Q4 2021 CureVac NV Earnings Call
Yeah.
Greetings and welcome to the <unk> fourth quarter and full year 2021 financial results and business update conference call.
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I will now turn the conference over to your host Sara Faqih. Thank you you may begin.
Thank you good morning, good afternoon, and welcome to our conference call. My name is Sir if I can I'm, the vice President of corporate Communications and Investor Relations that kill that please.
Please let me introduce today's speaker on.
Nicole with me a function of half the Chief Executive Officer, Phil Cusack.
Our Chief Development Officer, and Jackie Mueller, Chief Financial Officer off Kilter.
Note that this call is being webcast nice and will be archived on the events and presentations section under Investor Relations on our website.
Before we begin a few forward looking statements in the discussion and responses to your questions on this call reflect management's view as of today Thursday April 28th 2022 .
We will be making statements and providing responses to your questions that state our intentions beliefs.
Expectations or predictions of the future. These.
These constitute forward looking statements for the purpose of the Safe Harbor provisions.
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 statements.
For more information please refer to our filings with the U S Securities and Exchange Commission I will now turn the call over to class.
Thank you Sarah ladies and gentlemen, a warm welcome to this conference call from here from us at cubic.
Cubic has made significant process progress over the past several months, we are expanding our solid product development pipeline broad technology platform.
And robust manufacturing capacities to strengthen our competitive position.
Then the RNA fields as a central player.
Let me give you a short overview of selected key developments in these three areas.
Prophylactic vaccines, we are successfully conducting and executing on the infectious disease and dedicated COVID-19 programs in collaboration with our partner GSK.
We are extending our technology platform into multivalent as well as modified mrna approaches to identify and identify a highly differentiated vaccine candidates.
Together with GSK, we have advanced our vaccine candidates for Covid, 19, and influenza, respectively, and two phase one testing, which we believe will establish the clinical value of our improved second generation mrna backbone.
While these first two studies are investigating unmodified candidates two additional studies for these candidates and indications with modified candidates would be initiated later this year.
Our recently completed preclinical study assessing a bivalent COVID-19 candidates, combining two mrna's, including for better and the Delta Varian has provided first evidence of the flexible variant adoption of our second generation mrna backbone.
Encouragingly. The data also showed a potentially increased breadth of immune response against tested variants, including omicron, demonstrating the potential of our multivalent mrna vaccination approach.
Most recently together with GSK, we are awarded a tender for pandemic preparedness by the German government.
Strong sign from our point of view, a strong sign of confidence in our ability to support to safeguard public health.
In case of an ongoing COVID-19, or other infectious disease emergency the five year contract grants by its got crowded by the government access not only to Peel back some manufacturing capacity, but also to 80 million dosages of a vaccine developed by cubic and GSK.
Leveraging our technology platform advances, we are preparing to expand our oncology pipeline as well the next generation driver beyond our progress and prophylactic vaccines.
Our goal is to establish a meaningful pipeline of cancer vaccines with a strong focus on T cell mediated immune responses and supported by complementary antigen discovery and vaccine optimization technologies.
Our brokerage and oncology will be supported by a lot by the fast and flexible process of the <unk>.
And a printer our end to end solution for automated manufacturing of GMP grade RNA vaccines and therapeutics.
In March this year, we launched a fully owned company to accelerate development of the RNA printer with a dedicated operation of infrastructure and an experienced management team and lastly on the financial side, we closed 2021 with a solid cash position of around 800 million.
Euros.
We're late to talk you through the financial details.
On slide five I would like to Troy your attention to one of <unk>, most valuable yet potentially most under valued assets our extensive intellectual property portfolio.
Over the last two years, the development of safe and effective COVID-19 vaccines in record time was accomplish based on a technology is attached to be developed over the decades of intense scientific research for mrna to become a key technology in the fight against COVID-19.
Discoveries in multiple disciplines had to converge, most notably immunology biology, and molecular biology, but also mrna design delivery and advances in manufacturing.
As the pioneers and harnessing the medical potential of mrna cubic has played a critical role in developing many of the innovations that have enabled today's mrna vaccines against COVID-19, correspondingly, we hold one of the largest and most diverse patent portfolios in this field.
Our patent portfolio comprises 120 patent families with more than 1550 patent family members divided into large clusters that define our core competencies in mrna technology product development and manufacturing.
