Q1 2020 Earnings Call
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Thank you just starting by and welcome to the buy on Texas quota Twentytwenty operational progress.
Results Conference call.
Time, all participants are in listen only mode.
Your presentation, followed by a question answer session.
Time, if you wish to ask a question you will each person.
Thank you Pat.
Yeah.
I must advise you the conference is being recorded today.
The 12 May 2020.
Right.
She the Vice President Investor Relations and this is just G. Docomos. Please go ahead.
Thank you for joining us today violent <unk> first quarter Twentytwenty update call.
Before we start to encourage you to fuel the slides for this webcast as well as for financial results Press release issued this morning.
Both of which accessible on our website in the Investor section.
As shown on slide two during today's presentation, we wouldn't be making sub are forward looking statements.
These forward looking statements.
But I'm not limited to the timing for drilling and completion reporting data from all clinical trial at the potentially registration nature, So lucky that drives.
Perfect, Okay, cobot condemning when all business and our financial outlook.
Actual results could differ from those we currently anticipate you would therefore caution not to place.
Undue reliance on forward looking statements.
Which speak only as good date this conference call at West Coast.
[laughter] They book what questions today, we beat was <unk> Chief Executive Officer, that's led to hit G Chief Medical Officer instead.
Chief financial and operating system.
Ryan Richardson Chief strategy Officer, it's available hook acutely session.
I'd now and the court overlooked regarding biotechs CEO.
Thank you Jessica it's a pleasure to that commute to our Seth Twentytwenty conference call.
I will start with a few into actually remarks about a lot quality and recent highlights.
I will then provide an update on our cobot 19 Olga.
That's them to keep that pull back a brief pipeline update before handing the.
The quarter over to us that person, who believe you our financially we could starts and provide an update on our manufacturing scale activities.
I will then make a few closing remarks on the outlook for Turkey Sankey before opening up the caught all your questions.
I wanted to start by quickly highlighting the significant August we have made since the beginning of the Ya.
By the on Glenn Cohen, knocking pandemic.
Slide three it was price elevation of building a global next generation immuno topic company.
Oh, I guess you.
To utilize our suite of novel top <unk> platform.
40, it's got the potential of immune system.
Yeah, I'm seeing a pipeline of potentially so first in class in Utah piece for the critical cancers and infectious diseases.
The most recent corner of I was axiom Qualcomm.
Between that maybe poaching light speed.
Shows the speed and send it to your Oh I am on a vaccine technology.
We have invested significantly in our money section at the beach, but on the answer to help you Oh, yes.
Which is I keep it up on long term solution.
Hi, I'm incredibly proud that they have been able to creek degenerate GMP, great Cliniqa Cox supply.
A multiple vaccine candidates for ongoing coat 19 vaccine ties.
Finally, as the outcomes in our last car it could be implemented at three point pattern to manage the impact of the cobot 19 pandemic on our clinical programs.
To date that plan has been successful and expectations book then it could kind of timeline has not changed substantially since our last that's it.
This week, we achieved an important milestone.
Close offtake physician enough neon politics.
The on offices in Cambridge, Massachusetts, now, it's about U.S. had clock us and the hub for the U.S. research and development.
This has provided an immediate onto your foot put in the U.S.
Hi lots of previously the exhibition blanks novel, Neoantigen B T cell therapy.
And deep expertise in the development Neoantigen therapies. This both axiom and so as pizza capabilities.
We are pleased to be part that neon if they see a clinic a tidal conversation, but that has auto it de <unk>, New York PTC old one, which we have now named <unk> and T. Two to one.
The dock indeed, there is a personalized neo antigen pocket it seems that cannot be device from patients pets at black mono nobody yourself.
Oh PBM seats.
Consisting of multiple key subpopulations targeting the most top part b of element neo antigen for each patient's tumor.
The initial states Buncke clinic are tied up BNP two to one that would be in patients with metastatic melanoma why not responsive to checkpoint inhibitor.
These are focused on the integration in the coming month, and the fall, but to providing additional detail in the coming Claude.
Now, let's move to slide four.
And part of our pool class towards developing a vaccine to put then cobot 19 infection to combat the pandemic Todd.
Since the beginning of the poster that speed in late January gets elected for vaccine candidates and initiate the clinical ties into U.S. and in Europe. Following at Fox and the because preclinical testing program that included a number of studies in animal models, that's about as men.
He many meet with phase.
The first courts in both U.S. and Europe has now been too.
We expect a clinical data in late June and July timeframe.
Assuming that our tie that pull guess as Pat.
The Cliniqa Tyler Tias for this time, it's been money that's it that's our state of the odd GMP certified and on the manufacturing facilities in Europe.
In parallel we are working closely with Pfizer to scale up and touching quote global supply capacity.
That's good to provide the by supply.
Our goal is to be in a position to put your hundreds of millions of those this in beginning 2021.
One of the size if our vaccine program successfully in ties.
Slide five.
I want to provide a quick overview on the m. on their technology is being utilized thought being coupon and that's 62.
Well if that scientists.
Hosted at that caused that provided a detailed overview of the science behind or poor guy.
Yeah, we play that event is available on our website in the Investor Relations section dose that missed it and look like put no additional details.
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We believe that am on it exceeds Heidi she would put this challenge because.
Just.
On a big seems have been shown to be highly immunogenic and induced neutralizing antibodies.
T cell response.
