BioNTech - Earnings Call - Q1 2020

Transcript

Speaker 0

you for standing by, and welcome to the BioNTech First Quarter twenty twenty 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. I must advise you the conference is being recorded today, Tuesday, 05/12/2020. I would now like to hand the call over to the Vice President, Investor Relations and Business Strategy, Silkemalf.

Please go ahead.

Speaker 1

Thank you for joining us today for BioNTech's first quarter twenty twenty 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 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 Uwe Zahin, Chief Executive Officer Aslam Toreci, Chief Medical Officer and Sird Karin, Chief Financial and Operating Officer. Ryan Richardson, Chief Strategy Officer, is available for the Q and A session. I'll now hand the call over to Ugra Sahin, BioNTech's CEO.

Speaker 2

Thank you, Zirk. 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-nineteen program. Alstom Thurigi will provide a brief pipeline update before handing the call over to Svete Petting, 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-nineteen 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 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 versatility 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 nineteen vaccine trials. Finally, as we outlined in our last call, we quickly implemented a three point plan to manage the impact of the COVID-nineteen 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 US headquarters and the hub for The US research and development effort. This has provided an immediate R and D footprint in The US. 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. We are pleased to report that NEON recently received a clinical trial authorization from the Dutch Health Authority for NEON PTC01, 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 topologically relevant neoantigen from each patient's tumor. The initial phase one clinical trial of BNT221 will be in patients with metastatic melanoma, who are not responsive to checkpoint inhibitors. We will focus on the integration effort 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 nineteen infection to combat the pandemic threat.

Since the beginning of the project, I speak in late January, we have selected four vaccine candidates and initiated clinical trials in The US 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 in vitro assays. The first cohorts in both US 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 twenty twenty one along with Pfizer if our vaccine program is successful in TIFF.

Slide five. I want to provide a quick overview on the mRNA technologies being utilized for BNT162. On April 23, 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 sections for those that missed it and would like to know additional details. Our mRNA vaccine for COVID nineteen 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 uidine 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 type protein of the virus, and the other is the 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 diabetes domain. Ultimately, we will need to wait for clinical data before we can draw some 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 cohort in both our US as well as in our European Phase onetwo trials.

In both cases, BioNTech is the sponsor of this trial. The dose escalation portion of Phase onetwo trials will include about 200 healthy subjects in Europe, as well as three sixty healthy subjects in The US. In both parts, 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. The design of The US study has the advantage that it could allow us to move seamlessly into phase two testing if the phase one 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 one microgram to one hundred microgram.

The study will assess the effects of repeated vaccination following a prime injection for the three vaccine candidates that utilize iodine containing messenger RNA or nucleoside modified mRNA. The fourth vaccine candidate, contains self amplifying mRNA, will be evaluated after a single dose as well as a time boost vaccine. All the 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 nineteen. I will now hand over to Elsin to discuss key updates in our development program.

Speaker 1

Thank you, Ugo. Today, I'm going to provide key updates for our oncology pipeline since our last call. In our call at the 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 nineteen pandemic remains dynamic, we will continue to monitor the situation as it evolves and provide further updates accordingly.

As Ugar 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 seven. We have 11 product candidates in 12 ongoing clinical trials. We are planning to initiate two randomized phase two trials for our VixVac candidates, BNT one eleven and BNT one thirteen in melanoma and and in head and neck cancer, respectively. For BNT one eleven, our melanoma FixVac, we expect the next program update to be publication of our interim phase one 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 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 one two 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 two in June. We expect abstracts to be available on May 15. The data to be presented in June will include safety and immunogenicity data in multiple solid tumor types. For BNT one twenty two, two additional randomized phase two clinic clinical trials in the adjuvant setting are planned. The first adjuvant phase two 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.

For our next generation checkpoint immune modulatory program partnered with Genmed, the ongoing trial with BNT three eleven, the PD L1 for our own BB DuoBody continues to advance rapidly as the expansion cohort has been initiated. Data from this phase onetwo 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 vaccines as well. 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, Claudine six. I will now hand the call over to Burke to provide an update on our manufacturing scale up activities and discuss our current financial results for the 2020.

Speaker 3

Thank you, Eslen. 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 Eder Oberstein, Germany, and will soon be manufacturing in our Mainz, Germany facility as well. We started GMP manufacturing of mRNA in Eder Oberstein and Mainz in 2011 and 2017 respectively, so these teams have substantial experience in doing so. We have already established 20 fourseven operations in MINDS, 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 the 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 nine. Cash and cash equivalents as of 03/31/2020 were €452,000,000 Additional €217,000,000 in equity investments and non dilutive upfront payments are due in the 2020 from Pfizer and Fossil Pharma. We are on track with our previous guidance of approximately EUR 300,000,000 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 €27,700,000 for the three months ended 03/31/2020, compared to €26,200,000 for the three months ended March 3139. 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 €65,100,000 for the three months ended 03/31/2020, compared to €57,200,000 for the three months ended March 3139.