Our technology cluster income passes fundamental RNA optimization expertise as well as targeted strategies to improve mrna immuno stimulation and protein expression profiles.
Looking at an extract from an independent analysis of the patent landscape related to COVID-19 vaccines on slide six you can see the global patent portfolios of a number of industry players listed according to the size and technological strengths.
While the orange bars represent portfolio size, the blue bars represent the patent asset index, a measure for technological strengths of the portfolio based on the frequency.
With which the patent decided and other patent applications and filings.
The cubic portfolio show is by far the strongest technology relevance in comparison to other RNA, but also mrna companies.
<unk> patent asset index is in fact owed so almost twice as high as the patent asset index of the next mrna vaccine company, reflecting the strength of our innovation and our central position in the field.
On slide seven let me highlight the cubic pipeline to show how we are translating our strong mrna technology expertise into a diverse portfolio of product candidates across three therapeutic areas to address diseases with high met unmet need.
Unmet medical needs sorry.
Prophylactic vaccines oncology and molecular therapy.
Our technology platform improvements with the development of a second generation mrna backbone and have led to significant post crisis in our clinical pipeline for prophylactic vaccines, we have advanced development of CV to cough and unmodified mrna vaccine candidate and the first of our second generation.
<unk> COVID-19 vaccine candidates.
In addition, we have successfully extended our technology platform and most notably also our manufacturing capabilities to develop our first and highly differentiated multi valent unmodified mrna influenza vaccine candidate together with GSK.
Those candidates have been advanced into phase, one clinical trials and Klaus will talk about the clinical studies of both candidates in greater detail on the next slides.
Together with GSK, we have broadened our development strategy to also test chemically modified mrna technologies.
This unrestricted technology approach will enable data driven decisions to identify the best performing product candidates clinic.
Clinical programs with chemically modified mrna for COVID-19, and influenza are expected to start later this year.
In oncology our lead candidates C V. H one O. Two is currently being assessed in a phase one clinical trial in solid tumors.
A CB eight one O two expansion cohort is advanced and advanced melanoma is ongoing and we expect to provide an updated read out in the second half of this year.
Yeah.
Our technology platform improvements will have a clear read through into our immuno oncology pipeline, we plan to build a meaningful portfolio of cancer vaccine candidates eliciting strong systemic or tumor directed immune responses.
Third therapeutic area molecular therapy.
We are developing optimized mrna therapeutics together with several re knowns collaboration partners for the further development of antibodies and therapeutic proteins intended to treat diseases characterized by missing are in excess proteins.
Looking at the number of the studies on clinical trial data golf, only 10% to 15% of more than 2000 registered clinical trials involving mrna related to Sars cov, two vaccines, demonstrating the huge potential of mrna technology to revolutionize medicine.
In the years to come just started the era of RNA technology has just begun.
And we expect the global mrna pipeline to grow dramatically over the next decades.
Let me now hand over the call to close to try to dive deeper into the recent progress of our prophylactic vaccine and oncology programs.
Thank you Hans.
On slide eight to walk you through the phase one clinical trials that we're conducting in collaboration with GSK for our jointly developed COVID-19, and influenza vaccine candidates.
The first two clinical trials with the unmodified candidates have already been initiated.
Availability of unmodified Messenger RNA.
Clinical trial material based on existing manufacturing licenses initially prioritized these candidates.
In the meantime, clinical trial material for the modified candidates has been produced and clinical trials.
Our expected to start later this year.
So sidney to call a phase one dose escalation study was initiated in the U S. In March of this year.
Susan to cough and copes with original sauce talk to stream, which has allowed us to directly compare it's significantly improved immune responses. So our first generation candidate in several preclinical studies.
In addition.
Preclinical studies in mice has shown that the second generation messenger RNA that used to.
<unk> can be flexibly talking to two other areas.
It could be in responses to gain and coke batteries.
I will update you on these new findings later in this presentation.
The phase one trial.
Good.
So recruit up to 210 participants in sixth dose groups ranging from two to 20 microgram per dose.
Targets zero positive participants to test administration of two doses of CB, two cool as a booster vaccination.
Recruitment of participants is progressing according to plan.
So the influence of candidates.
Q I D.
Evelyn Phase one dose escalation study was initiated in February this year.
