Q1 2022 BioNTech SE Earnings Call

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Unknown Executive: Welcome to the BioNTech first quarter 2022 update call. I would like to hand the call over to the Vice President of Investor Relations and Strategy, Zohica Maas. Please go ahead, Zohica.

Welcome to the bio Tech first quarter 2022 update call I would like to hand, the call over to the Vice President of Investor Relations and stretch D. C. It come off. Please go ahead Sir.

Zohica Maas: Good morning and good afternoon and thank you for joining us today to review BioNTech's first quarter 2022 clinical and operational brokers and financial, A few housekeeping items before we start. Please view the slides that accompany the webcast and the first quarter 2022 press release. Both were issued this morning and can be found in the investor section of our website.

Good morning, and good afternoon, and thank you for joining us today to review Biotechs first Florida, 2022 clinical incorporation of brokerage and financial response, a few housekeeping items before we start.

This year the slides that accompany the webcast first quarter 2022 press release, both great issued this morning and can be found the investor section of our website.

Zohica Maas: As outlined on slide two, today's presentation will be making several forward-looking, These forward-looking statements include, but are not limited to, our current COVID-19 vaccine revenues as they include figures that are derived from preliminary estimates provided by our partners, our estimated financial results for 2022, the continued global demand for our COVID-19 vaccine, our target vaccine production capacity for 2022 and beyond, our ability to supply our COVID-19 vaccine, the planned next steps in our pipeline programs, the timing for enrollment, initiation, completion, and reporting of data from our preclinical studies and our clinical trials. Timing of and our ability to obtain and maintain regulatory approval for our product candidates and other risks described in our filings made with the U.S. Securities and Exchange Commission, including our most recent annual report on Form 28.

As outlined on slide two today's presentation, we'll be making several forward looking statements.

These forward looking statements include but are not limited to our current COVID-19 vaccine revenues as they include figures that ought to read from preliminary estimates provided by our partners.

Estimated financial results for 2022, the continued global demand for our COVID-19 vaccine.

We're talking vaccine production capacity for 'twenty, 'twenty, two and beyond our ability to supply our COVID-19 vaccine. The planned next steps on our pipeline programs the timing for enrollment initiation completion and reporting of data from our preclinical studies and clinical trials, the timing of and our ability to obtain.

In 19 regulatory.

It brought up kind of thing.

And other risks described in our filings made with the U S Securities Exchange Commission, including our most recent annual report on form 20-F.

Zohica Maas: As actual results could differ from those we currently anticipate, you are therefore cautioned not to place undue reliance on any forward-looking statements which speak only as of today, shared today, during this conference call and webinar. Also, please note that slides three and four provide detailed and important safety information regarding our COVID-19 vaccine. Finally, you can see the agenda for today's call on slide. It's my pleasure to introduce the members of BioNTech's management team participating in today's, I'm joined today by our CEO and co-founder, Ugur Sahin, Ozlem Tureci, our chief medical officer and co-founder, Jens Holstein, our chief financial officer, and Ryan Richardson, our chief strategist. I would like to turn the call over to Ugur Sahin.

It's extra besides could differ from those we currently anticipate you are therefore cautioned not to place undue reliance on any forward looking statements, which speak only as of today sure today during this conference call and webcast.

Also please note that slides three and four provide detailed and important safety information regarding our COVID-19 vaccine.

Finally, you can see the agenda for todays call on slide five.

It's my pleasure to execute the members of Biotechs management team participating in todays call.

I'm trying today by our CEO and cofounder without him.

To Ritchie, our Chief Medical Officer, and cofounder and CEO Stein, our Chief Financial Officer, and Ryan Richardson Chief strategy Officer.

I would like to turn the call over to resign.

Thanks, Jessica good morning, and good afternoon, and a warm welcome to all participants and thank you for your continued support.

Ugur Sahin: Thank you, Zeke. Good morning and good afternoon, and a warm welcome to all participants. And thank you for your continued support. Today, I am happy to provide you an overview about the key highlights from the first quarter and objectives for the year. Our team will provide further details. And then we will open the call for questions, starting on slide six.

Today I'm happy to provide you an overview about the P high that's from the test for icon.

Objectives for the year.

Jim will provide further detail.

And that would be the.

The call for questions.

Starting on slide six.

Ugur Sahin: Let me remind everyone about a few features of our company. Our vision is to harness the immune system to fight human diseases. Our response to the COVID-19 pandemic provided us with the unique opportunity to help protect well over 1 billion people with our first approved product. It provided us also a historic chance to accelerate our progress towards our long-term vision to bring the next generation of immunotherapy to patients. With a fully integrated spectrum of competencies for biopharmaceutical drug development, covering discovery, translational research, development, GMP manufacturing, and commercial capabilities, we are well positioned for success. We are pursuing a technology agnostic solution-focused multi-platform strategy and have built an innovation engine that covers various emerging technologies.

Let me remind everyone about a few futures.

Yeah.

Our vision is to harness the immune system to fight human.

Human diseases.

Our response to the COVID-19 pandemic provided us with a unique opportunity to help protect that over 1 billion people with our first approved product.

It provided us also historic chance for extra limit our progress towards our long term vision to bring the next generation of Immunotherapies to patients.

As a fully integrated spectrum of competencies for biopharmaceutical talked about it.

Cover and discovery translational research development, GMP manufacturing and commercial capabilities that.

That puts the shoot for success.

We are pursuing a technology agnostic solutions focused multi platform Pratt tissue and has built an innovation engine that cover various emerging technologies.

Ugur Sahin: We are advancing a diversified product pipeline of immunotherapies that aim to address high unmet medical needs in oncology and multiple infectious disease indications. We are building a 21st century immunotherapy powerhouse with a mission anchored to our strong sense of global social responsibility. We seek to make a positive impact on global health and democratize access to cutting-edge medicine. Highlights for the first quarter are summarized on slide 7. Our solid performance continued in the first quarter of 2022, following a strong fourth quarter in 2021. In the first quarter, we reported total revenues of 6.4 billion euros.

Yes.

Diversified product pipeline Immunotherapies that aims to address high unmet medical needs in oncology and multiple infectious disease indications.

We are building attentive to tentatively immunotherapy powerhouse.

Mission inkjet.

Two our strong sense of global social responsibility.

We seek to make a positive impact on global health and democratize access to cutting edge medicines.

And that's for the first quarter are summarized on slide seven.

Our solid performance continued in the first quarter of 2022 following a strong fourth quarter incentive to 'twenty one.

In the first quarter, we reported total revenues of $6 4 billion.

Ugur Sahin: We signed our first pandemic preparedness contract with the Federal Republic of Germany that runs through 2027. The framework agreement is aimed at pandemic preparedness, including development, manufacturing, and supply of mRNA vaccines in emerging situations in Germany. During the first quarter, we also engage into collaborations that complement our internal innovation engine.

We signed our first pandemic cockpit with contracted hydro.

The property, Germany, that's 2027.

The framework agreement is aimed at pandemic preparedness.

<unk> development manufacturing and supply of <unk>.

Imagine situations in Germany.

During the first quarter, we also engaged into collaborations that complement our internal innovation engine.

Ugur Sahin: The MATINAS collaboration combines our mRNA vaccine development expertise and MATINAS lipid nanocrystal delivery platform technology to advance novel formulations for mRNA vaccines, including a potential formulation for oral vaccines. With Regeneron, we plan to jointly conduct clinical trials evaluating fixed-back candidate BNT1-16 in combination with Liptario for the treatment of advanced non-small-cell lung cancer. Our impact on human health and economy around the globe continues in 2022.

The mattina colocalization combines our mrna vaccine development expertise and mattina lipid nano crystal delivery platform technology to advance novel formulations for <unk>, including a potential formulation for older vaccines.

There's the Regeneron, we plan to jointly conduct clinical trials.

Ali I think fixed that candidate PNC bank 16 in combination with sleep tile for the treatment of advanced non small cell lung cancer.

Our impact on human health and economy around the globe.

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Ugur Sahin: We have invoiced approximately 750 million doses of our COVID-19 vaccines globally in 2022 until end of the first quarter. In terms of expanding our label to help broader populations, we recently received certain approvals. This includes a fourth dose in adults aged 50 and over, as well as in certain types of immunocompromised patients. H. Zafias and older.

We have invoiced, approximately 750 million doses of our COVID-19 vaccines globally in 2022 and end of the first quarter.

In terms of expanding our labor broader population the recent U S approval.

This include.

In adults, aged 50 and over.

Certain types of immuno compromised patients.

SaaS and order.

Ugur Sahin: Our pediatric indications now include vaccinations in children aged 5 and over, as well as boosters for those 12 and up in multiple geographies. On the oncology front, our first hypo-med program, BNT141, entered a first in human study in solid tumors in January. BNT-141 is an mRNA-encoded IgG antibody targeting cloridine 18.2.

Our pediatric indications now includes explanations in Joseph a.

And over.

If booster protos SaaS and in multiple geographies.

On the oncology front, our first travel network on BMT band 41 entered our first in human study in solid tumors in January .

PMT 141 is an mrna encoded agg anti body targeting closing.

18 two.

Ugur Sahin: In April, we presented a promising preliminary clinical data from 14 available patients in our Phase 1-2 trial of BNT211, our next-generation clotin-6-targeting CAR-T cells in solid tumors at the AACR annual meeting. We documented first anti-tumor effects even at the lowest CAR-T cell dose in heavily predisposed patient populations, pointing to an encouraging activity of targeting clotin-6 and our CAR-REC approach, flat8. Since the start of the pandemic, we have delivered nearly 3.4 billion doses of commonality to people located in more than 175 countries and regions, demonstrating our strong global position in the fight against COVID-19.

April we presented a promising preliminary clinical data from 14 Evaluable patients.

