biontech q1 2020

Turning to Slide 8. I will now turn to Slide 6. The majority of BioNTech development costs for our BNT162 program in 2020 will be funded by Pfizer and Fosun Pharma via cost sharing, equity investments and upfront payments. 2021 The BioNTech covid-19 production facility in Marburg, Germany, on Dec. 2, 2020. We give you the access and tools to invest like a Wall Street money manager – at a Main Street price. So just to remind you, that RNA comes with not only with antibody response but also with a mixed T cell response, including CD4 and CD8 T cells. Q1 2020 Financial Report 48.8 KB. 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 type of signals were you seeing that allowed you to expand in that indication? And then, I guess, in regard to the Phase 2 program, based on the comments in your prepared remarks, I'm curious if we should expect this Phase 2 trial can start sometime in 2020 and that the trial size will be north of 1,000 patients. It might be that we update on the recruitment of patients into this trial late 2020, but we will not provide substantial updates for the clinical trials in 2020 but most likely mid-2021. So that means the upscaling of one candidate, the NMP formulation for one candidate would be -- would also serve for the upscaling of the other candidates. 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. I will then provide an update on our COVID-19 program. You talked about having, by the end of June, 50 to 70 subjects worth of data. Thank you, Ugur. Contents: Prepared Remarks; Questions and Answers; Call Participants; Prepared Remarks: Sylke Maas. So that's the overall strategy. Q1 2020 Earnings Results: 05/12/2020: Misc: Q1 2020 Earnings Call: 03/31/2020: Earnings: Q4 2019 Earnings Results: View All ... and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. And we'll provide mechanistics insights. Mensen van 60 jaar en ouder hebben het grootste risico op ernstige ziekte en sterfte door COVID-19. We thank our shareholders for their trust and support. Shares outstanding as of March 31, 2020, were approximately 226.8 million. Thank you, Sylke. The increase was primarily due to an increase in head count leading to higher wages, benefits and social security expenses; as well as an increase in expenses for purchased research services. And the second question is on the clinical strategy. To our knowledge, we are the only company currently in clinical testing with a vaccine targeting the RBD domain. We expect to evaluate BNT111 in combination with a checkpoint inhibitor in patients who are checkpoint inhibitor experienced at baseline. Our mRNA vaccine for COVID-19 exploits a highly potent lipid nanoparticle or LNP mRNA vaccine product. Well, thank you, everyone, for joining the call. ET. Just one for me, if I may, regarding ASCO 2020. T: +49 6131 9084-0. I think I just missed it and it's probably there in your slide, but could we get an update on time lines for data update for BNT312, your sialyl Lewis A antibody asset, please? Thank you. SVB Leerink analyst D. Graybosch now forecasts that the company will post earnings of ($0.17) per share for the quarter, up from their prior estimate of ($0.18). Moving on to our iNeST program, to BNT122, which is partnered with Genentech. There are currently ten oncology products in 11 ongoing trials with multiple data readouts expected in 2020. We are on track with our previous guidance of approximately EUR 300 million net cash to be used for operating activities and investments into property, plant and equipment as defined in our 2020 base business plan prior to reflecting the impact of the Neon acquisition and our BNT162 program. So we evaluated for each platform different immunogens, including the receptor-binding domain, as well as the full-length stabilized spike protein. BioNTech is now in the integration phase and expects the new subsidiary, based in Cambridge, Massachusetts, to serve as BioNTech’s U.S. headquarters. BNT411 – A Phase 1/2a clinical trial of BNT411 is still expected to be initiated in multiple solid tumors in 2H 2020. So this data is a readout based on relapse-free survival. Ryan Richardson, chief strategy officer, is available for the Q&A session. I wonder. Q1 2020 Presentation 1 MB. Based on those discussions, we believe there may be potential for it to be registrational. The increase was mainly due to revenues resulting from other sales transactions i.e. For the initial Phase 1 data in June or July, how many patients should we expect to see? Robert Burns -- H.C. Wainwright -- Analyst. This increase was mainly driven by higher legal expenses; an increase in head count leading to higher wages, benefits and social security expenses; as well as higher expenses due to newly concluded insurance premiums. And the second question with regard -- yeah. For BNT122, two additional randomized Phase 2 clinical trials in