BioNTech SE

BioNTech SE engages in the development of novel medicines at the intersection of immunology and synthetic biology. Its product pipeline include BNT162b2, BNT161, BNT164, FixVac, iNeST, RiboMabs, CAR-T Cells, TCRs and Next-Gen CP Immunomodulators. The company was founded by Christopher Huber, Ozlem Tureci and Ugur Sahin on June 2, 2008 and is headquartered in Mainz, Germany.

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BioNTech reports robust 2022 earnings, eyes growth in oncology and infectious diseases

BioNTech's strong financial performance in 2022 sets the stage for continued growth in 2023, with a focus on expanding its vaccine portfolio, advancing oncology programs, and navigating the evolving landscape of COVID-19. The company's strategic priorities align with market demands for infectious disease and oncology solutions, positioning BioNTech for future success and profitability.

BioNTech posts robust Q1 results, eyes growth in vaccines and oncology

BioNTech's Q1 2023 performance reflects strong financial results and promising developments in its vaccine and oncology programs.
While facing challenges such as seasonal trends and data constraints, the company is strategically positioned to leverage opportunities in commercial planning and therapeutic advancements.
With a focus on synergistic partnerships and innovative technologies, BioNTech aims to maintain its competitive edge in the biopharmaceutical industry.
The company's commitment to enhancing existing platforms and exploring new growth avenues underscores its resilience and adaptability in a dynamic market environment.

BioNTech reports mixed Q2 results, focuses on innovation and growth

BioNTech's Q2 2023 performance reflects a mix of strong revenue generation and financial challenges, emphasizing the importance of strategic focus.
The company's strengths lie in its innovative collaborations, pipeline advancements, and preparedness for market demands, despite facing financial losses.
Navigating challenges in financial sustainability, market competition, and stakeholder communication will be crucial for BioNTech's future growth and success.

BioNTech adjusts revenue guidance amidst vaccine demand challenges

BioNTech's Q3 2023 performance reflected revenue challenges from lower COVID-19 vaccine demand and write-downs, prompting revised revenue guidance.
Despite challenges, the company showcased strengths in vaccine development, oncology advancements, and strategic cost management initiatives.
Opportunities lie in shared R&D expenses, long-term growth prospects from combination vaccines, and maintaining financial strength during market transition.

BioNTech reports strong Q4 earnings, eyes diversified product expansion

BioNTech is strategically investing in expanding its product portfolio while navigating uncertainties in COVID-19 vaccine revenues. The company aims to transform into a multiproduct company by 2030, focusing on oncology and infectious diseases.

BioNTech advances oncology pipeline, eyes growth amid financial challenges

BioNTech is making significant strides in its oncology pipeline, aiming for multiple product launches by 2026 and focusing on cancer vaccines and mRNA treatments.
While facing financial losses and short-term profitability challenges, the company remains optimistic about its growth trajectory and revenue potential.
Strategic investments in technology platforms, commercial readiness, and partnerships position BioNTech for sustainable growth and value enhancement.
Balancing cost control, revenue generation, and clinical execution will be crucial for BioNTech to capitalize on opportunities and navigate challenges effectively.

BioNTech reports Q2 progress in oncology pipeline amid financial challenges

BioNTech's Q2 2024 earnings call highlighted progress in oncology and COVID-19 vaccines, with total revenues of EUR 129 million but a net loss of EUR 808 million. The company remains focused on advancing innovative therapies and expanding its global manufacturing capabilities.

BioNTech reports robust Q3 earnings, focuses on oncology pipeline

BioNTech's Q3 2024 performance was strong, driven by COVID-19 vaccines and oncology trials.
While facing revenue challenges in certain regions, the company remains focused on growth.
Opportunities lie in advancing oncology pipeline and demonstrating product potential.
Maintaining a strong cash position provides flexibility for future investments.

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BioNTech SE operates as immunotherapy company, which engages therapies for cancer and other serious diseases. Its product pipeline include BNT162b2, BNT161, BNT164, FixVac, iNeST, RiboMabs, CAR-T Cells, TCRs and Next-Gen CP Immunomodulators. The company was founded by Christopher Huber, Oezlem Tuereci, and Ugur Sahin on June 2, 2008 and is headquartered in Mainz, Germany.

Germany's BioNTech SE said in a regulatory filing on Monday the U.S. Food and Drug Administration has placed a partial clinical hold on an early-stage study of its experimental cancer drug.

US FDA puts partial clinical hold on BioNTech's early-stage study of cancer drug

Genmab - ADR

COPENHAGEN, Denmark & MAINZ, Germany--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) and BioNTech SE (Nasdaq: BNTX) today announced initial data from the Phase 2 GCT1046-04 trial (NCT05117242) evaluating acasunlimab (DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also known as GEN1046/BNT311, as monotherapy and in combination with pembrolizumab in patients with PDL(1)-positive mNSCLC who had disease progression following one or more prior lines of anti-PD(L)1 containing treatment. The.