Our phase II trial of PMT to 11, our next generation cloud six taxi Katja.

Car T cells in solid tumors at the ACR annual meeting.

Documented first antitumor effects, even at the lowest car T cells.

In heavily treated patient population pointing to an encouraging activity.

Targeting children, six and our caught back approach.

Slide eight.

Since the start of the pandemic. They have delivered nearly 3.4 billion doses of commonality to people located in more than 175 countries and regions.

Illustrating our strong global position in the fight against COVID-19.

Ugur Sahin: We remain on track to achieve our pledge to deliver a total of more than 2 billion doses to low- and middle-income countries by the end of 2022. To stay ahead of COVID-19, we continue to innovate and optimize our vaccine. This year, we have introduced a ready-to-use formulation that does not require deluant and receives approval for shelf-life extension from nine to 12 months, when stored at minus 90 to minus 60 Celsius.

We remain on track to achieve our pledge to deliver a total of more than 2 billion doses to low and middle income countries by the end of 2022.

To stay ahead of COVID-19, we continue to innovate and optimize our vaccine. This year, we have introduced a ready to use formulation that does not require daily rent and received approval for <unk> extension from nine to 12 months then start at minus 92 minus 60 SaaS.

Tasiast.

Ugur Sahin: To further expand the label to pediatric populations, we have filed for the approval of boosters in children five to under 12 years old. The filings were supported by recently reported positive data demonstrating that a third dose increased neutralizing antibodies six-fold in this age group. We are also evaluating a three-dose primary regimen in children six months to under five years old and expect data in the coming weeks. As part of our approach to pandemic preparedness, we are collaborating with InstaDeep on an early warning system that analyzes globally available sequencing data and predicts high-risk variants of SARS-CoV-2.

To further expand the label to pediatric populations if pilots for the approval of boosters in children.

And yes it does.

Sidings were supported by recently reported positive data demonstrating that a set dose increased neutralizing anti bodies six fourth in this age group. We are also evaluating it.

<unk> dose timely regimen in children six months to under five years old and expect data in.

The coming weeks.

Ugur Sahin: This warning system allows us to rapidly adapt our vaccine product candidates in a data-guided way. As part of our preemptive approach to variants, we have an ongoing comprehensive development program where we are evaluating several follow-on and next-generation COVID-19 vaccines, including variant-adapted vaccines. We also have initiated a broad research program to study the immune profile after vaccinations, boosters, and breakthrough infections.

As part of our approach to pandemic preparedness. They are collaborating as instead it on an early warning system that analyzes globally available sequencing sequencing data and predict high adverse variance of SaaS cost to this bonding systems allows us to rapidly adapt our vaccine product candidate and that data.

Okay.

As part of our approach.

Approach to variance that's an ongoing comprehensive development program.

Validating several follow on next generation.

19 vaccines, including Valeant adapted exceed.

We also have initiated a broad research program to study the immune profile after the explanations puts us in great full infections.

Ugur Sahin: This research program is informing our vaccine development strategy. To conclude my opening remarks, as shown on slide nine, we are building a differentiated pipeline that we believe could usher in a new era of immunotherapy through multiple ways of innovation. Our COVID-19 vaccine program is enabling a transformation of our company that will position us to broaden and accelerate our pipeline throughout the market, consistent with our vision to transform medicine. In oncology, we have 16 programs in 20 ongoing clinical trials, including five randomized phase two trials.

Research program is informing our vaccine development strategy.

Ugur Sahin: In infectious diseases, we have one ongoing phase one program and more than 10 preclinical programs, four of which we expect to bring into the clinic this year. Our aim is to bring multiple new products in oncology and infectious disease to market over the next three to five years. We believe that our technology innovation engine has the potential to address a broad set of diseases beyond our current core disease pillars of oncology and infectious diseases.

To conclude my opening remarks as shown on slide nine we are.

Building, a differentiated path and that he believes could usher in a new.

<unk> immunotherapy.

Multiple base of innovation.

Our COVID-19 vaccine program is enabling the transformation of our company this will position us to broaden and accelerate our pipeline throughout the market consistence.

Our vision to transform medicine.

Oncology, we have 16 programs in 'twenty ongoing clinical costs, including five randomized phase II trial in infectious diseases. They have an ongoing phase one program is more than 10 preclinical programs.

Which we expect to bring into the clinic. This year. Our aim is to bring multiple new products in oncology and infectious disease to market over the next three to five years.

We believe that our technology innovation engine has the potential to address a broad set of diseases beyond our current core disease pillar.

Carlos you in infectious diseases.

Ugur Sahin: There's multiple programs underway in new disease areas that are in the lead candidate selection phase. Advancing our technology into these new areas expands the future for BioNTech and will support our vision in the long term. With that, I will turn the call over to. Thank you, Ugur.

Our support programs underway in new disease areas that are in the lead candidate selection phase advancing our technology into this new areas expense the future for <unk> and the support our vision and the long term with that I will turn the call over to Ed.

Thank you Andy.

I'm delighted to speak with everyone today and provide a pipeline update.

Unknown Executive: I'm delighted, speak with everyone today and provide our pipeline. Our COVID-19 vaccine R&D strategy on slide 11 rests on three pillars, landscape research, product research and product development. Our landscape research aims to elucidate how the virus evolves within the context of vaccine- and infection-induced immunity. We are studying how immunity is being shaped over time by iterations of vaccinations, ongoing boosters, and infections with different variants of concern. The data we are continuously generating, will inform our evolving response to the pandemic. A recent research study has added to our understanding and may be crucial in the development of next-generation vaccines. These data have been submitted for peer review in a high-ranked journal and published on a preprint server.

Our COVID-19 vaccine R&D strategy on slide 11 rests on three pillars landscape research product research and product development.

Alright landscape research and so it looks good Dave How's the virus evolves within the context of that.

<unk> seen in detection in Georgia.

We are studying how immunity is being shaped overtime by iterations explanations ongoing.

And infections with different areas of concern.

The data we are continuously generate.

And from our evolving.

The pandemic.

Recent research study has added to our spending and may be caution it could be that next generation vaccine.

These data have been submitted for peer review and a high rate journals and published on the pre print shop in this study we evaluated it.

Unknown Executive: In this study, we evaluate.., the sera of individuals who had breakthrough infections with Omicron after either two or three doses of the original vaccine to determine the impact of Omicron infection on immune. We found that the exposure to Omicron spike by Omicron breakthrough infection of vaccinated individuals strongly enhances not only neutralizing activity against Omicron B.A.1 but broadly augments immune, including against Omicron VA2, previous SARS-CoV-2 variants of concern, and even SARS-CoV-1. Omicron breakthrough infections mediated a broad B-cell recall risk, primarily for expanded memory B-cells that recognize antigens shared broadly by different variants rather than inducing new B-cells against strictly Omicron-specific antigens. Taken together, these results suggest that despite possible imprinting of the immune response by previous vaccination, the preformed B-cell memory pool can be refocused and quantitatively remodeled by exposure to spike proteins from different strains.

Sarah.

George who had breakthrough infection waste.

Amit.

After either two or three doses of the origin of our vaccine to determine the impact of omicron infection on immunity.

Oh, that's the exposure so Amit from Pike buy omicron break sleep action of vaccinated individuals.

Romney enhance not only neutralizing activity again on the Crosby AUR, but broadly augment.

G, including again on the Crosby a tool.

South coast two areas of.

Concern and even south corridor.

Omicron breakthrough infection mediated abroad, B cell, we call with.

Primarily for debt.

Memory, b cells that recognize and kitchen, she yet broadly by different area, rather than inducing you'll be said again.

Strictly omicron specific antigen.

Taken together. These results suggest that this is possible and printing of the immune response by previous explanation the pre Franck <unk> memory.

Can be refocused and quantitatively, we modeled by exposure to spike proteins from different stream, we believe.

Unknown Executive: We believe this may allow neutralization of variants that evade a previously established neutralizing antibody. The observations also may suggest that a vaccine adapted to the Omicron strain spike could similarly reshape the B-cell memory repertoire and therefore may be more beneficial than an extended series of boosters with the existing vaccines directed against the original strain. We believe that the data may also suggest that exposure of ancestral strain vaccine experience individuals to an Omicron-like monoimmune vaccine could provide similar cross-strain immunity, to be prepared for future, we may face with further evolvement of the virus.

This may allow neutralization of varian that debate.

Previously had British neutralizing antibody response. The observations also made suggest that your vaccine adapted to vote on a.

Like quite similar already reshaped, the VSAT and Emory repertoire, and therefore may be more beneficial than an extended period of cool stuff with existing vaccines directed against their origin, Australia. We believe that the data also suggests.

That exposure.

Stretch strain vaccine experienced individuals.

Amit Cross like melanoma vaccine could provide similar cross strain.

Be prepared for future Chad we.

We may change with survey evolved from the Doctor by the way we have been engaged since the approval of <unk> hundred 60, it will be tool in a very robust product research effort.

Unknown Executive: We have been engaged since the approval of the NT162b2 in a very robust product research effort to explore various follow-on and novel next generation vaccines to prevent COVID-19. These are currently in development and several approaches may move into the clinic this year. We are evaluating mono and multivalent vaccines, T-cell enhancing approaches, and pan-coronavirus covering vaccine costs. Our landscape research helps our product development strategy, that currently focuses on responding to the need for vaccine adaptation due to the emergence of Omicron and its sub-disease. Our clinical program evaluating the safety, tolerability, and immunogenicity, of various variant-adapted vaccines in multiple clinical trials is advanced.

Well if there is follow on and novel next generation vaccines to prevent COVID-19.

Currently in development and server approaches may move into the clinic. This year, we are graduating mono and multi day than fixed speed. She said enhancing approach it and Concord whatnot virus covering vaccine concept.

