Q1 2020 Earnings Call

[music].

Good afternoon, My name is Kate and I will be your conference operator today.

I would like to welcome everyone to the convention bio call there won't be a question and answer session to follow please be advised the this call is being recorded at the company's request.

I would now like to turn the call over to Mr., Sam Martin from Argo partners.

Thank you operator, and thank you all for joining us on prevention Bio's first quarter financial results conference call joining.

Jason White, Chief commercial officer.

Andrew Drexler, Chief Financial Officer, San Francisco Leone, Chief Scientific Officer, and co founder.

On today's call Ashley will provide a corporate update with a focus on PRB O 31, or it's supposed to map and PRB 30 to 79.

Jason will update us on the commercial landscape, Andy will review financials, and we'll then open the call for questions.

First let me remind you that the various remarks, we'll make today constitute forward looking statements for the purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act of 1995.

These include statements about our future expectations clinical developments regulatory matters and timelines the potential success of our product candidates financial projections, and our plans and prospects.

Actual results may differ materially from those indicated by these forward looking statements as a result, various important factors, including those discussed in the risk factor section of our most recent annual report on form 10-K, which is on file with the FCC and another filings that we make with the FCC in the future.

Any forward looking statements represent our views as of today only.

While we may elect to update these forward looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change.

Therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today.

There was more complete information regarding forward looking statements risks and uncertainties and the reports prevention files with the FCC.

These documents are available on Preventions website at Www Dot prevention bio dot com under the Investor section and we encourage you to review these documents carefully.

I'll now turn the call over to actually Palmer, Chief Executive Officer, and co founder who will provide an update on prevention is corporate clinical and business development activities Ashley.

Thank you Sam and thank you all for joining us today.

We hope you and your loved ones are safe and healthy during these unprecedented time.

Well there has been tremendous disruption across all areas of daily living UTI Cobiz 19.

I am pleased to report the Dot team prevention has continued to execute our mission.

As a virtual company prevention have been able to seamlessly pivot to the new operating environment.

And we remain on track to achieve a key goals for 2020 <unk>.

Completing the submission of our rolling Biologics license application will be L.A. put the pick them up also known as PRB Oh 31.

Let me now review with you. The recent progress that has been made on our path to becoming a commercial organization.

Well as how compelling plans going forward.

<unk> disease for which there has been no significant advancements in therapy since insulin was first introduced in 1922.

Ali therapeutic candidate capitalism had an empty cdthree monoclonal antibody has the potential to delay.

Well with timely week dosing, possibly even prevent the onset of clinical stage T. One day.

Much like we read boot and computer to eliminate malware.

Mechanistically single cost of living lab reboot see immune system to neutralize pathogenic well to reactive T cells that would otherwise destroy the precious insulin producing beat itself in the past with.

We are preparing to bring capitalism. After the U.S. market based on the results of the T. M pain trial, which were published in the New England journalist Medicine last June.

This remarkable trial demonstrated that is single 14 day course of capitalism map administered to list individuals delayed the onset of clinical stage to me why a median of at least two years.

Compared with placebo.

This study was highly statistically significant and the result.

Only clinically relevant.

The corresponding potential benefit for patients and their families cannot be denied.

But the first time, we have an opportunity with diplomat to intercept all with timely week dosing indefinitely delay or prevent the progression of type one diabetes to end stage insulin dependent disease in individuals identified as being the risk by having at least two or more.

So he wanted the related auto antibodies.

As you might expect the potential for this first ever disease modifying therapy is generating tremendous enthusiasm and excitement within the T. One de community.

We remain laser focused on bringing capitalism up to market as rapidly and responsibly as well.

We're extremely pleased with our progress over recent months in trucking on course to potential regulatory approval and commercialization.

I mean last year obtain breakthrough therapy designation to cut please them out to the delay or prevention of clinical T. One de risking individuals.

