Q1 2020 Earnings Call

[music].

Ladies and gentlemen.

Super standing by and welcome to the Okay first quarter Twentytwenty conference call. At this time all participants are in listen only mode. Later, we'll conduct a question and answer session and instructions will follow at that time, if anyone should require assistance during the call.

Star then zero on your Touchtone telephone.

As a reminder, this conference call is being recorded I.

I would now like to turn the conference call over to your host Mr. Jill billion Chief Executive Officer. Please go ahead Sir.

Thank you.

Good afternoon, and Europe. Good morning here in the U.S. I'm.

Well bring your role will and see if and thanks for joining us for this Q1 Wendy earnings call. It feels like we're in a different worlds compared to the the previous call. It mid March.

You will have seen its we announced our business and financial update the yesterday evening should be able to find the press release and the earnings presentation on our Investor Relations page of our website.

I'm here today hold booked with me, but joining in this call our human El Hariry, our Chief Medical Officer, and Irix, <unk>, our chief financial and Chief operating Officer.

Turning to page to do the forward looking statements will draw your attention to the disclaimer and you see we highlighted the profit we provided an update recently and so we are managing.

Overall relatively or even well the situation, but obviously, we continue to monitor very closely the potential for the impacts.

Of the of to cope with.

So and I invite you to reach the rest of the forward looking statements obviously.

On slide three the agenda, it's the usual routine I'll start with a business update.

I'll hand over to add to every quarter financial highlights in the first quarter.

We then you will also summarized the news flow and the milestones and then we'll open up for you in a.

Great and all three of us will be available for the questions and answers.

On the next slide slide four I think you all know this by heart a us just 40 Minders completeness quick reminder, we are the leading red blood cell company and we'll stay focused on cancer metabolism late stage and fully operational manufacturing sites in India and.

Princeton, both producing for our clinical trials and indeed listed on.

Your next parish and and NASDAQ.

So I don't think any to remind to further this slide I go immediately to the heart of the matter slide slide five the public a one.

This year.

Now with more than 75% of patients enrolled in the trial. The interim analysis does infringe superiority analysis it'd be convicted by by D.I.D.M.C. at two thirds of the events fact will not be significantly be delayed by <unk> <unk> the events.

40, <unk> will be very large.

Extent from from the patients already in the trial.

But indeed and that we singled also in in the press release, what you observed when.

Repairing the database for the that that I didn't see blinded database is that events that we'd have less events in the in the trial than we had originally Ah Ah Ah dissipated, which indeed, we'll have an effect on the interim analysis and that's why we <unk>.

Analysis from and Q3, two around you and.

Right.

Just a quick reminder, this interim analysis is he superiority analysis that there's no futility do outcomes or continuous plant or if we already hit the primary endpoint still just to to study for superiority.

So that's about probably come on.

You have three other costs 200 miles ongoing and one in the making so that's on slight six and here will soon.

Withstanding do <unk> challenges that are affecting the trial, but we have no.

We don't have to change the guidance for these trials at this stage at least this will come back up to his continuing the face to study in people naked breast cancer first line.

<unk> 17 sites are open in three countries and we.

Although it's obviously.

It was already slow and even if it continues to be slow the enrollment right now we still expect that data in 2021.

The Nordic study, it's an I.S.D. and investigator sponsored study in second blind Hello, He's now very very close to fool enrollment of 50 patients into trial and so now we continue to expect to provide an <unk> update it will not get really interesting data, but <unk> update on this study.

Still in this quarter and we hope that the final analysis can be or that the the investigators will report the final analysis by the end of of this year to final results.

And then there's the third one of the phase one <unk> in first line pancreatic cancer, it's and face one two shows safety in combination with Folfirinox important do when they bring.

Hour every s. based product also <unk> a lot of Brown's This study will think it's but it's going on.

In the Georgetown Cancer Center display until this trial they have already.

Received their I, India, <unk> and are preparing to get get going it's obviously the golf it's <unk>.

Making a little bit delay there, but we still expect week I did before that this trials can start in the second half of of this year.