Second messenger and he is a naturally occurring molecule was up that characterize 60 properties.
Lets be fine for my thought to good it's a high.
And I and the mostly.
The belief that a lot excuse me off a separate advantage over traditional vaccine approaches, including the ability to precisely the sign and then the SEC shut them, let that be in lots of quality.
[noise] belief that our vaccine program is differentiated number <unk>.
It's just it's that our pool can utilize this multiple amani formats.
Two of our four vaccine candidates include a nuclear site modified am on a backbone.
It includes a you would think containing messing Johnny.
The fourth vaccine candidate utilizes a set amplifying amani.
They expect that these discipline on instruments to put you will get funded immunogenicity profile, which could be relevant in determining that those and dosing frequency okay.
<unk> to generate immunity.
Seth Amplifying Masson, Johnny in particular has that thought that that it may allow for greater potency and potentially in April Cygnet administration that evaluate no dose.
So I don't Oh programs differentiated in that yet, but you can vaccines against two distinct targets into clinical testing.
One is the pool lengths type 14 of the virus.
It's a much smaller optimize receptor binding domain, Bobby fungicide Pulte.
So all the knowledge we are the only company currently in clinical testing was a vaccine targeting topic deep domain.
Ultimately, we will need to date for clinical data before we can all some conclusions that this domain has its on pitch as compare to the floor links antigen.
I will now turn to slide six.
I will provide an update on our ongoing global development program for BNP when that 62.
As stated before they have completed dosing for the service costs in both color U.S., that's in our European based on two class.
Both cases.
I don't think it's the sponsors off this time.
The dose escalation portion of phase two Todd that include about 200 healthy subjects in New York, That's about 360 healthy subjects in the U.S.
In both caused the objective is to determine the safety immunogenicity and the optimum dose that but for all four messenger on epic see candidates.
And it is evaluated in a single continue study.
Did the sign off the U.S. study has that's on the ship it it could allow us to move seamlessly into phase two testing if the fed funds besides that successfully and allow us immunization several thousands of subjects.
Both <unk> and voting healthy subjects between the ages 18 to 55 and the target a dose and Oh.
At least by Michael come to 100 Micah.
The study but.
That's the Texas Pizzas vaccination following a prime injection for the three vaccine candidates that utilize your wedding containing messenger on a on notice that money, but I'm on a.
The fourth vaccine candidate, which contains Seth entry time and money they will be evaluated after a single dose as bad as a prime boost Betsy.
Oh that if it does the only be immunized with a given dose level of vaccine candidate, but the testing that candidate and that those 11 young Dot has provided initially if it did a safety and Immunogenicity. There's a number of key objectives as I tried to sun.
So statistic.
On to expedite the clinical development path to approval.
And I don't objective is to get insights into the immunogenicity of or vaccine candidates in different subject groups across multiple regions.
The ultimate goal is to click the identify saves vaccine candidate that can prevent covert 19.
And then I'll hand over to ask them to discuss key updates in our development book.
Thank you.
Today, I'm going to provide updates for a while oncology pipeline since our last quarter.
In our corn at the end of much we have indicated those problems for which we expect delays due to the pandemic there have been no major changes to our trial timeline since our last call. It as the cold that 19 pandemic remain dynamic was it continued to money.
The situation as it evolves and provide.
Accordingly.
Well I previously mentioned, we made progress in our oncology clinical trials and I'd to fool key updates talk syndicate pipeline as shown on slide seven.
We have 11 product candidates into have ongoing clinical trials.
We are tending to initiate two randomized phase two trials fall off she looks like it can be date, BNP 111, and beyond Q1, Turkey in melanoma in and in head and neck cancer, respectively.
Yes, he wants.
Well I mean on almost expect weeks. That's the next program update to be publication <unk> interim phase one trial data and advanced melanoma in a hiring peer reviewed journals in the next few months as we previously noted we have had discussions with regulatory.
Regarding Nick that's and the design also take too tight.
Based on those discussions we believe that maybe potential for it to be legislation that.
We expect to evaluate yes, you want 11 in combination with a checkpoint inhibitor in patients watch checkpoint inhibitor experience.
Yes.
We tend to provide absorb that state Oh on exit trial design and the third quarter of Twentytwenty.
Moving onto I know school glum, two beyond Q1, 20 tool, which is part not a with genentech.
On our last quarter, we indicated that did they top K 12, a phase one two trial in multiple college to loss was found at the annual meeting.
Which due to the cool that.
Pandemic Watts, we catch you would fall off with Twentytwenty at that time.
Since the age meeting has gone virtual we now plan to presented data at phase Yeah virtual and your meeting to in June we expect abstracts to be available on may 15th the data to be presented engine wedding food safety and Immunogenicity.
Operator: Thank you for standing by, and welcome to the BioNTech First Quarter 2020 Operational Progress and Financial Results. Please ensure that all participants are in listening mode.
They tighten magic, that's how did too much.
Well, yes, he wants and two additional randomized phase two clinical trials and the utrophin touching ups and the first Utrophin phase two study would evaluate the efficacy safety pharmacokinetics, Immunogenicity and Biomarkers of CNG Onetwenty tool that's oh.
