Q3 2023 CureVac NV Earnings Call
Greetings and welcome to the <unk> financial results for third quarter, and first nine months of 2023 business update.
At this time all participants are in a listen only mode.
A question and answer session will follow the formal presentation.
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It is now my pleasure to introduce your host Sara hockey.
Vice President of corporate Communications and Investor Relations. Thank you Sir you may begin.
Thank you.
Good morning, Good afternoon, and welcome to our conference call. My name is Sarah Funky and I'm, the Vice President of corporate Communications and Investor Relations at cubic.
Please let me introduce todays speakers on the call with me from Sugared Alexander syndrome, Chief Executive Officer of cubic you really haven't been Ddos or Chief Development Officer, and Cherokee Miller, Chief Financial Officer, Phil Cusick.
[noise] of intellectual properties smokers dog food will be present for the Q&A session.
Please note that this call is being webcast live and will be archived on the events and presentation section on the Investor Relations website.
Before we begin a few forward looking statements the discussions and responses to your questions on this call reflect management's view as of today Tuesday November 14th 2023.
We will be making statements and providing responses to your question that state our intentions beliefs expectations or predictions of the future. These.
These close to to forward looking statements for the purpose of the safe Harbor provision.
These statements involve risks and uncertainties that could cause actual results to differ materially from those projected.
<unk> disclaims any intention or obligation to revise any forward looking statement.
For more information please refer to our filings with the U S Securities and Exchange Commission I will now turn the call over to Alexander.
Ladies and gentlemen, good morning, good afternoon to everyone on the webcast.
Another year of strong performance drove still close we continued to successfully maintain our forward momentum in the clinical development programs in infectious diseases as well as in oncology and we are.
We are delivering on our strategic priorities.
Our lead programs in COVID-19, and seasonal flu jointly developed with GSK.
<unk> two and we are on track for delivering interim top line data in 'twenty to 'twenty four.
Phase two COVID-19 study recently completed enrollment and we expect interim data early next year.
In the phase two part of the combined phase one two study for seasonal flu. The first participants dosed and we expect interim phase two data in the first half 'twenty 'twenty four you.
We don't call a jeep our phase one study in patients with Resected Glioblastoma is advancing and has recently progressed to the opening of the third dose level at the initial dose escalation part of the study and we continue to expect data in the second half of 'twenty 'twenty four.
Supported this phase one study with promising data from preclinical studies presented at the beginning of these funds at the 11th mrna Health Conference, which killed back hosted in Berlin, and which is a global flagship mrna R&D event.
Also supporting our oncology strategy is the mrna printer cubic's end to end solution for integrated and automated manufacturing of GMP grade vaccines and therapeutics.
So prince Harry cheap and initial regulatory milestone by obtaining its first manufacturing license for an mrna cancer vaccine candidates.
Regulatory review.
<unk> is going to provide greater freedom and flexibility to manufacture different mrna cancer vaccine candidates.
Considering our cash runway our efforts in advancing our clinical development programs continue to be supported by prudent fiscal discipline.
Our cash position of $464 1 million U S dollars at the end of the third quarter provides a solid basis to continue to execute on our programs and priorities till mid 2025.
That's the pioneering company an mrna technology I think maintain the tradition of scientific leadership for more than two decades.
That continues to defend a broad and diversified intellectual property portfolio.
Our litigation against Pfizer biotech in Germany at the U S has progressed, it's favorable developments in the German court and a provision of a trial date in the U S. On October 1st 2024. Please.
Please let me remind you that in an industry, where innovation is a key driver of value at disputes are commonplace.
Or are currently pending cases, our interest is solely and having our intellectual property rights acknowledged and fairly compensated. So that all parties can continue advancing new transformative mrna based medicines.
On slide five we showed a clear correct product development pipeline, which forms the core of our business strategy.
The pipeline leveraging our unique platform in three therapeutic areas or prophylactic vaccines oncology and molecular therapy.
In our most advanced area prophylactic vaccines.
Two programs in phase, two which are driven by a clinically validated the technology platform and proprietary second generation mrna backbone.
For phase two COVID-19, and seasonal flu vaccine candidates are developed in collaboration with GSK.
Two phase one studies, we started last year have successfully evolved into two current phase two studies, which are testing updated candidates.