Last month, we announced our filing of the Nonclinical module of the company's rolling B.L.A. submission to the U.S. food and drug administration.

Rolling submission alliances for completed modules of the B.L.A. to be submitted and potentially reviewed by the FDA in a sequential manner.

Next we expect to submit our clinical module in quarter three of this yet.

And finally, the chemistry manufacturing and controls all CMC module in quarter four.

Oh, it's timing of the C.M.C. module represents the critical path for completion of our rolling BLA submission.

To this end, we successfully completed transfer of capitalism ABS commercial scale manufacturing process from Eli Lilly Historic manufacturing plants in Ireland to.

Two prevention contract manufacturing partner AGTC bio in Seattle, Washington.

Following completion of an engineering run in quarter four of last year I'm delighted to report that in the first quarter of this year. We reached another important C.M.C. milestone with AG see bio successful completion of a current good manufacturing practices or C.G.M.P. production run.

Of capitalism.

We now intend to submit the analytical data from both the engineering and C.G.M.P. runs two lots I presume that R&D to allow the S.P.A. to review in common with respect to compatibility between material made its AGTC not previously made by Lilly.

Going forward, we expect to proceed with three commercial scale process performance qualification or P.P. choose batches apps AG see bio this summer.

These will support the C N C module and enabled the completion of the rolling B.L.A. submission by year end.

Once we submit the final module.

Yes, he will determine if our filing is acceptable.

That's a prescription drug user fee act or to do the date.

Assuming a priority review for which we are eligible to file in connection with tourism knobs breakthrough therapy designation.

The stage could be set.

For a potential approval in mid 2021.

[noise] recall last year that in addition to breakthrough therapy designation received from the FDA.

We also received prime designation from the European Medicines Agency.

In the first quarter of this year, we held a kick off meeting with the M&A to discuss the regulatory pathway and the scheduling for populism that review in Europe.

As with the FDA, we believe that data from the T.N. 10 risks study.

Along with our database from historical studies of TEP lives the mob in newly diagnosed T. One de patients.

We will support an email marketing authorization application or M. A.

We expect to be able to submit this and a in the second half of 2021.

Today, the company has not experienced any Colgate 19 related interruption in our interactions with the he made all the FDIC or in the scheduled rolling submission of our be allay fully Atlas indication here in the United States.

However in much due to rapidly deteriorating public health and clinical research conditions Brewster bound by the Cogan pandemic, we elected to temporarily pools, the randomization of subjects into our global phase three Protex study of tourism not in Uli.

No it was T one de patients.

We took this proactive and protective measure out of an abundance of caution and cash for our patients and their caregivers.

The clinical site staff and for our clinical operations employees and contractors.

Patients who at the time, we're undergoing study therapy were allowed to complete their cost of study drug as a recommended by the Protex studies data monitoring committee.

Which we expanded to include an infectious diseases expert.

Well, we do not yet have any specific guidance regarding plane Protex study randomizations the we commence.

We don't anticipate I think we'll do so in a sequential manner as local conditions permit within each country.

And at each site.

Let me now turn the call over to Jason to provide an update on the progress being made without a prison up commercialization planning.

Jason.

Thank you Ashley and good afternoon, everyone.

We're excited about the advancements we've made and prevention commercial operations since the beginning of the year.

We've built a strong leadership foundation with a vice president of market access and distribution, who I mentioned on our last quarterly call and more recently, a vice president of marketing, who joins us with more than 20 years of industry experience, having done the chief marketing architect multiple blockbuster product launches.

Collectively we have extensive experience in rare disease product launches as well as launches a nascent markets novel therapeutic indications and a deep understanding of the type one diabetes space.

We're laying the foundation that will position us for the most effective path toward commercialization it wasn't that.

This month, we will engage hair advisory.

Representing more than 79 million covered lives to assist us in building. The most effective messaging to communicate our vision of a new standard of care for tier one de treatment.

We will also gain insights and feedback on the burden of disease burden of illness as well as how they view the C D market currently.

