Q4 2019 Earnings Call

Ugur Sahin: I will now ask Ryan to provide a brief update on our announced offer to acquire Neon Teleport. First, however, I wanted to highlight Ryan's appointment as Chief Strategy Officer has significantly contributed to multiple key corporate development initiatives, including the acquisition of Neon, and he was instrumental in successfully taking BioNTech topics in a challenging market environment. I want to thank him for his accomplishments so far and look forward to his continued efforts in helping to execute our global goals. Ryan

Ryan Richardson: Thank you, Ugur. During slide A, in January, we announced entry into a definitive merger agreement under which BioNTech would acquire Neon and all stock transactions. The transaction remains subject to a vote of NEON shareholders, which we expect to take place during the second quarter. For those unfamiliar with NEON, it's a biotechnology company based in Cambridge, Massachusetts, developing novel neoantigen-based T-cell therapy. From a strategic standpoint, this acquisition is a strong fit on multiple levels. For one, it will bring us some exciting preclinical programs, including NeoPTC-01, a personalized neoantigen-targeted T-cell therapy candidate consisting of multiple T-cell populations that target the most therapeutically relevant neoantigens from each patient's tumor. It also brings NeoSTC01, a T cell therapy candidate targeting shared grafts. In addition, NEON has assembled libraries of high-quality TCRs against various shared neoantigens across common HLAs, which we believe will complement our own technology toolkit. NEON's pipeline is underpinned by several complementary platform technologies, including Recon, its machine learning bioinformatics platform, and also Neostim, its proprietary process to directly prime, activate, and expand neoantigen-targeting T-cells ex vivo.

Ladies and gentlemen, thank you for standing by welcome to the biotech fourth quarter <unk> full year operational progress some financial results core.

At this time, all participants are they listen only mode.

I will be a presentation followed by a question is also session.

I must advise he's this call is being caught the today she's data sets effective March 2020.

Not to have the correlated to the Vice President Investor Relations on business strategy Silk Goodbye. Please go ahead.

Ryan Richardson: The acquisition will enable us to significantly expand our presence and capabilities in the United States, which remains a strategic priority for us. Under the terms of the agreement, Niagara would become a wholly owned subsidiary of BioNTech upon closure. As previously indicated, subject to a favorable vote of NEOM shareholders, we expect the transaction to close during the second quarter of 2020. We look forward to closing the acquisition and beginning the integration process. I will now hand over to Ozlem to discuss key updates in our development program.

Thank you for driving up the base, a biotech scope quota and four years 29 to update call.

Before we start quotes you if you decide for this webcast at whether its financial results press release issued this morning, both of which accessible on our website the investor section.

Slide two and three provides giga disclosures related to the pending acquisition no therapeutics.

As shown on slide four during today's presentation, we will be making several forward looking statements.

These forward looking statements include but not limited to the timing for enrollment and completion and reporting data from our clinical cries and preclinical programs.

Ozlem Tureci: Thank you, Ryan. Today I'm going to provide key updates for our pipeline since our last call in November. I'll start with some detail on the effects of the coronavirus pandemic on the timing of our clinical trials. The short message is that we do expect some impact on the timelines we have previously communicated. As shown on slide 9, while our review of the impact is ongoing, we are developing and implementing a three-point plan to manage the still-evolving disruptions that the pandemic is creating.

The potentially registration of nature.

Our clinical trials.

Expectations regarding the timing for completion and potential benefit opening your acquisition.

The impact the called <unk>, and then make on our business and our financial outlook.

Actual results could differ from those we currently anticipate.

You are therefore caution not to place undue reliance on any forward looking statements.

Which speak only as of the date of this conference call at what cost.

Speaking as available for questions today would be we're fine Chief Executive Officer.

Ozlem Tureci: First, we still intend to initiate phase two trials for BNT111, BNT113, and the INAS program as originally planned. We assume that the anticipated start dates of the end of the year 2020 will provide time for stabilization of the clinical trial environment. We believe that the trials of BNT1-11 and BNT1-13, our FIGSEC products for melanoma and for HPV positive cancers, have the potential to be registrational. Therefore, continuing the activities to progress towards initiating these trials is a key priority for the company. Second, we will manage ongoing phase one exploratory and escalation trials to support timely completion. We have seen evidence of floating enrollment in our trials given restrictions at clinical sites and travel restrictions for patients.

Accidentally G.

Our Chief Medical Officer, Some merit Chief business Officer.

With that right.

Right Richardson Chief strategy Officer.

Putting chief financial and operating officer.

I now hand, the call it over to resign biotechs CEO.

Thank you very good it's a catch up that can you all to the Htwo fourth quarter full year 2019 conference call.

I would start to pick up you can put actually mark.

Hello, Brian it's all a significant but that's the cobot 19 pandemic.

This is having a studio.

The globe.

I would invite time Richardson to provide that we see.

Anything you don't care a park acquisition.

In January of this year.

It's the deal with people, who buy some top line up.

But you can go down.

Absolutely.

Ozlem Tureci: We expect BNT111 and BNT114, the TNBC and melanoma FIXVAC trials to be less affected given that these trials are near completion of enrollment. The recently initiated programs, such as BNT112, which is a prostate cancer fix-back, are more likely to be affected by these delays. Third, we expect that there will be delays to some of our first in-human studies planned to commence this year.

Hi, Bill doesn't make a few closing remarks.

Okay. Thank you fancy before opening the call for questions.

To start on slide five.

Well was Uh huh.

Great and nimble pardon step toward our vision building a global next Gen really no telecom company.

Yeah, Bill that bodes well.

No I wouldn't have a parking platform takes blog.

We put catches up.

We ask Bob.

Something along with our upcoming collaborator <unk> pipeline.

Got you know talkies, but the prepaid okay.

We have built a growing number of programs targeting in Texas, we see.

Ozlem Tureci: For now, we maintain timing guidance for our CARVEC program, BNT 2.11. Delayed start of first in human phase one studies may occur for our Rebomax program, BNT 1.41 and 42, our ribocytokine program, BNT 1.51, 52, and 53, and our TLR7 agonist program, BNT 4.11, and also for our influenza program and our rare disease program. At this time, we estimate the delay for these trials at approximately three to six months. Overall, as the coronavirus situation remains dynamic, we will continue to monitor the situation as it evolves.

Most importantly.

Pool gone about reasons, you know I'm on a vaccine program.

Well, it's because anything cobot 19.

Which we initiated earlier this year as part of our project Lightspeed in response to the global coal now by this time that.

Although covert 19 vaccine forgone based on our deep experience in the cast of it feels good and gold footprint in infectious diseases.

Okay. Good dynamics, we have signed a fall.

The possibilities.

Our boat on either see platform.

Oh, it's Jim Fumigants actually its cost structure.

And our both David Gober workshops globally.

Are they come back to the Cobot 19.

Few minutes and provide an update on the status of our pool.

Turning to slide six how accomplishment in Turkey, 19, and so fine. Thank you Sandy didn't work that all right, but it due to execute on our vision.

Ozlem Tureci: We will update investors as appropriate. Now, I will discuss key updates to our clinical pipeline, as shown on the next slide, where we have 10 products and 11 ongoing trials. First, an update on BNT111, our FIXVAC candidate for the treatment of advanced melanoma. Data from our Phase I trial in advanced melanoma is on track to be published soon. Further regulatory discussions have occurred regarding next steps, and I will provide more details later.

The total 19 look a transformational year coupon.

Yeah continue.

Momentum this year.

A challenging market backdrop.

I want to pick the highlight a few.

Yeah cheap.

Consistent with consistent with our faith objective.

Yes increased the number of product candidates in clinical testing from seven to 10 since the completion, though I P October last year.

No.

Tension to initiate multiple late stage studies over the next month.

Yes, the increase of Apama partnerships for the recent expansion Oh by the collaborations.

And that now or.

Asian partnership.

[laughter] catching alliances.

I mean generally this year.

We announced the signing of a merger agreement Oh fluctuate by and beyond a party.

Ozlem Tureci: BNT112 is our fixer candidate for the treatment of prostate cancer. Losing of patients in a Phase 1, 2A study has been initiated. Eligible patients for dose titration have metastatic castration-resistant prostate cancer.

With me on shelf, we'll get more vote in favor of the merger and the other condition to closing on net.

Thanks to bring some exciting new pipeline candidates.

So therapy space.

These are complemented with technology and how.