The candidate is a differentiated multivalent vaccine featuring multiple messenger RNA construct.
It was designed.
Is it an immune response against recent entrants of the four different flu strains that course seasonal outbreaks.
The trial was initiated in Panama to be separated from the flu season in Europe and North America.
It is fully recruited with 240 participant in five dose groups ranging from three to 28 microgram per dose.
In accordance with conventional flu vaccines.
<unk> a one dose.
Mr Richmond.
Preliminary.
The Genesis of data across all dose groups has confirmed good tolerability.
With no serious adverse events or other dose limiting effects at the highest dose of 28 micrograms.
Let me give you a more detailed overview of the preliminary safety and Tolerability profile of CBS to IV on the next slide.
On slide nine you can see the percentage occurrence of question. This is systemic as well as local citizens for all tested dose groups.
Stratified according to pre defined age groups, including a younger population between the ages of $18 55.
And in old age group at all about the age of 65.
From left to right. The data shows adverse events in ascending order of starting some great CLO from no side effects to great free so severe side effects.
You see unexpected in general a dose dependent increase in adverse events.
Sandy Eskew IV was well tolerated.
Among systemic symptoms that are only very few quite great either events.
And the sixth in 'twenty Microstat dose groups in the younger population and to free microgram dose group in the older population.
Notably there were no grade three events in the highest 28 microgram dose group.
All all adverse events.
Transient and rapidly results within 24 to 48 hours.
Taking together these first preliminary safety data further strengthens our confidence in the increased clinical value of our <unk>.
Generation platform based on the targeted optimizations implemented going from the first so the second generation Messenger RNA.
Yeah.
And now moving to slide 10 to discuss our most recent preclinical COVID-19 study conducted in collaboration with the fleet replacement suite.
<unk> assessed CB two call.
CB two cost adaption.
Or delta variant.
Well as the first by the island candidates combining data and doses specific messenger RNA in one vaccine candidate.
In this study mice were fully vaccinated with <unk> five microgram dose of each candidate, including the bi valent candidate, which was composed of 25 micro clients permissions, you'll probably need.
Yeah.
Impact on neutralizing titers against the better or the Delta variant is shown on the left hand side of the slide.
It illustrates very nicely how candidates show higher antibody titers against the battery on state and Copel <unk>.
That is seeking to better perform better against the beta version.
<unk> cost Delta and CV to.
Perform better against the Delta there.
<unk> <unk> data.
Importantly, although the combined CB to call that a delta candidate.
<unk> only hospitals private area Messenger R. I bet it is.
Elicits neutralizing antibody titers against both variants that are fully comparable to the individual candidates specifically include coding.
Very good.
The middle graph shows that high neutralizing antibody titers are content, but robust T cell responses.
Then vaccinated animals directly exposed to the light Peter or bill to buyers all vaccine candidates efficiently suppressed viral replication in the long operating.
Shown in the graph on the right hand side of the slide is the detection of residual viral load and the upper respiratory tract infection is known to be challenging.
In case of exposure to the animals to the Delta.
<unk> reputation was almost fully suppressed in all but the control animals in the case of exposure of animals to the beta there.
All candidates strongly reduced.
The bio load.
<unk>.
Valent vaccine was equivalent to the matched to better candidate despite continuing only half the dose of messenger RNA.
Okay.
In a separate set of experiments in the same study.
Now I'll move to slide 11, Chevron from vaccinated Vista West was tested against the Delta on Recon variant animals vaccinated, either with CB <unk> CB two cost Delta bivalent candidates combined.
With CB, two cop delta or the CD to cope with a delta candidate.
Neutralizing antibody titers for fleets or nine times logo against the only come down against then against the Delta there for all candidates except for the bivalent CB two cockpit a delta candidate.
Including better make messenger RNA resulted in a two fold increase of neutralizing antibody titers against omnicom compared to Delta.
Taken together the preclinical study confirms the capacity of our second generation messenger RNA backbone to cope for flexible elicit strong.
No responses.
Different COVID-19 areas.
Furthermore, we were able to extend the technology applied to all multivalent influence a candidate.
In our COVID-19 vaccine program.
Data for <unk> in beta.
The desert candidate suggests that combining messenger RNA, so variants with unrelated Lynch's may increase the overall, but of the new response, and thus induce hits were lodged protection.
Yeah.