Investigational Acasunlimab (DuoBody® -PD-L1x4-1BB) in Combination with Pembrolizumab Demonstrates Meaningful Clinical Activity in Phase 2 Trial in Patients with Previously Treated Metastatic Non-small Cell Lung Cancer (mNSCLC)

Moderna

Pfizer

A new human bird-flu case identified in a Michigan dairy worker is the first in the U.S. to involve acute respiratory symptoms, the Centers for Disease Control and Prevention said Thursday.

New U.S. bird-flu case is first with respiratory symptoms, CDC says

COVID-19 vaccine maker BioNTech won up to $145 million in funding from a global coalition against infectious diseases to build a production network in African countries for messenger-RNA based shots.

BioNTech wins up to $145 mln in CEPI support for African mRNA vaccine plants

MAINZ, Germany/OSLO, Norway, May 29, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech”, “the Company”) and the Coalition for Epidemic Preparedness Innovations (“CEPI”) are expanding their strategic partnership to contribute to building a sustainable and resilient end-to-end African vaccine ecosystem. CEPI is committing up to US $145 million1 to support BioNTech to establish mRNA vaccine R&D, clinical and commercial-scale manufacturing capabilities at the Company's facility in Kigali, Rwanda. These capabilities will contribute to efforts to better prepare for potential future epidemic and pandemic threats in Africa.

BioNTech and CEPI Expand Partnership to Strengthen Africa's mRNA Vaccine Ecosystem

SUZHOU, China, May 26, 2024 /PRNewswire/ -- MediLink Therapeutics (Suzhou) Co., Ltd. ("MediLink"), a clinical-stage biotech company, today announces a new strategic collaboration with BioNTech SE (Nasdaq: BNTX, "BioNTech"), a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, under which BioNTech will receive an exclusive option to an exclusive global license to apply MediLink's TMALIN® antibody-drug conjugate (ADC) platform, for several novel targets chosen by BioNTech.

MediLink Therapeutics announces a multi-target TMALIN® ADC technology platform license agreement with BioNTech, expanding their global strategic partnership

Novavax

H5N1 bird flu was detected this week in Michigan and Australia. It's the first detection in humans since March, when news of an outbreak in cattle emerged.

Why Vaccine Stocks Rallied This Week

MAINZ, Germany, May 21, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected programs from the Company's diversified immuno-oncology pipeline at the American Society of Clinical Oncology (“ASCO”) Annual Meeting in Chicago, Illinois, from May 31 to June 4, 2024. Moreover, in support of the Company's ongoing CAR-T cell and individualized mRNA programs, BioNTech will also present epidemiological and real-world data from two observational studies in patient populations for which product candidates are being developed in the Company's respective clinical programs.

BioNTech to Present Clinical Data Updates for Next-Generation Immunotherapy Candidates at the ASCO Annual Meeting 2024

Planegg/Martinsried, May 21, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of differentiated T cell immunotherapies for solid tumors and BioNTech SE (Nasdaq: BNTX, “BioNTech”) have announced that their collaboration to advance T cell receptor (TCR) immunotherapies against cancer will extend beyond the initial three-year term outlined at the signing of the agreement in February 2022. This extension will enable ongoing and future work required to potentially generate novel TCRs directed against multiple newly nominated antigen targets that could further expand the BioNTech warehouse of TCR candidates.

Medigene's Global Research & Collaboration Agreement with BioNTech to Extend Beyond Initially Announced Term

MAINZ, Germany, May 17, 2024 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech” or the “Company”) held its Annual General Meeting (“AGM”) today, May 17, 2024. A total of 87.51 per cent of the share capital was represented at the virtual assembly. There were 14 items on the agenda of the AGM. All resolutions proposed on the agenda items put to the vote at today's AGM were approved by a large majority of the shareholders.

BioNTech SE Shareholders Approve All Agenda Items at the Annual General Meeting 2024

BioNTech SE (NASDAQ:BNTX ) Q1 2024 Earnings Conference Call May 6, 2024 8:00 AM ET Company Participants Victoria Meissner - VP, Strategy & IR Ugur Sahin - Co-Founder & CEO Ozlem Tureci - Chief Medical Officer & Co-Founder Jens Holstein - CFO Ryan Richardson - Chief Strategy Officer Conference Call Participants Tazeen Ahmad - Bank of America Daina Graybosch - Leerink Partners Akash Tewari - Jefferies Jessica Fye - JPMorgan Brendan Smith - TD Cowen Etzer Darout - BMO Capital Terence Flynn - Morgan Stanley William Maughan - Canaccord Hartaj Singh - Oppenheimer Ellie Merle - UBS Simon Baker - Redburn Atlantic Yifeng Liu - HSBC Suzanne Van Voorthuizen - VLK Operator Welcome to BioNTech's First Quarter 2024 Earnings Call. I would like to hand the call over to Dr. Victoria Meissner, Vice President of Strategy and Investor Relations.

