Q1 2021 Erytech Pharma SA Earnings Call

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Good day, and thank you for standing by and welcome to the every day. This is update and financial highlights for the first quarter of 'twenty 'twenty. One at this time all participants on listen only mode. After the speaker's presentation. There will be a question and answer session classic mesh and you need to press star one on your telephone.

After this conference being recorded if you require any further assistance. Please press star zero and I would now like behind the confidence Oberthur. Your speakers today, Mr. <unk>, Zhang Chief Executive Officer, You May go ahead Sir.

Thank you Dexter and good afternoon, and good morning bourgeois who's. Thank you for joining us for our first quarter doesn't and 'twenty one earnings call.

Hope everyone is well and safe wherever you may be and we announced our business and financial update yesterday evening and.

The press release and the Q1 earnings presentation can be found on the Investor Relations page of our website.

And joining me on this call today from three different locations, our Doctor Hema and <unk>, Our Chief Medical Officer, and every 48 hour Chief financial and Chief operating Officer.

We are on previous retreated from locations and there's some technical issues, but I hope that we all that demand and join us in debt in the meantime, and.

And in the meantime, before starting the day update draw your attention to slide two to remind you.

Today's call includes forward looking statements such as relating to the company's operations timelines and financials and as you know they involve risks and uncertainties that could cause actual timings and results to differ materially.

And then switching to slide three.

Gender, so as usual I will start with a short introduction and.

And indicating the key business highlights for the quarter.

She's able to join and time will then provide an update on the status and the progress of our clinical programs.

After which Erik will present, the financial results for the quarter and highlight our most recent recent financing from from last week.

We will people will summarize the expected milestones for the coming year before we open up the lines for Q&A.

All three of us will be available for your questions afterwards.

So now moving to slide four and as a quick reminder, for anyone new to the company every day and named tilted Erythrocyte technology is the leader and Red blood cell based cancer therapeutics on.

Our focus is on targeting cancer sales altered amino acid metabolism, and increasingly important and exciting area of cancer therapy.

And this area, we have late stage clinical programs and pancreatic cancer triple negative breast cancer and acute lymphoblastic leukemia Hello.

You can see from the pipeline chart on the right hand side of the slides.

I mentioned it at our coal and <unk>.

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2021 is truly a key year for Iridex all four of our clinical programs are expected to report defining events before the end of the year.

And two of which potentially supporting the application for regulatory approval within the next 12 months.

On that and in a minute.

Yeah.

We produced or we do the encapsulation of.

The API and the asparaginase in the case of the lead product in our manufacturing sites.

Fully operating facilities, one in Lille for Europe, and to take and Princeton, New Jersey for the U S.

And last point also from our U S. Europe company, not only our president and both on Europe and in U. S. We also are listed both from Euronext Euronext and NASDAQ and we have a shareholder base, which is approximately half of Europe and U.

U S.

So this is a short introduction and then going to slide five.

Highlights of the quarter.

Indeed.

It's continuing the progress that we've made in 2000 22020, what she really here with a lot of achievement on the different clinical programs to offer this first quarter.

And important one with important steps forward towards.

Bringing areas.

And lead product candidates to patients and this both in Europe and the United States. This four highlights I'd like to mention briefly the amount and Eric will zoom and more in detail and the first flawlessly on Tribeca one our.

Pivotal phase III trial, and second line advanced.

Pancreatic cancer, we completed enrollment actually in January.

Almost completed in December.

Two more patients coming in January and now 512 patients randomized.

And.

And then in February we had our interim analysis interim analysis performed by the <unk>.

Trials independent data monitoring come and TV <unk>.

This one.

I'd already been three safety only reviews.

All three with good safety profile and recommendations to continue the trial without modification. This one safety and efficacy combined and also the recommendation was to continue the trial.

Without modification. So now the eyes are really on the final analysis.

We continue to expect in the fourth quarter of this year.

And with this and get the ice really on this trial at Tribeca, One is to our knowledge the largest clinical trial ongoing in second line metastatic pancreatic cancer and.

And obviously has the potential if successful could lead to a treatment paradigm shift and this horrific disease.

Traffic on them, but what's first and second highlight staying and pancreatic cancer free them from the ISP. The investigator sponsored phase one trial in first line pancreatic cancer trial, we are doing in view of.

Bringing this.

I'll read products wholesale to first line pancreatic.

After having seen them.

Firming, the result index and the second line.

This trial is.

And patient standard dose escalating trial started enrolling in January and completed the first dose cohort of three patients.

