Good afternoon, ladies and gentlemen, and welcome to this Innate Pharma Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference call is being recorded. I would like to introduce Mrs.

Danielle Spangler, Director, Investor Relations at Innate Pharma. Madam, you may begin..

Thank you. And welcome everyone. This morning we issued a press release reporting our full year 2018 financial results and business update. The press release and the presentation for today's conference call is available on the company’s website.

As a reminder, we will make forward-looking statements regarding the financial outlook in addition to regulatory and product development plans. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. On Slide 3, you can see today's agenda for today's call.

We will highlight major news for our milestones over 2018 and provide some additional insight on the year to come. Participating from Innate Pharma's executive management today is Mondher Mahjoubi, Chairman of the Executive Board and Chief Executive Officer; Ms. Laure-Hélène Mercier, Executive Vice President and Chief Financial Officer; Dr.

Pierre Dodion, Executive Vice President and Chief Medical Officer; and Ms. Jennifer Butler, Executive Vice President and the U.S. General Manager. It is now my pleasure to turn it over to Mondher..

Thank you, Danielle. Good afternoon, and good morning, everyone. It's my pleasure to start this conference call and ask you to move to slide number 4. In which we provide a summary of 2018 execution. Last year was a very productive year for Innate Pharma.

It was marked by several clinical advancements, presentation of key data and publication in peer reviewed journals. At the major scientific conferences we reported positive data in both our lead partnered asset, monalizumab in head and neck cancer patient and also our proprietary asset IPH4102 in advanced CTCL patient.

We also expanded our proprietary pipeline with the initiation of the first Phase I study in cancer patient, assets in the combination of IPH5401, an anti-C5aR combined with PD-1/PD-L1 blockade which represent a novel combination approach in immune-oncology.

As you can tell, 2018 is a significant year in building blocks to value creation and such value creation includes the recent announcement of the landmark deal we announced with AstraZeneca, deal that has reinforced and expanded our R&D collaboration with AstraZeneca enabling Innate to develop a commercial footprint and the ability to further invest in its IO pipeline and R&D platforms.

With the acquisition of the US and EU commercial rights of Lumoxiti, we have accelerated our transition into a fully integrated biotech company strictly focused on oncology.

And let me first state that this was a strategic decision that we wanted to create our first commercial infrastructure, bolstering our property pipeline and providing a revenue stream to support and invest in our pipeline. As you know, Lumoxiti is an FDA approved drug for relapsed or refractory hairy cell leukemia patient.

The build out of this commercial infrastructure is a manageable investment for Innate. We will have the opportunity to go back to this later in the presentation. The small patient population for Lumoxiti requires a small limited commercial infrastructure.

Lumoxiti is complementary and has a perfect fit to our proprietary pipeline, especially IPH4102 and we will later be able to leverage this commercial infrastructure to underpin the creation of broader hemato-oncology franchise. It's my pleasure to be able to introduce Jen Butler our Executive VP and newly appointed US General Manager.

Jennifer joined us with product launch expertise and experience and will lead the Lumoxiti commercialization transition and lifecycle management in the US. Later in the call she will provide a brief update on Lumoxiti's commercial opportunity in hairy cell leukemia and summarize the ongoing transition at day plus eight or nine since the announcement.

As you know Innate has a long history of a very strong track record of partnership and collaboration with large pharma and in 2018 AstraZeneca has decided to double down the investment and extend the strategic collaboration beyond our initial 2018 and in 2015 mona agreement.

This is a strong long-term partnership that includes the co-development and cost sharing agreement. First of all, as per the initial agreement, AstraZeneca exercised its option from the 2015 agreement for the global oncology rights for monalizumab and this was based on the positive data presented last year at ESMO and later SCC.

As you know, they also further invested in Innate's pipeline by gaining an option to IPH5201 our anti-CD39 and four other non-disclosed preclinical assets. These as I said further validate Innate's immuno-oncology leadership and our novel antibody discovery platform.

Last but not least, on this slide, as you see Innate is well capitalized with multiple strategic investor and the transformational deal with AstraZeneca has further reinforced our financial runway by securing a total of €177.8 million of net cash proceeds from AstraZeneca.