We kept treating you to translate the inside from a clinical infectious disease study into our a quality area as well a proof of concept phase one trial in patients with resected Guy, but I still am I is well on track as previously mentioned combined with our highly differentiated capabilities in tumor antigen discovery.
The study will be an important basis to further optimize our mrna backbone to provide differentiated clinical cancer vaccines.
The third therapeutic area or in molecular therapy, you're developing optimized mrna therapeutics together with several collaboration partner.
Our intended to enable the expression of therapeutic proteins to treat rare metabolic diseases.
And we are continuously investing in our development pipeline to advance innovation and health care solutions for people in patients with this let me hand over to Maryann for an update on our clinical development programs.
Thank you Alexander.
Now on slide six.
Over to you all like to know.
Yeah.
And COVID-19, excuse me that's true John.
Okay.
I already mentioned, we recently reported solid progress in both program with the completion of enrollment.
COVID-19 phase two study and so.
The combined phase two.
No.
So COVID-19 study shown on the left side of the slide we expect to safety.
Good friends Zynga.
Or was this a flu vaccine can be D C.
Second generation.
That's kind of that mhm 0601, it's a modified loan or balan construct.
Holding the Omicron D 845 variant.
The second kind of debt.
Oh, that's an old one it's a modified five mainland construct and coating the only car T a fault.
It's actually Alex <unk>.
Right.
According to the I think as well and available.
When does not depend also face to corporate.
On August 23.
Sweet.
I think that's not likely.
Mrna vaccine comparator.
And so it's too.
Yeah.
Along with the design.
Sweet.
I'm going to stop it.
Paul.
Following the September update of the COVID-19 scenarios can give you that.
<unk> safety study.
Sure Jason.
We can do that.
I'm sorry, it was a husky economy. This is a major Swiss clients.
The phase one two studies for seasonal flu, it's shown on the right side life.
We are expecting to see reactor.
Our flu vaccine candidates contacts with licensed comparator vaccine.
The phase one dose escalation part has already completed initial data analysis.
It starts with a comprehensive theory of licensed agents modified H P.
With up to eight eight construct for candidates it's definitely so that goes.
And secondly, how it does.
It's not a phase one safety data showed no safety concerns.
Yeah.
Yep Yep antibody responses chocolate.
Perfect.
It's just not big and small.
The phase two part of the study.
The potentially differentiated Nike valent can do that and of course, the antigen, but also.
Okay.
Right.
It will be tested in both parts of young and old.
It's different because.
So every company has different licensees not Snoop comparator vaccine.
When did you sort of refresh this age group.
Excellent.
There's two parts I would expect it to myself.
Frankly, it's pretty small.
And let's take a closer look at the study design of the two ongoing phase two studies.
So its not smooth on slide seven.
While we don't disclose the exact those black Knight.
The COVID-19 safety features.
Teachers are need him Don framed by a higher I don't know what those are the bivalent.
Mhm or southern cone.
And the medium dose level for the vulnerable and can do that.
Oh boy.
All of those.
Including the license five minutes Tomorrow, and a comparison of her team are fully recruited with a total of 407 participants H H M. Here.
For seasonal flu.
That's my surveillance candidates being tested in two separate age groups.
Got it got it aged 18 to 64.
480.
It's 65 to 85.
Each age group.
It sounds like most of the time to that.
It's not age appropriate license comparison.
With it now.
I'll shift gears and talk to our development progress.
Yeah.
On slide eight I would like to provide a more detailed overview of the ongoing phase. One study. We are currently conducting in patients with that you can be at.
And as you can see I.
Escalated fly with Blackstone.
On the left side of the slide you can see with the market.
Okay.
Mhm TVN with a focus on it accordingly.
Based on our.
Second generation RNA backbones and seems to think that I have already explained.
Right.
It didn't cause a device from Q1.
Okay.
John Smith.
The entire Russell.
You expect nature.
Not being disclosed however, you can see that T V M in Cotai and that's a N a.
Once the smoke and Sweden.
Uh huh.
And it's pretty complex as a whole classes.
I mean I must say.
Thank you Jen, including two Washington, finishing at 38, including for systemic sponsors against those.
Mhm and user licenses concept to excavate eight and city for Tuesday morning.
Cumulative.
But clinically effective vaccine design and the open label Phase one study.
Describe in more detail on the license side.
The study will evaluate the safety and Tolerability of <unk> in two parts.