And now moving on to slide 12 to update you on our strategy.
Ecology that.
Next growth driver will be rapidly advancing.
And our progress in prophylactic vaccines.
Expanding our oncology footprint as based on mastering similar medical challenges is in infectious diseases, namely selection of antigens and adoption of strong targeted immune responses.
However, cancer is a complex and individual disease and engines vary greatly between patients to address these challenges we plan to execute on three strategic pillars.
Apply our learning.
Particularly from the second generation Messenger RNA.
To validate and optimize all technology for different classes of antigens and a focus on strong T cell mediated immune responses.
And in the second pillar build a meaningful pipeline of new cancer vaccine candidates based on assessing novel classes of antigen.
Leveraging the agility of speed on a printer our modular solution for integrated and automated manufacturing with DNP <unk> messenger RNA vaccines and therapeutics.
Finally at highly complementary technology platforms to expand our expertise for efficient antigen discovery as well as new avenues.
For immune stimulation and vaccine design, including formulation.
This let me hand, the call back to clients.
Thank you Claus.
I'm now on slide 13 to update you on the latest advances in the RNA printer.
As Klaus already mentioned the system is expected to play an important role in the <unk>.
<unk> expansion of our oncology pipeline.
The.
The scope of the RNA printer goes much further in March this year, we established a fully owned <unk> subsidiary to accelerate the development of the RNA printer under the leadership of Marquis Backman, a seasoned manager in the high Tech field and a physician by training a perfect match.
Yeah.
The dedicated operational infrastructure will unlock the broad scope of the system as a product enabling platform for academic and commercial partners, but also essentially for our own.
One <unk> technology. It is designed to facilitate broad access to mrna for the rapid translation of science into products.
The sign for flexible smaller scale quantities. The RNA printer is expected to accelerate clinical development and opening new avenues for point of need pandemic preparedness as well as personalized mrna based cancer vaccines and therapies.
The system is currently in regulatory review the next near term catalysts expected. This year are the GMP certification followed by a manufacturing license to produce first clinical trial material for the cubic pipeline.
I'm now on slide 14 to give you an overview of the pandemic preparedness tender we were recently happy to be awarded by the German government together with GSK to strengthen the national resilience for current COVID-19, pandemic as well as future infectious disease outbreaks.
The German tender seeks to secure manufacturing capacity in Germany, as well as access to a high volumes of pandemic vaccines to mitigate risks associated with potentially supply challenges and public health emergency.
Correspondingly the contracts concluded with five different companies and consortia differentiate between the contribution as the sole manufacturer.
And S. A so called originator for the additional supply of 80 million dosages of a pandemic vaccine needed in the case.
Out of the five consortia.
<unk> GSK consortium is one of only two originators.
In this role we plan to provide manufacturing capacity at our Germany based industrial scale manufacturing facility G&P for hearing tubing currently in an advanced state of construction.
For the vaccine part of.
The contract regulatory validation of our second generation mrna backbone will provide the basis for the rapid provision of pandemic vaccines developed by us and GSK.
We plan to prepare both delivery of boats within the now ongoing two year setup period.
Right now.
Under the contract the German government will pay <unk>, and GSK and annual standby fee to maintain manufacturing capacity at.
At constant readiness upon delivery of the then asked for 80 million dosages payment per dose would be added.
We appreciate the strong commitment of the German government acknowledging our ability to protect and support public health now and in the future based on new technologies in our case the mrna technology.
Now, let me hand over to Pierre for a review of the financial data.
Thank you <unk> and good morning, and good afternoon to everyone on the call.
Look at that looking at our cash position, we closed the fourth quarter and full year of 2021 with a strong cash position of $811 5 million euros. In 2021 cash inflows were mainly provided by the raising of 404 million euros and net proceeds in a follow on offering in Q1 of 2021.
The 75 million upfront payment in Q2 2021 related to our COVID-19 collaboration extension with GSK and an overall $93 5 million Euro grants received from the German Federal Ministry of Education and research.
In 2021 cash used in operation was mainly allocated to the advancement of R&D activities and preparing the supply of CV and Cove, a first generation COVID-19 vaccine candidate, which we withdrew from the regulatory approval process in October 2021.
Moving to our P&L statement revenues increased by $35 2 million euros to $41 2 million euros for the fourth quarter of 2021 and increased by $54 1 million euros to 103 million euros for the full year of 2020 compared to the same periods in 2020.