So that's until here about the clinical trials, maybe and I'm switching to slide eight week or on the Presley's off yesterday or the the evidence freshly. So we need we are part of a European horizon Twentytwenty grant or.

In the evidence consortium, it's and it's a consortium of leading experts in in Red blood cells with very proud to be part of it. It's it's not so much for the money, but for E.D. The effect that we are sort of in this network of leading experts working on that or understanding how red blood cells are improve.

Either excess trailer environment and by physiological conditions, which is obviously very important for us as we.

<unk> technology is based on this.

So this concludes.

The business update from my side I'll have no overt <unk>, you got us to to financials and milestones for the next to the next year.

[noise] Oh here.

Okay.

Good morning, everybody more laws.

So limited continuing now with the sports on the financial highlights caught up with this year.

<unk> quite as number eight I'll just <unk>.

My first.

Common sense, that's unlike normal times, we're not providing today 10 on information for the quarter with the coffee 19 situation and the reorganization of our accounting operation and teams are working from home no. It was a be challenging to compile fulltime fun information on the usual pace.

And also to organize the auditors review, which also in the remote so we'll be able to provide the quarterly p. on information at the length of time and those expected <unk> already today, the key financial information.

On on the test physician, who was on <unk>.

[noise] so small.

This year, everything and the cold cash position or 58.6 million Euro, which is approximately 64.6 million dollar.

Compared with the seven 373.2 million Europe position this talk of the year.

Oh this was 14.6 million euro decreasing cash position in the first call to 2020 and that was the results of a 16.3 million net cast utilization.

Which was mostly comprised of a 16.7 million euro net <unk> Oh pray think activities. We also had 1.1 million euro used for investing activities and we generated 2.4 million euro in financing activities would try mostly related to are indeed <unk>.

And at the same time, the evaluation of the U.S. as our against the Euro led to a 0.7 million euro favorable currency exchange impacts.

I want to mention the the 14.6 million euros decreasing kept position in the quarter was fully in line with all present time, we're still of course closely monitoring the impact of the cutting 19 pandemic on our operations.

Stage, we can confirm or creatures guidance on sufficient cash position to <unk> to the first quarter of 2021.

We all know moving to the next and last slide of the presentation of flight number nine.

A recap of the key new slow and most unexpected opened the next 12 month.

So I'm starting with the completes enrollments an interim updates on the face we trial <unk> place to trial in second line acute lymphoblastic. Latino again, this study, which because <unk> is an investigator sponsored trial on just convicted and the Nordic countries of Europe. We're.

Respect the infamous <unk> in the current quarter, which is cute you 2020, and the final results should be expected for the end up this year.

But again this isn't invest to get into the stick. It. Let's try also went nuts holding talks with the timeline here.

Next if the indication of the phase one study in post line I meant to study pancreatic cancer.

This is also an I.S.D. and then just to get a sponsored triangle in the U.S. with the <unk>.

And we expect to stop station enrollments in the second half of these.

And finally, but certainly most importantly, or the company and volume last one for this year is the interim analyses <unk> superiority in front of kill one the fifth Street clinical trial in second alignment that's made a static yeah I gotta cancer.

So we expect this interim results towards the end of this year.

With again.

Dimension to possible outcomes, either still poor superiority if the primary survival endpoint is already met with only two so <unk> of the events or we continue to what the final analysis, which is not expected.

In the second half of 2021.

[noise] with that's I would like to thank you are ready for your attention.

Open the cold for any question.

You may have again I would like to remind any of you who would like to ask questions. French nuts, you Oh of course, they will come to do so <unk> student who keep it sounds like was it <unk> if you didn't like because you.

<unk>.

Oh <unk> Elizabeth now over to you.

Ladies and gentlemen.

Question at this time please.

The number one on your attached.

Question has been answered.

Yeah.

Please press the pound.

Please wait while color schemes for their question.

And yet I think I'm from the line Frederick gone Mad.

Finally.

Yes, good afternoon, Jim <unk> and <unk>.