Our last quarterly call, we discussed the importance of screening patients as it relates to commercialization of tourism.

In addition to engaging a payer Advisory Committee. We're also building health care provider awareness campaign intended to encourage physicians to proactively offer screening to family members of their T. one de patients.

We plan to launch in the third quarter.

Our efforts coincide with broader recognition among the scientific community about the importance of screening.

A recent study published in Jama highlighted the positive impact of a mass screening effort and Bavaria.

Similar efforts are underway, northwestern Germany, and in U.S. stage, such a Colorado.

The potential for a therapy that could impact the course of studies in patients with two or more auto antibodies is also helping to ship attitude on prevention.

In a recent article in Science magazine.

After Olga quarter, nor who specializes in pediatric diabetes children's hospital and Hannover, Germany.

Got it up with a pleasant not data from the T.N. 10 study quote changes the thinking unquote around screening.

As previously stated our initial commercial strategy at launch will focus on a subset of that rest patients who are direct familiar relatives of known type one diabetics.

We know from the published literature that 15% of newly diagnosed patients have a relative with T. One day.

In total we believe there are 200000 stage two patients in the United States and if you apply that 15% having up nearly all relative with T. lundy. It would amount to an initial addressable market for treating what took wasn't a roughly 30000 patients.

Family members of T. why did the patients will be screen for two auto antibodies and subsequently disc like seemed to identify as many as possible of these 30000 individuals.

Standard blood tests are readily available and more than 1.5 million people have been screened in recent years.

In addition, there are hundreds of thousands tested every year given risk factors or in the differential diagnosis of T. One day.

Any clear initial feedback from families and caretakers with experience managing clinical T. One D. I understand the burden of disease and are generally highly motivated to screen their loved ones.

Ultimately, we will further expand screening into a broader patient population and to to this end. We look forward to working closely with advocacy groups such as JDRF beyond Taiwan, The Helmsley Foundation and other groups who share this goal.

Overtime, we believe this will allow us to identify a greater proportion of stage, one and two individuals who have not progress to clinical T. One day, and who are not direct Emilio relatives of known type one diabetics, thus increasing the market size dramatically.

Longer term through lifecycle management, we will seek to broaden the market potential by exploring repeat dosing expanding the targeted age group and eventually looking at subcutaneous formulations and combining to pleasant map with other therapeutics and potentially with I, let beta cell transplantation.

We are excited about the many opportunities ahead parts of it wasn't that and the T. One day community and we look forward to updating you on our commercial progress planning and insights throughout the remainder of the year.

Back to you Ashley.

Thank you Jason.

We could not be more pleased about your rival that prevention the elite commercial leadership team Youre building.

The progress you're making.

Before he discusses prevention first quarter financial results.

We provide you with a brief update on another one of our pipeline programs as we continue to make progress advancing the development of our other therapeutic candidates targeting like impacting auto immune diseases, such as lupus and Sylvia disease.

On our last cool in early March we discussed the positive topline results of the phase one be healthy volunteers stage of the appeal of the 30 to 79 prevailed trial.

Below the 30 to 79, if they humanized by specific scaffold targeting the b cell surface proteins, CD 32, B and C. D 79 b.

We believe the PRB 30 to 79 has the potential to intercept b cell mediated auto immune diseases.

We have prioritized lupus, that's all lead indication.

Yes. This is a chronic autoimmune disorder with a clear unmet need and for which therapeutic proof of mechanism for CD 30 to be agonism has already been established.

At least one and a half million Americans are afflicted with all forms of lupus.

Which can affect nearly every major organ system with tissue damaging inflammation that in some patients results in severe organ dysfunction and failure.

We look forward to commencing the phase two a portion of our prevail study in lupus patients during the first half of 2021, and we will keep you updated along the way.

PRB 70 to 79 has the potential to address over autoimmune conditions in which b cells play a pathophysiological roles, including more prevalent indications and lupus such as rheumatoid arthritis.

