Thank you for standing by, and welcome to the BioNTech 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, at which time, if you wish to ask a question, you will need to press star one on your telephone keypad and wait for your name to be announced. I must advise you, the conference is being recorded today, Tuesday May 12th 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 investor section. As shown on slide two, 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 the potentially registrational nature of certain of our clinical trials and the impact 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 Uğur Şahin , Chief Executive Officer, Özlem Türeci, Chief Medical Officer, and Sierk Pötting , 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 Uğur Şahin , 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 Pötting , 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 three illustrates our vision of building a global next generation immunotherapy company. Our strategy is to utilize our suite of novel therapeutic platforms to fully explore 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 facility 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 Cambridge, Massachusetts, will now serve as our U.S. headquarters and the hub for the U.S. research and development effort. 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 T-cell capabilities. We are pleased to report that Neon recently received a clinical trial authorization from the Dutch Health Authority for NEO-PTC-01, which we have now named BNT221. 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.
The initial phase I clinical trial of BNT221 will be in patients with metastatic melanoma who are not responsive to checkpoint inhibitors. We will focus on the integration aspect in the coming months and look forward to providing additional detail in the coming quarters. Now let's move to slide four. I'm proud of our progress towards developing a vaccine to prevent COVID-19 infection to combat the pandemic threat. Since the beginning of 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 in vitro assays.
The first cohorts in both U.S. and Europe have now been dosed, and we expect first clinical data in late June and July timeframe, assuming that our trial will progress as planned. The clinical trial material for this trial has been manufactured at our state-of-the-art GMP -certified mRNA manufacturing facilities in Europe. In parallel, we are working closely with Pfizer to scale up manufacturing for global supply capacity at risk to provide a worldwide supply. Our goal is to be in a position to produce hundreds of millions of doses in beginning 2021, along with Pfizer, if our vaccine program is successful in trials. Slide five. I want to provide a quick overview on the mRNA technologies being utilized for BNT162. On April 23rd, we hosted a webcast that provided a detailed overview of the science behind our program.
A replay of that event is available on our website in the investor relations section for those that missed it and would like to know additional details. Our mRNA vaccine for COVID-19 exploits a highly potent lipid nanoparticle, or LNP, mRNA vaccine product. 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. Second, messenger RNA is a naturally occurring molecule with a well-characterized safety properties, as well as defined biopharmaceuticals with a high purity and are animal free. We believe that our vaccines may offer several advantage over traditional vaccine approaches, including the ability to precisely design and manufacture them rapidly and in large quantities. We believe that our vaccine program is differentiated in a number of key aspects.
The first is that our program utilizes multiple mRNA formats. Two of our four vaccine candidates include a nucleoside modified mRNA backbone, one includes a uridine-containing messenger RNA, and the fourth vaccine candidate utilizes a self-amplifying mRNA. We expect that 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. 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. Further, our program is differentiated in that we are bringing vaccines against two distinct targets into clinical testing. One is the full length spike protein of the virus, and the other is a much smaller optimized receptor -binding domain, or RBD, from the spike protein.
To our knowledge, we are the only company currently in clinical testing with a vaccine targeting the RBD domain. Ultimately, we will need to wait for clinical data before we can draw firm conclusions whether this domain has advantage as compared to the full length antigen. I will now turn to slide six. I will provide an update on our ongoing global development program for BNT162. As stated before, we have completed dosing for the first cohorts in both our U.S. as well as in our European phase I/II trials. In both cases, BioNTech is the sponsor of these trials. The dose escalation portion of phase I/II trials will include about 200 healthy subjects in Europe, as well as 360 healthy subjects in the U.S.
In both trials, the objective is to determine the safety, immunogenicity, and the optimal dose levels for our four messenger RNA vaccine candidates, and is evaluated in a single continuous study. The design of the U.S. study has the advantage that it could allow us to move seamlessly into phase II testing if the phase I results are successful and allow us immunization of several thousands of subjects. Both trials are currently enrolling healthy subjects between the ages of 18 to 55 and will target a dose range of at least 1 μg - 100 μg. 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. The fourth vaccine candidate, which contains self-amplifying mRNA, will be evaluated after a single dose as well as a prime boost vaccine.