These proceeds include investment by AZ of 9.8% stake in Innate Pharma at €10 per share. Please move now to slide number 5, which provide a high level overview of the broad and balanced immuno-oncology franchise that we are developing at Innate Pharma.

And as I said earlier, 2018 was a productive year from R&D perspective as we have witnessed our dedication to discovering and developing novel first-in-class science that translate into meaningful clinical data in patient population with high unmet need. This hard work proved to be immensely valuable and validated.

Innate is committed to our R&D initiatives to bring novel therapeutics to oncology patient and deliver long-term value creation for its stakeholders. Now, I would like to hand it over to Pierre Dodion to provide a brief overview of the recent data highlighted and an update on our pipeline.

Pierre?.

Thank you, Mondher. As Mondher mentioned earlier 2018 has really being an exciting year, with significant progress across our pipeline, both on the preclinical but also the clinical perspective.

This afternoon for the interest of time, I will focus mainly on the clinical data illustrating the rationale for our clinical trial and providing some insight in terms of clinical data. So let's move to Slide 6, which is about our lead cohort IPH4102.

IPH4102 is a humanized cytotoxic antibody working through antibody directed cytotoxicity or ADCC, it targets a receptor called KIR3DL2 which is specifically expressed by T-cell lymphoma. We conducted initially a Phase I study in patients with Sézary Syndrome and relapsed or refractory setting.

And of note, this is a higher patient population with a very high expression of KIR3DL2. These patients have also acquired poor prognosis and basically no therapeutic option when they reached a stage and were enrolled in our clinical trial.

The data have been presented so for the last time at meeting of the American Society of Hematology in December focusing on 35 patients with Sézary Syndrome.

And if you look at this data in the middle of the slide you can see various metric starting with the objective response rate about 43% for the total group of 35 patients, median progression-free survival of about one year and quite interesting median duration response of about 14 months.

We had also the opportunity to accrue a certain number of patients who were previously exposed to monalizumab. Seven of such patients were accrued with basically efficacy data that are almost identical to those in the entire cohort in terms of response rate, progression-free survival and response duration.

You can see some additional data on the left side of the slide in the form of a waterfall [clock] showing that a vast majority of the patient did experience benefit from the treatment on the hindsight with the progression-free survival curve.

Also importantly IPH4102 is quite well tolerated and is also capable of inducing very frequent improvement of quality of life the patient with Sézary Syndrome suffer from colitis which can be really debilitating and as you can see on the slide about nine of out of 10 patients did experience of quality of life.

This was seen in respond but also to some extent in patients with stable disease. All those data are submitted admitted to the Food and Drug Administration which granted us a status of a Fast Track designation. The data also paved away, moving to Slide 7, for the next stage of our clinical development program.

This is an international multi-cohort Phase II study called TELLOMAK. It comprises five cohorts. The top one in green is with Sézary Syndrome and could very well serve as a pivotal trial in this particular disease. In the middle of the slide in light blue you can see two cohorts in Mycosis Fungoides.

This is another form of T-cell lymphoma affecting primarily the skin. And at the bottom in dark blue, the two cohort which we will test IPH4102 in combination with GemOx chemotherapy in patients with peripheral T-cell lymphoma. This is an important expansion of our program given the frequency of peripheral T-cell lymphoma. This trial is about to start.

It will be activated in the first half of the year. Also importantly and I think that Jen Butler will get to that point in her presentation. IPH4102 fits very nicely in our onco-hematology franchise uphold along with Lumoxiti. Moving to Slide 8, I would like to briefly discuss IPH5401 the wholly-owned asset by Innate.

A few words about the mechanism of action which I think is quite attractive. On the left side you can see the interaction between immune effector cells and cancer cells in black which is supposed to be activated by the treatment with PD-1 or PD-L1 blockers.

Unfortunately because the cancer cells, C5a which in turns binds to C5aR are suppressor cells so called myeloid-derived suppressor cells and neutrophils in the function but also the migration of immune effector cells in the tumor. This results in a particular signal type, which is probably very well known to you, the so called the tumor [cell].