And then graduate from flowing finally.

Yeah.

Since truck.

<unk>.

<unk> she'll speech two questions Nice had just fade streets on track.

In fact, you can't with the interior.

Then end up to you I was just wondering on the regulatory side are you working on an F.D.S. emission in that you French way now that you have the fast track teachers.

I would like to know where do you stand on the I'm just getting the C.N., they're pretty cool in the <unk> and the couldn't we expect early next show that kind of recordings from Michigan.

Case, that's put the T.V. and traveled weed out and I was just wondering that maybe you can refresh.

But so we'll both plants will be included in the <unk> or with you yeah, they're wanting prince found in the other one in France.

For this chance see because Ah the F.D.A. should during the inspection Oh, so each site teach me the case, so I'm just wondering oh, you're going to play with that.

And the second question is the stats for this.

<unk> try because because we may assume that so some patients you could <unk> 19.

So Oh, you get at East Coast, the results and <unk> for instance, thank you.

Thank you <unk>.

<unk>.

In answer both of the missed both of the questions.

Okay.

Okay.

<unk>.

And then.

<unk> and then last time component.

<unk>, Yes Ah Diana.

We have <unk> include voice manufacturing sites indie on as well it's interesting.

I <unk> that <unk> may decide to inspect the one on the boys sites.

On the second question that running from Michigan, that's exactly the client you know we're supposed to track that would give us an opportunity to just sent me and <unk> as they are making I certainly would allow it to do with this.

<unk>.

That's exactly what we have seen getting <unk> oh various margins.

That.

Neat way here, they're not.

Contingent or waiting for the outcome that came because drives so.

<unk> <unk> it it just doctor Theodric <unk>.

Oh <unk> a question that I think that's that and of course, the impact is things that that beginning of that crisis.

The S.T.E.S. went I forgot his sorry, just in Europe and.

<unk> dies.

We have <unk> image, it's me and.

And of course like in fact.

<unk> I added tracking.

<unk> I got and of course, but in fact, we could be operation I issues or that there are issues just quit affected the 15 or 16 of that patients.

We will.

Insured in our statistical analysis blank our children you'd have to I mean, I figured out insisted <unk> analysis basically if we have spacious really died but expected to have died due to go it impacts we add some censoring <unk> I'll for this patients.

To I <unk> I.

Interesting.

Just one just to remind you that that primary into point of that time is based on the intent to cheat so that shouldn't be always patients regardless, whether they died of course, they are not regardless, whether they have received any budget three things online, but it's it's sensitivity analyses decent when we're going to look.

This is names if you censor the spacious with.

<unk> coffee.

These odd to see like the charity's.

Okay. Thank you that's kill let's see I can go back into cute. Thank you.

Any your next question comes from the line Filipiak Gartner with Jeffrey.

Oh, hi back it up and then.

Question for me. Please she'll just coming back to one of your comments that you said that at the law.

<unk> you know you noticed that that was a low a number of event I guess that last time that you know too, but when you think compiling the reports for the other safety reviews.

If that does that mean something's changed between those would be the with the other ones just by so to patient sort of comes 20.

<unk> then my second question is did you just tell US you know when when the interim it's kind of duct tape. It's the trial. If it's decided that the trial should just continue as planned what level of information do you actually get from the review committee at that point do you get.

Details on the data so do you remain completely.

Cut to what the outcome of thank you.

Okay. Thank you flip up so on the first question. It was it seems effective now that we had the the the the the idea and she was now and <unk>. It was for the first time, but sort of it was sort of enough hook Buddha enough.

View on the on on on the event that this was sort of which put forward. So it was it doesn't mean that there is at least on any money and implemented or doesn't mean that that sort of has it changed lately, but it's just that there wasn't enough data to get a good view and on on sort of the.

The.

Two events in in in average.

For the second, but I'll I'll refer to the amount of swim.

Yeah.

<unk>.

<unk>.

Additional calls on the first point around a number of things.