And then in April there was a review by the trial steering Committee no dose limiting toxicities were identified and on top of this very encouraging and nice signal of clinical activity was observed two of the three patients showed a partial response and adult patients a stable.

So the investigator.

Markets and well motivated about this trial already we moved it now to the second dose and.

And the non will explain a bit more about this.

And then third clinical highlights is on.

Hello.

And that we.

Net.

Step in our path to.

And to seeking approval.

Patients, who develop allergies hypersensitivity regulated asparaginase.

Based on the phase II data of the no force sponsored trial that we.

That was communicated at the end of last year.

Following further interactions with the FDA, we now requested a pre BLA meeting.

Last month and mid last month.

Just a potential submission of a BLA or biologics license applications.

And subject to the feedback from that meeting we plan to submit the BLA in the second half of this year.

So thats on the debt highlights on the clinical and then clearly there was also last week.

Debt to be raised $30 million and a registered direct financing.

Eric will provide more detail in that and a few minutes.

So then moving to slide six.

Summary here as debt.

All of this sets us up the stack.

Age for a catalyst rich remainder of the year as you can see from this slide.

I will not repeat what I said earlier, but you see the green check marks debt, marking the achievements over the past six to nine months.

And then the four clinical practice that will now have are well positioned for significant and defining milestones in the coming eight to 12 months with two of them holding the potential regulatory approval submissions in debt type time horizon.

So I will stop here with the introduction.

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Two months was able to join in the meantime.

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We have consistent okay.

It is activity and our program so far.

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And it will be you've actually got to Rehabs and.

Additional data package to support this plan.

And that's what pockets that description.

And our upcoming and we think with.

Yeah.

I think this eight average I'll.

And I'll stop here and I'm kind of old work too.

Walk us through the financial results from the first.

Got it and then use flow Eric.

Eric over to you.

And.

Thank you thank you eamonn.

And everyone.

And.

And so and then reviewing the financial highlights for the first quarter of this year.

Slide number 14 of the slide deck, and we're starting with the P&L inflammation.

The net loss for the first quarter of 2021 was 11 9 million Euro.

Which was a decrease in net loss of $5 6 million Euro, it's minus 32% year over year.

The $5 8 million decrease minus 31% and operating loss and is that $1 2 million and decrease in financial income.

The $5 8 million decrease and operating loss was attributable to the $4 8 million decrease and preclinical and clinical development expenses and Thats whats concurrence with the sense of patient enrollments in the company's phase III clinical trial in pancreatic cancer.

Also on <unk>.

<unk> and decrease in DNA and is zero.

And they were one 7 million increase in other income, which was mostly related to R&D tax credits.

And the meantime, the $2 2 million decrease and financial income was mostly related to the accounting of the convertible.

Convertible notes.

And now moving to slide 15, so come on from cash.

As of March 31, this year and protect our cash and cash equivalents totaling $37 4 million Euro, which was approximately $43 9 million and that's compared with $44 4 million euros on December 31 2020.

So this was a 7 million euro decrease and cash position during the first quarter of this year and that's what the results on the $7 6 million of net cash utilization, which was mostly comprised of a $16 4 million utilization and operating and investing activities.

And $8 6 million euro generators and financing activities.

The variation of the U S dollar against the Euro led to a 6 million positive currency exchange effects.

Financing activities and the first quarter of this year included $6 4 million Euro two of the companies and the markets or ATM equity financing program and so the placements with a top tier U S investors specialized and Bezeq and.

And at two 9 million net proceeds from the drawdown of one trough and though the convertible notes financing agreements, which is also a cause for capstone.

And also dilution last year.

And now a word on our most recent financing initiatives.

And now on slide number 16 of the presentation.

And as you've seen and already mentioned by Gilles was announced last week and a new round of financing and <unk>.

More specifically of interest direct offering of $30 million.

Please with specialized health care investors, mostly in the U S. But also partially in Europe.

This financing and both the placement of new ordinary shares that are in the form of American depository shares idiots.

And it is well subscribed and $7 and 25.

Which is six zero on Europe.

The I D.

Were also associated with a 70% 75% warrant coverage.

The warrants have a two year maturity and and into place price of southern Europe and <unk>.

<unk>, which is $9 and place them.

We're of course extremely pleased with these important financing milestone for every day and.

And the mark of confidence and the company's current developments the net.

Proceeds from this financing round will further strengthen the company's financial position with a cash horizon beyond or anticipated key catalyst at this stage, we believe that the company's current cash position, including the net proceeds from the last week's offering.

Our planned operating expenses and current programs into the first quarter after eight and 22 and.

This cash runway could be extended into the third quarter of next year, if the company further hit the noises.