Well as rare orphan diseases, such as idiopathic thrombocytopenic purpura, Neuromyelitis Optica, Penford, plus and minus thing you had Roberts.

PRB 30 to 79 also has the potential to prevent or reduce the immunogenicity associated with biotherapeutics, including gene therapy products and we anticipate presenting results from animal studies supporting this opportunity in the second half of this year.

I will now turn the call over to Andy who will discuss the Preventions financial results for the first quarter Andy.

Thank you Ashley.

Good afternoon.

Before I begin I would encourage you to read our earnings press release, and our 10-Q that was filed today.

The 10-Q includes our financial state and risks factors as well as management's discussion and analysis of our financial condition.

Let me start with our current cash position and cash projection.

As of March 30, Onest 2020, our cash balance was 76.6 million.

Our cash based operating expenses for the three month ended March 30, Onest 2020 was 11.6 million.

We continue to expect to use approximately 24 to 29 million in operations for the first six months or 2020.

And we continue to expect that our current cash cash equivalents and marketable securities will be sufficient to fund projected operating requirements to the middle of 2021.

From a p., an l. perspective, we generated a net loss for the first quarter of 12.6 million or 26 cents per basic and diluted share.

The increase in net loss compared to the same period. In 2019 is the result of greater general and administrative costs, including the build out of our corporate and pre commercial infrastructure.

Lastly in April prevention received $523000 from the sale of a portion of the company's New Jersey State net operating losses.

The program was administered by the New Jersey, Economic development authority and allow qualify technology and biotechnology businesses in new Jersey to sell certain and noel's for cash.

With that let me turn the call over to actually for his closing remarks.

Thank you Andy.

Prevention demonstrated outstanding progress to date this year.

Throughout the remainder of 2020, we will continue to focus on tourism as manufacturing and I'll be L.A. rolling submission.

In parallel we will transition and transformed the company into a commercially viable organization.

Anticipation of the potential launch of capitalism out in 2021.

We all driven by the possibility of creating the first ever disease modifying therapy treatment.

Type one diabetes.

In addition to tech lives in that.

Our pipeline is rich with potential opportunities to fundamentally address the unmet need associated with other auto immune diseases and we are passionate about advancing these therapeutics to help patients and that can give us.

And now we will open the cool to take your questions.

We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone. If you are using a speakerphone. Please pick up your handset before printing a key to withdraw from the question can you. Please press Star then too at the time, we'll pause momentarily to assemble our roster.

The first question is from a lithia young with Cantor. Please go ahead.

Hey, guys definitely on selling tech and thanks for taking a car I guess first just on and Protax study I'm just wondering why not at mass talent that youre looking for unrelated to carbon 19 that what kind of tried the air to restart the study again.

And then I know, we still have some time from commercial lines that can you just talk about things that you're watching on she'll adds you can't affectations, so that they're more comps tip all the other thing and a young based therapies to treat their I'm happy to patients. Thanks.

Thank you very much for the question.

So the criteria that we will use to reestablish the randomization of patients into protect.

We will be a at a local level as each country comes through the crisis.

And begins to lift the.

Locked down procedures and other measures, but they have in place.

We will be relying heavily on data monitoring committee, including a expert infectious disease.

Key opinion leader, who will be helping us assess.

Each country's status.

And then with respect to each site because as you can appreciate there's great diversity.

In each country, if maybe some time before sites in the Middle of New York All San Francisco for example may be ready to begin Randomizations again.

Whereas sites in other states that.

Have.

A different local situation and the confidence of local fight.

On the data that we're actively working to prepare from a healthy economic standpoint, and then get an initial read on how they're thinking about coverage in the context of the way the market exists today, but setting the stage and helping them understand how the treatment paradigm is going to involved with a potential approval to put them out and how that factors into.

To their thinking and decision making around coverage.

And have you seen Jason any.

Indication to date why.