The currently ongoing dose escalation class eight is expected to enroll up to 24 patients.
So expensive part D will include approximately 20 patients.
And the dose escalation part.
What caused those levels at week 12.
And 100 microgram.
Yes.
[laughter].
That's really an open eye for Cooper.
Progressing well without dose limiting toxicities observed to date.
The trial is being conducted in Germany, Belgium, and the Netherlands.
First data readout is expected in the second half of 'twenty 'twenty four.
In this context on slide nine I would like to highlight the results of a preclinical studies that you presented.
11 internationally.
Awesome.
I feel like I believe.
We conducted an extensive study in mice.
Sure.
We took a design life of options that can do that.
T D.
Yes.
Oh come on.
He's dying and coding pattern.
Cancer antigen epitopes, you're right from the <unk> 16.
And I know Mark and Mike.
Similar to <unk>.
Our standalone growth very aggressively.
Got you and use it.
The tumor microenvironment.
I think two months she only payments any so called coach you want with it.
Try to find efficient.
It had only very little T cell infiltration.
Accordingly, the tumor.
It's known to be resistant to checkpoint inhibitors cannot be addressed with a PD one blocking antibody as monotherapy.
Therefore, all of them up to date.
Thank you Brian.
It's mainly from the left side on the slide demonstrates prominence and thats not to be a T cell responses against five actually for T cell responses against two of the uncoated epitope.
Okay.
S 10 tumor bearing mice.
That's one induction of T cell responses against the tumor antigen.
You have to kind of extend that median survival by approximately 60% are treated mice Comcast life vaccinated with a family legacy consoles.
Yeah.
Our success in monotherapy.
Hum.
So I was able to efficiently recruit T cells.
Similar microenvironment.
By inhibiting tumor growth and survival.
With this let me hand back the call to et cetera.
Thank you Maria.
Finalized our oncology update D.
RNA printer are highly automated solution for GMP grade manufacturer of cancer vaccines has achieved its first regulatory milestone.
The printer obtained its first manufacturing license for a defined mrna construct to support our oncology strategy.
The first license was granted for the manufacturing of the tariff burden and RNA DNA and mrna modules of the printer.
Two ongoing regulatory review, we aim to license to be extended to a framework license, which will allow the flexible manufacturing of different mrna cost structure based on the established processes.
Yeah.
In 2024, our goal is to further expand this approach and also include the formulation module of the printer to complete end to end capabilities of the system.
Let me now address over the next few slides a topic that has gained attention in 2023, mainly our broad and diversified intellectual property portfolio.
Over the next few slides I would like to address the background of the ongoing legal action in Germany into U S, but laying out intellectual property rights in both jurisdictions innovations they referred to the responsible courts as well as the timelines and upcoming milestones.
So let's start by looking at Germany, where the process is generally more complex compared to the U S.
On the left side.
Slide 11, you can see that there are a total of eight intellectual property rights and issue in Germany, which can be divided into three patents and five utility models.
Utility by others don't have in Cleveland in the U S, but are available at different countries, including Germany.
They represent a class of intellectual property rights, which unlike a patent is not subject to an examination and therefore does not have an initial perception of validity correspondingly utility marvelous registered rather than branches.
However, utility Muslims are much faster to obtain that patents day also the same protectionist.
But the term is limited to 10 years.
Claim for damages if political is confirmed associated proceedings, there will be a more than it did the same way as for a patent.
But in protection normally a boss alongside a multiyear product development in the case of COVID-19, we chose to fund utility Bolivars as Steve was critical to protect our innovations in the unprecedented dynamic mrna C are generated by the pandemic.
The right hand side up to slide eight IP rights are sorted by patent family.
The first two patent families cover foundation of inventions to improve mrna stability for medical use does include enrichment of the juicy content.
RNA molecule and implementation of a split poly a tail.
Third patent families cover inventions that were specific to the development of prophylactic vaccine against Sars Cov two.
On the German law, the coach that determined the IP infringement or separate from the authorities decided on IP validity.
This means infringement and validity cases of pros.
In parallel with damages assessed only when infringement and validity has been established.
On Slide 12, you can see a schematic of this bifurcated German process.
The upper stream represents the infringement proceedings that will lead to a subsequent damages trial.
Or I P disputed infringement as well as potential damages related to or with eight IP rights is initially decided by the regional quote additional doors.