On the right side after the addition of 5401 which blocks the C5aR receptor, this inhibitory loop is blocked and this is at that point in time unleashing the activity of immune effector cells stimulated by PD-1 and PD-L1.

Also in -- this mechanism of action also implies that we do not expect C5aR to have meaningful activity by itself but instead we’re really developing this compound in combination with PD-1 and PD-L1 blocker.

As Mondher said, Moving to Slide 9, we have activated the first clinical trial with IPH5401 in combination with durvalumab in September last year, this is the Phase I dose escalation study followed by cohort expansion in selected tumor types. The program is co-funded by AstraZeneca. This is a tactical agreement.

This does not mean that we have any partnership with AstraZeneca for this particular program. In terms of the selection of the solid tumors for this program, we looked very carefully at the expression of C5aR in variety of tumor types and this is shown in the middle of the slide.

We elected to go with a tumor therapy with highest expression in non-small-cell lung and hepatocarcinoma. Non-small-cell lung represents a tumor type which has some sensitivity to PD-1/PD-L1 blockade but patients do frequency relapse. So this is what we call, so going back to PD-1/PD-L1 blockade.

Patient with hepatocarcinoma has some sensitivity toward PD-1/PD-L1 blockade and here patient with IO-naïve hepatocarcinoma will be included in this expansion cohort. Of note down the road we have the opportunity to further expand the development program for C5aR in the other tumor types that are listed on the slide.

And finally moving to Slide 10, let me say a few words about monalizumab. As a reminder AstraZeneca has now the global rights for monalizumab in oncology but we continue to work very closely with our partner. On the left side in light blue, you can see a summary of our program in combination with cetuximab in my head and neck cancer.

We have presented quite exciting data in the course of 2018. The last presentation was at a meeting of the SITC. You can see a response rate of 27.5% median progression-free survival of five months out of the group of 40 patients. We also presented at the time data by higher exposure.

The patients do have substantial type tumor activity even in those patients previously exposed to both chemotherapy and IO and this particular population is now the topic of another expansion cohort that has been activated in the summer last year. We anticipate to have the first results about this patient cohort in the course of 2020.

In addition, the fact that we did see interesting activity in patient without prior exposure to IO form the basis for another expansion cohort combining monalizumab, cetuximab and durvalumab in patient with earlier stage of the disease.

On this slide on the right side in dark -- in light green, AstraZeneca has pursued a combination with durvalumab and presented initial data at the meeting of ASCO showing 8% response rate and 20% stable disease rate. Of note, this is seen in patients with colorectal cancer in the third line study and with micro satellite stable disease i.e.

the form of colorectal cancer that is going to be generally insensitive to PD-1/PD-L1 blockade. With that, I'm turning back over to Mondher. .

Thank you, Pierre. And before moving to the next slide, I would like just to introduce the next speaker by saying that our investment in Lumoxiti is the first building block to creating a broader hem-onc commercial franchise.

This is a long-term strategy that will allow us to leverage the -- as I said the commercial infrastructure for future commercialization of IPH4102, but also potentially other assets. Indeed Lumoxiti and 4102 are complementary. They are both focused on hem-onc, and they will create a large synergistic overlap in terms of commercialization.

As part of the deal with AstraZeneca, they are committed to launch Lumoxiti and they did back in November last year and we are working closely with them to ensure a smooth transition and a successful launch.

Per the agreement, AstraZeneca remains responsible for the ongoing launch and commercialization until mid-2020, and we have agreed on a 10 million sales milestone payment to AZ to incentivize them and ensure sales adoption and growth over the 2019 transition period.

And since we acquired Lumoxiti, we started working on building up commercial capability and reinforcing our team by hiring experienced leader to ensure that smooth completion through 2019. Most recently, as I said we have announced the appointment of Jennifer Butler, as Executive VP and US General Manager.

