Innate Pharma S.A. Q1 2023 Earnings Call
Thank you for joining the unite pharma publication of revenue first quarter 2023 conference call.
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Our speakers remarks, we will be opening the call for a question and answer session.
If you would like to ask a question. During this time by saying simply press star one on your telephone keypad.
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Questions via the webcast can be submitted online.
Finally, I would like to remind all participants this call is being recorded.
Without further Ado I am pleased to introduce Henry Wheeler, Vice President Investor Relations and Communications Henry I bet you do.
Thank you good morning, good afternoon, and welcome everyone.
This morning, <unk> issued a press release, providing a business update for Q1 2023.
We look forward to highlighting the progress made during the year to date as well as addressing future goals and milestones. The press release and today's presentation are both available on the IR section of our website.
On slide two before we start I'd like to remind you that we will make forward looking statements regarding the financial outlook. In addition to regulatory and product development.
These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
On slide three for today's call, we will be joined by London, <unk>, Our Chief Executive Officer. He will then hand over to Jason <unk>, Our Chief Medical Officer, who will kind of updates on the kitchen, mab and modeled as a map.
Yeah, let's morale.
Head of BD and product portfolio strategy will then cover some anchor updates on BD.
Then handover to wonderful place. We will also have our CFO fredrik Lombard on the line for questions Linda I'll now hand over to you.
Thank you Henry good morning, good afternoon, everyone.
Welcome to this call.
Maybe move to slide four first to remind everyone. What is our strategy. As you know we are early clinical stage company our business model.
Centers around three key priorities, where we look to drive value from our early R&D asphalt to a later stage partnership where it makes sense to do so.
Our ambition is to develop innovative drug candidates.
That contribute to transform cancer care through a very strong pipeline of differentiated antibodies. So.
So first we look to create near term value driven by our lead proprietary assets like with the map, which is in development for T cell lymphoma with final cutaneous T cell lymphoma, readouts expected to happen in the second half of this year.
Early peripheral T cell lymphoma data are underway.
Second we continued to fuel our pipeline and create longer term value by leveraging our antibody engineering capabilities to develop novel molecules with a primary focus on our multi specific NK cell engagement proprietary platform.
And Kate.
And as we develop antibody targets for our anchored platform. We recognize some of these binders may be more applicable for antibody drug conjugate technology, and we look to further leverage our expertise in these settings.
But not least we.
We are building a strong and sustainable foundation of our business with various partnership of course industry and academia here. Our Astrazeneca partnership with wondering if he may have is continuing in early stage non small cell lung cancer, our focus remains to leverage the value of our assets as much as possible we want to.
To ensure that if we can gain valuable competencies via a partner agreement, we would consider that in our development plans for the product. This will further validate our sites I know for capital that you can reinvest to adventure early R&D engine.
Before I hand over to Jason <unk> Slide five you had to.
With Europe , our pipeline, which shows.
How we are continuing to translate our science into a robust portfolio of both proprietary and partnered assets.
It also illustrates how we are executing against our strategy with our lead proprietary assets liquid them at the end.
<unk> portfolio with the lead candidate 65 and also the immersion ADC.
In the bottom of the slide we have our partnered products with Astrazeneca Sanofi announced aikido from late two early stage development.
As you know, we anticipate a series of potential clinical readouts and catalysts in the upcoming couple of years as well as our R&D engine <unk>.
<unk> continues to leverage our scientific knowhow to create a sustainable business.
I would like now to pass the call over to Jason who will review the progress made with our portfolio starting with <unk>, our most advanced proprietary asset Jason over to you.
Thank you Monte here on slide six let me summarize the progress we are making with what cuda map.
We are processing pursuing a fast to market strategy for liquid a map in the niche setting.
<unk> syndrome, where Likuta Mab was granted us fast track designation in the EU Prime designation in 2020.
We have expanded past surgery syndrome to mycosis, <unk>, where we have seen encouraging preliminary data from our phase II trial in both cohorts.
For the surgery syndrome in Mycosis <unk> enrollment is on track and the final data is due for both cohorts in the second half of 2023.
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I apologize there for the technical difficulty let me go ahead and continue where I had stopped for the surgery syndrome in mycosis <unk> enrollment is on track with final data do for both cohorts in the second half of 2023. Finally, we are continuing to enroll into peripheral T cell lymphoma.
