biontech q1 2020

So that means the challenge for upscaling for manufacturing for the different mRNA platforms are different scales. As stated before, we have completed dosing for the first cohorts in both our U.S., as well as in our European Phase 1/2 trials. And the second question is on the clinical strategy. Sierk Poetting -- Chief Operating Officer. And it's not the only study in this setting. And we will, of course, have data on the dose-dependent safety profile, as well as dose-dependent immunogenicity profile. And this would also cover like recruitment of up to several thousand subjects, but it will depend on regulatory approvals to -- so end point. Adjustments to reconcile loss before tax to net cash flows: Depreciation and amortization of property, plant, equipment and intangible assets, (Gain)/Loss on disposal of property, plant and equipment, Decrease/(Increase) in trade receivable and contract assets, (Decrease)/Increase in trade and other payables, contract liabilities and provisions, Purchase of property, plant and equipment, Proceeds from sale of property, plant and equipment, Acquisition of subsidiaries and businesses, net of cash acquired, Proceeds from issuance of share capital, net of costs, Change in cash resulting from exchange rate differences, Conference call and webcast scheduled for May 12, 2020 at 08:00 a.m. BNT111 – Data from a Phase 1 trial in advanced melanoma remains on track for publication in late 1H 2020. For questions on logistics, handling or other issues: service@biontech.de. LONDON — Before 2020, Germany's BioNTech was a relatively little-known biotechnology company. This program combines our CAR-T therapeutic approach with our mRNA vaccination and uses our proprietary tumor-selective target Claudin 6. The first is that our program utilizes multiple mRNA formats. I will then provide an update on our COVID-19 program. Please ask your question. © 2021 GlobeNewswire, Inc. All Rights Reserved. BioNTech intends to initiate four Phase 2 trials (BNT111, BNT113, BNT122) and two additional FIH trials (BNT211, BNT411) in 2020. Cumulative Growth of a $10,000 Investment in Stock Advisor, BioNTech SE (BNTX) Q1 2020 Earnings Call Transcript @themotleyfool #stocks $BNTX, BioNTech SE (BNTX) Q3 2020 Earnings Call Transcript, BioNTech SE (BNTX) Q2 2020 Earnings Call Transcript, BioNTech SE (BNTX) Q4 2019 Earnings Call Transcript, Copyright, Trademark and Patent Information. The larger spike sequence is included in two of the vaccine candidates, and the smaller optimized receptor binding domain (RBD) from the spike protein is included in the other two candidates. And as you know, there are no official statements, so far, from regulatory authorities, from EMA or FDA which kind of end point would be accepted, and therefore everything what we can share at the moment would be speculation. Akash Tewari -- Wolfe Research, LLC -- Analyst. That all changed when Covid-19 arrived. On April 23, we hosted a webcast that provided a detailed overview of the science behind our program. We have also started a second candidate, which is a uridine-based RNA, encoding also for RBD domain. The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of the four mRNA vaccine candidates. We expect that the nucleoside-modified mRNA and the dose for the nucleoside-modified mRNA will be in the range between 10 to 100 microgram, yes. Both trials are recruiting now first subjects, and the number of subjects is accumulating. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. A metastatic disease is, by definition, relatively low tumor load. Finanzbericht 1. We have already established 24/7 operations in Mainz, so we aim to start producing clinical trial materials soon around the clock for use in our global development program. On our last call, we indicated that a data update for the Phase 1/2 trial in multiple solid tumors was planned at the AACR annual meeting, which due to the COVID pandemic was rescheduled for August 2020 at that time. The following slide deck was published by BioNTech SE in conjunction with their 2020 Q1 earnings call. We aspire to utilize the full potential of the immune system to fight cancer and infectious diseases Interest expense related to lease liability, Basic & diluted, loss per share for the period attributable to ordinary equity holders of the parent*. Daina Graybosch -- SVB Leerink -- Analyst. Robert Burns -- H.C. Wainwright -- Analyst. On track with previous guidance of approximately €300 million net cash to be used for operating activities and investments into property, plant and equipment in 2020 base business plan (prior to impact of Neon acquisition and BNT162 program). ET. Hey, guys. Daarom adviseert de raad zo veel mogelijk van dit vaccin te reserveren voor deze groep en de vaccinatie te starten bij de oudsten. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. Finanzbericht 2. To our knowledge, we are the only company currently in clinical testing with a vaccine targeting the RBD domain. BioNTech Says Ended Q1 With $495M In Cash, Sales €27.7M First Quarter 2020 Financial Results Cash Position: Cash and cash equivalents as of March 31, 2020, were €451.6 million. Thank you for joining us today for BioNTech's first-quarter 2020 update call. Thank you. Then last question, sorry, for me. Pfizer and BioNTech had an advance purchase agreement to supply 40 million doses of their coronavirus vaccine to the COVAX facility. And this has so far no structural changes but single amino acid changes, and these single amino acid changes might change the biology of the virus. Total revenue, consisting primarily of revenue from collaborative agreements, was EUR 27.7 million for the three months ended March 31, 2020, compared to EUR 26.2 million for the three months ended March 31, 2019. BioNTech SE (NASDAQ:BNTX) Q1 2020 Results Earnings Conference Call May 12, 2020, 08:00 AM ET Company Participants Sylke Maas - Vice President of Investor Relations & … And actually, this data provided also the basis for discussing with FDA to start the randomized Phase 2 study which is going to -- which is expected to start in end of this year. Arlinda Lee -- Canaccord Genuity -- Analyst. Before we start, we encourage you to view the slides for this webcast as well as the financial results press release issued this morning, both of which are accessible on our website, in the Investors section. Neon offices in Cambridge, Massachusetts will now serve as our U.S. headquarters and the hub for the U.S. research and development site. My apologies. Thank you. Now let's move to Slide 4. * Numbers of shares for calculating the earnings per share for the three months ended March 31, 2019 have been adjusted to reflect capital increase due to 1:18 share split which occurred on September 18, 2019. One is the full-length type protein of the virus, and the other is the much smaller optimized receptor-binding domain or RBD from the spike protein. Thanks for taking my questions. We look forward to updating investors and other stakeholders throughout 2020. Please ask your question. That's the rationale behind that. And we are prepared, together with our partner Pfizer, to be able to scale up to supply nucleoside-modified mRNA. We have invested significantly in our manufacturing capabilities in the mRNA and cell therapy areas, which is a key pillar of our long-term strategy. The design of the U.S. study has the advantage that it could allow us to move seamlessly into Phase 2 testing if the Phase 1 results are successful and allow us immunization of several thousands of subjects. I want to provide a quick overview on the mRNA technologies being utilized for BNT162. Net loss was EUR 53.4 million for the three months ended March 31, 2020, compared to a net loss of EUR 40.8 million for the three months ended March 31, 2019. Any color on why you chose the full-length S protein versus the receptor-binding domain? ET (2:00 p.m. CEST), BNT162 (Europe) - The first cohort of BioNTech’s Phase 1/2 clinical trial was dosed. Better Buy: Moderna vs. BioNTech There are plenty of similarities between these two makers of coronavirus vaccine candidates, but the few differences make the choice clear. BioNTech expects to initiate a Phase 2 trial in advanced melanoma with registrational potential for BNT111 in 2H 2020. I had a few on 162. There have been no major changes to our trial time lines since our last call. To date, that plan has been successful, and expectations for clinical trial time lines have not changed substantially since our last update. You are aware that we are always trying to have a deeply scientific publication not only showing preclinical data but providing also some sort of understanding, and therefore we expect that this will not happen in the next two months. MUST CREDIT: Bloomberg photo by Alex Kraus. Yes. Self-amplifying messenger RNA in particular has the advantage that it may allow for greater potency and potentially enable a single administration at a very low dose. This bispecific antibody has outperformed conventional checkpoint inhibitors in preclinical animal models. BNT114 – Data update from a Phase 1 trial in triple negative breast cancer (TNBC) is expected in 2H 2020. So we are still collecting data in patients who had no metastatic lesions at the beginning. BNT162 (U.S) – The first cohort has been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program. Thank you. The next question comes from the line of Cory Kasimov of JP Morgan. Please ask your question. Slide 3 illustrates our vision of building a global next-generation immunotherapy company. So you are aware that we are using four different RNA backbones -- or three different RNA backbones and have four candidates, and all four candidates have to same lipid nanoparticle technology and exactly the same formulation. BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks apart, into the muscle. OK. * On July 27, 2020, BioNTech closed an underwritten offering of 5,500,000 American Depositary Shares (“ADSs”), each representing one of BioNTech’s ordinary … The companies currently expect to manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021, subject to final dose selection from their clinical trial. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended including, but not limited to, statements concerning: the planned next steps in BioNTech’s pipeline programs and specifically including, but not limited to, statements regarding plans to initiate clinical trials of BioNTech’s BNT111, BNT113, iNeST (BNT122), BNT211 and BNT411; expectations for data announcements with respect to BioNTech’s BNT111, BNT114, iNeST (BNT122), BNT131, BNT162 and BNT311 clinical trials; and our ability to scale-up manufacturing capacity for BNT162 and supply millions of vaccine doses by the end of 2020. Two for me, both on BNT162. BNT122 – Two Phase 2 clinical trials are expected to be initiated in the adjuvant setting in 2H 2020. For BNT111, our melanoma FixVac, we expect the next program update to be publication of our interim Phase 1 trial data in advanced melanoma in a high-ranked peer-reviewed journal in the next few months. Thank you. Pfizer, BioNTech sees 'dramatically' lower rates of COVID-19 in people vaccinated Mar. With that, I will return the call back to Ugur for concluding remarks. 