She will be responsible for leading the Lumoxiti market and commercialization in the US and will work also with our global team which include Hélène Arditti, as Strategic Executive Advisor for the commercialization of Innate Pharma portfolio; and Guillaume Gimonet, the Senior Director of Launch Excellence for Lumoxiti who joined us three months ago to prepare the future launches in Europe as well as working on the life cycle management of Lumoxiti.

And it is now my pleasure to introduce Jen Butler to provide you with a brief summary on Lumoxiti transition plan. Jen up to you..

Thank you, Mondher. First, let me say how excited I am to be joining Innate Pharma and participating in my first investor call with other members of the Innate leadership team. I'm looking forward to working closely with Mondher and the team during the build out and establishment of the US subsidiary across all functions and organization.

As my first matter of business I have been asked to provide a brief update on the Lumoxiti transition and commercial opportunity. So Lumoxiti is approved for an orphan indication in hairy cell leukemia and there is approximately a 1,000 new patients in the US per year.

Lumoxiti is currently indicated to treat hairy cell leukemia patients with relapsed or refractory who have received at least two prior systemic therapies. Although data sources are challenging given the small patient population, we estimate that the number of patients who fall within the current label is approximately 380 patients.

This is the target patient population currently indicated for Lumoxiti and therefore we will be building a organization that is fit to purpose given the scale and need of that patient population which will in fact be different from AZ’s current commercial model.

Today Lumoxiti is part of AZ’s hem-oncology franchise which [Indiscernible] and is designed at a much greater scale and reach due to the commercial needs of their lead product. And as mentioned previously -- noted, we anticipate a complementary fit to 4102 with the hem-onc commercial footprint that we will be building for Lumoxiti.

As stated previously, in the US, AZ still maintains commercial responsibility at this time and we continue to work closely with them during this transition period. Case in point, since Q4 2018 the company has established joint committee sessions across all aspects of the Lumoxiti for commercial smooth transition.

Personally I have already met with the AZ commercial team face to face and can ensure you that both teams are working collaboratively and very closely. Our early focus during this transition of Lumoxiti to the US subsidiary will be on medical affairs, market access and supply chain and distribution with sales and marketing to follow.

But 2019 is important for Innate to establish direct relationship with KOLs and the center of excellence and top oncology centers. So academic and community to ensure collaborative and seamless transition from AstraZeneca for Lumoxiti.

We continue to remain on track for the time line set out at the time of the deal for the full transition of Lumoxiti for mid-2020. And outside of the US we expect a filing in the EU in the second half of 2019. I think it’s important to restate the clinical benefit that Lumoxiti is providing to looking to hairy cell leukemia patients.

Lumoxiti was approved as a result of a 80% hematological remission, 30% durable complete response and 34% negative MRD or minimal residual disease.

This is coupled with a favorable safety profile and Lumoxiti marks the first treatment in hairy cell leukemia patients in over 20 years and addresses a significant unmet need as relapses occur in about half a patients in a long-term.

I would like to say as a final point, I’m excited about building a US commercial organization with Innate Pharma that is focused and dedicated to providing novel treatment options to the patients fighting cancer. .

Thank you, Jennifer and we’re all excited and happy to have you on board. It’s now my pleasure to introduce Innate Pharma CFO Laure-Hélène Mercier who will give an overview of our financial results.

Laure-Hélène?.

Yes. Thank you, Mondher. And good day, everyone. So before reviewing the financial for 2018, I would like to congrats my mate colleague for their execution this year. Thus, secured the $242 million from the AstraZeneca transaction which allows over two years of funding to multiple inflection points in our pipeline.

On Slide 13, I would like to remind the four immediate financial factors from AstraZeneca the deal. First of all AstraZeneca acquired a 9.8% equity stake in Innate Pharma at €10 per share, more than [100 premium] introduced at closing date for €62.2 million.

As part of the R&D collaboration, there was a $100 million payment for the global oncology rights for monalizumab as per the 2016 agreement that is €87.6 million, $50 million or €43.9 million for the option for the IPH5201 and lastly $20 million, €17.5 million for the option to four preclinical assets.

Another deal was potentially more than [$5.5 billion] in milestone payments in addition to potential royalties and profits in Europe. So obviously this had a major impact on our financial statement in 2018 and also in 2019.

