Page 1

BIONTECH BioNTech Announces Second Quarter 2021 Financial Results and Corporate Update August 9 , 2021 • More than one billion doses of BNT162b2 vaccine supplied to more than 100 countries or territories worldwide as of July 21 , 2021 • Signed agreements for approximately 2.2 billion doses of BNT162b2 in 2021 as of July 21 , 2021 • In oncology , the first patients were dosed in randomized Phase 2 trials for two Fix Vac programs , BNT111 and BNT113 , and first - in - human Phase 1 trials started for BNT152 + 153 and BNT221 • BioNTech's oncology pipeline has advanced : currently 15 product candidates in 18 ongoing trials Conference call and webcast scheduled for August 9 , 2021 , at 8:00 a.m. ET ( 2:00 p.m. CET ) MAINZ , Germany , August 9 , 2021 ( GLOBE NEWSWIRE ) BioNTech SE ( Nasdaq : BNTX , " BioNTech " or " the Company " ) , a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases , today provided an update on its corporate progress and reported financial results for the second quarter and first half - year ended June 30 , 2021 . " We and our partner Pfizer have crossed the one billion mark for COVID - 19 vaccine doses shipped worldwide . We are proud to have reached this great milestone after only six months and to have made a difference for people with our proprietary mRNA technology . To address the ongoing pandemic , we are expanding the supply of our COVID - 19 vaccine to more than 100 countries and regions worldwide , including enhancing access to low- and middle - income countries , " said Ugur Sahin , M.D. , CEO and Co - Founder of BioNTech . " At the same time , we further developed our oncology pipeline , including the recent initiation of randomized Phase 2 trials for two FixVac programs . We were able to advance multiple oncology programs across various technology platforms which are now entering later stage testing , providing the potential for introducing a series of product candidates to the market in the coming years . " Second Quarter 2021 and Subsequent Updates Infectious disease COVID - 19 Vaccine Program - BNT162b2 BNT162b2 clinical development updates Multiple clinical trials are ongoing to expand access to and authorization of BNT162b2 to additional regions and population groups , such as the studies in children from 6 months to 11 years of age , and in healthy pregnant women . • On April 1 , 2021 , BioNTech and Pfizer announced updated topline results from the global Phase 3 trial of BNT162b2 , which showed high efficacy and no serious safety concerns through up to six months following the second dose . The data were published on the medRxiv preprint server on July 29 , 2021.1 Topline efficacy was based on an analysis of 971 confirmed symptomatic cases of COVID - 19 observed in the pivotal Phase 3 trial through March 13 , 2021. BNT162b2 was 91.2 % effective against COVID - 19 , measured seven days through up to six months after the second dose . The vaccine was also 95.7 % effective against severe COVID - 19 as defined by the Food and Drug Administration ( FDA ) as measured seven days after the second dose . Safety data collected demonstrated a favorable safety and tolerability profile . An additional exploratory analysis of 800 trial participants enrolled in South Africa confirmed 100 % efficacy against SARS - CoV - 2 lineage B.1.351 ( Beta variant ) . These data support previous results from immunogenicity studies published in April 15 demonstrating that BNT162b2 induced a robust neutralizing antibody response to the B.1.351 lineage.² The updated results have been submitted to the regulatory authorities and are currently under review . • A clinical trial within the global Phase 1/2/3 trial is ongoing which includes : ( 1 ) an assessment of the impact of a third dose of BNT162b2 in prolonging immunity against COVID - 19 and in protecting against COVID - 19 caused by potential newly emerging SARS - CoV - 2 variants , and ( 2 ) an assessment of a modified , variant - specific version of BNT162b2 that targets the full spike protein of the Beta variant . The aim of these studies is to explore the development , manufacturing , and regulatory pathway that BioNTech and Pfizer would pursue if SARS - CoV - 2 were to change enough to require an updated vaccine . • On June 10 , 2021 , BioNTech and Pfizer published results in Nature from in vitro studies demonstrating that sera from individuals vaccinated with BNT 162b2 neutralize the SARS - CoV - 2 lineages B.1.617.1 ( Delta variant ) and B.1.525 ( Eta variant , first identified in Nigeria ) . Neutralization against the Eta variant was comparable to the neutralization against the wild - type virus , whereas the neutralization against the Delta variant was less than that against the wild - type virus , though still efficient . 3 • In July 2021 , BioNTech and Pfizer provided an update on their comprehensive booster strategy . In initial data from the ongoing Phase 1/2/3 booster trial of a third dose of the current BNT 162b2 vaccine the companies have observed that a booster dose given six months after the second dose has a consistent tolerability profile while eliciting high neutralization titers in both younger and older adults compared to those observed after two primary doses . The immune sera elicited neutralizing titers against the original SARS - CoV - 2 wild - type strain that are more than 5 to 8 - fold , and more than 15 to