In the phase, one b and two monotherapy and combination trials in the relapsed setting with initial data expected later this year.
On slide seven we have the preliminary phase II data published last year in salary syndrome in mycosis <unk>.
On the top half of the slide It says <unk> syndrome at the Ash annual Congress in December of 2022.
<unk> showed that in this heavily pretreated post <unk> gamma <unk> patient pool with a median prior lines of therapy upticks.
Or are in the ITT population was 21, 6% with an ore of 35, 1% of the skin and 37, 8% in the blood. It was very encouraging to see activity replicated in the larger phase II trial in these late line patients.
A favorable safety profile was also seen.
We look forward to further interactions with regulators as we get the final data later this year.
The lower half of the slide summarizes the preliminary cohort two and three data in mycosis <unk> presented at <unk> in September of last year.
And this data presentation in the Q3 deal two expressing cohort we were encouraged to see that in these late line patients with a median of four prior treatments Likuta Mab demonstrated a 28, 6% or six responses.
We are particularly encouraged by the responses in the skin, where we saw 57, 1% or with.
With 12 responses.
A reminder, that skin response is an important response.
In this skin predominant disease.
As many of you know a clarification of the glide guidelines for <unk> had been released this year and we will be issuing more guidance on our strategy based on these criteria.
In addition, we continue to engage with the FDA as to our FDA fast track designation.
On slide eight I would like to update you on <unk> map to remind you bundle is a mab as in NTN, <unk>, which acts upon the checkpoint pathway to potentiate NK cell activation that we have licensed to astrazeneca for oncology.
On this slide you can see an overview of the late stage development plan for <unk> in lung cancer.
Based on the Astrazeneca sponsored phase II coast data Astrazeneca commenced Pacific nine a phase III trial evaluating the combination of either <unk> or a liqueur mab cluster value map in the Unresectable stage III non small cell lung cancer setting.
In patients who have not progressed after Rick after concurrent chemotherapy.
Radiation therapy.
For phase II <unk> study the three arms evaluated the combination of <unk>, plus mentalism, Nab and devalue Mab plus our liqueur that Astrazeneca is anti CD 73.
As published in the journal of clinical oncology by Astrazeneca. After a median follow up of 11 five months. The results of an interim analysis showed a hazard ratio of <unk> 42 per door value Mab personnel as a mab versus their value Mab alone.
The results also showed an increase in the primary endpoint of confirmed or our premier value map, plus modalism app overdue value mab alone up 36% versus 18% respectively.
The Astrazeneca sponsored <unk>. Two study is also underway in an earlier lung cancer setting.
<unk> model is a mab and devalue map with chemo in neo adjuvant non small cell lung cancer patient.
We look forward to updates from these studies from Astrazeneca at the upcoming <unk> annual meeting.
I will now hand over to Dennis to cover <unk> platform.
Thank you Jason.
On slide nine I wanted to highlight our hopefully it'll NK cell on gauge of pet film that can call and get and get standing for antibody based NK cell <unk>.
And catches a versatile fit for purpose technology made the values building blocks that is taking an entirely new class of Nike is basically Congo during use synthetic immunity against cancer.
Technology platform, which is <unk>, our scientific expertise in the NK cell space will be an engine for our pipeline taking value series of drug candidates addressing manufacturing our targets.
The backbone of junket.
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So.
The backbone of young kids platform is based on the unique engagement activating NK cell adult and kids <unk> 46 in 2016 on Mankato, which allows for optimal auditing of the NK cell you picked a function, which can be further increased by the addition of <unk> to induce encase endpoint installation.
On slide 10, I wanted to share our enthusiasm for this platform.
You can see our pipeline of uncapped molecule is significantly growing with Sanofi I think in our license <unk> molecule and have been an option on two other undisclosed targets.
So our most advanced hopefully, Italy, and Curt I'd get 65, with one which is targeting <unk> 'twenty is heading towards an AMD this year in.
In addition, we are quickly until a preclinical program against much bigger target.
On the high panel you can see the detailed mechanism of action of the <unk> molecule, which we have recently published in a couple of articles in high impact journals.
Our natural biotechnology Paypal the beach in January this year describes the joined 12 incentive fee on the TD one to TNK said on good Joe.