Okay Research helps our product development strategy. That's currently focuses on responding to the need for a vaccine adaptation due to the emergence of the chronic Hep D niches.

Our clinical program evaluating the safety Tolerability and <unk>.

Genesis Chi.

Salaries variant adapted vaccines.

My two quick things I could try it.

Bonds.

Unknown Executive: Emerging data from these trials will be reviewed and discussed with regulators in the coming weeks to determine the appropriate regulatory path forward for either monovalent or bivalent variant-adapted vaccine products. As a reminder, slide 12 shows our comprehensive clinical response strategy to the Omicron. We are investigating different dose schedules of a monovalent Omicron-adapted vaccine, for example, in individuals aged 18 to 55 years, and evaluating bivalent approaches, as well. We expect data from these studies will be available in the coming weeks.

And the emerging data from these trials would it be a refuge and discussed with regulators in the coming weeks to determine the appropriate regulatory path forward for either monovalent abide by the very end of the decade X gene product candidates.

As a reminder, slide 12 shows our comprehensive clinical response strategy.

Army crop area.

Investigating different dosing schedules of our monovalent omicron adapted.

For example, if you had aged 18 to 55 here.

Radiating bivalent approaches.

While we expect data from these studies.

He available in.

In the coming weeks.

Unknown Executive: While there is currently no regulatory consensus on the benefit of Omicron-adapted vaccines, we anticipate regulatory developments as clinically meaningful data become available. As we evade the data, we remain prepared to adapt our technology and manufacturing processes to ensure that our vaccine provides robust protection against current and emerging variants of COVID. Slide 13 highlights our expansive oncology pipeline that is the result of our comprehensive, innovative multi-modality toolbox and our focused execution throughout 2021 and 2022.

While there is currently no regulatory consensus on the benefit off on the ground adept at X gene, we anticipate regulatory developments as clinically meaningful data become available.

As we await the data we remain prepared to adapt our technology and manufacturing processes to ensure that our vaccine provides robust protection against current and emerging bearing stuff.

Slide 13 highlights our.

Oncology pipeline that just a result of our country heads of innovative multi modality toolbox and I'll focus execution for our 2021 and 2022, we have might've been assets and development across different you can use your project and modalities with the Hudson.

Unknown Executive: We have multiple assets in development across different immunotherapeutic modalities with the possible potential to tackle tumors using complementary strategies either by targeting tumor cells directly or by modulating the immune response against the tumor. Many of our product candidates can be combined with our pipeline.

Potential ticket you want using complementary strategies, either by targeting tumor cells directly all by modulating the immune response against the tumor many of our product can be they can be combined with high brightness Oh I'll call.

Unknown Executive: Our oncology pipeline includes a total of 16 product candidates, across four different drug classes and 20 ongoing clinical trials, type of which are randomized. We expect continued pipeline advancement and expansion as well as further data readout from the ongoing trials in 2022. We believe that this will be a year of focused execution across our five phase two clinical trials and multiple tumor types as shown on slide 14. First, we have two phase two trials ongoing that are evaluating FIXAC, our off-the-shelf mRNA vaccine immune therapy platform, BMT111, which is being evaluated in N-type PD-1 refractory relapsed advanced melanoma, in quotes for tumor antigens that cover greater than 90% of cutaneous melanoma.

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16 product candidates across four different drug classes, and 20 ongoing clinical trial type of which our randomized phase two clinical trial, we expect continued pipeline advancement and expansion as well as from a data readout from the ongoing trial.

In 2022.

We believe that this would be a year of focused execution across our five phase two clinical trials and much of the tumor types.

As shown on slide 14, first we have to we have two phase two trial.

But evaluating takes a lot of the sheds mrna vaccine immunotherapy platform.

<unk> 11, which is being evaluated and anti PD, one refractory relapsed advanced Mega Watt and cold spots, you might antigens that cover greater than 90% of cutaneous melanoma patients.

Unknown Executive: Our approach may have the potential to improve outcomes when used in combination with anti-PD-1. We have received FDA path tracker endorphin drug designations for this program. The NT1-13, which encodes HPV-16 oncoproteins E6 and E7, is being evaluated in HPV-16 positive, PD-L1 positive head and neck cancers in combination with anti-PD-1.

<unk> may have the potential to improve outcomes when used in combination with anti PD. One we have reached six F. T. A pod track and orphan drug designation for this program the MTO onto a gene, which encodes HPV 16, Oncoprotein six 6%.

Seven is being evaluated in HPV 16 positive.

One positive head and neck cancer in combination with anti PD one.

Unknown Executive: Next, we have with our partner Genentech, to individualized neoantigen-based vaccine programs, INES programs, evaluating autogen, sarumarine, or BNT-122 in phase two trials. One in frontline melanoma, and one in colorectal cancer in the. If our melanoma trial is successful and accepted by regulators, we would unlock the possible use of INES as a frontline therapy in combination with N-Type PD-1 in N-Type PD-1 MEs advanced cancer. In colorectal cancer, we aim to address the residual cancer cells that remain after treatment with standard therapy, a key driver of, Finally, BNT311, our bi-specific antibody that we are developing with our partner, GenNet, is in an ongoing phase two study in refractory or recurrent non-small cell lines. This next generation.

We have with our partner Genentech.

To individualize Neo antigen based vaccine programs I Miss programs evaluating auto Jim Murren, albeit.

<unk> 22 in phase two trials, one in frontline melanoma and one in colorectal cancer in the adjuvant setting if a law Milano not tried it is successful and accepted by regulated tests, we would unlock the possible use of <unk> as a frontline therapy in combination.

Nation with anti PD, one and anti PD, one that Ive advanced cancers.

In colorectal cancer, we aimed to address the residual cancer said that remain after treatment with standard therapy It to drive Australia.

Finally be antifreeze 11 or by specific anti body that we are developing with our partner Genmab.

And then ongoing phase two study in refractory or recurrent non small cell lung cancer.

This next generation immune.

Unknown Executive: Immune Therapy uses conditional 4-1-B-B co-stimulation concurrent with PD-L1 blockade with the goal of tumor targeting. Enhancement of T-Cells and Natural Killer Cells. Turning now to slide 15, we recently presented Promising Efficacy and Safety Data for BNT2-11, our next generation CAR T-cell program at the AACR. The Nt211 combines two of our platforms that we believe have complementary modes of action. Clotin-6 CAR T-cells and a CAR T-cell amplifying RNA vaccine called CARBAC, based on our lipoplex technology used in other cancer vaccine programs.

Immunotherapy use this condition I for one BP co stimulation concurrent with PDL, one blockade with the goal of two more targeted enhancement of T cell and natural killer assumption.

Turning now to slide 15, we recently presented promising efficacy and safety data for BMD to elaborate on next generation car T cell program excellent ACR annual conference.

T 211, combined two of our platform that we believe have complementary modes of action clothing fixed car T cells or car T cell amplifying RNA vaccine card Kabak based on our <unk> technology used in other cancer vaccine.

Program.

Unknown Executive: So these Claudine-6 CAR T-cells are equipped with a second-generation chimeric antigen receptor of high sensitivity and specificity, for the Carcinoembryonic Tumor-Specific Antigen Coordination. Chlorine 6 is absent in healthy adult tissue, yet frequently expressed in high medical needs, making this tumor antigen an ideal candidate for CAR T cell therapy.

Claude and fixed car T cells are equipped with a second generation chimeric antigen receptor of high sensitivity and specificity public casino embryonic tumor specific antigen called <unk> six trillion six exit and has he adopted tissue yet frequently expressed in hindsight.

Kansas, making this tumor antigen ideal candidates for car T cell therapy.

Unknown Executive: In preclinical studies, we demonstrated that CARBAC drives in vivo expansion of transferred CAR T cells, increasing their persistence and efficacy. BNT211 aims to overcome CAR T-Cythera B limitations in patients with solid, The ongoing First in Human Phase 1-2 trial is evaluating the safety and efficacy of cloridine-6 CAR-T cells as monofurape and in combination with CAR-VAC in patients with cloridine-6 positive relapsed or refractory advanced early tumors. We are testing three dose levels of cloridine-6 CAR-T cells as monofurape dose escalation, as well as in combination with a sixth dose of the RLD-1. The subsequent dose expansion cohorts will include patients with ovarian, testicular, and endometrial cancer, as well as other rare COVID-positive cancer types, such as sarcoma. Slide 16 provides a summary of the AECR.

In preclinical studies have demonstrated that carve up drive and be like auctioning off transport Kaki said, increasing that persistence and efficacy.

The Yankee to 11 aims to overcome perhaps she says here of beauty mutations in patients with solid tumors.

The ongoing first in human Phase one two trial is evaluating the safety and efficacy of Claudius six car T says as monotherapy and in combination with <unk> in patients with Claudio six positive relapsed or refractory advanced so that charge. We are testing three dose levels of 36.

Car T. He says as monotherapy dose escalation that's the way it is in combination with a fixed dose of the R&D day.

The subsequent dose expansion cohorts will include patients with ovarian to securitize endometrial cancer. That's why that's about rare quality in six positive cancer types, such as sacral not slide 16 provides a summary of our ACR data. The presentation included data from 16 heavy.

Unknown Executive: The presentation included data from 16 heavily pre-treated patients who received Claudine 6-car T-cells alone at two dose levels, 1x107 and 1x108, all combined with CARVAX after lymphodepletion. Tumor indications included eight testicular cancer patients, four ovarian cancer patients, and one patient each for endometrial cancer, fallopian, tube cancer, sarcoma, and gastroenteritis. The results demonstrated a tolerable safety profile for both the CAR-T cells as monotherapy and when combined with CARVAC. As eight patients experienced cytokine release syndrome, grade one to two, which was manageable with facility, with no signs of neurotoxicity seen.