Lower stream represents validity proceedings validity of our IP rights is hurt by different authorities, depending on the nature of the IP rights.
This includes the European patent office for split for the H eight patents determine federal patent court for the Juicy enrichment patent and the German patent and trademark office for all sides, you Tuesday muscles.
I would like to draw your attention to the fact that these two streams setup place to each of the eight IP rights issue in Germany.
Each right is handled as a separate case for which infringement validity and potential damages will be decided separately.
So this provides us with multiple opportunities in our German proceedings to have some aspect of our intellectual property rights acknowledged and fairly compensated.
Yes.
On slide 13, you can see a timeline overview of infringement and validity proceedings in terms of the past as well as upcoming milestones in 2023 and 2024.
But the timeline for instance, infringement milestones part below basic two milestones.
Looking at the validity proceedings till the bottom part of the slide you can see that on April six 2023 determine federal patent court issued a positive preliminary opinion on the tooth enrichment patent supporting its validity at the same time the court set an oral hearing for December 19.
23, where we expect a ruling on the validity of the patent.
Looking at infringement proceedings at the top part of the slides a public hearing on the first five IP rights took place on August 15th 23 before the original court into stores.
This hearing the quota announced that on December 28th twenty-three ruling on infringement of the TC enrichment patent will be given.
This means that the juicy enrichment that will be the first IP rights for which both validity and infringement or decided that December 'twenty three it will be the first major milestones in our German litigation.
With the remaining four rights under consideration from the August 15 hearing infringement proceedings continued until September 28th went to court and district of postponed different infringement ruling or those remaining four rights until their validity challenges have been resolved by the respective authorities now let.
Explain why we consider this postponement a favorable outcome procure vac.
German infringement courts, typically delay their proceedings to wait for a decision on validity only in cases, where they considered that the challenged intellectual property rights to be infringed. Therefore, it can be inferred that the regional court distant dorf considers all four intellectual.
Property rights infringed. The court noted that the questions are politically is still needed to be determined accordingly, he decided to postpone the infringement proceedings until the validity of these four IP rights has been assessed.
This postponement does not reflect the preliminary assessment by the distant of quota validity.
But literally it can only be determined by authorities that are technically qualified and specialized in the liberty cases.
Moving on to the litigation in the U S. Again on the left hand side of Slide 14, you can see that there's a total of 10 U S patents currently at issue.
Patents closer into families, which mostly relate to the same innovations already discussed for the German litigation, namely to stabilization of mrna via T. C enrichment implementation of its place poly a tail as well as the design of Sars Cov two specific vaccines.
And additional patent family added in the U S relates to the innovation of filtration based mrna purification methods, which forms a critical part of the overall mrna manufacturing process.
Looking at the litigation timelines and milestones in the U S. On slide 15, the picture is more straightforward and a lot less complex compared to Germany for us.
Start all proceedings, including validity infringement and potential damages are public and hurt by the same court.
Also all three proceedings will be decided in one trial. This trial that will cover all 10 times. Therefore, there's no differentiation.
Between proceedings featured in this type of an overview.
As a brief reminder, do use litigation was initiated with the declaratory judgment action filed by Pfizer biotech Judy like July 2022, and the Federal District Court of Massachusetts, seeking confirmation that COVID-19 does not infringe three two or back pets.
May 23, we successfully transferred the case to the U S District Court for the Eastern District of Virginia, followed by our contract claim alleging infringement of six additional.
<unk>, which are a further extended by another person internet twenty-three to resolve independent overall patents being needed to get it now.
The district court for the Eastern District of Virginia is well known to have one of the fastest trial docs in the U S. Accordingly trial that has already been set for October 24.
We remain confident in the strength of our IP portfolio and continue to make progress towards the recognition of our pioneering contributions to the development of COVID-19 mrna vaccines.
With this I would like to conclude the business update and hand over to Pierre for a review of the financial data.
Thank you Alexander and good morning, and good afternoon to everyone on the call.
Looking at our cash position on slide 16, as already mentioned before.
The third quarter and the first nine months of 2023 with $464 1 billion euros.
Now she was in operation with maybe allocated to R&D activities expenditures for GMP full production facility and purchases of R&D material.
I will underline that this presentation significant one off effects that took place in 2022.
As a consequence of closing our first generation vaccine efforts, including 19.