61 to one.
579.
Dock 79 is cool engaging and KC 46, and 16 on NK cells, and therefore, <unk> potent anti gen dependent killing of IMS.
Tumors as well as production of key cytokines, while the anti tumor response.
Without inducing systemic cytokine release, which is dose limiting for most you said don't get Ya.
Although we have shown that in our February call, maybe some data that incorporation of <unk>.
Volume into our network gets induce a potential NK cell proliferation within the tumor microenvironment, increasing therefore, the number of antitumor picked up there.
On slide 11.
Can see another view of the.
<unk> 61 to one get pulled Houghton also named South 579.
Hi, can you guys studies demonstrate antitumor activity and Mike.
Most importantly efficacy against patients primarily chanelle.
Also showed good PK PD and safety in nonhuman primate.
In addition, one advantageous and get technology as shown on the graph here at.
As compared to what you said on <unk> against the same target here in Iraq.
<unk> 579 in Blue there is none.
It's in use systemic cytokine release, which is a very common side effect for that you said on <unk>.
Testing potentially better <unk> for the <unk> as well as allowing for potential how you are building.
SaaS 579 enter into phase one in December of 2021 based on discussion order and we look forward the presentation by Sanofi at next month's at ESCO as the stocks at <unk> 71 Phase one has been selected for an oral presentation.
On slide 13.
Yes, you will see the highlights.
Our recent executive deal we signed late drops.
We entered into an agreement whereby <unk>.
Gain exclusive rights to a panel of selected antibodies against an undisclosed target to develop antibody drug conjugate with a primary focus in <unk> disease, which is outside of oncology focused.
The terms of the agreement included a $5 million upfront and up to tight.
At up to $410 million in milestone and royalties on net sales.
The first of all demonstrate our antibody engineering expertise and its applicability to antibody drug conjugate development as well as our ability to monetize pipeline asset in therapeutic areas outside of our area of expertise.
Now I will no Andover optimum therefore summary.
Thank you Daniel.
As you can see on slide 14, we have.
Working diligently to execute to close all our strategic pillars and believe that we are laying the foundation to drive near and long term value.
Looking at our clinical program, we expect to achieve a number of milestones over the next two years.
As Youll know, Tom Jason our phase II Telemark study for liquid on AR continues to progress with final data due at the end of this year. In addition, we look forward to.
Any shade to initial petrol diesel implement data later in the year.
In parallel we continue to develop the <unk> technology platform further reinforced by our partner Sanofi and we are very encouraged by the preclinical results from our next generation in castle engages and progress in the clinic.
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15.
You can see the up Kevin abstract selected for the Ash annual meeting.
We look forward to for a data from our early on.
With the first clinical data on API 61 on one to be shared by Sanofi.
That hasnt, Nick I will provide a podcast on the two ongoing clinical trials with monolith demob and early stage non small cell lung cancer.
Let's move to the conclusion slide.
On slide 16, as you can tell we continue to our exciting journey.
We look to build our business to create value for patients and stakeholders.
In summary, we have positioned in each pharma for the future with our strategy and made meaningful progress across all three strategic pillars.
With our R&D engine in antibody engineering expertise, our science is producing more candidates to progress to the clinic. Some we are developing alone and some are bauknight, we have a focus on our NK cell engaging platform and kit as well as ADT.
In part in our late stage portfolio continues to advance as we look to maximize the late stage portfolio assets of record amount and more knowledge about.
Our partnership strategy continues to evolve with the recent <unk> deal, adding to the use of Astrazeneca incentives.
Finally, we have carefully managed our resources. So we can continue this sustainable business to invest in progressing our pipeline and I'm very pleased that we continue to have a strong cash position with a runway into mid 2025.
Collectively we are driving value across our business and actually a major advance in our goal to deliver innovative medicines to patients. We look forward to keeping you updated on our progress.
That concludes our prepared remarks, we will now open the call to questions.
Operator, do we have any questions.
Yes.
As a reminder, I would like to remind everyone in order to ask a question press star one on your telephone keypad and your first question comes from the line of equal not <unk> of <unk>.
Citi. Your line is open.
Hi, Tim This is Arthur Mubarak on for Yigal, Thanks for taking my questions.