Put caps on agreements.

Of course subject to the usual regulatory delish and limits of 20%.

Finally, and moving to the next slide number 17.

And I wanted to quickly summarize the upcoming key milestones before starting the Q&A session and all of this was already covered extensively by basically 18 months.

Starting of course with the final results from terrific and wanted us the phase III trial in semi and pancreatic cancer.

And I'll explain this final results are expected in the last quarter of <unk>.

This year Q4 'twenty one.

Obviously, a key milestone for the company.

Before that's potentially and.

Potential BLA filing with the Ria space a L. L E Myers of explain and job of explaining to you.

The regulatory.

Work on.

And on that front and that could be expected in the second half of this year.

We also expect the first results from Tribeca, the randomized phase two trial for aerospace and Tim the syndrome triple negative breast cancer.

And that is expected by the end of the year. So Q4 this year.

And finally.

Determination of the maximum tolerated dose and respect the phase one and first time pancreatic cancer This and I see and this is expected in the second half of this year.

So again, the rest of the year, which is full of potential and quite excited and catalyst.

But that's I would like to thank you already for your attention I will now open the call for any questions you may have.

And as always we'll also from the questions and friendship.

That's it from the other kits for the personal care Division.

And the multiple civil spooky.

And then it gets don't force if they generally democracy and resolved because you're on pace.

Hopefully.

Operator, Dexter it's over to you.

And next year.

As a reminder, and ask the question we've depressed per one on your telephone to withdraw your question press the pound key again Thats star one to ask a question. Please stand out and compile the Q&A roster.

Your first question comes from the line of Ren Benjamin from JMP Securities. Your line is open.

Hey, good morning, guys. Thanks for taking the questions.

I I might've missed this and I am on his comments and so I apologize.

You guys have to repeat it but what was the initial clinical activity that was observed.

In the and the ISP.

Frontline.

Study and and is there any way to kind of tell.

Why that response might be more or less due to the addition of aerospace versus versus not.

Hi, and good morning, Oh, sorry.

And Q2.

Okay go it.

Okay.

And your line is.

And I can't even related.

And then.

And maybe a memo.

So maybe I'll start because youre line is really weak and then you can add if I forget something.

So basically around the initial clinical activity was two partial responses.

Nice partial responses and stable disease so on.

And these controls.

It's only three patients obviously.

But still it's encouraging.

And create a cancer and.

And so that's what's really the day message.

And maybe you want to add to this.

Oh, yes.

Yes.

And it's really not and connection.

Really not dwell on them.

Yeah, well, what about duration and Jill.

So that is pretty promising but and anything regarding the duration of these.

And these partial responses.

This was partially responsible.

Soon after the day treatment towards the first first so I don't think theres much view on duration and yet.

Is there a view on duration of this partial responses.

And we have and so and we shall I say from toys.

Tweaks after right.

And.

So actually if anything from you.

But we.

We don't have the JV sales.

And you'll have debt.

Its progression and so that's where you'll have the critical niche and we've got.

It has moved up from around the current.

Thank you ladies and events that we now control one.

Non speech at Weyerhaeuser second described as one that can be.

And this is chip.

And we need to.

And just talk about that day.

Six points.

And that's why this is encouraging and of course.

So it's like taking.

Chemotherapy.

Once a day is about 50%.

Our absolute right and the thing on giant it is hard to know.

And accepted it as far as added to chemotherapy, but we.

And we've got discussed.

And based on that discussion.

It seems to be interest that you have.

On.

Thanks.

Got it.

And then maybe just switching gears real quick to the manufacturing and show you met you mentioned are we on and Princeton.

And you know just kind of given what's been happening and our industry with the <unk>.

And <unk> being handed out by the F. D. A I was wondering if you could kind of talk through.

How I guess, how prepared you are if everything works out the way that we all hope and the fourth quarter with a drawback on one study how prepared you are.

And regarding these manufacturing facilities have inspections. The inspection will take place you know prior to filing or do you have some sort of.

On.

And our confidence you might be able to give us regarding the.

And the preparedness of the manufacturing facility docks.

Yes. Thank you Ron good good question so basically.

You have to make a distinction between volume and for instance in June we're doing this seems to be done on the ninth.

<unk> produced 35000 beds.

And.

We have been inspected and regular basis, so GMP inspections happen in every every two years and.

This site is.

Which is the 12 premiums.

And so with this site, we have done and the programs, but also we anticipate to be able to do the early commercial sort of first year year and a half.

Commercial and so the estimates.

And we should be able to do.

And with that obviously as soon as we see the green lights.