First let us look at the revenues revenues increased by $5 3 million euros to $16 5 million euros in the third quarter and decreased by $24 5 million euros. So it's $1 2 million euros in the first nine months of 2023 compared to the same periods in 2000 Twenty's.
The decrease.
Although the first nine months of year on year was probably driven by lower revenues from our two GSK collaboration agreements.
Revenue from both collaboration decreased year on year and amounted to a total of $28 7 million euros. The first nine months of 2023 compared to $52 7 million in the same period in 2017.
The decrease was driven by two elements first the agreement both companies focus on larger indications in seconds.
2022, comparative days due to the recognition of the milestone related to the start of the flu phase one clinical trials in Panama.
Operating loss was 54 million users for the third quarter of 2023, representing a $1 6 million euro increase compared to the same quarter of 2022.
The first nine months of 2023 operating loss increased by $58 3 million euros to $186 2 million euros compared to the same period in 2022.
Beyond the level of revenues. The operating result was affected by several key drivers.
Forest.
Cost of sales decreased year on year, mainly as the impact of our first generation Covid vaccines subsided.
This resulted in lower write off of raw materials in the first nine months of 2023.
As lower feed costs related to the termination of the CMO securities.
R&D expenses increased with higher investments in later stage infectious disease and oncology development programs.
As well as strengthening the workforce.
The first nine months of 2022, R&D expenses were positively impacted in the amount of $36 8 million euros related to the reversal of an outstanding CRA provision as well as a one.
One of mitigated for a change in the contract termination provision, resulting primary and GSK taking over from the company committed capacity at the CMO.
Third.
And students with nine months of 2022 other income was positively impacted by one offs amounting to $32 5 million euros for reimbursement with prepayments and production activities.
Got it.
Financial results increased by <unk> 6 million euros to a profit of $5 4 million euros in the third quarter of 2023 and increased by $5 2 million euros to 12 7 million used for the first nine months of 2023.
For the same periods in 2022.
Mainly driven by interest income on cash investments.
Pretax losses were $48 7 million euros for the third quarter and Huntington $73 5 million euros for the first nine months of 2023.
This I would like to hand back the call to Alex that somebody of today's key messages.
Pierre So let me summarize the key takeaways for today.
Continued to deliver across our strategic priorities for 2023, I successfully advanced cigar clinical lead programs, both in infectious diseases as well as oncology.
Our phase two studies in Covid, 19, and seasonal flu, which are being conducted in collaboration with GSK as well as our phase one trials in glioblastoma are progressing well and according to plan.
And we expect to maintain our strong momentum in 'twenty four.
The key clinical data Readouts from all three studies as well as expected advancement to phase III development in infectious diseases.
Together with the progress we have made in safeguarding our investment in innovation and a strong cash position of $464 1 million euros, we will support the execution of our priorities to make 2025. This clinical progress underscores our strong commitment to introduce new house Crystal.
<unk> to the market.
With this I would like to conclude our presentation and we'll now open the webcast for your questions.
Thank you we will now be conducting a question and answer session.
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Kim.
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In the interest of time, yes that you. Please limit your questions to one and to one follow up question one.
One moment, please while we poll for questions.
Thank you.
Our first question comes from the line of Evan Wang with Guggenheim. Please proceed with your question.
Oh, great Hey.
Hey, guys. Thanks for taking the question.
I have one and then another follow up.
Just firstly with IP, you know number of dates coming up related.
Intellectual property.
Maybe just focusing on the upcoming German a ruling in December where you have the preliminary opinion.
Can you highlight are the pattern you know that.
September retail covers and how we should be thinking about you know how you know how damages would be assessed.
Particularly given some of the patent life, there and then.
One follow up thanks.
Thank you Evan.
I'm going to bring in Marcus Dalton, who is our head of IP to the call. Marcus I think there was a question on expectations for the December 28 mm.
Proceedings, and how potential damages would be accessed or because you want to take that.
Yes surely.
For the question.
The first thing that happens is the December 19th validity trial finally successful for US we will get the infringement proceedings.
As a practical matter the assessment of damages.
<unk> opens in AR.
And.
The citadel.
Whether the calculation of the amount of sales.
Those seats and all the rest of it.
Has to be assessed.
Then a reasonable royalty will be applied to that.
So that would take place throughout 'twenty cool.