You alluded to some regulatory discussions you plan later this year on <unk> I'm. Just wondering if you can give us a sense of when those might happen and what the scope of those discussions might be thanks.
Thank you.
Jonathan I Hope you heard the question.
About the regulatory strategy for <unk>.
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Yes.
You may now.
Okay, Yes.
Sure.
Operator.
No.
Hi.
Alright, Thanks for the question and thank you.
Hello.
So.
From a regulatory standpoint, we are continuing to talk with the FDA based on that.
<unk> designation.
I'm showing at this point.
Trying to best proceed in alignment.
To be able to.
Sure.
It looks like.
Thank you Joseph.
Thank you for the question you have another one.
Okay I'll ask one more then congrats on the recently signed Takeda deal.
Just wondering if you can comment at all on the sort of rationale for using an ADC in a disease like celiac I think we tend to think of ADC is very intensive.
These lifesaving treatments.
For something like Celiac I tend to think of it as a more manageable disease or something like that so I'm wondering if you can help us.
Put that into context, a little more thanks.
Thank you I'm not sure.
We are going to help you that much first of all as you know we are not.
Experts in the field of inflammatory and chronic disease like celiac disease.
Our cost basis.
First the agreement with our partner Takeda, we did not disclose any information on the target. So unfortunately I cannot provide more.
Angela on the rationale of this deal and why but nevertheless.
It has been.
Invested in this field for quite some time is that in there.
Of course expert in this development so.
I would refer to them to provide.
More.
Details on these deals.
Okay. Thanks very much.
Okay.
Youre welcome.
Question comes from the line of gaining a great boss from SFA based Securities. Your line is open.
Hi, guys. Thank you for the question I Wonder if you could give us any context.
For the upcoming oral presentation at the <unk> III, an ESCO in particular.
How much how many patients we're looking at PK PD efficacy and if you can't give us any of those details, which I understand you may not given its partnered with Sanofi what kind of data point, you think it's particularly important and necessary first in human data coming out from your own platform.
That would be validating for the overall plan.
Thank you Dana.
Very important question and.
Hi, Krish.
We could have.
The opportunity to provide more details and this is a sanofi phase while no. Other <unk> disclosure do you disclose that this time, you know that the upside the content will be disclose it on may the 20 <unk>.
Presentation is scheduled for June 2nd so where they can say this is a phase one trial that started back in <unk>.
By 2021 and of course.
Essentially in AML, but also.
Mds and also some form of <unk>. So you can certainly have an idea of the patient population. The number of patients that you can expect from the dose escalation phase one that's all I can say at this point in time, sorry for not disclosing more because it is not an overhang.
That's okay I understand how about just from an inkjet platform.
Type of data you think could be validating.
I guess I mean like are there particular, PD biomarkers that you're looking that you think are important to the platform for all the programs are.
And PK markers in addition to efficacy.
Yes, so, Italy, maybe I'm going to hand over to Jan is to provide a little bit more color on this second question.
Hi, Dana.
I think one important thing.
But we would like to see and that's why it will be less.
Late <unk> really looking forward to see.
Yes, hi on the 20 ships and as well as the presentation.
Is two <unk> that we are making based on the technical observation that we have made translate into a clinical observation is waived.
Sure.
In preclinical as I mentioned, we see antitumor activity.
In preclinical models. So you can see without the need for additional.
NK cells, but also most importantly is lack of systemic cytokine release, which.
Although the dosing of the molecule.
At a dose that is.
Molly microgram per kilogram range.
Nicole.
Which is.
Typical range for what you said on <unk>.
Okay.
Great.
Securities.
Thank you then you have another question okay. Thanks.
Your next question comes from the line of <unk> <unk> from H C. W. Your line is open.
Thank you this is RK from H C Wainwright.
Good afternoon Monday or on team.
So I'm talking about.
<unk> platform.
In terms of six 501.
<unk> 20th target targets.
Yes.
What sort of.
Additional work you need to do to get to that Andy and also.
In terms of.
Initiating the clinical trial.
Can you give us a little bit more color.
Stood that timing of that.
Yes. Thank you okay.
Thank you for your question.
It gives me of course the opportunity to.
Data everyone on page 65 of our Tetra specific and care that is.
Targeting <unk> <unk>.