We will work on a from them.

Additional sites.

Anyhow and need a backup site and so forth.

And for manufacturing so that will be triggered as soon as we see them.

Positive data in the cards.

Four ALLL on its own.

Yeah.

It's large enough.

And your indications hypersensitive CLO, so it's really the pancreatic data.

Trigger.

The extension manufacture of capacity.

And from.

And in Princeton decided newer and we started only we initiated or inaugurated decide and 2000.

19, and we started producing really and clinical in 19 and decided is doing really well, it's a larger side its more its more and expansion of facility. There has not been inspected yet so the FDA inspections happen after filing.

But we've obviously done mock inspections and we have.

And already.

And already had interactions with the NBA on TNT topic.

So also.

We believe and think that decided and it can cover the initial.

Commercial activity, probably year and a half.

And same thing it can cover.

And on its own.

And the full potentials.

Potentials of yellow.

Based on positive data pancreatic second U S sites.

And.

We are already preparing the ground for debt sort of anticipating locations looking for potential sites, but we're not spending money on it yet.

And until that data come out.

Great. Thanks for taking the questions.

Thank you.

Your next question comes from the life and greed golf and half from camera. Your line is open.

Oh good afternoon, Hi, good morning, Thank you for taking my.

And I haven't seen a brief one so I was wondering for debt.

And Oh.

L.

I just wanted to come from.

Is this going to be day intended.

And tended to be and it's sort of the accelerated approval pathway with debt load or as a regular approval pathway.

Yeah. Good question, we have not filed yet for fast strength, but we anticipate to do that.

Notice that things are sort of.

And so yes, we anticipate that this will be an expedited review.

And of the BLA meeting roughly eight months free too.

Yes.

Okay, and then you would expect per day it would be enough for formal approval right you wouldn't expect to have to do any other confirmatory trials.

And final upgrade that with 40 per home.

I think this will be the discussion on the pre BLA meeting so were indeed.

The base plan is a regular approval it could be and accelerated approval as it's called and the U S, which means that then there is a post approval commitment for additional additional work that free time being based on the unmet need based on everything we know so far.

Yeah.

Regular approval.

Base case.

Alright, that's fair thank you.

We have a question from Boris Speaker.

Your line is open.

Hi, This is Cynthia on from Boris I think a quick one from me.

And Tribeca, why and what was the final breakdown of patients from the U S versus Europe, and how does it impact the choice of chemotherapy.

And can you.

It is.

And I can't.

Hi, Ken.

It's still in force after interest.

I would put on it and we have about.

For two patients enrolled and Tommy.

And so this is.

On a decent number you know and you know.

And what is the if you would like to see if in fact, we have contribution from a from a U I speak English and still can we are we are comfortable and sac.

And just stepping down and of the Cumulus therapy the back from chemotherapy. It's.

Almost 60, 40, 60, tourism and vaccine and <unk>.

And just on that.

Yes.

Great. Thank you.

Okay.

Our next question is from Lucy Codrington from Jefferies. Your line is open.

Hi, Dan sorry, and again this is just something that I missed in terms of the debt.

The line quality and we're talking about potentially modifying the expansion kind of hope for the first line pancreatic cancer trial at this on.

And just to get more detail on that thank you.

Okay.

I think what I tried to say is that I know the expansion cohort, which is a typical interference on trial once we achieve that MTGE.

And I could be the first day or six patient day and rate dropping back non box.

Probably would be up to each and patients and that's actually I'm sorry.

And this is not surprisingly is not unusual and that in.

So try and goes on and that the investigator.

And if you just try and he is off to the industry.

Was there and this would be their continued interest to do expansion cohort or that you would like to do.

And maybe.

And then the randomized.

On the expansion to bandwidth backbone chemotherapy. So I think that's what I'm trying to say that right. Now she is an expansion cohort that's the plan, but we don't have.

And it tends to be open minded and because there are.

And any additional feedback interest from.

And from the P I.

And more defined that especially on par that could actually give us a better readout.

I think back on our strength to me, but and I know there are no actually no plans to change.

Thank you. Thank you.

Again, that's a real mind answering that question on press Star then the number one on your telephone and feedback thus far volume.

There are no verdict and Scott.

And I could turn the corner from her back to Mr. Jim Dan.

Okay.

Thank you.

Thank you all for your participation and attention and.

And obviously for your continued support for every day.

The key here and we will as always we will keep you posted on the progress.

Sort of issue and a great day. Thank you all.

This concludes today's conference call. Thank you for joining you may now disconnect per cent.

Please stay online for the post conference.

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