BioNTech Announces Fourth Quarter and Full Year 2024 Financial Results and Corporate Update - Advanced oncology pipeline including more than 20 active Phase 2 and Phase 3 clinical trials with a strategic focus on two priority pan-tumor programs: next-generation immunomodulator candidate BNT327 and mRNA cancer immunotherapies - Multiple data readouts expected in 2025 and 2026 aimed at providing clinical proof of BioNTech’s pipeline strategy and advancing the Company towards becoming a diversified multi-product oncology portfolio company by 2030 - Completed acquisition of Biotheus securing full control of next-generation immunomodulator candidate BNT327, a bispecific antibody targeting PD-L1 and VEGF-A1 - Successfully launched JN.1- and KP.2-adapted COVID-19 vaccines across different countries and regions and maintained global market leadership - Fourth quarter and full year 2024 revenues of €1.2 billion and €2.8 billion**, respectively - Full year 2024 net loss of €0.7 billion and diluted loss per share of €2.77 ($3.00)1 - Cash and cash equivalents plus security investments of €17.4 billion as of December 31, 20242 - Expects 2025 total revenues between €1.7 billion and €2.2 billion ** All numbers in this press release have been rounded.
BioNTech Provides Business and Pipeline Updates at 43rd Annual J.P. Morgan Healthcare Conference -Executing in oncology with investigational BNT327/PM8002 combinations and mRNA cancer immunotherapy candidates as pan-tumor treatment approaches -BioNTech aims to develop BNT327/PM8002 as a next-generation immuno-oncology (“IO”) backbone for the Company’s combination strategy targeting a broad range of indications -Progressing development of BNT327/PM8002 with initiation of global clinical trials with registrational potential in first-line small cell lung cancer (“SCLC”) and non-small cell lung cancer (“NSCLC”) -Advancing BNT327/PM8002 combination strategy with initiation of a second antibody drug conjugate (“ADC”) combination trial; additional ADC-combination trials planned to be initiated in 2025 -Progress in mRNA cancer immunotherapy portfolio with multiple randomized trial read-outs of personalized and off-the-shelf candidates expected in 2025 and 2026
BioNTech gibt auf der 43. J.P. Morgan Healthcare-Konferenz Updates zur Geschäfts- und Pipeline-Entwicklung -BioNTech fokussiert sich in der Umsetzung der Onkologie-Strategie auf tumorübergreifende (Pan-Tumor-) Therapieansätze basierend auf Kombinationen mit BNT327/PM8002 sowie den mRNA-Krebsimmuntherapie-Kandidaten -BioNTech will BNT327/PM8002 als innovativen immunonkologischen („IO“) Schlüsselkandidat für die Kombinationsstrategie des Unternehmens entwickeln, der auf ein breites Spektrum von Krebsindikationen abzielt -Fortschritte in der Entwicklung von BNT327/PM8002 mit dem Beginn der globalen, potenziell zulassungsrelevanten klinischen Studien zur Erstlinientherapie von kleinzelligem Lungenkrebs (small-cell lung cancer, „SCLC“) und nicht-kleinzelligem Lungenkrebs (non-small cell lung cancer, „NSCLC“) erzielt -Vorantreiben der Kombinationsstrategie für BNT327/PM8002 mit dem Start einer zweiten Kombinationsstudie mit einem Antikörper-Wirkstoff-Konjugat (antibody drug conjugate, „ADC”); weitere ADC-Kombinationsstudien sind für 2025 geplant -Fortschritte im mRNA-Krebsimmuntherapieportfolio werden mit Daten-Updates aus mehreren randomisierten Studien sowohl für die personalisierten- als auch die off-the-shelf-Kandidaten in den Jahren 2025 und 2026 erwartet
BioNTech to Report Third Quarter 2024 Financial Results and Corporate Update on November 4, 2024 BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the third quarter 2024 on Monday, November 4, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. ET (2:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast will be available via this link. Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page in the Investor Relations section of the Company’s website at www.BioNTech.com. A replay of the webcast will be made available shortly after the call and archived on the Company’s website for 30 days following the call.
BioNTech Announces Second Quarter 2024 Financial Results and Corporate Update -Announced positive data from multiple mRNA cancer vaccine clinical trials, including topline results from the ongoing Phase 2 evaluating FixVac candidate BNT111 -Launched updated variant-adapted COVID-19 vaccine in the European Union (“EU”), received approval in the United Kingdom and initiated rolling supplemental Biologics Licensing Application (“sBLA”) with the United States Food and Drug Administration (“U.S. FDA”) -Reiterates guidance for total revenues in the range of €2.5-3.1 billion -Reports second quarter 2024 revenues of €128.7 million, net loss of €807.8 million and loss per share of €3.36 ($3.621) -Invested €525.6 million or approximately 90% of the Company’s total R&D spend in Q2 in non-COVID-19 related activities, mainly oncology and mRNA; investments are in line with the reiterated full-year R&D expense guidance -Ended the second quarter of 2024 with €18.5 billion in cash, cash equivalents and security investments
Press Release BioNTech Announces Positive Topline Phase 2 Results for mRNA Immunotherapy Candidate BNT111 in Patients with Advanced Melanoma - Primary endpoint met in a Phase 2 trial evaluating the investigational mRNA immunotherapy BNT111 in combination with the PD-1 checkpoint inhibitor cemiplimab -Data demonstrated a statistically significant improvement of overall response rate (“ORR”) compared to historical control in patients with anti-PD-(L)1 relapsed/refractory advanced melanoma -BioNTech and Regeneron plan to present data from this trial at a forthcoming medical conference; the BNT111 program received a Fast Track designation and an Orphan Drug designation from the U.S. Food and Drug Administration (“FDA”) in 2021 -BNT111 is based on BioNTech’s fully owned FixVac platform and proprietary uridine mRNA-LPX technology
