Q1 2021 Innate Pharma SA Earnings Call

May 11, 2021

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Please continue to stand by your conference will start very shortly please continue just on by your conference will start very shortly.

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Good day, and thank you for standing by and welcome to the innate pharma 2021 first quarter business update conference call. At this time all participants are in a listen only mode. After the speaker presentation there'll be a question and answer session to ask a question. During the session you will need to press star one on your telephone I'm on.

Advisory was on this call is being recorded today Tuesday, the 11th of May 'twenty 'twenty. One if you require any further assistance. Please press star zero, and I would and I like to hand, the call over to your first speaker today bolt them on to my Juppe. Please go ahead Sir.

Good morning, and good afternoon, and welcome everyone on.

This morning, and eight ish.

The press release provides and a business a day for the first quarter 2021 and.

Look forward to explaining the progress made during the quarter is weighted to address and future goals and milestones.

The press release and today's presentation are both available on the IR section of our website.

Please move to slide number two and before we start I would like to remind you that we will make forward looking statements regarding the financial outlook, and addition to regulatory and product plan and development.

These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.

Please move to slide number three on <unk>.

This call I'm delighted to be joined by Dr. Joseph <unk>, EVP and Chief Medical Officer.

I would also like to take this opportunity to welcome our new CFO per day Colombo officially started at the company and April and will join the Q&A section of this webcast, which will follow the prepared remarks by myself and Joyce.

And you may have noticed the past and the first we have only held conference calls masking our half year and annual results.

However in order to provide more regular updates on our business progress we have decided to hold conference calls on a quarterly basis.

Important to note, though that as we do not publish full quarterly financials and there'll be no formal remarks about our financials during this call or the third quarter call.

On slide number four and you have the classic and true slide of innate pharma.

We are pioneering the field of innate immunity as you know and NK cells and we follow the science to develop innovative therapeutics for patients leverage and our know how and antibody generation platform.

Using this expertise and know how to develop a robust pipeline of novel medicines for cancers, but also for other life threatening diseases with high unmet medical need.

So and then the fire actually depicts our wholesale strategy.

And I'm very pleased to see the growing momentum and and.

Standing the important role NK cells play in and developing therapeutics to treat cancer, we are leader and the field of use and natural killer cells to activate innate immunity and these scientific foundation is at our call.

As you know early approaches to immunotherapy T cell centric.

And have mainly focused on enhancing T cell responses by targeted inhibitory pathways with immune checkpoint inhibitors for example.

<unk> therapies have led to an unprecedented successes and transforming the natural history of many cancers.

However, the unmet medical need is still high and only a small.

More fraction of patient response to T cell therapy, and there remains significant true lot among those who do.

Broadly speaking T cells, and autonomous and the effector function and need help from sales of innate immunity, which we believe represents the second wave on the next generation of immunotherapy.

And to us choosing the right targets to direct the budgets immune response is of Paramount. We do this by utilizing our fundamental and thus ending of NK cell biology tumor micro environment and tumor antigen.

Please move to slide number six.

Our pipeline shows.

How we have correlated these into robust.

Portfolio of proprietary.

And partnered assets.

It also illustrates how we are executing against our strategy with our lead asset like with them up and supported by a partner and earlier stage product.

Additionally, we have a rich pool of preclinical project, which we will carefully select and bring forward to assure our clinical pipeline.

Let me remind you our strategy on slide number seven.

Our strategy is centered around three core priorities.

First.

Creating near term value driven by our lead proprietary product candidate <unk>, which is in development for T cell lymphoma.

Second.

And our pipeline and create and Kate and longer term value by leveraging our antibody engineering capabilities to develop.

Innovative molecules with a primary focus on our multi specific and kitchen engage their deliveries from our proprietary platform.

And third we are building, a strong and sustainable foundation for our business leveraging the various partnerships across industry and academia, which further validate our science and offshore capital that we reinvest to advance our portfolio.

And during the first quarter of 2021, and we have worked diligently to execute against these three core priorities.

Number one and we have continued to advance liquid as we pursue a broad development strategy and cost T cell lymphoma.

Earlier this year and in February we held a virtual <unk> meeting, where we highlighted the advancement of the micros is from Gary This arm of our phase III <unk> study into stage, two which occurred earlier than anticipated.

In addition, we announced that our stepwise approach in developing liquid and up in peripheral T cell lymphoma with two clinical studies for Q3 deal to express and patients with relapsed ptca, including a randomized control trial and collaboration with our partner and the lymphoma study Association or Lisa.

We are also working hard to advance our R&D efforts with our early stage program moving forward on this.