And the U.S. on he.

With the park the going on both studies, we are conducting in the U.S.

Ozlem Tureci: In the expansion part, also patients with newly diagnosed high-risk localized prostate cancers are eligible and will be treated with BNT112. BNT-114 is a program that evaluates a range of novel antigens for the treatment of TNBC for immunogenicity in a phase 1-2 trial. Data was previously expected to be presented at the KIMT annual meeting, scheduled for May.

And be completed two successful financing healthier Vietnam.

Costamare IPO, which together both in cost puts it puts see 374 million for the company.

Lastly, we made good progress our multiyear investment book on.

Our in house Messenger on here, Ken Tarpey manufacturing capacity.

When a section the music Keith hedging Powerpc products.

We had bought a pop tarts.

Hi can.

We'll go to market.

And then I'll turn to start seven and discussed covert 90, the growing globally have correct. That's has dominated the but attention over the past.

Ozlem Tureci: Given the postponement of the conference due to the COVID pandemic, BioNTech is evaluating the appropriate opportunity to present the data later this year. Moving on to our individualized neoantigen-specific immune therapy, or INS, program. Earlier this year at our G.P.

Earlier this month, we announced that we are developing a vaccine which aims to infuse immunity and prevent covert 90.

You can issue that the project lightspeed because these periods, we have to beauty to fully utilize our technology and you look up the expertise so had talked about Dan Hutchinson paid by the global set the pace of packaging.

Ozlem Tureci: In Morgan's presentation, we provided some additional clinical data from the Phase I trial for BNT121, the precursor to RO7198457 or BNT122. This data update demonstrated stable disease in melanoma patients for up to 60 months post-vaccination. For BNP122, we disclosed with Genentech that two additional phase two clinical trials in the adjuvant setting are planned for initiation in 2020. The first etch-a-vent-case 2 study will evaluate the efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers of BNT1-22 plus atelzolizumab compared with atelzolizumab alone in patients with stage 2-3 non- The second indication has not yet been disclosed.

Bob covered 90 book on the I leveraging club popularity messenger Ami platform, but infectious diseases.

Oh wholly owned GMP manufacturing costs.

Let's see production.

Our global can you talk about capabilities.

Yeah popping up the cargo oversight development a few of US scene and have also kept the potential allies.

Welcome to develop the vaccine in China.

We have built in close contact with bank locally.

Automotive onto the birth and in ongoing discussions with good service organization.

We anticipate initiating clinical testing in late April subject to regulatory approval.

We expect to conduct a global development program and Europe, United States in China.

Our M&A vaccine for corporate 90 explored the highest importantly pick nanoparticle or Ellen Pete messenger on either seaport.

We believe that M. on it it seems I viewed it futures for this challenge.

Among the vaccines have been shown to be highly immunogenic and in Houston Youre not integrity.

T cell responses.

And money is a naturally occurring molecule.

Okay, all right safety properties.

Furthermore.

I am honored that fees are better defined by a from a thought because with type here with you and and movement here we.

Ozlem Tureci: Regarding the INS Phase II trial in first-line melanoma, we still plan to provide detailed interim data in 2021 and an enrollment update in H2 2020. We expect the interim data in 2021 to include top-line efficacy and safety data as of that date. Now turning to our intratumoral immune therapy program partnered with Sanofi, the data update from the ongoing Phase 1-2 trial of BNT131 in solid tumors remains on track for later. I'm also pleased to report that our Next Generation Checkpoint Immune Modulatory Program, partnered with GenMap, is moving rapidly. Top-line data from the Phase I-II trial, BNT311, in multiple solid tumors is now expected in the second half of this year, ahead of our previous expectations for data readout in the first half of 2021.

We believe M&A vaccines.

Several advantage over traditional vaccine approaches.

Looking at believe T. too precise it's Simon manufacture them the cat rapidly in a large quantities.

Sean do you want to say a few of US about our recently announced collaborations for October 19 vaccine.

Thanks to go.

The Cogent 19 that collaboration with one is the world's largest pharmaceutical companies high so I'm one of the leading healthcare groups in China, So since phone.

Just a few weeks ago, we signed a letter of intent the size of regarding development B and C. Onesix to outside China and expect to provide more details of the financial terms the article operations.

As we already have a successful collaboration with Pfizer for infectious diseases aimed at developing influenza vaccines.

I've been able to major Vista outdoor too aggressively iphones PMT, Brian Institutes was clinical testing for the prevention.

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We are currently utilizing multiple research and development sponsored by file that can find side.

Look forward to providing further updates on that softness in collaboration in the future.

Ozlem Tureci: And finally, progress has been made in our clinical program for BNT321. The first patient has been dosed in the Resumed Phase I-II Study, evaluating the safety and recommended Phase II dose of BNT321 in patients with pancreatic and other CA99-positive malignant tumors. I'll now move to slide 11 and provide some quick updates on our preclinical pipeline. First, for our six-pack portfolio, BNT116 has been added to our product portfolio and is currently in preclinical development for non-small cell lung cancer. As I mentioned earlier, BNT2-11, our CAR-T program targeting solid tumors, is on track to go into the clinic in the summer of this year. This program combines our CAR-T therapeutic approach with our mRNA vaccination and uses our proprietary tumor-selective target cloridine therapy.

We also recently announced our strategic alliance with Tyson Thomas.

Our first strategic collaboration in Asia to jointly develop figure in tea once it too in China.

Together with phase and solve that we intend to conduct clinical trials in China, leveraging already marinade vaccine technology, and manufacturing and folks move extensive clinical development regulatory and commercial capabilities in the country.

Under the agreement based companies will collaborate to conduct clinical trials in China.

Facing pharma has the right to the master license vaccine in China, and Wolcott type B on ticked up to a U.S. dollar those 175 million.

That's year AEZS 120 million in upfront on potential future investment a milestone payments.

The two companies, which have future gross profits from the sale of the vaccine in China.

Sure.

Well I move on I look back to note that got caught in monotone disagree we talk to the potential impact covert 19 on how operation.

That's an injectable provides additional detail later the core.

But there has been impact.

Oh, I see that the economy cases prize timeline.

Ozlem Tureci: For our TLR7 agonist, BNT411, the IND was allowed in Q4 2019. We expect Phase 1 initiation later this year. Lastly, Project LIFE.

In particular.

Got it.

For 2017.

He will continue to monitor the situation and provide updates as appropriate.

I will now on to pull back a brief update.

Ozlem Tureci: As Ugur mentioned earlier, we expect to dose the first patient in our clinical program testing BNT162, our COVID-19 vaccine candidate, in April this year. Now, on slide 12, I want to give some additional detail on two of our most advanced immune oncology programs, BNT1-11 and BNT1-22. For BNT111, our melanoma six-pack, we expect data from our phase one trial in advanced melanoma to be published in a medical journal in late H1, 2020. As I mentioned earlier, we have had further discussions with regulatory authorities regarding next steps and the design of a registrational trial. Based on those discussions, we believe there may be potential to conduct a registrational phase two trial instead of a phase three trial. We are not providing full trial design details at this time, but we can say that we expect ARMS to include BNT1-11 in combination with a checkpoint inhibitor and control.

Now I'll start by Aneel untapped politics.

First tell about I wanted to highlight kinds of president and Chief strategy Officer.

Yes significantly contributed to multiple key corporate development initiative.

Including the acquisition of New York.

And he was implemented successfully taken by on the topic in a challenging market and bad.

I'd like to thank him for his accomplishments of prime and look forward, but could continue efforts in how team to execute our global.

Go fishing.

Hi.

Thanks.

Turning to slide in January we announced entry into a defensive merger agreement under which bounce back would acquire.

Oh, sorry from Washington.

The question remains subject to a little shareholders, which we expect to take closed during the second quarter, but those are familiar with.

Biotechnology company based in Cambridge, Massachusetts, developing novel Neoantigen T cell therapies strategic standpoint, its acquisition of the strong sit on multiple levels.

One that will bring us something exciting preclinical programs, including Neo PTCL one.

Personalized neoantigen targeted T cell therapy candidate consisting of multiple T cell populations as hard as the most therapeutically relevant neoantigens from each patient's tumor.

It also brings new sgc or one.

He cell therapy candidate targeting showed RASK.

In addition, the arms assembled libraries of high quality cheese yards, which is very shared neoantigens across common utilities, which we believe will complement our own technology tool kit.