The increase was primarily driven by revenues from the GSK collaborations and the termination of the bill and get into the high end collaboration agreement.
Both GSK collaborations provided a total of $74 3 million euros for the full year 2021, compared to $8 8 million euros in 2020.
Following the termination of the billing of Ingelheim agreement.
Remaining contract liability related to the upfront payment was fully recognized.
In addition, an option fee of 5 million euros, and 7 million Euro development milestone were also recognized.
For the full year 2021. This led to a total of 26 million euro being recognized as revenue stemming from the Boehringer ingelheim collaboration compared to $1 9 million euros in the full year 2020.
Operating loss was $5 5 million euros for the fourth quarter of 2021, representing a $41 1 million a decrease compared to the fourth quarter of 2020.
For the 12 months ended 2000 and.
On December 31st 2021, operating loss increased by $302 5 million euros to a total of $412 3 million euros.
Although underlying previously this increase was mainly driven by the R&D activities and preparing for supply for CDN growth through 2021.
The operating results was affected by several key drivers.
Cost of sales increased primarily due primarily due to the recognition of expenses related to the CMO set up activities and to a lesser extent write offs related to inventory.
In the period preceding the withdrawal of the EMA applications for CDN costs.
R&D expenses increased primarily due to the significantly higher development expenses related to the phase II B three related.
Trials for CDN curve with 40000 subjects.
These expenses were mainly composed of cost in Kyoto Crows.
Onerous contract provision for the remaining C. The anchor of clinical trial costs and personnel costs involved in the remaining CDN costs development efforts.
In addition, the increase was also driven by the recognition of settlement costs related to the termination of several CMO contracts and write off of <unk> related prepayments and inventory.
G&A expenses increased due to the consulting services for CDN product launch readiness personnel related costs with increased head count and higher expense recognized on share based payments awards made in 2021.
Overall, the increase in expenses was partially compensated by income related to release of government contract liabilities related to the upfront payment from the European Commission and the ground by the German Federal Ministry of Education and research.
The advanced purchase agreements with European Commission.
Domestically terminated when we withdrew from the regulatory approval process in October 2021.
Since we were able to demonstrate that upfront payment was spent in accordance with the contract no repayments with required and the amount of 450 million euros was released and recognized as income related to the release of governmental contract liabilities in the fourth quarter of 2021.
The arrangement with the federal.
German Federal Ministry of Education Research consisted of a separate ground components and supply components with the German federal Ministry of Health.
The amount attributed to the supply of future deliveries was presented in contract liabilities in the balance sheet.
124 million euros were recognized as income related to the release of governmental contract liabilities in the P&L.
$67 7 million euros were recognized in other income.
Mainly driven by the from the ground components.
Financial results for the fourth quarter increased by $11 6 million euros, two 1 billion euros and increased $19 8 million euros to minus <unk> 2 million euros over the 12 months of 2021.
Net loss was based on negative interest on cash held in liquid funds to support the development and manufacturing activities of CV in club and CV Tucows. It was almost fully offset by foreign exchange gains.
Pre tax losses, with $4 5 million euros in the fourth quarter and.
$412 5 million euros in the full year 2021.
With this I would like to hand back to France for today's key messages.
Thank you peer.
Let me quickly summarize the key takeaways from today's presentation first.
Over the last several months, we have made significant progress in each of our core competencies, including technology product pipeline and manufacturing propelling us forward in our corporate development.
Second our competitive positioning in these three core competencies is built on one of the largest and most diverse IP portfolios in the industry, enabling our future ability to innovate and securing our competitive position as a central RNA player.
Third.
A total of four clinical trials that we will have begun in prophylactic vaccines. This year and COVID-19, and influenza two of which have already been initiated will provide a wealth of clinical data to advance and validate our second generation mrna backbone covering multi valent and.
Modified mrna approaches.
Fourth we are transferring our experience from our technology advances to our next generation driver oncology.
While we are preparing to build up a meaningful pipeline based on strategies for strong T cell induction.
Antigens and complementary platform technologies supported by the RNA printer.
Fifth.
The recent award of the pandemic preparedness tender by the German government six notes a strong confidence in our ability to contribute our technology.
And manufacturing expertise to protect public health.