Analog pricing that we've given diving song in the past is not appropriate.

No. So today that the the and thanks for their mind are actually no. We haven't seen any any reason to believe that the analog that have been previously discussed are are are are no longer valid, but as you know time I think you know we've talked about this that the the formal pricing work that we'll be doing we want to do is.

Close to the approval so that it does relevant as possible. So we wouldn't think about doing the formal pricing work until we've you know engage this advisory board evolved are thinking involved are massive drinks gauge more pairs and then have a well informed group of participants in the pricing research to be able to give us the most relevant and.

Up to date knowledge as possible leading into a potential approval at which point we were to know if I'm impressed.

Sure that makes sense, if I could just sneak in one last question just with 88, I guess switching to a a voice virtual format here in June I was wondering who could give us a sense of how you were approaching the meeting how you're thinking about engaging the k. wells there.

And what we should be watching for at that meeting.

Actually you want me to take that one.

I'm sorry, I was on you my apologies if that's exactly what I said, Jason would you mind [laughter] [laughter]. Yeah. So you know time, though for 80, a you know it it it's unfortunate the you know given the circumstances out there. So many of the major medical meetings have have been cancelled for.

<unk> has found a really innovative way to move their meeting to a virtual environment. So obviously will be actively watching and participating in in in doing the presentation and you know while we don't know specifically what data will be presented we would.

I hope that there would be an update onto a pleasant map coming out of out of the trial that group as you know they have a full you know responsibility for publication of the data.

But it does in fact limit how we're able to engage care well. So we're thinking about ways to augment the fact that we can't engage k. well live at the meeting and thinking about putting together virtual advisory boards in the latter part of of this year. Following 80 80. So we can engage them that way in in you know any of.

The things don't open up by that obviously, if things open up will start to really rapidly advance our engagement of K.O.L.'s, both at a national handle local level.

Right.

Okay. Thanks for taking the questions guys appreciate it.

But.

The next question is from Ron summarize you H.C. Wainwright. Please go ahead.

Hi, Thanks, very much for taking my questions queries on the commercial regulatory and clinical front. So let's start with a commercial I was wondering if you could elaborate on the principal differences that you see in the sales and marketing strategy that would be brought to bear target.

Getting the at risk population versus the early onset population and I mean, this maybe a bit premature since we don't know what the timeline is for the protect study at this juncture, but what the learning can you apply from the work you're doing to effectively target the at risk population and positioned the company.

Any for the launch of <unk> population that could be applied to the early onset population as and when you have you know to protect data and potential potentially a label for to put them out in that indicates.

Right from so again Jane sent it you could you know explain.

How you're looking at this because they are very different <unk>, which requires screening to identity fine.

Individuals at risk the other newly diagnosed within six weeks of presentation with <unk>.

<unk> tons of chemicals page type, one diabetes <unk> 10th of which.

Very often a diet diabetic <unk>.

So market, where we're looking for patients versus a market, where we know exactly where they are and how they're going to be research and then the chronology Jason.

Yeah. Thanks for the question round. So you know I think actually actually hit a lot of the key points. There right. I think you know we discussed that our initial launch focused for the at risk indication is going to be for the direct familial relatives of other type one diabetic and really being able to leverage the you know specific knowledge that.

Families and caregivers and patients have on you know both the diagnosis progression and you know ultimate implications of type one diabetes and having not group really advocate for their loved ones to get screen, while simultaneously going about educating H.C.P. as we talked about during the prepared remarks and ensuring that diet.

That pediatric endocrinologist are well educated on specifically what screening protocols, they should be using and offering that screening to those relative.

When we think about you know that the newly diagnosed population I think as our commercial team gets out there and starts to engage with the pediatric endocrinologist community starts to engage with the broader community that are caring for these direct familial relative we will have tremendous insights that we will learn.

About you know the pathways to care about you know referral networks and a lot of the work that you know, we're starting right now, but we won't necessarily have to do all of the leg work with regard to screening just because of the way the patients are presenting to that health care system and I think one of the things that.