Pre treated patients who received Claude in fixed car T cells.

Loan at two dose levels are one time.

And one times 10 to the eighth al.

Combined with Capex after depletion for more indications included eight testicular cancer patients fault varian cancer patients and one patient each for endometrial cancer and at El Pen chip can serve that format and gastric cancer the results demonstrated tolerable.

Safety profile for both a car T said as monotherapy and when combined with Kovack at eight patients experienced cytokine release syndrome, great wanted to add to a tool which was manageable with a series of luck.

With no signs of neurotoxicity scene.

Unknown Executive: So far, two dose-limiting toxicities were observed, both were manageable and patients fully recovered. One was hemophagocytic lymphohistiocytosis, observed in the combination part at dose level two. The other, observed in the monotherapy cohort at dose level two, was prolonged cytopenia in a testicular cancer patient with a recent relapse on high-dose chemotherapy and autologous stem cell transplantation.

So far two dose limiting toxicities were observed offer a manageable and patients 48 week trial.

It recovered one called him Admiral Fargo Citic influenced your side, Georgia observed as a combination pod at dose level two.

Other observed in the mono therapy cohort dose level tool was prolonged cytopenia and a test of cure for patients with a recent rehab on high dose chemotherapy and autologous stem cell transplantation.

Unknown Executive: A new cohort with reduced lymphodepletion chemotherapy was subsequently opened to avoid prolonged cytopenia and testicular cancer, with a history of high, The maximum tolerated dose has not yet been reached. The preliminary efficacy data showed encouraging signs of clinical activity with an overall disease control rate of 86% and an overall response rate of 45%, with partial response observed in patients with testicular and ovarian. Five patients with testicular cancer were treated at the 1 to 10 to the 8th CAR T-cell dose level and showed encouraging responses with an objective response rate of 80% and a disease control rate of 100%.

Cohort with reduced slim for depletion chemotherapy was subsequently opened two hard program size of opinion testicular cancer patients with a history of trying to keep them off here.

Maximum tolerated dose has not yet been reached but preliminary efficacy data showed encouraging signs of clinical activity with an overall disease control rate of 86% and an overall response rate of 43% with partial response.

Observed in patients with testicular and ovarian cancer patients.

Patients with testicular cancer were treated at the 110 to 208 car T cell dose level and showed encouraging responses with an objective response rate of eight two percentage and a disease control rate of 100% one patients had a complete response.

Unknown Executive: One patient had a complete response, three had partial responses, and one had stable disease. This sub-analysis includes one additional patient with partial response that received a reduced lymphodepletion rate. The addition of CARVAC-supported CAR-T engraftment and mediated physiological expansion plus upgrade regulation of survival pathways in patients receiving the combination. We also observed deepening of responses over time and continuing long-term persistence of CAR-T in some patients with CAR-T persistence lasting beyond 150 days post-infusion. Slide 17 shows the CAR-T engraftment.

We had partial responses and one had stable do you see this type of analysis includes one additional patients with partial responses that received a reduced input depletion regimen.

The addition of Kovack supported cut sheet and grassman.

Mitigated physiological expansion peds uptake eregulation of survival, possibly in patients receiving the combination. We also observed deepening of responses over time and continuing long term persistence of car T and some patients with car T.

Persistence lasting beyond 250 days post infusion.

<unk> 17 shows with car T and grassland, all 16 patients showed robust car T cell and glassman with peak expansion.

Unknown Executive: All 16 patients showed robust CAR-T cell engraftment with peak expansion 10 to 17 days after infusion, reaching cell frequencies above 10 to the eighth total cell count at the 10 to the eighth dose level. We observed that incremental improvement of CAR-T cell expansion either through a higher dose level or by adding the CAR-VAC vaccine translated into clinical activity and risk. Slide 18 provides an overview of the preliminary signs of clinical activity. 14 patients were evaluated for efficacy assessment with at least one scan six weeks post-intusion.

10% to 717 days after infusion.

Reaching says frequencies above tend to age towards us icon at the tend to win eight dose level, we observed that incremental improvement of car T cell expansion either through a higher dose level all by adding the car wreck vaccine translated into.

Clinical activity and response.

Slide 18 provides an overview of our preliminary signs of clinical activity 14 patients were evaluable for efficacy assessment with at least one scan six weeks plus institution six patient showed partial responses and an additional five patients had stable disease with shrinkage of.

Unknown Executive: Six patients showed partial responses, and an additional five patients had stable disease with shrinkage of target lesions, as shown in gray diamonds with green outlines. One patient had no change from baseline, and two patients had no signs of clinical activity, both of which were rapidly progressing prior to adoptive studies. This resulted in an objective response rate of 43% and a disease control rate of 86% across all patients, a 12-week four-of-the-six patient with a partial recovery, showed deepening and durability, with one patient reaching a complete response 18 weeks after infusion.

Cockatoos lesions.

It's shown in Gray Diamond, where screen outlines one patient had no change from baseline and two patients had no signs of clinical activity both of which were at to keep progressing prior to adoptive Citron. This resulted in an objective response rate of 43% and a disease control.

86% across all patients.

12 weeks for six patients with a partial response, so deepening and durability of responses with one patient wish reaching a complete response 18 weeks. After infusion also testicular cancer patients in the higher dose levels had disease control.

Unknown Executive: All four testicular cancer patients in the higher dose level had disease control and three of these patients showed objective risk. In addition, one testicular cancer patient showed a partial response after infusion of the lowest CAR T dose level in combination with CARB-X.

Three of these patients showed objective responses. In addition, one testicular cancer patient showed a partial response after infusion of the lowest car T dose level in combination with <unk>.

Very bottom of the slide Ive never great. Bob We wanted to say, a one well that testicular cancer patient who has shown a partial response after reduced them for depletion regimen that patient is not included in the 14 Evaluable patients. We discussed previously in summary, and most encouragingly all initiative.

Unknown Executive: At the very bottom of the slide, under the gray bar, we wanted to share one further testicular cancer patient who has shown a partial response after a reduced lymphodepletion regimen. That patient is not included in the 14 evaluable patients we discussed previously. In summary, and most encouragingly, all initial partial responses showed deepening at the second assessment, and one partial response patient transitioned to a complete recovery. The waterfall plot on the left of slide 19 shows the best response for those four testicular and two ovarian cancer patients who responded.

Responses show deepening.

Second assessment and one partial response patients transition to a complete response the waterfall plot on the left of slide 19 shows the best response for those for testicular into ovarian cancer patients who responded responded first focusing on batiste kill that cancer patients.

Unknown Executive: Responded, focusing on the testicular cancer patients, you see a spider plot on the right, depicting the duration of the responses. Besides one patient that only received the lower 10 to the seventh dose level without CARVAC, all other, showed a clinical benefit. All achieved responses showed signs of continuing response durability. This includes the patient whose initial partial response deepened to an ongoing complete response 18 weeks after infusion. Slide 20 shows scans of two testicular cancer patients with tumor regression.

You'll see it tied up lot underwrite depicting the duration of the responses. Besides one patient, but only received for lower tend to the seventh dose level without kovack all of our patients showed a clinical benefit all achieved responses showed signs of continuing response durability.

This includes the patient whose initial partial response deepened to an ongoing complete response 18 weeks. After infusion slide 20 shows Kent of two testicular cancer patients with tumor regression, both patients had multiple prior treatments entry level relapses.

Unknown Executive: Both patients had multiple prior treatments and relapses before receiving BNT211. Patient one is a 61-year-old male diagnosed in 2008. He had previously received six signs of treatment and showed a complete response after CAR-T treatment at dose level two without CARB-X. The large lung metastasis was completely eliminated over, and the patient remained tumor-free as of the latest scan with a serum tumor marker alpha-fetoprotein at normal values six months after infusion.

Before receiving <unk> 211 patient one is the 61 York made yet diagnosed in 2008. He had previously received six six lines of treatment and showed a complete response after car T treatment at dose level, two with our topic, but large long the test because this was completely.

And it eliminated overtime and the patient remained tumor free as of Friday to gain with the CRM tumor Mark Mark Hoppe I saw sito protein.

Normally that you were six.

Six months after infusion.

Unknown Executive: Patient 2 is a 56-year-old male testicular cancer patient diagnosed in 2020 who received dose level 1 and was additionally treated with CARB-X. Treatment translated into a robust response as you can see in those scans with substantial shrinkage of more than 50 nanometers. Following the week 12 scan, the patient had new lesions. As the on-treatment biopsy showed positivity for Claudine 6, the patient was re-dosed with CAR T-cells on day 197, and we have seen a tumor marker response already.

Patient tool is a 56 year old man testicular cancer patients diagnosed in 2020, we received those liberty one and was additionally treated with topical treatment translated into a robust response as you can see in the skin with substantial shrinkage of more than $15.

Yes.

Following the weak Twitch cat scan that patient had new lesions as the on treatment biopsy Shaun cousins pivot to you for closing six the patient once we dose with car T cells on days 197, and we have seen a tumor marker of response already.

Yes.

Ozlem Tureci: We are very encouraged by the safety and activity data and another data update from the ongoing Phase 1-2 trial is expected in the second half of 2022. I'd now like to turn over the call to Jens Holstein, who will cover our financial results. Thank you, Ozlem, and a warm welcome to those of you on the phone.

We are very encouraged by the safety and activity data and another data update from the ongoing phase one to try and is expected in the second half of 2022.

I'd now like to turn over the quarter, yet until it's done we'll cover our financial results.

Thank you Islam and a warm welcome to those of you on the phone.

