Thank you for standing by and welcome to the BioNTech’s First Quarter 2020 Operational Progress and Financial Results Conference Call. At this time, all participants are in listen-only mode. There will be a presentation followed by a question-and-answer session. [Operator Instructions] I must advise you the conference is being recorded today, Tuesday the 12th of May 2020. I would now like to hand the call over to the Vice President, Investor Relations and Business Strategy, Sylke Maas. Please go ahead.

Thank you for joining us today for BioNTech’s First Quarter 2020 Update Call. 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. As shown on Slide 2, during today’s presentation, we will be making several forward-looking statements. 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. Actual results could differ from those we currently anticipate. You are therefore cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this conference call and webcast. Speaking and available for questions today will be Ugur Sahin, Chief Executive Officer; Özlem Türeci, Chief Medical Officer; and Sierk Poetting, Chief Financial and Operating Officer. Ryan Richardson, Chief Strategy Officer, is available for the Q&A session. I’ll now hand the call over to Ugur Sahin, BioNTech’s CEO.

Thank you, Sylke. It’s a pleasure to welcome you to our first 2020 conference call. I will start with a few introductory remarks about our quarterly and recent highlights. I will then provide an update on our COVID-19 program. Özlem Türeci 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. I will then make a few closing remarks on the outlook for 2020 before opening up the call for your questions. 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. Slide 3 illustrates our vision of building a global next-generation immunotherapy company. Our strategy is to utilize our suite of novel therapeutic platforms to fully exploit the potential of the immune system. We are advancing a pipeline of potentially first-in-class immunotherapies for the treatment of cancer and infectious diseases. The most recent coronavirus vaccine program, which we named Project Lightspeed, shows the speed and flexibility of our mRNA vaccine technology. 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. 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. Finally, as we outlined in our last call, we quickly implemented a three-point plan to manage the impact of the COVID-19 pandemic on our clinical programs. To date, that plan has been successful and expectations for clinical trial timelines have not changed substantially since our last update. This week, we achieved an important milestone with the close of the acquisition of Neon Therapeutics. Neon offices in…

Thank you, Özlem. Before presenting the financial results, I would like to reiterate the measures that we put in place in order to mitigate the potential impact of the coronavirus pandemic on our operations, as we noted on our last call. We’ve put significant measures in place to protect supply chain, operations, employees and the execution of clinical trials. We have not seen any impact on our mRNA manufacturing, nor on our key manufacturing operations. BioNTech will continue to evaluate potential effects and provide updates as appropriate. Turning to Slide 8. We are currently manufacturing clinical trial material for the ongoing vaccine trials in the U.S. and Europe from our GMP facility in Idar-Oberstein, Germany and will soon be manufacturing in our Mainz, Germany facility as well. We started GMP manufacturing of mRNA in Idar-Oberstein and Mainz in 2011 and 2017, respectively, so these teams have substantial experience in doing so. 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. We are also working closely with Pfizer to ramp up our manufacturing capacity for global commercial supply. On the BioNTech side, this will involve increasing capacity at our current sites in Germany. Pfizer will also utilize 3 of their existing manufacturing sites in the US, in Massachusetts, Michigan and Missouri, and also at a site in Europe. BioNTech and Pfizer have established joint teams to work on process and supply chain scale-up and network planning. 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. Now I would like to summarize our financial results that are shown on Slide 9. Cash and cash…

Thank you, Sierk. 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. With the addition of BioNTech U.S. last week, we now have operations on both sides of the Atlantic. We have rapidly advanced our COVID-19 program and started dosing patients in Europe and in the US. We look forward to having data in the coming months from these trials. There is 11 product candidates now in the clinic. We have made significant progress towards our vision of bringing next-generation immunotherapies to patients. In the second half of 2020, we plan to release additional clinical data for six clinical programs. And we plan to initiate multiple registrational trails pending regulatory approval. We look forward to updating investors and other stakeholders throughout 2020. We thank our shareholders for their trust and support. We will now take any questions you may have. Operator?

Thank you. [Operator Instructions] Your first question comes from the line of Akash Tewari of Wolfe Research. Please ask your question.