Ozlem Tureci: The study population will be patients who are checkpoint inhibitor experienced; we expect to provide a further update on the expected trial design in Q3 2020 for BNT 122. A data update for the Phase 1-2 trial in multiple solid tumors was planned at the AACR annual meeting, which due to the COVID-19 pandemic, has been rescheduled for August 2020. Our data is embargoed until that presentation, so we are very pleased that INES was included during the recent Genentech Research and Early Development, or GRET, event for those that may have missed the presentation. Genentech highlighted INES' potential to provide a personalized cancer vaccine for a broad range of cancer patients. I will now hand the call over to Zirk to discuss our current financial results for the fourth quarter and full year 2019.

Yeah. Its pipeline is underpinned by several complimentary platform technologies, including recall is machine learning bio informatics platform and also Neos is proprietary parcels to directly PON. After they spend deal antigen party T cells ex vivo.

The acquisition will enable us to significantly expand our presence in capabilities in the United States, which remains a strategic priority for us.

Under the terms of the agreement Neon will become a wholly owned subsidiary bound tech upon closing as.

Indicated subject to a favorable shareholders, we expect the transaction to close during the second quarter of 2020, we look forward to closing the acquisition and beginning to integration process.

I'll now hand over to allow them to discuss Europe is an article.

Thank you Ryan.

Today, I'm going to provide updates for our pipeline our last call in November.

I'll start with some detail on the SEC I'll circle in a virus dynamic on the timing of I'll Luxottica trials.

Ozlem Tureci: Thank you, Ozlem. So before presenting the financial results, I would like to provide you with information on the measures that we put in place in order to mitigate the potential impact of the coronavirus pandemic on our operations. In response to the coronavirus outbreak, we continue to monitor the potential impact on our supply chain and manufacturing operations, which includes mRNA manufacturing for FIXVAC and INS platform products, as well as our CAR-T manufacturing site. So far, our manufacturing operations are unaffected and still running at full capacity. In terms of our personnel, we have instituted measures to ensure their safety for precautionary reasons. We are closely monitoring any employee that has potentially been in contact with affected individuals or in affected areas, and we are limiting access to BioNTech facilities as appropriate.

Pradman such as such we do a tax.

Impacts the timelines we have previously communicated.

As shown on slide nine why aren't you also in Texas ongoing we are developing and implementing the three point plan to manage their evolving disruptions. That's the pandemic is creating.

Yes, we still intends to initiate it takes to try its club Yankee 111, Yankee 113 into Imus program. As originally planned should we assume that the anticipated that tail end of year Twentytwenty provides sometimes for stabilization offer the clinical trial and bye.

We believe that's the trial.

Yes, he won 11 BMT 113.

Our success products for a particular fabiano Maia and for HPV positive cancer.

I have the potential to be registration studies, that's while continuing this.

The activities to coral crest towards initiation healthy trial is a key priority for company.

Unknown Executive: Now I would like to summarize our financial results, which are shown on slide 13. Cash and cash equivalents as of December 31st, 2019 were 519.1 million euros. As we indicated earlier in the year, we expect net cash used in operating activities and other investments to total approximately €300 billion for the full year of 2020. At this time, we are maintaining that guidance.

Second we wouldn't manageable ongoing pays one exploratory and dose escalation trial supports timely companies.

We have seen evidence of floats enrollment in our trials.

In the restrictions that clinical sites and travel restrictions for patient.

Yes, you want needed Aspen and a one for.

The key NBC and summit on no Moxi Vanc trials to be left the Texas given that these trials on near completion of enrollment.

Unknown Executive: The total revenue, consisting primarily of revenue from collaborative agreements, was €28 million for the fourth quarter of 2019 compared to €63.8 million for the prior year period. The decrease was primarily due to decreased revenues from our collaboration with Samovar. Total revenue, consisting primarily of revenue from collaborative agreements, was €108.6 million for the full year of 2019 compared to €127.6 million for the prior year. The decrease was primarily due to decreased revenues from our collaboration with Sanofi. The decrease in revenue from Sanofi is primarily driven by revenue of €33.2 million for a one-time reimbursement of certain substancing costs that were fully recognized in the year 2018. Research and development expenses were €65.4 million for the fourth quarter of 2019 compared to €51.8 million for the prior year period.

The recently initiated programs such as CNG, 112, which as prostate cancers that are more likely to be as hectic fivea ceiling.

Such that we expect that that there will be delayed some of our first in human step.

Blends to commence this year.

I'll now, we maintain timing guidance crawl walk Hawick program empty to 11.

Thanks, Todd first in human Phase one studies may occur caught a lot we will not program in Q1, 41, and 40 tool out right what cytokine programs Yankee 150, 150 253.

And our CAD seven agonist program began keep for 11.

And also for awhile.

That's helpful from and allow Ramsey.

At this time, we estimate the delay was flat at approximately three to six month.

Overall it as the core virus situation remains dynamic we will continue to want each office situation as it evolves, we will update investors as appropriate.

No I discussed updates Clarkson indicative pipeline as shown on.

The next lives, where we have products and 11 ongoing trials.

First an update on in Q1 11, almost expect candidate for the treatment of advanced melanoma.

Unknown Executive: The increase was primarily due to an increase in headcount and higher expenses regarding our collaboration project. Research and development expenses were €226.5 million for the full year of 2019, compared to €143 million for the prior year. The increase was primarily due to an increase in headcount, the full-year impact of our ESOP program, and higher spending for procurement services and laboratory supplies for the project.

Data from our phase one trial in advanced melanoma is on track.

Published who.

So I've got regulatory discussions have occurred regarding next.

I will provide more details later.

Yes. He won two assets I want to fix that can be dates arbitrate treatment of prostate cancer.

The hofh patients in a phase one two ace study has been initiated Elizabeth patient dose titration have much as Patrick castration resistant prostate cancer in the expansion parts also patients with newly diagnosed hiring localized prostate.

Unknown Executive: General and administrative expenses were €11.1 million for the fourth quarter of 2019 compared to €10.1 million for the prior year period. General and administrative expenses were €45.5 million for the full year of 2019 compared to €26.3 million for the prior year. The increase was primarily due to an increase in headcount, the full-year impact of our ESA program, and a charge in connection with certain withholding tax payments for intellectual property licenses that were recorded in the year 2019. The net loss was 58.2 million euros for the fourth quarter of 2019 compared to a net loss of 1.5 million euros for the prior year period. The net loss was €179.2 million for the full year of 2019 compared to a net loss of €48.3 million for the prior year. Shares outstanding as of December 31st, 2019 were approximately 226.8 million.

Handsets.

In digital and wed be treated with CNC one to have.

Nick Yes, Q1 14.

It's a program that they like the range of novel antigens for the treatment of T. N. He thought immunogenicity in a phase one two trial.

I was previously exits to be presented X cabinets, and you and Ching scheduled for May given the puts Coleman potent also conference due to the public pandemic biotech is evaluating the appropriate.

Switching to present the data later this year.

Moving onto our individualized neo antigen specific ones here Pete online this program.

Yeah. This year, it's all watching P. Morgan presentation, we provided some additional clinical data from the phase one trials Fabianski 121, the three cars that tool.

079.

45, seven Fabianski Onetwenty tool.

Data update demonstrates its David.

In melanoma patients up to 16 months post vaccination.

Ugur Sahin: With that, I will return the call to Ugur for concluding remarks.

Yes, 122 weakness notes with Genentech that two additional clinical trials in the extra than setting up 10 for initiation in Twentytwenty.

Ugur Sahin: Thank you, sir. Following a strong and productive 2019, we have several important milestones ahead of us in 2020, as shown on slide 14. This includes six trial updates, including publishing BNC111-Kickback Melanoma Phase I data in a peer-reviewed journal. We look forward to initiating a trial for our BNT111-6-VAC melanoma candidate, which we believe has registrational potential. We also expect the initiation of two additional IMF trials in acute stage cancer this year. By the end of next month, we expect the start of the clinical testing of our COVID-19 vaccine candidate, BNT-162. I would like to point out that we expect to start a Phase I-II trial using CARBAC BNT-211 in six positive solid tumors, and we want to start a phase one trial of our TLS7 program, BNT411 in solid tumors. Lastly, we will work to integrate our U.S. hub in Cambridge, Massachusetts following the expected closing of the NEON acquisition in the second quarter of 2020. We look forward to updating investors and other stakeholders throughout 2020. We thank our shareholders for their trust and support. We will now take any questions you may have.