And lastly, our strong cash balance positions us well to execute on our programs and priorities in 2022 and beyond.
With this we conclude our presentation and I would like now to open the webcast for your questions. Thank you.
Yeah.
At this time, we'll be conducting a question answer session.
If you'd like to ask a question. Please press star one on your telephone keypad.
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We ask that you please limit to one question and one follow up.
Our first question comes from the line of Roy Buchanan with JMP Securities. Please proceed with your question.
Hey, great. Thanks for taking the question. So I'll ask a couple and jump back in the queue I guess the first.
Set of questions for Pierre I, just can you break out the expense items for <unk> Cogs R&D and SG&A were there any one time items of note and then can you kind of give us a sense of the expense outlook for that for the rest of this year and then more generally how far do you think the current cash can get you.
From here, what's the most likely source of cash is at the ATM facility.
For the rest of the year. Thanks.
All up.
So thanks for your question. So, yes, I mean of course the <unk>.
Last quarter was of course impacted by significant impacts in the main one being the recognition of the revenue from government grants rights, where we have recognized in the P&L.
Contract liabilities, which was sitting in the balance sheet for.
450 million euros, and another extra 120, something right from the German government. So this is I would say the main element. Although elements of course is as we have built the CMO network and we are now reducing the size of course as the wave of initial CDN club is.
Of course, lower we will we have closed some of the contracts and we have some provisions of course in the P&L in terms of turning down turn down.
Re adapting the size of the CMO network right. So these would be the one off elements now looking forward right. So we will have.
We had in Q4, and we will have in Q1, some exceptional items.
Basically attached to the fact that we are reducing the CMO network and you will you will see that the whole thing will stabilize out of exceptional effects from from Q2 onwards. This is what we're seeing right. So I mean long story short, we have a solid cash position and.
We think that we have.
No problem in terms of you know having close to two years of cash ahead of us. So that's the first point now in terms of sources of revenues I think.
Youre right, we have an ATM, we have $600 million ATM that we havent used.
There could be one source of course of cash as we look forward but.
But there's no immediate need it at this stage.
Okay, great. Thank you and I have a follow up on the pipeline I guess.
Talk about plans for a meaningful pipeline of cancer vaccines.
Many new candidates or targets do you think might be announced this year or is that more of a 2023 and then any data we might expect for those new programs. This year. Thanks.
Yes.
Cause widely savings.
It's close.
Or <unk> candidates, but I can say.
It's a broad based approach.
Some chairs androgens that we will use bookends of explanation and then some.
Do you enter chips.
<unk>.
Especially emphasizing on the expansion.
Expansion all possibilities through internally.
Uh huh.
That form where we can identify new antigens.
With a name of eventually moving into a personalized.
The vaccine.
I am confident that these will be.
In a position to share.
Some preliminary data towards the end of the year.
Should look more into 2023.
Okay, great. Thank you.
Our next question comes from the line of Ian Yang with Jefferies. Please proceed with your question.
Thank you.
Question on cancer vaccine. So you mentioned that phase one expansion study data in melanoma is expected the second half of this year can.
Can you comment on what should we expect in terms of the data and I'll tell you said only four melanoma disappoint and second question is on <unk>.
The vaccine.
You recently dosed the first patient.
And then data is expected in the second half of this year, so what kind of what data should we expect in second half of this year. Thank you.
Okay start with the last of the Covid vaccine.
You're right to say this we initiated that.
First phase one.
<unk>.
Yes.
We have indicated we are recruiting at a dose level plan. So.
You would obviously at a later time point.
See the reactors and listen to data first and foremost.
Tom.
Dose escalation and then eventually you would also see that we can do.
The exact timing of that.
I cannot give you at this stage, but it will certainly be tools.
Later.
In the summer period.
On the on the cancer.
As I alluded to.
The new platform that you're looking into.
It's a base of shared antigens, meaning that Oh no.
To validate our backbone cancer vaccination strategy, but also new.
New antigen the traditional so there will be new.
On the <unk>.
Paul alluded to be decided only to expand into these.
Melanoma indication.
Recruitment has been completed.
And obviously, we are now just awaiting the data to see.
It would be that it can achieve.
Yes.
Hospital response rates in combination with 81 or two and the checkpoint inhibitor that will be towards the end of this year.