I remind you that proceeds were broken in two portion €103 million receiving October 2018 and additional €108.7 million in January '19. We also have an outflow of €43.8 million, the $50 million for the acquisition of the US and EU commercial right to Lumoxiti. The total opportunity equaled was about €211.6 million with net proceed of €167.8 million.

To complete this introduction let me say that the accounting treatment of the AstraZeneca is actually quite [duplicate] and so we have inserted the fact sheet in our press release this morning to explain each of the component treatment. And please if you have questions contact us directly on that matter.

Now, on Slide 15, if I turn over to the key feature in all biotech companies we ended 2018 with cash, cash equivalents and financial assets amounting to €202.7 million.

Because of those proceeds that were broken in two portion, we also give you the cash position at the end of January including the outflow from January and this amounts to €252 million. Please note that it doesn't take into account the €30 million payment due to Novo Nordisk as a result of the option of Astra in monalizumab pay in February.

Switching back to the end of '18, I will highlight the most relevant line items in our profit and loss statement. Starting with the revenue and other income at €94 million showing a 61% increase compared to the same period last year.

And of course this amount many results every year from licensing revenue, about €80 million and research tax credit €13.5 million.

As usual revenue from collaboration and licensing agreements mainly result from the spreading of payment obtaining from our R&D collaborations and this year we have increase that is result of first the basis of recognition in the monalizumab agreement after the option exercise.

And second, start of the recognition of the payment assigning for the IPH5201 option which are going to be recognized in the P&L and in the balance sheet with the same principle as mona i.e. I remind you that this has no impact on the cash but we paid the payment obtaining over the life of the work that we are engaged to perform under this agreement.

Now operating expense increased by €11.7 million to €87.7 million. It's a 15% increase, mainly related to the increase in research and development in relation of the broadening and maturing the pipeline Innate.

The company has historically invested heavily in pipeline and maintained historical trend in 2018 as well of R&D accounting for 80% of opening expense. The last item I'd like to highlight in these figures is the new line item in relation with Lumoxiti and that represent €1.1 million that results from the Lumoxiti operation.

It is the balance between the sales, the COGS, the commercial and distribution expenses of Lumoxiti currently performed by AstraZeneca during the transition period.

We remain focused on having a disciplined approach to capital allocation to support appropriate investments that will ensure the long-term success of Lumoxiti and as a reminder through the 2019 transition we have a cross-channel agreement with our AstraZeneca, the cost structure we foresee and that was discussed by Jen and we will enter into more detail later in the year is notable digit which will support the commercialization of Lumoxiti but also the implementation of the commercial infrastructure and robust cross functional operations.

The cash consumed for 2018 amounted to €76.7 excluding the portion of AstraZeneca and in 2019 we will continue to see an increase in our expenses relating to the broadening of our pipeline but also the launch of Lumoxiti and of the commercial affiliate.

To do so we are well financed ending January with €260 million in hand and more than two years of cash ahead rich pipeline with multiple inflection point in the period and as I mentioned earlier [indiscernible]. I will turn back to Mondher..

Thank you, Laure-Hélène and turn to slide number 16 which is somehow my concluding slide.

To provide you an overview on the upcoming milestones but let me start by reminding everyone that 2019 is really a year of execution, execution from a client, clinical and commercial view point with appropriate data dates starting most likely in the second half of this year.

As a matter of example at the upcoming ACR meeting our Chief Scientific Officer, Eric Vivier will provide an overview on the preclinical data on IPH52 and 53, as well as on our multi-specifics platform. Please visit our website for more information on this stuff.

Regarding IPH4102 it's about TELLOMAK and we think this is really ready to initiate the TELLOMAK study and to accrue the first patient and we will provide more comprehensive information regarding particularly peripheral T-cell lymphoma and the trial study design around midyear.

We are looking forward to being able to provide also clinical updates in the second half of the year if they become available.