On the second point, we were under the mean blind date, if the outcome of the I can see it. If you used to continue that tries to quotation. So we'd have upsets you have no clue what information they they have yeah.

So so that would be the case nothing still that started when we need to is I think she they would tell us a decent stage. We went through <unk>. Just started it took one thing I just completion and that would be it.

Okay, that's very clear thinking.

Mm mm.

Mhm.

Oh.

Yeah.

Thank you.

Yeah.

The next question comes from the line of angry Garofano Hall with Captain.

Oh hi.

Actually has two of them.

I see the study so appreciating that she has.

Oh.

Oh.

As long as motivation altogether.

Okay.

A.O.L. trial.

And why.

You go go after this time.

The second question is.

Part of that is evacuating every stays in the first line think that cancer. So that's a in that case isn't it.

Hello.

You see the second line is dark.

The favorable results.

Usually every season sorry.

Anything different don't drink, bringing everything's.

Okay.

I'd be any added expenses to that.

Yeah.

Okay, then hybrid good good afternoon.

And I'll I'll start and at least three month to compliment, but on the first on the P.L.L. study. Indeed, the no for study is you stick militias, who came to us of the Nordic M.L. to increase or this the Nordic organization of pediatric hematology oncology.

And they <unk>.

<unk>.

Many trials in in a in in in L.L. for it for example, and here specifically the issue is patients who develop allergies to the first time treatments could eat equally <unk>.

<unk> develop this this allergy they can or abandoned treatments with this badgers, but that's that's known to be.

<unk> Oh, just so it's it's known to be important the continuous balconies.

Or they will be treated with urban nice <unk> is in order for moves <unk> <unk>. It has it's too complex, probably think needs 12 <unk> per month.

They're also they t., but it was let's Lady that was not yet the case when we started to study as a supply issues shortages.

<unk> wanted to see whether it would make sense.

Forgoing or instead of going to to everyone needs to continue treatment on equal line, especially these but <unk> completed form because we had seen in our previous studies that even in patients who had prior allergies to equalize begging is that we were able to continue treating them without development of allergic reactions.

And that's really the the rationale behind the the study there. The study was originally set up to evaluate 30 patients in in these in about 20 sites.

Based.

I think we have had to request a.

Six months ago to extend the enrollment to 50 patients and now we are very close as I said 250 patients in this in this study.

So I hope that answers your first questions and your second question is is it would run indeed, so it's it's really the move to the front line is is basically obviously planning for success. It is under the assumption that we can come from what you've seen in seconds line and that we broaden the indication to.

<unk>.

So.

Your question would it make sense to go to first on if we don't see it in second line I think it'll be a challenge, but I would not excluded was the the it it is.

It will all depend on over to see what what we would see in in the second line study.

[noise] leave it to here, maybe I don't remember <unk> I missed something where do you want to compliment to list.

I think enriching also yeah, what can be it up going for the N.S. tie it off a trial.

And instead of going here <unk>, just like any other stodgy.

Or evaluating and as far as you need in D.C.T. is so so <unk> is that everything is <unk> activities in in patients you'll have to go to <unk>.

Essentially uncle spar.

B, primarily pharmaco kinetic.

I was when I is I love to dynamic employees.

So that says this is that the primary goal I have to try it.

And a second one and the ice tea in first line.

The only <unk> is the is that you know planning for success on the market, but but or so and you know and our next door.

Other diseases.

That shouldn't be a senior in a second line setting doesn't mean that but certain that I cannot work in any or did you say thanks. So that's number one.

Number two is the combination ways for screen looks which is interesting and it's on sale at an arrangement or a combination.

She would raise you mean that can be a sneak up on it and as our G.I. too much too.

So that's good has can have on so I in fact, if we would like to go beyond the pancreatic cancer.

That's very clear thinking.

Thank you and your next question comes from the line of ran Benjamin with J.M.P. security.

Hey, good morning, guys. Thanks for taking the questions [noise].

I have a couple maybe just starting off with.

The I.M.C. review can you talk a little bit about.