So can I ask you just my question on COVID-19 vaccine. So all you're going to see all the doses from two to 20 microgram.
In mid this year or second half of this year.
That's.
The plan, obviously provided that we can dose up to those levels.
Obviously gave you.
<unk> presentation of the reactor to listen to the theater in the seasonal flu.
Although you can clearly won't make a direct comparison bullish your soul.
Capable of dosing off in this case for a multivalent vaccine 28 microgram. So expectations are that we can dose about chico's stipulated dose.
And so those data at least broke reaction to initiative a profile that would be available afterwards.
We ended up with some.
To give you and Frank perhaps you gave you an impression that in flu for example, we already dosed up to 2008 microgram of course, exactly as close as saying.
One should not.
<unk> flew with Covid.
Covid.
The antigen.
And flew the different kind of a strange.
Strange composed with it but here, we could see even with the non modified that we could go up to the target of 28, Michael Quinn Alright.
Alright, thank you.
Okay.
Our next question comes from the line of Umar Robot with Evercore. Please proceed with your question.
Hi, This is Jessica away on for <unk>. Thanks for taking my question two questions on your flu program. Firstly interestingly in your phase one disclosures we saw grades III.
Systemic events in the lowest dose and also this was an older. Adults can you hypothesize why the lowest dose saw great results, but not in the highest dose.
And then secondly, another competitor flu mrna vaccine has shown less promising results against.
Influenza strains so what are your expectations on how this might affect your flu construct in trial.
And are the energy ratios between the four flu strains like all one to one and then lastly, very briefly what is the timeline, we should expect for the flu program and when should we expect a full data readout. Thank you.
The full data readout I think I'd have to look at too.
On a number of applications, especially.
The reaction.
It is a one to one for all of the construct studies.
In the one vaccine.
<unk> not disclosed exactly the number of construction the vacancy.
The vaccine.
The answer about the relative contribution yes 121.
Okay.
Uh huh.
It's too early for me to speculate.
Yes.
I can obviously not predict or see from an immunogenicity perspective before have the data.
I look to what can be.
Have achieved.
Our second generation Battle and that was the whole.
Idea about to initiate them.
Phase one program in the first place.
<unk> moved into a multiplier.
Right.
It was to test out.
Our second generation platform.
And as you can see from the data that you presented today.
Got it.
Mission has been successful we are capable of seeing a higher.
Entergy production for us.
If you wish.
Mount injected messenger.
And we are certainly also seeing it would be accurate your initiative profile that is different from what we were seeing.
In the first with the first generation Battle.
Thank you. Our next question comes from the line of <unk> Zhou with Bahrenburg. Please proceed with your question.
Great. Thanks, very much and congrats on the progress and maybe.
On the on the COVID-19 vaccine.
On slide 11, I think it shows in preclinical.
And results on a mountain of valent.
So vaccines Inc.
And in the mouse model.
I'm just looking at the beta Delta.
In a downturn a bivalent against downtown versus Omnicom is actually more.
Immunogenic against Omnicom.
Then why is that any hypothesis in terms of the scientific but what's happening there and then broadly on the Covid front I.
I want to get our thoughts around how you want to go about.
<unk> developed the army Crum.
[noise] monovalent vaccine versus potentially.
And Tomas I bet.
Going forward. Thanks.
Yes.
On the mice data that you report so it's pure speculation at this time point I think what I would extract out of it is that are there.
There is a likelihood that the potency of having a vaccine that contains the data stream would be more efficient against me.
Omnicom from.
Compared to the Delta, which is obviously how the virus.
They bought it.
It's spike protein.
Beyond that.
I do not have any sort of comment as to.
Why you see that difference I think I think the take home message.
The story is obviously that to be.
Indicating that the speculating about how do we approach.
The COVID-19 moving forward.
From a loan or is it the bivalent or is it something completely different.
You should take those data he said reflection that belief that we have it back where we can now explore these options together with our partner GSK.
The way do you want to go for development perspective against Omnicom.
Yes.
Finally decided when we also see the data.
The modified.
The construct against the Omnicom variant and then ultimately regulatory aim would be true.
Yeah.
And the approval.
Awesome.
Sure.
And then next question would likely be what are the timelines.
That's.
With that I will not speculate on at this stage it primarily depends on obviously the outcome of the trials that are running now or about to start and then off the whole regulatory setting as to whether you can fight.