Actually we expect on IPH5401 to be able to provide an update on the safety component of the Phase I study that it is ongoing Phase I that Pierre mentioned and I think we will be in a position to update with the safety results but in the same time if successful we will advance the program to the cohort expansion portion with the inclusion of two cohorts, one in IO resistant non-small cell lung cancer patient and IO naïve hepatocarcinoma patient.

Lastly, we continue to work closely with our partners at AstraZeneca and together we will provide an appropriate clinical update and clinical development objectives for the year regarding monalizumab in particular in head and neck cancer.

We are excited to provide updated -- looking forward to providing new story in both our partnered and proprietary program in 2019 but essentially in 2020 and beyond. With that, I conclude this call and I am now happy to open the stage for question with my colleagues here, with me and Jen Butler as well as Daniel Spangler on the phone.

Operator, back to you.

[Operator Instructions]. We have a first question from Graig Suvannavejh from Goldman Sachs. Please go ahead..

I’ve got three questions, if I may. First is actually for Jennifer, Jennifer welcome to the company, congrats on your new position.

I know it’s early days but could you provide more a little bit more color on your background in terms of the commercial launch experience and how that experience will directly apply here for the efforts behind Lumoxiti and hopefully eventually 4102 and then particularly like what are the strategies and how to win with this franchise? That’s my first question for Jennifer.

Second is probably more for Laure-Hélène, I just want to know about the evolution of spending in 2019.

Is this just going to be a gradual build in terms of SG&A and R&D quarter by quarter by quarter or first half to second half, so any color around on a periodic basis? And then my third question maybe more of a scientific question that has to do your C5aR program, so very interesting target a lot of interest in industry.

So question is how would you characterize your C5aR program, how does it differentiate from others and how are you initially seeing the market opportunity? Thank you. .

Thank you Graig for actually dispatching the question to the upper grades. So I’m going to hand over to Pierre maybe start by answering the last question on the science and then Jen will provide more color on how background and commercialization of Lumoxiti and Laure-Hélène will conclude with the evolution of the spending in 2019.

Pierre over to you for strategy and clinical development ..?.

Yes it is crystal clear that this pathway is attracting more and more interest all time and I think that that demonstrate in a way that we are acquiring this asset at the time.

I think having said that we think that we have really strong data about the combination of IPH5401 together with durvalumab and this really is forming the rationale for building the clinical development program that we have built.

As you know the response to PD-1, PD-L1 blocker is very good but many patients after initial response would eventually read up so this is creating a new unmet medical need and this is precisely the way of trying to grow in particular over our non-small cell lung core but also in particular carcinoma and potentially other tumor types that I indicated in the presentation.

.

Thank you, Pierre. Jen, would you like to address the first question about your background.

Your first analysis of the situation and the winning strategy for Lumoxiti in the US?.

Sure, happy to do so and thanks for the question. So at the time that AstraZeneca had received approval for development which was in the post patent [platter] setting, I was the global commercial lead about playing within AZ working very closely with the US team for that approval.

And then obviously throughout different roles having an opportunity to be in regional sales director launch things and other therapeutic categories and had an opportunity actually to work on the separation for pembrolizumab which is for AstraZeneca which is actually one of the most I think successful launch in the respiratory portfolio in many, many year.

My initial thoughts looking at the commercial model for Lumoxiti is that, I'm definitely going to be looking at opportunities to manage comp because of the patient population.

And so obviously we do are also looking at a ways to really ensure patient reimbursement support which I think is particularly critical as well as ensuring that we're finding all of these patients. As I mentioned these are kind of location numbers.

And so I do anticipate that in addition to a very, very strong medical affairs organization, and obviously a very, very strong partnership with our patient efficacy groups that are available to us, I think that will be some of the early prioritization for being successful for Lumoxiti.

And then obviously as we get closer to having more clarity on 4102, we will begin to look to see if there's additional resources wanting to put into the model to successfully support 4102. .

Thank you, Jen. Before handing to Lloyd and just to add one single Lumoxiti, Graig you know, I mean, the model overall has many similarities with other oncology launches and it has to do with the new data that you can generate and the whole medical activity that you are able to put in place and deliver anything with Lumoxiti.