the adjuvant setting are planned. We believe that our vaccine program is differentiated in a number of key aspects. Thanks for taking my questions. The dose escalation portion of Phase 1/2 trials will include about 200 healthy subjects in Europe, as well as 360 healthy subjects in the U.S. Quartal 2020 52.7 KB. Operator? Both trials are recruiting now first subjects, and the number of subjects is accumulating. As previously announced, the company has put significant measures in place to protect supply chain, operations, employees and the execution of clinical trials. So it will take a few more weeks until we have a full data set. BioNTech intends to initiate four Phase 2 trials (BNT111, BNT113, BNT122) and two additional FIH trials (BNT211, BNT411) in 2020. 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. “Most notably, we have rapidly initiated a global clinical development program in Europe and the U.S. for multiple COVID-19 vaccine candidates.”. And we will, of course, have data on the dose-dependent safety profile, as well as dose-dependent immunogenicity profile. Pfizer and BioNTech had an advance purchase agreement to supply 40 million doses of their coronavirus vaccine to the COVAX facility. Hi. The fourth vaccine candidate, which contains self-amplifying mRNA, will be evaluated after a single dose, as well as a prime-boost vaccine. Arlinda Lee -- Canaccord Genuity -- Analyst. BioNTech SE An der Goldgrube 12 55131 Mainz Germany. Two for me, both on BNT162. 13F filings are submitted quarterly to the SEC by hedge funds and other investment managers. In both cases, BioNTech is the sponsor of these trials. Q2. These forward-looking statements are based on BioNTech’s current expectations and speak only as of the date hereof. There's 11 product candidates now in the clinic. Yeah. Thank you for taking my question. Currently there are four vaccine candidates, two of the four vaccine candidates include a nucleoside modified mRNA (modRNA), one includes a uridine containing mRNA (uRNA), and the fourth vaccine candidate utilizes self-amplifying mRNA (saRNA). The first is on manufacturing. Those data are still maturing. For our next-generation checkpoint-immune modulatory program partnered with Genmab, the ongoing trial with BNT311, the PD-L1x4-1BB dual body, continues to advance rapidly, as the expansion cohort has been initiated. Real time BioNTech SE (BNTX) stock price quote, stock graph, news & analysis. As shown on Slide 2, during today's presentation, we will be making several forward-looking statements. Please ask your question. 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. 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. We will now take our last question from the line of Robert Burns of H.C. Wainwright. I'm proud of our progress toward developing a vaccine to prevent COVID-19 infection to combat the pandemic tide. ... BioNTech SE An der Goldgrube 12 55131 Mainz Please go ahead. Have you dived into that patient's immune response or tumor mutation profile in order to understand the disease progression? Data from this Phase 1/2 trial in multiple solid tumors is expected in the second half of this year. We expect abstracts to be available on May 15. Since the beginning of the Project Lightspeed in late January, we have selected four vaccine candidates; and initiated clinical trials in the U.S. and in Europe, following a fast and rigorous preclinical testing program that included a number of studies in animal models, as well as many, many me-too assays. 122 is iNeST. Yeah. This has provided an immediate R&D footprint in the U.S. As we have highlighted previously, the acquisition brings novel neoantigen-based T cell therapies and deep expertise in the development of neoantigen therapies, with both vaccine, and as well as T cell capabilities. The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks apart, into the muscle. So a question. And we expect that the dose of a potential active vaccine for uridine and self-amplifying RNA will be in the single-digit or even lower than single-digit concentration. Safety, immunogenicity and tumor response data will be included. Hong Kong to get Sinovac, Pfizer/BioNTech vaccines in Q1 Friday, 11 Dec 2020 04:30 PM MYT Medical workers collect samples from a man at a makeshift testing site for Covid-19 infections at the Queen Elizabeth Stadium in Hong Kong September 1, 2020. As Ugur previously mentioned, we made progress in our oncology clinical trials, and I'll lead you through key updates to our clinical pipeline, as shown on Slide 7. BioNTech has implemented a plan to manage the evolving disruptions on the Company’s clinical programs, and as previously detailed, is prioritizing execution of ongoing clinical trials, whereas certain first-in-human (FIH) clinical trial timelines have been affected. General and Administrative Expenses: General and administrative expenses were €15.8 million for the three months ended March 31, 2020, compared to €9.3 million for the three months ended March 31, 2019. Perfect. The clinical trial materials for these trials has been manufactured at our state-of-the-art GMP-certified mRNA manufacturing facilities in Europe. For questions on logistics, handling or other issues: service@biontech.de. Thank you. ET (2:00 p.m. CEST), BNT162 (Europe) - The first cohort of BioNTech’s Phase 1/2 clinical trial was dosed. We will focus on the integration efforts in the coming months and look forward to providing additional detail in the coming quarters. 