Alright, and then one follow up in terms of the vaccines and specifically flu we've seen some re formulations by both Pfizer and Nektar now address some of the influenza B strain denim group improved tolerability. So just thinking as you know.
Guys are looking at your phase two formulations.
Formulations now I guess, how confident are you that one of those safety formulations will be to go forward formulation for phase III.
So question, maybe I am.
On flu.
And.
Yeah, I guess, if I heard the question right to your question is how confident I mean, and I think you know we.
So we are confident we have passed the different concepts in our phase. One study we have tested different doses in the phase one study and from the data that we have seen and we have I think a reason that our level of confidence that.
The data from the phase two will look strong, including and get all of it in an immunogenicity and react Virginia city and against A&P frames and that we can move forward to phase III.
I cannot give you a likelihood of success, but but you know everybody is making I think great progress with mrna vaccines industrial space and I am very confident that we are have a very compact with different differentiated kind of do that.
Okay.
Thank you. Our next question comes from the line of Ellie Merle with UBS. Please proceed with your question.
Hey, guys. Thanks for taking the question just another on IP. So just from the German patent court ruling on December 19, I guess, what are the implications of that if at all.
For the other court decisions in Germany for the other patents and utility model and then just as you think about your IC landscape broadly.
In terms of the different patents and patent the patent of state as we think about potential damages are there certain patent families that you think would be more valuable versus others. If you were to prevail and winning the.
The validity and infringement of those versus others that says we think to up I'm sure are learning from economics.
Now on next year.
Yeah. Thank you Ellie so two two kind of questions. One is implications of a potential German ruling and to I think more broader thinking how do we think about the strength of the different patent rights for patent families.
Marcus you want to take that.
Yeah.
Thanks for the question.
In reality the impacts of the gym.
G. C. This is all about the cheese sandwich from pattern.
Impact from either other jurisdictions that are other patents they will be held on their merits.
In relation to you know, which ones are stronger than others.
The thing I think that's important to us to date.
When things are granted normally.
You can only collect royalty from the date of grant so in case of the utility model data registration and so youll see that.
You'll see from our sites will be presented that'd be it the patents were issued over a longer or shorter period of time and although there are some patents that were issued prior to the first sales of vaccine.
Some of the others will come a bit later.
We would expect less less from us.
Thank you Markus and maybe I'll, let just to add to that I think we feel really good about is the breadth of our portfolio with eight rights in Germany attended the U S and I think.
I guess I tried to outline as part of my presentation. Each one of these rights is assessed on an individual basis. So this gives us a lot of shots on goal.
To really make sure that either or.
Intellectual property rights is fairly valued.
Breaking the basis for a fair compensation as well.
Great. Thanks for the color.
Thank you. Our next question comes from the line of young Yang with Jefferies. Please proceed with your question.
Thank you I have one question on the IP and the second question.
Pierre on financial lines itself.
The European patent six.
Eight.
In one of your slides Alexander you mentioned I think it shows at least.
The ruling on the Lady.
The spring 2024, and I was under the assumption that.
Preliminary opinion on the validity of fix a six eight patent is expected sometime October and November this year. So could you give us an update on that on the preliminary opinion and then second question for Pierre.
So.
Of course, the patient dosing in the seasonal from a phase two trial.
15 million year round from GSK.
Is that booked in third quarter I believe you don't have it booked in the fourth quarter. Thank you.
She said IP youre, referring to this play poly a tail.
Yeah.
You are right we are expecting normally a preliminary opinion around this time now we cannot exactly say when thats going to happen. Because this is gonna be fully up to you know the relative authority that that that assesses. This so you know it hasn't happened yet but might happen soon.
But we have not received it yet, but it spending and then Pierre on the on the milestone triggered from the GSK collaboration sure. So thanks for the question I think you were referring to sort of 15 million milestone related to the interim phase III right. So it is not booked into Q3, right and we don't have the cash but we.
Hope to have that in Q4 of course.
Like you said that the $15 million.
And fourth quarter.
Yeah. So we hope to have both the booking the booking for sure the cash as well in the fourth quarter.
Okay, great. Thank you.
Yes.
Thank you our.
Our next question comes from the line of Manny for <unk> with Leerink Partners. Please proceed with your question.
Hi, good morning, or afternoon, this is living longer format.
I have maybe I guess, a two part question. The first one would be regarding the corporate market.
So all of the Korean players are reviewing their potential.