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 €15,800,000 for the three months ended 03/31/2020, compared to €9,300,000 for the three months ended March 3139. 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 €53,400,000 for the three months ended 03/31/2020, compared to a net loss of €40,800,000 for the three months ended March 3139. Shares outstanding as of 03/31/2020 were approximately 226,800,000.0.

With that, I will return the call back to Ugo for concluding remarks.

Speaker 2

Thank you, Zirk. The 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 US last week, we now have operations on both sides of The Atlantic. We have rapidly advanced our COVID-nineteen program and started dosing patients in Europe and in The US. We look forward to having data in the coming months from this trial.

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 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?

Speaker 0

Thank you. We will now begin the question and answer session. Your first question comes from the line of Akash Tewari of Wolfe Research. Please ask your question.

Speaker 4

Hey, guys. Thanks so much. So this is in regards to your update on BNT one two one. I think this was at ASCO earlier this year. We noticed one patient.

I think this is patient seven. He got a he or she got a CR and died around month twenty four after treatment. And so this was a one to one 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 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.

Speaker 2

Okay. So let's start with the question that it was the s a r and a related related question. So we 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 so just to remind you, the s aRNA comes with a with a with not only with a strong antibody response, but also with a mixed T cell response, including c d four and c d eight t t cells.

And the spike protein itself has multiple epitopes and more epitopes for t cell T cell generation than than the RBD domain. So in a nutshell, a benchmarking of the RBD and the spike spike domain for the self amplifying mRNA, we thought that the that the full length spike is a better immunogen for the for the SA RNA. The with regard to to to to one to two, can you can you repeat your question? One to two is INET, and we didn't we didn't get get the the background of your question.

Speaker 4

Yeah. My apologies. Just we noticed that you announced an adjuvant trial in NSCLT. And, you know, I think you you haven't released the the data from your basket study. So we're 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?

Speaker 2

Yeah. So so the abstracts for our of from our clinical trials will will come come out in a few days. What I can share is is is is an observation which we had already published in in the for our melanoma trial showing showing that patients with with with with melanoma, even even with with a with a post metastatic melanoma, could be controlled with with vaccine and lack of relapses after after application of INET. And we have now several indications from also from from from the PIKZAC trial that patients with a lower tumor mass could be could be ideally suited for this type of vaccine and vaccine checkpoint combination combination class. And the the ctDNA positive population in lung cancer is a population which has occult metastatic disease.

Metastatic disease is, by definition, relatively low tumor load, and we believe that this patient, therefore, will particularly benefit with regard to to to their disease free survival or and metastasis metastasis free survival survival rate. That's that's the rationale behind that. And it's not the only study in this setting. We will we will announce a second indication which will come with the same rationale.

Speaker 4

Thanks so much.

Speaker 2

Yeah. You're welcome.

Speaker 0

Thank you. The next question comes from the line of Cory Kasimov of JPMorgan. Please go ahead.

Speaker 5

Hey, guys. Thanks for taking my questions. And this is Matthew on for Cory. So my first question is on BMT one hundred twenty six or 01/1962. For the initial phase one 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?

Speaker 2

Yes. Yes. It's both. So so so so we started we started the trial in April twenty twenty first in in in in Germany and and about two weeks later in The US. Both trials are reporting now past subjects, and and the the the number of subjects is accumulating.

You know that the German study is going to recruit about 200 subjects. The US study in the first first initial phase is expected to record about 360 subjects. June, we will have we will have data available of about fifty, sixty, 70 subjects, and this will dynamically increase. And we will, of course, have have data on the dose dependent safety profile as well as dose dependent immunogenicity profile.

Speaker 5

Great. That's that's super helpful. And then, I guess, in regards to the phase two program, based on the comments in your prepared remarks, I'm curious if we should expect that this phase two trial could start in sometime in 2020 and that the trial size will be north of a thousand patients.

Speaker 2

Yes. So so that the the trial the trial as it as it is indicated in the clinical trials on the clinical trials website can okay. It's it's designed in a in a manner that it can seamless seamless go from phase one two to phase phase three. Yeah? And and this would also cover, like, recruitment of of up to several thousand subjects.

But it will depend on regulatory approvals to to to yeah. And and for.

Speaker 5

Great. Thanks for taking my questions.

Speaker 2

You're welcome.

Speaker 0

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

Speaker 6

Hi. Thank you for the questions. Two from me, both on BNT162. The first is on manufacturing, and I think we'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?

And a second question is on the clinical strategy. I wonder and you started to talk about this 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 one to two to three, and whether there's any plan to do some of the phase three in parallel to phase two. Thank you.

Speaker 2

Hi, Diana. So so so so to the first part the the first part of your question. So 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 the same lipid nanoparticle technology and exactly the same formulation. So that means that means the upscaling of of of one candidate, the LNP formulation for one candidate would would be would also serve for the upscaling of the other candidate. We expect that that that the nucleotide modified mRNA, the dose for the nucleotide modified mRNA will be will be in the in the range between ten to one hundred microgram.

Yeah. So that is that is more the the the higher end of the of dosing. And they expect that the that the dose of a of a potential potential active vaccine for iodine and and self amplifying RNA will be in the single digit or even lower than single digit concentration. So that means the the challenge for up scaling for manufacturing for the different different mRNA platforms are different scales. So for the nuclear that modified mRNA to scale, the manufacturing scale will be higher, And and we are prepared we are prepared together with our partner Pfizer to be able to scale up to supply a new process modified mRNA.