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. The most recent coronavirus vaccine program, which we named Project Lightspeed, shows the speed and flexibility of our mRNA vaccine technology. 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. These forward-looking statements include but are not limited to the timing for enrollment and completion and reporting of data from our clinical trials and then potentially registration later of certain of our clinical trials and the impacts of the COVID pandemic on our business and our financial outlook. We expect these different mRNA formats to produce different immunogenicity profiles, which could be relevant in determining the dose and dosing frequency ultimately required to generate immunity. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. So let's start with the question that -- the saRNA-related question. Akash Tewari -- Wolfe Research, LLC -- Analyst. We believe it has broad potential in a range of solid tumors, including those where checkpoint therapy is currently established but also more difficult tumors where first-generation checkpoint inhibitors have not been as successful. We’re motley! Daarom adviseert de raad zo veel mogelijk van dit vaccin te reserveren voor deze groep en de vaccinatie te starten bij de oudsten. Interim Condensed Consolidated Statements of Financial Position, Interim Condensed Consolidated Statements of Operations, Interim Condensed Consolidated Statements of Cash Flows, Investor RelationsSylke Maas, Ph.D. VP Investor Relations & Business Strategy Tel: +49 (0)6131 9084 1074 E-mail: Investors@biontech.de, Media RelationsJasmina AlatovicSenior Manager Global External Communications Tel: +49 (0)6131 9084 1513 or +49 (0)151 1978 1385 E-mail: Media@biontech.de, 190705_Biontech_Logo_RGB_Dark Green (Preferred)_0.png. My apologies. So the abstracts from our clinical trials will come out in a few days. 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. To date, that plan has been successful, and expectations for clinical trial time lines have not changed substantially since our last update. Second, messenger RNA is a naturally occurring molecule with well-characterized safety properties, as well as defined biopharmaceuticals with a high purity and are animal free. Quartal 2020 344.3 KB. We noticed one patient I think this patient seven. Thank you, Ozlem. Finally, BNT211, our CAR-T program targeting solid tumors, remains on track to go in the clinic this summer. Recently, BioNTech completed the acquisition of Neon Therapeutics, Inc. in an all-stock transaction. We plan to provide a further update on the expected trial design in the third quarter of 2020. The data to be presented in June will include safety and immunogenicity data in multiple solid tumors types. Thanks a lot, guys. Yeah. 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. Research and development expenses were EUR 65.1 million for the three months ended March 31, 2020, compared to EUR 57.2 million for the three months ended March 31, 2019. As we previously noted, we have held discussions with regulatory authorities regarding next steps and the design of the Phase 2 trial. ________________________________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. Thank you. 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. BioNTech expects to provide a data update, to include dose-escalation and potentially some limited expansion data from the trial in 2H 2020. Great. So that is more the higher end of dosing. BioNTech has also continued to advance its broad oncology pipeline. And we plan to initiate multiple registrational trails pending regulatory approval. So my first question is on BNT126 -- or BNT162. MUST CREDIT: Bloomberg photo by Alex Kraus. We expect that this data update will happen in the second half of 2020, yeah, most likely in the upcoming meeting, either ESMO or SITC. InternationalMar 11. Yeah. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. There have been some emerging publications or prepublications on potential mutations around the spike protein, including the receptor-binding domain. I noticed that it seems to be that there is going to be the presentation of our poster regarding BNT111. With regard to 122, can you repeat your question? Please continue.Ryan RichardsonOK. 