Jens Holstein: I'll start my section by presenting the key highlights for the first quarter of 2020, which you can find on slide. The first quarter of 2022 has been an extraordinary year, which also becomes visible by looking at our key financial highlights. Our total revenue is reported for the first quarter of 2020. 6.4 billion euros reflecting a record figure for the company since its inception. As a consequence of this top-line number, we ended the first quarter with an operating result of 4.8 billion euros and generated earnings per share on a fully diluted basis, of €14 and €24.

I'll stop my section by presenting the key highlights for the first quarter of 2022, which you can find on slide 22.

The first quarter of 2022 has been an extraordinary one which also becomes visible by looking at our key financial highlights.

Our total revenues reported for the first quarter of 2022 reached $6 4 billion euros, reflecting a record figure for the company since its inception.

As a consequence of this topline number we ended the first quarter with an operating result of $4 8 billion euros and generated earnings per share on a fully diluted basis of 14 euros in 'twenty four euro cents.

Jens Holstein: In respect of cash, we ended the first quarter of 2022 with 6.2 billion euros of cash and cash equivalents, as well as trade receivables of around 12.7. The trade receivables are mainly derived from our collaboration with Pfizer and mainly remained outstanding due to the contractual settlement of the gross profit share under the collaboration, from our outstanding trade receivables as of March 31st. We had already collected 5.2 billion euros in cash by mid-April 2020, proving our cash and in turn reducing our trade position subsequent to the end of Q1.

In respect of cash we ended the first quarter of 2022 was $6 2 billion euros of cash and cash equivalents as well as trade receivables of around $12 7 billion.

The trade receivables are mainly derived from our collaboration with Pfizer and many remained outstanding due to the contractual settlement of the gross profit share and the other collaborations.

Our outstanding trade receivables as of March 31, 2022, we had already collected $5 2 billion euros in cash by mid April 2022, improving our cash and in turn reducing our trade receivable position subsequent to the end of Q1 2022.

Jens Holstein: Continuing with slide 23, I want to point out how strong our first quarter in 2020, As mentioned before, we had recognized approximately €6.4 billion of COVID-19 vaccine revenues during the first quarter of 2020. This has been the result of an increased order volume initially placed in late 2021 following the then emerging Omicron variant. Let me give you some more details on our revenue stream. As a reminder, on our COVID-19 vaccine calibration...

Continuing with slide 23, I want to point out how strong our first quarter in 2022 has been.

Mentioned before we have recognized approximately $6 4 billion euros of COVID-19 vaccine revenues during the first quarter of 2022.

This has been the result of an increased order volume initially placed in late 2021 falling than emerging omicron variant.

Let me give you some more details on our revenue stream.

As a reminder, on our COVID-19 vaccine collaborations territories have been allocated between us and Pfizer and Fosun pharma based on marketing and distribution.

Jens Holstein: Territories have been allocated between us, Pfizer and Fosun Pharma based on marketing and distribution. Our COVID-19 vaccine revenues included 4.6 billion euros revenues related to our share of gross profit from COVID-19 vaccine sales, in the Collaboration Partners Territory. These revenues already represent a net figure, meaning that we generate a 100% gross margin of those revenues.

Our COVID-19 vaccine revenues included $4 6 billion euros revenues related to our share of gross profit from COVID-19 vaccine sales.

And the collaboration partners territories.

These revenues already represent a net figure meaning that we generate 100% gross margin on those revenues.

Jens Holstein: As we have mentioned in the past and explained in more detail in our financial statements and filings with the SEC, our profit share is, to some extent, estimated based on preliminary data shared between our collaboration partner Pfizer and IBM. Our COVID-19 vaccine revenues during the first quarter of 2022 comprised approximately 1.2 billion euro revenues from direct COVID-19 vaccine sales to customers in our territory, which is significantly driven by the orders that we placed in late.., one following the then-emerging Omicron.

As we have mentioned in the past and explained in more detail in our financial statements and filings with the SEC.

Profit share is to some extent estimated based on preliminary data shared between our collaboration partner Pfizer or not.

Our COVID-19 vaccine revenues during the first quarter of 2022 comprised approximately $1 2 billion Euro revenues from direct COVID-19 vaccine sales to customers in our territory, which is significantly driven by the orders that we placed in late 2021 following the tender.

Merchant Omicron variant.

Jens Holstein: Also included in our COVID-19 vaccine revenues during the first quarter of 2022 were 0.6 billion euros from sales to our collaboration. Again, we started the year very strong, which we believe gives us a solid foundation for achieving our previously announced guidance for the 2022 financial year. We expect the following quarters to be lower than Q1, given the current situation of the pandemic.

Also included in our COVID-19 vaccine revenues during the first quarter of 2022 were <unk> 6 billion euros from sales to our collaboration partners.

Again, we started the year very strong, which we believe gives us a solid foundation for achieving our previously announced guidance for the 2022 financial year, we expect the following quarters to be lower than Q1, given the current situation of the pandemic.

Jens Holstein: I'll be moving to our financial results for the first quarter of 2022 as shown on slide 22. Having explained our revenues on the previous slide, let me move now to the cost of sales that reached approximately 1.3 billion euros in the first quarter of 2020, compared to 0.2 billion euros for the comparative theory. The increase in cost of sales resulted mainly from the recognition of costs related to our COVID-19 vaccine revenues in our own territories that include the share of gross profit that we owe to our collaboration partner Pfizer. This increase in cost of sales is additionally attributed to expenses arising from inventory write-offs and for production capacities derived from contracts.

I'll be moving to our financial results for the first quarter of 2022 as shown on slide 24.

I haven't explained our revenues on the previous slide let me move now to the cost of sales reached approximately $1 3 billion euros in the first quarter of 2022 compared to <unk> 2 billion euros for the comparative period in 2021.

The increase in cost of sales resulted mainly from the recognition of costs related to our COVID-19 vaccine revenues.

Our own territories that include the shelf gross profit that we owe to our collaboration partner Pfizer.

This increase in cost of sales is additionally attributed to expenses arising from inventory write offs and full production capacities derived from contracts with contract manufacturing organizations.

Jens Holstein: Faxing, Organizing, Research and development expenses were approximately €0.3 billion for the first quarter of 2020, compared to around 0.2 billion euros for the comparative period. The increase was mainly due to the recognition of costs related to the production of pre-launched Omicron vaccine products as research and development expenses in the period incurred, as well as increase in headcount. The increase was partly offset by lower research and development expenses related to our COVID-19 vaccine program as compared to the prior year.

Research and development expenses were approximately <unk> 3 billion euros for the first quarter of 2022 compared to around <unk> 2 billion euros for the comparative period in 2021.

The increase was mainly due to the recognition of costs related to the production of prelaunch Omicron vaccine products as research and development expenses in the period incurred.

As well as increase in head count.

The increase was partly offset by lower research and development expenses related to our COVID-19 vaccine program as compared to the prior year period.

Jens Holstein: General and administrative expenses reached €90.8 million for the first quarter of 2022, compared to €38.9 million for the comparative period in 2021. The increase in G&A was mainly due to the increased expenses for purchased management consulting and legal services, as well as an increase in accounting.

General and administrative expenses reached $19 8 million euros for the first quarter of 2022 compared to $38 9 million euros for the comparative periods in 2021.

The increase in G&A was mainly due to the increased expenses for purchased management consulting and legal services as well as an increase in head count.

Jens Holstein: Income taxes were accrued in an amount of 1.3 billion euro tax expenses for the first quarter of 2022 compared to 0.5 billion euro tax expenses for the comparative period in 2021. They derived effective income tax rate for the first quarter of 2022 was 26.3% and is expected to be around 28% for the, For the first quarter of 2022 net profit reached 3.7 billion euros compared to 1.1 billion euros for the comparative period. Our diluted earnings per share for the first quarter of 2021 amounted to €14.24 compared to €4.39 for the comparative period.

Income taxes were accrued in an amount of 1.3 billion Euro tax expenses for the first quarter of 2022.

Where to open 5 billion euros tax expenses for the comparative period in 2021.

They derived effective income tax rate for the first quarter of 2022 was 26, 3% and is expected to be around 28% for the full year.

For the first quarter of 2022 net profit reached three 7 billion euros compared to $1 1 billion euros for the comparative period in 2021.

Our diluted earnings per share for the first quarter of 2021 amounted to 14 year olds and 24, you have a sense for euro since 2009 your sense for the comparative period in 2021.

Jens Holstein: Moving to slide 24 that shows that we reiterate our outlook for the 2020, We started very strong with Q122. We reiterate our full year guidance, even though we have to acknowledge the uncertainty derived from the course of the pandemic and the political uncertainties. Considering the unchanged order book of approximately 2.4 billion doses for delivery during the 2022 financial year, we are confirming our estimated COVID-19 vaccine revenues of approximately 13 to 17 billion euros for the full year 2021.

Moving to slide 24 that shows that we reiterate our outlook for the 2022 financial year.

We started very strong with Q1 2022.

Our full year guidance, even though we have to acknowledge the uncertainty derived from the course of the pandemic and the political uncertainties of the recent months.

Considering the unchanged order book of approximately $2 4 billion doses for delivery during the 2022 financial year. We are confirming our estimated COVID-19 vaccine revenues of approximately 13 to 17 billion euros for the full year 2022.

Jens Holstein: For 2022, we also reiterate our planned expenses and CAPEX, as well as the estimated annual effective income tax rate, which we have summarized for you on the slide. And with that, I turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our outlook for 2022 and concluding remarks. Thank you, Jens.

For 2022, we also reiterate our planned expenses and Capex as well as the estimated annual effective income tax rate, which we have summarized for you on the slide.

And with that I turn the call over to our Chief strategy Officer, Ryan Richardson for an update on our outlook for 2022 in concluding remarks. Thank you.

Thank you, yes, turning to slide 27, and our priorities for the remainder of the year.