Operator: There will be a presentation followed by a question and answer session. If you wish to ask a question, you will need to press star 1 on your telephone keypad and wait for your name. I advise you the conference is being recorded. Tuesday, the 12th. I would now like to hand the call over to the Vice President, Investor Relations, and Business Strategy. 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 two, during today's presentation, we will be making several forward-looking statements. Please forward your key statements, including but not limited to the timing for enrollment and completion and reporting of data from our clinical tribes and the potentially registration nature of certain of our clinical tribes and the impact of the COVID pandemic on our business and our financial outlook. Actual results could differ from those we currently anticipate.
Easily come up on patch with absolutely somewhat alone in patients with Sage two to three non small cell lung cancer was positive for circulating tumor yen eight following surgical resection and have received standard of care adjuvant platinum doublet chemotherapy.
Unknown Executive: 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; Ozlem Tureci, Chief Medical Officer; and Sirkazin, 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.
Well on next generation checkpoint immune modulatory problem part not with.
John that's the ongoing try other with yen chiefly 11, the PD one slot one.
Well body continues to advance threat that yes, lump sum Clarke as being initiated data from this phase one to try and multiple college humongous is expected in the second top off with.
We expect the updates to include dose escalation and safety data from the trials. We are excited about this problem. We believe it road potentially in the range of solid.
Including those with.
With checkpoint European currencies established but also more difficult you must work Hertz generation checkpoint inhibitors have not been asked success.
Despite the systemic anti body has outperformed conventional checkpoint inhibitors in preclinical animal models, we have seen strong evidence and the preclinical setting off its ability to one m. good fivea checked off all of it.
Good.
Hi, Mindy BNP to 11 or car T program targeting 42 months remains on track to go in the clinic. This summer.
Well from combines our parts pure partick approach with a lot and warranty vaccination and uses our proprietary too much selective targets audience.
Ugur Sahin: Thank you, Zeke. 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. Ozlem Tureci will provide a brief pipeline update before handing the call over to Zip 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 to your questions.
I went and I'll hand, the call it over to the up to provide an update on our manufacturing scale up activities and discuss our current financial results, while the first quarter off Twentytwenty.
Thank you.
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 Corona virus epidemic on our operations as we noted on our last call.
[laughter] significant measures in place to protect supply chain operations employees at the execution of clinical trials.
Ugur Sahin: 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 immunotherapeutic 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. Our 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 program.
We have not seen any impact on our MRM and you factory more on or for T. manufacturing operations.
Downtick would continue to evaluate potentially affect and provide updates as appropriate.
Turning to slide eight we're currently manufacturing clinical trial material for the ongoing vaccine trials in the western Europe from or GMP facility or Overstocking, Germany.
Soon be manufacturing in our minds, Germany facility as well.
We started GMP manufacturing of MRF <unk> mine in 2011 in 2017, respectively. So these teams have substantial experience in doing so.
We have already established 24 seven operations mine. So we aim to start producing clinical training materials round the clock for use in our global development program.
We also working closely with Pfizer to ramp up our manufacturing capacity for global commercial supply.
On the Baltic sites this will in both increasing capacity or current sites in Germany.
Pfizer will also utilize three of the existing manufacturing sites do worse, Massachusetts, Michigan in Missouri and also the sites in Europe.
Ugur Sahin: 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 program. 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 Terracotta. Neon's offices in Cambridge, Massachusetts will now serve as our U.S. headquarters and the hub for U.S. research and development.
Well, you optic and Pfizer has established joint teams to work on process and supply chain scale up network flattening.
Ultimately or joint goal is to be in a position to supply millions of doses or exceed 2020, and hundreds of millions of doses in 2021.
No I would like to summarize all financial results those shows like nine.
Ugur Sahin: 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, both as vaccines and as cell-as-t-cell capability. We are pleased to report that NEON recently received a clinical trial authorization from the Dutch Health Authority for NEON PGC-01, which we have now The Black Candidate is a personalized neoantigen-targeted T-cell therapy derived from patients' peripheral black mononuclear cells, of PBNC, 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 inhibition. 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.
Cash cash equivalents as of March 31st Twentytwenty were 452 million euros.
Additional 217 billion euros in equity investments and bummed dilutive upfront payments due in the second quarter of 20 to 20 from Pfizer and Fosun pharma.
We are on track with our previous guidance of approximately 300 million euros net cash to be useful operating activities and the investments at the property plant equipment. That's do you find that or Twentytwenty base business plan prior to reflecting the impact of the new on acquisition into or do you want seeks to program [noise].
The majority of play on took development costs for our BNP Onesix two program in Twentytwenty would be funded by Pfizer and Fosun pharma bio cost sharing equity investments upfront payments.
We also anticipate additional funding to support all manufacturing scale up for the BMT Onesix two program in Twentytwenty.
Total revenue consisting primarily of revenue from collaborative agreements was 27.7 billion euros for the three month ended March 31st 2020, compared to 26.2 million euros for the three month ended March 31st when do you like cheap.
The increase was mainly due to revenues, resulting from other six transactions are you development manufacturing services sold to third party customers ritual viral vectors for clinical supply and say it's peptides.
Research and development expenses were 65.1 billion euros for the three month and that.
Lots to your first 20 to 20 compared to 57.2 million euros for the three month ended March 31st 29 team.
Ugur Sahin: I'm proud of our progress towards developing a vaccine to prevent COVID-19 infection to combat the pandemic. 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, many in vitro assays. The first cards in both the U.S. and Europe have now been dosed, and we expect first clinical data in late June and July, assuming that our trial will progress as planned.
