Page 1

BIONTECH BioNTech Announces First Quarter 2021 Financial Results and Corporate Update May 10 , 2021 • More than 450 million doses of BNT162b2 supplied to 91 countries or territories worldwide as of May 6 , 2021 • Signed agreements for over 1.8 billion doses of BNT162b2 in 2021 and first contracts signed for periods 2022 and beyond • Announced planned expansion of global footprint to Asia with establishment of first regional headquarters for south east Asia in Singapore , including a fully - integrated and state - of - the art mRNA manufacturing facility • In oncology , a first - in - human Phase 1 trial started for the neoantigen - targeting T cell therapy , BNT221 . The development of BioNTech's oncology pipeline has continued to accelerate with 14 product candidates now in 15 ongoing trials Conference call and webcast scheduled for May 10 , 2021 , at 8:00 a.m. ET ( 2:00 p.m. CET ) MAINZ , GERMANY , May 10 , 2021 -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 quarter ended March 31 , 2021 . " BioNTech has continued to execute the delivery of our COVID - 19 vaccine globally to more than 90 countries and territories . Through our continued innovation , we are expanding access to new populations and geographies , and addressing emerging variants , " said Ugur Sahin , BioNTech's Co - founder and CEO . " We are moving into later stage testing for three of our oncology programs in the near future and plan to launch multiple new products over the next five years . Looking ahead , we will further optimize our technologies and expand our pipeline into additional therapeutic indications , as we meet our ambition to become a global , fully - integrated immunotherapy company . " First quarter 2021 and subsequent updates Infectious disease COVID - 19 vaccine program - BNT162b2 In March 2021 , BioNTech announced its Full Year 2020 Financial Results and Corporate Update as a part of the Annual Report filed on Form 20 - F , highlighting developments relating to its COVID - 19 vaccine program between January 1 and March 30 , 2021 ( Link to press release ) . A summary of these developments as well as full details of subsequent developments that occurred after March 30 , 2021 is provided below . As of May 6 , 2021 BioNTech and Pfizer have shipped approximately 450 million doses of BNT162b2 to 91 countries and territories around the world . To date , the companies have signed orders of approximately 1.8 billion doses for delivery in 2021 , and they have also signed the first contracts for 2022 and beyond . Further discussions for additional dose commitments are ongoing for 2021 and beyond . BioNTech expects BNT162b2 annual manufacturing capacity to reach 3 billion doses by the end of 2021 , and expects to have capacity to manufacture more than 3 billion doses in 2022 . Multiple clinical trials are ongoing to expand the authorization of BNT162b2 to additional population groups , such as children from 6 months to 11 years of age , and to collect further data in healthy pregnant women . To date , there is no evidence that an adaptation of BioNTech's current COVID - 19 vaccine against key identified emerging variants is necessary . Despite this , BioNTech has developed a comprehensive strategy to address these variants should the need arise in the future . As part of BioN Tech's strategy to contend with the variant challenge , BioNTech submitted to the U.S. Food and Drug Administration ( FDA ) , and the FDA has approved an additional amendment to the study protocol of the global Phase 1/2/3 trial 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 BNT 162b2 . The aim of this study is to explore the regulatory pathway that BioNTech and Pfizer would pursue if SARS - CoV - 2 were to change enough to require an updated vaccine . This trial started in March 2021 . In the first quarter of 2021 , BioNTech also advanced its work to broaden access through improvements to its cold chain distribution systems and processes . Both the FDA and the European Medicines Agency ( EMA ) have approved the transportation and storage of undiluted frozen vials of BNT162b2 at temperatures ( -20 ° C ) commonly found in pharmaceutical freezers for a period of up to two weeks . Further stability data have been assessed and formulation optimization activities are ongoing , including a study to evaluate a lyophilized ( or freeze - dried ) and a ready - to - use formulation of BNT162b2 . BNT 162b2 clinical development updates • On March 31 , 2021 , BioNTech and Pfizer announced that BNT162b2 demonstrated 100 % efficacy and robust antibody responses in a Phase 3 trial in adolescents aged 12 to 15 with or without prior evidence of SARS - CoV - 2 infection . The trial enrolled 2,260 adolescents in the United States . In the trial , 18 cases of COVID - 19 were observed in the placebo group ( n = 1,129 ) versus none in the vaccinated group ( n = 1,131 ) . Vaccination with BNT162b2 elicited high SARS - CoV - 2 neutralizing antibody titers , demonstrating strong immunogenicity in a subset of adolescents one month after the second dose . BNT162b2 administration was generally well tolerated . • On March 31 , 2021 , BioNTech and Pfizer began evaluating the administration of a single booster dose five to seven months after receiving the second dose of BNT162b2 . To demonstrate duration of protection , and protection against the emerging variants of concern , an additional dose of BNT162b2 or of BNT162b2SA ( encoding for the spike protein of the