Ryan Richardson: Turning to slide 27 and our priorities for the remainder of, We continue to focus on supply of our COVID-19 vaccine and the development of our pipeline of next-generation vaccines. Earlier this year, we announced a multi-year pandemic preparedness contract with the German government and discussions with other governments are under way. In Oncology, we expect our first readout from a randomized Phase 2 trial, in addition to data updates from our ongoing Phase 1-2 trial at BNT211, our CAR T-cell program for cells.

We continue to focus on supply of our COVID-19 vaccine and the development of our pipeline of next generation vaccines.

Earlier this year, we announced a multiyear pandemic preparedness contract with the German government and discussions with other governments are underway.

In oncology, we expect our first read out from our randomized phase II trial. In addition to data updates from our ongoing phase one two trial of <unk> 201, our car T cell program for solid tumors.

Ryan Richardson: We continue to prepare for the initiation of multiple registrational trials across our pipeline in the next 12 months, and we'll provide further updates on those plans later. In infectious disease, we plan to initiate first-in-human clinical trials for four additional mRNA vaccine programs in 2022, in addition to building on, Spanding Preclinical Portfol- Dr. Prasimov, Dr. Prasimov, Dr. Prasimov, Dr. Prasimov, Additionally, we are accelerating the expansion of our platforms into new therapeutic areas such as autoimmune disease. Regenerative Medicine and Cardiovascular, and expect to make lead candidate selections for several programs. We support our focused execution against these goals.

We continue to prepare for the initiation of multiple registrational trials across our pipeline in the next 12 months.

And we'll provide further updates on those plans later in the year.

In infectious disease, we plan to initiate first in human clinical trials for four additional mrna vaccine programs in 2022 in addition to building out.

Our expanding preclinical portfolio.

Additionally, we are accelerating the expansion of our platforms into new therapeutic areas, such as autoimmune diseases regenerative medicine in cardiovascular disease and expect to make lead candidate selections for several programs.

To support our focused execution against these goals, we are investing in our foundation, particularly in building out our digital and AI capabilities as well as our global development team to support further pipeline expansion, which we envision in the coming years.

Ryan Richardson: We are investing in our foundation, particularly in building out our digital and AI capabilities, as well as our global development team to support further pipeline expansion, which we envision in the coming year. On slide 28, our COVID-19 vaccine order book for the year stands at approximately 2.4 billion doses, with approximately 750 million doses invoiced by the end of the first quarter. We expect multiple BNT162b2 data updates throughout the rest of the year, including data for a three-dose regimen in children ages six months to five years, which we expect in the coming weeks.

On slide 28, our COVID-19 vaccine order book for the year stands at approximately $2 4 billion doses.

With approximately 750 million doses invoiced by the end of the first quarter.

We expect multiple B and T 106 to be two data updates throughout the rest of the year.

<unk> data for a three dose regimen in children, aged six months to five years, which we expect in the coming weeks.

Ryan Richardson: We are evaluating a fourth dose in adults ages 16 and older as part of a comprehensive variant-adapted vaccine. In addition, we expect to disclose safety and immunogenicity data for our Omicron-adapted and bivalent vaccines in the coming weeks, which will inform our ongoing regulatory discussion. Moving to slide 29 and our expected pipeline milestones for 2020. We expect to initiate seven first-in-human trials this year, including for our mRNA vaccines for shingles, tuberculosis, HSV-2, and malaria.

We are evaluating a fourth dose in adults ages 16 and older as part of a comprehensive variant adopted vaccine program.

In addition, we expect to disclose safety and Immunogenicity data for our own mccrone adopted in bivalent vaccines in the coming weeks, which will inform our ongoing regulatory discussions.

Moving to slide 29, and our expected pipeline milestones for 2022.

We expect to initiate seven first in human trials this year, including for our mrna vaccines for shingles tuberculosis.

Chesapeake to malaria.

Ryan Richardson: In January, we dosed the first patient for our BNT-141 ribomab. The first program from this exciting new... We anticipate our second RivaMap. BNT-142, which encodes the CD3-Claudin-18.2 bispecific antibody, will enter the clinic in the coming months.

In January we dosed the first patient for our <unk> one for one ribald map program.

First program from this exciting new platform.

We anticipate our second drive on that program to 104, two which encodes the CD three quarters $18. Two bi specific antibody will enter the clinic in the coming months.

Ryan Richardson: The NT116, our FIXVAC program for non-small cell lung cancer, which will be evaluated in combination with Leptio as part of our expanded Regeneron collaboration, is also expected to enter the clinic in the second. We expect data updates from three further programs this year. BNT161 and Influenza mRNA vaccine partnered with Pfizer.

The <unk> six are fixed back program for non small cell lung cancer, which will be evaluated in combination with lip tayo as part of our expanded Regeneron collaboration is also expected to enter the clinic in the second half of the year.

We expect data updates from three further programs this year.

<unk> 106, one and influenza mrna vaccine partnered with Pfizer.

Ryan Richardson: And in the second half of 2022, we expect to have a data update from BMT 1-2-2, our INES program, being evaluated in combination with pembrolizumab as a frontline treatment for melanoma. Finally, we expect further data updates this year for our BNT211 CAR T-cell program, which Ozlem highlighted. Before concluding on slide 30, I would like to remind investors that we will have our annual general meeting on June 1st, for which detailed information can be found on our website. And we will host our first virtual Capital Markets Day on Wednesday, June 29.

And then the second half of 2022, we expect to have a data update from <unk> or IMS program being evaluated in combination with timber lose them out as a frontline treatment for melanoma.

Finally, we expect further data updates this year for our <unk> to one one car T cell program, which <unk> highlighted.

Before concluding on slide 30, I would like to remind investors that we will have our annual general meeting on June 1st for which detailed information can be found on our website.

And we will host our first virtual capital markets day on Wednesday June 29.

Ryan Richardson: I would like to thank our shareholders for their continued support, and we'll now open the floor for questions. Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. Please limit yourself to one question only.

I would like to thank our shareholders for their continued support and we'll now open the floor for questions.

Thank you as a reminder to ask a question you in these press star one on your telephone please limit yourself to one question only to withdraw your question press the pound Husky once again star one if you would like to ask a question.

Unknown Executive: To withdraw your question, press the pound hash key. Once again, star 1 if you would like to ask a question. Your first question today comes from the line of Matthew Harrison from Morgan Stanley. Please go ahead, your line is open. Great. Good afternoon.

Your first question today comes from the line of Matthew Harrison from Morgan Stanley . Please go ahead. Your line is open.

Matthew Harrison: Thanks for taking the question. I guess maybe if you could just give us a little bit more detail on your current thinking around what regulatory discussions you need to have in terms of boosters and what the regulatory pathway, especially in the U.S, is going to look like here, you know, is your is your expectation that you can just run a simple bridging study or might it be more complicated than that? Thanks very much. Yeah, all the people here.

Great. Good afternoon, thanks for taking the question.

I guess, maybe if you could just give us a little bit more detail on your current thinking around.

What regulatory discussions you need to have in terms of the boosters and what the regulatory pathway, especially in the U S.

He's going to look like here.

Is your is your expectation that you can just run a simple bridging study or might it be more complicated than that thanks very much.

Right.

Yeah.

Unknown Executive: [inaudible] I'm sorry, I'm sorry, I'm sorry, So I think I can take the question and maybe Ozlem can complement. The regulatory path towards an authorization of a variant-adapted vaccine is not clearly defined yet. We had a number of meetings with regulatory authorities, including FDA and EMA, and they proposed to see the data on monovalent vaccines as well as b-valent vaccines and would like to make the decision based on the data. As you might have heard, the FDA is planning a VRBPAC meeting end of June, where they indicated that they would provide more clear guidance about the vaccines that are preferred for the next season.

Okay.

So I think I can I can take the question and.

Maybe I can complement.

The regulatory path towards all conversation Oh, sorry.

Valeant adapted vaccine is not clearly defined yet.

We had a number of meetings.

I'm told me, she's including FDA and EMA.

And they are they proposed to see the data on monovalent vaccines as well as balanced vaccines and put back to make the decision based on the data.

As you might have to the FTE is pending.

Meeting at end of June that they have that they.

<unk> indicated that they would provide.

A more clearer guidance.

About the vaccines vaccines that that Oh, yeah Oh.

Yeah, Chris.

For the next season.

Unknown Executive: A similar statement was made by the EMA, and both authorities seem to prefer an authorization of vaccines in the timeframe of August, September, October, so that the process is ongoing. We are generating data for monovalent and different bivalent vaccines, including lower and higher doses, and we'll have the data available for discussion with the authorities.

Similar similar statement may be it wasn't.

But by the EMA in both auto at Ts.

Yeah.

Seem to 2%.

And authorization of vaccines vaccines.

Vaccines in the timeframe of August September October .

So with that the process is ongoing we are generating data for monovalent, and bivalent vaccines, including lower and higher doses and we'd have the data available for discussion with the I'll call. It.

Yeah.

Okay.

Hum.

Unknown Executive: So I hope that answers the question, the next question. Thank you. Your next question comes from the line of Cory Kasimov from J.P. Morgan. Please go ahead, your line is open. Hi, good morning.

So I hope that answers the question the next question.

Thank you. Your next question comes from the line of Commie costume off from J P. Morgan. Please go ahead. Your line is open.

Cory Kasimov: Good afternoon. I wanted to follow up on this general line of thinking, recognizing that there's there's data from various COVID programs anticipated over the coming weeks and an uncertain regulatory pathways we just discussed. I'm just curious as to your views on how you see the relative value proposition between an Omicron-specific booster compared with a bivalent one over both the short and the longer term. Thank you. Yeah, so what we already know, so I refer to published data with regard to antibody titers after Omicron-1 infection.

