Page 1

BIONTECH BioNTech Announces Third Quarter 2021 Financial Results and Corporate Update November 9 , 2021 • Delivered more than 2 billion doses of COMIRNATY / BNT162b2 in 2021 as of November 2nd • Demonstrated progress in expanding access to COVID - 19 vaccine globally , including Biologics License Application ( BLA ) approval by U.S. FDA , regulatory authorizations of booster doses in multiple populations and first U.S. Emergency Use Authorization ( EUA ) in children for a COVID - 19 vaccine • Expansion of clinical oncology portfolio with first patient dosed in Phase 2 trial of mRNA - based individualized immunotherapy autogene cevumeran ( BNT122 , RO7198457 ) in circulating tumor DNA positive high - risk colorectal cancer patients after adjuvant treatment • Positive clinical data from BioNTech's oncology pipeline to be highlighted in seven presentations at SITC 36th Annual Meeting ; currently 15 product candidates in 19 ongoing trials Conference call and webcast scheduled for November 9 , 2021 , at 8:00 a.m. ET ( 2:00 p.m. CET ) MAINZ , Germany , November 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 third quarter and first nine months of 2021 ended September 30 , 2021 . COVID - 19 Vaccine Program - BNT162b2 BNT162b2 clinical development updates -- " We continue to work diligently to respond to global vaccine needs with a commitment to ensure equitable vaccine access . Our robust clinical and regulatory strategy has led to recent approvals that expand access to additional age groups , highlighted by the first EUA for a COVID - 19 vaccine in children 5 to under 12 years of age in the United States , and authorizations for booster doses for multiple populations , " said Ugur Sahin , M.D. , CEO and Co - Founder of BioNTech . " We also had a strong quarter with regard to our oncology pipeline . Our approach to oncology addresses each patient's unique needs by leveraging multiple therapeutic platforms with combination potential . With the recent dosing of the first patient with autogene cevumeran in high - risk colorectal cancer patients after adjuvant treatment , we now have four programs in Phase 2 development , as our pipeline advances into later - stage trials . We are reporting positive clinical data across 6 of our oncology programs at the upcoming SITC conference , including favorable safety profiles and robust immune responses . " Third Quarter 2021 and Subsequent Updates Infectious disease Infectious disease is a growth pillar for BioNTech , and the company is developing vaccine candidates to address multiple pathogens that pose significant global public health challenges . Multiple clinical trials are ongoing to expand COVID - 19 vaccine reach and explore booster doses to address waning immunity . Clinical data to date support a third dose booster of the vaccine in adults to augment vaccine protection over time . A third booster dose of BNT162b2 confers high neutralizing antibody titers against SARS - CoV - 2 ancestral virus and the Beta and Delta variants . The titers following a booster dose are higher than the levels observed after the two - dose primary series . Additionally , studies are underway evaluating variant - specific versions of the vaccine to generate data to inform BioN Tech and Pfizer's strategy to address emerging SARS - CoV - 2 variants . While to date , there is no clinical data suggesting the need for a variant - specific version of the vaccine , the companies are establishing a preemptive prototype approach to evaluate the development , manufacturing and regulatory processes for variant specific vaccines . This prototype approach is aimed to be substantiated by broad clinical data that are being prepared for submission to regulatory authorities . • In August 2021 , BioNTech and Pfizer started a clinical trial to evaluate the safety and immunogenicity of variant - encoding vaccine candidates , including a multivalent vaccine against two variants of concern . The study will enroll approximately 1,200 adults 18 to 85 years of age . Participants will receive a third 30 µg dose of a multivalent Delta and Alpha version of the vaccine , or monovalent Delta or Alpha versions administered six months after the second dose of the two - dose primary series of BNT162b2 . Vaccine- and SARS - CoV - 2 - naïve participants in the study will receive two doses of the multivalent Delta and Alpha vaccine administered 21 days apart . First data from this study are anticipated in the fourth quarter of 2021 . • On September 6 , 2021 , BioNTech and Pfizer announced data from a Phase 3 safety and immunogenicity clinical trial of 306 participants 18 to 55 years of age who received a booster dose approximately six months after completing the two - dose primary regimen , with a median follow - up time of 2.6 months post - third dose . The booster dose elicited significantly higher SARS - CoV - 2 neutralizing antibody titers against the ancestral strain compared to the levels observed after the two - dose primary series with titers against ancestral virus more than 5 times as high at 1 month after the third dose compared to 1 month after the two - dose primary series . The safety profile was favorable and similar to the safety profile after dose two of the primary series and generally consistent with other clinical data for BNT 162b2 . Previously reported Phase 1 data showed a similar pattern of third dose responses against the ancestral strain , Beta and Delta