The increase was primarily due to an increase in head count leading to higher wages benefits and social security expenses as well listen the increase in expenses for purchased research services.
General and administrative expenses were 15.8 million euros for the three month ended March 31st Twentytwenty compared to my point 3 billion euros for the three month ended March 31st when do 19.
This increase was mainly driven by higher legal expenses.
Increasing had cold leading to higher wages benefits and social security expenses as well as higher expenses due to newly concluded insurance premiums.
Net loss was 53.4 million Joe's for the three month ended March 31st when 20 compared to net loss of 40.8 million yours for the three month ended March 31st went to 19 shares outstanding as of March 31st Twentytwenty were approximately 226.8 million.
Ugur Sahin: 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 worthwhile supply. Our goal is to be in a position to produce hundreds of millions of doses beginning in 2021 along with Pfizer if our vaccine program is successful in time. Slide five.
With that I will return the call back to will for concluding remarks.
Thank you suck.
The first quarter of Twentytwenty has bought export another challenge and I'm extremely proud of how we had as an organization that was part of that to this challenges.
Let's say additional bounty U.S. last week.
Ugur Sahin: I want to provide a quick overview of the mRNA technologies being utilized for BNT162. On April 23, we hosted a webcast that provided a detailed overview of the strides 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.
Now have operations on both sides of the Atlantic.
Separately advanced about Kohut 19 program started dosing patients in Europe, and and the U.S.
They will probably having data in the coming months from this time.
Yes, 11 pulled that candidates now in the clinic.
Has made significant progress to that's about vision.
Ugur Sahin: Our mRNA vaccine for COVID-19 exploits a highly potent lipid nanoparticle, or LNP. M.A.N.E. 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 responses. Second, messenger RNA is a naturally occurring molecule with well-characterized safety properties, as well as defined by a pharmaceutical company with high purity and is animal-free.
But in next generation immuno topics to patients.
The second half of tend to 20, we plan to release additional clinical data plus six clinical programs.
We plan to initiate multiples I guess placement costs.
Pending regulatory approval.
We look forward to updating investors and out of they called us clock twentytwenty sank or showed us.
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We'll now take any questions you may have ocuvite huh.
Thank you will now begin the question answer session.
Ugur Sahin: We believe that our vaccines may offer several advantages over traditional vaccine approaches, including the ability to precisely design and manufacture them rapidly and in high quality. We believe that our vaccine program is differentiated in a number of key areas. The third is that our program utilizes multiple mRNA forms.
I will ask a question please press star one.
Keep hot.
Named.
If you wish to cancel your request please.
Once again that stuff one if you wish to ask a question.
Please standby compile the <unk>.
Your first question comes more into the cash to worry of Wolfe Research. Please ask your question.
Ugur Sahin: Two of our four vaccine candidates include a nucleoside-modified mRNA backbone, one including a uridine-containing messenger RNA, and the fourth vaccine candidate utilizes a self-amplifying mRNA. We expect that these different mRNA formants will 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. 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 the much smaller Optimized Receptor Binding Domain or RBD from the Spike. To our knowledge, we are the only company currently in clinical testing with a vaccine targeting the IBD domain. Ultimately, we will need to wait for clinical data before we can draw firm conclusions whether this domain has an advantage as compared to the full-length end. I will now turn to slide six.
Hey, guys. Thanks, so much so.
In regard to your update on VNC. Once you want I think this is that after earlier this year, we noticed one patient I think that's patient seven he's got he or she got to see our and died around 24 after treatment.
And so that's what they want your one pembro Cabo can you give any additional color on the death of education have you dive into that patients immune response or do you mean tumor mutational profile in order to understand the disease progression.
Next question, if I noticed on yourself amplifying formulation.
Choosing the full then that's protein has your antigen any color on why you chose the full that that's 13 versus the receptor binding domain and on your BMT. Once you do trial for and that's a C.L.C.
We noticed that you went into an adjuvant setting before the basketball or kind of read out what type of signaled where are you seeing that allowed you to expand about indication. Thanks a lot.
[noise], Okay. So let's start with the question that Oh, it was a on a related related question.
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Ugur Sahin: I will provide an update on our ongoing global development program for BNP162. As stated before, we have completed dosing for the first cohorts in both our U.S. as well as our European Phase I-II trials. In both cases, BioNTech is the sponsor of these trials.
Ah different immunogen, including the receptor binding domain as bad as the full line are stuck to that cycle quoting.
For the it's a on a the four legs Fyfourteen was significant piece I tested so just to remind you that a on a AD com so with a with a.
Ugur Sahin: 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 parts, the objective is to determine the safety, immunogenicity, and optimal dose levels for our four messenger RNA vaccine candidates, which will be 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 to immunize several thousands of subjects. Both tribes are currently enrolling healthy subjects between the ages of 18 to 55 and will target a dose range of at least 1 microgram to 100 micrograms.
Right and not only with a <unk> antibody response, but also with.
Service bonds, including city for it.
So and the spike protein stuff, that's multiple epitopes and life. He talks with T cells generation done then the I'd be deep domain. So in a nutshell benchmarking of the I'd be D and the Spike back fill me in Florida, South Amplifying I am on me with South.
That said that the pulling back is that that's not yet quota for the essay on.
Yeah, the but we got two to two adds to a one to two can you can you repeat your question I want to too is I know and they did not Vicki you didn't get gets a that the that count up your question.
Yeah My apologies.