Is is really attractive from a commercial perspective about this is the fact that.

I don't envision us meeting to have a scale up in our commercial infrastructure to adequately cover the newly diagnosed market since we're likely getting to be engaging the exact same physician groups and the pediatric endocrinologist community to target both populations and by the time the newly diagnosed indication.

Is approved we will have significantly well established relationships with those providers and they will have you know a deep understanding of prevention bio and how how specifically to go about acquiring and it Mary Anne and administering <unk>.

That's very helpful. Thank you on the European front.

I was wondering if you could answer a couple of questions that are both relevant to the commercial as well as the regulatory aspects here. Firstly, you know, maybe Jason and Ashley I'd be curious to know how your views are evolving regarding the best way to optimize <unk> value in Europe, whether you're.

Thinking about the go it alone strategy, the distributions strategy or a partnership strategy or some combination of the above and then also on the regulatory front I was interested to know in Europe discussions with European regulators to date, whether you have a sense at this juncture of who the rap or <unk> countries might be on the M.A.A.

And at what juncture, you might actually begin to start seeing interactions with the C.H.M.P. as well, even perhaps ahead of the formal M.A. submission.

Thanks again for the Great question.

So we have categorically space that we will not be doing this to ourselves in Europe. So it will be a combination of.

Regional pop machine or or distribute to ship for ships.

And we have a sort of 12 month lag from the time the.

Therapeutic would be who here in the United States and <unk> in in in Europe, and so <unk> timings of the essence, we do have.

More time to share what we're learning here in the United States.

And progress so it was partnering with distributorship discussions.

Do you want us to comment Jason on the difference in value.

How are we looking at.

The value of this therapy in in Europe, as compared to the United States.

Yeah. So you know is actually mention we have you know no intention of building our our own infrastructure in Europe, and you know, we'll be looking to partner and depending on the nature of of what the X.U.S. partnership looks like whether it's you know a regional European partner and then other geography is working through distributors I think remains to be seen base.

On how the partnering discussions evolve without being said, we know that you know they'll they'll likely pricing and value that we will be able to get in Europe will you know in all likelihood be lower than that of of what we're able to get in the United States, but we're just starting some of that work now to engage some of the European pairs to talk.

Through some of what they will want to see on the value side as we start working through what European pricing may look like and that's work that I think we're doing independently because we know that it will help add value to the discussions that we're having with potential partners.

[noise], we expect to regulate tree interactions to date, we have indicated we have the kickoff meeting with the E.N.A. following prime designations, but we've not yet provided any guidance regarding the details of the scientific review meetings all of Iraq.

But but we will in in in in short or.

Okay Perfect and then just three quick items on the clinical fronts can you comment at this juncture on what you are taking to effectively mitigate against the risk of data integrity issues are in particular, you know loss to follow up issues relating to patients who had.

Already been randomized into the Protract study before you pause randomization and also if you can give us a sense of you know kind of how far into the protect trial you were at the time that randomization was pause and then also I just had a quick question on the lupus program.

To what extent, you anticipate being able to specifically explore the efficacy profile if the drug lupus nephritis and what specific read out you are contemplating that would allow you to elucidate that thank you.

Thank you very much again for a great question. So we do not have Lenny rammer thought chief Medical officer, <unk> today, but Francisco <unk> is perhaps the closest to the details regarding.

The data integrity. A question you asked and he's also the best person, obviously, leading the program.

Discussed the lupus 70 to 79.

Protocol Francisco could you. Please take both of those questions for Huh.

Yes.

In terms of the integrity of the data, we we have provisions in place.

Ensure that Oh.

Oh, Oh, what's happening in it's not going to affect interpretation of the day the appropriate statistical methods.

That have been and will be discussed as regulators and there are guys huh.

Come out.

City topic symbols that V.A.N.N., they do insure that all the analysis I've done appropriately taking into account.

