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.

Partial clinical hold of BioNTech SE's BNT326/YL202 for the treatment of patients with solid tumors in phase 1 study was lifted by the FDA. The primary endpoint of ORR of BNT111 in combination with Libtayo, for the treatment of patients with anti-PD-1/anti-PD-L1 relapsed/refractory or unresectable stage III or IV melanoma, met with statistical significance. Positive results obtained from an open-label phase 2 study, using BNT311 + Keytruda for the treatment of patients with relapsed/refractory metastatic non-small cell lung cancer; 12-month overall-survival [OS] rate of 69%.

BioNTech: Clinical Hold Removal Pushes ADC Development Program Forward

BioNTech on Monday said the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on an early stage study of its experimental cancer drug.

BioNTech says FDA lifts partial hold on its cancer drug trial

Pfizer

Pfizer and BioNTech recently reported top-line results from a trial of its combination vaccine that was meant to protect against the flu and COVID-19. The partners' combination shot failed to achieve non-inferiority when compared to an approved flu vaccine.

Pfizer and BioNTech's Combo Shot Missed the Mark. Is It Time to Sell?

Shares of Pfizer (PFE) and American depositary receipts (ADRs) of BioNTech (BNTX) dropped in intraday trading Friday following disappointing results from a late-stage study of the drugmakers' combined COVID-19 and flu vaccine in adults.

Pfizer, BioNTech Combination Flu and COVID-19 Shot Misses 1 of 2 Endpoints

Pfizer stock toppled Friday after the pharma giant reported mixed results for its BioNTech-partnered combination flu and Covid vaccine.

Pfizer Slides Toward Sell Zone After BioNTech-Tied Covid/Flu Shot Misses Its Mark

Pfizer Inc. PFE, -0.59% and BioNTech SE BNTX, +2.83% said Friday a Phase 3 trial of their COVID-19-influenza vaccine candidate met one of its two objectives. The companies said the candidate showed “comparable” responses against the SARS-CoV-2 virus when compared with their licensed COVID-19 vaccine, which was one objective.

Pfizer, BioNTech COVID-19-flu combination drug meets 1 of 2 trial objectives

Pfizer and BioNTech said a late-stage trial of their experimental mRNA vaccine to protect against influenza and COVID-19 found the combination shot failed to meet one of the study's two main goals and they are evaluating next steps.

Pfizer, BioNtech say combined flu-COVID vaccine misses a main goal of Phase 3 trial

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced top-line results from their Phase 3 clinical trial to evaluate the companies' combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age. The combination candidate consists of Pfizer's mRNA-based influenza vaccine candidate with the companies' licensed COVID-19 vaccine. The Phase 3 trial measured two primary immuno.

Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age

Bristol-Myers

Regeneron Pharmaceuticals

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3 Biotech Stocks With Promising Drug Pipelines: August 2024

BioNTech SE reported Q2 2024 earnings yesterday, with a significant decrease in revenues from Comirnaty compared to previous years. The company reaffirmed guidance for 2024, for revenues of $2.7bn — $3.4bn, but is expecting a loss-making year due to increased costs. The cash position remains healthy at nearly $20bn, which helps to support a $19.5bn market cap valuation at the present times.

BioNTech Q2 Earnings Review: No Needle-Moving Catalysts Despite Oncology Promise

BioNTech SE (NASDAQ:BNTX ) Q2 2024 Earnings Conference Call August 5, 2024 8:00 AM ET Company Participants Victoria Meissner - Vice President, Strategy & Investor Relations Ugur Sahin - Chief Executive Officer & Co-Founder Özlem Türeci - Chief Medical Officer & Co-Founder Jens Holstein - Chief Financial Officer Ryan Richardson - Chief Strategy Officer Conference Call Participants Daina Graybosch - Leerink Partners Yaron Werber - TD Cowen Tazeen Ahmad - Bank of America Securities Etzer Darout - BMO Capital Markets Yifeng Liu - HSBC Bank Plc Jessica Fye - JPMorgan Chase Cory Kasimov - Evercore ISI Chris Shibutani - Goldman Sachs Simon Baker - Redburn Atlantic Eliana Merle - UBS John Newman - Canaccord Genuity Manos Mastorakis - Deutsche Bank Operator Welcome to BioNTech's Second 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) Q2 2024 Earnings Call Transcript

American depositary receipts (ADRs) of BioNTech (BNTX) fell Monday after the COVID-19 vaccine maker's second-quarter loss quadrupled on falling demand for the shots, and as it ended an agreement with biotech firm Genmab to develop a lung cancer drug.