BioNTech SE (BNTX) Q1 2024 Earnings Call Transcript

American depositary receipts (ADRs) of BioNTech (BNTX) were down less than 1% in intraday trading Monday after the COVID-19 vaccine maker shrugged off losses and tumbling sales in the first quarter, giving a positive outlook for the year.

BioNTech's Outlook Gives Vaccine Maker a Shot in the Arm

BioNTech stock fell early Monday after the German biotech reported wider-than-expected losses and short Covid vaccine sales.

BioNTech Slides After Reporting Losses As Covid Vaccine Sales Take A Hit

The pharmaceutical company posts a first-quarter loss of €1.31 a share, a swing from year-earlier profit of €2.05.

BioNTech Revenue Falls Sharply on Reduced Covid Vaccine Sales

Germany's BioNTech , whose COVID-19 vaccine in partnership with Pfizer was widely used during the pandemic, said on Monday that almost all of its expected 2024 revenues would come in at the end of the year.

BioNTech says 90% of 2024 revenues will accrue at end of year

Advancing toward goal of ten or more potentially registrational trials running by the end of 2024: first patient dosed in Phase 3 clinical trial evaluating BNT323/DB-1303 in HR+ HER2-low chemotherapy-naïve metastatic breast cancer patients, and a second Phase 3 trial with BNT323/DB-1303 in recurrent endometrial cancer planned to start soon Presented clinical data at the American Association for Cancer Research (“AACR”) Annual Meeting for individualized and off-the-shelf mRNA-based cancer vaccine candidates based on iNeST and FixVac platforms, including three-year follow-up data of an investigator-initiated trial in patients with resected pancreatic ductal adenocarcinoma (“PDAC”) Planning to share additional clinical data from multiple clinical programs at the American Society of Clinical Oncology (“ASCO”) Annual Meeting, including bispecific antibodies BNT311/GEN1046 (acasunlimab) and BNT327/PM8002 and antibody-drug conjugate (“ADC”) BNT326/YL202 Continued development and commercial preparation for a 2024 season variant-adapted COVID-19 vaccine First quarter 2024 revenues of €187.6 million, net loss of €315.1 million an d loss per share of €1.31 ($1.421) Maintained strong financial position with €16.9 billion in cash, cash equivalents and security investments Conference call and webcast scheduled for May 6, 2024, at 8:00 a.m. EDT (2:00 p.m.

BioNTech Announces First Quarter 2024 Financial Results and Corporate Update

BioNTech (BNTX) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Why Earnings Season Could Be Great for BioNTech (BNTX)

On BioNTech's (BNTX) first-quarter 2024 earnings call, investors' focus is likely to be on the updates related to its pipeline development now that the pandemic is over.

BioNTech (BNTX) to Report Q1 Earnings: Is a Beat in Store?

GlaxoSmithKline

GlaxoSmithKline sued Pfizer and BioNTech in Delaware federal court on Thursday, accusing them of infringing GSK patents related to messenger RNA (mRNA) technology in the companies' blockbuster COVID-19 vaccines.

GlaxoSmithKline sues Pfizer and BioNTech over Covid-19 vaccine technology

MAINZ, Germany, April 22, 2024 (GLOBE NEWSWIRE) --  BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the first quarter 2024 on Monday, May 6, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update.

BioNTech to Report First Quarter 2024 Financial Results and Corporate Update on May 6, 2024

MAINZ, Germany, April 7, 2024 -  BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced three-year follow-up data from a Phase 1 trial with the mRNA-based individualized neoantigen-specific immunotherapy (“iNeST”) candidate autogene cevumeran (also known as BNT122, RO7198457) in patients with resected pancreatic ductal adenocarcinoma (“PDAC”). The data show that in 8 out of 16 patients autogene cevumeran elicited an immune response up to three years post administration measured by activated T cells. The persistence of T cels was associated with a longer median recurrence-free survival in cancer vaccine responders.

Three-year Phase 1 Follow-Up Data for mRNA-based Individualized Immunotherapy Candidate Show Persistence of Immune Response and Delayed Tumor Recurrence in Some Patients with Resected Pancreatic Cancer

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BioNTech said on Monday the U.S. National Institutes of Health has sent a notice to the German company regarding default on the payment of royalties and other amounts related to its COVID-19 vaccine.

BioNTech gets US agency notice over default on COVID vaccine royalties

BioNTech's Q4 earnings shows a significant revenue drop and profitability concerns, with expectations of continued vaccine demand decline. Despite short-term challenges, BioNTech's mRNA technology and pipeline, including COVID/flu vaccines and oncology, highlight long-term potential. Financials suggest a strong balance sheet, but projected R&D expenses indicate potential future cash burns.

News for BioNTech SE Stock (BNTX)