The the situation.

And we did talk to we have not provided guidance on where we where we've enrollment.

<unk> pause we have indicated that we were on target to conclude.

Enrollment by the end of this year.

So it's not unreasonable at this point to assume that however, long way pools.

Will be.

A you know the indication of how how much further into next year.

We would expect enrollment.

To be completed.

And then as you know with the 18 months follow up.

The actual top line result, alright.

Off the.

And then when the enrollment completion.

Francisco do you want us to the lupus protocol.

This is for phone loop as as you know we recently you set up Landay Dolly today I, then we want to think sometimes as I did you say, though.

<unk> whatever K.O.L.

And design phase two a trial appropriately.

The most likely scenario since we're going to evaluate upstairs with lupus patients guitar.

Definitely.

Bible, that's just I tried it.

Yeah.

It hasn't <unk> <unk> <unk> <unk> <unk> <unk>.

Next question in time, but a lot I missed that Chardan. Please go ahead.

Hi Assembly, calling on behalf of all of them loose and things are taking my call.

I have two questions and then a follow up first question. What's your based on any advantages you've seen in the mid 19, and then they come having break through therapy designation onto is not as you're hoping to finish a rolling D.L.A. and then a U.S. approval and a second so it's obviously more difficult to run combination trials when both products in the combo.

Not yet approved given that where it took place enough to be approved in 2021, you think there'd be increased interest from external party seeking some combination from.

Oh, Thank you so we've been.

No indication that that would be a delay in a schedule has presented.

In in <unk> at the beginning of the coal <unk>.

Due to the Toby 19 pandemic, we intend to file.

The remaining module G.M.C. module in court for on on schedule, assuming that we complete the three D.B.Q. runs.

Ah commercial scale batches back to back in the summer when again based on my comments regarding our manufacturer.

We're on schedule to do that.

This point in time, I see no indication of of any disruption.

So the the combination question you know I I will.

Philosophy and strategy at this point.

He's that.

Ooh additional development Bessent done on the other side of an approval.

The at risk.

In indication.

So if we're talking about combinations to.

Enhance the delay in progression of the disease.

And and all reducing our goal is to get this therapy approved based on the.

Amazing breakthroughs therapy.

Designation result.

Oh, the yeah medium delay <unk> type one diabetes from a single cost.

A man having gotten.

The approval and have then a population of patient tool of receive one ghost.

We can then.

<unk>.

Those patient into sponsored studies into registry, the K.L.L. studies evaluate and not only combination.

But also reducing.

So to follow up on a combination and.

I sell therapy based approaches that people are are trying to work on right now. So in regards to you know stem cell therapy companies out there trying to figure out how to protect the transplant themselves from being attacked by the immune system.

<unk> easy to listen that as an alternative to those immunizations strategies or would you be synergistic to those protections strategy thing.

But it's very much so again francisco's that's two runs for this but we definitely see the established market all type one diabetic to have essentially lost their instantly production capabilities and that'd be to sell where where.

<unk>.

And and so the opportunities.

[noise] present as those therapies are developed by other companies, we believe that peppers in my town.

Play a very significant role.

In maintaining the.

The <unk> routine of the immune system will be necessary to protect.

To spelled in individuals who hunt.

You know last M.G. tool to immunity lost their original towels.

It still is a very relevant to that stage, perhaps even more so to protect the.

Establishment of new styles in the body Francisco.

Yes, Thank you bought it but yeah.

Obviously, that's better job.

Developing based therapies do.

The more of those sales will look like they've itself.

And then more they were subject to attack biting you.

And despite doing anything other than.

<unk> said you cannot Eddy out so for example.

<unk> have health immunity against incident.

Common you'd have on the installation activities and.

T. So against incident, so you cannot as it out insulin because that's the purpose of making those so they can make and so then we absolutely seat that at least in that.

That's an important.

After you huh.

This kind of therapy.