And and, currently, we are we are we are addressing everything what is required, including the supply chain to for for manufacturing, including nucleotides, lipids, enzymes, and so on to be able to deliver the the scale that we have that we have announced recently. Yeah. And this if this scale is is is can be produced on nucleoside modified mRNA across the same scale, would provide many more vaccine units, yeah, for the self amplifying or eudine mRNA. So that's the that's the overall strategy. The strategy for the clinical trial is is will be will be will be will be published in in in in a few weeks.

The overall strategy is to enable a clinical development plan which can give us give us at a certain time point full approval, but but might also be compatible with with an earlier endpoint. Yeah? And and as you know, there are no official statements so far from regulatory authorities from EMA or FDA which kind of endpoint would be accepted. And therefore, everything what we can share at the moment would be speculation.

Speaker 6

Great. Thank you very much.

Speaker 2

Thanks, Diana.

Speaker 0

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

Speaker 7

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

Okay. Perfect. Thank you. Sorry. It's you know?

But so thanks. So question. There have been some some emerging publications or pre publications on on potential mutations around the spike protein, including the receptor binding domain. Wondering if you if you've how you're thinking about that. And also wondering if you're if you're gonna be publishing your preclinical data for BNT one six two, please.

Speaker 2

Yeah. So so the so there are mutations also in the in the 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. And this single amino acid changes might change the biology of the virus. So so the virus may may increase the affinity or reduce the affinity or and the disease disease biology may change.

But this type of mutations is not expected to to change the responsiveness, the overall responsiveness of the virus towards towards the vaccine. And and since immune responses which we are generating via vaccine, even if you use just receptor binding domain, extremely polyspecific and single amino acid changes will not affect notarizing activity of this vaccine. The second question is the last one yeah. Yeah. And the second question is regarding Go ahead.

Sorry. Yeah. The second question with regard to the preclinical publication, where it will take a few few more weeks until until we have a full dataset. You are aware that we are always trying to have have have a deep, deep scientific publication, only showing preclinical data, but providing also some sort of understanding. And and, therefore, we expect that this will not happen in the next two months.

Speaker 7

Perfect. And last question, sorry for me. Could we I think I just missed it, and and it's probably there in your slide. But could we get an update on timelines for data update for BMP31 to your Cyali Lewis A antibody asset, please?

Speaker 2

312? 321321. 321321 is Yes. Yeah. 55531.

Speaker 1

CA99 and

Speaker 2

CACA99. So so so the the CA99 just just beginning beginning 2020 was restarted in in in pancreatic cancers and other c ninety nine positive tumors. We are collecting data. It might be that we we update on the on the on the recruitment of of patients into the trial late twenty twenty, but we will not provide provide substantial update update for the clinical trials in 2020, but most likely mid twenty twenty one.

Speaker 4

Thank you very much.

Speaker 2

Yeah. You're welcome.

Speaker 0

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

Speaker 8

Hi, guys. Thanks for taking my questions. I had a few on one six two. You talked about having, by the 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 we might have enough granularity on on the volunteer background and as well 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.

Speaker 2

Yeah. Yeah. So so so as you know as as you know, the the trial is has started with with the first candidate, which is the the nuclear that modified RBD domain. We have also started a second candidate, which is iodine based on a encoding also for the RBD domain. We are going to start with the two other candidates in the time frame of the next two to three weeks.

And and based on this on this staggered approach, the data updates for these candidates will be also provided in a staggered manner. The The US trial is is started to recruit, and the German trial also started to re re recruit subjects below the age of 55, and we will we will start recruitment of subjects older than 55 once we have safety data in US available. Yeah? So that means also the information with with regard to the immunogenicity and safety in subjects other than 55 will come with a certain setup delay. Thank you.

Speaker 0

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

Speaker 9

Hi, guys. Thanks for taking my question. Just one for me, if I may. Regarding ASCO twenty twenty, I noticed that it seems to be that there's going be a presentation or a poster regarding PNT111. 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 gonna see any information on the patients that had no macroscopic tumor lesions at baseline.

Thank you.

Speaker 2

Yeah. So so so we will so the the planned publication for BNT one one one is is a is a it's a it's will consist of data that have been presented presented, I think, and last updated in end of of of last last year. And they'll provide mechanistic insights, they'll provide deep immunological insights, and they'll provide correlation correlative data, how how immune responses and other biomarkers correlated with objective responses and clinical clinical control. And and, actually, this data provided also the basis basis for for for discussing with FDA to start the the the randomized randomized phase two the phase two study, which is going to which is expected to start in in end of this year. So we we are still collecting data in in in patients who had no metastatic lesions at the at the at the beginning.

So this data is a readout based based on relapse free survival. The data are still maturing. We expect that the data update will will happen in the 2020. Yeah. Most likely in the in the in the upcoming meeting, either ESMO or SITC.

Speaker 7

Thank you.

Speaker 2

Yeah.

Speaker 0

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