Hi, Good morning, and good afternoon, I wanted to follow up on the general line of thinking recognizing that there's there's data from various COVID-19 programs anticipated over the coming weeks and an uncertain regulatory pathways and just discussed.

Just curious as to your views on how you see the relative value proposition between and omicron specific booster compared with a bivalent won over both the short and the longer term. Thank you.

So what what the all the email with her and the.

I have a sort of published data because we got to two anti bodies taught us after omicron lung infection and this data clearly indicate that in pre vaccinated individuals and they have generated data.

Cory Kasimov: And this data clearly indicated in pre-vaccinated individuals, and we have generated data for individuals who have received our vaccine with two vaccinations or three vaccinations, and we evaluated what is happening after Omicron exposure. And what we see is that Omicron BA1 exposure results not only in an increase in antibody titers against the Omicron variant, but also against all other variants, including the Delta, Delta, Beta, Alpha, and the original Delta variant.

Those who have to see.

Our vaccine.

With two vaccinations of free vaccinations and be evaluated but what's happening up it only can exposure and let me see if the army corps and be a run exposure.

Besides not only an increase in anti body attack us against the I'll make one variant, but also against all other variants, including including the better better better I thought and the origin revised type variant.

And I'll make one exposure in vaccinated individuals really boost and both antibody response and this is what I mean by the published that in the meantime, other groups show it showed the same effects.

Unknown Executive: So an Omicron exposure in vaccinated individuals really boosts both antibody response. And this was meanwhile, we published that in the meantime, other groups showed the same effects. What is important is that an exposure to an Omicron infection, and we expect this is going to happen also in vaccinated individuals, primarily boost memory responses, pre-aseptic memory responses, and naive immune responses will most likely take additional months until naive B cells are generated.

What is important is.

Debt under an exposure.

So an army confection and we.

Expect this is going to happen also in vaccinated individuals time already boost memory of the sponsor.

He established minimally responsive.

And <unk> immune responses, the most likely pick up additional months until naive b cells generated we do not see a.

Unknown Executive: We do not see a rational advantage in combining the moment an Omicron vaccine with another vaccine, but at the end of the day, data count, so that means we are generating data in different individuals, and we will compare the antibody neutralization titers, not only against the prior Omicron variants, but also the newly emerging BA4 and BA5 variants, as well as former SARS-CoV-2 variants, regardless whether they have, they might have an impact or not in the future. Okay, thank you. Thank you. Your next question comes from the line of Kustafa Tsov from Goldman Sachs. Please go ahead, your line is open. Good morning.

Actually that advantage and combining combining the moment omicron vaccines and <unk>.

The vaccine, but at the analyst day and data count.

Generating data.

Yeah.

And if we do it and we will compare the N type of normalization process.

That's the only against them against the prior Omnicom variance, but also the newly imagined for NBA spot variance.

As bad as Palmer desktop to Valeant, regardless, where that they have there might have an impact on luck in the future.

Okay. Thank you.

Yes.

Thank you.

Your next question comes from the line of coastal thoughts up from Goldman Sachs. Please go ahead. Your line is open.

Kustafa Tsov: Thanks for taking the question. Congratulations on the quarter. Following up again on the same topic, based on the ACIP conversation that happened earlier that sort of started to lay out the framework for this decision, can you give us a sense of what data do you think they're looking for to try to make this decision? You talked a little bit about kind of neutralizing titers against different variants. Is it that simple, or are they going to be looking for other aspects aside from safety, of course?

Good morning, Thanks for taking my question and congratulations on the quarter.

Following up again on the same topics.

Based on the.

Conversation that happened earlier that sort of started to lay out the framework for this decision can you give us a sense of what data do you think they're looking forward to try to make this decision you talked a little bit about kind of neutralizing titers against different variance does it is it that simple or are they going to be looking for it because of other aspects. Besides safety of course.

Unknown Executive: And once these data on Omicron-specific vaccine are in hand, do you anticipate this may have an impact on other regulatory discussions like in China as well? Thank you. Yeah, of course, of course, safety is regarded, will be evaluated. And the safety evaluation happens in a few hundreds of subjects who received a booster vaccine.

And once these data are overcome specific vaccine or enhance anticipate this may have an impact on other regulatory discussions, but I can check that as well. Thank you.

Yeah.

Yeah of course of course.

Safety is weak August .

There'll be at that.

About eight.

And the safety evaluation happens in a few hundreds.

Subjects, who received a boost there.

Unknown Executive: So we don't expect that this is a larger trial will be needed, also based on the feedback from the regulatory authorities. I can say, as already stated, we had a number of conversations with the authorities. And every time they asked for the same data sets, they would like to see monovalent data and bivalent data. But they did not refer what kind of vaccine, monovalent or bivalent, is preferred by them.

So it would be going to expect that this is our largest prize.

We need it also based on the feedback from the regulatory authorities I can say.

And as already stated we had a number of conversations that's the ottava Ts and every time they they they are asked for the same dataset, yes. They.

I would like to see.

I would like to see mono data and I've been in data.

But that they did not at least what kind of vaccine.

Unknown Executive: I assume that this is a topic for the VRBPAC discussion end of June. And I don't think that we are going to be surprised by the request of non-expected data sets in addition to what we are already generating. Thank you. I will go to the next question. Your next question comes from Akash Tewari from Jeffreys. Please go ahead, your line is open.

Moreover, our bivalent is preferred by them I assume that this is a topic part of that pack discussion end of June .

And I would be I don't think that that we we are going to be surprised by it.

Cause excessive non expected data in addition to what you're already generating.

Okay.

Thank you, yes, I will go to the next question.

Next question comes from a cash to lobby from Jefferies. Please go ahead. Your line is open.

Akash Tewari: Hey, thanks so much. So it seems like you and Moderna have been talking up different approaches for an Omicron booster. Moderna seems to be talking up Bivalent, while you and Pfizer have been talking up more of a modified spike for patients who aren't naive. Can you talk about how antibody titers for both of these approaches may differ, especially at day 28, where Moderna has mentioned they may not be a big difference between wild type boosters and an Omicron booster, while you've already shown higher antibodies at day 28, at least with your alpha booster?

Hey, thanks, so much so it seems like you are in the journey I had been.

Talking up different approaches for an omnipod to assert mcdonalds seems to be talking a bivalent, while you and Pfizer have been talking up a more of a modified spike for patients who aren't naive can you talk about how antibody titers for both of these approaches may differ, especially at day 28, where Mcdermott has mentioned they may not be a big difference between wild type boosters.

And omnicom booster, while you've already shown higher antibodies at day 28 at least with your alpha easier and then given the uncertainty around the regulatory path forward in a scenario, where you would need robust b E data to get onto the market could there be a scenario, where we don't get an omnicom specific booster in 2022. Thank you.

Unknown Executive: And then given the uncertainty around the regulatory path forward, in a scenario where you would need robust VE data to get onto the market, could there be a scenario where we don't get an Omicron specific booster in 2022? Thank you. So let me just phrase the overall situation in which we are, regardless now of the thinking of different companies. We have a situation where with an ongoing Omicron pandemic, so 99.8 or 99.9% of all infections are mediated by Omicron sub-variants. We have a situation that currently multiple Omicron sub-variants exist with different escape profiles. So in Europe, we are seeing sub-variants like Omicron 2.9 or 2.12.1.

Yes.

And let me let me let me just.

Placed and the overall situation in which we are we got this now now the sinking of different companies, we have the situation there there.

It was an ongoing.

On the current pandemic so 99.8.

Eight or 99.9% of all infections are mediated by on the concept that means we have had situations that cause.

The multiple on the concept that exist.

There's different escape pool size.

So in Europe , we are seeing something like only two nine or two SaaS 0.1 is from Africa, and India and the easily CBA for MB five variants, which.

Unknown Executive: From Africa and in the East, we are seeing BA4 and BA5 variants, which appear to have perhaps even higher loss of neutralization titers. And any decision of a seasonal vaccine must be in line with the actual variants which are circulating at the moment. And we and Moderna and other companies started to evaluate Omicron-adapted vaccine, including monovalent and bivalent vaccines. So that means all companies will generate this data. And we have to match this data which has been generated with evaluating of neutralization titers against the actual variants. And based on that, we have to come to conclusions.

To have a path, even even a high a high a high a lot of neutralization titers.

And and any decision of a season with X gene.

Must.

Be in line with the extra.

Sure variance, which are circling at the moment.

We are.

We're gonna other companies started to as Elliot Omnicom, adaptability, including Warner verdant, vibrant and sexy, but that means or companies that generate this data.

We have two tours Mitch this data was generated.

But anything open authorization titers against the extra value and based on that we have to come to conclusions.

Unknown Executive: That's the way to go. I can't say what is now going to happen in the next few weeks, whether new variants will emerge. But I am pretty sure that any decisions made by an authority must reflect what is ongoing with regard to the sub-variants that are currently in circulation. Thank you. Your next question comes from the line of... Daina Graybosch from SVB, please go ahead, your line is open. Hi, thank you for the question.

To go up.

Can't say what is now going to happen in the next few weeks that are new that included in that but I'm pretty sure that any decisions they make by October .

What is what is ongoing and once they got to the to the cup there instead.

Our interconnection.

Thank you. Your next question comes from the line of.

Dana Gray bars from Seb. Please go ahead your line is open.

Hi, Thank you for the question I'm going to ask another one on this but maybe a slightly different direction you mentioned that the paper that you've published.

Unknown Executive: I'm going to ask another one on this, but maybe a slightly different direction. You mentioned that the paper that you published showing memory B-cell responses against some conserved epitopes after Omicron infection. I think there was a similar one published, I think, from some scientists at Rockefeller.

Showing memory b cell responses against them conserve epitope.

Crown infection I think there was a similar on published I think from some scientists at Rockefeller.