The first Utrophin takes one study will evaluate.

Safety pharmacokinetics, Immunogenicity and Biomarkers of Yankee 122, plus a piece. So you still have comes out with a piece would be some afternoon in patients with stage to sweep non small cell lung cancer was positive phosphate circulating tumor DNA eight following surgery.

<unk> resection and have received standard of care actual than platinum doublet chemotherapy.

I can indication has not yet.

Yes.

Regarding the Imus phase two trials in first line melanoma, we still plan to provide details interim data in 2021 and done enrollment updates.

H. to Twentytwenty.

We expect that interim data in trend. He 21 to include topline efficacy and safety data as of the interim data.

Now turning to our intra tumoral immunotherapy program partner with Sanofi.

The data update from the ongoing phase one two trials Yankee 131, and solid you must remains on track for later on this.

I'm also pleased to report said on next generation checkpoints immune Modulatory program hotness with gem that is moving rapidly topline data from the phase one two clients yen Keith Creel, you would happen in multiple so the two malls is now expected in the second top off this year ahead of our previous expected.

Unknown Executive: Thank you. Thank you. Thank you.

Unknown Executive: Thank you very much. As a reminder, if you'd like to ask a question over the phone today, please press star then 1 on your telephone keypad and wait for your name to be taken. You can cancel the request by pressing the hash key.

Patients hard data read out in the first hop off Thank you Spencer.

And finally progress made in our clinical program called Yankee Cretaprint Tivo one the first patient has been dose in the resumed phase one study evaluating the safety and we commend the pay those off CNPC 21 in patients with pancreatic and others.

Unknown Executive: Once again, stab in one if you'd like to ask a question over the phone today. The first question we have today comes from the line of Corey Casmoth from J.P. Morgan. Hey, good morning, guys. And thank you for taking my questions. A couple of them for you, I guess to start your COVID-19 program being BNT 162, is what are the gating factors to getting this product into the clinic? And can you maybe discuss at a high level how your vaccine approach might be differentiated?

The a 99 positive medical.

I know two slides 11 and provide some quick updates on our preclinical pipeline.

So I want to expect portfolio 116 has been added 12, Florida portfolio and currency in preclinical development, one non small cell lung cancer.

Ugur Sahin: Yeah, thanks for the question. So the development of the COVID vaccine is based on our in-house platforms. We have three messenger RNA platforms that are currently exploited for the development of COVID vaccines exploiting different epitopes. So it's the modified messenger RNA platform, then the eugene mRNA-based platform, which we are using currently for the treatment of cancer patients, and the self-emphasizing RNA platform. Then, the sequence of development events is based on preclinical evaluation of signals and on GMP manufacturing of the materials, GMP toxicology, and discussions about the clinical trial design with the regulatory authorities in Germany, China, and with the FDA and the related ethics committees. We are on track in the development of our vaccine approach and expect a timely start of the first clinical trial in Germany in the second half of 2020. The differentiation factors of our vaccine platform is one intention that we get, and develop a vaccine that is not only safe, but it enables an immune response with neutralizing antibodies with the lowest possible dose.

As I mentioned earlier the engines to 11, our Hearts and program targeting thought it you must is on track to go in vaccines in some of it Yeah. This program combines our Karachi Tierpoint Dick approach with <unk> and R&D vaccination and uses our proprietary too much selective target audience.

So let's get us seven.

Yes. He fought 11. The idea was allowed to include for 2019 weeks phase one initiation later this year.

The das projects nights.

Well I mentioned earlier, we expect to dose the first patients in our clinical program testing BNP 160 tool our cold with 19 vaccine candidates in April.

Now on slide 12, if I wanted to get some additional educated on two of our most it's on immuno oncology program.

Thank you won 11 and yes, you won 22.

12, Yankee 111, how long it on almost expect we package data from our phase one trial in advanced melanoma to be population the medical journal.

Unknown Executive: Okay, and then from a timeline point of view, would you expect us to follow a similar path to other vaccines that have been publicly commented on?

Right H ones.

As I mentioned earlier, we have had forgot discussions with regulatory authorities.

Unknown Executive: To which type of vaccines do you refer? Well, the other COVID-19 vaccines that we've heard about from other companies that have been commented on, that they've talked about, and they've talked about timelines, and they've talked about things like 12 to 18 months in a situation like this, potentially.

Regarding next steps.

Design author Registrational trials.

Based on those discussions we believe there may be potentially to conduct a registrational phase two trials instead of a phase three trial, we are not providing for trial design details at this time, but we can say that affects the arms to include with PNC 111 in combination with a checkpoint.

Unknown Executive: I think that's kind of a realistic expectation for your program as well.

Ozlem Tureci: So maybe I can take this one.

The trial and controls.

Unknown Executive: These are plausible sounding timelines. At the end of the day, the timelines will depend on the positions of regulatory authorities and on the basis of which type of data such a vaccine would be made available to a larger population. So this will need to be really worked out in the ongoing discussions. We and also the other companies you are referring to have with the regulators and the data which we can all present from our side.

Second population will be patients, who are checkpoint inhibitor <unk> billion.

We expect to provide further uptake on next steps of trial design in Q3 20 times.

[noise] club Yankee 122.

And data update for the phase one two trials in much of this target you malls was planned at the Ace yet HCR, England Kim.

Unknown Executive: OK.

Unknown Executive: Thank you.

Unknown Executive: Yeah.

Ozlem Tureci: And then one non-COVID-19 question, if I may, can you just give us a sense of where you are in terms of dose escalation for BNT311 and how much data we should maybe expect in the second half of this year?

Which skewed to the called its 19 pandemic has been we scheduled for August Twentytwenty.

Our data is embargoed until two that's presentation.

We have every piece that I just was included during the recent Genentech research and early development or Georadar event cargoes that may have missed the presentation Genentech highlighted I know potential to provide a personalized cancer vaccine for a broad range of cancer pain.

Ozlem Tureci: That's the dual bodies.

Unknown Executive: Yeah.

Unknown Executive: We are; you refer to the PD-L1-4.1BB dual body which we are developing.

Ozlem Tureci: In cooperation with our partner GenMap, we are pretty advanced in our dose escalation, so we have cleared a number of dose levels which were planned, and the data disclosure presentation would definitely include data referring to the safety of the different doses, probably also the phase 2 dose. OK. Very h

Yeah.

I will now hand, the call it over to discuss our current financially side of the fourth quarter and food Yeah Centsnine.

Thank you.

So before presenting the financial results I would like to provide you information of our measures that we put in place in order to mitigate the potential impact of the colonial powers endemic on our operations.

In response to the Corona virus outbreak, we continue to monitor for the potential impact to our supply chain manufacturing operations, which includes our manufacturing for fixed.

Unknown Executive: Okay, very helpful. Thank you for taking the time. Thank you very much. The next question today comes from the line of Tazeen Ahmad from Bangkok. Hi, good morning.

And this kind of core product as well as our car T manufacturing sites.

Ozlem Tureci: Thanks for taking my questions. With regard to your publication that you mentioned in your prepared remarks that is expected in the second half of the year with phase one data for melanoma, can you give us an idea of what level of detail you expect to have in that article? And as it relates to the potential for a registrational study, what in your discussions with FDA gives you confidence that you would be able to potentially use the next study as registrational versus having to do a full phase three? Thank you.

So far or manufacturing operations or unexpected and still running at full capacity.

In terms of our personnel, we instituted measures to ensure the safety precautionary reasons.

We're closely monitoring any employee that has potentially being in context.

Affected individuals or affected every us every limiting access to play on think facilities as appropriate.

Now I would like to summarize all financial results shown on slide 13.

Ozlem Tureci: So the first question referring to our publication, here, the data we will publish are data that come from our lipomeric trials of a dose escalation, dose expansion trial with our melanoma fix-back in a heterogeneous population of patients with advanced melanoma. And what we will publish, the focus here is primarily on the mode of action of the vaccine, which we show for the first time in humans, in particular the immune responses, their magnitude, their type, and their kinetics, but also some safety and activity data.

Cash cash equivalents as of December 31st 2019 works by sort of 19.1 billion euros.

As we indicated earlier in the year, we really expect net cash used in operating activities and other investments to total approximately 300 billion euros or the full year off 2020.

At this time, we are maintaining guidance.