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. Next question is I noticed on your self-amplifying formulation you're choosing the full-length S protein as your antigen. The U.S. study in the first initial stage is expected to recruit about 360 subjects. MAINZ, Germany, Nov. 14, 2019 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases, today provided an update on its corporate progress and reported financial results for the quarter ended September 30, 2019. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020, which … 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. Hey, guys. So this is in regards to your update on BNT121. And we are prepared, together with our partner Pfizer, to be able to scale up to supply nucleoside-modified mRNA. We also anticipate additional funding to support our manufacturing scale-up for the BNT162 program in 2020. Thanks for taking my questions. Actual results could differ from those we currently anticipate. 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. Thank you for joining us today for BioNTech's first-quarter 2020 update call. And it's not the only study in this setting. I wonder if you could help us understand the seamless design; if you can talk to any predefined thresholds to move from Phase 1 to 2, to 3; and whether there's any plan to do some of the Phase 3 in parallel to Phase 2. All the adults will only be immunized with a given dose level of a vaccine candidate once a testing of that candidate and the dose level in younger adults has provided initial evidence of safety and immunogenicity. And currently we are addressing everything what is required, including the supply chain to -- for manufacturing including nucleotides, lipids, enzymes and so on, to be able to deliver the scale that we have announced recently, yes. BioNTech will continue to evaluate potential effects and provide updates as appropriate. BioNTech SE (NASDAQ:BNTX) - Analysts at SVB Leerink increased their Q1 2020 earnings per share estimates for BioNTech in a research note issued on Wednesday, April 1st. We are excited about this program. About BioNTechBiopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. Interest expense related to lease liability, Basic & diluted, loss per share for the period attributable to ordinary equity holders of the parent*. We are going to start with the two other candidates in the time frame of the next two to three weeks. BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. Both trials are currently enrolling healthy subjects between the ages of 18 to 55 and will target a dose range of at least one microgram to 100 microgram. And for the saRNA, the full-length spike protein was significantly better. So that means also the information with regard to the immunogenicity and safety in subjects older than 55 will come with a certain setup delay. Slide 3 illustrates our vision of building a global next-generation immunotherapy company. Health Canada authorized this vaccine with conditions on December 9, 2020, under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. And based on this staggered approach, the data updates for these candidates will be also provided in a staggered manner. We are collecting data. Thank you. And we have now several indications from -- also from the FixVac trial that patients with a lower tumor mass could be ideally suited for this type of vaccine and vaccine-checkpoint combination trials. Q2 2020 Presentation 2 MB. And so this was a 121-pembro combo. 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. Two of our four vaccine candidates include a nucleoside-modified mRNA backbone. 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. Pfizer-BioNTech COVID-19 Vaccine. BNT131 – Data update from Phase 1/2 trial in solid tumors remains on track for 2H 2020. And we didn't get the background of your question. If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October 2020. And I think you've spoken a lot about the mRNA manufacturing. End of June, we will have data available of about 50, 60, 70 subjects; and this will dynamically increase. Net Loss: Net loss was €53.4 million for the three months ended March 31, 2020, compared to a net loss of €40.8 million for the three months ended March 31, 2019. Revenue: Total revenue, consisting primarily of revenue from collaborative Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support BioNTech will continue to evaluate potential effects and provide updates as appropriate. BioNTech will provide clinical supply of the BNT162 vaccine from its GMP-certified mRNA manufacturing facilities in Europe. We are advancing a pipeline of potentially first-in-class immunotherapies for the treatment of cancer and infectious diseases. The overall strategy is to enable a clinical development plan which can give us at a certain time point full