We noticed that you announced an AD you've been filed a in ER and that CLC.
Ugur Sahin: 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 first vaccine candidate, which contains self-amplifying mRNA, will be evaluated after a single dose as well as a prime 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 in our trial 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 Ozlem to discuss key updates in our development program.
And you know I think you haven't really the be 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 want to take for about a setting.
Yeah. So it so the abstract so oh, that's on our clinical ties to the come come out in a few days or what I can share is it's a it's a isn't up the observation, which we had already published a in the.
Well I mean, I don't watch time, showing showing that patients that's that's a with a.
In ER, which are.
I don't know my even even but with a with a pause metastatic melanoma.
It could be controlled with that 16 and lack of relapses.
As a application of I Miss and they have now several indications for most of them from a from the picks exercise that.
Issuances and know what to my math.
Could be could be I do you see what's called the type of fixing indexing check fund combination combination cuts and ER.
The C.T.D. in a positive population in lung cancer, because the population, which has <unk> metastatic disease metastatic disease, it's a by the nation.
Ozlem Tureci: Thank you, Ugur. 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 indicated those programs for which we expect delays due to the pandemic. There have been no major changes to our trial timelines since our call.
I looked at the low to moderate within the believed that the station therefore, the particularly benefit habits, they got to two or or would there be seasonally survivor and methods and that that says that we survive survivor that that's the professional beyond that and it's not the only study in this setting.
Ozlem Tureci: 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 have made progress in our oncology clinical trials. And I'll lead you through key updates to our clinical pipeline, as shown on slide 10. We have 11 product candidates and 12 ongoing clinical trials. We are planning to initiate two randomized phase 2 trials for our FIXVAC candidates, BNT1-11 and BNT1-13 in melanoma and in head and neck cancer respectively. For BNT111, our melanoma fix-back, 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 two trial. Based on those discussions, we believe there may be potential for it to be a registration.
The LIBOR and now the second indication, but to come but the same question.
Thanks, so much.
Yeah, you know that.
Thank you next question comes from kind of Cory Kasimov with JP Morgan. Please go ahead.
Hey, guys. Thanks for taking my questions on this as Matthew on for Korea. So My first question is on Bianchi, one to six or one six too 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 that's both the safety and Immunogenicity update.
Yes, yes, it's both so so it's really thought that we stopped at the tide in April 20, something that's in a in a in Germany.
About two weeks later in the U.S. at both sites like 14, now five subjects and I'm. The AD that the number of South Texas actually when they can get note that the gym study is going until they could about 200 sub six the U.S. Saudi enough so that Michelle.
Sector to like with about see on that 60 subjects and soon to be but have you but have data available about 50, 60, 70 subjects and thats the dynamic increase and do the cost.
Ozlem Tureci: 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 INES program, to BNT122, which is partnered with Genentech. On our last call, we indicated that the data update for the phase 1-2 trial in multiple solid tumors was planned at the AACR annual meeting, which due to the COVID pandemic was rescheduled for August 2020 at that time. Since the AACR meeting has gone virtual, we now plan to present the data at the AACR Virtual Annual Meeting 2 in June.
I have data on the dose dependent safety poolside, it's about it's still get condo units in a typical cut.
Great. That's that's Super helpful. Atlanta, I guess in regard 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 sometime in 2020 and not the trial size will be north of a thousand patients.
Yes, so to that.
Hi, good price.
As it did indicate that index and it goes cars or have the cooks in Qatar steps I can okay.
In.
No not that it can seem that seem to go from phase one to two faith based suite.
Ozlem Tureci: We expect abstracts to be available on May 15th. The data to be presented in June will include safety and immunogenicity data in multiple celled tumor types for BNT-122 in additional randomized phase 2 clinical trials in the adjuvant setting. 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 2 to 3 non-small cell lung cancer who are positive for circulating tumor DNA following surgical resection and have received standard of care adjuvant platinum doublet chemo.
So this will also cover like recruitment Oh after several thousand subjects.
But it will depend on the regulatory approvals or.
So so.
Yeah and point.
Great. Thanks for taking my questions.
Okay.
Thank you. The next question comes from Deanna Gray Bush of Leerink. Please ask your question.
Hi, Thank you for the question too from me a both from BNP one six to the first is on manufacturing and I think you spoken a lot about the NRT manufacturing I love to understand the limitation I've looked at nano particle formulation and fill and finish in the scale up and whether that be pen.
And which of the and learn a technology platform is and my second question is on the clinical strategy I Wonder if you started to talk about they sit previously I wanted you could help us understand the seamless design. If you can talk to any creative flying.
Ozlem Tureci: For our Next Generation Checkpoint Immune Modulatory Program partnered with GenNet, the ongoing trial with BNT311, the PD-L1 for R1BB, dual body continues to advance rapidly as the expansion cohort has been initiated, and data from the Phase 1-2 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 effective. This bi-specific antibody has outperformed conventional checkpoint inhibitors in preclinical animal models.
Actually the move from phase one to two to three and whether there's any plan to do some of the phase three in parallel to face to thank you.
[laughter], Hi, Deanna and so it's also took till the first part.
So that's part of your question. So so yeah yeah.
While there that you're using for different on aid phone Oh free different on it but phones and test for candidates and or for candidates has the same Olympic nano particle technology and execute the same formulation. So that means that means the apps scaling off.