Part of the year, we were pleased to announce that Sanofi made the decision to progress API 61 on one hour indeed, NK cell engagement into IND, enabling studies Aps and 61 on one and now is it.

$445 seven.

This is the first candidate to emerge from our multi specific NK cell engagement platform and we are excited by the prospect of this technology, which we believe will fuel our pipeline well into the future and we look forward to telling you more about our progress here later in this call and in the near future.

Sure.

I would like now to pass the call over to Jason who will review the progress made with our portfolio Joseph.

Yes.

Thank you on there.

On slide eight let me start with operating model.

Our first in class humanized monoclonal antibody that targets the immune receptor Q3 DLT.

As you May remember <unk> is an inhibitory receptor found and approximately 65% of patients across all cutaneous T cell lymphoma.

And even more and certain aggressive subtypes, but with limited expression in healthy tissue.

To date data from low <unk> have shown promise demonstrating compelling single agent activity and offering immense potential and lymphomas historically associated with our core prognosis for which there are few therapeutic options and to advance stages.

On slide nine as mine Darren mentioned this past quarter, we hosted a virtual investor event, featuring key opinion leaders and cutaneous and peripheral T cell lymphoma.

During this event and we highlighted both the unmet need and these populations as well as the therapeutic rationale for our telematics study evaluating likuta mab and subsets of CTO.

Additionally, we introduced a broad development strategy to advance this program initially for <unk> syndrome and.

Mitch <unk> indication with high unmet need into other forms of T cell lymphoma, notably mycosis, <unk> and the broader <unk> population.

On Slide 10, let me first highlight the progress on our ongoing phase II <unk> study for <unk> syndrome, and micro seats on <unk>.

We were pleased to share that we had moved the Q3 deal two expressing mycosis <unk> cohort from stage one to stage two.

Clearing a predetermined threshold before 50% of the cohort was involved.

This was very encouraging and I am pleased to announce that the preliminary data from the stage. One of this cohort will be presented by Dr. Martine Bogo and and oral session on.

On the 20 <unk> of June at the 16th International Conference on.

Malignant lymphoma, ICM al and Lugano.

And this year it is being held virtually.

For the century sensory syndrome cohort enrollment is on track and we expect to be able to report topline data in 2022.

Sensory syndrome offers us a potential fast to market opportunity as we received fast track designation and the U S and prime designation and the EU last year.

On slide 11.

Simultaneously, we are working to advance our recently announced clinical development plan for peripheral T cell lymphoma, which will focus initially on the relapsed setting where the unmet medical need is most significant and patients expressing the target Q3 deal too.

We expect to initiate our phase <unk> trial evaluating <unk> as monotherapy by mid year.

The study will enroll approximately 20 patients and it will.

We will evaluate safety and characterize clinical outcome.

First data are expected in 2022.

Separately, our partner, Lisa we will initiate and investigator sponsored phase II study to evaluate and Likuta mab in combination with chemotherapy gem ox vs Gem ox alone.

This study will be multicenter.

Randomized study with approximately 60 relapsed refractory patients outside the U S and is expected to be initiated and the second half of 2021.

We believe that this stepwise approach will prove efficient and <unk>.

Identifying the optimal regimen for lacuna map and the relapsed PTC offsetting.

Depending upon the data generated in these initial studies, we will consider initiating a separate trial in combination with other standard of care treatments and eventually we would look to move <unk> into earlier lines of treatment, including as potential combination and the chop regimen in frontline <unk> or is it.

<unk> therapy following standard first line treatment.

On slide 12, now turning to our <unk>.

Turning now to our R&D efforts, we continue to advance multiple programs forward based on our proprietary multi specific NK cell engagement platform.

Which we believe will be the key to unlocking next generation clinical molecules and immunotherapy.

At the start of the year, we announced that Sanofi had taken the decision to progress IP H 61 on one.

Or SA or 44% to $35 79 into IND, enabling studies.

As you May remember IP H 60, 101 is and NK P 46, based NK cell engagement using our proprietary multi specific antibody format.

IPA and 60 101 as a part of our ongoing research collaboration with Sanofi.

To evaluate up to two NK cell engages and is advancement into the IND, enabling studies that triggered a $7 million euro milestone payment and <unk>.

Sanofi is now responsible for all future development manufacturing and commercialization of IP H 60, 101, and we remain eligible for future development and commercial milestones.

On slide 13, as you know our NK cell engagement platform is at the heart of our research and is a major component of our long term development strategy.

To date, we have developed a robust portfolio of product candidates using our tri functional NK cells or NK CD, three which has demonstrated potent NK cell activation cytotoxicity and efficient control of tumor growth.