We don't know if it's going to be entirely Anna penalties for tend to just take we do know that that has been used in combination with I, let still transparent and it's been published with good results, but we haven't had experience with the new stem cells right.

We we look forward to get in some experience in that field and the teacher.

Oh that was helpful. Thank you so much.

The next question is from David S.N.D.C. Please go ahead.

Hey, guys. Thanks for taking questions and really great to Recapitalise progress.

I had a couple so you had mentioned you know certain geographic region. There have been I got you know broader format screening campaign, you mentioned, Bavaria in Germany and into Denver entered into U.S. I'm, just curious as to how how do campaign kind of would prevent or you know maybe a little bit.

Color on kind of what they look like and is there any I guess agreement among eat Endo dog in terms of.

The best way to do a broader meaning campaign.

H. and you'd be looking at you know how many times you we'd be greeny and childhood and then I guess you know our our general pediatricians the ones that would need to do that I suppose breathing.

It's a great question and it it it is diverse and ranges from no full blown general population screaming <unk> <unk> <unk> type, one diabetes and instantly and in a country like Finland.

And then you know less so in the United States like pull pocket.

Around centres of excellence like Barbara Davies or as part of the research console to your like try on it the times disco really is our expert in in in screening and maybe Francisco you could give some indication is what the drivers are behind that diversity.

And what role type Lindsay mine was going to me as a as a catalyst in driving <unk>, you know <unk> familial screening on general population screening and those.

She is wearing currently he's not established.

Oh yeah.

I save it.

We we have a number of God So show in the U.S. in Europe.

Determining risk of people on the identifying subjects, that's me either with genetic a. too late typing or.

Most part than most problem methods is the <unk> termination and often times in conjunction with silly I can see <unk> actually said.

Until though they're not about 1.5 million subject.

Have sign up for this.

<unk> surveys substantial amount of patient.

And subjects in the general population.

Our family members.

Yeah formulation, so what right.

<unk>.

We know that despite knowing that you have if you want to be you can't reduce the incidence of diabetic keep the ASCII those two <unk> a a very serious.

Complication of.

Diagnosed t., Wendy which is life threatening them and have substantial morbidity and mortality and healthcare costs.

So while the main drivers <unk> has been.

<unk> a purely academic research now we know they don't with all of these <unk> organize to South Carolina that one.

On the market spinning is going to grow exponentially because now you have some intervention that can change the trajectory of this season just patient.

And we expect that in addition to clinical indicated.

Spinning with just happened in <unk>.

Academic associate there will be a groundswell of screen worldwide and hopefully one day.

We'll all be like same level, where they're currently covering hospitals that population.

Screening for C., one d. and they're planning now two covers the entire country.

Okay right thing that was very helpful. And then I I just had one other follow up so I think you know our past conversation you mentioned hmm looking at sort of <unk> <unk> <unk> phenotype and.

Really detecting exhausted phenotype that could be an indicator of whether lies men sex are persisting overtime. So in terms of looking at you sell exhaustion is that something that really only available in.

Academic arena or is that something that position in the clinic would be able to take advantage of you know I, just relapse cap or something similar in determining maybe went to reduce wide map.

Yeah. So it's it's very accessible test because.

In my hand, any tough clinic does have a close that parameter.

Can do it locally follow cytometry is used for example to determine the C.D. for C.D.A. ratio.

H.I.V. or does phenotype.

Leukemia and lymphoma, it's a very common technique.

Oh of importance to take them, they they say <unk> and for those who don't have a full set something up there.

They can just stands just simple to the restaurant black.

And the sample is just but it's a blood that this ship at room temperature. So it's a simple mail envelope and it goes to the central lab. So it it's something that we really.

They used to implement the help of died read those and decision.

Okay, great. Thanks cruciate that.

This can claim that question and answer session I would like to turn the conference back over to actually Palmer.

For closing remark.

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When we sincerely hope that you and your loved ones.

Space Unwell at this time thank you.

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