Ozlem Tureci: We have seen strong evidence in the preclinical setting of its ability to amplify the effect of our vaccines as well. Finally, BNT-211, our CAR-T program targeting solid tumors, remains on track to go into the clinic this summer. This program combines our CAR-T therapeutic approach with our mRNA vaccination and uses our proprietary tumor-selective target claudinase. I will now hand the call over to Zirk to provide an update on our manufacturing scale-up activities and discuss our current financial results for the first quarter of 2021. Thank you, Ozlem.
Oh, one candidate a then p. formulation for button candidates have what would be it would also so that's good enough that I can do that they expect that that the that ER nokia's that modified and on a or those for the nuclear that money, but am I neighborhood.
It will be in the into his age between 10 to 100 microcom. Yeah. So that is that there's more that or the high end of the outsourcing and they expect that said that that go with no both potential potentially ex FX c. and for your with you and.
And that's everything on a they'll be into single digits or even lower than single digit constantly so that means that the challenge for ups scaling for money that's thing for the different different m. on a platforms.
Unknown Executive: 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 RRT manufacturing operation.
The from scale, so for the nuclear that modified am I need to scale. The money that's okay of the higher and be up could.
You have prepared to get up with our partner Pfizer to be able to clean up to supply.
Marty I am on it.
Unknown Executive: 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 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 mines, so we aim to start producing clinical trial materials soon, around the clock, for use in our global development program.
And can be we are we are we are investing amplifying what is required.
Clothing, the supply chain to pause for a manufacturing, including nucleotides ER visits and signs and so on to be able to deliver Ah Ah. Okay. Okay. So you have that you have announced.
Recently.
And then it gets killed it is it's a can be put your.
Marty if I am on it crossed the same care with provides many more units, yeah, Oh photos, SAP amplifying or youre, putting them on it. So that's the that's the over or strategies.
I think you put a clinical trial is it's a they'll be they'll be they'll be they'll be properly and in in a few weeks or the overall strategy is to either it's Andy could developments on which can give us give us at this time PON pool at Cooper.
Unknown Executive: 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 U.S., in Massachusetts, Michigan, and Missouri, and also at a site in Europe.
But might also be compatible with a with a they're already endpoint yeah.
And as you know down no official statement, so far from regulatory authorities from email and see a which kind of end point would be accepted and therefore that everything but he can share at the moment would be that good day.
Unknown Executive: 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, which are shown on slide 9. Cash and cash equivalents as of March 31st, 2020 were 452 million euros. Additional €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 €300 million in 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 BNT 162 program.
Great. Thank you very much.
Thanks, Dan.
Thank you next question comes in light of nothing Jacob.
Ask your question.
Hi, yes. Thank you for taking my question can you hear me okay.
Yes [laughter].
Okay perfect. Thank you sorry.
Ah, but so thanks.
And there are.
Some emerging publications are pretty vocation on.
On potential mutations around the spike protein, including the.
Receptor binding domain, a wondering if you do food or how you're thinking about that and Oh, Okay. I'm wondering if you're if you're going to be publishing a your preclinical data for a BNP weren't six two please.
Unknown Executive: The majority of BioNTech development costs for our BNT162 program in 2020 will be funded by Pfizer and Pfazer & 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 27.7 million euros for the three-month ended March 31, 2020, compared to 26.2 million euros for the three-month ended March 31, 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.
Yeah.
So with that so they are mutations that also and a in a in the receptor binding domain et cetera, as the into other regions of Fyfourteen.
Unknown Executive: Research and development expenses were 65.1 million euros for the three-month ended March 31, 2020, compared to 57.2 million euros for the three-month ended March 31, 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 €15.8 million for the three-month-ended March 31, 2020, compared to €9.3 million for the three-month-ended March 31, 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. The net loss was 53.4 million euros for the three months ended March 31, 2020, compared to a net loss of 40.8 million euros for the three months ended March 31, 2019. Shares outstanding as of March 31, 2020, were approximately 226.8 million.
Do stuff so far.
No possible or changes, but thing and you know I said changes.
And that doesn't seem that I mean, as it changes might change to buy all ship, thereby but so the violence in may and making ceased affinity or reduce the affinity or.
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Towards north of 16.
ER and ER and since immune responses, which we are generating the bio vaccine. Even if you use just what are we except a binding domain.
Excluding the party specific and thing that I mean, I said changes.
No not effects normalizing activity up to 16.
The second very unclear I think last one yeah, yeah, and the second question with regard to guard.
The second question with regard to the preclinical certification, but let's take a few a few more weeks a until until you have a full day test that you are bad that yeah, or theyre trying to have pets Heather.
Deep meet these scientific publication not on the showing preclinical data, but providing also some talk of understanding and therefore.
Specs that this will not happen in the next two months.
Perfect and last question sorry for me.
I think I just missed it and it's probably there in your slide but could you get a.
An update in timelines for data update for BMP, three one or two your salaried Louis antibody asset please.
Ugur Sahin: With that, I will return the call to Ugur for concluding remarks. Thank you, sir.
We won.
Ugur Sahin: The first quarter of 2020 has brought extraordinary challenges, and I am extremely proud of how we have, as an organization, responded to these challenges. With the addition of BioNTech US last week, we now have operations on both sides of the Atlantic. They 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 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 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 on our 2020 plans. We thank our shareholders for their trust and support. We will now take any questions you may have. Operator.
Q.
That's great to one three to one.
You too.
Free to run is yourself.