Potentially even more revenue for the year again based on the current market dynamic I was wondering how do you think about the kind of talent not to call. It a vaccine market and and everything she's out hope that you all I guess could you give us maybe a little more detail.
Our bookings for Q.
Tom will vaccine attempts.
How far are we to a potential development of the combination and how do you think about the construct that you'd be thinking.
Thank you.
Yeah. Thank you so two questions one on Covid and then no no no.
The combination of Covid and flu.
Maybe I can start and marry them. If you want to add as well I mean, I always see COVID-19 more broadly I would say, it's going to fluctuate a lot it might vary a lot.
Over time, so it's kind of hard to predict exactly how big the market will be.
Moving forward. However, we do believe based on our platform and we've seen very good induction of munis, David relatively little reacted or the city. So we believe it can have a competitive product here for COVID-19.
Also as part of the phase two trial that you've seen in the presentation. You know we are comparing our construct with a license. The competitor. So this will be interesting to see how our platform performs against an established player. So that would be interesting for us and then moving forward are nevertheless.
Even though.
You know it might be small it still going to be an important indication for us all.
Also from a development point of view.
Almost free option for us because we met the hundred million capped in terms of R&D expenses. So that's important and of course, it's gonna be a springboard for us to do the combination of Covid and flu, where we see the actual potential but that's part of our development strategy as well of course with GSK and I think one.
<unk>.
Early next year early to mid next year, we will see both phase twos are running out of that that will enable us to really to choose the best combination possible for a combination for a combination product.
Yeah, maybe I can add to this as well because you're right. The cobot market is going down, but the COVID-19 infection per se and the related charges.
Give me the names I will continue to be ahead Smith, especially for the Arizona population most countries in the meantime have moved on to recommend it and you'll have a vaccine.
Asian.
So I think that's trained especially for the elderly population and this reflects a similar situation like we have been having for flu for the last 20 years or more but basically the flu vaccinations recommended every year with the uptake of fluids train four, especially and as any patients at risk and for patients who have come in.
But it seems that the export them anyway.
So we do see a continued need for certain population to be regularly on an annual basis vaccinated with a vaccine against Covid, Oregon.
And that's why especially for that population.
The combination makes sense right, because you basically kind of increased vaccine and actually run by combining a basically a vaccine it gets to give me. This one.
Can make it for patient convenience and basically it's better to have the.
The side effects associated with a vaccine.
101 goal with one truck rather than having it twice.
By two separate vaccines that that's one path like why we do believe it's important to continue with a combination program. The other thing is that the health.
Our systems are really heavily burdened.
And in many many countries and especially feeling the vaccination season against certain call that and so by offering basically one combined vaccine. It's a relief and also for the practices applying those vaccines and pharma space in the U S and that that'd be awesome.
A significant advantage.
Thank you Maria.
Thank you as a reminder, if you would like to ask a question. Please press star one on your telephone keypad.
Our next question comes from the line of Charlie <unk> with Bank of America. Please proceed with your question.
Great. Thanks for taking the question I have one on the.
The patent infringement case can you just talk about the potential appeal.
I'm you know I'm, assuming the Neal the counterparty will appeal if they rule.
In favor of Karabakh, So how would that how would that time might come to potentially delay the damage from negotiation.
And then I have a follow up.
Thank you Charlie So a question on the appeal at timeline and impact on how that would impact the damages process, let Marcus comment further once the case we get.
You know related to confirm that infringement confirmed as well at the end of December that would start the damages proceeding irrespective of a potential appeal, but I will let Marcus comment further on this.
Yes.
Alexander This is exactly why it's such a Germany, but you will we would stop the damages assessment in parallel with any appeal and.
Likely timing is as it is a balance of year.
Suppose proceeding some so that the collection would happen.
At the end of next year beginning of.
25 that sort of thing.
For the first time.
In the U S to play that was what your question was also a direct sale.
And that appeal will likely take place and that would be another year from the ruling.
So we expect the rolling off towards the end of October.
There are three week trial.
And then the petrol.
Stuck in the.
Rule.
Roughly a year.
And then Tim just would be collected at that point.
Great Thanks for that Mike.
Second question is regarding the <unk>.
So vaccine can you just talk about how once we see the data the first half of next year.
Like how quickly can.
Can you hear about how moving to the pivotal study.
And then maybe just.
Another one just in terms of a kind of a broader cancer program.
