocrystal (LNC) Delivery Platform Technology. This partnership aims to advance innovative formulations for mRNA vaccines, including potential oral delivery options.

Matinas will receive an upfront access fee and additional research funding as part of the agreement. Discussions are underway for a formal license agreement for Matinas’ LNC platform technology.

BioNTech (BNTX) announced promising preliminary results from a Phase 1/2 trial of its CAR-T cell therapy, BNT211, targeting Claudin-6 in advanced solid tumors. The study involving 16 patients showed an disease control rate of 86% and an overall response rate of 43%. The treatment was well tolerated, with manageable adverse events like cytokine release syndrome. Notably, four testicular cancer patients achieved disease control. Further evaluations are planned, with the next data update expected later this year.

BioNTech SE announced the receipt of a pandemic preparedness contract from the German government, aimed at ensuring the supply of mRNA vaccines during emergencies. This agreement allows BioNTech to produce at least 80 million vaccine doses annually over an initial five-year term. Sean Marett, Chief Business Officer, emphasized the company's commitment to combating future pandemics and adapting vaccines to emerging variants. The contract reinforces BioNTech's role as a key player in pandemic response and showcases its ongoing investment in research and development.

BioNTech has initiated a $1.5 billion share repurchase program to enhance shareholder value, reflecting its strong 2021 performance. This program allows BioNTech to purchase American depositary shares (ADSs) over the next two years, primarily to meet obligations under share-based payment arrangements. CEO Jens Holstein emphasized the strategic nature of this initiative as part of the company's capital allocation strategy. The repurchase timing will depend on market conditions and will comply with SEC regulations.