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 patien ...

Highlights of BioNTech's updates to be presented at the ASCO Annual Meeting 2024: BioNTech has established a diversified clinical oncology pipeline based on its modular multi-platform approach. The Company is advancing more than 20 clinical programs in unmet medical need solid tumor indications, including mRNA-based immunotherapies, targeted therapies entailing cell therapies and antibody- drug conjugates (ADCs), and novel immunomodulators. These candidates are currently being evaluated in more than 30 clin ...

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 ...

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. "The past few years marked a leap in competence for BioNTech," said Helmut Jeggle, ...

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We are in the planning phase with our partner Genmab, so that we cannot disclose any specifics at this time. But you will hear more about this program sometime later this year. Operator Hi, Daina. So we have at the moment the clinical trial running in multiple indications, including also indications for single arm and combination. What we are going to update is -- on ASCO is on the cervical cancer and platinum-resistant ovarian cancer, and non-small-cell lung cancer trials. And you will see response data an ...

BioNTech's long-term outlook helped it shrug off a first-quarter loss and sinking revenue as demand for COVID-19 vaccines declined.CFO Jens Holstein said the drop for the shot was seasonal, and the company expected 90% of its revenue coming later in the year.Holstein noted that BioNTech has billions in cash on hand to drive the company's efforts into treatments for cancer. American depositary receipts (ADRs) of BioNTech (BNTX) were down less than 1% in intraday trading Monday after the COVID-19 vaccine make ...

Financial Performance - Net cash used in operating activities for Q1 2024 was €317.3 million, with a loss before tax of €331.8 million[4]. - The company reported a loss of €315.1 million for the three months ended March 31, 2024, compared to a profit of €502.2 million for the same period in 2023[71]. - Revenues for the three months ended March 31, 2024, were €187.6 million, a decrease of 85.3% compared to €1,277.0 million for the same period in 2023[91]. - COVID-19 vaccine revenues for Q1 2024 were €124.2 million, a significant decrease of 90.2% compared to €1,263.5 million in Q1 2023[136]. - The operating loss for the three months ended March 31, 2024, was €507.2 million, compared to an operating income of €654.4 million for the same period in 2023[91]. - The comprehensive loss for the period, net of tax, was €292.8 million for the three months ended March 31, 2024[94]. - Basic earnings per share for the three months ended March 31, 2024, were €(1.31), compared to €2.07 for the same period in 2023[91]. Cash Flow and Assets - The net cash flows used in operating activities amounted to €317.3 million for the current period, a decrease from €677.4 million in the previous year[71]. - The company reported a decrease in cash and cash equivalents to €8,976.6 million as of March 31, 2024, down from €12,143.9 million a year earlier[71]. - Total cash outflow for Q1 2024 was €2,629.5 million, compared to €1,704.1 million in Q1 2023, indicating an increase of 54.3%[126]. - As of March 31, 2024, total assets decreased to €22,256.8 million from €23,006.3 million as of December 31, 2023, reflecting a decline of approximately 3.2%[118]. - Total equity decreased to €19,968.2 million as of March 31, 2024, down from €20,245.9 million at the end of 2023, a decline of approximately 1.4%[118]. - Cash and cash equivalents decreased to €8,976.6 million as of March 31, 2024, from €11,663.7 million as of December 31, 2023, a decline of 23.1%[118]. Research and Development - The company plans to invest heavily in research and development to diversify its therapeutic area footprint and enhance capabilities through acquisitions and technologies[65]. - Research and development expenses increased to €507.5 million for the three months ended March 31, 2024, compared to €334.0 million for the same period in 2023, reflecting a 52% increase[91]. - The company incurred significant losses and negative cash flows from operations primarily due to high research and development expenses and investments in manufacturing capabilities[82]. - The company has entered into various agreements for research and development, including collaborations with universities and contract research organizations[7]. Market Dynamics and Competition - Demand for the COVID-19 vaccine is expected to decrease in the near future, impacting revenue heavily reliant on vaccine sales[10]. - The ability to generate revenue from the COVID-19 vaccine is uncertain due to unpredictable market dynamics and variant developments[40]. - The company faces intense competition from other COVID-19 vaccines and potential pricing pressures from governmental authorities[16]. - The company faces high barriers to market entry due to intense downward pressure on healthcare costs and pricing controls in various jurisdictions[56]. Regulatory and Legal Challenges - Significant adverse events during clinical trials could delay or prevent regulatory approval of product candidates[11]. - The company is actively seeking marketing approvals and reimbursement for its product candidates, indicating a focus on regulatory strategies[127]. - The company continues to face legal challenges regarding its intellectual property rights, which may impact its operational strategies and financial outlook[139]. - The company is currently involved in various contingencies, including intellectual property disputes and product liability claims, but does not believe these will have a material adverse effect on its financial position[197]. Future Outlook - Future funding requirements will depend on research results, regulatory compliance costs, and manufacturing expansion[8]. - The financial condition and operating results are expected to fluctuate significantly, making future results difficult to predict[12]. - The company’s future financial results will depend on the success of its commercial products and its ability to obtain funding through various means[83]. - The company may face challenges in obtaining adequate coverage and reimbursement from third-party payors, impacting product marketability[33]. - The enactment of the IRA in August 2022 is expected to reduce prices and reimbursement for the company's products in the U.S.[57].

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 soonPresented clinical data at the American Association for Cancer Research ("AACR") Annual Meeting for individualized and off-the-shelf mRNA-based cancer vaccine candidates b ...

We expect BioNTech SE (BNTX) to surpass expectations when it reports first-quarter 2024 results on May 6, before the opening bell.Let’s see how things have shaped up for the quarter to be reported.Factors at PlayBioNTech’s top line currently comprises sales of its mRNA-based COVID-19 vaccine, Comirnaty, developed in partnership with Pfizer (PFE) . The vaccine is approved in several countries and has been a key contributor to BioNTech’s top line.However, following the end of the pandemic, sales of BioNTech/P ...