Hey, guys. Thanks so much. So this is in regards to your update on BNT-121. I think this was at ASCO earlier this year. We noticed one patient, I think this is patient seven. He got - he or she got a CR and died around month 24 after treatment, and so this was a 121-pembro combo. Can you give any additional color on the death of that patient, have you dived into that patient’s immune response or tumor mutation profile in order to understand the disease progression? Next question is I noticed on your self-amplifying formulation you’re choosing the full-length S protein as your antigen. Any color on why you chose the full-length S protein versus the receptor-binding domain? And on your BNT-122 trial for NSCLC, we noticed that you went into an adjuvant setting before the basket trials kind of read out. What type of signals were you seeing that allowed you to expand in that indication? Thanks a lot guys.

Okay. So let’s start with the question that - the saRNA-related question, so we evaluated for each platform different immunogens, including the receptor-binding domain as well as the full-length stabilized spike protein. And for the saRNA, the full-length spike protein was significantly better. So just to remind you, the saRNA comes not only with some antibody response, but also with a mixed T cell response, including CD4 and CD8 T cells, and the spike protein itself has multiple epitopes and more epitopes for T cell generation than the RBD domain. So in a nutshell, in benchmarking of the RBD and the spike domain for the self-amplifying mRNA, we’ve felt that the full-length spike is a better immunogen for the saRNA. With regard to 122, can you repeat your question? 122 is iNeST, and we didn’t get the background of your question.

Yes. My apologies. Just we noticed that you announced an adjuvant trial in NSCLC. And I think you haven’t released the data from your basket study, so we were just wondering what type of signals did you see in your early clinical data that made you confident that you wanted to explore that setting?

Yeah. So the abstracts for our - from our clinical trials will come out in a few days. What I can share is an observation which we had already published in the - for our melanoma trials showing that patients with melanoma, even with a post-metastatic melanoma, could be controlled with the vaccine and lack of relapses after application of iNeST. And we have now several indications 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. And the CTD positive population in lung cancer is a population which has occult metastatic disease. A metastatic disease is, by definition, relatively low tumor load. And we believe that this patient, therefore, will particularly benefit with regard to their disease-free survival or - and metastasis-free survival rates. That’s the rationale behind that, and it’s not the only study in this setting. We will announce a second indication which will come with the same rationale.

Thanks so much.

Yeah. You’re welcome.

Thank you. The next question comes from the line of Cory Kasimov of JPMorgan. Please go ahead. Q –Unidentified Analyst: Hey, guys. Thanks for taking my questions and this is Matthew on for Cory. So my first question is on BNT-126 -- or BNT-162. For the initial Phase I data in June or July, how many patients should we expect to see and should we be thinking about this as both a safety and immunogenicity update?

Yes. Yes, it’s both. So we started the trial in April 21 in Germany, and about two weeks later in the US. Both trials are recruiting now first subjects, and the number of subjects is accumulating. You know that the German study is going to recruit about 200 subjects. The US study in the initial stage, is expected to recruit about 360 subjects. End of June, we will have data available of about 50, 60, 70 subjects; and this will dynamically increase. And we will, of course have data on the dose-dependent safety profile as well as dose-dependent immunogenicity profile. Q –Unidentified Analyst: Great. That’s super helpful. And then, I guess, in regard to the Phase II program, based on the comments in your prepared remarks, I am curious if we should expect this Phase II trial can start sometime in 2020 and that the trial size will be north of 1,000 patients?

Yes. So the trial, as it is indicated in the clinical trials - on the clinical trials website, can - it’s designed in a manner that it can seamless go from Phase I/II to Phase III, and this would also cover like recruitment of up to several thousand subjects, but it will depend on regulatory approvals to the end point. Q –Unidentified Analyst: Okay. Thanks for taking my questions.

Okay. You’re welcome.

Thank you. The next question comes from Daina Graybosch of Leerink. Please ask your question.

Hi. Thank you for the questions. Two for me, both on BNT-162. The first is on manufacturing, and I think you’ve spoken a lot about the mRNA manufacturing. I’d love to understand the limitation of lipid nanoparticle formulation and fill and finish in the scale-up and whether that depends on which of the mRNA technology platforms from you[ph]. And the second question is on the clinical strategy. I wonder. And you’ve started to talk about this previously. I wonder if you could help us understand the seamless design; if you can talk to any predefined thresholds to move from Phase I to II to III; and whether there’s any plan to do some of the Phase III in parallel to Phase II? Thank you.