Our innovative approach means that we are continually working with our NK CE platform to further develop and expand its capabilities, including the develop development of a next generation tetra functional NK CE or NK CE for.

Our Chief Science Officer, Eric EBITDA will speak more about these latest innovations and our platform. During his primary talk at the annual meeting of the Federation of clinical Immunology Society also known as <unk>.

On the 10th of June.

Additionally, we will hold an investor and analyst event mid year, well, we will cover both the next generation and Casey platform and present, the lacuna map and mycosis <unk> data that are being presented next month at the <unk>.

<unk> got on our conference.

In addition to our progress with Rakuten map and our next generation and Casey Enterprise. We have also made progress with IPA and 50 301, our CD 73 blocking antibody and a phase one trial is expected to begin later this year.

<unk> 53, and one targets the adenosine immunosuppressive pathway and has the potential to promote antitumor immune responses across a wide range of tumors.

Now I would like to turn the call back over to them on their for concluding remarks.

Thank you Joseph and <unk>.

And then see we are working diligently to execute across all our strategic pillar.

And believe that we are laying the groundwork to drive near and long term value from patients and shareholders.

Looking at our clinical program, we expect to achieve a number of milestone over the next 18 to 24 months.

As you've heard from Jonathan on our phase two <unk> study for academic and continues to progress and we expect to share preliminary data from stage one.

However, the Q <unk>, two expression and that cohort at the Lugano meeting in June as well as expecting throughput and potentially pivotal data and say very syndrome and 2022.

In addition, we anticipate moving our monotherapy party shale program into the clinic by mid year with initial data expected in 2022 with the combination study sponsored by Lisa expected also to start and the second half of this year.

In parallel we continue to develop our technology platform and we are very encouraged by the preclinical results.

For our next generation NK cell and T cell engages.

We believe that this represents a natural evolution of our platform. It is tight and the potential of natural killer cells to be potent cellular player for the next generation or off the shelf cancer Immunotherapies and we look forward to Eric sharing more details on the innovation. We have made at the <unk> meeting next month.

Highlights as you heard from duration of the next generation <unk> platform together with electric and as data presented at Lugano, We will also be presented.

And IR event to be held on June 20 <unk>.

<unk>.

One of Darren Thanks for the question so.

I think you know when we look at this we I would look at it similar to what Monday. It was just meant shrink in the phase one study we talked about the duration of response, but the surgery syndrome or the.

And that is wonder was mentioning is.

The.

You know longer than the benchmark of at that time.

I think when we look at the micro seats, if I'm glad the stage one cohort the key things to remember here is that the stage one to stage two was dependent upon response.

And due to that.

We would be showing early data.

What we are trying to also do is what we're also trying to do is show you. The totality of the data so I think during Lugano.

What you will be able to see.

Is both the Q3 deal to positive as well as the key or three of the non expressed in Q3 deal too.

Cohort two talent this will be early data. So clearly we may not have as much follow up as we would like.

But that's what we're hoping that's what we'd be present together kind of.

Okay. Thank you so <unk>.

Just on the data at Lugano, we will have some sense as to how well the spread the response correlates with the expression of of character of deal too.

Yeah, I think it will be so it will be very early data, but yes, I think you will get a sense of that.

So you got to let me maybe rephrase your question to make sure.

We understand it.

The.

The two cohorts and in MF.

The Q3, the her two positive.

All of expression and the Q3 to negative.

The stage one to stage two.

The translation, we talked about is in the Q3 deal to show in the patient population that express the.

The the tumor antigen so the level of activity that we will be presenting in the Q3 of the two positives.

We want to be showing.

The data in the Q3, the two negative so far because we are still.

It's still ongoing.

Okay I understand thank you.

Thanks. Thank you. Our next question comes from the line of Dana Gray Bush from SBB Leerink. Your line is open. Please ask your question.

Thanks for the questions. Two from me first do you have any data any updates on when we could see when I was the non data in particular of anything from the ongoing lung cancer trial.

And the second question is.

Whether you guys see of role for NK adoptive cell therapy to the combined with your NK cell engagement program.

And if you know whether Sanofi has any plans to look at the combination given the recent awkward the sort of an NK cell therapy company hiatus.

Thank you Dan.

Great questions.

In fact of without the second of the first one.

Sorry to disappoint, you, but as you know.

The the trial in particular, the cost of Neocart trial.

Trials sponsored by Astrazeneca and I do not have more information that they disclosed publicly which is that they plan to present. These data in the second half of 2021. So we are really looking forward to it.

These data in the second half of 2021.