Revenue, consisting primarily of revenue from collaborative agreements was 28 million for the fourth quarter of 2019 compared to 63.8 billion euros well. The prior periods. The decrease was primarily due to decreased revenues from all collaborations with similar.

Total revenue consisting primarily of revenue from calibration Greenlanders was 108.6 million euros for the full year 2000, Nike compared to 127.6 million dose for the prior year.

Ozlem Tureci: Okay, thank you. And as it relates to your discussions with the FDA on the potential for registrational studies,

Ozlem Tureci: The discussion with the FDA was, of course, based on the design of the clinical trial, the statistical parameters required to show the endpoints of the clinical trial, and the treatment and control arms. And based on this discussion, and we will further provide updates, specific updates about different arms and the size of the arms later on, based on our discussion with the FDA, we are confident that if we can deliver the requested study design, then the FDA would be in agreement with the registrational nature of the trial.

The decrease was primarily due to decreased revenues from all collaboration with Sanofi.

Decrease in revenue from Sanofi is primarily driven by revenue of 33.2 million Euro.

Or a onetime reimbursement of certain sub servicing costs that was fully recognized in the year 2018.

Research and development expenses were 65.4 million jewels for the fourth quarter of goods 19, compared to 51.8 billion yours for the prior periods.

The increase was primarily due to an increase in headcount and higher expenses regarding our collaboration projects [noise].

Ozlem Tureci: And would that require an in-person meeting once you deliver the study design?

Ozlem Tureci: Sorry, can you repeat that?

Unknown Executive: Once you deliver the study design to the agency, would you then need to have an in-person meeting with the agency to determine if this can be registered?

Research and development expenses were 20 to 26.5 million euros for the full year of 29 team compared to 143 million euros for the prior year.

Ozlem Tureci: In general, the agency also enables non-in-person meetings or phone conferences, so that would also be sufficient in this case. Okay, thank you.

Increase was primarily due to increasing headcount the for your in pick up or you saw program at higher spending Propetro services in the board through supplies for the projects.

Unknown Executive: Thank you very much. The next question today comes from the line of Shang Shan Zhu from Beirut. Hey, good morning.

General and administrative expenses were 11.1 billion euro for the fourth quarter offering by PD compared to 10.1 billion euros for the prior year period.

Ugur Sahin: Regarding BNT162, that's the COVID-19 vaccine, among SMEN proteins, what could be your targets? And are you thinking about receptor binding domains? And you also mentioned that you saw neutralizing antibodies. And I have one follow-up.

General and administrative expenses were 45.5 billion euros for the full year of 19 compared to 26.3 million euros for the prior year. The increase was primarily due to increasing headcount the full year inside of our Isa program and it's hard to connection with certainly withholding tax payments.

Ugur Sahin: Thank you, Shanshan, for the interesting question. So, yes, we are evaluating different epitopes, including the full-length spike protein, but also subdomains. We will provide details of our subdomain vaccines in the coming weeks and immune responses that we observe against the full-length protein and the subdomain parts. We have established a number of assays studying immune responses in mice, including antibody responses, T-cell responses, and neutralizing antibody responses using pseudotype and virus-based neutralization assays. And based on these assays, we are confident that we can reduce the spectrum of candidates to a meaningful number to be tested in the clinical trial.

Property licenses.

Recorded the 21 team.

Net loss was 58.2 million euros for the fourth quarter of 2019 compared to net loss of 1.5 billion euros for the prior year period.

Net loss was $175.2 million for the full year olds couldn't luncheon compared to net loss of 48.3 million for the prior year.

Yes outstanding as of December 31st 2019 were approximately 226.8.

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

Thank you stuck followed in the wrong and productive 2019, several important milestones ahead.

Thank you.

On slide 14.

These include six pride optics.

Including publishing BNP run one month excitement no no no it's been data in a piece of that John.

We did you look farther to the initiation of the car follow up BNC runs on exact melanoma candidates.

Ugur Sahin: Okay, thank you. And another question regarding the RNA format and also the delivery formulation. So modRNA, that's the modified RNA, that is the mRNA format you used in your Zika vaccine. To us, it is not highly immunogenic. Can you tell me...

The tree relief as we get price not potential.

You are also expects the initiation of two additional I'm not quite accurate stage cancer. This year.

By the end of next month Big fix the initiation of the clinical testing or covert 19 vaccine candidate BNP on is 62.

Ugur Sahin: What is the scientific rationale of using it in an infectious disease vaccine? And also for your delivery formulation, the lipid nanoparticle, ILNP, you saw that.

I would like to point out that they expect to stop at phase two trial using kabak BMT too on the 11 intelligent six posted solid tumor.

Unknown Executive: With this delivery technique, it was modified to shift the immune response more towards

And we want to start a pace on time or Pls seven program BNP.

Unknown Executive: Can you share with us what modifications have been made to this LNP formulation to increase Th2 activation? Thank you very much.

11.

So when it killed.

Not really feel we're up to integrate our.

Ugur Sahin: Yeah, you're welcome. Actually, we have a set of mechanistic data that the different platforms which we are using all produce different levels of Th1 responses. So, it is also the modified RNA platform together with a novel formulation has strong T-follicular helper immune responses and, most importantly, induces highly neutralizing antibiotic responses, which in our working hypothesis are the most important immune response parameters required to control COVID-19. We use the unmodified mRNA platform since it comes with a TLR7 co-stimulatory activity to evaluate if the additional TLR7 agonistic activity can further And we are using a self-amplifying RNA-based approach to further elaborate whether, due to the self-replication based on the vaccine amplification after delivery, we can further reduce the dose. There is evidence in preclinical settings. We have published data showing that this is the case for HIV, and this is the case for the influenza vaccine. And, therefore, based on the preclinical data that we have seen for COVID-19, which are encouraging, we decided to evaluate this platform in a clinical trial.

Have you, Cambridge, Massachusetts, probably always expected closing up and the on acquisition in the second quarter tend to attend.

We look forward to.

Update you invest that and that's a quota for authentic fenty.

Think about shell hurt us for the past and support.

We'll now take any questions you may have.

Uh huh.

Thank you very much as a reminder, if you'd like to ask a question over the phone today. Please press Star then one on your telephone keypad and what's your name to be taken you can cancel request by pressing the heskey.

Once again, stopping one she'd like to ask a question over the phone today.

First question, we have today comes from the line of the Cory Kasimov <unk> from JP Morgan. Please go ahead.

Hey, good morning, guys and thank you for taking my questions. A couple of them for you I guess to start your covert 19 program being be on T. Onesix too.

What are the gating factors to getting this this product into the clinic and can you maybe discuss at a high level, how your vaccine approach might be differentiated.

Yes, thanks for the Crescenzo ahead there.

The development of Cowen Sexiness based on our in house, perhaps farms, we have pre messenger on its grass farms, Mitch Mitch can explore it cuts for development of Colditz axiom.

Unknown Executive: Perfect, thanks. Thank you very much. Hi. Yes, thanks for taking my question, Naveen, from UBS. So a couple of questions. Just as it relates to targeting this spike protein, can you give us any kind of color of how you're thinking about whether mutations around the spike protein could create selective pressure? And then with regard to that, how are you thinking about timelines, what data you need to see to ensure that that won't be an issue? And then separately or along the same sort of lines, how are you thinking about antibody-dependent enhancement? Thank you so much.

Cartoon discern epitopes as rates, the and Marty talked messenger on it cuts farm than the Eugene.

On a basketball mature using currency in the treatment of cancer patients and and assess emphasizing on perhaps Tom.

Then the sequence of development events is based on preclinical and variation of self signals and.

Key money section of the materials GLP toxicology and discussions about the clinical trial discern, let's but the regulatory authorities in Germany, China and with it.

Ugur Sahin: Yes, thanks for the interesting questions. So first of all, first of all, there are now emerging publications showing the genetic profile of different COVID sequencing data, and the positive conclusion from the studies is that the COVID-19 genome is relatively stable. We have also done a deeper look, particularly at the epitopes that we are targeting, and we see minimal differences in different COVID variants isolated in different regions of the planet, so we are confident that escape of the spike protein is not an issue.

And the related conatus.

Yeah on correct in the development of our vaccine approach and expect that time he starts up.

Couldn't put aside and Jim and second tough consensus the differentiation sectors of our vaccine cuts from its just been burns intention is that you get to.