The the the push out of the interim results I guess, you know, they're they're different ways that kind of look at it obviously the very positive way is that that the treatment arm is having a significant impact other other scenarios that could result in this in this you know pushing out of event.

And have you looked at the impact of whether it's coded or or other things in terms of getting the you know appropriate analysis or.

I guess data from the patients that are currently in the study you know could that be impacting you know the push out or they'd be the I didn't see make this decision based on.

A complete you know full data set I guess just related to that when is the next to I.B.M.C. needed.

I think both or all three questions for you.

Okay.

Good morning, and how are you.

So on data is so nice for <unk> <unk> <unk>.

And if it's the most obvious <unk>, yes, there is ugly delta and between different story and that it affects our I'm still stations are.

Living junker.

Which is why we have I I know a number of days day and.

Anticipated.

It could also be potentially and no one wants trainee it couldn't be a combination of perhaps and.

The median survival.

Or the patience and you know both for autumn and active on our own still even longer best two ways and I think that'd between the two treatment honest.

And that's the second scenario.

Then they searched and now you, which we well I didn't see any what can be starting to get.

We actually some of these do you need a base is simply because we don't have all that these town and it could be one of you know.

Continuation of the about yeah. It has some of these events have not been anytime did anybody can be is again because of the of the <unk> in fact, it could be any old friend over the above what a combination of any of this city Tonight is.

And of course in fact.

I didn't see it did not offer that I didn't see it a views on me 50 information they don't have access to.

<unk> if they could see data. This is based on the ice skating chart done with.

The idea is cheap.

I'm sure they would only look at the effect to see that <unk> analysis.

And thing here I I know that's fine yes, they we agree with them on what information they would like to to see in in the <unk> beyond the survival in the I.T.T. <unk>.

And the next I didn't see it would be affected of U.I.N.I. and this would be applied.

Again I'm six months is around October timeframe.

Terrific.

That's your your answer my question.

Yep it that thank you very much and then just as.

A follow up thinking about the phase two I.S.P.L. results.

<unk>, what do when we think about it and then from update versus final update what would be <unk>, what should we be expecting from this interim update.

You know is it just on the on the first sort of 30 patients.

Should we be expecting you know response rates are primarily safety <unk>, how should we be.

Getting ready for this.

Do you mean Guy then also try it.

Yes.

Oh I see okay.

I didn't do interesting things socialite ticket <unk>.

Okay. So so the interim updates <unk>.

It's basically.

We don't expect to provide.

You know a quantitative sort of data.

This is an interest to get to initiate just try and that investigators or is extremely can to to preserve it the integrity of the study for for future applications. However, I they will have <unk>.

<unk> inches of the sixties and he says as I said earlier the frame of the endpoint of this study is pharmacokinetic, which is kind of <unk> point. So they will have an alliance the find the endpoint as I say 50, so they would have they wouldn't know the information.

And based on the information that the become aware of.

They <unk>.

And basically they wouldn't be.

Happy for for Us to communicate with our the client is sure what's expected to be showing.

So so yes, it should be on the primary in point as well as in the 50 and I think the applying to to provide <unk> data, it's something that would have to discuss ways that P.I. and we and since she is in no. She used on who isn't the driver see we wouldn't have to agree with what you would.

Like us to.

To provide to.

In the public domain.

God and and just as a follow up to that assuming that he K.P.D. as is spot on exactly where you want what would be the next step.

For a program like that outside of and I see so from a corporate perspective is there you know what's the future for.

This product in in <unk>.

Okay, I'll, especially in order to take it.

Maybe I'll start and then you.

But yeah, I think would we.

What we see daily is isn't it isn't it it's a small part available but it's in high unmet needs as patients who are doing really pretty well are are <unk> are typically on on the.

I'm just part and then all of sudden develop these these hyper since then.

A new treatment they would get them moving age, but as I mentioned earlier has shortage issues has many many <unk> 12, it's very expensive also.

So we think that indeed could D.C. business opportunity do continue in this.

Indication and the whole question will be that will depend on the data whether it can be on the.