And the idea is with regulators that business still on an emergency procedure dose interaction. So ongoing people, obviously have to be ongoing up onto the point that Sofia placement.
Patrick if I may add.
This one you'll have to see because the question was also omicron monovalent and.
Bivalent or so these are the differences what we tried to say in the presentation there as well we have to work on the different.
Let's say level as well as the one is the technology that you can have monovalent and bivalent or even what we're doing in flu multivalent, because we don't know what.
Later, this year or what's the variance will be and exactly what Klaus alluded to was that most probably in a bivalent setting. It will have an effect on them whatever the variance will be the biology will tell us at the end of the day, but therefore of the technology level as the second generation backbone, what we are developing maybe without chemical modification.
With chemical modification monovalent and bivalent a multivalent. So we really have to work on all ends of the technology and then to get the best product whatever is needed and this idea together with a manufacturing them is also the underlying basis for the German tender to say, okay. This fall and I'll start at the world's most probably cannot.
Not cover with a new kind of pandemic outbreak than what we have been experiencing last.
24 months and therefore it is so important to look in every corner of the technology level too.
Two of them have on the product level whatever is needed in order to be ready for that so that's exactly the story behind next to is it omicron or whatever kind of Larry and to come.
Great just to follow up on the on the German government contract tender contract there.
The 80 million doses.
Is that just a COVID-19 or does it specify any any any glamorous types it could be either a flu or other things.
Okay.
It's any various types right. The whole is the learnings from the current situation the pandemic situation, where the government wants to have access to.
As fast as possible to vaccine so it could be any.
They follow one of COVID-19, or anything else for that matter and therefore it is so important that there is a two who did win this tender.
Which are originators, who are working on both ends on the one side of the truck development for whatever it is for the next five years to come after the starting period.
Then also to have some manufacturing capacity ready.
That's great thanks very much.
Our next question is a follow up from Roy Buchanan with JMP Securities. Please proceed with your question.
Hi, Thanks for taking the follow ups I haven't quite a few sorry, so the first one.
Sorry, if I missed it but the unmodified flu phase one that's completed enrollment can we expect to see Immunogenicity data. This quarter are you holding that until that day.
Data from the modified RNA trial is available.
I had a broader question on that modified RNA, what benchmarks or expectations you have for that versus the unmodified form and do you think that the modified mrna program can be in the clinic in <unk>. Thanks.
We are not planning to.
Eventually be opposite traffic to release phase two.
To date or photos I also alluded to the both Chicago the GSK assess.
Got it.
You can get all the way acreage on motorcycles.
To implement modified.
The ultimate answer to your question about what the what is the benchmark going going to be obviously.
We will have to receive a tighter spot competitors.
<unk>.
So that's the ultimate guidance senior can that be achieved with the automotive products that remains to be seen.
And the decision will be taken thereafter.
Okay.
Okay, Great and then you said you had clinical trial material for the modified Kennedy has already produced.
I guess maybe.
Maybe this gets back here they actually just made but.
Are you planning to move forward with a single modification or are you going to try multiple modifications how does that look at this point.
I'm not sure about that.
We have disclosed that other half two.
Right.
So if someone else a twist.
That question.
Sorry, I have a couple more but that looks.
Looks like GSK stepping away from the self amplifying RNA.
Programs based on their earnings call can you just verify that this was totally unrelated to carry back you had no involvement with the self amplifying mrna.
Earnings.
Yes.
No involvement on Gsk's decision on the GSK program.
Okay.
We are working on our technology platform with GSK.
Yes.
What we what we want to bring into the clinic here is really the same construct on the RNA level than with the chemical modification.
None.
To start the clinical trials, there as well to really see the difference what does it do this chemical modification.
I see great. Okay, and then sorry, one last question, but any updates on that Genmab collaboration. Thank you.
No nothing what we can right now talk about a week.
Ongoing collaboration we are working on our work packages.
As defined with our partner Genmab, but nothing to report so far.
Thank you.
Ladies and gentlemen, we have reached the end of the question and answer session. I will now turn the call over to Sarah <unk> for closing remarks.
With this we would like to conclude this conference call. Thank you all very much for your participation. Please stay safe and don't hesitate to contact US should you have any further questions. Thank you goodbye.
This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.
Yeah.
Right.
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