The next year, because not only said, but it's an easy but ER immune responses merchandising anti bodies with those possible goes.

Unknown Executive: Perfect. Thank you so much. Hi. Thank you for the question.

Okay, and then from a timeline point of view would you expect us to follow similar path to other vaccines that have been publicly commented on.

Unknown Executive: First, a couple of questions on COVID-19, and I want to ask one about your oncology work. We've heard some people speculate that coronaviruses may need a T-cell immunogenesis response in addition to an antibody response, and you've talked mostly about an antibody response, and I wonder if you can talk about a cellular response and how important that is in your preclinical work. And the second question is, there's a lot of speculation about how durable immune responses are to coronaviruses, broadly in COVID-19 specifically, and can you help us understand how you're thinking about durability of protection with your vaccine and your hypothesis on necessary boost schedules?

Mmm, which type of fixed since it's a new laws are there other covert 19 vaccines that we've heard about from other companies that have been comment that they've talked about and they're talking about timelines and talked about things like 12 to 18 months in a situation like this potentially get it from start to finish do you think that's a kind of a realistic expectation for your program as well.

So it's so maybe some cannot yet I can take a this one.

These oh God with the sounding timelines at the end up a day.

This was the timelines will depend on a on positions of regulatory authorities and based on which type of data such a vaccine watch.

It would be made available to a larger population. So this will.

Needs to be really worked out in the ongoing discussions we and also the other companies you are referring to have what's a regulator sensor data, which we can on everything from our trials.

Ugur Sahin: Yes, yes, first of all, first of all, all of our formats in use in combination with the formulation we are using the powerful CD4 as well as CD85 response. So that's, that's, that's not an issue.

Yes, yes.

And then one non cobot 19 question if I make you just give us a sense of where you are in terms of dose escalation for a b M. T 311, and how much data we should maybe you expect in the second half of this year.

Ugur Sahin: The second is the durability of the immune response induced by the virus infection itself is something different than the durability of the immune response induced by a vaccine. So we are using here a vaccine with an inherent adjuvant effect. And we see with this type of vaccine, regardless of the epitopes that we are using, long-lasting immune responses. We have shown that for our, for our, for all of our platforms, that we observe long-lasting neutralizing antibody responses for more than one year with the different platforms and T-cell responses, long-lasting T-cell responses. So we are not concerned with regard to the durability of the immune responses that we are generating with the vaccine. With regard to the durability of immune responses that are generated by the COVID-19 infection, we have just to wait because the data are emerging, and long, long, long-term observational data are needed.

That's a 240.

Doing well we are.

You refer to.

PDL one for one BP dual body, which we are actively developing a in cooperation with our partner agenda.

We are pretty advanced and all odd dose escalation.

So a have a clear.

A number of those levers, which were planned and of a of the data a.

Close all presentation awards are definitely includes data they are referring to safety all for different doses, probably also the phase two dose.

Unknown Executive: And then oncology, you've talked a lot about delays, but we've heard reports of other challenges in conducting trials that are already enrolled, say, protocol violations like missed scans. And, you know, I think that's so important for your early Phase I trials, and I wonder how you're monitoring that and if you're taking any mitigating action to make sure the data you get is what you need, or at least we understand problems in the data.

Okay very helpful. Thanks for taking the questions.

Thank you very much the Knicks Christian today comes from the line of disease.

Thanks America. Please go ahead.

Hi, Good morning, Thanks for taking my question with regards to your publication that you mentioned in your prepared remarks, that's expected in the second half of the year a phase one data for melanoma I'm can you give us an idea of what level of detail you expect to have in that article and as such.

Leads to a potential for a registrational study what in your discussions with FDA. It gives you confidence that you would be able to potentially use the next study as registrational versus having to do.

Ozlem Tureci: Sure, sure. You are perfectly right.

Ozlem Tureci: That indeed is one of the major activities, namely monitoring the situation, understanding the specific impacts of what is happening at the clinical sites, how regulatory authorities see, for example, potential deviations, and how to mitigate those deviations we identify as potentially emerging patterns under the current situation. One of the major actions taken here in our company. You may have heard that some regulatory authorities give guidance, in particular for deviations, how to document them, for example, in order to ensure that they can then be addressed by regulators appropriately given the situation the entire clinical trial landscape is in. But fully agreed, this is one of the major aspects which is implemented in the way we deal now in this sort of emerging situation with the way we conduct our clinical trials and decide upon how the individual trials should be adapted or further conducted. Very helpful. Thank you very much.

A full phase three thank you.

So the first question.

During Q2, our property station.

Here.

The data we will publish a is data which comes from a lot of little marriage trials of a dose escalation dose expansion try a a with a long melanoma six back in a heterogeneous population of patients.

With advanced melanoma, and what we will publish a of the focus here is primarily on the mode of action also vaccine, which we show for the first time a in Schulman a in particular are also enjoy Lewis.

So that magnitude to that ties and that kinetics, but also some safety and activities state tough.

Unknown Executive: Very helpful. Thank you very much.

Okay. Thank you and as it relates to your discussions with F.D.A. aren't the potential for for Registrational study.

Unknown Executive: [inaudible] Hey, guys, I have a few questions. Roche made some comments that there are tweaks and optimizations that can be made to the INS program. Any color on what those tweaks are?

Okay, Yes, [laughter] towards though the discussion with if Dave was of course.

Based on the sign of the clinical Tyler to statistic or government as quickly as far as a fall.

Unknown Executive: And I think more broadly, where's the ideal setting for a personalized cancer vaccine? And would that be in the late stage, more bulky, solid tumors, or perhaps in earlier settings? Next, on your COVID vaccine, can you talk about yourself amplifying the mRNA platform in the context of your vaccine? And given your current manufacturing capacity, what's the largest dose you think is commercially feasible to serve a broader population? And then finally, there's been a lot of work recently that shows the growing role of B cells and tertiary lymphoid structures in the role of IO responses.

So.

For sure.

Showing showing the at the end points of the clinical trial and the at treatment and control and based on just this discussion then because SATA.

To provide upstate specific updates about about different arms and and and the.

Hi, so stuff data on based on the on the discussion with the XT eight we are confident that you see can deliver today, but as expressed.

Okay.

The study.

Despite a study design.

And then they would be would be would.

Unknown Executive: Okay.

Unknown Executive: I have many questions.

Unknown Executive: I don't know if I have any questions, so I'll start with Ozlem.

The in agreement with the make aspirational nature of some of the car.

Unknown Executive: So we have; we have it.

And would that require in person meeting once you deliver the study design.

Ugur Sahin: Next Generation Messenger RNA platforms running in collaboration with Genentech, and of course, we are further developing the platform and continuously evaluating improvements like, for example, improvements in antigen design, improvements in formulation, formulation optimization, in the number of epitopes that we are delivering, and improvements in the extent of TLR simulation which is included with our vaccine. And in the next 12 months, we are going to publish a number of collaborative studies with Genentech showing With regard to the positioning of personalized cancer vaccines, we at Genentech believe that particularly tumors with a lower tumor load and particularly tumors with an adjuvant stage could be ideally suited for the vaccine in combination or even without checkpoints. For diseases which are more in the advanced and later stage, it might be necessary to add additional combinations of I.O. drugs, for example, cytokines, to further improve the activity of a vaccine in this prior step. So, what was the last question?

Sorry can you repeat.

Sure.

Once you deliver the study design to the agency would you then need to have an in person meeting with the agency to determine if this can be registrational.

In January.

Hi can see also an Eva its a non noninterest micenko cellphone conferences.

So that what the Ah onez in this case be sufficient.

Okay. Thank you.

Thank you very much the Nick's question today comes from the line of changing Xu from Berenberg. Please go ahead.

Hey, good morning regarding BNP 162, that's the koby 19 vaccine.

Model as E N proteins, what could be your targets and are you thinking about receptor binding domains and you also mentioned that you saw neutralizing antibody.

Anybody anybody's generated end up being tier one six to preclinical study scale share with us, which epitopes you observed 40, neutralizing antibodies and do you think tighter often neutralizing antibodies cancers as surrogate clinical efficacy endpoint in called the night chain vaccine development.