We have opportunities of course through different mechanism working with academic centers and key experts in the US to develop this drug, firfst of all in hairy cell leukemia probably in different disease eventually in combination with other molecules that are being developed -- are being using and these diseases.

But eventually, even beyond hairy cell leukemia as next science to detect signals and better appreciate the role and the effect of this molecule in other CD 20 positive B cell malignancy. With that said, I'm going to hand over to Laure-Hélène to about the spending in 2019 and how we're going to report that..

So the question is related to the how we build expenses over the upcoming semester and the answer is yes, it's going to be incremental, especially when it comes to the new commercial activity of Innate.

So actually we anticipate that most of our expenses will still be in R&D by far, but you have seen a 15% increase in our R&D spending in 2018 over 2017. And we think that this trend is going to plateau whereas we are starting investing in the commercial operations for Lumoxiti, and normally with this US affiliate.

And this is going to we build over some quarters. In 2019, remind that we are going to have a posturing with AstraZeneca with regards to the commercial cost of Lumoxiti, so again and we will make it even more progressive.

Remind also in terms of our cash burn that’s on top of the €30 million that we paid to Novo Nordisk in February, we also have AstraZeneca being eligible for $10 million management payment for the achieving some specific sales level for Lumoxiti. .

Next question comes from [Paul Quay] from H.C. Wainwright. Please go ahead..

This is RK from H.C. Wainwright. A couple of quick questions.

In terms of getting Lumoxiti into the European territory what sort of -- is it -- is AstraZeneca going to be helping you guys out on that or you need to be bearing all the commercial structure and also getting ready to launch over there?.

So good morning and thank you RK for the question. On Lumoxiti, Europe, the deal is that AZ first of all will file, since they have started already interaction with head authority in Europe and it's exactly the same dossier used in the US.

So it's clear that they are helping us out there and of course us in that we are not involved because of course we would like to be with them in the driver seat since we will take over from the approval and will transfer the marketing authorization.

But when it comes to commercialization actually we won't have the same mechanism as in Europe so we will be doing everything ourselves from day one.

So it means that we will have to set up the commercial model in Europe from day one as an Innate Pharma model and to tell you the truth we are still working on which model because unlike the US in Europe we have a various mechanism for imbursements and access and when we need somehow to adapt and adopt the model to that reality.

So we will be working on that basis on the market research data that we have but let me tell you it's not going to be one affiliate per country that's not the model and it's going to be commercially..

And then regarding 4102 besides the Sézary Syndrome and the PTCL which you are looking at right now what are the potential indications to think about and also at what point would you be able to talk about any data that you probably have at this point?.

Since this is a more clinical development question I'm going to hand over to Pierre to update you on the clinical development plan and the next readout for the data. .

Yes, so as I had mentioned to the factor of IPH4102 is really expressed quite uniquely at least to the extent we know by T-cell lymphomas and this is directing us towards exactly which is sort of first entry point.

It is also the tumor type with relatively low incident but then the next step and that is what we are exploring within TELLOMAK is to go to tumor cell with a much bigger frequency, continue T-cell lymphoma and pay for T-cell lymphoma.

Finally we didn’t discuss today another potential indication which is called Adult T-Cell Lymphoma Leukemia or ATLL which is more patterned and seen in certain specific countries in particular in Japan but is also characterized by high frequency of expression of KIR3DL2. So there is another opportunity.

I will also point out here that as it’s probably done in oncology we start with patients sub-score which are factor into prior treatment, nothing would prevent us to progressively move up the ladder with latest higher treatment. So the half of number of indications and expansion of indication that could be pursued with 4102.

And maybe RK I take your question as an opportunity to maybe remind ourselves that IPH4102 is not a drug for [indiscernible] diseases actually the selection of Sézary Syndrome is clearly a way to get to the market with maybe less complex and sophisticated development strategy but it’s not the end of the story, it’s the beginning of the story and I think it’s important to remind ourselves that even though we don’t have data in total t-cell lymphoma I think the power of the signal served into the syndrome is not sufficient but it’s very encouraging because it’s a proof of concept if you may showing that when you have the target and you use the antibody, you kill the set and you kill them dramatically and if the same target is expressed on other T-cell, in particular partial T-cell lymphoma we should observe the same sort of activity.

