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BioNTech to Acquire Biotheus to Boost Oncology Strategy - Acquisition to support the global execution of BioNTech’s oncology strategy and provide full global rights to BNT327/PM8002, an investigational PD-L1 x VEGF-A bispecific antibody, with potential to replace current checkpoint inhibitor standard of care treatments for solid tumors - With the acquisition of Biotheus, BioNTech aims to further strengthen its capabilities to develop, manufacture and commercialize next-generation bispecific antibodies and novel treatment combinations - BioNTech and Biotheus plan to initiate multiple registrational trials with BNT327/PM8002 in late 2024 and 2025; further clinical trials evaluating BNT327/PM8002 as combination therapies are planned to start in 2024 and 2025 - BioNTech to pay $800 million to acquire 100 percent of the issued share capital and up to $150 million in potential milestone payments - Additional details will be shared at BioNTech’s Innovation Series R&D Day event on 14 November 2024
BioNTech Announces Third Quarter 2024 Financial Results and Corporate Update. • Presented clinical data for multiple assets across modalities, including bispecific antibody candidate BNT327/PM8002 and mRNA cancer vaccine candidate BNT113 based on BioNTech’s FixVac platform • Initiated two Phase 2 dose optimization trials with BNT327/PM8002 in small-cell lung cancer and in triple-negative breast cancer to inform planned pivotal Phase 3 trials • Phase 2 clinical trial on track to evaluate mRNA-based individualized cancer vaccine candidate autogene cevumeran (BNT122/RO7198457) as an adjuvant treatment in patients with high-risk muscle-invasive urothelial cancer • Successfully launched variant-adapted COVID-19 vaccines for the 2024/2025 vaccination season in multiple regions • Reports third quarter 2024 revenues of €1.2 billion, net profit of €198.1 million and diluted earnings per share of €0.81 ($0.89)1 • Ended the third quarter of 2024 with €17.8 billion in cash and cash equivalents plus security investments • Expects to be at low end of full year 2024 revenue guidance range (€2.5-3.1 billion) • Re-confirms guidance of planned full year 2024 R&D expenses of €2.4-2.6 billion and reduced guidance range for SG&A expenses to €600-700 million and for capital expenditures for operating activities to €300-400 million
BioNTech SE, will host an edition of the Company’s Innovation Series R&D Day at 10:30 a.m. Eastern Standard Time (16:30 p.m. CET) on Thursday, November 14, 2024 in New York City, U.S. On the day, BioNTech’s leadership team will provide an overview of the Company’s corporate strategy and clinical progress across its pipeline. Investors, analysts and the interested public are invited to join the event online via this link. A replay of the webcast will be available shortly after the conclusion of the event and archived on the Company’s website for one year following the call. The public may also access the presentation slides via the “Events & Presentations” page of the Investor Relations section of the Company’s website at www.BioNTech.com.
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 Highlights AI Capabilities and R&D Use Cases at Inaugural AI Day. -Provides updates on BioNTech’s strategy to scale and deploy AI-capabilities across the immunotherapy pipeline -Highlights InstaDeep’s new near exascale supercomputer, Kyber, with the aim of enabling BioNTech to compute at scale -Unveils novel AI Bayesian Flow Network (“BFN”) models for protein sequence generation -Highlights progress in deploying AI across BioNTech’s immunotherapy pipeline, including in immunohistochemistry, DNA/RNA sequencing, proteomics, protein design, and lab functional validation
BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected assets from its multi-platform oncology pipeline at the European Society for Molecular Oncology (“ESMO”) Congress 2024 in Barcelona, Spain from September 13-17, 2024. The oral and poster presentations will feature programs across BioNTech’s clinical pipeline, including mRNA-based cancer vaccines, next-generation immunomodulators and targeted therapy approaches. “We believe that the future of cancer treatment will be driven by the combination of modalities, including immunomodulators, targeted and mRNA-based therapies,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “At this year’s ESMO, we will present data from three clinical trials with BNT327/PM8002, one of the key backbones for our combination treatment strategy. This bispecific antibody will be an element in multiple novel combination treatment approaches that may open up new synergistic mechanisms of action. Our mRNA platforms are another important component of our combination strategy. At ESMO, we will present clinical data that further support the proof of concept of our mRNA-based FixVac approach, which targets non-mutated tumor-associated antigens, showing early clinical activity across various indications.”
Lift of Partial Clinical Hold for BNT326/YL202 On August 15, 2024, the U.S. Food and Drug Administration (“FDA”) lifted the partial clinical hold that was placed on MediLink Therapeutics’ (Suzhou) Co., Ltd. (“MediLink”) Phase I trial evaluating BNT326/YL202 (NCT05653752), which was announced on June 17, 2024. The complete response including data analysis, updated investigator brochure and informed consent for patients, and amended clinical trial protocol meets the FDA’s requirements by incorporating additional risk mitigation measures. BNT326/YL202 is a Human Epidermal Growth Factor Receptor 3 (“HER3”)-targeting antibody-drug conjugate (“ADC”) candidate that is being developed in collaboration between BioNTech SE (“BioNTech”) and MediLink. The trial recruitment will be re-initiated. Clinical development will focus on dose levels no higher than 3 mg/kg, where the safety profile was manageable and encouraging clinical activity was observed.
Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age - In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives - The trial did not meet one of its primary immunogenicity objectives of non-inferiority against the influenza B strain despite obtaining higher influenza A responses and comparable COVID-19 responses versus the comparator vaccines - The companies are evaluating adjustments to the candidate and will discuss next steps with health authorities - Pfizer also provides update on its separate Phase 2 second-generation trivalent influenza mRNA vaccine trial which showed encouraging data demonstrating robust immunogenicity against all strains compared to a standard of care influenza vaccine
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