When should we expect to see the next coach House.
Designed for the other indications thanks.
<unk>.
Okay. Okay. Her journey in the area and what affect that.
Yes of course, that's actually I think those are great question Charlie.
So regarding the TV and vaccine this is a try it.
That's basically it.
We are conducting to show.
The proof of principle or that our vaccine platform works in the oncology setting so far we have a shot.
Seen very very strong and promising preclinical data, but we have not tested so far our vaccine in the clinic. So the thing about too much private equity are designed to show that the platform works at our cancer vaccine candidates and use our strong immunogenicity and use the C V eight until the fourth.
Sponsors and against the encoded antigens.
That's why we selected the glioblastoma setting because we are encoding for antigen that has been shown to be immunogenic in glioblastoma patients at.
At the moment, we do not have intention to take the vaccine candidate that further into the Nextgen consulting because we have moved onto a much more advanced.
Antigen discovery platform and that's what we have been working on for the last year.
Yeah. We are again took a different approach to antigen discovery because in cancer vaccines, it's really all about finding the right cancer antigens and coding both in building Tommy is probably 10 to 15. So far these antigens. We have used the glioblastoma trial. He knows that they are you know genetic but we do not know what's not that they are the right ones.
He was a strong 10, because it's fun.
And so we really want to bring the output of our antigen discovery platform into the next vaccine candidate that we have been working on it.
It will be in additional cancer indications.
With the plan and again, you never know where science works I thought the plan is that going to have a clinical candidate nomination towards the end of this year beginning of next year and I already mentioned that the basically just talk for the next phase one try it exploring again the next vaccine candidates, which.
Costar antigens that came out as a result of our new antigen discovery platform, which is much much broader and much deeper.
And finding the right and again compared to what was done in the.
Pop.
Got it so in the.
Sure I got it.
Yeah.
So for them.
It is clear that talking about the sort of like pivotal programs in phase one programs of Destocking with a with a different country that.
And in the coming.
Let's take potentially 18 months and maybe one thing to add as well we are going again based on our antigen discovery.
Platform, we are going in two directions as the cancer vaccine space one is.
Basically designing off the shelf vaccines, where we are encoding for antigen. So that she is across different cancer types and patient populations and the other direction is the personalized cancer vaccine that basically every vaccine has to be manufactured for getting patients based on the genomic profile.
But you won't have that getting patients and the first trial that they are right now planning is for sure a cancer vaccine.
And in parallel we're already preparing also for our personalized cancer vaccine at those type of stocks makeup.
I hope that answers your question.
If I can just ask one clarifying question over there. So the two programs was seen by now.
Is the intention of moving those programs into Cal pivotal trial or are they more of a proof of concept programs.
So maybe I guess that payments are you referring to the oncology program right. The GBM current ongoing trials right, it's sort of like a proof of concept trial. So I would say unless we see overwhelming.
I guess it could see because this is kind of a <unk>.
Struck with known.
Antigens that are relevant for GBM, but we believe it or frame pro platform and our spirit mentioned you know we will be able to have a bunch of a comprehensive approach to add did you had to picking the right antigens right. So we've got to focus on that second generation, let's say based on our proprietary research coming from their freight in cancer.
Therapeutics acquisition and that's what we're working on moving this program into the clinic off the shelf.
As mentioned, we are working all day.
The personalized cancer vaccines as well.
I see so the C V. A one otsu. That's also a proof of concept program, but the main focus for you guys will be on the new antigen. One that those are kind of in the still in the preclinical development phases that.
Is that how I should think about it right.
Yeah. This is this is new I'm, sorry, I was kicked out of the call him back.
Yes, you're absolutely right our focus will be basically using the new antigens that we that came out of our own discovery work and and because we do believe that we have a very sophisticated approach our approach to select signals antisense impressed with its cover them, but also to select them to.
Predicted immunogenicity, and and and and and and hence that that's basically the way we want to go forward.
Great. Thanks, so much.
Thank you there are no further questions at this time I would like to turn the floor back over to Sarah <unk> for closing comments.
With this we would like to conclude this conference call. Thank you very much for your participation stay safe and please don't hesitate to contact US should you have any further questions. Thank.
Thank you and goodbye.
Thank you. This concludes today's teleconference. You may now disconnect your lines at this time. Thank you for your participation.
Hum.
[music] mhm.