Daina Graybosch: But you looked pretty soon after that breakthrough infection, I think 40 to 50 days. And I wonder what gives you confidence that those broader B-cells and neutralizing antibodies are going to be as durable as maybe neutralizing antibodies more specific against the variant spikes that have some longer durability, as we know from previous vaccinations. Daina, the durability of antibodies, at least in my opinion, is primarily driven by the initial antibody titers, so that is what is happening in the body fluid compartments, including plasma and in the mucosal surfaces.

But you look pretty soon after that breakthrough infection, I think 40 to 50 days and I Wonder what gives you confidence that those broader b cells and neutralizing antibodies are going to be as terrible as maybe neutralizing antibodies more specific it gets the variance spikes that.

That had some longer durability as we know from previous explanation.

Uh huh.

They know the durability of N type of it is in my opinion is primarily primarily driven by an initial antibody titer yeah.

That is that is what is happening in the.

But the fluid compartments, including plasma and.

And in.

And and mucosal surfaces.

Unknown Executive: And we have a second reaction ongoing, which is the continued memory B-cell maturation process. Directly after infection, we will have the memory B-cell response, as we have shown in our paper, is dominated by pre-established memory B-cells, but there will be new naive memory B-cells joining into this reaction, but this naive memory B-cells will have less mutations and lower affinity antibodies, and this will require several weeks, up to three months, until the maturation is established, and then a second booster might help to really generate high affinity antibodies against novel epitopes.

We have a second reaction ongoing with just.

With just a continuous memory b cells.

Maturation process, yes.

Correct Yep infection.

We will have and the number would be set response as we have shown in our paper is dominated by pre established normally be says, yes, but they're the new naive minimally be sad joining into into the screen action, but this is not even remotely be says they'll have a less.

Relocations and lower affinity anti bodies in this movie via.

Couple of weeks up to three months and to.

Maturation Matilda Asian is established and then.

Second booster my tab to really generate high affinity anti bodies anti bodies against novel Epitopes that that is what we bought.

Unknown Executive: That is what immunology taught us, and that is what we are going to expect. That means antibody titers will decline, but on the other side, we will generate novel memory B-cells, which are better adapted to the new epitopes coming from the omicron variant. That's helpful. Thank you. Thank you. Your next question comes from the line of... Say, Jiang Xu from Barenburg, please go ahead, your line is open. Great, thanks very much.

In allergy.

Bob.

And that is what what what we are going to expect that means anti body titusville decline, but.

But on the other side, we will generate nowhere minimally be sets, which are better adapted to that to the.

So the new epitopes coming.

From.

On the contrary.

That's helpful. Thank you.

Thank you.

Your next question comes from the line of.

Sorry, John Chu from Diamondback. Please go ahead your line is open.

Say Jiang Xu: Congrats on the strong quarter. I'd like to ask about the capital allocation. You have 19 billion euros on the balance sheet as of Q1.

Great. Thanks, very much and congrats on the strong quarter I like to ask you about the capital allocation you have 19 billion gross on our balance sheet as of Q1 how.

Unknown Executive: How do you think about spending that cash, particularly on the backdrop of the, The depressed biotech evaluation here thinking about BDM, M&A opportunity a quick quick one on the the, The clotting 18.2 mRNA program, given your history on that target, how do you see that approach differentiated from the antibody approach? Thanks very much. Yeah, thanks very much for the question. Let me start and then I'll pass on to Ugo.

How do we think about spending their cash.

A particular on the back of a backdrop of the.

The depressed biotech valuations here thinking about BD and M&A opportunity.

A quick.

Quick one on the <unk>.

Uh huh.

The clotting 18.2 mrna program, given where your history on that target how do you see that our approach differentiate it from from antibody approach.

Thanks very much.

Yes, thanks very much for the question, let me start and then I'll pass on to go.

Unknown Executive: We have reiterated the guidance, as you've seen, so 13 to 17 billion is the figure. After the first quarter, you know, we feel very, very good about it. I mean, the 6.4 billion that we have reported in revenues, and the profitability supports that we confirm that guidance, as stated at our year-end call, you know, the main focus of our investments remain to invest in our research and development activities and going forward.

We have reiterated the guidance.

So thinking to $17 billion is the figure.

After the first quarter, we feel very very good about it I mean, the $6 4 billion that we have reported in revenues and the profitability supports.

And that we confirm that guidance as stated at our year end call.

Main focus of our investments remain to invest in our research and development activities and going forward, but as you remember we also have announced that we will invest $1 5 billion and the share buyback program that we just had kickoff very recently and that we also will give.

Unknown Executive: But as you remember, we also have announced that we will invest 1.5 billion in the share buyback program that we just had kicked off very recently, and that we also will give our shareholders that have stayed with us for a long time in the past, we give shareholders 500 million euros of a dividend payment in the course of this year. Going forward in terms of, you know, M&A activities, etc., I mean, we have, of course, looked and continuously look into additions in terms of transactions that we can make, collaborations, all kinds of things that we are intending to proceed as we did in the past. But, you know, we can give you closer guidance on where and when we will invest and how much we got to see how things are evolving. But we feel good about the cash position.

Our shareholders that have stayed with us for a long time in the past and we give shareholders 500 million euros.

And payment in the course of this year going forward in terms of M&A activities et cetera. We have we have a quota looked and continuously look into additions in terms of transactions.

Transactions that we can may collaborations all kinds of things that we are intending to to proceed as we did in the past.

But we can give you a closer guidance on where and when we will invest in and how much we got to see how things are evolving, but we feel good about the cash position you've you've heard from me earlier.

Unknown Executive: You've heard from me earlier, that our cash position increased, we collected another 5.2 billion euros mid of April, so you know we're in the ballpark of round about 10 billion or above 10 billion at this point in time, so we feel good about our cash position and that gives us the opportunity to invest money in the years to come. Ugur, you want to take over the second question? I can take over for the second question, which was about our Claudin 18-2 ReBOMAP development.

And that cash position increased we collected another $5 2 billion euros.

Mid of April so we're in the ballpark of round about.

$10 billion or above 10 billion at this point in time, so we feel good about our cash position and that gives us the opportunity to invest money in the years to come.

Sure.

Oh, Glenn you want to take over as the second question.

I can I can take over have a second question, which was about a I'll call. It an 18 tool.

People not development.

Unknown Executive: As you have already pointed out, we have experience with clinical activity of an anti, of a Claudin 18-2 directed antibody, and using mRNA to encode the antibody and circumvent the production, the need for producing the antibody as a recombinant protein comes with many opportunities, and we want to leverage these opportunities for using our ReBOMAP as a single-agent therapy, but also for combining it with other modalities.

I have already pointed out we have.

With clinical activity of.

And tie often called in 18 towards directed anti body and using mrna tour and caught the anti body and circumvent the production the need for producing yantai body as a recombinant protein.

<unk> comes with many opportunities and we want to leverage these opportunities.

You would think a lot of people mop as a single agent therapy, but also for combining it with other modality.

Unknown Executive: Great, thank you very much. Thank you. We will take one further question and the last question comes from Ellie Merle from UBS. Please go ahead, your line is open. Hi, this is Sarah on for Allie.

Great. Thank you very much.

Thank you we will take one further question and the last question comes from Alan <unk> from UBS. Please go ahead. Your line is open.

Hi, This is Sarah on for Alex. Thanks, So much for taking our question.

Ellie Merle: Thanks so much for taking our question. Um, I guess, in terms of, um, CMT-211 and sort of moving into later stage development. What are you looking for and what's your expectation that would make you confident in moving forward?

I guess in terms of.

PMT to 11 and sort of moving into later stage development.

What are you looking for and what is your expectation that would make you confident and moving forward and then on a larger scale I guess, where do you see this fitting in in terms of the other treatment options available and what line of therapy. Thanks.

Unknown Executive: And then on a larger scale, I guess, where do you see this fitting in in terms of the other treatment options available and what line of therapy things? With BNT211, our CAR T-cell therapy directed against Claudine 6, we are still in the dose escalation stage. So we have even not reached the highest dose we actually wanted to administer, yet we see already encouraging and promising clinical activity in particular in testicular cancer as well as in ovarian cancer.

OSP anti 211 of our car T cells as European direct with against coding six yeah.

In the dose escalation stage. So we have not reached the highest dose we actually wanted to yes, we see already encouraging and promising clinical activity and particular in particular cancer.

Unknown Executive: So what we want to do is to continue to collect the data and decide based on aggregate data how to proceed. A CAR T-cell therapy would be something which we would like to position in later lines of treatment. We think that in those indications in which we assess Claudine 6 CAR T-cells, namely advanced metastatic testicular cancer, ovarian cancer, endometrial cancer, rare cancer such as sarcoma, there is considerable medical need.

Well as in ovarian cancer. So what do we want to do is to continue to to call that but they come and decide based on aggregate data how to pursue.

A car T cell therapy would be something which we awards I like our position in later lines of treatment.

We think that in those indications in which we as pets clothing, six car T cells, namely advanced metastatic.

Testicular cancer ovarian cancer endometrial cancer.

<unk> cancer, such as sarcoma, there is considering that the medical need and how exactly we will position would depend on the aggregate data we will produce.

Zohica Maas: And how exactly we will position will depend on the aggregate data we will produce in the dose escalation and dose expansion parts of this initial trial. Thank you. I will now hand the call back to Zilkha for closing remarks. Thank you for joining us today. We look forward to speaking with you in the future. Thank you and bye-bye. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Puts us in a dose escalation and dose expansion parts of this initial trial.

Thank you.

I will now hand, the call back to Bill Clough for closing remarks.

Thank you for joining us today, we look forward to speaking with you in Q2, Thank you and goodbye.

Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.

Thank you.

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