Ugur Sahin: SA RNA. So, with regard to the SA RNA, we have published a number of preclinical studies, and one of the interesting insights in using SA RNA is that SA RNA can reduce the dose which is required to induce a strong antibody and T cell response by up to 60 to 80-fold as compared to a non-amplified vaccine. This is, of course, an exciting opportunity to develop and to test in a setting where manufacturing of the sufficient scale We are currently continuously increasing our manufacturing scale. We will update you on the target scale for manufacturing in the coming weeks and months, but it is clearly our vision to have sufficient capacity to deliver hundreds of millions of individual doses of vaccine in a reasonable time period, and Aya. There was another question related to the B-cell.

And I have one follow up.

Yes.

No. Thank you Sean Sean for the for the for the interesting question. So.

Yes, we are evaluating disciplined different epitopes, including the four full length Spike 14, but also some domain. The good provides provides detail details of our success in Maine vaccines vaccines in the coming weeks and and the immune response.

Yes, that's the upsets against the holdings protein and and the SAP domain.

Cots be a half as Stephanie and number of essays studying immune responses in myos, including antibody responses T cells. The sponsors normalizing antibody responses using sort of tuck and and Biospace notes.

Ugur Sahin: in Human Tumors. Yes, I think there is a series of publications showing that different types of infiltrates, including infiltrates with dendritic cells and B-cells, are associated with improved prognosis and response to a transplant locator.

Validation assets and based on the S says, we have confidence tour to reduce the spectrum of candidates on meaningful number to be tested in the clinical trial.

Okay. Thank you end up another question regarding the Rx format and also the delivery formulation. So mark our eight that's the modified our eight that installed edmar a format you use your GE cutback seem to us it is not highly immunogenic pace.

Ugur Sahin: And, of course, we are aware of the studies, for example, for all of our INET studies, we are evaluating the transcripts of tumors and are able to see which type of infiltrate is associated with which type of immune response. And based on this type of information, we can, of course, exploit different types of immunomodulatory traits.

Tell us what is the scientific rationale of using it in infectious disease vaccines and also for your delivery formulation. The lippitt nano particles and keep you saw that dealt with this delivery technique. It whats modified you shifted the immune response more towards <unk> through south not teach oneself <unk>.

Ugur Sahin: Thanks so much. Thank you very much. We have time for one more question and a line from Alinda Lee from CG.

Sure I'll share with us what modifications have been done on this l. impede formulation to increase th to estimation. Thank you very much.

Unknown Executive: Hi guys, thanks for taking my questions. First, on the COVID vaccine, you mentioned that you were working with the German, Chinese, and US governments. I was wondering if you could provide some color on your conversations and maybe your strategy for potentially manufacturing at RID. Secondly, we had the chance to see some cancer care changes during COVID, and I was wondering if you could comment on modifications to your clinical trials or enrollment criteria. And also, you're doing a lot of biomarker studies. I'm wondering if some of these athletes can be done on, you know, archival samples and how that might be affected. Thank you.

Okay, so actually actually be Hep C. Abbvie has.

Setup mechanistic data that and that the defense platforms, which are using or put to use different levels of T.H. fundless sponsor. So it is also at a modified on a on a platform to get up it's a novel formulation.

It has a strong ti follicular helper.

Immune responses.

And to answer.

Most importantly, induces a highly neutralizing antibody responses, which are in our in our in Iowa, So AD blocking had positive.

The most important impossible.

Ugur Sahin: So we are talking to regulatory authorities in China, Germany, and the U.S., and part of the dialogue is, of course, harmonization of the clinical trial designs in these different countries, and not only harmonization but also complementary trial designs which allow to maximize the amount of information that can be generated, and interestingly, the situation where Europe and the U.S. are now in the world. With regard to the biomarker strategy, of course, we need to evaluate antibody responses before vaccination and after vaccination.

Immune response to on the tests required to come towards cold cough cold with 19th.

The used.

Unmodified amani platforms to since it comes vis a vis Trs heaven.

Similar to the activity to have that it. It's a it's the addition of Trs seven agonistic activity can side of it used to dose and they are using and Seth emphasizing on eight based approach to side I know surveys that are due to the SaaS application based on the vaccine.

A big seen amplification up the delivery because the that used to dose phase evidence in the preclinical settings.

As published data showing that this is the case for HIV and this was the case for influenza vaccine and thus far.

Or so based on preclinical data that you have seen Cobiz 19.

Which are encouraging we decided to also talked about it this platform in a in and that can cook time.

Ugur Sahin: And this is a straightforward approach. This is established. There is an established industry for collecting samples and analyzing samples. We have already identified CROs supporting us here, so this will not be a challenge.

Perfect. Thanks.

Thank you very much the.

Christian today comes from the being Jacobs from TV is doing.

Hi, yes, thanks for taking my question the being from a you'd be us so.

Two questions just as it relates to targeting this spike routine.

Can you.

Give us any kind of color and how you're thinking about.

Whether mutations around this my protein could create selective pressure and then separately and then and then with regards to that how how you're thinking about timelines what exact what data you need to see to ensure that that is not.

Ryan Richardson: Yeah, maybe just to add to that, Arlinda, in terms of the manufacturing at risk part of your question, I think it was our strategy from the beginning to try to get a global consortium in place. And we leveraged our partnerships, both existing and also new, to do that. And so we are continuing to evaluate how best to scale up the manufacturing effort and fund it through those relationships with existing partners and also potential new sources of capital.

Going to be.

That will be an issue and then separately or along the same sort of lines high rethinking about RMB antibody dependent enhancement. Thank you so much.

Yeah. Thanks for the interesting question. So first of all sorts of or they are now emerging emerging applications are showing.

Genetic kinetic profile of a distant yeah.

Unknown Executive: And maybe just following up on your oncology pipeline, just, you know, since biopsy volumes are down, I'm just curious if the enrollment criteria that you have in place enable the use of archival tissue and how you're collecting biomarker data for your oncology trials, collecting and processing. And then maybe lastly, can you talk about your strategy for your cytokine pipeline? Thank you.

Six sensing data.

And.

ER positive positive conclusion from the studies as and that covert 19 genome, it's better to 50 state, but they have also we have also done a deep I look, particularly to the to the epitopes that we are targeting and be seen minimal minimal differences in different in cobot.

Yes, I. So they took in different regions of the planet. So that we are confident that that escape Upsells Oh spiked 14, it's not an issue.

Ozlem Tureci: Okay, okay. So the archival tissues for the development of oncology cards. Yes, of course. Yes, Essam. Would you like to answer? I can take that one.

Perfect. Thank you so much.

Thank you very much. The next question today comes from the line of Dana graceful.

BB Leerink. Please go ahead hi, Thank you for the question first a couple uncovered 19 and I want to ask one about your oncology work.

Ozlem Tureci: So, it depends on the drug we are investigating in those trials, in trials where we want to see and collect biospecimens in order to see the effect of the drug and need a baseline and under treatment sort of biopsy or blood sample. There is no flexibility to work with archival tissues or samples because this is really about seeing the impact of the drug. In studies where we, for example, want to test whether the patient has a certain marker which is stable, we work in fact with archival tissue from this patient. So, it really depends on which question needs to be answered, and we have a mixture of both fresh tissues and materials and archival materials.

We put some people speculate that chronic all if they may need at T cell immunogenic.

Response in addition to an antibody and I know you've talked mostly about the antibody response and I Wonder if you can talk about a cellular responsive holiday quarter and that is in your preclinical work and the second question as there's a lot of speculation had terrible immune responses actually from the viruses, a broadly and cook igniting specific.

Okay and can you help us understand how you're thinking about durability of protection, what's your vaccine and your hypothesis and necessary to schedule.

Yes.

Yes, so first of all sorts of or all of 'em. That's interviews in the combination with the formulation to try you were saying powerful T.

Before so let's see the T cell response, so that's that's a that's not an issue. The second is still ability of the immune was phones induced by the by the virus infection SAS something different and intend to do ability of immune response induced by a vaccine. So they are using here and vaccine live.

Ozlem Tureci: And if your question refers to the enrollment of patients into INES studies, yes, we can use, and we are using archival material that is paraffin-fixed. So that means there is no essential need to do fresh biopsies.

In the haven't at you have an effect and we see with this type of Phyxius, regardless of the epitopes that using long lasting immune response, if they have shown that saw although our for all of our platforms that that ti and that the ups. So long lasting neutralizing antibody response, thus far more than.

Unknown Executive: Thank you very much. Would you like to make any closing remarks?

Yeah. This was the defense platforms and T cell responses long lasting peace ups funds. So we're not concerned because we got to the deal, but if you have to immune response, if that's the agenda of 18, but the vaccine.