We said R&D.
And defining as a plan.
Planning for this.
This year, we are working diligently and.
The.
Start of the Phase one is planned in 2023, that's that's what I can say, we are really actively working into executing.
The good is that.
Our strategy I didn't get the.
Final go from the FDA for <unk> for these phase, one which as you would.
Now anticipate is targeting <unk>.
<unk> disease, and <unk> is a classic dose escalation phase first and then it does exploration cost of it is.
Coming next.
Thank you for that and then.
Electric demand.
In terms of the <unk> data that's expected later this year from that too.
Studies.
What what sort of data.
Should we expect.
What do you think is meaningful.
For you folks to see so that you can take this to the next.
Stage of development.
Sure.
Other question, Jason did you hear the question about PTC and actually.
And then what would be meaningful from a clinical standpoint.
Sure. So yes, hi, David Thank you for the question.
<unk> I mean, Chris.
Good point, we are growing the monotherapy as well as the combination with.
Jim has kind of been unveiled.
Right.
And that data and as you mentioned is going to be.
At the end of this year, we will be disclosing data.
I think when we look at the what is meaningful.
It is a very aggressive disorder, and very high need with <unk>.
Streaming low incidence and today there is no really strongly established standard of care in relapsed refractory. So it is very complicated to at least have a comparison drug in this relapsed refractory cohort.
With that being said you know the.
Our response rates can range anywhere from a with the different agents that we've seen can range anywhere from 25% upwards to 40%.
Yes.
Thank you Chris.
Thank you, Jonathan and Amanda talked to folks.
Thank you Mike.
The next question comes from the line of Justin <unk> of Kepler Your line is open.
Hi, Ron just two questions on the financial side. Please first just for modeling purposes, how long we allowed the recognition of the two letter from Sui served after today agreements we finish in tequila.
And she comes what is the expected evolution of the cash burn is also coming you taking into account associated with one of the first quarter. Thank you.
Absolutely. Thank you Justin I'm going to hand over to <unk>, who will address the two questions maybe starting with the cash burn.
Yes, with regards to the cash burn.
We communicated that we live with.
In a way to meet 25, so we ended Q1 as expected.
So there is no change versus what has been communicated.
With regards to your first question, we do not disclose.
The exact detail of the deal and now we apologize on wind myself zac coming off obviously.
Okay. Thank you.
Thank you Joseph.
Okay that'll be proceeding to the next question.
Just a reminder, if you would like to ask a question today. Please press star one on your telephone keypad and your next question comes from the line of Lisa Baker from Evercore. Your line is open.
Hi, Thanks for taking our question. This is Jeremy on for Lisa for My first question is.
On <unk>.
Further post the second line study shall we also expect a futility analysis for that study and my second question is on ADC. So will you consider developing any ADC and health. Thanks.
Thank you so great question.
Probably.
And over to Jason.
For the first one any fertility analysis plan is for the past nine trial Jason.
Okay.
Great.
Okay.
For futility.
Okay.
Thank you. So the agency do we have an agency strategy beyond what we have communicated on the Takeda deal.
Yes, actually yes, well.
But that's all you're generating several candidates in.
Some of them depending on the targets for useful.
And then Keith I don't get your approach and some of the other depending on the target, but also depending on the property that the antibody.
More suitable for ADC, then that's something that we're contemplating for the moment.
Yes.
Got it. Thank you thank you Danielle.
Thank you.
Yes.
First of all.
Everyone sorry for this technical.
Issues and problems that we had joined this call.
But let me conclude this.
Q1 results by reminding everyone.
Key takeaways.
As you can see we are consistent and we stay focused on our strategic priorities, which are advanced electric them up and we are getting close.
<unk>.
Platform not only with the.
The deal we signed the end of last year with Sanofi, but now that we have clinical data coming around the corner and finally.
Continue to build strategic partnership in oncology, but also outside oncology.
<unk>.
<unk> announced the 30 days.
If you could help with that.
So thank you very much.
Stay tuned for the important readouts that we have from our.
Proprietary and partnered portfolio, which I expected it.
As I said over the next two years and finally.
<unk> financial position, we continue to be well funded into mid 2025. Thank you have a good day.
This concludes today's conference call enjoy the rest of your day you may now disconnect.
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