Hi, Steve.
99, and see a CA 19 nine so.
So the the CA 19, nine just just ER, beginning beginning 20 Ah lisanti.
Restocking in a in pancreatic cancer and I'd say 99 for the two most yeah collecting data it's might be that the the I've said on the on the on the recruitment of Oh.
Patients into the price.
Late Twentys FMT, but not pulled by provides substantial update or updates for the 10 could cost incentive 20, but most likely make twentytwenty line.
Thank you very much.
Yeah, you go back.
Thank you. The next question comes on entirely of Canaccord. Please ask your question.
Hi, guys.
Thanks for taking my questions.
I had a few on Wednesday to you talked about having.
Operator: Thank you. We will now begin the question and answer session. If you wish to ask a question, please press star 1 on the keypad, and wait for your name to be in it. If you wish to cancel your request again, that's star 1 if you wish to watch. At this time, please stand by while we compile the Q&A. Your first question comes from the line of Akash Tewari of Wolf Research.
By the end of June 50 to 70.
Subjects worth of data I'm wondering how granular.
And if you will have data from.
The first candidate or somebody other candidates as well and if they're right on the granularity said, whether it's you might have enough granularity on the volunteer.
Background and as well.
And as well.
Things are you looking for and what are just slowed with one formulations.
Akash Tewari: Hey guys, thanks so much. So, in regards to your update on BNT121, I think this was at ASCO earlier this year, we noticed one patient, I think this was patient seven, he or she got a CR and died around month 24 after treatment. And so this was a 1-2-1 Pembro combo.
When candidate for says.
Thank you.
Yeah, yes votes. So as you know as you know the tires is thought to a with the stuff can be takes the kids or the nuclear that Marty, but I'd be deep domain.
Akash Tewari: Can you give any additional color on the death of that patient? Have you delved into that patient's immune response or tumor mutation profile in order to understand the disease progression? Next question is, I noticed in your self-amplifying formulation, you chose 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 BASCA trial kind of read out. What type?
We have also started as a second can leap day rate to the you'll weekend based on a and coating whats so for the outer deep domain that going to start that's good to other candidates in the time paying off the next two to three weeks or.
And based on that on the fact that supports the data updates for the candidates out there will be also provided enough that got man up.
The U.S. hi.
Stocks is totally cool and the German pod also started it feels like you like a they cool subjects had below the age of 55 and people vivo stops equipment of subjects.
All that Dan or 55 bumps you have safety data U.S. available yet, but what that means also the information, but with regard to the immunogenicity and safety in subjects and other than 55, those come but just so you said that delay.
Akash Tewari: Okay, so let's start with the question that was related to the SA RNA. So we evaluated different immunogens on each platform, including the receptor binding domain, as well as the full-length stabilized spike protein. And for the SA RNA, the full-length spike protein was significantly better. So just to remind you, the SA RNA comes not only from an antibody response but also from 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, a benchmarking of the RBD and the spike domain for the self-amplifying mRNA, we conclude that the full-length spike is a better immunogen for the SA RNA. With regard to 1-2-2, can you repeat your question? 1-2-2 is INET, and we didn't understand the background to your question.
Thank you.
[noise] [noise]. Thank you we will now take on last question from the nine of offensive HC Wainwright. Please ask your question.
Hi, guys. Thanks for taking my questions just one for me if I'm right.
Regarding ask about 2020, I notice that it's it seems to be that there's going to be a presentation or poster regarding appealing to you want one won a and I was curious as to what sorts of incremental dates we can expect to see within the patients for met that hadn't metastatic usually that baseline as well as whether we're going to see any information on.
Patients that had no macroscopic tumor lesions that baseline. Thank you.
Yeah, so as a sobi, though.
The the 10 publication for PMT runs on been edge is a is it's a it's a though consist of they thought that testing presented presented I think last update that in end of Oh I'm off last last year.
And the provides a mechanistic inside the provide deep immunologically insights and they provide a coalition caught at the state to how how immune response and Ida <unk> bio marker coordinate the objective responses on cliniqa clinical controls and an x.
Ugur Sahin: Yeah, my apologies.
Ugur Sahin: We noticed that you announced an adjuvant trial in NSCLT, and you know, 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?
To be the data.
Provides us with the debate that spaces for four or four discussing with SD eight to start the to defend them I spend that much case too but.
Ugur Sahin: Yeah, so the abstracts from our clinical trials will come out in a few days. What I can share is an observation that we had already published in our melanoma trial showing that patients with melanoma, even with post-metastatic melanoma, could be controlled with the vaccine and have no relapses after the application of INS.
The phase two study, which is going to.
This is expected to start and end up the yes.
There will be a have yasir collecting data in a in a in.
Patients, who had no metastatic ah lesions at the at the at the beginning but this data is that meets our faith based on the Leslie survival data I still maturing, we expect that data updates the that happened.
Second title Twentytwenty, Yeah, most likely and the in the upcoming meeting either at or if it's ITC.
Ugur Sahin: We now have several indications, also from the FIGSAC trial, that patients with a lower tumor mass could be ideally suited for this type of vaccine and vaccine checkpoint combination trial. And the ctDNA positive population in lung cancer is a population that has occult metastatic disease. Metastatic disease is, by definition, a relatively low tumor load, and we believe that this patient will therefore particularly benefit with regard to their disease-free survival and metastasis-free survival rate.
Thank you.