2021 The BioNTech covid-19 production facility in Marburg, Germany, on Dec. 2, 2020. We are planning to initiate two randomized Phase 2 trials for our FixVac candidates BNT111 and BNT113 in melanoma and in head, neck cancer, respectively. View 13F filing holders of BioNTech SE ADR. BioNTech believes it has the potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and … BioNTech will continue to evaluate potential effects and provide updates as appropriate. BNT311 – The expansion cohort has been initiated in the Phase 1/2 trial in multiple solid tumors for BNT311 (PD-L1x4-1BB). As shown on Slide 2, during today's presentation, we will be making several forward-looking statements. BioNTech’s goal is to make a vaccine available to the public worldwide as quickly as possible. So the virus may increase the affinity or reduce the affinity or -- and the disease biology may change, but this type of mutations is not expected to change the responsiveness, the overall responsiveness of the virus toward a vaccine. And so this was a 121-pembro combo. BioNTech believes it has the potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval by regulatory authorities, and then rapidly scale up capacity to produce hundreds of millions of doses in 2021. Pfizer-BioNTech COVID-19 Vaccine. We believe that our vaccine program is differentiated in a number of key aspects. We believe that mRNA vaccines are highly suited for this challenge because, first, mRNA vaccines have been shown to be highly immunogenic and induce neutralizing antibodies, as well as T cell response. Shares Outstanding: Shares outstanding as of March 31, 2020 were 226,779,744. Hey, guys. We have no further questions at this time. And you've started to talk about this previously. And the spike protein itself has multiple epitopes and more epitopes for T cell generation than the RBD domain. To participate in the conference call, please dial the following numbers 10-15 minutes prior to the start of the call and provide the Conference ID: 9282359. What type of signals did you see in your early clinical data that made you confident that you wanted to explore that setting? In the second half of 2020, we plan to release additional clinical data for six clinical programs. For questions on logistics, handling or other issues: service@biontech.de. I wanted to start by quickly highlighting the significant progress we have made since the beginning of the year despite the ongoing COVID-19 pandemic. The data to be presented in June will include safety and immunogenicity data in multiple solid tumors types. The first quarter of 2020 has brought extraordinary challenges, and I am extremely proud of how we have -- as an organization have responded to these challenges. Stock Advisor launched in February of 2002. BioNTech SE An der Goldgrube 12 55131 Mainz Germany T: +49 6131 9084-0. Webcast Recording. You talked about having, by the end of June, 50 to 70 subjects worth of data. ________________________________1 We expect this data update to include an update on the ongoing study, including patient enrollment numbers, with full efficacy and safety data for an interim update expected in the second half of 2021. The next question comes from Daina Graybosch of Leerink. I think this was at ASCO earlier this year. So the planned publication for BNT111 will consist of data that have been presented, I think, and last updated in end of last year. Revenue: Total revenue, consisting primarily of revenue from collaborative A volunteer is injected with a vaccine as he participates in a coronavirus disease (COVID-19) vaccination study at the Research Centers of America, in Hollywood, Florida, U.S., September 24, 2020. With the addition of BioNTech U.S. last week, we now have operations on both sides of the Atlantic. We will announce a second indication which will come with the same rationale. Since the AACR meeting has gone virtual, we now plan to present the data at the AACR Virtual Annual Meeting 2 in June. You know that the German study is going to recruit about 200 subjects. I am incredibly proud that we have been able to quickly generate GMP-grade clinical drug supply for multiple vaccine candidates for our ongoing COVID-19 vaccine trials. What I can share is an observation which we had already published for our melanoma trials showing that patients that -- with melanoma, even with a post-metastatic melanoma, could be controlled with the vaccine; and lack of relapses after application of iNeST. MAINZ, Germany, May 05, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech”) will announce its financial results for the first quarter 2020 on Tuesday, May 12th, 2020. So that's the overall strategy. Yeah, yeah. Great. Conference Call and Webcast InformationBioNTech SE will host a conference call and webcast today at 08:00 a.m. So let's start with the question that -- the saRNA-related question. We expect to evaluate BNT111 in combination with a checkpoint inhibitor in patients who are checkpoint inhibitor experienced at baseline. As the COVID-19 pandemic remains dynamic, we will continue to monitor the situation as it evolves then provide further updates accordingly.

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