For the second question.

I'll start and please Jason chime in I think what we have seen it.

The last ACR and what also was published.

Already by the end of MD Anderson.

Last year is very encouraging and makes a lot of sense to somehow boost the.

The <unk>.

NK cell engaging <unk> platform on the NK cell engaging antibodies with the fresh.

Sales that you in choosing the same time, so it makes a lot of sense.

Of course, we cannot speak.

Or speculate on what Sanofi strategy is in this field I think the obvious next step is of course to move it.

101 into the clinic and start the phase one but the.

I can tell you that we are looking at the street very carefully and very excited about the <unk>.

Prospect of having this combination debt seems assisting in heme malignancies to produce a question of a spectacular tumor shrinkage of the clinical benefit.

Jason would you would you like to complete or add anything on this question as well as on the Mona Lisa you might be for you as you know.

Yes.

[laughter] no I have to say the.

One of the length of that I think you are.

Summed it up very well.

Also of the second question.

I think that was a great summary, and I hope that I think more of that.

Thank you for that you know of HOKA.

Off the bat for Glen Charles of Recline.

You have to.

If you do that.

Lastly, I would be surprised.

[laughter]. Thank you well just predict the question for the dialogue.

[laughter].

Thank you.

Thank you. Our next question comes from the line of <unk> Rama.

From Hey, CW. Your line is open please ask your question.

Thank you.

Okay from that Joanne.

Right.

No.

And good afternoon I'm on the.

Morning, Jason.

Hum.

In terms of.

The NK.

NK cell engagement program that sort of thing.

So we know that the force the first one is getting into the <unk>.

Studies.

On the on.

On the on the second molecule.

Potentially some if we can.

Taking too.

That meant.

Would that also be against the same target in the sense and kept the politics or it could be against.

You know the other.

Targets.

Not only you, but other for sales are looking at.

Thank you RK.

Thank you for your question on growth for Dr. <unk> as well.

I think.

Yeah.

I believe.

You know debt.

And keep your 46.

Is it activates the receptor.

Express it on NK cells, and it's one of the most specific and stable activates the receptor for NK cells. Unlike many other danone to commencement of <unk> 2016, we know that those receptors eventually may get Downregulates Edwin.

The NK cells travel.

Covenants of the tumor microenvironment here, we're talking about really of very specific and very stable and I think it's important for us to highlight the fact that our platform.

Is basically.

Versatile by the fact that you can test tumor antigen, but we are extremely.

Sure.

July did actually with the proprietary platform we developed around thank you for your 46 so the.

The various partnership that would be the property, including the second.

The program that we have with Sanofi is still using the <unk> 46, as an excavator receptive, but the different tumor antigen that Sanofi did not want to disclose at this point in time, sorry for the same technology as for the first 161 of one but with the different tumor antigens and beyond Sanofi again, we are developing both proprietary but also.

Our partner <unk>.

Multi specialty again, keeping the thank you for your 46 and <unk>.

Changing the tumor antigen dependent on of course the.

Collaborate for the collaboration of the partner that we are working with.

In addition, as <unk>.

<unk> seen in an adjacent.

Last slide with Eric of EBITDA will be presented next month at the proceeds basically even the next generation of multi specific NK, what we call of <unk> for where we are.

Leveraging the MTP 46.

The platform, but trying to ensure that we have even a more potent and efficient antibody.

Yeah.

The different tumor antigen.

I hope.

I answered your question.

Yes, yes your debt. Thank you for that and then Glenn.

Going to the.

For the clinical programs, especially the one with the lack of demand and the PTC L.

As is standard.

Your of initiating the monotherapy and the gem ox combination of starting being started.

The group.

However for the for the.

The combination of the chop do you need to see the data from the monotherapy study before you embark onto the chop combination are.

Yes, basically targeting these studies and don't have to wait for all of the data from the amount of people to come up.

Again, very very important question that we'll give jason the opportunity may be too.

Ill remind you of little bit the cash.

<unk> behind the.

Selection of the monotherapy.

Total strategy in the relapsed speaking shell Jonathan would you like to take of the question.

Sure. Thanks, a lot.

Gary Thanks for the question. So I think so when we look at the strategy for P T cell.

We are targeting first of all of Q3 deal too positive patient and the.

Whats going in with the at least early.

Data that we've seen in the microchip from going to a cohort based on that hypothesis.

Now when we look forward in time.

What we would see as debt the monotherapy will there is two approaches that we could take one is.

Sort of.

And I'm, specifically talking about <unk>.

Earlier lines of cutting which would be of chalk combination.