Daina, so to the first part of your question. 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. So that means the upscaling of one candidate, the MP formulation for one candidate would be - would also serve for the upscaling of the other 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, yeah, so that is more the higher end of dosing. 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. So that means the challenge for upscaling for manufacturing for the different mRNA platforms are different scales. So for the nucleoside-modified mRNA to scale, the manufacturing scale will be higher. And we are prepared, together with our partner Pfizer, to be able to scale up to supply nucleoside-modified mRNA. 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. And this - if this scale is - can be produced for nucleoside-modified mRNA across the same scale, we’ll provide many more vaccine units, yes, for the self-amplifying or uridine mRNA. So that’s the overall strategy. The strategy for the clinical trial is - will be published in a few weeks. 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. 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.

Okay. Thank you very much.

Thanks, Daina.

Thank you. The next question comes from the line of Navin Jacob of UBS. Please ask your question.

Hi. Thank you for taking my question. Can you hear me okay?

Yes.

Okay, perfect. Thank you. Sorry, its - so a question, there have been some emerging publications or prepublications on potential mutations around the spike protein, including the receptor-binding domain. Wondering if you’ve - how you’re thinking about that and also wondering if you’re going to be publishing your preclinical data for BNT-162, please.

Yeah. So there are mutations also in the receptor-binding domain as well as in the other regions of spike protein. 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. 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 towards a vaccine. And since immune responses which we are generating via vaccine, even if you use just a receptor-binding domain, are extremely polyspecific, single amino acid changes will not affect neutralizing activity of the vaccine.

That’s very clear - go ahead. Sorry.

The second question with regards to the preclinical publications, so it will take a few more weeks until we have a full data set. 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.

Perfect. Then last question, sorry, for me. 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 BNT-312, to your cellulose boost A [ph] antibody asset, please?

312...

321...

321. 321 is...

[indiscernible] Özlem Türeci: CA 19-9...

CA 19-9. So the CA 19-9, just beginning 2020, was restarted in pancreatic cancers and other CA 19-9-positive tumors. We are collecting data. 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.

Thank you very much.

Yes. You’re welcome.

Thank you. The next question comes from the line of Arlinda Lee of Canaccord. Please ask your question.

Hi, guys. Thanks for taking my question. I had a few on 162. You talked about having, by the end of June, 50 to 70 subjects worth of data. I’m wondering how granular that data might be; and if you will have data from just the first candidate or some of the other candidates as well, and if there might be - on the granularity side, whether you might have enough granularity on the volunteer background. And as well, what kind of things are you looking for in order to move forward with one formulation versus - or one candidate versus another one? Thank you.

Yeah. So as you know, the trial is - has started with the first candidate, which is the nucleoside-modified RBD domain. We have also started a second candidate, which is a uridine-based RNA, including also for RBD domain. We are going to start with the two other candidates in the time frame of the next two to three weeks. And based on this staggered approach, the data updates for these candidates will be also provided in a staggered manner. The US trial is started to recruit and the German trial also started to recruit subjects below the age of 55, and we will start recruitment of subjects older than 55 once we have safety data in US available. So that means also the information with regard to the immunogenicity and safety in subjects older than 55 will come with a certain kind of delay.

Thank you.

Thank you. We will now take our last question from the line of Robert Burns of H.C. Wainwright. Please ask your question.

Hi, guys. Thanks for taking my question. Just one for me, if I may, regarding ASCO 2020. I noticed that it seems to be that there is going to be the presentation of our poster regarding BNT-111. And I was curious as to what sort of incremental updates we can expect to see within the patients from - that had metastatic lesions at baseline as well as whether we’re going to see any information on the patients that had no macroscopic tumor lesions at baseline? Thank you.

Yeah. So the planned publication for BNT-111 will consist of data that have been presented, I think, and last updated in end of last year. And we’ll provide mechanistics insights. We’ll provide deep immunological insights, and we’ll provide collected data how immune responses and other biomarkers correlated with objective responses and clinical control. And actually, this data provided also the basis for discussing with FDA to start the randomized Phase II study which is going to - which is expected to start in end of this year. So we are still collecting data in patients who had no metastatic lesions at the beginning. So this data is a readout based on relapse-free survival. Those data are still maturing. We expect that this data update will happen in the second half of 2020, yes, most likely in the upcoming meeting, either ESMO or SITC.

Thank you.

Yeah.

We have no further questions at this time. Please continue.

Okay. Well, thank you, everyone, for joining the call.

That concludes the conference for today. Thank you for participating. You may all disconnect.