Of course the development path will be different and the initial feedback we’ve got from the HIMSS community and the HIMSS advisory board that helped us design the TELLOMAK study is rather encouraging.

That’s clearly IPH 4102 you guys have to start seeing it as much larger potential than just Sézary Syndrome, it’s something that can be active in partial T-cell lymphoma and just to give you the sense of the scale we are talking about. Sézary Syndrome we are talking about handful few hundred new patients per year.

The result T-cell lymphoma we’re talking about 16000 new patients per year just for Europe and Japan.

So will give you really an idea on the scale of what this molecule can deliver and of course we’re excited with the preliminary data from Sézary but we’re looking forward to generate data in partial T-cell lymphoma in order to really get the evidence that this is a drug that can be developed at a large scale.

Thank you for the opportunity to clarify this, back to you..

We have no further questions at the moment. [Operator Instructions]. We have another question from Graig Suvannavejh from Goldman Sachs..

Thank you for the follow-up opportunity.

I just want to go back to the C5aR compound and I know that the strategy is to show efficacy and safety in a combination setting, how important would be to also show efficacy and safety in a monotherapy setting? So I'm just trying to think from a regulatory perspective if that is something that is required?.

Thank you for the question. I think let me start with the question because this is very straight forward, we didn't go into all the details of the part, but to go inside does include single phase or actually patients are receiving single agent C5aR for short period of time.

So we think that we will get adequate description of the safety of this compound. And then keep also reminded that this has been explored by Novo Nordisk at the time, basic different indications that we nevertheless felt off safety data on C5aR.

In terms of your question about efficacy, yes the common of course is to think about A, show its efficacy; B, shows efficacy and then build combination but the full [indiscernible] in these patients particular has shown there is perfectly possible when there is a strong scientific rationale to build order of reports in particular combined with drug that could have no particular activity on its arm with another product.

So, and as I explained in my prior answer, we do have pretty strong data about a combination of IPH5401 with PD-1 blocker. So is it easy, physical development is always coming with some challenge that we think we are ready to deal with. And again I think that regulatory agencies have shown willingness towards growth and possibilities …..

Thank you Pierre, and may be Graig let me add two things. First of all you and I talked about this a while ago. It's quite hard as I would say really impossible to imagine, we can have a monotherapy activity with this type of mechanism of action. It's one thing to block MDSC migration.

It's another thing to make sure that the T-cell migrate to the tumor base. So clearly you need the consumption of two mechanism of action in order to have some sort of anti-tumor activity. Number two, I think the development strategy we choose, in particular the non-small cell-lung cancer IO resistant, it's a clever one.

Because this is really what I call it proof of principle study you have a disease that is sensitive to IO that becomes there is a significant point in time and enter PD-1/PD-L1 blocker and then you expose the patient to the same PD-1/PD-L1 blocker and you add C5aR on top of it.

And if you have activity, I think this is the best proof of concept that you're doing something by just blocking the MDSC.

Now, depending on the magnitude of the signal that we will see in this expansion Phase II we will certainly have a dialogue with authority in the US and Europe to figure out actually what would be the next step and what would be the best set into the most like for registration process, the clinical benefits of this molecule.

Did I answer your question? Now I gave you some background and context. .

Very helpful. Thank you very much, Mondher..

End of Q&A:.

We have no further questions at the moment. [Operator Instructions]. So back to you..

Okay, thank you. Okay, so with that, I would like again to extend my thanks to everyone that was involved in the preparation of these meeting from the Innate Pharma.

I would like to thank you all for dialing in and participating into this call, and I look forward to having more interactions in the future face-to-face hopefully or by phone with all of you and even for those who could not make it this morning or this afternoon I will conduct it later on just reach out to the IR team. Thank you and have a good day.

Bye-bye..

Ladies and gentlemen, this concludes the conference call. Thank you all for your participation. You may now disconnect..