And for that what we would what we'd like to do is one we could we would be waiting for the totality of the monotherapy data before beginning the.

The first line setting or to your point, we could staggering to where what we would do is basically.

As we start to see the data from the monotherapy single arm study, we would begin to.

If the data is very encouraging.

Start the earlier line setting at that point, so theres definitely those two approaches that are possible and we're considering both of those.

As tight as.

As we.

The start these trials will start looking at the data.

Okay. Thank you for thinking about and.

Talk to you guys soon.

Thanks, Okay.

Thank you Ella.

The phone question comes from the line of Lisa Gill from Evercore. Your line is open. Please ask your question.

Hi, there just a couple of questions from me first of all.

For the P T.

Tcl study.

This is not sort of following the general design of chemo Mac or can you maybe speak to how youre thinking about.

The design of that site.

Thank you for Lisa.

Okay go ahead.

Thank you out there.

Thanks for the question so.

We're considering all of the purchase of at this point in time, but at this point at least as the data and the mycosis <unk> starts to evolve as.

As well as.

We're placing our bets on the Q3 deal deposits now that's without the <unk>, that's not saying of course as we start to see longer term data, especially in the micro seats, we're going to where we may reevaluate our strategy and it starts to look more of like the telematics, where we have unexpressed yours as well as non expresses.

I think it's very early but we are definitely keeping all of those approaches in mind. So one to look at the monotherapy in the tier three D. L. P.

Positives.

And and only look at that subset number two.

Continuing to evaluate the mycosis <unk>.

In the telematics steady, especially the longer term data and considering putting in a.

The.

The non expressing cohort into PTC al.

And then as I.

Also the combination so.

Not only is Lisa of running a chemotherapy combination, but we would also be looking at looking.

Other standard of cares that are available in the U S. In combination depending upon the PTC I'll take that I hope that answered the question.

And can you maybe describe a little bit more on the kind of the non ex cluster is what would be the rationale for activity there.

Yes.

Good morning, guys.

I think when we.

Thanks.

So I think.

When we look at the non expresses.

If I understand the question correctly, you're asking if you were to see expression why would you why would you expect to see expression in the non express just considering the mechanism of action that we're good at that.

And.

What I would say it is I think it goes to.

What we see with a lot of.

Biomarker subset and that is the tumor heterogeneity. That's number one and then number two is sampling error. So.

I think both of these.

Lead to.

<unk>.

Sort of the I guess, you could say the sensitivity not only the.

Sure.

And not only the sensitivity of the test of being able to pick up which we're confident about that but more importantly is the are we.

Or is it the heterogeneity and that's why we're not picking up.

Okay I understand.

Hum.

Thanks for the 101, and then can you maybe talk of Wow.

What kind of IMD, enabling work Youre doing and when we can expect that to enter the clinic.

The more about the yeah I'm.

I'm, saying gauge of platform.

So as you know the 61 of one.

For <unk>.

Fully under the responsibility of Sanofi.

They are conducting the classic.

Our IND, enabling studies with the.

Ambition and goes to stop for the clinic as soon as possible. So we do not.

Have any any data of our comments to disclose at this point in time of about puts and of Pes doing to move this drug into the clinic.

Really its on their hands in the.

Yes, yes.

All of that Mike.

Kathy.

Yes.

Anthony in terms of when that will start of clinical development.

I mean.

The announcement early this year.

The testimony for the interest to move this.

For the clinic as quickly as possible and you know.

The usual process.

What type of R&D, enabling studies so the the plan is to go as fast as possible.

So they did not disclose specific dates.

Okay. Thanks, a lot.

I'll now like to hand, the call back to the user.

The webcast.

The question. Thank you.

Actually I have.

One question.

From the webcast.

Of the date on the force timeline.

The <unk>.

All of Us is the.

One of the mice phase II study.

That is the testing the potential rollout of the audience.

In the treatment of <unk>.

COVID-19.

The driven to mania as you know this is an investigator sponsored trial is currently ongoing I cannot give the timelines of further details about the progress on the study as you made is not responsible for the running I can only say that the trial has completed enrollment and is ongoing for patient follow up in debt analysis.

Should we view these data as soon as they become available.

That's with a C on the webcast so far.

Yes.

Okay, if for no more question.

I would like to.

Thank you all for joining the strong and I look forward to.

Our next investor relation event in June to update you on the progress of our portfolio, especially on the NK cell engagement platform as well as the lack of time update.

Michael just from grew this patient debt will be presented at the low kind of meeting with debt.

The call and thank you very much have a good day.

Thank you that does conclude today's conference. Thank you to everyone who has participated in today's call you may now disconnect.

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