BioNTech's Loss Quadruples as COVID-19 Vaccine Demand Falls

Monday, BioNTech SE  BNTX reported deeper losses in the second quarter of 2024, with an EPS loss of $(3.62) or (3.36) euros, missing the consensus of (1.89) euros and higher than (79) cents in the second quarter of 2023.

BioNTech's Q2 Loss Widens Amid Low Demand For Its Pfizer-Partnered COVID-19 Vaccine, Increases R&D Spending On New Cancer Products

BioNTech SE's stock BNTX, +1.65% fell 4% early Monday, after the company's second-quarter earnings fell short of estimates amid a continued slide in sales of its COVID-19 vaccine. The company had a net loss of 807.8 million euros ($883.5 million), or $3.36 a share, for the quarter, wider than the los of EUR109.4 million, or 79 cents a share, posted in the year-earlier period.

BioNTech's stock slides 4% after earnings fall short of estimates as COVID vaccine falls slide

Losses at Germany's BioNTech quadrupled year-on-year in the second quarter, the company said on Monday, as it banks on a strategy shift towards new cancer treatments following a sharp drop-off in sales of its COVID-19 vaccine.

BioNTech widens loss to 807.8 mln euro in second quarter

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 Conference call and webcast scheduled for August 5, 2024, at 8:00 a.m. EDT (2:00 p.m.

BioNTech Announces Second Quarter 2024 Financial Results and Corporate Update

COVID-19 vaccine maker BioNTech's cancer drug candidate BNT111 showed significant improvement in the response rate in patients with advanced melanoma during a Phase 2 trial, the German company said on Tuesday.

BioNTech's cancer drug meets primary endpoint in Phase 2 trial

MAINZ, Germany, July 30, 2024 (GLOBE NEWSWIRE) --  BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced positive topline data from the ongoing Phase 2 clinical trial (EudraCT No.: 2020-002195-12 ; NCT04526899 ) in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment. The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo® (cemiplimab), an anti-PD-1 monoclonal antibody being developed by Regeneron, and assesses the two single agents alone.

BioNTech Announces Positive Topline Phase 2 Results for mRNA Immunotherapy Candidate BNT111 in Patients with Advanced Melanoma

Britain's health regulator said on Wednesday it has authorised Pfizer and BioNTech's updated COVID-19 vaccine that targets the JN.1 subvariant of the coronavirus for use in infants, children and adults.

UK regulator authorises Pfizer-BioNTech shot for JN.1 COVID variant

NANJING, China--(BUSINESS WIRE)-- #3DPrintingPharmaceuticals--Triastek Inc. ("Triastek"), a global leader in 3D printing pharmaceuticals, today announced that it has entered into a research collaboration and platform technology license agreement with BioNTech SE ("BioNTech"), a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. Under the agreement, the companies will develop RNA therapeutics for oral delivery based on 3D printing technology. The collaboration aims to pro.

Triastek Announces Research Collaboration and Platform Technology License Agreement with BioNTech to Advance 3D Printed Oral RNA Therapeutics

MAINZ, Germany, July 22, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the second quarter 2024 on Monday, August 5, 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 Second Quarter 2024 Financial Results and Corporate Update on August 5, 2024

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NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies' Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on.

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine in the European Union

MAINZ, Germany and SHANGHAI, China, June 24, 2024 –  BioNTech SE  (Nasdaq: BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co., Ltd. (“DualityBio”) today announced that the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic castration-resistant prostate cancer (“CRPC”) who have progressed on or after standard systemic regimens. BNT324/DB-1311 is a next-generation antibody-drug conjugate (“ADC”) candidate targeting the transmembrane glycoprotein B7-H3, an immune checkpoint protein which is overexpressed in a range of tumor types and has been associated with disease progression and poor prognosis for patients. The candidate is currently being evaluated in an ongoing Phase 1/2 study ( NCT05914116) in patients with advanced solid tumors.

BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer

BioNTech SE's BNTX partner MediLink Therapeutics (Suzhou) Co., Ltd says the FDA has placed a partial clinical hold on the Phase 1 trial.

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