Yeah.
We have no further questions at this time please continue.
Okay, well, thank you everyone for joining the call.
That completes the conference for today, Thank you for participating.
[music].
Ugur Sahin: 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.
Ugur Sahin: Yeah, go back.
Operator: Thank you. The next question comes from the line of Corey Kazimov of J.P. Morgan. Please go ahead. Hey guys, thanks for taking my questions. And this is Matthew on behalf of Corey.
Matthew: So my first question is on BNT-126 or 162. 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?
Ugur Sahin: Yes, yes, it's both. So we started the trial in April 2021 in Germany and about two weeks later in the U.S. Both tribes are recruiting now FAST 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. By the end of June, we will have data available for 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.
Ugur Sahin: Great, that's super helpful. And then, based on the comments and 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.
Ugur Sahin: Yes, so the trial, as indicated in the clinical trials on the clinical trials website, is designed in a manner that it can seamlessly go from phase 1, 2, to phase 3. And this would also cover recruitment of up to several thousand subjects, but it will depend on regulatory approvals to the end point.
Matthew: Great, thanks for taking my questions.
Ugur Sahin: Thank you. You're welcome.
Daina Graybosch: Daina Graybosch of Hi. Thank you for the questions, too, from me, both on BNT162. The first is on manufacturing, and I think you've spoken a lot about mRNA manufacturing. I'd love to understand the limitations 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 the second question is about the clinical strategy. I wonder – and you started to talk about this just now – if you could help us understand the seamless design, if you can talk about 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.
Ugur Sahin: Hi Daina. So, to the first part...
Ugur Sahin: 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. So that means the upscaling of one candidate, the NMP formulation for one candidate would also serve for the upscaling of the other candidates. We expect that the nucleoside modified mRNA dose for the nucleoside modified mRNA will be in the range between 10 to 100 micrograms. 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.
Ugur Sahin: So that means the challenge for upscaling for manufacturing for the different mRNA platforms is at 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 a nucleoside modified mRNA. And currently, we are addressing everything that 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. And if this scale can be produced for a nucleotide-modified mRNA, of course, the same scale would provide many more vaccine units for the self-amplifying iodine m So that's the overall strategy. The strategy for the clinical trial will be published in a few weeks.
Ugur Sahin: The overall strategy is to enable a clinical development plan that can give us, at a certain point, full approval but might also be compatible with an earlier endpoint. And as you know, there have been no official statements so far from regulatory authorities, from EMA or FDA, about which kind of endpoint would be accepted. Therefore, everything that we can share at the moment would be speculation.
Ugur Sahin: Great, thank you very much. Thanks, Diana.
Operator: Thank you.
Naveen Jacob: Thank you. The next question comes from the line of Naveen Jacob of UBS. Hi.
Naveen Jacob: Yes.
Naveen Jacob: Okay, perfect. Thank you. Sorry. So, a 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 pre-clinical data for BNT162, please.
Ugur Sahin: Yeah, so there are mutations also in the receptor binding domain, as well as in the other regions of spike proteins. These are 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, and the disease biology may change, but this type of mutation is not expected to change the responsiveness, the overall responsiveness of the virus towards a vaccine, and immune responses which we are generating with a vaccine. If you use just a receptor binding domain, which is extremely The second question concerns the preclinical publications, which 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 some sort of understanding, and therefore, we expect that this will not happen.
Ugur Sahin: And the 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 timelines for data updating for BNT 3.1 to your Ciali-Lewis-A antibody asset, please?
Naveen Jacob: Thank you.
Ugur Sahin: 3-2-1, 3-2-1.
Ugur Sahin: 3, 2, 1, 3, 2, 1 is 5, 5, 5, 5, 3, 1.
Ugur Sahin: [inaudible]
Ugur Sahin: So the CA-99, just beginning in 2020, was restarted in pancreatic cancers and other CA-99 positive tumors. We are collecting data. It might be that we update on the recruitment of patients into this trial late in 2020, but we will not provide substantial updates for the clinical trials in 2020, but most likely mid-2021. Thank you very much. Yeah, you're right.
Operator: 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 162.
Arlinda Lee: 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 so on. 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.
Ugur Sahin: Yeah, so as you know, the trial 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 encoding also for the RBD domain.
Ugur Sahin: We are going to start with the two other candidates in the timeframe of the next two to three weeks. And based on this staggered approach, the data updates for these candidates will also be 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 recruiting subjects older than 55 once we have safety data in the U.S. available, so that means also information with regard to immunogenicity and safety in subjects older than 55 will come with a certain staggered delay.
Ugur Sahin: We will now take our last... Eliana Merle, Robert Burns, Hi, guys. Thanks for taking my question. Just one from me, if I may.
Operator: 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 in 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.
Ugur Sahin: So the planned publication for BNT111 will consist of data that has been presented, I think it was last updated at the end of last year, and will provide mechanistic insights, will provide deep immunological insights, and will provide correlative data on how immune responses and other biomarkers correlated with objective responses and clinical control. And actually, this data also provided the basis for discussing with FDA to start the randomized case two study, which is expected to start at the 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. The data is still maturing. We expect that this data update will happen in the second half of 2020, most likely at the upcoming meeting, either at SITC.
Ugur Sahin: Thank you. We have no further questions at this time. Please continue.
Operator: Okay, well, thank you everyone for joining the call. That concludes the conference for today. Thank you for participating.
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