Older adults will only be immunized with a given dose level of a vaccine candidate once the testing of that candidate and the dose level in younger adults has provided initial evidence of safety and immunogenicity. We have a number of key objectives of our trial design. First, it is designed to accelerate the clinical development path to approval. Another objective is to get insights into the immunogenicity of our vaccine candidates in different subject groups across multiple regions. The ultimate goal is to quickly identify a safe vaccine candidate that can prevent COVID-19. I will now hand over to Özlem to discuss key updates in our development program.
Thank you, Uğur. Today I'm going to provide key updates for our oncology pipeline since our last call. In our call at the end of March, we have indicated those programs for which we expect delays due to the pandemic. There have been no major changes to our trial timelines since our last call. As the COVID-19 pandemic remains dynamic, we will continue to monitor the situation as it evolves and provide further updates accordingly. As Ugur previously mentioned, we made progress in our oncology clinical trials. I'll lead you through key updates to our clinical pipeline as shown on slide seven. We have 11 product candidates in 12 ongoing clinical trials. We are planning to initiate two randomized phase II trials for our FixVac candidates, BNT111 and BNT113 in melanoma and in head neck cancer, respectively.
For BNT111, our melanoma FixVac, we expect the next program update to be publication of our interim phase I trial data in advanced melanoma in a high-ranked peer-reviewed journal in the next few months. As we previously noted, we have held discussions with regulatory authorities regarding next steps and the design of the phase II trial. Based on those discussions, we believe there may be potential for it to be registrational. We expect to evaluate BNT111 in combination with a checkpoint inhibitor in patients who are checkpoint inhibitor experienced at baseline. We plan to provide a further update on the expected trial design in the third quarter of 2020. Moving on to our iNeST program, to BNT122, which is partnered with Genentech.
On our last call, we indicated that a data update for the phase I/II 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. Since the AACR meeting has gone virtual, we now plan to present the data at the AACR Virtual Annual Meeting II in June. We expect extracts to be available on May 15th. The data to be presented in June will include safety and immunogenicity data in multiple solid tumor types. For BNT122, two additional randomized phase II clinical trials in the adjuvant setting are planned.
The first adjuvant phase II study will evaluate the efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers of BNT122, plus atezolizumab compared with atezolizumab alone in patients with Stage II to Stage III 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. For our next generation checkpoint immunomodulatory program partnered with Genentech, the ongoing trial with BNT311, the PD-L1x4-1BB DuoBody continues to advance rapidly as the expansion cohort has been initiated. Data from this phase I/II trial in multiple solid tumors is expected in the second half of this year. We expect the update to include dose escalation and safety data from the trial. We are excited about this program.
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. This bispecific antibody has outperformed conventional checkpoint inhibitors in preclinical animal models. We have seen strong evidence in the preclinical setting of its ability to amplify the effect of our vaccine. Finally, BNT211, our CAR -T program targeting solid tumors, remains on track to go in the clinic this summer. This program combines our CAR -T therapeutic approach with our mRNA vaccination and uses our proprietary tumor selective target, Claudin -6. I will now hand the call over to Sierk to provide an update on our manufacturing scale-up activities and discuss our current financial results for the first quarter of 2020.
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 have 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 CAR -T manufacturing operations. BioNTech will continue to evaluate potential effects and provide updates as appropriate. Turning to slide eight, 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 material 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 three of their existing manufacturing sites in the U.S., 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 is shown on slide nine. Cash and cash equivalents as of March 31st, 2020, were EUR 452 million. Additional EUR 217 million in equity investments and non-dilutive upfront payments are due in the second quarter of 2020 from Pfizer and Fosun Pharma. 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.
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. We also anticipate additional funding to support our manufacturing scale-up for the BNT162 program in 2020. Total revenue, consisting primarily of revenue from collaborative agreements, was EUR 27.7 million for the three months ended March 31st, 2020, compared to EUR 26.2 million for the three months ended March 31st, 2019. The increase was mainly due to revenues resulting from other sales transactions, i.e., development and manufacturing services sold to third-party customers, retroviral vectors for clinical supply, and sales of peptides. Research and development expenses were EUR 65.1 million for the three months ended March 31st, 2020, compared to EUR 57.2 million for the three months ended March 31st, 2019.