approval but might also be compatible with an earlier end point, yes. The US Food and Drug Administration's emergency use authorization of Pfizer and BioNTech's coronavirus vaccine is a crucial step in developing the new-generation vaccine, BioNTech CEO Ugur Sahin says. BNT 113 – Initiation of a Phase 2 trial in HPV+ head and neck cancer with registrational potential is on track for 2H 2020. BioNTech SE (NASDAQ:BNTX) Q1 2020 Earnings Call May 12, 2020, 5:00 p.m. The first adjuvant Phase 2 study will evaluate the efficacy, safety, pharmacokinetics, immunogenicity and biomarkers of BNT122 plus atezolizumab compared with atezolizumab alone in patients with stage two to three non-small cell lung cancer who are positive for circulating tumor DNA following surgical resection and have received standard-of-care adjuvant platinum-doublet chemotherapy. Then last question, sorry, for me. A metastatic disease is, by definition, relatively low tumor load. Ultimately, our joint goal is to be in a position to supply millions of doses of our vaccine in 2020 and hundreds of millions of doses in 2021. The drug candidate is a personalized neoantigen-targeted T cell therapy derived from patients' peripheral blood mononuclear cells or PBMCs consisting of multiple T cell populations targeting the most therapeutically relevant neoantigen from each patient's tumor. Now let's move to Slide 4. Since the AACR meeting has gone virtual, we now plan to present the data at the AACR Virtual Annual Meeting 2 in June. Ozlem Tureci will provide a brief pipeline update before handing the call over to Sierk Poetting, who will review our financial results and provide an update on our manufacturing-scale activities. Contents: Prepared Remarks; Questions and Answers; Call Participants; Prepared Remarks: Operator. In the second half of 2020, we plan to release additional clinical data for six clinical programs. So the trial, as it is indicated in the clinical trials -- on the clinical trials website, it's designed in a manner that it can seamless go from Phase 1/2 to Phase 3, yeah. 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. Speaking and available for questions today will be Ugur Sahin, chief executive officer; Ozlem Tureci, chief medical officer; and Sierk Poetting, chief financial and operating officer. The European Union has authorized the Pfizer/BioNTech Covid-19 vaccine, with the first phase of the bloc's mass vaccination program to begin later this week. We have no further questions at this time. We are also working closely with Pfizer to ramp up our manufacturing capacity for global commercial supply. Today, I'm going to provide key updates for our oncology pipeline since our last call. 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. It's a pleasure to welcome you to our first 2020 conference call. © 2021 GlobeNewswire, Inc. All Rights Reserved. We will now take any questions you may have. Thank you, Sierk. So the planned publication for BNT111 will consist of data that have been presented, I think, and last updated in end of last year. Cash and cash equivalents as of March 31, 2020, were EUR 452 million. This increase was mainly driven by higher legal expenses, an increase in headcount leading to higher wages, benefits and social security expenses as well as higher expenses due to newly concluded insurance premiums. Please ask your question. Wondering if you've -- how you're thinking about that and also wondering if you're going to be publishing your preclinical data for BNT162, please. So we started the trial in April 21 in Germany and about two weeks later in the U.S. Daina Graybosch -- SVB Leerink -- Analyst. In our call at the end of March, we have indicated those programs for which we expect delays due to the pandemic. That's the rationale behind that. The study will assess the effects of repeated vaccination following a prime injection for the three vaccine candidates that utilize uridine-containing messenger RNA or nucleoside-modified mRNA. I want to provide a quick overview on the mRNA technologies being utilized for BNT162. ET by Tomi Kilgore BioNTech SE ADR outperforms competitors on strong trading day The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. We'll provide deep immunological insights, and we'll provide [Inaudible] data how immune responses and other biomarkers correlated with objective responses and clinical control. Conference Call and Webcast InformationBioNTech SE will host a conference call and webcast today at 08:00 a.m. 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. I will now hand over to Ozlem to discuss key updates in our development program. In both trials, the objective is to determine the safety, immunogenicity and the optimal dose level for our four messenger RNA vaccine candidates; and is evaluated in a single continuous study.

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