Data that we will have an end the previous day that we've had in it reminded <unk> we have had.

Loading good data in L. already it was not good enough to get us <unk> approval in relapse <unk>, yeah level, but that was for for different reasons. So here in this I m- neat with a study with we'll have 50 patients and then.

Lot of other data in in L.L., we hope that can bring us to to wouldn't know yep.

Patients with this indications, but again it will depend on what we see.

The results.

Perfect back for taking the questions and get back to that you.

And once again, if anyone would like to ask a question. Please press star one on your touch tone telephone.

And your next question crossing the line of bars picker from Cohen.

Hi, This is Cynthia on for Boris Thanks for taking our questions on good afternoon. So just a breeze question for me for tobacco. One can you provide us marquee totaling how patient all up is going with covered and I think you mentioned in the remarks conditional measures are taken to preserve study integrity and he goes more context.

Ours are on with that looks like.

Yeah.

I think that's for you.

Okay Hi.

<unk>, so what's it doing physically.

<unk>.

The study a challenge for indicating tried including to pick on most it started recording easters are Ah working from home, but they have access to the electronic a database so they wouldn't <unk> they might insufficient <unk>.

The home and then go to decide when efficiency is if kids just for for a chased names.

So so that just that they shouldn't style that China's intros off on the operational front for Eddie Steak is also the Seattle are Oh external visitors to every single hospitals that we are working with our physically be prohibited so again the hour Seattle axes.

The data you're lucky so what we what we did at the beginning Oh Oh. This crisis. We we same idea just to get certain data. So alright, investigators and started recording eaters and physically try to to make sure what chicken decent.

They need to make sure. It is in the system to be able to make judgment call is for.

Ah fishing management, so should we put that.

<unk>, we also and <unk> the the size to <unk> again on a on the electronics older and more data access which actually worked very.

<unk>.

A number city or crimes tie is what information into his off for something <unk>.

And there's ways to Seattle, if you have six if you have <unk> Oh Ah, it's information that needs to go into that neat ideas or 14, <unk> or for sending queries, which one would be critical on the ongoing basis again for a to ensure that the patients fifties under treatment is.

Into it we have <unk> and the size to to share two two different no collapse for instance for the 50 evaluations and selecting you know loud counts chemistry et cetera to put all of these <unk> <unk> <unk>.

I mean, even wine, we we initiated and also we encouraged and then add a investigators as well as everyone in their teams do it each to US Dykes me for if there are any particular issues that they knew the immediate response and I continue you know is.

This what we have seen Ah, but particularly at the beginning of it and which is.

Physically the heat all stuck glasses everywhere you know.

We had another store communication was was on sites for for different stations issue.

<unk> <unk> kids support for.

<unk> captures or potential issues to guard think <unk> I'm. So that can help us <unk> statistical analysis plan as well as the evaluation of the 50 and other try and outcomes when we come to answer that the stage. So so this has been just it'd be just.

Oil sites, Seattle was working with on sides on on that's right. So so these are the the measures that we have is taken on foot <unk>. Once we are seeing is that so far.

We see many men up so we can minimal impact on the fission three things <unk> evaluation. So we'll see an action very it actually it was that it but I think would try to to to even go to the bare minimum of the fish evaluations to make it easier.

Sorry, I'm going along with support for for that for different stations.

I hope this answers your question.

Yes, that's that's very compact comprehensive unclear. Thank you so much.

And once again, if anyone would like to ask a question. Please press Dar one on your touch tone telephone.

Okay.

And there are no further audio questions and Mchugh at this time.

When I turn the call back over to Mr band.

Thank you Elizabeth Thank you all.

Thanks for your budget.

Fish and your attention and good questions and it was before your continued support everything <unk>. We will keep you updated all no progress as for the remainder of the year. Obviously, thanks again, thanks for joining and I wish you are a great big.

[noise], ladies and gentlemen distances today's conference. Thank you for participation and have a wonderful day all participants may now disconnecting speakers. Please hold one moment.

Yeah.

[laughter].

[laughter].

[music].