The increase was primarily due to an increase in headcount, leading to higher wages, benefits, and social security expenses, as well as an increase in expenses for purchased research services. General and administrative expenses were EUR 15.8 million for the three months ended March 31st, 2020, compared to EUR 9.3 million for the three months ended March 31st, 2019. 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. Net loss was EUR 53.4 million for the three months ended March 31st, 2020, compared to a net loss of EUR 40.8 million for the three months ended March 31st, 2019. Shares outstanding as of March 31st, 2020, were approximately 226.8 million. With that, I will return the call back to Uğur for concluding remarks.
Thank you, Sierk. The first quarter of 2020 has brought extraordinary challenges, and I am extremely proud of how we as an organization have responded to these challenges. With the addition of BioNTech US 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 U.S. We look forward to having data in the coming months from these trials.
We have 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 trials 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. We will now begin the question and answer session. If you wish to ask a question, please press star one on your telephone keypad and wait for your name to be announced. If you wish to cancel your request, please press the hash key. Once again, that's star one if you wish to ask a question. Please stand by while we compile the Q&A queue. Your first question comes from the line of Akash Tewari of Wolfe Research. Please ask your question.
Hey, guys. Thanks so much. This is in regards to your update on BNT121. I think this was at AACR earlier this year. We noticed one patient, I think this is Patient 7, he or she got a CR, and died around month 24 after treatment. This was a BNT121 pembrolizumab 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 spike protein as your antigen. Any color on why you chose the full-length spike protein versus the receptor-binding domain? On your BNT122 trial for NSCLC, we noticed that you went into an adjuvant setting before the basket trial kind of read out.
What type of signals were you seeing that allowed you to expand in that indication? Thanks a lot, guys.
Okay. Let's start with the question that was saRNA related question. We evaluated for each platform, different immunogens, including the receptor binding domain as well as the full length, stabilized, spike protein. For the saRNA, the full length spike protein was significantly better. Just to remind you that saRNA comes not only with some antibody response, but also with a mixed T -cell response, including CD4 and CD8 T -cells. The spike protein itself has multiple epitopes and more epitopes for T -cell generation than the RBD domain. In a nutshell, a benchmarking of the RBD and the spike domain for the self-amplifying mRNA, we found that the full-length spike is a better immunogen for the saRNA. With regard to one, two, can you repeat your question? One, two is iNeST, and we didn't get the background of your question.
Yeah. My apologies. Just, we noticed that you announced an adjuvant trial, in NSCLC. I think you haven't released the data from your basket study. 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. The abstract from our clinical trials will come out in a few days. What I can share is an observation which we had already published for our melanoma trial, showing that patients with melanoma, even with post-metastatic melanoma, could be controlled with vaccine and lack of relapses after application of iNeST. 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. The ctDNA-positive population in lung cancer is a population which has occult metastatic disease. Metastatic disease is, by definition, a relatively low tumor load, and we believe that this patient, therefore, will particularly benefit with regard to their disease-free survival and metastasis-free survival rate. That's the rationale behind that. 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.
Hey, guys. Thanks for taking my questions. This is Matthew on for Cory. My first question is on BNT126 or 162. For the initial phase I data in June or July, how many patients should we expect to see? Should we be thinking about this as both a safety and immunogenicity update?
Yes. It's both. We started the trial in April 2020 in Germany and about two weeks later in the U.S. 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 U.S. study in the first initial phase 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. We will, of course, have data on the dose-dependent safety profile as well as dose-dependent immunogenicity profile.
Great. That's super helpful. I guess in regards to the phase II program, based on the comments in your prepared remarks, I'm curious if we should expect that this phase II trial could start sometime in 2020 and that the trial size will be north of 1,000 patients.
Yes. The trial, as it is indicated on the clinical trials website, it's designed in a manner that it can seamlessly go from phase I, phase II to phase III. This would also cover recruitment of up to several thousand subjects. It will depend on regulatory approvals, so, up endpoint.
Great. Thanks for taking my questions.
Yeah. 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 from me, both on BNT162. 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 you use. A second question is on the clinical strategy. You started to talk about this previously. I wonder if you could help us understand the seamless design, if you can talk to any pre-defined thresholds to move from phase I to phase II to phase III, and whether there's any plan to do some of the phase III in parallel to phase II. Thank you.