Thank you for today's call, and we look forward to meeting you in the future.

Thank you very much, that does conclude the conference for today. Thank you for participating; you may all disconnect. Speakers, please stand by.

With regard to the deal, but if you have to younger sponsors.

But generated by the code nine in section B.S., just to see because the data nudging them long long term ups observational data needed.

Right and then on oncology, you've talked a lot about delays, but we've tried to of course, all other challenges and conducting trials that are already enrolled say protocol violations likeness scans and you know I think that sell import and for your early phase one trials and I wonder how you're monitoring.

And next you're taking any mitigating action to make sure. The data you get it's what you need or at least we understand problems in the data.

Sure Wash all yours you.

Perfect fee right. That's a indeed is a one off some major activities, namely monitoring the situation a understanding the specific impacts on what is happening at the clinical sites, how regulatory authorities Assi for example.

Essentially deviation and how to mitigate those San Diego and we identify as potentially a emerging patterns are under the current situation.

One of the nature actions taken.

Again, our company a and you may have heard that some regulatory authorities give guidance in particular in particular for a deviation and how to document them for example in order to.

Sure that they can then be addressed by regulators appropriately given the situation yantai excellent clinical trials landscape. It is in a about a 40 agreed visits one off the MH are FX, which implement.

Into the way we are dealing now and that's serving emerging situation with the way, we conduct clinical trials and decide upon how the individually trials.

Be adapt to offer of our contacts catch.

Very helpful. Thank you very much.

Thank you very much. The next question today comes from.

Sure.

[laughter] research.

Good.

Hey, guys Ive a few questions. So rotate some comments that theres tweaks that optimizations that can be made to the itis program any color on what those tweaks are and I think more broadly, whereas the ideal setting for personalized cancer vaccine and would that be in the late stage more bulky solid tumors or perhaps an earlier settings.

Next on your Coca vaccine can you talk about yourself amplify about a platform.

In the context of your vaccine and given your current manufacturing capacity, what's the largest so do you think it commercially feasible to serve a broader population.

And then finally, there's been a lot of work recently, that's shown the growing role would be cells in tertiary lymphoid structures in the role of Io responses. What's your opinion on some of this emerging research in the context of your cancer vaccine platform and also your PDL one for one BB by specific thanks, so much.

Okay.

[laughter], so a stocking starting with with our resolve personnel sexiness voice. So there will be has yes of course ongoing ties with Ah but.

With all that actually affect generation and messenger platform spawning, let's say in collaboration with Genentech and of course, we are.

I don't think developing the platform and continue to see.

Evaluating improvements like for example improvements in Entente science improvements in formulation formulation.

In the station improvements in the and the number or number of epitopes that I did say, but it didn't living and improvements in the end and the extent of T. at our simulation.

Richard said, which is included as our vaccine and and Abbey.

The next that's last month, we are going to to publish a number and number of callable at this.

I'd like to studies with Genentech shown how next generation vaccine could look like.

Finally got two or two or two to two the to the to the to the positioning of though a customized cancer vaccines, v. and Genentech Felipe and that the particularly too much too much but they'll go a little about two months to two more load and particularly tomorrow.

Too much less that with no actually one stage could see could to be ideally suited for the back half of thoughts for the vaccine in combination or even as.

Or even without this out.

Check funds located as saw so when do you see Ccs a switch on mine that science and beta stage, there might be necessary to add additional combinations combination so I old crops like sound, but.

Cytokine. So they include improved activity of a a vaccine in the in this price settings.

And so what was the last question, it's a on it but as we got to the as a on a little bit Yeah. We have published a number of preclinical preclinical studies and done but not the interesting insights and using as a on a is that yeah as a on a kind of its use those.

Most of it just because I Oh two views.

As Tong anti body and he surplus funds can produce the goes up to 60 to 84th as compared to them on MP, fysixteen and business or cost an exciting opportunity to elaborate and to test in a settings, where.

Manufacturing of the sufficient paid effect seen cooked could be and challenge yeah. We are constant currency continuously increasing our manufacturing scale.

Those updates about about about.

Targets <unk> ER tablets cares for for money section they manufacturing in the coming coming coming weeks and months, but it is clearly about vision, yeah to test sufficient capacity they live up to 100 million near the end.

Indeed, we built.

Those this 60 and a in a leasing both time period.

I guess the about another question was related to the be set in sensation interpretation in.

Any units you Wanna too much yes, I think I think just there is a theory itself because there's a series of publication showing that different type of interest rates, including instead of trades, but then with excess mpss Ah Ah associated with a in poor prognosis and because funds to tour checkpoint blockade.

Okay and and of course, the we are we at FPL to study the outlook for example for all of our I never studies.

[laughter] tomorrow.

And.

And.

Yes.

And are able to see it which type of interest paid associates. The type of immune response and based on this type of information because the kind of cost.

Taught different type of of immune a immune modulatory treatments.

Thanks, so much.

Yeah.

Thank you very much we havent talked to one more question that question comes from the line of Arlinda Lee from CJS. Please go ahead.

Hi, guys. Thanks for taking my question persons covered vaccine you mentioned that you were working with the German Chinese and U.S. government.

Wondering.

He could provide some color on your conversations and maybe your strategy on on and potentially manufacturing at risk.

Secondly, fine we had the chance channel count.

Cancer care change in Sternco then.

And I was wondering if you could comment on modifications to your clinical trials, where enrollment criteria and also you're doing a lot of biomarker studies I'm wondering.

Yes. Some of these I think it can be done on.

You know archival sample and how that might be affected thank you.

So we are talking tool to regulatory activities in China, Germany, and the U.S. and Ah.

Part of the dialogue is cost someone say snuff the clinical trial the science in some countries.

The and not on the amortization, but also close or having complement police car the science, which allow to to maximize the amount of information at that can be generated and.

Interestingly the situation the situation.

They asked us into a vast Europe and and U.S.

Now a.

Okay, the hot spots of the infection.

The section based in China is cooling down so, giving us different opportunities in different regions.

That's the Switzerland frequency of infections and this is also well. So also a good good to have situation because.

Based based based on the situation the can generate safety and the activity secrecy and effectivity data and in different regions.

Most of us.

Because we got to the biomarker presses, especially of course, we need to to evaluate the evaluate.

And pet body of a sponsor before before vaccination and after vaccination emphasis with pets fall, but approach. This establish the ism established established industry and for collecting samples for analyzing centers, we have already identified sia or supporting.

Yes, but this will not be a challenge.

Yes, maybe just to add to that arlinda in terms of the manufacturing at risk part of your question I think it was our strategy from the beginning to try to get Oh.

A global consortium in place and we leveraged our partnerships both existing and also knew to do that.

And so we are continuing to evaluate how best to scale up the manufacturing effort and funded.

Through our through those relationships with existing partners and also potential new sources.

Great. Thank you and maybe just following up on your oncology pipeline.

Just can you you know with biopsy volumes are down.

You know I'm just curious if.

If if the enrollment criteria that you haven't place enables you said archival tissue and how you're collecting biomarker data for your oncology trials.

Collecting and processing.

And then maybe lastly can you talk about your strategy for your cytokine pipeline. Thank you.

Okay. Okay. So the I caught I travel tissues trial for development of of oncology caught us off.

Yes, and would you like to I think that Ah Ah. So it depends on the on really that they dropped a we are investigating and in those trials in trial in which we wanted to see a and connect five sets of men in order to see.

That you ticked off a bit dropped into the need a baseline and under treatment sort off.

You will see a black Sam say, a there is no flexibility to work with our hybrid tissue and tissue with our family pets. Because this is really about seeing the impact also for drug.

Studies the way our Oh, we for example, one to test whether a patient has a certain market, which it stay bias or we are rock and checked with archival tissue from the best patients. So it really depends on which question needs to be.

Concept and we have a mixture of both a fresh tissue listens materials and archive and the Caribbean.

And if your question, we first talk to them to a tour enrollment of patients into I know that is yes. We can you use and the I'd using archival material just problems passing takes so that means there is no essential need to do fresh biopsies.

Thank you very much thanks.

Yes.

[noise]. So [laughter]. Thank you. Thank you Paul to today's cost Nvidia look far but far from meeting you in the future. Thank you.

Thank you very much that doesn't include the conference for today. Thank you to purchase money you may now disconnect speak instantly.

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