Hi, Daina. To the first part of your question. 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 the same lipid nanoparticle technology and exactly the same formulation. That means the upscaling of one candidate, the LNP formulation for one candidate, would also serve for the upscaling of the other candidates. We expect that the nucleoside modified mRNA, the dose for the nucleoside modified mRNA will be in the range between 10 μg - 100 μg . That is more the higher end of dosing. 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. That means the challenge for upscaling, for manufacturing for the different mRNA platforms are different scales.
For the nucleoside-modified mRNA, the scale, the manufacturing scale will be higher. We are prepared together with our partner, Pfizer, to be able to scale up to supply a nucleoside-modified mRNA. Currently, we are addressing everything what is required, including the supply chain for manufacturing, including nucleotides, lipids, enzymes, and so on, to be able to deliver the scale that we have announced recently. If this scale can be produced for nucleoside-modified mRNA, of course, the same scale would provide many more vaccine units for the self-amplifying or uridine mRNA. That's the overall strategy. The strategy for the clinical trial 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 endpoint.
As you know, there are no official statements so far from regulatory authorities, from EMA or FDA, which kind of endpoint would be accepted. Therefore, everything what we can share at the moment would be speculation.
Great. 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. Yes. Thank you for taking my question. Can you hear me okay?
Yes.
Okay, perfect. Thank you. Sorry. Thanks. Question, there have been some emerging publications or pre-publications on potential mutations around the spike protein, including the receptor binding domain. Wondering how you're thinking about that, and also wondering if you're going to be publishing your preclinical data for BNT162, please.
Yeah. There are mutations also in the receptor binding domain, as well as in the other regions of the spike protein. These are so far no structural changes, but single amino acid changes. These single amino acid changes might change the biology of the virus. The virus may increase the affinity or reduce the affinity, and the disease biology may change. This type of mutation is not expected to change the responsiveness, the overall responsiveness of the virus towards the vaccine. Since immune responses, which we are generating via vaccine, even if you use just receptor binding domain, are extremely polyspecific and single amino acid changes will not affect neutralizing activity of this vaccine. The second question.
That's very clear.
The last one Yeah. The second question with regard to.
Go ahead. Sorry.
Yeah. The second question with regard to the preclinical publication, 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 deep scientific publication, not only showing preclinical data, but providing also some sort of understanding. Therefore, we expect that this will not happen in the next two months.
Perfect. Last question, sorry, for me. Could we, I think I just missed it and it's probably there in your slide, but could we get an update on timelines for data update for BNT321, your sialyl Lewis A antibody asset, please?
Three one two?
Three two one.
Three two one.
Five three one.
Five three one.
CA19-9 antibody.
CA19-9. The CA19-9 just beginning 2020 was restarted in pancreatic cancers and other CA19-9 positive tumors. We are collecting data. It might be that we update on the recruitment of patients into this trial late 2020. We will not provide substantial update for the clinical trials in 2020, but most likely mid 2021.
Thank you very much.
Yeah. 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 questions. I had a few on BNT162. You talked about having, by the end of June, 50-70 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. If there might be, on the granularity side, whether you might have enough granularity on the volunteer background. 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.
As you know, the trial had 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, encoding also for the RBD domain. We are going to start with the two other candidates in the timeframe of the next two to three weeks. Based on this staggered approach, the data updates for these candidates will be also provided in a staggered manner. The U.S. trial 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 the U.S. available. That means also the information with regard to the immunogenicity and safety in subjects older than 55 will come with a certain data delay.
Thank you.
Yeah.
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 from me, if I may. Regarding ASCO 2020, I noticed that it seems to be that there's going to be a presentation or a poster regarding BNT111, and I was curious as to what sorts of incremental updates we can expect to see within the patients 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.
The planned publication for BNT111 will consist of data that have been presented, I think, and last updated in end of last year, and will provide mechanistic insights, will provide deep immunological insights, and will provide correlative data, how immune responses and other biomarkers correlated with objective responses and clinical control. Actually, this data provided also the basis for discussing with FDA to start the randomized phase II study, which is expected to start in end of this year. We are still collecting data in patients who had no metastatic lesions at the beginning. This data is a readout based on relapse-free survival. Data are still maturing. We expect that this data update will happen in the second half of 2020. Most likely in the upcoming meeting, either ESMO or SITC.
Thank you.
Yeah.
We have no further questions at this time. Please continue.